Extended Fiscal Year July 2019 - December 2020 Interim Report January - March 2020
The agreement enables Moberg Pharma to conduct an additional clinical study, depending on the outcome of the EU study.
STOCKHOLM, May 12, 2020 /PRNewswire/ -- FINANCING AGREEMENT OF UP TO SEK 216 MILLION
PERIOD (JUL 2019-MAR 2020)
- Net revenue SEK 50.5 million (15.6) *
- EBITDA SEK 34.6 million (-3.0) *
- Operating profit (EBIT) SEK 32.7 million (-4.2) *
- Profit after tax SEK 25.3 million (-4.7) *
- Comprehensive income SEK 25.3 million (499.4)
- Diluted earnings per share SEK 1.35 (-0.27) *
- Cash and cash equivalents amounted to SEK 51.6 million (919.1)
Comparative figures for the period refer to January 2019 - June 2019 (Note: 9 months vs. 6 months due to shortened financial year)
* All comparative figures refer to continuing operations
THIRD QUARTER (JAN-MAR 2020)
Net revenue SEK 0.0 million (15.6) *
- EBITDA SEK -3.6 million (7.3) *
- Operating profit (EBIT) SEK -4.2 million (5.0) *
- Profit after tax SEK -3.4 million (2.9) *
- Comprehensive income SEK -3.4 million (504.5)
- Diluted earnings per share SEK -0.18 (0.26) *
- Cash and cash equivalents amounted to SEK 51.6 million (1,596.9)
Comparative figures for the third quarter refer to January 2019 - March 2019
SIGNIFICANT EVENTS IN THE THIRD QUARTER (JAN-MAR 2020)
- All patients in the ongoing European MOB-015 study completed their last visit in the study. The data collection was completed without any negative impact from COVID-19. The timeline remains unchanged with topline results expected by the end of Q2 2020.
- Moberg Pharma entered into a convertible note agreement with Nice & Green S.A. of up to SEK 216 million for further investments in MOB-015. The agreement enables Moberg Pharma to conduct an additional clinical study, depending on the outcome of the EU study.
- The expert evaluation confirmed the validity of the results of the phase 3 study in North America, including:
- i) treatment with MOB-015 results in a mycological cure that compares favorably with oral antifungal drugs with the added advantage of an earlier onset of action;
- ii) the proprietary vehicle technology increases the hydration and permeability of the nail plate, enabling efficient terbinafine delivery, but it also confounds the assessment of clinical cure and complete cure
- iii) a likely solution to the problem - a shorter dosing regimen with the potential to deliver superior complete cure rates at 52 weeks.
- The Swedish Tax Agency declared that for the redemption of shares in Moberg Pharma for cash proceeds of SEK 46.50 per share, 60 percent the original acquisition cost will represent the redemption shares and 40 percent the remaining ordinary shares.
SIGNIFICANT EVENTS AFTER THE END OF THE THIRD QUARTER
- An Extraordinary General Meeting on May 28 resolved, among other things, to authorize the Board of Directors to resolve to issue convertibles and to introduce a long-term incentive program.
- To date, Moberg Pharma's operation have not been significantly impacted by COVID-19.
STATEMENT FROM THE CEO
In December 2019, Moberg Pharma reported that the primary endpoint for MOB-015 had been met in the North American phase 3 study. The evaluation of the study results showed that the rapid and high cure rate for MOB-015 is world leading, but that the dosing regimen can be optimized. Based on these data, MOB-015 has the potential to become the future market leader in onychomycosis. The financing agreement signed in March of up to SEK 216 million enables Moberg Pharma to exploit this potential and conduct an additional clinical study, depending on the outcome of the EU study expected by the end of Q2 2020.
EXPERT EVALUATION CONFIRMS THE VALIDITY OF THE RESULTS OF THE NORTH AMERICAN STUDY
The North American study was conducted at 32 clinics in the U.S. and Canada and included a total of 365 patients, 246 of whom received MOB-015 and 119 patients in a control group received the vehicle. The results of the study were surprising because the high mycological cure was not followed by a correspondingly high complete cure rate.
