Q XARACOLL Successful Phase 3 Results Confirm Innocoll s Technology Platform. Innocoll Corporate Presentation June 2016

Transcription

1 Q XARACOLL Successful Phase 3 Results Confirm Innocoll s Technology Platform Innocoll Corporate Presentation June 2016

2 Forward Looking Statements This presentation contains forward-looking statements about our ongoing development of XARACOLL and our other product candidates; our interpretation of the data and results from our MATRIX-1 and MATRIX-2 clinical trials; our plans for, and the expected timing of, our XARACOLL NDA submission with the FDA; our plans to develop and commercialize XARACOLL and its market potential; the potential therapeutic and other benefits of XARACOLL and our other product candidates; Innocoll's current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of XARACOLL, plans and objectives for present and future clinical trials and results of such trials, the risk that the FDA may not accept pooled data, plans and objectives for regulatory approval and other statements containing the words "anticipate," "believe," "estimate," "expect," "intend," "goal," "may", "might," "plan," "predict," "project," "target," "potential," "will," "would," "could," "should," "continue," and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of Forward-looking statements involve risks and uncertainties that may affect the company's business and prospects, including those discussed in our filings with the SEC, which includes, among other things, the actions and factors discussed in the "Risk Factors" section of our Annual Report on Form 20-F for the year ended December 31, 2015, and also on our website. All of our projections and other forward-looking statements represent our judgment as of today, June , and Innocoll does not take any responsibility to update such information. 2

3 2016 Innocoll Delivers Approvable post-op analgesic in the US Differentiated post-op analgesic Efficient in-house manufacturing Collagen platform for sustainable growth High value investment XARACOLL met primary endpoints with highly significant p-values Data and product characteristics for differentiation Expansion on-target XARACOLL results confirm platform; next brand will deliver Phase 3 results later this year Attractive high-margin growth opportunities 3

4 2016 Delivering on Attractive Growth Outlook For Surgical Adhesion Prevention IDE Registration Program Phase 3 for Diabetic Foot Infections Pivotal Phase 3 Program Results Phase 3 for Postoperative Pain Pivotal Phase 3 Program Results * These products have not been approved by the FDA and, therefore, the FDA has not determined their safety and effectiveness for commercial marketing and sale. Estimated timing. 4

5 Experienced Management Team Name Position Exp. Key Companies Anthony Zook President & CEO 30 yrs Jose (Pepe) Carmona Chief Financial Officer 20 yrs Lesley Russell, MBChB, MRCP Chief Medical Officer 25 yrs Rich Fante Chief Commercial Officer & Head of Business Development 25 yrs Charles Katzer VP Manufacturing and Technical Operations 43 yrs Nigel Jones VP Global Clinical Operations 28 yrs 5

6 Implantable collagen matrix with bupivacaine HCl for the management of postoperative pain long acting opioid-sparing targeted easy to use Analgesia for the critical time after surgery 1 Pain management designed to lower the opioid burden Targets both incisional and deep visceral pain Easily manipulated and readily conforms to the target site A XARACOLL matrix is approximately the width of 2 US quarters and contains 100 mg of bupivacaine HCl *Remains subject to FDA approval. 6

7 Program Design XARACOLL MATRIX Phase 3 Program Design Study Design Allowed Continuous Assessment Study Design for MATRIX 1 & patients 300 mg dose Background medication of 650 mg acetaminophen TID with rescue opioids as needed Primary Endpoint Time-weighted sum of pain intensity from Time 0 to 24 hours (SPI24) XARACOLL Matrix (n=200) Placebo Matrix (n=100) Day 0 Treatment Period / Visits Day 1 Day 2 Day 3 Safety (7 days) Follow-up Safety (15 days) Safety (30 days) Additional Endpoints 16 Secondary and 3 Exploratory endpoints focused on pain management and opioid consumption Time (hrs) MATRIX Implanted Clinic Visit; e-diary Collected Scheduled Pain Assessment Pre-APAP Pain Assessment 7 7

8 MATRIX Patient Demographics Top-line summary Patient Demographics and baseline characteristics At baseline, treatment groups were well-balanced across both studies for: age gender race history of previous hernia repair and surgery duration 8

