Ascendis Pharma A/S
Tuborg Boulevard 12
DK-2900 Hellerup
Central Business Registration No. 29 91 87 91
Annual Report 2025
(January 1 – December 31)
Adopted at the Annual General Meeting of Shareholders on March 23, 2026.
Chairman of the General Meeting
Contents
........................................................................................................................................
Company Information
3
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Statement by Management on the Annual Report
4
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Independent Auditor’s Report
5
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Management Commentary
8
.
Statements of Profit or Loss and Other Comprehensive Income for the Years Ended December 31
41
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Statements of Financial Position as of December 31
42
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Statements of Changes in Equity - Group
43
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Statements of Changes in Equity - Parent
44
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Cash Flow Statements for the Years Ended December 31
45
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Notes to the Financial Statements
46
Company Information
3
Company Information
Central Business Registration No. 29 91 87 91
Registered in: Gentofte
Phone: +45 70 22 22 44
Internet: www.ascendispharma.com
E-mail: info@ascendispharma.com
Board of Directors
Albert Cha, Chairman
Lisa Jane Morrison
William Carl Fairey Jr.
Lars Holtug
Siham Imani
Jan Møller Mikkelsen
Executive Board
Jan Møller Mikkelsen, Chief Executive Officer
Michael Wolff Jensen, Chief Legal Officer
Scott Thomas Smith, Chief Financial Officer
Anni Lotte Kirstine Pedersen, Chief Administration Officer
External Auditors
Statement by Management on the Annual Report 4
Executive Board
Board of Directors
Independent Auditor's Report
5
Independent Auditor's Report
6
Independent Auditor's Report
7
Deloitte
Statsautoriseret Revisionspartnerselskab
Business Registration No 33 96 35 56
Identification No (MNE) 34532
Identification No (MNE) 43596
Management Commentary
8
Management Commentary
Unless the context otherwise requires, references to the “Company,” “Group,” “we,” “us” and “our”
refer to Ascendis Pharma A/S and its subsidiaries.
Information and disclosure specifically addressing the Parent Company Ascendis Pharma A/S are
described separately in the notes. Additionally, references to “Ascendis Pharma A/S” and “Parent
Company” solely refer to the Parent Company Ascendis Pharma A/S.
Consolidated Key Figures
2025
2024
2023
2022
2021
(EUR’000)
Revenue
720,132
363,641
266,718
51,174
7,778
Operating Profit/(Loss)
(136,271)
(278,763)
(455,541)
(561,814)
(451,792)
Finance Income/(Expenses) (net)
(92,688)
(74,418)
(208)
1,694
55,807
Profit/(Loss) for the Year
(228,034)
(378,084)
(481,447)
(583,194)
(383,577)
Cash and Cash Equivalents
616,041
559,543
392,164
444,767
446,267
Total Assets
1,302,570
1,179,495
825,587
1,089,738
1,084,921
Equity
(162,821)
(105,706)
(145,697)
263,348
883,635
Investments in Property Plant & Equipment*
75,576
8,929
6,848
21,680
33,894
Return on Equity (%)**
169.8
(300.8)
(818.4)
(101.7)
(445.0)
Equity Ratio (%)**
(12.5)
(9.0)
(17.6)
24.2
81.4
*including IFRS 16 right of use assets.
**Key ratios are calculated as follows:
Return on Equity: (Profit / (Loss) for the Year x 100) / Average Equity
Equity Ratio: (Equity x 100) / Total Assets
Ascendis Pharma in Brief
We are a global biopharmaceutical company focused on applying our innovative TransCon
technology platform to make a meaningful difference for patients. Guided by our core values of
Patients, Science, and Passion, and following our algorithm for product innovation, we develop
TransCon-based therapies that demonstrate best-in-class potential to address unmet medical needs.
Our Organization
Certain of our operations are conducted through our following wholly-owned subsidiaries:
Management Commentary
9
Wholly-owned subsidiaries
Domicile
Ascendis Pharma GmbH
Germany
Ascendis Pharma Endocrinology GmbH
Germany
Ascendis Pharma, LLC
USA
Ascendis Pharma Endocrinology, Inc.
USA
Ascendis Pharma, Ophthalmology Division A/S
Denmark
Ascendis Pharma Endocrinology Division A/S
Denmark
Ascendis Pharma Bone Diseases A/S
Denmark
Ascendis Pharma Growth Disorders A/S
Denmark
Ascendis Pharma Oncology Division A/S
Denmark
Ascendis Pharma Europe A/S
Denmark
Ascendis Pharma UK Limited
United Kingdom
Ascendis Pharma Iberia S.L.
Spain
Ascendis Pharma France SASU
France
Ascendis Pharma Italia S.R.L.
Italy
Ascendis Pharma Sverige AB
Sweden
Ascendis Pharma Switzerland GmbH
Switzerland
Ascendis Pharma Belgium BV
Belgium
ASND Portugal, Unipessoal, Lda.
Portugal
The Company has increased its number of employees to 1,189 at the end of 2025 compared to 1,017
at the end of 2024. Employees engaged with selling, general, and administration increased, primarily
due to commercial activities, and extension of corporate functions to support those activities.
Our Vision
As announced in January 2024, Vision 2030 is our vision to achieve blockbuster status for multiple
products and expand our engine for future innovation, which include:
• Be the Leading Endocrinology Rare Disease Company
ο Achieve >€5B for TransCon PTH, TransCon hGH, and TransCon CNP through
worldwide commercialization
o Be the leader in growth disorders and hypoparathyroidism, pursuing clinical
conditions, innovative life cycle management, and complementary patient offerings
o Expand pipeline with Endocrinology Rare Disease blockbuster product opportunities
• Create Value in Additional Therapeutic Areas through Innovative Business Models
o Obtain accelerated approval in oncology with registrational trials ongoing
o Pursue TransCon product opportunities in >€5B indications
o Maximize value creation of these product opportunities through collaboration with
therapeutic area market leaders
• Differentiate with Ascendis Fundamentals
o Outperform industry drug development benchmarks with Ascendis’ product
innovation algorithm
o Remain independent as a profitable biopharma through lean and flexible ways of
working
ο Let our values Patients, Science, Passion drive our decisions to success
Our products and product candidates leverage clinically validated parent drugs or pathways, with the
goal of optimizing safety, efficacy, tolerability, and convenience.
Management Commentary
10
We apply our TransCon technologies using our algorithm for product innovation with the goal of
creating product candidates with the potential to be best-in-class. Using this approach, we plan to
expand our pipeline with Endocrinology Rare Disease product opportunities in large addressable
markets. In addition, our vision is to pursue TransCon product opportunities in >€5B indications in
other therapeutic areas and maximize value creation of these product opportunities through
collaboration with therapeutic area market leaders. We believe our approach to product innovation
may reduce the risks associated with traditional drug development.
Ascendis Algorithm for Product Innovation
Ascendis Approach to Patient Centric Drug Design
When we apply our TransCon technologies to clinically validated parent drugs or pathways, we may
benefit from established clinical safety and efficacy data, which we believe increases the probability of
success compared to traditional drug development. As illustrated above, our algorithm for product
innovation focuses on identifying indications that have an unmet medical need, have a clinically
validated parent drug or pathway, are suitable to our TransCon technologies, have potential for
creating a clearly differentiated product, have a potential established development pathway, and have
the potential to address a large market. When the indication is identified we make use of patient
centric drug design to optimally apply our TransCon technologies to address the unmet medical need.
Program Summaries
We currently have two marketed products and a diversified portfolio consisting of four product
candidates in clinical development in the areas of Endocrinology Rare Disease and Oncology. One of
the four product candidates, TransCon CNP (navepegritide), is currently under review in the United
States and European Union for the treatment of children with achondroplasia. Additionally, we are
working to apply our TransCon technology platform in additional therapeutic areas such as metabolic
diseases, where we believe we have designed a potentially best-in-class, once-monthly glucagon-like
peptide 1 (“GLP-1”) product.
Management Commentary
11
• YORVIPATH® (palopegteriparatide), was developed as TransCon PTH and was approved
by the U.S. Food & Drug Administration (“FDA”), and authorized by the European
Commission (“EC”) and other regulatory agencies for the treatment of adults with
hypoparathyroidism. In the European Union (“EU”), YORVIPATH is commercially available
for prescription in Germany, Austria, Spain and Luxembourg and is also available in other
countries through named patient programs. In the United States, YORVIPATH has been
commercially available for prescription since December 2024. In Japan, YORVIPATH has
been commercially available for prescription since November, 2025, through our partner
Teijin Limited (“Teijin”). YORVIPATH has also been authorized by other regulatory
authorities globally. Through December 31, 2025, more than 5,300 unique patients have
been prescribed YORVIPATH by nearly 2,400 prescribing healthcare providers in the U.S.
• SKYTROFA® (lonapegsomatropin-tcgd) was developed as TransCon hGH and approved
by the FDA for the treatment of pediatric patients one year and older who weigh at least
11.5 kg and have growth failure due to inadequate secretion of endogenous growth
hormone, also known as growth hormone deficiency (“GHD”) and for the replacement of
endogenous growth hormone in adults with GHD. SKYTROFA has been commercially
available for prescription in the United States since October 2021. In addition, the EC has
authorized SKYTROFA (lonapegsomatropin) in the EU for the treatment of children and
adolescents (3 – 18 years) with growth failure due to GHD. In the EU, SKYTROFA has
been commercially available for prescription in Germany since September 2023.
SKYTROFA has also been authorized by other regulatory authorities globally including in
China through our strategic collaboration partner, VISEN Pharmaceuticals (“VISEN”) in
January 2026.
• Endocrinology Rare Disease Pipeline – Two product candidates in our Endocrinology Rare
Disease portfolio are currently in development for additional indications and geographies.
These product candidates are TransCon hGH (lonapegsomatropin) for children with Turner
syndrome and TransCon CNP (navepegritide) for infants, children, and adolescents with
achondroplasia. We are also investigating the combination of TransCon CNP and
TransCon hGH in children with achondroplasia and other indications. In addition, we are
investigating TransCon hGH in other established daily growth hormone indications and
TransCon CNP, alone and in combination with TransCon hGH, for the treatment of
children with hypochondroplasia, a related FGFR3-driven skeletal dysplasia. Through our
strategic collaboration, Teijin is developing and, if approved, plans to commercialize
TransCon hGH, and TransCon CNP for endocrinology rare diseases in Japan. In addition,
VISEN is developing and, if approved, plans to commercialize TransCon PTH, and
TransCon CNP for endocrinology rare diseases in the People’s Republic of China, Hong
Kong, Macau, and Taiwan (“Greater China”).
• Oncology Pipeline – In Oncology, we are leveraging our TransCon technologies with the
goal of enhancing the anti-tumor effects of clinically-validated parent drugs and pathways
and to provide sustained modulation of tumor microenvironments and activate cytotoxic
immune cells. We initiated clinical development of two programs: TransCon TLR7/8
Agonist, an investigational, long-acting prodrug of resiquimod, a small molecule agonist of
Toll-like receptors (“TLR”) 7 and 8, for intratumoral delivery, and TransCon IL-2 β/γ
(onvapegleukin alfa) for systemic delivery, which is designed for prolonged exposure to an
IL-2 variant that selectively activates IL-2 β/γ with minimal binding to IL-2Rα. During the
fourth quarter of 2024, we closed enrollment in our BelieveIT-201 clinical trial and to dose
expansion cohorts involving TransCon TLR7/8 Agonist in the transcendIT-101 and IL-
Believe trials to prioritize our efforts on TransCon IL-2 β/γ.
TransCon Product Candidates Pipeline
Other than the rights we have granted to Eyconis Inc. (“Eyconis”), Novo Nordisk A/S (“Novo Nordisk”),
Teijin, and VISEN as noted in this report, we hold worldwide rights to our TransCon technologies and,
other than our royalty financing arrangements with Royalty Pharma as noted in this report, we owe no
third-party royalty or milestone payment obligations with respect to our TransCon technologies,
TransCon hGH, TransCon PTH, TransCon CNP, or any of our other product candidates.
Management Commentary
12
Note: The above chart lists our current clinical interventional trials related to the disclosed indication. Other ongoing clinical or
observational studies not expected to directly support regulatory submissions are not disclosed
1. ApproaCH Trial (NCT05598320). Priority Review granted by U.S. FDA, PDUFA goal date
February 28, 2026.
2. AttaCH Trial (NCT05929807). Includes patients from ACcomplisH and ApproaCH.
3. New InsiGHTS Trial (NCT05690386).
4. HighLiGHts Trial (NCT07221851).
5. PaTHway60 Trial (NCT07081997).
6. PaTHway Adolescent Trial (NCT05203198).
7. reACHin Trial (NCT06079398).
8. teACH Trial (NCT06732895).
9. Hypochondroplasia Monotherapy Trial (NCT pending).
10. COACH Trial (NCT06433557).
11. Trial Protocol filed (NCT pending),
12. Hypochondroplasia Combination Trial (NCT pending).
13. Japanese riGHt Trial.
14. PaTHway China Trial (NCT05387070).
15. ACcomplisH China Trial (NCT05246033).
16. Japanese ApproaCH Trial.
17. IL-Believe Trial (NCT05081609).
We maintain an intellectual property portfolio comprising over 465 granted patents and over 625
patent applications as of December 31, 2025, which includes patents and patent applications
applicable to our products and product candidates with claims directed to composition of matter,
process, formulation and/or methods-of-use for our products and product candidates, including a
product-specific device and core TransCon technologies.
Management Commentary
13
While our TransCon prodrugs may incorporate already approved parent drugs or product candidates,
TransCon hGH, TransCon PTH, TransCon CNP, and each of our other product candidates are new
molecular entities and therefore eligible to be granted new intellectual property rights, including new
composition of matter patents.
Global Commercialization Strategy
We are establishing a global presence to commercialize TransCon products, where approved, to
address patients’ unmet medical needs.
In the U.S., we have established an integrated organization to commercialize our approved
Endocrinology Rare Disease products, YORVIPATH and SKYTROFA. Our U.S. organization includes
various departments, including sales, market access, patient support, and medical affairs teams. The
sales team engages with healthcare providers to present products, usage, and safety guidelines in
accordance with the label. Our market access team engages with health authorities, insurance
companies, and payers to support patients in need of gaining access to our products. Our patient
support team facilitates reimbursement support and out-of-pocket assistance and provides
educational resources and product training. Our medical affairs team engages in scientific exchange
with the physician and medical community. We have also established a network of specialty
pharmacies to support product distribution.
In Europe, we have established our presence by building integrated organizations to commercialize
our approved Endocrinology Rare Disease products in select countries, which we call “Europe Direct.”
Our Europe Direct country clusters include DACH (Germany, Austria, and Switzerland), France &
BeNeLux (Belgium, the Netherlands, and Luxembourg), Iberia (Portugal and Spain), Italy, Nordics
(Denmark, Norway, Sweden, Iceland, and Finland), and the United Kingdom & Ireland.
Beyond the U.S. and Europe Direct, we are expanding global reach for our Endocrinology Rare
Disease products through exclusive sales and distribution agreements with geographic market
leaders, which we call “International Markets.” As of December 31, 2025, we have agreements
covering over 75 countries.
Finally, we are making our Endocrinology Rare Disease products commercially available in China and
Japan under exclusive license agreements with partners with local development and
commercialization expertise and infrastructure, which we call strategic collaborations. In Japan, Teijin
has exclusive license rights to develop and commercialize TransCon hGH, TransCon PTH, and
TransCon CNP. In Greater China, VISEN has exclusive license rights to develop and commercialize
TransCon hGH, TransCon PTH, and TransCon CNP.
Demand for our products has not been subject to material seasonal changes.
On April 2, 2025, an executive order was issued in the United States implementing “Reciprocal
Tariffs” on most U.S. trading partners, with a 10% baseline tariff on imports from most trading partners
and an additional individualized reciprocal tariff on countries with larger trade deficits. After a series of
pauses in implementation, on August 7, 2025, these tariffs went into effect. Some goods will not
initially be subject to the Reciprocal Tariffs, including pharmaceuticals. While there can be no
assurance that pharmaceuticals will remain free from Reciprocal Tariffs or other trade barriers in the
future, we currently believe the impact of the Reciprocal Tariffs on our operations will be immaterial.
As the Reciprocal Tariffs remain subject to ongoing scrutiny, including ongoing review by the
Supreme Court of the United States, we continue to monitor and assess the possible impacts of
existing and potential tariffs on our operations.
TransCon Technologies
Overview
Our TransCon technologies are designed to combine the benefits of conventional prodrug and
sustained release technologies to solve the fundamental limitations seen in other approaches to
extending duration of a drug’s action in the body, with the goal of developing highly differentiated
product candidates based on efficacy, safety, tolerability, and convenience.
Management Commentary
14
In addition to retaining the original mode of action of the parent drug and potentially supporting dosing
frequency from daily up to six months or more, we believe that predictable release over time can
improve treatment safety and efficacy, increase the likelihood of clinical development success, and
provide intellectual property benefits.
TransCon prodrugs can have up to three components: a parent drug, an inert TransCon carrier that
protects it, and a TransCon linker that temporarily binds the two. When bound in prodrug form, the
carrier inactivates the parent drug and shields it from receptor uptake, renal clearance, and enzymatic
degradation. When injected into the body, physiologic pH and temperature conditions initiate
sustained release of the active, unmodified parent drug at a predictable rate.
Depending upon the type of TransCon carrier we employ, we can design our TransCon prodrugs for
sustained localized or systemic delivery.
TransCon Technology Components
TransCon Carriers
Our TransCon technologies incorporate three carrier platforms that can be used to provide sustained
localized or systemic drug exposure. These biocompatible carrier platforms include our TransCon
systemic carriers and TransCon localized carriers (self-eliminating hydrogels). Our carriers inactivate
and protect the drug through a shielding effect, which may prevent rapid excretion and degradation of
the parent drug and enable benefits that include improved injection site tolerability, reduced systemic
adverse effects, and low immunogenicity.
• Systemic – Our TransCon systemic carriers are used to provide systemic drug exposure
and are based on soluble compounds such as methoxypolyethylene glycol (“mPEG”) or
other natural or synthetic polymers, as well as our albumin avidity approach, where 2 or
more albumin binding moieties are incorporated into the drug molecule to facilitate
sustained exposure. Prodrugs created using our systemic carriers are readily absorbed
into the bloodstream after administration, thus minimizing exposure of the subcutaneous
tissue to active drug, which we believe may improve injection site tolerability. TransCon
hGH, TransCon PTH, and TransCon CNP utilize mPEG as a carrier molecule. mPEG is
widely used to improve the pharmacokinetic or pharmacodynamic properties of marketed
therapeutics. Below is an illustration of our systemic carrier:
Management Commentary
15
• Localized – Our TransCon localized carriers include TransCon hydrogels based on PEG,
hyaluronic acid, or other biopolymers. TransCon hydrogel is designed to self-eliminate to
soluble, biocompatible molecules after the drug payload has been released. When applied
for localized delivery, the TransCon hydrogel enables the release of a parent drug at high
local concentrations within the target area while minimizing systemic exposure. We believe
this may widen the therapeutic window for parent drugs that suffer from significant
systemic side effects and toxicities, facilitating the development of highly efficacious
product candidates with improved safety and tolerability profiles. Below is an illustration of
our hydrogel carrier:
TransCon Linkers
Our reversible TransCon linkers are designed to enable the transient conjugation of a broad range of
therapeutics, including proteins, peptides, and small molecules, to our TransCon carriers. We have a
large library of TransCon linkers that may be applicable to various types of parent drugs, and that can
be tailored to potentially achieve half-life extension enabling daily, weekly, monthly, and half-yearly
dosing and to customize the potential pharmacokinetic profile for each individual product candidate
with the goal of optimizing the potential therapeutic effect. TransCon linkers are self-cleaving through
a process called intra-molecular assisted cleavage, which causes the linker to release the unmodified
parent drug. We can tailor the release properties of the linker to a given therapeutic indication and
parent drug by modifying the linker structures. We believe the self-cleaving process of our linker
avoids many of the shortcomings of conventional prodrug technologies, which often depend on
metabolic processes, such as enzymatic degradation, to convert the prodrug into the active drug. The
rate of metabolic conversion of prodrugs in these types of processes may differ between patients, and
even within different tissues in the same patient. As a result, conventional prodrugs do not always
offer predictable release of the parent drug. Our TransCon linkers are designed to predictably release
an unmodified active parent drug at predetermined rates governed by physiological pH and
temperature conditions, which are tightly regulated in the body. Consequently, we believe we can
design our prodrugs to release the unmodified parent drug at predictable rates.
Management Commentary
16
Parent Drugs
Our TransCon technologies are applicable across a broad range of therapeutic classes and are
currently used to create long-acting product candidates with best-in-class potential based on proteins,
peptides, and small molecules. By primarily focusing on biological targets that have been clinically
validated, we can leverage available knowledge regarding a target’s activity. Based on this selective
approach, we know what drug levels must be maintained in the body for optimal efficacy and safety,
and we can design the release half-life and dosing frequency of our TransCon prodrugs to maintain
these levels to achieve the desired pharmacological effect. We move a product candidate into
development after it demonstrates the desired profile in non-clinical models. Furthermore, based on
the established translational relationships between preclinical animal models and clinical efficacy, we
believe experimental results generated in animal models are highly predictive of clinical results and
reduce the development risk for our TransCon prodrugs. This strategy is designed to reduce risk and
increase productivity.
This approach has enabled us to develop two approved products and generate a pipeline of product
candidates designed to address significant unmet medical needs. Because our TransCon
technologies leverage clinically validated parent drugs or pathways, we believe we may benefit from a
higher development and regulatory success rate compared to development of drug compounds
without established biology.
TransCon Products and Product Candidates - Endocrinology Rare Disease
Hypoparathyroidism
Overview of Hypoparathyroidism
Hypoparathyroidism is a rare endocrine disease caused by insufficient levels of parathyroid hormone
(“PTH”). As reported in a 2016 paper by Clarke BL, et al. (J Clin Endocrinol Metab. 2016
Jun;101(6):2284-99), most patients with hypoparathyroidism (70-80% of cases) develop the disease
following damage to or accidental removal of the parathyroid glands during thyroid surgery. Other
etiologies include autoimmune disorders, genetic disorders such as autosomal dominant
hypocalcemia type 1, and idiopathic causes. Conventional therapy with oral calcium and active
vitamin D (also called calcitriol) does not effectively address the short-term symptoms, long-term
complications, or quality-of-life impacts of hypoparathyroidism.
Individuals with hypoparathyroidism may experience a range of severe and potentially life-threatening
short-term and long-term complications. Short-term symptoms of hypoparathyroidism include
weakness; severe muscle cramps (tetany); abnormal sensations such as tingling, burning, and
numbness (paresthesia); memory loss; impaired judgment; and headache. A survey published by
Hadker et al. (Endocrine Pr. 20(7), 671–679), in 2014 of 374 individuals with hypoparathyroidism
showed that 72% experienced more than ten symptoms in the preceding twelve months, with
symptoms experienced for a mean of 13 ± 9 hours a day. Prolonged use of conventional therapy may
increase the risk of major complications, such as calcium deposits in the brain, blood vessels, eyes,
and soft tissues. According to a systematic review by Gosmanova et al. published in 2021, chronic
hypoparathyroidism treated with conventional therapy is associated with higher rates of renal
complications compared to the general population, including nephrolithiasis (up to 36%),
nephrocalcinosis (up to 38%), and chronic kidney disease (up to 41%). Studies have found that the
burden of hypoparathyroidism negatively impacts health-related quality of life (“QoL”), physical
functioning, and psychological well-being. Compared with an age-matched general population
sample, individuals with hypoparathyroidism have reported markedly lower health-related QoL,
irrespective of serum calcium level, as measured by the physical (P<0.001) and mental (P<0.001)
component scores of the 36-Item Short Form Health Survey (SF-36) as well as the EuroQol-5
Dimensions Visual Analogue Scale. As reported in a 2021 paper by Brod et al. (Qual of Life Res.
2021 Jan; 30(1):277-291), in interviews conducted on 42 individuals with hypoparathyroidism, 98%
reported reduced functioning and well-being, including anxiety (81%), feeling sad or depressed (62%),
and feeling irritable or short-tempered (43%) despite management with conventional therapy.
Hypoparathyroidism also imposes a substantial burden on the healthcare system despite the use of
conventional therapy.
Management Commentary
17
For example, individuals with hypoparathyroidism may require hospitalizations or emergency
department visits due to acute severe hypocalcemia (calcium crashes) and those with post-surgical
hypoparathyroidism have an increased risk of hospitalization due to infection than age- and sex-
matched controls from the general population. Individuals with hypoparathyroidism also have an
increased risk of hospitalization due to renal complications, such as chronic kidney disease and renal
failure, compared to age- and sex-matched controls. According to a retrospective review (Chen K, et
al. J Med Econ. Nov 2019;22(11):1141-1152) published in 2019 of clinical burden and healthcare
resource utilization showed that 90.7% of individuals had ≥1 hypoparathyroidism-related healthcare
utilization event during a 12-month period, including 87.8% with ≥1 outpatient visit, 41% with ≥1
emergency department visit, and 19.5% with ≥1 hospitalization. The management of
hypoparathyroidism is also associated with substantial economic burdens and consequences of
hypoparathyroidism may negatively impact employment status and work productivity.
The 2022 Guidelines from the Second International Workshop addressing the prevention, diagnosis,
and management of hypoparathyroidism was published in September 2022 in the Journal of Bone
and Mineral Research and authored by leading clinicians from North America, Europe, and Asia. The
authors suggest consideration of PTH replacement therapy in patients whose hypoparathyroidism is
inadequately controlled with conventional therapy. Inadequate control is considered to be any one of
the following: symptomatic hypocalcemia, hyperphosphatemia, renal insufficiency, hypercalciuria, or
poor quality of life. In addition, the guideline indicates that individuals with poor compliance,
malabsorption, or intolerant of large doses of calcium and active vitamin D may also benefit from PTH
replacement therapy. Based on this current guideline, we believe PTH replacement therapy could be
applicable to most patients with hypoparathyroidism.
In 2015, Takeda’s NATPARA
®
(parathyroid hormone) was approved in the U.S. for once-daily
subcutaneous injection as an adjunct to vitamin D and calcium in patients with hypoparathyroidism.
NATPARA was voluntarily recalled in September 2019 in the U.S. and is now only available to a
limited number of patients through a Special Use Program offered by its manufacturer, Takeda. In
October 2022, Takeda announced that it would discontinue manufacturing NATPARA/NATPAR
globally by the end of 2024. In December 2025, Takeda announced that the NATPARA Special Use
Program would permanently close on December 31, 2025, after which no patients would have access
to NATPARA in the United States.
Other companies and groups are developing therapies for hypoparathyroidism at the clinical stage,
including Calcilytix (a BridgeBio company), Entera Bio/Opko Health, Extend Biosciences,
AstraZeneca, MBX Biosciences, and Septerna.
Forteo® (teriparatide, PTH [1-34]), approved since 2002 for the treatment of osteoporosis, has
sometimes been used for treatment of hypoparathyroidism using multiple daily injections, despite not
being approved for this indication. Clinical research conducted by the U.S. National Institutes of
Health in subjects receiving continuous exposure to PTH (1-34), administered by an infusion pump,
demonstrated simultaneous normalization of serum calcium and urinary calcium, as well as
normalization of bone turnover.
We estimate hypoparathyroidism affects more than 250,000 patients in the U.S. and Europe. In the
U.S., we estimate hypoparathyroidism affects approximately 70,000 to 90,000 patients, including
4,000 to 5,000 patients who we estimate have previously been treated with PTH therapy. In Germany,
we estimate hypoparathyroidism affects approximately 70,000 patients. Outside of Germany, we
estimate hypoparathyroidism affects more than 100,000 patients in the rest of Europe.
