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 NOVEMBER 2019
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.
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GENMAB A/S |
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BY: |
/s/ David A. Eatwell |
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Name: David A.Eatwell |
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Title: Executive Vice President & Chief Financial Officer |
DATE: November 6, 2019
EXHIBIT INDEX
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Exhibit |
Description of Exhibit |
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99.1 |
Interim Report Dated November 6, 2019 |
Exhibit 99.1
Interim Report for the Nine Months Ended September 30, 2019
November 6, 2019; Copenhagen, Denmark;
Interim Report for the First Nine Months Ended September 30, 2019
Highlights
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· |
Completion of public offering and listing of American Depository Shares (ADSs) on Nasdaq Global Select Market under the symbol “GMAB.” Total gross proceeds from the issuance of new shares amounted to USD 582 million (DKK 3,873 million) with a corresponding increase in share capital of 3,277,500 ordinary shares or 32,775,000 ADSs |
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· |
Positive data reported by Novartis for the Phase III ASCLEPIOS I & II studies of subcutaneous ofatumumab in relapsing multiple sclerosis (RMS) |
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DARZALEX® (daratumumab) approved in the U.S. in combination with bortezomib, thalidomide and dexamethasone (VTd) and in Japan in combination with bortezomib, melphalan and prednisone (VMP) in various multiple myeloma frontline settings |
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Positive topline results for daratumumab in both the Phase III CANDOR and Phase II GRIFFIN studies in various multiple myeloma settings |
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Biologics License Application (BLA) submitted to U.S. Food and Drug Administration (U.S. FDA) for the subcutaneous formulation of daratumumab; standard review received. An extension of marketing authorization for this formulation was also submitted to the European Medicines Agency (EMA) |
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DARZALEX net sales increased 50% compared to the first nine months of 2018 to USD 2,168 million, resulting in royalty income of DKK 2,033 million |
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Genmab is improving its 2019 financial guidance mainly due to positive foreign exchange movements between the USD and DKK resulting in increased milestone income and royalties on sales of DARZALEX |
“Genmab made excellent progress across many areas of the business during the third quarter of 2019. Of key significance was the completion of our public offering of American Depositary Shares and listing on the Nasdaq Global Select Market in the U.S. Genmab’s status as a dual listed company both increases our visibility as an innovation powerhouse and provides additional support for the development of our exciting pipeline of antibody product candidates,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “Over the past three months advances to this pipeline included positive data readouts for ofatumumab in relapsing multiple sclerosis and daratumumab in multiple myeloma, regulatory submissions for daratumumab and teprotumumab and additional approvals for daratumumab in the U.S. and Asia. In addition, we entered into new strategic collaborations with companies such as Tempus and BliNK Biomedical, which will allow us to expand our pipeline in new directions as Genmab continues to move towards our goal of transforming cancer treatment.”
Financial Performance First Nine Months of 2019
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Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
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Kalvebod Brygge 43 |
Fax: +45 7020 2729 |
Page 1/44 |
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1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
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Net sales of DARZALEX by Janssen were USD 2,168 million in the first nine months of 2019 compared to USD 1,441 million in the first nine months of 2018, an increase of USD 727 million, or 50%. |
Outlook
Genmab is improving its 2019 financial guidance published on August 14, 2019 mainly due to positive foreign exchange movements between the USD and DKK resulting in increased milestone income and royalties on sales of DARZALEX.
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Revised |
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Previous |
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MDKK |
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Guidance |
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Guidance |
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Revenue |
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5,100 |
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4,800 |
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Operating expenses |
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(2,750) |
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(2,750) |
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Operating income |
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2,350 |
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2,050 |
Conference Call
Genmab will hold a conference call in English to discuss the results for the first nine months of 2019 today, Wednesday, November 6, at 6:00 pm CET, 5:00 pm GMT or 12:00 pm EST. To join the call dial
+1 631 510 7495 (U.S. participants) or +44 2071 928000 (international participants) and provide conference code 7996106.
A live and archived webcast of the call and relevant slides will be available at www.genmab.com.
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
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Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
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Kalvebod Brygge 43 |
Fax: +45 7020 2729 |
Page 2/44 |
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1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
CONTENTS
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Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
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Kalvebod Brygge 43 |
Fax: +45 7020 2729 |
Page 3/44 |
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1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
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3rd Quarter of |
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3rd Quarter of |
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9 Months Ended |
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9 Months Ended |
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Full Year |
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2019 |
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2018* |
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September 30, 2019 |
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September 30, 2018* |
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2018* |
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DKK'000 |
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DKK'000 |
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DKK'000 |
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DKK'000 |
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DKK'000 |
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Income Statement |
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Revenue |
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1,039,844 |
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598,597 |
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2,404,767 |
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1,789,284 |
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3,025,137 |
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Research and development expenses |
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(607,886) |
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(343,242) |
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(1,717,342) |
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(974,682) |
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(1,431,159) |
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General and administrative expenses |
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(81,225) |
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(55,182) |
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(225,449) |
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(155,340) |
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(213,695) |
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Operating expenses |
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(689,111) |
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(398,424) |
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(1,942,791) |
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(1,130,022) |
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(1,644,854) |
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Operating result |
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350,733 |
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200,173 |
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461,976 |
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659,262 |
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1,380,283 |
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Net financial items |
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348,546 |
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30,425 |
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441,853 |
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162,216 |
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231,688 |
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Net result |
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537,047 |
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179,175 |
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694,141 |
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638,276 |
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1,472,141 |
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Balance Sheet |
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Cash position** |
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11,116,849 |
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5,895,423 |
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11,116,849 |
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5,895,423 |
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6,106,094 |
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Non-current assets |
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1,074,001 |
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831,752 |
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1,074,001 |
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831,752 |
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1,027,974 |
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Assets |
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13,330,303 |
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7,403,733 |
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13,330,303 |
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7,403,733 |
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8,460,999 |
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Shareholders' equity |
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12,514,631 |
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7,079,169 |
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12,514,631 |
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7,079,169 |
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8,014,360 |
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Share capital |
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64,989 |
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61,490 |
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64,989 |
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61,490 |
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61,498 |
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Investments in intangible and tangible assets |
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46,573 |
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408,754 |
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82,147 |
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456,545 |
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477,366 |
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Cash Flow Statement |
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Cash flow from operating activities |
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319,068 |
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211,741 |
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1,151,094 |
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810,688 |
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1,014,786 |
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Cash flow from investing activities |
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(46,241) |
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(414,402) |
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(832,323) |
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(1,201,093) |
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(1,777,553) |
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Cash flow from financing activities |
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3,637,030 |
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12,900 |
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3,652,648 |
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(72,611) |
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(70,901) |
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Cash and cash equivalents |
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4,643,035 |
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896,074 |
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4,643,035 |
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896,074 |
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532,907 |
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Cash position increase/(decrease) |
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4,165,896 |
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(175,512) |
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5,010,755 |
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472,686 |
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683,357 |
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Financial Ratios |
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Basic net result per share |
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8.38 |
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2.92 |
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11.14 |
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10.43 |
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24.03 |
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Diluted net result per share |
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8.28 |
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2.89 |
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11.03 |
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10.29 |
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23.73 |
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Period-end share market price |
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1,390.50 |
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1,010.00 |
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1,390.50 |
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1,010.00 |
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1,067.50 |
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Price / book value |
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7.22 |
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8.77 |
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7.22 |
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8.77 |
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8.19 |
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Shareholders' equity per share |
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192.57 |
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115.13 |
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192.57 |
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115.13 |
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130.32 |
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Equity ratio |
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94 |
% |
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96 |
% |
94 |
% |
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96 |
% |
95 |
% |
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Average number of employees (FTE***) |
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514 |
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334 |
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458 |
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297 |
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313 |
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Number of employees at the end of the period |
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533 |
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349 |
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533 |
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349 |
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377 |
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* As disclosed in note 1 of the financial statements, prior period amounts have not been adjusted under the modified retrospective method to adopt IFRS 16 as of January 1, 2019
** Cash, cash equivalents, and marketable securities.
*** Full-time equivalent
The figures and financial ratios have been prepared on a consolidated basis. The financial ratios have been calculated in accordance with the recommendations of the Association of Danish Financial Analysts (2017) and key figures in accordance with IFRS.
