14 aug: Salg af 75 % af Danske Andelskassers Banks aktier i Sparinvest Ho..
14 aug: Vestas - Nyt medlem af direktionen i Vestas Wind Systems A/S
14-08-2019 17:00:53

Genmab Announces Financial Results for the First Half of 2019 and Updates 2019 Financial Guidance

August 14, 2019; Copenhagen, Denmark;

Interim Report for the First Half of 2019

Highlights

  • Registration statement filed with the U.S. Securities and Exchange Commission for the proposed public offering of American Depository Shares and application submitted for listing of the ADSs on the

    Nasdaq Global Select Market under the symbol “GMAB.” The public offering and listing were completed in July.

  • Agreement signed with Janssen Biotech, Inc. (Janssen) to collaborate exclusively on next-generation CD38 antibody product candidate, HexaBody®-CD38.

  • The U.S. Food and Drug Administration (U.S. FDA) approved DARZALEX® (daratumumab) in combination with lenalidomide and dexamethasone for the treatment of adult patients with newly diagnosed multiple myeloma who are ineligible for autologous stem cell transplant.

  • The U.S. FDA granted Priority Review for daratumumab in combination with bortezomib, thalidomide and dexamethasone as treatment for newly diagnosed patients with multiple myeloma who are candidates for autologous stem cell transplant.

  • Janssen initiated Phase III study to examine daratumumab plus lenalidomide as maintenance treatment in patients with newly diagnosed multiple myeloma.

  • DARZALEX net sales increased 49% over H1 2018 to USD 1,403 million, resulting in royalty income of DKK 1,169 million.

  • Genmab is updating its 2019 financial guidance due to increased royalty income related to the sales of DARZALEX and increased operating expenses as a result of the advancement of our product pipeline, resulting in a small increase in projected operating income.

“The first half of 2019 brought truly transformational change to Genmab as we began the process of becoming a dual-listed company, with the potential to trade shares in both the U.S. (in the form of ADSs) and in Denmark. We also built upon our already successful relationship with Janssen with the signing of an agreement to collaborate exclusively on the next-generation CD38 antibody product candidate, HexaBody-CD38. We have seen encouraging pre-clinical data from HexaBody-CD38 and believe it has the potential to extend the promise of CD38-targeted therapies beyond what is currently available for patients,” said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. “In addition to these key events, the first half of 2019 also saw the highly anticipated U.S. FDA approval for DARZALEX, based on the Phase III MAIA data. Now that this indication has been approved many more patients in the U.S. who are newly diagnosed with multiple myeloma will have a DARZALEX containing regimen as a choice for their initial therapy.”

Financial Performance First Half of 2019

  • Revenue was DKK 1,365 million in the first half of 2019 compared to DKK 1,191 million in the first half of 2018. The increase of DKK 174 million, or 15%, 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 half of 2018 for lost potential milestones and royalties following announcement of Novartis’ intention to transition Arzerra® (ofatumumab) to limited availability via compassionate use programs for chronic lymphocytic leukemia (CLL) in non-U.S. markets.
  • Net sales of DARZALEX by Janssen were USD 1,403 million in the first half of 2019 compared to USD 943 million in the first half of 2018, an increase of USD 460 million, or 49%. According to Johnson & Johnson, sales in the second quarter of 2019 included a one-time adjustment related to the completion of pricing and reimbursement discussions in certain European countries, which positively impacted this worldwide second quarter operational growth by 16 percentage points.
  • Operating expenses were DKK 1,254 million in the first half of 2019 compared to DKK 732 million in the first half of 2018. The increase of DKK 522 million, or 71%, was driven by the advancement of enapotamab vedotin and tisotumab vedotin, additional investments in our product pipeline, and the increase in new employees to support the expansion of our product pipeline.
  • Operating income was DKK 111 million in the first half of 2019 compared to DKK 459 million in the first half of 2018. As anticipated, the decrease of DKK 348 million, or 76%, was driven primarily by increased operating expenses and the one-time payment from Novartis in 2018.

Subsequent Event

  • July:  Completion of public offering and listing of American Depository Shares (ADSs) on Nasdaq Global Select Market under the symbol “GMAB”. 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 American Depository Shares (“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 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). Total share capital following the public offering amounted to DKK 64,967,643.

Outlook                                                                                          

Genmab is updating its 2019 financial guidance published on February 20, 2019 due to increased royalty income related to the sales of DARZALEX and increased operating expenses as a result of the advancement of our product pipeline.

 

MDKK

Revised Guidance

Previous

Guidance

Revenue4,8004,600 
Operating expenses(2,750)(2,600)
Operating income2,0502,000

Conference Call

Genmab will hold a conference call in English to discuss the results for the first half of 2019 today, Wednesday, August 14, at 6:00 pm CEST, 5:00 pm BST or 12:00 pm EDT. To join the call dial

+1 631 510 7495 (U.S. participants) or +44 2071 928000 (international participants) and provide conference code 4966139.

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 

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 final prospectus for our U.S. public offering and listing and other filings with the U.S. Securities and Exchange Commission (SEC), 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®; the Y-shaped Genmab logo®; Genmab in combination with the Y-shaped Genmab logo®; HuMax®; DuoBody®; DuoBody in combination with the DuoBody logo®; HexaBody®; HexaBody in combination with the HexaBody logo®; DuoHexaBody®; HexElect®; and UniBody®. Arzerra® is a trademark of Novartis AG or its affiliates. DARZALEX® is a trademark of Janssen Pharmaceutica NV.

