Veru Inc. · NASDAQ:VERU
Veru — The Female Health Company — Investor Presentation (January 2017)
31 slides from Veru's investor presentation, January 2017
Slide 1: The Female Health Company
The Female Health Company A Leading Men’s and Women’s Health and Oncology Company The Female Health Company/ Veru Healthcare NASDAQ: FHCO Headquarters: Miami, Florida Offices: Chicago, London, and Malaysia January 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: A merger of a public and a private company October 31, 2016
VERU HEALTHCARE A merger of a public and a private company October 31, 2016 The Female Health Company + = 3
Slide 4: Public health sector product with ~$22 million of revenue in fiscal year 2016
THE FEMALE HEALTH COMPANY Public health sector product with ~$22 million of revenue in fiscal year 2016 • FC2 Female Condom is primarily a public health sector product • Sold in US and 144 countries • Over 500 million units sold to date • 42 million units sold in 2016 • Public sector represents appr
Slide 5: Men’s health product portfolio
ASPEN PARK PHARMACEUTICALS Men’s health product portfolio Expected Current US Product Indication Key Differentiation Intellectual Property NDA filing Market Size PREBOOST Premature Ejaculation OTC convenient individual Patent pending, expiry 2036 FDA OTC $500 million medicated wipes preapproved Tams
Slide 6: Deep clinical and industry expertise
EXPERIENCED MANAGEMENT TEAM Deep clinical and industry expertise Mitchell Steiner, MD Kevin Gilbert CEO and President. Urologist, Aspen Park SVP Corporate Development & Legal. JD & CPA, Legal Pharmaceuticals, OPKO Health, Inc. and GTx, Inc. & Corporate Development Consultant, Third Stream Bioscience
Slide 7: Utilize cash from operations to develop and commercialize pharmaceuticals
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 Operating Lower risk & les
Slide 8: NOW
NOW A Leading Men’s and Women’s Health and Oncology Company
Slide 9: Public health sector product with $22 million of revenue in fiscal year 2016
THE FEMALE HEALTH COMPANY Public health sector product with $22 million of revenue in fiscal year 2016 and now a dedicated division of the company • Valuable form of dual pregnancy and STI protection • Female Condom (FC2) primary focus will continue to be the global public health sector • As global
Slide 10: Create and grow prescription business in United States
PRESCRIPTION MARKET FEMALE CONDOM - DISPOSABLE CONTRACEPTION DEVICE (DCD) Create and grow prescription business in United States by converting public sector customer to prescription • DCD (FC2) is the only female condom FDA approved for market (Class III Device) • Non-hormonal birth control alternat
Slide 11: 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 • Packaged as 10 wipes at $29.99 per box • Launched Q1 2017 • Compliant with FDA
Slide 12: SOON
SOON A Leading Men’s and Women’s Health and Oncology Company 12
Slide 13: Plan is to prioritize and stagger programs to match resources
505(b)(2) PRESCRIPTION PRODUCTS Plan is to prioritize and stagger programs to match resources. 1Subject to installment payments upon certain milestones. | 3Projected costs through 2018 milestones as noted assume each project immediately 13 advanced.
