Exhibit 99.2
| Agile Therapeutics Progress and Results |
| Forward-Looking Statement Certain information contained in this presentation and other matters discussed today or answers that may be given in response to questions may include “forward-looking statements”. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements are subject to important factors, risks and uncertainties, including, but not limited to, the success, timing and cost of our ongoing clinical trials and anticipated clinical trials for our current product candidates, including statements regarding the timing of initiation, enrollment and completion of the trials; the timing of and our ability to obtain and maintain U.S. Food and Drug Administration or other regulatory authority approval of, or other action with respect to, our product candidates; the Company’s ability to obtain the capital necessary to fund its operations; the Company’s ability to generate revenues; the successful implementation of the Company’s research and development programs and collaborations; the acceptance by the market of the Company’s products; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; and other factors, including general economic conditions and regulatory developments, not within the Company’s control. These factors could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this presentation and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstance. |
| Agile Investment Thesis $4.1 Billion US market for combined hormonal contraceptives (CHC) Twirla will be the only low dose CHC patch Significant Market Opportunity One successful Pre-approval Inspection (PAI) completed Pharmacokinetic profile confirms low estrogen dose Significant clinical experience in over 1,500 women that showed favorable safety and tolerability Twirla® is a Late-Stage Asset That We Continue to De-risk Confirmatory Phase 3 trial initiated Continued market development and commercial launch planning Additional products in development 7 patents, expected protection to 2028 Continuing to expand intellectual property portfolio Agile has Generated Significant Momentum |
| Combination Market $4.1 Billion Total US Contraceptive Market $5.5 Billion Progestin Only Market $1.4 Billion AG200-ER AG200-SP AG890 *EC = Emergency Contraception Source: IMS NSP, retail + non-retail through Sep 2014 Loestrin is a registered trademark of Actavis, Nuvaring is a registered trademark of Merck, Evra is a registered trademark of Johnson & Johnson Contraceptive Market is a Significant Opportunity Oral Contraceptive Pills $3.3 Billion Vaginal Ring Transdermal Patches $634 Million $158 Million Large Market Opportunity |
| Identification of higher than expected EE levels led to significant market share decline Ortho Evra Patch was the Most Successful Contraceptive Launch Sources: IMS NPA and NSP, Sept 2014 Ortho Evra Package Insert and van den Heuvel, Contraception 2005;72:168-174 Most successful contraceptive launch in history Reached TRx share of 11% and nearly $400 million in annual sales Labeled as 20ug/day EE Meteoric Rise Thromboembolic events (VTEs) reported to FDA Studies showed EE levels higher than 20µg/day (~56µg/day) Bolded warning added to Evra label in Nov 2005 Johnson & Johnson stopped active promotion Precipitous fall Mylan launched Xulane (generic equivalent to Evra) April 2014 Total patch share of the market remains at 1.5% of TRx Generic Entry Apr 02 Nov 05 Sep 09 Jun 14 FDA Bolded Warning Generic Entry Validated Market |
| Twirla® will be the Only Low-Dose Contraceptive Patch Contains the active ingredients levonorgestrel (LNG) and ethinyl estradiol (EE), which have over 25 years of history of use in contraceptives LNG is used as a standard for comparison of VTE risk among progestins EE is the synthetic estrogen in most currently marketed contraceptives Agile’s proprietary Skinfusion® technology provides hormone delivery in an appealing form Twirla is <1mm in thickness Peripheral Backing (soft, silky fabric) Peripheral Adhesive System Active Matrix Integrated into a single patch Release Liner Outer Ring Inner Ring |
