Full Press Release Details
Interim Report for the Nine Months Ended September 30, 2019
November 6, 2019; Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September 30, 2019
Genmab made excellent progress across many areas of the business during the third quarter of 2019. Of key significance was the completion of our public offering of American Depositary Shares and listing on the Nasdaq Global Select Market in the U.S. Genmab's status as a dual listed company both increases our visibility as an innovation powerhouse and provides additional support for the development of our exciting pipeline of antibody product candidates, said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. Over the past three months advances to this pipeline included positive data readouts for ofatumumab in relapsing multiple sclerosis and daratumumab in multiple myeloma, regulatory submissions for daratumumab and teprotumumab and additional approvals for daratumumab in the U.S. and Asia. In addition, we entered into new strategic collaborations with companies such as Tempus and BliNK Biomedical, which will allow us to expand our pipeline in new directions as Genmab continues to move towards our goal of transforming cancer treatment.
Financial Performance First Nine Months of 2019
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 1/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
Genmab is improving its 2019 financial guidance published on August 14, 2019 mainly due to positive foreign exchange movements between the USD and DKK resulting in increased milestone income and royalties on sales of DARZALEX.
| Revised | Previous | |||
| MDKK | Guidance | Guidance | ||
| Revenue | 5,100 | 4,800 | ||
| Operating expenses | (2,750) | (2,750) | ||
| Operating income | 2,350 | 2,050 |
Genmab will hold a conference call in English to discuss the results for the first nine months of 2019 today, Wednesday, November 6, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call dial
+1 631 510 7495 (U.S. participants) or +44 2071 928000 (international participants) and provide conference code 7996106.
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. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 2/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
| CONSOLIDATED KEY FIGURES | 4 |
| OUTLOOK | 5 |
| KEY 2019 PRIORITIES | 6 |
| PRODUCT PIPELINE | 7 |
| PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST NINE MONTHS OF 2019 | 7 |
| SIGNIFICANT RISKS AND UNCERTAINTIES | 20 |
| FINANCIAL REVIEW | 21 |
| STATEMENT OF COMPREHENSIVE INCOME FOR THE 3RD QUARTER OF 2019 | 25 |
| STATEMENT OF COMPREHENSIVE INCOME FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2019 | 26 |
| BALANCE SHEET | 27 |
| STATEMENT OF CASH FLOWS | 28 |
| STATEMENT OF CHANGES IN EQUITY | 29 |
| NOTES TO THE FINANCIAL STATEMENTS | 30 |
| ABOUT GENMAB | 43 |
| DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT | 44 |
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 3/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
CONSOLIDATED KEY FIGURES
| 3rd Quarter of | 3rd Quarter of | 9 Months Ended | 9 Months Ended | Full Year | |||||||||
| 2019 | 2018* | September 30, 2019 | September 30, 2018* | 2018* | |||||||||
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | DKK'000 | |||||||||
| Income Statement | |||||||||||||
| Revenue | 1,039,844 | 598,597 | 2,404,767 | 1,789,284 | 3,025,137 | ||||||||
| Research and development expenses | (607,886) | (343,242) | (1,717,342) | (974,682) | (1,431,159) | ||||||||
| General and administrative expenses | (81,225) | (55,182) | (225,449) | (155,340) | (213,695) | ||||||||
| Operating expenses | (689,111) | (398,424) | (1,942,791) | (1,130,022) | (1,644,854) | ||||||||
| Operating result | 350,733 | 200,173 | 461,976 | 659,262 | 1,380,283 | ||||||||
| Net financial items | 348,546 | 30,425 | 441,853 | 162,216 | 231,688 | ||||||||
| Net result | 537,047 | 179,175 | 694,141 | 638,276 | 1,472,141 | ||||||||
