11 February, 2021

ZICCUM AB Year-end report January 1- December 31, 2020

Summary of year-end report, fourth quarter 2020

During the fourth quarter, Ziccum announced that it had carried out a pilot study on large-scale production of temperature-stable vaccines. The pilot study centred on a Fill and Finish facility (the last step in vaccine production), with the aim of evaluating the technical and financial viability of commercial production of temperature-stable vaccines. The results of the study show that there are significant economic benefits to Ziccum's LaminarPace technology. The pilot study was carried out in collaboration with KeyPlants AB, a leading specialist company in modular plants for pharmaceutical production.

In collaboration with Keyplants AB, Ziccum has also published a White Paper and a blueprint describing the world's first Fill and Finish plant for large-scale production of temperature-stable vaccines. Compared with today's standard Fill and Finish plants with freeze-drying as the core technology, new thermostable vaccines can be produced with an estimated 65 percent lower OPEX, and 50 percent lower CAPEX.

On December 1, Ziccum made a list change to Nasdaq First North Growth Market.

Fourth quarter (Oct-Dec 2020)
Net sales 0 KSEK (0)
Operating profit -3 423 KSEK (-3 344)
Earnings per share before and after dilution -0.36 SEK (-0.56)

Reporting period (Jan-Dec) 2020
Net sales 0 KSEK (0)
Operating profit -17 235 KSEK (-8 721)
Earnings per share before and after dilution -2.06 SEK (-1.45)

Significant events during the fourth quarter 2020

  • Ziccum has carried out a pilot study into the large-scale production of thermostable vaccines in partnership with KeyPlants.
  • Ziccum has published a White Paper describing the world's first facility for large-scale production of thermostable vaccines.
  • On October 26, we announced that Frida Hjelmberg has been appointed CFO. Frida took office on January 1, 2021.
  • On December 1, Ziccum made a list change to Nasdaq First North Growth Market

Significant events during the reporting period (Jan-Dec) 2020

  • Issue receipts regarding warrants amounted to approximately SEK 13.9 million received to the company during January 2020. The issue was registered by the Swedish Companies Registration Office on 14 January 2020.
  • On March 26, 2020, we announced that Ziccum signed a letter of intent to investigate the integration of Ziccum's technology into an innovative vaccine manufacturing process with a company that has a new innovative production technology for vaccines. The agreement includes an evaluation of the integration of Ziccum's formulation technology for measles and rubella vaccines. The goal is to significantly reduce the costs of childhood vaccines and to increase the availability of vaccines to all children in the world by manufacturing thermostable formulations.
  • On May 20, we announced that Ziccum is taking the next step in one of its industrial collaborations with continued development work to formulate temperature-stable vaccines after the first step has been successful.
  • The company has completed a private placement of a total of 2,216,815 shares to a limited number of qualified private investors. The company received SEK 38.8 million before issue costs and approximately SEK 36.6 million after issue costs, of which approximately SEK 32.3 million received during the second quarter and the remaining approximately SEK 6.5 million received during July 2020.
  • A patent application has been filed regarding thermostable formulations of VLP (Virus Like Particles) based vaccines as well as two patent applications regarding improved function of the LaminarPace system for commercial vaccine production.

Significant events after the reporting period

  • On January 12, Ziccum released its corporate 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 Fill and finish production facility for the filling and final packaging of dry powder, thermostable vaccines including necessary partnerships and financing plans. In the medium term (2-3 years), the goal is to establish a first facility in Sweden.
  • On January 25, Ziccum announced 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.
Summary financial highlights
  2020
Oct-Dec
2019
Oct-Dec
2020
Jan-Dec
2019
Jan-Dec
Net sales
Other income, KSEK 3 5 654
Operating profit KSEK -3 423 -3 344 -17 235 -8 721
Profit after tax, KSEK -3 448 -3 346 -17 289 -8 723
Balance sheet total, KSEK 39 640 18 395 39 640 18 395
Cash flow during period KSEK -5 941 -3 176 31 556 -8 473
Cash flow per share (SEK) -0.62 -0.53 3.75 -1.41
Cash and cash equivalents, KSEK 33 620 2 064 33 620 2 064
Results per share before and after dilution (SEK) -0.36 -0.56 -2.06 -1.45
Equity per share (SEK) 3.79 2.86 3.79 2.86
Equity ratio, % 92% 93% 92% 93%

 
CEO Statement
Vaccinations are and have always been one of the best ways to prevent pandemics and epidemics. The need has never been greater than today. New travel habits, population growth, climate change and overcrowding all increase the potential risk of epidemics and pandemics, and it is children who are 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.

Ziccum has a world-unique and patented technology – LaminarPace™ – which makes it possible to produce vaccines in dry powder form, which is neither practical nor economical using conventional techniques. 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 – vaccinating more people 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, importantly for the industry, "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 in viruses and vaccines in Marseille, several interesting and important projects are now underway. The results are promising and positively confirm what we have seen before, we will also strengthen our patent portfolio further with these results. A strong IP portfolio is the basis for being able to enter into commercial collaborations and create value for our shareholders.

We have two main goals for 2021, to develop plans for a Fill and Finish production facility for the filling and final packaging of vaccines to be established in Sweden, and to continue to license our technology. For the production facility, we are in discussion with a number of partners who are important in being able to carry out such a project. 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 signed an extension agreement with Janssen, owned by Johnsson & Johnsson, for further evaluation. This is following positive results that have been achieved so far.

Our external contacts are constantly being expanded and we are receiving an increasing response from the various players in the industry. Not least, our White Paper (available on our website) which broadly describes what a production facility based on our technology could look like has been much appreciated by important key players. We can see that we can make large cost savings in production in comparison with conventional freeze-drying technology.

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, enabling us to have other types of discussion with both bulk vaccine suppliers and International Vaccine Organizations.

It also means that we can now work in a way that ensures that our technology can deliver an end product that is adapted to the needs and wishes of both the industry and, not least, end users. Our ambition is to be one step ahead, and able to offer a unique complete solution for how a dry-formulated vaccine can be produced, handled and administered. The capital we raised during the summer will largely be used for this business area, thus accelerating the commercialization of our technology. We have previously announced three industrial collaboration agreements with the aim of evaluating our technology in their respective projects.

We also continue to develop our commercial work by collaborating with various companies and groups that work for better uptake of vaccinations worldwide, in order to increase knowledge about the importance of our method. We are getting deeper and deeper into these organizations, and we have high hopes of being able to formalize a collaboration with one of these partners in the coming year.

In conclusion, we are well on our way towards delivering on our goals for the current year and to position Ziccum for a very exciting future within an industry that will continue to be focused on for a long time to come – finally, I would like to welcome all those new shareholders who have joined during the quarter, and to thank them for their trust and confidence.

Lund, 11 February 2021
Göran Conradson
CEO

READ THE WHOLE REPORT HERE

This press release has been submitted for publication by the company's CEO at 08.00 (CET) on February 11, 2021.