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Genmab Announces Financial Results for the First Nine Months of 2020

Key Takeaway: Genmab Announces Financial Results for the First Nine Months of 2020 November 4, 2020; Copenhagen, Denmark; Interim Report for the First Nine Months Ended September 30, 2020 "Genmab continued to deliver on the promise of improving the lives of patients, with multiple regulator

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Genmab Announces Financial Results for the First Nine Months of 2020
November 4, 2020; Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September 30, 2020
"Genmab continued to deliver on the promise of improving the lives of patients, with multiple regulatory milestones for Genmab-created products under development by our partners, including the exciting U.S. FDA's approval of Kesimpta and the 8th U.S. FDA approval for DARZALEX," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "During the first nine months of 2020, with our solid financial footing Genmab has continued its focused investment in advancing its proprietary antibody product pipeline and building its capabilities as we evolve into a fully integrated biotech."
Financial Performance First Nine Months of 2020
Genmab is maintaining its 2020 financial guidance published on August 20, 2020.
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 1/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Genmab Announces Financial Results for the First Nine Months of 2020
Genmab will hold a conference call in English to discuss the results for the first nine months of 2020 today, Wednesday, November 4, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call dial
+1 646 741 3167 (U.S. participants) or +44 2071 928338 (international participants) and provide conference code 7839599.
A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.
Marisol Peron, Corporate Vice President, Communications & Investor Relations
T: +1 609 524 0065; E: mmp@genmab.com
For Investor Relations:
Andrew Carlsen, Senior Director, Investor Relations
T: +45 3377 9558; E: acn@genmab.com
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 2/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
CONSOLIDATED KEY FIGURES 4
OUTLOOK 5
KEY 2020 PRIORITIES 6
PRODUCT PIPELINE 6
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST NINE MONTHS OF 2020 7
SIGNIFICANT RISKS AND UNCERTAINTIES 21
FINANCIAL REVIEW FINANCIAL STATEMENTS 22
STATEMENT OF COMPREHENSIVE INCOME FOR THE 3RD QUARTER OF 2020 27
STATEMENT OF COMPREHENSIVE INCOME FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2020 28
BALANCE SHEET AS OF SEPTEMBER 30, 2020 29
STATEMENT OF CASH FLOWS AS OF SEPTEMBER 30, 2020 30
STATEMENT OF CHANGES IN EQUITY AS OF SEPTEMBER 30, 2020 31
NOTES TO THE FINANCIAL STATEMENTS 32
ABOUT GENMAB 46
DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT 47
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 3/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
CONSOLIDATED KEY FIGURES
3rd Quarter of 3rd Quarter of 9 Months Ended 9 Months Ended Full Year
2020 2019 September 30, 2020 September 30, 2019 2019
(DKK million)
Income Statement
Revenue 1,724 1,040 8,067 2,405 5,366
Research and development expenses (721) (608) (2,211) (1,717) (2,386)
General and administrative expenses (145) (81) (430) (226) (342)
Operating expenses (866) (689) (2,641) (1,943) (2,728)
Operating result 858 351 5,426 462 2,638
Net financial items (187) 348 (73) 442 221
Net result 530 537 4,177 694 2,166
Balance Sheet
Cash position* 17,469 11,117 17,469 11,117 10,971
Total non-current assets 2,018 1,074 2,018 1,074 1,183
Total assets 21,522 13,330 21,522 13,330 15,144
Shareholders' equity 18,477 12,515 18,477 12,515 14,048
Share capital 65 65 65 65 65
Cash Flow Statement
Cash flow from operating activities 5,078 319 7,231 1,151 1,326
Cash flow from investing activities (2,565) (46) (1,637) (832) (1,983)
Cash flow from financing activities 19 3,636 38 3,652 3,660
Cash and cash equivalents 8,892 4,643 8,892 4,643 3,552
Cash position increase/(decrease) 4,687 4,166 6,498 5,011 4,865
Investments in intangible and tangible assets 46 46 249 82 111
Financial Ratios
Basic net result per share 8.13 8.38 64.16 11.14 34.40
Diluted net result per share 8.04 8.28 63.46 11.03 34.03
Period-end share market price 2,300.00 1,390.50 2,300.00 1,390.50 1,481.50
Price / book value 8.09 7.22 8.09 7.22 6.85
Shareholders' equity per share 284.26 192.57 284.26 192.57 216.12
Equity ratio 86 % 94 % 86 % 94 % 93 %
Average number of employees (FTE**) 683 514 622 458 471
Number of employees at the end of the period 712 533 712 533 548
* Cash, cash equivalents, and marketable securities.