| Balance Sheet | |||||||||||||
| Cash position** | 11,116,849 | 5,895,423 | 11,116,849 | 5,895,423 | 6,106,094 | ||||||||
| Non-current assets | 1,074,001 | 831,752 | 1,074,001 | 831,752 | 1,027,974 | ||||||||
| Assets | 13,330,303 | 7,403,733 | 13,330,303 | 7,403,733 | 8,460,999 | ||||||||
| Shareholders' equity | 12,514,631 | 7,079,169 | 12,514,631 | 7,079,169 | 8,014,360 | ||||||||
| Share capital | 64,989 | 61,490 | 64,989 | 61,490 | 61,498 | ||||||||
| Investments in intangible and tangible assets | 46,573 | 408,754 | 82,147 | 456,545 | 477,366 | ||||||||
| Cash Flow Statement | |||||||||||||
| Cash flow from operating activities | 319,068 | 211,741 | 1,151,094 | 810,688 | 1,014,786 | ||||||||
| Cash flow from investing activities | (46,241) | (414,402) | (832,323) | (1,201,093) | (1,777,553) | ||||||||
| Cash flow from financing activities | 3,637,030 | 12,900 | 3,652,648 | (72,611) | (70,901) | ||||||||
| Cash and cash equivalents | 4,643,035 | 896,074 | 4,643,035 | 896,074 | 532,907 | ||||||||
| Cash position increase/(decrease) | 4,165,896 | (175,512) | 5,010,755 | 472,686 | 683,357 | ||||||||
| Financial Ratios | |||||||||||||
| Basic net result per share | 8.38 | 2.92 | 11.14 | 10.43 | 24.03 | ||||||||
| Diluted net result per share | 8.28 | 2.89 | 11.03 | 10.29 | 23.73 | ||||||||
| Period-end share market price | 1,390.50 | 1,010.00 | 1,390.50 | 1,010.00 | 1,067.50 | ||||||||
| Price / book value | 7.22 | 8.77 | 7.22 | 8.77 | 8.19 | ||||||||
| Shareholders' equity per share | 192.57 | 115.13 | 192.57 | 115.13 | 130.32 | ||||||||
| Equity ratio | 94 | % | 96 | % | 94 | % | 96 | % | 95 | % | |||
| Average number of employees (FTE***) | 514 | 334 | 458 | 297 | 313 | ||||||||
| Number of employees at the end of the period | 533 | 349 | 533 | 349 | 377 |
* As disclosed in note 1 of the financial statements, prior period amounts have not been adjusted under the modified retrospective method to adopt IFRS 16 as of January 1, 2019
** 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. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 4/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
| Revised | Previous | |||
| MDKK | Guidance | Guidance | ||
| Revenue | 5,100 | 4,800 | ||
| Operating expenses | (2,750) | (2,750) | ||
| Operating income | 2,350 | 2,050 |
Genmab is improving its 2019 financial guidance published on August 14, 2019 mainly due to positive foreign exchange movements between the USD and DKK resulting in increased milestone income and royalties on sales of DARZALEX.
We expect our 2019 revenue to be approximately DKK 5,100 million, an increase of DKK 300 million compared to the previous guidance. Our projected revenue for 2019 primarily consists of DARZALEX royalties of DKK 3,000 million, an increase of DKK 115 million from the previous guidance due to positive impact of USD/DKK exchange rate movements. The DARZALEX royalties are based on estimated net sales of USD 3.0 billion in 2019. We project DARZALEX milestones of approximately DKK 1,675 million driven by commercial net-sales based milestones of USD 100 million and USD 150 million, for achieving net-sales in a calendar year of USD 2.5 billion and USD 3.0 billion respectively, an increase of DKK 175 million from the previous guidance mainly due to positive impact of USD/DKK exchange rate movements. The remainder of the revenue consists of cost reimbursement income, Arzerra royalties, and DuoBody milestones.
We anticipate that our 2019 operating expenses will be approximately DKK 2,750 million driven by the advancement of our product pipeline and addition of new projects.
We now expect the operating income to be approximately DKK 2,350 million in 2019, an increase of DKK 300 million 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 financial guidance assumes that no significant agreements are entered during 2019 that could materially affect the results.
