Ascendis Pharma A/S
Tuborg Boulevard 12
DK-2900 Hellerup
Central Business Registration No. 29 91 87 91
Annual Report 2024
(January 1 – December 31)
Adopted at the Annual General Meeting of Shareholders on May 27, 2025.
Chairman of the General Meeting
Contents
Company Information.....................................................................................................................................
3
Statement by Management on the Annual Report....................................................................................
4
Independent Auditor’s Report.......................................................................................................................
5
Management Commentary ...........................................................................................................................
8
Statements of Profit or Loss and Other Comprehensive Income for the Years Ended December
31 ......................................................................................................................................................................
37
Statements of Financial Position as of December 31...............................................................................
38
Statements of Changes in Equity - Group..................................................................................................
40
Statements of Changes in Equity - Parent .................................................................................................
41
Cash Flow Statements for the Years Ended December 31.....................................................................
42
Notes to the Financial Statements...............................................................................................................
43
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
2024
2023
2022
2021
2020
(EUR’000)
Revenue
363,641
266,718
51,174
7,778
6,953
Operating Profit/(Loss)
(278,763
)
(455,541
)
(561,814
)
(451,792
)
(330,620
)
Finance Income/(Expenses) (net)
(74,418
)
(208
)
1,694
55,807
(79,030
)
Profit/(Loss) for the Year
(378,084
)
(481,447
)
(583,194
)
(383,577
)
(418,955
)
Cash and Cash Equivalents
559,543
392,164
444,767
446,267
584,517
Total Assets
1,179,495
825,587
1,089,738
1,084,921
979,793
Equity
(105,706
)
(145,697
)
263,348
883,635
838,711
Investments in Property, Plant & Equipment
1,427
2,442
14,489
23,704
19,860
Return on Equity (%)*
(300.8
)
(818.4
)
(101.7
)
(44.5
)
(58.4
)
Equity Ratio (%)*
(9.0
)
(17.6
)
24.2
81.4
85.6
*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:
Wholly-owned subsidiaries
Domicile
Ascendis Pharma GmbH
Germany
Ascendis Pharma Endocrinology GmbH
Germany
Ascendis Pharma, Inc.
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 SRL
Italy
Ascendis Pharma Sverige AB
Sweden
Ascendis Pharma Switzerland GmbH
Switzerland
Management Commentary
9
The Company has increased its number of employees to 1,017 at the end of 2024 compared to 879 at
the end of 2023. Employees engaged with selling, general, and administration increased, primarily due
to commercial activities, and extension of corporate functions to support those activities. Further, in
connection with formation of Eyconis, a separate company, certain employees of Ascendis Pharma,
engaged with research and development in the U.S., joined the newly formed company in 2024.
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. This includes:
• Be the Leading Endocrinology Rare Disease Company
o Achieve blockbuster status (>$1B) for each of 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
Let our values Patients, Science, Passion drive our decisions to success
Our products and product candidates combine our TransCon technologies with clinically validated
parent drugs or pathways, with the goal of optimizing safety, efficacy, tolerability, and convenience.
We apply these technologies using our algorithm 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
Management Commentary
10
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.
Program Summaries
We currently have two marketed products and a diversified portfolio of four product candidates in clinical
development in the areas of Endocrinology Rare Disease and Oncology, and we are working to apply
our TransCon technology platform in additional therapeutic areas such as the glucagon-like peptide 1
(“GLP-1”) class, where we believe we have designed a potentially best-in-class, once-monthly program.
• SKYTROFA – Our first marketed product is SKYTROFA
®
(lonapegsomatropin-tcgd),
developed as TransCon Growth Hormone (“TransCon hGH”), which has received regulatory
approval in the United States 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”). SKYTROFA has been
commercially available for prescription in the United States since October 2021. In addition,
SKYTROFA (lonapegsomatropin) was granted marketing authorization in the European
Union (“EU”), Norway, Iceland, Liechtenstein, and Great Britain (covering England, Wales,
Scotland) 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. In the EU, SKYTROFA has been commercially available for
prescription in Germany since September 2023.
• YORVIPATH – Our second marketed product is YORVIPATH
®
(palopegteriparatide),
developed as TransCon PTH. In the EU, Norway, Iceland, Liechtenstein, and Great Britain
(covering England, Wales, and Scotland), YORVIPATH has been granted marketing
authorization as a once-daily subcutaneous injection for the treatment of adults with chronic
hypoparathyroidism. In the EU, YORVIPATH has been commercially available for
prescription in Germany and Austria since January 2024 and has also been available to
patients in other countries under named patient programs. In August 2024, YORVIPATH
received regulatory approval in the U.S. for the treatment of hypoparathyroidism in adults.
YORVIPATH has been commercially available for prescription in the United States since
December 2024. As of February 7, 2025, 908 new prescriptions by 539 unique prescribing
healthcare providers in the U.S.
• Endocrinology Rare Disease Pipeline – Two product candidates in our Endocrinology Rare
Disease portfolio are currently in development spanning multiple indications and
geographies. These product candidates are TransCon hGH (lonapegsomatropin) for adult
GHD and children with Turner syndrome and TransCon CNP (navepegritide) for infants,
children, and adolescents with achondroplasia. We are also investigating TransCon CNP in
combination with TransCon hGH in children with achondroplasia. In addition, we plan to
investigate TransCon hGH in other established daily growth hormone indications. Through
our strategic collaboration, Teijin Limited is developing and, if approved, plans to
commercialize TransCon hGH, TransCon PTH, and TransCon CNP for endocrinology rare
disease in Japan. In addition, through our strategic investment, VISEN Pharmaceuticals
(“VISEN”) is developing and, if approved, plans to commercialize TransCon hGH, TransCon
PTH, and TransCon CNP for endocrinology rare diseases in Greater China.
Management Commentary
11
• 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 / (onvapegleukin
alfa) for systemic delivery, which is designed for prolonged exposure to an IL-2 variant that
selectively activates IL-2 / 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 /.
TransCon Product Candidates Pipeline
Other than the rights we have granted to Eyconis, Novo Nordisk, Teijin Limited, and VISEN as noted in
this annual report, we hold worldwide rights to our TransCon technologies and, other than our royalty
financing arrangements with Royalty Pharma as noted in this annual report, we owe no third-party
royalty or milestone payment obligations with respect to our TransCon technologies, TransCon hGH,
TransCon PTH or any of our other product candidates. The following chart lists our product candidates.
1. Pivotal ApproaCH Trial (NCT05598320).
2. sBLA submitted to U.S. FDA, PDUFA goal date July, 27
th
2025.
3. New InsiGHTS Trial (NCT05690386).
4. reACHin Trial (NCT06079398).
5. teACH Trial (NCT06732895).
6. COACH Trial (NCT06433557).
7. VISEN Pharmaceuticals’ Phase 3 trial.
8. Japanese riGHt Trial.
9. PaTHway China (NCT05387070).
10. PaTHway Japan.
11. ACcomplisH China (NCT05246033).
12. BelieveIT-201 Trial (NCT05980598).
13. IL-Believe Trial (NCT05081609).
We maintain an intellectual property portfolio comprising over 425 issued patents and over 525 patent
applications as of December 31, 2024, which includes patents and patent applications applicable to our
Management Commentary
12
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. While our TransCon prodrugs may incorporate already approved parent
drugs, TransCon hGH, TransCon PTH, 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 and product candidates,
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, SKYTROFA and YORVIPATH. Our U.S. organization includes
sales, market access, patient support, and medical affairs teams. The sales team engages with
healthcare providers and present products, usage and safety guidelines in accordance with the label.
Our market access team engages with health authorities, insurance companies, and payers to help
patients in need of our products gain access to them. Our patient support team facilitates
reimbursement support, out of pocket assistance, provides educational resources and product training.
Our medical affairs team provides scientific exchange to the physician and medical community. We
have also established a network of specialty pharmacies to support product distribution.
In Europe, we are expanding our presence by building integrated organizations in select countries,
which we call Europe Direct, beginning with Germany, where we have launched our Endocrinology
Rare Disease products, SKYTROFA and YORVIPATH. We are establishing commercial infrastructure
in other Europe Direct country clusters, including DACH (Germany, Austria, Switzerland), France &
BeNeLux (Belgium, the Netherlands, and Luxembourg), Iberia (Portugal and Spain), Italy, Nordics
(Denmark, Norway, Sweden, Iceland, Finland), and the United Kingdom & Ireland.
Beyond the U.S. and Europe Direct, we are expanding global reach for our Endocrinology Rare Disease
programs through exclusive distribution agreements with geographic market leaders, which we call
International Markets. As of December 31, 2024, we have established eight such regional agreements:
• Acino Pharma Proprietary Limited (South Africa)
• Adium Pharma S.A. (Argentina, Brazil, Colombia and Mexico)
• Er-Kim İlac Sanayi ve Ticaret A.S (Central & Eastern Europe, Turkey, and certain countries
in Eurasia)
• Neopharm (Israel) 1996 Ltd (Israel, Armenia, Azerbaijan, Georgia, Kazakhstan, Kyrgyzstan,
Tajikistan, Turkmenistan and Uzbekistan)
• Pendopharm, a division of Pharmascience Inc. (Canada)
• Specialised Therapeutics Asia Pte Ltd. (Australia, New Zealand, Singapore, Malaysia,
Brunei, Thailand, and Vietnam)
• SRS Pharmaceuticals Pvt. Ltd. (India and Philippines)
• Vector Pharma FZCO (Saudi Arabia, United Arab Emirates, Kuwait, Oman, Qatar, and
Bahrain)
Finally, we are making our products commercially available in select markets through exclusive license
agreements with partners with local development and commercialization expertise and infrastructure.
In China, VISEN has exclusive license rights to develop and commercialize TransCon hGH, TransCon
PTH, and TransCon CNP. In Japan, Teijin Limited has exclusive license rights to develop and
commercialize TransCon hGH, TransCon PTH, and TransCon CNP.
Management Commentary
13
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. 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 molecules can have up to three components: a parent drug, an inert carrier that protects it,
and a linker that temporarily binds the two. When bound, the carrier inactivates and shields the parent
drug from clearance. When injected into the body, physiologic pH and temperature conditions initiate
the release of the active, unmodified parent drug in a predictable release manner.
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
14
• 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
15
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 and to become potential sources of
significant revenue for our company. 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 – Endocrinology Rare Disease
TransCon Growth Hormone (hGH)
Market Opportunity for Recombinant Human Growth Hormone
Growth hormone deficiency is a serious orphan 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. (Kaplowitz P, Manjelievskaia J, Lopez-Gonzalez L, et al. Economic burden of growth hormone
deficiency in a US pediatric population. J Manag Care Spec Pharm. 2021; 27(8):1118-1128). The
observational retrospective cohort analysis utilized administrative claims data from two databases on
over 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 (“AGHD”) patients can experience reduced quality of life and increased risk of morbidity and
mortality. A retrospective cohort study presented at ENDO 2023 analyzed an electronic health records
database and selected adult patients with suspected AGHD. Of the 51,588 patients with suspected
AGHD, fewer than 4% were treated with growth hormone.
Management Commentary
16
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.
