J.P. Morgan Healthcare Conference - Dave Marek, CEO January 12, 2021 - MYOV Investor Presentation
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J.P. Morgan Healthcare Conference Dave Marek, CEO January 12, 2021
Forward-Looking Statements This presentation contains forward-looking statements, including without limitation, statements related to: Myovant’s aspiration to redefine care for women and for men; Myovant’s expectations regarding the potential benefits of ORGOVYX; Myovant’s expectations regarding the commercial launch of ORGOVYX in the United States, including revenues, coverage and reimbursement and Myovant’s goal of establishing ORGOVYX as the new standard of care in advanced prostate cancer; Myovant’s patient assistance program for patients and the features of such patient assistance program; the potential benefits of Myovant’s collaboration with Pfizer, including the potential effect on revenues; the timing and success of Myovant’s future regulatory filings and potential approvals for its development candidates; and Myovant’s business strategies, financial condition and trends, competitive position, potential growth opportunities, the effects of competition and expectations or probabilities for success. Forward- looking statements can be identified by “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words or other similar expressions or variations, although not all forward-looking statements contain these identifying words. Myovant cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors known and unknown that could cause actual results and the timing of certain events to differ materially from future results expressed or implied by the forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, unforeseen circumstances or other disruptions to normal business operations arising from or related to the COVID-19 pandemic; Myovant’s dependence on the success of ORGOVYX; the success of Myovant’s collaboration with Pfizer; Myovant’s ability to sustain a commercial field organization and distribution network; the degree of acceptance of ORGOVYX among physicians, patients, healthcare payors, patient advocacy groups and the general medical community; Myovant’s ability to obtain favorable coverage and reimbursement from third-party payors for ORGOVYX; Myovant’s reliance on third parties for the manufacture of ORGOVYX and those discussed under the heading "Risk Factors" in Myovant Sciences' Quarterly Report on Form 10-Q filed on November 12, 2020, as such risk factors may be amended, supplemented or superseded from time to time. These risks are not exhaustive. New risk factors emerge from time to time and it is not possible for its management to predict all risk factors, nor can Myovant 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. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Except as required by law, Myovant undertakes no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. 2
2020 Achievements Provide Foundation for Strong
Commercial Execution in 2021
Clinical Development Regulatory Commercial Readiness
• In men with advanced prostate • ORGOVYX approved by FDA for • Gedeon Richter agreement to
cancer, Phase 3 data for ORGOVYX advanced prostate cancer commercialize women’s health
published in the New England Journal indications outside U.S.
1
• NDA for uterine fibroids accepted
of Medicine
for review by FDA, target action • Built in-house commercialization
• In women with uterine fibroids, date of June 1, 2021 capabilities to support launches
positive one-year data demonstrating
• MAA for uterine fibroids • Sunovion Pharmaceuticals
maintenance of bone mineral density
validated for review by EMA in agreement for market access and
with relugolix combination therapy
March 2020 commercial infrastructure support
• In women with endometriosis,
• Pfizer agreement to jointly develop
positive Phase 3 data demonstrating
and commercialize relugolix in
improvement of dysmenorrhea,
oncology and women’s health in the
non-menstrual pain and dyspareunia
U.S. and Canada
with relugolix combination therapy
3 FDA = U.S. Food and Drug Administration; NDA = New Drug Application; MAA = Marketing Authorisation Application; EMA = European Medicines Agency
(1) Excluding Japan, China, Hong Kong, Indonesia, Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand, and Vietnam.
Transformative Collaboration to Fully Unlock the
Potential of Relugolix in Oncology and Women’s Heath
Myovant and Pfizer to jointly develop and commercialize
ORGOVYX and relugolix combination tablet in the U.S.
and Canada
Profits and certain expenses related to relugolix
development and commercialization to be shared equally
Myovant to receive up to $4.2 billion, including a $650
million upfront payment, $200 million of potential
regulatory milestones and additional tiered sales milestones
Pfizer obtains exclusive option to commercialize relugolix in
oncology outside the U.S. and Canada
1
4
(1) Excluding Japan, China, Hong Kong, Indonesia, Korea, Malaysia, Philippines, Singapore, Taiwan, Thailand, and Vietnam.
Pfizer Collaboration Creates Significant Value
for Myovant
Illustrative
Accelerated Uptake
Myovant + Pfizer
Higher Revenue Peak
Patient Adoption
Shared Expenses
Myovant alone
Substantial Deal Economics
Time
5
2021 Objectives to Advance Myovant’s Strategy for
Broad Patient Impact and Sustainable Growth
Execute Accelerate Invest
Launches in advanced Revenue growth by Pipeline expansion through
prostate cancer and leveraging the Pfizer relugolix development
uterine fibroids* collaboration
Explore MVT-602 and
Multiple regulatory business development
submissions opportunities
6
* Pending regulatory approval. Relugolix combination tablet is an investigational drug that has not been approved for any use.
