Full Press Release Details
Veru Healthcare Proposed Merger of
Aspen Park Pharmaceuticals & The Female Health Company Transforming into A Leading Men's and Women's Health Care Company June 2016 Abbreviated NASDAQ: FHCO Exhibit 99.1
This communication contains
forward-looking statements, including those regarding the proposed merger transaction between FHC and APP and the integration of our two businesses. 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 materially from those expressed or implied by such statements. These risks and uncertainties include but are not limited to:
the risk that the proposed transaction may not be completed in a timely manner or at all; the satisfaction of conditions to completing the transaction, including the ability to secure approval by a two-thirds vote of FHC's shareholders; risks
that the proposed transaction could disrupt current plans and operations; costs, fees and expenses related to the proposed transaction; risks related to the development of APP's product portfolio, including regulatory approvals and time and cost to
bring to market; risks relating to the ability of the combined company to obtain sufficient financing on acceptable terms when needed to fund development and company operations; the risk that, even if it is completed, we may not realize the expected
benefits from the transaction; and other risks described in FHC's filings with the Securities and Exchange Commission ("SEC"), including our Annual Report on Form 10-K for the year ended September 30, 2015 and our Quarterly Reports
on Form 10 Q for the quarters ended December 31, 2015 and March 31,2016. These documents are available on the "SEC Filings" section of our website at http://fhcinvestor.com. All forward-looking statements are based on
information available to us as of the date hereof, and FHC does not assume any obligation and does not intend to update any forward-looking statements, except as required by law. 3_85 Forward Looking Statements
Additional Information about the
Proposed Transaction and Where You Can Find It FHC plans to file a proxy statement with the SEC relating to a solicitation of proxies from its shareholders in connection with a special meeting of shareholders of FHC to be held for the purpose of
voting on matters relating to the proposed transaction. BEFORE MAKING ANY VOTING DECISION WITH RESPECT TO THE PROPOSED TRANSACTION, FHC SECURITY HOLDERS ARE URGED TO READ THE PROXY STATEMENT AND OTHER RELEVANT MATERIALS WHEN THEY BECOME
AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. The proxy statement and other relevant materials, and any other documents filed by FHC with the SEC, may be obtained free of charge at the SEC's website
at www.sec.gov. In addition, shareholders of FHC may obtain free copies of the documents filed with the SEC by contacting FHC's Chief Financial Officer at (312) 595-9123, or by writing to Chief Financial Officer, The Female Health Company, 515 North
State Street, Suite 2225, Chicago, Illinois 60654. Interests of Certain Participants in the Solicitation FHC and its executive officers and directors may be deemed to be participants in the solicitation of proxies from the shareholders
of FHC in favor of the proposed transaction. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy
statement and other relevant materials to be filed with the SEC when they become available.
Men Prostate cancer, including side
effects of treatments, >$6.4 billion1 Benign prostatic hyperplasia (BPH) >$5.2 billion2 Sexual dysfunction >$4 billion3 Premature ejaculation >$500 million4 Male infertility >$700 million5 Gout >$1.5 billion6 Women Breast cancer
>$3 billion7 Ovarian cancer >$1.5 billion8 Protection against pregnancy and sexual transmission of HIV, Zika virus and STDs 3_85 Veru Healthcare Addressing Large Global Markets MarketWatch 10/30/14 2. GlobalData 11/8/11 3. Transparency Market
Research 10/21/13 4. companiesandmarkets.com 6/30/11 5. www.alliedmarketresearch.com 6. GlobalData 4/29/2014 7. IMS 10/2/2014 8. Visiongain 7/31/2015
Mitchell Steiner, MD - CEO and
President. Urologist, Aspen Park Pharmaceuticals, OPKO Health, Inc. and GTx, Inc. Harry Fisch, MD - Chief Corporate Officer. Urologist, Aspen Park Pharmaceuticals and Millennium Sciences, Inc. Daniel Haines, CPA - Chief Financial Officer.
