Moberg Pharma AB Year-end report January - June 2019

EXECUTING ACCORDING TO PLAN WITH FOCUS ON MOB-015

PERIOD (JAN-JUN 2019)

  • Net profit after tax SEK 558.8 million (6.7)
  • Total profit for the period SEK 499.4 million (27.3)
  • Diluted earnings per share SEK 31.35 (0.38)
  • Net revenue SEK 15.6 million (0.0) *
  • EBITDA SEK -3.0 million (-21.0) *
  • Operating profit (EBIT) SEK -4.2 million (-21.1) *
  • Cash and cash equivalents amounted to SEK 919.1 million (122.2)

SECOND QUARTER (APR-JUN 2019)

  • Net profit after tax SEK -5.1 million (4.7)
  • Total profit for the period SEK -5.1 million (21.7)
  • Diluted earnings per share SEK -0.28 (0.27)
  • Net revenue SEK 0 million (0.0) *
  • EBITDA SEK -8.5 million (-11.1) *
  • Operating profit (EBIT) SEK -9.2 million (-11.1) *
  • Cash and cash equivalents amounted to SEK 919.1 million (122.2)

* from continuing operations

 The Extraordinary General Meeting on March 15 resolved to convert the company’s financial year from the calendar year to a fiscal year, July 1 – June 30. This year-end report covers the abbreviated fiscal year from January 1 to June 30, 2019.

The Board of Directors intends to propose a payment to the shareholders of tentatively SEK 43–45 per share by way of an automatic share redemption procedure following the Annual General Meeting on 30 October 2019.

SIGNIFICANT EVENTS IN THE SECOND QUARTER

  • On April 1, 2019, Moberg Pharma gave notice of early redemption of all outstanding bonds at an amount equal to 104 percent of the nominal amount. The bond loan, plus interest, was repaid in its entirety on April 29.
  • In connection with the Annual General Meeting on May 15, Peter Wolpert was elected as a new Board member and Executive Chairman of the Board of Directors. The Annual General Meeting also elected Fredrik Granström as a new Board member and resolved to re-elect Board members Mattias Klintemar and Andrew B. Hochman.
  • In direct connection with the Annual General Meeting, the Board of Directors resolved to appoint Anna Ljung as the new Chief Executive Officer of the company.
  • After being granted authorization by the Annual General Meeting, the Board of Directors implemented on June 28 a transfer of a total of 42,090 of the company’s own ordinary shares on Nasdaq Stockholm to cover certain costs, mainly social security costs, related to previous incentive programs.

SIGNIFICANT EVENTS AFTER THE END OF THE SECOND QUARTER

  • During July 2019, the exercise of warrants under Moberg Pharma's share-based compensation plan increased the number of shares with 488 905 ordinary shares.

STATEMENT FROM THE CEO

After the successful divestment of the OTC portfolio and the following organizational changes, focus now lies on our pipeline projects and the topline results of the Phase 3 study in North America are expected before year end. The business is progressing as planned with a focus on the Phase 3 studies for MOB-015, further commercialization preparations and preparations for the share redemption in November 2019.

I have worked at Moberg Pharma since the start in 2006. It is a privilege to take over the role of CEO for such a well-managed company and I look forward to further developing the business together with our skilled employees. We have an exciting period ahead of us with a focus on the pipeline projects MOB-015 and BUPI, whose combined potential is much greater than the divested business. At my side I have an outstanding management team, and together we have extensive experience from the company and the industry. We have also recently been joined by Dr. Amir Tavakkol, who brings unique experience in the development and registration of onychomycosis drugs in the US. In addition, we are fortunate to retain Peter Wolpert close to the business in the role of Executive Chairman who will focus on business development.

The company’s resources are focused mainly on MOB-015, where our work is progressing as planned with an emphasis on the two clinical Phase 3 studies and continuing business development. More than 95% of patients have now completed the US study, and we expect topline results in December. In the European study, the corresponding figure right now is around 60%, with topline results expected in the second quarter of 2020.

We aim to repeat the journey we took with Kerasal Nail®, where we combined direct sales in the US with collaborations with market-leading partners in major regions. The agreements for Canada with Cipher Pharmaceuticals and for Europe with the Consumer Health division of Bayer AG, a world leader in OTC fungus treatments with the brand Canesten, is in line with this strategy and means that strong partners are already in place for important regions. Moberg Pharma is conducting the clinical programs and registration, as well as manufacturing the product, while our partners are responsible for distribution and marketing.

In the US, the emphasis this time is on the considerably larger prescription market for nail fungus treatments. We see a very interesting opportunity to build our own commercial platform to target podiatrists, with MOB-015 as our main product and a portfolio of additional niche products. Also, we intend to collaborate with a US partner that already has an established sales force targeting dermatologists.

We look forward to the major milestones in the second half of the year, with the share repurchase and results of the Phase 3 study for MOB-015 in North America in parallel with the continuation of the Phase 3 study in Europe and preparations for commercialization. With the data we are hoping for, we will be able to offer patients who currently lack safe and efficacious treatment alternatives the market’s best topical product.

The second quarter involved transition activities related to the OTC business, a process that generates one-off revenue and where most of the activities have now been completed. The company’s previous bond loan, plus interest, was repaid in its entirety on April 29. The Annual General Meeting for the abbreviated fiscal year January – June 2019 is scheduled for October 30 and will focus on the shareholder distribution, which is estimated at SEK 43–45 per share and is expected to be paid through a share redemption in November 2019.

With SEK 919 million in cash reserves as at June 30, the company has sufficient funds to implement the share redemption as planned and 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

CONFERENCE CALL
CEO Anna Ljung will present the report at a telephone conference today on August 29, 2019 at 3:00 p.m. CET. Dial-in: SE: +46 8 566 427 07, US: +1 833 823 05 87

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 persons set out below, at 8.00 a.m. CET on August 29th, 2019

FOR ADDITIONAL INFORMATION, PLEASE CONTACT:
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

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About Us

Moberg Pharma AB (publ) is a Swedish pharmaceutical company focused on commercializing proprietary innovations based on drug delivery of proven compounds. The company’s main asset, MOB-015, is a novel topical treatment for onychomycosis, for which phase 3 data in more than 800 patients is expected in late 2019 in North America and the first half of 2020 in Europe. The pipeline also includes the late-stage asset BUPI for pain relief in oral mucositis. Clinical data generated for both assets indicate they have the potential to become market leaders in their respective niches. Moberg Pharma is headquartered in Stockholm and the company’s shares are listed on the Small Cap list of the NASDAQ OMX Nordic Exchange Stockholm (OMX: MOB).

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Quotes

After the successful divestment of the OTC portfolio, the business is progressing as planned with a focus on the Phase 3 studies for MOB-015, further commercialization preparations and preparations for the share redemption in November 2019
Anna Ljung, CEO of Moberg Pharma