gmab_Current_Folio_6K_News_Release_Q1 Interim_Report

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549



FORM 6-K


REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a‑16 OR 15d‑16

OF THE SECURITIES EXCHANGE ACT OF 1934

FOR THE MONTH OF MAY 2020


COMMISSION FILE NUMBER 001-38976 

Genmab A/S
(Exact name of Registrant as specified in its charter)

Kalvebod Brygge 43

1560 Copenhagen V

Denmark

+45 70 20 27 28
(Address of principal executive offices)


Indicate by check mark whether the registrant files or will file annual reports under cover Form 20‑F or Form 40‑F.

Form 20‑F       Form 40‑F 

Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(1)

Yes       No     

Indicate by check mark if the registrant is submitting the Form 6‑K in paper as permitted by Regulation S‑T Rule 101(b)(7)

Yes       No     

Exhibit 99.1 to this report on Form 6-K shall be deemed to be incorporated by reference in Genmab A/S’s registration statement on Form S-8 (File No. 333-232693) and in the outstanding prospectus contained in such registration statement.

 

 

 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

 

 

GENMAB A/S

 

 

 

 

BY:

/s/ Anthony Pagano

 

 

Name: Anthony Pagano

 

 

Title: Executive Vice President & Chief Financial Officer

 

DATE: May 6, 2020    

 

EXHIBIT INDEX

A

 

Exhibit

Description of Exhibit

 

 

99.1

Interim Report Dated May 6, 2020     

 

gmab_Ex99_1_Q1

Exhibit 99.1

 

Picture 15

 

Genmab Announces Financial Results for the First Quarter of 2020

 

May 6,  2020; Copenhagen, Denmark;

Interim Report for the First Quarter Ended March 31, 2020

 

Highlights

·

DARZALEX® (daratumumab) net sales increased approximately 49%  compared to the first quarter of 2019 to USD 937 million, resulting in royalty income of DKK 775 million

·

DARZALEX approved in Europe in combination with bortezomib, thalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant

·

U.S. FDA approved TEPEZZA™ (teprotumumab-trbw), developed and commercialized by Horizon Therapeutics, for thyroid eye disease

·

U.S. FDA accepted, with priority review, Novartis’ supplemental Biologics License Application for subcutaneous ofatumumab in relapsing multiple sclerosis

·

Anthony Pagano appointed Chief Financial Officer

·

Anthony Mancini appointed Chief Operating Officer

 

“Despite the unprecedented challenges posed by the coronavirus (COVID-19) pandemic, we will continue to invest in our innovative proprietary products, technologies and capabilities and use our world-class expertise in antibody drug development to create truly differentiated products with the potential to help cancer patients. While Genmab is closely monitoring the developments in the rapidly evolving landscape, we are extremely fortunate to have a solid financial foundation and a fabulous and committed team to carry us through these uncertain times,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

 

Financial Performance First Quarter of 2020

·

Revenue was DKK 892 million in the first quarter of 2020 compared to DKK 591 million in the first quarter of 2019.  The increase of DKK 301 million, or 51%, was mainly driven by higher DARZALEX royalties.

·

Operating expenses were DKK 821 million in the first quarter of 2020 compared to DKK 617 million in the first quarter of 2019. The increase of DKK 204 million, or 33%, was driven by the advancement of epcoritamab (DuoBody®-CD3xCD20) and DuoBody-PD-L1x4-1BB, additional investments in our product pipeline,  and the increase in new employees to support the expansion of our product pipeline.

·

Operating income was DKK 71 million in the first quarter of 2020 compared to an operating loss of DKK 26 million in the first quarter of 2019.  The increase of DKK 97 million was driven by higher revenue, which was partly offset by increased operating expenses.

 

Subsequent Event

·

May: The U.S. Food and Drug Administration (U.S. FDA) approved the use of the subcutaneous formulation of daratumumab, DARZALEX FASPRO™ (daratumumab and hyaluronidase-fihj) for the treatment of adult patients with multiple myeloma: in combination with bortezomib, melphalan and prednisone in newly diagnosed patients who are ineligible for autologous stem cell transplant (ASCT); in combination with lenalidomide and dexamethasone in newly diagnosed patients who are ineligible for ASCT and in patients with relapsed or refractory multiple myeloma who have received at least one prior therapy; in combination with bortezomib and dexamethasone in patients who have received at least one prior therapy; and as monotherapy, in patients who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent or who are double-refractory to a PI and an immunomodulatory agent.

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 1/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 14

 

Genmab Announces Financial Results for the First Quarter of 2020

 

Outlook

Genmab is maintaining its 2020 financial guidance published on February 19, 2020.

 

Conference Call

Genmab will hold a conference call in English to discuss the results for the first quarter of 2020 today,  Wednesday,  May 6, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial

+1 631 510 7495 (U.S. participants) or +44 2071 928000 (international participants) and provide conference code 6486367.

 

A live and archived webcast of the call and relevant slides will be available at www.genmab.com.

 

Contact:

Marisol Peron,  Corporate Vice President, Communications & Investor Relations

T: +1 609 524 0065; E: mmp@genmab.com

 

For Investor Relations:

Andrew Carlsen, Senior Director, Investor Relations

T: +45 3377 9558; E: acn@genmab.com

 

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 2/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

CONTENTS

 

 

 

CONSOLIDATED KEY FIGURES 

4

OUTLOOK 

5

KEY 2020 PRIORITIES 

6

PRODUCT PIPELINE 

7

PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST QUARTER OF 2020 

7

SIGNIFICANT RISKS AND UNCERTAINTIES 

16

FINANCIAL REVIEW 

17

STATEMENT OF COMPREHENSIVE INCOME FOR THE FIRST QUARTER OF 2020 

21

BALANCE SHEET 

22

STATEMENT OF CASH FLOWS 

23

STATEMENT OF CHANGES IN EQUITY 

24

NOTES TO THE FINANCIAL STATEMENTS 

25

ABOUT GENMAB 

36

DIRECTORS’ AND MANAGEMENT’S STATEMENT ON THE INTERIM REPORT 

37

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 3/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

CONSOLIDATED KEY FIGURES   

 

 

 

 

 

 

 

 

 

 

    

1st Quarter of

 

    

1st Quarter of

    

Full Year

 

 

 

2020

 

 

2019

 

2019

 

(DKK million)

 

 

 

 

 

 

 

 

Income Statement

 

 

 

 

  

 

 

 

Revenue

 

892

 

 

591

 

5,366

 

Research and development expenses

 

(715)

 

 

(546)

 

(2,386)

 

General and administrative expenses

 

(106)

 

 

(71)

 

(342)

 

Operating expenses

 

(821)

 

 

(617)

 

(2,728)

 

Operating result

 

71

 

 

(26)

 

2,638

 

Net financial items

 

283

 

 

120

 

221

 

Net result

 

269

 

 

72

 

2,166

 

 

 

 

 

 

 

 

 

 

Balance Sheet

 

 

 

 

 

 

 

 

Cash position*

 

12,960

 

 

6,830

 

10,971

 

Non-current assets

 

1,213

 

 

1,199

 

1,183

 

Assets

 

15,303

 

 

8,735

 

15,144

 

Shareholders' equity

 

14,398

 

 

8,127

 

14,048

 

Share capital

 

65

 

 

62

 

65

 

Investments in intangible and tangible assets

 

58

 

 

21

 

111

 

 

 

 

 

 

 

 

 

 

Cash Flow Statement

 

 

 

 

 

 

 

 

Cash flow from operating activities

 

2,192

 

 

648

 

1,326

 

Cash flow from investing activities

 

 9

 

 

(14)

 

(1,983)

 

Cash flow from financing activities

 

15

 

 

(11)

 

3,660

 

Cash and cash equivalents

 

5,543

 

 

1,177

 

3,552

 

Cash position increase/(decrease)

 

1,989

 

 

724

 

4,865

 

 

 

 

 

 

 

 

 

 

Financial Ratios

 

 

 

 

 

 

 

 

Basic net result per share

 

4.13

 

 

1.18

 

34.40

 

Diluted net result per share

 

4.09

 

 

1.17

 

34.03

 

 

 

 

 

 

 

 

 

 

Period-end share market price

 

1,362.50

 

 

1,155.00

 

1,481.50

 

Price / book value

 

6.15

 

 

8.74

 

6.85

 

 

 

 

 

 

 

 

 

 

Shareholders' equity per share

 

221.51

 

 

132.10

 

216.12

 

Equity ratio

 

94

%

 

93

%  

93

%

 

 

 

 

 

 

 

 

 

Average number of employees (FTE**)

 

569

 

 

403

 

471

 

Number of employees at the end of the period

 

579

 

 

419

 

548

 

 

* Cash, cash equivalents, and marketable securities.

** Full-time equivalent

 

The figures and financial ratios have been prepared on a consolidated basis. The financial ratios have been calculated in accordance with the recommendations of the Association of Danish Financial Analysts (2017) and key figures in accordance with IFRS.  

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 4/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

OUTLOOK 

 

 

 

 

 

2020

(DKK million)

    

Guidance

Revenue

 

4,750 - 5,150

Operating expenses

 

(3,850) - (3,950)

Operating income

 

850 - 1,250

 

Genmab is maintaining its 2020 financial guidance published on February 19, 2020.

 

Revenue

We expect our 2020 revenue to be in the range of DKK 4,750 – 5,150 million, compared to DKK 5,366 million in 2019. Our revenue in 2019 included DKK 1,684 million related to one-time sales milestones for DARZALEX net sales exceeding USD 2.5 billion and 3.0 billion in a calendar year.

 

Our projected revenue for 2020 primarily consists of DARZALEX royalties of DKK 4,075 – 4,475 million.  Our 2020 guidance for DARZALEX royalties represents a 30% to 43% increase compared to 2019.  Such royalties are based on estimated DARZALEX net sales of USD 3.9 – 4.2 billion.  We project cost reimbursement income of approximately DKK 475 million which is related to our collaborations with Seattle Genetics and BioNTech. The remainder of our revenue is approximately DKK 200 million and consists of milestones and other royalties.

 

Operating Expenses

We anticipate our 2020 operating expenses to be in the range of DKK 3,850 – 3,950 million, compared to DKK 2,728 million in 2019. The increase is driven by the advancement of our clinical programs, particularly epcoritamab (DuoBody-CD3xCD20) and DuoBody-PD-L1x4-1BB.

 

Operating Result

We expect our operating income to be in the range of DKK 850 – 1,250 million in 2020 compared to DKK 2,638 million in 2019. 

 

Outlook: Risks and Assumptions

In addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to the achievement of certain milestones associated with our collaboration agreements; the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; DARZALEX sales and corresponding royalties to Genmab; and currency exchange rates (the 2020 guidance assumes a USD/DKK exchange rate of 6.5). The financial guidance assumes that no significant agreements are entered into during 2020 that could materially affect the results. Refer to the section “Significant Risks and Uncertainties” in this interim report.

 

Additionally, the COVID-19 pandemic could potentially materially adversely impact our business and financial performance, including our clinical trials, projected regulatory approval timelines, supply chain and revenues, including our 2020 Guidance and Key 2020 Priorities in this interim report. In December 2019, a novel strain of coronavirus, COVID-19, was reported to have surfaced in Wuhan, China. Since then, the COVID-19 coronavirus has spread worldwide and has been declared a global pandemic. COVID-19 has resulted in global business and economic disruption, as many jurisdictions have prohibited international travel and implemented social distancing, quarantine and similar measures for their residents to contain the spread of the coronavirus. COVID-19 is also expected to put a strain on the healthcare systems in the major countries where our partners sell our products and where we and they conduct our clinical trials. The global outbreak of COVID-19 continues to rapidly evolve. The COVID-19

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 5/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

pandemic may be prolonged and may have long-term impacts on the development, regulatory approval and commercialization of our product candidates and on sales of our approved products by our collaboration partners. The longer the pandemic continues, the more severe the impacts described below will be on our business. The extent, length and consequences of the pandemic are uncertain and impossible to predict. Genmab has established a COVID-19 response team, led by the CEO, that is closely monitoring the evolving situation and has developed and implemented precautionary measures, including remote working for the majority of Genmab employees with a small subset of employees on-site to maintain critical laboratory activities that cannot be done remotely. The response team issues regular updates to employees with guidance to help limit the impact of COVID-19 at our workplace and on our communities and ensure business continuity. Genmab is also actively monitoring the potential impact on our 2020 key priorities and assessing the situation on an ongoing basis in close contact with clinical trial sites, physicians and contract research organizations (CROs) to evaluate the impact and challenges posed by the COVID-19 situation and manage them accordingly.