9 MATRIX Top-line Efficacy Results Met the Primary Endpoints (SPI24), the sum of pain intensity 0-24 hrs. MATRIX 1 met the primary endpoint (p=0.0004) MATRIX 2 met the primary endpoint (p<0.0001) First long-acting, opioid-sparing, local anesthetic with positive Phase 3 clinical results in hernia repair, a painful and commonly performed surgery XARACOLL treatment effect for pain reduction and opioid reduction was consistent across both studies 9

10 MATRIX Secondary Endpoints Pooled data from both trials were statistically significant for SPI48, the sum of pain intensity difference 0-48 hrs (p=0.0033) MATRIX 2 achieved statistical significance (p=0.0270) MATRIX 1 trended toward, but did not achieve statistical significance (p=0.0568) Pooled data was statistically significant for SPI72, the sum of pain intensity difference 0-72 hrs Neither individual study achieved statistical significance for SPI72 The MATRIX trials demonstrated that XARACOLL significantly reduces total opioid consumption and significantly increases the time prior to the first use of opioids 10

11 MATRIX Tolerability and Adverse Event Summary XARACOLL was well tolerated in both studies Incidence of overall adverse events in the XARACOLL arm was similar to the placebo arm in both studies There were no XARACOLL-related serious adverse events in either study Opioid-related adverse events were higher in the placebo arm in both studies (nausea, vomiting and constipation) Incidence of discontinuation was very low and balanced across the treatment arms and across both studies 11

12 MATRIX Trial Summary and Next Steps Summary XARACOLL met the Primary Endpoint in both studies with highly significant p-values XARACOLL was safe and well tolerated Confirms the Innocoll collagenbased technology platform Next Steps NDA preparation and submission Q3/early Q Analysis of a HECON study when completed Full analysis of the pivotal Phase 3 studies will be submitted to future medical conferences and for publication (targeting journals such as Pain, Anesthesia, Anesthesia & Analgesia and the Clinical Journal of Pain) 12

13 THE ISSUE Stronger, Longer, and Opioid-sparing Post-op Pain Management Approaches Are Urgently Needed pain decreases satisfaction opioid side effects longer stays postoperative pain persists Best predictor of 96 % of postoperative 55 % increase in length 73 % of inpatient and patient satisfaction is lower postoperative pain ratings 2 patients who receive opioids report AEs 3 of hospital stay due to opioid-related AEs 4 57 % of outpatient surgeries have moderate to extreme pain postoperatively, despite opioid use by nearly 90 % of patients 5 13

14 THE MARKET Untapped Opportunity: Long-acting Local Anesthetics Currently Make Up Only 5% of the Postoperative Pain Relief Market US addressable market 6 ~$6B addressable market US market pricing approximately $300/procedure Clearly identified surgical procedures 22M appropriate procedures annually Easily targeted surgeon audience key institutions Global market 7 The large global postoperative pain relief market is based on multi-modal pain therapy and heavily reliant on opioids 14

15 Value THE MARKET Long-acting Analgesic Market Will Grow Practice guidelines support multi-modal pain management Practice Guidelines for Acute Pain Management in the Perioperative Setting, Anesthesia Post-op Pain Market to Evolve Like Other Drug Classes 12 Heightened concern about opioid use FDA on the opioid epidemic: It s time for us to act and [address] this problem. 11 Robert M. Califf, M.D., FDA Commissioner of Food and Drugs, February 2016 Anti-diabetics Hypertension HIV Multiple cancers COPD Evolution driven by multi-modal care Propelled market growth CDC guidelines advise that for acute pain, opioids should be prescribed at the lowest effective dose and for the briefest amount of time 9 Centers for Disease Control and Prevention: Recommendations and Reports, March 2016 CMS received Citizen-backed petition requesting for reexamination of pain practice and reimbursement 10 2 nd Entrant Physicians for Responsible Opioid Prescribing: Letter to Congress, April 2016 Time Value Market Entrant Clinical Data / Guidelines For illustrative purposes only 15

16 MARKET INSIGHT What Customers Tell Us pain relief in first 24 hrs critical haven t seen a sales rep in a while post-op pain 0-72 hrs is mostly controlled with opioids, despite clear reservations shorter hospital stays desired cost is important desire to use more long-acting non-opioid analgesics MARKET RESEARCH H1 2016: 145 Physicians 20 Hospital Pharmacists 13 16

17 XARACOLL Commercial Strategic Levers Levers differentiated positioning promotional effort pricing quality teams Emerging profile offers significant opportunities for product positioning Efficacy Amount and focus of promotion can propel category growth and XARACOLL share Low-cost, in-house manufacturing allows pricing flexibility Innocoll team has launched billion dollar brands while at previous companies Procedure evidence Ease of use 17

18 XARACOLL Pivotal Results Confirm Innocoll s Technology Platform Extensive experience in the bioprocessing of collagen API (Active Pharmaceutical Ingredients) Highly purified Type 1collagen Porous, drug collagen matrix Lyophilization Technology platform sets the stage for current late-stage product opportunities - now confirmed by XARACOLL *Remains subject to FDA approval. 18

19 THE ISSUE Diabetic Foot Infection: Improved Infection Clearing and Faster Healing Times are Urgently Needed Moderate Severe treatment challenge frequent failure delayed healing 84 % of moderate-severe 30 % + failure rate for 83 day average healing DFIs contain multiple types of organisms, some of which may be drug resistant to standard oral antibiotics 14 current treatment approaches; 80,000+ amputations per year among diabetic patients in the US time for DFUs with softtissue infection; 115 days in cases of osteomyelitis 17 19

20 PHASE 3 RESULTS expected in Q3/early Q Daily topical collagen matrix with gentamicin, a broad spectrum antibiotic for diabetic foot infection targeted topical highly concentrated eradicate pathogens Flexible COGENZIA matrix. Approximate width of 2 US quarters; smaller size similar to single US quarter. Applied directly to the wound site with low systemic absorption Each matrix equals 3 full tubes of currently approved 0.1% gentamicin creams/ointments 18 Designed to quickly clear infection, reduce the likelihood of resistance, and speed healing *Remains subject to FDA approval. 20

21 THE ISSUE Adhesions Are Prevalent in Certain Surgeries and Can Cause Future Complications Uterine adhesion Adhesion adhesions are common Surgical adhesions occur in about half of primary C-sections and in the majority of multiple laparotomies 19 risk of complications Adhesions cause serious complications, including infertility and bowel obstruction 20 Image source: 21

22 REGISTRATION PROGRAM to begin late 2016 Collagen film implanted during surgery to help prevent adhesions during tissue repair and healing bioresorbable Bioresorbable collagen film implanted during surgery adhesiogenic barrier Designed to serve as a temporary barrier to separate apposing adhesiogenic surfaces during tissue repair easy to handle Handling properties make it easy to use: translucent, easily manipulated, non-tacky, and designed not to tear COLLAGUARD film before and during implantation *Remains subject to FDA approval. 22

23 Key Financial Metrics Balance Sheet as of March 31, 2016 $ Mio Cash and Cash Equivalents 22.8 Debt* 17.6 Capitalization as of December 31, 2015 # Shares Shares outstanding** 23.7 Diluted Shares Outstanding 29.8 *Innocoll has a EUR 25M loan from the European Investment Bank. Innocoll drew down EUR 15M of the loan commitment. Contingent upon achieving the primary endpoints for either XARACOLL or COGENZIA, Innocoll is entitled to draw down an additional EUR 10M ($11M). The criteria for the second tranche was met and the EIB is in process to deposit the funds ** Listed on NASDAQ under the INNL trading symbol. 23

24 Pillars For a Sound Financial Structure COGS expected to be at low-double and midsingle digit percentage of sales In-house manufacturing with small incremental capital needs Specialty and hospital US sales force requires associates for each brand Potential strategic partnership to launch in Europe and rest of world Lean back office to support corporate requirements post-domicile to Ireland Continue to have an attractive corporate tax rate based on Irish residency 24

25 Investment Highlights Summary XARACOLL Phase 3 program met primary endpoints Results announced May 25, 2016; FDA submission planned for late 3 rd /early 4 th quarter Multi-billion dollar post-op pain market; poised for 2 nd product entry with differentiated profile Efficient specialty commercialization and mid-single digit cost of goods Commercial team with a proven track record of launch success XARACOLL results confirm Innocoll s collagen-based technology platform 2 nd Phase 3 program, anti-infective for diabetic foot ulcers, on track for pivotal clinical results later in 2016 Third clinical program for adhesion barrier hospital product expected to begin in 2016 Sound financial structure with focused specialty product R&D programs, targeted and efficient commercialization, and high-margin in-house manufacturing Experienced executives with proven track records Delivering Phase 3 clinical trial results and regulatory agency approvals Building and leading successful organizations and billion dollar brands Innocoll (Nasdaq: INNL) is a specialty pharmaceutical company that improves existing medicines with its collagen-based technology 25

26 References 1. Kissin I. Preemptive Analgesia. Anesthesiology 2000; 93: Buvanendran A, Fiala J, Patel KA, Golden AD, Moric M, Kroin JS. The incidence and severity of postoperative pain following inpatient surgery. Pain Med. 2015;16(12): Gan TJ, Lubarsky DA, Flood EM, et al. Patient preferences for acute pain treatment. Br J Anaesth. 2004;92(5): Kessler ER, Shah M, Gruschkus SK, Raju A. Cost and quality implications of opioid-based postsurgical pain control using administrative claims data from a large health system: Opioid-related adverse events and their impact on clinical and economic outcomes. Pharmacotherapy. 2013;33(4): Gan TJ, Habib AS, Miller TE, White W, Apfelbaum JL. Incidence, patient satisfaction, and perceptions of post-surgical pain: Results from a US national survey. Curr Med Res Opin. 2014;30(1): /2015 Cofactor Group analysis of US Surgical Procedure Volumes (LIS 2013). Procedures were screened for severity of postoperative pain and suitability of long-acting local anesthetics. 7. GBI Research. Global Business Intelligence Industry Report. Pain Management Therapeutics Market to 2017 Price Competition to Intensify Following Patent Expiries of Lyrica and Cymbalta. November Accessed May 18, American Society of Anesthesiologists. Practice Guidelines for Acute Pain Management in the Perioperative Setting Anesthesia 2012;116: Centers for Disease Control and Prevention. Guideline for prescribing opioids for chronic pain: united states recommendations and reports. 2016;65(1): Physicians for Responsible Opioid Prescribing: Letter to Mark Chassin, President and CEO of The Joint Commission (March). Available at: Accessed May 10, Califf R. Changing course: A new approach to opioid pain medicationat FDA. FDA Voice (Feb). Available at: Accessed May 13, Cowen and Company. Equity Research: Health Care. Therapeutic Categories Outlook: Comprehensive Study. March Data on file , Innocoll Citron DM, Goldstein EJ, Merriam CV, Lipsky BA, Abramson MA. Bacteriology of moderate-to-severe diabetic foot infections and in vitro activity of antimicrobial agents. J Clin Microbiol. 2007;45(9): Lipsky BA, Stoutenburgh U. Daptomycin for treating infected diabetic foot ulcers: Evidence from a randomized, controlled trial comparing daptomycin with vancomycin or semi-synthetic penicillins for complicated skin and skin-structure infections. J Antimicrob Chemother. 2005;55(2): Kruse I, Edelman S. Evaluation and treatment of diabetic foot ulcers. Clin Diabetes: 2006;24(2): Milne TE, Schoen DE, Bower VM, Burrows SA, Westphal C, Gurr JM. Healing times of diabetic foot ulcers: Investigating the influence of infection and peripheral arterial disease. J Diabetic Foot Comp. 2013;5(2): Lipsky BA, Kuss M, Edmonds M, Reyzelman A, Sigal F. Topical application of a gentamicin-collagen sponge combined with systemic antibiotic therapy for the treatment of diabetic foot infections of moderate severity: A randomized, controlled, multicenter clinical trial. J Am Podiatr Med Assoc. 2012;102(3): Gonzalez-Quintero VH, Cruz-Pachano FE. Preventing adhesions in obstetric and gynecologic surgical procedures. Rev Obstet Gynecol. 2009;2(1): Bruggmann D, Tchartchian G, Wallwiener M, Münstedt K, Tinneberg H-R, Hackethal A. Intra-abdominal adhesions: Definition, origin, significance in surgical practice, and treatment options. Dtsch Arztebl Int. 2010;107(44):