Oasmia Pharmaceutical AB (publ)
March 02 2018 - 2:30AM
Oasmia Pharmaceutical AB (publ)
Interim report for the period May 2017 – January
2018
Commercial focus and lower cost base
THIRD QUARTER November 1, 2017 – January 31,
2018
- Consolidated net sales amounted to TSEK 656 compared to TSEK 36
in the third quarter the previous year
- The operating loss was TSEK 25,158 compared to TSEK 34,861 in
the third quarter the previous year
- The net loss after tax amounted to TSEK 29,120 compared to TSEK
39,897 in the third quarter the previous year
- The loss per share was SEK 0.16 compared to SEK 0.33 in the
third quarter the previous year
- The comprehensive loss was TSEK 29,102 compared to TSEK 39,897
in the third quarter the previous year
THE PERIOD May 1, 2017 – January 31, 2018
- Consolidated net sales amounted to TSEK 2,326 compared to TSEK
128 in the corresponding period the previous year
- The operating loss was TSEK 75,707 compared to TSEK 103,070 in
the corresponding period the previous year
- The net loss after tax amounted to TSEK 85,927 compared to TSEK
118,161 in the corresponding period the previous year
- The loss per share was SEK 0.53 compared to SEK 1.05 in the
corresponding period the previous year
- The comprehensive loss was TSEK 85,920 compared to TSEK 118,148
in the corresponding period the previous year
- The company has secured financing of MSEK 28 through
convertible debt instruments
- Paclical approved in Kazakhstan
- Loan of MSEK 108 secured
EVENTS AFTER CLOSING DAY
- All patients completed treatment in Docecal’s two ongoing
studies
COMMENTS FROM THE CEO
Dear Shareholders,
Sales of Paclical in Russia has started and we
shipped products to our distributor in both November and January.
The manufacturing costs for the product is invoiced at shipment and
later a share of the profits, which is a considerably larger
amount, is received in arrears. The actual revenue will become
increasingly visible during the year when profits are shared. Our
partner, Hetero Group, has laid the foundation for growth and is
making investments, amongst other things by increasing the number
of sales staff dedicated to the product. We now confidently look
forward to steadily increasing sales.
The supplementary analysis of data from a
previously performed PK study which EMA requested as part of the
registration process for Apealea has now been completed and we
expect to receive notification from EMA in April. As stated
previously, the specific question does not concern our phase III
study regarding ovarian cancer. In parallel we are working on
developing a registration application for Apealea for the American
market. We assess that the feedback that we have received from the
European Medicines Agency will reduce the time taken for the
regulatory process in the US.
Development of Docecal is proceeding according
to plan. Docecal is based on the cytostatic docetaxel, in
combination with XR17. Docetaxel is the main substance in
Taxotere®, which is the single most sold cytostatic product ever,
with peak sales of USD 3 billion in 2009. A phase I, so-called PK
crossover study and a randomized clinical study, both in comparison
with Taxotere, are ongoing for the indication of metastatic breast
cancer. Both these studies are approaching the final phase as all
of the 228 patients in total have now completed treatment. The
randomized study will form the basis for the sales and marketing
submission in Russia, as well as the registration discussions in
other countries.
AdvaVet Inc., Oasmia’s American subsidiary, is
being prepared for listing on the NASDAQ Capital Market in New
York. The process regarding the listing prospectus is ongoing and
we expect to submit it to the Securities and Exchange Commission,
SEC, shortly. The American market is the most important market for
veterinary drugs. By listing AdvaVet, Inc. we intend to give the
subsidiary a stable financial foundation in order to be able to
commercialize our veterinary products, Paccal Vet and Doxophos
Vet.
Furthermore, the company has secured extended
financing by signing an agreement to replace the loan we have from
Nexttobe AB in May. The existing loan will be replaced by a loan of
MSEK 108, which will mainly come from Arwidsro Investment AB,
formerly Granitplattan AB, currently our largest shareholder. The
company’s cost cutting programme continues to have an impact and
the cost mass has decreased significantly compared with the same
period the previous year.
Everyone at Oasmia has high expectations of what
2018 will bring for the company. The focus is now on accelerating
commercialization by growing sales in Russia, obtaining further
market approvals and establishing AdvaVet in the American
market.
CEOMikael Asp
Interimreport Q3-2017
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