COR CORPORA PORATE TE PRES PRESENT ENTATION TION August 9, - - PowerPoint PPT Presentation
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
Corporate Presentation I 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 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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Corporate Presentation I August 9, 2017
2017 IS A IS A TRANSFO TRANSFORM RMATI TIVE E YEAR YEAR FOR OR SYNER SYNERGY GY
January 19, 2017 FDA approves Trulance for the treatment of adults with CIC March 20, 2017 Synergy begins marketing Trulance in CIC April 12, 2017 Three new patents issued, expected to extend Trulance exclusivity until 2032 June 7, 2017 IBS-C sNDA accepted for FDA review; PDUFA date January 24, 2018
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March 24, 2017 Submitted IBS-C sNDA for FDA review
Corporate Presentation I August 9, 2017
- 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
TR TRULAN ULANCE: CE: FOU FOUND NDATIO TION N TO O OUR OUR SUCCE SUCCESS SS
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TR TRULAN ULANCE CE LA LAUNC UNCH H UPD UPDATE TE
Corporate Presentation I August 9, 2017
SYNER SYNERGY GY AND AND TR TRULANC ULANCE: E: WELL WELL POSITI POSITION ONED ED FOR SU FOR SUCCESS CCESS
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RIGHT RIGHT
STRATEGY
RIGHT RIGHT
TEAM
RIGHT IGHT
MARKET
RIGHT RIGHT
PRODUCT
Corporate Presentation I August 9, 2017
SYNER SYNERGY GY AND AND TR TRULANC ULANCE: E: WELL WELL POSITI POSITION ONED ED FOR SU FOR SUCCESS CCESS
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RIG IGHT HT
MARKET
RI RIGHT
STRATEGY
RIG RIGHT
TEAM
RI RIGHT
PRODUCT
- Large, Growing Market
- Clear Unmet Needs
- Significant Opportunity for Continued Branded Rx Growth
Corporate Presentation I August 9, 2017
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
10 20 30 40 50
Migraine GERD CIC/IBS-C
Estimated U.S. Prevalence (in millions)
~33 million U.S. adults suffer from CIC alone
Sources: Suares and Ford, Am J Gastroenterol 2011; 106:1582–159; GERD Prevalence : Sharma, Am J Gastroenterol 2008;103(11):2669-2680; Migraine Prevalence : Smitherman TA, Headache. 2013 Mar;53(3):427-36
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Corporate Presentation I August 9, 2017
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
11,729 12,606 12,878 13,412
1,288 1,345 1,476 1,488 1,422 2,112 2,691
13,578 15,373 16,465 17,591
5,000 10,000 15,000 20,000
2013 2014 2015 2016 TRxs in Thousands All Other Rx Amitiza Linzess
~ 4 MM
Last four years, TRx volume has grown by nearly 4 million or 30%
All Other Rx = Rx lactulose & Rx polyethylene glycol Source: QuintilesIMS, NPA
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Corporate Presentation I August 9, 2017
$182 $184 $171 $166 $326 $378 $436 $467 $382 $654 $959 $642 $945 $1,260 $0 $500 $1,000 $1,500 2013 2014 2015 2016 US $ in Millions All Other Rx Amitiza Linzess
VAL ALUE UE OF OF T THE HE PRES PRESCRIPT CRIPTION ION CON CONST STIP IPATIO TION N MARKET MARKET HAS HAS MORE MORE THAN THAN DOUBLED DOUBLED OVER VER THE THE PAST AST FOU FOUR R YEA YEARS RS + 148%
1,593 $133
All Other Rx = Rx lactulose & Rx polyethylene glycol Source: QuintilesIMS, NSP
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Corporate Presentation I August 9, 2017
ST STILL ILL AN AN UNT UNTAPP APPED ED US MARKE US MARKET OPP OPPOR ORTU TUNIT NITY
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~ 45MM U.S. ADULTS WITH CIC / IBS-C
Branded Rx market serving
< 5% > 95%
currently not treated with branded Rx therapies
GROWTH DRIVERS
- Increasing awareness of “gut health”
- Significant investment to build market
