Interim report January - September 2021
APPROVAL FROM THE EMA´s PEADIATRIC COMMITTEE
NINE MONTH PERIOD (JAN-SEP 2021)
- EBITDA SEK -12.9 million (-13.8) *
- Operating profit (EBIT) SEK -14.8 million (-15.7) *
- Profit after tax SEK -12.2 million (-13.3) *
- Total profit SEK 11.4 million (-13.3) **
- Diluted earnings per share SEK 0.26 (-0.71) **
- Cash and cash equivalents amounted to SEK 111.4 million (30.0)
THIRD QUARTER (JUL-SEP 2021)
- EBITDA SEK -4.0 million (-4.6) *
- Operating profit (EBIT) SEK -4.7 million (-5.2) *
- Profit after tax SEK -3.9 million (-4.7) *
- Total profit SEK -3.9 million (-4.7)
- Diluted earnings per share SEK -0.09 (-0.25)
- Cash and cash equivalents amounted to SEK 111.4 million (30.0)
* These comparative figures refer to continuing operations
**Note that the spin-off of BUPI had a positive effect on earnings of SEK 24 million, which affects total profit and earnings per share for the nine-month period
SIGNIFICANT EVENTS IN THE THIRD QUARTER
- Approval received for the pediatric plan of MOB-015 from the EMA’s pediatric committee (PDCO).
- Agneta Larhed, Vice President Pharmaceutical Innovation & Development, joined the company’s management team in September.
- The total number of ordinary shares in the company increased to 45,511,425. The purpose of the newly issued shares, 910,000 in total, is to secure the commitments in accordance with this year’s incentive program.
- The Swedish Tax Agency has published a notification on the updated acquisition cost of shares in Moberg Pharma AB after the distribution of shares in OncoZenge. Of the original acquisition cost of shares in Moberg Pharma, 88 percent represents the balance of shares in Moberg Pharma and 12 percent represents the received shares in OncoZenge.
SIGNIFICANT EVENTS AFTER THE THIRD QUARTER
- Moberg Pharma entered into collaboration with Allderma ahead of Scandinavian launch. Allderma is managed by the commercial leaders which were responsible for the successful Nordic launch of Nalox®, Moberg Pharma’s first-generation nail fungus product.
STATEMENT FROM THE CEO
The approval from the EMA’s paediatric committee in September is an important milestone towards our goal to submit a registration application for MOB-015 in Europe this year and enables us to pursue a full marketing authorization application with data exclusivity in Europe for up to 10 years after market approval. Hand in hand with registration preparations, commercialization preparations are underway, including through the collaboration with Allderma ahead of the Scandinavian launch.
With the approval of the EMA’s pediatric committee, we now have the necessary pieces in place to submit a registration application for MOB-015 in Europe for adults. We intend to submit the application through a decentralized process and are now in discussions with several regulatory authorities on the possibility of serving as a reference country and on when they can process our application based on their current workloads. Our goal to submit the application before the end of the year remains the same. As previously announced, the registration application is expected to be granted within 18 months after submission, allowing the planned launch of MOB-015 in late 2023.
The positive decision from the EMA’s pediatric committee means that Moberg Pharma will conduct a pediatric study with 30 children starting in the second half of 2022. This study does not affect the timing of the product’s approval in Europe for adults, only when the approval can be broadened to include children.
The Swedish Tax Agency has published a notification on the allocation of acquisition cost after the spin-off of BUPI through the distribution of shares in OncoZenge to Moberg Pharma’s shareholders and successful listing of OncoZenge on Nasdaq First North Growth Market earlier this year. The spin-off captures the value in the BUPI project and also had a positive effect on earnings of SEK 24 million, which is included in Moberg Pharma’s positive total profit for the period of SEK 11 million. Of the original acquisition cost of shares in Moberg Pharma, 88 percent is allocated to the remaining shares in Moberg Pharma AB and 12 percent to the distributed shares in OncoZenge AB.
In addition to the registration application in Europe, the company is preparing for the next clinical Phase 3 study for MOB-015 in North America. The purpose of the new study is to enable market approval in the U.S. and strengthen the product’s clinical data and marketing claims globally. The risk in the new study is significantly reduced through the experience gained from the previous studies and cooperation with the same CRO and lead investigator as in the previous North American study. The company intends to submit documentation on the new study to the FDA and ethical committee in the first quarter of 2022.
Ahead of the planned European launch in 2023, commercialization preparations are underway as well. Recently, a licensing agreement was signed for the Nordic market with Allderma AB, whose commercial leaders were previously responsible for the launch of Moberg Pharma’s first-generation nail fungus product, Nalox®, in the Nordic market. The new agreement entrusts Allderma with 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 at a later date to assume the license in these markets. When Nalox® was launched in Sweden, it quickly became the market leader and grew the market by 400%. We look forward to repeating this successful cooperation and see a great benefit in being directly involved in the launch of MOB-015 in our home market prior to additional launches with our partners.
We are advancing towards the company’s goal to register a new and better nail fungus product. The submission of the registration application in Europe and the start of the Phase 3 study in North America are the most important milestones in the near term.
Anna Ljung, CEO of Moberg Pharma
CONFERENCE CALL - NOVEMBER 9, 2021 at 3:00 p.m CET
CEO Anna Ljung will present the report at a telephone conference on November 9, 2021 at 3:00 p.m. CET.
Dial-in: SE: +46 8 505 583 57, U.S.: +1 646 722 4957.
ABOUT THIS INFORMATION
This information is information that Moberg Pharma AB 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 November 9, 2021.
FOR ADDITIONAL INFORMATION, PLEASE CONTACT
Anna Ljung, CEO, Phone: +46 70 766 60 30, e-mail: firstname.lastname@example.org
Mark Beveridge, CFO, Phone: +46 76 805 82 88, e-mail: email@example.com