Veru Inc. · NASDAQ:VERU
Veru — Jefferies Healthcare Conference 2019
36 slides from Veru's conference presentation, Jun 4, 2019
Slide 1: The Prostate Cancer Company Novel Medicines
Veru Inc. Nasdaq:VERU The Prostate Cancer Company Novel Medicines June 4th, 2019 Jefferies Healthcare Conference Presentation
Slide 2: Forward looking statements
Forward looking statements This communication contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or
Slide 3: Veru The Prostate Cancer Company
Veru is a leading prostate cancer company, but has revenues from Urology Specialty Pharmaceuticals and legacy product divisions Veru The Prostate Cancer Company Urology Specialty The Female Pharmaceuticals Health Company Division Division TADFINTM - NDA 2020 FC2 Female/internal condom PREBOOST®/Roma
Slide 4: Pipeline of proprietary product candidates and specialty pharmaceuticals
Pipeline of proprietary product candidates and specialty pharmaceuticals PRODUCT INDICATION TARGET PRECLINICAL PHASE 1 PHASE 2 PHASE 3 PHASE 4 MARKETED PROSTATE CANCER NOVEL MEDICINES Castration resistant Oral, targeted VERU-111 metastatic prostate α & β tubulin cancer inhibitor Hot flashes caused N
Slide 5: Prostate Cancer - Novel Medicines
Prostate Cancer - Novel Medicines 5
Slide 6: Our Strategy
Advanced prostate cancer has become a chronic disease requiring active management of the disease and side effects of from existing treatments Our Strategy New prostate cancer treatments directed to Prostate cancer supportive care- focuses cancer progression1 on ameliorating side effects of cancer tr
Slide 7: VERU-111, an oral selective antitubulin, may address largest growing unmet medical need
VERU-111,an oral selective antitubulin, may address largest growing unmet medical need in refractory metastatic prostate cancer The main effective agents against advanced and metastatic prostate cancer are hormonal and antitubulin cytotoxic drugs Androgen blocking agents ZYTIGA (abiraterone) and XTA
Slide 8: VERU-111 inhibits microtubule assembly by selective binding to α and β tubulin subunits
VERU-111 inhibits microtubule assembly by selective binding to α and β tubulin subunits of microtubules Destabilizes Microtubule assembly Microtubules (red) disrupted from spindle to globular shape control VERU-111 VERU-111 “spindle shape” “globular shape” (Crosslinks α and β subunits Triple negativ
Slide 9: VERU-111: novel, oral, next generation, selective tubulin inhibitor
VERU-111: novel, oral, next generation, selective tubulin inhibitor targeting α and β subunits of microtubules Preclinical Product profile1-3 ◆ Low nanomolar inhibition of tubulin polymerization ◆ High oral bioavailability ◆ Not a substrate for MDRs (P-gp, MRPs, and BCRP) ◆ Not a substrate for CYP3A
Slide 10: VERU-111 clinical development plan: PRECHEMO
VERU-111 clinical development plan: PRECHEMO - castration and novel androgen blocking agent resistant metastatic prostate cancer Open label Phase 1b/2 initiated January 2019- Johns Hopkins Cancer Center and 4 other clinical centers with results in 2019 Complete Complete by primary endpoint summer 20
Slide 11: VERU-111 market opportunity
VERU-111 market opportunity Current annual market for advanced prostate cancer drugs ◆ $6 billion market for secondary novel androgen blocking agents for prostate cancer in 20181 ◆ Zytiga $3.5 billion ◆ Xtandi $2.59 billion ◆ $1.5 billion market for taxanes for prostate cancer ◆ Docetaxel $1 billion
Slide 12: VERU-111 market opportunity beyond prostate cancer
VERU-111 market opportunity beyond prostate cancer VERU-111, like current antitubulins, may have efficacy against broad cancer types – Market > $5 billion ◆ VINCA ALKALOIDS: VELBAN (VINBLASTINE); ONCOVIN (VINCRISTINE); NAVELBINE (VINORELBINE) ◆ Primarily used in combination chemotherapy (ABVD, Stanf
Slide 13: VERU-111 has applications in multiple areas of oncology; strong IP
VERU-111 has applications in multiple areas of oncology; strong IP Over 29 peer-reviewed publications 7 issued composition of matter patents including U.S. 9029408, EU 2959900 and Japan 5507552 ◆ U.S. patent expiry 2029 with possible extension to 2034 and 63 foreign granted or pending patents ◆ Poly
