Moberg Pharma AB Interim report January - June 2021

2021-08-10 08:00:00
SIX-MONTH PERIOD (JAN-JUN 2021)
  • EBITDA SEK -8.9 million (-9.3) *
  • Operating profit (EBIT) SEK -10.2 million (-10.5)*
  • Profit after tax SEK -8.3 million (-8.6) *
  • Total profit SEK 15.3 million (-8,6) **
  • Diluted earnings per share SEK 0.36 (-0.46) **
  • Cash and cash equivalents amounted to SEK 124.2 million (43.0)
SECOND QUARTER (APR-JUN 2021)
  • EBITDA SEK -3.5 million (-5.7) *
  • Operating profit (EBIT) SEK -4.1 million (-6.3)*
  • Profit after tax SEK -3.3 million (-5.2) *
  • Total profit SEK -3.3 million (-5.2)
  • Diluted earnings per share SEK -0.08 (-0.28)
  • Cash and cash equivalents amounted to SEK 124,2 million (43.0)

*The comparative figures refer to continuing operations
**The spin-off of BUPI resulted in a positive earnings effect of SEK 24 million, included in total profit and earnings per share for the
six-month period.

SIGNIFICANT EVENTS IN THE SECOND QUARTER
  • The results from the North American phase 3 study with MOB-015 have been published in the Journal of the American Academy of Dermatology.
  • Agneta Larhed will be the new Vice President Pharmaceutical Innovation & Development at Moberg Pharma. Dr. Larhed will join the management team in September.
  • The Annual Meeting on May 18 resolved to introduce a long-term incentive program. Nikolaj Sörensen, CEO of Orexo, joined the Board of Directors as a new member.
SIGNIFICANT EVENTS AFTER THE SECOND QUARTER
  • The total number of ordinary shares in the company increased to 45,511,425. The newly issued shares, 910,000 in total, are being held to secure the commitments in this year's incentive program.

STATEMENT FROM THE CEO

The registration preparations for MOB-015 are progressing as planned, with the goal to submit a registration application in Europe in the second half of 2021. Further discussions with regulatory authorities are scheduled this autumn and a final decision from the EMA's Paediatric Committee is expected in September, which will determine the timing for submission of the registration application.

Registration preparations in Europe are progressing with a target to submit a full application, which offers the possibility of data exclusivity for up to 10 years following market approval. This means that regulatory approval of a pediatric plan will determine when we can submit the registration application. After submitting supplementary data, a final decision is anticipated from the EMA's Paediatric Committee in September. After discussions with regulatory authorities, we see a strong likelihood that we can utilize this registration route. In the unlikely event that the authority does not approve the pediatric plan, we intend to instead submit a hybrid application, since the patent on MOB-015 is considered to provide strong protection.

As previously announced, the registration application is expected to be granted within 18 months after submission, allowing a planned launch of MOB-015 in late 2023. The primary endpoint was reached in both phase 3 studies with a total of more than 800 patients, where mycological cure was achieved in 76% of patients, which is superior to other topical treatments and on par with oral treatment, but without the risk of serious side effects. The results from the North American phase 3 study were recently published in the prestigious Journal of the American Academy of Dermatology[1]. The article concluded that "MOB-015 was effective in treating onychomycosis in patients 12 to 74 years of age. The lack of systemic absorption of MOB-015 reduces the potential for systemic AEs seen in oral terbinafine. MOB-015 has a favorable benefit-to-risk ratio, making it a consideration for the treatment of dermatophyte onychomycosis."

Moberg Pharma has an important year ahead with frequent discussions with regulatory authorities regarding the registration application. Concurrently, we have strengthened our management team with the addition of Agneta Larhed, VP Pharmaceutical Innovation & Development, who has broad experience with regulatory issues and drug development, including with the Swedish MPA, Orexo and Q-Med, and as an expert in the European Pharmacopoeia Expert Group no. 12[2].

The company is advancing as planned toward the goal to register a new drug that will offer patients in many markets a significantly better treatment alternative for nail fungus. Submission of the registration application in the second half of the year will be an important milestone.

Anna Ljung, CEO of Moberg Pharma

[1] Volume 85, Issue 1, July 2021, Pages 95-104

[2] Dosage forms and pharmaceutical technical procedures

CONFERENCE CALL - AUGUST 10, 2021 at 3.00 p.m. CET
CEO Anna Ljung will present the report at a teleconference on August 10, 2021, at 3:00 p.m. CET.
Dial in: SE: +46 8 505 58 374, US: +1 646 722 49 03 

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 August 10th, 2021.

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