Genmab Announces Financial Results for the First Half of 2022
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 41
Kalvebod Brygge 43
Fax: +45 7020 2729
Page 1/35
1560 Copenhagen V, Denmark
www.genmab.com
CVR no. 2102 3884
August 10, 2022 Copenhagen, Denmark;
Interim Report for the First Six Months Ended June 30, 2022
H
ighlights
• Genmab and AbbVie Inc. (AbbVie) announced topline results for epcoritamab from the
Phase 1/2 trial in patients with relapsed/refractory large B-cell lymphoma (LBCL)
• Genmab announced its intent to submit a biologics license application (BLA) to the U.S.
Food and Drug Administration (U.S. FDA) for epcoritamab for the treatment of patients
with relapsed/refractory LBCL, in the second half of 2022
• DARZALEX
®
net sales as reported by Johnson & Johnson increased 37% compared to the
first six months of 2021 to USD 3,842 million, resulting in royalty revenue to Genmab of
DKK
4,024 million
• Genmab announced the resolution of its arbitration with Janssen Biotech, Inc. (Janssen
)
u
nder its daratumumab license agreement and subsequently commenced a new
arbitration under the daratumumab license agreement with Janssen
• Genmab improves its 2022 financial guidance
“G
enmab’s innovation was on display during the second quarter of 2022 with data presentations at
multiple prestigious conferences and the publication by Genmab, and our partner, AbbVie, of topline
results for epcoritamab from the Phase 1/2 trial in patients with relapsed/refractory LBCL. Based on this
data, we intend to submit a BLA to the U.S. FDA for epcoritamab in the second half of this year,” said Jan
van de Winkel, Ph.D., Chief Executive Officer of Genmab.
F
inancial Performance First Half of 2022
• Net sales of DARZALEX by Janssen were USD 3,842 million in the first six months of 2022
compared to USD 2,798 million in the first six months of 2021, an increase of USD 1,044 million,
or 37%.
• Royalty revenue was DKK 4,727 million in the first six months of 2022 compared to DKK 2,595
million in the first six months of 2021, an increase of DKK 2,132 million, or 82%. The increase i
n
r
oyalties was driven by higher net sales of DARZALEX, TEPEZZA
®
and Kesimpta
®
and higher
average exchange rate between the USD and DKK.
• Revenue was DKK 5,281 million for the first six months of 2022 compared to DKK 3,553 million
for the first six months of 2021. The increase of DKK 1,728 million, or 49%, was primarily driv
en
by
higher DARZALEX, TEPEZZA and Kesimpta royalties achieved under our collaborations wit
h
Janssen, Roche and Novartis Pharma AG (Novartis), respectively, partly offset by milestones
achieved under our collaborations with Janssen and AbbVie in the first six months of 2021.
• Operating expenses were DKK 3,520 million in the first six months of 2022 compared to DKK
2,234 million in the first six months of 2021. The increase of DKK 1,286 million, or 58%, was
driven by the continued advancement of epcoritamab and multiple pipeline projects, an increas
e
in new employees to support Tivdak
®
post launch and expansion of our product pipeline, and the
continued development of Genmab’s commercialization and broader organizational capabilities
and infrastructure.
• Operating profit was DKK 1,761 million in the first six months of 2022 compared to DKK 1,319
million in the first six months of 2021
.
Genmab Announces Financial Results for the First Half of 2022
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 41
Kalvebod Brygge 43
Fax: +45 7020 2729
Page 2/35
1560 Copenhagen V, Denmark
www.genmab.com
CVR no. 2102 3884
O
utlook
As announced in Company Announcement No. 40, Genmab is raising its 2022 financial guidance
published on May 11, 2022, driven primarily by increased royalty revenue due to higher net sales of
DARZALEX and the foreign exchange impact of the strong US Dollar.
Revised
Previous
(DKK million)
Guidance
Guidance
Revenue
12,000 - 13,000
11,000 - 12,000
Operating expenses
(7,600) - (8,200)
(7,200) - (7,800)
Operating profit
3,800 - 5,400
3,200 - 4,800
C
onference Call
Genmab will hold a conference call in English to discuss the results for the first half of 2022 today,
Wednesday, August 10, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
+1 631 913 1422 (U.S. participants) or +44 3333000804 (international participants) and provide
conference code 29756170. A live and archived webcast of the call and relevant slides will be available at
www.genmab.com/investors
.
C
ontact:
Marisol Peron, Senior Vice President, Communications and Corporate Affairs
T: +1 609 524 0065; E: mmp@genmab.com
A
ndrew Carlsen, Vice President, Head of Investor Relations
T: +45 3377 9558; E: acn@genmab.com
Interim Report for the First Half of 2022
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 41
Kalvebod Brygge 43
Fax: +45 7020 2729
Page 3/35
1560 Copenhagen V, Denmark
www.genmab.com
CVR no. 2102 3884
CONTENTS
MANAGEMENT’S REVIEW
CONSOLIDATED KEY FIGURES
4
OUTLOOK
5
KEY 2022 PRIORITIES
6
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST HALF OF 2022
6
SIGNIFICANT RISKS AND UNCERTAINTIES
14
FINANCIAL REVIEW
15
FINANCIAL STATEMENTS
STATEMENTS OF COMPREHENSIVE INCOME FOR THE 2ND QUARTER OF 2022
21
STATEMENTS OF COMPREHENSIVE INCOME FOR THE FIRST HALF OF 2022
22
BALANCE SHEETS AS OF JUNE 30, 2022
23
STATEMENTS OF CASH FLOWS FOR THE FIRST HALF OF 2022
24
STATEMENTS OF CHANGES IN EQUITY FOR THE FIRST HALF OF 2022
25
NOTES TO THE FINANCIAL STATEMENTS
26
ABOUT GENMAB
34
DIRECTORS’ AND MANAGEMENT’S STATEMENT ON THE INTERIM REPORT
35
Interim Report for the First Half of 2022
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 41
Kalvebod Brygge 43
Fax: +45 7020 2729
Page 4/35
1560 Copenhagen V, Denmark
www.genmab.com
CVR no. 2102 3884
CONSOLIDATED KEY FIGURES
2nd Quarter of
2nd Quarter of
6 Months Ended
6 Months Ended
Full Year
2022
2021
June 30, 2022
June 30, 2021
2021
(DKK million)
Income Statement
Revenue
3,162
1,972
5,281
3,553
8,482
Research and development expenses
(1,282)
(921)
(2,435)
(1,769)
(4,181)
Selling, general and administrative expenses
(633)
(264)
(1,085)
(465)
(1,283)
Operating expenses
(1,915)
(1,185)
(3,520)
(2,234)
(5,464)
Operating profit
1,247
787
1,761
1,319
3,018
Net financial items
1,242
(365)
1,340
527
965
Net profit
1,891
306
2,356
1,402
3,008
Balance Sheet
Marketable securities
11,799
8,398
11,799
8,398
10,381
Cash and cash equivalents
9,816
9,477
9,816
9,477
8,957
Total non-current assets
1,985
2,179
1,985
2,179
1,891
Total assets
27,476
22,483
27,476
22,483
24,627
Shareholders' equity
24,482
20,252
24,482
20,252
22,196
Share capital
66
66
66
66
66
Cash Flow Statement
Cash flow from operating activities
959
355
1,546
1,540
2,228
Cash flow from investing activities
(576)
1,545
(1,243)
966
(961)
Cash flow from financing activities
(214)
(240)
(278)
(460)
(420)
Investment in tangible assets
(68)
(79)
(125)
(107)
(252)
Financial Ratios and Other Information
Basic net profit per share
28.87
4.68
35.97
21.44
46.00
Diluted net profit per share
28.66
4.64
35.71
21.25
45.54
Period-end share market price
2,297
2,566
2,297
2,566
2,630
Price / book value
6.19
8.36
6.19
8.36
7.82
Shareholders' equity per share
370.94
306.85
370.94
306.85
336.30
Equity ratio
89
%
90
%
89
%
90
%
90
%
Shares outstanding
65,753,443
65,620,740
65,753,443
65,620,740
65,718,456
Average number of employees (FTE*)
Number of employees (FTE) at the end of the period
1,445
1,029
1,445
1,029
1,212
* Full-time equivalent or team members
Interim Report for the First Half of 2022
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 41
Kalvebod Brygge 43
Fax: +45 7020 2729
Page 5/35
1560 Copenhagen V, Denmark
www.genmab.com
CVR no. 2102 3884
OUTLOOK
Revised
Previous
(DKK million)
Guidance
Guidance
Revenue
12,000 - 13,000
11,000 - 12,000
Operating expenses
(7,600) - (8,200)
(7,200) - (7,800)
Operating profit
3,800 - 5,400
3,200 - 4,800
Genmab is raising its 2022 financial guidance published on May 11, 2022, driven primarily by increased
royalty revenue due to higher net sales of DARZALEX and the foreign exchange impact of the strong US
Dollar.
R
evenue
Genmab expects its 2022 revenue to be in the range of DKK 12,000 – 13,000 million, an increase to the
previous guidance of DKK 11,000 – 12,000 million, driven primarily by the expected continued strong
growth of DARZALEX net sales as well as the positive impact of the strong US Dollar. Genmab’s
projected revenue for 2022 primarily consists of DARZALEX royalties of DKK 8,800 – 9,300 million
compared to the previous guidance of DKK 8,000 – 8,500 million. Such royalties are based on Genmab’s
revised estimate of DARZALEX 2022 net sales of USD 7.8 – 8.2 billion compared to the previous
guidance of USD 7.5 – 8.0 billion. DARZALEX royalties are partly offset by Genmab’s share of Janssen’s
royalty payments to Halozyme in connection with subcutaneous (SC) net sales. The remainder of
Genmab’s revenue primarily consists of royalties from TEPEZZA, Kesimpta and RYBREVANT
®
,
reimbursement revenue, milestones for epcoritamab, teclistamab and other milestones as well as
collaboration revenue with Seagen for Tivdak.
O
perating Expenses
Genmab anticipates its 2022 operating expenses to be in the range of DKK 7,600 – 8,200 million, an
increase to the previous guidance of DKK 7,200 – 7,800 million, driven by increased investment related to
pipeline progression and epcoritamab launch readiness activities as well as the negative impact of the
strong US Dollar. Operating expenses continue to be driven by the advancement of Genmab’s clinical
programs, continued investment in research and development, as well as building Genmab’s commercial
organization and broader organizational infrastructure.
Operating Profit
Genmab now expects its 2022 operating profit to be in the range of DKK 3,800 – 5,400 million, an
increase to the previous guidance of DKK 3,200 – 4,800 million, driven primarily by the items described
above.
O
utlook: 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, Kesimpta, TEPEZZA
and RYBREVANT net sales and royalties paid to Genmab; and currency exchange rates (the 2022
guidance assumes a USD / DKK exchange rate of 6.8 compared to 6.4 in the previous guidance). The
financial guidance assumes that no significant new agreements are entered into during the remainder of
2022 that could materially affect the results. Refer to the section “Significant Risks and Uncertainties” in
this interim report. Additionally, depending on trends related to the coronavirus and future variants, the
Interim Report for the First Half of 2022
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 41
Kalvebod Brygge 43
Fax: +45 7020 2729
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1560 Copenhagen V, Denmark
www.genmab.com
CVR no. 2102 3884
COVID-19 pandemic could potentially have a material adverse impact on Genmab’s business and
financial performance, including clinical trials, projected regulatory approval timelines, supply chain and
revenues, and cause Genmab’s actual results to differ materially from 2022 Guidance and Key 2022
Priorities in this interim report.
S
hould the global outbreak of COVID-19 persist, it may have long-term impacts on the development,
regulatory approval and commercialization of Genmab’s investigational medicines and on net sales of
approved medicines created by Genmab and developed and marketed by Genmab or Genmab’s
collaboration partners. As the pandemic continues, there may be an impact on Genmab’s business.
Genmab has an established COVID-19 response team, led by the CEO, that closely monitors the
evolving situation, maintains precautionary measures to help limit the impact of COVID-19 at the
workplace and on our communities, and ensures business continuity. The full extent and nature of the
impact of the COVID-19 pandemic and related containment measures on Genmab’s business and
financial performance is uncertain as the situation continues. 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
on net sales of DARZALEX, Kesimpta, TEPEZZA and RYBREVANT by Genmab’s partners and on
Genmab’s royalty and milestone revenue therefrom.
KEY 2022 PRIORITIES
Priority
Targeted Milestones
Broad and rapid
development of late-stage
clinical pipeline and further
build US country
organization
Epcoritamab
1
• Expand clinical development program with multiple Phase
3 t
rials initiated and submission of first BLA (subject to
supportive FDA feedback)
Tivdak
2
• Establish Tivdak as a clear choice for 2L+ r/m Cervical
Cancer patients
• Broaden clinical development program including Phase 2
evaluation of combination therapy in earlier line treatment
for cervical cancer and other solid tumors
Growth and development of
differentiated early-stage
product candidates
DuoBody
®
-PD-L1x4-1BB
3
& DuoBody-CD40x4-1BB
3
• Data from clinical expansion cohorts to progress to next
steps
Expand and advance proprietary clinical product portfolio
Further scale organization
aligned with growing product
portfolio and brand needs
Further scale organization aligned with differentiated antibody
product portfolio growth and future launches
Use solid financial base to grow and broaden antibody product
and technology portfolio
1. Co-development w/ AbbVie; 2. Co-development w/ Seagen Inc. (Seagen); 3. Co-development w/ BioNTech SE (BioNTech)
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST HALF OF 2022
A
t the end of the first six months of 2022, Genmab’s proprietary pipeline of investigational medicines,
where we are responsible for at least 50% of development, consisted of seven antibody products in
Interim Report for the First Half of 2022
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 41
Kalvebod Brygge 43
Fax: +45 7020 2729
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1560 Copenhagen V, Denmark
www.genmab.com
CVR no. 2102 3884
clinical development. These include Genmab’s first U.S. FDA approved medicine, Tivdak, which Genmab
is co-developing and co-promoting in the U.S. with Seagen. In addition to our own pipeline, there are
multiple investigational medicines in development by global pharmaceutical and biotechnology
companies, including four approved medicines powered by Genmab’s technology and innovations.
Beyond the investigational medicines in clinical development, our pipeline also includes multiple
preclinical programs. An overview of the development status of each of our investigational medicines is
provided in the following sections, including updates for the second quarter of 2022. For events that
occurred during the first quarter of 2022, please refer to Genmab’s Q1 2022
r
eport. 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 stock exchange and may
also be found in Genmab’s filings with the U.S. Securities and Exchange Commission (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 Investigational Medicines
1
in Development
1
Investigational medicines where Genmab has ≥50% ownership. Certain investigational medicines in co-development,
partners as indicated
2
See U.S. prescribing information for precise indication and safety information
3
AbbVie has decided to discontinue co-development of DuoHexaBody-CD37. Upon expiry of the notice period, Genmab
will become solely responsible for the further development of DuoHexaBody-CD37 against low-single digit royalty
payments to AbbVie, up to an agreed maximum total royalty amount, based on future potential sales of the product.
4
Genmab is developing HexaBody-CD38 in an exclusive worldwide license and option agreement with Janssen
Interim Report for the First Half of 2022
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 41
Kalvebod Brygge 43
Fax: +45 7020 2729
Page 8/35
1560 Copenhagen V, Denmark
www.genmab.com
CVR no. 2102 3884
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 tissue factor (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 Tivdak, 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) Phase 2 single-
arm clinical study evaluating tisotumab vedotin as monotherapy in patients with previously treate
d
r
ecurrent or metastatic cervical cancer
• In addition to a Phase 3 study in recurrent or metastatic cervical cancer, multiple Phase 2 clinical
studies in other solid tumors are ongoing
• Co-developed globally and co-promoted in the U.S. in collaboration with Seagen
Ti
vdak 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 to generate the TF antibody forming part of Tivdak. 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. Tivdak 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 cost and profit split. In any 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 on the worldwide development and
commercialization strategy for Tivdak. The companies have a broad clinical development program for
Tivdak, including a confirmatory Phase 3 study in recurrent or metastatic cervical cancer.
Please consult the U.S. Prescribing Information
f
or Tivdak for the labeled indication and safety
information, including the boxed warning.
Second Quarter 2022 Upd
ate
• June: Genmab and Seagen presented multiple tisotumab vedotin abstracts at the Americ
an
S
ociety of Clinical Oncology (ASCO) Annual Meeting, including interim data from the Phase 1b/
2
i
nnovaTV 205 (NCT03786081) study of tisotumab vedotin, which was presented during an oral
session. The ongoing innovaTV 205 study is evaluating tisotumab vedotin as monotherapy and i
n
combination with other agents in recurrent or metastatic cervical cancer.
E
pcoritamab (DuoBody-CD3xCD20) – Potential Best-in-class Investigational Medicine
• B
ispecific antibody-based investigational medicine created with Genmab’s DuoBody technology
platform
• Multiple ongoing clinical studies across different settings and histologies, including a Phas
e 3
s
tudy in relapsed/refractory diffuse large B-cell lymphoma (DLBCL) with more studies in planning
• BLA submission to the U.S. FDA for SC epcoritamab for the treatment of patients with
relapsed/refractory LBCL planned in second half of 2022
• Co-developed in collaboration with AbbVie
Interim Report for the First Half of 2022
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 41
Kalvebod Brygge 43
Fax: +45 7020 2729
Page 9/35
1560 Copenhagen V, Denmark
www.genmab.com
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 well-validated target on
malignant B-cells. Genmab used technology licensed from Medarex to generate the CD20 antibody
forming part of epcoritamab. Epcoritamab is being co-developed by Genmab and AbbVie. The first Phase
3 clinical study (NCT04628494) of epcoritamab in relapsed/refractory DLBCL is ongoing. In addition,
Phase 1/2 clinical studies in B-cell non-Hodgkin lymphoma (B-NHL) including chronic lymphocytic
leukemia (NCT04623541) and in combination with standard of care therapies for B-NHL (NCT04663347)
are ongoing. Also currently recruiting are a Phase 2 study of epcoritamab in combination with anti-
neoplastic patients in adults with NHL (NCT05283720), a Phase 1 study of epcoritamab in pediatric
patients with relapsed/refractory aggressive mature B-cell neoplasms (NCT05206357) and a Phase 1
study of epcoritamab either as monotherapy or in combination with standard of care therapies in adult
patients with B-NHL in China (NCT05201248). The combination of epcoritamab and DuoHexaBody
®
-
CD37 (GEN3009) is also being explored in an arm of a Phase 1/2 clinical study (NCT04358458) of
DuoHexaBody-CD37 in hematologic malignancies.
S
econd Quarter 2022 Updates
• June: Genmab announced its intent to submit a BLA to the U.S. FDA for SC epcoritamab for the
treatment of patients with relapsed/refractory LBCL in the second half of 2022.
• June: Genmab and AbbVie presented multiple epcoritamab abstracts at both the ASCO Annual
Meeting and the 27
th
Annual Meeting of the European Hematology Association (EHA). Data from
the first cohort of the Phase 1/2 EPCORE NHL-1 (NCT03625037) trial of epcoritamab in
r
elapsed/refractory LBCL was presented as a late-breaking oral presentation during the
Presidential Symposium at EHA.
• April: Genmab and AbbVie announced topline results from the first cohort of the Phase 1/
2
EPC
ORE NHL-1 trial of epcoritamab in relapsed/refractory LBCL. The study cohort included 1
57
patients with relapsed/refractory LBCL who received at least two prior lines of systemic therapy,
including 38.9% who received prior treatment with chimeric antigen receptor (CAR) T-ce
ll
t
herapy. The topline results from this cohort demonstrated an overall response rate (ORR) of
63.1% as confirmed by an independent review committee (IRC), which exceeded the protocol
prespecified threshold for efficacy. The observed median duration of response (DOR) was
12
mont
hs. The most common treatment-emergent adverse event was cytokine release syndrome
(CRS) with 49.7%, including 2.5% grade 3. Based on the topline results, the companies will
engage global regulatory authorities to determine next steps.
D
uoBody-PD-L1x4-1BB (GEN1046) – Bispecific Next Generation Checkpoint Immunotherapy
• B
ispecific antibody-based investigational medicine created with Genmab’s DuoBody technology
platform
• C
linical studies in solid tumors ongoing, including a Phase 2 study in non-small cell lung cancer
(NSCLC)
• Co-developed in collaboration with BioNTech
DuoBody-PD-L1x4-1BB (GEN1046) 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
DuoBody-PD-L1x4-1BB on a 50:50 basis. DuoBody-PD-L1x4-1BB 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 studies in solid tumors are ongoing including a
Interim Report for the First Half of 2022
Genmab A/S
Tel: +45 7020 2728
Company Announcement no. 41
Kalvebod Brygge 43
Fax: +45 7020 2729
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1560 Copenhagen V, Denmark
www.genmab.com
CVR no. 2102 3884
Phase 2 study of DuoBody-PD-L1x4-1BB as monotherapy or in combination with pembrolizumab in
patients with recurrent metastatic NSCLC (NCT05117242).
D
uoBody-CD40x4-1BB (GEN1042) – Potential First-in-Class Bispecific Agonistic Antibody
• B
ispecific antibody-based investigational medicine created with Genmab’s DuoBody technology
platform
• Phase 1/2 clinical study in solid tumors ongoi
ng
• Co-dev
eloped in collaboration with BioNTech
DuoBody-CD40x4-1BB (GEN1042) 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
DuoBody-CD40x4-1BB 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. A Phase 1/2
clinical study of DuoBody-CD40x4-1BB in solid tumors is ongoing (NCT04083599).
D
uoHexaBody-CD37 (GEN3009) – First DuoHexaBody Program in the Clinic
• Antibody-based investigational medicine created with Genmab’s DuoHexaBody technology
platform
• Phase 1/2 clinical study in hematologic malignancies ongoing
D
uoHexaBody-CD37 (GEN3009) 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. A Phase 1/2 clinical study (NCT04358458) in hematologic malignancies, including an
arm in combination with epcoritamab, is ongoing.
