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Genmab Interim / Quarterly Report 2017

Nov 8, 2017

3365_iss_2017-11-08_23c2f8b3-6230-4ed1-9096-fc55a115d6fc.pdf

Interim / Quarterly Report

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Genmab Announces Financial Results for the First Nine Months of 2017

November 8, 2017; Copenhagen, Denmark; Interim Report for the First Nine Months Ended September 30, 2017

Highlights

  • USD 871 million in net sales of DARZALEX® (daratumumab); resulting in royalty income of DKK 707 million
  • DARZALEX approved for relapsed or refractory multiple myeloma in Japan
  • Announced positive topline results in Phase III ALCYONE study of daratumumab in front line multiple myeloma
  • Seattle Genetics exercised its option to co-develop tisotumab vedotin with Genmab

"This past quarter we continued to focus on progressing our innovative antibody pipeline. DARZALEX received its first approval in Japan, for the treatment of relapsed or refractory multiple myeloma. We also reported exciting data from the Phase III ALCYONE study of daratumumab in front line multiple myeloma. Finally, we were pleased to announce that Seattle Genetics exercised its option to co-develop tisotumab vedotin and we very much look forward to our collaboration to rapidly bring this product into the next stages of clinical evaluation," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Nine Months of 2017

  • Revenue was DKK 1,348 million in the first nine months of 2017 compared to DKK 889 million in the first nine months of 2016. The increase of DKK 459 million, or 52%, was mainly driven by higher DARZALEX royalties and milestones.
  • Operating expenses were DKK 707 million in the first nine months of 2017 compared to DKK 544 million in the first nine months of 2016. The increase of DKK 163 million, or 30%, was due to the additional investment in our pipeline of products, including the advancement of tisotumab vedotin, HexaBody® -DR5/DR5, DuoBody® -CD3xCD20, and other products in our pipeline.
  • Operating income was DKK 641 million in the first nine months of 2017 compared to DKK 345 million in the first nine months of 2016. The increase of DKK 296 million, or 86%, was driven by higher revenue, which was partly offset by increased operating expenses in 2017.
  • On September 30, 2017, Genmab had a cash position of DKK 5,184 million compared to DKK 3,922 million at December 31, 2016. This represented a net increase of DKK 1,262 million, which was mainly driven by positive working capital adjustments of DKK 575 million related to milestones achieved in the fourth quarter of 2016 that were received in 2017, our operating income of DKK 641 million, and proceeds from the exercise of warrants of DKK 208 million.

Outlook

Genmab is maintaining its 2017 financial guidance published on February 22, 2017 and reiterated on September 27, 2017.

Conference Call

Genmab will hold a conference call in English to discuss the results for the first nine months of 2017 today, Wednesday, November 8, at 6.00 pm CET, 5.00 pm GMT or 12.00 pm EDT. The dial in numbers are:

+1 646 254 3360 (US participants) and ask for the Genmab conference call +44 20 3427 1910 (international participants) and ask for the Genmab conference call

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]

CONSOLIDATED KEY FIGURES
3
OUTLOOK4
2017 GOALS5
PRODUCT PIPELINE
5
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST NINE MONTHS OF 20176
SIGNIFICANT RISKS AND UNCERTAINTIES12
FINANCIAL REVIEW
12
STATEMENT OF
COMPREHENSIVE INCOME FOR THE 3RD QUARTER OF 2017
16
STATEMENT OF COMPREHENSIVE INCOME FOR THE NINE MONTHS ENDED SEPTEMBER 30,
2017
17
BALANCE SHEET –
ASSETS18
BALANCE SHEET –
SHAREHOLDERS' EQUITY AND LIABILITIES
19
STATEMENT OF CASH FLOWS
20
STATEMENT OF CHANGES IN EQUITY
21
NOTES TO THE FINANCIAL STATEMENTS
22
ABOUT GENMAB
29
DIRECTORS' AND MANAGEMENT'S STATEMENT ON THE INTERIM REPORT30

CONSOLIDATED KEY FIGURES

3rd quarter of 3rd quarter of 9 Months Ended 9 Months Ended Full Year
2017 2016 September 30, 2017 September 30, 2016 2016
DKK'000 DKK'000 DKK'000 DKK'000 DKK'000
Income Statement
Revenue 323,449 364,664 1,347,574 888,662 1,816,122
Research and development expenses (227,767) (150,597) (599,406) (465,218) (660,876)
General and administrative expenses (37,382) (27,231) (107,383) (78,488) (102,413)
Operating expenses (265,149) (177,828) (706,789) (543,706) (763,289)
Operating result 58,300 186,836 640,785 344,956 1,052,833
Net financial items (65,509) 2,121 (236,572) 720 77,384
Net result (5,681) 188,957 317,683 345,662 1,187,075
Balance Sheet
Cash position* 5,183,902 3,942,473 5,183,902 3,942,473 3,921,965
Non-current assets 329,448 210,991 329,448 210,991 340,597
Assets 5,895,194 4,353,053 5,895,194 4,353,053 5,238,236
Shareholders' equity 5,466,853 3,934,112 5,466,853 3,934,112 4,826,696
Share capital 61,163 60,248 61,163 60,248 60,350
Investments in intangible and tangible assets 26,913 1,528 66,757 8,565 33,109
Cash Flow Statement
Cash flow from operating activities 41,967 204,704 1,337,926 405,994 327,719
Cash flow from investing activities 25,445 (32,731) (694,109) (534,723) (1,014,539)
Cash flow from financing activities 14,473 (16,285) 208,232 65,597 91,188
Cash and cash equivalents 1,086,471 796,665 1,086,471 796,665 307,023
Cash position increase/(decrease) (30,857) 180,351 1,261,937 449,244 428,736
Financial Ratios
Basic net result per share (0.09) 3.15 5.23 5.78 19.83
Diluted net result per share (0.09) 3.06 5.12 5.60 19.22
Period-end share market price 1,390.00 1,130.00 1,390.00 1,130.00 1,173.00
Price / book value 15.55 17.31 15.55 17.31 14.67
Shareholders' equity per share 89.38 65.30 89.38 65.30 79.98
Equity ratio 93% 90% 93% 90% 92%
Average number of employees (FTE**) 242 199 228 193 196
Number of employees at the end of the period 251 202 251 202 205

* Cash, cash equivalents, bank overdraft 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.