 

The full extent and nature of the impact of the COVID-19 pandemic and related containment measures on our business and financial performance is uncertain as the situation continues to develop. The factors discussed above, as well as other factors which are currently unforeseeable, may result in further and other unforeseen material adverse impacts on our business and financial performance, including on the sales of DARZALEX, Arzerra® and TEPEZZA, by our partners and on our royalty and milestone income therefrom.

KEY 2020 PRIORITIES

 

 

 

 

 

Priority

Targeted Milestones

Genmab proprietary* products

 

Tisotumab vedotin1 - Phase II innovaTV 204 safety and efficacy analysis in recurrent/metastatic cervical cancer and engage U.S. FDA for BLA submission subject to trial results

 

 

Tisotumab vedotin - data on other solid tumor types

 

 

Enapotamab vedotin – data to support late stage development

 

 

Epcoritamab (DuoBody-CD3xCD20) Phase I/II – decision on recommended Phase II dose and initiate expansion cohorts

 

 

HexaBody-DR5/DR5 Phase I/II - advance dose escalation

 

DuoBody-PD-L1x4-1BB2 Phase I/II – initiate expansion cohorts

 

 

DuoBody-PD-L1x4-1BB initial data in H2 2020

 

 

File INDs and/or CTAs for 2 new products

Daratumumab3

 

U.S. FDA and EMA decision on Phase III COLUMBA multiple myeloma SubQ submission

 

 

sBLA and MAA Submission Phase III ANDROMEDA amyloidosis

 

 

sBLA and MAA submission Phase III APOLLO multiple myeloma

Ofatumumab4

 

U.S. FDA decision on regulatory dossier submission in RMS

Teprotumumab5

U.S. FDA decision on Phase III OPTIC active thyroid eye disease submission

*Certain product candidates in development with partners, as noted.

1. 50:50 dev. w/ Seattle Genetics; 2. 50:50 dev. w/ BioNTech; 3. In dev. by Janssen; 4. In dev. by Novartis; 5. In dev. by Horizon Therapeutics

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 6/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

PRODUCT PIPELINE

Our own and partnered product pipeline consists of twenty antibodies in clinical development, including three approved partnered products created by Genmab. In addition to the antibodies in clinical development, our pipeline includes more than twenty in-house and partnered pre-clinical programs. An overview of the development status of each of our products is provided in the following sections. Detailed descriptions of dosing, efficacy and safety data from certain clinical trials have been disclosed in company announcements and media releases published via the Nasdaq Copenhagen stock exchange and may also be found in Genmab’s filings with the U.S. Securities and Exchange Commission (SEC). Additional information is available on Genmab’s website, www.genmab.com.

PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST QUARTER OF 2020

 

Products Created by Genmab*

 

A screenshot of a cell phone

Description automatically generated

*Out-licensed products marketed by partner

1See local country prescribing information for precise indications, 2Not in active development

 

DARZALEX (daratumumab) – First CD38 Antibody Approved in the World

·

First-in-class human CD38 antibody

·

Approved in combination with other therapies for frontline and for relapsed/refractory multiple myeloma in territories including the U.S., Europe and Japan and as monotherapy for heavily pretreated or double-refractory multiple myeloma in territories including the U.S. and Europe

·

Multiple Phase III studies ongoing in multiple myeloma including for a subcutaneous (SubQ) formulation, as well as a Phase III study in amyloid light-chain (AL) amyloidosis

·

Early stage studies ongoing in other blood cancers

·

Collaboration with Janssen Biotech, Inc. (Janssen)

·

Net sales of DARZALEX by Janssen were USD 937 million in the first quarter of 2020

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 7/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients:

Jurisdiction

Approval

Key Underlying Clinical Trial(s)

United States

 

 

Relapsed / Refractory MM

 

 

November 2015

Monotherapy for patients who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent

SIRIUS (MMY2002)

November 2016

In combination with Rd or Vd, for patients who have received at least one prior therapy

CASTOR (MMY3004); POLLUX (MMY3003)

June 2017

In combination with Pom-d for patients who have received at least two prior therapies, including lenalidomide and a PI

EQUULEUS (MMY1001)

Frontline MM

 

 

May 2018

In combination with VMP for newly diagnosed patients who are ineligible for ASCT

ALCYONE (MMY3007)

June 2019

In combination with Rd for newly diagnosed patients who are ineligible for ASCT

MAIA (MMY3008)

September 2019

In combination with VTd for newly diagnosed patients who are eligible for ASCT

CASSIOPEIA (MMY3006)

Split Dosing Regimen

 

 

February 2019

Option to split first infusion over two consecutive days

EQUULEUS (MMY1001)

European Union

 

 

Relapsed / Refractory MM

 

 

April 2016

Monotherapy for patients whose prior therapy included a PI and an immunomodulatory agent and who have demonstrated disease progression on the last therapy

SIRIUS (MMY2002)

February 2017

In combination with Rd or Vd for patients who have received at least one prior therapy

CASTOR (MMY3004); POLLUX (MMY3003)

Frontline MM

 

 

July 2018

In combination with VMP for newly diagnosed patients who are ineligible for ASCT

ALCYONE (MMY3007)

November 2019

In combination with Rd for newly diagnosed patients who are ineligible for ASCT

MAIA (MMY3008)

January 2020

In combination with VTd for newly diagnosed patients who are eligible for ASCT

CASSIOPEIA (MMY3006)

Split Dosing Regimen

 

 

December 2018

Option to split first infusion over two consecutive days

EQUULEUS (MMY1001)

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 8/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

Japan

 

 

Relapsed / Refractory MM

 

 

September 2017

In combination with Rd or Vd

CASTOR (MMY3004); POLLUX (MMY3003)

Frontline MM

August 2019

In combination with VMP for newly diagnosed patients ineligible for ASCT

ALCYONE (MMY3007)

December 2019

In combination with Rd for newly diagnosed patients who are ineligible for ASCT

MAIA (MMY3008)

PI = proteasome inhibitor; Rd = lenalidomide and dexamethasone; Vd = bortezomib and dexamethasone; VMP = bortezomib, melphalan and prednisone; VTd = bortezomib, thalidomide and dexamethasone; ASCT = autologous stem cell transplant; Pom-d = pomalidomide and dexamethasone

 

The warnings and precautions for DARZALEX include infusion reactions, interference with serological testing and interference with determination of complete response. The most frequently reported adverse reactions (incidence ≥20%) in clinical trials were: infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy and upper respiratory tract infection. 

 

Please consult the full U.S. Prescribing Information and the full European Summary of Product Characteristics for all the labeled safety information for DARZALEX.

 

First Quarter Updates

·

February: A pre-approval access study (NCT04264884) for SubQ daratumumab in patients unable to receive intravenous (IV) daratumumab was published on www.clinicaltrials.gov.

·

February: Janssen submitted a supplemental Biologics License Application (sBLA) to the U.S. FDA seeking approval of daratumumab in combination with carfilzomib and dexamethasone (DKd) for relapsed / refractory multiple myeloma. The submission was supported by data from the Phase III CANDOR study, sponsored by Amgen and co-funded by Janssen Research & Development, LLC. In March, Janssen submitted a supplemental New Drug Application (sNDA) to the Ministry of Health, Labor and Welfare (MHLW) in Japan for the same indication.

·

February: The Phase III AURIGA (MMY3021) study of SubQ daratumumab plus lenalidomide as maintenance treatment in patients with newly diagnosed multiple myeloma resumed recruiting following a temporary hold due to a U.S. FDA request for additional information related to analytical methods included in the study protocol.

·

January: The European Commission (EC) granted marketing authorization for DARZALEX in combination with bortezomib, thalidomide and dexamethasone (VTd) for the treatment of adult patients with newly diagnosed multiple myeloma who are eligible for autologous stem cell transplant (ASCT). The approval was supported by data from the Phase III CASSIOPEIA (MMY3006) study.

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 9/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

Daratumumab Development Covering All States of Multiple Myeloma – Key Ongoing* Trials     

A screenshot of a cell phone

Description automatically generated

 = recruitment completed

*Does not include trials that may still be ongoing but have clinical data and/or are the basis for an existing approval.

 

Daratumumab Development – Beyond Multiple Myeloma

 

A screenshot of a cell phone

Description automatically generated

= recruitment completed

 

Arzerra (ofatumumab) –First Genmab Created Product on the Market

·

Human CD20 monoclonal antibody commercialized by Novartis under a license agreement with Genmab

·

Arzerra is available for certain chronic lymphocytic leukemia (CLL) indications in the U.S., Japan and certain other territories

 

In the U.S., Arzerra solution for infusion is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate; for use in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed CLL; and for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. It is also indicated as monotherapy for the treatment of patients with CLL who are refractory to fludarabine and alemtuzumab.

 

In 2019, the marketing authorization for Arzerra was withdrawn in the EU and several other territories. Arzerra is commercially available in Japan as well as in the U.S. and certain other territories.

 

The overall safety profile of Arzerra in CLL is based on exposure in clinical trials and the post-marketing setting. The most common side effects for Arzerra include adverse events associated with infusion reactions, cytopenias, and infections (lower respiratory tract infection, including pneumonia, upper respiratory tract infection, sepsis, including neutropenic sepsis and septic shock, herpes viral infection, urinary tract infection).

 

Please consult the full U.S. Prescribing information, including Boxed Warning for all the labeled safety information for Arzerra.

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 10/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

 

TEPEZZA (teprotumumab-trw) – Latest Genmab Created Product to be Approved

·

Developed and commercialized by Horizon Therapeutics, plc (Horizon) for thyroid eye disease (TED)

·

First and only U.S. FDA-approved medicine for the treatment of TED

 

Teprotumumab, approved by the U.S. FDA in January 2020 under the trade name TEPEZZA, is a fully human antibody that targets the Insulin-like Growth Factor-1 Receptor, a well-validated target. TEPEZZA is being developed and is commercialized by Horizon. The antibody was created by Genmab under a collaboration with Roche and development and commercialization of the product is now being conducted by Horizon under a license from Roche. Under the terms of Genmab’s agreement with Roche, Genmab will receive mid-single digit royalties on sales of TEPEZZA.

 

Please consult the full U.S. Prescribing Information for all the labeled safety information for TEPEZZA.

 

First Quarter Update

·

January: The U.S. FDA approved TEPEZZA for the treatment of TED.

 

Genmab Proprietary Products*

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Description automatically generated

*Certain products in co-development, partners as indicated

 

Tisotumab vedotin – A Next Generation Therapeutic

·

Antibody-drug conjugate (ADC), an antibody coupled to a cell-killing agent, in development to treat solid tumors

·

Phase II potential registration study in cervical cancer ongoing, enrollment completed; Phase II clinical studies in ovarian and other solid tumors ongoing

·

Co-developed under a 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 costs and profits for the product on a 50:50 basis. 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 11/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

 

Enapotamab vedotin – A First-in-Class ADC Targeting AXL

·

ADC in development to treat solid tumors

·

Phase I/II clinical study for multiple types of solid tumors ongoing

 

Enapotamab vedotin is an ADC targeted to AXL, a signaling molecule expressed on many solid cancers and implicated in tumor biology. Enapotamab vedotin is fully owned by Genmab and the ADC technology used with enapotamab vedotin was licensed from Seattle Genetics. A Phase I/II clinical study of enapotamab vedotin for multiple types of solid tumors is ongoing.

 

HexaBody®-DR5/DR5  (GEN1029) – First HexaBody Program in Clinical Development

·

Proprietary antibody therapeutic created with Genmab’s HexaBody technology

·

Composed of two non-competing HexaBody antibody molecules that target two distinct DR5 epitopes

·

Phase I/II clinical trial in solid tumors ongoing

 

HexaBody-DR5/DR5 is a product comprising a mixture of two non-competing HexaBody molecules that target two distinct epitopes on death receptor 5 (DR5), a cell surface receptor that mediates a process called programmed cell death. Increased expression of DR5 has been reported in several types of tumors. The product was created with our HexaBody technology and DR5 antibodies acquired from IDD Biotech. HexaBody-DR5/DR5 is fully owned by Genmab and a Phase I/II clinical trial in solid tumors is ongoing.

 

Epcoritamab (DuoBody-CD3xCD20) – A Proprietary Bispecific Antibody

·

Proprietary bispecific antibody created with Genmab’s DuoBody technology

·

Phase I/II clinical trial in B-cell malignancies ongoing

 

Epcoritamab is a proprietary bispecific antibody created using Genmab’s DuoBody technology. Epcoritamab targets CD3,  which is expressed on T-cells, and CD20, a clinically well-validated target. Genmab used technology licensed from Medarex to generate the CD20 antibody forming part of epcoritamab. Genmab fully owns epcoritamab and a Phase I/II clinical study of epcoritamab in B-cell malignancies is ongoing.

 

First Quarter Update

·

February:  “DuoBody-CD3xCD20 induces potent T-cell-mediated killing of malignant B cells in preclinical models and provides opportunities for subcutaneous dosing” published in EBioMedicine, a Lancet journal focused on translational biomedical research.

 

DuoBody-PD-L1x4-1BB (GEN1046) – Bispecific Next Generation Checkpoint Immunotherapy

·

Bispecific antibody created with Genmab’s DuoBody technology

·

Phase I/II clinical trial in solid tumors ongoing

·

Developed in collaboration with BioNTech

 

DuoBody-PD-L1x4-1BB (GEN1046) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all future costs and profits for the product on a 50:50 basis. DuoBody-PD-L1x4-1BB targets PD-L1 and 4-1BB, selected to block inhibitory PD-1 / PD-L1 axis and simultaneously activate essential co-stimulatory activity via 4-1BB using inert DuoBody antibody format. A  Phase I/II clinical study of DuoBody-PD-L1x4-1BB in solid tumors is ongoing.

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 12/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

First Quarter Update

·

Q1:  Expansion cohort initiated in Phase I/II trial in solid tumors.

 

DuoBody-CD40x4-1BB (GEN1042) – Potential First-in-Class Bispecific Agonistic Antibody

·

Bispecific antibody created with Genmab’s DuoBody technology

·

Phase I/II clinical trial in solid tumors ongoing 

·

Developed in collaboration with BioNTech

 

DuoBody-CD40x4-1BB (GEN1042) is a proprietary bispecific antibody, jointly owned by Genmab and BioNTech, created using Genmab’s DuoBody technology. It is being co-developed by Genmab and BioNTech under an agreement in which the companies share all future costs and profits for the product on a 50:50 basis. CD40 and 4-1BB were selected as targets to enhance both dendritic cells (DC) and antigen-dependent T-cell activation, using an inert DuoBody format.  A  Phase I/II clinical study of DuoBody-CD40x4-1BB in solid tumors is ongoing.

 

DuoHexaBody®-CD37 (GEN3009) – First DuoHexaBody in the Clinic

·

Investigational New Drug Application (IND) submitted in 2019

·

First DuoHexaBody product candidate in the clinic

·

Novel target for hematologic malignancies

 

DuoHexaBody-CD37 (GEN3009)  is a bispecific IgG1 antibody created with Genmab’s proprietary DuoHexaBody technology platform. The DuoHexaBody platform combines the dual targeting of our DuoBody technology with the enhanced potency of our HexaBody technology, creating bispecific antibodies with target-mediated enhanced hexamerization. In preclinical settings, DuoHexaBody-CD37 has been shown to induce potent in vivo and in vitro anti-tumor activity. This suggests that DuoHexaBody-CD37 is a promising candidate for clinical development in B-cell malignancies. An IND was submitted to the U.S. FDA in November 2019 and the first patient was dosed with DuoHexaBody-CD37 in March.

 

First Quarter Update

·

March: First patient dosed in first-in-human trial of DuoHexaBody-CD37 in hematologic malignancies.

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 13/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

Partner-owned Products Incorporating Genmab’s Innovation*

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*Products under development by a third-party incorporating Genmab technology and innovation

 

Ofatumumab (OMB157)

·

Human CD20 monoclonal antibody developed by Novartis under a license agreement with Genmab

·

SubQ  formulation in development to treat relapsing forms of multiple sclerosis (RMS)

·

Positive data available from the two Phase III ASCLEPIOS studies with SubQ ofatumumab in RMS 

·

Based on ASCLEPIOS data Novartis initiated regulatory submissions to U.S. and European health authorities

 

Ofatumumab is a human IgG1k mAb that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. A  SubQ formulation of ofatumumab was investigated in two Phase III clinical studies in RMS. The studies compared the efficacy and safety of SubQ ofatumumab versus teriflunomide in patients with RMS and were comprised of approximately 900 patients each. A Phase III study examining the long-term safety, tolerability and effectiveness of ofatumumab in patients with RMS who participated in a previous study is ongoing. Novartis also conducted a Phase II (APLIOS) study to evaluate the bioequivalence of 20mg of SubQ ofatumumab injected by either pre-filled syringe or autoinjector-pen in adult RMS patients.

 

First Quarter Updates

·

February: Positive data from the Phase II APLIOS study, which evaluated the bioequivalence of SubQ administration of ofatumumab via pre-filled syringe, as used in the Phase III ASCLEPIOS I and II trials, and an autoinjector-pen in patients with RMS, was presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum in Florida.

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 14/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

·

February: The U.S. FDA accepted, with Priority Review, the sBLA submitted by Novartis for SubQ ofatumumab for the treatment of RMS in adults. A Marketing Authorization Application (MAA) that Novartis submitted to the European Medicines Agency (EMA), was also accepted for review.

 

Amivantamab (JNJ-61186372) 

·

DuoBody product targeting EGFR and cMet

·

Phase II study ongoing in non-small cell lung cancer (NSCLC)

·

Developed by Janssen under the DuoBody technology collaboration

 

Amivantamab (JNJ-61186372) is a bispecific antibody that targets EGFR and cMet, two validated cancer targets. Amivantamab was created under a collaboration between Genmab and Janssen using Genmab’s DuoBody technology. The two antibodies used to generate amivantamab were both created by Genmab. Janssen is investigating amivantamab in a Phase II clinical study to treat NSCLC.