Management Commentary
18
TransCon PTH
TransCon PTH (palopegteriparatide) is a prodrug of PTH (1-34) that is administered once-daily to
achieve and maintain a steady concentration of PTH in the bloodstream within the physiological range
TransCon PTH is designed to provide PTH in the physiological range for 24 hours per day, thereby
more fully addressing aspects of the disease, including maintaining normal serum calcium and
phosphate levels and normalizing urinary calcium.
TransCon PTH for the Treatment of Hypoparathyroidism
In November 2025, Teijin announced that YORVIPATH is commercially available for prescription.
In August 2024, the FDA approved YORVIPATH (palopegteriparatide; developed as TransCon PTH)
for the treatment of hypoparathyroidism in adults. In September 2024, the FDA granted Orphan Drug
exclusivity to YORVIPATH, providing seven years of market exclusivity for YORVIPATH in the United
States for the treatment of hypoparathyroidism in adults. YORVIPATH has been commercially
available for prescription since late December 2024 in the United States.
In April 2024, TransCon PTH received regulatory approval in Great Britain as a PTH replacement
therapy indicated for the treatment of adults with chronic hypoparathyroidism. In addition, in April
2024, we announced that the United Kingdom’s Medicines & Healthcare products Regulatory Agency
granted YORVIPATH Orphan Drug status.
In January 2024, we announced commercial availability of YORVIPATH in Germany and Austria, and
we began shipping to customers in February 2024.
In November 2023, TransCon PTH received regulatory approval in the EU and European Economic
Area and is marketed as YORVIPATH (palopegteriparatide), a parathyroid hormone replacement
therapy indicated for the treatment of adults with chronic hypoparathyroidism. In addition,
YORVIPATH was granted Orphan status in the EU in November 2023 and provides ten years of
market exclusivity.
In July 2021, the Ministry of Health, Labour and Welfare in Japan granted Orphan Drug Designation
(“ODD”) to TransCon PTH for the treatment of hypoparathyroidism.
Clinical Development of TransCon PTH for Treatment of Hypoparathyroidism in Adults
TransCon PTH was evaluated for the treatment of hypoparathyroidism in adults in the Phase 3
PaTHway Trial, Phase 3 PaTHway Japan Trial (open label extension ongoing), and the Phase 2
PaTH Forward Trial.
The PaTHway Trial completed with 73 of 82 patients originally enrolled and dosed completing the 3.5-
year trial. Nine patients withdrew from the trial for reasons unrelated to safety.
The PaTH Forward Trial recently completed with 56 patients out of 59 patients originally enrolled and
dosed completing the five-year trial. Three patients withdrew from the trial for reasons unrelated to
safety or efficacy of the study drug.
In November 2025, we presented a new pooled analysis showing sustained and clinically meaningful
improvements in renal function in adults with hypoparathyroidism treated with TransCon PTH
(palopegteriparatide) through Year 3 of our Phase 2 PaTH Forward and Phase 3 PaTHway trials.
Management Commentary
19
The trials included a combined 141 adults with hypoparathyroidism, 139 of whom (mean age 49
years) are represented in the pooled analysis. The PaTH Forward and PaTHway trials comprised
randomized, double-blind, placebo-controlled periods through Weeks 4 and 26 and open-label
extension periods through Weeks 266 and 182, respectively. An eGFR ≥30 mL/min/1.73 m
2
was
required for trial eligibility. The three-year data were analyzed post-hoc and included evaluation of the
long-term impact of TransCon PTH on renal function as assessed by eGFR. Mean (SD) baseline
eGFR in the trials was 69 (17) mL/min/1.73 m
2
. The pooled analysis included 41 patients with
baseline eGFR <60 mL/min/1.73 m
2
and 98 patients with baseline >60 mL/min/1.73 m
2
. Safety
assessments included 24-hour urine calcium excretion and treatment-emergent adverse events
(TEAEs).
At Year 3, ≥91% of patients receiving palopegteriparatide in both trials were independent from
conventional therapy (defined as taking no active vitamin D and ≤600 mg/day of calcium) and ≥84%
patients had normocalcemia (8.3-10.6 mg/dL). Sustained and clinically meaningful improvements in
eGFR (≥5 mL/ min / 1.73 m
2
) were observed in 70.3%, with numerically greater improvements
observed in those with lower baseline eGFR. The greatest increases in eGFR were observed in the
first 6 months of treatment with TransCon PTH, with a continued upward trend thereafter. Mean (SD)
eGFR increased from baseline to Year 3 by 9.8 (10.9) mL/min/1.73 m
2
in PaTH Forward and by 8.8
(11.9) mL/min/1.73 m
2
in PaTHway.
In July 2025, we announced new data from Week 156 of our Phase 3 PaTHway Trial, confirming that
long-term treatment with TransCon PTH (palopegteriparatide) continued to provide a durable
response in adults with hypoparathyroidism regardless of its cause (post-surgical, autoimmune,
genetic, or idiopathic), including improvements in biochemistries, kidney function, and quality of life. At
Week 156, 64 patients (88%) had normal albumin-adjusted serum calcium levels and 70 patients
(96%) were independent from conventional therapy (defined as taking < 600 mg/day of calcium and
not taking active vitamin D). Reflecting clinically meaningful improvements in kidney function,
improvements in eGFR from baseline were sustained through Week 156: mean eGFR increased by
8.76 mL/min/1.73 m
2
across all participants and by 13.98 mL/min/1.73 m
2
in participants with baseline
eGFR < 60. Patients in the trial reported continued improvements from baseline in their
hypoparathyroidism-related symptoms and health-related QOL and showed continued normalization
of 24-hour urine calcium excretion through Week 156. In the trial, TransCon PTH treatment was
generally well-tolerated, with no new safety signals identified. TEAEs were mostly mild or moderate
and no serious TEAEs or discontinuations were related to study drug.
Management Commentary
20
In May 2025, we announced four-year (Week 214) results from our Phase 2 PaTH Forward Trial
showing that long-term treatment with TransCon PTH (palopegteriparatide) continued to provide a
durable response in adults with hypoparathyroidism. At Week 214, nearly all patients (98%) continued
to have normal albumin-adjusted serum calcium levels and 93% remained independent from
conventional therapy (defined as taking < 600 mg/day of calcium and not taking active vitamin D).
Bone turnover markers CTx and P1NP increased from the low end of normal at baseline, peaked by
Week 26, then declined and remained stable above baseline levels through Week 214. The data also
showed continued improvement in skeletal dynamics, with bone mineral density remaining within age-
and sex-matched norms. In addition, at Week 214, most participants (67.8%) had a clinically
meaningful (≥ 5 mL/min/1.73 m
2
) increase in eGFR from baseline, with changes in eGFR evident at
Week 4. In the trial, TransCon PTH treatment was generally well-tolerated, with no new safety signals
identified. TEAEs were mostly mild or moderate and no serious TEAEs or discontinuations were
related to study drug.
In September 2024, we announced results from the Phase 2 PaTH Forward Trial of adults with
hypoparathyroidism showing that long-term treatment with TransCon PTH (palopegteriparatide;
marketed as YORVIPATH) through Week 162 drove bone remodeling into the normal range.
Deficiency of PTH is associated with low rates of bone remodeling, accumulation of overly mature
bone, and higher-than-average bone mineral density that may correspond with poorer overall bone
quality compared to that seen in the general population. In contrast, these results suggest that long-
term palopegteriparatide treatment promotes attainment of skeletal health parameters in line with
those expected with states of parathyroid sufficiency.
In May 2024, we announced two-year (Week 104) results from a post-hoc analysis of the Phase 3
PaTHway Trial demonstrating sustained improvements (nominal p-value <0.05) in renal function in
adults with chronic hypoparathyroidism treated with TransCon PTH. The post-hoc analysis examined
the impact of treatment with TransCon PTH on renal function using estimated glomerular filtration rate
(“eGFR”) through Week 104 (n=76) of PaTHway, a Phase 3, double-blind, placebo-controlled trial of
82 dosed adults with chronic hypoparathyroidism randomized 3:1 (TransCon PTH: placebo; both arms
initially co-administered with conventional therapy of active vitamin D and calcium), with a 26-week
blinded period followed by an ongoing 156-week open-label extension period. Across both treatment
arms, TransCon PTH treatment resulted in a mean eGFR increase of 8.9 mL/min/1.73m
2
(p<0.0001)
from baseline at Week 52, sustained at Week 104 with a mean change from baseline of 9.0
mL/min/1.73m
2
(p<0.0001). Treatment was generally well-tolerated, with no new safety signals.
On January 8, 2023, we announced top-line data from PaTHway Japan, a single-arm Phase 3 trial to
evaluate the safety, tolerability, and efficacy of TransCon PTH in adults with hypoparathyroidism. The
study achieved its primary objective, with top-line results consistent with our trials in North America
and the EU.Twelve out of thirteen patients met the primary multi-component endpoint, which was
defined as serum calcium levels in the normal range (8.3–10.6 mg/dL) and independence from
conventional therapy (no active vitamin D and ≤600 mg/day of calcium). In this trial, TransCon PTH
was generally well-tolerated, with no discontinuations related to study drug. The open-label extension
(“OLE”) of this trial has been extended, and all patients have transitioned into the Investigational
Medical Product supply period designed to ensure continuous treatment through the launch of
YORVIPATH in Japan. In November 2025, Teijin announced that YORVIPATH is commercially
available for prescription.
In March 2022, we announced that top-line data from the randomized, double-blind, placebo-
controlled portion of the Phase 3 PaTHway Trial of TransCon PTH in adults with hypoparathyroidism
demonstrated statistically significant higher proportion of participants treated with TransCon PTH
achieved the primary multi-component endpoint compared to placebo. The primary endpoint, defined
as serum calcium levels in the normal range (8.3–10.6 mg/dL) and independence from conventional
therapy (no active vitamin D and ≤600 mg/day of calcium) with no increase in prescribed study drug
within the 4 weeks prior to the Week 26 visit, was achieved by 78.7% of TransCon PTH-treated
patients (48 of 61), compared to 4.8% for patients (1 of 21) in control group (p-value <0.0001). In
addition, all key pre-specified secondary endpoints were met with statistical significance. TransCon
PTH was generally well tolerated, with no discontinuations related to study drug. Three patients
discontinued during the treatment period, two from the placebo arm and one from the TransCon PTH
arm. TransCon PTH-treated patients showed a mean decrease in 24-hour urine calcium excretion into
the normal range.
Management Commentary
21
Growth Disorders
Market Opportunity for Recombinant Human Growth Hormone
GHD is a serious rare disease that affects both children and adults. Children with GHD are
characterized by short stature, metabolic and cardiovascular abnormalities, cognitive deficiencies, and
poor quality of life. GHD in adults is associated with increased adiposity, or fat mass, as well as
psychiatric-cognitive, cardiovascular, muscular, metabolic and skeletal abnormalities. In childhood
and adolescence, growth hormone plays an essential role in normal longitudinal growth, muscle and
bone strength, and distribution of body fat. In adults, growth hormone contributes to body composition,
cardiovascular function, and bone health. The current standard of care for GHD has been daily
subcutaneous injections of somatropin, a recombinant human growth hormone (“hGH”). These daily
hGH therapies have been shown to be safe and well-tolerated.
In both therapy-compliant children and adults with GHD, daily subcutaneous injections of hGH have
resulted in improved body composition parameters, bone density, cardiovascular outcomes, and
quality of life. Growth hormone-deficient children who are fully adherent to their daily hGH treatment
regimen may achieve a height in adulthood that is comparable to that of their family members and
national norms.
Despite the demonstrated benefits of daily hGH therapy, many GHD patients are not adequately
treated, and adherence continues to be a challenge, as reported in a 2021 paper published by
Kaplowitz et al. J Manag Care Spec Pharm. 2021; 27(8):1118-1128). The observational retrospective
cohort analysis utilized administrative claims data from two databases on more than 20,000 pediatric
patients diagnosed with GHD. Approximately 68% of commercial patients and approximately 63% of
Medicaid patients received daily growth hormone treatment, whereas approximately 32% of
commercial patients and approximately 37% of Medicaid patients were untreated. In addition, mean
adherence as measured by proportions of days covered, which is defined as the number of days
covered by any daily growth hormone prescription during the follow-up period, was approximately
60% in the commercial cohort and approximately 50% in the Medicaid cohort. Only 32% of
commercial and 18% of Medicaid patients reported adherence rates greater than 80%.
For adult patients with GHD, underdiagnosis and undertreatment are also a concern. Untreated adult
GHD patients can experience reduced quality of life and increased risk of morbidity and mortality. In a
retrospective observational study by Hoffman et al. (Advances in Therapy, 2025; 42(6):2853–2873)
which analyzed electronic health records in the U.S. to identify patients with a high likelihood of adult
GHD, 54,310 patients were identified as at risk for adult GHD, of which, only 3.1% were treated with
growth hormone.
Since the introduction of hGH in 1981, a number of the world’s largest pharmaceutical companies
have developed and marketed daily-administered hGH products. All currently marketed daily hGH
products in the United States – Norditropin
®
(Novo Nordisk A/S), Humatrope
®
(Eli Lilly and Company),
Genotropin
®
(Pfizer Inc.), Zomacton
®
(Ferring Pharmaceuticals, Inc.) and Omnitrope
®
(Sandoz GmbH)
– contain unmodified somatropin and are administered by subcutaneous injections. The global market
for daily hGH products is largely composed of products from Novo Nordisk, Pfizer, Eli Lilly, Sandoz,
and Merck KGaA, which together account for most of the global market share. However, according to
the FDA drug shortage website, Humatrope has been discontinued due to a business decision which
might impact the hGH global market share in the future.
Primary indications for hGH in children are GHD, idiopathic short stature, chronic kidney disease,
Prader-Willi syndrome, small for gestational age, and Turner syndrome. In adults, primary indications
for hGH include GHD and AIDS-induced weight loss. We estimate pediatric indications comprise up to
90% of the total hGH market, of which approximately half is for pediatric GHD.
Since the 1990s, the pharmaceutical industry has employed various approaches to develop long-
acting growth hormone products to reduce the burden of daily injections on patients and increase
patient compliance with the dosing regimen. These approaches generally fall into two categories:
unmodified somatropin and permanent modification of growth hormone:
Management Commentary
22
• Unmodified somatropin: Two long-acting growth hormone products using encapsulation
technologies previously received regulatory approval in the U.S. and Europe, but were
subsequently discontinued due to commercial challenges. These include Nutropin Depot
®
,
formerly marketed by Genentech, and Somatropin Biopartners, developed by LG Life
Sciences and Biopartners GmbH. Nutropin Depot was approved by the FDA in 1999 and
later withdrawn; Somatropin Biopartners (LB03002) was authorized by the EC in 2013, and
later withdrawn. We believe that the lack of market acceptance was a result of the various
safety and tolerability issues that tend to arise with encapsulation technologies.
• Permanent modification of growth hormone: Modification technologies prolong activity in
the body by creating analogs of growth hormone through permanent modification of the
growth hormone molecule. This modification may alter the molecular size and interaction
with the growth hormone receptor and/or change the natural association affinity to
endogenous proteins, as well as the distribution in the body. These changes may alter and
reduce the efficacy of these drugs compared to unmodified daily somatropin and may also
negatively impact the drug’s safety.
Novo Nordisk received regulatory approval in various countries and regions including the U.S., Japan,
and EU for once-weekly somapacitan (SOGROYA
®
) in adult and pediatric patients with GHD.
Pfizer (in collaboration with OPKO Health Inc.) received regulatory approval of once-weekly
somatrogon (NGENLA™) in various countries and regions including the U.S., Japan, and EU for
pediatric GHD.
A permanently PEGylated long-acting growth hormone developed by GeneScience Pharmaceuticals
Co., Ltd. (Jintrolong
®
) is available in China for pediatric GHD, Turner syndrome and idiopathic short
stature and the Somatropin Biopartners product (LB03002) is available in Korea. Other experimental
growth hormone therapies based on permanent modification are in different stages of clinical
development by various companies, including Genexine Inc., I-MAB, Amoytop, UnionGene, Anhui
Anke Biotechnology, Alteogen, JCR Pharmaceuticals Co., Ltd., Kexing Biopharm, Qianhon
Biopharma (Zonhon) and Evive Biotech (Yifan).
TransCon Growth Hormone (hGH)
TransCon hGH (lonapegsomatropin) is a prodrug composed of somatropin that is transiently bound to
a TransCon carrier by a proprietary TransCon linker. TransCon hGH is administered once weekly and
is designed to maintain the same mode of action as daily therapies by providing sustained release of
active, unmodified somatropin, the same recombinant growth hormone molecule used in the daily
hGH therapies that have historically been the standard of care.
TransCon Growth Hormone (hGH) for Pediatric and Adult GHD
TransCon hGH, marketed under the brand name SKYTROFA (lonapegsomatropin-tcgd), received
regulatory approval in the U.S. for the treatment of pediatric patients one year and older who weigh at
least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone,
also known as GHD. SKYTROFA has been commercially available for prescription in the United
States since October 2021. In the EU, Norway, Iceland, Liechtenstein, and Great Britain (covering
England, Wales, Scotland), we received marketing authorization for TransCon hGH – known by its
brand name SKYTROFA (lonapegsomatropin) – as a once-weekly subcutaneous injection for the
treatment of children and adolescents aged 3 to 18 years with growth failure due to insufficient
secretion of endogenous growth hormone. SKYTROFA has been commercially available for
prescription in Germany since September 2023.
In July 2025, we announced that the FDA had approved SKYTROFA (lonapegsomatropin-tcgd;
developed as TransCon hGH) for the replacement of endogenous growth hormone in adults with
growth hormone deficiency (GHD), a rare disorder resulting from decreased or total loss of growth
hormone production. Further, on October 22, 2025, we announced commercial availability of
SKYTROFA (TransCon hGH) in broader dosing ranges in the United States for the replacement of
endogenous growth hormone in adults with growth hormone deficiency.
Management Commentary
23
Clinical Trial of TransCon hGH in Japanese Pediatric GHD
In the ongoing Phase 3 riGHt Trial, we are evaluating TransCon hGH (N=15) compared to somatropin
(N=16) as a treatment in Japanese children with GHD. The trial achieved its primary objective with
Week 52 top-line results consistent with our pivotal heiGHt Trial and VISEN’s Phase 3 trial. In the
riGHt Trial, TransCon hGH was generally well tolerated with a safety profile that was similar to that of
somatropin’s. Trial subjects continue in the extension period.
Proprietary Auto-Injector
SKYTROFA includes the SKYTROFA Auto-Injector and cartridges. The auto-injector provides for
room temperature storage, includes an empty-all design, and is expected to last for at least four
years. The device enables a single, low-volume injection of less than 0.6 mL for the majority of
patients with a thin, 31-gauge needle that is only 4 millimeters in length, which is comparable to
needles used to administer daily hGH. We are also working on strategies that will enable the auto-
injector to integrate with the digital healthcare system, including Bluetooth connectivity features to
allow for easy tracking of dosing adherence over time.
Figure: Our state-of-the-art auto-injector is designed to address important patient needs.
TransCon Growth Hormone (hGH) for Other Indications
In December 2024, we announced positive top-line results from the Phase 2 New InsiGHTS Trial.
New InsiGHTS randomized and dosed 49 children with Turner syndrome aged 1 to 10 years old into
one of four treatment groups 1:1:1:1 – one of three starting doses of TransCon hGH (0.24, 0.30, or
0.36 mg/kg/week) or an active comparator of daily somatropin with a starting dose of 0.35
mg/kg/week. Doses were individualized based on IGF-1. On the primary endpoint of annualized
height velocity (“AHV”) and secondary endpoint of change from baseline in height SDS, children
treated with TransCon hGH demonstrated improved growth similar to daily somatropin at Week 26,
independent of starting dose. As of December 31, 2025, 45 out of the 49 children are ongoing in the
trial. TransCon hGH was generally safe and well tolerated, and with comparable safety and tolerability
to daily somatropin, with four discontinuations from the trial for reasons unrelated to safety or efficacy
of the study drug.
Management Commentary
24
During the third quarter of 2025, we submitted the protocol for a basket trial evaluating additional
growth disorder indications (planned for small for gestational age without catch-up growth; idiopathic
short stature; SHOX deficiency (including Turner syndrome)). In addition, we are investigating
potential combinations of TransCon hGH and TransCon CNP. For more information see the section
entitled “Combination Therapy (TransCon CNP + TransCon hGH).”
Achondroplasia
Overview of Achondroplasia
Achondroplasia is a rare genetic condition arising from a systemic fibroblast growth factor receptor 3
(“FGFR3”) variant, which causes serious muscular, neurological, and cardiorespiratory complications
in addition to the well-characterized skeletal dysplasia that leads to disproportionate short stature.
Achondroplasia is associated with a well-delineated range of clinical complications and
manifestations, occurring in about one in 10,000 to 30,000 newborns or more than 250,000
worldwide. Achondroplasia results in severe skeletal complications and comorbidities including spinal
stenosis due to premature fusion of the foramen magnum, sleep apnea, chronic ear infections, and
muscular complications. Patients often face multiple surgeries to alleviate its many complications.
There is significant unmet need for treatments that ameliorate complications and improve quality of
life in achondroplasia.
Achondroplasia is caused by gain-of-function variants of the FGFR3 gene resulting in constitutive
activation of FGFR3 that leads to an imbalance between the effects of the FGFR3 and C-type
natriuretic peptide (“CNP”) signaling . In achondroplasia, FGFR3 is constitutively activated,
suppressing the differentiation of chondrocytes in the growth plate leading to poor endochondral bone
growth and causing dysfunction in the skeletal muscle. Preclinical and clinical data show that
therapeutic continuous CNP exposure helps to counteract the constitutively activated FGFR3
downstream.
In November 2021, BioMarin Pharmaceutical Inc.’s (“BioMarin”) daily VOXZOGO® (vosoritide) was
approved by the FDA to increase linear growth in pediatric patients with achondroplasia with open
epiphyses. Additionally, BioMarin is developing a long-acting CNP product candidate.
BioMarin has initiated certain legal proceedings aimed at delaying or preventing patient access to
TransCon CNP. We believe BioMarin’s claims lack merit and that these actions threaten potential
harm to patients by limiting or preventing access to a treatment option that has the potential to
address multiple unmet clinical needs.
These legal proceedings include a case filed by BioMarin before the Unified Patent Court (“UPC”) in
Munich related to alleged infringement against EP3175863 (the “‘863 patent”), along with a complaint
filed with the U.S. International Trade Commission (“ITC”) related to alleged infringement of U.S.
Reissue Patent No. 48,267. Trial in the ITC is set for April 2026. In response to the ITC action, we
initiated legal action before the District Court in the U.S. Northern District of California. The District
Court litigation has been stayed in view of the pending ITC proceedings.
In the European case, we took the view that we did not infringe the ‘863 patent and that the patent
was, in any event, invalid. Following opposition proceedings against the ‘863 patent that were initiated
before the European Patent Office (“EPO”) in September 2022, the EPO Technical Boards of Appeal
revoked the ‘863 patent in its entirety on October 16, 2025. As a consequence of the revocation, the
UPC dismissed the infringement case on December 29, 2025, which included an agreement for
BioMarin to reimburse Ascendis for certain legal expenses related to the case. In addition, we have
instituted proceedings before the Danish Maritime and Commercial High Court, claiming entitlement to
European patent applications EP21211450.8, EP25151367.7 and EP25175852.0, all of which are
divisional applications of the revoked ‘863 patent. The EPO has granted a stay of proceedings with
respect to these divisional applications.
On June 12, 2025, BioMarin also submitted a Citizen Petition to the FDA under Section 505(q) of the
Federal Food, Drug and Cosmetic Act requesting that FDA refrain from approving any analog of
human CNP as a treatment for achondroplasia until orphan-drug exclusivities applicable to
Management Commentary
25
VOXZOGO expire. We submitted a response to the FDA in September 2025 and do not believe that
our pending NDA for TransCon CNP (navepegritide) should be impacted by the Citizen Petition.
Also, on October 21, 2025, we filed a petition before the Korean Intellectual Property Trial and Appeal
Board (“IPTAB”) for the invalidation of BioMarin’s Korean patent KR2033680.
Changing the Treatment Paradigm of Achondroplasia
Clinical manifestations of achondroplasia are associated with significant, potentially life-threatening
complications and reduced quality of life. While achondroplasia has historically been considered a
growth disorder, secondary manifestations beyond linear growth, including reduced muscle strength
and stamina, suggest that achondroplasia is also a muscle disorder.
ACH-AE: Increased incidence of Achondroplasia-related Adverse Events.
HRQoL: Reduced Health-Related QOL; Height; Reduced height. Muscle Strength/Stamina; Reduced
muscular functionality, including reduced strength and stamina.
TransCon CNP
TransCon CNP (navepegritide) is an investigational prodrug of CNP administered once weekly and
designed to provide sustained release of active CNP supporting continuous exposure for the
treatment of achondroplasia. TransCon CNP is designed to provide effective shielding of CNP from
neutral endopeptidase degradation in subcutaneous tissue and the blood compartment, minimize
binding of CNP to the NPR-C receptor to decrease clearance, and release unmodified CNP (89-126),
which is small enough in size to allow effective penetration into growth plates. Shorter-acting CNP and
CNP analogs in development have resulted in high maximum serum concentration (“C
max
”) levels that
may cause adverse hypotensive events. We believe the therapeutically sustained release of
TransCon CNP offers advantages that may mitigate this issue, leading to continuous CNP exposure
while avoiding a high C
max
to correlate with better therapeutic outcomes.
Management Commentary
26
TransCon CNP for the Treatment of Achondroplasia
We submitted a New Drug Application (“NDA”) for the treatment of children with achondroplasia on
March 31, 2025 and the FDA has accepted for priority review our NDA for TransCon CNP
(navepegritide). As a result of further information from the Company submitted to the FDA on
November 5, 2025, related to the post-marketing requirement in response to the FDA’s ongoing
review of the NDA, the FDA has set a Prescription Drug User Fee Act (“PDUFA”) goal date
of February 28, 2026 to complete its review. In addition, we submitted a Marketing Authorisation
Application (“MAA”) to the European Medicines Agency (“EMA”) for the treatment of children with
achondroplasia on October 8, 2025.
In February 2019, we were granted ODD by the FDA for TransCon CNP for the treatment of
achondroplasia. In July 2020, we received ODD from the EC for TransCon CNP for the treatment of
achondroplasia.
Clinical Development of TransCon CNP for Achondroplasia
Our pivotal ApproaCH Trial, our Phase 2 ACcomplisH Trial, and our long-term extension trial AttaCH,
are evaluating the safety and efficacy of TransCon CNP in children with achondroplasia. The reACHin
Trial is evaluating the safety, tolerability, and efficacy of TransCon CNP in infants with achondroplasia
(aged 0 to < 2 years at the time of randomization). The teACH Trial is evaluating the safety,
tolerability, and efficacy of TransCon CNP in adolescents with achondroplasia (aged 12 to 18). As of
December 31, 2025, 80 children who completed the ApproaCH trial have rolled over into the AttaCH
open-label extension trial and are all continuing treatment in the extension trial.
In November 2025, we announced that Week 52 results from the pivotal ApproaCH trial were
published in JAMA Pediatrics titled “Once-Weekly Navepegritide in Children with Achondroplasia: The
ApproaCH Randomized Clinical Trial.”
The authors reported that treatment with TransCon CNP led to significantly higher annualized growth
velocity (AGV) at Week 52 compared to placebo (primary endpoint), as well as improved lower limb
alignment and body proportionality and positive changes in health-related QOL, with a safety and
tolerability profile similar to placebo. The publication is available at Savarirayan R, et al. JAMA
Pediatr. 2026;180(1):18-25. doi:10.1001/jamapediatrics.2025.4771.
