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2020-09-09

Oasmia Pharmaceutical AB (publ)

Interim report[1] for the period year May 1, 2020 – July 31, 2020

SIGNIFICANT EVENTS DURING THE FIRST QUARTER

  • Oasmia announced in May the outcome of a strategic review to deliver long-term, profitable growth as a specialty pharma company. As a result of the review, Oasmia will discontinue commercial manufacturing and implement cost reductions that will result in savings of MSEK 100 on an annual basis and a monthly burn rate of below MSEK 10.
  • An Extraordinary General Meeting in May elected existing Board member Anders Härfstrand as new Chairman of the Board and Birgit Stattin Norinder as new member of the Board. Jörgen Olsson, former Chairman of the Board, and Gunilla Öhman, former Board member, stepped down from the Board.
  • Oasmia signed in June a Phase 1b Trial Agreement with SAKK, the Swiss Group for Clinical Cancer Research, for evaluation of docetaxel micellar for the treatment of metastatic prostate cancer.
  • In July Oasmia’s partner Elevar Therapeutics and Tanner Pharma Group announced a global Named Patient Program to provide access to Apealea® in areas outside of the United States.
  • The outbreak of COVID-19 and its effects around the world accelerated during the first quarter of the financial year. The pandemic has entailed heavily reduced access to health care providers and oncologists, which continues to have a profound negative impact on the marketing activities of the company.

SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD

  • In August Oasmia appointed Peter Selin as Chief Business Officer.
  • Oasmia’s CFO Michael af Winklerfelt resigned from his role in August.
  • In September Oasmia’s Nomination Committee revised its proposal for the AGM regarding Board of Directors and Sven Rohmann notified that he is no longer available for re-election.
  • In September Oasmia appointed Fredrik Järrsten as Chief Financial Officer.


FIRST QUARTER[2]: MAY 1, 2020 – JULY 31, 2020

  • Consolidated net sales amounted to TSEK 208 (182)
  • Operating income was TSEK -49,220 (-35,764)[3]
  • Net income after tax amounted to TSEK -53,105 (-39,783)[3]
  • Earnings per share was SEK -0.12 (-0.13)[3,4]

CEO’S COMMENTS

During the first quarter at Oasmia, we continued to work to deliver the strategic vision we set out following the announcement of the global strategic partnership with Elevar Therapeutics to commercialize our anti-cancer therapy Apealea®.

Oasmia retains the rights to Apealea® in the Nordic countries under the agreement with Elevar and is now making the product commercially available. The Covid-19 pandemic has inevitably impacted the ability of our medical scientific liaisons to meet oncologists during the quarter. An easing of lockdown restrictions will help resuming medical activities to return to more normal levels during the rest of the year.

Elevar entered into an agreement with Tanner Pharma Group in July to establish a named patient program that will facilitate patient access to Apealea® in countries outside the US where it is not yet commercially available. The goal of the program is to assist cancer patients who have no alternative therapeutic options to get access to the drug. Apealea® is the only cremophor-free product approved in Europe for use in combination with carboplatin for the treatment of adults with first relapse of platinum-sensitive epithelial ovarian cancer, primary peritoneal cancer and fallopian tube cancer. The initial target population for ovarian cancer is therefore patients with potential or previously established hypersensitivity reactions to currently used solubility enhancer containing paclitaxel formulations. We hope that this will make them particularly eligible to our XR-17™ based paclitaxel formulation.

The collaboration with Elevar that started in 2020, as well as the transfer of all commercial manufacturing of Apealea® to Baxter at the end of 2018, were important developments in realigning our growth strategy, enabling us to focus resources where they can bring the best return for shareholders.

The Board’s long-term vision is to build a cash flow-positive specialty pharmaceutical company. To help achieve this, we have implemented a strategic reorganization of Oasmia to focus on R&D and Business Development and to reduce unnecessary expenditure. With a proven technology in XR-17™, a highly promising approved anti-cancer product, Apealea®, and a global commercialisation agreement worth up to $678 million plus royalties, we are well positioned to grow through M&A and licensing deals for late-stage and marketed products. We will seek further opportunities to apply our proprietary XR-17™ solubility-enhancing technology platform, primarily in oncology but also in other therapeutic areas. We are also looking at the potential to out-license the technology in non-core applications. We are already in the process of reviewing strategic options for our Animal Health business.

We will continue to drive the development of our pipeline of XR-17™-based products and leverage the Company’s manufacturing expertise for R&D. Current promising lead programs include docetaxel micellar in metastatic prostate cancer. In June, we signed an agreement with the Swiss research group SAKK to conduct the first clinical trial of docetaxel micellar in advanced prostate cancer. Oasmia’s docetaxel micellar formulation is based on XR-17™, which enables greater use of otherwise water-insoluble cancer drugs while reducing the side effects or need for additional medications associated with traditional solubility enhancers. In addition, we continue the assessment of XR-19, the dual encapsulation technology platform.

During the rest of 2020 we will continue to advance key areas of our growth strategy, including working closely with Elevar to deliver key milestones for Apealea® and support efforts to identify the most appropriate commercial partners for the product in Europe and China. The appointment of Peter Selin as Chief Business Officer, announced a few weeks ago, together with our strong cash position, will be invaluable as we continue to pursue growth through M&A and in- and out-licensing opportunities that complement our technology and business model.

I look forward to keeping you updated on our progress. Please accept my thanks for your patience and continued support as we further transform Oasmia into a sustainable and profitable growth business with long-term potential. Above all, we are here to help patients to better manage their cancer diseases.

Dr. Francois Martelet, M.D., CEO of Oasmia

For more information: 
Francois Martelet, Chief Executive Officer 
Phone: +46 18-50 54 40 
E-mail: IR@oasmia.com  

Consilium Strategic Communications
Jonathan Birt, Chris Welsh
Phone: +44 (0)20 3709 5700
E-mail: oasmia@consilium-comms.com

About Oasmia Pharmaceutical
Oasmia Pharmaceutical AB develops, manufactures, markets and sells an improved generation of drugs within human and veterinary oncology. Oasmia produces novel formulations of well-established cytostatic agents which show improved performance, an improved side-effect profile and a wider range of therapeutic areas compared with existing alternatives. Product development is based on Oasmia’s proprietary technology platform XR17. Oasmia has been successful in moving its first product candidate, Apealea® (paclitaxel micellar), through clinical development, and has received market authorization in the European Union and other territories. Oasmia is in the process of transitioning into the commercialization phase of the product Apealea and making the product accessible to patients via its partnership with Elevar and its existing operations and partnerships in its retained territories. The company’s shares are traded on Nasdaq Stockholm (ticker: OASM). Visit www.oasmia.com for further information.

[1] Figures in brackets show outcomes for the corresponding period of the previous financial year.
[2] During the previous financial year, errors were corrected in prior periods. This correction is reported in the annual report
2019/2020, especially in Note 4. In the present interim report, relevant items in the comparison periods have been recalculated.
To the extent that these recalculations do not appear in the said annual report, they are marked in this report.
[3] The comparison period has been recalculated to take into account the correction of errors in prior periods made during
2019/2020, see Note 4 in the 2019/2020 annual report.
[4] Earnings/loss per share for the comparison periods has been adjusted for the bonus issue component in the rights issue carried out during the 2019/2020 financial year.

This information is information that Oasmia Pharmaceutical 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 2020-09-09 08:00 CEST.

Attachments


Oasmia Pharmaceutical Interim Report Q1 200909

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