Competitive Landscape for Long-Acting Growth Hormone Therapies
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:
• 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 approved by the European
Medicines Agency (“EMA”) 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, and JCR Pharmaceuticals Co., Ltd.
Our Solution: TransCon hGH
TransCon hGH is a prodrug composed of somatropin that is transiently bound to a carrier by a
proprietary 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.
Management Commentary
17
TransCon Growth Hormone (hGH) for Pediatric 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 September 2023, we announced top-line results from the completed enliGHten Trial, an open-label
extension trial evaluating the long-term safety and efficacy of TransCon hGH as a once-weekly
treatment for children and adolescents with GHD. The enliGHten Trial enrolled 298 participants (mean
age 10.3 years) from the Phase 3 heiGHt Trial of treatment-naïve pediatric GHD patients and the Phase
3 fliGHt Trial of pediatric GHD patients switching from daily somatropin treatment. Patients in these
trials received a total of up to 6 years of treatment with TransCon hGH. At the time of the enliGHten
Trial closure, 81 participants were designated as treatment completers, based on their physician’s
determination that treatment for pediatric GHD was no longer required. Of these treatment completers,
59% met or exceeded their average parental height standard deviation score (“SDS”), with mean
TransCon hGH treatment duration of 3.2 years.
Clinical Trial of TransCon hGH in Japanese Pediatric GHD
In the 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.
Management Commentary
18
Figure: Our state-of-the-art auto-injector is designed to improve treatment compliance.
TransCon Product Candidates – Endocrinology Rare Diseases
TransCon Growth Hormone (hGH) for Other Indications
Clinical Development in Adult GHD
In September 2024, we announced the submission of a supplemental Biologics License Application
(“sBLA”) to the FDA for TransCon hGH to expand its currently approved label to include eligible adults
for the treatment of GHD. The submission was based on results from foresiGHt, a Phase 3 randomized,
parallel-arm, placebo-controlled (double-blind), and active-controlled (open-label) trial that compared
the efficacy and safety of weekly TransCon hGH with weekly placebo and daily hGH in adults with GHD.
In December, we announced the FDA accepted the sBLA for review and set a Prescription Drug User
Fee Act (“PDUFA”) goal date of July 27, 2025.
In December 2023, we announced positive top-line results from foresiGHt. The trial aims to evaluate
the metabolic benefits of TransCon hGH in adults, with the primary objective to evaluate change in trunk
fat percentage.
The foresiGHt Trial evaluated 259 adults with GHD aged 23 to 80 years old, randomized 1:1:1, titrated
to receive a target fixed dose of TransCon hGH, placebo, or daily hGH based on age and oral estrogen
intake, with approximately equivalent hGH mg/week for TransCon hGH and daily hGH.
• TransCon hGH demonstrated superiority on its primary efficacy endpoint at Week 38:
o Change from baseline in trunk percent fat as measured by dual x-ray absorptiometry
(TransCon hGH -1.67% vs. placebo +0.37%, LS mean difference = -2.04%, p <
0.0001)
• TransCon hGH demonstrated superiority on its key secondary efficacy endpoints at Week
38:
o Change from baseline in total body lean mass (TransCon hGH +1.60 kg vs placebo -
0.10 kg, LS mean difference = 1.70 kg, p < 0.0001)
o Change from baseline in trunk fat mass (TransCon hGH -0.48 kg vs placebo +0.22 kg,
LS mean difference = -0.70 kg, p = 0.0053)
Management Commentary
19
• Exploratory post-hoc analysis at Week 38 demonstrated comparable treatment effect of
TransCon hGH and daily hGH on target tissues. For patients with average insulin-like
Growth Factor 1 (“IGF-1”) SDS levels ≤ 1.75 at Week 38:
o Change from baseline in trunk percent fat (TransCon hGH -2.42% vs. daily hGH -
2.59%)
o Change from baseline in total body lean mass (TransCon hGH +1.70 kg vs daily hGH
+1.37 kg)
o Change from baseline in trunk fat mass (TransCon hGH -0.90 kg vs daily hGH -0.94
kg)
• TransCon hGH was generally safe and well tolerated, with no discontinuations related to
study drug and with comparable safety and tolerability to daily hGH.
Clinical Development in Turner Syndrome
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 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.
TransCon hGH was generally safe and well tolerated, with no discontinuations related to study drug
and with comparable safety and tolerability to daily somatropin.
Other Development Plans
During the third quarter of 2025, we plan to submit an Investigational New Drug (“IND”) application or
similar for a basket trial evaluating other indications (planned for small for gestational age without catch-
up growth (“SGA”); idiopathic short stature (“ISS”); SHOX deficiency (including Turner syndrome)). In
addition, we are investigating other potential indications for TransCon hGH where we believe a long-
acting hGH therapy may offer benefits to patients with rare growth disorders, including in combination
with our TransCon CNP product candidate in our Phase 2 COACH Trial for children with
achondroplasia.
TransCon PTH
Market Opportunity in Hypoparathyroidism
Hypoparathyroidism is a rare endocrine disease caused by insufficient levels of parathyroid hormone
(“PTH”). As reported in a 2016 paper, 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 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%).
Management Commentary
20
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, 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. 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. A retrospective review 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.
We are also aware of several academic groups and companies working on making longer-acting
agonists of the PTH receptor. In addition, other companies and groups are developing therapies for
hypoparathyroidism at the clinical stage, including Calcilytix (a BridgeBio company), Entera Bio, Extend
Biosciences, Massachusetts General Hospital, 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 over 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 over 100,000 patients in the rest of Europe.
Management Commentary
21
Our Solution: 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.
By providing steady levels of PTH in the physiological range, we believe TransCon PTH may be a highly
differentiated therapy for hypoparathyroidism.
TransCon PTH for the Treatment of Hypoparathyroidism
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 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. In January 2024, we announced commercial
availability of YORVIPATH in Germany and Austria, and we began shipping to customers in February
2024.
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 December 2022, the FDA allowed us to initiate a U.S. expanded access program (“EAP”) for
TransCon PTH for eligible adult patients with hypoparathyroidism with prior PTH treatment experience.
The EAP closed to new patients on November 29, 2024, in preparation for the U.S. commercial
availability of YORVIPATH. Beginning in December 2024, we started enrolling EAP patients into the
Ascendis Signature Access Program Ascendis’ patient support program. Patients enrolled in the EAP
are now working with their healthcare providers (“HCPs”) to transition to the commercially available
YORVIPATH.
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.
In October 2020, we were granted Orphan Designation (“OD”) by the European Commission (“EC”) for
TransCon PTH for the treatment of hypoparathyroidism.
Clinical Development of TransCon PTH for Treatment of Hypoparathyroidism in Adults
TransCon PTH is being evaluated for the treatment of hypoparathyroidism in adults in the Phase 3
PaTHway Trial, Phase 3 PaTHway Japan Trial, and the Phase 2 PaTH Forward Trial. Last patient, last
visit (“LPLV”) in the Phase 3 PaTHway Trial occurred in January 2024. LPLV in the Phase 2 PaTH
Forward Trial is expected in March of 2025.
In September 2024, we announced results from the ongoing 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 parathyroid hormone 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. As of December 31, 2024, 10 patients successfully
completed the trial, while 46 out of the 59 patients originally enrolled in the trial continued in the open
Management Commentary
22
label (“OLE”) portion and had exceeded four and a half years of follow-up. Three patients withdrew from
the trial for reasons unrelated to safety or efficacy of the study drug.
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.
eGFR* Change from Baseline by Study Arm
Baseline
Week 26
Week 52
Week 104
Study Arm
eGFR
(mL/min/1.73m
2
)
N
Mean
(p value)
N
Mean
(p value)
N
Mean
(p value)
eGFR < 60
19
+11.4
(p=0.0002)
19
+11.5
(p=0.0003)
18
+13.4
(p<0.0001)
eGFR ≥ 60
41
+6.3
(p=0.0002)
40
+8.6
(p<0.0001)
40
+6.9
(p<0.0001)
TransCon PTH /
TransCon PTH
All
60
+7.9
(p<0.0001)
59
+9.3
(p<0.0001)
58
+8.9
(p<0.0001)
eGFR < 60
4
+0.1
(p=0.9877)
4
+11.7
(p=0.0018)
4
+15.6
(p=0.0067)
eGFR ≥ 60
15
-2.4
(p=0.3280)
15
+6.5
(p=0.0199)
14
+7.6
(p=0.0121)
Placebo
(first 26 weeks)
/ TransCon
PTH**
All
19
-1.9
(p=0.3468)
19
+7.6
(p=0.0014)
18
+9.4
(p=0.0006)
*eGFR (an assessment of kidney filtering capacity) was calculated by the trial’s central lab using the
Modification of Diet in Renal Disease Study Group (MDRD) equation (Levey, Ann Intern Med 2006). An
eGFR level <60 mL/min/1.73m
2
is considered the threshold for impaired kidney function.
**Patients in the placebo arm switched to TransCon PTH following the Week 26 visit.
TransCon PTH treatment was associated with clinically meaningful increases (≥ 5 mL/min/1.73 m
2
) in
eGFR within 26 weeks that were sustained through Week 104 of PaTHway:
Proportion of Participants (%) with ≥ 5 and ≥ 10 mL/min/1.73 m
2
Increases in eGFR
from Baseline through Week 104*
All Participants
TransCon PTH / TransCon PTH
(n=61)
Placebo (first 26 weeks) / TransCon PTH**
(n=21)
Week 26
Week 52
Week 104
Week 26
Week 52
Week 104
eGFR Change from
Baseline
PTH
PTH
PTH
Placebo
Switch to PTH
Switch to PTH
≥ 5 mL/min/1.73 m
2
57%
64%
61%
24%
52%
62%
≥ 10 mL/min/1.73 m
2
43%
43%
46%
10%
29%
38%
Participants with Baseline eGFR < 60 mL/min/1.73 m
2
eGFR Change from
Baseline
TransCon PTH / TransCon PTH
(n=19)
Placebo (first 26 weeks) / TransCon PTH**
(n=4)
Management Commentary
23
Week 26
Week 52
Week 104
Week 26
Week 52
Week 104
PTH
PTH
PTH
Placebo
Switch to PTH
Switch to PTH
≥ 5 mL/min/1.73 m
2
74%
68%
74%
25%
100%
100%
≥ 10 mL/min/1.73 m
2
47%
42%
53%
0%
75%
75%
*Percentages were calculated based on all participants. Patients who did not have an eGFR
assessment at the visit were still included in the denominator.
**Patients in the placebo arm switched to TransCon PTH following the Week 26 visit.
As of December 31, 2024, 58 patients successfully completed the 182 week follow-up in the PaTHway
Trial while 15 of the 82 originally enrolled in the trial continue in the OLE portion of the trial. Nine patients
withdrew from the trial for reasons unrelated to safety or efficacy of the study drug.
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. As of December 31, 2024, 12 patients
continue in the ongoing 3-year extension portion of the PaTHway Japan Trial.
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.
