Regulated information
MIThRA ANNOUNCES 2017 HALF YEAR RESULTS
Liège, Belgium, 21 September 2017 - Mithra (Euronext Brussels: MITRA), a company specialized in women's health, today announces its financial results for the six-month period ending 30 June 2017, prepared in accordance with IFRS. The full interim report is available on the website in the Investors section (investors.mithra.com).
Operational Highlights (including post-period end)
- Estelle® oral contraceptive Phase III program on track - recruitment completed in Europe/Russia, as well as recruitment for an additional safety study and the initiation of a PK ethnobridging study
- Recruitment in final stages for Donesta® Phase II menopause study; on track to report top-line results in Q1 2018
- European Orphan Drug Designation in neonatal encephalopathy underlines potential of E4 beyond women's health, including neuroprotection
- Myring(TM) submitted for EU approval post period end - on track for launch in 2018; GMP approval received for production at Mithra CDMO
- Tibelia® received marketing authorization in France; exclusive agreement signed for Canada, where Tibelia® would be the first tibolone-based product in this market if approved
- Accelerated business development including license and supply agreement with Fuji Pharma for Donesta® in Japan and ASEAN markets; commercialization agreements with Mayne Pharma for Myring(TM) in the US and Gynial in Austria
Financial Highlights
- Revenues increased by 51.4% to EUR 12.7 million (H1 2016: EUR 8.4 million) thanks to license agreements with Fuji Pharma for Donesta® as well as with Mayne Pharma and Gynial for Myring(TM), with slightly increased revenues for the Benelux business
- R&D expenditure increased by 51.7% to EUR 25.5 million (H1 2016: EUR 16.8 million), reflecting targeted investment in the Phase III Estelle® and Phase II Donesta® programs
- Private placement of EUR 26.1 million in June supported by existing and new specialist life sciences investors, strengthening financial profile
- Cash at June 30 2017 of EUR 44.7 million, compared to EUR 45.8 million at the end of 2016
François Fornieri, CEO of Mithra, commented: "I am pleased to report significant progress during the first six months of the year, both in terms of advancing our pipeline programs and delivering on Mithra's corporate objectives. Our advanced E4-based programs for Estelle® in contraception and Donesta® in menopause are progressing according to schedule, as are the Complex Therapeutics programs Myring(TM), Zoreline® and Tibelia®. Business development activities continued to accelerate, including partnerships with Fuji Pharma for Donesta® and Mayne Pharma for Myring(TM). These collaborations are an endorsement of the commercial potential of our products and further highlight Mithra's growing reputation in the increasingly attractive field of women's health.
The Company also strengthened its financial position thanks to an oversubscribed private placement of EUR 26.1 million. The fundraising was supported by existing shareholders as well as new, specialized life sciences investors, demonstrating investor confidence in Mithra's strategy to become a fully-fledged biopharmaceutical company. The additional funding will be used to advance our lead clinical programs while also allowing the Company to pursue further business development opportunities to realize the full commercial potential of our pipeline programs. With a strengthened financial position, continued progress on all our key programs and accelerating partnering discussions, we look forward to the rest of 2017 with confidence."
For more information, please contact:
Investor Relations
Sofie Van Gijsel, IRO +32 485 19 14 15 investorrelations@mithra.com s vangijsel@mithra.com
Consilium Strategic Communication Jonathan Birt, Sue Stuart, Philippa Gardner, Ivar Milligan, Hendrik Thys mithra@consilium-comms.com +44 2 037 095 700
Press
Julie Dessart Chief Communication Officer +32 4 349 28 22 / +32 475 86 41 75
About Mithra
Mithra (Euronext: MITRA) is dedicated to providing innovation and choice in Women's Health, with a particular focus on fertility, contraception and menopause. Mithra's goal is to develop new and improved products that meet women's needs for better safety and convenience. Its two lead development candidates - a fifth generation oral contraceptive Estelle® and next-generation hormone therapy Donesta® - are built on Mithra's unique natural estrogen platform, E4 (Estetrol). Mithra also develops, manufactures and markets complex therapeutics and offers partners a complete spectrum of research, development and specialist manufacturing at its CDMO. Mithra was founded in 1999 as a spin-off from the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart. Mithra is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com
Important information
The contents of this announcement include statements that are, or may be deemed to be, "forward-looking statements". These forward-looking statements can be identified by the use of forward-looking terminology, including the words "believes", "estimates," "anticipates", "expects", "intends", "may", "will", "plans", "continue", "ongoing", "potential", "predict", "project", "target", "seek" or "should", and include statements the Company makes concerning the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. The Company's actual results may differ materially from those predicted by the forward-looking statements. The Company undertakes no obligation to publicly update or revise forward-looking statements, except as may be required by law.
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