SIGNIFICANT EVENTS DURING THE SECOND QUARTER
- In August Oasmia appointed Peter Selin as Chief Business Officer.
- Oasmia’s CFO Michael af Winklerfelt resigned from his role in August and Fredrik Järrsten was appointed as Chief Financial Officer in September.
- 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 brought an action against the company’s former Board of Directors as a direct result of findings from an investigation into the former Board of Directors’ responsibilities by the auditing firm Deloitte.
- In October Oasmia’s partner Elevar Therapeutics signed an agreement with Taiba Middle East FZ LLC for commercialization of Apealea® in the Middle East and North Africa Region.
- In October the disciplinary committee of Nasdaq Stockholm ordered Oasmia to pay a fine due to the former Board of Directors, in connection with the EGM in March 2019, in several respects violating generally accepted behavior in the securities market.
- Oasmia announced in October that the company has continued to secure IP rights, including the approval of XMeNa patent in India and soon in Australia as well as approved Apealea trademark registrations in Switzerland, Israel, South Africa, Malaysia and Indonesia.
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
- In November Robert Maiorana joined Oasmia as acting CFO, with effect from December 1, 2020 until Fredrik Järrsten commenced in the role. Thereafter, Robert will work as Finance Manager and support Fredrik.
- On 3rd December Oasmia shared an update from its partner Elevar Therapeutics on the development plan for Apealea® (paclitaxel micellar) in ovarian cancer.
SECOND QUARTER[2]: AUGUST 1, 2020 – OCTOBER 31, 2020
- Consolidated net sales amounted to TSEK 154 (252)
- Operating profit/loss was TSEK -53,693 (-47,436)[3]
- Net profit/loss after tax amounted to TSEK –53,538 (-18,309)[3]
- Earnings per share was SEK -0.12 (-0.06)[3],[4]
THE PERIOD2: MAY 1, 2020 – OCTOBER 31, 2020
- Consolidated net sales amounted to TSEK 362 (433)
- Operating profit/loss was TSEK -102,914 (-83 201)[3]
- Net profit/loss after tax amounted to TSEK –106,643 (-58,093)[3]
- Earnings per share was SEK -0.24 (-0.18)[3,4]
CEO’S COMMENTS
The last quarter at Oasmia has seen us focusing on building on the solid foundations we have laid so far this year following the implementation of recommendations highlighted by the strategic review initiated following my appointment as CEO in March. Since then, we have focused our activities on R&D and lab testing in line with our new strategy and reduced our rate of cash burn as the consequence of the rightsizing of our Company. Throughout the period we have continued to make progress on delivering our vision of creating a sustainable specialty pharma company.
In early December Elevar Therapeutics, our global strategic partner shared an update on the development plan for Apealea® (paclitaxel micellar) in ovarian cancer. Following interactions with the FDA Elevar has decided to complete two new studies with Apealea which will be initiated in the first half of 2021 before filing the new drug application (NDA). These studies of Apealea may potentially help to secure a successful registration in the U.S. and provide new data to support a strong product label.
Over the period we have also been working with Elevar to support their partnering efforts for Apealea® in key global territories. In October, Elevar announced an agreement with Taiba Middle East FZ LLC for the commercialization of Apealea® in the Middle East and North Africa region. This is the first regional partnership deal for Apealea® and Elevar is in late stage discussions with a number of potential partners for other regions around the world. Most recently, Elevar and Tanner Pharma Group announced the launch of a global Named Patient program to provide access to Apealea® in areas outside of the United States and Middle East North Africa (MENA) where Apealea® is not yet commercially available.
As previously communicated Oasmia retains marketing rights for Apealea® in the Nordic countries and has made the product commercially available earlier this year. The COVID-19 pandemic continues to significantly impact the ability of our medical scientific liaisons to meet oncologists in the Nordics. However, we are pleased to report that as of November we have started to record initial sales in Finland. In Sweden a positive interest for Apealea has been shown in a few centres in a highly competitive oncology ward environment that is mostly closed to any face-to-face interactions with the Industry. In Denmark, against a negative outcome from the health technology assessment submission we are working on alternatives to generate clinical data.