OUTLOOK

MDKK 2017
Guidance
Revenue 1,950

2,150
Operating expenses (1,000) –
(1,100)
Operating income 900 –
1,100
Cash position at end of year* >4,500

*Cash, cash equivalents, and marketable securities

Genmab is maintaining its 2017 financial guidance published on February 22, 2017 and reiterated on September 27, 2017.

We expect our 2017 revenue to be in the range of DKK 1,950 – 2,150 million. Our projected revenue for 2017 consists primarily of DARZALEX royalties of DKK 930 – 1,100 million that are based on an estimated USD 1,100 – 1,300 million of DARZALEX net sales in 2017 and DARZALEX milestones of DKK 800 million. The remainder of the revenue mainly consists of Arzerra® royalties, DuoBody milestones, and non-cash amortization of deferred revenue. Genmab will earn milestone payments of USD 25 million from Janssen upon the first commercial sale of DARZALEX in Japan. As the first commercial sale could take place in either late 2017 or early 2018, these milestone payments are not included in the financial guidance for 2017. If the first commercial sale is achieved prior to year end, Genmab expects to update its financial guidance at that time.

We anticipate that our 2017 operating expenses will be in the range of DKK 1,000 – 1,100 million. The increased expense level from 2016 is driven by the advancement and continued investment in our pipeline of products, including tisotumab vedotin, HuMax-AXL-ADC, HexaBody-DR5/DR5, DuoBody-CD3xCD20, and our earlier stage pre-clinical programs.

We expect the operating income for 2017 to be approximately DKK 900 – 1,100 million.

Cash Position

We are projecting our cash position at the end of 2017 to be greater than DKK 4,500 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; fluctuations in the value of our marketable securities; and currency exchange rates. The financial guidance does not include any potential proceeds from future warrant exercises and also assumes that no significant agreements are entered into during 2017 that could materially affect the results.

2017 GOALS

Priority Targeted
Milestone
Maximize daratumumab
progress




EMA decision & launch in 2nd line + multiple myeloma
(MM) relapsed / refractory setting
FDA decision 3rd line MM setting (daratumumab +

pomalidomide)

Phase III MM interim efficacy analysis in frontline
(ALCYONE trial)

Start Phase III subcutaneous trial

Start trials in solid tumors and non-MM blood cancers

Report non-MM clinical data
Optimize ofatumumab value 2018*
Phase III refractory FL headline results
Strengthen differentiated
product pipeline

Phase I/II tisotumab vedotin data

Progress HuMax-AXL-ADC Phase I/II clinical trial

IND/CTA submission HexaBody-DR5/DR5

IND/CTA submission DuoBody-CD3xCD20

Progress pre-clinical pipeline
Strengthen
partnership
portfolio with next
generation technologies

Enter new technology collaborations

Progress partnered programs
Disciplined financial
management

Execute controlled company growth with selective
investments in product pipeline

*The data read out for the Phase III study of ofatumumab in refractory FL is data driven and as the events are occurring at a slower pace than anticipated, the data read out is now expected to occur in 2018.

PRODUCT PIPELINE

Our own and partnered product pipeline includes ten antibodies in clinical development, including two marketed products, and over 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 Most Advanced Development
Status
Daratumumab
Target: CD38
Multiple Myeloma (MM) Marketed in certain indications; in
Phase III
development for others
Partner: Janssen Amyloidosis Phase III study announced
Natural killer/T-cell lymphoma
(NKTCL), Nasal type
Phase II study ongoing
Myelodysplastic syndromes
(MDS)
Phase II study ongoing
Solid tumors Phase II
studies
ongoing
Ofatumumab
Target: CD20
Chronic Lymphocytic Leukemia
(CLL)
Marketed in certain indications
Indication: Cancer
Partner: Novartis
Follicular Lymphoma (FL) Phase III study ongoing
Product Disease Most Advanced Development
Status
Ofatumumab
Subcutaneous formulation
Target: CD20
Indication: Autoimmune
Partner: Novartis
Relapsing Multiple Sclerosis Phase III studies
ongoing
Tisotumab vedotin
Target: Tissue factor (TF)
Partner: Seattle Genetics
Solid cancers Phase I/II studies ongoing; Phase
II continued treatment
study
ongoing
HuMax-AXL-ADC
Target: AXL
Solid cancers Phase I/II study ongoing
Teprotumumab
Target: IGF-1R
Partner: Horizon Pharma
(sublicensed from Roche)
Graves' orbitopathy (GO) Phase II study
completed
AMG 714
Target: IL-15
Partner: Celimmune
(sublicensed from Amgen)
Celiac disease Phase II studies ongoing
ADCT-301
Target: CD25
Partner: ADC Therapeutics
Lymphoma
Acute myeloid leukemia (AML) or
acute lymphoblastic leukemia
Phase I study ongoing
Phase I study ongoing
(ALL)
JNJ-61186372
Targets: EGFR, cMET
Partner: Janssen
Non-small-cell lung cancer
(NSCLC)
Phase I study ongoing
JNJ-63709178
Targets: CD3, CD123
Partner: Janssen
Acute myeloid leukemia (AML) Phase I study ongoing
JNJ-64007957
Targets: BCMA, CD3
Partner: Janssen
Relapsed or refractory MM Phase I study ongoing
>20
Active Pre-clinical
Programs
Partnered & proprietary
programs: HuMab, HuMab-ADC,
DuoBody, DuoBody-ADC &
HexaBody
Pre-clinical

Announced = study has been announced via a company announcement or www.clinicaltrials.gov but the first patient has not yet been dosed

Ongoing = first patient has been dosed in the study; study has started

PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST NINE MONTHS OF 2017

DARZALEX (daratumumab) – A First-in-Class Antibody

  • First-in-class CD38 antibody in development to treat cancer
  • Approved 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 or announced in multiple myeloma and amyloidosis

  • Early stage studies ongoing or announced in solid tumors and other indications
  • Collaboration with Janssen
  • Net sales of DARZALEX by Janssen were USD 871 million in the first nine months of 2017

DARZALEX (daratumumab) injection for intravenous infusion is approved in the U.S. 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.

