Moberg Pharma´s interim report January - June 2024

TERCLARA IS THE MARKET LEADER IN SWEDEN

SIX-MONTH PERIOD (JAN-JUNE 2024)

• Net revenue SEK 4.9 million (0)
• EBITDA SEK -12.7 million (-10.7)
• Operating profit (EBIT) SEK -13.4 million (-12.0)
• Profit for the period SEK -10.5 million (-8.9)
• Diluted earnings per share SEK -0.36 (-0.90)
• Cash and cash equivalents amounted to SEK 326.0 million (52.0)

SECOND QUARTER (APR-JUN 2024)

• Net revenue SEK 4.1 million (0)
• EBITDA SEK -5.2 million (-4.7)
• Operating profit (EBIT) SEK -5.5 million (-5.3)
• Profit for the period SEK -4.0 million (-3.9)
• Diluted earnings per share SEK -0.13 (-0.39)
• Cash and cash equivalents amounted to SEK 326.0 million (52.0)

SIGNIFICANT EVENTS IN THE SECOND QUARTER

• Television advertising started on April 1 and Terclara® became the market leader in Sweden in April, the first full launch month for the product. Terclara® has subsequently maintained its market-leading position both in terms of value and number of units sold.
• National approvals have been received in the following countries: Belgium, Italy and the Netherlands. In all three countries MOB-015 has been approved for OTC use. MOB-015 has thereby received national approval for all countries included in the decentralized procedure.
• An application to include the intended terbinafine supplier in the company’s registration file for MOB-015 has been submitted. Approval is expected before the end of the year. The company has also had MOB-015 produced using an alternative terbinafine manufacturer, and stability studies from this production are currently ongoing.
• The Annual General Meeting on May 14 resolved to among other things to introduce a long-term incentive program. Jonas Ekblom was elected as a new member of the Board of Directors.
• Moberg Pharma received proceeds of SEK 336 million through the exercise of series 2023:1 warrants (TO 2) and implemented a directed issue of ordinary shares to top guarantors - the subscription rate in TO 2 was 98%.

SIGNIFICANT EVENTS AFTER THE QUARTER

• No significant events

STATEMENTS FROM THE CEO

We can look back at a successful launch in Sweden, where Terclara® has quickly become established as the market leader and is now available at all Swedish pharmacy chains. Terclara® became the market leader already in April, the first month with consumer marketing, and has since maintained its market-leading position in terms of both value and number of units sold.

For the quarter as a whole, we reached a market share of 39% in value and 34% in units in pharmacy sales to consumers.[1] Furthermore, the product is now available at a majority of Swedish pharmacies and through all pharmacy chains in Sweden. We are also seeing the category as a whole grow with 46%, in line with our assumption that many people previously chose not to treat their nail fungus due to a lack of suitable treatment alternatives.

Manufacturing to Meet Demand
The success in sales has led us to bring forward the next planned production, which was completed in July. This ensures a continued well-stocked inventory for the Swedish market. Our previous analysis remains unchanged; we have secured sufficient terbinafine (the active substance in Terclara®) to meet the Swedish market’s demand until a new supplier is in place. In April, we submitted an application to the Medical Products Agency to add a new terbinafine supplier for MOB-015, with approval expected before year-end. Moreover, we have had MOB-015 manufactured using material from another terbinafine supplier, and stability studies from this production are ongoing with the goal of adding this manufacturer as well. Consequently, we have two parallel tracks and are continuing to deliver as planned to ensure a stable long-term supply of terbinafine ahead of the planned pan-European rollout.

National Approval in All 13 Countries
The launch in Sweden and the learnings it has given us are an important part of the preparations ahead of the upcoming pan-European launch. Another significant element is the regulatory work, and during the quarter the series of national approvals was completed, with the last country approving the product in May. MOB-015 has thereby received national approval in all 13 European countries included in the decentralized procedure.

Preparations for Phase 3 Results in the U.S.
The North American study is progressing according to plan and during the summer we completed a “soft lock”[2] to minimize the time to topline results. The code will be broken and the study will be unblinded after the fungal culture from the last patient’s final visit has been analyzed, and we expect topline results in January 2025. In anticipation of these data, we are intensifying our business development activities and participated in the BIO International Convention in June together with Back Bay Life Science Advisors. This marked the start of our process to find the right partners for prioritized markets, and our intention is to enter into such collaborations after topline data has been released. 

Strengthened Cash Position and Shareholder Base
When we designed the oversubscribed units issuance (consisting of shares and warrants TO 2) last summer, the intention was to raise approximately SEK 200 million, half of which through TO 2 warrants. The outcome of TO 2, with a subscription rate was 98%, where the company raised a total of SEK 336 million through TO 2 and a directed issue to top guarantors, is a demonstration of strength that is expected to support growth and shareholder value. TO 2 has also provided an opportunity to further strengthen our shareholder base.

Clear Focus Going Forward
With a successful funding round behind us and good progress in our key activities in the near term – the North American study, long-term terbinafine access and rollout of Terclara® in Sweden – we now look forward to focusing on the most value-driving activities in the company, preparations for the upcoming pan-European launch and commercialization in the U.S. The aim of the Swedish launch was to achieve a market-leading position, which has already been accomplished. This success reaffirms our strategy and gives us a solid foundation to build on as we prepare to expand into new markets.

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 August 13th, 2024.

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

Tags: