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TRANSCRIPT
Corporate Pres entation
Jefferies Healthcare ConferenceNew York, 4 June 2019
This presentation contains forward looking statements including, but not limited to, statements concerning the outcome or success of Mithra Pharmaceuticals’ clinical trials; its ability to successfully gain regulatory approvals and commercialize products; its ability to successfully advance its pipeline of product candidates; the rate and degree of market acceptance of its products ; and its ability to develop sales and marketing capabilities. Forward looking statements are subject to a number of risks, uncertainties and assumptions. Moreover, Mithra Pharmaceuticals operates in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for Mithra Pharmaceuticals’ management to predict all risks, nor can Mithra Pharmaceuticals assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward looking statements it may make. In light of these risks, uncertainties and assumptions, the forward looking events and circumstances discussed in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward looking statements. You should not rely upon forward looking statements as predictions of future events. Although Mithra Pharmaceuticals believes that the expectations reflected in the forward looking statements are reasonable, it cannot guarantee that the future results, levels of activity, performance or events and circumstances reflected in the forward looking statements will be achieved or occur. Moreover, except as required by law, neither Mithra Pharmaceuticals nor any other person assumes responsibility for the accuracy and completeness of the forward looking statements. Forward looking statements in this presentation represent Mithra Pharmaceuticals’ views only as of the date of this presentation. Mithra Pharmaceuticals undertakes no obligation to update or review any forward looking statement, whether as a result of new information, future developments or otherwise, except as required by law. This presentation has been prepared by the management of Mithra Pharmaceuticals. It does not constitute or form part of, and should not be construed as, an offer, solicitation or invitation to subscribe for, underwrite or otherwise acquire, any securities of Mithra Pharmaceuticals or any member of its group nor should it or any part of it form the basis of, or be relied on in connection with, any contract to purchase or subscribe for any securities of Mithra Pharmaceuticals or any member of its group, nor shall it or any part of it form the basis of or be relied on in connection with any contract or commitment whatsoever. The information included in this presentation has been provided to you solely for your information and background and is subject to updating, completion, revision and amendment and such information may change materially. No person is under any obligation to update or keep current the information contained in this presentation and any opinions expressed in relation thereto are subject to change without notice. No representation or warranty, express or implied, is made as to the fairness, accuracy, reasonableness or completeness of the information contained herein. Neither Mithra Pharmaceuticals nor any other person accepts any liability for any loss howsoever arising, directly or indirectly, from this presentation or its contents.
Disclaimer
Transforming options for women through innovation
Euronext Brus s els
MITR A
200 S taff members
Partners hips in
>85countries
At the heart of Europe
Belgium (Liège)
Created in
1999
S pecialis ts in
Women’s Health
Biotech
Our mission is to develop innovative products offering better efficacy, safety and quality of life,
meeting women’s needs throughout their life span
François FornieriChief Executive Officer
J ean-Michel FoidartScientific Committee & Board member
Co-founders
• Over 30 years in the Pharma industry
• Founder & CEO of UteronPharma (soldto Watson/Actavis)
• Master in Chemical Engineering
• Former CSO of UteronPharma & Actavis Belgium
• Former Head of the Gynecology and Obstetrics Department of the University of Liège
• MD & PhD in Cell Biology& Biochemistry
We help trans form women’s health by offering new choices through innovation
with a particular focus on fertility, contraception and menopaus e
Complex TherapeuticsEstetrol (E4)
Today, Mithra has two complementary innovation s treams powered by a unique
CDMO facility: its unique E4-bas ed pipeline and its portfolio of Complex Therapeutics
E4 (Estetrol)
• E4: native estrogen produced by human fetus around week 9
• Fetal plasma levels 12x higher than those of mother
• E4’s broad potential for use in Women’s Health validated in multiple peer-reviewed academic journals1-8
• E4-based programs protected by 30 patent families, including synthesis pathway until 2032
1 Kluft C et al., Contraception 2016.; 2 Gerard C et al., Oncotarget 2015;6(19):17621-36.; 3 Visser M et al., Horm Mol Biol ClinInvest. 2012;9:95-103.; 4 Visser M et al., Climacteric 2008; 11 Suppl 1:64-8.; 5 Mawet M et al., Eur. J. Contracept. Reprod. Healthcare 2015:1-13.; 6 Apter D. et al., Contraception 2016;94(4):366-73; 7 Abot et al., EMBO 2014: 6 (10); 8 Apter et al., Eur. J. Contracept. Reprod. Healthcare 2017:22(4)
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E4 (Es tetrol) Ans wer from Nature with Unique Potential
Brain
Liver
Breast Heart
Ovary, uterus
& vagina
Bone
What is the role of es trogens in the human body?
Unique Agonist-Antagonis t mode of action
Nuclear receptor
• E4 acts as an estrogen in brain, bone, vagina, endometrium & heart to provide beneficial effects
Membrane receptor
• E4 is antagonist on the membrane receptor in breast and has a neutral effect on the liver
Leveraging our E4-bas ed as s et portfolio
12
Several potential blockbusters offering solutions throughout a woman’s hormonal life s pan
Estelle® PeriNestaTM Donesta®
The first & only 5th generation combined oral contraceptive
Innovative peri-menopausal treatment
Next generation Menopausal Hormone Therapy
Fertile women aged 14 – 51, BMI ≤ 35.0 kg/m2
Active women aged 45 -- 51 that are s till fertile and have firs t s igns of
menopaus e (hot flus hes and irregular cycles )
Hys terectomized and non-hys terectomized women aged
51 – 65, s uffering of s ymptoms of menopaus e
US D 22 bn(WW contraceptive market) Under evaluation Under evaluation
Filing YE 2019, commercialization expected in
late 2020 / early 2021
P has e 3 to begin by end 2019; commercialization expected in
2023
P has e 3 to begin in H2 2019; commercialization expected in
late 2023
K ey ValueP ropos ition
Affected P opulation
MarketOpportunity
S tatus
15 mg Es tetrol (E4) and 3 mg Dros pirenone
Women are s eeking new contraceptive s olutions offering an improved s afety profile and tolerability for better reproductive health
Celmatix Press Release December 2018
Es telle®
The role of female s ex hormones in COCs
Objective:
optimize women’s
physiological hormonal
balance by combining the
best progestin & estrogen
according to their profile
Estrogens• Cycle control
Progestins• Prevent ovulation• Thicken cervical lining• Endometrial protection
Prevents ovulation
Endometrial safety
Androgenic activity
Anti-androgenic
Glucocorticoid activity(favorise insulin resistance)
Antimineralocorticoid(sodium excretion)
Progesterone Drospirenone
- +++ +- -- +
- -
+ ++
Cyproterone
+++-
+++
-
-
Levonorgestrel / Norethindrone
++++-
-
-
Masculinize metabolism & appearance
Demasculinizemetabolism& appearance
oily skin, acne, alopecia
1st & 2d gen
The impact of the Progestin
4th gen Other
Sexual dysfunction, breast tendernes,
fatigue, depression
Androgenic Anti-androgenic
Natural Cycle control
R eceptor, vas cular &
tis s ues electivity
Duration of half life
Bio-availability
Binding to circulating
proteins
VTE ris k profile (changesin hemo-
s tas ismarkers )
Breas tcancer
promotion
Drug-druginteraction potential
Effectson bone
Impact on Triglycerids
(CV)
S odium and fluid retention
(CV)
HDL-C/LDL-C
increas e(CV)
EE No high - ~12h >70% high high high high high high high moderate
E2 Yes poor - ~2 h 0.1-12% high moderate high high high high high moderate
E4 Yes high + ~28 h > 70% No low low low high low low moderate
Positive Averageto positive Negative
Characteristics of Estrogens
Benefits of Estelle®
• Excellent contraceptive efficacy
• Improved cycle control
• Favorable VTE ris k profile
• Favorable breas t profile
• Favorable CV s afety profile with minimal increas e of lipids (triglycerides )
• Neutral impact on body weight
• High us er s atis faction with improved quality of life
• Lower ris k of drug-drug interaction
• Environmentally friendly
E4 is set to be a new paradigm for Women’s Health, allowing Mithrato re-energize a $30bn+ combined market and outperform competition
