Full Press Release Details
Genmab Announces Financial Results for the First Half of 2020
August 12, 2020; Copenhagen, Denmark;
Interim Report for the First Half of 2020
"At Genmab our core purpose is to improve the lives of patients by creating differentiated antibody medicines. Despite the unprecedented challenges created by the global coronavirus pandemic, the motivation provided by this core purpose, along with our passion for innovation and determination to be the best at what we do have driven our company to transformational success during the first half of 2020. From our broad collaboration with AbbVie to the impressive results from the tisotumab vedotin innovaTV 204 study, the second quarter of 2020 has further strengthened Genmab's position as a world-class innovation powerhouse," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half of 2020
Genmab is improving its 2020 financial guidance published on June 10, 2020 due to increased royalty income related to the sales of TEPEZZA .
| MDKK | Revised | Previous |
| Guidance | Guidance | |
| Revenue | 9,100 - 9,700 | 9,100 - 9,500 |
| Operating expenses | (3,850) - (3,950) | (3,850) - (3,950) |
| Operating income | 5,200 - 5,800 | 5,200 - 5,600 |
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 34 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 1/41 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Genmab Announces Financial Results for the First Half of 2020
Genmab will hold a conference call in English to discuss the results for the first half of 2020 today, Wednesday, August 12, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial +1 646 741 3167 (U.S. participants) or +44 2071 928338 (international participants) and provide conference code 5658476.
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. 34 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 2/41 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Half of 2020
| M | |
| MANAGEMENT S REVIEW | |
| CONSOLIDATED KEY FIGURES | 4 |
| OUTLOOK | 5 |
| KEY 2020 PRIORITIES | 6 |
| PRODUCT PIPELINE | 7 |
| PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST HALF OF 2020 | 8 |
| SIGNIFICANT RISKS AND UNCERTAINTIES | 19 |
| FINANCIAL REVIEW | 20 |
| FINANCIAL STATEMENTS | |
| STATEMENT OF COMPREHENSIVE INCOME FOR THE 2ND QUARTER OF 2020 | 24 |
| STATEMENT OF COMPREHENSIVE INCOME FOR THE FIRST HALF OF 2020 | 25 |
| BALANCE SHEET | 26 |
| STATEMENT OF CASH FLOWS | 27 |
| STATEMENT OF CHANGES IN EQUITY | 28 |
| NOTES TO THE FINANCIAL STATEMENTS | 29 |
| ABOUT GENMAB | 40 |
| DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT | 41 |
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 34 |
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| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Half of 2020
CONSOLIDATED KEY FIGURES
| 2nd Quarter of | 2nd Quarter of | 6 Months Ended | 6 Months Ended | Full Year | ||||||||||
| 2020 | 2019 | June 30, 2020 | June 30, 2019 | 2019 | ||||||||||
| (DKK million) | ||||||||||||||
| Income Statement | ||||||||||||||
| Revenue | 5,451 | 774 | 6,343 | 1,365 | 5,366 | |||||||||
| Research and development expenses | (775) | (564) | (1,490) | (1,110) | (2,386) | |||||||||
| General and administrative expenses | (179) | (73) | (285) | (144) | (342) | |||||||||
| Operating expenses | (954) | (637) | (1,775) | (1,254) | (2,728) | |||||||||
| Operating result | 4,497 | 137 | 4,568 | 111 | 2,638 | |||||||||
| Net financial items | (169) | (26) | 114 | 94 | 221 | |||||||||
| Net result | 3,378 | 85 | 3,647 | 157 | 2,166 | |||||||||
| Balance Sheet | ||||||||||||||
| Cash position* | 12,782 | 6,951 | 12,782 | 6,951 | 10,971 | |||||||||
| Non-current assets | 1,542 | 1,166 | 1,542 | 1,166 | 1,183 | |||||||||
| Assets | 20,683 | 8,977 | 20,683 | 8,977 | 15,144 | |||||||||
| Shareholders' equity | 17,871 | 8,287 | 17,871 | 8,287 | 14,048 | |||||||||
| Share capital | 65 | 62 | 65 | 62 | 65 | |||||||||
| Investments in intangible and tangible assets | 145 | 15 | 203 | 36 | 111 | |||||||||
| Cash Flow Statement | ||||||||||||||
| Cash flow from operating activities | (39) | 184 | 2,153 | 832 | 1,326 | |||||||||
| Cash flow from investing activities | 919 | (772) | 928 | (786) | (1,983) | |||||||||
| Cash flow from financing activities | 4 | 27 | 19 | 16 | 3,660 | |||||||||
| Cash and cash equivalents | 6,605 | 583 | 6,605 | 583 | 3,552 | |||||||||
| Cash position increase/(decrease) | (178) | 121 | 1,811 | 845 | 4,865 | |||||||||
| Financial Ratios | ||||||||||||||
| Basic net result per share | 51.88 | 1.38 | 56.07 | 2.56 | 34.40 | |||||||||
| Diluted net result per share | 51.35 | 1.35 | 55.52 | 2.53 | 34.03 | |||||||||
| Period-end share market price | 2,220.00 | 1,207.00 | 2,220.00 | 1,207.00 | 1,481.50 | |||||||||
| Price / book value | 8.07 | 8.99 | 8.07 | 8.99 | 6.85 | |||||||||
| Shareholders' equity per share | 274.94 | 134.32 | 274.94 | 134.32 | 216.12 | |||||||||
| Equity ratio | 86 | % | 92 | % | 86 | % | 92 | % | 93 | % | ||||
| Average number of employees (FTE**) | 614 | 456 | 591 | 430 | 471 | |||||||||
| Number of employees at the end of the period | 636 | 478 | 636 | 478 | 548 |
* Cash, cash equivalents, and marketable securities.