| SUN MON TUE WED THU FRI SAT 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 How Would Women use Twirla? Well-established 21/7 regimen Women apply a patch once-a-week for three weeks followed by a 4th week without a patch Can be applied to abdomen, buttock, or upper torso Buttock 48% Abdomen 40% Source: Data on File, Agile Therapeutics Upper Torso 12% 7 days no patch |
| Twirla Product Development Summary Completed Phase 2 and 3 studies have enrolled over 2,100 women Over 1,500 women have received Twirla 485 women have received Twirla for 12 months Pharmacokinetic profile is consistent with a low-dose contraceptive* Twirla was well-tolerated with low rate of estrogen-associated adverse events** The Skinfusion technology performed well with daily activities and conditions, including showering, exercise, swimming, and heat/humidity Effectiveness in prior Phase 3 studies generally comparable to approved low-dose oral contraceptive (OC) comparators** *Archer DF, et al, Contraception 2012 Jun;85(6):595-601 **Kaunitz A, et al, Obstetrics and Gynecology 2014 Feb;123(2):1-10 Extensive Experience Results from prior studies have shown: |
| Twirla Regulatory Interactions and Clear Path Forward *Pooled data from 2 clinical trials, CL-12 and CL-13. Data on File, Agile Therapeutics, CRL response to FDA, Aug 2013 2014 2013 2012 2011 2010 Prior Phase 3 Trials Effectiveness comparable to low dose OC comparators* NDA Filed CRL Received FDA Requested New Phase 3 Study Pearl Index (effectiveness measure) results not sufficient for approval Study conduct issues Initiate Confirmatory Phase 3 Trial |
| Impact of New Users and Minorities on Twirla Pearl Index The Pearl Index (PI) is the primary measure of effectiveness for contraceptives The highest approved PI in the US is 3.2, and the highest approved upper bound of the 95% confidence interval is ~5.0 We believe clinical results were affected by study conduct issues at several sites, including rapid enrollment, high discontinuation and loss to follow-up rates 36% of on-drug pregnancies reported at 4 of 96 sites* Study population comprised high proportion of new users of hormonal contraception and minorities who are known to be at higher risk of non-compliance and pregnancy** Twirla PI Stratified by New Users and Minority Subjects Current usersa 0.0 Experienced usersb 3.0 New usersc 8.7 Black subjects who were new users 16.0 (a) Current users = subjects who used a hormonal contraceptive within seven days of enrollment (b) Experienced users = recent (used a hormonal contraceptive within 6 months of enrollment) and current users (c) New users = never used hormonal contraception (HC) or had not used HC in the 6 months prior to enrollment *These 4 sites represented 15% of the randomized subject population **Hatcher, et al. Contraceptive Technology 20th Ed, 2011, page 50 and Pooled data from 2 clinical trials, CL-12 and CL-13. Data on File, Agile Therapeutics, CRL response to FDA, Aug 2013 |
| Two Investigator meetings conducted 74 experienced sites selected and trained Subject screening, eDiary run-in commenced Sep 2014 Active treatment phase ongoing New Phase 3 Confirmatory Trial Initiated Simplified Study Design: Single-arm, open-label study ~2,100 subjects treated for up to 1 year |
| Why We Think the SECURE Study Will Be Successful Technology platforms allow real-time oversight Experienced CRO Electronic diary |
| Materials to Aid Compliance Website Text Messages eDiary Appointment Reminder Flip Chart Study Guide eDiary Insert Instructional Video |
| *Source: IMS sales retail + non-retail, MAT through Sept 2014 Loestrin and Minastrin a registered trademarks of Actavis (formerly Warner-Chilcott), Ortho Evra and Tri-Cyclen are registered trademarks of J&J, Yaz is a registered trademark of Bayer, Nuvaring is a registered trademark of Merck The CHC Market is Dominated by Branded Products AG200-ER AG200-SP Ring Patches Pills Combination Hormonal Contraceptive Market $4.1 Billion Brands Dominate |