Now Approved: ORGOVYX Poised to Become the New
Androgen Deprivation Therapy Standard of Care
ORGOVYX is the first and only oral
gonadotropin-releasing hormone receptor
antagonist indicated for the treatment of adult
patients with advanced prostate cancer
7 Pill not shown in actual size.
NOT FOR PROMOTIONAL USE
~3M men
diagnosed with
prostate cancer
alive in the U.S.3
Prostate Cancer ~300K men
is the 2nd Most in U.S. expected to
be treated with
Common Cancer
ADT in 20214
Affecting Men 1
Death from cardiovascular
~100K men
causes is the leading cause in U.S. expected
of death in patients with to initiate ADT
prostate cancer
2 in 20214
2 out of 3
men with
prostate cancer
(1)
(2)
American Cancer Society.
Shore ND, Saad F, Cookson MS, et al. Oral relugolix for androgen-deprivation therapy in advanced prostate cancer. have cardiovascular ~30% of men
(3)
New England Journal of Medicine. 2020 May 29. DOI: 10.1056/NEJMoa2004325
SEER Incidence Data, 2017.
risk factors5 in U.S. with prostate
(4) National Sales Perspective data and claims data. cancer have
(5) Leong DP, Fradet V, Shayegan B, et al.. Cardiovascular risk in men with prostate cancer: insights from the RADICAL
8
PC Study. J Urol 2020 Jun;203(6):1109-1116. cardiovascular
Cardwell, C et al, The Risk of Cardiovascular Disease in Prostate Cancer Patients Receiving Androgen Deprivation Therapies,
disease6
(6)
Epidemiology • Volume 31, Number 3, May 2020 (table 1).
Limitations of Current ADT Standard of Care
Attributes of LHRH Agonist Class Warnings and Precautions 1
Injectable • Tumor Flare
• Hyperglycemia and Diabetes
Clinical flare
• Cardiovascular Diseases: Increased risk
of developing myocardial infarction,
Delayed testosterone suppression
sudden cardiac death, and stroke
PSA response can take weeks • QT/QTc Interval Prolongation
• Convulsions
Delayed testosterone recovery following
treatment discontinuation • Laboratory Tests
9 ADT = Androgen deprivation therapy; LHRH = Luteinizing Hormone-Releasing Hormone; PSA = Prostate-specific antigen
(1) Warnings and Precautions from LUPRON DEPOT (leuprolide acetate for depot suspension) prescribing information: https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/020517s036_019732s041lbl.pdfORGOVYX is First and Only Oral GnRH Antagonist
Approved for Advanced Prostate Cancer
Rapid, profound, and sustained testosterone
suppression without hormonal flare 1
Testosterone recovery within 90 days of
treatment discontinuation 1
Lower incidence of major adverse
cardiovascular events compared to leuprolide 2
One-pill, once-a-day 3
GnRH = Gonadotropin-releasing hormone
(1) Full prescribing information for ORGOVYX is available at www.myovant.com/orgovyx-prescribing-information.pdf
(2) Shore ND, Saad F, Cookson MS, et al. Oral relugolix for androgen-deprivation therapy in advanced prostate cancer. New England Journal of Medicine. 2020 May 29. DOI: 10.1056/NEJMoa2004325
10 (3) Following initial loading dose of 360 mg (three 120 mg tablets) on first day of treatment.
NOT FOR PROMOTIONAL USE.Early Execution on Our Launch Priorities
Educate Establish Engage
Prescribers Broad Access Patients
Educate oncologists and Enable seamless prescribing Ensure patients and care partners
urologists to drive confidence and treatment initiation are aware of ORGOVYX and
and intent to prescribe participate in treatment decisions
• 100 Myovant sales • Distribution channel fully • ORGOVYX website and social
professionals actively stocked within 72 hours media channels active and already
promoting to prescribers engaging patients
• Patient support program fully
• Initiating peer-to-peer launched, with access to free • Top patient advocacy groups
educational programs trial and co-pay support proactively sharing information
about ORGOVYX approval to
• Engaging key payers to support their networks
timely coverage decisions
11Pfizer Collaboration to Accelerate Uptake and
Maximize Commercial Potential of ORGOVYX
• Sales team fully deployed, average 8 years of • Uro-oncology sales team of >100 being trained,
urology/oncology selling experience expected to join Myovant in the field by
February 2021
• 90% top-tier achievers, many with strong • Demonstrated success promoting XTANDI®, a
endorsements from prominent opinion leaders leading prostate cancer therapeutic that is
co-administered with ADT
• Experienced market access team leading • Key account and payer teams will support access
organized customer relationships in organized provider and payer accounts
12 ADT = Androgen deprivation therapy
XTANDI® is a registered trademark of Astellas Pharma Inc. XTANDI® in the U.S. is being developed and commercialized through a collaboration between Astellas Pharma Inc. and Pfizer.Relugolix Combination Tablet* Has Potential to Transform
Multiple Hormone-Driven Diseases in Women’s Health
Relugolix 40 mg
+ estradiol 1.0 mg
+ norethindrone acetate 0.5 mg
Designed to be a long-term treatment for
women with symptomatic uterine fibroids
or endometriosis as an alternative to
surgery or other invasive procedures
13
* Relugolix combination tablet is an investigational drug that has not been approved for any use.Uterine
Fibroids:
A Common,
Debilitating
Disease
COMMON SYMPTOMS:
Heavy Urinary Pregnancy
Anemia Pelvic Pain
Bleeding Symptoms ComplicationsLarge Patient Population with
Significant Unmet Need
PREVALENCE MEDICAL NEED (U.S. WOMEN AGES 15-49) 1,3,4
1
SEEKING TREATMENT
2
(1) Stewart. Uterine Fibroids. New England Journal of Medicine. 2015;372(17):1646-1655.
