How can we as biotech companies contribute with our research and what funding is available?
16 March 2020 The EU’s IMI initiative funds innovation projects based on research on the COVID-19 outbreak, known as the coronavirus. Projects can focus on antivirals, diagnostics or tools to deal with current and future COVID-19 outbreaks. The aim is to highlight medical innovations to stop the coronavirus and its spread. Read more on the Vinnova website.
The EU has also opened a fast-track call for funding for small innovative companies that can contribute to solutions through the EIC Accelerator. Applications close on March 18. Read more here. Please contact SwedenBIO’s EU SME Support if you have any questions.
What is the government’s support package?
17 March 2020 The government’s proposed support package consists of three parts. A liquidity boost through tax deferrals, short-term layoffs to save jobs, and the state taking over responsibility for sick pay for two months. The Parliament will decide on the package on March 19.
Deferment of tax payments. The proposal allows companies to apply for a deferral of payment of preliminary tax on salary, employer contributions and VAT, for a maximum of three months during the period January to September 2020. The fact that the rules apply retroactively from January 1 means that companies that have paid tax into their tax account for January to March can have the tax refunded by the Swedish Tax Agency. The purpose of the temporary stays is to overcome temporary liquidity problems of basically viable companies. This applies both to the current emergency situation and to knock-on effects, which is why it is possible to apply for a postponement until September.
The state bears an increased cost for short-term layoffs. Under the proposal, the state would pay half the cost of wages for short-term layoffs and the worker would receive more than 90% of the salary. The proposal is proposed to be applied from today and to apply in 2020. The measure is mainly tailored to industries with a decline in orders as a direct consequence of the virus and is likely to have a limited impact on the life science industry.
The state takes over responsibility for sick pay for two months. The state is proposed to temporarily assume the entire cost of all sick pay during April and May. The self-employed are also compensated by receiving a standardized sickness benefit for days 1-14. It has already been decided that the state will pay sickness benefit for the first day of the sickness case between March 11 and May 31. Read more at Tillväxtverket. /Frida Lawenius, Vice President SwedenBIO
To avoid viable companies being destroyed by the spread of the coronavirus, the Executive Board of the Riksbank has decided to lend up to SEK 500 billion to companies via the banks. The aim is to maintain the supply of credit to Swedish companies. Does SwedenBIO believe that this particular measure can have an impact on the life science industry?
March 17, 2020 Many of our member companies are still in the product development stage and have not yet reached profitability. Therefore, they do not have access to debt financing. Our assessment is therefore that this measure has a very limited impact on our industry. A more important measure for our industry would be to ensure access to risk capital during the emergency period. We know from experience that in periods of stock market decline, access to risk capital is cut off, which has a negative impact on our member companies. Almi, Vinnova and Saminvest are all important instruments available to the government. Read more at the Riksbank. /SwedenBIO business development and financing working group
What are the new government regulations?
Here is a short HR manual for regulations related to the Corona situation (sickness benefit, short-term leave, contagion allowance, etc.).
The state pays sickness benefit for the first day of the sickness case between March 11 and May 31. As an employer, you make the usual deductions for waiting time. The employee subsequently applies for reimbursement from the Social Insurance Agency.
The state takes full responsibility for sick pay during April and May. Read more about sickness benefit rules and the handling of deductions for waiting periods at Försäkringskassan.
Self-employed persons receive a flat-rate sickness benefit for days 1-14.
The requirement for a medical certificate during the sick pay period is temporarily abolished.Employees can stay home due to illness for up to 14 days without submitting a medical certificate to your employer.
The state pays half of the wage costs for short-term layoffs. The worker receives more than 90% of the salary. The support will be available on April 7, but will be applied from March 16 and throughout 2020.
There are now central collective agreements on short-term layoffs between IKEM and the trade unions – Naturvetarna, Sveriges Ingenjörer, Ledarna, Unionen and IF Metall. There must also be support for short-time working in the local collective agreement. Prepare yourself by concluding a local agreement that regulates the reduction in working time and who is covered.
In the absence of a collective agreement, there must be a written agreement supporting short-term leave with at least 70% of employees.
Read more at Tillväxtverket.
Deferment of payment of preliminary tax on salary, social security contributions and VAT, for a maximum of three months during the period January to September 2020.The fact that the rules apply retroactively from January 1 means that companies that have paid tax into their tax account for January to March can have the tax refunded by the Swedish Tax Agency. Read more about the application and requirements at the Swedish Tax Agency.
