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Genmab — Interim / Quarterly Report 2018
Aug 8, 2018
3365_rns_2018-08-08_8c4c7b2e-93fb-4ea7-b89c-d67a3c929505.pdf
Interim / Quarterly Report
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Genmab
Genmab Announces Financial Results for the First Half of 2018
August 8, 2018; Copenhagen, Denmark;
Interim Report for the First Half of 2018
Highlights
- USD 943 million in net sales of DARZALEX® (daratumumab), resulting in royalty income of DKK 695 million
- U.S. FDA approved DARZALEX (daratumumab) in combination with bortezomib, melphalan and prednisone (VMP) for frontline multiple myeloma
- Phase III study of Arzerra® (ofatumumab) plus bendamustine in indolent B-cell non-Hodgkin's lymphoma (iNHL) did not meet primary endpoint
- Phase Ib/II study (CALLISTO/LUC2001) of daratumumab in combination with atezolizumab in non-small cell lung cancer stopped following data monitoring committee review
"We reached a number of key milestones with our clinical development programs during the second quarter including: treating the first patients in the Phase II study of tisotumab vedotin in cervical cancer and in the Phase I/II study of HexaBody®-DR5/DR5 in solid tumors, and advancing the Phase I/II study of HuMax®-AXL-ADC in solid tumors into the expansion phase of the trial. In addition, while we did have disappointing results with daratumumab in lung cancer, this product continues to rapidly progress in the multiple myeloma space, where DARZALEX received another label expansion in the U.S., making it the first antibody ever approved for treatment of frontline multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
Financial Performance First Half of 2018
- Revenue was DKK 1,191 million in the first half of 2018 compared to DKK 1,024 million in the first half of 2017. The increase of DKK 167 million, or 16%, was mainly driven by the payment from Novartis of USD 50 million and higher DARZALEX royalties, partly offset by a decrease in DARZALEX milestones.
- Operating expenses were DKK 732 million in the first half of 2018 compared to DKK 442 million in the first half of 2017. The increase of DKK 290 million, or 66%, was driven by the advancement of tisotumab vedotin, additional investments in our product pipeline, and the increase in employees to support expansion of our product pipeline.
- Operating income was DKK 459 million in the first half of 2018 compared to DKK 582 million in the first half of 2017. The decrease of DKK 123 million, or 21%, was driven by increased operating expenses, which was partly offset by higher revenue.
Subsequent Events
- July: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending broadening the existing marketing authorization for DARZALEX in the European Union. The recommendation is for the use of DARZALEX in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
- July: Genmab entered into a research collaboration and exclusive license agreement with Immatics Biotechnologies GmbH (Immatics) to discover and develop next-generation bispecific immunotherapies to target multiple cancer indications. Genmab received an exclusive license to three proprietary targets from Immatics, with an option to license up to two additional targets at predetermined economics. The companies will conduct joint research, funded by Genmab, on multiple antibody and/or T-cell receptor-based bispecific therapeutic product concepts. Genmab may elect to progress any resulting product candidates, and will be responsible for development, manufacturing and worldwide commercialization. For any products that are commercialized by Genmab, Immatics will have an option to limited co-promotion efforts in selected countries in the EU. Under the terms of the agreement, Genmab will pay Immatics an upfront fee of USD 54
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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CVR no. 2102 3884
Genmab
Genmab Announces Financial Results for the First Half of 2018
million and Immatics is eligible to receive up to USD 550 million in development, regulatory and commercial milestone payments for each product, as well as tiered royalties on net sales.
Outlook
Genmab is maintaining its 2018 financial guidance published on February 21, 2018.
Conference Call
Genmab will hold a conference call in English to discuss the results for the first half of 2018 today, Wednesday, August 8, at 6.00 pm CEST, 5.00 pm BST or 12.00 pm EDT. To join the call dial +1 646 828 8193 (US participants) or +44 330 336 9125 (international participants) and provide conference code 6488927.
A live and archived webcast of the call and relevant slides will be available at www.genmab.com.
Contact:
Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications
T: +45 33 44 77 20; M: +45 25 12 62 60; E: [email protected]
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Genmab
Interim Report First Half 2018
CONTENTS
CONSOLIDATED KEY FIGURES ... 4
OUTLOOK ... 5
2018 GOALS ... 6
PRODUCT PIPELINE ... 7
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST HALF OF 2018 ... 8
SIGNIFICANT RISKS AND UNCERTAINTIES ... 13
FINANCIAL REVIEW ... 14
STATEMENT OF COMPREHENSIVE INCOME FOR THE 2ND QUARTER OF 2018 ... 18
STATEMENT OF COMPREHENSIVE INCOME FOR THE FIRST HALF OF 2018 ... 19
BALANCE SHEET ... 20
STATEMENT OF CASH FLOWS ... 21
STATEMENT OF CHANGES IN EQUITY ... 22
NOTES TO THE FINANCIAL STATEMENTS ... 23
ABOUT GENMAB ... 37
DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT ... 38
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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CVR no. 2102 3884
Genmab
Interim Report First Half 2018
CONSOLIDATED KEY FIGURES
| 2nd Quarter of 2018 | 2nd Quarter of 2017* | 6 Months Ended June 30, 2018 | 6 Months Ended June 30, 2017* | Full Year 2017* | |
|---|---|---|---|---|---|
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | DKK'000 | |
| Income Statement | |||||
| Revenue | 509,675 | 773,348 | 1,190,687 | 1,024,125 | 2,365,436 |
| Research and development expenses | (318,889) | (201,568) | (631,440) | (371,639) | (874,278) |
| General and administrative expenses | (55,742) | (35,365) | (100,158) | (70,001) | (146,987) |
| Operating expenses | (374,631) | (236,933) | (731,598) | (441,640) | (1,021,265) |
| Operating result | 135,044 | 536,415 | 459,089 | 582,485 | 1,344,171 |
| Net financial items | 200,271 | (145,475) | 131,791 | (171,063) | (280,451) |
| Net result | 260,527 | 307,265 | 459,101 | 323,364 | 1,103,551 |
| Balance Sheet | |||||
| Cash position** | 6,070,935 | 5,214,759 | 6,070,935 | 5,214,759 | 5,422,737 |
| Non-current assets | 524,090 | 309,788 | 524,090 | 309,788 | 543,515 |
| Assets | 7,199,663 | 6,028,515 | 7,199,663 | 6,028,515 | 6,602,942 |
| Shareholders' equity | 6,861,225 | 5,439,354 | 6,861,225 | 5,439,354 | 6,272,192 |
| Share capital | 61,437 | 61,118 | 61,437 | 61,118 | 61,186 |
| Investments in intangible and tangible assets | 19,019 | 35,988 | 47,791 | 39,844 | 88,510 |
| Cash Row Statement | |||||
| Cash flow from operating activities | 134,876 | 544,038 | 598,947 | 1,295,959 | 1,588,972 |
| Cash flow from investing activities | (103,924) | (332,345) | (786,691) | (719,554) | (667,574) |
| Cash flow from financing activities | 42,332 | 90,481 | (85,511) | 193,759 | 214,911 |
| Cash and cash equivalents | 1,087,165 | 1,031,721 | 1,087,165 | 1,031,721 | 1,347,545 |
| Cash position increase/(decrease) | 369,763 | 464,134 | 648,198 | 1,292,794 | 1,500,772 |
| Financial Ratios | |||||
| Basic net result per share | 4.26 | 5.05 | 7.51 | 5.33 | 18.14 |
| Diluted net result per share | 4.21 | 4.95 | 7.41 | 5.21 | 17.77 |
| Period-end share market price | 984.80 | 1,389.00 | 984.80 | 1,389.00 | 1,029.00 |
| Price / book value | 8.82 | 15.61 | 8.82 | 15.61 | 10.04 |
| Shareholders' equity per share | 111.68 | 89.00 | 111.68 | 89.00 | 102.51 |
| Equity ratio | 95% | 90% | 95% | 90% | 95% |
| Average number of employees (FTE***) | 293 | 228 | 278 | 221 | 235 |
| Number of employees at the end of the period | 309 | 234 | 309 | 234 | 257 |
- As disclosed in note 1 of the financial statements, prior period amounts have not been adjusted under the modified retrospective method to adopt IFRS 15 as of January 1, 2018
** 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 (2015) and key figures in accordance with IFRS.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Genmab
Interim Report First Half 2018
OUTLOOK
| MDKK | 2018 Guidance |
|---|---|
| Revenue | 2,700 – 3,100 |
| Operating expenses | (1,400) – (1,600) |
| Operating income | 1,300 – 1,500 |
Genmab is maintaining its 2018 financial guidance published on February 21, 2018.
We expect our 2018 revenue to be in the range of DKK 2,700 – 3,100 million. Our projected revenue for 2018 consists primarily of DARZALEX royalties of approximately DKK 1,750 million that are based on an estimated USD 2.0 – 2.3 billion of DARZALEX net sales in 2018. We project DARZALEX milestones of approximately DKK 550 million in 2018, consisting primarily of a commercial net sales-based milestone. In addition, the 2018 guidance includes the upfront payment from Novartis of approximately DKK 300 million related to the transition of Arzerra from commercial availability to compassionate use programs in non-US markets. The remainder of the revenue consists of cost reimbursement income, Arzerra royalties, and DuoBody® milestones.
We anticipate that our 2018 operating expenses will be in the range of DKK 1,400 – 1,600 million. The increase compared to 2017 is driven by the advancement of tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and an increase in employees to support the expansion of our product pipeline.
We expect the operating income for 2018 to be approximately DKK 1,300 – 1,500 million.
