Genmab Announces Financial Results for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
Page 1/40
2500 Valby, Denmark
CVR no. 2102 3884
November 7, 2023 Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September 30, 2023
H
ighlights
• Epcoritamab (TEPKINLY
®
) was granted conditional marketing authorization by the
European Commission (EC) to treat adults with relapsed or refractory diffuse large B-cell
lymphoma (DLBCL) after two or more lines of systemic therapy
• Epcoritamab (EPKINLY
™
) was approved by the Japan Ministry of Health, Labour and
Welfare to treat adults with certain types of relapsed or refractory large B-cell lymphom
a
(L
BCL) after two or more lines of systemic therapy
• Genmab and Seagen Inc. (Seagen) announced that the Phase 3 innovaTV 301 confirmatory
trial of tisotumab vedotin for the treatment of recurrent or metastatic cervical cancer me
t
i
ts primary endpoint of improved overall survival (OS) at a predetermined, independen
t
interim analysis
• Genmab revenue increased 26% compared to the first nine months of 2022, to DKK 11,796
million
• Genmab 2023 financial guidance updated
“
With regulatory approvals in Japan and Europe, EPKINLY/TEPKINLY is the first Genmab-owned
medicine to become available to patients outside of the United States. In addition to being an important
milestone for Genmab, these approvals mark an important milestone for patients in these territories who
are in need of alternative therapeutic options,” said Jan van de Winkel, Ph.D., Chief Executive Officer of
Genmab. “We look forward to continue to work with our partner, AbbVie Inc. (AbbVie), to further explore
epcoritamab as a potential future core therapy across B-cell malignancies.”
F
inancial Performance First Nine Months of 2023
• Net sales of DARZALEX
®
by Janssen Biotech, Inc. (Janssen) were USD 7,194 million in the first
nine months of 2023 compared to USD 5,894 million in the first nine months of 2022, an increas
e
of
USD 1,300 million, or 22%.
• Royalty revenue was DKK 9,803 million in the first nine months of 2023 compared to DKK 8,207
mi
llion in the first nine months of 2022, an increase of DKK 1,596 million, or 19%. The increase i
n
r
oyalties was driven by higher net sales of DARZALEX and Kesimpta
®
, partly offset by negative
f
oreign exchange rate impacts due to a lower average exchange rate between the USD and DKK.
• Rev
enue was DKK 11,796 million for the first nine months of 2023 compared to DKK 9,368
million for the first nine months of 2022. The increase of DKK 2,428 million, or 26%, was primarily
driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations wit
h
J
anssen and Novartis Pharma AG (Novartis), respectively, a milestone achieved under our
collaboration with AbbVie for the first commercial sale of EPKINLY in the United States, a
nd
hi
gher reimbursement revenue driven by increased activities under our collaboration wit
h
B
ioNTech SE (BioNTech).
• Operating expenses were DKK 8,045 million in the first nine months of 2023 compared to DKK
5,676 million in the first nine months of 2022. The increase of DKK 2,369 million, or 42%, was
driven by the expansion of our product pipeline, EPKINLY launch in the U.S., the continue
d
dev
elopment of Genmab’s broader organizational capabilities, and related increase in team
members to support these activities.
Genmab Announces Financial Results for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
Page 2/40
2500 Valby, Denmark
CVR no. 2102 3884
• Operating profit was DKK 3,651 million in the first nine months of 2023 compared to DKK 3,692
million in the first nine months of 2022.
• Net financial items resulted in income of DKK 1,060 million for the first nine months of 2023
compared to DKK 2,681 million in the first nine months of 2022. The decrease of DKK 1,621
million, or 60%, was primarily driven by movements in USD to DKK foreign exchange rates
impacting Genmab’s USD denominated cash and cash equivalents, and marketable securities in
the respective periods.
Outlook
Genmab is updating the lower end of its revenue and operating expenses of its 2023 financial guidance
driven by higher total royalty revenues from DARZALEX and other marketed products and increased and
accelerated investment for epcoritamab clinical trials and progression of other pipeline products.
Revised
Previous
(DKK million)
Guidance
Guidance
Revenue
15,900 - 16,500
15,500 - 16,500
Operating expenses
(10,600) - (10,900)
(10,400) - (10,900)
Operating profit*
4,800 – 5,750
4,500 - 6,000
*Operating profit includes DKK~0.2 billion of cost of product sales, which is not classified within operating expenses
Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2023
today, Tuesday, November 7, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call please
use the below registration link. Registered participants will receive an email with a link to access dial-in
information as well as a unique personal PIN:
https://register.vevent.com/register/BIa45c5d7cd5384835a879e0ab083d0577. A live and archived
webcast of the call and relevant slides will be available at www.genmab.com/investors/.
Contact
Marisol Peron, Senior Vice President, Global Communications & Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com
Andrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
Page 3/40
2500 Valby, Denmark
CVR no. 2102 3884
CONTENTS
4
5
6
6
17
17
25
29
39
40
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
Page 4/40
2500 Valby, Denmark
CVR no. 2102 3884
CONSOLIDATED KEY FIGURES
Three Months Ended
Nine Months Ended
(DKK million)
September 30,
September 30,
Full Year
Income Statement
2023
2022
2023
2022
2022
Revenue
4,744
4,087
11,796
9,368
14,595
Cost of product sales
(100)
—
(100)
—
—
Research and development expenses
(2,088)
(1,486)
(5,682)
(3,921)
(5,562)
Selling, general and administrative expenses
(839)
(670)
(2,363)
(1,755)
(2,676)
Operating expenses
(2,927)
(2,156)
(8,045)
(5,676)
(8,238)
Operating profit
1,717
1,931
3,651
3,692
6,357
Net financial items
985
1,341
1,060
2,681
678
Net profit
2,129
2,582
3,712
4,938
5,522
Balance Sheet
Marketable securities
13,252
13,411
13,252
13,411
12,431
Cash and cash equivalents
14,273
10,377
14,273
10,377
9,893
Total non-current assets
2,211
1,947
2,211
1,947
1,901
Total assets
35,238
30,686
35,238
30,686
30,278
Shareholders’ equity
31,112
26,657
31,112
26,657
27,441
Share capital
66
66
66
66
66
Cash Flow Statement
Cash flow from operating activities
2,037
1,968
5,708
3,514
3,912
Cash flow from investing activities
1,008
(1,382)
(840)
(2,625)
(2,761)
Cash flow from financing activities
20
(642)
(584)
(920)
(789)
Investment in intangible assets
—
—
(10)
—
—
Investment in tangible assets
(98)
(82)
(299)
(207)
(317)
Financial Ratios and Other Information
Basic net profit per share
32.60
39.55
56.84
75.48
84.45
Diluted net profit per share
32.32
39.17
56.35
74.83
83.65
Period-end share market price
2,508
2,461
2,508
2,461
2,941
Price / book value
5.32
6.09
5.32
6.09
7.07
Shareholders’ equity per share
471.39
403.89
471.39
403.89
415.77
Equity ratio
88
%
87
%
88
%
87
%
91
%
Shares outstanding
66,067,481
65,829,282
66,067,481
65,829,282
65,961,573
Average number of employees (FTE*)
2,096
1,516
1,953
1,402
1,460
Number of employees (FTE) at the end of the period
2,132
1,560
2,132
1,560
1,660
* Full-time equivalent or team members
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
Page 5/40
2500 Valby, Denmark
CVR no. 2102 3884
OUTLOOK
Revised
Previous
(DKK million)
Guidance
Guidance
Revenue
15,900 - 16,500
15,500 - 16,500
Operating expenses
(10,600) - (10,900)
(10,400) - (10,900)
Operating profit*
4,800 - 5,750
4,500 - 6,000
*Operating profit includes DKK~0.2 billion of cost of product sales, which is not classified within operating expenses
Genmab is updating the lower end of its revenue and operating expenses of its 2023 financial guidance
driven by higher total royalty revenues from DARZALEX and other marketed products and increased and
accelerated investment for epcoritamab clinical trials and progression of other pipeline products.
Revenue
Genmab expects its 2023 revenue to be in the range of DKK 15,900 – 16,500 million, an increase to the
previous guidance of DKK 15,500 – 16,500 million, driven by higher total royalty revenues from
DARZALEX and other marketed products. DARZALEX royalties of DKK 11.3 – 11.5 billion are based on
Genmab’s estimate of DARZALEX 2023 net sales of USD 9.8 – 10.0 billion.
Operating Expenses
Genmab anticipates its 2023 operating expenses to be in the range of DKK 10,600 – 10,900 million, an
increase to the previous guidance of DKK 10,400 – 10,900 million, primarily related to increased and
accelerated investment for epcoritamab clinical trials and progression of other pipeline products.
Operating Profit
Genmab now expects its 2023 operating profit to be in the range of DKK 4,800 – 5,750 million, compared
to the previous guidance of DKK 4,500 – 6,000 million, driven primarily by the items described above.
Outlook: Risks and Assumptions
In addition to factors already mentioned, the estimates above are subject to change due to numerous
reasons, including but not limited to, the achievement of certain milestones associated with Genmab’s
collaboration agreements; the timing and variation of development activities (including activities carried
out by Genmab’s collaboration partners) and related income and costs; DARZALEX, DARZALEX
FASPRO
®
, Kesimpta, TEPEZZA
®
, RYBREVANT
®
, TECVAYLI
®
and TALVEY
®
net sales and royalties
paid to Genmab; changing rates of inflation; and currency exchange rates (the 2023 guidance assumes a
USD / DKK exchange rate of 6.8). The financial guidance assumes that no significant new agreements
are entered into during the remainder of 2023 that could materially affect the results. Refer to the section
“Significant Risks and Uncertainties” in this interim report for matters that may cause Genmab’s actual
results to differ materially from 2023 Guidance and Key 2023 Priorities in this interim report.
The factors discussed above, as well as other factors that are currently unforeseeable, may result in
further and other unforeseen material adverse impacts on Genmab’s business and financial performance,
including on the sales of Tivdak and EPKINLY/TEPKINLY, and on the net sales of DARZALEX, Kesimpta,
TEPEZZA, RYBREVANT, TECVAYLI and TALVEY by Genmab’s collaboration partners and on
Genmab’s royalties, collaboration revenue and milestone revenue therefrom.