E&Y, Equity One, Inc. (NYSE:EQY), OPKO Health (NYSE:OPK) and Lennar Corp (NYSE:LEN) Expected to join at closing: Chief Medical Officer VP Clinical Development VP of Chemistry, Manufacturing, and Controls 3_81 Experienced Management Team for Veru
Healthcare Clinical and Industry Expertise
3_85 Veru Healthcare A Men's and
Women's Health Care & Oncology Company Focused on Pharmaceutical and Consumer Health Products Veru Healthcare Women's Health Men's Health Tamsulosin DRS- BPH MSS-722- Male infertility APP-944- Hot flashes prostate cancer
APP-111- Prostate cancer APP-111/112- Gout and FMF APP-111- Breast cancer APP-111- Ovarian cancer PREBOOST Sexual health supplement FC2 Warming lube w/niacin Sexual health supplement Drugs Consumer Health Products Separate men's and
women's health divisions Drugs Consumer Health Products
Men's Health Division
Pharmaceuticals and Products Candidates in Development Benign prostate hyperplasia Tamsulosin Delayed Release Sachet (DRS) 505(b)(2) FDA pathway Bioequivalence study planned Q4 2016 and file NDA 2017 U.S. patent on proprietary formulation applied
for in 2016 Male infertility MSS-722, oral drug product candidate 505(b)(2) FDA pathway & orphan drug eligible confirmed by FDA 5/28/15 Increases GnRH, LH & FSH and restores sperm production Planned Phase 2 Q4 2016 2 issued U.S. patents with
expiration in 2021. Also seeking FDA orphan drug status exclusivity. Addition provisional application being enhanced. Hot flashes in men with prostate cancer on prostate cancer hormonal therapies APP-944, oral drug product candidate 505(b)(2) FDA
pathway PreIND meeting with FDA planned Q3 2016 PCT provisional application filed in 2015 3_85
Men's Health Division
Pharmaceuticals and Products Candidates in Development Anti-tubulin cytotoxic therapy prostate cancer APP-111, oral tubulin targeting chemotherapy drug product candidate New chemical entity Preclinical toxicology study 2016 Phase 1a/1b planned 2017
Licensed IP includes 3 U.S. issued patents with expiration in 2029 with possible extension to 2034. Numerous foreign issuances and applications. Gout and Familial Mediterranean Fever (MEFV mutations) APP-111/112,oral agent that binds tubulin with
wide therapeutic index New chemical entity Preclinical toxicology 2016 Phase 1 planned 2017 Licensed IP includes 3 U.S. issued patents with expiration in 2029 with possible extension to 2034. Numerous foreign issuances and applications. 3_85
Alpha blocker benign prostatic
hyperplasia (BPH) therapeutics class generated $4.1 billion in U.S. pharmacy sales1 (in 2014) 12% is associated with long-term care facilities1 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 a15% prevalence for the elderly, and 60% for those men living in long-term care facilities2 Solution and powder formulations are preferred in long-term
care setting Poor compliance with alpha blocker BPH drugs leads to increased risk of acute urinary retention, urosepsis and death APP's Tamsulosin DRS is a novel oral formulation for men with BPH and swallowing difficulties. 3_85 Benign
Prostate Hyperplasia, Well-Established Market Alpha Blockers Most Commonly Prescribed Drug Class 1 Source: IMS Health Data March 2015 2 Source: Clinical Interventions in Aging 2013:8 221-227
BPH Alpha Blocker Sales Tamsulosin