| Branded Contraceptives Continue to Take Aggressive Price Increases Source: Price Rx Select, as of Dec 2014. *includes price increases which occurred through Dec 15, 2014 Avg. Price/cycle calculation includes 13 leading branded contraceptive products. Xulane launch price $95.12 Apr 2014. Avg. Annual Price Increase 2006 2007 2008 2009 2010 2011 2012 2013 2014* 12.2% 9.7% 10.3% 17.3% 13.5% 11.6% 7.7% 8.5% 11.3% Branded Potential |
| Twirla has Significant Peak Revenue Potential Revenue Potential for each Market Share Point is Significant Sources: IMS NPA Sept 2014 and Wolters Kluwer Price Rx Select, Dec 2014 Significant Potential 89.5 Million TRx (Total Market, 2014) $100 per cycle (Avg. WAC, 2014) 1.4 cycles/TRx (Avg. Rx size, 2014) 1% $126 Million per 1% TRx share |
| ObGyn Focus on Contraceptives Allows for Small Sales Force of ~70 to 100 Reps ObGyns and NP/PAs Account for ~70% of U.S. Contraceptive Prescriptions Source: IMS NPA, TRx Volume by Prescriber Type, 2013 Source: IMS NPA, TRX Volume by Category, 2010 Contraceptive TRx Volume by Prescriber Type ObGyn TRx Volume by Category ObGyn/NP’s 69% Focused Promotion ObGyns and NP/PAs Prescribe Contraceptives More than any Other Therapy |
| Agile Has Additional Products in Development |
| Agile Exclusivity Strategies for Twirla Expected Hatch-Waxman exclusivity (3 years) 7 issued patents to list in Orange Book Issued patents expire in 2021 (5) & 2028 (2) Additional patents under prosecution Limited patch manufacturers Transdermal know-how Specialized equipment Agile pipeline / line extensions Late-Stage De-Risked AG200-ER AG200-SP AG890 |
| Feb 2014 Dan Shames, MD joined Scientific Advisory Board (SAB) Former FDA Director, Division of Reproductive and Urologic Products/CDER Mar 2014 William McKee appointed to Board of Directors Former CFO, Barr Pharmaceuticals, LLC May 2014 Completed initial public offering (IPO) for $55 Million Jun 2014 Sixth U.S. patent granted on Skinfusion® transdermal technology – to list in Orange Book Jun 2014 Agile joins Russell Microcap® Index Jul 2014 Seventh U.S. patent - additional claims allowed for Skinfusion Aug 2014 clinical trial initiated Oct 2014 James Tursi, MD appointed to Board of Directors Chief Medical Officer, Auxilium Pharmaceuticals Nov 2014 John Hubbard, Ph.D. appointed to Board of Directors Former Head of Development Operations, Pfizer, Inc. Jan 2015 Completed Private Placement for $20 Million Agile Corporate Accomplishments Significant Momentum |
| Financial Profile Background and Recent Financings Initial Public Offering (IPO) Completed in May 2014 $55.0 Million gross proceeds (~$49.7 Million net proceeds) Private Placement Completed in January 2015 $20.0 Million gross proceeds (~19.3 Million net proceeds) Debt Facility of up to $25.0 Million (Hercules Technology Growth Capital) Completed in February 2015 $16.5 Million funded at loan closing (primarily to repay prior debt) Balance Sheet Data $45.7 Million cash on hand at September 30, 2014 18.6 Million common shares outstanding at September 30, 2014 3.4 Million common shares issued in January 2015 Private Placement |
| Development Milestones 2H 2015: Expected completion of patient enrollment 2H 2016: Expected last patient, last visit 2H 2016: Potential submission of CRL response 2H 2016: Qualification of commercial manufacturing line 1H 2015: Select product regimen(s); potential to initiate development of pipeline product 1 2 3 4 1 4 5 2 3 5 |
| Agile Investment Thesis $4.1 Billion US market for combined hormonal contraceptives (CHC) Twirla will be the only low dose CHC patch Significant Market Opportunity One successful Pre-approval Inspection (PAI) completed Pharmacokinetic profile confirms low estrogen dose Significant clinical experience in over 1,500 women that showed favorable safety and tolerability Twirla® is a Late-Stage Asset That We Continue to De-risk Confirmatory Phase 3 trial initiated Continued market development and commercial launch planning Additional products in development 7 patents, expected protection to 2028 Continuing to expand intellectual property portfolio Agile has Generated Significant Momentum |
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