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
Page 6/40
2500 Valby, Denmark
CVR no. 2102 3884
KEY 2023 PRIORITIES
Bring Our Own Medicines to Patients
Epcoritamab
1
• Launch in relapsed/refractory DLBCL
• Submit a Supplemental Biologics License
Application (sBLA)
2
• Broaden clinical development program
Tivdak
3
• Progress successful uptake in second
line+ recurring or metastatic cervical
cancer patients
• Progress clinical development program
Build World-class Differentiated Pipeline
DuoBody-CD40x4-1BB
4
• Establish efficacy and safety data in solid
tumor indication
• Progress towards late-stage clinical
development
DuoBody-PD-L1x4-1BB
4
• Establish proof of concept data in solid
tumor indication
Expand and advance proprietary clinical
product portfolio
Invest in Our People & Culture
Further scale organization aligned with
differentiated antibody product portfolio
growth and future launches
Become a Leading Integrated Biotech
Innovation Powerhouse
Use solid financial base to grow and
broaden antibody product and technology portfolio
1. Co-development w/ AbbVie; 2. Subject to supportive U.S. FDA feedback; 3. Co-development w/ Seagen; 4. Co-development w/
BioNTech
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST NINE MONTHS OF 2023
At the end of the first nine months of 2023, Genmab’s proprietary pipeline of investigational medicines,
where we are responsible for at least 50% of development, consisted of nine antibodies in clinical
development. These include Genmab’s approved medicines, Tivdak, which Genmab is co-developing
globally and co-promoting in the U.S. in collaboration with Seagen and EPKINLY/TEPKINLY, which
Genmab is co-developing and co-commercializing in the U.S. and Japan in collaboration with AbbVie. In
addition to our own pipeline, there are multiple investigational medicines in development by global
pharmaceutical and biotechnology companies, including five approved medicines powered by Genmab’s
technology and innovations. Beyond the investigational medicines in clinical development, our pipeline
also includes multiple pre-clinical programs. An overview of the development status of our approved
medicines and of each of our investigational medicines is provided in the following section, including
updates for the third quarter of 2023. For events that occurred during the first and second quarters of
2023, please refer to Genmab’s Q1 2023 and Genmab’s Q2 2023 Interim Reports, respectively. Detailed
descriptions of dosing, efficacy and safety data from certain clinical trials have been disclosed in company
announcements and media releases published via the Nasdaq Copenhagen A/S (Nasdaq Copenhagen)
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
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2500 Valby, Denmark
CVR no. 2102 3884
stock exchange and may also be found in Genmab’s filings with the U.S. Securities and Exchange
Commission (U.S. SEC). Additional information is available on Genmab’s website, www.genmab.com.
The information accessible through our website is not part of this report and is not incorporated by
reference herein.
Genmab Proprietary Products
1
Approved Medicines
Approved Product
Target
Developed By
Disease Indication
Tivdak
(tisotumab vedotin-tftv)
Tissue factor (TF)
Co-development
Genmab/Seagen
Approved in the U.S.
for adult patients with
recurrent or metastatic
cervical cancer with
disease progression on
or after chemotherapy
2
EPKINLY
(epcoritamab-bysp,
epcoritamab)
TEPKINLY
(epcoritamab)
CD3xCD20
Co-development
Genmab/AbbVie
Approved in the U.S.
and Europe for adult
patients with relapsed
or refractory DLBCL
after two or more lines
of systemic therapy and
in Japan for adult
patients with certain
types of relapsed or
refractory LBCL after
two or more lines of
systemic therapy
2
1
Approved and investigational medicines where Genmab has ≥50% ownership, in co-development with partners as indicated.
2
Refer to relevant local prescribing information for precise indication and safety information.
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
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2500 Valby, Denmark
CVR no. 2102 3884
Pipeline, Including Further Development for Approved Medicines
3
Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen.
Tivdak (tisotumab vedotin-tftv) – First and only U.S. FDA approved antibody-drug conjugate (ADC)
for recurrent or metastatic cervical cancer
• An ADC directed to TF, a protein highly prevalent in solid tumors, including cervical cancer, which
is associated with poor prognosis
• Accelerated approval granted by the U.S. FDA for tisotumab vedotin-tftv, marketed as Tivdak, as
the first and only approved ADC for the treatment of adult patients with recurrent or metastatic
cervical cancer with disease progression on or after chemotherapy
• U.S. FDA approval was based on data from the innovaTV 204 (NCT03438396) clinical trial
• In addition to a confirmatory Phase 3 trial in recurrent or metastatic cervical cancer (innovaTV
301, NCT04697628), clinical trials in other solid tumors are ongoing
• Co-developed globally and co-promoted in the U.S. in collaboration with Seagen
Tisotumab vedotin is an ADC composed of Genmab’s human monoclonal antibody directed to TF and
Seagen’s ADC technology that utilizes a protease-cleavable linker that covalently attaches the
microtubule-disrupting agent monomethyl auristatin E to the antibody. Genmab used technology
licensed from Medarex Inc. (Medarex) to generate the TF antibody forming part of tisotumab vedotin.
Tisotumab vedotin-tftv, marketed as Tivdak, is the first and only U.S. FDA approved ADC for the
treatment of adult patients with recurrent or metastatic cervical cancer with disease progression on or
after chemotherapy. Tisotumab vedotin is being co-developed by Genmab and Seagen. Under a joint
commercialization agreement, Genmab is co-promoting Tivdak in the U.S. and will lead commercial
operational activities in Japan. Seagen is leading commercial operational activities in the U.S. and will
lead commercial operational activities in Europe and China. In these four markets there will be a 50:50
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
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Carl Jacobsens Vej 30
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CVR no. 2102 3884
cost and profit split. In other markets, Seagen will commercialize Tivdak and Genmab will receive
royalties based on a percentage of aggregate net sales ranging from the mid-teens to the mid-twenties.
The companies have joint decision-making power on the worldwide development and commercialization
strategy for Tivdak. The companies have a number of additional ongoing clinical trials for Tivdak,
including a confirmatory Phase 3 trial in recurrent or metastatic cervical cancer, which met its primary
endpoint of improved OS at predetermined, independent interim analysis in September 2023.
Please consult the U.S. Prescribing Information for Tivdak for the labeled indication and safety
information, including the boxed warning.
Third Quarter 2023 Update
• September: The Phase 3 innovaTV 301(ENGOT cx-12/GOG 3057) global trial in recurrent or
metastatic cervical cancer patients with disease progression on or after front-line therapy who
received tisotumab vedotin, compared with chemotherapy alone, met its primary endpoint of OS
at predetermined, independent interim analysis. The key secondary endpoints of investigator-
assessed progression-free survival and objective response rate also demonstrated statistical
significance. The safety profile of tisotumab vedotin in innovaTV 301 is consistent with the known
safety profile of Tivdak as presented in the U.S. prescribing information, and no new safety
signals were observed. The results of the trial add to the previous results of innovaTV 204, which
served as the basis for the accelerated approval of Tivdak in the U.S. Subject to discussions with
regulatory authorities, the results from innovaTV 301 are intended to serve as the pivotal
confirmatory trial for the U.S. accelerated approval and support other regulatory applications.
EPKINLY/TEPKINLY (epcoritamab) – Approved in U.S., Europe and Japan
• Bispecific antibody-based medicine created with Genmab’s DuoBody technology
• Accelerated approval granted by the U.S. FDA for epcoritamab-bysp, marketed as EPKINLY, as
the first T-cell engaging bispecific antibody for the treatment of adult patients with relapsed or
refractory DLBCL, not otherwise specified (NOS), including DLBCL arising from indolent
lymphoma, and high-grade B‑cell lymphoma, after two or more lines of systemic therapy
• Conditional marketing authorization granted by the EC for epcoritamab, marketed as TEPKINLY,
as the first and only subcutaneous (SC) bispecific antibody approved as a monotherapy for the
treatment of adult patients with relapsed or refractory DLBCL after two or more lines of systemic
therapy
• Approval granted by the Japan Ministry of Health, Labour and Welfare for epcoritamab, marketed
as EPKINLY, as the first and only bispecific antibody approved in Japan to treat adult patients
with certain types of relapsed or refractory LBCL, including DLBCL, high-grade B-cell lymphoma
(HGBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B
(FL3B), after two or more lines of systemic therapy
• Regulatory approvals were based on data from the pivotal EPCORE NHL-1 (NCT03625037)
clinical trial. Approval in Japan was also based on the EPCORE NHL-3 (NCT04542824) clinical
trial
• Multiple ongoing clinical trials across different settings and histologies, such as Phase 3 trials in
DLBCL, including a confirmatory trial and an ongoing trial in newly diagnosed DLBCL (EPCORE
DLBCL-1, NCT04628494 and EPCORE DLBCL-2, NCT05578976) and a confirmatory trial in
relapsed/refractory FL (EPCORE FL-1, NCT05409066) with more trials in planning
• Co-developed and co-commercialized in collaboration with AbbVie
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
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2500 Valby, Denmark
CVR no. 2102 3884
Epcoritamab is a proprietary bispecific antibody created using Genmab’s DuoBody technology platform.
Epcoritamab targets CD3, which is expressed on T-cells, and CD20, a clinically validated target on
malignant B-cells. Genmab used technology licensed from Medarex to generate the CD20 antibody
forming part of epcoritamab. Epcoritamab is marketed as EPKINLY in the U.S. and will be in Japan, and
as TEPKINLY in Europe. See local prescribing information for precise indications. In 2020, Genmab
entered into a collaboration agreement with AbbVie to jointly develop and commercialize epcoritamab.
The companies share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for
further global commercialization. Genmab will record sales in the U.S. and Japan and receive tiered
royalties on remaining global sales outside of these territories. The companies have a broad clinical
development program for epcoritamab including three ongoing Phase 3 trials and additional trials in
planning.
Please consult the U.S. Prescribing Information for EPKINLY and the European Summary of Product
Characteristics for TEPKINLY for the labeled indication and safety information.
Third Quarter 2023 Updates
• September: The EC granted conditional marketing authorization for TEPKINLY (epcoritamab) as
a monotherapy for the treatment of adult patients with relapsed or refractory DLBCL after two or
more lines of systemic therapy. TEPKINLY is the first and only SC T-cell engaging bispecific
antibody approved for the treatment of this patient population in the European Union (EU), as well
as Liechtenstein, Norway and Iceland.
• September: The Japan Ministry of Health, Labour and Welfare approved EPKINLY (epcoritamab)
as the first and only T-cell engaging bispecific antibody treatment in Japan for the treatment of
adult patients with certain types of relapsed or refractory LBCL, including DLBCL, HBCL, PMBCL
and FL3B, after two or more lines of systemic therapy.
GEN1046 (BNT311) – Bispecific next-generation immunotherapy
• Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology
targeting PD-L1, 4-1BB
• Clinical trials in solid tumors ongoing, including a Phase 2 trial in NSCLC (NCT05117242) and a
Phase 2 trial in endometrial cancer (NCT06046274)
• Co-developed in collaboration with BioNTech
GEN1046 (DuoBody-PD-L1x4-1BB, BNT311) is a proprietary bispecific antibody, jointly owned by
Genmab and BioNTech, created using Genmab’s DuoBody technology platform. It is being co-developed
by Genmab and BioNTech under an agreement in which the companies share all costs and future
potential profits for GEN1046 on a 50:50 basis. GEN1046 is designed to induce an antitumor immune
response by simultaneous and complementary PD-L1 blockade and conditional 4-1BB stimulation using
an inert DuoBody format. Three clinical trials in solid tumors are ongoing, including a Phase 2 trial of
GEN1046 as monotherapy or in combination with pembrolizumab in patients with recurrent metastatic
NSCLC. An additional Phase 2 trial of GEN1046 in combination with pembrolizumab for the treatment of
advanced endometrial cancer has also been initiated.
Third Quarter 2023 Update
• September: A Phase 2 open-label trial to determine the safety and preliminary activity of
GEN1046 in combination with pembrolizumab in patients with advanced endometrial cancer was
initiated.