In September 2025, we announced new analyses from the pivotal ApproaCH Trial were presented at
the American Society for Bone and Mineral Research (ASBMR) Annual Meeting. The new analyses
showed that children treated with TransCon CNP had improvements in the Physical Functioning
domain of the Achondroplasia Child Experience Measure (ACEM-PF), with greatest benefits in
younger children who had more severe genu varum (≥5°) at baseline, supporting benefits beyond
linear growth. Further analyses showed correlations between improvements in physical functioning
and improvements in lower limb alignment in these children, supporting the potential for TransCon
CNP to provide benefits beyond linear growth.
In May 2025, we announced data demonstrating improvements in growth and bone morphometry
from Week 52 of our pivotal ApproaCH Trial of TransCon CNP (navepegritide) in children with
achondroplasia. TransCon CNP demonstrated superiority over placebo in annualized growth velocity
(AGV), with a safety and tolerability profile comparable to placebo that included a low rate of injection
site reactions, no treatment-related serious adverse events (SAEs), no cases of symptomatic
hypotension, no fractures, and no acceleration of bone age versus chronological age. Analyses also
showed that TransCon CNP improved aspects of bone morphometry at Week 52. This included
improvement in lower limb alignment and proportional growth, as well as increases in spinal canal
dimensions, versus placebo.
In January 2025, we announced data demonstrating improvements in leg bowing, a common
complication in achondroplasia, observed with TransCon CNP compared to worsening observed with
placebo in the pivotal ApproaCH Trial.
Management Commentary
27
In September 2024, we announced top-line data from ApproaCH, a pivotal, multicenter, randomized,
double-blind, placebo-controlled trial of once-weekly TransCon CNP versus placebo in 84 children
(aged 2 to 11 years) with achondroplasia. Participants were randomized 2:1 to receive TransCon CNP
100 µg/kg/week or placebo for 52 weeks in the double-blind period, after which all participants could
choose to receive TransCon CNP at the 100 µg/kg/week dose in an ongoing open-label extension. In
the trial, children treated with once-weekly TransCon CNP demonstrated annualized growth velocity
(“AGV”) superior to those treated with placebo. TransCon CNP also demonstrated statistically
significant improvements in other growth parameters, including height Z-score and change from
baseline AGV.
Highlights of the ApproaCH Trial Top-line Data
Primary Endpoint
• For the primary endpoint of AGV at Week 52, children treated with TransCon CNP (n=57)
demonstrated an LS mean AGV of 5.89 cm/year compared to 4.41 cm/year in the placebo
arm (n=27), an LS mean difference of 1.49 cm/year (p<0.0001).
• Sub-group analyses:
ο Children aged 2 to <5 years treated with TransCon CNP (n=21) demonstrated an LS
mean AGV at Week 52 of 6.07 cm/year compared to 5.06 cm/year in the placebo arm
(n=10), an LS mean difference of 1.02 cm/year (p=0.0084).
ο Children aged 5-11 years treated with TransCon CNP (n=36) demonstrated an LS
mean AGV at Week 52 of 5.79 cm/year compared to 4.02 cm/year in the placebo arm
(n=17), an LS mean difference of 1.78 cm/year (p<0.0001).
AGV Change from Baseline
• Children aged 2 to <5 years, treated with TransCon CNP (n=19) demonstrated a change
from baseline AGV at Week 52 of 1.57 cm/year compared to 0.43 cm/year in the placebo
arm (n=10), an LS mean difference of 1.15 cm/year (p=0.0047).
• Children aged 5-11 years, treated with TransCon CNP (n=35) demonstrated a change
from baseline AGV at Week 52 of 2.29 cm/year compared to 0.52 cm/year in the placebo
arm (n=17), an LS mean difference of 1.78 cm/year (p<0.0001).
Secondary Endpoints
• For the secondary endpoint of change in achondroplasia-specific height Z-score, children
treated with TransCon CNP (n=57) demonstrated an LS mean change from baseline
achondroplasia-specific height Z-score of 0.30 compared to 0.01 in the placebo arm
(n=27), an LS mean difference of 0.28 (p<0.0001).
• For the secondary endpoint of change in CDC-based height Z-score, children treated with
TransCon CNP (n=55) demonstrated an LS mean change from baseline CDC Height Z-
score of 0.15 compared to -0.15 in the placebo arm (n=27), an LS mean difference of 0.30
(p=0.0003).
Management Commentary
28
Safety Results Summary
• TransCon CNP was generally well-tolerated and demonstrated safety profile similar to that
observed in the placebo arm, with generally mild treatment emergent adverse events
(“TEAEs”), no evidence of hypotensive effect, and a low frequency of injection site
reactions (0.41 events per patient year), all mild.
• No adverse events (“AEs”) led to discontinuation of TransCon CNP or withdrawal from the
trial and no serious adverse events (“SAEs”) were assessed as related to TransCon CNP.
In December 2023, we announced new analyses demonstrating benefits beyond linear growth from
the blinded and ongoing OLE periods of ACcomplisH, a Phase 2 randomized, double-blind, placebo-
controlled, dose-escalation trial of TransCon CNP in children aged 2 to 10 years with achondroplasia.
In the trial, all 57 patients have now completed one year of treatment with TransCon CNP at 100
µg/kg/week, the dose agreed with regulatory agencies for the active arm in our pivotal ApproaCH
Trial.
We analyzed available data for patients who only received TransCon CNP at the 100 µg/kg/week
dose in either the blinded or OLE period and were treated for one year (n=19), compared to those
administered placebo for one year (n=15). Results showed that these TransCon CNP-treated patients
(data available for 9-16 patients) showed improvements (nominal p-value <0.05) in health-related QoL
and disease impacts compared to those receiving placebo (data available for 5-13 patients).
Assessments were performed with the SF-10 (a 10-item non-disease specific survey of a child’s
functional health and well-being that has been validated to assess children aged 5 years and older)
and the Achondroplasia Child Experience Measure (“ACEM”) a condition-specific clinical outcome
measure that assesses the impact of achondroplasia on a child’s health-related QOL, with statistically
significant improved outcome in TransCon CNP-treatment versus placebo for:
• SF-10 Physical Summary (p=0.002, aged 5 years and older)
• ACEM Daily Living Function (p=0.047)
• ACEM Emotional Well-being (p=0.045)
The 46 children switching from placebo or a lower dose of TransCon CNP to the 100 µg/kg/week
dose in the OLE demonstrated improved growth after one year of treatment, similar to the growth
benefits seen in the 11 children treated with 100 µg/kg/week in the one-year randomized, double-blind
period of ACcomplisH.
The 46 children switching from placebo or a lower dose of TransCon CNP to the 100 µg/kg/week
dose in the OLE demonstrated improved growth after one year of treatment, similar to the growth
benefits seen in the 11 children treated with 100 µg/kg/week in the one-year randomized, double-blind
period of ACcomplisH.
Management Commentary
29
During the third quarter of 2023, we filed an Investigational New Drug Application amendment with the
FDA to initiate reACHin, a Phase 2, multicenter, double-blind, randomized, placebo-controlled trial,
designed to evaluate the safety, tolerability, and efficacy of 100 μg/kg of TransCon CNP once-weekly
for 52 weeks in infants with achondroplasia, aged 0 to < 2 years at the time of randomization.
In November 2022, we announced top-line results from ACcomplisH, a Phase 2 randomized, double-
blind, placebo-controlled, dose-escalation trial evaluating the safety and efficacy of once-weekly
TransCon CNP compared to placebo in children with achondroplasia aged 2 to 10 years old.
The ACcomplisH Trial evaluated 57 children with achondroplasia aged 2 to 10 years old, randomized
in a 3:1 ratio to receive either sequential ascending doses of once-weekly TransCon CNP (6
µg/kg/week, 20 µg/kg/week, 50 µg/kg/week, 100 µg/kg/week) or placebo for 52 weeks. The trial met
its primary objectives, demonstrating that TransCon CNP at 100 µg/kg/week (n=11) was superior to
placebo (n=15) on the primary efficacy endpoint of AGV at 52 weeks (p=0.0218).
The ACcomplisH Trial completed in October 2024, with 55 of the original 57 children transitioning into
AttaCH (n=53) a multicenter, long-term, open-label extension trial to continue treatment with
TransCon CNP 100 µg/kg/week, and into COACH (n=2), a TransCon CNP and TransCon hGH
combination therapy trial. Two children did not roll-over for reasons unrelated to safety or efficacy of
the study drug. For more information, see section entitled, “Combination Therapy TransCon CNP +
TransCon hGH.”
As of December 31, 2025, 53 children continue in AttaCH with three children withdrawn from
treatment, for reasons unrelated to safety or efficacy of the study drug. Seven (n=7) children from
AttaCH were enrolled and continue in COACH. There have been no withdrawals from COACH.
In 2019, we initiated the ACHieve Study, a five-year, multi-center natural history study designed to
gain insight into the experiences of pediatric patients with achondroplasia. ACHieve was designed to
evaluate growth velocity, body proportionality, and comorbidities over time in children with
achondroplasia up to eight years old. No study medication was administered in the ACHieve Study.
The study ended in the first quarter of 2024.
Combination Therapy (TransCon CNP + TransCon hGH)
TransCon CNP has demonstrated improvement in linear growth and in benefits beyond height.
Clinical use of daily growth hormone monotherapy has demonstrated some growth improvements in
children with achondroplasia; however, without reports of benefits beyond height, as it does not
address the underlying overactive FGFR3 signaling pathway.
We believe the combination of once-weekly TransCon CNP and TransCon hGH, through two
independent and complementary mechanisms of action, may provide benefits beyond monotherapies
in achondroplasia. The active CNP released from TransCon CNP continuously relieves the pre-
hypertrophic block in the growth plate, enabling the strong complementary effect of unmodified
somatropin released from TransCon hGH.
COACH, a Phase 2 open-label single-arm trial is the first clinical trial to evaluate combination
treatment with once-weekly investigational TransCon CNP (navepegritide) and once-weekly
TransCon hGH (lonapegsomatropin) in children with achondroplasia (age 2 to 11 years). The primary
objective is to evaluate the treatment effect on linear growth and safety. Secondary objectives are to
evaluate treatment effect on quality of life, radiological endpoints, physical functioning, and body
composition. The trial enrolled 21 children (treatment naïve, n=12; prior treatment with TransCon CNP
(100 µg/kg/week) for at least 1 year, n=9).
Management Commentary
30
In January 2026, we announced topline results from Week 52 of COACH, the first Phase 2 clinical trial
to evaluate combination therapy with once-weekly TransCon CNP (navepegritide) and once-weekly
TransCon hGH (lonapegsomatropin) in children with achondroplasia. Annualized growth velocity
exceeded the 97th percentile of average stature children and the improvement in achondroplasia-
specific height Z-score indicated a tripling of efficacy compared to TransCon CNP monotherapy.
Additionally, combination therapy demonstrated benefits beyond linear growth with improvements in
body proportionality and arm span, aligning with the increase in linear growth. The combination
therapy was generally well tolerated, with generally mild TEAEs, consistent with TransCon CNP and
TransCon hGH monotherapies.
At week-52, the mean AGV with TransCon CNP and TransCon hGH combination treatment continued
to exceed the 97th percentile of average-stature children.
At week-52, TransCon hGH + TransCon CNP treatment demonstrated accelerated improvement in body
proportionality, aligning with the increase in linear growth.
At week-52, arm span of children treated with combination therapy improved beyond the 84th-
percentile of children with achondroplasia.
Management Commentary
31
TransCon Product Candidates—Oncology
Market Opportunity in Oncology
Cancer continues to be one of the leading causes of mortality. Improved understanding of the cellular
and molecular mechanisms involved in anti-tumor immune responses has fueled the rapid growth of
immuno-oncology therapeutics. Immune checkpoint inhibitors, such as anti-PD-(L)1 and anti-CTLA-4
antibodies, have provided new therapeutic options for patients.
Despite recent advances, a high need for new treatment options remains for patients who do not
respond to, or who respond inadequately to, current therapies. In addition to insufficient efficacy,
many current treatments are limited by toxicities that result in dose reductions, treatment
discontinuations, or long-term health risks to patients.
We believe that one approach to potentially improve efficacy while limiting adverse events is to create
long-acting product candidates using our sustained systemic release TransCon technology, allowing
for more consistent circulating drug levels and potentially avoiding high peak concentrations that are
often associated with toxicity.
We are currently developing TransCon technology in oncology for a variety of solid tumors, with
encouraging early data in HER2+ breast cancer, platinum resistant ovarian cancer and melanoma.
Aside from Proleukin being the only approved IL-2, TransCon IL-2 β/γ may face competition from
other IL-2 type drug candidates in development, including those being developed by Anaveon, Asher
Bio, Aulos, Dragonfly, GI Innovation, Hanmi Pharmaceutical, Innovent, Medicenna,
Roche, Synthekine, and Werewolf. In addition, TransCon IL-2 β/γ may face competition from drug
candidates in development for platinum resistant ovarian cancer, including Astra Zeneca, Corcept,
Daiichi Sankyo, Eli Lilly, Genelux, Genmab, and Merck. In melanoma, TransCon IL-2 β/γ may face
competition from drug candidates in development including from Immatics, Immunocore, Innovent,
Replimune, Regeneron, and Philogen.
TransCon Technologies for Oncology
We believe prolonging the therapeutic activity and targeting the drug activity to the relevant cell types
and tissues have the potential to improve treatment outcomes. We believe TransCon is well-suited to
improve cancer treatments given the large number of validated targets with known limitations. By
applying our unique algorithm for product innovation to clinically validated targets and pathways, we
believe TransCon has the potential to improve outcomes currently limited by suboptimal efficacy and
systemic toxicity.
We believe TransCon technologies may have the potential to increase the efficacy of small molecules,
peptides and proteins without increasing toxicity, which could offer the potential to treat more patients
with new combinations and multi-agent regimens that would not otherwise be feasible.
Management Commentary
32
We are currently investigating one clinical-stage product candidate designed to activate the patient’s
own immune system to eradicate malignant cells. We believe our approach, if successfully developed,
has the potential to improve the efficacy of systemically administered, clinically validated therapies
while limiting adverse effects.
Our early clinical and nonclinical studies have shown sustained activation of cytotoxic immune cells
that resulted in robust anti-tumor responses by TransCon product candidates using infrequent
administration.
TransCon IL-2 β/γ for Sustained Systemic Release
TransCon IL-2 β/γ (onvapegleukin alfa) is an investigational long-acting prodrug designed to improve
cancer immunotherapy through sustained release of an IL-2 variant that selectively activates IL-2 β/γ,
with minimal binding to IL-2Rα. The IL-Believe Trial, a Phase 1/2 clinical trial to evaluate the safety
and efficacy of TransCon IL-2 β/γ in locally advanced or metastatic solid tumors, alone or in
combination with pembrolizumab or other anti-cancer therapies, has completed dose escalation and is
enrolling patients in multiple indication-specific dose expansion cohorts, including platinum-resistant
ovarian cancer (“PROC”), melanoma, and HER2+ breast cancer.
In October 2025, we reported updated results at the European Society for Medical Oncology
(“ESMO”) that further indicate clinical activity in late-line patients with PROC treated with TransCon IL-
2 β/γ with weekly paclitaxel (Cohort 3, 3SK, and 14 in the IL-Believe Trial). As of data cutoff date of
September 2, 2025, 70 patients (median 4 prior lines of therapy; 67% previously treated with at least 2
lines of taxane-containing therapy) were enrolled and 53 were efficacy-evaluable to-date, with 7
pending first post-baseline scan. Clinical responses were observed in 25% (13/53) of patients who
had received two to ten prior lines of therapy (three confirmed and ten unconfirmed responses, with
six of the unconfirmed continuing on study treatment). Data continued to suggest that TransCon IL-2
β/γ in combination with weekly paclitaxel is generally well-tolerated with the majority of TransCon IL-2
β/γ-related TEAEs being grade 1 or 2 in severity.
TransCon IL-2 b/g induced significant peripheral expansion of cytotoxic CD8+ T cells and natural killer
cells with minimal expansion of regulatory T cells, despite concurrent chemotherapy. Proliferating
antigen-experienced PD-1+CD8+ T cells expanded significantly at 1 week post dose. Expanded PD-
1+CD8+ T cells predominantly exhibited stem-like or transitory states, with limited progression to
terminally differentiated or exhausted phenotypes. In addition, clinical responses significantly
correlated with peripheral CD8+ T cell expansion in PROC. Furthermore, significant increase in CD8+
T cells was observed in the tumor of paired on-treatment biopsies from all available paired pre-
treatment and on-treatment tumor samples from IL Believe Trial as of September 2, 2025, dosed at 80
(n=2) or 120 μg/kg (n=11).
We expect to provide median overall survival (“OS”) data for this cohort of 70 patients in the second
quarter of 2026 as the dataset continues to mature.
In September 2024, we announced initial data showing signs of clinical activity in heavily pre-treated
patients with PROC treated (cohort 3) with TransCon IL-2 β/γ in combination with chemotherapy in the
ongoing Phase 1/2 IL-Believe Trial of TransCon IL-2 β/γ. As of a cutoff date of July 29, 2024, of the 18
patients (median age 64 years) included in the initial assessment, 14 were efficacy evaluable patients
who had one or more post-baseline tumor assessment(s), plus an additional four who discontinued
treatment before the first post-baseline tumor assessment due to disease progression or death.
As of the data cutoff, clinical responses were observed in 29% (4/14) of the efficacy evaluable
patients (two confirmed and two unconfirmed partial responses in patients who had received three to
seven prior lines of treatment – including patients whose disease had previously progressed on
mirvetuximab soravtansine-gynx), suggesting the potential for clinical activity in heavily pre-treated
patients. The data suggest that TransCon IL-2 β/γ was generally well-tolerated: the most common
TEAEs related to combination therapy with TransCon IL-2 β/γ plus chemotherapy were fatigue,
thrombocytopenia, neutropenia, and anemia. Most TransCon IL-2 β/γ-related TEAEs were grade 1 or
2.
Management Commentary
33
In June 2024, we reported updated results from our ongoing Phase 1/2 IL-Believe Trial of TransCon
IL-2 β/γ. Data included the first presentation of Phase 2 dose expansion Cohort 4 (TransCon IL-2
b/gin combination with TransCon TLR7/8 Agonist) in post anti-PD-1 melanoma and new analyses of
patients from dose escalation cohorts with prior disease progression on checkpoint inhibitors, along
with biomarker studies correlating cytotoxic immune cell expansion and observed clinical benefit. As
of the April 16, 2024 data cutoff, confirmed clinical partial responses were observed in 40% (two out of
five) of efficacy-evaluable patients from Cohort 4, suggesting potential synergy of our two novel
immunotherapy candidates in patients who did not derive sufficient benefit from checkpoint inhibitors.
Of efficacy-evaluable patients with prior disease progression on checkpoint inhibitors to date (from
Phase 1 dose escalation cohorts) in the IL-Believe Trial, confirmed clinical responses (per RECIST
v1.1) were observed in 45% (five out of eleven) administered TransCon IL-2 β/γ doses ≥80 μg/kg
every 3 weeks, suggesting clinical benefit in treatment-resistant settings (monotherapy (n=4): 1
confirmed partial response (“PR”) in colorectal cancer; combination with pembrolizumab (n=2): 1
confirmed complete response and 1 confirmed PR in small-cell lung cancer; combination with
TransCon TLR7/8 Agonist (n=5): 2 confirmed PRs in melanoma). In this trial, TransCon IL-2 β/γ alone
or in combination with pembrolizumab or TransCon TLR7/8 Agonist was generally well tolerated with
no new safety signals.
In October 2023, we announced updated data from the ongoing Phase 1 dose escalation cohort from
IL-Believe Trial. Forty-six patients were enrolled into dose escalation cohorts: 25 to monotherapy and
21 to combination therapy. As of the August 15, 2023, data cutoff, anti-tumor clinical responses were
observed with TransCon IL-2 β/γ monotherapy (colorectal cancer with PR) or in combination with
pembrolizumab (small cell lung cancer, one with confirmed PR and one ongoing with unconfirmed
complete response) in heavily pre-treated patients who previously progressed on checkpoint
inhibitors. TransCon IL-2 β/γ every three weeks was generally well-tolerated, with no meaningful effect
on Tregs and eosinophils.
In September 2023, we announced completion of Phase 1 dose escalation in combination with
pembrolizumab of the IL-Believe Trial with a total of 21 patients enrolled and recommended Phase 2
dose (“RP2D”) determined at 120 µg/kg IV every three weeks. Twenty-one patients were enrolled.
In May 2023, we announced completion of the Phase 1 monotherapy dose escalation of the IL-
Believe Trial with RP2D determined at 120 µg/kg IV every three weeks with 25 heavily pre-treated
patients enrolled and a median of four prior lines of systemic therapies.
Strategic Collaborations and Investments
We also engage in strategic collaborations to further leverage our TransCon technologies in certain
geographies and therapeutic areas with market-leading biopharmaceutical companies. These
collaborations aim to make promising treatment options available to more patients and to further
monetize both our TransCon technologies and our internal product candidates, particularly into
therapeutic areas where we believe a partner may have more expertise, capability, and capital. In
addition, we may choose to pursue a collaboration to develop and market our internal, wholly owned
product candidates in geographic markets outside our core focus areas of the United States and
Europe.
Novo Nordisk A/S
In November 2024, we entered into a research and development collaboration and license agreement
with Novo Nordisk pursuant to which we granted Novo Nordisk an exclusive worldwide license to the
TransCon technology platform to develop, manufacture and commercialize Novo Nordisk proprietary
products (including Semaglutide) in metabolic diseases (including obesity and type 2 diabetes) and a
product-by-product exclusive license in cardiovascular diseases.
Management Commentary
34
The agreement includes provisions requiring at least one TransCon Semaglutide product and at least
one other TransCon technology-based product to be identified, developed and commercialized in
metabolic diseases to maintain certain exclusivities in the field, with additional provisions for
cardiovascular diseases. Under the terms of the agreement, Novo Nordisk also receives exclusive
rights to expand any resulting metabolic disease products into other therapeutic areas. The lead
program in the collaboration is a once-monthly TransCon Semaglutide product candidate that will
initially target obesity and type 2 diabetes.
Under the agreement, we have the potential to receive total payments of up to $285 million in upfront,
development and regulatory milestone payments for the lead program. In addition, we have the
potential to receive sales-based milestone payments and tiered royalties on global net sales. The
$285 million includes an upfront fee of $100 million for the exclusive license that was paid to us in
January 2025. For each additional metabolic or cardiovascular disease product candidate, we are
eligible to receive payments of up to $77.5 million in development and regulatory milestone payments.
In addition, we have the potential to receive sales-based milestone payments and tiered royalties on
global net sales. Novo Nordisk agreed to pay royalties for each potential licensed product developed
under the agreement that are an escalating tiered, mid-single digit percentage of the annual net sales
of such licensed product and are subject to reduction due to patent valid claim expiration, biosimilar
product market share, payment made under certain licenses for third party intellectual property and
Inflation Reduction Act price negotiations.
Under the agreement, we have agreed to conduct certain pre-agreed early research and development
of TransCon product candidates under the collaboration and we are eligible to receive cost
reimbursement from Novo Nordisk for its performance of such research and development activities
under the agreement with respect to such TransCon product candidates. Novo Nordisk is responsible
for any other non-clinical and clinical development, regulatory, commercial manufacturing, and
commercialization of such TransCon product candidates, and all costs associated with such activities.
Subject to the terms of the agreement, we granted Novo Nordisk an exclusive, worldwide, royalty-
bearing license, with the right to grant sublicenses, to use its proprietary TransCon technology
platform to develop, manufacture and commercialize Novo Nordisk proprietary products in metabolic
diseases (including obesity and type 2 diabetes) and a product-by-product exclusive license in
cardiovascular diseases. Additionally, we granted Novo Nordisk an exclusive, worldwide, royalty-
bearing license, with the right to grant sublicenses, to use its proprietary TransCon technology
platform to develop, manufacture and commercialize GLP-1 receptor products using the TransCon
technology for all indications, except for (i) certain pre-agreed rare endocrine indications, (ii) all
indications in respect of the eye and adnexa and (iii) all indications in respect of oncology.
Until expiry of the last royalty term and for one-year thereafter, we are not permitted to research,
develop, manufacture, commercialize, or otherwise exploit outside of the collaboration, any GLP-1
receptor product or any other licensed products that have been subject to the collaboration. We are
also not permitted to undertake any research, development, manufacture, commercialization, or other
exploitation of products outside of the collaboration in the metabolic field until expiry of the last royalty
term of any licensed products that have been subject to the collaboration in metabolic diseases.
Unless earlier terminated, the agreement has a royalty term that continues, on a per licensed product
and per country basis, until the later of (i) the expiration of the last valid patent claim for any of our
patents, joint improvement patents, licensed product patents as well as any improvements made by
Novo Nordisk covering the licensed product’s dosage regimen or target product profile, or (ii) 11 years
after the first commercial sale of such licensed product in such country.
Novo Nordisk has the right to terminate the agreement without cause in its entirety or on a per
licensed product basis. We have the right to terminate the agreement in its entirety in case Novo
Nordisk brings patent challenges with respect to our patents. The agreement may also be terminated
by either party based on an uncured material breach by the other party or the bankruptcy of the other
party.
Upon termination of the agreement due to Novo Nordisk’s default, some or all of the licenses granted
by us to Novo Nordisk to develop, manufacture and commercialize any of the licensed products will
automatically terminate.
Management Commentary
35
Upon termination of the agreement due to certain defaults by us, Novo Nordisk may choose to either
(i) have the license granted by us to Novo Nordisk to develop, manufacture and commercialize
licensed products terminate in its entirety or on a product-by-product basis; or (ii) continue with
respect to the affected licensed product at a reduced payment rate.
In January 2025, we announced that our multi-product collaboration with Novo Nordisk for TransCon
technology-based therapies in obesity and metabolic diseases continues and that the lead program
TransCon Semaglutide, remains on track to enter the clinic as anticipated.
Teijin Limited
In November 2023, we announced that we entered into an exclusive license agreement with Teijin for
the further development and commercialization of TransCon hGH, TransCon PTH, and TransCon
CNP for endocrinology rare disease in Japan. Under the terms of the agreement with Teijin, we
received an upfront payment of $70 million, with additional development and regulatory milestones of
up to $175 million, transfer pricing and commercial milestones. In addition, we are eligible to receive
royalties on net sales in Japan, of up to a mid-20’s percentage, varying by product.
In November 2025, Teijin announced that YORVIPATH is commercially available for prescription.
VISEN Pharmaceuticals
In November 2018, we announced the formation of VISEN, a company established to develop and
commercialize our endocrinology rare disease therapies in Greater China. In connection with the
formation of VISEN, we granted VISEN exclusive rights to develop and commercialize certain product
candidates based on our proprietary TransCon technologies, including TransCon hGH, TransCon
PTH, and TransCon CNP, in Greater China for use in all human indications, subject to certain
exceptions. As consideration for the rights granted to VISEN, we received 50.0% ownership in the
outstanding shares of VISEN and concurrently with the rights we granted to VISEN, entities affiliated
with Vivo Capital and Sofinnova Ventures purchased shares in VISEN for an aggregate purchase
price of $40 million in cash. In January 2021, we invested an additional $12.5 million in VISEN as part
of VISEN’s $150 million Series B financing.
On March 20, 2025, VISEN announced the pricing of its initial public offering (“IPO”) on the Hong
Kong Stock Exchange. The shares offered in the IPO were priced at HKD 68.80 per share and
expected to result in gross proceeds of HKD 783,288,000 (approximately USD 100 million) plus a
potential greenshoe of up to HKD 117,489,760 (approximately USD 15 million). This amount was
calculated before deducting underwriting discounts, commissions, and other offering expenses. The
IPO closed on March 21, 2025, and VISEN’s shares began trading under the stock code 2561.HK.
