BUSINESS UPDATE CALL September 7, 2017 INTRODUCTION Gem Hopkins - - PowerPoint PPT Presentation
BUSINESS UPDATE CALL September 7, 2017 INTRODUCTION Gem Hopkins - - PowerPoint PPT Presentation
BUSINESS UPDATE CALL September 7, 2017 INTRODUCTION Gem Hopkins VP, Investor Relations & Corporate Communications SAFE HARBOR STATEMENT This presentation and any statements made for and during any presentation or meeting contain
INTRODUCTION
Gem Hopkins VP, Investor Relations & Corporate Communications
Business Update I September 7, 2017
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;
- ur 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
- therwise 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.
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Business Update I September 7, 2017
AGENDA
- Business Overview – Gary S. Jacob
- Financial Update – Gary Gemignani
- Launch Update – Troy Hamilton
- Closing Remarks – Gary Jacob
- Q&A Portion
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OVERVIEW
Gary S. Jacob, PhD Chairman & CEO
Business Update I September 7, 2017
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
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Business Update I September 7, 2017
KEY BUSINESS PRIORITIES
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- 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
FINANCIAL UPDATE
Gary Gemignani EVP, Chief Financial Officer
Business Update I September 7, 2017
- 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 ENSURING A STRONG FINANCIAL FOUNDATION
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TRULANCE LAUNCH UPDATE
Troy Hamilton EVP, Chief Commercial Officer
Business Update I September 7, 2017
RIGHT
STRATEGY
RIGHT
PRODUCT
RIGHT
MARKET
RIGHT
TEAM
SYNERGY AND TRULANCE: WELL POSITIONED FOR SUCCESS
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Business Update I September 7, 2017
KEY CUSTOMERS AND LAUNCH STRATEGIES
Launch Strategies
Drive Awareness of Trulance and Stimulate Trial and Adoption
HCPs PAYERS PATIENTS
Ensure Access Activate and Support the Rx Ready Patient
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Business Update I September 7, 2017
LESS THAN 20% OF PRESCRIBERS ARE WRITING 70% OF THE TOTAL BRANDED PRESCRIPTIONS
Decile Rx Mean # of Doctors % of Doctors # of Prescriptions % of Prescriptions 10 460 753 0.5% 346,054 10.0% 9 245 1,411 0.9% 346,028 10.0% 8 163 2,120 1.3% 346,114 10.0% 7 113 3,057 1.9% 346,196 10.0% 6 78 4,440 2.7% 346,134 10.0% 5 54 6,448 4.0% 346,132 10.0% 4 36 9,484 5.9% 346,141 10.0% 3 24 14,549 9.0% 346,145 10.0% 2 14 25,109 15.5% 346,109 10.0% 1 4 94,563 58.4% 346,071 10.0% Total 161,934 100% 3,461,124 100% 4-10 27,713 17% 2,422,799 70% Branded Rx Combined
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)
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Business Update I September 7, 2017
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
TARGETED COMMERCIAL STRATEGY FOCUSED ON A CONCENTRATED PRESCRIBER BASE
1.0MM TRx (30%)
2.4MM TRx (~70%)
Branded Rx Market
27,713 Prescribers
134,221 Prescribers
Source: QuintilesIMS Xponent - March 2017; excluding non-called on specialties (peds, pain, hem/onc)`
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Business Update I September 7, 2017
HCPs
- Drive Awareness of
Trulance and Stimulate Trial / Adoption
- Activate and Support the
Rx Ready Patient
- Ensure Access
ü Sales force of ~ 250 educating ~ 27,000 prescribers 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 ü DDW 2017 – significant promotional presence; 6 abstracts (two posters of distinction, one oral presentation)
KEY LAUNCH STRATEGIES AND ACTIVITIES