Third Quarter Update

  • September: DARZALEX was approved in combination with lenalidomide and dexamethasone or bortezomib and dexamethasone for relapsed or refractory multiple myeloma in Japan. Upon the first commercial sale in Japan, Genmab will receive USD 25 million in milestone payments.
  • September: Daratumumab was granted Orphan Drug Status from the U.S. FDA in amyloidosis.
  • August: The Phase III ALCYONE study of daratumumab in combination with bortezomib, melphalan and prednisone (VMP) in front line multiple myeloma met the primary endpoint of improving progression free survival (PFS) at a pre-planned interim analysis (Hazard Ratio (HR) = 0.50 (95% CI 0.38-0.65), p < 0.0001). Treatment with daratumumab reduced the risk of disease progression or death by 50%, as compared to those who did not receive daratumumab. The median PFS for patients treated with daratumumab in combination with VMP has not been reached, compared to an estimated median PFS of 18.1 months for patients who received VMP alone. Overall the safety profile of daratumumab in combination with VMP was consistent with the known safety profiles of the VMP regimen and daratumumab. An Independent Data Monitoring Committee (IDMC) recommended unblinding the data. The potential for a regulatory submission based on this data will be discussed with the health authorities.
  • August: An Investigational New Drug application (IND) was submitted to the U.S. FDA for the use of daratumumab in rheumatoid arthritis (RA).
  • Q3: A number of new daratumumab studies were published on www.clinicaltrials.gov including a Phase I study of the subcutaneous formulation of daratumumab in multiple myeloma in Japan and a Phase III study of daratumumab in combination with bortezomib and dexamethasone in relapsed/refractory multiple myeloma in China.

First Half Update

  • June: The U.S. FDA approved the use of DARZALEX 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 PI. Genmab achieved milestone payments totaling USD 25 million from Janssen in connection with the approval and first commercial sale of DARZALEX under the newly expanded label.
  • May: Janssen announced plans to start new studies of daratumumab in multiple myeloma and amyloidosis: a Phase III study in smoldering multiple myeloma; a Phase III study comparing the subcutaneous and intravenous administration of daratumumab in relapsed and refractory multiple myeloma; a Phase III study of subcutaneous daratumumab in combination with bortezomib, cyclophosphamide and dexamethasone for amyloidosis; a Phase III study combining daratumumab with bortezomib, lenalidomide and dexamethasone in frontline multiple myeloma; and a Phase II study of subcutaneous daratumumab in combination with standard of care regimens for frontline and relapsed multiple myeloma. The Phase III studies with subcutaneous daratumumab in amyloidosis and relapsed and refractory multiple myeloma and the Phase III study in smoldering multiple myeloma have been published on www.clinicaltrials.gov. The studies are planned to start between the second half of 2017 and the first quarter of 2018 and may be subject to change.
  • April: In collaboration with the European Myeloma Network (EMN) and Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Janssen announced plans to start a Phase III study (MMY3013, APOLLO) comparing daratumumab in combination with pomalidomide and dexamethasone versus pomalidomide and dexamethasone in patients who have previously been treated with an immunomodulatory drug and a PI. The study is open for patient recruitment.
  • April: The European Commission granted a marketing authorization for DARZALEX 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. The approval converts the previous conditional marketing authorization for DARZALEX to a full approval. Genmab achieved milestone payments totaling USD 48 million from Janssen in connection with the first commercial sales of DARZALEX under the expanded label.
  • April: A Phase I/II study investigating selinexor in combination with daratumumab and other backbone treatments for multiple myeloma and a Phase I/II study of daratumumab in combination with nivolumab in solid tumors was published via www.clinicaltrials.gov. A number of investigator sponsored studies have also been announced, see www.clinicaltrials.gov for full list of daratumumab trials.
  • March: Janssen decided not to initiate stage 2 of the Phase II study (CARINA, LYM2001) of daratumumab in three types of relapsed or refractory NHL. A data review showed that two cohorts of the study, in follicular lymphoma and diffuse large B-cell lymphoma, did not reach the predefined futility thresholds of overall response rates (ORR) of 50% and 30%, respectively. In the third cohort of the study, in mantle cell lymphoma, ORR was not evaluable due to slow recruitment. This decision has no impact on other ongoing or planned studies with daratumumab.
  • February: The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending broadening the existing marketing authorization for DARZALEX (daratumumab) in the European Union. The recommendation is for the use of DARZALEX 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.
  • Q1: Several new studies of daratumumab were published on www.clinicaltrials.gov including a Phase II study in combination with nivolumab for colon cancer; a Phase I/II study in combination with atezolizumab in previously treated advanced or metastatic NSCLC; a Phase I/II study in combination with nivolumab for virus associated tumors; a Phase II study comparing

daratumumab with talacotuzumab in myelodysplastic syndromes and a Phase I/II study in combination with nivolumab for advanced or metastatic solid tumors.