• Belgian Federation for Chemistry and Life Sciences
Industries
• Winner of the prestigious
“essenscia Innovation Award” with the
development of Estelle®, the 5th generation COC based on E4
• Most important prize for industrial innovation in Belgium
• Biennial prize; previous winner : GSK (2016)19
EssensciaInnovation Award2019
Complex Therapeutics
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Leveraging know-how of Complex Therapeutics
• Expertis e in developing complex and innovative polymer products
• Targeting safer, long-lasting delivery and controlled release of trus ted, es tablis hed approaches to contraception, menopause and hormone-dependent cancers
• Duration ranging from 1 month to 5 years
• One of handful of companies that can deliver multiple drug delivery strategies including vaginal rings, implants and intra-uterine systems (IUS)
• To be developed and manufactured in-house at Mithra‘s dedicated CDMO research, development and specialist manufacturing center
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Advancing our generic’s businessMyringTM Zoreline® Tibelia®
Contraceptive vaginal ring (based on etonogestrel /EE/polymers)
Biodegradable SQ implant for prostate and breast cancer & benign gyn indications (based on tibolone )
HT indicated for menopause & osteoporosis (based on tibolone )
Fertile women aged 18 -- 40
Prostate cancer: > 1.1 mn cases WW in ‘12; breast cancer: most common
cancer among women WW, 521k deaths/year (WHO ‘12)
For postmenopausal women with ≤12 mo. s ince their las t natural
period (avg. treatment duration of 5 years )
Nuvaring Market: ~ € 867 mn (‘16)(ref. June 2017 IMS HEALTH)
Gosereline Market : ~ € 623 mn(ref. MAT Q1/2017 IMS HEALTH)
Tibolone Market : > $126 mn (‘16)(ref. IMS HEALTH, June 2017)
To be launched shortly PK/PD on human started; commercialization expected in 2022
Launched
K ey ValueP ropos ition
AffectedP opulation
MarketOpportunity
S tatus
Originator Nuvaring (Organon) Zoladex (As traZeneca) Livial (Organon)
Mithra CDMO: Fully Integrated R &D & manufacturing platform
Specialized pharmaceutical ecosystem, to take products from POC to market
Rationale for CDMO:> Keep quality control, IP & expertise in-house> Operate independently from 3rd parties using its own proprietary production
technology> Additional source of revenue via production of (partnered) programs> Leverage development expertise through 3rd party production contracts
2-Phase construction process:> H2 2016: R&D facility and polymeric forms, implants and sterile
injectables production line facilities> Received European GMP approval for MyringTM (May 2017)> H1 2019: Production line for tablets to be completed
SummaryHighlights
Advanced pipeline offering multiple near-term catalys ts
© 2019 | Mithra Investor Presentation | March 2019 25
Product
Product Phase 1 Phase 2 Phase 3 Market Appr. Key milestonesIndication
Contraception
Menopause
Positive Phase III results in Europe/Russia and US/CanadaFiling preparation end 2019
2018: positive Phase IIb resultsPhase III (E4 monotherapy) submission H2 2019
Formulation Clinical/BioEq Filing Market Appr. Key milestonesIndication
Contraception
Menopause
MA EU Q3 2018
2019/20 clinical trials for one and three-month injectable formulationsZoreline® Oncology
Additional launches
PeriNesta™*
E4Perimenopause
Estelle®
Donesta®
Under development
CNS, dermatology,oncology, etc.