Ascendis Pharma holds 41,136,364 shares in VISEN. Following the IPO, the Company owned
39.2% in VISEN. The management and existing shareholders of VISEN, including Ascendis Pharma,
have entered into customary lock-up agreements restricting the sale of VISEN shares for six months
following the IPO; additionally, certain significant shareholders of VISEN, including Ascendis Pharma,
are subject to an additional lock-up obligation during the period commencing on the date that is six
months after the IPO and ending on the date that is 12 months after the IPO during which such
shareholders may not sell shares of VISEN to an extent that would cause such shareholder to cease
being a controlling shareholder of the VISEN pursuant to applicable listing rules. As of December 31,
2025 and 2024, the Company’s ownership in VISEN was 39.2% and 43.9%, respectively. As of
December 31, 2025, VISEN’s share price at the Hong Kong Stock Exchange was HK$32.80,
reflecting the market value of the Company’s equity position of €147.5 million.
In January 2026, VISEN announced its biologics license application (“BLA”) for lonapegsomatropin
(TransCon hGH) was approved by the National Medical Products Administration (“NMPA”) of China
for the treatment of pediatric patients who have growth failure due to inadequate secretion of growth
hormone in China.
In September 2025, VISEN announced that palopegteriparatide (TransCon PTH) was approved by
the Hainan Medical Products Administration for clinical use in the Boao Lecheng Pilot Zone for the
treatment of adults with chronic hypoparathyroidism.
Management Commentary
36
In August 2024, VISEN announced top-line data from the 26-week randomized, double-blind,
placebo-controlled portion of the Phase 3 PaTHway China Trial of Palopegteriparatide (TransCon
PTH) in adults with chronic hypoparathyroidism. VISEN reported a statistically significant higher
proportion of patients treated with palopegteriparatide achieved the primary multi-component endpoint
compared to placebo. The primary multi-component endpoint was achieved by 77.6% of
palopegteriparatide-treated patients (45 of 58), compared to 0.0% of patients (0 of 22) in the placebo
group (p-value <0.0001). Results were consistent with those announced by us for its
palopegteriparatide Phase 3 trial.
In November 2023, VISEN announced top-line results from the Phase 2 ACcomplisH China Trial in
children with achondroplasia aged 2 to 10 years. VISEN reported that patients dosed with TransCon
CNP at the 100 μg CNP/kg/week showed significantly higher AGV than placebo at Week 52.
In November 2022, VISEN announced data from its pivotal Phase 3 study of TransCon hGH in
children with GHD in China. VISEN reported that patients dosed with TransCon hGH demonstrated an
AHV of 10.66 cm/year compared to 9.75 cm/year for the daily hGH at 52 weeks (treatment difference
at 0.91 cm/year with a 95 percent confidence interval: 0.37 – 1.45 cm/year, p=0.0010), reaching its
primary objective, demonstrating that TransCon hGH is non-inferior to the daily hGH.
Market Opportunity in China
China is the second largest pharmaceutical market in the world after the United States and represents
one of the fastest growing pharmaceutical markets worldwide. In recent years, the Chinese
government has initiated a number of regulatory reforms that are expected to accelerate drug
development, as well as drive growth and demand for new therapeutics in China. In addition to joining
an international organization that standardizes regulations for clinical development, the National
Medical Products Administration has introduced initiatives such as fast track review for drugs for
unmet medical needs and adopted new rules that streamline the drug approval process in China for
global companies.
The purpose of our investment in VISEN is to support our strategy to extend our endocrinology rare
disease portfolio globally and establish a presence in China in partnership with collaborators who
have significant experience and knowledge of the biopharmaceutical opportunity in China.
Eyconis, Inc
In January 2024, we announced the formation and launch with Frazier Life Sciences of Eyconis, a
separate company created to develop, manufacture, and commercialize TransCon ophthalmology
assets globally, together with a $150 million commitment from an investor syndicate that included
Frazier, RA Capital Management, venBio, and HealthQuest Capital. We have granted Eyconis
exclusive rights to develop and commercialize TransCon ophthalmology products globally and
received an equity position in the newly formed company. In addition, we are eligible to receive
development, regulatory, and sales milestone payments, plus single digit royalties on global net sales
of commercialized products, if any. As of December 31, 2025, and 2024, the Company’s ownership in
Eyconis was 33.2% and 41.6%, respectively.
Financial Review
Compared to the year ended December 31, 2024, revenue for the year ended December 31, 2025,
primarily benefited from the continued growth of YORVIPATH global sales. Operating loss was €136.3
million, representing an improvement of €142.5 million compared to December 31, 2024, which, in
addition to an increase in revenue, was impacted by higher operating expenses related to commercial
expansion. We had a net loss of €228.0 million for the year ended December 31, 2025, which, in
addition to operating loss, was driven primarily by non-cash financial items. In addition, net loss was
positively impacted by share of profit/(loss) of associates, which includes a non-cash gain of
€35.7 million related to the Initial Public Offering of VISEN in March 2025.
Management Commentary
37
Cash flows from operating activities were positive for the year ended December 31, 2025 representing
an improvement of €360.1 million, compared to last year, attributable to improved operating
performance. Refer to section “Liquidity and Capital Resources” for further information.
Foreign currency translation reduced reported revenue for the year ended December 31, 2025 by
€38.9 million compared to last year´s exchange rate. Similarly, operating expenses decreased due to
currency translation by €14.6 million compared to last year.
Our total equity presented a deficit of €162.8 million as of December 31, 2025, compared to a deficit
of €105.7 million as of December 31, 2024.
Further details about our results of operations are described in the following sections.
All employees in Denmark (domicile country) are employed by the Parent Company, and accordingly,
neither of the Danish subsidiaries have employees. Furthermore, all external, project related
expenses, as well as site costs incurred by foreign subsidiaries are being financed by the Parent
Company. All direct related project expenses are invoiced to subsidiaries that holds the license rights
for the product candidates. In addition, the Parent Company provides services to subsidiaries, which
are disclosed as revenue in the Parent Company’s separate financial statements. All intergroup
transactions are made on an arms-length basis and eliminated in the consolidated financial
statements.
Accordingly, operating results in the Parent Company highly depend on project related activities in the
Group.
Income and Expenses
Revenue from sale of commercial products and clinical trial supply is recognized when the customer
has obtained control of the goods and it is probable that we will collect the consideration to which we
are entitled for transferring the goods. Control is transferred upon delivery. Cost of sales are
recognized when the sales take place. Rendering of services is recognized as revenue over the
service period as stipulated under the applicable agreement. License agreements which transfer
rights to our intellectual property (“IP”) with significant stand-alone value are classified as “right-to-
use,” with revenue recognized at the point in time when the customer can use and benefit from the IP.
Our operating expenses relate to research and development activities and to selling, general, and
administration activities. Research and development expenses (“R&D expenses”) consist primarily of
product development and pre-commercial manufacturing costs, preclinical and clinical study costs and
costs for process optimizations and improvements performed by Clinical Research Organizations
(“CROs”) and Contract Manufacturing Organizations (“CMOs”), salaries and other personnel costs
including pension and share-based payment, the cost of facilities, professional fees, cost of obtaining
and maintaining our IP portfolio, and depreciation of non-current assets used in research and
development activities. Selling, general, and administrative expenses (“SG&A expenses”) comprise
salaries and other personnel costs including pension and share-based payment, office supplies, cost
of facilities, professional fees, and depreciation and amortization of non-current assets related to
selling, general, and administrative activities, and pre-commercial and commercial activities.
A material portion of our operating expenses are denominated in other currencies than the Euro,
which expose our operating expenses to volatility. We do not currently enter into derivative financial
instruments to manage our exposure to foreign exchange risks.
Revenue
Revenue for the year ended December 31, 2025, was €720.1 million, representing an increase of
€356.5 million compared to last year. This increase was primarily attributable to the continued growth
of YORVIPATH global sales, partly offset by the recognition of a $100 million upfront payment in 2024
related to our exclusive license agreement with Novo Nordisk.
Management Commentary
38
Cost of Sales
Cost of sales for the year ended December 31, 2025, was €94.9 million, representing an increase of
€50.7 million compared to last year. This increase was primarily attributable to increased sales of
commercial products and costs under our Strategic Collaborations.
Research and Development Expenses
R&D expenses for the year ended December 31, 2025, were €303.6 million representing a decrease
of €3.4 million compared to last year. This decrease was primarily due to completion of certain clinical
trials and development activities within our Endocrinology Rare Disease pipeline, partly offset by
reversal (income) of prior period write-downs related to pre-launch inventories for Hypoparathyroidism
in 2024 of €12.6 million due to the launch of YORVIPATH, and by higher employee costs to support
future growth.
Selling, General, and Administrative Expenses
SG&A expenses for the year ended December 31, 2025, were €457.9 million representing an
increase of €166.7 million compared to last year. This increase was primarily due to the continued
impact from global commercial expansion, including global launch activities for YORVIPATH.
Finance Income and Finance Expenses
The development was driven primarily by remeasurement loss from financial liabilities, partly offset by
translation net-gain of U.S. dollar denominated monetary positions into Euro, primarily cash and cash
equivalents, convertible notes and royalty funding liabilities. The development was further driven by
amortization charges, accruals, and other items, primarily due to our royalty funding liabilities which
we entered into in September 2023 and September 2024.
Liquidity and Capital Resources
Our liquidity and capital resources comprise cash and cash equivalents. As of December 31, 2025,
these amounted to €616.0 million.
Our expenditures primarily relate to research and development activities and selling, general, and
administrative activities to support our business, including our continued development of products and
product candidates within Endocrinology Rare Disease and Oncology portfolios, the
commercialization of YORVIPATH and SKYTROFA, and expenses made in anticipation of potential
future product launches. We manage our liquidity risk by maintaining adequate cash reserves. The
risk of shortage of funds is monitored, through the financial forecasting process, to ensure sufficient
funds are available to settle liabilities as they fall due.
Historically, we have funded our operations primarily through the issuance of preference shares,
ordinary shares (including public offerings and exercise of warrants), convertible debt securities,
payments to us made under collaboration agreements, and our royalty funding agreements. Including
our initial public offering, since February 2015, we have completed public offerings of American
Depositary Shares (“ADSs”), latest in September 2024, with total net proceeds of $2,580.2 million (or
€2,259.0 million at the time of the offerings). Refer to Note 17, “Financial Assets and Liabilities” for
further information about our convertible notes and royalty funding agreements.
Cash flows from/(used in) Operating Activities
Cash flows from operating activities for the year ended December 31, 2025 were €53.9 million,
representing an improvement of €360.1 million compared to last year, of which €182.0 million related
to improved operating performance, primarily driven by commercial revenue growth, and €178.1
million related to working capital improvements, which include settlement of the upfront payment from
our exclusive license agreement with Novo Nordisk of $100 million plus related indirect taxes.
Management Commentary
39
Cash flows from/(used in) Investing Activities
Cash flows used in investing activities for the year ended December 31, 2025 were €8.5 million,
representing an increase of €15.4 million compared to last year. This increase was primarily
attributable to €7.3 million settlements of marketable securities in 2024 and from leasehold
improvements in 2025.
Cash Flows from/(used in) Financing Activities
Cash flows from financing activities for the year ended December 31, 2025, were €36.3 million,
representing a decrease of €407.6 million compared to the last year. This decrease was primarily due
to:
• The follow-on public offering of ADSs with net proceeds of €290.6 million and the $150.0
million capped synthetic royalty funding agreement with Royalty Pharma, with net
proceeds of €134.2 million, both completed in September 2024;
• Acquisition of treasury shares of €17.4 million in 2025; and
• Payment of withholding taxes under stock incentive programs of €11.4 million in 2025,
partly offset by increased warrant exercise activity of €56.6 million in 2025.
Uncertainty Relating to Recognition and Measurement
When preparing the annual report, it is necessary that Management, in accordance with legislative
provisions, makes a number of accounting judgements and estimates which form the basis for the
annual report. The accounting judgements and estimates made by Management are described in
Note 3, “Significant Accounting Judgements and Estimates.”
Risk Management
Business Risks
The Group is exposed to certain risks that are common across the biopharmaceutical industry,
including but not limited to risks that pertain to research and development, regulatory approval,
commercialization, intellectual property rights and access to financing, and some risks that are
specific to the Group’s development programs and technology platform.
Some of these risks may significantly affect the Group’s ability to execute its strategy and in order to
mitigate such risks, the Group has identified and categorized these risks as critical risks and has
programs in place to ensure proactive identification, management and mitigation of such risks.
Financial Risks
We regularly monitor the access to domestic and international financial markets, manage the financial
risks relating to our operations, and analyze exposures to risk, including market risk, such as currency
risk and interest rate risk, credit risk and liquidity risk. Financial risk management is further described
in Note 18, “Financial Risk Management.”
Corporate Responsibility
Ascendis Pharma A/S has established a framework of corporate policies and rules which governs
compliance by the Company, employees and business partners with applicable laws and regulations,
and the Ascendis Pharma Code of Business Conduct & Ethics.
The Ascendis Pharma A/S Corporate Responsibility & P|ESG Report 2025 defines our compliance
with Section 99a (CSR) and Section 99d (Data ethics) of the Danish Financial Statements Act.
Find more detailed information in the Ascendis Pharma Corporate Responsibility & P|ESG Report
2025 at: https://investors.ascendispharma.com/financial-and-filings/annual-general-
meetings/sustainability-and-p-esg-report-2025
Management Commentary
40
Events after the Balance Sheet Date
On January 9, 2026, we announced that our Board has authorized a $120 million share repurchase
program (the “Share Repurchase Program”). Purchases under the Share Repurchase Program may
be made from time to time through a variety of methods, which may include open-market purchases,
privately negotiated transactions, or other methods permitted under applicable securities laws. The
timing and amount of any repurchases pursuant to the Share Repurchase Program will be determined
based on market conditions, share price and other factors. The Share Repurchase Program does not
require us to repurchase any specific number of shares, and may be modified, suspended or
terminated at any time without notice.
No other events have occurred after the reporting date that would influence the evaluation of these
financial statements.
Outlook
Having achieved pivotal milestones in 2025, we expect continued global commercial growth, mainly
from YORVIPATH, and development of operating expenses to support growth.
The Company is listed under the symbol “ASND” in the United States on The Nasdaq Global Select
Market, where the Company at the time of approval of this annual report, has not provided a
quantitative financial outlook. Accordingly, and due to equal information to investors, no further
outlook is disclosed in this annual report.
Financial Statements
41
Statements of Profit or Loss and Other Comprehensive Income for the
Years Ended December 31
Group
Parent
(EUR’000, except per share data)
Notes
2025
2024
2025
2024
Statement of Profit or (Loss)
Revenue
4
458,266
405,780
Cost of sales
7, 12
116,997
45,777
Gross profit
341,269
360,003
Research and development expenses
7, 12
94,335
80,596
Selling general and administrative expenses
7, 12
242,745
153,273
Operating profit/(loss)
(136,271 )
(278,763 )
4,189
126,134
Share of profit/(loss) of associates
13
(20,060 )
—
—
Finance income
17
237,338
94,173
Finance expenses
17
143,368
45,567
Profit/(loss) before tax
(212,651 )
(373,241 )
98,159
174,740
Income taxes (expenses)
10
(15,383 )
(4,843 )
(39,692)
(40)
Net profit/(loss) for the year
(228,034 )
(378,084 )
58,467
174,700
Attributable to owners of the Company
(228,034 )
(378,084 )
58,467
174,700
Basic earnings/(loss) per share (€)
5
(3.76
(6.53
—
—
Diluted earnings/(loss) per share (€)
5
(3.76 )
(6.53 )
—
—
Statement of Comprehensive Income or
(Loss)
Net profit/(loss) for the year
(228,034 )
(378,084 )
58,467
174,700
Other comprehensive income/(loss)
Items that may be reclassified subsequently to
profit or (loss):
Exchange differences on translating foreign
operations
(3,538 )
—
—
Other comprehensive income/(loss) for the
year net of tax
(3,538 )
—
—
Total comprehensive income/(loss) for the
year net of tax
(231,572 )
(377,022 )
58,467
174,700
Attributable to owners of the Company
(231,572 )
(377,022 )
58,467
174,700
Financial Statements
42
Statements of Financial Position as of December 31
Group
Parent
(EUR’000)
Notes
2025
2024
2025
2024
Assets
Non-current assets
Intangible assets
6, 11
—
444
Property plant and equipment
6, 12
41,996
23,889
Investments in associates
13
—
—
Investments in group enterprises
21
—
—
163,648
156,306
Receivables from group enterprises
17
2,312,372
1,992,224
Other receivables
17
2,112
1,429
2,520,128
2,174,292
Current assets
Inventories
14
301,533
295,603
Trade receivables
17
6,898
120,643
Income tax receivables
1,475
738
Receivables from group enterprises
17
170,833
28,204
Other receivables
17
5,732
8,952
Prepayments
26,223
24,552
Cash and cash equivalents
17, 18
404,571
492,174
917,265
970,866
Total assets
3,437,393
3,145,158
Equity and liabilities
Equity
Share capital
18
8,322
8,149
Distributable equity
(171,143 )
(113,855 )
2,617,173
2,384,422
Total equity
(162,821 )
(105,706 )
2,625,495
2,392,571
Non-current liabilities
Borrowings
17, 18
25,759
9,223
Contract liabilities
15
1,123
—
Deferred tax liabilities
10
—
—
26,882
9,223
Current liabilities
Convertible notes matures in April 2028
Borrowings
17, 18
429,391
458,207
Derivative liabilities
17, 18
256,231
150,670
685,622
608,877
685,622
608,877
Other current liabilities
Borrowings
17, 18
4,763
3,173
Contract liabilities
15
3,050
—
Trade payables and accrued expenses
17, 18
63,057
84,117
Payables to group enterprises
17, 18
5,196
2,085
Other liabilities
22,715
44,998
Income tax payables
—
—
Provisions
16
613
114
383,769
298,986
99,394
134,487
785,016
743,364
Total liabilities
811,898
752,587
Total equity and liabilities
3,437,393
3,145,158
Financial Statements
43
Statements of Changes in Equity - Group
Group
Distributable Equity
(EUR’000)
Notes
Share
Capital
Share
Premium
Treasury
Shares
Foreign
Currency
Translation
Reserve
Accumulated
Deficit
Total
Equity as of January 1
2024
(146 )
(2,277,095 )
(145,697 )
Net profit / (loss) for the
year
(378,084 )
(378,084 )
Other comprehensive
income/(loss) net of tax
Total comprehensive
income/(loss)
(378,084 )
(377,022 )
Transactions with
Owners
Share-based payment
8
Transfer under stock
incentive programs
18
(33 )
Capital increase
18
Cost of capital increase
(19,291 )
(19,291 )
Equity as of
December 31 2024
(113 )
(2,559,700 )
(105,706 )
Net profit / (loss) for the
year
(228,034 )
(228,034 )
Other comprehensive
income/(loss) net of tax
(3,538 )
(3,538 )
Total comprehensive
income/(loss)
(3,538 )
(228,034 )
(231,572 )
Transactions with
Owners
Share-based payment
8
Acquisition of treasury
shares
18
(16 )
(17,380 )
(17,396 )
Transfer under stock
incentive programs
18
(49 )
Net settlement under stock
incentive programs
(11,396 )
(11,396 )
Capital increase
18
Equity as of
December 31 2025
(80 )
(1,755 )
(2,700,388 )
(162,821 )
Financial Statements
44
Statements of Changes in Equity - Parent
Parent
Distributable Equity
(EUR’000)
Notes
Share
Capital
Share
Premium
Treasury
Shares
Foreign
Currency
Translation
Reserve
Accumulated
Deficit
Total
Equity as of January 1
2024
7,749
2,123,074
(146)
(53)
(329,766)
1,800,858
Net profit / (loss) for the
year
—
—
—
—
174,700
174,700
Total comprehensive
income/(loss)
—
—
—
—
174,700
174,700
Transactions with
Owners
Share-based payment
8
—
—
—
—
95,512
95,512
Acquisition of treasury
shares
—
—
33
—
(33)
—
Capital increase
18
400
340,392
—
—
—
340,792
Cost of capital increase
—
(19,291)
—
—
—
(19,291)
Equity as of
December 31 2024
8,149
2,444,175
(113)
(53)
(59,587)
2,392,571
Net profit / (loss) for the
year
—
—
—
—
58,467
58,467
Other comprehensive
income/(loss) net of tax
—
—
—
—
—
—
Total comprehensive
income/(loss)
—
—
—
—
58,467
58,467
Transactions with
Owners
Share-based payment
8
—
—
—
—
116,171
116,171
Acquisition of treasury
shares
—
—
(16)
—
(17,380)
(17,396)
Transfer under stock
incentive programs
18
—
—
49
—
(49)
—
Net settlement under stock
incentive programs
—
—
—
—
(11,396)
(11,396)
Capital increase
18
173
86,905
—
—
—
87,078
Equity as of
December 31 2025
8,322
2,531,080
(80)
(53)
86,226
2,625,495
Financial Statements
45
Cash Flow Statements for the Years Ended December
Group
Parent
(EUR’000)
Notes
2025
2024
2025
2024
Operating activities
Net profit/(loss) for the year
(228,033 )
(378,084 )
58,467
174,700
Reversal of finance income
(113,999 )
(25,609 )
(237,338)
(94,173)
Reversal of finance expenses
143,368
45,567
Reversal of (gain)/loss on disposal of property plant
and equipment
(91 )
—
—
Reversal of income taxes
39,692
40
Adjustments for non-cash items:
Non-cash consideration relating to revenue
(5,630 )
(27,069 )
—
—
Share of (profit)/loss of associates
(16,308 )
—
—
Share-based payment
68,319
61,038
Depreciation
6,116
4,918
Impairment of property plant and equipment
—
—
Amortization
444
445
Changes in working capital:
Inventories
(5,920 )
(86,678 )
(5,920)
(86,678)
Receivables
(118,607 )
116,587
(111,199)
Receivables from group enterprises
(277,089)
(145,433)
Prepayments
(6,051 )
(1,670)
11,363
Contract liabilities
(1,197 )
4,173
—
Trade payables accrued expenses and other
liabilities
(10,373 )
(42,292)
23,563
Payables to group enterprises
3,111
2,072
Provisions
499
114
Cash flows generated from/(used in) operations
(299,854 )
(123,533)
(113,663)
Finance income received
10,406
11,825
Finance expenses paid
(22,935 )
(15,205 )
(12,645)
(12,196)
Income taxes received/(paid)
(6,679 )
(5,512 )
—
738
Cash flows from/(used in) operating activities
(306,197 )
(125,772)
(113,295)
Investing activities
Investment in group enterprises
—
(67)
Proceeds from disposal of property plant and
equipment
—
—
Acquisition of intangible assets and property plant
and equipment
(8,485 )
(1,427 )
(3,013)
(394)
Settlement of marketable securities
—
7,353
Cash flows from/(used in) investing activities
(8,485 )
(3,013)
6,892
Financing activities
Repayment of borrowings
(21,958 )
(11,365 )
(3,071)
(2,834)
Net proceeds from borrowings
17
—
—
Proceeds from exercise of warrants
87,078
30,514
Proceeds from follow-on public offering
—
309,913
Costs of follow-on public offering
(19,291 )
—
(19,291)
Acquisitions of treasury shares, net of transactions
costs
(17,396 )
(17,396)
—
Payment of withholding taxes under stock incentive
programs
(11,396 )
(11,396)
—
Cash flows from/(used in) financing activities
55,215
318,302
Increase/(decrease) in cash and cash
equivalents
(73,570)
211,899
Cash and cash equivalents at January 1
492,174
263,909
Effect of exchange rate changes on balances held
in foreign currencies
(25,242 )
(14,032)
16,366
Cash and cash equivalents at December 31
404,571
492,174
Financial Statements
46
Notes to the Financial Statements
Note 1 – General Information
Ascendis Pharma A/S, together with its subsidiaries, is a global biopharmaceutical company focused
on applying its innovative TransCon technology platform to make a meaningful difference for patients.
Ascendis Pharma A/S was incorporated in 2006 and is headquartered in Hellerup, Denmark. Unless
the context otherwise requires, references to the “Company,” “we,” “us,” and “our,” refer to Ascendis
Pharma A/S and its subsidiaries.
The address of the Company’s registered office is Tuborg Boulevard 12, DK-2900 Hellerup, Denmark.
The Company’s registration number in Denmark is 29918791.
On February 2, 2015, the Company completed an initial public offering, which resulted in the listing of
American Depositary Shares (“ADSs”), representing the Company’s ordinary shares, under the
symbol “ASND” in the United States on The Nasdaq Global Select Market.
The Company’s Board of Directors (or “Board”) approved these financial statements on February 11,
2026. The financial statements can be obtained from https://datacvr.virk.dk/
Note 2 – Summary of Material Accounting Policies
Basis of Preparation
The financial statements, which include the consolidated financial statements and the parent financial
statements of Ascendis Pharma A/S, are prepared in accordance with the IFRS Accounting Standards
(“IFRS”), as issued by the International Accounting Standards Board (“IASB”), and as adopted by the
E uropean Union (“EU”). The financial statements include additional disclosures for reporting class C
large sized enterprises as required by the Danish Executive Order on Adoption of IFRS as issued in
accordance with the Danish Financial Statements Act.
The accounting policies applied when preparing the financial statements are described in detail below
and are applied for all group entities. Significant accounting judgements and sources of estimation
uncertainties used when exercising the accounting policies are described in Note 3, “Significant
Accounting Judgements and Estimates.”
These financial statements have been prepared under the historical cost convention, apart from
certain financial instruments that are measured at fair value at initial recognition.
New and Amended IFRS Accounting Standards and Interpretations
In August 2023, the IASB amended IAS 21, “The Effects of Changes in Foreign Exchange Rates:
Lack of Exchangeability,” to help entities determine whether a currency is exchangeable into another
currency and which spot exchange rate to use when it is not. These new requirements apply for
annual reporting periods beginning on or after January 1, 2025. The Company has assessed this
amendment and concluded that this did not have an impact on its operations or financial statements
for the year ended December 31, 2025.
No other new and amended standards and interpretations applied for the first time in 2025.
Going Concern
These consolidated financial statements have been prepared on a going concern basis. Management
has assessed the Company’s ability to continue as a going concern and has concluded that there are
no material uncertainties that may cast significant doubt on the Company’s ability to continue in
operational existence for at least twelve months after the reporting date.
Financial Statements
47
Basis of Consolidation
The consolidated financial statements include the Parent Company, Ascendis Pharma A/S, and all
enterprises over which the Parent Company has control. Control of an enterprise exists when the
Company has exposure, or rights to, variable returns from its involvement with the enterprise and has
the ability to control those returns through its power over the enterprise. Accordingly, the consolidated
financial statements include Ascendis Pharma A/S and the subsidiaries listed in Note 21,
“Investments in Group Enterprises and Associates”.
Consolidation Principles
Subsidiaries, which are enterprises the Company controls, are fully consolidated from the date upon
which control is transferred to the Company. They are deconsolidated from the date control ceases.
Control over an enterprise is reassessed if facts and circumstances indicate that there are changes to
one or more of the three elements of control, respectively:
• the contractual arrangement(s) with the other vote holders of the enterprise;
• the Company’s voting rights and potential voting rights; and
• rights arising from other contractual arrangements.
All intra-group assets and liabilities, equity, income, expenses and cash flows relating to transactions
between group enterprises are eliminated in full on consolidation.
Subsidiaries apply accounting policies in line with the Company’s accounting policies. When
necessary, adjustments are made to bring the entities’ accounting policies in line with those of the
Company.
Investments in Associates
An associate is an entity over which the Company has significant influence over financial and
operational decisions but without having control or joint control. The Company’s associates are
accounted for using the equity method and initially recognized at cost. Thereafter, the carrying amount
of the investment is adjusted to recognize changes in the Company’s share of net assets and other
comprehensive income of the associates since the acquisition or establishment date. The Company
discontinues recognition of further losses when its interest in an associate is reduced to nil, except
where the Company has legal or constructive obligations to cover such losses.