Expansive Daratumumab Development Program

Disease Stage Therapy Development Phase
No.
Pts
Pre-
Clinical
1/11 Ш Ш
High Risk Smoldering Subcutaneous 360 AQUILA
Monotherapy 126 CENTAURUS
Front line (transplant & non- Dara + VMP 700 ALCYONE
transplant) Dara + VMP (Asia Pacific) 192
Dara + Rd 744 MAIA
Dara + VTd 1,080 CASSIOPEIA
Dara + RVd 216 GRIFFIN
Multi combo study (6 arms) 250 EQUULEUS
Relapsed or Refractory Dara + Vd (China) 210
Dara + Kd 450 CANDOR
Dara + Pom + d 302 APOLLO
Subcutaneous vs IV 480 COLUMBA
Dara + Imfinzi* 264 FUSION
Dara + Keytruda 57
Dara + Opdivo* 375
Dara + Tecentrig* 288
Disease Stage Therapy Development Phase
No.
Pts
Pre-Clinical 1/11 Ш Ш
Amyloidosis Dara + CyBorD 370 ANDROMEDA
NKTCL (nasal type) Monotherapy 32 VOLANS
Colon cancer Dara + Opdivo $340*$
MDS Dara or talacotuzumab 31
NSCLC Dara + Tecentrig 96 CALLISTO
NSCLC, pancreatic,
triple neg. breast
cancers
Dara + Opdivo 120
Virus associated
tumors
Dara + Opdivo 500*

Genmab A/S Tel: +45 7020 2728 Company Announcement no. 37 Kalvebod Brygge 43 Fax: +45 7020 2729 Page 9/30 1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884

Arzerra (ofatumumab) – Our First Marketed Product

  • Human CD20 monoclonal antibody in development to treat cancer & autoimmune disease
  • Arzerra approved in certain territories for certain 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 27 million in the first nine months of 2017

In the U.S., Arzerra 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 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 more than 60 countries worldwide, including 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.

The overall safety profile of Arzerra in CLL is based on exposure in clinical trials and the post-marketing setting. Arzerra has been used in more than 3,500 patients treated alone or in combination with other therapies in clinical trials. It is estimated that more than 9,000 patients have been exposed to Arzerra for at least one treatment course in the post-marketing setting.

The most common side effects for Arzerra include adverse events associated with infusion reactions, cytopenias (neutropenia, anemia, thrombocytopenia), 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 European Summary of Product Characteristics and full US Prescribing information, including Boxed Warning, for all the labeled safety information for Arzerra.

A subcutaneous formulation of ofatumumab is also being investigated in two Phase III clinical studies in relapsing multiple sclerosis.

Tisotumab vedotin – A Next Generation Therapeutic

  • Antibody-drug conjugate (ADC, antibody coupled to a cell-killing agent) in development to treat solid tumors
  • Two Phase I/II clinical studies and a Phase II continued treatment study in solid tumors ongoing
  • 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.

Third Quarter Update

  • August: Seattle Genetics exercised its option to co-develop & co-commercialize tisotumab vedotin with Genmab. All costs and profits for tisotumab vedotin will be shared on a 50:50 basis.
  • August: A Phase II continued treatment study of tisotumab vedotin was started allowing patients who achieved a response in the Phase I/II study to continue treatment with tisotumab vedotin.

First Half Update

June: Preliminary data from the ongoing Phase I/II study of tisotumab vedotin in solid tumors (GEN701) was reported. In Part 2 of the study, 11 of 34 evaluable patients in the cervical cancer cohort achieved a response; with a median time of treatment of 4.9 months, 7 responders were still ongoing or in follow up for progression. The safety profile of tisotumab vedotin was generally consistent with known MMAE based ADCs including peripheral neuropathy and neutropenia. Conjunctivitis was identified as a toxicity specifically related to tisotumab vedotin, which led to the introduction of prophylactic management. Genmab and Seattle Genetics plan further clinical development of tisotumab vedotin in cervical cancer.

HuMax-AXL-ADC

  • ADC in development to treat solid tumors
  • Phase I/II clinical study for 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. HuMax-AXL-ADC is fully owned by Genmab and the ADC technology used with HuMax-AXL-ADC was licensed from Seattle Genetics.

JNJ-63709178

  • DuoBody product targeting CD3 and CD123
  • Phase I study in relapsed or refractory AML ongoing
  • 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 Tcell mediated killing of CD123+ AML cells. JNJ-63709178 was created by Janssen using Genmab's DuoBody technology under the companies' collaboration agreement. JNJ-63709178 is being investigated in a Phase I study in relapsed or refractory AML.

First Quarter Update

March: The Phase I study of JNJ-63709178 in AML was released from clinical hold and the study is actively recruiting.

JNJ-64007957

  • DuoBody product targeting BCMA and CD3
  • Phase I study in relapsed or refractory multiple myeloma ongoing
  • Developed by Janssen under the DuoBody technology collaboration

JNJ-64007957 is a bispecific antibody that targets BCMA, which is expressed in mature B lymphocytes, and CD3, which is expressed on T-cells, was created under a collaboration between Genmab and Janssen using Genmab's DuoBody technology. JNJ-64007957 is being investigated in a Phase I clinical study to treat relapsed or refractory multiple myeloma.

Third Quarter Update

September: The first patients were dosed in the Phase I study of JNJ-64007957, triggering a USD 2 million milestone payment from Janssen to Genmab.

First Half Update

May: A Phase I study of JNJ-64007957 in relapsed or refractory multiple myeloma was published by Janssen on www.clinicaltrials.gov.

Pre-clinical Programs

  • Broad pre-clinical pipeline of over 20 programs including HexaBody-DR5/DR5, and DuoBody-CD3xCD20
  • 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 over 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.

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 2016 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 2016 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 1,348 million for the first nine months of 2017 compared to DKK 889 million for the first nine months of 2016. The increase of DKK 459 million, or 52%, was driven by increased DARZALEX royalties and milestones. Royalties were 55% of total revenue in the first nine months of 2017 compared to 39% in the first nine months of 2016.