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 and Arzerra sales and corresponding royalties to Genmab; and currency exchange rates (the 2018 guidance assumes a USD/DKK exchange rate of 6.0). The financial guidance assumes that no significant agreements are entered into during 2018 that could materially affect the results.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Genmab
Interim Report First Half 2018
2018 GOALS
| Priority | ✓ | Targeted Milestone |
|---|---|---|
| Maximize daratumumab progress | X | • FDA and EMA decision on Phase III ALCYONE multiple myeloma (MM) submission |
| • Start new Phase III MM study | ||
| • Report early clinical data in solid tumors | ||
| • Phase III MAIA MM efficacy analysis in frontline | ||
| • Phase III CASSIOPEIA MM efficacy analysis in frontline | ||
| Optimize ofatumumab value | ✓ | • Complete recruitment Phase III subcutaneous ofatumumab relapsing MS studies |
| Maximize tisotumab vedotin progress | • Start two Phase II studies in cervical cancer (recurrent / metastatic & combination study in frontline) | |
| • Start Phase II study in additional solid tumor indications | ||
| Strengthen differentiated product pipeline and technology partnership portfolio | ✓ | • Start HuMax-AXL-ADC expansion phase in ongoing Phase I/II study |
| ✓ | • Progress HexaBody-DR5/DR5 Phase I/II study | |
| • Progress DuoBody-CD3xCD20 Phase I/II study | ||
| • Accelerate proprietary Immuno-Oncology DuoBody programs towards clinic | ||
| • Enter new technology or product collaborations | ||
| Disciplined financial management and building a commercial footprint | • Execute controlled company growth with selective investments in product & technology pipeline | |
| • Continue investing in building commercialization and launch capabilities |
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Genmab
Interim Report First Half 2018
PRODUCT PIPELINE
Our own and partnered product pipeline consists of thirteen antibodies in clinical development, including two marketed products, and approximately 20 in-house and partnered pre-clinical programs. The following chart illustrates the disease indications and most advanced development status for each of our pipeline products. For additional information, visit www.genmab.com/product-pipeline.
| Product | Disease Indications | Most Advanced Clinical Development Phase | ||||||
|---|---|---|---|---|---|---|---|---|
| Pre-Clinical | I | I/II | II | III | ||||
| Daratumumab | BTD (2 - MM) | Multiple myeloma (MM) | ||||||
| Target: CD38 | Amyloidosis | |||||||
| Partner: Janssen | Non-MM blood cancers | |||||||
| Ofatumumab | BTD (CLL) | Relapsing multiple sclerosis (RMS) | ||||||
| (OMB157) | (SubQ) | |||||||
| Target: CD20 | ||||||||
| Partner: Novartis | ||||||||
| Tisotumab vedotin | Cervical cancer | |||||||
| Target: TF | Solid tumors | |||||||
| Partner: Seattle Genetics | ||||||||
| HuMax-AXL-ADC | Solid tumors | |||||||
| Target: AXL | ||||||||
| HexaBody-DR5/DR5 | Solid tumors | |||||||
| Target: DR5 | ||||||||
| DuoBody-CD3xCD20 | Hematological malignancies | |||||||
| Targets:CD3, CD20 | ||||||||
| Teprotumumab (RV001) | BTD | Graves' orbitopathy | ||||||
| Target: IGF-1R, Partner: Horizon Pharma | ||||||||
| HuMax-IL8 | Advanced cancers | |||||||
| Target: IL8, Partner: BMS | ||||||||
| Camidanlumab tesirine (ADCT-301) | Lymphoma | |||||||
| Target: CD25, Partner: ADCT | Acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) | |||||||
| JNJ-61186372 | Non-small-cell lung cancer (NSCLC) | |||||||
| Targets: EGFR, cMet, Partner: Janssen | ||||||||
| JNJ-63709178* | Acute Myeloid Leukemia (AML) | |||||||
| Targets: CD3, CD123, Partner: Janssen | ||||||||
| JNJ-64007957 | Relapsed or refractory MM | |||||||
| Targets: BCMA, CD3, Partner: Janssen | ||||||||
| JNJ-64407564 | Relapsed or refractory MM | |||||||
| Targets: CD3, GPRC5D, Partner: Janssen | ||||||||
| ~20 Active Pre-clinical programs incl. DuoBody CD40x4-1BB | Proprietary programs: HuMab, HuMab-ADC, DuoBody, DuoBody-ADC & HexaBody | |||||||
| Partnered programs: HuMab, DuoBody & HexaBody |
*Study on clinical hold
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Genmab
Interim Report First Half 2018
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST HALF OF 2018
Marketed Products
DARZALEX (daratumumab) – First CD38 Antibody Approved Anywhere in the World
- First-in-class CD38 antibody in development to treat cancer
- Approved in combination with other therapies for frontline multiple myeloma in U.S., in combination with other therapies in relapsed/refractory multiple myeloma in U.S., EU and Japan; and as monotherapy for heavily pretreated or double-refractory multiple myeloma in U.S. and EU
- Multiple Phase III studies ongoing in multiple myeloma and amyloidosis, including studies with a subcutaneous formulation
- Early stage studies ongoing in other blood cancers
- Collaboration with Janssen
- Net sales of DARZALEX by Janssen were USD 943 million in the first half of 2018
DARZALEX (daratumumab) injection for intravenous infusion is approved in the U.S. in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who have received at least one prior therapy; in combination with pomalidomide and dexamethasone for the treatment of patients with multiple myeloma who have received at least two prior therapies, including lenalidomide and a proteasome inhibitor (PI); and as a monotherapy for the treatment of patients with multiple myeloma 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. In the EU, DARZALEX is approved for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of adult patients with multiple myeloma who have received at least one prior therapy, and as a monotherapy for the treatment of adult patients with relapsed and refractory multiple myeloma, whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy. In Japan, DARZALEX is approved in relapsed or refractory multiple myeloma based on Phase III studies evaluating daratumumab in combination with lenalidomide and dexamethasone or bortezomib 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.
Second Quarter Update
- May: The U.S. FDA approved the use of DARZALEX in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.
- May: The Data Monitoring Committee (DMC) recommended that the Phase Ib/II study (CALLISTO/LUC2001) of daratumumab in combination with atezolizumab versus atezolizumab monotherapy in patients with previously treated advanced or metastatic non-small cell lung cancer should be stopped. The DMC made this recommendation as there was no observed benefit within the combination treatment arm, daratumumab plus atezolizumab, over atezolizumab monotherapy, and noted a numerical increase in mortality-related events in the
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Interim Report First Half 2018
combination arm, which were primarily due to disease progression. In addition the Phase I MMY2036 study of daratumumab plus JNJ-63723283, an anti PD-1 antibody in patients with multiple myeloma will be discontinued. Janssen has contacted its partner companies conducting daratumumab and anti-PD-(L)1 combination studies to discuss ceasing enrollment and dosing of the combination while the data is being further investigated.
First Quarter Update
- January: The U.S. FDA granted Priority Review to daratumumab in combination with bortezomib, melphalan and prednisone for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant. The FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of May 21, 2018 to take a decision on daratumumab in this indication.
- Q1: A number of new studies of daratumumab were published on www.clinicaltrials.gov: a Phase II study of daratumumab in pediatric and young adult patients with relapsed/refractory acute lymphoblastic leukemia (ALL); a Phase II study of daratumumab in combination with tamibarotene in patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS), a Phase II study of subcutaneous daratumumab in combination with standard multiple myeloma treatments; a Phase II study of daratumumab in combination with ixazomib and dexamethasone in relapsed and/or refractory multiple myeloma.
Daratumumab Development Covering All States of Multiple Myeloma – Key Ongoing Trials
| Disease Stage | Therapy | Most Advanced Clinical Development Phase | ||||
|---|---|---|---|---|---|---|
| Pre-Clinical | I | I/II | II | III | ||
| High Risk Smoldering | Subcutaneous | AQUILA | ||||
| Monotherapy | VENTAURUS | |||||
| Front line (transplant & non-transplant) | Dara + VMP | ALCYONE | ||||
| Dara + VMP (Asia Pacific) | ||||||
| Dara + Rd | MAIA | |||||
| Dara + VTd | CASSIOPEIA | |||||
| Dara + RVd | GRIFFIN | |||||
| Relapsed or Refractory | Dara + Vd (China) | |||||
| Dara + Kd | CANDOR | |||||
| Dara + Pom + d | APOLLO | |||||
| Subcutaneous vs IV | COLUMBA | |||||
| Dara + combinations | NINLARO® (Ph II), Venclexta™ (Ph II), Selinexor (Ph I/II) | |||||
| Dara + I.O. (PD1 & PDL1) | Keytruda® (Ph II), Opdivo® (Ph I/II), Tecentriq® (Ph I) |
V = Velcade®, MP = melphalan-prednisone, T = thalidomide, d = dexamethasone, R = Revilimid®, K = Kyprolis®, Pom = Pomalyst®
☑ Fully recruited
Daratumumab Development – Beyond Multiple Myeloma
| Amyloidosis • Ph III D (SC) + cyclophosphamide, bortezomib & dexamethasone (CyBorD) | MDS • Ph II D | ALL • Ph II D + standard of care chemotherapy | NKTCL (nasal type) • Ph II monotherapy |
|---|---|---|---|
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Interim Report First Half 2018
Arzerra (ofatumumab) – Our First Marketed Product
- Human CD20 monoclonal antibody in development to treat autoimmune disease
- Arzerra approved in certain territories for certain chronic lymphocytic leukemia (CLL) indications
- Two Phase III studies with low dose subcutaneous ofatumumab in relapsing multiple sclerosis ongoing
- Collaboration with Novartis
- Net sales of Arzerra by Novartis were USD 11 million in the first half of 2018
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. In the EU, Arzerra is approved for use in combination with chlorambucil or bendamustine for the treatment of adult patients with CLL who have not received prior therapy and who are not eligible for fludarabine-based therapy and in combination with fludarabine and cyclophosphamide for adult patients with relapsed CLL. In the U.S. and EU member countries, Arzerra is also indicated as monotherapy for the treatment of patients with CLL who are refractory after prior treatment with fludarabine and alemtuzumab. On January 22, 2018, it was announced that Novartis intends to transition Arzerra from commercial availability to limited availability via compassionate use programs in non-U.S. markets.
A subcutaneous formulation of ofatumumab is being investigated in two Phase III clinical studies in relapsing multiple sclerosis. Novartis expects to complete the studies during 2019 and then will evaluate the potential for a regulatory filing soon thereafter, based on study completion and positive results.
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 US Prescribing information, including Boxed Warning, and the full European Summary of Product Characteristics for all the labeled safety information for Arzerra.