** Full-time equivalent
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 4/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
2020
(DKK million) Guidance
Revenue 9,250 - 9,850
Operating expenses (3,850) - (3,950)
Operating income 5,350 - 5,950
Genmab is maintaining its 2020 financial guidance published on August 20, 2020.
We expect our 2020 revenue to be in the range of DKK 9,250 - 9,850 million. Our projected revenue for 2020 consists primarily of DKK 4,398 million related to the portion of the upfront payment from AbbVie under our collaboration announced in June that was allocated to the license grants and recognized in June 2020 and DARZALEX royalties of DKK 4,075 - 4,475 million. Such royalties are based on expected DARZALEX net sales of USD 3.9 - 4.2 billion. We project cost reimbursement revenue of approximately DKK 475 million which is related to our collaborations with Seagen Inc. and BioNTech SE. The remainder of our projected revenue is approximately DKK 350 - 550 million, and consists of other milestones, license fees and royalties.
We anticipate our 2020 operating expenses will be in the range of DKK 3,850 - 3,950 million. From the execution date (June 2020) of the agreement with AbbVie, our operating costs will include 50% of the costs for epcoritamab (DuoBody-CD3xCD20), DuoHexaBody -CD37 and DuoBody-CD3x5T4 and 100% of the costs for the discovery research collaboration. The reduction in our operating costs due to AbbVie's contribution to the existing clinical programs will be offset by increased investment to further expand and accelerate the partnership programs with AbbVie.
We expect our operating income to be approximately DKK 5,350 - 5,950 million in 2020.
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 our collaboration agreements; our ongoing binding arbitration of two matters under our license agreement with Janssen relating to daratumumab; the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; DARZALEX, Kesimpta and TEPEZZA net sales and royalties paid to Genmab; and currency exchange rates (the 2020 guidance assumes a USD/DKK exchange rate of 6.5). The financial guidance assumes that no significant new agreements are entered into during the remainder of 2020 that could materially affect the results. Refer to the section "Significant Risks and Uncertainties" in this interim report. Additionally, the COVID-19 pandemic could potentially materially adversely impact our business and financial performance, including our clinical trials, projected regulatory approval timelines, supply chain and revenues, and cause our actual results to differ materially from our 2020 Guidance and Key 2020 Priorities in this interim report. The global outbreak of COVID-19 continues to evolve, may be prolonged and may have long-term impacts on the development, regulatory approval and commercialization of our product candidates and on net sales of our approved products by our collaboration partners. The longer the pandemic continues, the more severe the impacts described below will be on our business. The extent, length and consequences of the pandemic are uncertain and impossible to predict. Genmab has established a COVID-19 response team, led by the CEO, that closely monitors the evolving situation, develops and implements
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 5/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
precautionary measures to help limit the impact of COVID-19 at our workplace and on our communities, and ensures business continuity. Genmab is also actively monitoring the potential impact on our Key 2020 Priorities and assessing the situation on an ongoing basis in close contact with clinical trial sites, physicians and contract research organizations (CROs) to evaluate the impact and challenges posed by the COVID-19 situation and manage them accordingly. 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 as the situation continues to develop. The factors discussed above, as well as other factors which are currently unforeseeable, may result in further and other unforeseen material adverse impacts on our business and financial performance, including on the net sales of DARZALEX, Kesimpta and TEPEZZA, by our partners and on our royalty and milestone revenue therefrom.
Priority Targeted Milestones
Genmab proprietary* products Tisotumab vedotin 1 - Phase 2 innovaTV 204 safety and efficacy analysis in recurrent/metastatic cervical cancer and engage U.S. FDA for BLA submission subject to trial results
** Tisotumab vedotin - data on other solid tumor types
Enapotamab vedotin - data to support late stage development
Epcoritamab (DuoBody-CD3xCD20) 2 Phase 1/2 - decision on recommended Phase 2 dose and initiate expansion cohorts
HexaBody-DR5/DR5 Phase 1/2 - advance dose escalation
DuoBody-PD-L1x4-1BB 3 Phase 1/2 - initiate expansion cohorts
DuoBody-PD-L1x4-1BB initial data in H2 2020
File INDs and/or CTAs for 2 new products
Daratumumab 4 U.S. FDA and EMA decision on Phase 3 COLUMBA multiple myeloma SubQ submission
sBLA and MAA Submission Phase 3 ANDROMEDA amyloidosis
sBLA and MAA submission Phase 3 APOLLO multiple myeloma
Ofatumumab 5 U.S. FDA decision on regulatory dossier submission in RMS
Teprotumumab 6 U.S. FDA decision on Phase 3 OPTIC active thyroid eye disease submission
*Certain product candidates in development with partners, as noted.