TransCon CNP
Market Opportunity in Achondroplasia
Achondroplasia is the most common genetic form of skeletal dysplasia leading to disproportionate short
stature and is associated with a well-delineated range of clinical complications and manifestations,
occurring in about one in 10,000 to 30,000 newborns or approximately 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 primarily caused by gain-of-function variants of the FGFR3 gene resulting in
constitutive activation of FGFR3 that leads to an imbalance in the effects of the FGFR3 and C-type
natriuretic peptide (“CNP”) signaling pathways. In achondroplasia, mutations in FGFR3 result in
constitutive activation, suppressing the proliferation and differentiation of chondrocytes resulting in
improper cartilage to bone conversion in the growth plate, and dysfunction in the skeletal muscle.
Preclinical and clinical data show that the CNP pathway helps to counteract the effects of the FGFR3
mutation downstream.
In November 2021, BioMarin Pharmaceutical Inc.’s 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 to build on VOXZOGO. Other companies that
Management Commentary
24
are developing therapies for achondroplasia include QED Therapeutics (a BridgeBio company), Sanofi,
Ribomic, Tyra Biosciences, GeneScience and ProLynx.
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 Quality of Life; Height; Reduced height. Muscle Strength/Stamina;
Reduced muscular functionality, including reduced strength and stamina.
Our Solution: 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, reduce binding of CNP to the NPR-B receptor in
the cardiovascular system to avoid hypotension, and release unmodified CNP, which is small enough
in size to allow effective penetration into growth plates. Shorter-acting CNP and CNP analogs in
development have resulted 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 with a lower C
max
to
correlate with better therapeutic outcomes.
In February 2019, we were granted ODD by the FDA for TransCon CNP for the treatment of
achondroplasia. In July 2020, we received OD from the EC for TransCon CNP for the treatment of
achondroplasia.
Clinical Development of TransCon CNP for Achondroplasia.
Our ongoing pivotal ApproaCH Trial, our long-term extension trial AttaCH, and COACH, 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).
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 pivotal ApproaCH Trial.
Management Commentary
25
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
100µg/kg/week or placebo for 52 weeks in the double-blind period, after which all participants could
choose to receive TransCon CNP at the 100µg/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:
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).
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 ACH Height Z-score, children treated with
TransCon CNP (n=57) demonstrated an LS mean change from baseline ACH 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 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
26
Safety Results Summary
• TransCon CNP was generally well-tolerated and demonstrated safety profile comparable to
those 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.
Following our pre-NDA meeting with FDA, we plan to submit a New Drug Application (“NDA”) for the
treatment of children with achondroplasia during the first quarter of 2025 and submit a Marketing
Authorisation Application (“MAA”) for the treatment of children with achondroplasia to the EMA during
the third quarter of 2025.
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
quality of life 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 quality of life, 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.
Management Commentary
27
While the CNP pathway may restore normal growth and skeletal muscle function, we believe delayed
initiation of therapy could lead to a permanent height deficit. Clinical use of daily growth hormone
injection has consistently demonstrated growth improvements in children with achondroplasia, including
catch up growth; however, without reports of benefits beyond linear growth. We believe the combination
of TransCon hGH and TransCon CNP, taken together once per week, could enable catch up growth
beyond normal growth while maintaining potential benefits on skeletal muscle of continuous CNP
exposure. COACH, a Phase 2 open-label single-arm trial, is evaluating TransCon CNP and TransCon
hGH 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 plans to enroll
approximately 18 patients (treatment naïve, n=12; prior treatment with TransCon CNP (100 µg/kg/week)
for at least 1 year, n=6). Week 26 top-line data from the COACH Trial are expected in the second
quarter of 2025.
During the third quarter of 2023, we filed an IND 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). All 57 randomized
children completed the blinded portion of ACcomplisH and continued in the OLE portion of ACcomplisH
at the 100 µg/kg/week dose.
As of December 31, 2024, 55 patients completed the OLE portion of the ACcomplisH Trial; 2 patients
prematurely withdrew during the OLE. From ACcomplisH OLE, 53 patients transitioned into the Phase
2 AttaCH Trial, a multicenter, long-term, open-label extension trial to continue treatment with TransCon
CNP 100 µg/kg/week and 2 patients transitioned into COACH, a TransCon CNP/TransCon hGH
combination trial. As of December 31, 2024, 43 patients continue in AttaCH, on long-term OLE
treatment; 3 patients prematurely withdrew from treatment and 7 patients transitioned into COACH.
With the last subject completing the OLE portion of the ACcomplisH Trial, the ACcomplisH Trial has
completed.
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. We plan to make the results available in 2025.
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
Management Commentary
28
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 improving 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 platinum resistant ovarian cancer and melanoma. Aside from Proleukin being
the only approved IL-2, TransCon IL-2 / may face competition from other IL-2 type drug candidates
in development, including those being developed by Mural, Anaveon, Medicenna, Roche, Innovent,
Synthekine, Dragonfly, Sotio, and Aulos. In addition, TransCon IL-2 / may face competition from drug
candidates in development for platinum resistant ovarian cancer, including Merck, Corcept, Novartis,
Advenchen Laboratories, Genelux, Daiichi Sankyo and Mereo/OncXerna. In melanoma, TransCon IL-
2 / may face competition from drug candidates in development including from Replimune, Philogen,
OncoSec, Immunocore, and Regeneron.
Our Solution: 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 combination and multi-agent regimens that would not otherwise be feasible.
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 TransCon product candidate currently being investigated in solid tumors is designed to provide
sustained systemic administration, which we believe could provide potent and durable anti-tumor
efficacy. Our 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 / for Sustained Systemic Release
TransCon IL-2 /(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 /,
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 / in locally advanced or metastatic solid tumors, alone or in combination
with pembrolizumab or standard of care chemotherapy, has completed dose escalation and is enrolling
patients in multiple indication-specific dose expansion cohorts, including platinum-resistant ovarian
cancer (“PROC”), cervical cancer, melanoma, non-small cell lung cancer (“NSCLC”), and small cell lung
cancer (“SCLC”) at the RP2D.
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.
Management Commentary
29
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.
In June 2024, we reported updated results from our ongoing Phase 1/2 IL-Believe Trial of TransCon IL-
2 /. Data included the first presentation of Phase 2 dose expansion Cohort 4 (TransCon IL-2 β⁄γ in
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 / 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 / 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 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
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.
Management Commentary
30
Novo Nordisk A/S
In November 2024, we entered into a research and development collaboration and license agreement
with Novo Nordisk A/S (“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.
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. For each additional metabolic or
cardiovascular disease product candidate, we will be 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
Management Commentary
31
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.
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.
Teijin Limited
In November 2023, we announced that we entered into an exclusive license agreement with Teijin
Limited 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
Limited, 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 December 2024, Teijin Pharma Limited announced the submission of an application for
manufacturing and marketing approval of palopegteriparatide for the treatment of hypoparathyroidism
in Japan.
Strategic Investments
VISEN Pharmaceuticals
In November 2018, we announced the formation of VISEN, a company established to develop and
commercialize our endocrinology rare disease therapies in the People’s Republic of China, Hong Kong,
Macau, and Taiwan (“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 additional $12.5 million in VISEN as part of VISEN’s $150 million Series B financing. As of
December 31, 2024, our ownership in VISEN was 43.9%.
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 March 2024, VISEN announced that the BLA for lonapegsomatropin (TransCon hGH) was accepted
by the China National Medical Products Administration.
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.
Management Commentary
32
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
annualized height velocity (“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, Inc., 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, 2024, our ownership in Eyconis
was 41.6%.
Financial Review
We had a net loss of €378.1 million for the year ended December 31, 2024 compared to a net loss of
€481.4 million for the year ended December 31, 2023. Operating loss was €278.8 million, representing
an improvement of €176.8 million compared to December 31, 2023, which, in addition to an increase in
revenue, was driven by reduced operating expenses. Our total equity presented a negative balance of
€105.7 million as of December 31, 2024, compared to a negative balance of €145.7 million as of
December 31, 2023. 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 takes place. Rendering of services is recognized as revenue over the service period as
Management Commentary
33
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 costs (“R&D costs”) 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, 2024 was €363.6 million, representing an increase of €96.9
million compared to last year. This increase was primarily attributable to higher revenue from licenses
associated with our exclusive license agreement with Novo Nordisk, signed in November 2024, which
includes a $100 million upfront payment, recognized in 2024, and our exclusive license agreement with
Eyconis in January 2024 of €27.1 million (non-cash) upfront payment adjusted for internal profit,
compared to the $70 million upfront payment received from our exclusive license agreement with Teijin
in 2023.
In addition, revenue was positively impacted from increased sales of SKYTROFA in the U.S. and the
commercial launch of YORVIPATH in Europe. Revenue for SKYTROFA was negatively impacted by an
adjustment to estimates and assumptions for sales deductions of €4.7 million, which were attributable
to years prior to January 1, 2024. The adjustment was primarily attributable to a different payer and
rebate mix than anticipated, and on which provisions for prior years were based.
Cost of Sales
Cost of sales for the year ended December 31, 2024 was €44.3 million, representing a decrease of €0.1
million compared to last year. This decrease was primarily attributable to lower costs under our license
and collaboration agreements, partly offset by increased sales of commercial products.
Research and Development Costs
R&D costs for the year ended December 31, 2024 were €307.0 million representing an decrease of
€106.5 million compared to last year. This decrease was primarily due to:
• Maturity of our endocrinology rare disease pipeline, especially regarding TransCon hGH and
TransCon PTH. In addition, 2024 include reversal (income) of prior period write-downs of
pre-launch inventories for TransCon PTH of €12.6 million, due to the commercial launch of
YORVIPATH in Europe and the U.S. in 2024;
• Lower product development activities on our TransCon TLR7/8 Agonist and TransCon IL-2
/ programs, partly offset by increased clinical trial activities. 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 /; and
Management Commentary
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• Cessation of ophthalmology expenses, including related employee costs, due to the grant of
exclusive rights to develop and commercialize TransCon ophthalmology to Eyconis in
January 2024.
Selling, General and Administrative Expenses
SG&A expenses for the year ended December 31, 2024 was €291.1 million representing an increase
of €26.7 million compared to last year. This increase was primarily due to higher employee related
expenses and other general and administrative expenses attributable to organizational growth in
support of launch of YORVIPATH in Europe and the U.S., partly offset by lower administrative
expenses.
Finance Income and Finance Expenses
Finance income and Finance Expenses for the year ended December 31, 2024 was a net expense of
€74.4 million representing a decrease of €74.2 million. This decrease was primarily driven foreign
exchange losses from translation 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, and from lower
remeasurement gains from financial liabilities.
For further details, please refer to Note 16, “Financial Assets and Liabilities”.
Cash Flows from / (used in) Operating Activities
Cash flows used in operating activities for the year ended December 31, 2024 were €306.2 million,
representing a decrease of €161.2 million compared to last year.
This improvement was primarily related to higher revenue and reduced operating expenditures, and to
further adjustment for changes to non-operating financial income and expenses, taxes and non-cash
items of total €168.5 million, partly offset by negative impact from working capital balances with €7.4
million. The negative impact from working capital balances includes $100 million plus indirect taxes
related to upfront payment from our exclusive license agreement with Novo Nordisk, which was
subsequently settled in January 2025.