 

First Quarter Update

·

March: The U.S. FDA granted Breakthrough Therapy Designation (BTD) for amivantamab for the treatment of patients with NSCLC with epidermal growth factor receptor (EGFR) Exon 20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. This is the first BTD granted to a DuoBody product candidate.

 

Mim8

·

DuoBody product in development by Novo Nordisk for hemophilia

·

First DuoBody in indication outside of oncology

·

Phase I/II trial in healthy subjects or patients with hemophilia A ongoing

 

Mim8 is a bispecific antibody created under a collaboration between Genmab and Novo Nordisk using Genmab’s DuoBody technology. Novo Nordisk is investigating Mim8 in a Phase I/II study of healthy subjects (part 1) followed by patients with hemophilia A with or without Factor VIII inhibitors (part 2).

 

First Quarter Update

·

January:  The first healthy subject was dosed in the Phase I/II study of Mim8.

 

Pre-clinical Programs

·

Broad pre-clinical pipeline of more than twenty programs including DuoBody-CD3x5T4 and HexaBody-CD38

·

Pre-clinical pipeline includes both partnered products and in-house programs based on our proprietary technologies or antibodies

·

Multiple new INDs expected to be submitted over coming years

·

Genmab has  entered multiple strategic collaborations to support the expansion of our innovative pipeline

 

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.

 

First Quarter Update

·

January: First Clinical Trial Applications (CTAs) submitted for DuoBody-CD3x5T4 in Europe.

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 15/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

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 2019 Annual Report and the Form 20-F filed with the U.S. Securities and Exchange Commission (SEC) in March 2020. At the date of this interim report, there have been no significant changes to Genmab’s overall risk profile since the publication of the Form 20-F, though the full extent and nature of the impact of the COVID-19 pandemic and related containment measures on our business and financial performance is uncertain as the situation continues to develop. See Genmab’s Form 20-F for a detailed summary of risks related to the COVID-19 pandemic.

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 16/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

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 892 million for the first quarter of 2020 compared to DKK 591 million for the first quarter of 2019.  The increase of DKK 301 million, or 51%, was mainly driven by higher DARZALEX royalties.

 

 

 

 

 

(DKK million)

    

Q1 2020

    

Q1 2019

Royalties

 

781

 

508

Milestone payments

 

32

 

-

License fees

 

 -

 

-

Reimbursement income

 

79

 

83

Total revenue

 

892

 

591

 

Royalties

Royalty income amounted to DKK 781 million in the first quarter of 2020 compared to DKK 508 million in the first quarter of 2019. The increase of DKK 273 million, or 54%, was mainly driven by higher DARZALEX royalties achieved under our daratumumab collaboration with Janssen. 

 

Net sales of DARZALEX by Janssen were USD 937 million in the first quarter of 2020 compared to USD 629 million in the first quarter of 2019. The increase of USD 308 million, or 49%, was driven by the continued strong uptake of DARZALEX. Royalty income on net sales of DARZALEX was DKK 775 million in the first quarter of 2020 compared to DKK 502 million in the first quarter of 2019,  an increase of DKK 273 million. The increase in royalties of 54% is higher than the increase in the underlying sales due primarily to the change in royalty tiers and currency fluctuations between the USD and DKK. During the first quarter of 2020, the royalty rate on net sales of DARZALEX moved into the 13% royalty tier on net sales exceeding USD 750 million in a calendar year, compared to the first quarter of 2019, where the royalty rate on net sales of DARZALEX was the 12% royalty tier on net sales up to USD 750 million in a calendar year.

 

Royalty income may fluctuate from period to period based on the level of sales, various accruals and foreign currency exchange rates.

 

Milestone Payments

Milestone Income was DKK 32 million in the first quarter of 2020 compared to no milestone income in the first quarter of 2019. The increase of DKK 32 million was driven by certain milestone achievements under our DuoBody collaboration with Novo Nordisk and our Teprotumumab collaboration with Horizon Therapeutics. 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.

 

Licenses Fees

There was no license fee income during the first quarter of 2020 or the first quarter of 2019.

 

Reimbursement Income

Reimbursement income amounted to DKK 79 million in the first quarter of 2020 compared to DKK 83 million in the first quarter of 2019. The decrease of DKK 4  million, or 5%, was driven by timing of activities under our collaboration agreements with Seattle Genetics and BioNTech.

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 17/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

Refer to note 2 in this interim report for further details about revenue.

 

Research and Development Costs

Research and development costs amounted to DKK 715 million in the first quarter of 2020 compared to DKK 546 million in the first quarter of 2019. The increase of DKK 169 million, or 31%, was driven by the advancement of epcoritamab (DuoBody-CD3xCD20) and DuoBody-PD-L1x4-1BB, the additional investment in our product pipeline, and the increase in research and development employees.

 

Research and development costs accounted for 87% of the total operating expenses in the first quarter of 2020 compared to 88% in the first quarter of 2019. 

 

General and Administrative Expenses

General and administrative expenses were DKK 106 million in the first quarter of 2020 compared to DKK 71 million in the first quarter of 2019.  The increase of DKK 35 million, or 49%, was driven by growth across all support areas including enhanced technology and systems, early investment in commercial, and other areas  due to the expansion of our product pipeline.

 

General and administrative expenses accounted for 13% of the total operating expenses in the first quarter of 2020 compared to 12% in the first quarter of 2019.

 

Operating Result

Operating income was DKK 71 million in the first quarter of 2020 compared to an operating loss of DKK 26 million in the first quarter of 2019.  The increase of DKK 97 million was driven by higher revenue, which was partly offset by increased operating expenses.

 

As of March 31, 2020, the total number of employees was 579 compared to 419 employees as of March 31, 2019.  The increase in employees was driven by the expansion and acceleration of our pipeline.