Download the full Interim Report for the First Half of 2019 on attachment or at www.genmab.com.

CVR no. 2102 3884

LEI Code 529900MTJPDPE4MHJ122

Genmab A/S

Kalvebod Brygge 43

1560 Copenhagen V

Denmark                                                                                                 

Attachment

Primary Logo

Relateret indhold
16 sep - 
Mandagens aktier: Svingende Lundbeck endte lavere i rød..
16 sep - 
Aktier/middag: Lundbeck vender rundt og topper rødt C25..
16 sep - 
Aktier/åbning: Lundbeck helt i bund på milliardopkøb i ..
Relateret debat
16 sep - 
Dejligt
16 sep - 
GENMAB/GUGGENHEIM: LØFTER KURSMÅLET MED 12,4 PCT. 06:36..
13 sep - 
13.9.19: “Novartis' ofatumumab to be 'strong' competito..
Del

Opret kommentar

Relateret debat

  • 1 uge
  • 1 måned
  • 1 År
16 sep
GEN
GENMAB/GUGGENHEIM: LØFTER KURSMÅLET MED 12,4 PCT. 06:36 Finanshuset Guggenheim Securities løfter sit..
9
11 sep
GEN
Starter idag. Novartis vil præsenteres resultater af deres MS med Genmabs Ofatumumab i løbet af ugen..
9
13 sep
GEN
13.9.19: “Novartis' ofatumumab to be 'strong' competitor to Roche drug, says Deutsche Bank Deutsche ..
5
12 sep
GEN
https://classic.nordnet.dk/mux/web/analys/nyheter/visaNyhet.html?itemid=538639013&sourcecode=ddk
5
13 sep
GEN
BofA/Merrill analyst Sachin Jain upgraded Genmab to Buy from Neutral with an increased price target ..
2
13 sep
GEN
Vi kunne jo starte med 1000 hver, men det flytter nok ikke det store. Tror på Genmab er et guldæg, e..
1
13 sep
GEN
Mit svar var et forsøg på at besvare QueenMary og IKKE nogen anbefaling. Har desværre heller ikke se..
1
13 sep
GEN
GENMAB: POSITIVE RESULTATER I KOMBINATIONSSTUDIE MED DARZALEX - NY 16:22Biotekselskabet Genmab kan g..
1
13 sep
GEN
Kan du så ikke bare købe 20.000 stk. så sker der nok lidt med kursen.   Taastrup 
1
13 sep
GEN
Når man skimmer de resultater, der deles på Twitter, lader det til at der er tale om et meget succes..
1

Riksbanken nedtoner behov for renteforhøjelser - svensk krone svækkes

17-09-2019 09:48:14
Den svenske centralbank, Riksbanken, ser ikke længere samme behov for at stramme pengepolitikken. Det fremgår af referatet af det seneste rentemøde den 4. september.Her var rentekomitéens medlemmer enige om, at de økonomiske udsigter er forværret, og at riskoen for en hurtigere afmatning er øget. Årsagen er blandt andet handelskonflikten mellem USA og Kina og usikkerheden om Storbritanniens udtræd..

Aktier/åbning: Lundbeck helt i bund på milliardopkøb i rødt marked

16-09-2019 09:13:54
Lundbecks melding om at ville købe amerikanske Alder Biopharmaceuticals i en handel, der er værdisat op til 1,95 mia. dollar - eller omkring 13 mia. kr., får i de første handler investorerne til at sende aktien ned.Aktien falder helt til bunds i eliteindekset med et fald på 3,6 pct. til 228 kr. mandag morgen, i et marked der samlet i C25 falder 0,5 pct. til indeks 1140,69.Lundbeck er i negativt ra..

Prisen på råolie ryger i vejret efter angreb i Saudi-Arabien

Relaterede nyheder
16-09-2019 06:34:09
Prisen på råolie stiger med over ti procent efter lørdagens droneangreb mod to olieanlæg i Saudi-Arabien.Dermed er der også udsigt til dyrere benzin.Da handlen med råolie begyndte klokken 00.00 dansk tid hoppede prisen op med omkring 15 procent, skriver nyhedsbureauet Reuters. Efter omkring en time ligger prisen på en tønde Nordsø-olie omkring 13 procent højere i lidt over 68 dollar.Det var på for..

Mest læste nyheder

  • 24 timer
  • 48 timer
  • 1 uge
1
Aktier/tendens: Børshuse kan puste til Novo og Lundbeck
2
Lars Marcher bryder tavsheden: Overrasket over fyring hos Ambu
3
Novo præsenterer ny analyse af fase 3-program med oral Semaglutid
4
Bavarian: FDA giver Merck hurtigere behandlingstid for ebolavaccine-NY
5
Tirsdagens aktier: Novo trak C25 i grønt - Danske Bank til bunds

Relaterede aktiekurser

Genmab A/S 1.363,50 -1,0% Fald i aktiekurs

Copyright Berlingske Media 2019  Handelsbetingelser  |  Cookiedeklaration  |  Cookie- og Privatlivspolitik  |  Ophavsret og vilkår
Aktieinformation leveres af Morningstar.
Data er forsinket 15-20 minutter iht. de enkelte børsers regler om videredistribution.
 
18. september 2019 07:55:15
(UTC+01:00) Brussels, Copenhagen, Madrid, Paris
Version: LiveBranchBuild_20190829.2 - EUROWEB6 - 2019-09-18 07:55:15 - 2019-09-18 07:55:15 - 1 - Website: OKAY