Moberg Pharmas Year-end report 2021

THE MEDICAL PRODUCTS AGENCY IN SWEDEN WILL BE REFERENCE MEMBER STATE IN MOBERG PHARMA´S EUROPEAN REGISTRATION APPLICATION  

PERIOD (FULL-YEAR 2021)

• EBITDA SEK -17.1 million (-18.4) *
• Operating profit (EBIT) SEK -19.7 million (-21.0) *
• Profit after tax SEK -16.2 million (-18.4) *
• Total profit SEK 7.4 million (-20.0) **
• Diluted earnings per share SEK 0.17 (-1.05) **
• Cash and cash equivalents amounted to SEK 102.7 million (19.3)

FOURTH QUARTER (OCT-DEC 2021)

• EBITDA SEK -4.2 million (-5.3) *
• Operating profit (EBIT) SEK -4.9 million (-6.0) *
• Profit after tax SEK -4.0 million (-5.7) *
• Total profit SEK -4.0 million (-6.7)
• Diluted earnings per share SEK -0.09 (-0.34)
• Cash and cash equivalents amounted to SEK 102.7 million (19.3)

* These comparative figures refer to continuing operations
**Note that the spin‐off of OncoZenge AB had a positive effect on earnings of SEK 24 million, which affects total profit and earnings per share for the year

SIGNIFICANT EVENTS IN THE FOURTH QUARTER

• The Medical Products Agency in Sweden has agreed to be reference member state for Moberg Pharma AB’s registration application for MOB-015. The company will submit the registration application in Europe through the decentralized process, and market approval is expected in 2023.
• Moberg Pharma entered into a collaboration with Allderma for the launch in Scandinavia. Allderma is managed by the commercial leaders which were responsible for the successful Nordic launch of Moberg Pharma’s first-generation nail fungus product, Nalox®.
• Moberg Pharma’s Chairman, Peter Wolpert, has been appointed CEO of Industrifonden and will not be available for reelection at the Annual General Meeting in 2022.

SIGNIFICANT EVENTS AFTER THE QUARTER

• The Nomination Committee is proposing Kerstin Valinder Strinnholm as the new Chairman of the Board of Moberg Pharma and Anders Lundmark as a new Board member.

STATEMENT FROM THE CEO

The most important event in the quarter was that the Medical Products Agency in Sweden has agreed to be reference member state for the registration application for MOB-015 in Europe. The company also signed a new collaboration agreement with Allderma for the launch in Scandinavia in 2023. In addition, preparations are fully underway for the new North American Phase 3 study.

In December, the Swedish Medical Products Agency announced that it had agreed that Sweden will be reference member state for Moberg Pharma’s registration application. We intend to submit the application through a decentralized process and will submit a full application, which offers the possibility of data exclusivity in Europe for up to 10 years following market approval. Moberg Pharma has been ready to submit the registration application as soon as the authority can receive it. Due to limited resources and many parallel ongoing applications, the Swedish Medical Products Agency has announced that the application can be submitted in March 2022. The company's goal remains unchanged, to receive its first market approval and launch MOB-015 in 2023.

Ahead of the scheduled launch in Europe in 2023, commercialization preparations are also underway to maximize value and create future growth. In November, a licensing agreement was signed with Allderma AB, whose commercial leaders were responsible for the successful Nordic launch of Moberg Pharma’s first-generation nail fungus product, Nalox®. The new agreement gives Allderma responsibility for marketing, distribution and sales in Sweden, Denmark and Norway, while Moberg Pharma is responsible for the manufacture and delivery of the product. The collaboration with Allderma complements the existing licensing agreement for MOB-015 in Europe and our European partner retains the right to take over the license in these markets at a later date. When it was launched in Sweden, Nalox® quickly became the market leader and the market grew by 400%. We look forward to a similar successful collaboration and see a big advantage in being closely involved in the launch of MOB-015 in our home market prior to additional launches with our partners.

Preparations are also fully underway for the company’s next clinical Phase 3 study for MOB-015, which is scheduled to include 350 patients in North America. We intend to submit documentation on the new study to the FDA and the Ethics Committee in the first quarter of 2022. The purpose of the new study is to facilitate market approval in the US as well as strengthen the product’s clinical evidence and marketing claims globally.

We continue to advance according to our strategic plan. That the Swedish Medical Products Agency would agree to be reference member state and support us through the registration process is an important step as we strive toward our goal to register a new and better nail fungus drug. Submission of the registration application in Europe and the start of the Phase 3 study in North America are the most important near-term milestones.

Anna Ljung, CEO of Moberg Pharma
 

ABOUT THIS INFORMATION
This information is information that Moberg Pharma is Obliged to make public persuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact persons set out below, at 8.00 a.m. CET on February 8th, 2022. 

FOR ADDITIONAL INFORMATION
Anna Ljung, CEO, Phone: +46 70 766 60 30, e-mail: anna.ljung@mobergpharma.se
Mark Beveridge, VP Finance, Phone: +46 76 805 82 88, e-mail: mark.beveridge@mobergpharma.se

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