S
econd Quarter 2022 Update
• June: AbbVie has decided to discontinue co-development of DuoHexaBody-CD37. Upon expiry of
the notice period, Genmab will become solely responsible for the further development of
DuoHexaBody-CD37 against low-single digit royalty payments to AbbVie, up to an agreed
max
imum total royalty amount, based on future potential sales of the product.
H
exaBody-CD38 (GEN3014) – HexaBody Molecule with Potential in Hematological Malignancies
• Antibody-based investigational medicine created with Genmab’s HexaBody technology platform
• Phase 1/2 clinical study in hematological malignancies ongoing
• Developed in an exclusive worldwide license and option agreement with Janssen
H
exaBody-CD38 (GEN3014) is a human CD38 monoclonal antibody-based investigational medicine
created using Genmab’s HexaBody technology platform. In preclinical models of hematological
malignancies HexaBody-CD38 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 HexaBody-CD38. A Phase 1/2 clinical
study (NCT04824794) in hematologic malignancies is ongoing.
Interim Report for the First Half of 2022
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CVR no. 2102 3884
DuoBody-CD3xB7H4 (GEN1047) – Most Recent Investigational Medicine in the Clinic
• Bispecific antibody-based investigational medicine created with Genmab’s DuoBody technology
platform
• Phase 1/2 clinical study in malignant solid tumors ongoing
DuoBody-CD3xB7H4 (GEN1047) 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 preclinical studies, DuoBody-
CD3xB7H4 induced T-cell mediated cytotoxicity of B7H4-positive tumor cells. DuoBody-CD3xB7H4 is
being developed for the potential treatment of solid cancer indications known to express B7H4. A Phase
1/2 clinical study (NCT05180474) of DuoBody-CD3xB7H4 in malignant solid tumors is ongoing.
P
roducts Powered by Genmab’s Technology and Innovations
I
n 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
*
See local country prescribing information for precise indications and safety information
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Genmab A/S
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CVR no. 2102 3884
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 Gen
mab
• Intravenous (IV) formulation approved in combination with other therapies for frontline and for
relapsed/refractory multiple myeloma in territories including the U.S., Europe and Japan and as
monotherapy for heavily pretreated or double-refractory multiple myeloma in territories includin
g
t
he U.S. and Europe
• First and only SC CD38-directed antibody approved in territories including the U.S., Europe a
nd
J
apan 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 light-chain (AL) amyloidosis in th
e
U
.S., Europe and Japan
• Net sales of DARZALEX by Janssen were USD 3,842 million in the first six months of 2022
D
ARZALEX 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 forming
part of daratumumab. Daratumumab is being developed by Janssen under an exclusive worldwide
license from Genmab to develop, manufacture and commercialize daratumumab. Under the terms of the
agreement, Genmab is entitled to double digit royalties between 12% and 20% with Janssen reducing its
royalty payments for Genmab’s share of Janssen’s royalty payments made to Halozyme Therapeutics,
Inc. (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.
P
lease consult the European Summary of Product Characteristics
f
or DARZALEX and DARZALEX SC
and the U.S. Prescribing Information for DARZALEX and DARZALEX FASPRO for the labeled indication
and safety information.
K
esimpta (ofatumumab) – Approved in treatment of relapsing forms of multiple sclerosis (RMS)
• Human CD20 monoclonal antibody developed and commercialized by Novartis under a licens
e
agr
eement 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
K
esimpta 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 forming part of Kesimpta. 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-cel
l
therapy that can be self-administered by patients at home using the Sensoready autoinjector pen, once
mont
hly after starting therapy. Kesimpta is being developed and marketed worldwide by Novartis under a
license agreement between Genmab and Novartis. Under the terms of the agreement, Genmab is entitled
to 10% royalties on net sales of Kesimpta.
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CVR no. 2102 3884
Please consult the U.S. Prescribing Information and the European Summary of Product Characteristics
for the labeled indication and safety information for Kesimpta.
T
EPEZZA (teprotumumab-trbw) – First U.S. FDA-approved medicine for the treatment of thyroid
eye disease (TED)
• Developed and commercialized by Horizon Therapeutics, plc (Horizon) 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, 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 well-validated target. Genmab
used technology licensed from Medarex to generate the IGF-1R antibody forming part of teprotumumab.
The antibody was created by Genmab under a collaboration with Roche and development and
commercialization of the product is now being conducted by Horizon under a sublicense from Roche.
Under the terms of Genmab’s agreement with Roche, Genmab will receive mid-single digit royalties on
net sales of TEPEZZA.
P
lease consult the U.S. Prescribing Information
f
or the labeled indication and safety information for
TEPEZZA.
RYBREVANT (amivantamab-vmjw) – 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 platform
• Under the agreement with Janssen, Genmab will receive milestones and royalties on net sales of
RYBREVANT
I
n July 2012, Genmab entered into a collaboration with Janssen to create and develop bispecific
antibodies using Genmab’s DuoBody technology platform. The most advanced of these,
Janssen’s RYBREVANT, is a fully human bispecific antibody that targets epidermal growth factor
receptor (EGFR) and Met, two validated cancer targets. The two antibody libraries used to
produce amivantamab were both generated 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 RYBREVANT for
the treatment of certain adult patients with NSCLC with EGFR exon 20 insertion mutations. These
are the first regulatory approvals for a therapy that was created using Genmab’s proprietary
DuoBody bispecific technology platform. Under our agreement with Janssen, Genmab will receive
milestones and 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.
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CVR no. 2102 3884
Clinical Stage Investigational Medicines, >Phase 2 Development
*
UltiMAb
transgenic mouse technology licensed from Medarex, Inc., a wholly owned subsidiary of Bristol Myers Squibb.
Preclinical Programs
• Broad preclinical pipeline that includes both partnered products and in-house programs based on
our
proprietary technologies or antibodies
• Multiple new Investigational New Drug (IND) applications expected to be submitted over coming
years
• Genmab has entered multiple strategic collaborations to support the expansion of our innovative
pipeline
O
ur preclinical 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 preclinical programs are carried out in cooperation with our collaboration partners.
S
econd Quarter 2022 Update
• May: IND application and first Clinical Trial Application (CTA) submitted for HexaBody-CD27
(GEN1053/BNT313). GEN1053 is being co-developed in collaboration with BioNTech under a
n
agr
eement in which the companies share all costs and future potential profits for GEN1053 on a
50:50 basis.
S
IGNIFICANT 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
2021 Annual Report filed with NASDAQ Copenhagen and the Form 20-F filed with the U.S. SEC, both of
which were filed in February 2022. 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; however, the full extent
and nature of the impact of the COVID-19 pandemic and related containment measures on our business
and financial performance is uncertain. See Genmab’s Form 20-F for a detailed summary of risks related
to our collaborations as well as risks related to the COVID-19 pandemic.
Interim Report for the First Half of 2022
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CVR no. 2102 3884
FINANCIAL REVIEW
The interim report is prepared on a consolidated basis for the Genmab group. The financial statements
are published in Danish Kroner (DKK).
Revenue
Genmab’s revenue was DKK 5,281 million for the first six months of 2022 compared to DKK 3,553 million
for the first six months of 2021. The increase of DKK 1,728 million, or 49%, was primarily driven by higher
DARZALEX, TEPEZZA and Kesimpta royalties achieved under our collaborations with Janssen, Roche
and Novartis, respectively, partly offset by milestones achieved under our collaborations with Janssen
and AbbVie in the first six months of 2021.
