STOCKHOLM, Feb. 11, 2019 /PRNewswire/ -- This year-end report 2018 is made public in advance due to the transaction press release announced earlier today regarding the divestment of Moberg Pharma's OTC-business.
PERIOD (FULL YEAR 2018)
FOURTH QUARTER (OCT-DEC 2018)
* In fixed rates excluding milestones
* Capital gains of SEK 5 million in Q2 2018 from the divestment of Balmex® and SEK 13 million in Q3 2017 of Fiber Choice®.
SIGNIFICANT EVENTS IN THE FOURTH QUARTER
SIGNIFICANT EVENTS AFTER THE END OF THE QUARTER
STATEMENT FROM THE CEO
Today we announce the divestment of Moberg Pharma's commercial business, realizing a premium value for our OTC business while indicating the significant value of MOB-015. This transformative event is the result of great work by our team over the past years, all leading up to the strong progress in 2018 when EBITDA exceeded 100 MSEK for the first time. As for MOB-015, patient screening for the European Phase 3 study was recently finalized along with the second major license agreement, for Europe, marking the start of a very exciting year for our main pipeline asset.
Continued momentum in the commercial operations
U.S. sales were strong in the fourth quarter, contributing to double-digit growth for the full year. Our three major brands ? Kerasal Nail®, Dermoplast® and New Skin® ? strengthened their category leading positions, behind execution of the brand-specific growth plans. Kerasal Nail® in particular, stands out with a third consecutive year of double-digit growth in the U.S. and in 2018 became ranked as the #1 individual product, in the nail fungus segment as well as in the entire Foot Care category. The entire portfolio continues to benefit from successful positioning, compelling advertising and optimization of marketing investment. This spring we are launching a number of initiatives to further progress the growth plan of the business.
Distributor sales adjusted for milestone payments also grew in the fourth quarter, in line with our stabilization plan, and for the full year were at the level of the previous year. We have submitted an application on Emtrix® registration in Russia and are preparing for an initial launch in the Middle East/Africa region.
Overall, our strategy to streamline the portfolio and focus on the key brands has resulted in healthy organic growth as well as increased profitability. Adjusted for items affecting comparability, net sales increased by 16% for the full year. EBITDA increased by 15% to the equivalent of SEK 102 million (89) and the gross margin rose to 76% (71). With an EBITDA margin of 23% for 2018, we are approaching the company's long-term profitability goal.
Today, Moberg Pharma entered into an agreement with RoundTable Healthcare Partners and Signet Healthcare Partners to divest the entire commercial operation and realize the value that we have created in this business over the past years. Additional details on the transaction are available in today's press release, which also is enclosed to this year-end report.
Important milestones for the pipeline
In the beginning of 2019, screening of patients to the European Phase 3 study for MOB-015 was finalized and we expect randomization to be completed during the first quarter of 2019. This means we can expect topline results for the U.S. Phase 3 study in late 2019 and corresponding results from the European Phase 3 study in the second quarter of 2020.
Commercialization preparations are underway in several territories. A milestone was reached in November when we were granted a patent for MOB-015 in China, which means that the product is now protected in all major markets, including the EU, U.S, Canada and Japan. After last fall's license agreement with Cipher Pharmaceuticals in Canada, we recently signed another significant license agreement, this time with the Consumer Health division of Bayer, a world leader in OTC antifungal treatments. The agreement with Bayer covers commercialization in Europe and can bring up to EUR 50 million in total milestone payments, including EUR 1.5 million paid at signing, as well as supply fees and royalties for delivered products. Naturally, we are very proud of this progress. We look forward to further development and intend in the year ahead to focus the company's development resources on MOB-015.
An exciting year
Our decision to divest the commercial business is transformational for Moberg Pharma and enables shareholders to recognize a compelling value for both components of our business. The upfront cash consideration of USD 155 million offers near-term liquidity and the incremental consideration of USD 5 million provides continued funding for MOB-015 at an attractive implied value. Overall, we are very excited with the outcome and look forward to continuing to create value for the shareholders of Moberg Pharma with a more focused strategy. The upcoming year will be pivotal for the company, with Phase 3 data for MOB-015 in North America expected in the fourth quarter and progressing commercialization plans with current and future partners.
Peter Wolpert, CEO Moberg Pharma
 Note that nonrecurring sales amounted to SEK 1.3 million in Q4 18, compared to SEK 8.0 million in Q4 17.
 In fixed currency adjusted for milestone revenues.
PRESS CONFERENCE AND CONFERENCE CALL, FEBRUARY 12, 2019
Press Conference: 9:00 a.m., at Gernandt & Danielsson Advokatbyrå, Hamngatan 2, Stockholm. Dial-in: SE +46 8 566 427 03; US: +1 646 722 4957
Telephone conference : 3:00 p.m. Telephone: SE +46-8-505 583 53, US +1 646 722 49 57
ABOUT THIS INFORMATION
This information is information that Moberg Pharma AB is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication, through the agency of the contact person set out above on February 11th, 2019.
FOR ADDITIONAL INFORMATION, PLEASE CONTACT:
Peter Wolpert, CEO, Phone: +46 707 35 71 35, US +1 908 432 22 03, E-mail: firstname.lastname@example.org
Mark Beveridge, VP Finance, Phone: + 46 76 805 82 88, e-post: email@example.com
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The following files are available for download:
Moberg Pharma AB Year-end report 2018
SOURCE Moberg Pharma
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