15
(2) Fraser, Ian S., et al. Prevalence of Heavy Menstrual Bleeding and Experiences of Affected Women in a European Patient Survey. Int J Gynaecol Obstet. 2015;128(3):196-200.
(3) 2010 US Census data.
(4) Marjoribanks, et al. Surgery versus medical therapy for heavy menstrual bleeding. Cochrane Database Syst Rev. 2006;19(2):CD003855.Relugolix Combination Tablet* has Potential to
Become Best-in-Class Therapy for Uterine Fibroids
Top Ob/Gyn Priorities Significant symptom reduction
When Considering Uterine 84.7% reduction in menstrual blood loss at week 24
Fibroid Treatments (vs. 19.5% for placebo)
1 2
65.0% of patients experienced a reduction in pain on
Reduces symptoms, bleeding days (vs. 19.3% for placebo)
2
such as heavy menstrual
bleeding and pain Well-tolerated, with bone health maintained
Bone mineral density and hot flashes comparable to
placebo over 52 weeks
2
Minimal side effects
Easy, convenient dosing Combination therapy from the start
Achieves symptom reduction and is well-tolerated
Simplicity & Convenience
One dose, one pill, once-a-day
GYN Segmentation Research, Q2 2020: N = 405 OB/GYNs.
(1)
16
Pooled results of LIBERTY 1 and LIBERTY 2 Phase 3 clinical trials.
(2)
* Relugolix combination tablet is an investigational drug that has not been approved for any use.1-4
COMMON SYMPTOMS MEDICAL NEED (U.S. WOMEN AGES 15-49)
Relugolix Pain
8M
Combination Painful
6M
Tablet has * Intercourse
Potential to Bowel
1M
Symptoms
Address Unmet Women
have
endometriosis
Women
experience
symptoms
Women
Fail first-line
therapy
Need in Fatigue
Endometriosis IMPACT
Infertility
3 in 4
women with endometriosis experience
1
debilitating symptoms
(1) Bulletti, et al. Endometriosis and infertility. J Assist Reprod Genet. 2010;27(8):441–447.
(2) 2010 US Census Data.
(3) Louis, et al. Incidence of endometriosis by study population and diagnostic method: the ENDO Study. Fertil Steril. 2011;96(2):360-365.
17 (4) Quaas, et al. On-label and off-label drug use in the treatment of endometriosis. Fertil Steril. 2015.103(3):612-625.
* Relugolix combination tablet is an investigational drug that has not been approved for any use.Upcoming Women’s Health Launches Strengthened
with Pfizer Collaboration
Rich Heritage in Leader in Direct-to-Consumer
Women’s Health Promotion
Strong relationships established with OB/GYNs, Deep expertise in consumer marketing,
will dedicate ~100 sales professionals to detail media strategy and buying, as well as
relugolix combination tablet* analytics and insights
18
* Relugolix combination tablet is an investigational drug that has not been approved for any use.Investing in the Next Wave of Innovation in
Oncology and Women’s Health
Relugolix Lifecycle MVT-602 Business Development
Oncology • Novel mechanism of action • Focus areas include oncology
suitable to address multiple and women’s health with other
• Additional studies to support
indications therapeutic areas assessed for
ORGOVYX indication expansion
• Plan to continue development unique opportunities
Women’s Health in 2021 in infertility and assess • Will take a disciplined and
• Complete long-term extension proof of concept in other opportunistic approach
studies in uterine fibroids and indications
endometriosis
• Additional development
opportunities
19Myovant Well-Positioned for Strong Commercial
Execution and Sustainable Growth
First Quarter 2021
ORGOVYX poised to become the new androgen One-year data from SPIRIT
extension study in endometriosis
deprivation therapy standard of care
Randomized withdrawal study
results in uterine fibroids
Relugolix combination tablet* has potential to EU regulatory submission for
transform multiple hormone-driven diseases in advanced prostate cancer
women’s health First Half 2021
U.S. regulatory submission for
Pfizer collaboration to accelerate uptake and endometriosis
maximize commercial potential of relugolix franchise FDA decision on uterine fibroids filing
by June 1st action date
Plan to expand pipeline of potential medicines Mid 2021
EMA decision on uterine fibroids filing
20 FDA = U.S. Food and Drug Administration; EMA = European Medicines Agency
* Relugolix combination tablet is an investigational drug that has not been approved for any use.investors@myovant.com 21
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