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Home  /   Forum   /   BioPharma   /   Genmab, de Deense parel

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Genmab, de Deense parel

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Pagina: «« 1 ... 166 167 168 169 170 ... 177 »» | Laatste | Omlaag ↓
  1. Pokerface 23 februari 2023 13:14
    PB:
    Genmab Publishes 2022 Annual Report
    Company Announcement

    COPENHAGEN, Denmark; February 22, 2023 – Genmab A/S (Nasdaq: GMAB) announced today the publication of its Annual Report for 2022. Below is a summary of business progress in 2022, financial performance for the year and the financial outlook for 2023. The full report is attached as a PDF file and in iXBRL format and can be found in the investor section of the company’s website, www.genmab.com/investors.

    Conference Call
    Genmab will hold a conference call in English to discuss the full year results for 2022 today, February 22, 2023 at 6:00 pm CET, 5:00 pm GMT, 12:00 pm EST. To join the call please use the below registration link. Registered participants will receive an email with a link to access dial-in information as well as a unique personal PIN: register.vevent.com/register/BI4ae0b2...

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

    2022 ACHIEVEMENTS

    Business Progress

    The U.S. Food and Drug Administration (U.S. FDA) granted orphan-drug designation to epcoritamab for the treatment of follicular lymphoma.
    The publication by Genmab and collaboration partner AbbVie Inc. (AbbVie) of topline results from the large B-cell lymphoma (LBCL) cohort of the pivotal EPCORE™ NHL-1 epcoritamab study.
    Regulatory submissions for subcutaneous (SC) epcoritamab were made in the U.S. and Japan by Genmab and in Europe by AbbVie.
    The Biologics License Application for SC epcoritamab for the treatment of patients with relapsed/refractory LBCL after two or more lines of systemic therapy was accepted for Priority Review by the U.S. FDA with a Prescription Drug User Fee Act target action date of May 21, 2023.
    The Marketing Authorization Application for epcoritamab for the treatment of patients with relapsed/refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy was validated by the European Medicines Agency.
    2022 was the first full year of Tivdak® (tisotumab vedotin-tftv), in co-development with Seagen Inc., available for certain cervical cancer patients in the U.S.
    We continued the development of our commercialization capabilities and broader organizational infrastructure.
    We expanded our global strategic collaboration with BioNTech SE, including investigational medicine HexaBody®-CD27 (GEN1053/BNT313).
    Janssen Biotech Inc. (Janssen)’s TECVAYLI® (teclistamab) became the second DuoBody®-based medicine to receive regulatory approval.

    Financial Performance

    Net sales of DARZALEX® by Janssen were USD 7,977 million in 2022 compared to USD 6,023 million in 2021, an increase of USD 1,954 million, or 32%.
    Royalty revenue was DKK 11,672 million in 2022 compared to DKK 6,977 million in 2021, an increase of DKK 4,695 million, or 67%. The increase in royalties was driven by higher net sales of DARZALEX, Kesimpta® and TEPEZZA® and higher average exchange rate between the USD and DKK.
    Revenue was DKK 14,595 million in 2022 compared to DKK 8,482 million in 2021. The increase of DKK 6,113 million, or 72%, was primarily driven by higher DARZALEX and Kesimpta royalties achieved under our collaborations with Janssen and Novartis, respectively, due to higher net sales and higher average exchange rate between the USD and DKK, and milestones achieved in 2022 under our collaboration with AbbVie.
    Operating expenses were DKK 8,238 million in 2022 compared to DKK 5,464 million in 2021. The increase of DKK 2,774 million, or 51%, was driven by the continued advancement of epcoritamab and multiple pipeline projects, an increase in team members to support Tivdak post launch and expansion of our product pipeline, and the continued development of Genmab’s commercialization and broader organizational capabilities and infrastructure.
    Operating profit was DKK 6,357 million in 2022 compared to DKK 3,018 million in 2021.