(FLOMAX ) Has ~85% Market Share ATC4 MAT Mar 2015 TRx MAT Mar 2015 TRx Market Share MAT Mar 2015 TRx Pharmacy $ MAT Mar 2015 TRx Pharmacy $ Market Share MAT Mar 2015 EUTRx $/Unit G04C2 BPH A-ADRENERG ANTAG PLN 29,233,610 100.00% $4,142,576,343
100.00% 1,478,295,890 2.80 TAMSULOSIN 23,317,951 79.76% $3,475,988,912 84.84% 1,150,429,482 3.02 COMBINED RETAIL 18,399,025 78.90% $2,606,030,239 88.56% 883,435,533 2.95 LONG-TERM CARE 3,131,953 13.43% $336,594,324 11.44% 86,185,219 3.91 MAIL
SERVICE 1,759,171 7.54% $ 527,632,160 0.00% 178,865,537 2.95 SPECIALTY MAIL SERVICE 27,802 0.12% $ 5,732,189 0.00% 1,943,193 2.95 TERAZOSIN 3,747,430 12.82% $224,324,678 5.45% 225,105,689 1.00 COMBINED RETAIL 3,014,920 80.45% $173,334,504 91.73%
178,021,751 0.97 LONG-TERM CARE 377,636 10.08% $15,621,210 8.27% 10,758,540 1.45 MAIL SERVICE 348,340 9.30% $ 34,867,700 0.00% 35,810,579 0.97 SPECIALTY MAIL SERVICE 6,534 0.17% $ 501,264 0.00% 514,819 0.97 SILODOSIN 960,001 3.28% $243,925,303 5.53%
41,088,243 5.94 COMBINED RETAIL 797,089 83.03% $183,758,517 95.87% 30,994,595 5.93 LONG-TERM CARE 63,001 6.56% $7,921,218 4.13% 1,281,375 6.18 MAIL SERVICE 99,645 10.38% $ 52,160,242 0.00% 8,797,881 5.93 SPECIALTY MAIL SERVICE 266 0.03% $ 85,326
0.00% 14,392 5.93 ALFUZOSIN 1,208,228 4.13% $198,337,450 4.18% 61,672,476 3.22 COMBINED RETAIL 974,681 80.67% $140,176,755 96.58% 43,813,168 3.20 LONG-TERM CARE 48,917 4.05% $4,960,066 3.42% 1,231,101 4.03 MAIL SERVICE 182,833 15.13% $ 52,741,746
0.00% 16,484,780 3.20 SPECIALTY MAIL SERVICE 1,797 0.15% $ 458,883 0.00% 143,427 3.20 Source: IMS Health Data March 2015
Initiate a contracting strategy with
specialty GPOs to provide immediate access to long term care population 12% of market in long term care facilities 2 Labs, Inc. has expertise in contracting with all third party logistics and providers Tamsulosin DRS can be differentiated in
pharmaceutical compendium Priced at 70% of branded tamsulosin (FLOMAX ) tablet, tamsulosin DRS could capture ~5% of the total alpha blocker BPH market in US: Tamsulosin DRS ~$300 million annually Grow revenue by pharmacy switch and by expanding
reach into geriatric PCPs & urologists Build awareness of a new formulation of gold standard product among geriatric and urology health care providers 15% of elderly men who are not in long-term care suffer from dysphagia and could provide
upside1 3_85 Tamsulosin DRS No Sales Force Needed- Pharmacy switch strategy 1.Sura L et al. Clinical Interventions in Aging 7:287-298 2012
Drug API/ Product Tamsulosin DRS
Anticipated Clinical Development Plan 505(b)(2) Indication: BPH 2015 2016 2017 BE study 140294_84 3_84 4_84 48_84 65_84 70_84 2Q 1Q 3Q 4Q 2Q 1Q 3Q 4Q 2Q 1Q 3Q 4Q PreIND Meeting 505(b)(2) File NDA 2018 2Q 1Q 3Q 4Q PreNDA Meeting 505(b)(2)
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
idiopathic hypogonadotropic hypogonadism (abnormal hypothalamic-pituitary-gonadal axis) 1-4 hCG injection (LH-like activity) and FSH injections are only FDA approved therapies4,5 Clomiphene (racemic mixture) is used as first line empirical therapy
in 90% of idiopathic infertile men6 Off-label use Most effective and safe dose as well as schedule are not known No FDA approved oral therapies5 MSS-722 is being developed as the first oral agent for the treatment of idiopathic male infertility 3_85
1.Roth LW et al. Semin Reprod Med 31:245-250 2013; 2.Chehab M et al Fertil Steril 103:595-604 2015; 3.Whitten SJ etal Fertil Steril 86:1664-1668 2006; 4. Nachtigall LB et al. N Engl J Med 336:410-415 1997. 5.