Share of profit/(loss) of associates in the consolidated statements of profit or loss include the
Company’s share of result after tax of the associates after any adjustments made to bring the
associates accounting policies in line with those of the Company. Transactions between the
associates and the Company are eliminated proportionally according to the Company’s interest in the
associates. Unrealized gains and losses resulting from transactions between the Company and its
associates are eliminated to the extent of the Company’s interest in the associates.
When the Company’s interest in an associate is reduced but significant influence is retained, the
transaction is accounted for as a partial disposal. A gain or loss is recognized in profit or loss for the
portion of the investment derecognized including the proportionate share of amounts previously
recognized in other comprehensive income that relates to the disposed interest. Any increase in the
associate’s net assets arising from the issuance of new shares is reflected in share of profit/(loss) of
associates. The retained interest continues to be accounted for using the equity method.
On each reporting date, the Company determines whether there are indications that the investment is
impaired. If there is such evidence, the amount of impairment is calculated as the difference between
the recoverable amount of the associate and its carrying amount. Any impairment loss is recognized
in the consolidated statements of profit or loss.
Financial Statements
48
Foreign Currency
Functional and Presentation Currency
Items included in the consolidated financial statements are measured using the functional currency of
each group entity. Functional currency is the currency of the primary economic environment in which
the entity operates. The financial statements are presented in Euros (or “EUR”), which is also the
functional currency of the Parent Company.
Translation of Transactions and Balances
On initial recognition, transactions in currencies other than the individual entity’s functional currency
are translated applying the exchange rate in effect at the date of the transaction. Receivables,
payables and other monetary items denominated in foreign currencies that have not been settled at
the reporting date are translated using the exchange rate in effect at the reporting date. Monetary
items carried at fair value that are denominated in foreign currencies are translated at the rates
prevailing at the date when the fair value was determined.
Exchange rate differences that arise between the rate at the transaction date and the rate in effect at
the payment date, or the rate at the reporting date, are recognized in profit or loss as finance income
or finance expenses. Property, plant and equipment, intangible assets and other non-monetary items
that are measured in terms of historical cost in a foreign currency are translated using the exchange
rates as of the dates of the initial transactions.
Currency Translation of Group Enterprises
When subsidiaries or associates present their financial statements in a functional currency other than
EUR, their statements of profit or loss are translated at average exchange rates. Balance sheet items
are translated using the exchange rates at the reporting date. Exchange rate differences arising from
translation of foreign entities’ balance sheet items at the beginning of the year to the reporting date
exchange rates as well as from translation of statements of profit or loss from average rates to the
exchange rates at the reporting date are recognized in other comprehensive income. Similarly,
exchange rate differences arising from changes that have been made directly in a foreign subsidiary’s
equity are recognized in other comprehensive income.
Revenue
Commercial Products
Revenue is recognized when the customer has obtained control of the goods and it is probable that
the Company will collect the consideration to which it is entitled for transferring the goods. Control is
transferred upon delivery.
Revenue is measured at the contractual sales price, reflecting the consideration received or
receivable from customers, net of value added taxes, and provisions for a variety of sales deductions
such as prompt pay discounts, shelf stock adjustments and applicable sales deductions attributable to
various commercial arrangements, managed healthcare organizations, government programs and co-
pay arrangements. In addition, goods are principally sold on a “sale-or-return” basis, where customers
may return products in line with the Company’s return policy. Sales deductions and product returns
are considered variable consideration and are estimated at the time of sale using the expected value
method. The amount of variable consideration that is included in the transaction price may be
constrained and is included in the net contractual price only to the extent that it is highly probable that
a significant reversal will not occur.
Unsettled sales deductions and product returns are recognized as provisions when timing or amount
is uncertain. Payable amounts that are absolute are recognized as other liabilities. Sales discounts
and deductions that are payable to customers are offset in trade receivables.
Financial Statements
49
Sales-based royalty and sales-based milestone income promised in exchange for a license of
intellectual property, which is interdependent with sale of goods under such license agreements, is
recognized as revenue from commercial products upon occurrence of the later of subsequent sale or
satisfaction of the performance obligation.
Other Revenue
Other revenue relates to collaboration and license agreements (or “Strategic Collaborations”), where
the counterparts are considered customers of the Company. When contracts with these customers
are entered into, the goods and/or services promised in the contract are assessed to identify distinct
performance obligations. A promise in the agreement is considered a distinct performance obligation if
both of the following criteria are met:
• the customer can benefit from the good or service either on its own or together with other
resources that are readily available to the customer (i.e., the good or service is capable of
being distinct); and
• the entity’s promise to transfer the good or service to the customer is separately identifiable
from other promises in the contract (i.e., the promise to transfer the good or service is distinct
within the context of the contract).
For collaboration and license agreements that contain multiple promises to the customer, the
promises are identified and accounted for as separate performance obligations if these are distinct. If
promises are not distinct, those goods or services are combined with other promised goods or
services until a bundle of goods or services that is distinct is identified.
The transaction price in the contract is measured at fair value and reflects the consideration the
Company expects to be entitled to in exchange for those goods or services. Under license
agreements, the transaction price may include up-front payments, royalty and milestone payments.
Sales-based royalty and sales-based milestone income promised in exchange for a license of
intellectual property is recognized as revenue at the later of the occurrence of subsequent sale or
satisfaction of the performance obligation to which some or all of the royalty or milestone has been
allocated. Milestone income related to regulatory activities is included in the transaction price at the
point in time that it is highly probable that the applicable milestone criteria is met.
The transaction price is allocated to each performance obligation according to their stand-alone
selling prices and is recognized when control of the goods or services is transferred to the customer,
either over time or at a point in time, depending on the specific terms and conditions in the contracts.
License agreements, which transfer rights to the Company’s intellectual property (“IP”), are classified
as “right-to-access”, with revenue recognized over time, or as “right-to-use” with revenue recognized
at a point in time, depending on the specific terms and conditions in the agreements.
Sale of clinical trial supply is recognized as revenue when the customer has obtained control of the
goods, and it is probable that the Company will collect the consideration to which it is entitled for
transferring the goods. Control is transferred upon delivery. Rendering of services is recognized as
revenue over the service period as stipulated under the applicable agreement.
Financial Statements
50
Research and Development Expenses
Research and development expenses consist primarily of manufacturing costs, preclinical and clinical
study costs and costs for process optimizations and improvements performed by Clinical Research
Organizations (“CROs”) and Contract Manufacturing Organizations (“CMOs”), salaries and other
personnel costs including pension and share-based payment, the cost of facilities, professional fees,
cost of obtaining and maintaining the Company’s intellectual property portfolio, and depreciation of
non-current assets related to research and development activities.
Research costs are incurred at the early stages of the drug development cycle from the initial drug
discovery and include a variety of preclinical research activities in order to assess potential drug
candidates in non-human subjects, prior to filing an Investigational New Drug Application (“IND”), or
equivalent. Research costs are recognized in the statement of profit or loss when incurred.
Development activities relate to activities following an IND, or equivalent, and typically involve a single
product candidate undergoing a series of studies to illustrate its safety profile and effect on human
beings, prior to obtaining the necessary approval from the appropriate authorities. Development
activities comprise drug candidates undergoing clinical trials starting in Phase I (first time drug is
administered in a small group of humans), and further into Phase II and III, which include
administration of drugs in larger patient groups. Following, and depending on clinical trial results, a
Biologic License Application (“BLA”) or New Drug Application (“NDA”) may be submitted to the
authorities, to apply for marketing approval, which, with a positive outcome will permit the Company to
market and sell the products. Long-term extension trials may be ongoing following submission of a
BLA or NDA.
Development costs also include product development and pre-commercial manufacturing costs
related to development product candidates, and write-downs of inventories manufactured for late-
stage development product candidates prior to marketing approval being obtained (pre-launch
inventories) and any reversal of such write-downs.
Due to the risk related to the development of pharmaceutical products, the Company cannot estimate
the future economic benefits associated with individual development activities with sufficient certainty
until the development activities have been finalized and the necessary market approval of the final
product has been obtained. As a consequence, all development costs are recognized in the statement
of profit or loss when incurred.
Selling, General, and Administrative Expenses
Selling, general, and administrative expenses comprise salaries and other personnel costs including
pension and share-based payment, office supplies, cost of facilities, professional fees, and
depreciation of non-current assets related to selling general and administrative activities, including
pre-commercial and commercial activities. Selling, general and administrative expenses are
recognized in the statement of profit or loss when incurred.
Share-based Incentive Programs
Share-based incentive programs comprise warrant programs, Restricted Stock Unit programs (“RSU-
programs”) and Performance Stock Unit Programs (“PSU-programs”) which are classified as equity-
settled share-based payment transactions.
The cost of equity-settled transactions is determined by the fair value at the date of grant. For warrant
programs, the fair value of each warrant granted is determined using the Black-Scholes option pricing
model. For RSU-programs and PSU-programs, the fair value of each RSU or PSU granted is equal to
the closing share price on the date of grant of the underlying ADS. Any social security contributions
payable in connection with the grant or exercise of the warrants are recognized as expenses when
incurred. The assumptions used for estimating the fair value of share-based payment transactions are
disclosed in Note 8, “Share-based Payment.”
Financial Statements
51
The cost is recognized together with a corresponding increase in equity over the period in which the
performance and/or service conditions are fulfilled (i.e., the vesting period). The fair value determined
at the grant date of the equity-settled share-based payment is expensed on a straight-line basis over
the vesting period for each tranche, based on the best estimate of the number of equity instruments
that will ultimately vest. No expense is recognized for grants that do not ultimately vest.
Where an equity-settled grant is cancelled other than upon forfeiture when vesting conditions are not
satisfied, the grant is treated as if it vested on the date of the cancellation, and any expense not yet
recognized for the grant is recognized immediately.
Where the terms and conditions for an equity-settled grant are modified, the services measured at the
grant date fair value over the vesting period are recognized, subject to performance and/or service
conditions that were specified at the initial grant date(s). Additionally, at the date of modification,
unvested grants are re-measured and any increase in the total fair value is recognized over the
vesting period. If a new grant is substituted for the cancelled grant and designated as a replacement
grant on the date that it is granted, the cancelled and new grants are treated as if they were a
modification of the original grant.
The Parent Company, together with its subsidiaries have entered into group share-based payment
arrangements. The Parent Company incurs share-based payment transactions, whereas subsidiaries
receive the services, and the Parent Company incur an obligation to settle the transaction with the
subsidiaries. While the obligations are settled in the Parent Company’s own equity instruments, group
share-based payments are in the Parent Company’s separate financial statements recognized as cost
of investment in subsidiaries with a corresponding increase in equity over the vesting period. Where
applicable, subsidiaries settle share-based payment transactions with the Parent Company, which are
off-set to investments in subsidiaries.
Finance Income and Expenses
Finance income and expenses comprise interest income and expenses, realized and unrealized
exchange rate gains and losses on transactions denominated in foreign currencies, fair value
remeasurement gains and losses on derivative liabilities, and remeasurement gains and losses on
royalty funding liabilities.
Interest income and interest expenses are stated on an accrual basis using the principal and the
effective interest rate. The effective interest rate is the discount rate that is used to discount expected
future cash payments or receipts through the expected life of the financial asset or financial liability to
the amortized cost (the carrying amount) of such asset or liability.
Income Taxes
Tax for the year, which consists of current tax for the year and changes in deferred tax, is recognized
in the statement of profit or loss by the portion attributable to the profit or loss for the year and
recognized directly in equity or other comprehensive income by the portion attributable to entries
directly in equity and in other comprehensive income. The current tax payable or receivable is
recognized in the statement of financial position, stated as tax computed on this year’s taxable
income, adjusted for prepaid tax.
When computing the current tax for the year, the tax rates and tax rules enacted or substantially
enacted at the reporting date are used. Current tax payable is based on taxable profit or loss for the
year. Taxable profit or loss differs from net profit or loss as reported in the statements of profit or loss
because it excludes items of income or expense that are taxable or deductible in prior or future years.
In addition, taxable profit or loss excludes items that are never taxable or deductible.
Financial Statements
52
Deferred tax is recognized according to the balance sheet liability method of all temporary differences
between carrying amounts and tax-based values of assets and liabilities, apart from deferred tax on
all temporary differences occurring on initial recognition of goodwill or on initial recognition of a
transaction which is not a business combination, and for which the temporary difference found at the
time of initial recognition neither affects profit or loss nor taxable income.
Deferred tax liabilities are recognized on all temporary differences related to investments in
subsidiaries and/or associates, unless the Company is able to control when the deferred tax is
realized, and it is probable that the deferred tax will not become due and payable as current tax in the
foreseeable future.
Deferred tax assets, including the tax base of tax loss carry forwards, are recognized in the statement
of financial position at their estimated realizable value, either as a set-off against deferred tax liabilities
or as net tax assets for offset against future positive taxable income. Deferred tax assets are only
offset against deferred tax liabilities if the entity has a legally enforceable right to offset, and the
deferred tax assets and deferred tax liabilities relate to income taxes levied by the same tax
jurisdiction. Deferred tax is calculated based on the planned use of each asset and the settlement of
each liability, respectively.
Deferred tax is measured using the tax rates and tax rules in the relevant countries that, based on
acts in force or acts in reality in force at the reporting date are expected to apply when the deferred
tax is expected to crystallize as current tax. Changes in deferred tax resulting from changed tax rates
or tax rules are recognized in the statement of profit or loss unless the deferred tax is attributable to
transactions previously recognized directly in equity or other comprehensive income. In the latter
case, such changes are also recognized in equity or other comprehensive income. On every reporting
date, it is assessed whether sufficient taxable income is likely to arise in the future for the deferred tax
asset to be utilized.
Intangible assets
Goodwill
Goodwill acquired in a business combination is initially measured at cost, being the excess of the
aggregate of the consideration transferred and the amount recognized for non-controlling interests
over the net identifiable assets acquired and liabilities assumed.
After initial recognition, goodwill is measured at cost less any accumulated impairment losses.
Goodwill is not amortized but is subject to impairment testing at least on a yearly basis. For the
purpose of impairment testing, goodwill acquired in a business combination is allocated to each of the
cash-generating units, or group of cash-generating units, that are expected to benefit from the
synergies of the combination. Each cash-generating unit or group of cash-generating units to which
goodwill is allocated represents the lowest level within the Company at which the goodwill is
monitored for internal management purposes.
Software
Software assets comprise administrative applications and serve general purposes to support the
Company’s operations.
Development costs that are directly attributable to the design, customization, implementation, and
testing of identifiable and unique software assets controlled by the Company are recognized as
intangible assets from the time that; (1) the software asset is clearly defined and identifiable; (2)
technological feasibility, adequate resources to complete, and an internal use of the software asset
can be demonstrated; (3) the expenditure attributable to the software asset can be measured reliably;
and (4) the Company has the intention to use the software asset internally. The Company does not
capitalize software with no alternative use, or where economic benefit depends on marketing
approvals of drug candidates and where marketing approvals have not been obtained.
Financial Statements
53
Following initial recognition of the development expenditure as an asset, the asset is carried at cost
less any accumulated amortization and accumulated impairment losses. Amortization of the asset
begins when the development is complete, and the asset is available for use.
Software assets are amortized over the period of expected future benefits. Amortization is recognized
in research and development expenses, and selling, general and administrative expenses, as
appropriate. Expenditures that do not meet the criteria above are recognized as an expense as
incurred.
Other Intangible Assets
Intangible assets comprise acquired intellectual property rights in the form of patents and licenses,
which are measured at cost less accumulated amortization and accumulated impairment losses. Cost
comprises the acquisition price and costs directly attributable to the acquisition of the asset. The
amortization period is determined based on the expected economic and technical useful life of the
asset, and amortization is recognized on a straight-line basis over the expected useful life of 5-10
years depending on the planned use of the specific asset and the lifetime of the patents protecting the
intellectual property rights. Subsequent costs to maintain the intangible assets are recognized as
expenses in the period to which they relate.
Property, Plant and Equipment
Property, plant and equipment primarily comprise leasehold improvements, office facilities, and
process equipment and tools which are located at CMOs. Property, plant and equipment also includes
right-of-use assets. Refer to the separate section “Leases.”
Property, plant and equipment is measured at cost less accumulated depreciation and impairment
losses. Cost comprises the acquisition price, costs directly attributable to the acquisition and
preparation costs of the asset until the time when it is ready to be used in operation. Subsequent
costs are included in the carrying amount of the asset or recognized as a separate asset, as
appropriate, only when it is probable that future economic benefits associated with the assets will flow
to the Company and costs of the items can be measured reliably. All repair and maintenance costs
are charged to the statement of profit or loss during the financial periods in which they are incurred.
Plant and equipment acquired for research and development activities with alternative use, which is
expected to be used for more than one year, is capitalized and depreciated over the estimated useful
life as research and development expenses. Plant and equipment acquired for research and
development activities, which have no alternative use, is recognized as research and development
expenses when incurred.
If the acquisition or use of the asset involves an obligation to incur costs of decommissioning or
restoration of the asset, the estimated related costs are recognized as a provision and as part of the
relevant asset’s cost, respectively.
The basis for depreciation is cost less estimated residual value. The residual value is the estimated
amount that would be earned if selling the asset today net of selling costs, assuming that the asset is
of an age and a condition that is expected after the end of its useful life.
Cost of a combined asset is divided into smaller components, with such significant components
depreciated individually if their useful lives vary. Depreciation commences when the asset is available
for use, which is when it is in the location and condition necessary for it to be capable of operating in
the manner intended.
Depreciation is calculated on a straight-line basis, based on an asset’s expected useful life, being
within the following ranges:
Process plant and machinery
5-10 years
Other equipment
3- 5 years
Leasehold improvements
3-15 years
Right-of-use assets
2-15 years
Financial Statements
54
Depreciation methods, useful lives and residual amounts are reassessed at least annually.
Property, plant and equipment is written down to the lower of recoverable amount and carrying
amount, as described in the “Impairment of Non-current Assets” section below. Depreciation and
impairment losses of property, plant and equipment is recognized in the statement of profit or loss as
cost of sales, research and development expenses or as selling, general, and administrative
expenses, as appropriate.
Gains and losses on disposal of property, plant and equipment are recognized in the consolidated
statement of profit or loss at its net proceeds, as either research and development expenses or as
selling, general, and administrative expenses, as appropriate.
Investments in Group Enterprises – Parent Company
Investments in group enterprises are recognized and measured at cost. Investments that are
measured in terms of historical cost in a foreign currency are translated using the exchange rates as
of the dates of the initial transactions.
Investments are written down to the lower of recoverable amount and carrying amount which is further
described below in the section “Impairment."
Impairment of Non-current Assets
The recoverable amount of goodwill is estimated annually irrespective of any recorded indications of
impairment. Property, plant and equipment and finite-lived intangible assets are reviewed for
impairment whenever events or circumstances indicate that the carrying amount may not be
recoverable.
An impairment loss is recognized for the amount by which the asset’s carrying amount exceeds its
recoverable amount. The recoverable amount is the higher of an asset’s fair value less costs of
disposal and value in use.
For the purpose of assessing impairment, assets are grouped at the lowest levels for which there are
largely independent cash inflows, or cash-generating units, which for goodwill represent the lowest
level within the enterprise at which the goodwill is monitored for internal management purposes. Prior
impairments of non-current assets, other than goodwill, are reviewed for possible reversal at each
reporting date.
Inventories
Inventories comprise raw materials, work in progress and finished goods. The cost of work in progress
and finished goods comprise service expenses incurred at CMOs, raw materials consumed,
incremental storage and transportation, other direct materials, and a proportion of manufacturing
overheads based on normal operation capacity.
Inventories are measured at the lower of cost incurred in bringing it to its present location and
condition, and net realizable value. Net realizable value is the estimated selling price in the ordinary
course of business, less estimated costs of completion and the estimated costs necessary to make
the sale. Cost is measured using the first-in, first-out method.
Work in progress and finished goods are measured under a standard cost method that takes into
account normal levels of consumption, yields, labor, efficiency and capacity utilization. Production
processes are complex, where actual yields and consumptions are sensitive to a wide variety of
manufacturing conditions. Standard cost variances are reviewed regularly and adjusted to ensure
inventories approximate actual cost of production.
Financial Statements
55
If net realizable value is lower than cost, a write-down is recognized as the excess amount by which
cost exceeds net realizable value, as part of cost of sales, or selling, general, and administrative
expenses, as appropriate. The amount of reversal of write-down of inventories arising from an
increase in net realizable value is recognized as a reduction in the same profit or loss line item as the
original write-down was recognized, in the period in which the reversal occurs.
Manufacturing of pre-launch inventories is initiated for late-stage product candidates where
manufacturing costs are recognized as inventories. However, since pre-launch inventories are not
realizable prior to obtaining marketing approval, pre-launch inventories are immediately written down
to zero through research and development expenses. If marketing approval is obtained, prior write-
downs of pre-launch inventories are reversed through research and development expenses.
Cost of inventories is recognized as part of cost of sales in the period in which the related revenue is
recognized.
Receivables
Receivables comprise trade receivables, lease receivables, income tax receivables and other
receivables.
Trade receivables are classified as financial assets at amortized cost, as these are held to collect
contractual cash flows and thus give rise to cash flows representing solely payments of principal and
interest. Trade receivables are initially recognized at their transaction price and subsequently
measured at amortized cost.
Where the Company acts as an intermediate lessor and a sublease is classified as a finance lease,
the Company recognize a net investment in the lease (lease receivable) and derecognize the portion
of the asset that is subject to the sublease. The lease receivable is initially measured at the present
value of lease payments receivable plus any unguaranteed residual value. Any difference on
derecognition of the right‑of‑use asset is recognized in the consolidated statement of profit or loss.
Subsequently, finance income is recognized using the effective interest method. Further the lease
receivable is reduced by lease payments received.
Income tax receivables and other receivables related to deposits, VAT and other indirect taxes are
measured at cost less impairment. Carrying amounts of receivables usually equals their nominal value
less provision for impairments.
Prepayments
Prepayments comprise advance payments relating to a future financial year. Prepayments are
measured at cost.
Marketable Securities
Marketable securities may comprise government bonds, treasury bills, commercial papers, and other
securities traded on established markets.
At initial recognition (trade-date), contractual terms of individual securities are analyzed to determine
whether these give rise on specified dates to cash flows that are solely payments of principal and
interest on the principal outstanding (“SPPI-test”). All marketable securities held at the reporting date
have passed the SPPI-test.
Marketable securities are initially recognized at fair value at trade-date, and subsequently measured
at amortized cost under the effective interest method. Interest income is recognized as finance
income in the statement of profit or loss. Marketable securities are subject to an impairment test to
accommodate expected credit loss. Gains and losses are recognized as finance income or expenses
in the statement of profit or loss when the specific security or portfolio of securities is derecognized,
modified or impaired.
Financial Statements
56
Marketable securities, having maturity profiles of three months or less after the date of acquisition are
presented as cash equivalents in the statements of financial position, where securities having
maturities of more than three months after the date of acquisition are presented separately as
marketable securities as current (i.e., those maturing within twelve months after the reporting date) or
non-current assets, as appropriate.
Cash and Cash Equivalents
Cash and cash equivalents comprise cash and on-demand deposits with financial institutions, and
highly liquid marketable securities with a maturity of three months or less after the date of acquisition
(trade-date). Cash and cash equivalents are measured at amortized cost.
Allowance for Expected Credit Losses on Financial Assets
Financial assets comprise receivables (excluding receivables relating to VAT, other indirect tax and
income tax), marketable securities, and cash and cash equivalents. Impairment of financial assets is
determined on the basis of a forward-looking Expected Credit Loss (“ECL”) model. ECLs are based
on the difference between the contractual cash flows due in accordance with the contract and the
cash flows expected to be received, discounted by an approximation of the original effective interest
rate.
For receivables, a simplified approach in calculating ECLs is applied. Therefore, changes in credit
risks are not tracked, but instead, a loss allowance based on lifetime ECL is assessed at each
reporting date. Lifetime ECLs are assessed on historical credit loss experience, adjusted for forward-
looking factors specific to the counterparts and the economic environment.
For cash, cash equivalents and marketable securities, ECLs are assessed for credit losses that result
from default events that are possible within the next twelve months (12-month ECL). Credit risk is
continuously tracked and monitored in order to identify significant deterioration. For those credit
exposures for which there have been a significant increase in credit risk since initial recognition, an
allowance is recognized for credit losses expected over the remaining life of the exposure,
irrespective of the timing of the default.
Shareholders’ Equity
The share capital comprises the nominal amount of the Parent Company’s ordinary shares, each at a
nominal value of DKK 1, or approximately €0.13. All shares are fully paid.
Share premium comprises the amounts received, attributable to shareholders’ equity, in excess of the
nominal amount of the shares issued at the Parent Company’s capital increases, reduced by any
expenses directly attributable to the capital increases. Under Danish legislation, share premium is an
unrestricted reserve that is available to be distributed as dividends to a company’s shareholders. Also,
under Danish legislation, the share premium reserve can be used to offset accumulated deficits.
Treasury shares reserve comprise nominal amounts of holding of own equity instruments. No gain or
loss is recognized in profit or loss on the purchase, sale, transfer or cancellation of the Company’s
own equity instruments. The treasury shares reserve is part of unrestricted reserves and accordingly,
reduce the amount available to be distributed as dividends to the Company’s shareholders.
Foreign currency translation reserve includes exchange rate adjustments relating to the translation of
the results and net assets of foreign operations from their functional currencies to the presentation
currency.
The accumulated reserve of a foreign operation is reclassified to the statement of profit or loss at the
time the Company loses control, and thus cease to consolidate such foreign operation. The foreign
currency translation reserve is an unrestricted reserve that is available to be distributed as dividends
to the Company’s shareholders.
Financial Statements
57
Retained earnings/(accumulated deficit) represents the accumulated profits or losses from the
Company’s operations, including corresponding entries to share-based payments recognized in the
statement of profit or loss. In addition, premiums from acquisition and sale of treasury shares are
recognized as part of this reserve. A positive reserve is available to be distributed as dividends to the
Company’s shareholders.
Convertible Senior Notes and Embedded Derivative Liabilities
Convertible senior notes (“convertible notes”) are separated into a financial liability and an embedded
derivative component based on the terms and conditions of the contract. The embedded derivative
component is accounted for separately if it is not deemed closely related to the financial liability.
The convertible notes include an embedded equity conversion option which is not deemed closely
related to the financial liability, and initially recognized and measured separately at fair value as
derivative liabilities based on the stated terms upon issuance of the convertible notes. The conversion
option is classified as a foreign currency conversion option and thus not convertible into a fixed
number of shares for a fixed amount of cash. Accordingly, the conversion option is subsequently
recognized and measured as a derivative liability at fair value through profit or loss, with any
subsequent remeasurement gains or losses recognized as part of finance income or expenses.
In addition, the convertible notes include a redemption option, which entitle the Company to redeem
the notes at a cash amount equal to the principal amount of the convertible notes, plus accrued and
unpaid interest. The redemption option is closely related to the financial liability, and not separately
accounted for. The initial carrying amount of the financial liability component including the redemption
option is the residual amount of the proceeds, net of transaction costs, after separating the derivative
component.
Transaction costs are apportioned between the financial liability and derivative component based on
the allocation of proceeds when the instrument is initially recognized. Transaction costs apportioned
to the financial liability component form part of the effective interest and are amortized over the
expected lifetime of the liability. Transaction costs allocated to the derivative component are expensed
as incurred.
The financial liability is subsequently measured at amortized cost until it is extinguished on
conversion, upon optional redemption or repayment at maturity. Convertible notes are presented as
borrowings, together with the derivative liabilities on the statement of financial position, separately
under current liabilities as “Convertible notes, matures in April 2028.”