(DKK million)
6 Months Ended
June 30, 2022
6 Months Ended
June 30, 2021
Royalties
4,727
2,595
Reimbursement revenue
287
227
Milestone revenue
176
731
Collaboration revenue
91
—
Total revenue
5,281
3,553
Royalties
Royalty revenue amounted to DKK 4,727 million in the first six months of 2022 compared to DKK 2,595
million in the first six months of 2021. The increase of DKK 2,132 million, or 82%, was primarily driven by
higher DARZALEX, TEPEZZA and Kesimpta royalties achieved under our daratumumab collaboration
with Janssen, teprotumumab collaboration with Roche and ofatumumab collaboration with Novartis,
respectively. The table below summarizes Genmab’s royalty revenue by product.
(DKK million)
6 Months Ended
June 30, 2022
6 Months Ended
June 30, 2021
DARZALEX
4,024
2,360
TEPEZZA
390
162
Kesimpta
296
72
Other
17
1
Total royalties
4,727
2,595
N
et sales of DARZALEX by Janssen were USD 3,842 million in the first six months of 2022 compared to
USD 2,798 million in the first six months of 2021. The increase of USD 1,044 million, or 37%, was driven
by the continued strong uptake of DARZALEX. Royalty revenue on net sales of DARZALEX
was DKK
4,024 million in the first six months of 2022 compared to DKK 2,360 million in the first six months of 2021,
an increase of DKK 1,664 million. The percentage increase in royalties of 71% is higher than the
percentage increase in the underlying net sales primarily due to the higher average exchange rate
between the USD and DKK and a higher effective royalty rate for the first six months of 2022, partly offset
by the increase in Genmab’s share of Janssen’s royalty payments to Halozyme in connection with SC net
sales.
N
et sales of TEPEZZA by Horizon were USD 981 million in the first six months of 2022 compared to USD
455 million in the first six months of 2021. TEPEZZA net sales in the first quarter of 2021 were negatively
impacted by the U.S. government-mandated COVID-19 production interruption. Royalty revenue on net
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CVR no. 2102 3884
sales of TEPEZZA was DKK 390 million in the first six months of 2022 compared to DKK 162 million in
the first six months of 2021, an increase of DKK 228 million.
N
et sales of Kesimpta by Novartis were USD 434 million in the first six months of 2022 compared to USD
116 million in the first six months of 2021. The increase of USD 318 million was driven by US launch
momentum due to strong access and increased demand. Royalty revenue on net sales of Kesimpta was
DKK 296 million in the first six months of 2022 compared to DKK 72 million in the first six months of 2021,
an increase of DKK 224 million.
J
anssen was granted U.S. FDA approval for RYBREVANT during the second quarter of 2021, and
Genmab subsequently started recognizing royalties on net sales of RYBREVANT. Royalties were not
material for the first six months of 2022 or 2021.
Royalty revenue fluctuations from period to period are due primarily to the level of product net sales,
foreign currency exchange rates and more specifically to DARZALEX, Genmab’s share of Janssen’s
royalty payments to Halozyme in connection with SC sales.
R
eimbursement Revenue
Reimbursement revenue amounted to DKK 287 million in the first six months of 2022 compared to DKK
227 million in the first six months of 2021. The increase of DKK 60 million, or 26%, was primarily driven by
higher activities under our collaboration agreement with BioNTech for DuoBody-CD40x4-1BB.
Milestone Revenue
Milestone revenue was DKK 176 million in the first six months of 2022 compared to DKK 731 million in
the first six months of 2021, a decrease of DKK 555 million, or 76%, primarily driven by milestones
achieved in the first six months of 2021 under our Janssen and AbbVie collaborations.
Mi
lestone 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.
C
ollaboration Revenue
In September 2021, Genmab and Seagen announced U.S. FDA accelerated approval for Tivdak in
previously treated recurrent or metastatic cervical cancer. Collaboration revenue was DKK 91 million for
the first six months of 2022.
Refer to Financial Statement Note 2 in this interim report for further details about revenue.
R
esearch and Development Expenses
Research and development expenses amounted to DKK 2,435 million in the first six months of 2022
compared to DKK 1,769 million in the first six months of 2021. The increase of DKK 666 million, or 38%,
was driven by the continued advancement of epcoritamab under our collaboration with AbbVie, continued
advancement of DuoBody-CD40x4-1BB under our collaboration with BioNTech, and the increase in new
team members to support the expansion of our product pipeline.
Research and development expenses accounted for 69% of total operating expenses in the first six
months of 2022 compared to 79% in the first six months of 2021.
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CVR no. 2102 3884
Selling, General and Administrative Expenses
Selling, general and administrative expenses were DKK 1,085 million in the first six months of 2022
compared to DKK 465 million in the first six months of 2021. The increase of DKK 620 million, or 133%,
was driven by the increase in new team members to support Tivdak post launch, continued expansion of
Genmab’s commercialization capabilities in support of future launches, and investment in broader
organizational infrastructure, including our technology portfolio.
Selling, general and administrative expenses accounted for 31% of total operating expenses in the first
six months of 2022 compared to 21% in the first six months of 2021.
O
perating Profit
Operating profit was DKK 1,761 million in the first six months of 2022 compared to DKK 1,319 million in
the first six months of 2021.
Net Financial Items
N
et financial items were comprised of the following:
6 Months Ended
6 Months Ended
(DKK million)
June 30, 2022
June 30, 2021
Interest and other financial income
87
127
Foreign exchange rate gain, net
1,792
573
Total financial income
1,879
700
Interest and other financial expenses
(10)
(6)
Loss on marketable securities, net
(315)
(134)
Loss on other investments, net
(214)
(33)
Total financial expenses
(539)
(173)
Net financial items
1,340
527
N
et financial items increased by DKK 813 million, which were primarily driven by:
• I
ncrease in foreign exchange rate gain, net due to the USD strengthening against the DKK whic
h
was more favorable to our marketable securities, and cash and cash equivalents in the first six
months of 2022,
• Loss on marketable securities driven by increases in interest rates in the United States an
d
E
urope, and
• Loss on other investments due to the decrease in fair value of Genmab’s investments in common
shares of CureVac and Bolt.
R
efer to Financial Statement Note 4 in this interim report for further details about the net financial items.
Corporate Tax
Corporate tax expense for the first six months of 2022 was DKK 745 million compared to DKK 444 million
for the first six months of 2021. The increase in corporate tax expense is primarily the result of Genmab’s
higher net result before tax. The effective tax rate in the first six months of 2022 and 2021 was 24%.
Interim Report for the First Half of 2022
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CVR no. 2102 3884
Net Profit
Net profit for the first six months of 2022 was DKK 2,356 million compared to DKK 1,402 million in the first
six months of 2021. The increase was driven by the items described above.
Liquidity and Capital Resources
(DKK million)
June 30, 2022
December 31, 2021
Marketable securities
11,799
10,381
Cash and cash equivalents
9,816
8,957
Shareholders' equity
24,482
22,196
Cash Flow (DKK million)
6 Months Ended
June 30, 2022
6 Months Ended
June 30, 2021
Cash provided by operating activities
1,546
1,540
Cash (used in) / provided by investing activities
(1,243)
966
Cash (used in) financing activities
(278)
(460)
Exchange rate adjustments
834
171
N
et 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 was in line with the first six months of 2021 primarily driven by an
increase in operating profit of DKK 442 million offset by the timing of corporate tax payments of DKK 455
million in Denmark in the first six months of 2022 that were not required in the first six months of 2021.
