On February 24, 2022 Oasmia reported Year-end report January 1, 2021 – December 31, 2021 (Press release, Oasmia, FEB 24, 2022, View Source [SID1234608978])
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SIGNIFICANT EVENTS DURING THE FOURTH QUARTER
In October, Oasmia announced a global settlement of all disputes with MGC Capital, former Board Members of Oasmia and members of former management. The settlement resulted in a negative cashflow of approx. MSEK 25 while having a positive earnings effect of approx. MSEK 33.
In December, Oasmia announced that the transfer of its marketing authorization for Apealea (paclitaxel micellar) to Inceptua AB had received approval from the European Commission and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
SIGNIFICANT EVENTS AFTER THE REPORTING PERIOD
With the purpose to finance the continued development of Oasmia and its projects in accordance with its business plan and strategy, the Board of Directors in January, subject to approval by an Extraordinary General Meeting, resolved on a fully secured rights issue of approximately SEK 151 million.
In January Oasmia announced the intention, subject to approval by an Extraordinary General Meeting, to change its name to Vivesto AB.
In January Oasmia announced progress on the development of XR-18 and that the company has identified and synthesized a promising novel candidate for use in the drug delivery platform.
On 21 February an Extraordinary General Meeting approved the Board of Directors’ resolution on 19 January 2022 on a new issue of shares with preferential rights for existing shareholders, and to approve an amendment to the Articles of Association whereby the company’s corporate name is changed to Vivesto AB.
In February Oasmia gave an update on the progress of the SAKK investigator-initiated Phase 1b trial of Docetaxel Micellar in advanced prostate cancer.
FOURTH QUARTER: OCTOBER 1, 2021 – DECEMBER 31, 2021
Consolidated net sales amounted to TSEK 9,639 (131)
Operating profit/loss var TSEK -2,068 (-59,441)
Net profit/loss after tax amounted to TSEK -2,849 (-65,373)
Earnings per share amounted to SEK -0.01 (-0.15)
FINANCIAL YEAR: JANUARY 1, 2021 – DECEMBER 31, 2021
Consolidated net sales amounted to TSEK 26,192 (201,760)
Operating profit/loss var TSEK -128,647 (-44,323)
Net profit/loss after tax amounted to TSEK -132,722 (-57,541)
Earnings per share amounted to SEK -0.30 (-0.13)
CEO REVIEW
The last quarter of 2021 was one of sustained progress towards delivering our goal of transforming the business and laying the groundwork to create a Nordic oncology powerhouse. Much of the important work undertaken in Q4 was announced early in 2022, including plans to secure financing to drive the value in our portfolio, and changing our name to Vivesto AB to mark the completion of our initial transformation and the next phase in our journey.
In January 2022, we announced plans to raise ~SEK 150 million through a fully secured rights issue. This will strengthen our balance sheet and help us achieve potential value inflection points for our existing development programs as well as financing general business operations for 18-24 months. It is a vital steppingstone to secure the short to medium term future of the business and an important initial step towards achieving our broader vision to build our oncology pipeline through in-licensing and M&A – our "string of pearls" strategy.
Our new identity was approved by shareholders at our EGM on 21 February. This marks the completion of the initial phase of transforming the company set out two years ago. Vivesto – from the Spanish word "alive" – was selected after extensive research among the international medical community, patients and investors, who shared our view that it embodies our mission to build a diversified pipeline focused on hard-to-treat and late-stage cancers using different mechanisms of action.
Since I joined Oasmia I have focused on a number of goals to build the foundations for a strong, business and set us up for success:
Rightsizing the Company and terminating commercial drug production
Strengthening the management of our finances
Positioning us an attractive partner for innovative assets and companies
Settling legacy litigation and reducing business risks
Progressing our pipeline and building critical mass in our portfolio.
Rightsizing the Company and terminating commercial drug production
We are now fully focused on product development, having terminated commercial drug production. Our lead program Apealea (paclitaxel micellar) is out-licensed globally through our global strategic partner Elevar Therapeutics and selected partners in key territories. Elevar has assumed responsibility for commercial drug production of Apealea and XR-17 is manufactured by a sub-contractor.
In September 2021 Paclical (Apealea) was out licensed to the Swiss-based FarmaMondo Group for commercialization in Russia and the Commonwealth of Independent States. As a result, marketing authorizations which Oasmia holds in Russia and Kazakhstan have been transferred to FarmaMondo. FarmaMondo has also taken responsibility for all future development and commercialization activities in Russia and the Commonwealth of Independent States.