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
Kalvebod Brygge 43 |
Fax: +45 7020 2729 |
Page 4/44 |
|
1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
|
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Revised |
|
Previous |
|
MDKK |
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Guidance |
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Guidance |
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Revenue |
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5,100 |
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4,800 |
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Operating expenses |
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(2,750) |
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(2,750) |
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Operating income |
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2,350 |
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2,050 |
Genmab is improving its 2019 financial guidance published on August 14, 2019 mainly due to positive foreign exchange movements between the USD and DKK resulting in increased milestone income and royalties on sales of DARZALEX.
Revenue
We expect our 2019 revenue to be approximately DKK 5,100 million, an increase of DKK 300 million compared to the previous guidance. Our projected revenue for 2019 primarily consists of DARZALEX royalties of DKK 3,000 million, an increase of DKK 115 million from the previous guidance due to positive impact of USD/DKK exchange rate movements. The DARZALEX royalties are based on estimated net sales of USD 3.0 billion in 2019. We project DARZALEX milestones of approximately DKK 1,675 million driven by commercial net-sales based milestones of USD 100 million and USD 150 million, for achieving net-sales in a calendar year of USD 2.5 billion and USD 3.0 billion respectively, an increase of DKK 175 million from the previous guidance mainly due to positive impact of USD/DKK exchange rate movements. The remainder of the revenue consists of cost reimbursement income, Arzerra® royalties, and DuoBody® milestones.
Operating Expenses
We anticipate that our 2019 operating expenses will be approximately DKK 2,750 million driven by the advancement of our product pipeline and addition of new projects.
Operating Result
We now expect the operating income to be approximately DKK 2,350 million in 2019, an increase of DKK 300 million compared to the previous guidance.
Outlook: Risks and Assumptions
In addition to factors already mentioned, the estimates above are subject to change due to numerous reasons, including but not limited to the achievement of certain milestones associated with our collaboration agreements; the timing and variation of development activities (including activities carried out by our collaboration partners) and related income and costs; DARZALEX sales and corresponding royalties to Genmab; and currency exchange rates. The financial guidance assumes that no significant agreements are entered during 2019 that could materially affect the results.
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
Kalvebod Brygge 43 |
Fax: +45 7020 2729 |
Page 5/44 |
|
1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
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Priority |
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Targeted Milestones |
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Daratumumab |
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U.S. FDA decision on Phase III MAIA multiple myeloma (MM) submission U.S. FDA decision on Phase III CASSIOPEIA MM submission Phase III COLUMBA MM subcutaneous daratumumab safety and efficacy analysis |
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Ofatumumab |
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Phase III ASCLEPIOS I & II relapsing multiple sclerosis subcutaneous ofatumumab study completion and reporting |
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Tisotumab vedotin |
Phase II innovaTV 204 tisotumab vedotin recurrent / metastatic cervical cancer study enrollment complete by mid-year |
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Innovative pipeline |
* |
Phase II enapotamab vedotin expansion cohort efficacy analysis Phase I/II HexaBody®-DR5/DR5 initial clinical data Phase I/II DuoBody-CD3xCD20 clinical data dose escalation cohorts File INDs or CTAs for 3 new products |
*Initial data now anticipated in 2020. A status update will be available in 2019.
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
Kalvebod Brygge 43 |
Fax: +45 7020 2729 |
Page 6/44 |
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1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
Our own and partnered product pipeline consists of eighteen antibodies in clinical development, including two marketed partnered products, and approximately 20 in-house and partnered pre-clinical programs. An overview of the development status of each of our products is provided in the following sections. Detailed descriptions of dosing, efficacy and safety data from certain clinical trials have been disclosed in company announcements and media releases published via the Nasdaq Copenhagen stock exchange and may also be found in Genmab’s filings with the U.S. Securities and Exchange Commission (SEC). Additional information is available on Genmab’s website, www.genmab.com.
PRODUCT PIPELINE AND TECHNOLOGY PROGRESS FIRST NINE MONTHS OF 2019
Marketed Partnered Products
DARZALEX (daratumumab) – First CD38 Antibody Approved in the World
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First-in-class human CD38 antibody in development to treat cancer |
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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 |
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Multiple Phase III studies ongoing in multiple myeloma and amyloid light-chain (AL) amyloidosis, and for a subcutaneous formulation |
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Early stage studies ongoing in other blood cancers |
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Collaboration with Janssen Biotech, Inc. (Janssen) |
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Net sales of DARZALEX by Janssen were USD 2,168 million in the first nine months of 2019 |
DARZALEX (daratumumab) intravenous infusion is indicated for the treatment of adult patients:
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Jurisdiction |
Approval |
Key Underlying Clinical Trial(s) |
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United States |
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Relapsed / Refractory MM |
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November 2015 |
Monotherapy for patients who have received at least three prior lines of therapy, including a PI and an immunomodulatory agent, or who are double refractory to a PI and an immunomodulatory agent |
SIRIUS (MMY2002) |
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
Kalvebod Brygge 43 |
Fax: +45 7020 2729 |
Page 7/44 |
|
1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
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November 2016 |
In combination with Rd or Vd, for patients who have received at least one prior therapy |
CASTOR (MMY3004); POLLUX (MMY3003) |
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June 2017 |
In combination with Pom-d for patients who have received at least two prior therapies, including lenalidomide and a PI |
EQUULEUS (MMY1001) |
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Frontline MM |
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May 2018 |
In combination with VMP for newly diagnosed patients who are ineligible for ASCT |
ALCYONE (MMY3007) |
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June 2019 |
In combination with Rd for newly diagnosed patients who are ineligible for ASCT |
MAIA (MMY3008) |
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September 2019 |
In combination with VTd for newly diagnosed patients who are eligible for ASCT |
CASSIOPEIA (MMY3006) |
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Split Dosing Regimen |
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February 2019 |
Option to split first infusion over two consecutive days |
EQUULEUS (MMY1001) |
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European Union |
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Relapsed / Refractory MM |
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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) |
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February 2017 |
In combination with Rd or Vd for patients who have received at least one prior therapy |
CASTOR (MMY3004); POLLUX (MMY3003) |
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Frontline MM |
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July 2018 |
In combination with VMP for newly diagnosed patients who are ineligible for ASCT |
ALCYONE (MMY3007) |
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Split Dosing Regimen |
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December 2018 |
Option to split first infusion over two consecutive days |
EQUULEUS (MMY1001) |
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Japan |
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Relapsed / Refractory MM |
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September 2017 |
In combination with Rd or Vd |
CASTOR (MMY3004); POLLUX (MMY3003) |
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Frontline MM |
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August 2019 |
In combination with VMP for newly diagnosed patients ineligible for ASCT |
ALCYONE (MMY3007) |
PI = proteasome inhibitor; Rd = lenalidomide and dexamethasone; Vd = bortezomib and dexamethasone; VMP = bortezomib, melphalan and prednisone; VTd = bortezomib, thalidomide and dexamethasone; ASCT = autologous stem cell transplant; Pom-d = pomalidomide and dexamethasone
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
Kalvebod Brygge 43 |
Fax: +45 7020 2729 |
Page 8/44 |
|
1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
The warnings and precautions for DARZALEX include infusion reactions, interference with serological testing and interference with determination of complete response. The most frequently reported adverse reactions (incidence ≥20%) in clinical trials were: infusion reactions, neutropenia, thrombocytopenia, fatigue, nausea, diarrhea, constipation, vomiting, muscle spasms, arthralgia, back pain, pyrexia, chills, dizziness, insomnia, cough, dyspnea, peripheral edema, peripheral sensory neuropathy and upper respiratory tract infection.