 

 

 

 

 

 

Workforce

    

March 31, 2020

    

March 31, 2019

Research and development employees

 

490

 

361

Administrative employees

 

89

 

58

Total employees

 

579

 

419

 

Net Financial Items

The  net financial items for the first quarter of 2020 were net income of DKK 283 million compared to net income of DKK 120 million in the first quarter of 2019.  The increase of DKK 163 million was driven primarily by foreign exchange movements between the USD and DKK. During the first quarter of 2020, the USD strengthened against the DKK to a greater extent than 2019,  resulting in greater realized and unrealized exchange rate gains.  In addition, interest income increased due to a combination of higher yield and level of investment in marketable securities in the first quarter of 2020 as compared to the first quarter of 2019. 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 quarter of 2020 was DKK 85 million compared to DKK 22 million for the first quarter of 2019.  The estimated annual effective corporate tax rate in the first quarter of 2020 was 24% compared to 23% in the first quarter of 2019.  There has been no reversal of the valuation allowances on deferred tax assets in the first quarter of 2020 or the first quarter of 2019.

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 18/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

Net Result

Net result for the first quarter of 2020 was a net income of DKK 269 million compared to DKK 72 million in the first quarter of 2019. The increase was driven by the items described above. 

 

Cash Position 

 

 

 

 

 

 

Cash Position (DKK million)

    

March 31, 2020

    

December 31, 2019

Marketable securities

 

7,417

 

7,419

Cash and cash equivalents

 

5,543

 

3,552

Cash position

 

12,960

 

10,971

 

As of March 31, 2020, cash, cash equivalents,  and marketable securities (cash position) amounted to DKK 12,960 million,  an increase of DKK  1,989 million from the beginning of 2020.  The increase was mainly driven by positive working capital adjustments of DKK 2,102 million related to milestones achieved in the fourth quarter of 2019, which were received in the first quarter of 2020,  which was partly offset by corporate taxes paid of DKK 97 million during the first quarter of 2020.

 

Cash and cash equivalents included short-term marketable securities of DKK 1,708 million at the end of March 2020, compared to DKK 668 million at the end of December 2019. 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 (DKK million)

    

Q1 2020

    

Q1 2019

Cash provided by (used in) operating activities

 

2,192

 

648

Cash provided by (used in) investing activities

 

 9

 

(14)

Cash provided by (used in) financing activities

 

15

 

(11)

 

Net cash provided by operating activities is primarily related to our operating result, working capital fluctuations, reversal of net financial items, and adjustments related to non-cash expenses, all of which may be highly variable period to period. In the first quarter of 2020, the primary driver of higher cash provided by operating activities was higher positive working capital adjustments in 2020 related to milestones achieved in the fourth quarter of 2019 that were received in 2020.  

 

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.  

 

Net cash provided by financing activities is primarily related to the issuance of shares, purchase of treasury shares, exercise of warrants and lease payments. In the first quarter of 2020, the primary driver of the higher cash provided by financing activities was related to the proceeds from the exercise of warrants partially offset by the payment of withholding taxes on behalf of employees on net settled RSUs. 

 

Balance Sheet

As of March 31, 2020, total assets were DKK 15,303 million compared to DKK 15,144 million as of December 31, 2019. As of March 31, 2020, assets are mainly comprised of a cash position of DKK 12,960 million and current receivables of DKK  1,130 million. The receivables consist primarily of royalties from our license and collaboration agreements and other receivables, which are due less than one year from the balance sheet date.

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 19/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

Shareholders’ equity as of March 31, 2020 was DKK 14,398 million compared to DKK 14,048 million at the end of December 2019.  The increase of DKK 350 million, or 2%, was driven primarily by our net income. As of March 31, 2020, Genmab’s equity ratio was 94% compared to  93% as of December 31, 2019. 

 

General Corporate Matters – Changes in Executive Management

Anthony Pagano was appointed the role of Executive Vice President and Chief Financial Officer of Genmab on March 1, 2020 following the retirement of David Eatwell from the position on February 29, 2020. Anthony joined Genmab in 2007 and was appointed Senior Vice President in 2011. He most recently served as Senior Vice President Finance and Corporate Development prior to becoming Executive Vice President and Chief Financial Officer in March. He is a Certified Public Accountant and received a B.S. in Accounting from The College of New Jersey, as well as an M.B.A. from the Stern School of Business at New York University.

 

Anthony Mancini joined Genmab in March 2020 as Executive Vice President and Chief Operating Officer. Prior to joining Genmab, Mr. Mancini served in a variety of strategic and operational leadership roles over a nearly 24-year career at Bristol-Myers Squibb (BMS). Most recently, he led BMS’ US Innovative Medicines Unit, a team of over 1100 people focused on Immunology & Cardiovascular diseases. He holds a Bachelor of Science in Biochemistry from the University of Ottawa, Canada, an MBA from Clemson University, South Carolina, USA, and completed the General Management Program, CEDEP at INSEAD, Fontainebleau, France.

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 20/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

STATEMENT OF COMPREHENSIVE INCOME FOR THE FIRST QUARTER OF 2020

 

 

 

 

 

 

 

Income Statement

    

    

    

1st Quarter of

    

1st Quarter of

(DKK million)

 

Note

 

2020

 

2019

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Revenue

 

2

 

892

 

591

 

 

 

 

 

 

 

Research and development expenses

 

  

 

(715)

 

(546)

General and administrative expenses

 

  

 

(106)

 

(71)

Operating expenses

 

  

 

(821)

 

(617)

 

 

 

 

 

 

 

Operating result

 

  

 

71

 

(26)

 

 

 

 

 

 

 

Financial income

 

4

 

285

 

122

Financial expenses

 

4

 

(2)

 

(2)

 

 

 

 

 

 

 

Net result before tax

 

  

 

354

 

94

 

 

 

 

 

 

 

Corporate tax

 

  

 

(85)

 

(22)

 

 

 

 

 

 

 

Net result

 

  

 

269

 

72

 

 

 

 

 

 

 

Basic net result per share

 

  

 

4.13

 

1.18

Diluted net result per share

 

  

 

4.09

 

1.17

 

 

 

 

 

 

 

Statement of Comprehensive Income

 

  

 

 

 

  

 

 

 

 

 

 

 

Net result

 

  

 

269

 

72

 

 

 

 

 

 

 

Other comprehensive income:

 

  

 

 

 

  

 

 

 

 

 

 

 

Amounts which will be re-classified to the income statement:

 

  

 

 

 

  

Adjustment of foreign currency fluctuations on subsidiaries

 

  

 

 9

 

 4

 

 

 

