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February 16, 2023

Oncopeptides publishes year-end report 2022

February 16, 2023

Regulatory

Oncopeptides AB (publ), a biotech company focused on research, development and commercialization of therapies for difficult-to-treat hematological diseases, has today published the year-end report 2022.

Financial overview October-December

  • Net sales amounted to SEK 0.6 M (-21.7)
  • Operating profit amounted to SEK -100.5 M (-389.8)
  • Net profit amounted to SEK -91.1 M (-394.0)
  • Profit per share, before and after dilution, amounted to SEK -1.01 (-5.23)
  • Cash balances at the end of the period amounted to SEK 344.5 M (362.2)

Financial overview January-December

  • Net sales amounted to SEK 8.4 M (118.3)
  • Operating profit amounted to SEK -349.3 M (-1,420.9)
  • Net profit amounted to SEK -338.0 M (-1,430.3)
  • Profit per share, before and after dilution, amounted to SEK -4.11 (-19.00)
  • Cash balances at the end of the period amounted to SEK 344.5 M (362.2)

Significant events October-December

  • New clinical and preclinical data presented at the Annual American Society of Hematology Meeting (ASH).
  • Oncopeptides provides update on Pepaxto® US marketing authorization.
  • Submission of a Type II variation application for Pepaxti® to the European Medicines Agency (EMA).
  • Renewal of loan agreement with the European Investment Bank of the amount 30 MEUR.
  • Pepaxti is granted marketing authorization in the UK.
  • Phase 3 LIGHTHOUSE data further confirms the clinical benefit of melflufen.
  • Commercialization of Pepaxti in Europe initiated in Germany.

Significant events after the reporting period

  • Monica Shaw is appointed CEO and takes office on the 4th of January, and Jakob Lindberg assumes role as Chief Scientific Officer.
  • Holger Lembrér is appointed CFO and takes office on the 18th of January 2023.

Selected Key Indicators

(SEK thousand)2022
Oct-Dec		2021
Oct-Dec		2022
Jan-Dec		2021
Jan-Dec
Net sales560-21 7108 355118 295
Operating profit-100 547-389 836-349 350-1 420 917
Profit after tax-91 098-393 991-337 951-1 430 317
Earnings per share before and after dilution (SEK)-1.01-5.23-4.11-19.00
Cash flow from operating activities-77 630-446 455-420 509-1 516 391
Cash at the end of the period344 515362 187344 515362 187
R&D costs/operating expenses, %57%53%61%46%

This publication is a translation of the original Swedish text. In the event of inconsistency or discrepancy between the Swedish version and this publication, the Swedish language version shall prevail.

Webcast for investors, analysts and media 
Investors, financial analysts, and media are invited to participate in a webcast and a following QnA session at 09:00 CET on the same day. The presentation will be hosted by Monica Shaw, CEO, together with Holger Lembrér, CFO, and Jakob Lindberg, CSO. The presentation will be held in English. 
 
If you wish to participate via the webcast, please use the link below. Via the webcast you can ask written questions. 
https://ir.financialhearings.com/oncopeptides-q4-2022 

If you wish to participate via teleconference, please register on the link below. After the registration you will be provided a phone number and a conference ID to access the conference. You can ask questions verbally via the teleconference.
https://conference.financialhearings.com/teleconference/?id=5004216 

For more information, please contact:
Rolf Gulliksen, Global Head of Corporate Communications, Oncopeptides AB (publ.)
E-mail: rolf.gulliksen@oncopeptides.com
Cell phone: + 46 70 262 96 28

This information is information that Oncopeptides is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out above, at 2023-02-16 08:00 CET.

About Oncopeptides
Oncopeptides is a biotech company focused on commercialization, research, and development of therapies for difficult-to-treat hematological diseases. The company uses its proprietary Peptide Drug Candidate platform, PDC, to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. 

Pepaxti® (melphalan flufenamide, also called melflufen) has been granted Marketing Authorization, in the European Union, the EEA-countries Iceland, Lichtenstein and Norway, as well as in the UK. Pepaxti is indicated in combination with dexamethasone for the treatment of adult patients with multiple myeloma who have received at least three prior lines of therapies, whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one anti-CD38 monoclonal antibody, and who have demonstrated disease progression on or after the last therapy. For patients with a prior autologous stem cell transplantation, the time to progression should be at least 3 years from transplantation. Melflufen has been granted accelerated approval in the US under the trade name Pepaxto®. The drug is currently not marketed in the US. On December 7, 2022, the FDA recommended that the Company voluntarily withdraw the US marketing authorization for Pepaxto.

Oncopeptides is developing several new compounds based on its proprietary technology platforms and is listed on the Small Cap segment on Nasdaq Stockholm with the ticker ONCO. For more information see: www.oncopeptides.com. 

Documents

Source: Oncopeptides