Net cash (used in) / provided by 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 assets. Purchases of marketable securities exceeded sales and maturities in the
first six months of 2022, whereas sales and maturities of marketable securities exceeded purchases in
the first six months of 2021. For the first six months of 2021, investing activities also include the proceeds
from the sale of CureVac shares of DKK 438 million. There were no sales of other investments in the first
six months of 2022.
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 cash used in financing activities for the periods is
primarily driven by cash payments for the purchase of treasury shares of DKK 437 million in the first six
months of 2021 which were more significant than the cash payments for the purchase of treasury shares
in the first six months of 2022 of DKK 211 million.
E
xchange rate adjustments represent foreign currency gains or losses on Genmab’s cash and cash
equivalents, primarily driven by our cash and cash equivalents holdings denominated in USD. The
increase in exchange rate adjustments results from the USD strengthening against the DKK to a much
greater extent in the first six months of 2022 compared to the first six months of 2021.
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CVR no. 2102 3884
Genmab’s USD denominated cash and cash equivalents, and marketable securities represented 87% of
Genmab’s total cash and cash equivalents, and marketable securities as of June 30, 2022 compared to
86% as of December 31, 2021.
Cash and cash equivalents included short-term marketable securities of DKK 1,006 million as of June 30,
2022 compared to DKK 296 million as of December 31, 2021. 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.
Balance Sheet
As of June 30, 2022, total assets were DKK 27,476 million compared to DKK 24,627 million on December
31, 2021. As of June 30, 2022, assets were mainly comprised of marketable securities of DKK 11,799
million, cash and cash equivalents of DKK 9,816 million and current receivables of DKK 3,876 million.
The current receivables consist primarily of amounts related to royalties from our collaboration
agreements.
As of June 30, 2022, total liabilities were DKK 2,994 million compared to DKK 2,431 million on December
31, 2021. The increase in total liabilities of DKK 563 million, or 23%, was primarily driven by the increase
in corporate tax payable due to Genmab’s net result before tax and timing of estimated tax payments, and
lease liabilities related to the commencement of leases in the Netherlands with respect to office and
laboratory space.
Shareholders’ equity as of June 30, 2022 was DKK 24,482 million compared to DKK 22,196 million on
December 31, 2021. The increase of DKK 2,286 million, or 10%, was driven primarily by Genmab’s net
profit and share-based compensation expense related to the issuance of shares under Genmab’s warrant
and RSU programs, partly offset by the purchase of treasury shares during the period. Genmab’s equity
ratio was 89% as of June 30, 2022 compared to 90% as of December 31, 2021.
T
eam Members
As of June 30, 2022, the total number of team members was 1,445 compared to 1,029 as of June 30,
2021. 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 Tivdak
post launch and future launches, and broader organizational infrastructure.
Team Members
June 30, 2022
June 30, 2021
Research and development team members
1,050
793
Selling, general and administrative team members
395
236
Total team members
1,445
1,029
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. Under the license agreement, Genmab is, among
other things, entitled to royalties from Janssen on net sales of daratumumab (marketed as DARZALEX for
IV administration and as DARZALEX FASPRO in the United States and as DARZALEX SC in Europe for
SC administration). In April 2022, the arbitral tribunal issued an award in the binding arbitration of the two
matters. Genmab did not seek a review of the award, and the award is now final.
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CVR no. 2102 3884
The first matter concerned the question as to whether Janssen’s obligation to pay royalties on net sales of
licensed product extends, in each applicable country, until the expiration or invalidation of the last-to-
expire relevant Genmab-owned patent or the last-to-expire relevant Janssen-owned patent covering the
product, as further defined and described in the license agreement. As to that matter, the tribunal
determined by majority opinion that Janssen’s obligation to pay royalties to Genmab on net sales of
licensed product, in each applicable country, extends through the expiration or invalidation of the last-to-
expire relevant Genmab-owned patent covering the product or use thereof, but not the relevant Janssen-
owned patent. The relevant Genmab-owned issued U.S., European and Japanese patents will expire in
the late 2020s and early 2030s.
T
he second matter concerned the question as to whether Genmab is required to share in Janssen’s
royalty payments to Halozyme for the Halozyme enzyme technology used in the SC formulation of
daratumumab (marketed as DARZALEX FASPRO in the U.S.). The royalties Janssen pays to Halozyme
represent a mid-single digit percentage rate of SC daratumumab net sales. As to that matter, the tribunal
ruled by majority opinion that Janssen is permitted to continue reducing its royalty payments to Genmab
as an offset against a share of Janssen’s royalty payments made to Halozyme.
O
n June 9, 2022, Genmab announced the commencement of a new arbitration under the daratumumab
license agreement with Janssen. This new arbitration follows 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 SC formulation of daratumumab.
The tribunal based its ruling on the finding that DARZALEX FASPRO constitutes a new licensed product
under the license agreement.
In this new arbitration, Genmab is consequently seeking an award of USD 405 million plus interest in
accrued milestone payments for DARZALEX FASPRO and a declaration that it is entitled to a new 13-
year royalty term from the date of DARZALEX FASPRO’s first commercial sale. See Company
Announcement no. 21.
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CVR no. 2102 3884
STATEMENTS OF COMPREHENSIVE INCOME FOR THE 2ND QUARTER OF 2022
Income Statement
2nd Quarter of
2nd Quarter of
2022
2021
(DKK million)
Revenue
Research and development expenses
(1,282 )
(921 )
Selling, general and administrative expenses
(633 )
(264 )
Operating expenses
(1,915 )
(1,185 )
Operating profit
Financial income
Financial expenses
(200 )
(430 )
Net profit before tax
Corporate tax
(598 )
(116 )
Net profit
Basic net profit per share
Diluted net profit per share
Statement of Comprehensive Income
Net profit
Other comprehensive income:
Amounts which will be re-classified to the income statement:
Adjustment of foreign currency fluctuations on subsidiaries
(13 )
Total comprehensive income
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STATEMENTS OF COMPREHENSIVE INCOME FOR THE FIRST HALF OF 2022
Income Statement
6 Months Ended
6 Months Ended
Note
June 30, 2022
June 30, 2021
(DKK million)
Revenue
2
Research and development expenses
(2,435 )
(1,769 )
Selling, general and administrative expenses
(1,085 )
(465 )
Operating expenses
(3,520 )
(2,234 )
Operating profit
Financial income
4
Financial expenses
4
(539 )
(173 )
Net profit before tax
Corporate tax
(745 )
(444 )
Net profit
Basic net profit per share
Diluted net profit per share
Statement of Comprehensive Income
Net profit
Other comprehensive income:
Amounts which will be re-classified to the income
statement:
Adjustment of foreign currency fluctuations on
subsidiaries
Total comprehensive income
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BALANCE SHEETS
June 30,
December 31,
Note
2022
2021
(DKK million)
ASSETS
Intangible assets
Property and equipment
Right-of-use assets
7
Receivables
Deferred tax assets
Other investments
3
Total non-current assets
Corporate tax receivable
Receivables
Marketable securities
3
Cash and cash equivalents
Total current assets
Total assets
SHAREHOLDERS’ EQUITY AND LIABILITIES
Share capital
Share premium
Other reserves
Retained earnings
Total shareholders' equity
Provisions
Lease liabilities
7
Deferred revenue
Other payables
Total non-current liabilities
Provisions
Corporate tax payable
Lease liabilities
7
Deferred revenue
Other payables
Total current liabilities
Total liabilities
Total shareholders' equity and liabilities
Share-based instruments
5
Related parties
6
Subsequent events to the balance sheet date
8
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STATEMENTS OF CASH FLOWS
6 Months Ended
6 Months Ended
Note
June 30, 2022
June 30, 2021
(DKK million)
Net profit before tax
Reversal of financial items, net
(1,340 )
(527 )
Adjustments for non-cash transactions
Changes in operating assets and liabilities
(179 )
(105 )
Cash flows from operating activities before financial items
Interest received
Interest elements of lease payments
7
(7 )
(6 )
Interest paid
(1 )
Corporate taxes paid
(455 )
(2 )
Net cash provided by operating activities
Investment in tangible assets
(125 )
(107 )
Marketable securities bought
(4,061 )
(7,410 )
Marketable securities sold
Other investments bought
(22 )
(92 )
Other investments sold
Net cash (used in) / provided by investing activities
(1,243 )
Warrants exercised
Principal elements of lease payments
(30 )
(29 )
Purchase of treasury shares
(211 )
(437 )
Payment of withholding taxes on behalf of employees on net
settled RSUs
(71 )
(40 )
Net cash (used in) financing activities
(278 )
(460 )
Change in cash and cash equivalents
Cash and cash equivalents at the beginning of the period
Exchange rate adjustments
Cash and cash equivalents at the end of the period
Cash and cash equivalents include:
Bank deposits
Short-term marketable securities
Cash and cash equivalents at the end of the period
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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, 2020
Net profit
Other comprehensive income
Total comprehensive income
Transactions with owners:
Exercise of warrants
Purchase of treasury shares
(447 )
(447 )
Share-based compensation expenses
Net settlement of RSUs
(40 )
(40 )
Balance at June 30, 2021
Balance at December 31, 2021
Net profit
Other comprehensive income
Total comprehensive income
Transactions with owners:
Exercise of warrants
—
Purchase of treasury shares
—
—
—
(270 )
(270 )
Share-based compensation expenses
Net settlement of RSUs
(71 )
(71 )
Balance at June 30, 2022
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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.