MDKK First 9 Months
2017
First 9 Months
2016
Royalties 743 346
Milestone payments 502 462
Deferred revenue 69 69
Reimbursement income 34 12
Total revenue 1,348 889

Royalties

Royalty income amounted to DKK 743 million in the first nine months of 2017 compared to DKK 346 million in the first nine months of 2016. The increase of DKK 397 million was driven by higher DARZALEX royalties, which were partly offset by lower Arzerra royalties.

Net sales of DARZALEX by Janssen were USD 871 million in the first nine months of 2017 compared to USD 372 million in the first nine months of 2016. The increase of USD 499 million, or 134%, was driven by strong uptake following the regulatory approvals in the U.S. and EU. Royalty income on net sales of DARZALEX was DKK 707 million in the first nine months of 2017 compared to DKK 298 million in the first nine months of 2016, an increase of DKK 409 million, or 137%. During the third quarter of 2017, the royalty rate on net sales of DARZALEX moved into the next royalty tier, which is 13% on net sales exceeding USD 750 million in a calendar year.

Novartis' net sales of Arzerra were USD 27 million in the first nine months of 2017 compared to USD 35 million in the first nine months of 2016. The decrease of USD 8 million, or 23%, was due to continued competition in the refractory CLL market. Royalty income on net sales of Arzerra was DKK 36 million in the first nine months of 2017 compared to DKK 48 million in the first nine months of 2016, a decrease of DKK 12 million, or 25%.

Milestone Payments

Milestone income was DKK 502 million in the first nine months of 2017 compared to DKK 462 million in the first nine months of 2016. The increase of DKK 40 million, or 9%, was driven by higher DARZALEX milestone income which was partially offset by lower milestones under our DuoBody collaboration with Janssen. 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 collaboration agreements.

Deferred Revenue

In the first nine months of 2017, deferred revenue amounted to DKK 69 million compared to DKK 69 million in the first nine months of 2016. The deferred revenue is related to our collaboration agreements and is recognized in the income statement on a straight line basis over planned development periods. As of September 30, 2017, DKK 160 million was included as deferred income in the balance sheet. Refer to note 2.1 in the 2016 annual report for further details about the accounting treatment of deferred revenue.

Reimbursement Income

Reimbursement income, comprised of the reimbursement of certain research and development costs under our collaboration agreements, amounted to DKK 34 million in the first nine months of 2017 compared to DKK 12 million in the first nine months of 2016. The increase of DKK 22 million was driven by our collaboration agreements with BioNTech and Seattle Genetics.

Research and Development Costs

Research and development costs amounted to DKK 599 million in the first nine months of 2017 compared to DKK 465 million in the first nine months of 2016. The increase of DKK 134 million, or 29%, was driven by the additional investment in our product pipeline, combined with the increase in research and development employees.

Research and development costs accounted for 85% of the total operating expenses in the first nine months of 2017 compared to 86% in the first nine months of 2016.

General and Administrative Expenses

General and administrative expenses were DKK 108 million in the first nine months of 2017 compared to DKK 78 million in the first nine months of 2016. The increase of DKK 30 million, or 38%, was driven by higher non-cash share-based compensation expenses and an increase in administrative employees and other support functions due to the expansion of our pipeline.

General and administrative expenses accounted for 15% of the total operating expenses in the first nine months of 2017 compared to 14% in the first nine months of 2016.

Operating Result

Operating income was DKK 641 million in the first nine months of 2017 compared to DKK 345 million in the first nine months of 2016. The increase of DKK 296 million, or 86%, was driven by higher revenue, which was partly offset by increased operating expenses.

As of September 30, 2017, the total number of employees was 251 compared to 202 employees as of September 30, 2016. The increase in employees was driven by the expansion of our pipeline.

Workforce September 30, 2017 September 30, 2016
Research and development employees 215 173
Administrative employees 36 29
Total employees 251 202

Net Financial Items

The net financial items for the first nine months of 2017 were a net loss of DKK 237 million compared to a net income of DKK 1 million in the first nine months of 2016. The main driver for the variance between the two periods is foreign exchange movements, which negatively impacted our USD denominated portfolio and cash holdings. The USD weakened significantly against the DKK during 2017, resulting in realized and unrealized exchange rate losses. Refer to note 3 in this interim report for further details about the net financial items.

Corporate Tax

The corporate tax expense for the first nine months of 2017 was DKK 86 million, or an effective tax rate of 21%, which was based on the estimated average effective corporate tax rate for the full year. There has been no reversal of the valuation allowances on deferred tax assets in the first nine months of 2017. There was minimal corporate tax expense in the first nine months of 2016 as a tax loss was projected for the full year and no benefit for the loss was expected to be recognized due to the full valuation allowance on deferred tax assets.

Net Result

Net result for the first nine months of 2017 was a net income of DKK 318 million compared to a net income of DKK 346 million in the first nine months of 2016. The decrease was driven by the items described above.

Cash Position

Cash Position (MDKK) September 30, 2017 December 31, 2016
Marketable securities 4,097 3,615
Cash
and cash equivalents
1,087 307
Cash position 5,184 3,922

As of September 30, 2017, cash, cash equivalents, and marketable securities (cash position) amounted to DKK 5,184 million. This represents a net increase of DKK 1,262 million from the beginning of 2017, which was mainly driven by positive working capital adjustments of DKK 575 million related to milestones achieved in the fourth quarter of 2016 that were received in 2017, our operating income of DKK 641 million, and proceeds from the exercise of warrants of DKK 208 million.

There were no short term marketable securities included in cash and cash equivalents at the end of September 2017 or at the end September 2016. 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. The cash and cash equivalents at the end of September 2017 relate to bank deposits. Refer to note 2 in this interim report for further details about our marketable securities.

