Oasmia Pharmaceutical AB (publ). Year-end report for the financial year May 1, 2019 – April 30, 2020

EVENTS IN FOURTH QUARTER

  • Oasmia and Elevar signed a global strategic partnership for the commercialization of Apealea® with an upfront payment of USD 20 million, milestone payments with a potential of up to USD 678 million and double digit royalties. Oasmia received the upfront payment of USD 20 million.
  • The Board of Directors appointed Dr. Francois Martelet as the new CEO. He took up his position on March 9 and replaced Dr. Sven Rohmann, who has been acting CEO during a crucial turnaround period. Dr. Rohmann remains as a Board member.
  • In early February, Oasmia launched its product, Apealea® 60 mg, in Sweden, Denmark and Finland. The first batch of the drug was shipped to distributors in these countries.
  • The outbreak of Covid19 and its effects on society accelerated during the quarter. Due to the situation with the Covid19 virus, the company experiences a negative impact on its business due to the lack of access to health care providers and oncologists.
  • Oasmia’s Nomination Committee suggested changes to the Board of Directors to focus on members with pharmaceutical industry experience. The Company sent out a notice of an Extraordinary General Meeting on May 14 to decide on these changes.

EVENTS AFTER THE BALANCE SHEET DATE

  • Oasmia announced outcome of strategic review to deliver long-term, profitable growth as a specialty pharma company.
  • The company held an Extraordinary General Meeting on May 14, at the offices of the company in Uppsala. The Extraordinary General Meeting resolved, in accordance with the Nomination Committee’s proposal, about the following changes in the Board of Directors up to the next Annual General Meeting. Existing board member Anders Härfstrand became the new Chairman of the Board and Birgit Stattin Norinder became new member of the Board. Jörgen Olsson, former Chairman of the Board, and Gunilla Öhman, former Board member, left the Board.
  • On June 1, Oasmia announced that it had entered into a comprehensive settlement agreement with the plaintiffs in a Class Action filed against the Company in the United States in 2019.
  • On June 8, Oasmia announced that it had signed Phase 1b Trial Agreement with SAKK, The Swiss Group for Clinical Cancer Research for Evaluation of Docetaxel Micellar in advanced prostate cancer patients.

FOURTH QUARTER February 1, 2020 – April 30, 2020

  • Consolidated net sales amounted to TSEK 201,265 (266)
  • Operating income was TSEK 110,531 (-75,192)
  • Net income after tax amounted to TSEK 106,480 (-79,538)
  • Earnings per share was SEK 0.24 (-0.31)2

FINANCIAL YEAR May 1, 2019 – April 30, 2020

  • Consolidated net sales amounted to TSEK 201,843 (1,980)
  • Operating loss was TSEK -30,667 (-150,818)
  • Net loss after tax amounted to TSEK -11,114 (-201,881)
  • Loss per share was SEK -0.03 (-0.80)2

CEO’S COMMENTS

A new vision for growth

Since joining Oasmia in March 2020, I have been impressed by the quality and potential of our technology and capabilities, and the untapped potential of the development pipeline. During the first few months of 2020, Oasmia has signed a transformative global strategic partnership for our lead product Apealea®, started to launch Apealea® in the Nordics and set out a clear plan to accelerate growth both organically and through acquisitions, as well as significantly control our costs.

Apealea®, our water-soluble, intravenously injectable formulation of paclitaxel, has continued to make progress since its approval in the European Union for the treatment of advanced ovarian cancer. Apealea® was developed using our proprietary XR-17 platform technology, which facilitates the solubility of paclitaxel, improving safety, reducing infusion time for patients and almost eliminating the need for corticotherapy ahead or after treatment. Apealea®’s approval and launch has demonstrated Oasmia’s ability to develop and deliver new products to market that meet unmet medical needs and enhance drug safety.
In early February, Apealea® became commercially available in the Nordic region, a first step towards a pan-European launch. The launch in the Nordic countries has been significantly limited due to the Covid19 pandemic.

In March, we announced a global strategic partnership with Elevar Therapeutics, the US subsidiary of the multinational South Korean company HLB Co., LTD, to commercialize Apealea®, in return for an upfront payment of $20 million, potential milestone payments of up to $678 million and double-digit royalties on future sales. This transformative agreement is a significant endorsement of the potential of the XR-17 platform in oncology and gives us a solid foundation for further significant progress.

Oasmia is now ideally placed to move into the next phase of growth. Following an extensive review assessing all aspects of the business initiated shortly after my appointment as CEO, we set out the strategic vision to broaden our focus and establish Oasmia as a leading specialty pharmaceutical company based in Sweden. To fulfil this goal, we have announced plans to maximize Oasmia’s resources, realise the full potential of the XR-17 platform technology and optimise the Company’s path towards long-term, profitable growth. We have identified a number of areas of strategic focus.

Firstly, we will continue to explore additional opportunities to apply Oasmia’s proprietary XR-17 solubility-enhancing technology platform in oncology, as well as in other therapeutic areas. This may include the out-licensing of non-core applications.

Secondly, we will continue to drive the development of our pipeline of XR-17-based products, including docetaxel micellar in prostate cancer and in collaboration with the well-known swiss research group SAKK, and we will assess the feasibility of the combination cancer therapy XR-19. We will leverage the experience of the Company’s GMP manufacturing facilities for R&D purposes.

Finally, we will look to expand Oasmia’s pipeline through acquisitions and/or in-licensing deals, with a focus on specialty pharmaceutical assets that will move the company towards positive cash flow.

In parallel, we are undertaking a comprehensive cost control program designed to maximise resources and enable us to invest in areas which can deliver the greatest return. We aim to achieve annualised cost savings of more than SEK 100 million, a ~50% reduction in the cash burn rate to below SEK 10 million a month. With Elevar assuming a greater role in the manufacturing of Apealea® following the commercial agreement, Oasmia will be able to focus more on R&D manufacturing, which will significantly improve our operating efficiency.

At the same time we are working to strengthen the skills and capabilities of the management team and will aim to bring in highly talented and experienced managers from the pharmaceutical/biotechnology world.

The outlook is very promising. Oasmia is in a strong cash position, has a product approved in Europe with global potential and near-term value drivers in the pipeline. With our flexibility and proven expertise in product development and commercialization, we are also well placed for M&A, Business Development and partnering opportunities. We look forward to the initiation of a Phase I study investigating our product candidate docetaxel micellar, a solvent-free formulation of docetaxel (Taxotere®) which is extensively used in the treatment of breast cancer, head and neck cancer, stomach cancer, prostate cancer and non-small-cell lung cancer. We hope to see Phase 1 results for docetaxel micellar in advanced prostate cancer within the next 12-18 months.

We continue to focus our efforts on developing compounds and/or products for unmet medical needs of patients suffering from cancer.

I would like to thank our shareholders and employees for their continued support. I am proud to be leading Oasmia at this important time in its development and I am confident we are well positioned to begin the next stage of innovation, growth and value generation to benefit both patients and shareholders.
Dr. Francois Martelet, M.D., CEO of Oasmia

For more information:

Francois Martelet, Chief Executive Officer
Michael af Winklerfelt, Chief Financial Officer
Phone: +46 18-50 54 40
E-mail: IR@oasmia.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.

[1] Figures in brackets show outcomes for the corresponding period of the previous financial year.2 Earnings/loss per share for the comparison periods has been adjusted for the bonus issue component in the rights issue carried out during the year.