Slide 14: 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 15: 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 Tamsulosin sales in $337M long-term care Source: IMS Health Data March 2015 1.Sura L et al. Clinical Interventions
Slide 16: Pharmacy switch strategy: No sales force initially needed
TAMSULOSIN DRS for BENIGN PROSTATIC HYPERPLASIA (BPH) Pharmacy switch strategy: No sales force initially needed • Tamsulosin DRS – will be our brand name • Our product is not a generic product and will have unique NDC code • Pricing could be at comparable to FLOMAX® (AWP=$828.06/100 tablets WAC=$731
Slide 17: Anticipated clinical development plan 505(b)(2) Indication: BPH
TAMSULOSIN DRS for BENIGN PROSTATIC HYPERPLASIA (BPH) Anticipated clinical development plan 505(b)(2) Indication: BPH • BE Study Design • Stage 1 – 18 patients, 18 day study, test multiple formulations, single dose • Stage 2 – 28 patients, 25 day study, selected single formulation vs. FLOMAX® 17
Slide 18: 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 conceive 1 • 50% of infertility is attributed to males who present with abnormal semen analysis1,2 • 2% of infertile men have adult onset form of hyp
Slide 19: FDA advisory committee presentation
MSS – 722 FOR MALE INFERTILITY FDA advisory committee presentation • FDA Advisory Committee Meeting – December 6, 2016 • Agenda: To discuss appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonadis
Slide 20: Off label use of clomiphene is growing significantly year over year
MSS – 722 FOR MALE INFERTILITY Off label use of clomiphene is 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 21: Clinical development plan: testicular dysfunction in men with low sperm concentrations
MSS – 722 FOR MALE INFERTILITY Clinical development plan 505(b)(2) Indication: testicular dysfunction in men with low sperm concentrations and hypogonadism 21
Slide 22: Hot flashes in men on prostate cancer hormonal 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 23: FUTURE
FUTURE A Leading Men’s and Women’s Health and Oncology Company
Slide 24: New chemical entity
PRESCRIPTION PRODUCTS Large premium market opportunities to increase enterprise value New chemical entity 1Projected costs through 2018 milestones as noted assume each project immediately advanced. | 2Subject to 3% running royalty rate. 24
Slide 25: Oral novel tubulin targeting chemotherapy for advanced prostate cancer
APP-111 FOR ADVANCED PROSTATE CANCER Oral novel tubulin targeting chemotherapy for advanced prostate cancer • Current Market • $5 billion market for secondary hormone therapies for prostate cancer1 • $4.8B market for taxanes & vinca alkaloids (Docetaxel $1B & cabazitaxel $500 million in prostate can
Slide 26: Oral novel tubulin targeting chemotherapy
APP-111 FOR ADVANCED PROSTATE CANCER Oral novel tubulin targeting chemotherapy • Proof-of-concept preclinical studies were successful. We have a drug!! • Low nanomolar tubulin inhibition • Binds to colchicine site of tubulin • High oral bioavailability • High brain penetration • Not substrate MDRs (
Slide 27: Potential Platform Technology: IV anti-tubulins
APP-111 FOR ADVANCED PROSTATE CANCER Potential Platform Technology: IV anti-tubulins have established activity against many other tumors • Vinca Alkaloids • Primarily used in combination chemotherapy (ABVD, Stanford-V, CHOP, MOPP) for hematologic malignancies (leukemia, lymphoma, myeloma, sarcoma),
Slide 28: Clinical development plan Indication: Advanced Prostate Cancer
APP-111 FOR ADVANCED PROSTATE CANCER Clinical development plan Indication: Advanced Prostate Cancer • Preclinical • Manufacture of API • 28 day animal study • Phase 1a • APP-111 combined with enzalutamide • Patients with metastatic castration resistant prostate cancer who progressed on enzalutamide
Slide 29: Flow of clinical & regulatory news creates opportunities
ANTICIPATED MILESTONES Flow of clinical & regulatory news creates opportunities to influence shareholder value 2017 2018 • Launch PREBOOST • Expand into US prescription FC2 markets • Complete BE study • Launch • preNDA meeting Tamsulosin DRS • File NDA for FDA • File MAA for EMA • File IND • Initiat
Slide 30: Grow both short- and long term shareholder value
Veru Healthcare/The Female Health Company Grow both short- and long term shareholder value (NASDAQ:FHCO) A leading men’s and women’s health and oncology company with a multi-product portfolio of promising potential products to provide near and future upside FUTURE to shareholders New Innovative Drug
Slide 31: A Leading Men’s and Women’s Health and Oncology Company
A Leading Men’s and Women’s Health and Oncology Company 31
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