Various stages of non-clinical development of future E4-based pipeline
Development of perimenopause E4 product, leveraging on Estelle & Donesta studiesPhase III in preparation for 2019
Myring™
Tibelia®
Neuroprotection (ODD granted in EU/ filed in US**), wound healing and E4 therapy in breast and prostate cancer
Complex Therapeutics
EU / RoW
US MA US 2020
* : See Press Release of 7/01/19 : New potential E4 blockbuster indication development in perimenopause, Acceleration of Donesta Phase III program** Hypoxic ischemic encephalopathy
EU US RoW
Estelle®Partnering ongoing
Donesta® Partnering intended for commercializationPartnering ongoing
(Japan & ASEAN)
Myring™Partnering discussions ongoing
Austria Czech Republic Russia Denmark
Partnering discussions ongoing
Other products(incl. Zoreline®; Tibelia®)
Partnering discussions ongoing** Partnering discussions
ongoing
Partnering discussionsongoing
Partnering with leaders in Women’s Health
26*Non-exclus ive license; **Tibelia® distribution partners include Gedeon, Mercury, Procare, Campus
P artnering intended for commercialization
Chile
(Brazil)
(Japan & ASEAN) (Canada)
(BeLux*)
(South Korea) (South Africa)
Australia & NZMENA
(MENA)
© 2019 | AGM | May 2019
Argentina, Paraguay & DR
FY 2017 FY 2018
Revenues 46.2 65.4
R&D Expenses (48.2) (35.7)
G&A (8.7) (9.0)
Selling expenses (1.7) (2.0)
EBITDA (18.4) 38.3
* Shareholdership in accordance with transparency declarations received by the company and notified managers’ transactions. Market Cap: €987mn as of December 31, 2018 (Euronext: MITRA)** CEO (François Fornieri) holds warrants for 1,023,000 additional shares of Mithra
28.2%CEO**
16.5%Alychlo / Mylecke
33.4% Free Float
4.5% Scorpiaux/Versluys BVBA
3.1% OGESIPInvest SA
14.4%Meusinvest
Share capital as of December 31, 2018 * IFRS P&L and cash balance (in m€, FY as of 31/12/2018)**
27
> S trong revenue growth due to s teady inflow of licens ing revenues
> R ecord level of EBITDA, thanks to gain on s ale to Ceres P harma
> Cas h: EUR 77.5m private placement in May 2018
Summary Financial Information
Dec 2017 Dec 2018
Cash & Equivalents 36.2 119.0
Key inflection points in 2019/20
28
Estelle: Topline results Ph III US/Canada Ѵ
2018 20192019 2020
H1 H2 H1
CDMO: Phase II
Donesta: Start Ph III
MyRing: FDA Approval
PeriNesta:Start Ph III
© 2019 | AGM | May 2019
E4: ODD in HIE (FDA) ѴMyRing: first commercial batchѴ
Zoreline: pivotal trials completeTibelia: Health Canada approval Ѵ
Building a transformative Women’s Health company
• Multiple prospective near- and mid-term milestones and launches to drive long-term growth
• Estelle® , PeriNestaTM and Donesta® – late-stage potential blockbusters built on unique E4 platform
• Acceleration of business development including partnerships for E4-based programs
• Industry partner with specialist research, development and manufacturing capabilities
• Diversified model spreads risk and maximizes product opportunities through collaborations 2017
Complex Therapeutics
2018 -2020
Estelle®
Complex Therapeutics
> 2020
Complex Therapeutics
Estelle®
Donesta®
Additionalindications(e.g. neuroprotection)
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PeriNesta™
Contact Us
Mithra MITRA (Euronext)
Rue Saint-Georges 5/74000, Liège
Belgium
Website: investors.mithra.com
Alexandra Des chner
Investor Relations Officer+32 490 58 35 [email protected]
Thank you