A central pillar of our new strategy is to explore licensing and partnering opportunities for our existing assets. To drive this process forward in a timely manner I have appointed consultancy firms that will aid us in finding and selecting partners for our Animal Health division as well as the wider XR-17™ platform.
To maximise the value of our platform we have hired a strategic firm to assist Oasmia and facilitate analysis, selection and engagement with potential partners related to licensing/M&A. A four-step project has therefore been initiated with developing a positioning analysis of the XR-17 ™ platform against competing alternatives based on identification and validation of perceived industry needs among potential licensees.
I have also appointed an international investment bank focusing on healthcare with animal health experts to provide us strategic advisory services related to our Animal Health portfolio.
Our pipeline of development programmes continues to progress well. Docetaxel micellar is poised to enter on time in clinical development for advanced prostate cancer with the renowned Swiss Group for Clinical Cancer Research (SAKK). We are also working on adding a novel product candidate in pre-clinical development, using our XR-17™ technology. I hope to be able to disclose further details soon provided a positive outcome.
Protecting intellectual property is critical at any innovative company in our sector, and during the period we worked to bolster our already strong position in this area. In October we announced that our XMeNa patent was approved in India and will soon to be approved in Australia. The XMeNa patent protects an improved method for producing our technology platform XR-17™, which is a unique carrier system for anticancer drugs. We have also secured new trademark registrations for Apealea® in Switzerland, Israel, South Africa, Malaysia and Indonesia during the year.
A key objective for Oasmia is to ensure that we have the right people in place to execute our plans and deliver success. We have made several senior level executive appointments over the last few months including the appointment of two senior scientists to our technical operations team. We believe that investing in this crucial area of the business will enable us to further develop and potentially upgrade our XR-17 platform.
In September we announced that Peter Selin would be joining us as Chief Business Officer and he is now on board since the start of November. His expertise in business development and strategy in the life sciences sector will be invaluable to Oasmia as we continue to pursue growth by seeking M&A and licensing opportunities that complement our technology and business model. Another key addition to the team, announced in October, was the appointment of Fredrik Järrsten as Chief Financial Officer. He has over 25 years of experience across the financial, medical technology and life sciences sectors in the Nordic region and internationally. I know that Fredrik will be an incredible asset to Oasmia when he joins us early next year.
With this experienced new senior team in place I look forward to the remainder of 2020 and beyond with confidence and optimism. Oasmia is in great shape to deliver our strategic objectives as a business and I look forward to keeping you up to date on our progress.
Dr. Francois Martelet, M.D., CEO of Oasmia
The report is available on the company’s website: https://www.vivesto.com/en/financial-reports-and-presentations/
Conference call
The company will hold a conference call and an online presentation on December 9, 2020 at 10.00 am CET. The call will be hosted by CEO Francois Martelet, CEO and Acting CFO Robert Maiorana. The presentation will be in English.
The conference call will be broadcast live on the web via the link:
https://tv.streamfabriken.com/oasmia-pharmaceutical-q2-2020
Telephone number for the conference call is:
SE: +46850558359
UK: +443333009269
US: +18338230586
For more information:
Oasmia Pharmaceutical AB
Francois Martelet, Chief Executive Officer
Phone: +46 18-50 54 40
E-mail: IR@oasmia.com
Consilium Strategic Communications
Jonathan Birt, Chris Welsh, Ashley Tapp
Phone: +44 (0)20 3709 5700
E-mail: oasmia@consilium-comms.com
About Oasmia Pharmaceutical AB
Oasmia is a specialty pharma company dedicated to improving the lives of patients by enhancing the intravenous delivery of established and novel drugs in significant diseases, including cancer. Product development is based on the Company’s proprietary drug delivery technology platform XR-17™ which can be applied to medicines used in many therapeutic areas, to develop water soluble formulations of drugs that currently require chemical solubilizers for dissolution. The first product approved using this technology is Apealea® (paclitaxel micellar). Apealea has received market authorization in the European Union and several other territories for the treatment of first relapse in platinum-sensitive ovarian cancer, in combination with carboplatin. The Company is making Apealea accessible to patients through its partnership with Elevar Therapeutics, together with its existing commercial operations in the Nordic region. Oasmia’s shares are traded on the Nasdaq Stockholm stock exchange (ticker: OASM). To find out more about Oasmia please visit www.vivesto.com.
[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.