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
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Carl Jacobsens Vej 30
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2500 Valby, Denmark
CVR no. 2102 3884
GEN1042 (BNT312) – Potential first-in-class bispecific agonistic antibody
• Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology
targeting CD40, 4-1BB
• Phase 1/2 clinical trials in solid tumors ongoing (NCT04083599, NCT05491317)
• Co-developed in collaboration with BioNTech
GEN1042 (DuoBody-CD40x4-1BB, BNT312) is a proprietary bispecific antibody, jointly owned by
Genmab and BioNTech, created using Genmab’s DuoBody technology platform. It is being co-developed
by Genmab and BioNTech under an agreement in which the companies share all costs and future
potential profits for GEN1042 on a 50:50 basis. CD40 and 4-1BB were selected as targets to enhance
both dendritic cells and antigen-dependent T-cell activation, using an inert DuoBody format. Phase 1/2
clinical trials of GEN1042 in solid tumors are ongoing.
GEN3014 – HexaBody-based investigational medicine with potential in hematological
malignancies
• Antibody-based investigational medicine created with Genmab’s HexaBody technology targeting
CD38
• Phase 1/2 clinical trial in relapsed/refractory multiple myeloma and other hematological
malignancies ongoing (NCT04824794)
• Developed in an exclusive worldwide license and option agreement with Janssen
GEN3014 (HexaBody-CD38) is a human CD38 monoclonal antibody-based investigational medicine
created using Genmab’s HexaBody technology platform. In pre-clinical models of hematological
malignancies, GEN3014 demonstrated highly potent complement-dependent cytotoxicity and showed
potent anti-tumor activity. In June 2019, Genmab entered into an exclusive worldwide license and option
agreement with Janssen to develop and commercialize GEN3014. A Phase 1/2 clinical trial in
hematologic malignancies is ongoing and includes an arm comparing GEN3014 to daratumumab in anti-
CD38 monoclonal antibody-naïve relapsed or refractory multiple myeloma patients.
GEN3009
• Antibody-based investigational medicine created with Genmab’s DuoHexaBody technology
targeting CD37
• The program has been discontinued due to strategic evaluation within the context of Genmab’s
portfolio
GEN3009 (DuoHexaBody-CD37) is a bispecific antibody that targets two non-overlapping CD37 epitopes,
created using Genmab’s DuoHexaBody technology platform. The DuoHexaBody technology platform
combines the dual targeting of our DuoBody technology platform with the enhanced potency of our
HexaBody technology platform, creating bispecific antibodies with target-mediated enhanced
hexamerization. The GEN3009 program, including the Phase 1/2 trial in B-cell NHLs (NCT04358458) was
discontinued in the third quarter of 2023 due to a strategic evaluation of GEN3009 within the context of
Genmab’s portfolio. The decision was not based on safety or regulatory concerns.
GEN1047 – Bispecific antibody with potential in solid tumors
• Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology
targeting CD3, B7H4
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• Phase 1/2 clinical trial in malignant solid tumors ongoing (NCT05180474)
GEN1047 (DuoBody-CD3xB7H4) is a bispecific antibody-based investigational medicine created using
Genmab’s DuoBody technology platform. B7H4 is an immune checkpoint protein expressed on malignant
cells in various solid cancers including breast, ovarian and lung cancer. In pre-clinical studies, GEN1047
induced T-cell mediated cytotoxicity of B7H4-positive tumor cells. GEN1047 is being developed for the
potential treatment of solid cancer indications known to express B7H4. A Phase 1/2 clinical trial of
GEN1047 in malignant solid tumors is ongoing.
GEN1053 (BNT313) – HexaBody-based investigational medicine with potential in solid tumors
• Antibody-based investigational medicine created with Genmab’s HexaBody technology targeting
CD27
• Phase 1/2 clinical trial in solid tumors ongoing (NCT05435339)
• Co-developed in collaboration with BioNTech
GEN1053 (HexaBody-CD27, BNT313) is a CD27 antibody that utilizes Genmab’s HexaBody technology,
specifically engineered to form an antibody hexamer (a formation of six antibodies) upon binding its target
on the cell membrane of T cells. It is being co-developed by Genmab and BioNTech under an agreement
in which the companies share all costs and future potential profits for GEN1053 on a 50:50 basis. A
Phase 1/2 clinical trial of GEN1053 in solid tumors is ongoing.
GEN1056 (BNT322) – First-in-human trial recruiting
• Phase 1 clinical trial in solid tumors ongoing (NCT05586321)
• Co-developed in collaboration with BioNTech
GEN1056 (BNT322) is an antibody product being co-developed by Genmab and BioNTech for the
treatment of solid tumors and for use in combination with other products. A first-in-human Phase 1 clinical
trial of GEN1056 in patients with advanced solid tumors is ongoing.
GEN3017 –DuoBody-based investigational therapy in the clinic
• Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology
targeting CD3, CD30
• Phase 1 clinical trial in relapsed or refractory classical Hodgkin lymphoma and NHL ongoing
(NCT06018129)
GEN3017 (DuoBody-CD3xCD30) is a bispecific antibody-based investigational medicine created using
Genmab’s DuoBody technology platform. CD30 is highly expressed in multiple hematologic malignancies,
including classical Hodgkin lymphoma and anaplastic large cell lymphoma. In pre-clinical studies,
GEN3017 induced potent T-cell mediated cytotoxicity of CD30-expressing tumor cells in vitro, which was
associated with induction of CD4+ and CD8+ T-cell activation, proliferation and cytokine production.
GEN3017 is being developed for the potential treatment of certain hematological malignancies. A Phase
1/2 clinical trial of GEN3017 in relapsed or refractory classical Hodgkin lymphoma and NHL is ongoing.
Pre-clinical Programs
• Broad pre-clinical pipeline that includes both partnered products and in-house programs based on
our proprietary technologies and/or antibodies
• Multiple new Investigational New Drug (IND) applications expected to be submitted over coming
years
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• Genmab has entered multiple strategic collaborations to support the expansion of our innovative
pipeline
Our pre-clinical pipeline includes immune effector function enhanced antibodies developed with our
HexaBody technology platform and bispecific antibodies created with our DuoBody technology platform.
We are also working with our partners to generate additional new antibody-based product concepts. A
number of the pre-clinical programs are carried out in cooperation with our collaboration partners.
Third Quarter 2023 Update
• August: An IND was submitted for GEN1059/BNT314 (DuoBody-EpCAMx4-1BB), which is being
co-developed by Genmab and BioNTech.
Programs Powered by Genmab’s Technology and Innovations
In addition to Genmab’s own pipeline of investigational medicines, our innovations and proprietary
technology platforms are applied in the pipelines of global pharmaceutical and biotechnology companies.
These companies are running clinical development programs with antibodies created by Genmab or
created using Genmab’s proprietary DuoBody bispecific antibody technology platform. The programs run
from Phase 1 development to approved medicines. The tables in this section include those therapies that
have been approved in certain territories as well as clinical stage investigational medicines in Phase 2
development or later. Under the agreements for these products Genmab is entitled to certain potential
milestones and royalties.
Approved Medicines
Approved Product
Discovered and/or Developed &
Marketed By
Disease Indication(s)
DARZALEX
(daratumumab)/DARZALEX
FASPRO (daratumumab and
hyaluronidase-fihj)
Janssen (Royalties to Genmab on
net global sales)
Multiple myeloma
1
Light-chain (AL) Amyloidosis
1
Kesimpta
(ofatumumab)
Novartis (Royalties to Genmab on
net global sales)
Relapsing multiple sclerosis
(RMS)
1
TEPEZZA
(teprotumumab-trbw)
Amgen Inc. (Amgen)
2
(under
sublicense from Roche, royalties
to Genmab on net global sales)
Thyroid eye disease (TED)
1
RYBREVANT
(amivantamab/amivantamab-
vmjw)
Janssen (Royalties to Genmab on
net global sales)
NSCLC
1
TECVAYLI
(teclistamab/teclistamab-cqyv)
Janssen (Royalties to Genmab on
net global sales)
Relapsed and refractory
multiple myeloma
1
TALVEY
(talquetamab/talquetamab-tgvs)
Janssen (Royalties to Genmab on
net global sales)
Relapsed and refractory
multiple myeloma
1
1
See local prescribing information for precise indication and safety information; Previously Horizon Therapeutics plc (Horizon),
acquired by Amgen in October 2023.
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≥ Phase 2 Development, Including Further Development for Approved Medicines
2
UltiMAb
transgenic mouse technology licensed from Medarex, a wholly owned subsidiary of Bristol Myers Squibb.
DARZALEX (daratumumab) – Redefining the treatment of multiple myeloma
• First-in-class human CD38 monoclonal antibody
• Developed and commercialized by Janssen under an exclusive worldwide license from Genmab
• Intravenous (IV) product approved in combination with other therapies and as monotherapy for
certain multiple myeloma indications
• First and only SC CD38-directed antibody approved for the treatment of certain multiple myeloma
indications, known as DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) in the U.S.,
and DARZALEX SC in Europe
• SC daratumumab is the first and only approved therapy for AL amyloidosis in the U.S., Europe
and Japan
• Net sales of DARZALEX by Janssen were USD 7,194 million in the first nine months of 2023
Daratumumab is a human monoclonal antibody that binds with high affinity to the CD38 molecule, which
is highly expressed on the surface of multiple myeloma cells and is also expressed by AL amyloidosis
plasma cells. Genmab used technology licensed from Medarex to generate the CD38 antibody.
Daratumumab is being developed and commercialized by Janssen under an exclusive worldwide license
from Genmab. Under the terms of the agreement, Genmab will receive double digit royalties between
12% and 20% with Janssen reducing such royalty payments for Genmab’s share of Janssen’s royalty
payments made to Halozyme. Daratumumab (marketed as DARZALEX for IV administration and as
DARZALEX FASPRO in the United States and as DARZALEX SC in Europe for SC administration) is
approved in a large number of territories for the treatment of adult patients with certain multiple myeloma
indications and is the only approved therapy in the U.S., Europe and Japan for the treatment of adult
patients with AL amyloidosis.
Please consult the European Summary of Product Characteristics for DARZALEX and DARZALEX SC
and the U.S. Prescribing Information for DARZALEX and DARZALEX FASPRO for the labeled indication
and safety information.
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Kesimpta (ofatumumab) – Approved for the treatment of RMS
• Human CD20 monoclonal antibody developed and commercialized by Novartis under a license
agreement with Genmab
• Approved in territories including the U.S., EU and Japan for the treatment of RMS in adults
• First B-cell therapy that can be self-administered by patients at home using the Sensoready
®
autoinjector pen
Ofatumumab is a human monoclonal antibody that targets an epitope on the CD20 molecule
encompassing parts of the small and large extracellular loops. Genmab used technology licensed from
Medarex to generate the CD20 antibody. Ofatumumab, marketed as Kesimpta, is approved in territories
including the U.S., Europe and Japan for the treatment of certain adult patients with RMS. Kesimpta is the
first B-cell therapy that can be self-administered by patients at home using the Sensoready autoinjector
pen, once monthly after starting therapy. Ofatumumab is being developed and marketed worldwide by
Novartis under a license agreement between Genmab and Novartis. Under the terms of the agreement,
Genmab will receive 10% royalties on net sales of Kesimpta.
Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics
for the labeled indication and safety information for Kesimpta.
TEPEZZA (teprotumumab-trbw) – First U.S. FDA-approved medicine for the treatment of TED
• Development and commercialization by Amgen for the treatment of TED
• First and only U.S. FDA-approved medicine for the treatment of TED
• Also being explored in a clinical trial for the treatment of diffuse cutaneous systemic sclerosis
(dcSSC)
Teprotumumab-trbw, approved by the U.S. FDA under the trade name TEPEZZA, is a human monoclonal
antibody that targets the Insulin-like Growth Factor 1 Receptor (IGF-1R), a validated target. Genmab
used technology licensed from Medarex to generate the IGF-1R antibody. The antibody was created by
Genmab under a collaboration with Roche. Development and commercialization of the product was
subsequently conducted by Horizon under a sublicense from Roche. In October 2023, Amgen completed
its acquisition of Horizon, including all commercialization and development of teprotumumab. Under the
terms of Genmab’s agreement with Roche, Genmab will receive mid-single digit royalties on net sales of
TEPEZZA.
Please consult the U.S. Prescribing Information for the labeled indication and safety information for
TEPEZZA.
RYBREVANT (amivantamab) – First regulatory approvals for a DuoBody-based medicine
• Part of Genmab and Janssen DuoBody research and license agreement
• First approved medicine created using Genmab’s proprietary DuoBody technology
• Under the agreement with Janssen, Genmab is eligible to receive milestones and receives
royalties on net sales of RYBREVANT
In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific
antibodies using Genmab’s DuoBody technology platform. One of these, Janssen’s amivantamab, is a
fully human bispecific antibody that targets epidermal growth factor receptor (EGFR) and cMet, two
validated cancer targets. The two antibody libraries used to produce amivantamab were both generated
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by Genmab. In collaboration with Janssen, the antibody pair used to create amivantamab was selected.
Janssen is responsible for the development and commercialization of amivantamab.
In 2021, Janssen received approvals in the U.S., Europe and other markets for amivantamab, marketed
as RYBREVANT, for the treatment of certain adult patients with NSCLC with EGFR exon 20 insertion
mutations. These were the first regulatory approvals for a therapy that was created using Genmab’s
proprietary DuoBody bispecific technology platform. Under our agreement with Janssen, Genmab is
eligible to receive milestones and receives royalties between 8% and 10% on net sales of RYBREVANT.
Please consult the U.S. Prescribing Information and the European Summary of Product
Characteristics for RYBREVANT for the labeled indication and safety information.
TECVAYLI (teclistamab) – Bispecific antibody approved for the treatment of relapsed and
refractory multiple myeloma
• Part of Genmab and Janssen DuoBody research and license agreement
• Second approved medicine created using Genmab’s proprietary DuoBody technology
• Under the agreement with Janssen, Genmab is eligible to receive milestones and receives
royalties on net sales of TECVAYLI
In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific
antibodies using Genmab’s DuoBody technology platform. One of the products subsequently discovered
and developed by Janssen is teclistamab, a bispecific antibody that targets CD3, which is expressed on
T-cells and B-cell maturation antigen (BCMA), which is expressed in mature B lymphocytes.
In August 2022, Janssen received conditional marketing authorization from the EC for subcutaneously
administered teclistamab, marketed as TECVAYLI, as monotherapy for the treatment of adult patients
with relapsed and refractory multiple myeloma. Patients must have received at least three prior therapies,
including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have
demonstrated disease progression on the last therapy. In October 2022, Janssen received U.S. FDA
approval of TECVAYLI (teclistamab-cqyv) for the treatment of adult patients with relapsed or refractory
multiple myeloma, who previously received four or more prior lines of therapy, including a proteasome
inhibitor, immunomodulatory drug and anti-CD38 monoclonal antibody.
Under our agreement with Janssen, Genmab is eligible to receive milestones and receives a mid-single
digit royalty on net sales of TECVAYLI.
Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics
for TECVAYLI for the labeled indication and safety information.
TALVEY (talquetamab) – Bispecific antibody approved for the treatment of relapsed and refractory
multiple myeloma
• Part of Genmab and Janssen DuoBody research and license agreement
• Fourth approved medicine created using Genmab’s proprietary DuoBody technology
• Under the agreement with Janssen, Genmab will receive milestones and royalties on net sales of
TALVEY
In July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific
antibodies using Genmab’s DuoBody technology platform. One of the products subsequently discovered
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and developed by Janssen is talquetamab, a bispecific antibody that targets CD3, which is expressed on
T-cells and G protein-coupled receptor, family C, group 5, member D (GPRC5D), an orphan receptor
expressed in malignant plasma cells.
In August 2023, Janssen received accelerated approval from the U.S. FDA for subcutaneously
administered talquetamab-tgvs, marketed as TALVEY, for the treatment of adult patients with relapsed or
refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome
inhibitor, an immunomodulatory agent, and an anti-CD38 antibody. Subsequently Janssen received
conditional marketing authorization from the EC for TALVEY for the treatment of adult patients with
relapsed and refractory multiple myeloma who have received at least three prior therapies, including an
immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody and have demonstrated
disease progression on the last therapy.
Under our agreement with Janssen, Genmab will receive milestones and a mid-single digit royalty on net
sales of TALVEY.
Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics
for TALVEY for the labeled indication and safety information.
SIGNIFICANT RISKS AND UNCERTAINTIES
As a biotech company, Genmab faces a number of risks and uncertainties. These are common for the
industry and relate to operations, intellectual property, research and development, commercialization and
financial activities. For further information about risks and uncertainties which Genmab faces, refer to the
2022 Annual Report filed with NASDAQ Copenhagen and the Form 20-F filed with the U.S. SEC, both of
which were filed in February 2023. At the date of this interim report, there have been no significant
changes to Genmab’s overall risk profile since the publication of these reports. See Genmab’s Form 20-F
for a detailed summary of risks related to our collaborations.
FINANCIAL REVIEW
The interim report is prepared on a consolidated basis for the Genmab Group. The financial statements
are published in Danish Kroner (DKK).
Genmab received regulatory approvals during 2023 for epcoritamab marketed as EPKINLY in the U.S.
and Japan, and TEPKINLY in Europe. EPKINLY/TEPKINLY is the first Genmab-owned medicine to
become available to patients outside of the United States.
Revenue
Genmab’s revenue was DKK 11,796 million for the first nine months of 2023 compared to DKK 9,368
million for the first nine months of 2022. The increase of DKK 2,428 million, or 26%, was primarily driven
by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Janssen and
Novartis, respectively, a milestone achieved under our collaboration with AbbVie for the first commercial
sale of EPKINLY in the United States, and higher reimbursement revenue driven by increased activities
under our collaboration agreements with BioNTech.
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Three Months Ended
Nine Months Ended
September 30,
September 30,
(DKK million)
2023
2022
2023
2022
Royalties
3,868
3,480
9,803
8,207
Reimbursement revenue
306
307
789
594
Milestone revenue
342
112
797
288
Collaboration revenue
78
182
218
273
License revenue
—
6
—
6
Net product sales
150
—
189
—
Total revenue
4,744
4,087
11,796
9,368
Royalties
Royalty revenue amounted to DKK 9,803 million in the first nine months of 2023 compared to DKK 8,207
million in the first nine months of 2022. The increase of DKK 1,596 million, or 19%, was primarily driven
by higher DARZALEX and Kesimpta royalties achieved under our daratumumab collaboration with
Janssen and ofatumumab collaboration with Novartis, respectively, partly offset by negative foreign
exchange rate impacts due to a lower average exchange rate between the USD and DKK. The table
below summarizes Genmab’s royalty revenue by product.
Three Months Ended
Nine Months Ended
September 30,
September 30,
(DKK million)
2023
2022
2023
2022
DARZALEX
3,177
3,049
8,081
7,073
Kesimpta
449
213
1,049
509
TEPEZZA
180
207
516
597
Other
62
11
157
28
Total royalties
3,868
3,480
9,803
8,207
Net sales of DARZALEX by Janssen were USD 7,194 million in the first nine months of 2023 compared to
USD 5,894 million in the first nine months of 2022. The increase of USD 1,300 million, or 22%, was driven
by share gains in all regions. Royalty revenue on net sales of DARZALEX
was DKK 8,081 million in the
first nine months of 2023 compared to DKK 7,073 million in the first nine months of 2022, an increase of
DKK 1,008 million. The percentage increase in royalties of 14% is lower than the percentage increase in
the underlying net sales primarily due to a lower average exchange rate between the USD and DKK for
the first nine months of 2023, other foreign exchange impacts and the increase in Genmab’s Halozyme
royalty deductions in connection with the increase in SC product net sales. Under our license agreement
with Janssen for DARZALEX, for purposes of calculating royalties due to Genmab, net sales for non-U.S.
denominated currencies are translated to U.S. dollars at a specific annual Currency Hedge Rate. This
contractual agreement is the driver for the other foreign exchange rate impacts discussed above, which
were significantly more favorable in the first nine months of 2022 compared to the first nine months of
2023.
Net sales of Kesimpta by Novartis were USD 1,530 million in the first nine months of 2023 compared to
USD 723 million in the first nine months of 2022. The increase of USD 807 million, or 112%, was primarily
driven by increased demand, strong access, and benefiting from a one-time revenue adjustment in
Europe. Royalty revenue on net sales of Kesimpta was DKK 1,049 million in the first nine months of 2023
compared to DKK 509 million in the first nine months of 2022, an increase of DKK 540 million, or 106%.
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Royalty revenue on estimated net sales of TEPEZZA was DKK 516 million in the first nine months of
2023 compared to DKK 597 million in the first nine months of 2022, a decrease of DKK 81 million, or
14%.
Janssen was granted approval for TECVAYLI for the treatment of relapsed or refractory multiple myeloma
during the third quarter of 2022 in Europe and in the fourth quarter of 2022 in the U.S. Royalties were not
material for the first nine months of 2023. There were no royalties for the first nine months of 2022.
During the third quarter of 2023, Janssen was granted approval in the U.S. and in Europe for TALVEY for
the treatment of relapsed or refractory multiple myeloma. Royalties were not material for the first nine
months of 2023.
Royalty revenue fluctuations from period to period are driven by the level of product net sales, foreign
currency exchange rate movements and more specifically to DARZALEX, the contractual arrangement
related to annual Currency Hedge Rate, and Genmab’s share of Janssen’s royalty payments to Halozyme
in connection with SC product net sales.
Reimbursement Revenue
Reimbursement revenue amounted to DKK 789 million in the first nine months of 2023 compared to DKK
594 million in the first nine months of 2022. The increase of DKK 195 million, or 33%, was primarily driven
by higher activities under our collaboration agreements with BioNTech for DuoBody-CD40x4-1BB and
DuoBody-PD-L1x4-1BB.