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 2021 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.
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 the group’s financial
statements. For a description of significant judgements and estimates, refer to Note 1.3 in the Annual
Report.
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 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
T
he table below summarizes Genmab’s revenue by type and collaboration partner, and royalties by
product, under Genmab’s agreements.
6 Months Ended
6 Months Ended
June 30, 2022
June 30, 2021
(DKK million)
Revenue by type:
Royalties
4,727
2,595
Reimbursement revenue
287
227
Milestone revenue
176
731
Collaboration revenue
91
—
Total
5,281
3,553
Revenue by collaboration partner:
Janssen
4,206
2,846
AbbVie
—
245
Roche
390
162
Novartis
305
73
BioNTech
231
171
Seagen
138
56
Other
11
—
Total
5,281
3,553
Royalties by product:
DARZALEX
4,024
2,360
TEPEZZA
390
162
Kesimpta
296
72
Other
17
1
Total
4,727
2,595
In September 2020, Genmab commenced binding arbitration of two matters arising under its license
agreement with Janssen relating to daratumumab. Under the license agreement, Genmab is, among
other things, entitled to royalties from Janssen on net sales of daratumumab (marketed as DARZALEX for
IV administration and as DARZALEX FASPRO in the United States and as DARZALEX SC in Europe for
SC administration). In April 2022, the arbitral tribunal issued an award in the binding arbitration of the two
matters. Genmab did not seek a review of the award, and the award is now final.
T
he first matter concerned the question as to whether Janssen’s obligation to pay royalties on net sales of
licensed product extends, in each applicable country, until the expiration or invalidation of the last-to-
expire relevant Genmab-owned patent or the last-to-expire relevant Janssen-owned patent covering the
product, as further defined and described in the license agreement. As to that matter, the tribunal
determined by majority opinion that Janssen’s obligation to pay royalties to Genmab on net sales of
licensed product, in each applicable country, extends through the expiration or invalidation of the last-to-
expire relevant Genmab-owned patent covering the product or use thereof, but not the relevant Janssen-
owned patent. The relevant Genmab-owned issued U.S., European and Japanese patents will expire in
the late 2020s and early 2030s.
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The second matter concerned the question as to whether Genmab is required to share in Janssen’s
royalty payments to Halozyme for the Halozyme enzyme technology used in the SC formulation of
daratumumab (marketed as DARZALEX FASPRO in the U.S.). The royalties Janssen pays to Halozyme
represent a mid-single digit percentage rate of SC daratumumab net sales. As to that matter, the tribunal
ruled by majority opinion that Janssen is permitted to continue reducing its royalty payments to Genmab
as an offset against a share of Janssen’s royalty payments made to Halozyme.
Refer to Note 2.1 in the Annual Report for further details regarding revenue.
N
ote 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:
June 30,
December 31,
2022
2021
Percent
USD
79
%
75
%
DKK
13
%
16
%
EUR
7
%
8
%
GBP
1
%
1
%
Total
100
%
100
%
As
of June 30, 2022, 71% 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 compared to 68% as of December 31, 2021.
T
he table below shows the fair value measurements by level for Genmab’s financial assets measured at
fair value through profit or loss:
(DKK million)
June 30, 2022
December 31, 2021
Assets Measured at Fair Value
Level 1
Level 2
Level 3
Total
Level 1
Level 2
Level 3
Total
Marketable securities
11,799
—
—
11,799
10,381
—
—
10,381
Other investments
150
—
51
201
344
—
27
371
Mar
ketable 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).
Other Investments
Other investments as of June 30, 2022 consist primarily of a DKK 138 million investment in common
shares of CureVac, compared to DKK 318 million as of December 31, 2021. During the second quarter of
2021, Genmab made an investment in common shares of Bolt. As of June 30, 2022, the investment in
Bolt was valued at DKK 12 million, compared to DKK 26 million as of December 31, 2021.
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The investments in CureVac and Bolt are recorded at fair value through profit or loss. The fair value of
Genmab’s investments in CureVac and Bolt are determined using unadjusted quoted prices in
established markets (Level 1).
R
efer to Note 4.3 and Note 4.4 in the Annual Report for further details regarding Genmab’s marketable
securities and other investments.
Note 4 – Financial Income and Expenses
6 Months Ended
6 Months Ended
June 30, 2022
June 30, 2021
(DKK million)
Financial income:
Interest and other financial income
87
127
Foreign exchange rate gain, net
1,792
573
Total financial income
1,879
700
Financial expenses:
Interest and other financial expenses
(10)
(6)
Loss on marketable securities, net
(315)
(134)
Loss on other investments, net
(214)
(33)
Total financial expenses
(539)
(173)
Net financial items
1,340
527
F
oreign exchange rate gain, net was DKK 1,792 million in the first six months of 2022 compared to DKK
573 million in the first six months of 2021. The USD strengthened against the DKK in each period which
positively impacted our USD denominated marketable securities and cash holdings, but to a greater
extent in 2022. Refer to Note 4.2 in the Annual Report for further details regarding foreign currency risk.
Loss on marketable securities, net was DKK 315 million in the first six months of 2022 compared to DKK
134 million in the first six months of 2021. The increase in fair value losses on marketable securities was
primarily driven by increases in interest rates in the United States and Europe.
Loss on other investments, net was DKK 214 million in the first six months of 2022 compared to DKK 33
million in the first six months of 2021. The change was driven by the decrease in fair value of Genmab’s
investment in common shares of CureVac and Bolt.