In Q4 Inceptua, Elevar’s partner in Europe, informed us it had received approval from the European Commission and UK Medicines and Healthcare products Regulatory Agency (MHRA) for transfer of Apealea’s marketing authorization, enabling it to assume full regulatory responsibility for Apealea in the EU, Norway, Iceland, Liechtenstein, and the UK. Inceptua have confirmed their intention to launch Apealea in the UK and Germany in the first half for 2022, which is expected to lead to us receiving the first royalties during the year.
Strengthening the management of our finances
As part of the comprehensive cost control program launched in 2020, we have significantly reduced operating costs during the year, and we have now realized annualized cost savings of more than SEK 100 million since 2020. We have also reduced our so-called "burn rate" and adjusted for a one-time negative cash flow effect in Q4 from settlement of litigation, the average burn rate per month in 2021 amounted to SEK 10 million which then is in the lower part of our target range of SEK 10-12 million per month. These cost savings have enabled us to invest in areas which in the long run can deliver the greatest return, including pipeline development which is critical for our success and future growth.
Positioning us as an attractive partner
We have made significant progress in building our in-house capabilities over the past two years. We now have a team with proven development and regulatory expertise able to take products from early-to late-stage development and potentially through commercialization and partnering. We believe this makes us more attractive to companies with promising assets targeting hard-to-treat and late-stage cancers. We are currently seeking a new oncology-focused Chief Medical Officer following Heidi Ramstad’s decision to leave the company in April for personal reasons. Most recently and post period, Kai Wilkinson, Head of Research & Development and Manufacturing was promoted to the position of Chief Technology Officer and joined Oasmia’s Management team. I look forward to working more closely with Kai. His skills and expertise will be useful as we continue the transform our Technical Operations to support our broader business objectives.
Settling legacy litigation and reducing business risks
During Q4 we announced a global settlement for all inherited outstanding legal disputes with MGC Capital, former Board Members of Oasmia and members of former management. The settlement resulted in a negative cashflow of approx. MSEK 25 while having a positive earnings effect of approx. MSEK 33. Reported debt in relation to MGC Capital of MSEK 80, as well as a receivable of MSEK 40, was settled as a result of the agreement leading to the positive earnings effect as reported in the income statement for the quarter. This is excellent news and ends a notable risk for the business. Most importantly, this has resulted in Oasmia being debt free, a considerable achievement.
Progressing our pipeline and expanding our portfolio
Cantrixil, the first in-licensed oncology program of our string of pearls strategy, continued to make progress towards a Phase 2 study, building on promising Phase 1 results in late-stage ovarian cancer. Valuable insights provided by our Scientific Advisory Board are helping us to design the Phase 2 trial and the longer-term clinical and regulatory path. We are planning to engage with regulatory authorities this year in preparation for a multi-center Phase 2 study in the US and EU. We have also continued to work on securing manufacturing agreements to ensure drug supply. Our aim is to have made substantial progress by the end of 2022 towards initiating the Phase 2 trial.
A Phase 1b trial of our second clinical-stage program, Docetaxel micellar, in development for advanced prostate cancer, continued to recruit patients in Switzerland under the leadership of the Swiss Group for Clinical Cancer Research (SAKK). SAKK has made excellent progress, with three centers open and enrolment is expected to be completed by the end of 2022. Most recently, post period end in February 2022, we reported that the first patient has now fully completed the study. Furthermore, the first of three dosing groups in the trial has been successfully recruited and the first patient has started in the second dose group.
Over the last year we have completed a significant number of due diligence exercises on public and private companies and in-licensing targets in oncology. In Q4 we continued this work to analyze promising business development opportunities that will leverage our in-house expertise, expand our portfolio of cancer therapies around multiple modalities and create long-term value for shareholders. 2022 should see the materialization of this work and we look forward to updating the market on our progress.
Exploring the full potential of our technologies
Recently and post period we announced progress on the in-house development of XR-18, the next generation of our proprietary drug delivery technology. We believe XR-18 could offer enhanced capabilities compared with XR-17, which is designed to increase the solubility of intravenously delivered compounds and has been used successfully in Apealea. The next-generation formulation applied in XR-18 is already being tested in combination with a widely used oncology compound, and steps for securing Intellectual Property are being taken.
A solid end to the year
We made continued progress towards achieving all our key goals in Q4. With a solid platform for growth, we are fully focused on moving our promising oncology development pipeline forward and continuing to expand our portfolio through our "string of pearls" in-licensing and acquisition strategy to build critical mass and bring innovation to patients with hard-to-treat cancers.
In 2022, we will see Apealea launched in Europe via Elevar’s partner Inceptua. Apealea offers a non cremophor formulation of paclitaxel which may offer substantial benefits to some patients, and this makes us very proud.