Second Quarter Update
- May: Topline results from the Phase III study of ofatumumab plus bendamustine showed that the study did not meet the primary endpoint of improved progression-free survival (PFS) in patients with indolent B-cell non-Hodgkin's lymphoma (iNHL) who were unresponsive to rituximab or a rituximab-containing regimen, compared to those given bendamustine alone. The safety profile observed in this study was consistent with that observed in other trials of ofatumumab and no new safety signals were observed.
- May: Patient recruitment was completed in the Phase III studies of subcutaneous ofatumumab in relapsing MS.
First Quarter Update
- January: Announced Novartis' intent to transition the commercial availability of Arzerra to limited availability via compassionate use programs or alternative solutions for patients continuing to benefit from Arzerra in non-U.S. markets, but will continue to market for CLL in the U.S. Novartis will work with key stakeholders, including regulatory authorities to establish compassionate use programs or alternative solutions so that patients benefitting from Arzerra can remain on
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Interim Report First Half 2018
treatment. Genmab received USD 50 million from Novartis as payment for lost potential milestones and royalties. Planning to transition the commercial availability of Arzerra to limited availability via compassionate use programs for the treatment of CLL in non-U.S. markets is underway and Novartis' goal is to start implementation in early 2019, as soon as carefully structured plans are agreed upon with key stakeholders, including regulatory authorities in countries involved.
Proprietary Products in Development
Tisotumab vedotin – A Next Generation Therapeutic
- Antibody-drug conjugate (ADC, antibody coupled to a cell-killing agent) in development to treat solid tumors
- Phase II potential registration study in cervical cancer ongoing; Phase II clinical studies in solid tumors announced
- License and collaboration agreement with Seattle Genetics
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 future costs and profits for the product on a 50:50 basis.
Second Quarter Update
- June: The first patient was dosed in the Phase II potential registration innovaTV204 study of tisotumab vedotin as monotherapy for recurrent and/or metastatic cervical cancer.
- April: A Phase II study of tisotumab vedotin (innovaTV207) for locally advanced or metastatic solid tumors was published on www.clinicaltrials.gov.
HuMax-AXL-ADC – A First-in-Class ADC
- ADC in development to treat solid tumors
- Phase I/II clinical study for six types of solid tumors ongoing
HuMax-AXL-ADC is an ADC targeted to AXL, a signaling molecule expressed on many solid cancers and implicated in tumor biology. HuMax-AXL-ADC is in Phase I/II clinical development for six different solid tumors: ovarian, cervical, endometrial, thyroid, non-small cell lung cancer (NSCLC), and melanoma. HuMax-AXL-ADC is fully owned by Genmab and the ADC technology used with HuMax-AXL-ADC was licensed from Seattle Genetics.
Second Quarter Update
- June: A USD 7 million milestone payment from Genmab to Seattle Genetics was triggered by the initiation of expansion cohorts in the ongoing Phase I/II trial of HuMax-AXL-ADC in solid tumors.
- May: Expansion cohorts in the ongoing Phase I/II study of HuMax-AXL-ADC in NSCLC, melanoma and sarcoma started.
HexaBody-DR5/DR5 – First HexaBody Program in Development
- Proprietary antibody therapeutic created with Genmab's HexaBody technology
- Composed of two non-competing HexaBody molecules that target two distinct DR5 epitopes
- Phase I/II clinical trial in solid tumors ongoing
HexaBody-DR5/DR5 is 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. HexaBody-
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Interim Report First Half 2018
DR5/DR5 may have potential in a number of solid cancers including colorectal, NSCLC, triple negative breast cancer, renal cell cancer, gastric cancer and urothelial cancer. A Phase I/II clinical trial in solid tumors is ongoing.
Second Quarter Update
- May: The first patient was dosed in the Phase I/II study of HexaBody-DR5/DR5.
DuoBody-CD3xCD20 – A Proprietary Bispecific Antibody
- Proprietary bispecific antibody created with Genmab's DuoBody technology
- Phase I/II clinical trial in B-cell malignancies starting in Q3 2018
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. DuoBody-CD3xCD20 could have potential to treat B-cell malignancies such as diffuse large B-cell lymphoma, indolent non-Hodgkin's lymphoma and mantle cell lymphoma. A Phase I/II clinical study of DuoBody-CD3xCD20 is starting in the third quarter of 2018.
Partner Programs Built on Genmab's Innovation
Teprotumumab
- In clinical development by Horizon Pharma, plc
- In Phase III development for active thyroid eye disease
Teprotumumab is a fully human antibody that targets the Insulin-like Growth Factor-1 Receptor (IGF-1R), which is a well-validated target. Teprotumumab was created by Genmab under our collaboration with Roche. Clinical Development of teprotumumab is being conducted by Horizon Pharma plc under a license from Roche. Teprotumumab has been granted Fast Track designation, Orphan Drug designation and Breakthrough Therapy Designation for Graves' orbitopathy (thyroid eye disease) by the U.S. FDA.
First Quarter Update
- March: A Phase III extension study for patients who participated in the Phase III study (NCT03298867) of teprotumumab in patients with active thyroid eye disease was published on www.clinicaltrials.gov.
HuMax-IL8
- Fully human antibody in development under a collaboration with Bristol-Myers Squibb (BMS-986253)
- In Phase I/II development in advanced cancers
HuMax-IL8 is a high affinity fully human antibody directed towards IL-8. IL-8 has been shown to be involved in several aspects of tumor development including tumor spread (metastasis), cancer stem cell renewal and tumor immune-suppression. HuMax-IL8 has been shown to inhibit these processes and to inhibit tumor growth in pre-clinical tumor models. HuMax-IL8 is in development for the treatment advanced cancers under an agreement with Bristol-Myers Squibb.
First Quarter Update
- January: A Phase I/II study of HuMax-IL8 in combination with nivolumab in advanced cancers was published on www.clinicaltrials.gov (NCT 02536469).
JNJ-64407564
- DuoBody product targeting CD3 and GPRC5D
- Phase I study in relapsed or refractory multiple myeloma announced
Genmab A/S
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- Developed by Janssen under the DuoBody technology collaboration
JNJ-64407564 is a bispecific antibody that targets CD3, which is expressed on T-cells and GPRC5D, which is highly expressed in multiple myeloma cells. JNJ-64407564 was created under a collaboration between Genmab and Janssen using Genmab's DuoBody technology. JNJ-64407564 is being investigated in a Phase I clinical study to treat relapsed or refractory multiple myeloma.
Second Quarter Update
- May: The first patients were dosed in the Phase I study of JNJ-64407564 in relapsed or refractory multiple myeloma, triggering a milestone payment from Janssen to Genmab.
First Quarter Update
- January: A Phase I study of JNJ-64407564 in relapsed or refractory multiple myeloma was published on www.clinicaltrials.gov.
JNJ-63709178
- DuoBody product targeting CD3 and CD123
- Phase I study in relapsed or refractory AML
- Developed by Janssen under the DuoBody technology collaboration
JNJ-63709178 is a bispecific antibody that targets CD3, which is expressed on T-cells and CD123, which is overexpressed in various hematologic malignancies. JNJ-63709178 can redirect T-cells, resulting in T-cell mediated killing of CD123+ AML cells. JNJ-63709178 was created under a collaboration between Genmab and Janssen using Genmab's DuoBody technology. JNJ-63709178 is being investigated in a Phase I clinical study to treat relapsed or refractory AML.
Second Quarter Update
- June: The Phase I study of JNJ-63709178 in relapsed or refractory AML was placed on clinical hold due to the occurrence of a Grade 3 adverse event.
Pre-clinical Programs
- Broad pre-clinical pipeline of approximately 20 programs including DuoBody-CD40x4-1BB
- Pre-clinical pipeline includes both partnered products and in-house programs based on our proprietary technologies
- Multiple new INDs expected to be submitted over coming years
Genmab has approximately 20 active in-house and partnered pre-clinical programs. Our pre-clinical pipeline includes naked antibodies, immune effector function enhanced antibodies developed with our HexaBody technology, and bispecific antibodies created with our DuoBody platform. A number of the pre-clinical programs are carried out in cooperation with our collaboration partners, such as programs targeting central nervous system disease with Lundbeck, and the DuoBody-CD40x4-1BB immune-oncology program with BioNTech.
Second Quarter Update
- June: Genmab achieved milestones and license fees from Janssen related to the option of an additional DuoBody target pair under our DuoBody license agreement.
- June: A pre-clinical milestone has been reached in the DuoBody collaboration with Novo Nordisk, triggering a milestone payment to Genmab. In addition, Novo Nordisk has extended exclusivity of the commercial license for a target pair under this collaboration, triggering a payment to Genmab.
Genmab A/S
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Tel: +45 7020 2728
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Genmab
Interim Report First Half 2018
SIGNIFICANT RISKS AND UNCERTAINTIES
As a biotech company, Genmab faces a number of risks and uncertainties. These are common for the industry and relate to operations, research and development, commercial and financial activities. For further information about risks and uncertainties which the Genmab group faces, refer to the 2017 annual report. At the date of this interim report, there have been no significant changes to Genmab's overall risk profile since the publication of the 2017 annual report.
FINANCIAL REVIEW
The interim report is prepared on a consolidated basis for the Genmab group. The financial statements are published in Danish Kroner (DKK).
Revenue
Genmab's revenue was DKK 1,191 million for the first half of 2018 compared to DKK 1,024 million for the first half of 2017. The increase of DKK 167 million, or 16%, was driven by the upfront payment from Novartis of USD 50 million and increased DARZALEX royalties, partly offset by a decrease in DARZALEX milestones.
| MDKK | H1 2018 | H1 2017* |
|---|---|---|
| Royalties | 709 | 479 |
| Milestone payments | 40 | 489 |
| License fees | 336 | 47 |
| Reimbursement income | 106 | 9 |
| Total revenue | 1,191 | 1,024 |
- As disclosed in note 1 of the financial statements, prior period amounts have not been adjusted under the modified retrospective method to adopt IFRS 15 after January 1, 2018.
Royalties
Royalty income amounted to DKK 709 million in the first half of 2018 compared to DKK 479 million in the first half of 2017. The increase of DKK 230 million, or 48%, was driven by higher DARZALEX royalties, which were partly offset by lower Arzerra royalties.