Cash Flow

Cash Flow (MDKK) First 9 Months
2017
First 9 Months
2016
Cash provided by (used in) operating activities 1,338 406
Cash provided by (used in) investing activities (694) (535)
Cash provided by (used in) financing activities 208 66

Net cash provided by operating activities is primarily related to our operating result, working capital fluctuations, and changes in non-cash expenses, all of which may be highly variable period to period. In the first nine months of 2017, the primary drivers of increased cash provided by operating activities were positive working capital adjustments related to milestones achieved in the fourth quarter of 2016 that were received in 2017 and higher operating income.

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 nine months of 2017 and 2016, which has resulted in significant growth in our marketable securities balance.

Net cash provided by financing activities for the first nine months of 2017 is related to the proceeds from the exercise of warrants of DKK 208 million. Net cash provided by financing activities for the first nine months of 2016 is related to proceeds from the exercise of warrants of DKK 184 million offset by the purchase of treasury shares of DKK 118 million.

Balance Sheet

As of September 30, 2017, total assets were DKK 5,895 million compared to DKK 5,238 million as of December 31, 2016. As of September 30, 2017, the assets are mainly comprised of a cash position of DKK 5,184 million and receivables of DKK 391 million. The receivables consist primarily of royalties and milestone payments from our collaboration agreements and non-interest bearing receivables, which are due less than one year from the balance sheet date. The credit risk on receivables is considered to be limited.

Shareholders' equity as of September 30, 2017 was DKK 5,467 million compared to DKK 4,827 million at the end of December 2016. The increase was driven by our net income as well as the exercise of warrants. On September 30, 2017, Genmab's equity ratio was 93% compared to 92% at the end of 2016.

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.

STATEMENT OF COMPREHENSIVE INCOME FOR THE 3RD QUARTER OF 2017

Income Statement

3rd quarter of 3rd quarter of
2017
DKK'000
2016
DKK'000
Revenue 323,449 364,664
Research and development expenses (227,767) (150,597)
General and administrative expenses (37,382) (27,231)
Operating expenses (265,149) (177,828)
Operating result 58,300 186,836
Net financial items (65,509) 2,121
Net result before tax (7,209) 188,957
Corporate tax 1,528 -
Net result (5,681) 188,957
Basic net result per share
Diluted net result per share
(0.09)
(0.09)
3.15
3.06
Statement of Comprehensive Income
Net result (5,681) 188,957
Other comprehensive income:
Amounts which will be re-classified to the income statement:
Adjustment of foreign currency fluctuations on subsidiaries (4,553) (381)
Fair value adjustments of cash flow hedges:
Fair value adjustments during the period
Fair value adjustments reclassified to the income statement
637
(4,283)
-
-
Total comprehensive income (13,880) 188,576

STATEMENT OF COMPREHENSIVE INCOME FOR THE NINE MONTHS ENDED SEPTEMBER 30, 2017

Income Statement

9 Months Ended 9 Months Ended
Note September 30, 2017
DKK'000
September 30, 2016
DKK'000
Revenue 1,347,574 888,662
Research and development expenses (599,406) (465,218)
General and administrative expenses (107,383) (78,488)
Operating expenses (706,789) (543,706)
Operating result 640,785 344,956
Net financial items 3 (236,572) 720
Net result before tax 404,213 345,676
Corporate tax (86,530) (14)
Net result 317,683 345,662
Basic net result per share 5.23 5.78
Diluted net result per share 5.12 5.60
Statement of Comprehensive Income
Net result 317,683 345,662
Other comprehensive income:
Amounts which will be re-classified to the income statement:
Adjustment of foreign currency fluctuations on subsidiaries (14,904) (2,313)
Fair value adjustments of cash flow hedges:
Fair value adjustments during the period 16,174 -
Fair value adjustments reclassified to the income statement (9,082) -
Total comprehensive income 309,871 343,349

BALANCE SHEET – ASSETS

September 30, December 31, September 30,
Note 2017 2016 2016
DKK'000 DKK'000 DKK'000
Intangible assets 155,128 181,895 169,084
Property, plant & equipment 90,175 32,194 30,215
Receivables 8,764 1,473 5,491
Deferred tax assets 75,381 125,035 6,201
Total non-current assets 329,448 340,597 210,991
Receivables 381,844 975,674 199,589
Marketable securities 2 4,097,431 3,614,942 3,145,808
Cash and cash equivalents 1,086,471 307,023 796,665
Total current assets 5,565,746 4,897,639 4,142,062
Total assets 5,895,194 5,238,236 4,353,053

BALANCE SHEET – SHAREHOLDERS' EQUITY AND LIABILITIES

Note September 30,
2017
December 31,
2016
September 30,
2016
DKK'000 DKK'000 DKK'000
Share capital 61,163 60,350 60,248
Share premium 7,976,996 7,769,577 7,744,089
Other reserves 95,071 102,883 92,163
Accumulated deficit (2,666,377) (3,106,114) (3,962,388)
Shareholders' equity 5,466,853 4,826,696 3,934,112
Other payables 1,549 - -
Total non-current liabilities 1,549 - -
Provisions 1,433 1,433 1,433
Deferred income 159,674 228,150 251,854
Corporate taxes payable 61,612 61,612 -
Other payables 204,073 120,345 165,654
Total current liabilities 426,792 411,540 418,941
Total liabilities 428,341 411,540 418,941
Total shareholders' equity and liabilities 5,895,194 5,238,236 4,353,053
Share-based instruments 4

Shareholdings by the Board of Directors and Executive Management 5 Subsequent events to the balance sheet date 6

