1. How has Saniona been impacted by COVID-19?
Despite the challenges of the ongoing COVID-19 pandemic, our dedicated team continues to make progress at Saniona. We have adapted to efficiently continue our efforts under the new, and ever-changing public health guidelines across our global locations, prioritizing the safety of our employees and the patients and physicians who participate in our clinical studies. Given what we know as of this publication, Saniona’s clinical trials have not been significantly impacted by COVID-19. The hypothalamic obesity Phase 2 clinical trial was concluded in March 2020, and the open-label extension study was concluded in November 2020, despite the COVID-19 pandemic. Our partner Medix has stated that review of its new drug application for tesofensine in general obesity by the Mexican food and drug administration has been delayed into 2021, due to the ongoing COVID-19 pandemic. Please see our latest financial report for the most updated information.
2. Why is Saniona considering a possible listing on the U.S. Nasdaq?
We continue to evaluate strategic options aligned with our strategy of positioning Saniona to access U.S. patients, physicians and the U.S. capital markets, and as such we are considering listing our shares on the U.S. Nasdaq exchange. There are multiple potential advantages to Saniona listing at on the U.S. Nasdaq exchange, including increased visibility and access to a greater number of potential investors, as well as potential increased liquidity (trading volume) from different markets with different macroeconomic conditions. Please see our latest financial report for the most updated information.
3. What is Saniona doing to optimize investor communications?
Our philosophy on investor relations is to present accurate, transparent information to the investing community, which enables each investor to make appropriate decisions for themself. Our mandate is not to attempt to manage the short-term share price; it is to advance our rare disease pipeline and build and grow the company to reach its full potential over the long term. Drug development is not a short-term endeavor and progress is not always reflected in the stock price in the short term. We believe if we remain focused and execute on our longterm objectives, this will deliver value to patients and shareholders in the future.
Our efforts to optimize Saniona’s investor communication are ongoing. Some improvements that we have already made to provide greater transparency, information and service for our investors include: switching the provider of ownership data on the website, implementing a system to triage and respond to investor inquiries, conducting an investor monitor/survey to understand investor perceptions, adding detail to the analyst coverage page on the website, creating this FAQ document, and enhancing our interaction with analysts and media to provide greater visibility for Saniona. In 2021, we look forward to continuing these and other improvements - such as updating our website, further enhancing our analyst and media communications, and additional initiatives - all in order to better highlight and communicate Saniona’s business strategy and investment case. We are committed to controlling the things we can control and ultimately bringing medicines to patients who need them.
4. What is Saniona’s business strategy?
Saniona’s business model is transforming with the objective to provide the most value to patients and shareholders. While historically the rights to many of Saniona’s novel molecules had been out-licensed to other companies, Saniona is now aiming to become a fully-integrated pharmaceutical company with the ability to discover, develop and commercialize our own innovative treatments for rare diseases. The focus thus shifts from external collaborations to internal development of Saniona’s proprietary compounds. This strategy requires large initial investments to support clinical development; it is anticipated that these investments will result in significant value to both patients and shareholders when these medicines reach the market.
5. Why does Saniona focus on rare diseases?
Saniona’s corporate strategy is to develop new medicines for rare disease. There is a tremendous unmet need within the rare disease patient population: there are an estimated 7,000 rare diseases, and less than 10% have FDA-approved treatments. Additionally, many rare diseases lead to the premature deaths of infants and young children. The potential to bring medicines to these patients can have a significant impact. Additionally, clinical trials and regulatory reviews of medicines for rare diseases can potentially require less time and/or less financial investment than in more common, larger disorders, therefore making rare diseases better aligned with Saniona’s capabilities as a small biotech company.
6. Why has Saniona been expanding in the U.S.?
The U.S. has the most established regulatory pathways, the most developed rare disease market, and the most extensive healthcare investor base in the world. We believe access to U.S. patients, physicians and the U.S. capital markets are critical for Saniona to unlock its long-term potential, and due to this we are continuing to build our team in the U.S. We need an experienced team in the U.S. to design clinical trials and navigate discussions with the FDA. We are also considering listing our shares on the U.S. Nasdaq exchange, which will further facilitate access to U.S. investors.
7. On what stock exchange is Saniona traded and what is the stock symbol (ticker)?
Saniona’s shares are listed at Nasdaq Stockholm, small cap, under the ticker SANION.
8. What is Saniona’s dividend policy?
Saniona focuses on developing medicines for rare diseases. Developing drugs requires large investments of capital. Saniona thus does not plan to pay any dividends for the foreseeable future. 9. Who are the largest shareholders in Saniona? Consistent with all Swedish listed companies, we disclose Saniona’s ownership structure (top 10 owners) on our website. Market practice for Swedish companies is that the information is updated quarterly, but we have recently chosen to update the list monthly to maintain a higher level of transparency. You can find more about Saniona’s ownership structure in the Investors section of our web site, on the page titles “Ownership Structure.”
10. Where can I find information on the August 2020 directed issue of shares?
On August 10, 2020, Saniona announced a direct issue of shares raising USD $65 million (approximately SEK 567 million) with a syndicate of U.S. and international institutional investors and sector specialists. The Directed Issue was led by RA Capital Management with participation from Pontifax Venture Capital, New Leaf Venture Partners, and other U.S. and international investors including the Second Swedish National Pension Fund (AP2), the Third Swedish National Pension Fund (AP3) and the Fourth Swedish National Pension Fund (AP4). This financing was necessary for Saniona to be able to conduct Phase 2b clinical studies of lead program Tesomet in PWS and HO as well as to advance candidates SAN711 into Phase 1. In this financing, Saniona focused on attracting long-term investors who are aligned with our mission of bringing innovative treatments to patients. We brought in the right Investors on the best terms possible. You can find more information about the directed share issue in the press release issued 10 August 2020.
11. Where can I find information about the equity incentive program?
On October 23, 2020 the EGM resolved to adopt an option program for company employees, including the company’s CEO, certain members of the executive team, vice presidents and all other employees. Our equity incentive plan is aligned with standards for attracting the best talent in the competitive U.S. market, so that Saniona can grow and achieve our goals. You can read more about the equity incentive program in the press release dated 23 October 2020.
12. Which analysts cover Saniona?
You can find more information about Saniona’s current analyst coverage on the Investor section of the website, on the page titled “Analyst Coverage.”
13. How can I get a copy of the Annual report?
You can download a pdf of Saniona’s interim and annual reports from the Investors Section of Saniona’s web site, on the page titled “Financial Reports.”
Do you have questions that were not addressed in this FAQ?
Please contact: Trista Morrison, Chief Communications Officer, Saniona. Office: + 1 (781) 810-9227. Email: firstname.lastname@example.org