Launch dynamics encouraging, but US regulatory situation challenging
Financial overview April-June
- Net sales amounted to
SEK 66.4 M (0.0) -
Operating loss amounted to
SEK 344.8 M (loss: 399.3) -
Loss for the period was
SEK 24.1 M (loss: 401.0) -
Loss per share, before and after dilution, was
SEK 0.32 (loss: 6.79) -
Cash and cash equivalents amounted to
SEK 999.4 M (937.8) onJune 30
Financial overview January-June
- Net sales amounted to
SEK 85.7 M (0.0) -
Operating loss amounted to
SEK 692.2 M (loss: 696.2) -
Loss for the period was
SEK 258.8 M (loss: 698.4) -
Loss per share, before and after dilution, was
SEK 3.63 (loss: 12.20) -
Cash and cash equivalents amounted to
SEK 999.4 M (937.8) onJune 30
Significant events April-June
- An application for conditional marketing authorization of melflufen in the EU was submitted in April
- Topline results from the phase 3 OCEAN study were announced in May
- Patient enrollment in the phase 2 PORT study was completed in May
- A German affiliate was established in May
-
Clinical abstracts on melflufen was presented at the 2021
American Society of Clinical Oncology in June -
New clinical and preclincal melflufen data was presented at the
European Hematology Association meeting in June
Significant events after the reporting period
- Updated results from the phase 3 OCEAN study were announced on
July 8 : melflufen met the primary endpoint of superior PFS -
Overall survival data, also released on
July 8 , led to the FDA requesting a partial clinical hold of all clinical studies with melflufen, pending further investigation -
FDA issued a safety alert to patients and health care professionals on
July 28 , regarding an increased risk of death associated with Pepaxto® in the OCEAN study.
Financial overview of the Group
(SEK thousand) | 2021 Apr-Jun | 2020 Apr-Jun | 2021 Jan-Jun | 2020 Jan-Jun | 2020 Jan-Dec |
Net sales | 66,374 | - | 85,729 | - | - |
Gross profit | 63,552 | - | 82,579 | - | - |
Gross margin | 96 % | N/A | 96 % | N/A | N/A |
Operating loss | -344,836 | -399,332 | -692,167 | -696,208 | -1,591,279 |
Loss after tax | -24,116 | -401,041 | -258,780 | -698,370 | -1,594,693 |
Earnings per share before and after dilution (SEK) | -0.32 | -6.79 | -3.63 | -12.20 | -25.57 |
Cash flow from operating activities | -346,695 | -285,665 | -733,409 | -598,506 | -1,296,509 |
Cash and cash equivalents at the end of the period | 999,384 | 937,773 | 999,384 | 937,773 | 840,255 |
R & D costs/operating expenses, % | 41 % | 57 % | 45 % | 63 % | 54 % |
Conference call for investors, analysts and the media
Investors, financial analysts and media are invited to participate in a webcast with a Q&A session at
The webcast will be streamed via this link which can also be found on the website: www.oncopeptides.com.
Phone numbers for participants from:
For more information, please contact:
E-mail: rolf.gulliksen@oncopeptides.com
Cell phone: + 46 70 262 96 28
E-mail: linda.holmstrom@oncopeptides.com
Cell phone: +46 70 873 40 95
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