FOURTH QUARTER February 1 – April 30, 2016
- Consolidated net sales amounted to TSEK 59 compared to TSEK 36 in the fourth quarter previous year
- Operating loss was TSEK 30,619 compared to a loss of TSEK 28,250 in the fourth quarter previous year
- Net loss after tax amounted to TSEK 32,982 compared to a loss of TSEK 30,081 in the fourth quarter previous year
- Loss per share was SEK 0.31 compared to a loss of SEK 0.31 in the fourth quarter previous year
- Comprehensive loss was TSEK 32,996 compared to a loss of TSEK 30,081 in the fourth quarter previous year
THE FISCAL YEAR May 1, 2015 – April 30, 2016
- Consolidated net sales amounted to TSEK 6,373 compared to TSEK 2,070 in the previous fiscal year
- Operating loss was TSEK 132,691 compared to a loss of TSEK 108,225 in the previous fiscal year
- Net loss after tax amounted to TSEK 141,539 compared to a loss of TSEK 117,497 in the previous fiscal year
- Loss per share was SEK 1.39 compared to a loss of SEK 1.28 in the previous fiscal year
- Comprehensive loss was TSEK 141,557 compared to a loss of TSEK 117,497 in the previous fiscal year
- Enrollment of first patient in clinical study with Docecal
- Reports of positive clinical study results for proprietary XR17 nanotechnology
- Successfully completion of a private placement of new convertible instrument and new shares in the total amount of MSEK 45.5
- Announcement of positive Overall Survival-results from Phase III study of Paclical for treatment of Ovarian cancer
- The Board does not intend to propose any dividends for the fiscal year May 1, 2015 – April 30, 2016.
EVENTS AFTER THE CLOSING DAY
- Oasmia has confirmed on-going negotiations for licensing of Paclical/Apealea and XR17.
I am taking this opportunity to emphasize the importance of recent Oasmia Pharmaceutical announcements that we believe will continue to drive the Company forward and realize shareholder value.
Oasmia Pharmaceutical achieved several key milestones during its fourth quarter, February 1, 2016 to April 30, 2016. We applied for marketing approval of Apealea (the alternatively branded name for Paclical) to the European Medicines Agency (EMA). This is an important step in the development of Oasmia products, as not only will approval in the European Union allow us to market to that region, but it will set a benchmark that will form the basis of applications for marketing approval in other regions, including the United States.
As Oasmia is entering the commercial phase for Paclical in Russia, we made the decision to strengthen our supply chain, appointing Amir Tatarevic to the position of Chief Operating Officer. Amir has significant experience overseeing supply chains and meeting demands within the pharmaceutical industry, and has extensive knowledge about Oasmia and our vision for growth. In an effort to bolster Oasmia’s clinical research and development capabilities, the Company contracted Dr. Ulf Jungnelius as Senior Medical Advisor. Dr Jungnelius is a highly respected oncologist with an extensive track record of working alongside major pharmaceutical companies including Eli Lilly, Pfizer and Celgene. His advice will be invaluable to Oasmia as we continue to develop and commercialize our suite of products.
Our distribution partner in Russia, Pharmasyntez, continued the sales activities in the period and for instance obtained approval of the pricing of Paclical and thus also received reimbursement by the insurance system. Purchasing of pharmaceuticals in the Russian health care regions is carried annually or on a half-year basis depending on the region and we are now entering the first period where our partner can be an active part.
Oasmia has also continued to advance the development of its suite of next generation pharmaceutical candidates. Recently, we announced enrollment of the first patient in a clinical study using Docecal, a novel formulation of docetaxel and XR17, to be performed internationally. We believe the potential for this candidate is great, as docetaxel is the existing standard treatment for multiple cancers including prostate, breast, lung and stomach.
In late April, Oasmia announced positive overall survival results for Paclical in a Phase III study that included a total of 789 patients with epithelial ovarian cancer. These preliminary results indicated non-inferiority between the two treatment groups of Paclical in combination with carboplatin, versus Taxol in combination with carboplatin. These results, while expected, represent an achievement for the Company, as this overall survival data is required for a marketing authorization in the US, and will be added to the marketing approval submission for the EMA.
Another recent, critical announcement surrounds the positive results stemming from a clinical study of Oasmia’s proprietary excipient, XR17. XR17 transforms novel or existing un-soluble molecules into water soluble nanoparticle formations. These characteristics give pharmaceutical companies the opportunity to drastically shorten the development time for their formulations. We believe this breakthrough creates potential for licensing and deployment for XR17 as an excipient for additional pharmaceutical indications, creating a key revenue channel to supplement existing and future commercial sales of our oncology treatments.
Mikael Asp, CEO