Synergy Pharmaceuticals — Oppenheimer Healthcare Conference 2017
24 slides from Synergy Pharmaceuticals's conference presentation, Mar 21, 2017
Slide 1: Safe Harbor Statement
SAFE HARBOR STATEMENT 2 This presentation and any statements made for and during any presentation or meeting contain forward-looking statements related to Synergy Pharmaceuticals Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and are subj
Slide 2: Trulance is now available in the U.S. for the treatment of CIC in adults
TRULANCE IS NOW AVAILABLE IN THE U.S. FOR THE TREATMENT OF CIC IN ADULTS 3 Only product thought to replicate the pH-sensitive activity of naturally occurring uroguanylin Highly experienced sales force trained and now fully deployed – 100% focused on Trulance On-track to submit supplemental NDA (sNDA
Slide 3: Trulance and Synergy are well positioned
TRULANCE AND SYNERGY ARE WELL POSITIONED 4 ~ 33M U.S. Adults with CIC Significant unmet need; multiple drivers for future growth Strong Product Profile Based on clinical data, the label and market research/customer insights Strong. Focused. Efficient. Launch brand / launch mode, targeting most produ
Slide 4: Commercial Opportunity
TRULANCE commercial opportunity 5
Slide 5: Estimated million U.S. adults suffer from CIC or IBS-C
ESTIMATED 45 MILLION U.S. ADULTS SUFFER FROM CIC OR IBS-C 6 Source: Johanson 2004 ; Suares 2011 Estimated U.S. Prevalence (in millions) COMMON SYMPTOMS: Constipation (< 3 bowel movements per week for > 3 months) Hard or lumpy stools Incomplete bowel movements Straining CIC Abdominal pain Constipatio
Slide 6: New entrants are growing the market, not cannibalizing existing products
NEW ENTRANTS ARE GROWING THE MARKET, NOT CANNIBALIZING EXISTING PRODUCTS 7 ~ 4 MM Source: IMS Health Incorporated, NPA All Other Rx = Rx lactulose & Rx polyethylene glycol Last three years, TRx volume has grown by nearly 4 million or 30% RIGHT MARKET RIGHT MARKET Oppenheimer Healthcare Conference I
Slide 7: Value of the prescription constipation market has more than doubled over the past 3 years
VALUE OF THE PRESCRIPTION CONSTIPATION MARKET HAS MORE THAN DOUBLED OVER THE PAST 3 YEARS 8 + 148% Source: IMS Health Incorporated, NSP All Other Rx = Rx lactulose & Rx polyethylene glycol 1,593 $133 RIGHT MARKET RIGHT MARKET Oppenheimer Healthcare Conference I March 21, 2017 $182 $184 $171 $166 $32
Slide 8: Still an untapped US market opportunity
Source: IMS Monthly NPA Dec. 2015 STILL AN UNTAPPED US MARKET OPPORTUNITY 9 FUTURE GROWTH DRIVERS DTC campaigns continue to grow disease awareness Growth in category with new IBS-D / OIC brands Increasing awareness of the importance of “gut health” Aging population Launch of Trulance ~ 45MM U.S. ADU
Slide 9: Commercial Launch
TRULANCE commercial launch 10
Slide 10: Provides a new treatment option for millions of patients with CIC
TRULANCE PROVIDES A NEW TREATMENT OPTION FOR MILLIONS OF PATIENTS WITH CIC 11 Evaluated in the two largest Phase 3 CIC trials to-date Improved stool consistency Provided more regular bowel movements Diarrhea was most common adverse event (5%) Established efficacy, safety and tolerability profile ~33
Slide 11: Showed early and sustained efficacy
Follow-up Period Follow-up Period Follow-up Period *** Change from Baseline in CSBMs (No/Week) *** *** *** *** *** *** *** *** *** *** *** Follow-up Period *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** *** SHOWED EARLY AND SUSTAINED EFFICACY 12 STUDY 1 S
Slide 12: Restored stool consistency to normal physiological value (BSFS = 4)
Follow-up Period RESTORED STOOL CONSISTENCY TO NORMAL PHYSIOLOGICAL VALUE (BSFS = 4) 13 Mean Bristol Stool Form Scale Score Ideal stool consistency Note: Weekly BSFS Scores displayed are results from first Trulance Phase 3 CIC trial. RIGHT Product Oppenheimer Healthcare Conference I March 21, 2017 1