Please consult the full U.S. Prescribing information and the full European Summary of Product Characteristics for all the labeled safety information for DARZALEX.
Third Quarter Update
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· |
September: Recruitment complete in the Phase III CEPHEUS (MMY3019) study of subcutaneous daratumumab in combination with bortezomib, lenalidomide and dexamethasone (VRd) in patients with untreated multiple myeloma for whom hematopoietic stem cell transplant is not planned as initial therapy. |
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September: Enrollment temporarily on hold for Phase III AURIGA (MMY3021) trial based on U.S. FDA request for additional information related to analytical methods included in the study protocol. |
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· |
September: Topline results from the Phase III CANDOR study, sponsored by Amgen, of daratumumab in combination with carfilzomib and dexamethasone (Kd) versus Kd alone in relapsed or refractory multiple myeloma met the primary endpoint of improvement in progression free survival (PFS). Daratumumab in combination with Kd resulted in a 37% reduction in the risk of progression or death in patients with relapsed or refractory multiple myeloma (HR=0.630; 95% CI: 0.464, 0.854; p=0.0014). The median PFS for patients treated with daratumumab in combination with Kd had not been reached by the cut-off date compared to a median PFS of 15.8 months for patients who received Kd alone. There was a higher frequency of adverse events reported with daratumumab plus Kd, a three-agent regimen, than with Kd, a two-agent regimen. The types of observed adverse events were consistent with the known safety profiles of the individual agents. Amgen will discuss the data with health authorities in preparation for regulatory submissions. |
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· |
September: Data from multiple daratumumab studies, including the first public presentations of the Phase II GRIFFIN (MMY2004) and PLEIADES (MMY2040) studies, were presented at the 17th International Myeloma Workshop. |
|
· |
August: Recruitment complete in the Phase III LEPUS (MMY3009) study of daratumumab plus Vd in Chinese patients with relapsed or refractory multiple myeloma. |
|
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August: DARZALEX approved in combination with VMP for the treatment of patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant in Japan. The approval was based on data from the Phase III ALCYONE (MMY3007) study. Genmab received USD 7 million milestone payment. |
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July: A BLA was submitted to the U.S. FDA and an extension of the marketing authorization was submitted to the European Medicines Agency for the subcutaneous formulation of daratumumab. The submissions were based on data from Phase III COLUMBA (MMY3012) and Phase II PLEIADES (MMY2040) studies. In September the BLA received a standard review from the U.S. FDA. |
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· |
July: The Phase II GRIFFIN (MMY2004) study of daratumumab in combination with VRd versus VRd alone for transplant eligible patients with newly diagnosed multiple myeloma met the primary |
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
Kalvebod Brygge 43 |
Fax: +45 7020 2729 |
Page 9/44 |
|
1560 Copenhagen V, Denmark |
www.genmab.com |
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Interim Report for the Nine Months Ended September 30, 2019
endpoint of stringent complete response (sCR). The topline data showed that 42.4% of patients treated with daratumumab in combination with VRd achieved a sCR, compared to 32.0% of patients who received VRd alone, with an odds ratio of 1.57 (95% CI: 0.87 - 2.82, p=0.1359, exceeding the statistical significance at the pre-set 2-sided alpha level of 0.2). Secondary endpoints, including the results of the minimal residual disease (MRD) analysis, supported the primary endpoint favoring daratumumab in combination with VRd. Overall, the safety profile of daratumumab in combination with VRd was consistent with the safety profile for each therapy separately. |
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July: DARZALEX was approved as monotherapy in China for adult patients with relapsed or refractory multiple myeloma. |
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July: Recruitment complete in the Phase III ANDROMEDA (AMY3001) study of daratumumab in combination with cyclophosphamide, bortezomib and dexamethasone (CyBorD) in patients with newly diagnosed systemic AL amyloidosis. |
First Half Update
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June: The U.S. FDA approved the use of DARZALEX in combination with Rd for the treatment of adult patients newly diagnosed with multiple myeloma who are ineligible for ASCT. The approval was based on the Phase III MAIA (MMY3008) study. |
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June: Data from Phase III daratumumab trials CASSIOPEIA (MMY3006) and COLUMBA (MMY3012) were presented in oral sessions at both the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting and the 24th European Hematology Association (EHA) Annual Congress. |
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June: Enrollment complete in the Phase III APOLLO (MMY3013) trial of daratumumab in combination with pomalidomide and dexamethasone (Pom-dex) for patients with relapsed or refractory multiple myeloma who have received at least one prior line of therapy with both lenalidomide and a proteasome inhibitor. |
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May: Enrollment complete in the Phase III AQUILA (SMM3001) trial of daratumumab in high-risk smoldering multiple myeloma. |
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May: The U.S. FDA granted Priority Review for daratumumab in combination with VTd as treatment for newly diagnosed patients with multiple myeloma who are candidates for ASCT. The submission was based on the Phase III CASSIOPEIA (MMY3006) data. |
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April: A Supplemental new drug application (sNDA) was submitted in Japan for daratumumab in combination with lenalidomide and dexamethasone as a treatment for patients newly diagnosed with multiple myeloma who are not candidates for high-dose chemotherapy and ASCT. The submission was based on data from Phase III MAIA (MMY3008) study. |
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April: The Phase III AURIGA (MMY3021) study was announced to examine daratumumab plus lenalidomide as maintenance treatment in patients with newly diagnosed multiple myeloma and utilizes the subcutaneous formulation of daratumumab. The first patient was dosed in June. |
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March: The Phase II LYNX (MMY2065) study of subcutaneous daratumumab in combination with Kd compared to Kd in patients with relapsed refractory multiple myeloma who were previously treated with intravenous daratumumab was published on www.clinicaltrials.gov. |
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March: Regulatory submissions to broaden the label for daratumumab to include use in combination with VTd as treatment for newly diagnosed patients with multiple myeloma who are candidates for ASCT were submitted to the EMA and the U.S. FDA. The submissions were based on data from the Phase III CASSIOPEIA (MMY3006) study. |
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March: A regulatory submission to broaden the existing marketing authorization for daratumumab to include use in combination with Rd as treatment for newly diagnosed patients with multiple myeloma who are not candidates for high dose chemotherapy and ASCT was submitted to the EMA. The submission was based on data from the Phase III MAIA (MMY3008) study. |
