REGULATED INFORMATION INSIDE INFORMATION
Mithra signs landmark contract for commercialization of Estelle® in Europe and Russia with Gedeon Richter
Disclaimer
Agenda 1. Scope of agreement
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- Estelle® Status
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- Market: Europe + Russia
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- Richter
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- Agreement Terms
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- Royalty Guidance
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- Summary
1. Scope of agreement
- 20-year Exclusive* License for Estelle®
- Territories :
- Western & Eastern Europe
- Russia
2. Estelle® – Status
- Oral contraceptive product candidate composed of 15 mg Estetrol (E4) and 3 mg drospirenone (DRSP).
- Recent positive top-line results for pivotal Phase III study in Europe and Russia*
- Excellent contraceptive efficacy
- Outstanding bleeding profile, cycle control, quality of life and safety and tolerability
- Top-line results of the US/Canada Phase III study on track to report in Q1 2019
* Cf Press release 8-08-2018 « Mithra announces positive top-line results of Estelle Phase III oral contraceptive study in EU/Russia »
3. Market: Europe + Russia
- The European market (including Russia) for contraceptives is valued at approximately EUR 1.6 billion annually, with combined oral contraceptives (COCs) accounting for over 69.1%.
- The territories under the agreement represent 21.6% in value of the worldwide oral contraceptive market (EUR 5.2 billion), making this a key region for the commercialization of Estelle®.
*IMS Analytics Link Q3/2017. CAGR volume 2013-2027: -1.7%. IMS numbers based on the 30 most important countries of the 54 countries under the agreement.
4. Richter – An ideal partner for Estelle®
- Headquartered in Budapest, Hungary
- A significant player in international Women's Healthcare
- Major pharmaceutical company in Central & Eastern Europe, with an expanding direct presence in Western Europe, China and Latin America
- Market capitalization of EUR 3.5 billion; consolidated sales of approximately EUR 1.4 billion in 2017
- Richter product portfolio covers important therapeutic areas, including Women's Health, Central Nervous System and Cardiovascular
- Largest R&D unit in Central & Eastern Europe, original research activity focuses on CNS disorders, also active in biosimilar product development
- Gedeon Richter Plc. (www.richter.hu)
4. Richter – An ideal partner for Estelle®
- Women's Health sales amounted to EUR 469.4 million in 2017 (40% of total sales for the company), with the oral contraceptive portfolio representing a turnover of EUR 292.9 million.
- Richter is a market leader in Russia & Eastern Europe
- Rapidly growing presence in Western Europe is an important driver of the Women's Health division
- The company has a clear strategy to further strengthen the franchise in Eastern and Western Europe, with the addition of innovative products such as Estelle®.
*Richter company report: https://www.richter.hu/en-US/investors/company-reports/Quarterly%20reports/RCH180212QR01E.pdf
5. Agreement Terms: license
- Milestones: 55 million downpayment
- o EUR 35 million upfront on contract signature
- o EUR 20 million related to market approvals
- Potential additional sales-related milestones
- Royalties
- o Tiered royalties from high single-digit to substantial double-digits in view of sales volumes
4. Agreement Terms : Supply
- Mithra to receive guaranteed annual recurring revenues (MAQ)
- Production options
- Mithra to manufacture initial supplies of Estelle® for Richter at its CDMO*.
- Richter to evaluate the option to manufacture and supply Estelle® as well as key API's in territories under the agreement.
- In view of the production forecasts of this contract and previously closed agreements, this option may offer Mithra a competitively priced future manufacturing source when the Mithra CDMO reaches full capacity.
6. Deal potential
- Annual partner (Gedeon Richter) revenue if Estelle reaches a market share of:
- A. 5% in Europe and 7,5% in Russia = € 175 Million
- B. 7,5% in Europe and 10% in Russia = € 260 Million
- C. 10% in Europe and 15% in Russia = € 350 Million
- D. 15% in Europe et 20% in Russia = € 520 Million
7. Summary
- Major endorsement of Estelle®'s potential as a next-generation COC with enhanced benefit / risk profile
- Significant partnership with Women's Health leader in world's second-largest market by value
- Potential for substantial royalties and revenues over lifetime of contract
Thank you for your attention Any questions?
[email protected] +32 4 349 28 22
[email protected] +32 4 349 28 22
investors.mithra.com
N.V Mithra Pharmaceuticals S.A.
Rue St-Georges 5/7 - 4000 Liège • Tel : +32 (0)4 349 28 22 • Fax : +32 (0)4 349 28 21 • [email protected] • www.mithra.com