Stockholm - November 8, 2023 - Oncopeptides AB (publ), a biotech company focused on difficult-to-treat cancers, today publishes the report for the third quarter 2023.
"Three quarters into yet another highly transformative year for Oncopeptides, we have been able to successfully check off some of the most important boxes in order to ensure future success for our company," says Sofia Heigis, CEO of Oncopeptides. "I am pleased to see that we have tripled the number of sold vials in Germany quarter over quarter, despite the vacation period in the third quarter. The positive trend continues into the fourth quarter as the number of sold vials in Europe in October alone almost reached the number of the entire third quarter."
Financial overview July-September
- Net sales amounted to SEK 2.8 M (0.0)
- Operating profit amounted to SEK -37.3 M (-88.9)
- Net profit amounted to SEK -40.5 M (-88.4)
- Profit per share, before and after dilution, amounted to SEK-0.45 (-1.00)
- Cash balances at the end of the period amounted to SEK 233.6 M (427.4)
Significant events July-September
- In July, Oncopeptides received a formal request from the U.S. Food and Drug Administration (FDA) to voluntarily withdraw the Pepaxto® approval in the U.S. The company has decided to proceed with a formal appeal.
- Sofia Heigis appointed CEO as per 7th of August.
- Henrik Bergentoft appointed CFO and will assume his position during the fourth quarter.
- Information regarding the formal request from the U.S. Food and Drug Administration (FDA) to voluntarily withdraw the Pepaxto approval in the U.S made available by the FDA as per 25th of August.
- Two articles with results from ANCHOR and LIGHTHOUSE studies published in Haematologica as per 4th of September.
- CHMP issues positive opinion on Type II variation to extend the therapeutic indication of Pepaxti® based on OCEAN trial result.
- Successful price negotiations for Pepaxti in Germany where reimbursed price was agreed on 26th September.
- Decision 28th of September to abandon Type II variation process for Pepaxti to optimize patient and shareholder value.
Financial overview of the group
| (SEK thousand) | 2023 Jul-Sep | 2022 Jul-Sep | 2023 Jan-Sep | 2022 Jan-Sep | 2022 Jan-Dec |
| Net sales | 2 805 | - | 29 883 | 7 795 | 8 355 |
| Operating profit | -37 297 | -88 852 | -172 467 | -248 803 | -349 350 |
| Profit after tax | -40 543 | -88 439 | -167 900 | -246 853 | -337 951 |
| Earnings per share, before and after dilution (SEK) | -0.45 | -1.00 | -1.86 | -3.10 | -4.11 |
| Cash flow from operating activities | -57 793 | -70 818 | -224 098 | -342 879 | -420 509 |
| Cash at the end of the period | 233 595 | 427 393 | 233 595 | 427 393 | 344 515 |
| R&D costs/operating expenses, % | 15% | 57% | 36% | 63% | 61% |
Conference call for investors, analysts and the media
Investors, financial analysts, and media are invited to participate in a webcast and a following Q&A session on November 8 at 09:00 CET. The presentation will be hosted by Sofia Heigis, CEO, together with Holger Lembrér, CFO. The webcast will be held in English and be published on Oncopeptides' website -www.oncopeptides.com/en - in conjunction with the start of the presentation.
Information for participants
If you wish to participate via webcast, please use the link below.
https://ir.financialhearings.com/oncopeptides-q3-2023
If you wish to participate via teleconference, please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference.
https://conference.financialhearings.com/teleconference/?id=5007314
For more information, please contact:
David Augustsson, Director of Corporate Affairs, Oncopeptides AB (publ)
E-mail: david.augustsson@oncopeptides.com
Cell phone: +46 76 229 38 68
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 2023-11-08 08:00 CET.
About Oncopeptides
Oncopeptides is a biotech company focused on research, development, and commercialization 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.
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.