STATEMENT OF CASH FLOWS

Note 9 Months Ended
September 30, 2017
DKK'000
9 Months Ended
September 30, 2016
DKK'000
Net result before tax 404,213 345,676
Reversal of financial items, net 236,572 (720)
Adjustments for non-cash transactions 93,516 69,205
Changes in working capital 574,977 (32,026)
Cash flow from operating activities before financial items 1,309,278 382,135
Financial interest received 29,226 24,041
Financial expenses paid (564) (168)
Corporate taxes received/(paid) (14) (14)
Cash flow from operating activities 1,337,926 405,994
Investments in tangible assets (66,757) (8,565)
Marketable securities bought 2 (2,407,043) (1,917,677)
Marketable securities sold 1,779,691 1,391,519
Cash flow from investing activities (694,109) (534,723)
Warrants exercised 208,232 183,815
Purchase of treasury shares - (118,099)
Paid installments on lease liabilities - (119)
Cash flow from financing activities 208,232 65,597
Change in cash and cash equivalents 852,049 (63,132)
Cash and cash equivalents at the beginning of the period 307,023 873,986
Exchange rate adjustments (72,601) (14,189)
Cash and cash equivalents at the end of the period 1,086,471 796,665
Cash and cash equivalents include:
Bank deposits and petty cash 1,086,471 796,665
Short-term marketable securities - -
Cash and cash equivalents at the end of the period 1,086,471 796,665

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, 2015 59,531,263 59,531 7,560,991 94,476 - (4,228,278) 3,486,720
Total comprehensive income - - - (2,313) - 345,662 343,349
Transactions with owners:
Exercise of warrants
717,334 717 183,098 - - - 183,815
Purchase of treasury shares - - - - - (118,099) (118,099)
Share-based compensation expenses - - - - - 38,327 38,327
September 30, 2016 60,248,597 60,248 7,744,089 92,163 - (3,962,388) 3,934,112
Total comprehensive income - - - 6,548 4,172 841,413 852,133
Transactions with owners:
Exercise of warrants
101,459 102 25,488 - - - 25,590
Share-based compensation expenses - - - - - 14,861 14,861
December 31, 2016 60,350,056 60,350 7,769,577 98,711 4,172 (3,106,114) 4,826,696
Total comprehensive income - - - (14,904) 7,092 317,683 309,871
Transactions with owners:
Exercise of warrants
813,086 813 207,419 - - - 208,232
Share-based compensation expenses - - - - - 57,904 57,904
Tax on items recognized directly in equity - - - - - 64,150 64,150
September 30, 2017 61,163,142 61,163 7,976,996 83,807 11,264 (2,666,377) 5,466,853

NOTES TO THE FINANCIAL STATEMENTS

Note 1 – Accounting Policies

Basis of Presentation

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.

Accounting Policies

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 2016 annual report.

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, sharebased 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 2016 annual report.

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 September 30, 2017 December 31, 2016
Assets Measured at Fair Value Note Level 1 Level 2 Level 1 Level 2
Marketable securities 2 4,097 - 3,615 -
Receivables –
derivatives
- 20 - 4

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).

Treasury Shares

The total amount paid to acquire treasury shares including directly attributable costs and the proceeds from the sale of treasury shares are recognized in accumulated deficit.

Derivative Financial Instruments

Genmab entered into derivative instruments (forward contracts) to hedge currency exposure associated with future royalties on net sales of DARZALEX by Janssen. The derivatives are not traded on an active market based on quoted prices. The fair value is determined using valuation techniques that utilize market based data such as currency rates, yield curves and implied volatility (Level 2).

Note 2 – Marketable Securities

September 30,
2017
December 31,
2016
September 30,
2016
DKK'000 DKK'000
(full year)
DKK'000
Cost at the beginning of the period 3,603,111 2,636,642 2,636,642
Additions for the period 2,407,043 3,008,484 1,917,677
Disposals and maturities for the period (1,773,755) (2,042,015) (1,399,069)
Cost at the end of the period 4,236,399 3,603,111 3,155,250
Fair value adjustment at the beginning of the period 11,831 (17,399) (17,399)
Fair value adjustment for the period (150,799) 29,230 7,957
Fair value adjustment at the end of the period (138,968) 11,831 (9,442)
Net book value at the end of the period 4,097,431 3,614,942 3,145,808
Net book value in percentage of cost 96.7% 100.3% 99.7%
Average effective duration 1.35 1.41 1.18

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 September 30, 2017, 96% of our marketable securities had a triple A-rating, compared to 94% as of December 31, 2016.

The total fair value adjustment for the first nine months of 2017 was a loss of DKK 151 million, which was driven primarily by foreign exchange adjustments of DKK 137 million due the significant weakening of the USD against the DKK which negative impacted our USD denominated portfolio. In the first nine months of 2016, the total fair value adjustment was an income of DKK 8 million, which included positive foreign exchange adjustments of DKK 7 million on our USD denominated portfolio as the USD strengthened against the DKK during the period.

Note 3 – Financial Income and Expenses

9 Months Ended 9 Months Ended
September 30, 2017 September 30, 2016
DKK'000 DKK'000
Financial income:
Interest and other financial income 31,021 23,400
Realized and unrealized gains on fair value hedges, net 18,141 -
Realized and unrealized gains on markertable securities
(fair value through the income statement), net - 556
[I/S] Total financial income 49,162 23,956
Financial expenses:
Interest and other financial expenses 564 168
Realized and unrealized losses on markertable
securities (fair value through the income statement), net 11,843 -
Realized and unrealized exchange rate losses, net 273,327 23,068
[I/S] Total financial expenses 285,734 23,236
Net financial items (236,572) 720

Note 4 – 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 a 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 RSUs. 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.

During the third quarter of 2016, Genmab acquired 100,000 of its own shares, approximately 0.2% of share capital, to cover its future obligations under the RSU program. The total amount paid to acquire the shares, including directly attributable costs, was DKK 118 million and has been recognized as a deduction to shareholders' equity. There were no additional acquisitions of treasury shares in the first nine months of 2017. These shares are classified as treasury shares and are presented within accumulated deficit as of September 30, 2017 and September 30, 2016.

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 nine months of 2017 and 2016, respectively, is outlined below.

9 Months Ended
September 30, 2017
9 Months Ended
September 30, 2016
Outstanding RSUs at January 1 102,387 72,895
Granted 10,252 -
Vested - -
Forfeited/Cancelled (179) (3,256)
Outstanding RSUs at September 30 112,460 69,639

During the first nine months of 2017, 10,252 RSUs were granted with a weighted average fair value of DKK 1,416.64 per RSU. There were no RSUs granted during the first nine months of 2016.