Net sales of DARZALEX by Janssen were USD 943 million in the first half of 2018 compared to USD 554 million in the first half of 2017. The increase of USD 389 million, or 70%, was driven by the continued strong uptake following the regulatory approvals in the U.S. and EU. Royalty income on net sales of DARZALEX was DKK 695 million in the first half of 2018 compared to DKK 454 million in the first half of 2017, an increase of DKK 241 million. The increase in royalties of 53% is lower than the increase in the underlying sales due to currency fluctuations between the USD and DKK.
Novartis' net sales of Arzerra were USD 11 million in the first half of 2018 compared to USD 18 million in the first half of 2017, a decrease of USD 7 million, or 39%. Royalty income on net sales of Arzerra was DKK 14 million in the first half of 2018 compared to DKK 25 million in the first half of 2017, a decrease of DKK 11 million, or 44%.
Milestone Payments
Milestone income was DKK 40 million in the first half of 2018 which was driven by the Janssen and Novo Nordisk DuoBody collaborations. In the first half of 2017 milestone income was DKK 489 million. The decrease of DKK 449 million, or 92%, was mainly driven by milestones related to the first commercial sales of DARZALEX in the second and third indications under the expanded label granted by the European Commission in April 2017 and the filing and first commercial sale of DARZALEX in the fourth indication in the US in June 2017. Milestone income may fluctuate significantly from period to period due to both the timing of achievements and the varying amount of each individual milestone under our license and collaboration agreements.
Genmab A/S
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Interim Report First Half 2018
Licenses Fees
License fee income was DKK 336 million during the first half of 2018 which was driven by the USD 50 million upfront payment from Novartis with the amendment of the Arzerra/ofatumumab license and collaboration agreement, payment from Janssen for an additional DuoBody target pair under the license agreement and the payment from Novo Nordisk for extending exclusivity of the commercial license for a DuoBody target pair under the agreement. In the first half of 2017, license fee income was DKK 47 million and related to the amortization of upfront payments received under our license and collaboration agreements on a straight line basis over the planned development periods. As disclosed in note 1 of the financial statements, prior period amounts have not been adjusted under the modified retrospective method to adopt IFRS 15 after January 1, 2018.
Reimbursement Income
Reimbursement income amounted to DKK 106 million in the first half of 2018 compared to DKK 9 million in the first half of 2017. The increase of DKK 97 million was driven by our collaboration agreements with Seattle Genetics and BioNTech.
Refer to note 1 for further details on the impact of adoption of IFRS 15 and note 2 in this interim report for further details about revenue.
Research and Development Costs
Research and development costs amounted to DKK 632 million in the first half of 2018 compared to DKK 372 million in the first half of 2017. The increase of DKK 260 million, or 70%, was driven by the advancement of tisotumab vedotin, additional investment in our product pipeline, and the increase in research and development employees.
Research and development costs accounted for 86% of the total operating expenses in the first half of 2018 compared to 84% in the first half of 2017.
General and Administrative Expenses
General and administrative expenses were DKK 100 million in the first half of 2018 compared to DKK 70 million in the first half of 2017. The increase of DKK 30 million, or 43%, was driven by an increase in administrative employees due to the expansion of our product pipeline.
General and administrative expenses accounted for 14% of the total operating expenses in the first half of 2018 compared to 16% in the first half of 2017.
Operating Result
Operating income was DKK 459 million in the first half of 2018 compared to DKK 582 million in the first half of 2017. The decrease of DKK 123 million, or 21%, was driven by increased operating expenses, which was partly offset by higher revenue.
As of June 30, 2018, the total number of employees was 309 compared to 234 employees as of June 30, 2017. The increase in employees was driven by the expansion of our pipeline.
| Workforce | June 30, 2018 | June 30, 2017 |
|---|---|---|
| Research and development employees | 263 | 199 |
| Administrative employees | 46 | 35 |
| Total employees | 309 | 234 |
Net Financial Items
The net financial items for the first half of 2018 were net income of DKK 132 million compared to a net loss of DKK 171 million in the first half of 2017. The main driver for the variance between the two periods is foreign exchange movements, which positively impacted our USD denominated portfolio and cash
Genmab A/S
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1560 Copenhagen V, Denmark
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Interim Report First Half 2018
holdings. The USD strengthened against the DKK during the first half of 2018, resulting in realized and unrealized exchange rate gains. Refer to note 4 in this interim report for further details about the net financial items.
Corporate Tax
The corporate tax expense for the first half of 2018 was DKK 132 million compared to DKK 88 million for the first half of 2017. The estimated annual effective corporate tax rate in the first half of 2018 was 22% compared to 21% in the first half of 2017. There has been no reversal of the valuation allowances on deferred tax assets in the first half of 2018 or the first half of 2017.
Net Result
Net result for the first half of 2018 was a net income of DKK 459 million compared to a net income of DKK 323 million in the first half of 2017. The increase was driven by the items described above.
Cash Position
| Cash Position (MDKK) | June 30, 2018 | December 31, 2017 |
|---|---|---|
| Marketable securities | 4,984 | 4,075 |
| Cash and cash equivalents | 1,087 | 1,348 |
| Cash position | 6,071 | 5,423 |
As of June 30, 2018, cash, cash equivalents, and marketable securities (cash position) amounted to DKK 6,071 million. This represents a net increase of DKK 648 million from the beginning of 2018, which was mainly driven by our operating income of DKK 459 million, positive working capital adjustments of DKK 54 million primarily related to milestones achieved in 2017 which were received in 2018, and proceeds from the exercise of warrants of DKK 61 million, which were partly offset by the purchase of treasury shares for DKK 146 million.
There were no short term marketable securities included in cash and cash equivalents at the end of June 2018. Cash and cash equivalents included short term marketable securities of DKK 54 million at the end of June 2017. In accordance with our accounting policy, securities purchased with a maturity of less than three months at the date of acquisition are classified as cash and cash equivalents. Refer to note 3 in this interim report for further details about our marketable securities.
Cash Flow
| Cash Flow (MDKK) | H1 2018 | H1 2017 |
|---|---|---|
| Cash provided by (used in) operating activities | 599 | 1,296 |
| Cash provided by (used in) investing activities | (787) | (720) |
| Cash provided by (used in) financing activities | (86) | 194 |
Net cash provided by operating activities is primarily related to our operating result, working capital fluctuations, and adjustments related to non-cash expenses, all of which may be highly variable period to period. In the first half of 2018, the primary driver of lower cash provided by operating activities was higher positive working capital adjustments in 2017 related to milestones achieved in the fourth quarter of 2016 that were received in 2017.
The change in cash used in investing activities primarily reflects differences between the proceeds received from sale and maturity of our investments and amounts invested. Purchases of marketable securities exceeded sales and maturities in both the first half of 2018 and 2017, which has resulted in significant growth in the marketable securities portion of the cash position.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
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Interim Report First Half 2018
Net cash used in financing activities for the first half of 2018 is related to the purchase of treasury shares of DKK 146 million partly offset by the proceeds from the exercise of warrants of DKK 61 million. Net cash provided by financing activities for the first half of 2017 is related to proceeds from the exercise of warrants of DKK 194 million.
Balance Sheet
As of June 30, 2018, total assets were DKK 7,200 million compared to DKK 6,603 million as of December 31, 2017. As of June 30, 2018, assets are mainly comprised of a cash position of DKK 6,071 million and receivables of DKK 552 million. The receivables consist primarily of royalties from our license and collaboration agreements and non-interest bearing receivables, which are due less than one year from the balance sheet date.
Shareholders' equity as of June 30, 2018 was DKK 6,861 million compared to DKK 6,272 million at the end of December 2017. The increase was driven by our net income and the impact of the adoption of IFRS 15, which were partly offset by the purchase of treasury shares. As of June 30, 2018, Genmab's equity ratio was 95%, which remained unchanged compared to December 31, 2017.
