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COR CORPORA PORATE TE PRES PRESENT ENTATION TION August 9, - PowerPoint PPT Presentation

COR CORPORA PORATE TE PRES PRESENT ENTATION TION August 9, 2017 SAFE SAFE HARBOR HARBOR ST STATE TEME MENT NT This presentation and any statements made for and during any presentation or meeting contain forward-looking statements


  1. COR CORPORA PORATE TE PRES PRESENT ENTATION TION August 9, 2017

  2. SAFE SAFE HARBOR HARBOR ST STATE TEME MENT NT 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 subject to risks and uncertainties that could cause actual results to differ materially from those projected. These statements may be identified by the use of forward-looking words such as "anticipate," "planned," "believe," "forecast," "estimated," "expected," and "intend," among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, the development, launch, introduction and commercial potential of TRULANCE™; growth and oppo rtunity, including peak sales and the potential demand for TRULANCE, as well as its potential impact on applicable markets; market size; substantial competition; our ability to continue as a going concern; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payer reimbursement; dependence upon third parties; our financial performance and results, including the risk that we are unable to manage our operating expenses or cash use for operations, or are unable to commercialize our products, within the guided ranges or otherwise as expected; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that future clinical trials discussed in this presentation will be completed or successful or that any product will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in our most recent periodic reports filed with the Securities and Exchange Commission, including our Form 10-K for the year ended December 31, 2016. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and we do not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances except as required by law. The information in this presentation is not targeted at the residents of any particular country or jurisdiction and is not intended for distribution to, or use by, any person in any jurisdiction or country where such distribution or use would be contrary to local law or regulation. 2 Corporate Presentation I August 9, 2017

  3. 2017 IS A IS A TRANSFO TRANSFORM RMATI TIVE E YEAR YEAR FOR OR SYNER SYNERGY GY April 12, 2017 March 20, 2017 Three new patents issued, Synergy begins marketing expected to extend Trulance Trulance in CIC exclusivity until 2032 January 19, 2017 June 7, 2017 March 24, 2017 FDA approves Trulance for Submitted IBS-C sNDA for IBS-C sNDA accepted for the treatment of FDA review FDA review; PDUFA date adults with CIC January 24, 2018 3 Corporate Presentation I August 9, 2017

  4. TR TRULAN ULANCE: CE: FOU FOUND NDATIO TION N TO O OUR OUR SUCCE SUCCESS SS • Positive early launch signals – significant opportunity ahead • Expect to launch with IBS-C indication early next year • Control 100% worldwide rights • Strong patent portfolio with long life span • Commercial team and sales force with significant GI experience and several product launches – 100% focused on Trulance 4 Corporate Presentation I August 9, 2017

  5. TR TRULAN ULANCE CE LA LAUNC UNCH H UPD UPDATE TE

  6. SYNERGY SYNER GY AND AND TR TRULANC ULANCE: E: WELL WELL POSITI POSITION ONED ED FOR SU FOR SUCCESS CCESS RIGHT IGHT RIGHT RIGHT RIGHT RIGHT RIGHT RIGHT MARKET PRODUCT TEAM STRATEGY 6 Corporate Presentation I August 9, 2017

  7. SYNERGY SYNER GY AND AND TR TRULANC ULANCE: E: WELL WELL POSITI POSITION ONED ED FOR SU FOR SUCCESS CCESS RIG IGHT HT RIGHT RI RI RIGHT RIG RIGHT PRODUCT STRATEGY MARKET TEAM • Large, Growing Market • Clear Unmet Needs • Significant Opportunity for Continued Branded Rx Growth 7 Corporate Presentation I August 9, 2017

  8. ESTI ESTIMA MATED TED 45 45 MI MILL LLION ION U.S. .S. ADU ADULTS TS SUFFE SUFFER R FR FROM OM CIC OR CIC OR IBS IBS-C C Estimated U.S. Prevalence (in millions) CIC/IBS-C ~33 million U.S. adults suffer GERD from CIC alone Migraine 0 10 20 30 40 50 Sources: Suares and Ford, Am J Gastroenterol 2011; 106:1582 – 159; GERD Prevalence : Sharma, Am J Gastroenterol 8 2008;103(11):2669-2680; Migraine Prevalence : Smitherman TA, Headache. 2013 Mar;53(3):427-36 Corporate Presentation I August 9, 2017

