Moberg Pharma´s interim report January - June 2022

ANOTHER AGREEMENT IN PLACE AND PATIENT ENROLLMENT ONGOING IN THE NORTH AMERICAN PHASE 3 STUDY

SIX MONTH PERIOD (JAN-JUN 2022)

• EBITDA SEK -9.1 million (-8.9) *
• Operating profit (EBIT) SEK -10.4 million (-10.2) *
• Profit after tax SEK -8.3 million (-8.3) *
• Total profit SEK -8.3 million (15.3) **
• Diluted earnings per share SEK -0.13 (0.36)
• Cash and cash equivalents amounted to SEK 160.0 million (124.2)

SECOND QUARTER (APR-JUN 2022)

• EBITDA SEK -4.3 million (-3.5) *
• Operating profit (EBIT) SEK -4.9 million (-4.1) *
• Profit after tax SEK -3.9 million (-3.3) *
• Total profit SEK -3.9 million (-3.3)
• Diluted earnings per share SEK -0.06 (-0.08)
• Cash and cash equivalents amounted to SEK 160.0 million (124.2)

* All comparative figures refer to continuing operations
** Note that the spin-off of BUPI in 2021 resulted in a positive earnings effect of SEK 24 million, which affects total profit and earnings per share in the comparable figures

SIGNIFICANT EVENTS IN THE SECOND QUARTER

• In April, the Board of Directors resolved to carry out a fully guaranteed issue of new ordinary shares with preferential rights for existing shareholders. The Board also resolved on a directed issue to guarantors in the rights issue. The Board’s decision on the rights issue was approved by the Extraordinary General Meeting on May 3, 2022. Moberg Pharma thereby received approximately SEK 121 million before transaction costs. The net proceeds will be used for registration activities and clinical work for MOB-015.
• Enrollment of patients has begun for the Phase 3 study for MOB-015. The randomized, vehicle-controlled, multicenter Phase 3 study will include approximately 350 patients in North America.
• The Annual General Meeting on May 18 resolved, among other things, to implement a long-term incentive program. The purpose of the newly issued shares, 1,125,000 in total, is to secure fulfillment of the commitments under this year’s incentive program.
• The total number of ordinary shares in the company increased to 100,859,335, including 52,516,260 ordinary shares through registration of the rights issue, 536,952 ordinary shares in the directed issue to guarantors in the rights issue and 1,125,000 shares through the issuance of class C shares.

SIGNIFICANT EVENTS AFTER THE SECOND QUARTER

• In August, a distribution agreement was signed with Padagis for MOB-015 in Israel. Padagis will conduct registration activities in Israel, and will be marketing, distributing and selling MOB-015 in Israel and the Palestinian territories upon completion of registration.

STATEMENT OF THE CEO

Patients are now being enrolled in the new North American Phase 3 study, which is fully financed thanks to the rights issue carried out in the quarter. Concurrently, the registration process is now underway for MOB-015 in Europe, where the company submitted a registration application in March of this year and expects an approval and launch next year.

Moberg Pharma has submitted a registration application in Europe through the decentralized process, with the Medical Products Agency in Sweden as the reference member state for the application. Moberg Pharma has submitted a full application, which offers the possibility of data exclusivity in Europe for up to 10 years following market approval. Our goal is to receive the first market approval and launch MOB-015 in 2023.
The war in Ukraine has unleashed turbulence in the market, and the global economy has been hurt by increased inflation and higher interest rates. We have no direct exposure to Ukraine or Russia, have no debt financing and benefit from operating in a relatively stable industry with underlying, demographically driven demand. The rights issue carried out in May provided the company with SEK 121 million before transaction costs and means that the new North American Phase 3 study is fully financed, which gives us the opportunity to capture the full potential of MOB-015.
Patient recruitment is now fully underway for the North American Phase 3 study and the first patients were enrolled in May. The randomized, vehicle-controlled, multicenter Phase 3 study will enroll a total of 350 patients in the U.S. and Canada. The patients will be evaluated over 52 weeks and the primary endpoint will be the proportion of subjects achieving complete cure of their target nail. The study design builds on the experience gained from the previous Phase 3 studies and Moberg Pharma is cooperating with the same CRO, same lead investigator and high-performance clinics from the previous North American study. The purpose of the new study is to facilitate market approval in the U.S. as well as strengthen the product’s clinical evidence and marketing claims globally.

The company just recently signed a new distribution agreement, this time with Padagis for Israel, to complement the five commercial agreements we already have in place. The agreement gives Padagis exclusive rights to market and sell MOB-015 in Israel and the Palestinian territories, while Moberg Pharma assumes production and supply responsibility.
Moberg Pharma is progressing towards its goal to create the future market leader in nail fungus. In 2022, the company made important progress in our three critical activities: the registration process, the clinical study and the preparations together with our partners prior to launch 2023.

Anna Ljung, CEO of Moberg Pharma