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 5/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
| Priority | Targeted Milestones | |
| Daratumumab | U.S. FDA decision on Phase III MAIA multiple myeloma (MM) submission U.S. FDA decision on Phase III CASSIOPEIA MM submission Phase III COLUMBA MM subcutaneous daratumumab safety and efficacy analysis | |
| Ofatumumab | Phase III ASCLEPIOS I & II relapsing multiple sclerosis subcutaneous ofatumumab study completion and reporting | |
| Tisotumab vedotin | Phase II innovaTV 204 tisotumab vedotin recurrent / metastatic cervical cancer study enrollment complete by mid-year | |
| Innovative pipeline | * | Phase II enapotamab vedotin expansion cohort efficacy analysis Phase I/II HexaBody -DR5/DR5 initial clinical data Phase I/II DuoBody-CD3xCD20 clinical data dose escalation cohorts File INDs or CTAs for 3 new products |
*Initial data now anticipated in 2020. A status update will be available in 2019.
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 6/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
Our own and partnered product pipeline consists of eighteen antibodies in clinical development, including two marketed partnered products, and approximately 20 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 NINE MONTHS OF 2019
Marketed Partnered Products
DARZALEX (daratumumab) First CD38 Antibody Approved in the World
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) |
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 7/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
| 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) |
| Split Dosing Regimen | ||
| December 2018 | Option to split first infusion over two consecutive days | EQUULEUS (MMY1001) |
| 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) |
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
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 8/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
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.
Third Quarter Update
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 9/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 10/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
Daratumumab Development Covering All States of Multiple Myeloma Key Ongoing Trials
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 11/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
Daratumumab Development Beyond Multiple Myeloma
Arzerra (ofatumumab) Our First Marketed Product
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, and urinary tract infection).
Please consult the full U.S. Prescribing information, including Boxed Warning for all the labeled safety information for Arzerra.
Ofatumumab (OMB157) - Potential in Relapsing Multiple Sclerosis
Ofatumumab is a human IgG1k mAb that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. A subcutaneous formulation of ofatumumab is being
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 12/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
investigated in two Phase III clinical studies in RMS. The studies compare the efficacy and safety of subcutaneous ofatumumab versus teriflunomide in patients with relapsing MS and are comprised of approximately 900 patients each. A Phase III study examining the long-term safety, tolerability and effectiveness of ofatumumab in patients with relapsing MS who participated in a previous study is also ongoing as is a study to evaluate the bioequivalence of 20mg of subcutaneous ofatumumab injected by either pre-filled syringe or autoinjector in adult relapsing MS patients.
Third Quarter Update
Proprietary Products in Development*
*Certain products in co-development, partners as indicated
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 13/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
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.
Third Quarter Update
Enapotamab vedotin (HuMax-AXL-ADC) A First-in-Class ADC
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.
Third Quarter Update
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. A Phase I/II clinical trial in solid tumors was on a brief partial clinical hold for discussions with the U.S. FDA. This partial hold has been lifted and the dose escalation part of the trial is ongoing.
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 14/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
DuoBody-CD3xCD20 (GEN3013) A Proprietary Bispecific Antibody
DuoBody-CD3xCD20 is a proprietary bispecific antibody created using Genmab's DuoBody technology. DuoBody-CD3xCD20 targets CD3, which is expressed on T-cells, and CD20, a clinically well-validated target. A Phase I/II clinical study of DuoBody-CD3xCD20 in B-cell malignancies is ongoing.
DuoBody-PD-L1x4-1BB (GEN1046) Potential in Solid Tumors
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.
DuoBody-CD40x4-1BB (GEN1042) New in the Clinic
DuoBody-CD40x4-1BB (GEN1042) 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. CD40 and 4-1BB were selected as targets to enhance both dendritic cells (DC) and antigen-dependent T-cell activation, using an inert DuoBody format. A Phase I/II clinical study of DuoBody-CD40 x4-1BB in solid tumors is ongoing.
Third Quarter Update
| Genmab A/S | Tel: +45 7020 2728 | Company Announcement no. 53 |
| Kalvebod Brygge 43 | Fax: +45 7020 2729 | Page 15/44 |
| 1560 Copenhagen V, Denmark | www.genmab.com | CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019