11/19/2019 | Press release | Distributed by Public on 11/19/2019 01:23
FIRST QUARTER (JUL-SEP 2019)
* All comparative figures refer to continuing operations
The Annual General Meeting on October 30 has resolved to convert the company's financial year from a fiscal year to the calendar year, July 1, 2019 - December 31, 2020. This interim report therefore covers the first quarter of the extended fiscal year from July 1, 2019.
SIGNIFICANT EVENTS IN THE FIRST QUARTER
SIGNIFICANT EVENTS AFTER THE END OF THE FIRST QUARTER
STATEMENT FROM THE CEO
The Phase 3 program for MOB-015 is on schedule. We expect data from the North American study in December, followed by data from the European study in the second quarter of 2020. At the same time, the commercialization preparations for MOB-015 are underway and license agreements have now been signed for more key markets, most recently Japan and the Republic of Korea, to complement previous agreements in Europe and Canada.
The work on MOB-015 is progressing as planned with a focus on the two clinical Phase 3 studies and continued commercialization preparations. All the patients in North America have completed the study and we are expecting the data in December. In Europe, around 70% of patients have now completed the study, with the data expected in the second quarter of 2020. The Phase 3 program comprises a total of 817 patients, including 365 patients randomized at 32 clinics in the US and Canada as well as 452 patients in Europe.
In September, Moberg Pharma signed a license agreement granting Taisho Pharmaceutical exclusive rights to MOB-015 in Japan, a market that in 2018 amounted to USD 290 million with annual growth of more than 8%. Moberg Pharma will provide know-how and documentation from the international development program for MOB-015, and after completion of registration will be responsible for production, while Taisho will fund development and registration activities in Japan and take responsibility for marketing, distribution and sales. Moberg Pharma is eligible to receive up to USD 50 million in milestone payments, including USD 5 million paid at signing. The majority of the milestone payments are contingent on sales targets, with the balance contingent on development and regulatory milestones. Moberg Pharma will also receive supply fees including royalties.
In October, a distribution agreement for MOB-015 was signed in the Republic of Korea, this time with DongKoo, the market leader in dermatology, with excellent coverage of dermatology clinics. The Korean market for topical drugs for onychomycosis amounts to USD 40 million, and over 90% of prescriptions are written by the clinics. The agreement gives DongKoo exclusive rights to market and sell MOB-015 in the Republic of Korea. Moberg Pharma assumes production and supply responsibility.
This means that two more agreements for MOB-015 are in place in addition to the previous agreements with Cipher Pharmaceuticals for Canada and the Consumer Health division of Bayer AG, a world leader in OTC fungus treatments with the brand Canesten, for Europe. The aim is to repeat the journey we took with Kerasal Nail®, where we combined direct sales in the US with strategic collaborations in a number of major regions. The most important markets for MOB-015 are expected to the US, the EU, Japan, Canada and China, all with patent protection until 2032.
With regard to our other drug candidate, BUPI, discussions are underway with potential new partners in North America and Europe.
On October 30, the Annual General Meeting resolved in accordance with the Board of Directors' proposal on an extraordinary distribution to the shareholders of SEK 46.50 per share through a share redemption in November 2019. With SEK 893 million in cash reserves as at September 30, the company has sufficient funds to implement the share redemption as planned and to finalize the clinical program for MOB‐015. Moberg Pharma 2.0 remains fully dedicated to the goal of creating the future market leader in the treatment of nail fungus.
Anna Ljung, CEO of Moberg Pharma
CEO Anna Ljung will present the report at a telephone conference on November 19, 2019 at 3:00 p.m. CET.
Dial-in: SE: +46 8 566 427 04, US: +1 833 526 683 98
ABOUT THIS INFORMATION
Moberg Pharma discloses this information pursuant to the Swedish Securities Markets Act and/or the Financial Instruments Trading Act. The information was submitted for publication, through the agency of the contact person set out below, at 8.00 a.m. (CET) on November 19th 2019