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Note 5 – Share-Based Instruments
R
estricted Stock Unit Program
Genmab A/S established RSU programs as an incentive for all Genmab employees, members of the
registered Executive Management, and members of the Board of Directors.
6 Months Ended
6 Months Ended
June 30, 2022
June 30, 2021
RSUs granted
240,741
159,567
Weighted average fair value per RSU granted (DKK)
2,178.22
2,149.55
RSUs vested
82,001
49,012
R
efer to Note 4.6 in the Annual Report for details on the RSU programs.
Wa
rrant Program
Genmab A/S established warrant programs as an incentive for all Genmab employees, and members of
the registered Executive Management.
6 Months Ended
6 Months Ended
June 30, 2022
June 30, 2021
Warrants granted
230,112
147,568
Weighted average exercise price per warrant granted (DKK)
2,178.40
2,189.21
Weighted average Black-Scholes fair value per warrant granted (DKK)
629.05
683.79
Warrants exercised
34,987
74,992
Weighted average exercise price on date of grant per warrant exercised (DKK)
983.98
606.22
% change in share capital - warrants exercised
0.05%
0.11%
R
efer to Note 4.6 in the Annual Report for details on the warrant programs.
Sh
are-based compensation expense
Share-based compensation expenses related to Genmab RSU and warrant programs for the first
six months of 2022 was DKK 208 million compared to DKK 142 million for the first six months of
2021.
Share repurchases
In general, Genmab intends to purchase its own shares in order to cover a portion of obligations in
relation to RSUs. As of June 30, 2022, Genmab has two authorizations to repurchase shares: the 2021
and 2019 authorizations. The 2016 authorization expired in March 2021.
2021
Authorization
2019
Authorization
2016
Authorization
Number of shares authorized for repurchase
500,000
500,000
500,000
Actual shares repurchased under authorization
—
294,000
255,000
Shares available for repurchase as of June 30, 2022
500,000
206,000
—
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As announced on June 17, 2022, Genmab initiated a share buy-back program. During the first six months
of 2022, Genmab acquired 124,000 of its own shares, representing approximately 0.2% of share capital
as of December 31, 2021. The total amount paid to acquire the shares, including directly attributable
costs, was DKK 270 million and was recognized as a deduction to shareholders’ equity. During the first
six months of 2021, Genmab acquired 200,000 of its own shares, representing approximately 0.3% of
share capital as of December 31, 2020. The total amount paid to acquire the shares, including directly
attributable costs, was DKK 447 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 June 30, 2022.
A
s of June 30, 2022, 357,885 treasury shares were held by Genmab to cover obligations in relation to the
RSU programs and to mitigate the dilutive effect of share capital increases resulting from future exercises
of warrants.
Note 6 – Related Parties
G
enmab’s related parties are Genmab A/S’ (parent company) subsidiaries, Board of Directors, the
registered 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 registered Executive Management.
O
ther than the remuneration and other transactions relating to the Board of Directors and the registered
Executive Management described in Note 5.1 in the Annual Report, there were no material related party
transactions during the first six months of 2022.
C
hanges to the Executive Management Team and the Board of Directors
During the first six months of 2022, there were two changes to the Executive Management Team.
Effective March 1, 2022, Chris Cozic was appointed Executive Vice President and Chief People Officer,
and Birgitte Stephensen was appointed Executive Vice President and Chief Legal Officer. They join the
existing Executive Management Team of Jan van de Winkel, President and Chief Executive Officer,
Judith Klimovsky, Executive Vice President and Chief Development Officer, Anthony Pagano, Executive
Vice President and Chief Financial Officer, Anthony Mancini, Executive Vice President and Chief
Operating Officer, and Tahamtan Ahmadi, Executive Vice President and Chief Medical Officer. Chris
Cozic and Birgitte Stephensen are not regarded as executive managers pursuant to the Danish
Companies Act and will therefore not be registered with the Danish Business Authority.
Following Genmab A/S’ Annual General Meeting on March 29, 2022, 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, Dr. Paolo
Paoletti, and Dr. Anders Gersel Pedersen were re-elected to the Board of Directors for a one-year period.
Elizabeth O’Farrell was newly elected for a one-year period. Mijke Zachariasse, Martin Schultz and
Takahiro Hamatani were elected to the Board of Directors by the employees for a three-year period. Peter
Storm Kristensen and Rima Bawarshi Nassar stepped down from the Board of Directors.
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Note 7 – Leases
A
mounts recognized in the balance sheet
T
he balance sheet shows the following amounts relating to leases:
June 30,
December 31,
2022
2021
(DKK million)
Right-of-use assets
Properties
553
352
Equipment
1
2
Total right-of-use assets
554
354
Lease liabilities
Current
80
62
Non-current
554
363
Total lease liabilities
634
425
D
uring the first six 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. During the first six months of 2021, there were additions to Genmab’s right-of-use assets and
lease liabilities related to the commencement of a lease in Japan with respect to office space.
Significant leases not yet commenced
D
uring 2020, Genmab entered into a lease agreement with respect to the new headquarters in Denmark
with a commencement date in March 2023 and is non-cancellable until March 2038. The total future
minimum payments over the term of the lease are approximately DKK 339 million and estimated capital
expenditures to fit out the space are approximately DKK 40 million.
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Amounts recognized in the statement of comprehensive income
T
he statement of comprehensive income shows the following amounts relating to leases:
6 Months Ended
6 Months Ended
June 30, 2022
June 30, 2021
(DKK million)
Depreciation charge of right-of-use assets
Properties
30
25
Equipment
1
1
Total depreciation charge of right-of-use assets
31
26
Interest expense
7
6
Expense relating to short-term leases
—
1
I
nterest expense is included in net financial items and expenses relating to short-term leases are included
in operating expenses in the statement of comprehensive income.
N
ote 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 June 30, 2022.
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Interim Report for the First Half of 2022
ABOUT GENMAB
Genmab’s vision to transform cancer treatment has driven its passionate, innovative and collaborative teams to invent next-generation
antibody technology platforms and leverage translational research and data sciences, fueling multiple differentiated cancer treatments that
make an impact on people’s lives. To develop and deliver novel therapies to patients, Genmab has formed 20+ strategic partnerships with
biotechnology and pharmaceutical companies. Genmab’s proprietary pipeline includes bispecific T-cell engagers, next-generation immune
checkpoint modulators, effector function enhanced antibodies and antibody-drug conjugates.
Genmab is headquartered in C openhagen, D enmark 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 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
®
; DuoBody in combination with the DuoBody logo
®
; HexaBody
®
; HexaBody in
combination with the HexaBody logo
®
; DuoHexaBody
®
; and HexElect
®
. Tivdak
®
is a trademark of Seagen Inc.; EPCORE™ is a
trademark of AbbVie Biotechnology Ltd.;
Kesimpta
®
and Sensoready
®
are trademarks of Novartis AG or its affiliates; DARZALEX
®
,
DARZALEX FASPRO
®
and RYBREVANT
®
are trademarks of Johnson & Johnson; TEPEZZA
®
is a trademark of Horizon Therapeutics
Ireland DAC.
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Interim Report for the First Half of 2022
DIRECTORS’ AND MANAGEMENT’S STATEMENT ON THE INTERIM REPORT
Registered Members of Executive Management
Jan van de Winkel
Anthony Pagano
Judith Klimovsky
Anthony Mancini
Tahamtan Ahmadi
(President & CEO)
(Executive Vice
President & CFO)
(Executive Vice
President & CDO)
(Executive Vice
President & COO)
(Executive Vice
President & CMO)
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)