Full Press Release Details
Genmab Announces Financial Results for the First Quarter of 2020
May 6, 2020; Copenhagen, Denmark;
Interim Report for the First Quarter Ended March 31, 2020
Despite the unprecedented challenges posed by the coronavirus (COVID-19) pandemic, we will continue to invest in our innovative proprietary products, technologies and capabilities and use our world-class expertise in antibody drug development to create truly differentiated products with the potential to help cancer patients. While Genmab is closely monitoring the developments in the rapidly evolving landscape, we are extremely fortunate to have a solid financial foundation and a fabulous and committed team to carry us through these uncertain times, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Quarter of 2020
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 20 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 1/37 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Genmab Announces Financial Results for the First Quarter of 2020
Genmab is maintaining its 2020 financial guidance published on February 19, 2020.
Genmab will hold a conference call in English to discuss the results for the first quarter of 2020 today, Wednesday, May 6, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial
+1 631 510 7495 (U.S. participants) or +44 2071 928000 (international participants) and provide conference code 6486367.
A live and archived webcast of the call and relevant slides will be available at www.genmab.com.
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. 20 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 2/37 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Quarter of 2020
| CONSOLIDATED KEY FIGURES | 4 |
| OUTLOOK | 5 |
| KEY 2020 PRIORITIES | 6 |
| PRODUCT PIPELINE | 7 |
| PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST QUARTER OF 2020 | 7 |
| SIGNIFICANT RISKS AND UNCERTAINTIES | 16 |
| FINANCIAL REVIEW | 17 |
| STATEMENT OF COMPREHENSIVE INCOME FOR THE FIRST QUARTER OF 2020 | 21 |
| BALANCE SHEET | 22 |
| STATEMENT OF CASH FLOWS | 23 |
| STATEMENT OF CHANGES IN EQUITY | 24 |
| NOTES TO THE FINANCIAL STATEMENTS | 25 |
| ABOUT GENMAB | 36 |
| DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT | 37 |
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 20 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 3/37 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Quarter of 2020
CONSOLIDATED KEY FIGURES
| 1st Quarter of | 1st Quarter of | Full Year | ||||||
| 2020 | 2019 | 2019 | ||||||
| (DKK million) | ||||||||
| Income Statement | ||||||||
| Revenue | 892 | 591 | 5,366 | |||||
| Research and development expenses | (715) | (546) | (2,386) | |||||
| General and administrative expenses | (106) | (71) | (342) | |||||
| Operating expenses | (821) | (617) | (2,728) | |||||
| Operating result | 71 | (26) | 2,638 | |||||
| Net financial items | 283 | 120 | 221 | |||||
| Net result | 269 | 72 | 2,166 | |||||
| Balance Sheet | ||||||||
| Cash position* | 12,960 | 6,830 | 10,971 | |||||
| Non-current assets | 1,213 | 1,199 | 1,183 | |||||
| Assets | 15,303 | 8,735 | 15,144 | |||||
| Shareholders' equity | 14,398 | 8,127 | 14,048 | |||||
| Share capital | 65 | 62 | 65 | |||||
| Investments in intangible and tangible assets | 58 | 21 | 111 | |||||
| Cash Flow Statement | ||||||||
| Cash flow from operating activities | 2,192 | 648 | 1,326 | |||||
| Cash flow from investing activities | 9 | (14) | (1,983) | |||||
| Cash flow from financing activities | 15 | (11) | 3,660 | |||||
| Cash and cash equivalents | 5,543 | 1,177 | 3,552 | |||||
| Cash position increase/(decrease) | 1,989 | 724 | 4,865 | |||||
| Financial Ratios | ||||||||
| Basic net result per share | 4.13 | 1.18 | 34.40 | |||||
| Diluted net result per share | 4.09 | 1.17 | 34.03 | |||||
| Period-end share market price | 1,362.50 | 1,155.00 | 1,481.50 | |||||
| Price / book value | 6.15 | 8.74 | 6.85 | |||||
| Shareholders' equity per share | 221.51 | 132.10 | 216.12 | |||||
| Equity ratio | 94 | % | 93 | % | 93 | % | ||
| Average number of employees (FTE**) | 569 | 403 | 471 | |||||
| Number of employees at the end of the period | 579 | 419 | 548 |
* Cash, cash equivalents, and marketable securities.
** Full-time equivalent
The figures and financial ratios have been prepared on a consolidated basis. The financial ratios have been calculated in accordance with the recommendations of the Association of Danish Financial Analysts (2017) and key figures in accordance with IFRS.