**Data now anticipated in 2021
1. 50:50 dev. w/ Seagen; 2. 50:50 dev. w/ AbbVie 3. 50:50 dev. w/ BioNTech; 4. In dev. by Janssen; 5. In dev. by Novartis; 6. In dev. by Horizon Therapeutics
As of the end of the third quarter, Genmab's proprietary pipeline of product candidates, where we are responsible for at least 50% of development, consisted of eight clinical stage antibodies. Combined with partnered product candidates, our pipeline consists of over twenty antibodies in clinical development, including multiple approved partnered products created by Genmab. In addition to the antibodies in clinical development, our pipeline includes around twenty in-house and partnered pre-clinical programs. An overview of the development status of each of our products is provided in the following sections. 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
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 6/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
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 and is not incorporated by reference herein.
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST NINE MONTHS OF 2020
Products Created by Genmab*
*Out-licensed products marketed by partner
1See local country prescribing information for precise indications, 2Not in active development
DARZALEX (daratumumab)
- First and Only Subcutaneous (SubQ) CD38 Antibody Approved in the World
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 7/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients:
Jurisdiction Approval Key Underlying Clinical Trial(s)
United States: IV infusion
Relapsed / Refractory MM
November 2015 Monotherapy for patients who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent SIRIUS (MMY2002)
November 2016 In combination with Rd or Vd, for patients who have received at least one prior therapy CASTOR (MMY3004); POLLUX (MMY3003)
June 2017 In combination with Pom-d for patients who have received at least two prior therapies, including lenalidomide and a PI EQUULEUS (MMY1001)
August 2020 In combination with Kd for patients with RRMM who have received one to three previous lines of therapy CANDOR EQUULEUS (MMY1001)
Frontline MM
May 2018 In combination with VMP for newly diagnosed patients who are ineligible for ASCT ALCYONE (MMY3007)
June 2019 In combination with Rd for newly diagnosed patients who are ineligible for ASCT MAIA (MMY3008)
September 2019 In combination with VTd for newly diagnosed patients who are eligible for ASCT CASSIOPEIA (MMY3006)
Split Dosing Regimen
February 2019 Option to split first infusion over two consecutive days EQUULEUS (MMY1001)
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 8/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
European Union: IV infusion or SubQ administration
Relapsed / Refractory MM
IV: April 2016 SubQ: June 2020 Monotherapy for patients whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy IV: SIRIUS (MMY2002) SubQ: COLUMBA/ PLEIADES
IV: February 2017 SubQ: June 2020 In combination with Rd or Vd for patients who have received at least one prior therapy IV: CASTOR (MMY3004); POLLUX (MMY3003) SubQ: COLUMBA/ PLEIADES
Frontline MM
IV: July 2018 SubQ: June 2020 In combination with VMP for newly diagnosed patients who are ineligible for ASCT IV: ALCYONE (MMY3007) SubQ: COLUMBA/ PLEIADES
IV: November 2019 SubQ: June 2020 In combination with Rd for newly diagnosed patients who are ineligible for ASCT IV: MAIA (MMY3008) SubQ: COLUMBA/ PLEIADES
IV: January 2020 SubQ: June 2020 In combination with VTd for newly diagnosed patients who are eligible for ASCT IV: CASSIOPEIA (MMY3006) SubQ: COLUMBA/ PLEIADES
Split Dosing Regimen
December 2018 (N/A SubQ) Option to split first infusion over two consecutive days EQUULEUS (MMY1001)
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 9/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
Japan: IV infusion
Relapsed / Refractory MM
September 2017 In combination with Rd or Vd CASTOR (MMY3004); POLLUX (MMY3003)
Frontline MM
August 2019 In combination with VMP for newly diagnosed patients who are ineligible for ASCT ALCYONE (MMY3007)
December 2019 In combination with Rd for newly diagnosed patients who are ineligible for ASCT MAIA (MMY3008)
DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) SubQ administration is indicated for the treatment of adult patients in the U.S.:
Approval Key Underlying Clinical Trial(s)
Relapsed / Refractory MM
May 2020 In combination with Rd or Vd, for patients who have received at least one prior therapy Monotherapy for patients who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent COLUMBA/ PLEIADES
Frontline MM
May 2020 In combination with VMP for newly diagnosed patients who are ineligible for ASCT In combination with Rd for newly diagnosed patients who are ineligible for ASCT COLUMBA/ PLEIADES
PI = proteasome inhibitor; Rd = lenalidomide and dexamethasone; Vd = bortezomib and dexamethasone; VMP = bortezomib, melphalan and prednisone; VTd = bortezomib, thalidomide and dexamethasone; ASCT = autologous stem cell transplant; Pom-d = pomalidomide and dexamethasone
The warnings and precautions for DARZALEX (daratumumab) include infusion reactions, interference with serological testing and interference with determination of complete response. The most frequently reported adverse reactions (incidence 20%) in clinical trials were: infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy and upper respiratory tract infection.