Slide 14: Hot flashes is one of the most common side effects of androgen deprivation therapy
Hot flashes is one of the most common and debilitating side effect of androgen deprivation therapy and of novel androgen blocking agents1,2 Occurs in up to 80% of men treated with ADT (leuprolide or degarelix) with 30- 40% having moderate to severe hot flashes1-3 Symptoms do not subside over time ◆
Slide 15: Estrogen deficiency side effects of androgen deprivation therapy
Estrogen deficiency Side effects of androgen deprivation therapy ADT reduces testosterone and estrogen to castration levels ◆ ADT lowers testosterone to castrate levels. As estrogen is derived from testosterone, ADT lowers estrogen levels too! ◆ Estrogen deficiency related side effects ◆ Hot flashes
Slide 16: Zuclomiphene is a weak oral estrogen receptor agonist
Zuclomiphene is a weak oral estrogen receptor agonist Clomiphene Zuclomiphene (aka cis-clomiphene) (CLOMID) ≈70% ≈30% ◆ Isolated cis-clomiphene from CLOMID (30% cis- and 70% trans-clomiphene; approved in 1967 for female infertility) ◆ Zuclomiphene is an oral weak estrogenic agent1 never approved as
Slide 17: Zuclomiphene as a part of CLOMID has a long safety database
Zuclomiphene as a part of CLOMID (clomiphene) has a long safety database Zuclomiphene (aka cis-clomiphene) ◆ FDA database and scientific literature show Clomiphene zuclomiphene component of CLOMID is well 88,837 tolerated with over 88,000 men/year using CLOMID off label for infertility or hypogonadi
Slide 18: Zuclomiphene clinical development plan: Phase 2 trial design
Zuclomiphene clinical development plan: Phase 2 trial design Phase 2 placebo controlled dose finding study Top line data expected summer 2019 Placebo Plan to enroll ≈100 men who have moderate & Randomize severe hot flashes on ADT in ≈ 17 US clinical sites 10 mg ◆ Primary efficacy endpoint- change in
Slide 19: Zuclomiphene: potential to be the first FDA approved drug for hot flashes
Zuclomiphene: potential to be the first FDA approved drug for hot flashes caused by prostate cancer hormone therapy Market potential ◆ Indication: treatment of castration-induced hot flashes in men with advanced prostate cancer on ADT ◆ Estimated 600,000 men on hormonal therapies (androgen deprivati
Slide 20: Androgen deprivation therapy - current situation
Androgen deprivation therapy - current situation GnRH Antagonist Commercial Opportunity LHRH Agonist FIRMAGON® (degarelix)(SC) Long-acting products: LUPRON® Depot (IM) and ELIGARD® (SC) are leuprolide products • Loading Injection of 240mg in 6 mL (2 injections of 3mL each) • Concern over initial T “
Slide 21: VERU-100 a biologic for the treatment of advanced prostate cancer
VERU-100 a biologic for the treatment of advanced prostate cancer Target product profile • Novel proprietary GnRH antagonist decapeptide formulation1 • 3 month slow release subQ depot (<1 cc SQ injection) and no loading dose • Immediate testosterone suppression no initial testosterone surge • Suppre
Slide 22: VERU-100 clinical development program - now have FDA clarity
VERU-100 for the treatment of advanced prostate cancer Clinical development program- now have FDA clarity • PreIND meeting with FDA 4/22/19 reached agreement on an expedited regulatory pathway: • Single Phase 2 – Open label, multicenter dose finding study of three doses of VERU-100 in men with advan
Slide 23: VERU-100 Market as ADT for advanced prostate cancer
VERU-100 Market as ADT for advanced prostate cancer Total global sales of ADT drugs in 2018 was $2.6 billion VERU-100 would have peak sales of $750 million with 28% global market share Intellectual property ◆ Formulation patents owned by Veru pending expiry 2038 23
Slide 24: Disease focused: Prostate cancer continuum of care