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February: Topline results from the Phase III COLUMBA study (MMY3012) of subcutaneous versus intravenous (IV) daratumumab for patients with relapsed or refractory multiple myeloma were reported. The results showed that subcutaneous administration of daratumumab co-formulated with recombinant human hyaluronidase PH20 is non-inferior to IV administration of daratumumab with regard to the co-primary endpoints of overall response rate (ORR) and Maximum Trough concentration (Ctrough) of daratumumab on day 1 of the third treatment cycle. The ORR for patients treated with subcutaneous daratumumab was 41.1% versus 37.1% in patients treated with IV daratumumab. The lower limit of the 95% Confidence Interval (CI) for the ratio of the two met the specified non-inferiority criterion for this co-primary endpoint. The geometric mean of Ctrough for patients treated with subcutaneous daratumumab was 499 mg/mL versus 463 mg/mL in patients treated with IV daratumumab. The lower limit of the 95% CI for the ratio of the two met the specified non-inferiority criterion for this co-primary endpoint. No new safety signals were detected and Janssen plans to discuss the potential for a regulatory submission for subcutaneous daratumumab with health authorities. |
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February: The U.S. FDA approved an update to the Prescribing Information for DARZALEX to provide healthcare professionals the option to split the first infusion of DARZALEX over two consecutive days. |
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January: The first part of a regulatory application was submitted to the U.S. FDA for a label expansion to include the use of daratumumab in combination with Rd for the treatment of patients with newly diagnosed multiple myeloma who are not candidates for high dose chemotherapy and ASCT. The submission was based on data from the Phase III MAIA (MMY3008) study. The U.S. FDA reviewed this application under their Real-Time Oncology Review (RTOR) pilot program. The submission was completed in March. |
Daratumumab Development Covering All States of Multiple Myeloma – Key Ongoing Trials
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Daratumumab Development – Beyond Multiple Myeloma
Arzerra (ofatumumab) – Our First Marketed Product
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Human CD20 monoclonal antibody developed and marketed worldwide by Novartis under a license agreement with Genmab |
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Novartis is marketing Arzerra for certain chronic lymphocytic leukemia (CLL) indications in the U.S. and Japan and certain other territories |
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Net sales of Arzerra by Novartis were USD 13 million in the first nine months of 2019 |
In the U.S., Arzerra solution for infusion is approved for use in combination with chlorambucil for the treatment of previously untreated patients with CLL for whom fludarabine-based therapy is considered inappropriate; for use in combination with fludarabine and cyclophosphamide (FC) for the treatment of patients with relapsed CLL; and for extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive CLL. It is also indicated as monotherapy for the treatment of patients with CLL who are refractory to fludarabine and alemtuzumab.
In 2019, the marketing authorization for Arzerra was withdrawn in the EU and several other territories. Arzerra is commercially available in Japan as well as in the U.S. and certain other territories.
The overall safety profile of Arzerra in CLL is based on exposure in clinical trials and the post-marketing setting. The most common side effects for Arzerra include adverse events associated with infusion reactions, cytopenias, and infections (lower respiratory tract infection, including pneumonia, upper respiratory tract infection, sepsis, including neutropenic sepsis and septic shock, herpes viral infection, and urinary tract infection).
Please consult the full U.S. Prescribing information, including Boxed Warning for all the labeled safety information for Arzerra.
First Half Update
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February: The marketing authorization for Arzerra was withdrawn in the EU and several other territories. |
Ofatumumab (OMB157) - Potential in Relapsing Multiple Sclerosis
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Human CD20 monoclonal antibody developed and marketed worldwide by Novartis under a license agreement with Genmab |
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Subcutaneous formulation in development to treat RMS |
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Positive data available from the two Phase III ASCLEPIOS studies with low dose subcutaneous ofatumumab in RMS |
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Based on ASCLEPIOS data Novartis plans to initiate submissions to health authorities by end of 2019 |
Ofatumumab is a human IgG1k mAb that targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops. A subcutaneous formulation of ofatumumab is being
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investigated in two Phase III clinical studies in RMS. The studies compare the efficacy and safety of subcutaneous ofatumumab versus teriflunomide in patients with relapsing MS and are comprised of approximately 900 patients each. A Phase III study examining the long-term safety, tolerability and effectiveness of ofatumumab in patients with relapsing MS who participated in a previous study is also ongoing as is a study to evaluate the bioequivalence of 20mg of subcutaneous ofatumumab injected by either pre-filled syringe or autoinjector in adult relapsing MS patients.
Third Quarter Update
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August: Novartis reported that the Phase III ASCLEPIOS I & II studies of subcutaneous ofatumumab versus teriflunomide in adults with relapsing forms of multiple sclerosis met the primary endpoints where ofatumumab showed a highly significant and clinically meaningful reduction in the number of confirmed relapses, evaluated as the annualized relapse rate (ARR). Key secondary endpoints of delaying the time to confirmed disability progression were also met. According to Novartis, ofatumumab delivered sustained efficacy and the safety profile of ofatumumab as seen in the ASCLEPIOS studies is in line with the observations from prior Phase II results. Detailed data from these studies was subsequently presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September. Patients with RMS on ofatumumab had a reduction in ARR by 50.5% (0.11 vs. 0.22) and 58.5% (0.10 vs 0.25) compared to teriflunomide (both studies p<0.001) in ASCLEPIOS I and II studies respectively. Regarding secondary endpoints of the trials, ofatumumab showed highly significant suppression of gadolinium (Gd) enhancing T1 lesions when compared to teriflunomide demonstrating a profound suppression of new inflammatory activity. Ofatumumab showed a relative risk reduction of 34.4% in 3-month confirmed disability worsening (CDW) (p=0.002) and 32.5% in 6-month CDW (p=0.012) versus teriflunomide in pre-specified pooled analyses. Based on the ASCLEPIOS data Novartis plans to initiate submissions to health authorities by the end of 2019. |
Proprietary Products in Development*
*Certain products in co-development, partners as indicated
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Tisotumab vedotin – A Next Generation Therapeutic
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Antibody-drug conjugate (ADC, antibody coupled to a cell-killing agent) in development to treat solid tumors |
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Phase II potential registration study in cervical cancer ongoing, enrollment completed; Phase II clinical studies in ovarian and other solid tumors ongoing |
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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.