Legal Matter – MorphoSys Patent Infringement Complaint
In April 2016, MorphoSys filed a complaint at the U.S. District Court of Delaware against Genmab and Janssen Biotech, Inc., for patent infringement under U.S. patent no. 8,263,746 based on activities relating to the manufacture, use and sale of DARZALEX in the U.S. In February 2017, MorphoSys was allowed to amend its complaint to include a second U.S. patent, U.S. patent no. 9,200,061, into the case. In October 2017, the U.S. District Court of Delaware allowed MorphoSys to amend its complaint to include a third U.S. patent, U.S. patent no. 9,758,590, which is related to the '746 and '061 patents. The parties agreed to include this third patent for case efficiency, and it is not expected to change the merits of the case. The trial date has been rescheduled to February 2019 from the original trial date of August 2018. Jury trial has been requested by MorphoSys. Genmab and Janssen disagree with the allegations made by MorphoSys in its complaint for patent infringement and vigorously contest those allegations.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
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Interim Report First Half 2018
STATEMENT OF COMPREHENSIVE INCOME FOR THE 2ND QUARTER OF 2018
Income Statement
| 2nd Quarter of 2018 | 2nd Quarter of 2017 | |
|---|---|---|
| DKK'000 | DKK'000 | |
| Revenue | 509,675 | 773,348 |
| Research and development expenses | (318,889) | (201,568) |
| General and administrative expenses | (55,742) | (35,365) |
| Operating expenses | (374,631) | (236,933) |
| Operating result | 135,044 | 536,415 |
| Net financial items | 200,271 | (145,475) |
| Net result before tax | 335,315 | 390,940 |
| Corporate tax | (74,788) | (83,675) |
| Net result | 260,527 | 307,265 |
| Basic net result per share | 4.26 | 5.05 |
| Diluted net result per share | 4.21 | 4.95 |
| Statement of Comprehensive Income | ||
| Net result | 260,527 | 307,265 |
| Other comprehensive income: | ||
| Amounts which will be re-classified to the income statement: | ||
| Adjustment of foreign currency fluctuations on subsidiaries | 10,335 | (8,646) |
| Fair value adjustments of cash flow hedges: | ||
| Fair value adjustments during the period | - | 13,422 |
| Fair value adjustments reclassified to the income statement | - | (4,296) |
| Total comprehensive income | 270,862 | 307,745 |
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
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STATEMENT OF COMPREHENSIVE INCOME FOR THE FIRST HALF OF 2018
Income Statement
| Note | 6 Months Ended June 30, 2018 | 6 Months Ended June 30, 2017 | |
|---|---|---|---|
| DKK'000 | DKK'000 | ||
| Revenue | 2 | 1,190,687 | 1,024,125 |
| Research and development expenses | (631,440) | (371,639) | |
| General and administrative expenses | (100,158) | (70,001) | |
| Operating expenses | (731,598) | (441,640) | |
| Operating result | 459,089 | 582,485 | |
| Net financial items | 4 | 131,791 | (171,063) |
| Net result before tax | 590,880 | 411,422 | |
| Corporate tax | (131,779) | (88,058) | |
| Net result | 459,101 | 323,364 | |
| Basic net result per share | 7.51 | 5.33 | |
| Diluted net result per share | 7.41 | 5.21 | |
| Statement of Comprehensive Income | |||
| Net result | 459,101 | 323,364 | |
| Other comprehensive income: | |||
| Amounts which will be re-classified to the income statement: | |||
| Adjustment of foreign currency fluctuations on subsidiaries | 5,444 | (10,351) | |
| Fair value adjustments of cash flow hedges: | |||
| Fair value adjustments during the period | - | 15,537 | |
| Fair value adjustments reclassified to the income statement | - | (4,799) | |
| Total comprehensive income | 464,545 | 323,751 |
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
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BALANCE SHEET
| Note | June 30, 2018 | December 31, 2017 | June 30, 2017 | |
|---|---|---|---|---|
| DKK'000 | DKK'000 | DKK'000 | ||
| ASSETS | ||||
| Intangible assets | 153,791 | 124,395 | 164,039 | |
| Property, plant and equipment | 147,026 | 113,415 | 66,725 | |
| Receivables | 4,728 | 8,756 | 4,146 | |
| Deferred tax assets | 218,545 | 296,949 | 74,878 | |
| Total non-current assets | 524,090 | 543,515 | 309,788 | |
| Receivables | 546,950 | 579,002 | 503,968 | |
| Corporate tax receivable | 57,688 | 57,688 | - | |
| Marketable securities | 3 | 4,983,770 | 4,075,192 | 4,183,038 |
| Cash and cash equivalents | 1,087,165 | 1,347,545 | 1,031,721 | |
| Total current assets | 6,675,573 | 6,059,427 | 5,718,727 | |
| Total assets | 7,199,663 | 6,602,942 | 6,028,515 | |
| SHAREHOLDERS' EQUITY AND LIABILITIES | ||||
| Share capital | 61,437 | 61,186 | 61,118 | |
| Share premium | 8,044,066 | 7,983,652 | 7,962,568 | |
| Other reserves | 87,524 | 82,080 | 103,270 | |
| Accumulated deficit | (1,331,802) | (1,854,726) | (2,687,602) | |
| Shareholders' equity | 6,861,225 | 6,272,192 | 5,439,354 | |
| Provisions | 1,430 | 1,200 | - | |
| Other payables | 2,144 | 2,429 | - | |
| Total non-current liabilities | 3,574 | 3,629 | - | |
| Provisions | - | - | 1,433 | |
| Deferred income | - | 150,648 | 181,509 | |
| Corporate tax payable | 31,471 | - | 61,612 | |
| Other payables | 303,393 | 176,473 | 344,607 | |
| Total current liabilities | 334,864 | 327,121 | 589,161 | |
| Total liabilities | 338,438 | 330,750 | 589,161 | |
| Total shareholders' equity and liabilities | 7,199,663 | 6,602,942 | 6,028,515 |
Share-based instruments 5
Shareholdings by the Board of Directors and Executive Management 6
Subsequent events to the balance sheet date 7
Genmab A/S
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STATEMENT OF CASH FLOWS
| Note | 6 Months Ended June 30, 2018 | 6 Months Ended June 30, 2017 | |
|---|---|---|---|
| DKK'000 | DKK'000 | ||
| Net result before tax | 590,880 | 411,422 | |
| Reversal of financial items, net | (131,791) | 171,063 | |
| Adjustments for non-cash transactions | 70,673 | 60,253 | |
| Changes in working capital | 53,940 | 629,963 | |
| Cash flow from operating activities before financial items | 583,702 | 1,272,701 | |
| Financial interest received | 20,643 | 23,647 | |
| Financial expenses paid | (273) | (375) | |
| Corporate taxes received/(paid) | (5,125) | (14) | |
| Cash flow from operating activities | 598,947 | 1,295,959 | |
| Investments in tangible assets | (47,791) | (39,844) | |
| Marketable securities bought | 3 | (1,792,044) | (2,124,580) |
| Marketable securities sold | 1,053,144 | 1,444,870 | |
| Cash flow from investing activities | (786,691) | (719,554) | |
| Warrants exercised | 60,413 | 192,991 | |
| Shares issued for cash | 251 | 768 | |
| Purchase of treasury shares | (146,175) | - | |
| Cash flow from financing activities | (85,511) | 193,759 | |
| Change in cash and cash equivalents | (273,255) | 770,164 | |
| Cash and cash equivalents at the beginning of the period | 1,347,545 | 307,023 | |
| Exchange rate adjustments | 12,875 | (45,466) | |
| Cash and cash equivalents at the end of the period | 1,087,165 | 1,031,721 | |
| Cash and cash equivalents include: | |||
| Bank deposits | 1,087,165 | 978,151 | |
| Short-term marketable securities | - | 53,570 | |
| Cash and cash equivalents at the end of the period | 1,087,165 | 1,031,721 |
Genmab A/S
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STATEMENT OF CHANGES IN EQUITY
| Number of shares | Share capital | Share premium | Translation reserves | Cash flow hedges | Accumulated deficit | Shareholders' equity | |
|---|---|---|---|---|---|---|---|
| DKK'000 | DKK'000 | DKK'000 | DKK'000 | DKK'000 | DKK'000 | ||
| December 31, 2016 | 60,350,056 | 60,350 | 7,769,577 | 98,711 | 4,172 | (3,106,114) | 4,826,696 |
| Net result | - | - | - | - | - | 323,364 | 323,364 |
| Other comprehensive income | - | - | - | (10,351) | 10,738 | - | 387 |
| Total comprehensive income | - | - | - | (10,351) | 10,738 | 323,364 | 323,751 |
| Transactions with owners: | |||||||
| Exercise of warrants | 768,346 | 768 | 192,991 | - | - | - | 193,759 |
| Purchase of treasury shares | - | - | - | - | - | - | - |
| Capital increase | - | - | - | - | - | - | - |
| Expenses related to capital increases | - | - | - | - | - | - | - |
| Share-based compensation expenses | - | - | - | - | - | 37,055 | 37,055 |
| Tax on items recognized directly in equity | - | - | - | - | - | 58,093 | 58,093 |
| June 30, 2017 | 61,118,402 | 61,118 | 7,962,568 | 88,360 | 14,910 | (2,687,602) | 5,439,354 |
| December 31, 2017 | 61,185,674 | 61,186 | 7,983,652 | 82,080 | - | (1,854,726) | 6,272,192 |
| Change in accounting policy: Adoption of IFRS 15 | - | - | - | - | - | 150,648 | 150,648 |
| Adjusted total equity at January 1, 2018 | 61,185,674 | 61,186 | 7,983,652 | 82,080 | - | (1,704,078) | 6,422,840 |
| Net result | - | - | - | - | - | 459,101 | 459,101 |
| Other comprehensive income | - | - | - | 5,444 | - | - | 5,444 |
| Total comprehensive income | - | - | - | 5,444 | - | 459,101 | 464,545 |
| Transactions with owners: | |||||||
| Exercise of warrants | 251,144 | 251 | 60,414 | - | - | - | 60,665 |
| Purchase of treasury shares | - | - | - | - | - | (146,175) | (146,175) |
| Share-based compensation expenses | - | - | - | - | - | 43,225 | 43,225 |
| Tax on items recognized directly in equity | - | - | - | - | - | 16,125 | 16,125 |
| June 30, 2018 | 61,436,818 | 61,437 | 8,044,066 | 87,524 | - | (1,331,802) | 6,861,225 |
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Genmab
Interim Report First Half 2018
NOTES TO THE FINANCIAL STATEMENTS
Note 1 – Basis of Presentation
Accounting Policies
The interim report is prepared in accordance with International Accounting Standard No. 34 (IAS 34), "Interim Financial Reporting" and additional Danish disclosure requirements for interim reports of listed companies. The interim report has not been reviewed or audited by Genmab's external auditors.
The interim report has been prepared using the same accounting policies as outlined in section 1 – Basis of Presentation in the financial statements in the 2017 annual report, except for the adoption of new accounting standards detailed below.
Management Judgments and Estimates under IFRS
In preparing interim reports, certain provisions under IFRS require management to make judgments (various accounting estimates and assumptions) which may significantly impact the group's financial statements. The most significant judgments include, among other things, revenue recognition, share-based compensation, deferred tax assets, and recognition of internally generated intangible assets. For additional descriptions of significant judgments and estimates, refer to note 1.3 in the 2017 annual report, except for revenue recognition, which is described below.
Fair Value Measurement
For financial instruments that are measured in the balance sheet at fair value, IFRS 13 for financial instruments requires disclosure of fair value measurements by level of the following fair value measurement hierarchy for:
- Level 1 – Quoted prices (unadjusted) in active markets for identical assets or liabilities
- Level 2 – Inputs other than quoted prices included within level 1 that are observable for the asset or liability, either directly (that is, as prices) or indirectly (that is, derived from prices)
- Level 3 – Inputs for the asset or liability that are not based on observable market data (that is, unobservable inputs).
| MDKK | June 30, 2018 | December 31, 2017 | |||
|---|---|---|---|---|---|
| Assets Measured at Fair Value | Note | Level 1 | Level 2 | Level 1 | Level 2 |
| Marketable securities | 3 | 4,984 | - | 4,075 | - |
| Receivables – derivatives | - | - | - | 12 |
Marketable Securities
All fair market values are determined by reference to external sources using unadjusted quoted prices in established markets for our marketable securities (Level 1).