Royalty Funding Liabilities
Royalty funding liabilities relate to the Company’s contractual obligations to pay a predetermined
percentage of future revenue from sale of commercial products until reaching a predetermined
multiple of proceeds received, pursuant to the detailed provisions of the capped synthetic royalty
funding agreements.
Where relevant, royalty funding liabilities are separated into a financial liability and embedded
derivative components based on the terms and conditions of the applicable royalty funding
agreement. Embedded derivative components are accounted for separately, unless these are
deemed closely related to the financial liability. The royalty funding agreements include a buy-out
option where the value is dependent on non-financial variables that are specific to the Company.
Accordingly, the buy-out option is not accounted for separately as a derivative.
The financial liability is recognized when the Company becomes party to the contractual provisions of
the royalty funding agreement and measured at amortized cost until it is extinguished upon exercising
a buy-out option or upon achieving the predetermined multiple of proceeds received.
Financial Statements
58
The effective interest rate is estimated at initial recognition and takes into account incremental
transaction costs and anticipated amount and timing of future cash flows, which further depends on
future commercial revenue forecasts and the probability of exercising the buy-out option. The
amortized cost is remeasured prospectively when there is a material change in expectations to
amount and timing of future cash flows, which will increase or decrease future interest expenses.
Remeasurement gain or losses are recognized through the profit or loss as finance income or
expenses, respectively.
Royalty funding liabilities that are classified as a financial liability are presented as part of borrowings
in the statement of financial position.
Leases
Right-of-use Assets
Right-of-use assets are recognized at the lease commencement date, defined as the date the
underlying asset is available for use. Right-of-use assets are measured at cost, less any accumulated
depreciation and impairment losses, and adjusted for any remeasurement of lease liabilities. The cost
of right-of-use assets include the amount of lease liabilities recognized, initial direct costs incurred,
and lease payments made at or before the commencement date less any incentives received. In
addition, right-of-use assets also include an estimate of costs to be incurred by the Company in
dismantling or restoring the underlying asset to the condition if required by the terms and condition of
the lease, if any.
Right-of-use assets are presented as part of property, plant and equipment, and depreciated on a
straight-line basis over the shorter of the lease term and the estimated useful lives of the assets.
Lease Liabilities
At the lease commencement date, lease liabilities are recognized and measured at the present value
of fixed lease payments and variable lease payments that depend on an index or a rate, whereas
variable lease payments and payments related to non-lease components are excluded. Variable lease
payments that do not depend on an index or a rate are recognized as expenses in the statement of
profit or loss when incurred.
When interest rates implicit in the lease contracts are not readily available, the present value of lease
payments are calculated by applying the incremental borrowing rate of the relevant entity holding the
lease. Following the commencement date, the incremental borrowing rate is not changed unless the
lease term is modified, or if the lease payments are modified and this modification results from a
change in floating interest rates. From the lease commencement date and over the lease term, the
carrying amount of lease liabilities is increased to reflect the accretion of interest and reduced for the
lease payments made. In addition, the carrying amount of lease liabilities is remeasured if there is a
modification, a change in lease term, or a change in lease payments, including changes to future
payments resulting from a change in an index used to determine such lease payments.
Lease liabilities are presented as part of borrowings in the statement of financial position.
Short-term Leases and Leases of Low-value Assets
Expenses related to short-term leases (12 months or less) and leases of low-value assets are
recognized on a straight-line basis through profit or loss.
Provisions
Provisions comprise unsettled sales deductions and product returns regarding revenue from sale of
commercial products where amount or timing of payment is uncertain.
Provisions for sales deductions attributed to various commercial arrangements, managed healthcare
organizations, government programs, and co-pay arrangements are recognized when the related
sales takes place and measured using the expected value method.
Financial Statements
59
Payable amounts for managed healthcare organizations and government programs are generally
settled within 180 days from the transaction date.
Provisions for estimated product returns are measured according to the contractual sales price based
on expected product returns.
Trade Payables and Accrued Expenses
Trade payables and accrued expenses are measured at amortized cost.
Other Liabilities
Other liabilities comprise payables to public authorities, short-term employee benefits, and sales
deductions. Other liabilities are measured at their net-realizable values.
Contract Liabilities
Contract liabilities comprise deferred income from collaboration and license agreements, where
consideration received does not match the individual deliverables with respect to amount and satisfied
performance obligations.
Contract liabilities are measured at the fair value of the consideration received and is recognized as
revenue in the statement of profit or loss when the relevant performance obligation, to which the
deferred income relates, is satisfied.
Statement of Cash Flows
The statement of cash flows shows cash flows from operating, investing and financing activities as
well as cash and cash equivalents at the beginning and the end of the financial year.
Cash flows from operating activities are presented using the indirect method and calculated as the
profit or loss adjusted for non-cash items, working capital changes as well as finance income, finance
expenses and income taxes paid.
Cash flows from investing activities include payments in connection with acquisition, development,
improvement and sale, etc., of property, plant and equipment, investments in associates and
marketable securities.
Cash flows from financing activities comprise payments related to the capital structure of the
Company, including changes in the share capital and treasury shares and issuance and repayments
under the Company’s borrowing activities.
The effect of exchange rate changes on cash and cash equivalents held or due in a foreign currency
is presented separately from cash flows from operating, investing and financing activities. Cash flows
in currencies other than the functional currency are recognized in the statements of cash flows, using
the average exchange rates.
Cash and cash equivalents comprise cash and on-demand bank deposits with financial institutions
and highly liquid marketable securities with a maturity of three months or less after the date of
acquisition.
Basic Earnings per Share
Basic Earnings per Share (“EPS”) is calculated as the consolidated net income or loss from continuing
operations for the period divided by the weighted average number of ordinary shares outstanding
adjusted for the weighted average number of treasury shares during the year.
Financial Statements
60
Diluted Earnings per Share
Diluted EPS is calculated as the consolidated net income or loss from continuing operations for the
period divided by the weighted average number of ordinary shares outstanding adjusted for the
weighted average number of treasury shares during the year, and the dilutive effect of outstanding
warrants, RSUs, PSUs, and convertible notes, if any.
New IFRS Accounting Standards Not Yet Effective
The IASB has issued a number of new or amended standards, which have not yet become effective
or have not yet been adopted by the EU. Therefore, these new standards have not been incorporated
in these financial statements.
IFRS 18, “Presentation and Disclosure in Financial Statements”
In April 2024, the IASB issued IFRS 18, “Presentation and Disclosure in Financial Statements” (“IFRS
18”), which replaces IAS 1, “Presentation in Financial Statements.” IFRS 18 introduces new
categories and subtotals in the statement of profit or loss, into:
• Operating activities;
• Investing activities;
• Financing activities;
• Income taxes; and
• Discontinued operations.
In addition, IFRS 18 includes new requirements for the location, aggregation and disaggregation of
financial information, and disclosure of management-defined performance measures, as defined, if
any. IFRS 18 does not include any measurement changes.
If approved by the EU, the amendments will be effective for annual reporting periods beginning on or
after January 1, 2027, and must be applied retrospectively, with early adoption permitted. While IFRS
18 will change the structure and subtotal in the statement of profit or loss, the full impact from
implementing IFRS 18 is currently being analyzed.
The consolidated financial statements are not expected to be affected by other new or amended
standards.
Note 3 – Significant Accounting Judgements and Estimates
In the application of the Company’s accounting policies, management is required to make
judgements, estimates and assumptions about the carrying amounts of assets and liabilities that are
not readily apparent from other sources. Judgements, estimates and assumptions applied are based
on historical experience and other factors that are relevant, and which are available at the reporting
date. Uncertainty concerning estimates and assumptions could result in outcomes that require a
material adjustment to assets and liabilities in future periods.
Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting
estimates are recognized prospectively.
While the application of critical accounting estimates is subject to material estimation uncertainties,
management’s ongoing revisions of critical accounting estimates and underlying assumptions have
not revealed any material impact to any of the years presented in these consolidated financial
statements compared to December 31, 2024.
Financial Statements
61
Significant accounting judgements which have a significant impact on the consolidated financial
statements, and key assumptions concerning the future and other key sources of estimation
uncertainty at the reporting date, that have a risk of causing a material adjustment to the carrying
amounts of assets and liabilities within the next financial year, are described below.
Revenue and Provisions
Provisions for Sales Deductions and Product Returns
Sales deductions and product returns are considered variable consideration and constrained to the
extent that a significant reversal in the amount of recognized revenue will not occur when the
uncertainties associated with the rebate or chargeback item are subsequently resolved, or for product
returns, when the products are distributed to patients.
Provisions for unsettled sales deductions and product returns are estimated on the basis of a
percentage of sales as defined by individual agreements and contracts, and for government rebates
by individual state- and plan agreements. Further inputs to the calculations are based on payer
channel mix, current contract prices under eligible programs and current inventory levels in the
distribution channels. Inputs to the calculations are subject to estimation and assumptions and are
based on historical experience and other factors that are relevant, and which are available at the
reporting date. Provisions are adjusted to absolute amounts and recognized as other liabilities when
estimated sales deductions are processed.
As of December 31, 2025, provisions for sales deductions and product returns were €166.4 million
compared to €99.1 million, as of December 31, 2024. The development in total provisions is disclosed
in Note 16, “Provisions.” Due to the nature of these provisions, it is not practicable to give meaningful
sensitivity estimates due to the large volume of variables that contribute to the overall rebates,
chargebacks, product returns and other sales deductions. Provisions are reviewed and adjusted
regularly considering contractual terms, regulatory obligations, payer trends, historical experiences
and market projections.
Share-based Payment
Warrant Compensation Costs
IFRS 2, “Share-Based Payment” requires an entity to reflect in its statement of profit or loss and
financial position, the effects of share-based payment transactions. Warrant compensation costs are
recognized as cost of sales, research and development expenses or selling, general and
administrative expenses, as appropriate, over the vesting period, based on management’s best
estimate of the number of warrants that will ultimately vest, which is subject to uncertainty.
Warrant compensation costs are measured according to the grant date fair value of the warrants
granted. Estimating fair values requires the Company to apply generally accepted valuation models
and apply these models consistently according to the terms and conditions of the specific warrant
program. Under all warrant programs, the Black-Scholes option-pricing model has been applied to
determine the fair value of warrants granted. Subjective judgements and assumptions, which are
subject to estimation uncertainties, need to be exercised in determining the appropriate input to the
valuation model. These inputs include expected volatility of the Company’s share price for a historic
period equaling the expected lifetime of the warrants, reflecting the assumption that the historical
volatility over a period similar to the life of the warrants is indicative of future trends, expected
forfeitures and expected lifetime of warrants.
Warrant compensation cost recognized in the consolidated statement of profit or loss was €23.0
million, and €19.7 million for the years ended December 31, 2025, and 2024, respectively. Changes to
inputs applied to the Black-Scholes option pricing model could affect the warrant compensation cost.
Refer to Note 8, “Share-based Payment,” for additional details.
Valuation of Embedded Derivatives
Foreign currency conversion options embedded in the convertible notes are accounted for separately
as derivative liabilities at fair value through profit or loss.
Financial Statements
62
Fair value cannot be measured based on quoted prices in active markets, or other observable input,
and accordingly, derivative liabilities are measured by use of valuation techniques in the form of the
Black-Scholes option pricing model. Subjective judgements and assumptions, which are subject to
estimation uncertainties, need to be exercised in determining the appropriate unobservable input to
the valuation model (Level 3 in the fair value hierarchy). This includes volatility of the Company’s
share price for a historic period, reflecting the assumption that the historical volatility is indicative of a
period similar to the expected lifetime of the options.
As of December 31, 2025, the valuation of the derivative liabilities was €256.2 million compared to
€150.7 million as of December 31, 2024. Changes in assumptions relating to these factors could
affect the reported fair value of derivative liabilities. Refer to Note 17 “Financial Assets and Liabilities”,
for additional details.
Measurement of Royalty Funding Liabilities
The carrying amount of royalty funding liabilities is measured according to anticipated future cash
flows, which further depends on the amount and timing of future revenue from sale of commercial
products. Assumptions that impact the amount and timing of future sale of commercial products are
subject to estimation uncertainties, and are subject to a number of factors which are not within the
Company’s control.
As of December 31, 2025, the carrying amount of the royalty funding liabilities was €290.9 million
compared to €305.4 million as of December 31, 2024. The Company will periodically revisit the
anticipated amount and timing of future sale of commercial products and to the extent such amount or
timing is materially different from the previous estimates, a remeasurement gain or loss is recognized
through the profit or loss as finance income or expenses, as appropriate, which would further increase
or decrease future interest expenses. Refer to Note 17 “Financial Assets and Liabilities” for additional
details.
Note 4 – Revenue
Revenue has been recognized in the statements of profit or loss with the following amounts:
Group
Parent
(EUR’000)
2025
2024
2025
2024
Revenue
Commercial products
683,572
225,728
118,189
47,940
Services and clinical supply
18,008
15,570
340,077
252,566
Licenses
5,630
122,343
—
105,274
Milestones
12,922
—
—
—
Total revenue
720,132
363,641
458,266
405,780
Specified per geographical area
United States
(1)
546,388
233,115
45,670
394
Europe
(2)
120,946
123,336
387,882
405,386
Rest of world
(1)
52,798
7,190
24,714
—
Total revenue
720,132
363,641
458,266
405,780
(1) From 2025, revenue related to the United States has been disclosed separately. Comparatives for the
United States and Rest of World have been restated for comparative purposes.
(2) For the years ended December 31, 2025 and December 31, 2024 Denmark, the country of domicile,
contributed with €12.9 million and €95.4 million of revenue (Parent Company €381.8 million and €405.0
million for 2024) respectively.
Financial Statements
63
Commercial Products
Revenue from sale of commercial products were as follows:
Group
(EUR’000)
2025
2024
Revenue from commercial products
YORVIPATH®
477,412
28,727
SKYTROFA®
206,160
197,001
Total revenue from commercial products
683,572
225,728
In the U.S., the Company has established an integrated organization to commercialize the Company’s
approved Endocrinology Rare Disease products, YORVIPATH® and SKYTROFA®. In Europe, the
Company has established its presence by building integrated organizations in select countries
(“Europe Direct”), where the Company has launched YORVIPATH and SKYTROFA. Beyond the U.S.
and Europe Direct, YORVIPATH and SKYTROFA may also be sold through exclusive sales and
distribution agreements with geographic market leaders (“International Markets”) and under Strategic
Collaborations.
YORVIPATH and SKYTROFA is approved by the U.S. Food and Drug Administration (“FDA”) and
authorized by the European Commission (“EC”) and other regulatory agencies. The Company began
selling YORVIPATH in Europe in the first quarter of 2024 and in the U.S. in December 2024. The
Company began selling SKYTROFA in the U.S. in the fourth quarter of 2021 and in Europe in the third
quarter of 2023.
For the year ended December 31, 2025 two and for the year ended December 31 2024, four
commercial customers represented more than 10% of revenue from commercial products.
Other Revenue
Other revenue is attributable to the Company’s Strategic Collaborations, and relates to Novo Nordisk
A/S (“Novo Nordisk”), Eyconis, Inc. (“Eyconis”), Teijin Limited (“Teijin”) and VISEN Pharmaceuticals
(“VISEN”).
Novo Nordisk
In November 2024, the Company entered into a research and development collaboration and license
agreement (the “Novo Nordisk Agreement”) with Novo Nordisk pursuant to which the Company
granted Novo Nordisk an exclusive worldwide license to the TransCon technology platform to
develop, manufacture and commercialize Novo Nordisk proprietary products (including Semaglutide)
in metabolic diseases (including obesity and type 2 diabetes) and a product-by-product exclusive
license in cardiovascular diseases (the “IP”).
The Novo Nordisk Agreement includes provisions requiring at least one TransCon Semaglutide
product and at least one other TransCon technology-based product to be identified, developed and
commercialized in metabolic diseases to maintain certain exclusivities in the field, with additional
provisions for cardiovascular diseases. Under the terms of the Novo Nordisk Agreement, Novo
Nordisk also receives exclusive rights to expand any resulting metabolic disease products into other
therapeutic areas. The lead program in the collaboration is a once-monthly TransCon Semaglutide
product candidate that will initially target obesity and type 2 diabetes.
Under the Novo Nordisk Agreement, the Company has the potential to receive total payments of up to
$285 million in upfront, development and regulatory milestone payments for the lead program. In
addition, the Company has the potential to receive sales-based milestone payments and tiered
royalties on global net sales. The $285 million includes an upfront fee of $100 million for the exclusive
license. For each additional metabolic or cardiovascular disease product candidate, the Company will
be eligible to receive payments of up to $77.5 million in development and regulatory milestone
payments. In addition, the Company has the potential to receive sales-based milestone payments and
tiered royalties on global net sales.
Financial Statements
64
Novo Nordisk agreed to pay royalties for each potential licensed product developed under the
agreement that are an escalating tiered, mid-single digit percentage of the annual net sales of such
licensed product and are subject to reduction due to patent valid claim expiration, biosimilar product
market share, payment made under certain licenses for third party intellectual property and Inflation
Reduction Act price negotiations.
Under the Novo Nordisk Agreement, the Company agreed to conduct certain pre-agreed early
research and development of TransCon product candidates under the collaboration and is eligible to
receive cost reimbursement from Novo Nordisk for its performance of such research and development
activities under the Novo Nordisk Agreement with respect to such TransCon product candidates.
Novo Nordisk is responsible for any other non-clinical and clinical development, regulatory,
commercial manufacturing, and commercialization of such TransCon product candidates, and all
costs associated with such activities.
Subject to the terms of the Novo Nordisk Agreement, the Company granted Novo Nordisk an
exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses, to use its proprietary
TransCon technology platform to develop, manufacture and commercialize Novo Nordisk proprietary
products in metabolic diseases (including obesity and type 2 diabetes) and a product-by-product
exclusive license in cardiovascular diseases. Additionally, the Company granted Novo Nordisk an
exclusive, worldwide, royalty-bearing license, with the right to grant sublicenses, to use its proprietary
TransCon technology platform to develop, manufacture and commercialize GLP-1 receptor products
using the TransCon technology for all indications, except for (i) certain pre-agreed rare endocrine
indications, (ii) all indications in respect of the eye and adnexa and (iii) all indications in respect of
oncology.
Unless earlier terminated, the Novo Nordisk Agreement has a royalty term that continues, on a per
licensed product and per country basis, until the later of (i) the expiration of the last valid patent claim
for any of our patents, joint improvement patents, licensed product patents as well as any
improvements made by Novo Nordisk covering the licensed product’s dosage regimen or target
product profile, or (ii) 11 years after the first commercial sale of such licensed product in such country.
The IP comprises the patent protected TransCon technology platform, where future activities do not
affect its existing stand-alone functionalities. Accordingly, the IP is classified as “right-to-use” licenses,
with revenue recognized at a point in time, where the licensee is granted access to the IP. For the
year ended December 31 2024, “Licenses” includes revenue of €95.3 million related to the upfront
payment, which is allocated to transfer of the Company’s intellectual property.
Eyconis
In January 2024, the Company announced the formation and launch with Frazier Life Sciences of
Eyconis, a separate company created to develop, manufacture, and commercialize TransCon
ophthalmology assets globally, together with a $150 million commitment from an investor syndicate
that includes Frazier, RA Capital Management, venBio, and HealthQuest Capital.
The Company has granted Eyconis exclusive rights to develop and commercialize TransCon
ophthalmology products globally (the “Eyconis Agreement”) and received, as consideration, an equity
position in the newly formed company. In addition, the Company is eligible to receive development,
regulatory, and sales milestone payments, plus single digit royalties on global net sales of
commercialized products, if any.
The Company is expected to provide various research and development services, which are subject
to separate remuneration, and which will be recognized as revenue over time as rendering of services
or reimbursement revenue, as applicable.
For the year ended December 31 2024, “Licenses” includes revenue of €27.1 million related to the
non-cash upfront payment through an equity position in Eyconis, adjusted for internal profit, which is
allocated to transfer of the Company’s intellectual property (the “IP”). The internal profit relates to the
Company’s share of the non-cash upfront payment which is recognized as part of “Investments in
associates” and recognized as revenue from “Licenses” as the IP is amortized in the associate.
Financial Statements
65
Teijin
In November 2023, the Company entered into an exclusive license agreement (the “Teijin
Agreement”) with Teijin for the further development and commercialization of TransCon hGH,
TransCon PTH, and TransCon CNP for endocrinology rare disease (the “Licensed Products”) in
Japan. Under the terms of the Teijin Agreement, the Company received an upfront payment of $70
million, with additional development and regulatory milestones of up to $175 million and commercial
milestones. In addition, the Company is eligible to receive royalties on net sales of the Licensed
Products in Japan, of up to mid-20’s percent.
Further, the Company will provide clinical and commercial supply, and development services for joint
activities, which are subject to separate remuneration, and which will be recognized as revenue over
time as rendering of services or reimbursement revenue, as applicable.
The Licensed Products (the “IP”) are patent protected, where future activities do not affect their
existing stand-alone functionalities. Accordingly, all three licenses are classified as “right-to-use”
licenses, with revenue recognized at a point in time, where the licensee is granted access to the IP.
For the year ended December 31, 2023, “Licenses” includes revenue of €63.7 million related to the
upfront payment, which is allocated to transfer of the Company’s IP. In Japan, YORVIPATH has been
commercially available for prescription since November 6, 2025, through Teijin.
VISEN
In November 2018, the Company entered into three exclusive license agreements with VISEN, and
includes rendering of services, sale of clinical supply and commercial products.
Note 5 – Earnings Per Share
The following table reflects the earnings and share data used in the basic and diluted earnings per
share calculations:
Group
(EUR’000 except per share data)
2025
2024
Earnings
Net profit/(loss) for the year
(228,034
)
(378,084
)
Number of shares
Weighted average number of ordinary shares for the purposes of
basic and diluted earnings per share
60,607,131
57,891,570
Basic earnings per share (€)
(3.76
)
(6.53
)
Diluted earnings per share (€)
(1)
(3.76
)
(6.53
)
(1) For the years ended December 31, 2025, December 31, 2024 and December 31, 2023, outstanding
warrants, restricted stock units and performance stock units can potentially dilute earnings per share in the
future but have not been included in the calculation of diluted earnings per share because they are
antidilutive for the years presented. Similarly, 575,000 convertible senior notes which can potentially be
converted into 3,456,785 ordinary shares, can potentially dilute earnings per share in the future but have
not been included in the calculation of diluted earnings per share because they are antidilutive for the years
presented. Refer to Note 8 “Share-based Payment” and Note 17, “Financial Assets and Liabilities,” for
further information about the share-based incentive programs and convertible notes, respectively.
Financial Statements
66
Note 6 – Segment Information
The Company is managed and operated as one business unit. Accordingly, no additional information
on business segments or geographical areas is disclosed apart from revenue on geographical areas
as disclosed in Note 4, “Revenue.” Revenue is specified on geographical areas according to the
location of the customer.
The Company’s non-current segment assets, which comprise intangible assets, and property, plant
and equipment, and investments in associates, are located by region as follows:
Group
(EUR’000)
2025
2024
Non-current segment assets
(1)
North America
74,651
76,677
Europe
(2)
108,064
39,640
Total non-current segment assets
182,715
116,317
(1) From 2025, non-current segment assets include investments in associates. Comparatives have been
restated for comparative purposes.
(2) As of December 31, 2025 and December 31, 2024, intangible assets and property, plant and equipment of
€33.6 million and €27.9 million, respectively, is located in Denmark, the country of domicile. In addition, as
of December 31, 2025 and December 31, 2024, intangible assets and property, plant and equipment of
€71.8 million and €11.6 million, respectively, is located in Germany.
Note 7 – Employee costs
Group
Parent
(EUR’000)
2025
2024
2025
2024
Employee costs
Wages and salaries
227,118
173,474
92,871
76,448
Share-based payment
116,171
95,512
68,319
61,038
Pensions (defined contribution plans)
6,921
4,485
3,068
1,766
Social security costs
21,134
15,003
765
633
Other employee costs
5,221
4,061
2,497
2,133
Total employee costs
376,565
292,535
167,520
142,018
Included in the profit or loss
Cost of sales
(1)
20,474
16,487
20,474
16,487
Research and development expenses
145,673
131,867
74,303
66,073
Selling general and administrative expenses
210,418
144,181
72,743
59,458
Total employee costs
376,565
292,535
167,520
142,018
Average number of employees
520
445
(1) Includes employee costs capitalized as part of inventories.
Key Management Personnel comprises the Board of Directors and the Executive Board and Non-
executive Senior Management ("Senior Management"). Compensation to Key Management
Personnel comprises salaries, participation in annual bonus schemes, pensions (defined contributions
plans), and share-based compensation. Share-based compensation is elaborated in further details in
Note 8, “Share-based Payment.”
Financial Statements
67
Compensation to Key Management Personnel included in total employee costs is summarized below:
Board of Directors
(1)
Executive Board
(2)
Non-executive
Senior
Management
(EUR’000)
2025
2024
2025
2024
2025
2024
Compensation
Wages and salaries
442
482
5,466
4,148
6,466
3,286
Share-based payment
2,425
2,169
18,568
18,334
14,464
10,266
Pensions (defined contribution plans)
—
—
73
57
136
98
Social security costs
—
—
598
118
316
52
Other employee cost
—
—
20
20
40
25
Total compensation
2,867
2,651
24,725
22,677
21,422
13,727
(1) The Board of Directors comprised six persons in 2025 and 2024.
(2) The Executive Board comprised four persons in 2025 and 2024.
Note 8 – Share-based Payment
As an incentive to the Senior Management, other employees, members of the Board and select
consultants, Ascendis Pharma A/S has established warrant programs, a Restricted Stock Unit (“RSU”)
program adopted in December 2021, and a Performance Stock Unit (“PSU”) program adopted in
February 2023, which are all classified as equity-settled share-based payment transactions. Share-
based compensation costs are determined using the grant date fair value and are recognized over the
vesting period as research and development expenses, selling, general and administrative expenses,
or cost of sales.
Restricted Stock Unit Program
RSUs are granted by the Board to members of Senior Management, other employees and members
of the Board (the “RSU-holders”), as stipulated in the program. In addition, RSUs may be granted to
select consultants.
One RSU represents a right for the RSU-holder to receive one ADS representing ordinary shares of
Ascendis Pharma A/S upon vesting, if the vesting conditions are met.
Performance Stock Unit Program
PSUs are granted by the Board to certain members of Senior Management (the “PSU-holders”), as
stipulated in the program. In addition, PSUs may be granted to other employees, select consultants
and members of the Board. One PSU represents a right for the PSU-holder to receive one ADS
representing ordinary shares of Ascendis Pharma A/S upon vesting.
Vesting Conditions
RSUs granted vest over a predetermined service period, and accordingly require RSU-holders to be
employed, or provide a specified period of service (“service conditions”). RSUs vest over three years
with 1/3 of the RSUs vesting on each anniversary date from the date of grant. RSUs generally cease
to vest from the date of termination of employment, or for the Board, termination of board
membership, whereas unvested RSUs will lapse.
One PSU represents a right for the PSU-holder to receive one ADS representing ordinary shares of
Ascendis Pharma A/S upon vesting. PSUs vest in a manner similar to the service conditions of the
RSUs. In addition to service conditions, vesting is also contingent upon achievement of performance-
based targets as determined by the Board, provided that no more than 10% of each tranche may be
directly attributable to accomplishment of financial results achieved in the financial year prior to the
vesting date for PSUs granted in 2023, and upon achievement of long-term strategic goals as
evaluated by the Board no later than two weeks prior to each vesting date. Exceeding performance
targets will not result in vesting of more PSUs than 100%, nor will it result in additional grants.
Financial Statements
68
RSUs and PSUs generally cease to vest from the date of termination of employment or board
membership, as applicable, whereas unvested RSUs or PSUs will be forfeited. The Board may at its
discretion and on an individual basis decide to deviate from the vesting conditions, including deciding
to accelerate vesting in the event of termination of employment or board membership, as applicable.