** Full-time equivalent
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 34 |
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| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Half of 2020
| Revised | Previous | |
| MDKK | Guidance | Guidance |
| Revenue | 9,100 - 9,700 | 9,100 - 9,500 |
| Operating expenses | (3,850) - (3,950) | (3,850) - (3,950) |
| Operating income | 5,200 - 5,800 | 5,200 - 5,600 |
Genmab is improving its 2020 financial guidance published on June 10, 2020, due to increased royalty income related to the sales of TEPEZZA.
We expect our 2020 revenue to be in the range of DKK 9,100 - 9,700 million, an increase of DKK 200 million at the upper end of the range, compared to the previous guidance. Our projected revenue for 2020 consists primarily of DKK 4,398 million related to the portion of the upfront payment from AbbVie that was allocated to the license grants and recognized on the execution date and DARZALEX royalties of DKK 4,075 - 4,475 million. 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 - 400 million, an increase of DKK 200 million at the upper end of the range, compared to the previous guidance, and consists of milestones and other royalties.
We anticipate our 2020 operating expenses will be in the range of DKK 3,850 - 3,950 million. From the execution date 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 now expect our operating income to be approximately DKK 5,200 - 5,800 million in 2020, an increase of DKK 200 million at the upper end of the range, compared to the previous guidance.
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 new 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
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 34 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 5/41 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the First Half of 2020
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 evolve, 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 closely monitors the evolving situation, develops and implements 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 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 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.
1. 50:50 dev. w/ Seattle Genetics; 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
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Interim Report for the First Half of 2020
About the AbbVie Collaboration
On June 10, 2020, Genmab entered into a broad oncology collaboration agreement to jointly develop and commercialize epcoritamab (DuoBody-CD3xCD20), DuoHexaBody-CD37 and DuoBody-CD3x5T4 and a discovery research collaboration for future differentiated antibody therapeutics for cancer. For epcoritamab, the companies will share commercial responsibilities in the U.S. and Japan, with AbbVie responsible for further global commercialization. Genmab will be the principal for net sales in the U.S. and Japan and receive tiered royalties on remaining global sales. For DuoHexaBody-CD37, DuoBody-CD3x5T4 and any product candidates developed as a result of the companies' discovery research collaboration, Genmab and AbbVie will share responsibilities for global development and commercialization in the U.S. and Japan. Genmab retains the right to co-commercialize these products, along with AbbVie, outside of the U.S. and Japan. For the discovery research collaboration, which combines proprietary antibodies from both companies along with Genmab's DuoBody technology and AbbVie's payload and ADC technology, the companies will select and develop up to four additional differentiated next-generation antibody-based product candidates, potentially across both solid tumors and hematological malignancies. Genmab will conduct Phase 1 studies for these programs and AbbVie retains the right to opt-in to program development.
Under the terms of the agreement, Genmab received a USD 750 million upfront payment from AbbVie with the potential for Genmab to receive up to USD 3.15 billion in additional development, regulatory and sales milestone payments for all programs as well as tiered royalties between 22% and 26% on net sales for epcoritamab outside the U.S. and Japan. Except for these royalty-bearing sales, the parties share in pre-tax profits from the sale of products on a 50:50 basis. Included in these potential milestones are up to USD 1.15 billion in payments related to clinical development and commercial success across the three existing bispecific antibody programs. In addition, if all four next-generation antibody product candidates developed as a result of the discovery research collaboration are successful, Genmab is eligible to receive up to USD 2.0 billion in option exercise and success-based milestones. Genmab and AbbVie split the costs related to epcoritamab, DuoHexaBody-CD37 and DuoBody-CD3x5T4 50:50 while Genmab will be responsible for 100% of the costs for the discovery research programs.
As of the end of the second quarter, Genmab's proprietary pipeline of product candidates, where we are responsible for at least 50% of development, consisted of seven clinical stage antibodies. Combined with partnered product candidates, our 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.
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Interim Report for the First Half of 2020
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST HALF 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
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Interim Report for the First Half of 2020
DARZALEX (daratumumab) 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) |
| 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: 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 |
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Interim Report for the First Half of 2020
| 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) |
| 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 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 | ||
| April 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 |
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Interim Report for the First Half of 2020
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 DARZALEX and the full U.S. Prescribing Information for DARZALEX FASPRO for all the labeled safety information.
Second Quarter Updates
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Interim Report for the First Half of 2020
First Quarter Updates
Daratumumab Development Covering All States of Multiple Myeloma (MM) and Beyond - Key Ongoing* Trials
*Does not include trials that may still be ongoing but have clinical data and/or are the basis for an existing approval.
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
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Interim Report for the First Half of 2020
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 though it is no longer in active development for CLL.
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.
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
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Interim Report for the First Half of 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 Seattle Genetics, under an agreement in which the companies share all costs and profits for the product on a 50:50 basis.
Second Quarter Update
Enapotamab vedotin - A First-in-Class ADC Targeting AXL
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Interim Report for the First Half of 2020
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/2 clinical study of enapotamab vedotin for multiple types of solid tumors is ongoing.
HexaBody -DR5/DR5 (GEN1029) - First HexaBody Program in Clinical Development