Derivative Financial Instruments
The fair value is determined using valuation techniques that utilize market based data such as currency rates, yield curves and implied volatility (Level 2). As of June 30, 2018, there were no derivatives outstanding.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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New Accounting Standards - Recently Adopted
IFRS 15 Revenue from Contracts with Customers
Effective January 1, 2018, we adopted IFRS 15 using the modified retrospective transition method. Under this method, the cumulative effect of initially applying the new revenue standard was recognized as an adjustment to the opening balance of accumulated deficit. The comparative information has not been restated and continues to be reported under the accounting standards in effect for those periods. IFRS 15 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance, and financial instruments.
Under IFRS 15, Genmab recognizes revenue when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that Genmab determines are within the scope of IFRS 15, Genmab performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of IFRS 15, we assess the goods or services promised within each contract and identify, as a performance obligation, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Evaluating the criteria for revenue recognition under license and collaboration agreements requires management's judgement to assess and determine the following:
- The nature of performance obligations and whether they are distinct or should be combined with other performance obligations to determine whether the performance obligations are satisfied over time or at a point in time.
- An assessment of whether the achievement of milestone payments is highly probable
- The stand-alone selling price of each performance obligation identified in the contract using key assumptions which may include forecasted revenues, development timelines, reimbursement rates for personnel costs, discount rates and probabilities of technical and regulatory success.
In accordance with the requirements of IFRS 15, the disclosure of the impact of adoption on our consolidated financial statements was as follows:
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Interim Report First Half 2018
| 2nd Quarter of 2018 | |||
|---|---|---|---|
| As Reported | Balances Without Adoption of IFRS 15 | Effect of Change Higher/(Lower) | |
| DKK'000 | DKK'000 | DKK'000 | |
| Income Statement: | |||
| Revenue | 509,675 | 531,654 | (21,979) |
| Net result before tax | 335,315 | 357,294 | (21,979) |
| Corporate tax | (74,788) | (79,689) | 4,901 |
| Net result | 260,527 | 277,605 | (17,078) |
| Basic net result per share | 4.26 | 4.54 | (0.28) |
| Diluted net result per share | 4.21 | 4.48 | (0.27) |
| 6 Months Ended June 30, 2018 | |||
| --- | --- | --- | --- |
| As Reported | Balances Without Adoption of IFRS 15 | Effect of Change Higher/(Lower) | |
| DKK'000 | DKK'000 | DKK'000 | |
| Income Statement: | |||
| Revenue | 1,190,687 | 1,234,812 | (44,125) |
| Net result before tax | 590,880 | 635,005 | (44,125) |
| Corporate tax | (131,779) | (141,619) | 9,840 |
| Net result | 459,101 | 493,386 | (34,285) |
| Basic net result per share | 7.51 | 8.07 | (0.56) |
| Diluted net result per share | 7.41 | 7.96 | (0.55) |
| June 30, 2018 | |||
| --- | --- | --- | --- |
| As Reported | Balances Without Adoption of IFRS 15 | Effect of Change Higher/(Lower) | |
| DKK'000 | DKK'000 | DKK'000 | |
| Balance Sheet: | |||
| Deferred income | - | 106,523 | (106,523) |
| Accumulated deficit | (1,331,802) | (1,438,325) | 106,523 |
The impact of the adoption of IFRS 15 on the consolidated financial statements is detailed in the tables above and is due to changes in the accounting policy for revenue recognition compared to prior accounting standards, which is described below:
- Changes in revenue recognition for licenses of functional intellectual property resulted in a timing difference of revenue recognition between prior accounting standards and IFRS 15. For certain of our agreements, the value associated with the licenses and certain other deliverables had been assessed as one unit of accounting and recognized over a period of time pursuant to revenue recognition guidance in effect at the time of such agreements. Under IFRS 15, the licenses of functional intellectual property were determined to be distinct from other deliverables and the customers obtained the right to use the functional intellectual property on the effective
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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date of the agreements when control transferred. This timing difference of revenue recognition resulted in the full deferred revenue balance of DKK 151 million as of December 31, 2017 being reclassified to accumulated deficit in the first quarter of 2018.
IFRS 15 may have an impact on the timing of recognition of milestone payments. Under prior accounting standards, we recognized such payments as revenue in the period that the payment-triggering event occurred or was achieved. IFRS 15 requires Genmab to recognize such payments as revenue before the payment-triggering event is completely achieved, subject to management's assessment of whether it is highly probable that the triggering event will be achieved and that a significant reversal in the amount of cumulative revenue recognized will not occur.
IFRS 15 will not have an impact on revenue recognition for sales-based royalties and commercial sales-based milestone payments and they will continue to be recognized in the period to which the sales relate based on estimates provided by collaboration partners.
IFRS 9 Financial Instruments
Effective January 1, 2018 we adopted IFRS 9 which replaces the provisions of IAS 39 that relate to the classification, measurement and derecognition of financial assets and financial liabilities, hedge accounting, and impairment of financial assets. The adoption of IFRS 9 resulted in changes in accounting policies (included below) but did not result in material adjustments to amounts recognized in the consolidated financial statements. In accordance with the transitional provisions of IFRS 9, comparative figures have not been restated.
On January 1, 2018 Genmab classifies its financial assets held into the following measurement categories:
- those to be measured subsequently at fair value (either through other comprehensive income, or through profit or loss), and
- those to be measured at amortized cost.
The classification depends on the business model for managing the financial assets and the contractual terms of the cash flows.
For assets measured at fair value, gains and losses will either be recorded in profit or loss or other comprehensive income.
Genmab reclassifies debt investments when and only when its business model for managing those assets changes.
Marketable Securities
Marketable securities consist of investments in securities with a maturity greater than three months at the time of acquisition. Measurement of marketable securities depends on the business model for managing the asset and the cash flow characteristics of the asset. Under IFRS 9, there are three measurement categories into which the group classifies its debt instruments:
- Amortized cost: Assets that are held for collection of contractual cash flows, where those cash flows represent solely payments of principal and interest, are measured at amortized cost. Interest income from these financial assets is included in finance income using the effective interest rate method. Any gain or loss arising on derecognition is recognized directly in profit or loss and presented in other gains/(losses), together with foreign exchange gains and losses. Impairment losses are presented as a separate line item in the statement of profit or loss.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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- Fair value through other comprehensive income (FVOCI): Assets that are held for collection of contractual cash flows and for selling the financial assets, where the assets' cash flows represent solely payments of principal and interest, are measured at FVOCI. Movements in the carrying amount are taken through OCI, except for the recognition of impairment gains or losses, interest revenue and foreign exchange gains and losses which are recognized in profit or loss. When the financial asset is derecognized, the cumulative gain or loss previously recognized in OCI is reclassified from equity to profit or loss and recognized in other gains/(losses). Interest income from these financial assets is included in finance income using the effective interest rate method. Foreign exchange gains and losses are presented in other gains/(losses) and impairment expenses are presented as separate line item in the statement of profit or loss.
- Fair value through profit and loss (FVPL): Assets that do not meet the criteria for amortized cost or FVOCI are measured at FVPL. A gain or loss on a debt investment that is subsequently measured at FVPL is recognized in profit or loss and presented net within other gains/(losses) in the period in which it arises.
Genmab's portfolio is managed and evaluated on a fair value basis in accordance with its investment guidelines and the information provided internally to management. This business model does not meet the criteria for amortized cost or FVOCI and as a result marketable securities are measured at fair value through profit and loss. This classification is consistent with the prior year's classification.
Derivatives and Hedging Activities
The one foreign currency forward in place as of December 31, 2017 qualified as a cash flow hedge under IFRS 9. The group's risk management strategies and hedge documentation are aligned with the requirements of IFRS 9 and this relationship is therefore treated as a continuing hedge.
Derivatives are initially recognized at fair value on the date a derivative contract is entered into and are subsequently re-measured at their fair value. The method of recognizing the resulting gain or loss depends on whether the derivative is designated as a hedging instrument, and if so, the nature of the item being hedged. Genmab designates certain derivatives as either:
- Fair value hedge (hedges of the fair value of recognized assets or liabilities or a firm commitment); or
- Cash flow hedge (hedges of a particular risk associated with a recognized asset or liability or a highly probable forecast transaction).
At the inception of a transaction, Genmab documents the relationship between hedging instruments and hedged items, as well as its risk management objectives and strategy for undertaking various hedging transactions. Genmab also documents its assessment, both at hedge inception and on an ongoing basis, of whether the derivatives that are used in hedging transactions are highly effective in offsetting changes in fair values or cash flows of hedged items.
Movements on the hedging reserve in other comprehensive income are shown as part of the statement of shareholders' equity. The full fair value of a hedging derivative is classified as a non-current asset or liability when the remaining maturity of the hedged item is more than 12 months and as a current asset or liability when the remaining maturity of the hedged item is less than 12 months.
The effective portion of changes in the fair value of derivatives that are designated and qualify as cash flow hedges is recognized in other comprehensive income. The gain or loss relating to the ineffective portion and changes in time value of the derivative instrument is recognized immediately in the income statement within financial income or expenses.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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When forward contracts are used to hedge forecast transactions, Genmab generally designates the full change in fair value of the forward contract (including forward points) as the hedging instrument. In such cases, the gains or losses relating to the effective portion of the change in fair value of the entire forward contract are recognized in the cash flow hedge reserve within equity.
Changes in the fair value of derivatives that are designated and qualify as fair value hedges are recorded in the income statement, together with any changes in the fair value of the hedged asset or liability that is attributable to the hedged risk.
Receivables
Receivables are designated as loans and receivables and are initially measured at fair value or transaction price and subsequently measured in the balance sheet at amortized cost, which generally corresponds to nominal value less expected credit loss provision.
Genmab applied the IFRS 9 simplified approach to measuring expected credit losses which uses a lifetime expected loss allowance for all receivables. To measure the expected credit losses, receivables have been grouped based on credit risk characteristics and the days past due. The provision for expected credit losses was not significant given that there have been no credit losses over the last three years and the high quality nature (top tier life science companies) of Genmab's customers.
