Mithra Announces 2018 Half Year Results

 

Mithra (Euronext Brussels: MITRA), a company dedicated to Women’s Health, today announces its financial results for the six-month period ending 30 June 2018, prepared in accordance with IFRS. The full interim report is available on the Investors sections of the website (https://investors.mithra.com/en/).

Operational Highlights (including post-period end)

 

Clinical progress

  • Positive top-line results for the Phase III Estelle® (E4 Freedom) study in Europe and Russia. The study successfully met its primary endpoint and achieved key secondary endpoints including outstanding bleeding profile, cycle control, quality of life and safety and tolerability. US/Canada study on track to report top-line results in Q1 2019
  • Positive results from the Phase II hemostasis study of Estelle® were reported which corroborate earlier findings and delineate the unique safety profile of Estelle®
  • Positive top-line results from the E4 Relief Phase II study for Donesta® for the treatment of Vasomotor Symptoms (VMS), in particular hot flushes relief, in post-menopausal women.
  • Abbreviated New Drug Application (ANDA) filed with the US Food and Drug Administration (FDA) for vaginal ring for contraception, Myring™. Potential launch expected in H1 2019.
  • Applied for additional patents to further strengthen and exten intellectual property estate for Estelle®, Donesta® and E4.

 

Licensing and supply agreements

  • Exclusive license and supply agreement signed with Gedeon Richter to commercialize Estelle® in Europe and Russia (semi-exclusive license in Benelux)
  • Exclusive license and supply agreement signed with Searchlight Pharma to commercialize Estelle® in Canada
  • Exclusive license and supply agreement signed with Hyundai Pharm to commercialize Estelle® in South Korea
  • Exclusive license and supply agreement signed with Alvogen for the commercialization of Myring™[1] in Russia
  • Exclusive license and supply agreement signed with Orifarm for the commercialization of Myring™[2] in Denmark
  • Mithra received its first Marketing Authorization (MA) for Myring™ in the United Kingdom
  • Exclusive license and supply agreement signed with Pei Li Pharm for the commercialization of Tibelia®[3] in Taiwan
  • Exclusive license and supply agreement signed with Mediner for the commercialization of Tibelia®[4] in Hungary

Financial Highlights (including post-period end)

  • Revenues remain stable at EUR 12.6 million (H1 2017: EUR 12.7 million). Although stable, an increase of revenues was reported for license agreements thanks to Libbs for Estelle®; increase in revenues which was offset by decreased revenues for the Benelux business
  • R&D expenditure decreased by 24% to EUR 19.4 million (H1 2017: EUR 25.5 million), reflecting end of investment in the Phase III Estelle® and Phase II Donesta® programs
  • Raised EUR 77.5 million in gross proceeds by means of a private placement of 2,672,414 new shares through an accelerated bookbuild offering to fund clinical development of the Company’s key assets
  • Signed a comprehensive Belux partnership with Ceres Pharma, a Belgian-based company focused on over-the-counter (OTC) and specialist healthcare. The agreement covers the sale of the Women’s Health branded generics business in Belgium and Luxembourg as well as license and supply agreements for a number of Mithra’s products and product candidates developed in-house, including licenses for the commercialization in Belux of Tibelia®, Myring™ and Estelle®
  • Higher expected future revenues related to Estelle® captured in our business plan led to an increase of fair value for the contingent consideration reported for Estelle® (EUR 68,319k in June 2018 compared to EUR 41,811k in 2017); an IFRS adjustment in the fair values which was the main driver of the financial expenses of EUR 28,933k, a non-cash element in the income statement
  • Cash at June 30 2018 of EUR 85.8 million, compared to EUR 36.2 million at the end of 2017

 

François Fornieri, CEO of Mithra Women’s Health commented: “Mithra made good progress in the first half of 2018 as we continue to focus on bringing our innovative E4-based oral contraceptive and hormone therapy products to market. The unique profile of Estelle® as a new generation oral contraceptive was underlined by a number of studies, including positive top-line results from the Europe/Russia Phase III. Its uniqueness was further recognised by the broad commercialization agreement recently signed with Gedeon Richter for Estelle in Europe and Russia. We look forward to the results from the North American Phase III trial early next year. 

 

“Positive Phase IIb results were announced for our hormone therapy candidate, Donesta®, which demonstrated a statistically significant reduction in the frequency of hot flushes. Preparations for Phase III initiation are well under way. Myring™ saw its first launches in Europe and is on track for launch in the US in 2019 following acceptance of the regulatory filing by the FDA.

 

“We further strengthened our financial position with a private placement and raised EUR 77,5 million. This strengthening will continue in the second half through the signed divestment of our Belux commercial portfolio to Ceres Pharma for up to EUR 40 million; and with significant upfront, milestone and sales-related royalty payments from the signed Gedeon Richter agreement for Estelle®. With a robust financial position, new partnering deals in key territories around the world and continued further progress on our key programs, we remain confident in our vision to transform women’s health through innovation.”

 

[1] MyringTM will be marketed under a different trademark name in Russia

[2] MyringTM will be marketed under a different trademark name in Denmark

[3] Tibelia® will be marketed under a different trademark name in Taiwan

[4] Tibelia® will be marketed under a different trademark name in Hungary

Note

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 a next generation hormone therapy, Donesta®- are built on Mithra's unique native 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 Mithra CDMO. Mithra was founded in 1999 as a spin-off of the University of Liège by Mr. François Fornieri and Prof. Dr. Jean-Michel Foidart and is headquartered in Liège, Belgium. Further information can be found at: www.mithra.com

 

 

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