Slide 13: Diarrhea was the only adverse reaction reported in at least 2% of patients
DIARRHEA WAS THE ONLY ADVERSE REACTION (AT AN INCIDENCE > PLACEBO) REPORTED IN AT LEAST 2% OF PATIENTS Placebo (N=870) TRULANCE 3 mg (N=863) % Diarrhea 1% 5% % Severe Diarrhea 0.3% 0.6% Discontinuations due to adverse reactions 2% 4% Discontinuations due to diarrhea 0.5% 2% 14 RIGHT Product Note: Sa
Slide 14: Provides simple dosing and convenient packaging that is patient preferred
TRULANCE PROVIDES SIMPLE DOSING AND CONVENIENT PACKAGING THAT IS PATIENT PREFERRED* 15 Convenient & Innovative Packaging Simple Dosing & Administration *When asked, the majority of patients preferred Trulance blister packaging to a traditional pill bottle. Once a day Any time of day With or Without
Slide 15: Strong creative campaign based on extensive market research and customer insights
STRONG CREATIVE CAMPAIGN BASED ON EXTENSIVE MARKET RESEARCH AND CUSTOMER INSIGHTS 16 RIGHT STRATEGY Oppenheimer Healthcare Conference I March 21, 2017
Slide 16: Well positioned to enter a clearly defined market
WELL POSITIONED TO ENTER A CLEARLY DEFINED MARKET Most productive prescribers and influencers (~27,000) gastroenterologists primary care physicians 17 Experienced Sales Force Congress and Conventions Promotional Peer to Peer Programs Non-Personal Promotion Trulance samples RIGHT STRATEGY Oppenheimer
Slide 17: Experienced field force executing on a strong and focused launch strategy
EXPERIENCED FIELD FORCE EXECUTING ON A STRONG AND FOCUSED LAUNCH STRATEGY 19 Synergy Regional Business Directors average over 11 years of management experience with over 10 years in relevant GI fields Synergy Regional GI Account Specialists average 13 years of pharmaceutical experience and 8.5 years
Slide 18: IBS-C Clinical Program
TRULANCE ibs-c CLINICAL program 20
Slide 19: Phase 3 IBS-C Program Overview
TRULANCE PHASE 3 IBS-C PROGRAM OVERVIEW 21 STUDY DESIGN: Two randomized, 12-week, double-blind, placebo-controlled trials evaluating the efficacy and safety of TRULANCE treatment in IBS-C patients DOSAGE / ADMINISTRATION: TRULANCE 3 mg and 6 mg taken once-daily without respect to food intake STUDY P
Slide 20: Met the primary endpoint in both Phase 3 IBS-C trials (top-line data)
TRULANCE MET THE PRIMARY ENDPOINT IN BOTH PHASE 3 IBS-C TRIALS (TOP-LINE DATA) 22 STUDY 1 **p=0.009; ***p<0.001 ** *** STUDY 2 *** *** primary endpoint defined as a patient who fulfills > 30% reduction in worst abdominal pain and an increase of > 1 CSBMs from baseline, in the same week, for at least
Slide 21: Low adverse events reported (top-line data)
LOW ADVERSE EVENTS REPORTED (TOP-LINE DATA) Placebo TRULANCE = TRULANCE Placebo TRULANCE TRULANCE (n=379) 3mg 6 mg (n=354) 3mg 6mg (0-377) (0=379) (0-351) (n=349) AE ° 1.9% 1.8% AE 08 2.6% 23% Withdrawal Withdrawal %Diarrhea 1.3% 32% 37% %Diarthea 0.6% 54% 4.3% Diarrhea ° 0.8% 1.6% Diarrhea 0 1.7% 1
Slide 22: Key Investment Highlights
KEY INVESTMENT HIGHLIGHTS 25 Trulance – high value asset now available in the U.S. for the treatment of CIC in adults Well positioned to enter a clearly defined market Highly experienced sales force trained and now fully deployed – 100% focused on Trulance Expanding utility of Trulance and advancing
Slide 23: Igniting change for new solutions
AT SYNERGY, we’re challenging the status quo in gastrointestinal (GI) medicine to develop new treatments that offer the potential to change people’s lives. IGNITING CHANGE FOR NEW SOLUTIONS
Slide 24: Igniting change for new solutions
IGNITING CHANGE FOR NEW SOLUTIONS AT SYNERGY, we're challenging the status quo in gastrointestinal (Gl) medicine to develop new treatments that offer the potential to change people’s lives.
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