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 20 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 4/37 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Quarter of 2020
| 2020 | ||
| (DKK million) | Guidance | |
| Revenue | 4,750 - 5,150 | |
| Operating expenses | (3,850) - (3,950) | |
| Operating income | 850 - 1,250 |
Genmab is maintaining its 2020 financial guidance published on February 19, 2020.
We expect our 2020 revenue to be in the range of DKK 4,750 5,150 million, compared to DKK 5,366 million in 2019. Our revenue in 2019 included DKK 1,684 million related to one-time sales milestones for DARZALEX net sales exceeding USD 2.5 billion and 3.0 billion in a calendar year.
Our projected revenue for 2020 primarily consists of DARZALEX royalties of DKK 4,075 4,475 million. Our 2020 guidance for DARZALEX royalties represents a 30% to 43% increase compared to 2019. Such royalties are based on estimated DARZALEX net sales of USD 3.9 4.2 billion. We project cost reimbursement income of approximately DKK 475 million which is related to our collaborations with Seattle Genetics and BioNTech. The remainder of our revenue is approximately DKK 200 million and consists of milestones and other royalties.
We anticipate our 2020 operating expenses to be in the range of DKK 3,850 3,950 million, compared to DKK 2,728 million in 2019. The increase is driven by the advancement of our clinical programs, particularly epcoritamab (DuoBody-CD3xCD20) and DuoBody-PD-L1x4-1BB.
We expect our operating income to be in the range of DKK 850 1,250 million in 2020 compared to DKK 2,638 million in 2019.
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; the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; DARZALEX sales and corresponding royalties 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 agreements are entered into during 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, including our 2020 Guidance and Key 2020 Priorities in this interim report. In December 2019, a novel strain of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China. Since then, the COVID-19 coronavirus has spread worldwide and has been declared a global pandemic. COVID-19 has resulted in global business and economic disruption, as many jurisdictions have prohibited international travel and implemented social distancing, quarantine and similar measures for their residents to contain the spread of the coronavirus. COVID-19 is also expected to put a strain on the healthcare systems in the major countries where our partners sell our products and where we and they conduct our clinical trials. The global outbreak of COVID-19 continues to rapidly evolve. The COVID-19
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 20 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 5/37 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Quarter of 2020
pandemic may be prolonged and may have long-term impacts on the development, regulatory approval and commercialization of our product candidates and on 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 is closely monitoring the evolving situation and has developed and implemented precautionary measures, including remote working for the majority of Genmab employees with a small subset of employees on-site to maintain critical laboratory activities that cannot be done remotely. The response team issues regular updates to employees with guidance to help limit the impact of COVID-19 at our workplace and on our communities and ensure business continuity. Genmab is also actively monitoring the potential impact on our 2020 key 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 sales of DARZALEX, Arzerra and TEPEZZA, by our partners and on our royalty and milestone income therefrom.
| Priority | Targeted Milestones | ||
| Genmab proprietary* products | Tisotumab vedotin 1 - Phase II 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) Phase I/II decision on recommended Phase II dose and initiate expansion cohorts | |||
| HexaBody-DR5/DR5 Phase I/II - advance dose escalation | |||
| DuoBody-PD-L1x4-1BB 2 Phase I/II initiate expansion cohorts | |||
| DuoBody-PD-L1x4-1BB initial data in H2 2020 | |||
| File INDs and/or CTAs for 2 new products | |||
| Daratumumab 3 | U.S. FDA and EMA decision on Phase III COLUMBA multiple myeloma SubQ submission | ||
| sBLA and MAA Submission Phase III ANDROMEDA amyloidosis | |||
| sBLA and MAA submission Phase III APOLLO multiple myeloma | |||
| Ofatumumab 4 | U.S. FDA decision on regulatory dossier submission in RMS | ||
| Teprotumumab 5 | U.S. FDA decision on Phase III OPTIC active thyroid eye disease submission |
*Certain product candidates in development with partners, as noted.
1. 50:50 dev. w/ Seattle Genetics; 2. 50:50 dev. w/ BioNTech; 3. In dev. by Janssen; 4. In dev. by Novartis; 5. In dev. by Horizon Therapeutics
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 20 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 6/37 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Quarter of 2020
Our own and partnered product pipeline consists of twenty antibodies in clinical development, including three approved partnered products created by Genmab. In addition to the antibodies in clinical development, our pipeline includes more than 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 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.
