Veru Inc. · NASDAQ:VERU
Veru — Female Health — Investor Presentation (December 2016)
32 slides from Veru's investor presentation, Dec 8, 2016
Slide 1: The Female Health Company: A Leading Men's and Women's Health and Oncology Company
The Female Health CompanyA Leading Men’s and Women’s Health and Oncology CompanyDecember 2016The Female Health Company/ Veru Healthcare NASDAQ: FHCOHeadquarters: Miami, FloridaOffices: Chicago, London, and Malaysia
Slide 2: Forward Looking Statements
Forward Looking StatementsThis 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 resultscould differ ma
Slide 3: Veru Healthcare: A merger of a public and a private company
VERU HEALTHCAREA merger of a public and a private company October 31, 20161a148a7145_logo-01.jpg+The Female Health Company=Combined Capitalization•Approximately 53M1common shares outstanding on fully diluted/converted basis•29M FHCO diluted shares outstanding prior to merger•2M Common and 547,756 40
Slide 4: FC2 Female Condom public health sector product
pg8-1.jpg•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 approx. 90% of revenue (customers include UNFPA, USAID, Brazil, and South Africa)•Manufacturing plant in Mal
Slide 5: Aspen Park Pharmaceuticals men's health product portfolio
ASPEN PARK PHARMACEUTICALSMen’s health product portfolioProductIndicationKey DifferentiationIntellectualPropertyExpected NDA filingCurrent US Market SizePREBOOSTPremature EjaculationOTC convenient individual medicated wipesPatent pending, expiry 2036FDA OTC preapproved$500 millionTamsulosin DRSBenig
Slide 6: Addressing large global markets
VERU HEALTHCAREAddressing large global markets1 MarketWatch 10/30/14 | 2GlobalData 11/8/11 | 3 Transparency Market Research 10/21/13 | 4 companiesandmarkets.com 6/30/11 5www.alliedmarketresearch.com 6 GlobalData 4/29/2014 | 7IMS 10/2/2014 | 8 Visiongain 7/31/2015Women•Breast cancer >$3 billion7•Ovar
Slide 7: Experienced Management Team
EXPERIENCED MANAGEMENT TEAMDeep clinical and industry expertiseDaniel Haines, CPA Chief Financial Officer. Lennar Corp, Equity One, OPKO Health, Inc. and Ernst & Young.Shiao ZhuVP of Marketing. Watson Pharmaceuticals and Actavis, Novartis, expensive experience in pharmaceutical launchesDenise Van Di
Slide 8: Strategy
STRATEGYUtilize cash from operations to develop and commercialize pharmaceuticals for men’s and women’s health and oncology•Debt fee, profitable 10 years•Added PREBOOST for men’s health•FC2 -significant opportunity seen in US prescription and expansion of public sector Profitable Operating CompanyPo
Slide 9: NOW
NOWA Leading Men’s and Women’s Health and Oncology Company
Slide 10: The Female Health Company
THE FEMALE HEALTH COMPANYFHC_FC2_LOGO•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 leader, will intensify efforts to grow product for immediate revenue•Appointed Denise van Dijk as President
Slide 11: Prescription Market Female Condom - Disposable Contraception Device
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 alternative •Ma
Slide 12: PREBOOST - temporarily prolong time to ejaculation
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•Compliant with FDA OTC monograph•Top line results of interim analys
Slide 13: SOON
SOONA Leading Men’s and Women’s Health and Oncology Company
Slide 14: 505(b)(2) Prescription Products
505(b)(2) PRESCRIPTION PRODUCTSPlan 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 acceptable as a 505(b)(2). | 3Projected costs through 2018 miles
Slide 15: Tamsulosin DRS for Benign Prostatic Hyperplasia (BPH)
TAMSULOSIN DRS for BENIGN PROSTATIC HYPERPLASIA (BPH)Alpha blockers most commonly prescribed drug class1Source: IMS Health Data March 2015 | 2Source: Clinical Interventions in Aging 2013:8 221–227•FLOMAX® (Tamsulosin HCl) is currently the number one prescribed alpha blocker treating the Medicare (lo
Slide 16: Tamsulosin DRS: ~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 MarketSource: IMS Health Data March 2015 1.Sura L et al. Clinical Interventions in Aging 7:287-298 2012$4.1BTamsulosinLong-term CareTamsulosin $3.5BAll Alpha Blockers$337M
Slide 17: Tamsulosin DRS: 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 market in long ter
Slide 18: Tamsulosin DRS: Anticipated clinical development plan 505(b)(2)
TAMSULOSIN DRS for BENIGN PROSTATIC HYPERPLASIA (BPH)Anticipated clinical development plan 505(b)(2)Indication: BPH18/12/16 PreINDmeeting: FDA does not require new IND and single BE study would be acceptable as a 505(b)(2). •BE Study Design•Stage 1 –18 patients, 18 day study, multiple formulations,
Slide 19: MSS-722 for Male Infertility: A growing and underserved market
MSS –722 FOR MALE INFERTILITY A growing and underserved market1Roth LW et al. Semin Reprod Med 31:245-250 2013 | 2Chehab M et al Fertil Steril 103:595-604 2015 | 3Whitten SJ etal Fertil Steril 86:1664-1668 2006 | 4Nachtigall LB et al. N Engl J Med 336:410-415 1997 | 5https://rarediseases.info.nih.go
Slide 20: MSS-722: 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 hypogonadism wh
Slide 21: MSS-722: Off label use of clomiphene growing
MSS –722 FOR MALE INFERTILITY Off label use of clomiphene is growing significantly year over yearSource: IMS Health Data –Moving Annual Total TRx over the past 3 years (2013 to 2015)ProductMAT Apr 2013TRxMATApr 2014TRxMAT Apr2015TRxCLOMIPHENE CIT869,286902,370915,851FEMALE709,518679,195630,825MALE15
Slide 22: MSS-722: 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
Slide 23: APP-944 for Hot Flashes
APP-944 FOR HOT FLASHESHot 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 experience
Slide 24: FUTURE
FUTUREA Leading Men’s and Women’s Health and Oncology Company
Slide 25: Prescription Products
PRESCRIPTION PRODUCTSPlan 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.
Slide 26: APP-111 for Advanced Prostate Cancer
APP-111 FOR ADVANCED PROSTATE CANCEROral 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 cancer)2•E
Slide 27: APP-111: Oral novel tubulin targeting chemotherapy
APP-111 FOR ADVANCED PROSTATE CANCEROral 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 (P-gp, MRPs, a
Slide 28: APP-111: Potential Platform Technology
APP-111 FOR ADVANCED PROSTATE CANCERPotential 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), and
Slide 29: APP-111: Clinical development plan
APP-111 FOR ADVANCED PROSTATE CANCERClinical 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 alone
Slide 30: Anticipated Milestones
ANTICIPATED MILESTONESFlow of clinical & regulatory news creates opportunities to influence shareholder value201620172018PREBOOST•Launch FC2•Expand into US prescription markets•Expand into US prescription marketsTamsulosin DRS•Complete PreIND meeting•IND•Initiate BE Study•Complete BE study•preNDA me
Slide 31: Veru Healthcare/The Female Health Company maximizes 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 NOWFUTUREA financially
Slide 32: A Leading Men's and Women's Health and Oncology Company
A Leading Men’s and Women’s Health and Oncology Company
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