TIDMGEN 
 

May 11, 2022 Copenhagen, Denmark;

Interim Report for the First Quarter Ended March 31, 2022

Highlights

   -- DARZALEX(R) net sales as reported by Johnson & Johnson increased 36% 
      compared to the first three months of 2021 to USD 1,856 million, 
      resulting in royalty revenue of DKK 1,501 million 
 
   -- Genmab updates its 2022 financial guidance 

"During the first quarter of 2022, there were continued advancements in our pipeline, including the first patient dosed with DuoBody(R) -CD3xB7H4 (GEN1047), the presentation of data from the tisotumab vedotin innovaTV 207 study, and the U.S. Food and Drug Administration (U.S. FDA) granting orphan-drug designation to epcoritamab for the treatment of follicular lymphoma (FL). Together these events help to progress us further in our evolution into a fully integrated biotech innovation powerhouse," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter of 2022

   -- Net sales of DARZALEX by Janssen were USD 1,856 million in the first 
      three months of 2022 compared to USD 1,365 million in the first three 
      months of 2021, an increase of USD 491 million, or 36%. 
 
   -- Royalty revenue was DKK 1,836 million in the first three months of 2022 
      compared to DKK 1,017 million in the first three months of 2021, an 
      increase of DKK 819 million, or 81%. The increase was driven by higher 
      net sales of DARZALEX, TEPEZZA(R) and Kesimpta(R) resulting in higher 
      royalties. 
 
   -- Revenue was DKK 2,119 million for the first three months of 2022 compared 
      to DKK 1,581 million for the first three months of 2021. The increase of 
      DKK 538 million, or 34%, was primarily driven by higher DARZALEX, TEPEZZA 
      and Kesimpta royalties achieved under our collaborations with Janssen, 
      Roche and Novartis, respectively, partly offset by milestones achieved 
      under our collaborations with AbbVie and Janssen in the first three 
      months of 2021. 
 
   -- Operating expenses were DKK 1,605 million in the first three months of 
      2022 compared to DKK 1,049 million in the first three months of 2021. The 
      increase of DKK 556 million, or 53%, was driven by the continued 
      advancement of multiple pipeline projects, the increase in new employees 
      to support Tivdak(R) post launch and expansion of our product pipeline, 
      as well as the continued development of commercialization capabilities 
      and Genmab's broader organizational infrastructure. 
 
   -- Operating profit was DKK 514 million in the first three months of 2022 
      compared to DKK 532 million in the first three months of 2021. 

Subsequent Events

   -- April: Genmab and AbbVie Inc. (AbbVie) announced topline results for 
      epcoritamab from the first cohort of the EPCORE(TM) NHL-1 phase 1/2 
      clinical trial evaluating epcoritamab. The study cohort includes 157 
      patients with relapsed / refractory large B-cell lymphoma who received at 
      least two prior lines of systemic therapy, including 38.9% who received 
      prior treatment with chimeric antigen receptor T-cell therapy. The 
      topline results from this cohort demonstrated an overall response rate of 
      63.1% as confirmed by an independent review committee, which exceeded the 
      protocol prespecified threshold for efficacy. The observed median 
      duration of response was 12 months. The most common treatment-emergent 
      adverse event was cytokine release syndrome with 49.7%, including 2.5% 
      grade 3. Based on the topline results, the companies will engage global 
      regulatory authorities to determine next steps. 
 
   -- April: The arbitral tribunal issued an award in the binding arbitration 
      of two matters arising under Genmab's license agreement with Janssen 
      relating to daratumumab. Genmab did not seek a review of the award, and 
      the award is now final. The arbitral tribunal decided both issues in 
      favor of Janssen. The first issue concerned the question as to whether 
      Janssen's obligation to pay royalties on sales of licensed product 
      extends, in each applicable country, until the expiration or invalidation 
      of the last-to-expire relevant Genmab-owned patent or the last-to-expire 
      relevant Janssen-owned patent covering the product, as further defined 
      and described in the license agreement. As to that issue, the tribunal 
      determined by majority opinion that Janssen's obligation to pay royalties 
      to Genmab on sales of licensed product, in each applicable country, 
      extends through the expiration or invalidation of the last-to-expire 
      relevant Genmab-owned patent covering the product or use thereof, but not 
      the relevant Janssen-owned patent. The relevant Genmab-owned issued U.S., 
      European and Japanese patents will expire in the late 2020s and early 
      2030s. The second issue concerned the question as to whether Genmab is 
      required to share in Janssen's royalty payments to Halozyme Therapeutics, 
      Inc. (Halozyme) for the Halozyme enzyme technology used in the 
      subcutaneous (SC) formulation of daratumumab (marketed as DARZALEX 
      FASPRO(R) in the U.S.). The royalties Janssen pays to Halozyme represent 
      a mid-single digit percentage rate of SC daratumumab sales. As to that 
      issue, the tribunal ruled by majority opinion that Janssen is permitted 
      to continue reducing its royalty payments to Genmab as an offset against 
      a share of Janssen's royalty payments made to Halozyme. 