- HCP promotion will continue providing
appropriate information to prescribers regarding branded CIC/IBS-C Rx products
- 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
Corporate Presentation I August 9, 2017
ST STILL ILL CLEAR CLEAR UNME UNMET T NEE NEEDS DS IN IN THE THE MARKE MARKET
KEY KEY INS INSIGHT IGHTS
- Bowel-Centered life
- Still seeking solutions
- Dissatisfied with OTCs
- Seek normalcy
PATI TIENT ENTS
- Challenging patients
- Frustrated
- Recycling
- Any BM = Good BM
HCPs HCPs
Source: Company Data
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Corporate Presentation I August 9, 2017
SYNER SYNERGY GY AND AND TR TRULANC ULANCE: E: WELL WELL POSITI POSITION ONED ED FOR SU FOR SUCCESS CCESS
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RIG IGHT HT
PRODUCT
- Clinical Data
- Market Research and Customer Insights
- Label
RI RIGHT
STRATEGY
RIG RIGHT
TEAM
RI RIGHT
MARKET
Corporate Presentation I August 9, 2017
TR TRULAN ULANCE CE PR PROVIDES VIDES A A NEW NEW TRE TREATM TMEN ENT T OPT OPTION ION FOR FOR MILLION MILLIONS S OF ADUL OF ADULTS TS WITH WITH CIC CIC
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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)
Corporate Presentation I August 9, 2017
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*
Convenient & Innovative Packaging
Simple Dosing & Administration Once a day Any time of day With or without food
*Source: Company Data
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Corporate Presentation I August 9, 2017
- Launch Brand = Launch Mode
- Key Launch Strategies and Activities
SYNER SYNERGY GY AND AND TR TRULANC ULANCE: E: WELL WELL POSITI POSITION ONED ED FOR SU FOR SUCCESS CCESS
RIG IGHT HT
STRATEGY
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RIG RIGHT
TEAM
RI RIGHT
PRODUCT
RI RIGHT
MARKET
Corporate Presentation I August 9, 2017
LESS LESS THAN THAN 20 20% OF % OF PRE PRESCR SCRIB IBERS ERS ARE ARE CURRE CURRENTL TLY Y WRIT WRITING ING 70 70% OF % OF THE THE TOTAL AL BRAND BRANDED ED PRE PRESCR SCRIPT PTIO IONS NS
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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Corporate Presentation I August 9, 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
TAR ARGET GETED ED SALE SALES ST S STRA RATE TEGY Y FOCU FOCUSE SED D ON ON A A CON CONCENTR CENTRATED ED PRES PRESCRI CRIBER ER BASE ASE
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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Corporate Presentation I August 9, 2017
KEY KEY CUST CUSTOME OMERS S AND AND LA LAUNCH UNCH ST STRA RATE TEGIE GIES
Lau Launc nch h Str Strate tegies gies
Drive Awareness of Trulance and Stimulate Trial and Adoption
HCPs CPs PAYERS YERS PATIE TIENTS TS
Ensure Access Activate and Support the Rx Ready Patient
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Corporate Presentation I August 9, 2017
HCPs HCPs
- Drive Awareness of
Trulance and Stimulate Trial / Adoption
- Activate and Support the
Rx Ready Patient
- Ensure Access
✓ Sales force of ~ 250 educating ~ 27,000 prescribers ✓ Over 360,000 sample packs distributed to field to date ✓ ~ 400 peer-to-peer speaker programs, > 5,200 attendees ✓ Launched comprehensive HCP media plan ✓ DDW 2017 – significant promotional presence; 6 abstracts (two posters of distinction, one oral presentation)
KEY KEY LA LAUNCH UNCH ST STRA RATE TEGIES IES AND AND ACTI CTIVI VITIE TIES
Source: Company Data
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Corporate Presentation I August 9, 2017
✓ Trulance Campaign:
▬ Point of Care Promotion: ~ 20,000 offices ▬ Web Sponsorships/Display Ads: > 101M impressions ▬ Search Engine Marketing: > 312,000 clicks ▬ Trulance.com visits: > 500,000 for consumer site