Third Quarter Update
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August: Expansion phase initiated in innovaTV 206 study of tisotumab vedotin as monotherapy for patients in Japan with recurrent and/or metastatic cervical cancer. |
First Half Update
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March: First patient was dosed in the Phase I/II innovaTV 206 study of tisotumab vedotin as monotherapy for patients in Japan with recurrent and/or metastatic cervical cancer. |
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March: Patient enrollment was completed in the potential registration Phase II innovaTV 204 study of tisotumab vedotin as a monotherapy for patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment. |
Enapotamab vedotin (HuMax-AXL-ADC) – A First-in-Class ADC
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ADC in development to treat solid tumors |
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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.
Third Quarter Update
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September: Preliminary data from the non-small cell lung cancer (NSCLC) expansion cohort of the Phase I/II study of enapotamab vedotin in solid tumors was presented during an oral session at the International Association for the Study of Lung Cancer 2019 World Conference on Lung Cancer (IASLC 2019 WCLC). |
HexaBody-DR5/DR5 (GEN1029) – First HexaBody Program in Clinical Development
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Proprietary antibody therapeutic created with Genmab’s HexaBody technology |
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Composed of two non-competing HexaBody antibody molecules that target two distinct DR5 epitopes |
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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. A Phase I/II clinical trial in solid tumors was on a brief partial clinical hold for discussions with the U.S. FDA. This partial hold has been lifted and the dose escalation part of the trial is ongoing.
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DuoBody-CD3xCD20 (GEN3013) – A Proprietary Bispecific Antibody
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Proprietary bispecific antibody created with Genmab’s DuoBody technology |
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Phase I/II clinical trial in B-cell malignancies ongoing |
DuoBody-CD3xCD20 is a proprietary bispecific antibody created using Genmab’s DuoBody technology. DuoBody-CD3xCD20 targets CD3, which is expressed on T-cells, and CD20, a clinically well-validated target. A Phase I/II clinical study of DuoBody-CD3xCD20 in B-cell malignancies is ongoing.
DuoBody-PD-L1x4-1BB (GEN1046) – Potential in Solid Tumors
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Bispecific antibody created with Genmab’s DuoBody technology |
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Phase I/II clinical trial in solid tumors ongoing |
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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.
First Half Update
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May: First patient dosed in the first-in-human Phase I/II trial of DuoBody-PD-L1x4-1BB in solid tumors. |
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January: A CTA for DuoBody-PD-L1x4-1BB was submitted to regulatory authorities in Spain. |
DuoBody-CD40x4-1BB (GEN1042) – New in the Clinic
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Bispecific antibody created with Genmab’s DuoBody technology |
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Phase I/II clinical trial in solid tumors ongoing |
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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-CD40 x4-1BB in solid tumors is ongoing.
Third Quarter Update
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September: First patient dosed in the first-in-human Phase I/II trial of DuoBody-CD40x4-1BB in solid tumors. |
First Half Update
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March: A Clinical Trial Application (CTA) for DuoBody-CD40x4-1BB was submitted to regulatory authorities in the UK. |
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Partner Programs Built on Genmab’s Innovation
Teprotumumab
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In clinical development by Horizon Therapeutics, plc (Horizon) for thyroid eye disease (TED) |
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A BLA submitted to the U.S. FDA by Horizon for teprotumumab in active TED received Priority Review |
Teprotumumab is a human antibody that targets the Insulin-like Growth Factor-1 Receptor (IGF-1R), which is a well-validated target. Teprotumumab was created by Genmab under our collaboration with Roche. Clinical development of teprotumumab is being conducted by Horizon under a license from Roche. Teprotumumab has been granted Fast Track designation, Orphan Drug designation and Breakthrough Therapy Designation for TED, also known as Graves’ orbitopathy by the U.S. FDA.
Third Quarter Update
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September: U.S. FDA granted Priority Review to the BLA submitted by Horizon for teprotumumab in the treatment of active TED. The U.S. FDA assigned a Prescription Drug User Fee Act (PDUFA) target date of March 8, 2020 to take a decision on the BLA for teprotumumab. |
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August: Horizon, in partnership with the U.S. FDA, developed an expanded access program for teprotumumab to make it available for people living with active TED who meet protocol criteria. |
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The expanded access program will be available for a limited time while the U.S. FDA reviews Horizon’s BLA for teprotumumab. |
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July: Horizon submitted a BLA to the U.S. FDA for teprotumumab in the treatment of active TED. |
First Half Update
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February: Topline results from the Phase III confirmatory trial evaluating teprotumumab for the treatment of active thyroid eye disease showed that the study met its primary endpoint. |
Camidanlumab tesirine (ADCT-301)
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ADC in development under a collaboration and license agreement with ADC Therapeutics |
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In Phase II development for relapsed or refractory Hodgkin lymphomas and Phase I development in solid tumors |
Camidanlumab tesirine is an ADC that combines Genmab’s HuMax-TAC antibody and ADC Therapeutics’ PBD-based warhead and linker technology. Camidanlumab tesirine targets CD25, which is expressed on a variety of hematological tumors and shows limited expression on normal tissues, making it an attractive target for antibody-payload approaches. Camidanlumab tesirine is in clinical development under a Collaboration and License Agreement between Genmab and ADC Therapeutics, under which Genmab owns 25% of the product rights. A Phase II study of camidanlumab tesirine to treat relapsed or refractory Hodgkin lymphoma and a Phase I study of camidanlumab tesirine to treat solid tumors are ongoing.
Third Quarter Update
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August: A Phase II trial of camidanlumab tesirine in patients with relapsed or refractory Hodgkin lymphoma was published on www.clinicaltrials.gov. |
JNJ-61186372
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DuoBody product targeting EGFR and cMet |
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Phase I studies ongoing in NSCLC |
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Developed by Janssen under the DuoBody technology collaboration |
JNJ-61186372 is a bispecific antibody that targets EGFR and cMet, two validated cancer targets. JNJ-61186372 was created under a collaboration between Genmab and Janssen using Genmab’s DuoBody technology. The two antibodies used to generate JNJ-61186372 were both created by Genmab. Janssen is investigating JNJ-61186372 in Phase I clinical studies to treat NSCLC.
Third Quarter Update
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September: A Phase I study of JNJ-61186372 in combination with lazertinib (JNJ-73841937) in Japanese patients with advanced NSCLC published on clinicaltrials.gov. |
First Half Update
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June: Updated data from the Phase I study of JNJ-61186372 in NSCLC was presented in an oral session at the 2019 ASCO Annual Meeting. |
JNJ-67571244
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DuoBody product targeting CD33 and CD3 |
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In Phase I study for relapsed or refractory acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) |
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Developed by Janssen under the DuoBody technology collaboration |
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JNJ-67571244 is a bispecific antibody that targets CD3, which is expressed on T-cells and CD33, which is frequently expressed in AML and MDS. JNJ-67571244 was created under a collaboration between Genmab and Janssen using Genmab’s DuoBody technology. JNJ-67571244 is being investigated in a Phase I clinical study to treat relapsed or refractory AML or MDS.
Third Quarter Update
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July: Genmab received a milestone payment for progress with the program. |
First Half Update
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May: A Phase I study of JNJ-67571244 in relapsed or refractory AML or MDS was initiated. |
JNJ-63898081
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DuoBody product targeting PSMA and CD3 |
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In Phase I study for advanced solid tumors |
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Developed by Janssen under the DuoBody technology collaboration |
JNJ-63898081 is a bispecific antibody that targets CD3, which is expressed on T-cells and prostate-specific membrane antigen (PSMA) is highly expressed on prostate adenocarcinomas. JNJ-63898081 was created under a collaboration between Genmab and Janssen using Genmab’s DuoBody technology. JNJ-63898081 is being investigated in a Phase I clinical study to treat advanced solid tumors.
