Veru Inc. · NASDAQ:VERU
Veru — The Female Health Company — Investor Presentation (December 2016)
32 slides from Veru's investor presentation, December 2016
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 December 2016
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
VERU HEALTHCARE A merger of a public and a private company October 31, 2016 The Female Health Company + = Combined Capitalization Combined Financial Highlights • Approximately 53M1 common shares outstanding As of and for the Six Months Ended March 31, 2016 on fully diluted/converted basis (in millio
Slide 4: Public health sector product with $33 million of revenue in fiscal year 2015
THE FEMALE HEALTH COMPANY Public health sector product with $33 million of revenue in fiscal year 2015 • FC2 Female Condom is primarily a public health sector product • Sold in US and 144 countries • Over 500 million units sold to date • 62 million units sold in 2015 • Public sector represents appro
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: Addressing large global markets
VERU HEALTHCARE Addressing large global markets Men Women • Prostate cancer, including side • Breast cancer >$3 billion7 effects of treatments, >$6.4 • Ovarian cancer >$1.5 billion8 billion1 • Protection against pregnancy • Benign prostatic hyperplasia and sexual transmission of (BPH) >$5.2 billion2
Slide 7: Deep clinical and industry expertise
EXPERIENCED MANAGEMENT TEAM Deep clinical and industry expertise Mitchell Steiner, MD Daniel Haines, CPA CEO and President. Urologist, Aspen Park Chief Financial Officer. Lennar Corp, Equity One, OPKO Pharmaceuticals, OPKO Health, Inc. and GTx, Inc. Health, Inc. and Ernst & Young. Harry Fisch, MD Sh
Slide 8: 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 9: NOW
NOW A Leading Men’s and Women’s Health and Oncology Company
Slide 10: Public health sector product with $33 million of revenue in fiscal year 2015 - Now a dedicated division
THE FEMALE HEALTH COMPANY Public health sector product with $33 million of revenue in fiscal year 2015 - Now a dedicated division of 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 market
Slide 11: 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 3 Device) • Non-hormonal birth control alternativ
Slide 12: PREBOOST (4% benzocaine wipe)
CONSUMER HEALTH PRODUCTS PREBOOST® (4% benzocaine wipe) • PREBOOST – temporarily prolong time to ejaculation • Only individual medicated wipe containing benzocaine • Temporarily desensitizes penis after topical application • Packaged as 10 wipes at $29.99 per box • Planned launch of product Q4 2016
Slide 13: SOON
SOON A Leading Men’s and Women’s Health and Oncology Company 13
Slide 14: 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. | 28/12/16 PreIND meeting: FDA does not require new IND and single BE study would be 14 acceptable as a 505(b)(2). | 3Projected costs through 2018
Slide 15: 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 16: FLOMAX and generic tamsulosin have ~80% market share of $4.1B Market
TAMSULOSIN DRS for BENIGN PROSTATIC HYPERPLASIA (BPH) FLOMAX® and generic tamsulosin have ~80% market share of $4.1B Market $4.1B All Alpha Blockers Tamsulosin $3.5B Tamsulosin $337M Long-term Care Source: IMS Health Data March 2015 1.Sura L et al. Clinical Interventions in Aging 7:287-298 2012 16
Slide 17: No sales force initially needed - pharmacy switch strategy
TAMSULOSIN DRS for BENIGN PROSTATIC HYPERPLASIA (BPH) No sales force initially needed - pharmacy switch strategy • Tamsulosin DRS – Brand Name • Not a generic and will have unique NDC code • Differentiate from generics by pricing at 70% of FLOMAX® • Focus on Long-term care populations • 13% of marke
Slide 18: Anticipated clinical development plan 505(b)(2)
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, multiple formulations, single dose • Stage 2 – 28 patients, 25 day study, selected formulation vs. FLOMAX® 1 8/12/16 PreIND m
Slide 19: 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 idi
Slide 20: FDA advisory committee presentation
MSS – 722 FOR MALE INFERTILITY FDA advisory committee presentation • FDA Advisory Committee Presentation – December 6, 2016 • Agenda: discuss appropriate clinical trial design features, including acceptable endpoints for demonstrating clinical benefit, for drugs intended to treat secondary hypogonad
Slide 21: 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 22: Clinical development plan 505(b)(2)
MSS – 722 FOR MALE INFERTILITY Clinical development plan 505(b)(2) Indication: Infertility in men with hypogonadism • Phase 2 • 7.5 month duration • 2.5 month interim analysis • Approximately 120 patients 22
Slide 23: 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 24: FUTURE
FUTURE A Leading Men’s and Women’s Health and Oncology Company
Slide 25: Plan is to prioritize and stagger programs to match resources.
PRESCRIPTION PRODUCTS Plan is to prioritize and stagger programs to match resources. 1Projected costs through 2018 milestones as noted assume each project immediately advanced. | 2Subject to 3% running royalty rate. 25
Slide 26: 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 27: 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 28: 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 29: 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 30: Flow of clinical & regulatory news creates opportunities to influence shareholder value
ANTICIPATED MILESTONES Flow of clinical & regulatory news creates opportunities to influence shareholder value 2016 2017 2018 PREBOOST • Launch • Expand into US prescription • Expand into US prescription FC2 markets markets • Complete PreIND meeting • Complete BE study • Launch • IND • preNDA meetin
Slide 31: Veru Healthcare/The Female Health Company maximizes short- and long-term shareholder value
Veru Healthcare/The Female Health Company maximizes 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 to shareholders FUTURE New Innovativ
Slide 32: A Leading Men's and Women's Health and Oncology Company
A Leading Men’s and Women’s Health and Oncology Company 32
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