 

 

 

 

Total comprehensive income

 

  

 

278

 

76

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 21/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

BALANCE SHEET

 

 

 

 

 

 

 

 

    

 

    

March 31, 

    

December 31,

 

 

Note

 

2020

 

2019

(DKK million)

 

 

 

 

 

 

ASSETS

 

  

 

  

 

  

 

 

 

 

 

 

 

Intangible assets

 

  

 

442

 

470

Property, plant and equipment

 

  

 

321

 

237

Right-of-use assets

 

7

 

170

 

177

Receivables

 

  

 

12

 

11

Deferred tax assets

 

  

 

119

 

139

Other Investments

 

  

 

149

 

149

 

 

 

 

 

 

 

Total non-current assets

 

  

 

1,213

 

1,183

 

 

 

 

 

 

 

Receivables

 

  

 

1,130

 

2,990

Marketable securities

 

3

 

7,417

 

7,419

Cash and cash equivalents

 

  

 

5,543

 

3,552

 

 

 

 

 

 

 

Total current assets

 

  

 

14,090

 

13,961

 

 

 

 

 

 

 

Total assets

 

  

 

15,303

 

15,144

 

 

 

 

 

 

 

SHAREHOLDERS’ EQUITY AND LIABILITIES

 

  

 

 

 

 

 

 

 

 

 

 

 

Share capital

 

  

 

65

 

65

Share premium

 

  

 

11,796

 

11,755

Other reserves

 

  

 

107

 

98

Retained earnings

 

  

 

2,430

 

2,130

 

 

 

 

 

 

 

Shareholders' equity

 

  

 

14,398

 

14,048

 

 

 

 

 

 

 

Provisions

 

  

 

 2

 

 2

Lease liabilities

 

7

 

148

 

155

Other payables

 

  

 

15

 

 1

 

 

 

 

 

 

 

Total non-current liabilities

 

  

 

165

 

158

 

 

 

 

 

 

 

Corporate tax payable

 

  

 

39

 

73

Lease liabilities

 

7

 

26

 

26

Other payables

 

  

 

675

 

839

 

 

 

 

 

 

 

Total current liabilities

 

  

 

740

 

938

 

 

 

 

 

 

 

Total liabilities

 

  

 

905

 

1,096

 

 

 

 

 

 

 

Total shareholders' equity and liabilities

 

  

 

15,303

 

15,144

 

 

 

 

 

 

 

Share-based instruments

 

5

 

  

 

 

Shareholdings by the Board of Directors and Executive Management

 

6

 

  

 

 

Subsequent events to the balance sheet date

 

8

 

  

 

 

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 22/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

STATEMENT OF CASH FLOWS

 

 

 

 

 

 

 

 

 

 

 

1st Quarter

 

1st Quarter

 

    

Note

    

March 31, 2020

    

March 31, 2019

(DKK million)

 

 

 

 

 

 

 

 

 

 

 

 

 

Net result before tax

 

 

 

354

 

94

 

 

 

 

 

 

 

Reversal of financial items, net

 

 

 

(283)

 

(120)

Adjustments for non-cash transactions

 

 

 

87

 

69

Changes in working capital

 

 

 

2,102

 

733

 

 

 

 

 

 

 

Cash flow from operating activities before financial items

 

 

 

2,260

 

776

 

 

 

 

 

 

 

Interest received

 

 

 

33

 

14

Interest elements of lease payments

 

7

 

(2)

 

(2)

Interest paid

 

 

 

(2)

 

 -

Corporate taxes (paid)/received

 

 

 

(97)

 

(140)

 

 

 

 

 

 

 

Cash flow from operating activities

 

 

 

2,192

 

648

 

 

 

 

 

 

 

Investment in tangible assets

 

 

 

(58)

 

(21)

Marketable securities bought

 

3

 

(5,812)

 

(642)

Marketable securities sold

 

3

 

5,879

 

649

 

 

 

 

 

 

 

Cash flow from investing activities

 

 

 

 9

 

(14)

 

 

 

 

 

 

 

Warrants exercised

 

 

 

37

 

 5

Principal elements of lease payments

 

 

 

(8)

 

(7)

Payment of withholding taxes on behalf of employees on net settled RSUs

 

 

 

(14)

 

(9)

 

 

 

 

 

 

 

Cash flow from financing activities

 

 

 

15

 

(11)

 

 

 

 

 

 

 

Changes in cash and cash equivalents

 

 

 

2,216

 

623

Cash and cash equivalents at the beginning of the period

 

 

 

3,274

 

533

Exchange rate adjustments

 

 

 

53

 

21

 

 

 

 

 

 

 

Cash and cash equivalents at the end of the period

 

 

 

5,543

 

1,177

 

 

 

 

 

 

 

Cash and cash equivalents include:

 

 

 

 

 

 

Bank deposits and petty cash

 

 

 

3,835

 

1,177

Short-term marketable securities

 

 

 

1,708

 

 -

 

 

 

 

 

 

 

Cash and cash equivalents at the end of the period

 

 

 

5,543

 

1,177

 

 

Genmab A/S

Tel: +45 7020 2728

Company Announcement no. 20

Kalvebod Brygge 43

Fax: +45 7020 2729

Page 23/37

1560 Copenhagen V, Denmark

www.genmab.com

CVR no. 2102 3884

 

Picture 1

 

Interim Report for the First Quarter of 2020

 

STATEMENT OF CHANGES IN EQUITY

 

 

 

 

 

 

 

 

 

 

 

 

 

    

Share

    

Share

    

Translation

    

Retained

    

Shareholders'

 

 

capital

 

premium

 

reserves

 

earnings

 

equity

(DKK million)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

December 31, 2018

 

61

 

8,059

 

92

 

(198)

 

8,014

 

 

 

 

 

 

 

 

 

 

 

Net result

 

 -

 

 -

 

 -

 

72

 

72

Other comprehensive income

 

 -

 

 -

 

 4

 

 -

 

 4

Total comprehensive income

 

 -

 

 -

 

 4

 

72

 

76

 

 

 

 

 

 

 

 

 

 

 

Transactions with owners:

 

  

 

  

 

  

 

  

 

  

Exercise of warrants

 

 -

 

 5

 

 -

 

 -

 

 5