Settlement Options
All RSUs and PSUs are settled at the time of vesting by transfer of treasury shares that are ADSs
repurchased in the market. In jurisdictions where the Company is required to withhold and settle tax
with the tax authority on behalf of the RSU/PSU-holders, the Company withholds the number of RSUs
or PSUs that are equal to the estimated monetary value of the RSU/PSU-holders tax obligation from
the total number of RSUs or PSUs that otherwise would have been transferred to the RSU/PSU
holder upon vesting. These settlements are presented as “Net settlement under stock incentive
programs” in the consolidated statement of equity. The Company may at its sole discretion choose to
make a cash settlement instead of delivering ADSs.
Adjustments
RSU-holders and PSU-holders are entitled to an adjustment of the number of RSUs or PSUs granted,
in the event of certain corporate changes, including among other events, increases or decreases to
the share capital at a price below or above market value, the issuance of bonus shares, and changes
in the nominal value of each share. In addition, the RSU and PSU Programs contain provisions to
accelerate vesting, or compensate with grant of new equity instruments, in the event of restructuring
events including change in control events.
RSU and PSU Activity
The following table specifies the number of RSUs and PSUs outstanding:
Restricted
Stock Units
Performance
Stock Units
Total
(Number)
Outstanding
January 1, 2024
576,625
105,023
681,648
Granted during the year
(1)
717,980
92,655
810,635
Transferred during the year
(212,160
)
(35,007
)
(247,167
)
Forfeited during the year
(88,638
)
(6,004
)
(94,642
)
December 31, 2024
993,807
156,667
1,150,474
Granted during the year
(1)
634,589
73,583
708,172
Settled during the year
(60,056
)
(15,716
)
(75,772
)
Transferred during the year
(321,351
)
(46,588
)
(367,939
)
Forfeited during the year
(67,161
)
(2,688
)
(69,849
)
December 31, 2025
1,179,828
165,258
1,345,086
Specified by vesting date
2026
566,011
86,659
652,670
2027
411,030
54,066
465,096
2028
202,787
24,533
227,320
December 31, 2025
1,179,828
165,258
1,345,086
(1) The fair value of RSUs and PSUs is determined on the basis of the closing ADS price on the grant date.
The fair value of one RSU and one PSU at the date of grant was €150.40 and €141.01 for the years ended
December 31, 2025 and December 31, 2024, respectively.
Financial Statements
69
Warrant Program
Warrants are granted by the Board in accordance with authorizations given to it by the shareholders
of Ascendis Pharma A/S to all employees, members of the Board and select consultants (“warrant
holders”). Each warrant carries the right to subscribe for one ordinary share of a nominal value of DKK
1. The exercise price is equal to the fair market value of the Company’s ordinary shares at the time of
grant as determined by the Board. Apart from exercise prices, exercise periods and vesting conditions
for board members, the programs are similar.
Vesting Conditions
Warrants granted vest over a predetermined service period and require warrant-holders provide a
specified period of service. Warrants generally cease to vest from the date of termination. In relation
to board members, the vesting shall cease on the termination date of the board membership
regardless of the reason. In relation to consultants, the vesting shall cease on the termination date of
the consultancy relationship. The warrant-holder will, however, be entitled to exercise vested warrants
in the exercise periods after termination.
In the event that the employment contract is terminated, and the employee has not given the
Company good reason to do so, the warrant-holder may keep the right to continued vesting and
exercise of warrants as if the employment was still in effect. In such case, any expense not yet
recognized for the outstanding warrants is recognized immediately.
For warrants granted to employees and consultants, 25% of the warrants vest one year after the date
of grant, and the remaining 75% of the warrants granted vest over 36 months, with 1/36 of the
warrants vesting per month, from one year after the date of grant.
For warrants granted to board members upon the board members accession, 25% of the warrants
vest one year after the date of grant, and the remaining 75% of the warrants granted vest over 36
months, with 1/36 of the warrants vesting per month, from one year after the date of grant.
Regarding subsequent grants of warrants to board members, 50% of the warrants vest one year after
the date of grant, and the remaining 50% of the warrants vest over 12 months, with 1/12 per month
from one year after the date of grant.
Exercise Periods
Vested warrants may be exercised during certain exercise periods each year, within certain periods
after publication of earnings data of a fiscal quarter, interim and annual reports, as per each
program’s terms and conditions.
Warrants expire ten years after the grant date. Warrants not exercised by the warrant holder during
the last exercise period shall become null and void without further notice or compensation or payment
of any kind to the warrant-holder. If the warrant-holder is a consultant, advisor or board member, the
exercise of warrants is conditional upon the warrant-holder’s continued service to the Company at the
time the warrants are exercised. If the consultant’s, advisor’s or board member’s relationship with the
Company should cease without this being attributable to the warrant-holder’s actions or omissions,
the warrant-holder shall be entitled to exercise vested warrants in the pre-defined exercise periods.
Adjustments
Warrant-holders are entitled to an adjustment of the number of warrants issued and/or the exercise
price applicable in the event of certain corporate changes.
Events giving rise to an adjustment include, among other things, increases or decreases to the share
capital at a price below or above market value, the issuance of bonus shares, changes in the nominal
value of each share, and payment of dividends in excess of 10% of the Company’s equity.
Financial Statements
70
Warrant Activity
The following table specifies the number and weighted average exercise prices of, and movements in
warrants:
Warrants
(number)
Weighted
Average
Exercise Price
(EUR)
(Number)
Outstanding
January 1, 2024
6,523,784
86.38
Granted during the year
504,105
122.48
Exercised during the year
(1)
(682,048
)
43.35
Forfeited during the year
(141,719
)
107.85
December 31, 2024
6,204,122
93.25
Vested at the reporting date
5,226,643
89.33
Granted during the year
434,883
148.06
Exercised during the year
(1)
(1,287,921
)
68.76
Forfeited during the year
(128,243
)
109.52
Expired during the year
(250
)
15.68
December 31, 2025
5,222,591
103.24
Vested at the reporting date
4,419,487
97.98
(1) The weighted average share price (listed in $) at the date of exercise was €162.08 and €135.86 for the years
ended December 31, 2025 and 2024, respectively.
At December 31, 2025, the Board was authorized to grant up to 1,725,233 additional warrants to
employees, board members and select consultants without preemptive subscription rights for the
shareholders of Ascendis Pharma A/S.
The following table specifies the weighted average exercise prices and weighted average remaining
contractual life for outstanding warrants at December 31, 2025 per grant year.
Outstanding
Warrants
(number)
Weighted
Average
Exercise
Price (EUR)
Weighted
Average
Remaining
Life
(months)
Granted before January 1, 2023
4,208,147
97.25
50
Granted in 2023
175,231
92.48
89
Granted in 2024
430,190
122.52
102
Granted in 2025
409,023
149.15
113
Outstanding at December 31, 2025
5,222,591
103.24
61
At December 31, 2025, the exercise prices of outstanding warrants under the Company’s warrant
programs range from €11.98 to €180.65 depending on the grant dates.
The range of exercise prices for outstanding warrants was €11.98 to €145.50 for the year ended
December 31, 2024. The weighted average remaining life for outstanding warrants was 65 months for
the year ended December 31, 2024.
Financial Statements
71
Warrant Compensation Costs
Warrant compensation costs are determined with basis in the grant date fair value of the warrants
granted and recognized over the vesting period. Fair value of the warrants is calculated at the grant
dates by use of the Black-Scholes option pricing model with the following assumptions: (1) an
exercise price equal to the estimated market price of the Company’s shares at the date of grant; (2)
an expected lifetime of the warrants determined as a weighted average of the time from grant date to
date of becoming exercisable and from grant date to expiry of the warrants; (3) a risk-free interest rate
equaling the effective interest rate on a Danish government bond with the same lifetime as the
warrants; (4) no payment of dividends; and (5) an expected volatility using the Company’s own share
price.
The following table summarizes the input to the Black-Scholes option pricing model and the calculated
fair values for warrant grants in 2025 and 2024:
2025
2024
Expected volatility
49 % - 50 %
50 %
Risk-free interest rate
2.00 % - 2.32 %
1.71 % - 2.57 %
Expected life of warrants (years)
6.0
6.0
Weighted average exercise price
€
148.06
122.48
Fair value of warrants granted in the year
€
56.45 - 87.55
50.86 - 70.39
Note 9 – Principal Accountant Fees and Services
The following table sets forth, for each of the years indicated, the fees billed by the Company’s
independent public accountants and the proportion of each of the fees out of the total amount billed
by the accountants.
Group
(EUR’000)
2025
2024
Principal accountant fees and services
Audit fees
840
811
Audit-related fees
11
147
Tax fees
—
91
Total principal accountant fees and services
851
1,049
Financial Statements
72
Note 10 – Tax on Profit/(Loss) for the Year and Deferred Tax
Group
Parent
(EUR’000)
2025
2024
2025
2024
Tax on profit/(loss) for the year
Current tax (expense)/income
(12,556)
(3,289)
(39,692)
—
Current tax, adjustments to prior years
513
(126)
—
(40)
Deferred tax, movement for the year
(3,410)
(2,035)
—
—
Deferred tax, adjustments to prior years
70
607
—
—
(15,383)
(4,843)
(39,692)
(40)
Tax for the year can be explained as follows
Profit/(loss) before tax
(212,651)
(373,241)
98,159
174,740
Tax at the Danish corporation tax rate of 22%
46,783
82,113
(21,595)
(38,443)
Tax effect of:
Non-deductible costs
29,358
(9,740)
4,880
(14,900)
Additional tax deductions
37,715
3,161
4,584
670
Impact from associates
3,588
(4,413)
—
—
Prior year adjustments
583
481
—
—
Other effects including effect of different tax rates
(2,121)
182
—
(40)
Deferred tax assets not recognized
(131,289)
(76,627)
(27,561)
52,673
Tax on profit/(loss) for the year
(15,383)
(4,843)
(39,692)
(40)
Effective tax rate
7.23%
1.30%
(40.44)%
(0.02)%
Group
Parent
(EUR’000)
2025
2024
2025
2024
Development in deferred tax assets/(liabilities)
January 1
(7,258)
(5,830)
—
—
Deferred income tax (expense)/income through profit or
loss
(3,340)
(1,428)
—
—
Foreign exchange translation
975
—
—
—
December 31
(9,623)
(7,258)
—
—
Tax deductible losses
430,011
434,997
—
9,522
Other temporary differences assets
291,759
164,479
77,618
38,391
Deferred tax assets not recognized
(721,631)
(599,476)
(77,618)
(47,913)
Other temporary differences liabilities
(9,762)
(7,258)
—
—
Total Deferred Tax Assets/(Liabilities) at December
31
(9,623)
(7,258)
—
—
Deferred Tax Assets, Not Recognized
Deferred tax assets have not been recognized in the consolidated statements of financial position as
of December 31, 2025, due to uncertainty relating to future utilization. The majority of the deferred tax
assets can be carried forward without timing limitations, however tax credits can only be deducted in
future payable taxes over a period up to 20 years.
As of December 31, 2025, the Company has tax losses carried forward and other temporary
deductible differences with a gross amount of €3,280.0 million (Parent Company €352.7 million). The
deferred tax assets, not recognized of €721.6 million (Parent Company €77.6 million), mainly
attributable to tax-losses carried forward, future R&D depreciations, future tax deductions related to
share based payments, additional tax deductions related to up-lift on R&D expenses and additional
tax deductions related to tax credits.
The Company had tax losses carried forward of €1,954.6 million (Parent Company €0 million) at
December 31, 2025, and €1,946.2 million (Parent Company €43.2 million) as of December 31, 2024,
Tax losses can be carried forward infinitely, where certain limitations exist for amounts to be utilized
each year. Under Danish tax legislation, tax losses may be partly refunded by the tax authorities to
the extent such tax losses arise from research and development activities.
Financial Statements
73
The jointly taxed Danish entities had a negative taxable income and accordingly were entitled to a tax
refund of approximately €0.7 million for each of the years ended December 31, 2025December 31,
2025 and 20242024.
Other temporary differences include future tax deductions related to share based payments
(Warrants, RSUs and PSUs). Tax deductions can be taken when the warrants/RSUs/PSUs are
exercised/transferred. For the year ended December 31, 2025, the future tax deductions have been
estimated to have a tax value of €67.0 million (Parent Company €38.0 million) compared to €21.7
million (Parent Company €21.0 million) for the year ended December 31, 2024, respectively. These
future tax deductions depend on the future share price, timing and amounts of warrants/RSUs/PSUs
exercises/transfers, and accordingly, the future tax deductions are subject to uncertainties. Refer to
Note 8, “Share-based Payment,” regarding a description of warrant and RSU/PSU programs.
For the year ended December 31, 2025, the Company is entitled to additional future tax deduction
related to uplift on R&D deductions and tax credits with a total tax value of €29.7 million (Parent
Company €2.9 million) compared to €24.8 million (Parent Company €2.4 million) for the year ended
December 31, 2024. Additional future tax deductions are included in other temporary differences.
International Tax Reform - Pillar Two Model Rules
On May 23, 2023, the IASB issued “International Tax Reform - Pillar Two Model Rules - Amendments
to IAS 12,” which clarifies that IAS 12 applies to income taxes arising from tax law enacted or
substantively enacted to implement the Pillar Two model rules published by the OECD/G20 Inclusive
Framework on Base Erosion and Profit Shifting Pillar Two model rules. The Company has adopted
these amendments; however, they are not applicable for the year ended December 31, 2025, as the
Company’s consolidated revenue is currently below the threshold of €750 million.
Uncertain Tax Positions
The Company operates across numerous tax jurisdictions with complex, interpretative legislation.
Management evaluates uncertain tax positions to ensure proper recognition and measurement of tax
assets and liabilities.
Note 11 – Intangible Assets
Group
(EUR’000)
Goodwill
Software
Total
Cost
January 1 2024
3,495
2,296
5,791
Additions
—
76
76
December 31 2024
3,495
2,372
5,867
Additions
—
172
172
December 31 2025
3,495
2,544
6,039
Amortization and impairment
January 1 2024
—
(1,372
)
(1,372
)
Amortization charge
—
(467
)
(467
)
December 31 2024
—
(1,839
)
(1,839
)
Amortization charge
—
(490
)
(490
)
December 31 2025
—
(2,329
)
(2,329
)
Carrying amount
December 31 2024
3,495
533
4,028
December 31 2025
3,495
215
3,710
Financial Statements
74
Parent
(EUR’000)
Software
Acquired
intellectual
property
Total
Cost
January 1 2024
2,222
1,326
3,548
December 31 2024
2,222
1,326
3,548
Additions
—
—
—
December 31 2025
2,222
1,326
3,548
Amortization and impairment
January 1 2024
(1,333
)
(1,326
)
(2,659
)
Amortization charge
(445
)
—
(445
)
December 31 2024
(1,778
)
(1,326
)
(3,104
)
Amortization charge
(444
)
—
(444
)
December 31 2025
(2,222
)
(1,326
)
(3,548
)
Carrying amount
December 31 2024
444
—
444
December 31 2025
—
—
—
At the reporting date, no internally generated intangible assets from development of pharmaceutical
drug candidates have been recognized. Thus, all related research and development expenses
incurred for the years ended December 31, 2025, and 2024, were recognized in the statements of
profit or loss.
Goodwill relates to the acquisition of Complex Biosystems GmbH (now Ascendis Pharma GmbH) in
2007. Goodwill was calculated as the excess amount of the purchase price to the fair value of
identifiable assets acquired, and liabilities assumed at the acquisition date. Ascendis Pharma GmbH
was initially a separate technology platform company but is now an integral part of the Company’s
research and development activities. Accordingly, it is not possible to look separately at Ascendis
Pharma GmbH when considering the recoverable amount of the goodwill. Goodwill is monitored and
tested for impairment on a consolidated level as the Company is considered to represent one cash-
generating unit.
The recoverable amount of the cash-generating unit is determined based on an estimation of the
Company’s fair value less costs of disposal. The fair value of goodwill has been determined after
taking into account the market value of the Company’s ADSs as of the reporting date. The
computation of the market value including an estimation of selling costs, significantly exceeded the
carrying amount of the net assets, leaving sufficient value to cover the carrying amount of goodwill.
Considering the excess value, no further assumptions are deemed relevant to be applied in
determining whether goodwill is impaired.
Financial Statements
75
Note 12 – Property, Plant and Equipment
Group
(EUR’000)
Plant and
Machinery
Other
Equipment
Leasehold
Improve-
ments
Right-of-
Use
Assets
Total
Cost
January 1 2024
27,436
11,420
19,375
123,920
182,151
Additions
299
951
76
861
2,187
Disposals
(5,995
)
(1,635
)
—
(89
)
(7,719
)
Transferred
66
(66
)
—
—
—
Foreign exchange translation
127
306
847
5,462
6,742
December 31 2024
21,933
10,976
20,298
130,154
183,361
Additions
996
5,704
1,678
78,646
87,024
Transferred
(1)
(162
)
(1,311
)
(13,658
)
(21,264
)
(36,395
)
Foreign exchange translation
(2
)
(517
)
(1,271
)
(9,299
)
(11,089
)
December 31 2025
22,765
14,852
7,047
178,237
222,901
Depreciation and impairment
January 1 2024
(12,784
)
(7,175
)
(10,946
)
(40,612
)
(71,517
)
Depreciation charge
(2,330
)
(1,322
)
(1,283
)
(12,312
)
(17,247
)
Disposals
5,296
1,501
—
88
6,885
Foreign exchange translation
(112
)
(194
)
(556
)
(1,906
)
(2,768
)
December 31 2024
(9,930
)
(7,190
)
(12,785
)
(54,742
)
(84,647
)
Depreciation charge
(2,325
)
(1,301
)
(1,230
)
(12,350
)
(17,206
)
Impairment charge
—
(196
)
(618
)
(6,694
)
(7,508
)
Impairment reversal
16
201
2,008
—
2,225
Transferred
(1)
529
731
11,667
12,797
25,724
Foreign exchange translation
(18
)
368
793
3,847
4,990
December 31 2025
(11,728
)
(7,387
)
(165
)
(57,142
)
(76,422
)
Carrying amount:
December 31 2024
12,003
3,786
7,513
75,412
98,714
December 31 2025
11,037
7,465
6,882
121,095
146,479
(1) Includes transfer from right-of-use assets to finance lease receivables. For further details, refer to Note 17,
“Financial Assets and Liabilities.”
The impairment charge for the year ended December 31, 2025, relates to change in activities at one
of the Company´s sites. The site is partially subleased (commencing in 2026) and is recognized as a
right-of-use asset with a carrying amount of €30.9 million as of December 31, 2025. The impairment
charge represents the difference between the carrying amount of the right‑of‑use subleased asset
and the lease receivable, subsequently recognized at the lease commencement date.
Depreciation charges are specified below:
Group
(EUR’000)
2025
2024
Depreciation charges
Cost of sales
(1)
1,835
3,197
Research and development expenses
8,468
7,453
Selling general and administrative expenses
6,903
6,597
Total depreciation charges
17,206
17,247
(1) Includes depreciation charges capitalized as part of inventories.
Financial Statements
76
Parent
(EUR’000)
Plant and
Machinery
Other
Equipment
Leasehold
Improve-
ments
Right-of-
Use
Assets
Total
Cost
January 1 2024
7,730
2,594
3,030
30,684
44,038
Additions
-
268
76
49
393
Disposals
-
-
-
(88
)
(88
)
December 31 2024
7,730
2,862
3,106
30,645
44,343
Additions
-
1,989
1,024
21,210
24,223
December 31 2025
8,092
4,388
4,147
51,855
68,566
Depreciation and impairment
January 1 2024
(638
)
(2,159
)
(727
)
(12,100
)
(15,624
)
Depreciation charge
(787
)
(247
)
(296
)
(3,588
)
(4,918
)
Disposals
-
-
-
88
88
December 31 2024
(1,425
)
(2,406
)
(1,023
)
(15,600
)
(20,454
)
Deprecation charge
(821
)
(408
)
(405
)
(4,482
)
(6,116
)
December 31 2025
(2,246
)
(2,814
)
(1,428
)
(20,082
)
(26,570
)
Carrying amount
December 31 2024
6,305
456
2,083
15,045
23,889
December 31 2025
5,846
1,574
2,719
31,773
41,996
Depreciation charges are specified below:
Parent
(EUR’000)
2025
2024
Depreciation charges
Cost of sales
(1)
1,835
3,197
Research and development expenses
2,997
1,053
Selling general and administrative expenses
1,284
668
Total depreciation charges
6,116
4,918
(1) Includes depreciation charges capitalized as part of inventories.
Note 13 – Investments in Associates
The Company’s associates relate to investments in Eyconis (principal place of business; U.S.), and
VISEN (principal place of business; China). The Company’s investments in Eyconis and VISEN are
accounted for using the equity method in the consolidated financial statements as the Company has
determined that it has significant influence over the investments.
Eyconis
In January 2024, the Company announced the formation and launch with Frazier Life Sciences of
Eyconis, a separate company created to develop, manufacture, and commercialize TransCon
ophthalmology assets globally, together with a $150 million commitment from an investor syndicate
that includes Frazier, RA Capital Management, venBio, and HealthQuest Capital. As of December 31,
2025 and 2024, the Company’s ownership in Eyconis was 33.2% and 41.6%, respectively. As of
December 31, 2025 and 2024, the carrying amount of Eyconis using the equity method was €9.2
million and €13.6 million, respectively.
Financial Statements
77
VISEN
In November 2018, the Company entered into three exclusive license agreements with VISEN for the
further development and commercialization of TransCon hGH, TransCon PTH and TransCon CNP in
Greater China, and as consideration for the granting of such rights has received a 50.0% ownership of
VISEN’s issued and outstanding shares. On March 20, 2025, VISEN Pharmaceuticals (“VISEN”)
announced the pricing of its initial public offering (“IPO”) on the Hong Kong Stock Exchange. The IPO
closed on March 21, 2025, and VISEN’s shares began trading under the stock code 2561.HK. Prior to
the IPO the Company’s ownership in VISEN was 43.9%. Following the IPO, the Company’s
ownership in VISEN was 39.2%. As a result, a non-cash gain of €35.7 million was recognized in the
consolidated statement of profit or loss as part of share of profit/(loss) of associates. The IPO did not
change the accounting treatment of VISEN. As of December 31, 2025 and 2024 the Company’s
ownership in VISEN was 39.2% and 43.9%, respectively. As of December 31, 2025 VISEN’s share
price at the Hong Kong Stock Exchange was HK$32.80, reflecting the market value of the Company’s
equity position of €147.5 million. As of December 31, 2025 and 2024, the carrying amount of VISEN
using the equity method was €23.3 million and €0.0 million, respectively.
The management and existing shareholders of VISEN, including Ascendis Pharma, have entered into
customary lock-up agreements restricting the sale of VISEN shares for six months following the IPO;
additionally, certain significant shareholders of VISEN, including the Company, are subject to an
additional lock-up obligation during the period commencing on the date that is six months after the
IPO and ending on the date that is 12 months after the IPO during which such shareholders may not
sell shares of VISEN to an extent that would cause such shareholder to cease being a controlling
shareholder of VISEN pursuant to applicable listing rules.
Financial Statement Information from Associates
The aggregated profit or loss, total comprehensive income as per the associates latest available
interim financial statements, transactions and outstanding balances with associates as of
December 31, 2025 and 2024 were as follows.
Group
(EUR’000)
2025
2024
Statement of profit or (loss)
Profit/(loss) for the year from continuing operations
(47,507
)
(59,235
)
Total comprehensive income
(47,490
)
(59,218
)
Transactions and outstanding balances as of December 31
Invoicing of goods and services to associates
31,808
18,225
Trade receivables from associates
824
1,759
Contract liabilities
4,944
5,936
Note 14 – Inventories
Inventories are specified below:
Group and Parent
(EUR’000)
2025
2024
Inventories
Raw materials and consumables
19,083
17,596
Work in progress
253,494
235,688
Finished goods
28,956
42,325
Total inventories
301,533
295,609
Due to production lead time, work in progress includes inventories that are not sellable before more
than twelve months after the reporting date.
Inventories were reduced by write-downs of €24.9 million and €15.7 million for the years ended
December 31, 2025 and 2024 respectively.
Financial Statements
78
Note 15 – Contract Liabilities
At December 31, 2025, contract liabilities comprise unsatisfied performance obligations related to
delivery of commercial supply under one of the Company’s license agreements. Non-current contract
liabilities are expected to be recognized as revenue within 1-2 years.
Revenue recognized from contract liabilities were €5.9 million (Parent Company: €— million) and €1.4
million (Parent Company: €— million) for the years ended December 31, 2025 and 2024, respectively.
Note 16 – Provisions
Development in provisions is specified below:
Group
Parent
(EUR’000)
2025
Provisions
January 1
99,149
114
Additions related to prior years
3,936
—
Net additions for the year
74,288
499
Reversals and other adjustments
(639
)
—
Foreign exchange translation
(10,338
)
—
December 31
166,396
613
Financial Statements
79
Note 17 – Financial Assets and Liabilities
Financial assets and liabilities comprise the following:
Group
Parent
(EUR’000)
2025
2024
2025
2024
Financial assets by category
Trade receivables
141,333
166,280
6,898
120,643
Receivables from group enterprises
—
—
2,483,205
2,020,428
Other receivables (excluding indirect tax
receivables)
Lease receivables
10,268
—
—
—
Other receivables
9,322
3,964
4,541
3,035
Cash and cash equivalents
616,041
559,543
404,571
492,174
Financial assets measured at amortized cost
776,964
729,787
2,899,215
2,636,280
Total financial assets
776,964
729,787
2,899,215
2,636,280
Classified in the statement of financial position
Non-current assets
10,870
2,317
2,314,484
1,993,653
Current assets
766,094
727,470
584,731
642,627
Total financial assets
776,964
729,787
2,899,215
2,636,280
Financial liabilities by category
Borrowings
Convertible senior notes
429,391
458,207
429,391
458,207
Royalty funding liabilities
290,871
305,379
—
—
Lease liabilities
151,524
93,030
30,522
12,396
Trade payables and accrued expenses
90,657
96,394
63,057
84,117
Payables to group enterprises
—
—
5,196
2,085
Other liabilities (excluding indirect tax and employee
related payables)
1,046
311
—
—
Financial liabilities measured at amortized cost
963,489
953,321
528,166
556,805
Derivative liabilities
256,231
150,670
256,231
150,670
Financial liabilities measured at fair value through
profit or loss
256,231
150,670
256,231
150,670
Total financial liabilities
1,219,720
1,103,991
784,397
707,475
Classified in the statement of financial position
Non-current liabilities
385,254
365,080
25,759
9,223
Current liabilities
834,466
738,911
758,638
698,252
Total financial liabilities
1,219,720
1,103,991
784,397
707,475
Financial Statements
80
Finance income and expenses are specified below:
Group
Parent
(EUR’000)
2025
2024
2025
2024
Finance income
Interest income
15,301
14,361
10,406
11,812
Interest income from group enterprises
—
—
183,566
82,361
Remeasurement gain of financial liabilities
20,469
11,248
—
—
Foreign exchange translation (net)
78,229
—
43,366
—
Total finance income
113,999
25,609
237,338
94,173
Finance expenses
Interest expenses
80,647
65,504
37,807
36,493
Interest expenses to group enterprises
—
—
—
13
Remeasurement loss of financial liabilities
126,040
7,374
105,561
7,374
Foreign exchange translation (net)
—
27,149
—
1,687
Total finance expenses
206,687
100,027
143,368
45,567
Interest income and interest expenses relate to financial assets and liabilities measured at amortized
cost. Net exchange rate gains and losses primarily relate to U.S. Dollar/Euro fluctuations pertaining to
the Company’s cash, cash equivalents, marketable securities and borrowings.