Warrant Program

Genmab A/S established warrant programs as an incentive for the members of the Executive Management and the group's employees.

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.

Warrant Activity

The warrant activity in the first nine months of 2017 and 2016 is outlined below.

9 Months Ended 9 Months Ended
September 30, 2017 September 30, 2016
Outstanding warrants at January 1 2,190,311 2,876,517
Granted 24,336 41,150
Exercised (813,086) (717,334)
Expired/lapsed/cancelled (15,967) (12,466)
Outstanding warrants at September 30 1,385,594 2,187,867
Weighted average exercise price DKK 256.10 DKK 256.25

During the first nine months 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 nine months of 2016, 41,150 warrants were granted to our employees with a weighted average exercise price of DKK 985.95 per warrant and a weighted average Black-Scholes fair market value of DKK 340.53 per warrant.

During the first nine months of 2017, 813,086 warrants were exercised with proceeds to Genmab of DKK 208 million. The warrants exercised increased share capital accordingly and corresponded to approximately 1.3% of share capital. During the first nine months of 2016, 717,334 warrants were exercised with proceeds to Genmab of DKK 184 million.

Share-based compensation expenses for the first nine months of 2017 totaled DKK 58 million compared to DKK 39 million in the corresponding period for 2016.

Note 5 - 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 September 30, 2017.

December 31, September 30,
2016 Acquired Sold Transferred 2017
Number of ordinary shares owned
Board of Directors
Mats Pettersson 10,000 - - - 10,000
Anders Gersel Pedersen 7,000 - - - 7,000
Burton G. Malkiel 19,375 2,000 - (21,375) -
Pernille Erenbjerg - - - - -
Paolo Paoletti 637 - - - 637
Rolf Hoffmann - 1,050 - - 1,050
Deirdre P. Connelly - - - - -
Peter Storm Kristensen - - - - -
Rick Hibbert - - - - -
Daniel Bruno - - - - -
37,012 3,050 - (21,375) 18,687
Executive Management
Jan van de Winkel 602,500 37,500 - - 640,000
David A. Eatwell 2,500 15,000 - - 17,500
Judith Klimovsky - - - - -
605,000 52,500 - - 657,500
Total 642,012 55,550 - (21,375) 676,187
December 31,
2016
Granted Exercised Transferred September 30,
2017
Number of warrants held
Board of Directors
Mats Pettersson 38,750 - - - 38,750
Anders Gersel Pedersen 54,000 - (21,250) - 32,750
Burton G. Malkiel 14,500 - (4,500) (10,000) -
Pernille Erenbjerg - - - - -
Paolo Paoletti - - -
- -
Rolf Hoffmann - - - - -
Deirdre P. Connelly - - - - -
Peter Storm Kristensen 1,917 - - - 1,917
Rick Hibbert
Daniel Bruno
1,962
18,613
-
-
(750)
(5,125)
-
-
1,212
13,488
129,742 - (31,625) (10,000) 88,117
Executive Management
Jan van de Winkel 392,841 - (252,500) - 140,341
David A. Eatwell
Judith Klimovsky
484,577
-
-
8,400
(125,000)
-
-
-
359,577
8,400
877,418 8,400 (377,500) - 508,318
Total 1,007,160 8,400 (409,125) (10,000) 596,435

Kalvebod Brygge 43 Fax: +45 7020 2729 Page 27/30 1560 Copenhagen V, Denmark www.genmab.com CVR no. 2102 3884

December 31,
2016
Granted Settled Transferred September 30,
2017
Number of RSUs held
Board of Directors
Mats Pettersson 4,043 - - - 4,043
Anders Gersel Pedersen 3,032 - - - 3,032
Burton G. Malkiel 2,021 - - (2,021) -
Pernille Erenbjerg 3,571 - - - 3,571
Paolo Paoletti 3,571 - - - 3,571
Rolf Hoffmann - 1,121 - - 1,121
Deirdre P. Connelly - 1,121 - - 1,121
Peter Storm Kristensen 508 - - - 508
Rick Hibbert 458 - - - 458
Daniel Bruno 1,484 - - - 1,484
18,688 2,242 - (2,021) 18,909
Executive Management
Jan van de Winkel 39,606 - - - 39,606
David A. Eatwell 24,652 - - - 24,652
Judith Klimovsky - 2,800 - - 2,800
64,258 2,800 - - 67,058
Total 82,946 5,042 - (2,021) 85,967

Following Genmab A/S' Annual General Meeting on March 28, 2017, 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, Dr. Paolo Paoletti and Pernille Erenbjerg were re-elected to the Board of Directors for a one year period. Rolf Hoffmann and Deirdre P. Connelly were elected to the Board of Directors for a one year period. Dr. Burton G. Malkiel stepped down from the Board of Directors. The reclassification of the board members' shares and share-based instruments is shown in the transferred column of the tables above. The Board of Directors convened and constituted itself with Mr. Pettersson as Chairman and Dr. Pedersen 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 nine months of 2017. For further information on the remuneration of the Board of Directors and the Executive Management, refer to note 5.1 in the 2016 annual report.

Note 6 - Subsequent Events to the Balance Sheet Date

No events have occurred subsequent to the balance sheet date that could significantly affect the financial statements as of September 30, 2017.

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, other blood cancers, and solid tumors. 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.

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 nine months ended September 30, 2017.

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 3-15, 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, November 8, 2017

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)
Anders Gersel Pedersen
(Deputy Chairman)
Rolf Hoffmann
Pernille Erenbjerg Paolo Paoletti Deirdre P. Connelly

(Employee elected) (Employee elected) (Employee elected)

Rick Hibbert Daniel J. Bruno Peter Storm Kristensen