Third Quarter Update
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July: Genmab received a milestone payment for progress with the program. |
First Half Update
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April: A Phase I study of JNJ-63898081 in advanced solid tumors was published on www.clinicaltrials.gov. |
JNJ-64407564
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DuoBody product targeting CD3 and GPRC5D |
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Phase I studies in multiple myeloma announced and ongoing |
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Developed by Janssen under the DuoBody technology collaboration |
JNJ-64407564 is a bispecific antibody that targets CD3, which is expressed on T-cells, and GPRC5D, which is highly expressed in multiple myeloma cells. JNJ-64407564 was created under a collaboration between Genmab and Janssen using Genmab's DuoBody technology. JNJ-64407564 is being investigated in Phase I clinical studies to treat multiple myeloma.
Third Quarter Update
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September: Phase Ib trial (MMY1002) of subcutaneous daratumumab in combination with either JNJ-64407564 or JNJ-64007957 for patients with multiple myeloma published on clinicaltrials.gov. |
JNJ-64007957
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DuoBody product targeting BCMA and CD3 |
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Phase I studies in multiple myeloma announced and ongoing |
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Developed by Janssen under the DuoBody technology collaboration |
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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 Phase I clinical studies to treat multiple myeloma.
Third Quarter Update
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September: Phase Ib trial (MMY1002) of subcutaneous daratumumab in combination with either JNJ-64407564 or JNJ-64007957 for patients with multiple myeloma published on clinicaltrials.gov. |
Pre-clinical Programs
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Broad pre-clinical pipeline of approximately 20 programs including DuoHexaBody®-CD37 |
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Pre-clinical pipeline includes both partnered products and in-house programs based on our proprietary technologies |
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Multiple new Investigational New Drug Applications (INDs) expected to be submitted over coming years |
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In 2019 entered multiple strategic collaborations to support the expansion of Genmab’s 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.
Third Quarter Update
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September: Entered into a strategic collaboration agreement with Tempus, building upon existing service agreements between the companies. Under the terms of the agreement, the companies will jointly work on research projects that are identified by Genmab to explore novel product concepts and biomarkers. For any resulting products, Genmab will lead all development and commercial activities. Tempus will be eligible for undisclosed milestones and royalties from Genmab and will also have the option to fund part of product development programs in exchange for increased royalty payments due to Tempus under the agreement. |
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September: An antibody research program targeting HIV underway at Gilead Sciences, Inc., which incorporated Genmab’s DuoBody technology, was concluded and the underlying Exclusive License and Option Agreement, signed in 2016, was terminated. |
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August: An antibody research program underway at Gilead Sciences, Inc., which incorporated Genmab’s DuoBody technology, was concluded and the underlying Research Evaluation Agreement, signed in 2014, was terminated. |
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July: Entered into an agreement with BliNK Biomedical for an exclusive commercial license to certain antibodies targeting CD47, for potential development and commercialization into novel bispecific therapeutics created via Genmab’s proprietary DuoBody Platform technology. Under the terms of the agreement, Genmab paid BliNK Biomedical an upfront fee of USD 2.25 million. BliNK Biomedical is also eligible to receive up to approximately USD 200 million in development, regulatory and commercial milestone payments for each product, as well as tiered royalties on net sales. |
First Half Update
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June: Entered into exclusive worldwide license and option agreement with Janssen to develop and commercialize HexaBody-CD38, a next-generation human CD38 monoclonal antibody product incorporating Genmab’s HexaBody technology. Genmab will fund research and development activities until completion of clinical proof of concept studies in multiple myeloma |
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CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
and diffuse large B-cell lymphoma. Based on the data from these studies, Janssen may exercise its option and receive a worldwide license to develop, manufacture and commercialize HexaBody-CD38. Should this occur, Janssen will pay Genmab a USD 150 million option exercise fee and up to USD 125 million in development milestones, as well as a flat royalty rate of 20% on sales of HexaBody-CD38 until a specified time in 2031, followed by 13-20% tiered royalties on sales thereafter. Should Janssen not exercise its option, the terms of the agreement allow Genmab to continue to develop and commercialize HexaBody-CD38 for DARZALEX-resistant patients, and in all other indications except those multiple myeloma or amyloidosis indications where DARZALEX is either approved or is being actively developed. |
The agreement is the outcome of pre-clinical research on novel CD38 targeting concepts conducted by Genmab. HexaBody-CD38 showed encouraging in vitro complement-dependent cytotoxicity (CDC) activity in B-cell lymphoma and leukemia, including for cells with low CD38 expression levels. HexaBody-CD38 also showed similar antibody-dependent cellular cytotoxicity (ADCC) in vitro compared to daratumumab.
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 2018 annual report and the final prospectus for our U.S. public offering and listing, filed with the U.S. Securities and Exchange Commission (SEC) in July of 2019. At the date of this interim report, there have been no significant changes to Genmab’s overall risk profile since the publication of the 2018 annual report.
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
Kalvebod Brygge 43 |
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|
1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
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 2,405 million for the first nine months of 2019 compared to DKK 1,789 million for the first nine months of 2018. The increase of DKK 616 million, or 34%, was mainly driven by higher DARZALEX royalties and reimbursement income from our collaborations with Seattle Genetics and BioNTech, partly offset by the one-time payment from Novartis of USD 50 million (DKK 304 million) during the first nine months of 2018.
|
MDKK |
|
First 9 Months |
|
First 9 Months |
|
Royalties |
|
2,051 |
|
1,134 |
|
Milestone payments |
|
100 |
|
142 |
|
License fees |
|
- |
|
338 |
|
Reimbursement income |
|
254 |
|
175 |
|
Total revenue |
|
2,405 |
|
1,789 |
Royalties
Royalty income amounted to DKK 2,051 million in the first nine months of 2019 compared to DKK 1,134 million in the first nine months of 2018. The increase of DKK 917 million, or 81%, was driven by higher DARZALEX royalties, which were partly offset by lower Arzerra royalties.
Net sales of DARZALEX by Janssen were USD 2,168 million in the first nine months of 2019 compared to USD 1,441 million in the first nine months of 2018. The increase of USD 727 million, or 50%, was driven by the continued strong uptake following the regulatory approvals in the U.S., EU and Japan. Royalty income on net sales of DARZALEX was DKK 2,033 million in the first nine months of 2019 compared to DKK 1,111 million in the first nine months of 2018, an increase of DKK 922 million. The increase in royalties of 83% is higher than the increase in the underlying sales due to the change in royalty tiers in 2019. During the third quarter of 2019, the royalty rate on net sales of DARZALEX moved into the 16% royalty tier on net sales exceeding USD 1.5 billion in a calendar year and the 18% royalty tier on net sales exceeding USD 2 billion in a calendar year.