Borrowings
Convertible Senior Notes
In March 2022, the Company issued an aggregate principal amount of $575.0 million of fixed rate
2.25% convertible notes. The net proceeds from the offering of the convertible notes were $557.9
million (€503.3 million), after deducting the initial purchasers’ discounts and commissions- and
offering expenses. The convertible notes rank equally in right of payment with all future senior
unsecured indebtedness. Unless earlier converted or redeemed, the convertible notes will mature on
April 1, 2028.
The convertible notes accrue interest at a rate of 2.25% per annum, payable semi-annually in arrears
on April 1 and October 1 of each year. At any time before the close of business on the second
scheduled trading day immediately before the maturity date, noteholders may convert their convertible
notes at their option into the Company’s ordinary shares represented by ADSs, together, if applicable,
with cash in lieu of any fractional ADS, at the then-applicable conversion rate. The initial conversion
rate is 6.0118 ADSs per $1,000 principal amount of convertible notes, which represents an initial
conversion price of $166.34 per ADS. The conversion rate and conversion price will be subject to
customary adjustments upon the occurrence of certain events.
The convertible notes will be optionally redeemable, in whole or in part (subject to certain limitations),
at the Company’s option at any time, and from time to time, on or after April 7, 2025, but only if the
last reported sale price per ADS exceeds 130% of the conversion price on (i) each of at least 20
trading days, whether or not consecutive, during the 30 consecutive trading days ending on, and
including, the trading day immediately before the date the Company sends the related optional
redemption notice; and (ii) the trading day immediately before the date the Company sends such
notice.
On December 31, 2025, the carrying amount of the convertible notes was €429.4 million, and the
disclosed fair value was €426.4 million. Fair value cannot be measured based on quoted prices in
active markets or other observable input, and accordingly the fair value was, from 2025, measured by
using input from the private placement market. Up until 2024, the fair value the fair value was
measured by using an estimated market rate for an equivalent non-convertible instrument.
Financial Statements
81
Royalty Funding Liabilities
The Company has entered into capped synthetic royalty funding agreements with Royalty Pharma
(the “Purchaser”), which is presented as part of borrowings, and represents the Company’s
contractual obligations to pay a predetermined percentage of future commercial revenue until
reaching a predetermined multiple of proceeds received, according to the detailed provisions of the
synthetic royalty funding agreements.
On December 31, 2025, the carrying amount of the royalty funding liabilities was €290.9 million, and
the disclosed fair value was €296.9 million. Fair value cannot be measured based on quoted prices in
active markets or other observable input, and accordingly the fair value was measured by using an
estimated market rate for an equivalent instrument.
YORVIPATH Agreement
In September 2024, the Company entered into a $150.0 million capped synthetic royalty funding
agreement (the “Royalty Pharma Yorvipath Agreement”) with the Purchaser. The net proceeds were
$148.2 million (€134.2 million) after deducting offering expenses.
Under the terms of the Royalty Pharma Yorvipath Agreement, the Company received an upfront
payment of $150.0 million (the “Yorvipath Purchase Price”) in exchange for a 3% royalty on net
revenue from sales of YORVIPATH in the U.S. (the “Yorvipath Revenue Payments”). The Yorvipath
Revenue Payments to the Purchaser will cease upon reaching a multiple of the Yorvipath Purchase
Price of 2.0 times, or 1.65 times if the Purchaser receives Yorvipath Revenue Payments in that
amount by December 31, 2029.
The Royalty Pharma Yorvipath Agreement includes a buy-out option, which provides the Company
with the right to settle all outstanding liabilities at any time by paying a buy-out amount equal to 2.0
times the Yorvipath Purchase Price minus the Yorvipath Revenue Payments paid to the Purchaser as
of the effective date of the buy-out notice. However, if the buy-out notice is provided on or prior to
September 30, 2028, and the Company has paid the Purchaser, Yorvipath Revenue Payments equal
to the Yorvipath Purchase Price as of the date of the buy-out notice, then the buy-out amount is equal
to 1.65 times the Yorvipath Purchase Price minus the Yorvipath Revenue Payments paid to the
Purchaser as of the effective date of the buy-out notice.
SKYTROFA Agreement
In September 2023, the Company entered into a $150.0 million capped synthetic royalty funding
agreement (the “Royalty Pharma Skytrofa Agreement”) with the Purchaser. The net proceeds were
$146.3 million (€136.3 million) after deducting offering expenses.
Under the terms of the Royalty Pharma Skytrofa Agreement, the Company received an upfront
payment of $150.0 million (the “Skytrofa Purchase Price”) in exchange for a 9.15% royalty on net
revenue from sales of SKYTROFA in the U.S., beginning on January 1, 2025 (the “Skytrofa Revenue
Payments”). The Skytrofa Revenue Payments to the Purchaser will cease upon reaching a multiple of
the Skytrofa Purchase Price of 1.925 times, or 1.65 times if the Purchaser receives Skytrofa Revenue
Payments in that amount by December 31, 2031.
The Royalty Pharma Skytrofa Agreement includes a buy-out option, which provides the Company with
the right to settle all outstanding liabilities at any time by paying a buy-out amount equal to 1.925
times the Skytrofa Purchase Price minus the Skytrofa Revenue Payments paid to the Purchaser as of
the effective date of the buy-out notice. However, if the buy-out notice is provided on or prior to
December 31, 2028, and the Company has paid the Purchaser, Skytrofa Revenue Payments equal to
the Skytrofa Purchase Price as of the date of the buy-out notice, then the buy-out amount is equal to
1.65 times the Skytrofa Purchase Price minus the Skytrofa Revenue Payments paid to the Purchaser
as of the effective date of the buy-out notice.
Financial Statements
82
Leases
The Company primarily leases offices and laboratory facilities. Lease arrangements contain a range
of different terms and conditions and are typically entered into for fixed periods. In order to improve
flexibility to the Company’s operations, lease arrangements may provide the Company with option to
extend the lease or terminate the lease within the enforceable lease term. In the Company’s current
lease portfolio, extension and termination options are up to ten years, in addition to the non-
cancellable periods. These lease arrangements are recognized as right-of-use assets and lease
liabilities (“lease activities”). In addition, the Company enter into various lease arrangements of assets
with low value and/or on short term basis (12 months or less).
The following expenses related to lease activities were recognized in the statements of profit or loss:
Group
Parent
(EUR’000)
2025
2024
2025
2024
Lease expenses
Depreciation
12,350
12,312
4,482
3,588
Lease interest
4,186
3,303
1,065
376
Total lease expenses
16,536
15,615
5,547
3,964
Financing Activities
The development in borrowings related to financing activities is specified below:
Group
Cash payments
Non-cash items
(EUR’000)
Beginning
of year
Repay-
ments
Net
proceeds
Additions/
(disposals)
Remeasure
-
ments
Accretion
of interest
Foreign
exchange
translation
End of
year
Financing
activities
December 31
2025
Borrowings
(excluding
lease
liabilities)
763,586
(29,065)
—
—
10
76,247
(90,516)
720,262
Lease
liabilities
93,030
(15,548)
—
78,517
—
4,186
(8,661)
151,524
Total
financing
activities
856,616
(44,613)
—
78,517
10
80,433
(99,177)
871,786
Financing
activities
December 31
2024
Borrowings
(excluding
lease
liabilities)
545,472
(11,819)
134,158
—
(11,248)
62,116
44,907
763,586
Lease
liabilities
98,793
(14,677)
—
861
—
3,303
4,750
93,030
Total
financing
activities
644,265
(26,496)
134,158
861
(11,248)
65,419
49,657
856,616
Financial Statements
83
Parent
Cash
payments
Non-cash items
(EUR’000)
Beginning
of year
Repayments
Additions/
(disposals)
Accretion
of interest
Foreign
exchange
translation
End of
year
Financing
activities
December 31,
2025
Borrowings
(excluding lease
liabilities)
458,207
(11,513)
—
36,675
(53,978)
429,391
Lease liabilities
12,396
(4,068)
21,129
1,065
—
30,522
Total financing
activities
470,603
(15,581)
21,129
37,740
(53,978)
459,913
Financing
activities
December 31,
2024
Borrowings
(excluding lease
liabilities)
407,095
(11,819)
—
36,116
26,815
458,207
Lease liabilities
15,187
(3,216)
49
376
—
12,396
Total financing
activities
422,282
(15,035)
49
36,492
26,815
470,603
Derivative Liabilities
Derivative liabilities relate to the foreign currency conversion option embedded in the convertible
notes.
Fair value cannot be measured based on quoted prices in active markets or other observable inputs
and accordingly, derivative liabilities are measured by using the Black-Scholes option-pricing model.
Fair value of the option is calculated, applying the following assumptions: (1) conversion price; (2) the
Company’s share price; (3) maturity of the option; (4) a risk-free interest rate equaling the effective
interest rate on a U.S. government bond with the same lifetime as the maturity of the option; (5) no
payment of dividends; and (6) an expected volatility using the Company’s share price (48.9% and
49.6% as of December 31, 2025 and December 31, 2024, respectively).
For additional description of fair values, refer to the following section “Fair Value Measurement.”
Sensitivity Analysis
On December 31, 2025, all other inputs and assumptions held constant, a 10% relative increase in
volatility, will increase the fair value of derivative liabilities by approximately €13.2 million and
indicates a decrease in profit or loss and equity before tax. Similarly, a 10% relative decrease in
volatility indicates the opposite impact.
Similarly, on December 31, 2025, all other inputs and assumptions held constant, a 10% increase in
the share price, will increase the fair value of derivative liabilities by approximately €50.8 million and
indicates a decrease in profit or loss and equity before tax. Similarly, a 10% decrease in the share
price indicates the opposite impact.
Financial Statements
84
Fair Value Measurement
Because of the short-term maturity for cash and cash equivalents, receivables and trade payables,
their fair value approximate carrying amount. Fair value of lease liabilities are not disclosed. Fair value
compared to carrying amount of convertible notes, royalty funding liabilities and derivatives and their
level in the fair value hierarchy is summarized in following table, where;
Level 1 inputs are quoted prices (unadjusted) in active markets for identical assets or liabilities that
the entity can access at the measurement date;
Level 2 inputs are inputs other than quoted prices included within Level 1 that are observable for the
asset or liability, either directly or indirectly; and
Level 3 inputs are unobservable inputs for the asset or liability.
Group
2025
2024
(EUR’000)
Carrying
Amount
Fair
Value
Carrying
Amount
Fair
Value
Fair
Value
Level
Convertible senior notes
429,391
426,429
458,207
438,288
2
Royalty funding liabilities
290,871
296,899
305,379
305,673
3
Financial liabilities measured at amortized
cost
720,262
723,328
763,586
743,961
Derivative liabilities
256,231
256,231
150,670
150,670
3
Financial liabilities measured at fair value
through profit or loss
256,231
256,231
150,670
150,670
Parent
2025
2024
(EUR’000)
Carrying
Amount
Fair
Value
Carrying
Amount
Fair
Value
Fair
Value
Level
Convertible senior notes
429,391
426,429
458,207
438,288
2
Financial liabilities measured at amortized
cost
429,391
426,429
458,207
438,288
Derivative liabilities
256,231
256,231
150,670
150,670
3
Financial liabilities measured at fair value
through profit or loss
256,231
256,231
150,670
150,670
The following table specifies movements in level 3 fair value measurements:
Group and Parent
(EUR’000)
2025
2024
Derivative liabilities
January 1
150,670
143,296
Remeasurement recognized in financial income or expense
105,561
7,374
December 31
256,231
150,670
Note 18 – Financial Risk Management
The Company manages capital to ensure that all group enterprises will be able to continue as a going
concern while maximizing the return to shareholders through the optimization of debt and equity
balances.
Financial Statements
85
Capital Structure
The Company’s capital structure consists of equity and external debt obtained through issuance of
convertible notes and royalty funding liabilities. The Company is not subject to any contractually
imposed capital requirements or financial covenants. The capital structure is reviewed on an ongoing
basis for the adequacy of the Company’s capital compared to the resources required for carrying out
ordinary activities.
Development in the Company’s share capital and treasury shares reserves are described in the
following sections. Other equity reserves are described in Note 2, “Summary of Material Accounting
Policies.”
Share Capital
The share capital of Ascendis Pharma A/S consists of 61,977,408 fully paid shares at a nominal value
of DKK 1, all in the same share class, and which includes 597,096 ordinary shares represented by
ADSs held by Ascendis Pharma A/S.
The development in outstanding shares of the Company was as follows:
2025
2024
2023
2022
2021
(Number)
Changes in share capital
January 1
60,689,487
57,707,439
57,152,295
56,937,682
53,750,386
Increase through cash
contributions
1,287,921
2,982,048
555,144
214,613
3,187,296
December 31
61,977,408
60,689,487
57,707,439
57,152,295
56,937,682
Capital increases in 2024 and 2021 were impacted by follow-on public offerings with net proceeds of
€290.6 and €367.9 million, respectively.
Treasury Shares Reserve
The development in the holding of treasury shares was as follows:
Nominal
value
Holding
Holding in
% of total
outstanding
shares
Treasury shares
(EUR’000)
(Number)
January 1 2024
146
1,093,054
Transferred under stock incentive programs
(33)
(247,167)
December 31 2024
113
845,887
1.4%
Acquired from third parties
16
119,148
Transferred under stock incentive programs
(49)
(367,939)
December 31 2025
80
597,096
1.0%
Financial Risk Management Objectives
The Company regularly monitors the access to domestic and international financial markets, manages
the financial risks relating to its operations, and analyzes exposures to risk, including market risk,
such as foreign currency risk and interest rate risk, credit risk and liquidity risk.
The Company’s financial risk exposure and risk management policies are described in the following
sections.
Market Risk
The Company’s activities expose the group enterprises to the financial risks of changes in foreign
currency exchange rates, inflation rates, and interest rates. Derivative financial instruments are not
applied to manage exposure to such risks.
Financial Statements
86
Foreign Currency Risk Management
The Company is exposed to foreign currency exchange risks arising from various currency exposures,
primarily with respect to the U.S. Dollar (“USD”). Foreign currency exchange risks to the USD are
unchanged to prior year, and primarily relate to sales and purchases in foreign currencies, convertible
notes and royalty funding liabilities, countered by cash and cash equivalents.
The exposure from foreign currency exchange risks is managed by maintaining cash positions in the
currencies in which the majority of future expenses are denominated, and payments are made from
those reserves.
Foreign Currency Sensitivity Analysis
The following table details how a strengthening of the USD against the EUR would impact profit or
loss, and equity before tax at the reporting date. A similar weakening of the USD would have the
opposite effect. A positive number indicates an increase in profit or loss and equity before tax, while a
negative number indicates the opposite. The sensitivity analysis is deemed representative of the
inherent foreign currency exchange risk associated with the operations.
Group
Hypothetical impact on consolidated financial
statements
(EUR’000)
Nominal
positions
(net)
Increase
in foreign
currency
exchange
rate
Profit/(loss
) before tax
Equity
before tax
USD/EUR
December 31 2025
(508,858)
10%
(50,886)
(50,886)
December 31 2024
(735,064)
10%
(73,506)
(73,506)
Parent
Hypothetical impact on separate financial statements
(EUR’000)
Nominal
positions
(net)
Increase
in foreign
currency
exchange
rate
Profit/(loss
) before tax
Equity
before tax
USD/EUR
December 31 2025
(323,576)
10%
(32,358)
(32,358)
December 31 2024
(374,691)
10%
(37,469)
(37,469)
Interest Rate Risk Management
Outstanding convertible notes comprise a 2.25% coupon fixed rate structure. Further, the effective
interest rate on royalty funding liabilities is estimated at initial recognition and takes into account
anticipated amount and timing of future cash flows, which further depends on future commercial
revenue forecasts and the probability of exercising the embedded buy-out option. Material changes to
anticipated future cash flows could potentially increase or decrease future interest expense. In
addition, the interest rate on lease liabilities is fixed at the lease commencement date.
Future indebtedness, including those related to lease arrangements, if any, may be subject to higher
interest rates. In addition, future interest income from interest-bearing bank deposits may fall short of
expectations due to changes in interest rates.
Derivative liabilities are measured at fair value through profit or loss. Since the fair value is exposed
from the development in interest rates, the profit or loss is exposed to volatility from such
development.
The effects of interest rate fluctuations are not considered a material risk to the Company’s financial
position. Accordingly, no interest sensitivity analysis has been presented.
Financial Statements
87
Credit Risk Management
The Company has adopted an investment policy with the primary purpose of preserving capital,
fulfilling liquidity needs and diversifying the risks associated with cash, cash equivalents and
marketable securities. This investment policy establishes minimum ratings for institutions with which
the Company holds cash and cash equivalents, as well as rating and concentration limits for
marketable securities held. All material counterparties are considered creditworthy. While the
concentration of credit risk may be significant, the credit risk for each individual counterpart is
considered to be low. The exposure to credit risk primarily relates to cash and cash equivalents. The
credit risk on bank deposits is limited because the counterparties, holding significant deposits, are
banks with minimum credit-ratings of A3/A- assigned by international credit-rating agencies.
The majority of cash and cash equivalents are held in accounts at major financial institutions, and the
deposits at these institutions exceed insured limits. Market conditions can impact the viability of these
institutions. In the event of failure of any of the financial institutions where cash and cash equivalents
are held, there can be no assurance that uninsured funds are accessible in a timely manner or at all.
Any inability to access or delay in accessing these funds could adversely affect the business and
financial position. The banks are reviewed on a regular basis and deposits may be transferred during
the year to mitigate credit risk.
In order to mitigate the concentration of credit risks on bank deposits and to preserve capital, a portion
of the bank deposits may be placed into investment grade rated marketable securities. The
Company’s investment policy, approved by the Board, only allows investment in marketable securities
having investment grade credit-ratings, assigned by international credit-rating agencies. As of
December 31, 2025, the Company do not hold marketable securities.
On each reporting date, the risk of expected credit loss on bank deposits and marketable securities, if
any, including the hypothetical impact arising from the probability of default, is considered in
conjunction with the expected loss caused by default by banks or securities with similar credit-ratings
and attributes. In line with previous periods, this assessment did not reveal a material impairment
loss, and accordingly no provision for expected credit loss has been recognized.
At the reporting dates, there are no significant overdue trade receivable balances. As a result, write-
down to accommodate expected credit-losses is not deemed material.
Liquidity Risk Management
Historically, the risk of insufficient funds has been addressed through proceeds from sale of the
Company’s securities in private and public offerings, through issuance of convertible notes in 2022,
and through royalty funding liabilities in 2024 and 2023.
Liquidity risk is managed by maintaining adequate cash reserves. The risk of shortage of funds is
monitored, through the financial forecasting process, to ensure sufficient funds are available to settle
liabilities as they fall due. Besides long term deposits on leases and finance lease receivables, the
Company’s financial assets are recoverable within twelve months after the reporting date.
Maturity Analysis
The following table summarizes maturity analysis (on an undiscounted basis) for non-derivative
financial liabilities recognized in the consolidated statements of financial position:
Financial Statements
88
Group
(EUR’000)
<1 year
1-5 years
>5 years
Total
contractual
cash-flows
Carrying
amount
Financial liabilities
December 31 2025
Borrowings (excluding lease
liabilities)
51,081
812,294
140,555
1,003,930
720,262
Lease liabilities
20,438
82,299
93,898
196,635
151,524
Trade payables accrued expenses
and other liabilities
91,703
—
—
91,703
91,703
Total financial liabilities
163,222
894,593
234,453
1,292,268
963,489
Financial liabilities
December 31 2024
Borrowings (excluding lease
liabilities)
32,303
1,027,558
13,660
1,073,521
763,586
Lease liabilities
15,482
52,007
39,127
106,616
93,030
Trade payables accrued expenses
and other liabilities
96,705
—
—
96,705
96,705
Total financial liabilities
144,490
1,079,565
52,787
1,276,842
953,321
Parent
(EUR’000)
<1 year
1-5 years
>5 years
Total
contractual
cash-flows
Carrying
amount
Financial liabilities
December 31 2025
Borrowings (excluding lease
liabilities)
11,011
505,878
—
516,889
429,391
Lease liabilities
4,841
19,775
12,862
37,478
30,522
Payables to group enterprises
5,196
—
—
5,196
5,196
Trade payables accrued expenses
and other liabilities
63,057
—
—
63,057
63,057
Total financial liabilities
84,105
525,653
12,862
622,620
528,166
Financial liabilities
December 31 2024
Borrowings (excluding lease
liabilities)
12,453
584,603
—
597,056
458,207
Lease liabilities
3,203
6,532
3,814
13,549
12,396
Payables to group enterprises
2,085
—
—
2,085
2,085
Trade payables accrued expenses
and other liabilities
84,117
—
—
84,117
84,117
Total financial liabilities
101,858
591,135
3,814
696,807
556,805
“Borrowings (excluding lease liabilities)” comprise convertible notes and royalty funding liabilities.
Expected maturity for royalty funding liabilities is based on anticipated amount and timing of future
revenue from sale of commercial products. Further details regarding the payment structure of the
royalty funding agreements are provided above.
Note 19 – Commitments and Contingencies
The Company has agreed minimum commitments related to the manufacturing of product supply,
subject to continuous negotiation and adjustments according to the individual contractual terms and
conditions. Cost of product supply is recognized when the Company obtains control of the goods. In
addition, the Company has commitments related to short-term leases and leases of low value assets,
contracts of various lengths in respect of research and development with CROs, and IT and facility
related services. Costs relating to those commitments are recognized as services are received.
Financial Statements
89
The Company is not aware of any significant legal claims or disputes.
The Parent Company is jointly registered for VAT purposes with its Danish subsidiaries and is jointly
liable for the payment thereof.
Letter of Support – Parent Company
The Parent Company has provided letters of support to five of it´s wholly-owned subsidiaries Ascendis
Pharma Ophthalmology Division A/S, Ascendis Pharma Endocrinology Division A/S, Ascendis
Pharma Bone Diseases A/S, Ascendis Pharma Growth Disorders A/S and Ascendis Pharma
Oncology Division A/S.
At December 31, 2025, Ascendis Pharma Ophthalmology Division A/S, Ascendis Pharma
Endocrinology Division A/S, Ascendis Pharma Bone Diseases A/S, Ascendis Pharma Growth
Disorders A/S and Ascendis Pharma Oncology Division A/S have negative net assets. To support the
five companies, the Parent Company has confirmed the technical and financial support that it has
committed and further will commit for the period until at least June 30, 2027.
Ascendis Pharma A/S undertakes to make all reasonable technical efforts to support the companies
to conduct all pre-clinical, manufacturing, clinical and regulatory activities with their product
candidates for the period. In addition, Ascendis Pharma A/S undertakes to provide the companies
with the necessary funds to ensure that the companies can conduct their activities for the period in
compliance with Danish company regulation and to ensure that the companies can meet their
financial obligations as they fall due during the period.
Applied Exception - Subsidiary
Ascendis Pharma Bone Disease A/S has prepared its statutory financial statements for 2025 pursuant
to section 78(a) of the Danish Financial Statements Act, thereby reporting under the requirements for
enterprises of reporting class B instead of reporting class C medium.
Note 20 – Related Party Transactions
The Board of Directors and Senior Management (“Key Management Personnel”) are considered
related parties as they have authority and responsibility for planning and directing the Company’s
operations. Related parties also include undertakings in which such individuals have a controlling or
joint controlling interest. Additionally, all group enterprises and associates are considered related
parties.
Neither the Company’s related parties nor major shareholders hold a controlling, joint controlling, or
significant interest in the Group.
The Company has entered into employment agreements with and issued warrants, RSUs and PSUs
to Key Management Personnel. In addition, the Company pays fees for board tenure and board
committee tenure to the independent members of the Board of Directors. For further details, refer to
Note 7, “Employee Costs.” Indemnification agreements have been entered with members of the Board
of Directors, the Executive Board and Non-executive Senior Management.
Transactions between the Parent Company and group enterprises comprise management and license
fees, research and development services, administration services and clinical and commercial
supplies. These transactions have been eliminated in the consolidated financial statements.
Transactions and outstanding balances with the associates are disclosed in Note 13, “Investments in
Associates.”
In addition, the Parent Company Ascendis Pharma A/S is jointly taxed with its Danish subsidiaries,
where the current Danish corporation tax is allocated between the jointly taxed Danish companies.
For further details, refer to Note 10, “Tax on Profit/(Loss) for the Year and Deferred Tax.”
Financial Statements
90
Except for the information disclosed above, the Company has not undertaken any significant
transactions with members of the Key Management Personnel, or undertakings in which the identified
related parties have a controlling or joint controlling interest.
Transactions with subsidiaries are specified below:
Parent
(EUR’000)
2025
2024
Rendering of services
326,759
252,443
Sale of products
89,695
47,540
Milestone payments
—
10,000
Total revenue
416,454
309,983
License expenses
(100
)
(100
)
Purchase of services
(94,895
)
(28,901
)
Total expenses
(94,995
)
(29,001
)
Interest income
183,566
82,361
Interest expenses
—
(13
)
Net financial income
183,566
82,348
Note 21 – Investments in Group Enterprises and Associates
Ascendis Pharma A/S’s (Parent Company) investments in group enterprises and associates at
December 31, 2025, comprise:
Subsidiaries
Domicile
Ownership
Ascendis Pharma GmbH
Germany
100%
Ascendis Pharma Endocrinology GmbH
Germany
100%
Ascendis Pharma, LLC
USA
100%
Ascendis Pharma Endocrinology, Inc.
USA
100%
Ascendis Pharma, Ophthalmology Division A/S
Denmark
100%
Ascendis Pharma Endocrinology Division A/S
Denmark
100%
Ascendis Pharma Bone Diseases A/S
Denmark
100%
Ascendis Pharma Growth Disorders A/S
Denmark
100%
Ascendis Pharma Oncology Division A/S
Denmark
100%
Ascendis Pharma Europe A/S
Denmark
100%
Ascendis Pharma UK Limited
United Kingdom
100%
Ascendis Pharma Iberia S.L.
Spain
100%
Ascendis Pharma France SASU
France
100%
Ascendis Pharma Italia S.R.L.
Italy
100%
Ascendis Pharma Sverige AB
Sweden
100%
Ascendis Pharma Switzerland GmbH
Switzerland
100%
Ascendis Pharma Belgium BV
Belgium
100%
ASND Portugal, Unipessoal, Lda.
Portugal
100%
Associates
Domicile
Ownership
VISEN Pharmaceuticals
Cayman Island
39.2%
Eyconis Inc.
USA
33.2%
Note 22 – Ownership
The following investors, or groups of affiliated investors, are known by us to beneficially own more
than 5% of the Company’s outstanding ordinary shares at December 31, 2025:
• Entities affiliated with RA Capital Management, LLC, USA
Financial Statements
91
• Westfield Capital Management Company, L.P., USA
• Entities affiliated with FMR LLC, USA
• Avoro Capital Advisors LLC, USA
• Entities affiliated with Artisan Partners LP, USA
• Entities affiliated with Janus Henderson Group plc, United Kingdom
• Entities affiliated with Capital International Investors
The Company’s American Depository Shares are held through BNY (Nominees) Limited as nominee,
of The Bank of New York Mellon, UK (as registered holder of the Company’s outstanding ADSs).
Note 23 – Subsequent Events
On January 9, 2026, the Company announced that our Board has authorized a $120 million share
repurchase program (the “Share Repurchase Program”). Purchases under the Share Repurchase
Program may be made from time to time through a variety of methods, which may include open-
market purchases, privately negotiated transactions, or other methods permitted under applicable
securities laws. The timing and amount of any repurchases pursuant to the Share Repurchase
Program will be determined based on market conditions, share price and other factors. The Share
Repurchase Program does not require the Company to repurchase any specific number of shares,
and may be modified, suspended or terminated at any time without notice.
No other events have occurred after the reporting date that would influence the evaluation of these
financial statements.