Milestone Revenue
Milestone revenue was DKK 797 million in the first nine months of 2023 compared to DKK 288 million in
the first nine months of 2022, an increase of DKK 509 million primarily driven by an AbbVie milestone
achieved related to the first commercial sale of EPKINLY in the U.S. and Janssen milestones achieved
related to approvals of TALVEY in the U.S. and Europe.
Milestone revenue may fluctuate significantly from period to period due to both the timing of
achievements and the varying amount of each individual milestone under our license and collaboration
agreements.
Collaboration Revenue
Collaboration revenue was DKK 218 million in the first nine months of 2023 compared to DKK 273 million
in the first nine months of 2022, a decrease of DKK 55 million, or 20%, driven by a one-off payment in the
first nine months of 2022 from Seagen of approximately USD 15 million (DKK 112 million) which reflects
Genmab’s share (50%) of payments received by Seagen in connection with the sublicense of its rights to
develop and commercialize tisotumab vedotin in China to Zai Lab Hong Kong, partly offset by an increase
in net sales of TIVDAK.
Net Product Sales
Following the approval of EPKINLY in the U.S. on May 19, 2023, Genmab recognized net product sales
of DKK 189 million through September 30, 2023. As EPKINLY is Genmab’s first commercialized product
for which Genmab is recording net product sales, there were no net product sales recognized during the
first nine months of 2022.
Refer to Financial Statement Note 2 in this interim report for further details about revenue.
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Cost of Product Sales
Genmab recognized cost of product sales of DKK 100 million following the approval of EPKINLY in the
U.S. on May 19, 2023 through September 30, 2023. Cost of product sales related to EPKINLY sales is
primarily comprised of profit-sharing amounts payable to AbbVie of DKK 90 million as well as product
costs. There were no cost of product sales recognized during the first nine months of 2022.
Key Developments to Revenue – Third Quarter of 2023
Genmab’s revenue was DKK 4,744 million for the third quarter of 2023 compared to DKK 4,087 million for
the third quarter of 2022. The increase of DKK 657 million, or 16%, was primarily driven by higher
Kesimpta and DARZALEX royalties achieved under our collaborations with Novartis and Janssen,
respectively, and milestones achieved under our collaboration with Janssen for the approvals of TALVEY
in the U.S. and Europe, partly offset by negative foreign exchange rate impacts due to a lower average
exchange rate between the USD and DKK.
Research and Development Expenses
Research and development expenses amounted to DKK 5,682 million in the first nine months of 2023
compared to DKK 3,921 million in the first nine months of 2022. The increase of DKK 1,761 million, or
45%, was driven by the increased and accelerated advancement of epcoritamab under our collaboration
with AbbVie, increased activities of DuoBody-CD40x4-1BB and DuoBody-PD-L1x4-1BB under our
collaboration with BioNTech, further progression of pipeline products, and the increase in team members
to support the continued expansion of our product portfolio.
Research and development expenses accounted for 71% of total operating expenses in the first nine
months of 2023 compared to 69% in the first nine months of 2022.
Key Developments to Research and Development Expenses – Third Quarter of 2023
No significant key developments other than the items described above.
Selling, General and Administrative Expenses
Selling, general and administrative expenses were DKK 2,363 million in the first nine months of 2023
compared to DKK 1,755 million in the first nine months of 2022. The increase of DKK 608 million, or 35%,
was driven by the continued expansion of Genmab’s commercialization capabilities through the increase
in team members to support the launch of EPKINLY in the U.S., and the investment in Genmab’s broader
organizational capabilities.
Selling, general and administrative expenses accounted for 29% of total operating expenses in the first
nine months of 2023 compared to 31% for the first nine months of 2022.
Key Developments to Selling, General and Administrative Expenses – Third Quarter of 2023
No significant key developments other than the items described above.
Operating Profit
Operating profit was DKK 3,651 million in the first nine months of 2023 compared to DKK 3,692 million in
the first nine months of 2022. Operating profit was DKK 1,717 million in the third quarter of 2023
compared to DKK 1,931 million in the third quarter of 2022.
Net Financial Items
Net financial items includes the following:
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Three Months Ended
Nine Months Ended
September 30,
September 30,
(DKK million)
2023
2022
2023
2022
Interest and other financial income
243
97
644
184
Gain on marketable securities, net
69
—
158
—
Gain on other investments, net
—
—
4
—
Foreign exchange rate gain, net
714
1,456
275
3,248
Total financial income
1,026
1,553
1,081
3,432
Interest and other financial expenses
(8)
(6)
(21)
(16)
Loss on marketable securities, net
—
(140)
—
(455)
Loss on other investments, net
(33)
(66)
—
(280)
Total financial expenses
(41)
(212)
(21)
(751)
Net financial items
985
1,341
1,060
2,681
Interest Income
Interest income was DKK 644 million in the first nine months of 2023 compared to DKK 184 million in the
first nine months of 2022. The increase of DKK 460 million was driven by higher effective interest rates in
the U.S., Europe and Denmark, and higher cash and cash equivalents and marketable securities.
Foreign Exchange Rate Gains and Losses
Foreign exchange rate gain, net was DKK 275 million in the first nine months of 2023 compared to DKK
3,248 million in the first nine months of 2022. The USD strengthened against the DKK in the first nine
months of 2023 and 2022, positively impacting our USD denominated securities and cash holdings, but to
a greater extent in 2022.
September 30,
2023
December
31, 2022
September 30,
2022
December 31,
2021
USD/DKK Foreign Exchange Rates
7.0390
6.9722
7.6287
6.5612
% Increase from prior year-end
1.0%
16.3%
Marketable Securities Gains and Losses
Gain on marketable securities, net was DKK 158 million in the first nine months of 2023 compared to loss
on marketable securities, net of DKK 455 million in the first nine months of 2022. The increase of DKK
613 million was primarily driven by interest rate outlooks for the U.S. and Europe.
Other Investments
Gain on other investments, net was DKK 4 million in the first nine months of 2023 compared to loss on
other investments, net of DKK 280 million in the first nine months of 2022. The change was primarily due
to the significant decrease in fair value of Genmab’s investment in common shares of CureVac impacting
the first nine months of 2022.
Refer to Financial Statement Note 4 in this interim report for further details about the net financial items.
Key Developments to Net Financial Items – Third Quarter of 2023
No significant key developments other than the items described above.
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Corporate Tax
Corporate tax expense for the first nine months of 2023 was DKK 999 million compared to DKK 1,435
million for the first nine months of 2022. The decrease in corporate tax expense is primarily the result of
Genmab’s lower net profit before tax and a decrease in the estimated annual effective tax rate in the first
nine months of 2023 to 21.2% from 22.5% in the first nine months of 2022. The decrease in Genmab’s
effective tax rate was mainly driven by the ability to realize unrecognized deferred tax assets.
Key Developments to Corporate Tax – Third Quarter of 2023
No significant key developments other than the items described above.
Net Profit
Net profit for the first nine months of 2023 was DKK 3,712 million compared to DKK 4,938 million in the
first nine months of 2022. Net profit for the third quarter of 2023 was DKK 2,129 million compared to DKK
2,582 million in the third quarter of 2022. The decrease was driven by the items described above.
Liquidity and Capital Resources
(DKK million)
September 30, 2023
December 31, 2022
Marketable securities
13,252
12,431
Cash and cash equivalents
14,273
9,893
Shareholders' equity
31,112
27,441
Three Months Ended
Nine Months Ended
September 30,
September 30,
Cash Flow (DKK million)
2023
2022
2023
2022
Cash provided by operating activities
2,037
1,968
5,708
3,514
Cash provided by (used in) investing activities
1,008
(1,382)
(840)
(2,625)
Cash provided by (used in) financing activities
20
(642)
(584)
(920)
Increase (decrease) in cash and cash equivalents
3,065
(56)
4,284
(31)
Exchange Rate adjustments
334
617
96
1,451
Net cash provided by operating activities is primarily related to our operating profit, changes in operating
assets and liabilities, reversal of net financial items, and adjustments related to non-cash transactions.
Cash provided by operating activities increased in the first nine months of 2023 compared to the first nine
months of 2022 primarily driven by significant AbbVie milestones achieved with related cash received
during the first nine months of 2023 and cash received for DARZALEX royalties as a result of increasing
net sales.
Net cash (used in) investing activities primarily reflects differences between the proceeds received from
the sale and maturity of our investments and amounts invested, and the cash paid for investments in
tangible and intangible assets. The decrease in net cash (used in) investing activities is primarily driven
by purchases of marketable securities exceeding sales and maturities to a greater extent during the first
nine months of 2022 compared to the first nine months of 2023.
Net cash (used in) financing activities is primarily related to the purchase of treasury shares, exercise of
warrants, lease payments, and payment of withholding taxes on behalf of employees on net settled
Restricted Stock Units (RSUs). The decrease in net cash (used in) financing activities between the
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periods is primarily driven by cash payments for the purchase of treasury shares of DKK 564 million in the
first nine months of 2023 compared to DKK 908 million for the first nine months of 2022.
Genmab’s USD denominated cash and cash equivalents, and marketable securities represented 89% of
Genmab’s total cash and cash equivalents, and marketable securities as of September 30, 2023
compared to 86% as of December 31, 2022.
There were no short-term marketable securities classified as cash and cash equivalents as of September
30, 2023. Cash and cash equivalents included short-term marketable securities of DKK 594 million as of
December 31, 2022. In accordance with our accounting policy, securities purchased with a maturity of
less than ninety days at the date of acquisition are classified as cash and cash equivalents. Refer to
Financial Statement Note 3 in this interim report for further details about our marketable securities.
Key Developments to Cash Flows – Third Quarter of 2023
No significant key developments other than the items described above.
Balance Sheet
As of September 30, 2023, total assets were DKK 35,238 million compared to DKK 30,278 million on
December 31, 2022. As of September 30, 2023, assets were mainly comprised of marketable securities
of DKK 13,252 million, cash and cash equivalents of DKK 14,273 million and current receivables of DKK
5,432 million. The current receivables consist primarily of amounts related to royalties from our
collaboration agreements.
As of September 30, 2023, total liabilities were DKK 4,126 million compared to DKK 2,837 million on
December 31, 2022. The increase in total liabilities of DKK 1,289 million, or 45%, was primarily driven by
accruals related to the expansion of our product pipeline, and the increase in corporate tax payable due
to Genmab’s net profit before tax and timing of estimated tax payments.
Shareholders’ equity as of September 30, 2023 was DKK 31,112 million compared to DKK 27,441 million
on December 31, 2022. The increase of DKK 3,671 million, or 13%, was primarily driven by Genmab’s
net profit for the period and share-based compensation expenses, partly offset by the purchase of
treasury shares. Genmab’s equity ratio was 88% as of September 30, 2023 compared to 91% as of
December 31, 2022.
Team Members
As of September 30, 2023, the total number of team members was 2,132 compared to 1,560 as of
September 30, 2022. The increase was primarily driven by the expansion and acceleration of our
pipeline, as well as the investment in the expansion of Genmab’s commercialization capabilities, including
support for the launch of EPKINLY in the U.S. and Japan, and broader organizational capabilities.