Carrier’s allowance can be applied for from Försäkringskassan when employees are infected but otherwise able to work. Entitlement to carrier’s allowance requires a medical certificate. Read more about carrier’s allowance from Försäkringskassan.
Responsibility for systematic work environment management and risk assessment.As an employer, your responsibility for systematic health and safety management includes conducting a risk assessment regarding exposure to the coronavirus and COVID-19 disease. Read more about your health and safety responsibilities in relation to Corona on the Agency’s website.
/Frida Lawenius, Vice President SwedenBIO
What general approach should listed companies take when communicating with investors?
In times of crisis and uncertainty, rumors and speculation quickly arise. It is particularly important to be as clear and transparent as possible about the short-term impact on the company. At the same time, you should explain the long-term fundamentals that will determine how you return to normal and build value in the long term.
At the same time, the European Securities and Markets Authority (ESMA) has issued a recommendation suggesting that listed companies should communicate as soon as possible all relevant information on the impact of COVID-19 in accordance with their obligations under MAR. In addition, ESMA believes that listed companies should be transparent about the actual and potential impact of COVID-19, to the extent possible. They should base that assessment on both a qualitative and quantitative analysis of the companies’ business activities, financial situation and financial performance and then report it in the 2019 annual report, if it has not yet been completed. Otherwise, this should be done by other means, such as in the company’s forthcoming interim reports.
The question was answered by: Paues Åberg Communications. For further information, please contact Jonas Rodny, jonas.rodny@pauesaberg.se, 076-190 90 51 or Carolin Wiken, carolin.wiken@pauesaberg.se, 070-092 91 70.
We have not issued a forecast, but do we still need to inform the market about how we are affected by the Coronavirus?
It is difficult to give a general answer to this question as the assessment must be made on a case-by-case basis. According to Nasdaq’s rules, factors may be considered in the assessment: the expected magnitude or significance of the event in relation to the company’s overall business; the significance of the new information in relation to the factors that determine the share price; or other factors that could affect the share price.
The regulations specifically state that if the company’s financial results or position deviate from what could reasonably be expected on the basis of the information that the company has published or otherwise communicated previously, the information regarding the deviation may constitute inside information. In assessing whether a change in the company’s financial performance or position is sufficiently material to constitute inside information, the company shall evaluate the deviation on the basis of recent financial developments, forecasts or forward-looking statements. Such an assessment should take into account the company’s specific operations together with known changes in financial conditions during the remainder of the financial period. The prerequisites may include e.g. include seasonal variations and general market developments. Account should also be taken of other information provided by the company regarding external factors, such as sensitivity analyses regarding, for example, interest rates, currency and commodity prices. Compilations of analysts’ expectations of the company are not decisive for the assessment.
Although it is difficult to draw any general conclusions from the regulations, listed companies should consider whether there might not be a long-term value in being as transparent as possible by telling how the company is affected by current developments, with the caveat that it is of course difficult to know what will happen in the future. It builds trust capital and also avoids speculation as it always arises in the absence of information. Moreover, it is in line with ESMA guidelines.
The question was answered by: Paues Åberg Communications. For further information, please contact Jonas Rodny, jonas.rodny@pauesaberg.se, 076-190 90 51 or Carolin Wiken, carolin.wiken@pauesaberg.se, 070-092 91 70.
We estimate that one of our clinical studies will be delayed as we are conducting it in a number of clinics in Northern Italy that have been heavily affected by the Coronavirus, do we need to notify the market?
It is difficult to give a general answer to this question as the assessment must be made on a case-by-case basis. According to Nasdaq’s rules, factors may be considered in the assessment: the expected magnitude or significance of the event in relation to the company’s overall business; the significance of the new information in relation to the factors that determine the share price; or other factors that could affect the share price. Although it is difficult to draw any general conclusions from the regulations, listed companies should consider whether there might not be a long-term value in being as transparent as possible by telling how the company is affected by current developments, with the caveat that it is of course difficult to know what will happen in the future. It builds trust capital and also avoids speculation as it always arises in the absence of information. Moreover, it is in line with ESMA guidelines.
The question was answered by: Paues Åberg Communications. For further information, please contact Jonas Rodny, jonas.rodny@pauesaberg.se, 076-190 90 51 or Carolin Wiken, carolin.wiken@pauesaberg.se, 070-092 91 70.Hide
Have the authorities issued any instructions on how listed companies should communicate about Corona?