The expert evaluation in January of this year clarified the discrepancy and confirmed the validity of the results of the phase 3 study in North America, including:
i) treatment with MOB-015 results in a mycological cure rate of 70 percent, which is substantially higher than reported for other topical treatments and compares favorably with oral antifungal drugs with the added advantage of an earlier onset of action;
ii) the proprietary vehicle technology increases the hydration and permeability of the nail plate, enabling efficient terbinafine delivery, but it also confounds the assessment of clinical cure and complete cure, since its hydrating properties also cause temporary whitening/discoloration in the nail
iii) a likely solution to the problem - a shorter dosing regimen with the potential to deliver superior complete cure rates at 52 weeks. A higher complete cure rate can probably be obtained with a shorter dosing regimen followed by maintenance dosing. This should maintain sufficiently high concentrations of terbinafine in the tissue, while allowing the hydration of the nail plate to normalize.
From a medical and commercial perspective, a regimen with daily dosing for up to three months followed by less frequent treatment is highly attractive and further improves the target product profile of MOB-015. This is further supported by U.S. market data indicating that real-life usage of current topicals on average is 3-4 months, despite being labeled for 48 weeks' daily treatment. The improved product profile with a shorter treatment period offers key competitive advantages versus oral terbinafine; if MOB-015 can show the same mycological cure rate as the oral treatment and can show a high complete cure rate, there is no medical reason to choose oral rather than topical treatment.
ALL PATIENTS HAVE COMPLETED THEIR LAST VISIT IN STUDY DESPITE COVID-19
We are now in the final phase of the European study and all patient visits have been completed without any negative impact from COVID-19 in Europe, thanks in large part to the intensive work by our medical team and our CRO partner. In the European study, 452 patients were initially randomized and 379 patients completed the study, a drop-out rate of only 16 percent. All planned patient visits were completed despite the current COVID-19 situation in Europe. After the patients completed their last visit, nail samples were sent to a central lab for mycological testing. Data base lock and statistical analysis are on schedule and will be completed by the CRO partner. The timeline remains unchanged and we expect the topline results from the study by the end of the second quarter of 2020.
FINANCING AGREEMENT OF UP TO SEK 216 MILLION FOR FURTHER INVESTMENTS IN MOB-015In March, the company entered into a convertible note agreement with Nice & Green S.A., which has committed to subscribe for convertible notes with a nominal value of up to SEK 216 million, in tranches of initially SEK 3 million per month for the first six months and thereafter, depending on market conditions, with possibility to increase to SEK 6 million per month. According to the agreement, Moberg Pharma has only committed to draw the first two tranches and can then decide if and when the remaining tranches will be drawn. This financing can cover the company's capital requirements to product registration following a positive outcome in the European phase 3 study and can secure financing for an additional study if needed before registration. The agreement provides Moberg Pharma access to flexible financing at a reasonable cost under current market conditions. The financing solution does not preclude other financing solutions, contains a profit sharing program and does not entail any fixed costs. As part of the agreement, Nice & Green will introduce Moberg Pharma to its wide network of biotech investors in Switzerland, Germany and France.
CLEAR PLAN TO CREATE THE FUTURE MARKET LEADER
To fully capitalize on MOB-015's potential, the advantages of a shorter treatment period will have to be documented in another study. The timing of such a study depends on whether the outcome of the EU study provides a basis for product registration. We and our commercial partners look forward to the topline data from the EU study by the end of the second quarter 2020 and are fully committed to creating the future market leader in onychomycosis. The earlier onset of action and exceptional ability to eliminate the fungus as well as the outlook for a shorter treatment period are very promising.
Anna Ljung, CEO of Moberg Pharma
CONFERENCE CALL - MAY 12, 2020 AT 3:00 P.M CET
CEO Anna Ljung will present the report at a telephone conference on May 12, 2020, at 3:00 p.m CET.
Dial-in: SE: +46 8 505 583 69, US: +1 833 249 84 04
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 May 12, 2020.
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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Extended fiscal year July 2019 - December 2020 Interim report January â€" March 2020 |
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SOURCE Moberg Pharma