Nine Months Ended
September 30,
Team Members
2023
2022
Research and development team members
1,484
1,129
Selling, general and administrative team members
648
431
Total team members
2,132
1,560
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Legal Matters – Janssen Binding Arbitrations
In September 2020, Genmab commenced binding arbitration of two matters arising under its license
agreement with Janssen relating to daratumumab. In April 2022, the arbitral tribunal issued an award in
the binding arbitration of the two matters in favor of Janssen. Genmab did not seek a review of the award,
and the award is now final.
On June 9, 2022, Genmab announced the commencement of a second arbitration under the
daratumumab license agreement with Janssen with claims for milestone payments for daratumumab SC
of USD 405 million and a separate 13-year royalty term for daratumumab SC on a country-by-country
basis, from the date of the first commercial sale of daratumumab SC in each such country. This second
arbitration followed from the award in the prior arbitration, where the tribunal ruled in favor of Janssen on
the question as to whether Genmab is required to share in Janssen’s royalty payments to Halozyme for
its technology used in the daratumumab SC product. The tribunal based its ruling on the finding that
DARZALEX FASPRO constitutes a new licensed product under the license agreement.
On April 21, 2023, the arbitral tribunal dismissed Genmab’s claims regarding the second arbitration, on
the basis that these claims should have been brought in the first arbitration. One arbitrator dissented.
Genmab has filed a request for review of the award. See Company Announcement nos. 24 and 25.
Interim Report for the First Nine Months of 2023
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STATEMENTS OF COMPREHENSIVE INCOME
Income Statement
Three Months Ended
Nine Months Ended
September 30,
September 30,
Note
2023
2022
2023
2022
(DKK million)
Revenue
2
4,744
4,087
11,796
9,368
Cost of product sales
(100)
—
(100)
—
Research and development expenses
(2,088)
(1,486)
(5,682)
(3,921)
Selling, general and administrative expenses
(839)
(670)
(2,363)
(1,755)
Operating expenses
(2,927)
(2,156)
(8,045)
(5,676)
Operating profit
1,717
1,931
3,651
3,692
Financial income
4
1,026
1,553
1,081
3,432
Financial expenses
4
(41)
(212)
(21)
(751)
Net profit before tax
2,702
3,272
4,711
6,373
Corporate tax
(573)
(690)
(999)
(1,435)
Net profit
2,129
2,582
3,712
4,938
Basic net profit per share
32.60
39.55
56.84
75.48
Diluted net profit per share
32.32
39.17
56.35
74.83
Statement of Comprehensive Income
Net profit
2,129
2,582
3,712
4,938
Other comprehensive income:
Amounts which may be re-classified to the
income statement:
Exchange differences on translation of foreign
operations
30
41
44
70
Total comprehensive income
2,159
2,623
3,756
5,008
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BALANCE SHEETS
September 30,
December 31,
Note
2023
2022
(DKK million)
ASSETS
Intangible assets
115
146
Property and equipment
943
799
Right-of-use assets
7
708
523
Receivables
37
48
Deferred tax assets
252
252
Other investments
3
156
133
Total non-current assets
2,211
1,901
Corporate tax receivable
—
143
Inventories
70
—
Receivables
5,432
5,910
Marketable securities
3
13,252
12,431
Cash and cash equivalents
14,273
9,893
Total current assets
33,027
28,377
Total assets
35,238
30,278
SHAREHOLDERS’ EQUITY AND LIABILITIES
Share capital
66
66
Share premium
12,452
12,309
Other reserves
142
98
Retained earnings
18,452
14,968
Total shareholders' equity
31,112
27,441
Lease liabilities
7
710
523
Deferred revenue
2
480
480
Other payables
34
11
Total non-current liabilities
1,224
1,014
Corporate tax payable
445
—
Lease liabilities
7
83
74
Deferred revenue
2
33
33
Other payables
2,341
1,716
Total current liabilities
2,902
1,823
Total liabilities
4,126
2,837
Total shareholders' equity and liabilities
35,238
30,278
Share-based instruments
5
Related parties
6
Subsequent events to the balance sheet date
8
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STATEMENTS OF CASH FLOWS
Nine Months Ended
September 30,
Note
2023
2022
(DKK million)
Net profit before tax
4,711
6,373
Reversal of financial items, net
(1,060)
(2,681)
Adjustments for non-cash transactions
670
574
Changes in operating assets and liabilities
1,204
(454)
Cash flows from operating activities before
financial items
5,525
3,812
Interest received
612
169
Interest elements of lease payments
7
(18)
(11)
Interest paid
—
(1)
Corporate taxes paid
(411)
(455)
Net cash provided by operating activities
5,708
3,514
Investment in intangible assets
(10)
—
Investment in tangible assets
(299)
(207)
Marketable securities bought
(8,382)
(7,238)
Marketable securities sold
7,868
4,850
Other investments bought
(17)
(30)
Net cash (used in) investing activities
(840)
(2,625)
Warrants exercised
143
112
Principal elements of lease payments
(66)
(47)
Purchase of treasury shares
5
(564)
(908)
Payment of withholding taxes on behalf of employees
on net settled RSUs
(97)
(77)
Net cash (used in) financing activities
(584)
(920)
Change in cash and cash equivalents
4,284
(31)
Cash and cash equivalents at the beginning of the
period
9,893
8,957
Exchange rate adjustments
96
1,451
Cash and cash equivalents at the end of the
period
14,273
10,377
Cash and cash equivalents include:
Bank deposits
14,273
9,082
Short-term marketable securities
—
1,295
Cash and cash equivalents at the end of the
period
14,273
10,377
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STATEMENTS OF CHANGES IN EQUITY
Share
Share
Translation
Retained
Shareholders'
capital
premium
reserves
earnings
equity
(DKK million)
Balance at December 31, 2021
66
12,029
81
10,020
22,196
Net profit
—
—
—
4,938
4,938
Other comprehensive income
—
—
70
—
70
Total comprehensive income
—
—
70
4,938
5,008
Transactions with owners:
Exercise of warrants
—
112
—
—
112
Purchase of treasury shares
—
—
—
(908)
(908)
Share-based compensation expenses
—
—
—
326
326
Net settlement of RSUs
—
—
—
(77)
(77)
Balance at September 30, 2022
66
12,141
151
14,299
26,657
Balance at December 31, 2022
66
12,309
98
14,968
27,441
Net profit
—
—
—
3,712
3,712
Other comprehensive income
—
—
44
—
44
Total comprehensive income
—
—
44
3,712
3,756
Transactions with owners:
Exercise of warrants
—
143
—
—
143
Purchase of treasury shares
—
—
—
(564)
(564)
Share-based compensation expenses
—
—
—
433
433
Net settlement of RSUs
—
—
—
(97)
(97)
Balance at September 30, 2023
66
12,452
142
18,452
31,112
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NOTES TO THE FINANCIAL STATEMENTS
Note 1 – Basis of Presentation
Accounting Policies
These interim statements of the Genmab Group (Genmab or the Company) have been prepared in
accordance with IAS 34 as issued by the International Accounting Standards Board (IASB) and in
accordance with IAS 34 as endorsed by the EU and additional Danish disclosure requirements for interim
reports of listed companies. The interim report has not been reviewed or audited by Genmab’s external
auditors.
Except as described below, the interim report has been prepared using the same accounting policies as
outlined in Section 1 – Basis of Presentation in the financial statements in the Genmab 2022 Annual
Report (Annual Report). A number of new or amended standards became applicable for the current
reporting period. Genmab was not required to change its accounting policies as a result of adopting these
standards. These interim financial statements should be read in conjunction with the Annual Report.
The below accounting policies have been implemented upon Genmab receiving U.S. FDA approval on
May 19, 2023 for EPKINLY. As of September 30, 2023, product sales, cost of product sales and inventory
relate entirely to EPKINLY.
Revenue Recognition - Product Sales
Revenue is recognized when control is transferred to the customer and it is probable that Genmab will
collect the consideration to which it is entitled for transferring the products. Control of the products is
transferred at a single point in time which occurs upon delivery to the customer. The amount of sales to
be recognized is based on the consideration Genmab expects to receive in exchange for its goods. When
sales are recognized, an estimate for a variety of sales deductions is also recorded such as cash
discounts, government rebates, chargebacks, wholesaler fees, other rebates and administrative fees,
sales returns and allowances and other sales discounts. Sales deductions are estimated and recognized
as a reduction of gross product sales to arrive at net product sales, by assessing the expected value of
the sales deductions (variable consideration).
Accounts Receivable – Product Sales
Accounts receivable arising from product sales are initially measured at transaction price and
subsequently measured at amortized cost, which generally corresponds to nominal value less expected
credit losses. Genmab utilizes a simplified approach to measuring expected credit losses and uses a
lifetime expected loss allowance for all receivables. To measure the expected credit losses, accounts
receivables have been grouped based on credit risk characteristics and the days past due.
Accounts receivable arising from product sales consists of amounts due from customers, net of customer
allowances for chargebacks, cash and other discounts and estimated credit losses. Genmab’s contracts
with customers have initial payment terms that range from 30 to 180 days.
Inventories
Inventories are stated at the lower of cost or net realizable value with costs determined on a first-in, first-
out basis. Genmab assesses the recoverability of capitalized inventories during each reporting period and
will write down excess or obsolete inventories to its net realizable value in the period in which the
impairment is identified within Cost of product sales in the statements of comprehensive income.
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Included in inventories are materials used in the production of clinical products, which are charged to
research and development expenses when shipped to the clinical packaging site. Inventory manufactured
prior to regulatory approval of a product (prelaunch inventory) is capitalized but immediately written down
to zero. The cost of this write down is recognized in the statements of comprehensive income as research
and development expenses. Once there is a high probability of regulatory approval being obtained for the
product, the write-down is reversed, up to no more than the original cost. The reversal of the write-down
is recognized as an offset to research and development expenses in the statements of comprehensive
income.
Prior to receiving regulatory approval of EPKINLY in the U.S. and Japan, Genmab had written down
inventory costs relating to the manufacture of EPKINLY to a net realizable value of zero. Capitalization of
inventory costs associated with certain products prior to regulatory approval of such products is only
appropriate when management considered it highly probable that pre-approval inventory costs would be
recoverable through future sales of the drug product. The determination to capitalize was based on the
particular facts and circumstances related to the expected regulatory approval of the product. The write
down was recorded as research and development expenses in Genmab’s statements of comprehensive
income. Upon receiving regulatory approval for EPKINLY in the U.S and Japan, Genmab reversed
previously recorded inventory write downs which were not material. The reversal of previously recorded
inventory write downs was based on a number of factors existing at that time, including the existence of
inventory on hand and estimated demand, as well as expiration dating. The reversal of these inventory
write downs was recorded as a reduction to research and development expenses in Genmab’s
statements of comprehensive income.
Cost of Product Sales
Cost of product sales includes direct and indirect costs relating to the manufacture of inventory mainly
from third-party providers of manufacturing as well as costs related to internal resources and distribution
and logistics. Inventory amounts written down as a result of excess or obsolescence are charged to cost
of product sales in the statements of comprehensive income.
