Moberg Pharmas Year-end report 2020

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Feb 09, 2021, 02:13 ET

STOCKHOLM, Feb. 9, 2021 /PRNewswire/ --

Financing for both MOB-015 and BUPI

PERIOD (JUL 2019-DEC 2020)

Net revenue SEK 50.5 million (15.6) *
EBITDA SEK 19.8 million (-1.7) *
Operating profit (EBIT) SEK 16.0 million (-3.0) *
Profit after tax SEK 10.2 million (-3.8) *
Total profit SEK 8.6 million (499.4)
Diluted earnings per share SEK 0.54 (-0.21) *
Cash and cash equivalents amounted to SEK 29.3 million (919.1)

Comparative figures for the period refer to January 2019 - June 2019 (Note: 18 months vs. 6 months due to shortened fiscal year)

SIXTH QUARTER (OCT-DEC 2020)

Net revenue SEK 0.0 million (0.0) *
EBITDA SEK -5.3 million (-8.1) *
Operating profit (EBIT) SEK -6.0 million (-8.8) *
Profit after tax SEK -5.7 million (-7.3) *
Total profit SEK -6.7 million (-5.1)
Diluted earnings per share SEK -0.30 (-0.43) *
Cash and cash equivalents amounted to SEK 29.3 million (919.1)

Comparative figures for the sixth quarter refer to April 2019 - June 2019. Note that the rights issue of 150 million SEK was completed in January 2021, after the end of the reporting period

* All comparative figures refer to continuing operations

SIGNIFICANT EVENTS IN THE SIXTH QUARTER (OCT-DEC 2020)

Moberg Pharma announced its intention to submit a registration application for MOB-015 in Europe in 2021. With a normal processing time of about 1.5 years, approval is expected in early 2023 and launch in Europe by the end of 2023.
In November, the company's Board of Directors resolved to carry out a fully guaranteed rights issue of approximately SEK 150 million for further financing of MOB-015. The rights issue was approved by the Extraordinary General Meeting in December and was fully subscribed without issue guarantees. The issue provided Moberg Pharma with proceeds of approximately SEK 150 million before transaction costs.
The BUPI project was placed in the subsidiary OncoZenge AB, which is now distributed to Moberg Pharma's shareholders and, as planned, will be separately listed on Nasdaq First North Growth Market in February 2021. OncoZenge has implemented a directed share issue of SEK 10 million and received binding commitments for a fully guaranteed rights issue of approximately SEK 60 million. The investors, including John Fällström, Linc AB and Moberg Pharma's largest shareholder, Östersjöstiftelsen, subscribed for shares in the directed issue, entered into subscription commitments and guarantee the remainder of the rights issue in OncoZenge.

SIGNIFICANT EVENTS AFTER THE END OF THE SIXTH QUARTER

OncoZenge was granted a new European patent for BUPI. The patent provides broad protection for sustained-release lozenges containing bupivacaine, for treatment or alleviation of pain in the oral cavity and is based on a previously granted patent that specifically protects the use of lozenges for treatment of pain due to oral mucositis in cancer patients.
February 5^th was the record date for the Lex Asea distribution of OncoZenge shares. For every ten ordinary shares in Moberg Pharma on the record date of the distribution, shareholders are entitled to one share in OncoZenge

STATEMENTS FROM THE CEO

In December, a rights issue was fully subscribed which meant that no issue guarantees had to be used. The proceeds of SEK 150 million secure the financing for registration activities as well as clinical work for MOB-015. The path forward is clear, with submission of a registration application in Europe in the second half of 2021 as the next step. Concurrently, we are spinning off and separately listing the BUPI project through the subsidiary OncoZenge AB, with secured financing of SEK 70 million and a first day of trading on Nasdaq First North Growth Market on February 12.

Moberg Pharma's primary asset is MOB-015, where preparations are underway for registration in Europe, based on two large Phase 3 studies totaling more than 800 patients. Since the primary endpoint was met in both the North American and European studies, both studies are expected to be used as a basis for product registration in Europe. Our plan is to submit a registration application in Europe in the second half of 2021, after which we expect the application to be approved within 18 months, indicating that MOB-015 could be launched in Europe by the end of 2023. For the U.S., we intend to discuss the next step in an advice meeting with the FDA after pre-submission meetings have been completed with regulatory authorities in the EU, with the assumption that an additional study may be needed for registration in the U.S.

For the commercialization of MOB-015, Moberg Pharma plans to drive the promotion of MOB-015 in the U.S. - the largest and most important market - to be able to share best practices with our partners. We know this market well after having taken Kerasal Nail® from launch to a leading position with 30% market share in the U.S. We made Kerasal Nail® available in more than 30,000 U.S. stores and achieved broad reach, thanks to effective consumer marketing and excellent partners in logistics and sales. With a prescription product we will focus on the largest segment, podiatrists, who fill approximately 40% of the prescriptions, and will collaborate with partners and distributors to reach dermatologists and general practitioners. Our experience of DTC marketing to U.S. consumers in the nail fungus category is a significant advantage.

Prior to year-end, the BUPI project was placed in the subsidiary OncoZenge AB with a separate listing on Nasdaq First North Growth Market planned in February. The spin-off into a separate company ensures focus and offers an opportunity to develop the product's full potential and create significant value for our shareholders. OncoZenge completed a directed issue in December which secured the working capital requirement for 2021 and bolstered the shareholder base with respected shareholders, such as John Fällström and Linc AB. In addition, a new patent was recently granted which substantially broadens intellectual property rights for BUPI in Europe, where it protects the use of BUPI within all relevant indications for oral pain relief. The next step in the spin-off of OncoZenge is ongoing. Moberg Pharma's shares in OncoZenge are distributed to Moberg Pharma's shareholders according to Lex ASEA rules, where shareholders who owned shares on February 5 receive one share in OncoZenge for every ten ordinary shares they own in Moberg Pharma.

All in all, I am very satisfied that the financing has been secured for both companies and that spin-off of OncoZenge soon will be completed. Both teams are now well-positioned to fully focus on achieving our business goals.

Anna Ljung, CEO of Moberg Pharma

CONFERENCE CALL - February 9, 2021 at 3:00 p.m. CET
CEO Anna Ljung will present the report at a telephone conference on February 9, 2021 at 3:00 p.m. CET.
Dial in: SE: +46 8 505 583 53, US: +1 833 249 84 04

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 February 9th, 2021

FOR ADDITIONAL INFORMATION
Anna Ljung, CEO, Phone: +46 70 766 60 30, e-mail: [email protected]
Mark Beveridge, VP Finance, Phone: +46 76 805 82 88, e-mail: [email protected]

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Moberg Pharmas Year-end report 2020

SOURCE Moberg Pharma