https://rarediseases.info.nih.gov/gard/diseases-with-medical-products/H 6.Ko EY et al J Urol 187:973-978 2012
FDA confirmed that MSS-722 qualifies
for 505(b)(2) pathway Utilize a fixed proprietary ratio of cis and trans isomers Indication of idiopathic male infertility with hypogonadotropic hypogonadism not due to primary testicular failure would be acceptable* Population - men with
hypogonadotropic hypogonadism (low testosterone levels) and infertility (low sperm counts) Acute therapy (5 months = 2 cycles) No carcinogenicity studies or additional animal studies would be required in this setting Primary endpoint that would
represent clinical benefit may be the proportion of men who become fertile (improvement in sperm count into fertile range) Orphan drug request sent to FDA January 7th 2016 18_85 11_84 MSS-722 Treatment of Male Infertility- FDA Meeting May 28th 2015
* Rare Diseases with FDA approved products- https://rarediseases.info.nih.gov/gard/diseases-with-medical-products/H
Drug API/ Product MSS-722 Clinical
Development Plan 505(b)(2) Indication: Infertility in Men with Hypogonadism 2015 2016 2017 Phase 2 Dose finding Interim analysis 2.5 months Final 5 months 120 patients 140294_84 3_84 4_84 48_84 65_84 70_84 2Q 1Q 3Q 4Q 2Q 1Q 3Q 4Q 2Q 1Q 3Q 4Q Phase 3
X 2 8 months PreIND Meeting 505(b)(2) File IND File NDA 2018 2Q 1Q 3Q 4Q
18_85 11_84 APP-944 Oral Drug
Product for the Treatment of 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 experience hot flashes Abiraterone and enzalutamide exacerbate hot flashes Currently, no FDA approved therapies to treat hot flashes in men on prostate cancer hormonal therapies 505(b)(2) pathway Market
700,000 men on androgen deprivation therapy in the US 30% penetration = 255,000 men translates to $700 million/year Gomella LG et al BJU Int S1:25-29 2007; Karling P, et al. J Urol 152:1170-1173 1994
APP-111 Oral Novel Tubulin Targeting
Chemotherapy for Advanced Prostate Cancer 4_81 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
Emerging Indications Secondary hormone therapies like enzalutamide and abiraterone/prednisone have almost complete cross resistance and should not be used in sequence in advanced prostate cancer3 Androgen deprivation therapy and docetaxel increase
survival in men with hormone sensitive prostate cancer and high volume disease4 Agents that target tubulin have been the only effective cytotoxic chemotherapy in advanced prostate cancer, but there are challenges5: Route of administration-only
available as IV dosing Drug resistance is common - multidrug resistance proteins, tubulin mutations and overexpression Safety concerns - hypersensitivity reactions, myelosuppression, and neurotoxicity (peripheral neuropathy & muscle
weakness) 1.MarketWatch 10/30/14; 2. Dimopoulos G Seeking Alpha 11/14/12; 3. Omlin A et al Therapeutic Advances in Urology 6:3-14 2014; 4. Sweeney C et al J Clin Oncol 32:5s 2014; 5.Diamond E et al Curr Treat Options Oncol 16:9 2015
APP-111 Oral Novel Tubulin Targeting
Chemotherapy 4_81 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, and BCRP)
Not substrate for CYP3A4 Demonstrated activity against taxane-, vinca alkaloid- and doxorubicin-refractory cancers High activity against many cancer types including prostate cancer in vitro and in vivo Favorable safety profile (less neurotoxicity
& leukopenia) Over 28 peer-reviewed publications
APP-111 Anticipated Clinical
Development Plan Indication: Enzalutamide Resistant Prostate Cancer 2015 2016 2017 140294_84 3_84 4_84 48_84 65_84 70_84 2Q 1Q 3Q 4Q 2Q 1Q 3Q 4Q 2Q 1Q 3Q 4Q 2018 2Q 1Q 3Q 4Q Drug API/ Product Open label Phase1a Phase 2 PreIND Meeting File IND Safety
Pharm & Acute Tox 28d nonclinical study Open label Phase1b
Market In the US, 8.3 million people
with gout and the incidence is increasing Global market for gout drugs exceeds $1.5 billion Colchicine is effective to treat and to prevent acute attacks, but has side effects such as abdominal cramping, nausea, and diarrhea Low therapeutic index
(low safety margin) Drug-drug interactions are common APP-111/112 is an oral, novel small molecule that binds to same drug target site as colchicine, but potentially better safety profile No drug-drug interactions, with potentially wide therapeutic
index (wider safety margin) 3_85 Gout is the Most Common Form of Inflammatory Arthritis in Men Over 40 Years of Age
18_85 11_84 Men's Health
Division Consumer Health Products PREBOOST Compliant with FDA OTC monograph Only individual medicated wipes containing benzocaine that temporarily desensitizes penis after topical application Helps in temporarily prolonging time to ejaculation
Each box contains 10 individually packaged medicated wipes priced at $29.99 per box Planned launch of product Q3 2016 Phase 4 to be completed in 2016
Men's Health Division 2016
2017 140294_84 3_84 4_84 48_84 65_84 70_84 2018 Products APP-111 advanced prostate cancer** Phase 1a Phase 2 Tamsulosin DRS For BPH* Phase 1b BE study NDA Launch MSS-722 for male infertility NDA Phase 2 Phase 3 APP-944 for hot flashes Phase 2 Phase