Additionally, cost of product sales includes net profit-sharing amounts owed to collaboration partners for
the sale of commercial products when Genmab is determined to be the principal in sales to end
customers. As of September 30, 2023, the only net profit-sharing amounts owed recorded as cost of
product sales relate to sales of EPKINLY pursuant to the Collaboration Agreement with AbbVie. Refer to
Note 5.6 in the Annual Report for detailed information regarding Genmab’s Collaboration Agreement with
AbbVie.
Management Judgements and Estimates under IFRS
In preparing interim reports, certain provisions under IFRS require management to make judgements
(various accounting estimates and assumptions), which may significantly impact Genmab’s financial
statements. For a description of significant judgements and estimates, refer to Note 1.3 in the Annual
Report. Additionally, upon Genmab receiving U.S. FDA approval of EPKINLY during the quarter ended
June 30, 2023, management has determined that estimation of sales deductions related to product sales
is an area that requires significant estimation. Refer below for further information on the key accounting
estimates related to sales deductions utilized in preparation of the consolidated financial statements.
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Sales Deductions
Sales deductions are estimated and provided for at the time the related sales are recorded. Genmab’s
estimates related to sales deductions require significant use of estimates as not all conditions are known
at the time of sale. The estimates are based on analyses of existing contractual obligations, historical
experience, drug product analogs and payer channel mix.
Genmab considers the provisions established for sales deductions to be reasonable and appropriate
based on currently available information; however, the actual amount of deductions may differ from the
amounts estimated by management as more information becomes available. Estimates will be assessed
each period and adjusted as required based on updated information and actual experience.
Information about Geographical Areas
Genmab is managed and operated as one business unit, which is reflected in the organizational structure
and internal reporting. No separate lines of business or separate business entities have been identified
with respect to any licensed products, product candidates, product sales or geographical markets and no
segment information is currently prepared for internal reporting. Refer to Note 2.2 in the Annual Report for
further details.
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Note 2 – Revenue
The table below summarizes Genmab’s revenue by type and collaboration partner, and royalties by
product, under Genmab’s agreements.
Three Months Ended
Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
(DKK million)
Revenue by type:
Royalties
3,868
3,480
9,803
8,207
Reimbursement revenue
306
307
789
594
Milestone revenue
342
112
797
288
Collaboration revenue
78
182
218
273
License revenue
—
6
—
6
Net product sales
150
—
189
—
Total
4,744
4,087
11,796
9,368
Revenue by collaboration partner:
Janssen
3,581
3,172
8,684
7,378
Roche
180
207
516
597
Novartis
455
234
1,061
539
BioNTech
286
280
732
511
Seagen
92
192
266
330
AbbVie
—
—
348
—
Other
—
2
—
13
Total*
4,594
4,087
11,607
9,368
Royalties by product:
DARZALEX
3,177
3,049
8,081
7,073
Kesimpta
449
213
1,049
509
TEPEZZA
180
207
516
597
Other
62
11
157
28
Total
3,868
3,480
9,803
8,207
* Excludes Genmab’s Net product sales
In September 2020, Genmab commenced binding arbitration of two matters arising under its license
agreement with Janssen relating to daratumumab. In April 2022, the arbitral tribunal issued an award in
the binding arbitration of the two matters in favor of Janssen. Genmab did not seek a review of the award,
and the award is now final.
Net Product Sales
Following the approval of EPKINLY in the U.S. on May 19, 2023, Genmab recognized net product sales
of DKK 189 million through September 30, 2023. As EPKINLY is Genmab’s first commercialized product
for which Genmab is recording net product sales, there were no net product sales recognized during the
first nine months of 2022.
Deferred Revenue
As part of the continued evaluation of deferred revenue related to the AbbVie Agreement, during the first
nine months of 2023, Genmab’s classification of deferred revenue reflects the current estimate of co-
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
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2500 Valby, Denmark
CVR no. 2102 3884
development activities as of September 30, 2023. These co-development activities are related to a
performance obligation in connection with the product concepts under a research option agreement.
Refer to Note 2.1 in the Annual Report for further details regarding revenue.
Note 3 – Financial Instruments
Genmab’s portfolio is spread over a number of different securities with a focus on liquidity and the
preservation of capital. Genmab’s marketable securities in USD, DKK, EUR, and GBP as a percentage of
total marketable securities was as follows:
September 30,
December 31,
2023
2022
Percent
USD
83
%
80
%
DKK
12
%
12
%
EUR
5
%
7
%
GBP
—
%
1
%
Total
100
%
100
%
As of September 30, 2023, and December 31, 2022, 75% of Genmab’s marketable securities were long-
term A rated or higher, or short-term A-1 / P-1 rated by S&P, Moody’s or Fitch.
The table below shows the fair value measurements by level for Genmab’s financial assets measured at
fair value through profit or loss:
(DKK million)
September 30, 2023
December 31, 2022
Assets Measured at Fair Value
Level 1
Level 2
Level 3
Total
Level 1
Level 2
Level 3
Total
Marketable securities
13,252
—
—
13,252
12,431
—
—
12,431
Other investments
74
—
82
156
67
—
66
133
Marketable Securities
All fair values are determined by reference to external sources using unadjusted quoted prices in
established markets for Genmab’s marketable securities (Level 1).
Refer to Note 4.3 and Note 4.4 in the Annual Report for further details regarding Genmab’s marketable
securities and other investments.
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
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2500 Valby, Denmark
CVR no. 2102 3884
Note 4 – Financial Income and Expenses
Three Months Ended
Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
(DKK million)
Financial income:
Interest and other financial income
243
97
644
184
Gain on marketable securities, net
69
-
158
-
Gain on other investments, net
-
-
4
-
Foreign exchange rate gain, net
714
1,456
275
3,248
Total financial income
1,026
1,553
1,081
3,432
Financial expenses:
Interest and other financial expenses
(8)
(6)
(21)
(16)
Loss on marketable securities, net
-
(140)
-
(455)
Loss on other investments, net
(33)
(66)
-
(280)
Total financial expenses
(41)
(212)
(21)
(751)
Net financial items
985
1,341
1,060
2,681
Interest Income
Interest income was DKK 644 million in the first nine months of 2023 compared to DKK 184 million in the
first nine months of 2022. The increase of DKK 460 million was driven by higher effective interest rates in
the U.S., Europe and Denmark, and higher cash and cash equivalents and marketable securities.
Foreign Exchange Rate Gains and Losses
Foreign exchange rate gain, net was DKK 275 million in the first nine months of 2023 compared to DKK
3,248 million in the first nine months of 2022. The USD strengthened against the DKK in the first nine
months of 2023 and 2022, positively impacting our USD denominated marketable securities, and cash
and cash equivalents, but to a greater extent in 2022.
September 30,
2023
December
31, 2022
September 30,
2022
December 31,
2021
USD/DKK Foreign Exchange Rates
7.0390
6.9722
7.6287
6.5612
% Increase from prior year-end
1.0%
16.3%
Marketable Securities Gains and Losses
Gain on marketable securities, net was DKK 158 million in the first nine months of 2023 compared to loss
on marketable securities, net of DKK 455 million in the first nine months of 2022. The increase of DKK
613 million was primarily driven by interest rate outlooks for the U.S. and Europe.
Other Investments
Gain on other investments, net was DKK 4 million in the first nine months of 2023 compared to loss on
other investments, net of DKK 280 million in the first nine months of 2022. The change was primarily due
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
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2500 Valby, Denmark
CVR no. 2102 3884
to the significant decrease in fair value of Genmab’s investment in common shares of CureVac impacting
the first nine months of 2022.
Note 5 – Share-Based Instruments
Restricted Stock Unit Program
Genmab has established RSU programs as an incentive for all Genmab employees, members of the
registered Executive Management, and members of the Board of Directors.
Nine Months Ended
September 30,
2023
2022
RSUs granted
288,670
260,523
Weighted average fair value per RSU granted (DKK)
2,636.71
2,209.10
RSUs vested
91,514
87,213
Refer to Note 4.6 in the Annual Report for details on the RSU programs.
Warrant Program
Genmab has established warrant programs as an incentive for all Genmab employees. Following
Genmab’s Annual General Meeting on March 29, 2023, members of the registered Executive
Management and members of the Board of Directors may only be granted RSUs.
Nine Months Ended
September 30,
2023
2022
Warrants granted
201,726
249,901
Weighted average exercise price per warrant granted (DKK)
2,650.53
2,210.60
Weighted average Black-Scholes fair value per warrant granted (DKK)
932.20
647.44
Warrants exercised
105,908
110,826
Weighted average exercise price on date of grant per warrant exercised (DKK)
1,347.69
1,014.66
% change in share capital - warrants exercised
0.16%
0.17%
Refer to Note 4.6 in the Annual Report for details on the warrant programs.
Share-Based Compensation Expense
Share-based compensation expenses related to Genmab’s RSU and warrant programs for the
first nine months of 2023 were DKK 433 million compared to DKK 326 million for the first nine
months of 2022.
Share Repurchases
Genmab intends to purchase its own shares primarily to honor commitments in relation to share-based
remuneration programs.
As of September 30, 2023, Genmab’s 2021 authorization has shares available for repurchase, while
Genmab’s 2019 authorization has been fully used. In addition, at Genmab’s Annual General Meeting on
March 29, 2023, a new authorization to acquire treasury shares up to a nominal amount of DKK 500,000
to settle obligations under the share-based remuneration programs and for other more general purposes
was granted.
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
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2500 Valby, Denmark
CVR no. 2102 3884
2023
Authorization
2021
Authorization
2019
Authorization
Number of shares authorized for repurchase
1
500,000
500,000
500,000
Actual shares repurchased under authorization
—
260,000
500,000
Shares available for repurchase as of September 30, 2023
500,000
240,000
—
1
Nominal value of DKK 500,000
A
s announced on February 22, 2023, Genmab initiated a share buy-back program. During the first nine
months of 2023, Genmab acquired 220,000 of its own shares, representing approximately 0.3% of share
capital as of December 31, 2022. The total amount paid to acquire the shares, including directly
attributable costs, was DKK 564 million and was recognized as a deduction to shareholders’ equity.
These shares are classified as treasury shares and are presented within retained earnings on the balance
sheet as of September 30, 2023. During the first nine months of 2022, Genmab acquired 370,000 of its
own shares, representing approximately 0.6% of share capital as of December 31, 2021. The total
amount paid to acquire the shares, including directly attributable costs, was DKK 908 million and was
recognized as a deduction to shareholders’ equity.
As
of September 30, 2023, 752,074 treasury shares were held by Genmab.
N
ote 6 – Related Parties
G
enmab’s related parties are its Board of Directors, Executive Management, and close members of the
family of these persons.
G
enmab has not granted any loans, guarantees or other commitments to or on behalf of any of the
members of the Board of Directors or members of the Executive Management.
O
ther than the remuneration and other transactions relating to the Board of Directors and the Executive
Management described in Note 5.1 in the Annual Report, there were no material related party
transactions during the first nine months of 2023.
C
hanges to the Executive Management and the Board of Directors
G
enmab implemented an administrative organizational change whereby effective January 1, 2023, only
Jan van de Winkel, President and Chief Executive Officer, and Anthony Pagano, Executive Vice
President and Chief Financial Officer, are formally registered as executive managers with the Danish
Business Authority.