Cash Flows from / (used in) Investing Activities
Cash flows from investing activities for the year ended December 31, 2024 were €6.9 million,
representing a decrease of €279.6 million compared to last year. This increase was primarily attributable
to higher net settlement of marketable securities.
Cash Flows from / (used in) Financing Activities
Cash flows from financing activities for the year ended December 31, 2024, were €443.9 million,
representing an increase of €309.6 million compared to the last year. This increase was primarily
attributable to our follow-on public offering of ADSs completed in September 2024 with net proceeds of
€290.6 million and increased warrant exercise activity of €20.2 million. Similar to 2023, we entered into
a $150.0 million capped synthetic royalty funding agreement with Royalty Pharma.
Liquidity and Capital Resources
Our liquidity and capital resources comprise cash and cash equivalents. As of December 31, 2024,
these amounted to €559.5 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 product and
product candidates within Endocrinology Rare Disease and Oncology portfolios, the commercialization
of SKYTROFA and YORVIPATH, and expenses made in anticipation of potential future product
launches. We manage our liquidity risk by maintaining adequate cash reserves and banking facilities.
Management Commentary
35
We monitor the risk of a shortage of funds through a liquidity planning tool to ensure sufficient funds
are available to settle liabilities as they become due.
As of December 31, 2024, the consolidated statements of financial position presented a negative
balance of equity of €105.7 million. Under Danish corporate law, as Ascendis Pharma A/S, the parent
company of the Company, holds a positive balance of equity, the Company is currently not subject to
legal or regulatory requirements to re-establish the balance of equity. There is no direct impact from the
negative balance of equity to the liquidity and capital resources.
Based on our current operating plan, we believe that our existing capital resources as of December 31,
2024 will be sufficient to meet our projected cash requirements for at least twelve months from the date
of this annual report. However, our operating plan may change as a result of many factors currently
unknown to us, and we may need to seek additional funds sooner than planned.
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).
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 a
program 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 17, “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 Sustainability & P|ESG Report 2024 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 Sustainability & P|ESG Report 2024 at:
https://investors.ascendispharma.com/financial-and-filings/annual-general-meetings/sustainability-
and-p-esg-report-2024
Management Commentary
36
Events after the Balance Sheet Date
No events have occurred after the reporting date that would influence the evaluation of these financial
statements.
Outlook
Having achieved pivotal milestones in 2024, Ascendis is positioned to continue strong revenue growth
in 2025 and beyond. We believe YORVIPATH is well on its way to establishing itself as the new global
standard for the treatment of hypoparathyroidism in adults. SKYTROFA has achieved a leading position
in value in the U.S. growth hormone market. And for TransCon CNP, we have a clear path to submit
our NDA and MAA as a differentiated treatment of achondroplasia in children.
We expect that our SG&A expenses may increase over the years as we expand our commercial
organization. We expect stable R&D investments as our current portfolio matures and early stage
pipeline renews.
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
37
Statements of Profit or Loss and Other Comprehensive Income for the
Years Ended December 31
Group
Parent
(EUR’000)
Notes
2024
2023
2024
2023
Statement of Profit or (Loss)
Revenue
4
405,780
302,712
Cost of sales
6,11
45,777
51,942
Gross profit
360,003
250,770
Research and development costs
6,11
80,596
75,026
Selling, general and administrative expenses
6,11
153,273
178,935
Operating profit/(loss)
(278,763
)
(455,541
)
126,134
(3,191
)
Share of profit/(loss) of associates
12
(20,060
)
(18,395
)
—
—
Finance income
16
94,173
77,624
Finance expenses
16
45,567
34,714
Profit/(loss) before tax
(373,241
)
(474,144
)
174,740
39,719
Income taxes (expenses)
9
(4,843
)
(7,303
)
(40
)
(3
)
Net profit/(loss) for the year
(378,084
)
(481,447
)
174,700
39,716
Attributable to owners of the Company
(378,084
)
(481,447
)
174,700
39,716
Basic and diluted earnings/(loss) per share
(6.53
)
(8.55
—
—
Number of shares used for calculation (basic and
diluted)
(1)
—
—
Statement of Comprehensive Income or
(Loss)
Net profit/(loss) for the year
(378,084
)
(481,447
)
174,700
39,716
Other comprehensive income/(loss)
Items that may be reclassified subsequently to
profit or (loss):
Exchange differences on translating foreign
operations
(2,731
)
—
—
Other comprehensive income/(loss) for the
year, net of tax
(2,731
)
—
—
Total comprehensive income/(loss) for the
year, net of tax
(377,022
)
(484,178
)
174,700
39,716
Attributable to owners of the Company
(377,022
)
(484,178
)
174,700
39,716
(1) As of December 31, 2024 and 2023 a total of 6,204,122 and 6,523,784 warrants outstanding, respectively,
each carrying the right to subscribe for one ordinary share, and 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.
Financial Statements
38
Statements of Financial Position as of December 31
Group
(EUR’000)
Notes
December
31, 2024
December
31, 2023
(Restated)
(1)
January 1,
2023
(Restated)
(1)
Assets
Non-current assets
Intangible assets
5, 10
Property, plant and equipment
5, 11
Investments in associates
12
Other receivables
16
Marketable securities
16, 17
Current assets
Inventories
13
Trade receivables
16
Income tax receivables
Other receivables
16
Prepayments
Marketable securities
16, 17
Cash and cash equivalents
16, 17
Total assets
Equity and liabilities
Equity
Share capital
17
Distributable equity
(113,855
)
(153,446
)
Total equity
(105,706
)
(145,697
)
Non-current liabilities
Borrowings
16, 17
Contract liabilities
14
Deferred tax liabilities
9
Current liabilities
Convertible notes, matures in April 2028
Borrowings
16, 17
Derivative liabilities
16, 17
608,877
550,391
557,136
Other current liabilities
Borrowings
16, 17
Contract liabilities
14
Trade payables and accrued expenses
16, 17
Other liabilities
Income tax payables
Provisions
15
298,986
186,118
159,641
Total liabilities
Total equity and liabilities
(1) Restatement relates to adoption of amendments to IAS 1 “Presentation of Financial Statements.” Refer to
Note 2 for further details.
Financial Statements
39
Statements of Financial Position as of December 31
Parent
(EUR’000)
Notes
December
31, 2024
December
31, 2023
(Restated)
(1)
January 1,
2023
(Restated)
(1)
Assets
Non-current assets
Intangible assets
5, 10
444
889
1,333
Property, plant and equipment
5, 11
23,889
28,414
25,344
Investments in group enterprises
20
156,306
146,267
122,759
Receivables from group enterprises
16
1,992,224
1,759,806
1,372,347
Other receivables
16
1,429
1,425
1,303
Marketable securities
16, 17
—
—
7,492
2,174,292
1,936,801
1,530,578
Current assets
Inventories
13
295,603
208,931
130,673
Trade receivables
16
120,643
—
281
Income tax receivables
738
739
740
Receivables from group enterprises
16
28,204
—
—
Other receivables
16
8,952
18,414
10,949
Prepayments
24,552
35,916
27,261
Marketable securities
16, 17
—
7,275
290,688
Cash and cash equivalents
16
492,174
263,909
407,184
970,866
535,184
867,776
Total assets
3,145,158
2,471,985
2,398,354
Equity and liabilities
Equity
Share capital
17
8,149
7,749
7,675
Distributable equity
2,384,422
1,793,109
1,678,334
Total equity
2,392,571
1,800,858
1,686,009
Non-current liabilities
Borrowings
16, 17
9,223
12,011
13,362
9,223
12,011
13,362
Current liabilities
Convertible notes, matures in April 2028
Borrowings
16, 17
458,207
407,095
399,186
Derivative liabilities
16, 17
150,670
143,296
157,950
608,877
550,391
557,136
Other current liabilities
Borrowings
16, 17
3,173
3,176
2,950
Trade payables and accrued expenses
16, 17
84,117
85,784
95,174
Payables to group enterprises
16, 17
2,085
—
6,558
Other liabilities
44,998
19,765
37,165
Provisions
15
114
—
—
134,487
108,725
141,847
743,364
659,116
698,983
Total liabilities
752,587
671,127
712,345
Total equity and liabilities
3,145,158
2,471,985
2,398,354
(1) Restatement relates to adoption of amendments to IAS 1 “Presentation of Financial Statements.” Refer to
Note 2 for further details.
