BUSINESS UPDATE CALL. September 7, 2017

Transcription

1 BUSINESS UPDATE CALL September 7, 2017

2 INTRODUCTION Gem Hopkins VP, Investor Relations & Corporate Communications

3 SAFE HARBOR STATEMENT 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 opportunity, 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, 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. 3

4 AGENDA Business Overview Gary S. Jacob Financial Update Gary Gemignani Launch Update Troy Hamilton Closing Remarks Gary Jacob Q&A Portion 4

5 OVERVIEW Gary S. Jacob, PhD Chairman & CEO

6 RECENT HIGHLIGHTS Completed first full quarter of launch of Trulance in CIC More than 12,600 prescriptions, $2.3M net revenues, for 2Q17 Trulance snda for IBS-C accepted for FDA review January 24, 2018 PDUFA date Secured $300 million debt financing 6

7 KEY BUSINESS PRIORITIES Optimize the value of Trulance Continue to grow market share in CIC Expand utility in IBS-C January 24, 2018 PDUFA date Ensure a strong financial foundation Continue to evaluate opportunities to improve expense management Transition Company to cash flow positive Maximize long-term shareholder value 7

8 FINANCIAL UPDATE Gary Gemignani EVP, Chief Financial Officer

9 ENSURING A STRONG FINANCIAL FOUNDATION Secured $300 million debt financing Funds will be used primarily to support the commercial launch of Trulance Non-dilutive source of capital that enhances cash position Continue to evaluate opportunities to improve operating efficiency and expense management 9

10 TRULANCE LAUNCH UPDATE Troy Hamilton EVP, Chief Commercial Officer

11 SYNERGY AND TRULANCE: WELL POSITIONED FOR SUCCESS RIGHT MARKET RIGHT PRODUCT RIGHT STRATEGY RIGHT TEAM 11

12 KEY CUSTOMERS AND LAUNCH STRATEGIES Launch Strategies HCPs Drive Awareness of Trulance and Stimulate Trial and Adoption PATIENTS Activate and Support the Rx Ready Patient PAYERS Ensure Access 12

13 LESS THAN 20% OF PRESCRIBERS ARE WRITING 70% OF THE TOTAL BRANDED PRESCRIPTIONS Branded Rx Combined Decile Rx Mean # of Doctors % of Doctors # of Prescriptions % of Prescriptions % 346, % , % 346, % , % 346, % , % 346, % , % 346, % , % 346, % , % 346, % , % 346, % , % 346, % , % 346, % Total 161, % 3,461, % ,713 17% 2,422,799 70% 27,713 HCPs = 70% of Rx s ~ 45% primary care physicians ~ 30% gastroenterologists ~ 18% nurse practitioners or physician assistants Decile 3: 2 Rx s per month Decile 2: ~ 1 Rx per month Decile 1: = 1 Rx every 3 months Source: QuintilesIMS Xponent - March 2017; excluding non-called on specialties (peds, pain, hem/onc) 13

14 TARGETED COMMERCIAL STRATEGY FOCUSED ON A CONCENTRATED PRESCRIBER BASE Branded Rx Market 27,713 Prescribers 134,221 Prescribers 2.4MM TRx (~70%) 1.0MM TRx (30%) Key Points: The ~27K prescribers are within 15K group practices/offices Reaching the 27K prescribers with an experienced sales force and surround sound of promotional efforts Source: QuintilesIMS Xponent - March 2017; excluding non-called on specialties (peds, pain, hem/onc)` 14

15 KEY LAUNCH STRATEGIES AND ACTIVITIES ü Sales force of ~ 250 educating ~ 27,000 prescribers HCPs Drive Awareness of Trulance and Stimulate Trial / Adoption Activate and Support the Rx Ready Patient ü Over 360,000 sample packs distributed to field to date ü ~ 430 peer-to-peer speaker programs, > 6000 attendees ü Launched comprehensive HCP media plan Ensure Access ü DDW 2017 significant promotional presence; 6 abstracts (two posters of distinction, one oral presentation) Source: Company Data 15

16 KEY LAUNCH STRATEGIES AND ACTIVITIES PATIENTS Drive Awareness of Trulance and Stimulate Trial / Adoption Activate and Support the Rx Ready Patient Ensure Access ü Trulance Campaign: Point of Care Promotion: ~ 20,000 offices Web Sponsorships/Display Ads: > 245,000,000 impressions Search Engine Marketing: > 403,000 clicks Trulance.com visits: > 615,000 for consumer site ü Confront Constipation Campaign: Disease awareness initiative 33 original media placements > 310,000,000 media impressions > 95,000 Emoji App downloads Source: Company Data 16