Novartis’ net sales of Arzerra were USD 13 million in the first nine months of 2019 compared to USD 19 million in the first nine months of 2018, a decrease of USD 6 million, or 32%. Royalty income on net sales of Arzerra was DKK 18 million in the first nine months of 2019 compared to DKK 23 million in the first nine months of 2018, a decrease of DKK 5 million, or 22%.
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 100 million in the first nine months of 2019, which was driven by the first commercial sale of DARZALEX in Japan in the third indication under the expanded label and milestones under the Janssen DuoBody collaboration. Milestone income was DKK 142 million in the first nine months of 2018, which was driven by the first commercial sale of DARZALEX in the EU in the fourth indication under the expanded label and the Janssen and Novo Nordisk DuoBody collaborations. Milestone income may fluctuate significantly from period to period due to both the timing of achievements and the varying amount of each individual milestone under our license and collaboration agreements.
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
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|
1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
Licenses Fees
There was no license fee income during the first nine months of 2019. License fee income was DKK 338 million during the first nine of 2018, which was driven by the USD 50 million upfront payment from Novartis with the amendment of the Arzerra/ofatumumab license and collaboration agreement, payment from Janssen for an additional DuoBody target pair under the license agreement and the payment from Novo Nordisk for extending exclusivity of the commercial license for a DuoBody target pair under the agreement.
Reimbursement Income
Reimbursement income amounted to DKK 254 million in the first nine months of 2019 compared to DKK 175 million in the first nine months of 2018. The increase of DKK 79 million, or 45%, was driven by increased activities under our collaboration agreements with Seattle Genetics and BioNTech.
Refer to note 2 in this interim report for further details about revenue.
Research and Development Costs
Research and development costs amounted to DKK 1,717 million in the first nine months of 2019 compared to DKK 975 million in the first nine months of 2018. The increase of DKK 742 million, or 76%, was driven by the advancement of tisotumab vedotin and enapotamab vedotin, the additional investment in our product pipeline, and the increase in research and development employees.
Research and development costs accounted for 88% of the total operating expenses in the first nine months of 2019 compared to 86% in the first nine months of 2018.
General and Administrative Expenses
General and administrative expenses were DKK 226 million in the first nine months of 2019 compared to DKK 155 million in the first nine months of 2018. The increase of DKK 71 million, or 46%, 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 12% of the total operating expenses in the first nine months of 2019 compared to 14% in the first nine months of 2018.
Operating Result
Operating income was DKK 462 million in the first nine months of 2019 compared to DKK 659 million in the first nine months of 2018. As anticipated, the decrease of DKK 197 million, or 30%, was driven primarily by increased operating expenses and the one-time payment from Novartis in 2018.
As of September 30, 2019, the total number of employees was 533 compared to 349 employees as of September 30, 2018. The increase in employees was driven by the expansion and acceleration of our pipeline.
|
Workforce |
|
September 30, 2019 |
|
September 30, 2018 |
|
Research and development employees |
|
452 |
|
299 |
|
Administrative employees |
|
81 |
|
50 |
|
Total employees |
|
533 |
|
349 |
Net Financial Items
The net financial items for the first nine months of 2019 were net income of DKK 442 million compared to net income of DKK 162 million in the first nine months of 2018. The increase of DKK 280 million was driven primarily by foreign exchange movements between the USD and DKK. During the first nine months
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
Kalvebod Brygge 43 |
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|
1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
of 2019, the USD strengthened against the DKK to a greater extent than 2018, resulting in greater realized and unrealized exchange rate gains. Refer to note 4 in this interim report for further details about the net financial items.
Corporate Tax
The corporate tax expense for the first nine months of 2019 was DKK 210 million compared to DKK 183 million for the first nine months of 2018. The estimated annual effective corporate tax rate in the first nine months of 2019 was 23% compared to 22% in the first nine months of 2018. There has been no reversal of the valuation allowances on deferred tax assets in the first nine months of 2019 or the first nine months of 2018.
Net Result
Net result for the first nine months of 2019 was a net income of DKK 694 million compared to DKK 638 million in the first nine months of 2018. The increase was driven by the items described above.
Cash Position
|
Cash Position (MDKK) |
|
September 30, 2019 |
|
December 31, 2018 |
|
Marketable securities |
|
6,474 |
|
5,573 |
|
Cash and cash equivalents |
|
4,643 |
|
533 |
|
Cash position |
|
11,117 |
|
6,106 |
As of September 30, 2019, cash, cash equivalents, and marketable securities (cash position) amounted to DKK 11,117 million, an increase of DKK 5,011 million from the beginning of 2019. The increase was mainly driven by net proceeds from the issuance of new shares in connection with the public offering and listing of ADSs on the Nasdaq Global Select Market of DKK 3,638 million, positive working capital adjustments of DKK 567 million related to milestones achieved in the fourth quarter of 2018, which were received in the first nine months of 2019, and our operating income of DKK 462 million, which were partly offset by corporate taxes paid of DKK 140 million during the first nine months of 2019.
There were no short-term marketable securities included in cash and cash equivalents at the end of September 2019 or at the end December 2018. In accordance with our accounting policy, securities purchased with a maturity of less than three months at the date of acquisition are classified as cash and cash equivalents. Refer to note 3 in this interim report for further details about our marketable securities.
Cash Flow
|
Cash Flow (MDKK) |
|
First 9 Months |
|
First 9 Months |
|
Cash provided by (used in) operating activities |
|
1,151 |
|
811 |
|
Cash provided by (used in) investing activities |
|
(832) |
|
(1,201) |
|
Cash provided by (used in) financing activities |
|
3,653 |
|
(73) |
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 nine months of 2019, the primary driver of higher cash provided by operating activities was higher positive working capital adjustments in 2019 related to milestones achieved in the fourth quarter of 2018 that were received in 2019.
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 the first nine months of 2019 and 2018.
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
Kalvebod Brygge 43 |
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|
1560 Copenhagen V, Denmark |
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CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
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 nine months of 2019, the primary driver of the higher cash provided by financing activities was related to net proceeds from the issuance of new shares in connection with the public offering and listing of ADSs on the Nasdaq Global Select Market of DKK 3,638 million, and purchase of treasury shares during the first nine months of 2018 of DKK 146 million. There were no purchases of treasury shares during the first nine months of 2019.
Balance Sheet
As of September 30, 2019, total assets were DKK 13,330 million compared to DKK 8,461 million as of December 31, 2018. As of September 30, 2019, assets are mainly comprised of a cash position of DKK 11,117 million and receivables of DKK 1,151 million. The receivables consist primarily of royalties from our license and collaboration agreements and non-interest bearing receivables, which are due less than one year from the balance sheet date.
Shareholders’ equity as of September 30, 2019 was DKK 12,515 million compared to DKK 8,014 million at the end of December 2018. The increase of DKK 4,501 million, or 56%, was driven primarily by the issuance of shares and by our net income. As of September 30, 2019, Genmab’s equity ratio was 94% compared to 95% as of December 31, 2018.
Legal Matter – MorphoSys Patent Infringement Complaint
On January 25, 2019, the District Court ruled on summary judgment that the three MorphoSys patents were invalid for lack of enablement. MorphoSys had the opportunity to appeal the District Court’s decision. In addition, a further claim by Janssen and us that the three MorphoSys patents were unenforceable due to inequitable conduct by MorphoSys was included in the case. On January 31, 2019, MorphoSys dismissed its infringement claims against us and Janssen with prejudice, and we and Janssen, in turn, dismissed our inequitable conduct claims against MorphoSys. As such, there will be no further proceedings in the case.
