Veru Inc. · NASDAQ:VERU
Veru — Veru Healthcare — Investor Presentation (June 2017)
31 slides from Veru's investor presentation, Jun 2, 2017
Slide 1: A Leading Men's and Women's Health and Oncology Company
A Leading Men’s and Women’s Health and Oncology Company Veru Healthcare NASDAQ: FHCO June 2, 2017
Slide 2: Forward Looking Statements
Forward Looking Statements This communication contains forward-looking statements. These statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ
Slide 3: About us
VERU HEALTHCARE About us • Started as The Female Health Company (NASDAQ CM: FHCO) • Incorporated in 1971, focus on manufacturing and marketing of only 1 product: the female condom • Received FDA approval for FC1 female condom in 1993 and for FC2 female condom in 2009 as a class 3 medical device. WHO
Slide 4: Experienced Management Team
EXPERIENCED MANAGEMENT TEAM Mitchell Steiner, MD – CEO/President Daniel Haines, CPA – Chief Financial Officer Urologist, Aspen Park Pharmaceuticals, OPKO Health, Inc. and GTx, Inc. Lennar Corp, Equity One, OPKO Health, Inc. and Ernst & Young. Harry Fisch, MD – Chief Corporate Officer Brian Groch – C
Slide 5: Pharmaceutical Pipeline
PHARMACEUTICAL PIPELINE Veru Healthcare Product Indication Target Preclinical Phase 1 Phase 2 Phase 3 Filing Marketed Protection FC2 female condom Barrier STD and (Class 3 medical device) contraception pregnancy PREBOOST Premature (4% benzocaine) ejaculation Desensitizer Tamsulosin DRS Super Selecti
Slide 6: Men's Health
Men’s Health 505(b)(2) products A Leading Men’s and Women’s Health and Oncology Company
Slide 7: 505(b)(2) Prescription Men's Health Products
505(b)(2) PRESCRIPTION MEN’S HEALTH PRODUCTS Lower risk, shorter time, and less cost to access large markets 7
Slide 8: Tamsulosin DRS for BPH: Alpha blockers most commonly prescribed drug class
TAMSULOSIN DRS for BENIGN PROSTATIC HYPERPLASIA (BPH) Alpha blockers most commonly prescribed drug class • FLOMAX® (tamsulosin HCl) is currently the number one prescribed alpha blocker treating the Medicare long-term care population1 • Difficulty swallowing (dysphagia) is a major problem with a 15%
Slide 9: Tamsulosin DRS: Anticipated clinical development plan
TAMSULOSIN DRS for BENIGN PROSTATIC HYPERPLASIA (BPH) Anticipated clinical development plan 505(b)(2) Indication: BPH • Bioequivalence (BE) Study Design • Stage 1 (completed) – 12 patients, single dose FLOMAX fed versus Tamsulosin DRS fed and fasted results reported successful Stage 1 study : • Tams
Slide 10: FLOMAX and generic tamsulosin have ~80% US market share
TAMSULOSIN DRS for BENIGN PROSTATIC HYPERPLASIA (BPH) FLOMAX® and generic tamsulosin have ~80% US market share $4.1B All Alpha Blockers sales $3.5B FLOMAX® and tamsulosin generic sales FLOMAX® and tamsulosin generic $337M sales in long-term care Source: IMS Health Data March 2015 and Sura L et al. C
Slide 11: Opportunity to introduce new branded BPH product
TAMSULOSIN DRS for BENIGN PROSTATIC HYPERPLASIA (BPH) Opportunity to introduce new branded BPH product • Our product is NOT a generic and pricing strategy will be more comparable to FLOMAX® (AWP=$828.06/100 tablets WAC=$731.45/100 tablets as of 3/8/2016 Kinray Cardinal Health) • Advantages of new fo
Slide 12: MSS-722 for Male Infertility: A growing and underserved market
MSS–722 FOR MALE INFERTILITY A growing and underserved market • Infertility affects 6.1 million couples in US, which is 15% of all couples trying to conceive1 • 50% of infertility is attributed to males who present with abnormal semen analysis1,2 • 2% of infertile men have adult onset form of hypogo
Slide 13: MSS-722 Clinical Development
MSS–722 FOR MALE INFERTILITY CLINICAL DEVELOPMENT 505(b)(2) Indication: men with low sperm count and low testosterone as a cause of their male infertility • Clinical Trial Design • Patient population: Men who have testicular dysfunction which oligozoospermia (impaired spermatogenesis) and hypogonado
Slide 14: Off label market in men has been growing significantly
MSS–722 FOR MALE INFERTILITY Off label market in men has been growing significantly year over year Number of Prescriptions Number of Patients MAT Apr 2013 MAT Apr 2014 MAT Apr 2015 Product TRx TRx TRx CLOMIPHENE CIT 869,286 902,370 915,851 FEMALE 709,518 679,195 630,825 MALE 156,691 220,083 282,198
Slide 15: APP-944 for Hot Flashes in men on prostate cancer therapy
APP-944 FOR HOT FLASHES Hot flashes in men on prostate cancer hormonal therapy • Hot flashes are the most common and distressing side effect of androgen deprivation therapy and other hormone therapies for prostate cancer • Up to 80% of men treated with hormone therapies like Lupron and Zoladex exper
Slide 16: Market: Hot flashes in men on prostate cancer hormonal therapy