Source: Company Data
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Business Update I September 7, 2017
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
KEY LAUNCH STRATEGIES AND ACTIVITIES
- Drive Awareness of
Trulance and Stimulate Trial / Adoption
- Activate and Support the
Rx Ready Patient
- Ensure Access
PATIENTS
Source: Company Data
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Business Update I September 7, 2017
ü Removing barriers and gaining commercial open 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
KEY LAUNCH STRATEGIES AND ACTIVITIES
PAYERS
- Drive Awareness of
Trulance and Stimulate Trial / Adoption
- Activate and Support the
Rx Ready Patient
- Ensure Access
Source: Company Data
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KEY PERFORMANCE METRICS
Business Update I September 7, 2017
TRULANCE TOTAL MONTHLY PRESCRIPTION VOLUME HAS INCREASED OVER 140% ON AVERAGE MONTH-OVER-MONTH
Source: QuintilesIMS
19 394 1843 4149 6262 7186
1,000 2,000 3,000 4,000 5,000 6,000 7,000 8,000 Mar-17 Apr-17 May-17 Jun-17 Jul-17
TRx Volume
Trulance Monthly Total Prescriptions
394 2237 6386 12648 19834
5,000 10,000 15,000 20,000 25,000 Mar-17 Apr-17 May-17 Jun-17 Jul-17
TRx Volume
Cumulative Trulance Monthly Total Prescriptions
Business Update I September 7, 2017
124 244 282 422 489 628 730 856 952 1,115 1,002 1,252 1,327 1,576 1,624 1,348 1,754 1,742 1836 1867 1901 1923 2006
500 1,000 1,500 2,000 2,500 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
TRx Volume
Trulance Weekly TRx Volume
TRULANCE TOTAL WEEKLY PRESCRIPTION VOLUME SHOWING CONSISTENT GROWTH
Holiday Week Holiday Week
148 392 674 1096 1585 2213 2943 3799 4751 5866 6868 8120 9447 11023 12647 13995 15749 17491 19327 21194 23095 25018 27024
5,000 10,000 15,000 20,000 25,000 30,000 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
TRx Volume
Cumulative Trulance Weekly TRx Volume
Source: QuintilesIMS
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Business Update I September 7, 2017
TRULANCE NEW-TO-BRAND PRESCRIPTION MARKET SHARE AT 13.3% AMONG GASTROENTEROLOGISTS
Source: QuintilesIMS
LAUNCH
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31.8% 21.0% 66.9% 65.7% 12.9% 13.3% 0% 10% 20% 30% 40% 50% 60% 70% 80%
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 Apr-17 May-17 Jun-17 Jul-17
NBRx Market Share
NBRx Market Share Among Gastroenterologists
Amitiza Brand Linzess Brand Linzess 72mcg Trulance 3mg
LAUNCH
Business Update I September 7, 2017
TRULANCE PRESCRIBERS HAVE INCREASED AN AVERAGE OF 136% MONTH-OVER-MONTH SINCE LAUNCH
Source: QI XPT, Mar – Jul 2017
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257 1,145 2,427 3,768 4,949 1,000 2,000 3,000 4,000 5,000 March April May June July
Cumulative Trulance Prescribers
Business Update I September 7, 2017
MAJORITY OF TRULANCE GROWTH COMING FROM PATIENTS NEW TO BRANDED RX TREATMENTS
- 51% of Trulance NRx were new branded
Rx therapy starts
- 43% of Trulance patients have converted
from other Rx treatments
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Source: Weeks ending 3/17 – 6/30, QIMS XPD
Switch To 43% New Therapy Starts 51%
Trulance NRx Breakdown
Add on 6%
Business Update I September 7, 2017
- 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
OPTIMIZING THE VALUE OF TRULANCE
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CONCLUSION
Gary S. Jacob, PhD Chairman & CEO
Business Update I September 7, 2017
RECAP OF OUR KEY BUSINESS PRIORITIES
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- Optimize the value of Trulance
- Ensure a strong financial foundation
- Maximize long-term shareholder value