“Having delivered on our promise of continuous growth quarter over quarter in 2023, with as many sold vials in the fourth quarter as the rest of 2023 combined, we are ready for a 2024 where sales are expected to take off from current levels through German sales and expanding access to Pepaxti in other European markets.” says
Financial overview October-December
- Net sales amounted to
SEK 5.3 M (0.6) - Operating profit amounted to
SEK -81.0 M (-100.5) - Net profit amounted to
SEK -81.2 M (-91.1) - Profit per share, before and after dilution, amounted to
SEK-0.90 (-1.01) - Cash balances at the end of the period amounted to
SEK 173.4 M (344.5)
Significant events October-December
- Henrik Bergentoft takes over as CFO on
November 13 . Oncopeptides selected to present additional data from the OCEAN study at theAmerican Society of Hematology (ASH) congress.- Article from Oncopeptides’ OCEAN trial observing longer PFS and OS in melflufen compared to pomalidomide published in the
European Journal of Hematology . - The
European Commission decided to formally approve the company's application to theEuropean Medicines Agency (EMA) for an extended indication for Pepaxti to previous lines. Oncopeptides’ previously communicated decision to end the process to extend the indication remains.
Events after the period
- On
February 15 , it was announced that the company will be granted an extension of the key patent that ensures market exclusivity for melflufen, marketed inEurope as Pepaxti, inEurope until 2037, an extension of five years. - On
February 23 it was announced that positive progress has been made in the market access procedure inSpain . - On
February 23 it was announced that a decision has been received from theU.S. Food and Drug Administration reconfirming withdrawal of Pepaxto from the U.S. market.
Financial overview of the group
(SEK thousand) | 2023 Oct-Dec | 2022 Oct-Dec | 2023 Jan-Dec | 2022 Jan-Dec |
Net sales | 5 337 | 560 | 35 220 | 8 355 |
Whereof reversal of returns reserve | 55 | - | 24 330 | 7 795 |
Operating profit | -80 980 | -100 547 | -253 447 | -349 350 |
Profit after tax | -81 211 | -91 098 | -249 111 | -337 951 |
Earnings per share, before and after dilution (SEK) | -0.90 | -1.01 | -2.76 | -4.11 |
Cash flow from operating activities | -55 395 | -77 630 | -279 493 | -420 509 |
Cash at the end of the period | 173 407 | 344 515 | 173 407 | 344 515 |
R&D costs/operating expenses, % | 39% | 57% | 37% | 61% |
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CEO statement
The fourth quarter sets the stage for revenue acceleration in 2024
Having delivered on our promise of continuous growth quarter over quarter in 2023, with as many sold vials in the fourth quarter as the rest of 2023 combined, we are ready for a 2024 where sales are expected to take off from current levels through German sales and expanding access to Pepaxti in other European markets. Recent progress in
During the last quarter of 2023,
I am incredibly proud of everyone involved in ensuring that we have progressed our market access efforts in
In
The market position of Pepaxti is on a slow but steady climb to a market position comparable to drugs such as Selinexor and Belantamab in
As for the rest of
Regarding our next generation value drivers, sales of Pepaxti outside of
As for sales in the rest of the world, our ambition to identify and execute opportunities outside of
The process of realizing the potential of our pipelines assets has also progressed during the last quarter of 2023, and we recently made the strategic decision to focus our short-term efforts on advancing our SPiKE platform towards an investigational new drug application (IND). We are currently in the process of selecting a drug candidate. Meanwhile, our PDC platform already has assets ready for clinical development, and we will now make a strategic assessment considering the FDA outcome.
Shortly before the publication of this report, we received the decision from the
If history is any indication, 2024 will be another year of both new challenges and opportunities for
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