Financial Statements
40
Statements of Changes in Equity - Group
Distributable Equity
(EUR’000)
Share
Capital
Share
Premium
Treasury
Shares
Foreign
Currency
Translation
Reserve
Accumulated
Deficit
Total
Equity at January 1, 2023
(149
)
(1,860,493
)
Net profit / (loss) for the
period
(481,447
)
(481,447
)
Other comprehensive
income/(loss), net of tax
(2,731
)
(2,731
)
Total comprehensive
income/(loss)
(2,731
)
(481,447
)
(484,178
)
Transactions with
Owners
Share-based payment
(Note 7)
Transfer under stock
incentive programs
(3
)
Net settlement under stock
incentive programs
(1,812
)
(1,812
)
Capital increase
Equity at December 31,
2023
(146
)
(2,277,095
)
(145,697
)
Net profit / (loss) for the
period
(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
(Note 7)
Transfer under stock
incentive programs
(33
)
Capital Increase (Note 17)
Cost of capital increase
(19,291
)
(19,291
)
Equity at December 31,
2024
(113
)
(2,559,700
)
(105,706
)
Financial Statements
41
Statements of Changes in Equity - Parent
Distributable Equity
(EUR’000)
Share
Capital
Share
Premium
Treasury
Shares
Foreign
Currency
Translation
Reserve
Accumulated
Deficit
Total
Equity at January 1, 2023
7,675
2,112,863
(149
)
(53
)
(434,327
)
1,686,009
Net profit /(loss) for the
period
—
—
—
—
39,716
39,716
Total comprehensive
income/(loss)
—
—
—
—
39,716
39,716
Transactions with
Owners
Share-based payment
(Note 7)
—
—
—
—
66,660
66,660
Transfer under stock
incentive programs
—
—
3
—
(3
)
—
Net settlement under stock
incentive programs
—
—
—
—
(1,812
)
(1,812
)
Capital increase
74
10,211
—
—
—
10,285
Equity at December 31,
2023
7,749
2,123,074
(146
)
(53
)
(329,766
)
1,800,858
Net profit /(loss) for the
period
—
—
—
—
174,700
174,700
Total comprehensive
income/(loss)
—
—
—
—
174,700
174,700
Transactions with
Owners
Share-based payment
(Note 7)
—
—
—
—
95,512
95,512
Acquisition of treasury
shares
—
—
33
—
(33
)
—
Capital Increase (Note 17)
400
340,392
—
—
—
340,792
Cost of capital increase
—
(19,291
)
—
—
—
(19,291
)
Equity at December 31,
2024
8,149
2,444,175
(113
)
(53
)
(59,587
)
2,392,571
Financial Statements
42
Cash Flow Statements for the Years Ended December
Group
Parent
(EUR’000)
Notes
2024
2023
2024
2023
Operating activities
Net profit/(loss) for the year
(378,084 )
(481,447 )
174,700
39,716
Reversal of finance income
(25,609 )
(43,857 )
(94,173)
(77,624)
Reversal of finance expenses
45,567
34,714
Reversal of (gain)/loss on disposal of property, plant
and equipment
(91 )
—
—
Reversal of income taxes (expenses)
40
3
Adjustments for non-cash items:
Non-cash consideration relating to revenue
(27,069 )
(2,354 )
—
—
Share of (profit)/loss of associates
—
—
Share-based payment
61,038
43,259
Depreciation
4,918
4,267
Impairment of property, plant and equipment
—
—
Amortization
445
444
Changes in working capital:
Inventories
(86,678 )
(78,258 )
(86,678)
(78,258)
Receivables
(118,607 )
(32,773 )
(111,199)
(8,130)
Receivables from group enterprises
(145,433)
(350,885)
Prepayments
(11,413 )
11,363
(13,158)
Contract liabilities
(1,197 )
(7,080 )
—
—
Trade payables, accrued expenses and other
liabilities
23,563
(26,791)
Payables to group enterprises
2,072
(6,558)
Increase/(decrease) in provisions
114
—
Cash flows generated from/(used in) operations
(299,854 )
(464,271 )
(113,663)
(439,001)
Finance income received
11,825
15,283
Finance expenses paid
(15,205 )
(15,672 )
(12,196)
(12,489)
Income taxes received/(paid)
(5,512 )
(4,466 )
738
738
Cash flows from/(used in) operating activities
(306,197 )
(467,361 )
(113,295)
(435,469)
Investing activities
Investment in group enterprises
(67)
(107)
Proceeds from disposal of property, plant and
equipment
—
—
Acquisition of intangible assets and property, plant
and equipment
(1,427 )
(2,442 )
(394)
(1,230)
Settlement of marketable securities
7,353
288,865
Cash flows from/(used in) investing activities
6,892
287,528
Financing activities
Repayment of borrowings
(11,365 )
(10,438 )
(2,834)
(2,714)
Net proceeds from borrowings
16
—
—
Proceeds from exercise of warrants
30,514
10,286
Proceeds from follow-on public offering
309,913
—
Costs of follow-on public offering
(19,291 )
(19,291)
—
Payment of withholding taxes under stock incentive
programs
(1,812 )
—
(1,812)
Cash flows from/(used in) financing activities
318,302
5,760
Increase/(decrease) in cash and cash
equivalents
(46,595 )
211,899
(142,181)
Cash and cash equivalents at January 1
263,909
407,184
Effect of exchange rate changes on balances held
in foreign currencies
(6,008 )
16,366
(1,094)
Cash and cash equivalents at December 31
492,174
263,909
Cash and cash equivalents include
Bank deposits
492,174
263,909
Cash and cash equivalents at December 31
492,174
263,909
Financial Statements
43
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 12,
2025. 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
European 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
The Company has applied amendments to paragraphs 69 to 76 of IAS 1, “Presentation of Financial
Statements,” which was effective for annual reporting periods beginning on or after January 1, 2024
and must be applied retrospectively. The amendments to IAS 1 specify the requirements for classifying
liabilities as current or non-current. The amendments clarify:
• What is meant by a right to defer settlement;
• That a right to defer must exist at the end of the reporting period;
• That classification is unaffected by the likelihood that an entity will exercise its deferral
right; and
• That only if an embedded derivative in a convertible liability is itself an equity instrument
would the terms of a liability not impact its classification.
Financial Statements
44
The convertible senior notes (“convertible notes”) include an embedded equity conversion option which
is not deemed closely related to the financial liability and was 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.
Since the embedded derivative is not an equity instrument under IFRS, the amendments require the
convertible notes (presented as part of borrowings in the statement of financial position) and derivative
liabilities, presented as non-current liabilities as of December 31, 2023, to be presented as current
liabilities. The amendments require presentation of the convertible notes as current liabilities even
though: the initial conversion price of $166.34 per ADS is not met; the conversion would not require
cash settlement; and, the convertible notes do not mature until April 1, 2028. Further details, including
(cash) maturity analysis are provided in Note 16, “Financial Assets and Liabilities.” On December 31,
2023, the carrying amount of convertible notes and derivative liabilities were €407.1 million and €143.3
million, respectively. Comparative amounts have been reclassified to reflect the change to presentation,
including a third statement of financial position as of the beginning of the preceding period i.e. January
1, 2023.
On December 31, 2023, lease liabilities were presented separately in the consolidated statements of
financial position. As of December 31, 2023, carrying amount of lease liabilities was €84.6 million and
€14.2 million, for non-current liabilities and current liabilities, respectively. Since March 31, 2024, lease
liabilities are presented as part of borrowings in the consolidated statements of financial position.
Comparative amounts have been reclassified to reflect the change in presentation.
Accordingly, since March 31, 2024, borrowings comprise convertible notes, royalty funding liabilities,
and lease liabilities, where convertible notes are presented separately as “Current liabilities -
Convertible notes, matures in 2028.” The change to presentation had no other impact on the
consolidated financial statements. Refer to Note 16, “Financial Assets and Liabilities” for a specification
of borrowings.
The applied amendments had no other impact on the consolidated financial statements.
Other IFRS Accounting Standards and Interpretations
Other amendments apply for the first time in 2024, but do not have an impact on the financial
statements.
Going Concern
The Company’s Board of Directors has, at the time of approving the financial statements, a reasonable
expectation that the Company has adequate resources to continue in operational existence for the
foreseeable future. Thus, the Company continues to adopt the going concern basis of accounting in
preparing the financial statements.
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 20, “Investments
in Group Enterprises”.
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.
Financial Statements
45
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 of the
associates since the acquisition or establishment date.
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.
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.
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
Financial Statements
46
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
Revenue from 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 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.
Other Revenue
Other revenue relates to collaboration and license agreements. When contracts with 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.
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47
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.
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.
Research and Development Costs
Research and development costs 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).
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.
Financial Statements
48
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 7, “Share-based Payment.”
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 settles 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
Financial Statements
49
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.
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
50
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 costs, 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 comprises 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 costs. Plant and equipment acquired for research and development
activities, which has no alternative use, is recognized as research and development costs 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
3-11 years
Right-of-use assets
2-11 years
Depreciation methods, useful lives and residual amounts are reassessed at least annually.
Financial Statements
51
Property, plant and equipment is written down to the lower of recoverable amount and carrying amount,
as described in the “Impairment” 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 costs 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 costs 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.
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 cost of sales in the period in which the reversal
occurs.
Financial Statements
52
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 costs. If marketing approval is obtained, prior write-downs of
pre-launch inventories are reversed through research and development costs.
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, 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. 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.
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
Financial Statements
53
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.
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.
Financial Statements
54
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.
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.
Financial Statements
55
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.
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. 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.
Cash Flow Statement
The cash flow statement 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.
Financial Statements
56
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 cash flow statement, 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. The
weighted average number of shares takes into account the weighted average number of treasury shares
during the year.
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 effect of changes in treasury shares during the year, and the dilutive effect of
outstanding warrants and convertible notes. If the consolidated statement of profit or loss shows a net
loss, no adjustment is made for the dilutive effect, as such effect would be anti-dilutive.
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.
Financial Statements
57
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 by the Company.
The 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 in any of the years presented in
these financial statements.
There have been no changes to the application of significant accounting judgements, or estimation
uncertainties regarding accounting estimates compared to December 31, 2023.
Significant Accounting Judgements
Significant accounting judgements which have a material impact on the financial statements are
described in the following sections.
Internally Generated Intangible Assets
Development of Drug Candidates
IAS 38, “Intangible Assets” prescribes that intangible assets arising from development projects must be
recognized in the statements of financial position if the criteria for capitalization are met. That means
(1) that the development project is clearly defined and identifiable; (2) that technological feasibility,
adequate resources to complete and a market for the product or an internal use of the project can be
documented; (3) that the expenditure attributable to the development project can be measured reliably;
and (4) that the Company has the intent to produce and market the product. Such an intangible asset
shall be recognized if it can be demonstrated that the future income from the development project will
exceed the aggregate cost of development, production, sale and administration of the product.
Due to the risk associated with drug development, future income from development projects related to
drug candidates cannot be determined with sufficient certainty until the development activities have
been completed and the necessary marketing approvals have been obtained. Accordingly, the
Company does not recognize internally generated intangible assets at this time.
Significant Estimation Uncertainties
The 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
Financial Statements
58
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, 2024, provisions for sales deductions and product returns were €99.1 million
compared to €32.7 million, as of December 31, 2023. The development in total provisions is disclosed
in Note 15, “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 costs 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 €19.7 million,
and €28.8 million for the years ended December 31, 2024, and 2023, respectively. Changes to inputs
applied to the Black-Scholes option pricing model could affect the warrant compensation cost. Refer to
Note 7, “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.
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, 2024, the valuation of the derivative liabilities was €150.7 million compared to
€143.3 million as of December 31, 2023. Changes in assumptions relating to these factors could affect
Financial Statements
59
the reported fair value of derivative liabilities. Refer to Note 16 “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, 2024, the carrying amount of the royalty funding liabilities was €305.4 million
compared to €138.4 million as of December 31, 2023. As of December 31, 2024, royalty funding
liabilities comprised two agreements compared with one agreement as of December 31, 2023. 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 16
“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)
2024
2023
2024
2023
Revenue
Commercial products
225,728
178,663
47,940
54,710
Rendering of services
11,794
21,659
252,566
243,002
Clinical supply
3,776
319
—
—
Licenses
122,343
66,077
105,274
5,000
Total revenue
363,641
266,718
405,780
302,712
Attributable to
Commercial customers
225,728
178,663
400
—
Collaboration partners and license agreements
137,913
88,055
95,397
—
Group enterprises
—
—
309,983
302,712
Total revenue
363,641
266,718
405,780
302,712
Specified by timing of recognition
Recognized over time
11,794
21,659
252,566
243,002
Recognized at a point in time
351,847
245,059
153,214
59,710
Total revenue
363,641
266,718
405,780
302,712
Specified per geographical area
Europe
(1)
123,336
869
405,386
302,712
North America
233,220
191,677
394
—
Rest of world
7,085
74,172
—
—
Total revenue
363,641
266,718
405,780
302,712
(1) For the year ended December 31, 2024 Denmark, the country of domicile, contributed with €95.4 million of
revenue (parent €405.0 million and €302.7 million for 2023).
Financial Statements
60
Commercial Customers
Revenue attributable to commercial customers by product were as follows:
Group
2024
2023
(EUR’000)
Revenue from commercial products
SKYTROFA®
197,001
178,663
YORVIPATH®
28,727
—
Total revenue from commercial products
225,728
178,663
Revenue from sales of SKYTROFA® is primarily sold to specialty pharmacies and specialty distributors
in the U.S. market, and to wholesalers and pharmacies in Germany. Revenue from sale of SKYTROFA
for the year ended December 31, 2024 was negatively impacted by an adjustment to estimates and
assumptions for sales deductions of €4.7 million, which was related to periods prior to January 1, 2024.