APP-944 FOR HOT FLASHES Market: Hot flashes in men on prostate cancer hormonal therapy • Oral agent to treat hot flashes in men who have advanced prostate on hormonal therapy • LHRH agonists and antagonists (androgen deprivation therapy) • Abiraterone • Enzalutamide • Added benefits: treatment of es
Slide 17: Oncology
Oncology A Leading Men’s and Women’s Health and Oncology Company
Slide 18: Oncology Products: Large premium market opportunities
ONCOLOGY PRODUCTS Large premium market opportunities to increase enterprise value New chemical entity 18
Slide 19: APP-111: Oral novel agent that targets α and β subunits of tubulin
APP-111 FOR ADVANCED PROSTATE CANCER Oral novel agent that target α and β subunits of tubulin • Emerging Indications for anti-tubulins like αβ tubulin inhibitor • Second line: enzalutamide and abiraterone/prednisone have almost complete cross resistance and should not be used in sequence in advanced
Slide 20: APP-111: Oral novel agent that targets α and β subunits of tubulin
APP-111 FOR ADVANCED PROSTATE CANCER Oral novel agent that target α and β subunits of tubulin • Proof-of-concept preclinical studies were successful. We have a drug!! • Low nanomolar tubulin inhibition • Binds to both α and β subunits of tubulin • High oral bioavailability • High brain penetration •
Slide 21: APP-111 Clinical development plan
APP-111 FOR ADVANCED PROSTATE CANCER Clinical development plan Indication: Advanced Prostate Cancer • Preclinical- Matt Gosnell PhD and Robert Getzenberg PhD • Manufacture drug substance • 28 day animal study and safety pharmacology • Phase 1 - April 2018 IND • APP-111 for men with metastatic castra
Slide 22: APP-111 Potential Platform Technology
MARKET: APP-111 FOR ONCOLOGY APP-111 (αβ TUBULIN INHIBITOR) Potential Platform Technology: FOCUS ON OTHER TUMORS THAT RESPOND TO IV ANTI-TUBULINS • Current Market for prostate cancer • $5 billion market for secondary hormone therapies for prostate cancer1 • $4.8B market for vinca alkaloids & taxanes
Slide 23: Commercial Products
Commercial Products A Leading Men’s and Women’s Health and Oncology Company
Slide 24: FC2 Product had ~$22 million of revenue in fiscal year 2016
THE FEMALE HEALTH COMPANY DIVISION for PUBLIC GLOBAL HEALTH SECTOR FC2 Product had~$22 million of revenue in fiscal year 2016 • FC2 Female Condom only product that protects against pregnancy and STD • Sold in US and 144 countries • Over 550 million units sold to date • Public sector represents appro
Slide 25: FC2 prescription business in United States launched April 2017
PRESCRIPTION MARKET FEMALE CONDOM FC2 prescription business in United States as new revenue launched April 2017 • FC2 is the only FDA approved female condom as a Class III medical device • Fully reimbursable by private and public insurance: • Mandated by Affordable Care Act (ACA) 2010 • Grandfathere
Slide 26: Commercial strategy for FC2 prescription business in US
PRESCRIPTION MARKET FEMALE CONDOM Commercial strategy for FC2 prescription business in United States • Call to action against sexually transmitted disease epidemic including Zika virus, HPV, and HIV • $16 billion US expense • Established pricing, national distribution agreements, and fulfillment inf
Slide 27: PREBOOST (4% benzocaine wipe)
CONSUMER HEALTH PRODUCTS PREBOOST® (4% benzocaine wipe) • PREBOOST – prevention of premature ejaculation • Only individual medicated wipe containing benzocaine • Temporarily desensitizes penis after topical application • Launched Q1 2017 • Compliant with FDA OTC monograph • Plan to find major OTC di
Slide 28: Corporate Commercial Strategy
CORPORATE COMMERCIAL STRATEGY Utilize cash from operations to develop and commercialize pharmaceuticals for men’s and women’s health and oncology New Innovative Drugs Large premium global market opportunities 505(b)(2) Drugs Partnerships with large pharma More revenue starts in 2018 Profitable Opera
Slide 29: Financial highlights
VERU HEALTHCARE Financial highlights Capitalization Financial Highlights (in millions) • Approximately 53.3M1 common shares outstanding on fully diluted/converted P&L - Year ended September 30, 20163 basis Net Revenues $22.1 • 31.3M FHCO diluted shares outstanding Gross Profit $13.3 prior to merger
Slide 30: Anticipated Milestones
ANTICIPATED MILESTONES Flow of clinical & regulatory news creates opportunities to influence shareholder value 2017 2018 • Launch Q1 PREBOOST • Partner 2H • Launch US prescription business in NY and FL Q2 • Launch US prescription in other FC2 • Grow public sector- New Brazil and South African territ
Slide 31: A Leading Men's and Women's Health and Oncology Company
A Leading Men’s and Women’s Health and Oncology Company