  9. NEW NEW ENT ENTRANTS RANTS ARE ARE GROWING GROWING THE THE MARKE MARKET, T, NOT NOT CANNIB CANNIBALIZIN LIZING G EXI EXIST STING ING PRODUCT PRODUCTS Last four years, ~ 4 MM TRx volume has TRxs in Thousands 20,000 17,591 grown by nearly 16,465 15,373 4 million or 30% 2,691 13,578 2,112 15,000 1,422 1,488 1,476 1,345 1,288 10,000 13,412 12,878 12,606 11,729 5,000 0 2013 2014 2015 2016 All Other Rx Amitiza Linzess All Other Rx = Rx lactulose & Rx polyethylene glycol 9 Source: QuintilesIMS, NPA Corporate Presentation I August 9, 2017

  10. VAL ALUE UE OF OF T THE HE PRES PRESCRIPT CRIPTION ION CON CONST STIP IPATIO TION N MARKET MARKET HAS MORE HAS MORE THAN THAN DOUBLED DOUBLED OVER VER THE THE PAST AST FOU FOUR R YEA YEARS RS + 148% 1,593 $1,500 $1,260 US $ in Millions $959 $945 $1,000 $654 $382 $642 $133 $500 $467 $436 $378 $326 $182 $184 $171 $166 $0 2013 2014 2015 2016 All Other Rx Amitiza Linzess All Other Rx = Rx lactulose & Rx polyethylene glycol 10 Source: QuintilesIMS, NSP Corporate Presentation I August 9, 2017

  11. ST STILL ILL AN AN UNT UNTAPP APPED ED US MARKE US MARKET OPP OPPOR ORTU TUNIT NITY ~ 45MM U.S. ADULTS WITH CIC / IBS-C GROWTH DRIVERS • Increasing awareness of “gut health” • Significant investment to build market > 95% Branded - HCP promotion will continue providing currently not Rx market appropriate information to prescribers treated with serving regarding branded CIC/IBS-C Rx products branded Rx < 5% therapies - Disease awareness/education and direct to consumer campaigns will continue to enable patients to ask about treatment options • Launch of Trulance Source: QuintilesIMS, NPA - December 2016 11 Corporate Presentation I August 9, 2017

  12. ST STILL ILL CLEAR CLEAR UNME UNMET T NEE NEEDS DS IN IN THE THE MARKE MARKET PATI TIENT ENTS HCPs HCPs • Bowel-Centered life • Challenging patients KEY KEY • Still seeking solutions • Frustrated INSIGHT INS IGHTS • Dissatisfied with OTCs • Recycling • Seek normalcy • Any BM = Good BM Source: Company Data 12 Corporate Presentation I August 9, 2017

  13. SYNER SYNERGY GY AND AND TR TRULANC ULANCE: E: WELL WELL POSITI POSITION ONED ED FOR SU FOR SUCCESS CCESS RIG IGHT HT RI RIGHT RIGHT RI RIGHT RIG PRODUCT STRATEGY MARKET TEAM • Clinical Data • Market Research and Customer Insights • Label 13 Corporate Presentation I August 9, 2017

  14. TR TRULAN ULANCE CE PR PROVIDES VIDES A A NEW NEW TRE TREATM TMEN ENT T OPT OPTION ION FOR FOR MILLIONS MILLION S OF ADUL OF ADULTS TS WITH WITH CIC CIC Pharmacology • Only product thought to replicate the pH-sensitive activity of uroguanylin Efficacy • Evaluated in the two largest Phase 3 CIC trials to-date Safety / Tolerability • Diarrhea was most common adverse event (5%) Dosing • Once a day, any time of the day, with or without food Note: Trulance Phase 3 CIC studies were conducted vs. placebo (and not an active comparator) 14 Corporate Presentation I August 9, 2017

  15. TR TRULAN ULANCE CE PR PROVIDES VIDES SIM SIMPLE PLE DOSING DOSING AND AND CONVENI CONVENIENT ENT PACKA CKAGIN ING G THA THAT T IS P IS PATIE TIENT NT PRE PREFERRE FERRED* D* Simple Dosing & Administration Once a day Any time of day Convenient & Innovative Packaging With or without food *Source: Company Data 15 Corporate Presentation I August 9, 2017

  16. SYNER SYNERGY GY AND AND TR TRULANC ULANCE: E: WELL WELL POSITI POSITION ONED ED FOR SU FOR SUCCESS CCESS RIG IGHT HT RI RIGHT RIGHT RI RIG RIGHT PRODUCT MARKET STRATEGY TEAM • Launch Brand = Launch Mode • Key Launch Strategies and Activities 16 Corporate Presentation I August 9, 2017

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