Outlook

Genmab is updating the lower end of its 2022 financial guidance published on February 16, 2022, driven by increased royalty revenue related to net sales of DARZALEX.

 
 
                             Revised           Previous 
  (DKK million)             Guidance           Guidance 
--------------------- 
  Revenue                 11,000 - 12,000    10,800 - 12,000 
  Operating expenses    (7,200) - (7,800)  (7,200) - (7,800) 
  Operating profit          3,200 - 4,800      3,000 - 4,800 
 

Conference Call

Genmab will hold a conference call in English to discuss the results for the first quarter of 2022 today, Wednesday, May 11, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial

+1 631 913 1422 (U.S. participants) or +44 3333000804 (international participants) and provide conference code 48414786. A live and archived webcast of the call and relevant slides will be available at www.genmab.com/investors.

Contact:

Marisol Peron, Senior Vice President, Communications and Corporate Affairs

T: +1 609 524 0065; E: mmp@genmab.com https://www.globenewswire.com/Tracker?data=WsnAyiLgYg_lctx4f-7U-_JAOg3RZaeHmAmoiqyH3z9Fj6E82h7biYc5xUzJTpuo_Xowjmb-7USwB5yBx-G8cw==

Andrew Carlsen, Vice President, Head of Investor Relations

T: +45 3377 9558; E: acn@genmab.com https://www.globenewswire.com/Tracker?data=xW_g9ZGe-iNrk8jw4bxmnrIIRWVWZ9jV8W-VPZwzc_h87rJDpF7eFxwgDdt-gNV_Ad5w-R5RL7jR7pM7eezZJw==

The Interim Report contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. Actual results or performance may differ materially from any future results or performance expressed or implied by such statements. The important factors that could cause our actual results or performance to differ materially include, among others, risks associated with pre-clinical and clinical development of products, uncertainties related to the outcome and conduct of clinical trials including unforeseen safety issues, uncertainties related to product manufacturing, the lack of market acceptance of our products, our inability to manage growth, the competitive environment in relation to our business area and markets, our inability to attract and retain suitably qualified personnel, the unenforceability or lack of protection of our patents and proprietary rights, our relationships with affiliated entities, changes and developments in technology which may render our products or technologies obsolete, and other factors. For a further discussion of these risks, please refer to the risk management sections in Genmab's most recent financial reports, which are available on www.genmab.com and the risk factors included in Genmab's most recent Annual Report on Form 20-F and other filings with the U.S. Securities and Exchange Commission (SEC), which are available at www.sec.gov. Genmab does not undertake any obligation to update or revise forward looking statements in the Interim Report nor to confirm such statements to reflect subsequent events or circumstances after the date made or in relation to actual results, unless required by law.

Genmab A/S and/or its subsidiaries own the following trademarks: Genmab(R) ; the Y-shaped Genmab logo(R) ; Genmab in combination with the Y-shaped Genmab logo(R) ; HuMax(R); DuoBody(R) ; DuoBody in combination with the DuoBody logo(R) ; HexaBody(R) ; HexaBody in combination with the HexaBody logo(R) ; DuoHexaBody(R) ; and HexElect(R) . Tivdak(R) is a trademark of Seagen Inc.; EPCORE(TM) is a trademark of AbbVie Biotechnology Ltd.; Kesimpta(R) and Sensoready(R) are trademarks of Novartis AG or its affiliates; DARZALEX(R) , DARZALEX FASPRO(R) and RYBREVANT(R) are trademarks of Johnson & Johnson; TEPEZZA(R) is a trademark of Horizon Therapeutics Ireland DAC.

Download the full Interim Report for the First Quarter of 2022 on attachment or at www.genmab.com/investors.

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V

Denmark

Attachment

   -- 110522_CA17_Q1 2022 Interim Report 
      https://ml-eu.globenewswire.com/Resource/Download/2d2588be-2057-4987-9a3f-9d7a04f5742b 
 
 
 

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May 11, 2022 11:01 ET (15:01 GMT)

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