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST QUARTER 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 CD38 Antibody Approved in the World
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 20 |
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| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Quarter of 2020
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients:
| Jurisdiction | Approval | Key Underlying Clinical Trial(s) |
| United States | ||
| 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) |
| 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) |
| European Union | ||
| Relapsed / Refractory MM | ||
| April 2016 | Monotherapy for patients whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy | SIRIUS (MMY2002) |
| February 2017 | In combination with Rd or Vd for patients who have received at least one prior therapy | CASTOR (MMY3004); POLLUX (MMY3003) |
| Frontline MM | ||
| July 2018 | In combination with VMP for newly diagnosed patients who are ineligible for ASCT | ALCYONE (MMY3007) |
| November 2019 | In combination with Rd for newly diagnosed patients who are ineligible for ASCT | MAIA (MMY3008) |
| January 2020 | In combination with VTd for newly diagnosed patients who are eligible for ASCT | CASSIOPEIA (MMY3006) |
| Split Dosing Regimen | ||
| December 2018 | Option to split first infusion over two consecutive days | EQUULEUS (MMY1001) |
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 20 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 8/37 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Quarter of 2020
| Japan | ||
| 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 ineligible for ASCT | ALCYONE (MMY3007) |
| December 2019 | In combination with Rd for newly diagnosed patients who are ineligible for ASCT | MAIA (MMY3008) |
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 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.
Please consult the full U.S. Prescribing Information and the full European Summary of Product Characteristics for all the labeled safety information for DARZALEX.
First Quarter Updates
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 20 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 9/37 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Quarter of 2020
Daratumumab Development Covering All States of Multiple Myeloma Key Ongoing* Trials
= recruitment completed
*Does not include trials that may still be ongoing but have clinical data and/or are the basis for an existing approval.
Daratumumab Development Beyond Multiple Myeloma
= recruitment completed
Arzerra (ofatumumab) First Genmab Created Product on the Market
In the U.S., Arzerra solution for infusion is 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 is 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. Arzerra is commercially available in Japan as well as in the U.S. and certain other territories.
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.
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 20 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 10/37 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Quarter of 2020
TEPEZZA (teprotumumab-trw) Latest Genmab Created Product to be Approved
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 is being developed and is commercialized by 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.
First Quarter Update
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 Seattle Genetics, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 20 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 11/37 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Quarter of 2020
Enapotamab vedotin A First-in-Class ADC Targeting AXL
Enapotamab vedotin is an ADC targeted to AXL, a signaling molecule expressed on many solid cancers and implicated in tumor biology. Enapotamab vedotin is fully owned by Genmab and the ADC technology used with enapotamab vedotin was licensed from Seattle Genetics. A Phase I/II clinical study of enapotamab vedotin for multiple types of solid tumors is ongoing.
HexaBody -DR5/DR5 (GEN1029) First HexaBody Program in Clinical Development
HexaBody-DR5/DR5 is a product comprising a mixture of two non-competing HexaBody molecules that target two distinct epitopes on death receptor 5 (DR5), a cell surface receptor that mediates a process called programmed cell death. Increased expression of DR5 has been reported in several types of tumors. The product was created with our HexaBody technology and DR5 antibodies acquired from IDD Biotech. HexaBody-DR5/DR5 is fully owned by Genmab and a Phase I/II clinical trial in solid tumors is ongoing.
Epcoritamab (DuoBody-CD3xCD20) A Proprietary Bispecific Antibody
Epcoritamab is a proprietary bispecific antibody created using Genmab's DuoBody technology. Epcoritamab targets CD3, which is expressed on T-cells, and CD20, a clinically well-validated target. Genmab used technology licensed from Medarex to generate the CD20 antibody forming part of epcoritamab. Genmab fully owns epcoritamab and a Phase I/II clinical study of epcoritamab in B-cell malignancies is ongoing.
First Quarter Update
DuoBody-PD-L1x4-1BB (GEN1046) Bispecific Next Generation Checkpoint Immunotherapy
DuoBody-PD-L1x4-1BB (GEN1046) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab's DuoBody technology. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all future costs and profits for the product on a 50:50 basis. DuoBody-PD-L1x4-1BB targets PD-L1 and 4-1BB, selected to block inhibitory PD-1 / PD-L1 axis and simultaneously activate essential co-stimulatory activity via 4-1BB using inert DuoBody antibody format. A Phase I/II clinical study of DuoBody-PD-L1x4-1BB in solid tumors is ongoing.
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 20 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 12/37 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Quarter of 2020
First Quarter Update
DuoBody-CD40x4-1BB (GEN1042) Potential First-in-Class Bispecific Agonistic Antibody