Note 2 – Revenue
Genmab enters into license and collaboration agreements which are within the scope of IFRS 15, under which it licenses certain rights to its product candidates to third parties and also may participate in the development of the product candidates. The terms of these arrangements typically include payment to Genmab of one or more of the following: non-refundable, upfront license fees; exclusive designation fees; annual license maintenance fees; additional target fees; development, regulatory and commercial milestone payments; payments for research and development services; and royalties on net sales of licensed products. Each of these payments results in revenue from contracts with customers.
In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under each of its agreements, Genmab performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations; and (v) recognition of revenue when (or as) Genmab satisfies each performance obligation.
License Fees for Intellectual Property
If the license to Genmab's functional intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, Genmab recognizes revenues from non-refundable upfront fees allocated to the license at the point in time the license is transferred to the licensee and the licensee is able to use and benefit from the license. For licenses that are bundled with other promises, Genmab utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. Under all of Genmab's existing license and collaboration agreements the license to functional intellectual property has been determined to be distinct from other performance obligations identified in the agreement.
Milestone Payments
At the inception of each arrangement that includes milestone payments, Genmab evaluates whether the achievement of milestones are considered highly probable and estimates the amount to be included in the transaction price using the most likely amount method. If it is highly probable that a significant revenue reversal would not occur, the associated milestone value is included in the
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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transaction price. Milestone payments that are not within the control of Genmab or the license and collaboration partner, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which Genmab recognizes revenue as or when the performance obligations under the contract are satisfied. At the end of each subsequent reporting period, Genmab re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and earnings in the period of adjustment. Under all of Genmab's existing license and collaboration agreements, milestone payments have been allocated to the license transfer performance obligation.
Reimbursement Income for R&D Services: License and collaboration agreements include the reimbursement or cost sharing for research and development services and payment for FTEs at contractual rates. R&D services are performed and satisfied over time given that the customer simultaneously receives and consumes the benefits provided by Genmab and revenue for R&D services is recognized over time rather than a point in time.
Royalties: License and collaboration agreements include sales-based royalties, including commercial milestone payments based on the level of sales, and the license has been deemed to be the predominant item to which the royalties relate. As a result, Genmab recognizes revenue when the related sales occur.
The table below disaggregates our revenue by type of payment and collaboration partner under our agreements which provides additional information regarding how the nature, amount, timing and uncertainty of our revenue and cash flows might be affected by economic factors.
| 6 Months Ended June 30, 2018 | 6 Months Ended June 30, 2017 | |
|---|---|---|
| DKK'000 | DKK'000 | |
| Revenue: | ||
| Royalties | 708,933 | 478,901 |
| Milestone payments | 40,010 | 489,537 |
| License fees | 336,045 | 46,641 |
| Reimbursement income | 105,699 | 9,046 |
| Total | 1,190,687 | 1,024,125 |
| Revenue split by collaboration partner: | ||
| Janssen (Darzalex/Daratumumab & DuoBody) | 745,302 | 985,471 |
| Novartis (Arzerra/Ofatumumab) | 317,738 | 25,226 |
| Other collaboration partners | 127,647 | 13,428 |
| Total | 1,190,687 | 1,024,125 |
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Note 3 – Marketable Securities
| June 30, 2018 | December 31, 2017 | June 30, 2017 | |
|---|---|---|---|
| DKK'000 | DKK'000 (full year) | DKK'000 | |
| Cost at the beginning of the period | 4,194,743 | 3,603,111 | 3,603,111 |
| Additions for the period | 1,792,044 | 3,425,025 | 2,124,580 |
| Disposals and maturities for the period | (1,053,386) | (2,833,393) | (1,448,110) |
| Cost at the end of the period | 4,933,401 | 4,194,743 | 4,279,581 |
| Fair value adjustment at the beginning of the period | (119,551) | 11,831 | 11,831 |
| Fair value adjustment for the period | 169,920 | (131,382) | (108,374) |
| Fair value adjustment at the end of the period | 50,369 | (119,551) | (96,543) |
| Net book value at the end of the period | 4,983,770 | 4,075,192 | 4,183,038 |
| Net book value in percentage of cost | 101.0% | 97.1% | 97.7% |
| Average effective duration | 1.53 | 1.55 | 1.73 |
In accordance with the group's risk management guidelines, Genmab's marketable securities are administrated by two external investment managers who solely invest in securities from investment grade issuers. Genmab invests its cash in deposits with major financial institutions, Danish mortgage bonds and notes issued by Danish, European, and American governments.
As of June 30, 2018, 88% of our marketable securities had a triple A-rating, compared to 91% as of December 31, 2017.
The total fair value adjustment for the first half of 2018 was a gain of DKK 170 million, which was driven primarily by foreign exchange adjustments of DKK 174 million due to the strengthening of the USD against the DKK which positively impacted our USD denominated portfolio. The total fair value adjustment for the first half of 2017 was a loss of DKK 108 million, which was driven primarily by foreign exchange adjustments of DKK 108 million due to the weakening of the USD against the DKK which negatively impacted our USD denominated portfolio.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Note 4 – Financial Income and Expenses
| 6 Months Ended June 30, 2018 | 6 Months Ended June 30, 2017 | |
|---|---|---|
| DKK'000 | DKK'000 | |
| Financial income: | ||
| Interest and other financial income | 28,007 | 20,228 |
| Realized and unrealized gains on fair value hedges, net | 2,282 | 7,227 |
| Realized and unrealized exchange rate gains, net | 111,238 | - |
| Total financial income | 141,527 | 27,455 |
| Financial expenses: | ||
| Interest and other financial expenses | 273 | 375 |
| Realized and unrealized losses on marketable securities, net | 9,463 | 13,603 |
| Realized and unrealized exchange rate losses, net | - | 184,540 |
| Total financial expenses | 9,736 | 198,518 |
| Net financial items | 131,791 | (171,063) |
Realized and unrealized exchange rate gains, net of DKK 111 million in the first half of 2018 were driven by the strengthening of the USD against the DKK which positively impacted our USD denominated portfolio and cash holdings. Realized and unrealized exchange rate losses, net of DKK 185 million in the first half of 2017 were driven by the weakening of the USD against the DKK which negatively impacted our USD denominated portfolio and cash holdings.
Note 5 – Share-Based Instruments
Restricted Stock Unit Program
Genmab A/S established a Restricted Stock Unit (RSU) program as an incentive for all the Genmab group's employees, members of the Executive Management, and members of the Board of Directors.
Under the terms of the RSU program, RSUs are subject to a cliff vesting period and become fully vested on the first banking day of the month following a period of three years from the date of grant. Within 30 days of the vesting date, the holder of an RSU receives one share in Genmab A/S for each RSU.
Genmab A/S intends to purchase its own shares in order to cover its obligations in relation to the RSU program. Authorization to purchase Genmab A/S' own shares up to a nominal value of DKK 500,000 (500,000 shares) was given at the Annual General Meeting in March 2016. As of June 30, 2018, DKK 275,000 (275,000 shares) remain available for purchase under this authorization.
During the first half of 2018, Genmab acquired 125,000 of its own shares, approximately $0.2\%$ of share capital, to cover its obligations under the RSU program. The total amount paid to acquire the shares, including directly attributable costs, was DKK 146 million and has been recognized as a deduction to shareholders' equity. These shares are classified as treasury shares and are presented within accumulated deficit as of June 30, 2018. There were no acquisitions of treasury shares in the first half of 2017.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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The shares were acquired in accordance with the authorization granted by the Annual General Meeting in March 2016 and the acquisition was carried out in compliance with applicable laws, the Nasdaq Copenhagen issuer rules and Genmab's internal policies on trading with shares of Genmab A/S.
RSU Activity
The RSU activity in the first half of 2018 and 2017, respectively, is outlined below.
| 6 Months Ended June 30, 2018 | 6 Months Ended June 30, 2017 | |
|---|---|---|
| Outstanding RSUs at January 1 | 168,044 | 102,387 |
| Granted | 10,489 | 10,252 |
| Vested | (47,450) | - |
| Forfeited | (1,971) | (156) |
| Outstanding RSUs at June 30 | 129,112 | 112,483 |
During the first half of 2018, 10,489 RSUs were granted with a weighted average fair value of DKK 1,084.57 per RSU. During the first half of 2017, 10,252 RSUs were granted with a weighted average fair value of DKK 1,416.64 per RSU.
During the first half of 2018, 47,450 RSUs vested and a corresponding amount of treasury shares were issued to cover the obligation. During the first half of 2017, no RSUs vested. As of June 30, 2018, 177,550 treasury shares were held by Genmab to cover its future obligations in relation to the RSU program.
Warrant Program
Genmab A/S established warrant programs as an incentive for all the Genmab group's employees, and members of the Executive Management.
Warrants Granted from August 2004 until April 2012
Under the August 2004 warrant program, warrants vest annually over a four year period on the anniversary of the grant date. Warrants granted under the August 2004 warrant program will lapse on the tenth anniversary of the grant date. As a general rule, the warrant holder may only exercise 25% of the warrants granted per full year of employment or affiliation with Genmab after the grant date. However, the warrant holder will be entitled to retain rights to exercise all warrants on a regular schedule in instances where the employment relationship is terminated by Genmab without cause.
Warrants Granted from April 2012 until March 2017
In April 2012, a new warrant program was adopted by the Board of Directors. Whereas warrants granted under the August 2004 warrant program will lapse on the tenth anniversary of the grant date, warrants granted under the April 2012 warrant program will lapse at the seventh anniversary of the grant date. All other terms in the warrant programs are identical.