Yes, the European Securities and Markets Authority (ESMA) has issued a recommendation suggesting that listed companies should communicate as soon as possible all relevant information on the impact of COVID-19 in line with their obligations under MAR. In addition, ESMA believes that listed companies should be transparent about the actual and potential impact of COVID-19, to the extent possible. They should base that assessment on both a qualitative and quantitative analysis of the companies’ business activities, financial situation and financial performance and then report it in the 2019 annual report, if it has not yet been completed. Otherwise, this should be done by other means, such as in the company’s forthcoming interim reports.
The question was answered by: Paues Åberg Communications. For further information, please contact Jonas Rodny, jonas.rodny@pauesaberg.se, 076-190 90 51 or Carolin Wiken, carolin.wiken@pauesaberg.se, 070-092 91 70.Hide
How to think about the general meeting? Is it possible to postpone the AGM?
There are a number of actions to be taken here:
- Propose that the AGM decides that it should be possible to follow the meeting via live webcast.
- Make a pre-recording of the CEO’s speech and then post it on the website after the AGM.
- Enables shareholders to appoint a proxy to vote on their behalf. For example, Euroclear can help to administer this.
- Encourage shareholders to follow the recommendations of the Public Health Agency.
- Do not offer refreshments and if it is expected that many people will physically participate, divide the participants into several different rooms if possible.
Yes, it is possible to postpone the AGM, but not indefinitely. The annual general meeting is required by law and must take place within 6 months of the end of the financial year.hide
What happens to my patents and patent applications if my results are delayed?
Experimental results are often a very important component of patent applications in the life sciences in order to demonstrate that the invention works, which is a requirement in the patent context. Depending on where you are in the patent application process, different solutions are possible.
Situation 1: First patent application (priority application)
As it is not possible to add new data to a patent application after the filing date, it may be wise to consider postponing the filing of the application until results have been generated. This presupposes that the invention can be kept secret until the filing of the application, otherwise the novelty of the invention will be lost and thus the possibility of patenting it. Therefore, if publication of the invention is imminent, e.g. through a public presentation, an article or a thesis that cannot be postponed, it is better to file the patent application without experimental results and make the best of the situation, even if there is an increased risk that the patent authorities will consider that the invention is not sufficiently clearly described or not disclosed, and that the patent application will therefore not be granted.
Situation 2: Second patent application (e.g. PCT application)
Within 12 months from the filing of a first patent application, a second patent application can be filed with priority from the first one (see priority here: https://www.prv.se/sv/patent/ansoka-om-patent/innan-ansokan/prioritet/). As the 12-month deadline cannot, as a general rule, be extended and as it is not possible to file supplements to the application that are not supported by the information on the invention already filed, if the results are important for the granting of the application, one can consider withdrawing the first patent application and re-filing it once results have been generated, thus creating a new “first patent application”. This assumes that no publication of the invention has taken place, either by you or by anyone else, before the application is resubmitted. It also requires that the earlier, withdrawn application leaves no rights behind, which in practice means that it must be fully completed and not linked to other patent applications. Please contact your patent attorney if you are considering this option.
Situation 3: National application process
In some situations, experimental results are needed to respond to an injunction, e.g. in the US or before the European Patent Office (EPO). This may be the case if the patent applicant has to prove a certain claimed effect of the invention. In such a situation, it can be examined whether it is possible to request an extension of the deadline under the national law of the country concerned. As patent law is not harmonized, different rules apply in different countries, and taking into account that some patent offices have been completely closed during periods of the Corona pandemic, there may be possibilities in some countries to request the reinstatement of deadlines that could not be met.
The question was answered by: AWA Sweden AB. For further information, please contact Louise Jonshammar, Louise.Jonshammar@awa.com or Johanna Berg, Johanna.Bergh@awa.com.Hide
Can we request an extension of deadlines due to the coronavirus pandemic?
In a national application process, it is often possible to request an extension of deadlines, consult your national patent attorney. See also the comment above (Situation 3).
However, in general, it cannot be expected that the statutory deadlines in the patent application process can be postponed by the patent authorities due to circumstances related to the current pandemic. For example, the period for claiming priority in the novelty assessment of a second patent application (the “priority period”) cannot be expected to be overridden, except to the extent that there are specific exceptions in law.
The question was answered by: AWA Sweden AB. For further information, please contact Louise Jonshammar, Louise.Jonshammar@awa.com or Johanna Berg, Johanna.Bergh@awa.com.