Disease focused: Prostate cancer continuum of care Prostate Cancer Progression and Therapy VERU-100 3 month depot (Long Acting GnRH Antagonist ADT) Zuclomiphene (Treatment of hot flashes and other side effects of ADT) PSA levels and tumor volume VERU-111 VERU-111 Oral Antitubulin Oral Antitubulin De
Slide 25: Urology Specialty Pharmaceuticals
Urology Specialty Pharmaceuticals 25
Slide 26: TADFIN tablet (tadalafil 5mg + finasteride 5mg combo)
TADFINTM tablet (tadalafil 5mg + finasteride 5mg combo) to improve compliance & safety Co-administration of CIALIS (tadalafil 5 mg) and Each component is approved for: PROSCAR (finasteride 5 mg) is currently ◆ CIALIS (tadalafil 5 mg) daily- symptoms of approved for the initial treatment of symptoms
Slide 27: Coadministration of Tadalafil and Finasteride more effective than finasteride alone
Coadministration of Tadalafil and Finasteride for 6 months more effective than finasteride alone to treat men with lower urinary tract symptoms and BPH1 BPH symptom score ED symptom score Safety ◆ International, randomized, double-blind study in approximately 700 men ◆ 350 men treated with placebo +
Slide 28: Successful Proprietary TADFIN tablet BA/BE study
Successful Proprietary TADFINTM tablet BA/BE study • Single dose randomized two period, crossover study in 33 healthy males over the age 45 years • Successful BA/BE study • Tadalafil Cmax in TADFIN is 25% less than Tadalafil alone • Process of getting 6 month stability data on commercial batches • N
Slide 29: TADFIN for benign prostatic hyperplasia - market
TADFINTM for benign prostatic hyperplasia - market Market potential • BPH market is up to 25% of male population and estimated 1.1 billion males world wide in 20181 • Independent market research by MME and telemedicine estimates US and global markets to be >$200 million • Target men who have enlarge
Slide 30: Roman Swipes (PREBOOST; 4% benzocaine wipes for premature ejaculation)
Roman Swipes (PREBOOST® ; 4% benzocaine wipes for premature ejaculation) Veru signed supply and distribution agreement with Get Roman (Roman Health Ventures Inc.) Q2 FY 2019 ◆ Telemedicine company ◆ Multi-year US supply and distribution agreement ◆ Minimum sales requirement obligates purchase of mil
Slide 31: FC2 Female Condom business revenues is growing
FC2 Female Condom® business revenues is growing FC2 Female Condom only FDA approved female use product that protects against pregnancy & STDs ◆ Sold in U.S. and 149 countries ◆ Manufacturing plant with 100 million units annual capacity ◆ Public sector represents approx. 61% of revenue (customers inc
Slide 32: Financial highlights: FC2 US prescription business net revenues
Financial highlights: FC2 US prescription business net revenues FC2 US Rx Net Revenues $2,594,271 $2,440,045 $1,563,694 $304,098 $372,981 $153,445 Q1 FY18 Q2 FY18 Q3 FY18 Q4 FY18 Q1 FY19 Q2 FY19 32
Slide 33: Financial highlights: Veru Business Mar FYTD 2018 versus Mar FYTD 2019
Financial highlights: Veru Business Mar FYTD 2018 versus Mar FYTD 2019 Net Revenues Gross Profit Operating Loss $13,347,924 $9,252,931 $5,159,485 $2,511,557 $(3,136,317) $(12,133,131) Mar FYTD18 Mar FYTD19 33
Slide 34: Financial highlights (in millions)
Financial highlights (in millions) Capitalization – approximately 62.8 million1 common shares outstanding as of March 31, 2019 Revenue Estimate for FY 2019 between $29 and $32 Results of Operations for Mar FYTD 2019 ◆ Net revenues $ 13.3 ◆ Gross profit $ 9.3 ◆ Operating loss $ 3.1 Balance sheet as o
Slide 35: Veru projected milestones
Veru projected milestones PRODUCT INDICATION 2019 2020 2021 2022 2023 PROTATE CANCER NOVEL MEDICINES VERU-111 Castration resistant metastatic prostate P1b P2 P3 NDA US launch Oral antitubulin cancer Zuclomiphene Hot flashes caused P2 P3 NDA US launch citrate by ADT VERU-100 Advanced hormone GnRH ant
Slide 36: Key takeaways
Key takeaways • Clinical stage assets in prostate cancer supportive care and treatment will have patient results in 2019 for VERU-111 and Zuclomiphene • VERU-111 Phase 1b/2 for metastatic castration and androgen blocking agent resistant prostate cancer • Zuclomiphene Phase 2 for hot flashes in men o