The adjustment was primarily attributable to a different payer and rebate mix than anticipated, and on
which provisions for prior years were based.
In November 2023, TransCon PTH received marketing approval in the EU and European Economic
Area countries and is marketed as YORVIPATH®. In August 2024, TransCon PTH received marketing
approval in the U.S. and is marketed in the U.S. as YORVIPATH. The Company began selling
YORVIPATH, primarily to pharmacies in Europe in the first quarter of 2024, and to specialty pharmacies
in the U.S. in December 2024. In addition, the Company began selling YORIVPATH to distributors in
the second quarter of 2024.
For the years ended December 31, 2024 and 2023, four commercial customers represented more than
10% of sales to commercial customers.
Collaboration Partners and License Agreements
Revenue attributable to collaboration partners and license agreements relates to Novo Nordisk A/S
(“Novo Nordisk”), Eyconis, Inc. (“Eyconis”), Teijin Limited (“Teijin”) and VISEN Pharmaceuticals
(“VISEN”). Under the collaboration agreements, the Company also provides various research and
development services which are invoiced to collaboration partners. Revenue for these activities is
presented as part of “Rendering of services.” Employment costs related to these activities are presented
as Research and Development Costs in the consolidated statement of profit or loss.
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
Financial Statements
61
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. 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
Financial Statements
62
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.
No revenue from royalties or milestones has been recognized under the Eyconis agreement.
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.
At December 31, 2024, none of the Licensed Products have received marketing authorization in
Japan. 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.
No revenue from royalties or milestones has been recognized under the Teijin Agreement.
VISEN
In November 2018, the Company entered into three exclusive license agreements with VISEN.
Revenue from collaboration partners and license agreements also includes license income, rendering
of services and sale of clinical supply under the VISEN Agreements.
Note 5 – 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 intangible assets and property, plant and equipment located by region are specified
below:
Group
(EUR’000)
2024
2023
Intangible assets and property, plant and equipment
Europe
(1)
39,640
46,464
North America
63,102
68,589
Total intangible assets and property, plant and equipment
102,742
115,053
(1) As of December 31, 2024 and December 31, 2023, intangible assets and property, plant and equipment of
€27.9 million and €32.9 million, respectively, is located in Denmark, the country of domicile
The Parent Company has no non-current segment assets outside Denmark (domicile country).
Financial Statements
63
Note 6 – Employee costs
Group
Parent
(EUR’000)
2024
2023
2024
2023
Employee costs
Wages and salaries
173,474
170,278
76,448
70,561
Share-based payment
95,512
66,660
61,038
43,259
Pensions (defined contribution plans)
4,485
4,403
1,766
2,086
Social security costs
15,003
12,877
633
559
Other employee costs
4,061
4,238
2,133
2,605
Total employee costs
292,535
258,456
142,018
119,070
Included in the profit or loss
Cost of sales
(1)
16,487
15,748
16,487
15,748
Research and development costs
131,867
127,002
66,073
57,756
Selling, general, and administrative expenses
144,181
115,706
59,458
45,566
Total employee costs
292,535
258,456
142,018
119,070
Average number of employees
445
404
(1) Includes employee costs capitalized as part of inventories.
Key Management Personnel comprises the Board of Directors, the Executive Board and Non-executive
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 7, “Share-based Payment.”
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)
2024
2023
2024
2023
2024
2023
Compensation
Wages and salaries
482
543
4,148
4,375
3,286
4,673
Share-based payment
2,169
1,276
18,334
13,243
10,266
9,529
Pensions (defined contribution plans)
—
—
57
54
98
122
Social security costs
—
—
118
103
52
45
Other employee cost
—
—
20
20
25
40
Total compensation
2,651
1,819
22,677
17,795
13,727
14,409
(1) The Board of Directors comprised six persons in 2024 and six to seven persons 2023.
(2) The Executive Board comprised four persons in 2024 and 2023.
Note 7 – 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 RSU program (adopted in
December 2021), and a PSU program (adopted in February 2023), which are all classified as equity-
settled share-based payment transactions.
Restricted Stock Unit Program
RSUs are granted by the Board in accordance with authorizations given to it by the shareholders of
Ascendis Pharma A/S to members of senior management, certain other employees and certain
members of the Board (“RSU-holders”) in accordance with the Company’s RSU Program adopted in
December 2021. Further, RSUs may be granted to select consultants. One RSU represents a right for
the RSU-holder to receive one ADS of Ascendis Pharma A/S upon vesting if the vesting conditions are
met or waived by the Board at its discretion.
Financial Statements
64
Performance Stock Unit Program
PSUs are granted by the Board in accordance with authorizations given to it by the shareholders of
Ascendis Pharma A/S to certain members of senior management (the “PSU-holders”). In addition, PSUs
may be granted to other employees, select consultants and members of the Board. PSUs were granted
for the first time in March 2023. One PSU represents a right for the PSU-holder to receive one ADS of
Ascendis Pharma A/S upon vesting if the vesting conditions are met or waived by the Board at its
discretion.
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. For the March 2023 PSU grant, 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 the March 2024 PSU grant, in addition to service conditions,
vesting is also contingent 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.
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.
Financial Statements
65
RSU and PSU Activity
The following table specifies the number of RSUs and PSUs granted and outstanding:
Restricted
Stock Units
Performance
Stock Units
Total
(Number)
Outstanding at January 1, 2022
148,148
—
148,148
Transferred during the year
(41,685
)
—
(41,685
)
Forfeited during the year
(23,971
)
—
(23,971
)
Outstanding at December 31, 2022
82,492
—
82,492
Granted during the year
(1)
609,860
112,268
722,128
Settled during the year
(18,132
)
—
(18,132
)
Transferred during the year
(20,098
)
—
(20,098
)
Forfeited during the year
(77,497
)
(7,245
)
(84,742
)
Outstanding at December 31, 2023
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
)
Outstanding at December 31, 2024
993,807
156,667
1,150,474
Specified by vesting date
2025
384,098
62,304
446,402
2026
384,438
63,478
447,916
2027
225,271
30,885
256,156
Outstanding at December 31, 2024
993,807
156,667
1,150,474
(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 €141.01 and €105.96 for the years ended
December 31, 2024 and December 31, 2023, respectively.
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. For warrants
granted until November 2021, special vesting conditions apply in the event 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.
Warrants Granted Until November 2021
Warrants granted from 2012 until November 2021, generally vest over 48 months with 1/48 of the
warrants vesting per month from the date of grant. However, effective from January 2015, certain
warrants granted to board members vest over 24 months with 1/24 of the warrants vesting per month
from the date of grant.
Financial Statements
66
Warrants Granted From December 2021
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
granted vest one year after the date of grant, and the remaining 75% of the warrants granted shall vest
over 36 months, with 1/36 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.
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 at January 1, 2023
6,864,011
81.30
Granted during the year
395,275
91.07
Exercised during the year
(1)
(555,144
)
17.76
Forfeited during the year
(180,358
)
115.79
Outstanding at December 31, 2023
6,523,784
86.38
Vested at the reporting date
5,273,056
80.02
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
Outstanding at December 31, 2024
6,204,122
93.25
Vested at the reporting date
5,226,643
89.33
(1) The weighted average share price (listed in $) at the date of exercise was €135.86 and €98.10 for the years
ended December 31, 2024 and 2023, respectively.
Financial Statements
67
At December 31, 2024, the Board was authorized to grant up to 2,060,116 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, 2024, per grant year.
Outstanding
Warrants
(number)
Weighted
Average
Exercise
Price (EUR)
Weighted
Average
Remaining
Life
(months)
Granted before January 1, 2022
5,185,556
89.67
57
Granted in 2022
235,408
100.71
90
Granted in 2023
292,648
90.66
101
Granted in 2024
490,510
122.34
114
Outstanding at December 31, 2024
6,204,122
93.25
65
At December 31, 2024, the exercise prices of outstanding warrants under the Company’s warrant
programs range from €11.98 to €145.50 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, 2023. The weighted average remaining life for outstanding warrants was 71 months for
the financial year ended December 31, 2023.
Warrant Compensation Costs
Warrant compensation costs are recognized in the statements of profit or loss over the vesting period
of the warrants granted.
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 (from 2021).
The following table summarizes the input to the Black-Scholes option pricing model and the calculated
fair values for warrant grants in 2024 and 2023:
2024
2023
Expected volatility
50 %
49-51 %
Risk-free interest rate
1.71 - 2.57 %
2.40 - 2.97 %
Expected life of warrants (years)
6.0
6.0
Weighted average exercise price
€ 122.48
€ 91.07
Fair value of warrants granted in the year
€ 50.86 - 70.39
€ 37.34 - 52.03
Note 8 – 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.
Financial Statements
68
Group
(EUR’000)
2024
2023
Principal accountant fees and services
Audit fees
811
739
Audit-related fees
147
—
Tax fees
91
122
Total principal accountant fees and services
1,049
861
Note 9 – Tax on Profit/(Loss) for the Year and Deferred Tax
Group
Parent
(EUR’000)
2024
2023
2024
2023
Tax on profit/(loss) for the year:
Current tax (expense)/income
(3,289
)
(5,377
)
—
40
Current tax, adjustments to prior years
(126
)
3,904
(40
)
(43
)
Deferred tax, movement for the year
(2,035
)
(1,044
)
—
—
Deferred tax, adjustments to prior years
607
(4,786
)
—
—
(4,843
)
(7,303
)
(40
)
(3
)
Tax for the year can be explained as follows:
Profit/(loss) before tax
(373,241
)
(474,144
)
174,740
39,719
Tax at the Danish corporation tax rate of 22%
82,113
104,312
(38,443
)
(8,738
)
Tax effect of:
Non-deductible costs
(9,740
)
(8,494
)
(14,900
)
(10,644
)
Additional tax deductions
3,161
9,077
670
348
Impact from associates
(4,413
)
(4,047
)
—
—
Prior year adjustments
481
(1,294
)
—
—
Other effects including effect of different tax rates
182
(882
)
(40
)
(43
)
Deferred tax asset, not recognized
(76,627
)
(105,975
)
52,673
19,074
Tax on profit/(loss) for the year
(4,843
)
(7,303
)
(40
)
(3
)
Effective tax rate
1.30
%
1.54
%
0.02
%
(0.01
)%
Group
Parent
(EUR’000)
2024
2023
2024
2023
Specification of Deferred Tax Assets/(Liabilities)
Tax deductible losses
434,997
521,697
9,522
102,921
Other temporary differences, assets
164,479
16,256
38,391
3,522
Deferred tax asset, not recognized
(599,476
)
(537,953
)
(47,913
)
(98,635
)
Other temporary differences, liabilities
(7,258
)
(5,830
)
—
(7,808
)
Total Deferred Tax Assets/(Liabilities) at December,
31
(7,258
)
(5,830
)
—
—
At December 31, 2024 a deferred tax liability has been recognized in relation to taxable temporary
differences in one jurisdiction, as we do not believe we will have any deductible temporary differences
nor tax losses to deduct the taxable difference in, when they are expected to reverse.