General Corporate Matter – Initial Public Offering of ADSs in the U.S. and Capital Increase
On May 28, 2019, Genmab filed a registration statement with the U.S. Securities and Exchange Commission for a proposed initial public offering of ADSs and applied for listing of the ADSs on the Nasdaq Global Select Market. Genmab commenced the initial public offering of ADSs on July 9, 2019 and priced the offering on July 17, 2019.
On July 22, 2019, the public offering and listing of ADSs on Nasdaq Global Select Market under the symbol “GMAB” was completed. Gross proceeds from the issuance of new shares amounted to USD 506 million (DKK 3,368 million) with a corresponding increase in share capital of 2,850,000 ordinary shares or 28,500,000 ADSs. Further, the underwriters’ exercised in full their option to purchase an additional 427,500 ordinary shares or 4,275,000 ADSs bringing the total gross proceeds of the offering to USD 582 million (DKK 3,873 million). The closing of the overallotment was completed on July 23, 2019. The public offering price of $17.75 per ADS, corresponded to a subscription price of DKK 1,181.80 per New Share at the U.S. dollar/DKK exchange rate of DKK 6.6580 per USD 1.00 on July 17, 2019, multiplied by the ADS-to-share ratio of ten-to-one. Underwriting commissions paid were USD 32 million (DKK 213 million). Expenses related to the issuance amounted to DKK 22 million. Total share capital following the public offering amounted to DKK 64,967,643.
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
Kalvebod Brygge 43 |
Fax: +45 7020 2729 |
Page 24/44 |
|
1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
STATEMENT OF COMPREHENSIVE INCOME FOR THE 3RD QUARTER OF 2019
|
Income Statement |
|
3rd Quarter of |
|
3rd Quarter of |
|
|
|
2019 |
|
2018 |
|
|
|
DKK'000 |
|
DKK'000 |
|
|
|
|
|
|
|
Revenue |
|
1,039,844 |
|
598,597 |
|
|
|
|
|
|
|
Research and development expenses |
|
(607,886) |
|
(343,242) |
|
General and administrative expenses |
|
(81,225) |
|
(55,182) |
|
Operating expenses |
|
(689,111) |
|
(398,424) |
|
|
|
|
|
|
|
Operating result |
|
350,733 |
|
200,173 |
|
|
|
|
|
|
|
Net financial items |
|
348,546 |
|
30,425 |
|
|
|
|
|
|
|
Net result before tax |
|
699,279 |
|
230,598 |
|
|
|
|
|
|
|
Corporate tax |
|
(162,232) |
|
(51,423) |
|
|
|
|
|
|
|
Net result |
|
537,047 |
|
179,175 |
|
|
|
|
|
|
|
Basic net result per share |
|
8.38 |
|
2.92 |
|
Diluted net result per share |
|
8.28 |
|
2.89 |
|
|
|
|
|
|
|
Statement of Comprehensive Income |
|
|
|
|
|
|
|
|
|
|
|
Net result |
|
537,047 |
|
179,175 |
|
|
|
|
|
|
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
Amounts which will be re-classified to the income statement: |
|
|
|
|
|
Adjustment of foreign currency fluctuations on subsidiaries |
|
4,676 |
|
1,064 |
|
|
|
|
|
|
|
Total comprehensive income |
|
541,723 |
|
180,239 |
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
Kalvebod Brygge 43 |
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Page 25/44 |
|
1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
STATEMENT OF COMPREHENSIVE INCOME FOR THE FIRST NINE MONTHS OF 2019
|
Income Statement |
|
|
|
9 Months Ended |
|
9 Months Ended |
|
|
|
Note |
|
September 30, 2019 |
|
September 30, 2018 |
|
|
|
|
|
DKK'000 |
|
DKK'000 |
|
|
|
|
|
|
|
|
|
Revenue |
|
2 |
|
2,404,767 |
|
1,789,284 |
|
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
|
(1,717,342) |
|
(974,682) |
|
General and administrative expenses |
|
|
|
(225,449) |
|
(155,340) |
|
Operating expenses |
|
|
|
(1,942,791) |
|
(1,130,022) |
|
|
|
|
|
|
|
|
|
Operating result |
|
|
|
461,976 |
|
659,262 |
|
|
|
|
|
|
|
|
|
Net financial items |
|
4 |
|
441,853 |
|
162,216 |
|
|
|
|
|
|
|
|
|
Net result before tax |
|
|
|
903,829 |
|
821,478 |
|
|
|
|
|
|
|
|
|
Corporate tax |
|
|
|
(209,688) |
|
(183,202) |
|
|
|
|
|
|
|
|
|
Net result |
|
|
|
694,141 |
|
638,276 |
|
|
|
|
|
|
|
|
|
Basic net result per share |
|
|
|
11.14 |
|
10.43 |
|
Diluted net result per share |
|
|
|
11.03 |
|
10.29 |
|
|
|
|
|
|
|
|
|
Statement of Comprehensive Income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net result |
|
|
|
694,141 |
|
638,276 |
|
|
|
|
|
|
|
|
|
Other comprehensive income: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amounts which will be re-classified to the income statement: |
|
|
|
|
|
|
|
Adjustment of foreign currency fluctuations on subsidiaries |
|
|
|
8,679 |
|
6,508 |
|
|
|
|
|
|
|
|
|
Total comprehensive income |
|
|
|
702,820 |
|
644,784 |
|
Genmab A/S |
Tel: +45 7020 2728 |
Company Announcement no. 53 |
|
Kalvebod Brygge 43 |
Fax: +45 7020 2729 |
Page 26/44 |
|
1560 Copenhagen V, Denmark |
www.genmab.com |
CVR no. 2102 3884 |
Interim Report for the Nine Months Ended September 30, 2019
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
Note |
|
2019 |
|
2018 |
|
|
|
|
|
DKK'000 |
|
DKK'000 |
|
ASSETS |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets |
|
|
|
419,632 |
|
470,359 |
|
Property, plant and equipment |
|
|
|
187,464 |
|
161,545 |
|
Right-of-use assets |
|
7 |
|
184,085 |
|
— |
|
Receivables |
|
|
|
11,580 |
|
9,621 |
|
Deferred tax assets |
|
|
|
271,240 |
|
386,449 |
|
|
|
|
|
|
|
|
|
Total non-current assets |
|
|
|
1,074,001 |
|
1,027,974 |
|
|
|
|
|
|
|
|
|
Receivables |
|
|
|
1,139,453 |
|
1,326,931 |
|
Marketable securities |
|
3 |
|
6,473,814 |
|
5,573,187 |
|
Cash and cash equivalents |
|
|
|
4,643,035 |
|
532,907 |
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
|
12,256,302 |
|
7,433,025 |
|
|
|
|
|
|
|
|
|
Total assets |
|
|
|
13,330,303 |
|
8,460,999 |
|
|
|
|
|
|
|
|
|
SHAREHOLDERS’ EQUITY AND LIABILITIES |
|
|
|
|
|
|
|
|
|
|
|
|