Genmab and AbbVie Announce Broad Oncology Collaboration
Company Announcement
Revenue
We expect our 2020 revenue to be in the range of DKK 9,100 - DKK 9,500 million, an increase of DKK 4,350 million compared to our previous guidance. The increase is due to nearly 90% of the USD 750 million upfront payment from this agreement being recognized immediately with the remainder being recognized over a number of years. The other elements of our original revenue guidance remain unchanged and are primarily related to 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 million and consists of milestones and other royalties.
Operating Expenses
We anticipate our 2020 operating expenses will continue to be in the range of DKK 3,850 ? 3,950 million. From the execution date of the agreement, our operating costs will include 50% of the costs for epcoritamab, DuoHexaBody-CD37 and DuoBody-CD3x5T4 and 100% of the costs for the discovery research collaboration. We expect that the reduction in our operating costs due to partner contribution to the existing clinical programs will be offset by increased investment to further expand and accelerate the partnership programs.
Operating Result
We now expect our operating income to be approximately DKK 5,200 to DKK 5,600 million in 2020.
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.
Conference Call
Genmab will hold a conference call in English to discuss this news today, Wednesday, June 10, 2020, at 6:00 AM CDT / 7:00 AM EDT / 1:00 PM CEST. The dial in numbers are:
+1 855 857 0686 (US participants)
+44 3333000804 (international participants)
Confirmation code: 48035919
A live and archived webcast of the call and relevant slides will be available at?www.genmab.com.
About Epcoritamab (DuoBody-CD3xCD20)
Epcoritamab (DuoBody-CD3xCD20) is a bispecific antibody created using Genmab?s proprietary DuoBody technology. Epcoritamab is designed to target CD3, which is expressed on T cells and is part of the T cell receptor signaling complex, and CD20, a clinically well validated therapeutic target. CD20 is expressed on a majority of B cell malignancies, including chronic lymphocytic leukemia (CLL), diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL) and mantle cell lymphoma (MCL). In a number of laboratory models, epcoritamab has shown highly effective killing of CD20+ tumors and induced potent tumor cell lysis across a panel of B cell tumor lines. Epcoritamab is currently evaluated in a Phase 1/2 study for multiple hematological B cell malignancies.
Complete dose escalation data for epcoritamab was presented at the American Society of Clinical Oncology 2020 (ASCO20) Virtual Scientific Program. The data and preliminary activity from the Phase 1/2 study of subcutaneous epcoritamab in patients with relapsed / refractory B-cell non-Hodgkin lymphoma (B-NHL) are highly encouraging showing substantial single-agent activity for epcoritamab with a manageable safety profile. In the study, epcoritamab induced rapid and deep responses in heavily pretreated patients with B-NHL across different subtypes and no dose-limiting toxicities were observed.
About Genmab
Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated antibody therapeutics for the treatment of cancer. Founded in 1999, the company is the creator of three approved antibodies: DARZALEX??(daratumumab, under agreement with Janssen Biotech, Inc.) for the treatment of certain multiple myeloma indications in territories including the U.S., Europe and Japan, Arzerra??(ofatumumab, under agreement with Novartis AG), for the treatment of certain chronic lymphocytic leukemia indications in the U.S., Japan and certain other territories and TEPEZZA? (teprotumumab, under agreement with Roche granting sublicense to Horizon Therapeutics plc) for the treatment of thyroid eye disease in the U.S. A subcutaneous formulation of daratumumab, DARZALEX?FASPRO? (daratumumab and hyaluronidase-fihj), has been approved in the U.S. for the treatment of adult patients with certain multiple myeloma indications. Daratumumab is in clinical development by Janssen for the treatment of additional multiple myeloma indications, other blood cancers and amyloidosis. A subcutaneous formulation of ofatumumab is in development by Novartis for the treatment of relapsing multiple sclerosis. Genmab also has a broad clinical and pre-clinical product pipeline. Genmab's technology base consists of validated and proprietary next generation antibody technologies - the DuoBody??platform for generation of bispecific antibodies, the HexaBody??platform, which creates effector function enhanced antibodies, the HexElect??platform, which combines two co-dependently acting HexaBody molecules to introduce selectivity while maximizing therapeutic potency and the DuoHexaBody??platform, which enhances the potential potency of bispecific antibodies through hexamerization. The company intends to leverage these technologies to create opportunities for full or co-ownership of future products. Genmab has alliances with top tier pharmaceutical and biotechnology companies. Genmab is headquartered in Copenhagen, Denmark with sites in Utrecht, the Netherlands, Princeton, New Jersey, U.S. and Tokyo, Japan.
About AbbVie
AbbVie?s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people?s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women?s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at?www.abbvie.com. Follow?@abbvie?on?Twitter,?Facebook,?Instagram,?YouTube?and?LinkedIn.
Contacts for Genmab:
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
Contacts for AbbVie:
Media:
Adelle Infante
847-938-8745
Adelle.infante@abbvie.com
- Genmab and AbbVie entered into a broad collaboration to jointly develop and commercialize three of Genmab?s next-generation bispecific antibody products, including epcoritamab
- Companies establish a discovery research collaboration to create additional differentiated antibody therapeutics for cancer
- AbbVie to pay Genmab an upfront payment of USD 750 million with total potential milestone payments of up to USD 3.15 billion
(DKK million) | Revised Guidance | Previous Guidance |
Revenue | 9,100 - 9,500 | 4,750 - 5,150 |
Operating expenses | (3,850) - (3,950) | (3,850) - (3,950) |
Operating income | 5,200 - 5,600 | 850 - 1,250 |