Deferred tax assets have not been recognized in the statements of financial position as of December 31,
2024 due to uncertainty relating to future utilization. The deferred tax asset can be carried forward
without timing limitations. For parent the deferred tax liabilities can be offset in deferred tax assets within
the Danish joint taxation group.
The Company had tax losses carried forward of €1,946.2 million (Parent Company: €43.3 million) and
€2,371.3 million (Parent Company: €467.8 million) at December 31, 2024 and December 31, 2023,
respectively. 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 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, 2024 and 2023, respectively.
The tax losses carried forward at December 31, 2023 (€2,371.3 million) has been reduced with €456.8
million (Parent Company €130.5 million). The reduction is as a consequence of two changes of tax
Financial Statements
69
principles made in the Danish tax returns for the taxable year 2023 (filed in June 2024). The changes
are related to R&D costs (depreciations) and inventory write-down (cost price). This reduction in tax
losses is still available as deferred tax assets, that can be recognized for future utilization; only not as
a “Tax deductible losses,” but as “Other temporary differences, assets.”
The Company is entitled to additional tax deductions related to share based payments (Warrants, RSUs
and PSUs). Tax deductions can be taken when the warrants and RSUs/PSUs are exercised/transferred.
For the year ended December 31, 2024, the Company was entitled to additional tax deductions with a
tax value of €21.7 million, (Parent company:€7.5 million) compared to €10.6 million (Parent company:
€3.4 million) for the year ended December 31, 2023. These future tax deductions depend on the timing
and amounts of warrants/RSUs/PSUs exercises/transfers, and accordingly, future additional tax
deductions are subject to uncertainties. Refer to Note 7, “Share-based Payment,” regarding a
description of warrant and RSU/PSU programs.
The Company is entitled to additional tax deductions for which deferred tax asset cannot be
recognized due the initial recognition exception in IAS 12, “Income Taxes.” For the year ended
December 31, 2024, the Company is entitled to additional future tax deduction with a tax value of
€11.0 million (parent € 2.5 million), compared to €0.3 million (parent € 0.3 million) for the year ended
December 31, 2023. In addition, the Company is entitled to additional tax deductions related to tax
credits. Tax credits can be taken in future taxes. For the year ended December 31, 2024, the
Company was entitled to additional tax deduction with a tax value of €13.8 million (parent € —
million), compared to €8.4 million (parent €— million) for the year ended December 31, 2023.
On May 23, 2023, the IASB issued International Tax Reform - Pillar Two Model Rules - Amendments
to IAS 12 which clarify 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, including tax
law that implements Qualified Domestic Minimum Top-up Taxes. The Company has adopted these
amendments; however, they are not applicable for the year ended December 31, 2024, as the
Company’s consolidated revenue is currently below the threshold of €750 million.
The Parent Company Ascendis Pharma A/S, is jointly taxed with its Danish subsidiaries. The current
Danish corporation tax is allocated between the jointly taxed Danish companies in proportion to their
taxable income (full absorption with refunds for tax losses). The jointly taxed companies are included in
the on-account tax scheme.
Note 10 – Intangible Assets
Group
(EUR’000)
Goodwill
Software
Total
Cost
January 1, 2023
3,495
2,222
5,717
Additions
—
53
53
Transferred
—
21
21
December 31, 2023
3,495
2,296
5,791
Additions
—
76
76
December 31, 2024
3,495
2,372
5,867
Amortization and impairment
January 1, 2023
—
(889
)
(889
)
Amortization charge
—
(483
)
(483
)
December 31, 2023
—
(1,372
)
(1,372
)
Amortization charge
—
(467
)
(467
)
December 31, 2024
—
(1,839
)
(1,839
)
Carrying amount
December 31, 2023
3,495
924
4,419
December 31, 2024
3,495
533
4,028
Financial Statements
70
Parent
(EUR’000)
Software
Acquired
intellectual
property
Total
Cost
January 1, 2023
2,222
1,326
3,548
Additions
—
—
—
December 31, 2023
2,222
1,326
3,548
Additions
—
—
—
December 31, 2024
2,222
1,326
3,548
Amortization and impairment
January 1, 2023
(889
)
(1,326
)
(2,215
)
Amortization charge
(444
)
—
(444
)
December 31, 2023
(1,333
)
(1,326
)
(2,659
)
Amortization charge
(445
)
—
(445
)
December 31, 2024
(1,778
)
(1,326
)
(3,104
)
Carrying amount
December 31, 2023
889
—
889
December 31, 2024
444
—
444
At the reporting date, no internally generated intangible assets from development of pharmaceutical
drug candidates have been recognized. Thus, all related research and development costs incurred for
the years ended December 31, 2024, and 2023, 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
71
Note 11 – Property, Plant and Equipment
Group
(EUR’000)
Plant and
Machinery
Other
Equipment
Leasehold
Improve-
ments
Right-of-
Use
Assets
Total
Cost
January 1, 2023
24,944
11,203
20,130
119,466
175,743
Additions
2,580
503
228
7,547
10,858
Disposals
(383
)
(57
)
—
—
(440
)
Transferred
504
(21
)
(504
)
—
(21
)
Foreign exchange translation
(209
)
(208
)
(479
)
(3,093
)
(3,989
)
December 31, 2023
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
Depreciation and impairment
January 1, 2023
(7,584
)
(5,023
)
(4,497
)
(29,544
)
(46,648
)
Depreciation charge
(2,569
)
(1,899
)
(2,085
)
(11,875
)
(18,428
)
Impairment charge
(2,869
)
(405
)
(4,560
)
—
(7,834
)
Disposals
146
54
—
—
200
Foreign exchange translation
92
98
196
807
1,193
December 31, 2023
(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
)
Carrying amount:
December 31, 2023
14,652
4,245
8,429
83,308
110,634
December 31, 2024
12,003
3,786
7,513
75,412
98,714
The impairment charge for the year ended December 31, 2023, relates to change in activities at one of
our R&D sites and is determined according to its estimated value in use. The R&D site is subleased
and is recognized as a right-of-use asset with a carrying amount of €11.2 million and €12.5 million as
of December 31, 2024 and 2023, respectively.
Depreciation charges are specified below:
Group
(EUR’000)
2024
2023
Depreciation charges
Cost of sales
(1)
3,197
2,509
Research and development costs
7,453
10,296
Selling, general and administrative expenses
6,597
5,623
Total depreciation charges
17,247
18,428
(1) Includes depreciation charges capitalized as part of inventories.
Financial Statements
72
Parent
(EUR’000)
Plant and
Machinery
Other
Equipment
Leasehold
Improve-
ments
Right-of-
Use
Assets
Total
Cost
January 1, 2023
6,539
2,594
2,991
24,577
36,701
Additions
1,191
—
39
6,107
7,337
December 31, 2023
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
Depreciation and impairment
January 1, 2023
(268
)
(1,845
)
(439
)
(8,805
)
(11,357
)
Depreciation charge
(370
)
(314
)
(288
)
(3,295
)
(4,267
)
December 31, 2023
(638
)
(2,159
)
(727
)
(12,100
)
(15,624
)
Deprecation charge
(787
)
(247
)
(296
)
(3,588
)
(4,918
)
Disposals
—
—
—
88
88
December 31, 2024
(1,425
)
(2,406
)
(1,023
)
(15,600
)
(20,454
)
Carrying amount
December 31, 2023
7,092
435
2,303
18,584
28,414
December 31, 2024
6,305
456
2,083
15,045
23,889
Depreciation charges are specified below:
Parent
(EUR’000)
2024
2023
Depreciation charges
Cost of sales
(1)
3,197
2,509
Research and development costs
1,053
1,128
Selling, general and administrative expenses
668
630
Total depreciation charges
4,918
4,267
(1) Includes depreciation charges capitalized as part of inventories.
Note 12 – 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.
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, 2024,
the Company’s present ownership in Eyconis was 41.6%.
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. As of December 31, 2024, the Company’s present ownership
in VISEN was 43.9%.
The aggregated profit or loss, total comprehensive income, transactions and outstanding balances with
associates as of December 31, 2024 and 2023 were as follows.
Financial Statements
73
Group
(EUR’000)
2024
2023
Statement of profit or (loss)
Profit/(loss) for the year from continuing operations
(59,235
)
(41,873
)
Total comprehensive income
(59,218
)
(41,859
)
Transactions and outstanding balances as of December 31
Invoicing of goods and services to associates
18,225
15,026
Trade receivables from associates
1,759
991
Contract liabilities
5,936
7,133
Note 13 – Inventories
Inventories are specified below:
Group and Parent
(EUR’000)
2024
2023
Inventories
Raw materials and consumables
17,596
18,566
Work in progress
235,688
171,030
Finished goods
42,325
19,335
Total inventories
295,609
208,931
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 €15.7 million and €22.9 million for the years ended
December 31, 2024 and 2023 respectively, which include write-downs on pre-launch inventories.
Note 14 – Contract Liabilities
At December 31, 2024, 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 €1.4 million (Parent Company: €— million) and €13.3
million (Parent Company: €— million) for the years ended December 31, 2024 and 2023, respectively,
and primarily related to delivery of clinical supply and research and development services.
Note 15 – Provisions
Development in provisions is specified below:
Group
Parent
(EUR’000)
2024
Provisions
January 1
32,719
—
Additions related to prior years
4,684
—
Net additions for the year
57,284
114
Foreign exchange translation
4,462
—
December 31
99,149
114
Financial Statements
74
Note 16 – Financial Assets and Liabilities
Financial assets and liabilities comprise the following:
Group
Parent
(EUR’000)
2024
2023
2024
2023
Financial assets by category
Trade receivables
166,280
35,874
120,643
—
Receivables from group enterprises
—
—
2,020,428
1,759,806
Other receivables (excluding indirect tax receivables)
3,964
3,909
3,035
3,111
Marketable securities
—
7,275
—
7,275
Cash and cash equivalents
559,543
392,164
492,174
263,909
Financial assets measured at amortized cost
729,787
439,222
2,636,280
2,034,101
Total financial assets
729,787
439,222
2,636,280
2,034,101
Classified in the statement of financial position
Non-current assets
2,317
2,127
1,993,653
1,761,231
Current assets
727,470
437,095
642,627
272,870
Total financial assets
729,787
439,222
2,636,280
2,034,101
Financial liabilities by category
Borrowings
Convertible senior notes
458,207
407,095
458,207
407,095
Royalty funding liabilities
305,379
138,377
—
—
Lease liabilities
93,030
98,793
12,396
15,187
Trade payables and accrued expenses
96,394
94,566
84,117
85,784
Payables to group enterprises
—
—
2,085
—
Other liabilities (excluding indirect tax and employee
related payables)
311
—
—
—
Financial liabilities measured at amortized cost
953,321
738,831
556,805
508,066
Derivative liabilities
150,670
143,296
150,670
143,296
Financial liabilities measured at fair value through
profit or loss
150,670
143,296
150,670
143,296
Total financial liabilities
1,103,991
882,127
707,475
651,362
Classified in the statement of financial position
Non-current liabilities
365,080
222,996
9,223
12,011
Current liabilities
738,911
659,131
698,252
639,351
Total financial liabilities
1,103,991
882,127
707,475
651,362
Finance income and expenses are specified below:
Group
Parent
(EUR’000)
2024
2023
2024
2023
Finance income
Interest income
14,361
16,857
11,812
15,096
Interest income from group enterprises
—
—
82,361
37,313
Remeasurement gain of financial liabilities
11,248
14,654
—
14,654
Foreign exchange translation (net)
—
12,346
—
10,561
Total finance income
25,609
43,857
94,173
77,624
Finance expenses
Interest expenses
65,504
44,065
36,493
34,714
Interest expenses to group enterprises
—
—
13
—
Remeasurement loss of financial liabilities
7,374
—
7,374
—
Foreign exchange translation (net)
27,149
—
1,687
—
Total finance expenses
100,027
44,065
45,567
34,714
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.