Warrants Granted from March 2017
In March 2017, a new warrant program was adopted by the Board of Directors. Whereas warrants granted under the April 2012 warrant program vested annually over a four year period, warrants granted under the new March 2017 warrant program are subject to a cliff vesting period and become fully vested three years from the date of grant. All other terms in the warrant programs are identical.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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Warrant Activity
The warrant activity in the first half of 2018 and 2017 is outlined below.
| 6 Months Ended June 30, 2018 | 6 Months Ended June 30, 2017 | |
|---|---|---|
| Outstanding warrants at January 1 | 1,518,186 | 2,190,311 |
| Granted | 29,668 | 24,336 |
| Exercised | (251,144) | (768,346) |
| Forfeited | (38,631) | (12,219) |
| Outstanding warrants at June 30 | 1,258,079 | 1,434,082 |
| Weighted average exercise price | DKK 241.55 | DKK 252.18 |
During the first half of 2018, 29,668 warrants were granted to our employees with a weighted average exercise price of DKK 1,087.00 per warrant and a weighted average Black-Scholes fair market value of DKK 383.48 per warrant. During the first half of 2017, 24,336 warrants were granted to our employees with a weighted average exercise price of DKK 1,413.70 per warrant and a weighted average Black-Scholes fair market value of DKK 465.36 per warrant.
During the first half of 2018, 251,144 warrants were exercised with proceeds to Genmab of DKK 61 million. The warrants exercised increased share capital accordingly and corresponded to approximately 0.41% of share capital. During the first half of 2017, 768,346 warrants were exercised with proceeds to Genmab of DKK 194 million.
Share-based compensation expenses for the first half of 2018 totaled DKK 43 million compared to DKK 37 million for the first half of 2017.
Note 6 - Shareholdings by the Board of Directors and Executive Management
The tables below set forth certain information regarding the beneficial ownership of the issued share capital and the outstanding share-based instruments held by the members of the Board of Directors and the Executive Management as of June 30, 2018.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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| December 31, 2017 | Acquired | Sold | Transferred | June 30, 2018 | |
|---|---|---|---|---|---|
| Number of ordinary shares owned | |||||
| Board of Directors | |||||
| Mats Pettersson | 10,000 | 2,300 | - | - | 12,300 |
| Anders Gersel Pedersen | 7,000 | 5,475 | (4,475) | - | 8,000 |
| Pernille Erenbjerg | - | 2,700 | - | - | 2,700 |
| Paolo Paoletti | 637 | 2,700 | - | - | 3,337 |
| Rolf Hoffmann | 1,050 | - | - | - | 1,050 |
| Deirdre P. Connelly | - | 1,000 | - | - | 1,000 |
| Peter Storm Kristensen | - | - | - | - | - |
| Rick Hibbert | - | - | - | - | - |
| Daniel Bruno | - | - | - | - | - |
| 18,687 | 14,175 | (4,475) | - | 28,387 | |
| Executive Management | |||||
| Jan van de Winkel | 640,000 | 22,400 | - | - | 662,400 |
| David A. Eatwell | 17,500 | 13,325 | - | - | 30,825 |
| Judith Klimovsky | - | - | - | - | - |
| 657,500 | 35,725 | - | - | 693,225 | |
| Total | 676,187 | 49,900 | (4,475) | - | 721,612 |
| December 31, 2017 | Granted | Exercised | Forfeited | June 30, 2018 | |
| Number of warrants held | |||||
| Board of Directors | |||||
| Mats Pettersson | 38,750 | - | - | - | 38,750 |
| Anders Gersel Pedersen | 32,750 | - | (3,750) | - | 29,000 |
| Pernille Erenbjerg | - | - | - | - | - |
| Paolo Paoletti | - | - | - | - | - |
| Rolf Hoffmann | - | - | - | - | - |
| Deirdre P. Connelly | - | - | - | - | - |
| Peter Storm Kristensen | 2,515 | - | - | - | 2,515 |
| Rick Hibbert | 1,451 | - | (925) | - | 526 |
| Daniel Bruno | 16,776 | - | (3,750) | - | 13,026 |
| 92,242 | - | (8,425) | - | 83,817 | |
| Executive Management | |||||
| Jan van de Winkel | 164,802 | - | (80,000) | - | 84,802 |
| David A. Eatwell | 373,056 | - | (50,000) | - | 323,056 |
| Judith Klimovsky | 21,879 | - | - | - | 21,879 |
| 559,737 | - | (130,000) | - | 429,737 | |
| Total | 651,979 | - | (138,425) | - | 513,554 |
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
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CVR no. 2102 3884
Genmab
Interim Report First Half 2018
| December 31, 2017 | Granted | Vested | Forfeited | June 30, 2018 | |
|---|---|---|---|---|---|
| Number of RSUs held | |||||
| Board of Directors | |||||
| Mats Pettersson | 4,818 | - | (2,300) | - | 2,518 |
| Anders Gersel Pedersen | 3,613 | - | (1,725) | - | 1,888 |
| Pernille Erenbjerg | 3,959 | - | (2,700) | - | 1,259 |
| Paolo Paoletti | 3,959 | - | (2,700) | - | 1,259 |
| Rolf Hoffmann | 1,509 | - | - | - | 1,509 |
| Deirdre P. Connelly | 1,509 | - | - | - | 1,509 |
| Peter Storm Kristensen | 1,091 | - | - | - | 1,091 |
| Rick Hibbert | 924 | - | - | - | 924 |
| Daniel Bruno | 2,946 | - | - | - | 2,946 |
| 24,328 | - | (9,425) | - | 14,903 | |
| Executive Management | |||||
| Jan van de Winkel | 47,597 | - | (22,400) | - | 25,197 |
| David A. Eatwell | 29,056 | - | (13,325) | - | 15,731 |
| Judith Klimovsky | 7,204 | - | - | - | 7,204 |
| 83,857 | - | (35,725) | - | 48,132 | |
| Total | 108,185 | - | (45,150) | - | 63,035 |
Following Genmab A/S' Annual General Meeting on April 10, 2018, the Board of Directors is comprised of five independent directors, one non-independent director, and three employee-elected directors. Mats Pettersson, Dr. Anders Gersel Pedersen, Deirdre P. Connelly, Pernille Erenbjerg, Rolf Hoffmann and Dr. Paolo Paoletti were re-elected to the Board of Directors for a one year period. The Board of Directors convened and constituted itself with Mats Pettersson as Chairman and Deirdre P. Connelly as Deputy Chairman.
Other than the remuneration to the Board of Directors and the Executive Management and the transactions detailed in the tables above, no other significant transactions took place during the first half of 2018. For further information on the remuneration of the Board of Directors and the Executive Management, refer to note 5.1 in the 2017 annual report.
Note 7 - Subsequent Events to the Balance Sheet Date
On July 12, 2018, Genmab entered into a research collaboration and exclusive license agreement with Immatics Biotechnologies GmbH (Immatics) to discover and develop next-generation bispecific immunotherapies to target multiple cancer indications. Genmab received an exclusive license to three proprietary targets from Immatics, with an option to license up to two additional targets at predetermined economics. The companies will conduct joint research, funded by Genmab, on multiple antibody and/or T-cell receptor-based bispecific therapeutic product concepts. Genmab may elect to progress any resulting product candidates, and will be responsible for development, manufacturing and worldwide commercialization. For any products that are commercialized by Genmab, Immatics will have an option to limited co-promotion efforts in selected countries in the EU. Under the terms of the agreement, Genmab
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
Page 35/38
CVR no. 2102 3884
Genmab
Interim Report First Half 2018
will pay Immatics an upfront fee of USD 54 million and Immatics is eligible to receive up to USD 550 million in development, regulatory and commercial milestone payments for each product, as well as tiered royalties on net sales.
On July 27, 2018, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending broadening the existing marketing authorization for DARZALEX in the European Union. The recommendation is for the use of DARZALEX in combination with bortezomib, melphalan and prednisone (VMP) for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant (ASCT).
No other events have occurred subsequent to the balance sheet date that could significantly affect the financial statements as of June 30, 2018.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
Page 36/38
CVR no. 2102 3884
Genmab
Interim Report First Half 2018
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 has two approved antibodies, DARZALEX® (daratumumab) for the treatment of certain multiple myeloma indications, and Arzerra® (ofatumumab) for the treatment of certain chronic lymphocytic leukemia indications. Daratumumab is in clinical development for additional multiple myeloma indications and other blood cancers. A subcutaneous formulation of ofatumumab is in development for 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, and the HexaBody® platform which creates effector function enhanced antibodies. 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. For more information visit www.genmab.com.
This interim report contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with product discovery and development, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products obsolete, and other factors. For a further discussion of these risks, please refer to the section "Risk Management" in Genmab's annual report, which is available on www.genmab.com and the "Significant Risks and Uncertainties" section in this interim report. Genmab does not undertake any obligation to update or revise forward looking statements in this interim report nor to confirm such statements in relation to actual results, unless required by law.
Genmab A/S and its subsidiaries own the following trademarks: Genmab®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo™; the DuoBody logo®; the HexaBody logo™; HuMax®; HuMax-CD20®; DuoBody®; HexaBody® and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Biotech, Inc.
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
Page 37/38
CVR no. 2102 3884
Genmab
Interim Report First Half 2018
DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT
The Board of Directors and the Executive Management have today considered and adopted the unaudited interim report of the Genmab group for the six months ended June 30, 2018.
The interim report is prepared in accordance with International Accounting Standard No. 34 (IAS 34), "Interim Financial Reporting", as endorsed by the EU and additional Danish disclosure requirements for interim reports of listed companies.
We consider the applied accounting policies to be appropriate and, in our opinion, the interim report gives a true and fair view of the assets and liabilities, financial position, results of operation and cash flows of the group.
Furthermore, we consider the Management's Review, pages 4-17, to give a true and fair account of the development in the group's activities and financial affairs, results of operations and the group's financial position as a whole as well as a description of the significant risks and uncertainties which the group faces.
Copenhagen, August 8, 2018
Executive Management
Jan van de Winkel
(President & CEO)
David A. Eatwell
(Executive Vice President & CFO)
Judith Klimovsky
(Executive Vice President & CDO)
Board of Directors
Mats Pettersson
(Chairman)
Deirdre P. Connelly
(Deputy Chairman)
Rolf Hoffmann
Pernille Erenbjerg
Paolo Paoletti
Anders Gersel Pedersen
Rick Hibbert
(Employee elected)
Daniel J. Bruno
(Employee elected)
Peter Storm Kristensen
(Employee elected)
Genmab A/S
Kalvebod Brygge 43
1560 Copenhagen V, Denmark
Tel: +45 7020 2728
Fax: +45 7020 2729
www.genmab.com
Company Announcement no. 23
Page 38/38
CVR no. 2102 3884