17 KEY LAUNCH STRATEGIES AND ACTIVITIES ü Removing barriers and gaining commercial open access PAYERS Drive Awareness of Trulance and Stimulate Trial / Adoption Activate and Support the Rx Ready Patient Ensure Access ü > 67% of patients with commercial insurance currently have unrestricted access; 2018 discussions ongoing ü Trulance Access Support Services Program Savings-to-Go program: copay of $25/Rx for > 95% of patients with commercial insurance Prior authorization support ü Medicare Part D and Medicaid Discussions Ongoing Source: Company Data 17

18 KEY PERFORMANCE METRICS

19 TRULANCE TOTAL MONTHLY PRESCRIPTION VOLUME HAS INCREASED OVER 140% ON AVERAGE MONTH-OVER-MONTH Trulance Monthly Total Prescriptions Cumulative Trulance Monthly Total Prescriptions 8, ,000 7,000 6, , TRx Volume 5,000 4, TRx Volume 15, ,000 2,000 1, ,000 5, Mar-17 Apr-17 May-17 Jun-17 Jul-17 Mar-17 Apr-17 May-17 Jun-17 Jul-17 Source: QuintilesIMS 19

20 TRULANCE TOTAL WEEKLY PRESCRIPTION VOLUME SHOWING CONSISTENT GROWTH Trulance Weekly TRx Volume Cumulative Trulance Weekly TRx Volume TRx Volume 2,500 2,000 1,500 1, Holiday Week ,115 1,002 1,252 1,327 1,576 1,624 Holiday Week 1,348 1,754 1, TRx Volume 30,000 25,000 20,000 15,000 10,000 5, /24/17 3/31/17 4/7/17 4/14/17 4/21/17 4/28/17 5/5/17 5/12/17 5/19/17 5/26/17 6/2/17 6/9/17 6/16/17 6/23/17 6/30/17 7/7/17 7/14/17 7/21/17 7/28/17 8/4/17 8/11/17 8/18/17 8/25/17 3/24/17 3/31/17 4/7/17 4/14/17 4/21/17 4/28/17 5/5/17 5/12/17 5/19/17 5/26/17 6/2/17 6/9/17 6/16/17 6/23/17 6/30/17 7/7/17 7/14/17 7/21/17 7/28/17 8/4/17 8/11/17 8/18/17 8/25/17 Source: QuintilesIMS 20

21 TRULANCE NEW-TO-BRAND PRESCRIPTION MARKET SHARE AT 13.3% AMONG GASTROENTEROLOGISTS 80% NBRx Market Share Among Gastroenterologists 70% 60% 66.9% 65.7% NBRx Market Share 50% 40% 30% 20% 10% 31.8% 21.0% 13.3% 12.9% 0% Jan-16 Feb-16 Mar-16 Apr-16 May-16 Jun-16 Jul-16 Aug-16 Sep-16 Oct-16 Nov-16 Dec-16 Jan-17 Feb-17 Mar-17 LAUNCH Apr-17 May-17 LAUNCH Jun-17 Jul-17 Amitiza Brand Linzess Brand Linzess 72mcg Trulance 3mg Source: QuintilesIMS 21

22 TRULANCE PRESCRIBERS HAVE INCREASED AN AVERAGE OF 136% MONTH-OVER-MONTH SINCE LAUNCH 5,000 4,949 4,000 3,768 Cumulative Trulance Prescribers 3,000 2,000 1,000 1,145 2, March April May June July Source: QI XPT, Mar Jul

23 MAJORITY OF TRULANCE GROWTH COMING FROM PATIENTS NEW TO BRANDED RX TREATMENTS Trulance NRx Breakdown Add on 6% 51% of Trulance NRx were new branded Rx therapy starts New Therapy Starts 51% Switch To 43% 43% of Trulance patients have converted from other Rx treatments Source: Weeks ending 3/17 6/30, QIMS XPD 23

24 OPTIMIZING THE VALUE OF TRULANCE Positive early launch results Early prescriber and patient experience appears promising Continue to execute on our launch plan Opportunity to broaden the base and build off of successful Trulance launch DTC development Prepare for IBS-C launch 24

25 CONCLUSION Gary S. Jacob, PhD Chairman & CEO

26 RECAP OF OUR KEY BUSINESS PRIORITIES Optimize the value of Trulance Ensure a strong financial foundation Maximize long-term shareholder value 26

27 Q&A SESSION September 7, 2017