Financial Statements
75
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 transaction
costs. 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, beginning on October 1, 2022. 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 each of (i) 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.
Royalty Funding Liabilities
The Company has entered into capped synthetic royalty funding agreements with Royalty Pharma (the
“Purchaser”), which is presented as royalty funding liabilities, 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.
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.
Financial Statements
76
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.
Leases
The Company primarily leases office 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 five years, in addition to the non-cancellable
periods.
The following expenses related to lease activities were recognized in the statements of profit or loss:
Group
Parent
(EUR’000)
2024
2023
2024
2023
Lease expenses
Depreciation
12,312
11,875
3,588
3,295
Short term leases and leases of low value assets
285
353
78
164
Lease interest
3,303
3,581
376
425
Total lease expenses
15,900
15,809
4,042
3,884
In February 2022, the Company entered into a facility lease in Germany with an enforceable lease term
of 15 years, and comprises total lease cash-outflows of €81.1 million. In addition, in December 2024,
the Company entered into additional leases in Denmark with enforceable lease terms of 12 years with
option to terminate earlier and comprise total lease cash-outflows of €16.2 million if not terminated
earlier. The leases are expected to commence in 2025.
Financial Statements
77
Financing Activities
The development in borrowings related to financing activities is specified below:
Group
Cash payments
Non-cash items
(EUR’000)
Beginning
of year
Repayments
Net
proceeds
Additions/
(disposals)
Remeasure-
ments
Accretion
of
interest
Foreign
exchange
translation
End of
year
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
December 31,
2023
Borrowings
(excluding
lease liabilities)
399,186
(12,054
)
136,256
—
—
40,386
(18,302
)
545,472
Lease liabilities
109,191
(14,006
)
—
2,973
—
3,581
(2,946
)
98,793
Total
financing
activities
508,377
(26,060
)
136,256
2,973
—
43,967
(21,248
)
644,265
Parent
Cash payments
Non-cash items
(EUR’000)
Beginning
of year
Repayments
Net
proceeds
Additions/
(disposals)
Remeasure-
ments
Accretion
of
interest
Foreign
exchange
translation
End of
year
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
December 31,
2023
Borrowings
(excluding
lease liabilities)
399,186
(12,054
)
—
—
—
34,227
(14,264
)
407,095
Lease liabilities
16,312
(3,085
)
—
1,535
—
425
—
15,187
Total
financing
activities
415,498
(15,139
)
—
1,535
—
34,652
(14,264
)
422,282
Financial Statements
78
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 (49.6% and
50.5% as of December 31, 2024 and December 31, 2023, respectively).
For additional description of fair values, refer to the following section “Fair Value Measurement.”
Sensitivity Analysis
On December 31, 2024, all other inputs and assumptions held constant, a 10% relative increase in
volatility, will increase the fair value of derivative liabilities by approximately €15.0 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, 2024, all other inputs and assumptions held constant, a 10% increase in
the share price, will increase the fair value of derivative liabilities by approximately €30.8 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.
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 compared to carrying amount of marketable
securities, 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
2024
2023
(EUR’000)
Carring
Amount
Fair
Value
Carring
Amount
Fair
Value
Fair Value
Level
Financial assets
(1-3)
Marketable securities
—
—
7,275
7,266
1
Financial assets measured at amortized cost
—
—
7,275
7,266
Financial liabilities
Convertible senior notes
458,207
438,288
407,095
385,410
3
Royalty funding liabilities
305,379
305,673
138,377
143,975
3
Financial liabilities measured at amortized
cost
763,586
743,961
545,472
529,385
Derivative liabilities
150,670
150,670
143,296
143,296
3
Financial liabilities measured at fair value
through profit or loss
150,670
150,670
143,296
143,296
Financial Statements
79
Parent
2024
2023
(EUR’000)
Carring
Amount
Fair
Value
Carring
Amount
Fair
Value
Fair Value
Level
Financial assets
(1-3)
Marketable securities
—
—
7,275
7,266
1
Financial assets measured at amortized cost
—
—
7,275
7,266
Financial liabilities
Convertible senior notes
458,207
438,288
407,095
385,410
3
Financial liabilities measured at amortized
cost
458,207
438,288
407,095
385,410
Derivative liabilities
150,670
150,670
143,296
143,296
3
Financial liabilities measured at fair value
through profit or loss
150,670
150,670
143,296
143,296
The following table specifies movements in level 3 fair value measurements:
Group and Parent
(EUR’000)
2024
2023
Derivative liabilities
January 1
143,296
157,950
Remeasurement recognized in financial income or expense
7,374
(14,654
)
December 31
150,670
143,296
Note 17 – 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.
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 60,689,487 fully paid shares at a nominal value
of DKK 1, all in the same share class, and which includes 845,887 ordinary shares represented by
ADSs held by Ascendis Pharma A/S.
The development in outstanding shares of the Company was as follows:
(EUR’000)
2024
2023
2022
2021
2020
Changes in share capital
January 1
57,707,439
57,152,295
56,937,682
53,750,386
47,985,837
Increase through cash
contributions
2,982,048
555,144
214,613
3,187,296
5,764,549
December 31
60,689,487
57,707,439
57,152,295
56,937,682
53,750,386
Financial Statements
80
Treasury Shares Reserve
The development in holding of treasury shares was as follows:
Nominal
value
Holding
Holding in
% of total
outstanding
shares
Treasury shares
(EUR’000)
(Number)
January 1, 2023
149
1,113,152
Transferred under stock incentive programs
(3
)
(20,098
)
December 31, 2023
146
1,093,054
1.9
%
Transferred under stock incentive programs
(33
)
(247,167
)
December 31, 2024
113
845,887
1.4
%
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 and interest rates. Derivative financial instruments are not applied to manage
exposure to such risks.
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
position
Increase
in foreign
currency
exchange
rate
Profit/(loss)
before tax
Equity
before tax
USD/EUR
December 31, 2024
(735,064
)
10
%
(73,506
)
(73,506
)
December 31, 2023
(369,091
)
10
%
(36,909
)
(36,909
)
Financial Statements
81
Parent
Hypothetical impact on separate
financial statements
(EUR’000)
Nominal
position
Increase
in foreign
currency
exchange
rate
Profit/(loss)
before tax
Equity
before tax
USD/EUR
December 31, 2024
(374,691
)
10
%
(37,469
)
(37,469
)
December 31, 2023
(403,063
)
10
%
(40,306
)
(40,306
)
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.
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.
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 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. Accordingly, the risk from probability of default
is low. 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.
Financial Statements
82
Liquidity risk is managed by maintaining adequate cash reserves and banking facilities. The risk of
shortage of funds is monitored, using a liquidity planning tool, to ensure sufficient funds are available to
settle liabilities as they fall due. Besides long term deposits on leases, 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:
Group
(EUR’000)
<1 year
1-5 years
>5 years
Total
contractual
cashflows
Carrying
amount
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
Group
(EUR’000)
<1 year
1-5 years
>5 years
Total
contractual
cashflows
Carrying
amount
Financial liabilities
December 31, 2023
Borrowings (excluding lease
liabilities)
11,708
742,925
42,397
797,030
545,472
Lease liabilities
14,385
51,426
49,056
114,867
98,793
Trade payables, accrued expenses
and other liabilities
94,566
—
—
94,566
94,566
Total financial liabilities
120,659
794,351
91,453
1,006,463
738,831
Parent
(EUR’000)
<1 year
1-5 years
>5 years
Total
contractual
cashflows
Carrying
amount
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
Financial Statements
83
Parent
(EUR’000)
<1 year
1-5 years
>5 years
Total
contractual
cashflows
Carrying
amount
Financial liabilities
December 31, 2023
Borrowings (excluding lease
liabilities)
11,708
561,340
—
573,048
407,095
Lease liabilities
3,206
8,607
4,905
16,718
15,187
Trade payables, accrued expenses
and other liabilities
85,784
—
—
85,784
85,784
Total financial liabilities
100,698
569,947
4,905
675,550
508,066
“Borrowings (excluding lease liabilities)” comprise convertible notes and royalty funding liabilities.
Further details regarding classification of convertible notes as current liabilities in the consolidated
statement of financial position are provided in Note 2, “Summary of Material Accounting Policies,”
section “New and Amended IFRS Accounting Standards and Interpretations.” 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 18 – Commitments and Contingencies
Contractual commitments for the acquisition of property, plant and equipment were €0.3 million and
€1.2 million for the years ended December 31, 2024 and 2023, respectively. Further, with certain
suppliers, 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.
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 its five 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, 2024, 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 reported negative net assets of €31.9 million, €896.8
million, €507.2 million, €498.0 million and €391.5 million, respectively. 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, 2026.
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.
Financial Statements
84
Applied Exception - Subsidiary
Ascendis Pharma Bone Disease A/S has prepared its statutory financial statements for 2024 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 19 – Related Party Transactions
The Board of Directors, the Executive Board and non-executive 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 6,
“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 12, “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 9, “Tax on Profit/(Loss) for the Year and Deferred Tax.”
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)
2024
2023
Rendering of services
252,443
243,002
Sale of products
47,540
54,710
Milestone payments
10,000
5,000
Total revenue
309,983
302,712
Milestone payments (expenses)
—
(100
)
License expenses
(100
)
(100
)
Purchase of services
(28,901
)
(56,161
)
Total expenses
(29,001
)
(56,361
)
Interest income
82,361
37,313
Interest expenses
(13
)
—
Net financial income
82,348
37,313
Financial Statements
85
Note 20 – Investments in Group Enterprises
Ascendis Pharma A/S’s (parent company) investments in Group enterprises at December 31, 2024,
comprise:
Subsidiaries
Domicile
Ownership
Ascendis Pharma GmbH
Germany
100%
Ascendis Pharma Endocrinology GmbH
Germany
100%
Ascendis Pharma, Inc.
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 SRL
Italy
100%
Ascendis Pharma Sverige AB
Sweden
100%
Ascendis Pharma Switzerland GmbH
Switzerland
100%
Associate
Domicile
Ownership
VISEN Pharmaceuticals
Cayman Island
43.9%
Eyconis, Inc.
USA
41.6%
Financial Statements
86
Note 21 – 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, 2024:
• Entities affiliated with RA Capital Management, LLC, USA
• 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
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 22 – Subsequent Events
No events have occurred after the reporting date that would influence the evaluation of these financial
statements.