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 10/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
Please consult the full U.S. Prescribing Information and the full European Summary of Product Characteristics for DARZALEX (daratumumab) and the full U.S. Prescribing Information for DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) for all the labeled safety information.
Third Quarter 2020 Updates
First Half 2020 Updates
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 11/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
Daratumumab Development Covering All States of Multiple Myeloma (MM) and Beyond - Key Ongoing* Trials
Kesimpta (ofatumumab) - Approved in RMS in the U.S.
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 12/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
Ofatumumab is a human IgG1k mAb that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. A SubQ formulation of ofatumumab was investigated in two Phase 3 ASCLEPIOS clinical studies in RMS. The studies compared the efficacy and safety of SubQ ofatumumab versus teriflunomide in patients with RMS and were comprised of approximately 900 patients each. Based on these studies, and data from the Phase 2 APLIOS study, which evaluated the bioequivalence of SubQ administration of ofatumumab via pre-filled syringe, in August 2020, Kesimpta (ofatumumab) was approved by the U.S. FDA for the treatment of RMS in adults. 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. Additional studies with RMS patients are ongoing. Ofatumumab in RMS is being developed and marketed worldwide by Novartis under a license agreement between Genmab and Novartis Pharma AG.
Please consult the full U.S. Prescribing Information for all the labeled safety information for Kesimpta.
Third Quarter 2020 Update
First Half 2020 Updates
TEPEZZA (teprotumumab-trw) - First U.S. FDA-approved medicine for the treatment of TED
Teprotumumab, approved by the U.S. FDA in January 2020 under the trade name TEPEZZA, is a fully human antibody that targets the Insulin-like Growth Factor-1 Receptor, a well-validated target. TEPEZZA
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 13/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
is being developed and is commercialized by Horizon Therapeutics, plc (Horizon). 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 license from Roche. Under the terms of Genmab's agreement with Roche, Genmab will receive mid-single digit royalties on sales of TEPEZZA.
Please consult the full U.S. Prescribing Information for all the labeled safety information for TEPEZZA.
Third Quarter 2020 Update
First Half 2020 Update
Arzerra (ofatumumab) - First Genmab Created Product on the Market
In the U.S., Arzerra (ofatumumab) solution for infusion was approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate; for use in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed CLL; and for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. It was also indicated as monotherapy for the treatment of patients with CLL who are refractory to fludarabine and alemtuzumab.
In 2019, the marketing authorization for Arzerra was withdrawn in the EU and several other territories. Subsequently, in August 2020, Genmab announced that Novartis intends to transition availability of Arzerra to an oncology patient access program for CLL patients in the U.S. Arzerra is commercially available in Japan.
The overall safety profile of Arzerra in CLL is based on exposure in clinical trials and the post-marketing setting. The most common side effects for Arzerra include adverse events associated with infusion reactions, cytopenias, and infections (lower respiratory tract infection, including pneumonia, upper respiratory tract infection, sepsis, including neutropenic sepsis and septic shock, herpes viral infection, urinary tract infection).
Please consult the full U.S. Prescribing information, including Boxed Warning, for all the labeled safety information for Arzerra.
Third Quarter 2020 Update
Genmab A/S Tel: +45 7020 2728 Company Announcement no. 46
Kalvebod Brygge 43 Fax: +45 7020 2729 Page 14/47
1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884
Interim Report for the Nine Months Ended September 30, 2020
Genmab Proprietary Products*
*Certain products in co-development, partners as indicated
Tisotumab vedotin - A Next Generation Therapeutic
Tisotumab vedotin is an ADC targeted to tissue factor (TF), a protein involved in tumor signaling and angiogenesis. Based on its high expression on many solid tumors and its rapid internalization, TF is a suitable target for an ADC approach. Tisotumab vedotin is in clinical development for solid tumors. Tisotumab vedotin is being co-developed by Genmab and Seagen, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.
Last updated: Nov 4, 2020