    2023 OUTLOOK

    (DKK million) 2023 Guidance 2022 Actual Result
    Revenue 14,600 - 16,100 14,595
    Operating expenses (9,800) - (10,600) (8,238)
    Operating profit 3,900 - 6,200* 6,357
    *Operating profit does not sum due to rounding

    Revenue
    Genmab expects its 2023 revenue to be in the range of DKK 14,600 – 16,100 million, compared to DKK 14,595 million in 2022. Our revenue in 2022 was driven primarily by DARZALEX royalties due to the continued strong growth of DARZALEX net sales, favorable exchange rate movements between the USD and DKK and the positive impact of applying the DARZALEX contractual annual Currency Hedge Rate.

    Genmab’s projected revenue growth for 2023 is driven by recurring revenues related to DARZALEX, TEPEZZA and Kesimpta royalties from net sales growth, partly offset by negative exchange rate movements between the USD and DKK due to a lower assumed USD/DKK exchange rate.

    Genmab’s projected revenue for 2023 primarily consists of DARZALEX royalties of DKK 10,400 – 11,100 million. Such royalties are based on estimated DARZALEX 2023 net sales of USD 9.4 – 10.0 billion compared to actual net sales in 2022 of approximately USD 8.0 billion. DARZALEX royalties are partly offset by Genmab’s share of Janssen’s royalty payments to Halozyme Therapeutics, Inc. (Halozyme) in connection with SC net sales. The remainder of Genmab’s revenue consists of increasing royalties from TEPEZZA, Kesimpta, RYBREVANT and TECVAYLI, reimbursement revenue, milestones including those for epcoritamab and collaboration revenue with Seagen for Tivdak.

    Operating Expenses
    Genmab anticipates its 2023 operating expenses to be in the range of DKK 9,800 – 10,600 million, compared to DKK 8,238 million in 2022. The growth in operating expenses is to support Genmab’s continued portfolio advancement and investing for future product launches, including epcoritamab.

    Operating Profit
    Genmab expects our operating profit to be in the range of DKK 3,900 – 6,200 million in 2023, compared to DKK 6,357 million in 2022.

    More information on the Risks and Assumptions for the 2023 Financial Guidance can be found in the 2022 Annual Report available on our website www.genmab.com/investors.
  6. Biotech1982 3 maart 2023 13:47
    Ja mee eens catch22. In mijn vorige berichten heb ik de p/e vaak naar voren gehaald; de kosten door de gigantische groei van Genmab en door het dragen van hogere kosten in de pipeline (en dus potentieel ook meer winst in de toekomst) geven nu wel meer onzekerheid.

    Veel investeerders kiezen nu waarschijnlijk iets veiligere havens. Genmab dobbert nu maar wat rond in de ogen van deze mensen vermoed ik. Totdat er positief nieuws komt over 1 of meerdere producten in de pijplijn zal het niet veel omhoog bewegen. Of inderdaad een overname / positieve uitspraak in gerecht. Zelf geloof ik niet meer zo in een overname en zou je voor alleen die reden ook iet in een bedrijf moeten beleggen naar mijn mening omdat het dan snel speculeren wordt.

    Het is erg jammer dat we nog weer meer geduld moeten hebben en dat Genmab toch weer zover naar beneden zakt. Ik had ook gehoopt dat het vertrouwen nog wat hoger zou blijven en het wat stabieler zo blijven liggen.
    Maar weer op onze handen zitten. Of eruit wippen als er iets beters te kopen js. Ik blijf vooralsnog zitten al heb ik vorig jaar 1/6 deel verkocht.
  7. Biotech1982 6 maart 2023 07:19
    Je merkt het hier ook in het forum, er is niet zoveel nieuws. Ook op het Deense forum is het rustiger, of nou ja er wordt vooral geroddeld op het moment en vrij weinig echt nieuws.
    www.proinvestor.com/chathistory/-25/g... (Site vertalen naar Engels of Nederlands vertalen tenzij je Deens kan lezen :)).
  9. sheriff Grover 13 april 2023 13:49
    Helemaal niets te melden maar ik dacht het is inmiddels een maand geleden dat er voor het laatst gepost is op ons forum vandaar ;o) . Bij ons Deens zusterforum is het trouwens niet heel veel beter .... ruim een week op 1 pagina ... volgens mij nog niet eerder gezien ?! vrgr SG
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