2017 Q4 report, October-December for Panion Animal Health AB

Period October-December

• Net sales: kSEK 0 (0).
• Operating profit: kSEK -854 (-643).
• Earnings per share: SEK -0,32 (-0,09).
• Liquidity at the end of the period: kSEK 2 124 (306)

Period January-December

• Net sales: kSEK 0 (0).
• Operating profit: kSEK -4 200 (-692).
• Earnings per share: SEK -0,32 (-0,09).
• Liquidity at the end of the period: kSEK 2 124 (306)

Milestones October-December 2017 

• • Panion’s epilepsy drug candidate shows positive initial results in a long-term study by CombiGene, which was published on December 7, 2017.
• Panion’s epilepsy product was classified as MUMS in EU for dogs and cats on December 11, 2017. This means that we can apply reduced data requirements when we submit a marketing authorisation application in the EU.
• The renewal of the US-MUMS status for 2018 and the connected fee waiver for fiscal year 2018 was received from the US FDA. This means that Panion will not have to pay the large annual fee for its application in the USA.
• The cooperation with Copenhagen University was continued with the aim of conducting an experimental dog study in Q1 2018. • The preparations for a pilot field trial in the USA were continued with the assistance of the US consultants and investigator.
• The Letter of Intent and cooperation with GeneQuine Biotherapeutics GmbH was terminated on December 5 based on the boards evaluation of the business opportunity.
• A stock transaction of 200,000 shares was conducted on October 26 from the chairman of the board, 
• Lars Thunberg, to the two scientific founders of Panion’s epilepsy drug candidate, Merab Kokaia and David Woldbye.
• The new CFO in Panion, Sofia Josephson, took over the role on Dec 29, 2017

CEO statement

Allow me first to thank all our investors and cooperation partners, who support Panion’s development and interesting work!

Looking back on the fourth quarter of 2017, there are lots of topics to comment on and celebrate. Very good news about Panion’s epilepsy drug candidate was communicated in December 2017, where the initial results of a long-term study in rats were released, showing that the treatment caused fewer seizures in the groups of animals that had been treated with the drug. This gave an understandable positive reaction in the market for both CombiGene and Panion.

The second large jump in share prices came with the announcement just after New Year, that Panion has secured financing agreements with two robust investors for a total of 9.5 MSEK over the coming period. An article in Investerarbrevet went as far as calling Panion a “rocket”. We all know that shares prices fluctuate over time, but this recent development is indeed very welcome.

During Q4, we have worked hard on getting the development of our epilepsy project rolling. Our initial plan was to start a study in patient dogs in 2017, but we had to reevaluate the starting time. To be able to run a successful study, we needed to broaden the inclusion criteria, which required more safety data. Authority permission for this is now obtained and we are confident that the development process speeds up again. The positive side is that a broader inclusion of patients is expected to give a broader patient base when the product reaches the market. Panion’s epilepsy product is a very innovative treatment, and close cooperation with the regulatory authorities is necessary for planning and conducting the adequate type of trials for approval. We have opened the application file with FDA, renewed the MUMS (“Minor Use and Minor Species”) status with market exclusivity rights and renewed the feewaiver for the year 2018 from USA. We have also received a 5-year MUMS status from the European Medicines Agency for both dogs and cats. With an active registration in Europe as a SME-company, we also gain access to regulators’ help and assistance during the development and later application process.

It is Panion’s firm ambition to extend our product portfolio and we have been investigating several options. In December, we had to terminate a longer due-diligence process and negotiations with another gene therapy development company, because the opportunity was not sufficiently promising for Panion’s business and investors. However, we continue the search and dialogue with other potential in-licensing products.

We aim to inform our investors well, and Panion representatives have given interviews in Swedish magazines and presented on our website. We will continue to inform about the progress and development as early as possible. I encourage you to read more details and the full company description of Panion, which can be found on our website in both Swedish and English.

Epilepsy in dogs is a serious disease that affects millions of family dogs across the world and for which medicine is not effective in approximately 30% of cases. The prospect of treating epilepsy – and other chronic diseases in animals – with gene therapy is very promising and we continue to work hard to realize the potential.

Anja Holm,
CEO, Panion Animal Health AB

Anja E. H. Holm, CEO
+ 45-22 94 66 00
anja.holm@panion-animalhealth.com

Bolaget ska utveckla och kommersialisera genterapi för behandling av epilepsiliknande tillstånd hos hundar och andra djur, samt utveckla och kommersialisera andra veterinärmedicinska produkter och nya behandlingsformer som kan ge sjuka djur bättre livskvalitet.
Panion will develop and commercialize a gene therapy treatment for dogs with drug refractory epilepsy, and other new animal health products and treatments that improve the quality of life for animals suffering from chronic diseases.

This report contains information which Panion Animal Health AB is obliged to publish according to the EU market abuse regulation (MAR). This information was submitted by Panion’s CEO, Anja E. H. Holm, for publications on February 22 2018.