23 April, 2021

ZICCUM AB Interim Report January 1-March 31, 2021

Summary of interim report, first quarter 2021

Ziccum has announced its goals for 2021, the main goals are to enter into a first licensing agreement for one or more vaccines and to present a detailed plan to establish a production facility for filling and final packaging of dry powder, thermostable vaccines including necessary partnerships and financing plan.
 
During the first quarter, Ziccum extended the evaluation agreement that was concluded on October 3, 2019 with Janssen Vaccine & Prevention B.V., one of Janssen's pharmaceutical companies belonging to Johnson & Johnson. The purpose is to complete the analysis of Ziccum's air drying technology with Janssen's vaccine platforms.
 
During Q1, Ziccum was accepted as a member of NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals. NIIMBL's mission is to accelerate the development of new biomedical manufacturing technologies in the United States.
 
Jan – Mar 2021
Net sales 0 KSEK (0)
Operating profit -4 387 KSEK (-3 980)
Earnings per share before and after dilution -0.46 SEK (-0.55)
 
Significant events during the first quarter 2021
On January 12, Ziccum announced its goals for 2021, the main goals being to enter into a first licensing agreement for one or more vaccines and to present a detailed plan to establish a production facility for filling and final packaging of dry powder, thermostable vaccines including necessary partnerships and financing plan. In the medium term (2-3 years), the goal is to establish a first facility in Sweden.
 
Ziccum announced on January 25 that the company has extended the evaluation agreement that was concluded on October 3, 2019 with Janssen Vaccine & Prevention B.V., one of Janssen's pharmaceutical companies belonging to Johnson & Johnson. The purpose is to complete the analysis of Ziccum's air drying technology with Janssen's vaccine platforms.
 
On March 17, Ziccum announced that the company had been accepted as a member of NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals. NIIMBL's mission is to accelerate the development of new biomedical manufacturing technologies in the United States. Among others, the US National Institute of Standards and Technology (NIST) and the U.S. Department of Commerce founder, giving the organization opportunities to distribute federal grants to its members.
 
Significant events after the reporting period
No significant events occurred after the reporting period.

Summary Financial Highlights
  2021
Jan-Mar
2020
Jan-Mar
2020
Jan-Dec
Net sales
Operating profit, KSEK -4 387 -3 980 -17 235
Profit after tax, KSEK -4 416 -3 980 -17 289
Balance sheet total, KSEK 35 715 14 271 39 640
Cash flow during period, KSEK -4 818 8 995 31 556
Cash flow per share, (SEK) -3.00 1.25 3.75
Cash and cash equivalents, KSEK 28 802 11 058 33 620
Results per share before and after dilution (SEK) -0.46 -0.55 -2.06
Equity per share, (SEK) 3.33 1.77 3.79
Equity ratio, % 90% 91% 92%

CEO Statement
Vaccinations are and have been one of the best ways to prevent pandemics and epidemics. Now, the need has never been greater. New travel habits, population growth, climate change and overcrowding all potentially increase the risk of epidemics and pandemics, and children are the most vulnerable; one child in five still does not receive adequate vaccination protection. Approximately 1.5 million children die each year from diseases for which vaccines are available. With the Covid-19 pandemic, many countries have come to realize the importance of taking responsibility for vaccine production, not least many countries on the African continent. Our solution described in a White Paper on our website, of a Fill & Finish production facility, may therefore be very suitable.
 
Ziccum has a unique and patented technology – LaminarPace ™ – which enables us to produce vaccines in dry powder form, which is not practically or economically possible with conventional technologies. The benefits are many. It increases the stability and thus the lifespan of the vaccine, it facilitates the entire transport chain from factory to patient and it enables the distribution of vaccines to new places where, for example, cold- and freezer storage is a major challenge. The result is greater vaccination coverage at a lower cost.
 
Ziccum's focus is described in three main areas: Development of thermostable formulations of vaccines, preparations for production on a commercial scale and external collaborations with industrial actors who develop vaccines and also, for the industry very importantly, NGOs, "non-governmental organizations".
 
Despite Covid-19, our internal work continues to develop thermostable formulations of vaccines. In collaboration with our academic partner, the world-leading University of Marseilles’ virus and vaccine department, several interesting and important projects are now underway. The results are very promising and are in good agreement with what we have seen before. Our work on developing a system for an industrial production environment is progressing well, and we have also worked on mathematical simulated models of the process, which has given us a deeper insight into commercial production.
 
We have two main goals for 2021, partly to develop concrete plans to build and establish a Fill & Finish production facility for filling and final packaging of vaccines in Sweden, and partly to continue licensing our technology. The goal of concluding a license agreement remains from the previous year. License revenues continue to be a central part of Ziccum's business model. A license agreement would validate LaminarPace and be a clear acknowledgment of the commercial value of Ziccum's offering.  We are of course pleased to have entered into an extension of our collaboration agreement with Janssen, which is owned by Johnsson & Johnsson, for further evaluation of our technology in combination with their vaccine program. We are expected to be able to come up with new updates about this project during the second half of the year. We have already presented a detailed proposal on what a Fill & Finish production facility based on our technology will look like. The response from industry players has been positive and we are constantly making new contacts with potential key players to be able to carry out the project. We have shown that a Fill & Finish production facility based on our LaminarPace technology has the potential to lead to significant cost savings compared to conventional freeze-drying technology, in addition to the fact that dry vaccines can be produced without dependence on the costly and complicated Cold Chain.
 
Vaccines are a low-cost product in large parts of the world, which is why these results are so important. Now that we can describe a production facility, we have expanded our business model and added additional revenue opportunities. We can now have another type of discussion with both bulk vaccine suppliers and International Vaccine Organizations. The ambition to establish a production facility for dry vaccines also means that we now focus a lot on ensuring that our technology can deliver an end product that is adapted to the industry's and not least the end users' wishes and requirements. Our ambition is to be one step ahead and be able to offer a unique complete solution for how a dry-formulated vaccine is to be produced, handled and administered.
 
We also continue to develop our commercial work by actively processing and engaging in dialogue with various companies, interest groups and even nation states that work for better vaccine coverage worldwide. We are building deeper and stronger relationships in these arenas, we have high hopes of being able to formalize one or more collaboration in the coming year.
 
It is also, of course, very gratifying that we have very recently been admitted as members of the American organization NIIMBL (The National Institute for Innovations in Manufacturing Biopharmaceuticals). One of NIIMBL's main purposes is to ultimately strengthen American competitiveness in the manufacture of biological drugs, and we now have direct contact with the heavy American biotech industry. To become a member, you must in principle have some form of business in the US, which we do not have, but sometimes they make exceptions for companies with particularly interesting technology. With membership, we also have the right to apply for US federal grants channelled through NIIMBL and we can be invited to participate directly in projects without having to make applications.
 
In summary, we are well positioned for a very exciting future in an industry that will remain a top priority for all of us for a long time to come.
 
Lund, 23 April 2021
Göran Conradson
CEO
 
Read the full report HERE.
 
This press release has been submitted for publication by the company's CEO at 08.45 (CET) on April 23, 2021.