A
dditionally, during the first nine months of 2023, there was one change to the Executive Management.
Effective March 29, 2023, Martine van Vugt was appointed to Executive Vice President and Chief
Strategy Officer. Martine joins the existing Executive Management team of Jan van de Winkel, President
and Chief Executive Officer, Anthony Pagano, Executive Vice President and Chief Financial Officer,
Judith Klimovsky, Executive Vice President and Chief Development Officer, Anthony Mancini, Executive
Vice President and Chief Operating Officer, Tahamtan Ahmadi, Executive Vice President and Chief
Medical Officer, Birgitte Stephensen, Executive Vice President and Chief Legal Officer and
Christopher Cozic, Executive Vice President and Chief People Officer.
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
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2500 Valby, Denmark
CVR no. 2102 3884
Following Genmab’s Annual General Meeting on March 29, 2023, the Board of Directors is comprised of
five independent board members, one non-independent board member, and three employee-elected
board members. Deirdre P. Connelly (Chair), Pernille Erenbjerg (Deputy Chair), Rolf Hoffmann, Elizabeth
O’Farrell, Paolo Paoletti and Anders Gersel Pedersen were re-elected to the Board of Directors for a one-
year period. Mijke Zachariasse, Martin Schultz and Takahiro Hamatani continue to serve as employee-
elected board members for a three-year period expiring in 2025.
Note 7 – Leases
A
mounts recognized in the balance sheet
T
he balance sheet shows the following amounts relating to leases:
September 30,
December 31,
2023
2022
(DKK million)
Right-of-use assets
Properties
708
523
Total right-of-use assets
708
523
Lease liabilities
Current
83
74
Non-current
710
523
Total lease liabilities
793
597
D
uring the first nine months of 2023, there were additions to Genmab’s right-of-use assets and lease
liabilities related to the commencement of a lease for the new headquarters in Denmark. During the first
nine months of 2022, there were additions to Genmab’s right-of-use assets and lease liabilities related to
the commencement of leases in the Netherlands with respect to office and laboratory space.
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
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2500 Valby, Denmark
CVR no. 2102 3884
Amounts recognized in the statements of comprehensive income
The statements of comprehensive income shows the following amounts relating to leases:
Three Months Ended
Nine Months Ended
September 30,
September 30,
2023
2022
2023
2022
(DKK million)
Depreciation charge of right-of-use assets
Properties
22
22
66
53
Total depreciation charge of right-of-use assets
22
22
66
53
Interest expense
7
4
18
11
Interest expense is included in net financial items in the statements of comprehensive income.
Variable lease payments, short-term leases, and sublease income are immaterial.
Note 8 – Subsequent Events to the Balance Sheet Date
No events have occurred subsequent to the balance sheet date that could significantly affect the financial
statements as of September 30, 2023.
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
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2500 Valby, Denmark
CVR no. 2102 3884
ABOUT GENMAB
Genmab is an international biotechnology company with a core purpose guiding its unstoppable team to strive towards improving
the lives of patients through innovative and differentiated antibody therapeutics. For more than 20 years, its passionate, innovative
and collaborative team has invented next-generation antibody technology platforms and leveraged translational research and data
sciences, which has resulted in a proprietary pipeline including bispecific T-cell engagers, next-generation immune checkpoint
modulators, effector function enhanced antibodies and antibody-drug conjugates. To help develop and deliver novel antibody
therapies to patients, Genmab has formed 20+ strategic partnerships with biotechnology and pharmaceutical companies. By 2030,
Genmab’s vision is to transform the lives of people with cancer and other serious diseases with Knock-Your-Socks-Off (KYSO™)
antibody medicines.
Established in 1999, Genmab is headquartered in Copenhagen, Denmark with locations in Utrecht, the Netherlands, Princeton, New
Jersey, U.S. and Tokyo, Japan. For more information, please visit Genmab.com and follow us on Twitter.com/Genmab.
This Interim Report contains forward looking statements. The words “believe,” “expect,” “anticipate,” “intend” and “plan” and similar
expressions identify forward looking statements. Actual results or performance may differ materially from any future results or
performance expressed or implied by such statements. The important factors that could cause our actual results or performance to
differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related
to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the
lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business
area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our
patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render
our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management
sections in Genmab’s most recent financial reports, which are available on https://www.genmab.com/and the risk factors included in
Genmab’s most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC),
which are available at www.sec.gov/Genmab does not undertake any obligation to update or revise forward looking statements in
this Interim Report nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation
to actual results, unless required by law.
Genmab A/S and/or its subsidiaries own the following trademarks: Genmab
®
; the Y-shaped Genmab logo
®
; Genmab in combination
with the Y-shaped Genmab logo
®
; HuMax
®
; DuoBody
®
; HexaBody
®
; DuoHexaBody
®
; HexElect
®
and KYSO™; Tivdak
®
is a
trademark of Seagen Inc.; EPCORE™, EPKINLY™, TEPKINLY
®
and their designs are trademarks of AbbVie Biotechnology Ltd.;
Kesimpta
®
and Sensoready
®
are trademarks of Novartis AG or its affiliates; DARZALEX
®
, DARZALEX FASPRO
®
, RYBREVANT
®
,
TECVAYLI
®
and TALVEY
®
are trademarks of Johnson & Johnson; TEPEZZA
®
is a trademark of Horizon Therapeutics Ireland DAC.
Interim Report for the First Nine Months of 2023
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 44
Carl Jacobsens Vej 30
www.genmab.com
Page 40/40
2500 Valby, Denmark
CVR no. 2102 3884
DIRECTORS’ AND MANAGEMENT’S STATEMENT ON THE INTERIM REPORT
The Board of Directors and the registered members of Executive Management have today
considered and adopted the unaudited interim report of the Genmab Group for the nine months
ended September 30, 2023.
The interim report is prepared in accordance with IAS 34, “Interim Financial Reporting,” as issued
by the IASB and in accordance with IAS 34 as endorsed by the EU, and additional Danish
disclosure requirements for interim reports of listed companies.
We consider the applied accounting policies to be appropriate and, in our opinion, the interim
report gives a true and fair view of the assets and liabilities, financial position, results of operation
and cash flows of the Group.
Furthermore, we consider the Management’s Review to give a true and fair account of the
development in the Group’s activities and financial affairs, results of operations and the Group’s
financial position as a whole as well as a description of the significant risks and uncertainties
which the Group faces, as further described in our 2022 Annual Report and the Form 20-F filed
with the U.S. Securities and Exchange Commission in February 2023.
Copenhagen, November 7, 2023
Registered Members of Executive Management
Jan van de Winkel
Anthony Pagano
(President & CEO)
(Executive Vice President & CFO)
Board of Directors
Deirdre P. Connelly
Pernille Erenbjerg
Anders Gersel Pedersen
(Chair)
(Deputy Chair)
Rolf Hoffmann
Paolo Paoletti
Elizabeth O’Farrell
Mijke Zachariasse
Takahiro Hamatani
Martin Schultz
(Employee elected)
(Employee elected)
(Employee elected)
Interim report (other than 6 months)No audit assistanceParsePort XBRL Converter2023-01-072023-09-302022-01-072022-09-30529900MTJPDPE4MHJ122Reporting class D2023-11-07529900MTJPDPE4MHJ1222023-01-072023-09-30cmn:ConsolidatedMember529900MTJPDPE4MHJ1222023-01-072023-09-30529900MTJPDPE4MHJ1222022-01-072022-09-30529900MTJPDPE4MHJ1222023-01-012023-09-30529900MTJPDPE4MHJ1222022-01-012022-09-30529900MTJPDPE4MHJ1222023-09-30529900MTJPDPE4MHJ1222022-12-31529900MTJPDPE4MHJ1222021-12-31529900MTJPDPE4MHJ1222022-09-30529900MTJPDPE4MHJ1222021-12-31ifrs-full:IssuedCapitalMember529900MTJPDPE4MHJ1222022-01-012022-09-30ifrs-full:IssuedCapitalMember529900MTJPDPE4MHJ1222022-09-30ifrs-full:IssuedCapitalMember529900MTJPDPE4MHJ1222021-12-31ifrs-full:SharePremiumMember529900MTJPDPE4MHJ1222022-01-012022-09-30ifrs-full:SharePremiumMember529900MTJPDPE4MHJ1222022-09-30ifrs-full:SharePremiumMember529900MTJPDPE4MHJ1222021-12-31ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember529900MTJPDPE4MHJ1222022-01-012022-09-30ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember529900MTJPDPE4MHJ1222022-09-30ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember529900MTJPDPE4MHJ1222021-12-31ifrs-full:RetainedEarningsMember529900MTJPDPE4MHJ1222022-01-012022-09-30ifrs-full:RetainedEarningsMember529900MTJPDPE4MHJ1222022-09-30ifrs-full:RetainedEarningsMember529900MTJPDPE4MHJ1222022-12-31ifrs-full:IssuedCapitalMember529900MTJPDPE4MHJ1222023-01-012023-09-30ifrs-full:IssuedCapitalMember529900MTJPDPE4MHJ1222023-09-30ifrs-full:IssuedCapitalMember529900MTJPDPE4MHJ1222022-12-31ifrs-full:SharePremiumMember529900MTJPDPE4MHJ1222023-01-012023-09-30ifrs-full:SharePremiumMember529900MTJPDPE4MHJ1222023-09-30ifrs-full:SharePremiumMember529900MTJPDPE4MHJ1222022-12-31ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember529900MTJPDPE4MHJ1222023-01-012023-09-30ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember529900MTJPDPE4MHJ1222023-09-30ifrs-full:ReserveOfExchangeDifferencesOnTranslationMember529900MTJPDPE4MHJ1222022-12-31ifrs-full:RetainedEarningsMember529900MTJPDPE4MHJ1222023-01-012023-09-30ifrs-full:RetainedEarningsMember529900MTJPDPE4MHJ1222023-09-30ifrs-full:RetainedEarningsMember529900MTJPDPE4MHJ1222023-01-072023-09-30cmn:ConsolidatedMember1529900MTJPDPE4MHJ1222023-01-072023-09-30cmn:ConsolidatedMember2529900MTJPDPE4MHJ1222023-01-072023-09-30cmn:ConsolidatedMember1529900MTJPDPE4MHJ1222023-01-072023-09-30cmn:ConsolidatedMember2529900MTJPDPE4MHJ1222023-01-072023-09-30cmn:ConsolidatedMember3529900MTJPDPE4MHJ1222023-01-072023-09-30cmn:ConsolidatedMember4529900MTJPDPE4MHJ1222023-01-072023-09-30cmn:ConsolidatedMember5529900MTJPDPE4MHJ1222023-01-072023-09-30cmn:ConsolidatedMember6529900MTJPDPE4MHJ1222023-01-072023-09-30cmn:ConsolidatedMember7529900MTJPDPE4MHJ1222023-01-072023-09-30cmn:ConsolidatedMember8529900MTJPDPE4MHJ1222023-01-072023-09-30cmn:ConsolidatedMember9529900MTJPDPE4MHJ1222022-01-072022-09-30cmn:ConsolidatedMemberiso4217:DKKiso4217:DKKxbrli:sharesxbrli:pure