✓ Confront Constipation Campaign:
▬ Disease awareness initiative ▬ 33 original media placements ▬ > 300M media impressions ▬ ~ 92,000 Emoji App downloads
KEY KEY LA LAUNCH UNCH ST STRA RATE TEGIES IES AND AND ACTI CTIVI VITIE TIES
- Drive Awareness of
Trulance and Stimulate Trial / Adoption
- Activate and Support the
Rx Ready Patient
- Ensure Access
PATIE TIENTS TS
Source: Company Data
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Corporate Presentation I August 9, 2017
✓ Removing barriers and gaining commercial open access ✓ > 61% of patients with commercial insurance have unrestricted access ✓ Trulance “Savings-to-Go” program ensures copay of $25/Rx for > 95% of patients with commercial insurance ✓ Trulance Access Support Services Program ✓ Medicare Part D and Medicaid Discussions Ongoing
KEY KEY LA LAUNCH UNCH ST STRA RATE TEGIES IES AND AND ACTI CTIVI VITIE TIES
PAYERS YERS
- Drive Awareness of
Trulance and Stimulate Trial / Adoption
- Activate and Support the
Rx Ready Patient
- Ensure Access
Source: Company Data
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Corporate Presentation I August 9, 2017
SYNER SYNERGY GY AND AND TR TRULANC ULANCE: E: WELL WELL POSITI POSITION ONED ED FOR SU FOR SUCCESS CCESS
- Highly experienced team
- Significant launch experience
- Significant GI and PCP experience
- From peer GI, specialty, and PCP companies
RIG IGHT HT
TEAM
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RI RIGHT
STRATEGY
RI RIGHT
PRODUCT
RI RIGHT
MARKET
Corporate Presentation I August 9, 2017
SYNE SYNERGY GY HYBRID HYBRID SALE SALES MODE S MODEL L
Hired our own Sales Leaders
- Synergy Area Business Directors average ~16 years
- f pharma experience and ~ 10 years in GI
- Synergy Regional Business Directors average over 11
years of management experience with over 10 years in relevant GI fields
- Synergy Regional GI Account Specialists / Field
Trainers average 13 years of pharmaceutical experience and 8.5 years of GI experience
Flexible & Operationally Efficient CSO Approach
- Strong partnership with Publicis Touchpoint in
recruiting and hiring all of the GI Account Specialists
- Synergy leads training, territory management, sales
direction / tactical activities
- Average 11.5 years of pharmaceutical experience and
nearly 6 years in GI, with over 93% coming from peer GI / Specialty / PCP companies
Synergy Sales Leaders GI Account Specialists
FULLY DEDICATED TO TRULANCE
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KEY KEY LA LAUNCH UNCH PERFOR PERFORMA MANC NCE E METRICS METRICS
Corporate Presentation I August 9, 2017
TR TRULANC ULANCE T E TOTAL M AL MONTHL ONTHLY PRESCRIPT Y PRESCRIPTION ION VOL OLUM UME E HAS HAS INCREASED O INCREASED OVER VER 182% ON A 182% ON AVERA VERAGE MONTH GE MONTH-OVER VER-MO MONTH NTH
Source: QuintilesIMS
26 394 1847 4162 6272
1,000 2,000 3,000 4,000 5,000 6,000 7,000 Mar-17 Apr-17 May-17 Jun-17
TRx Volume
Trulance Monthly Total Prescriptions
394 2241 6403 12675
2,000 4,000 6,000 8,000 10,000 12,000 14,000 Mar-17 Apr-17 May-17 Jun-17
TRx Volume
Trulance Cumulative Monthly Total Prescriptions
Corporate Presentation I August 9, 2017
148 392 674 1096 1585 2213 2943 3799 4751 5866 6868 8120 9447 11023 12647 13995 15749 17491 19327
5,000 10,000 15,000 20,000 25,000 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
TRx Volume
Trulance Cumulative Weekly TRx Volume
TR TRUL ULANCE ANCE TOTAL AL WEEKL WEEKLY Y PRES PRESCRI CRIPT PTION ON VOL OLUME UME SHO SHOWING WING ST STRONG ONG CONSIS CONSISTE TENT NT GR GROWTH WTH
Holiday Week Holiday Week
124 244 282 422 489 628 730 856 952 1115 1002 1252 1327 1576 1624 1348 1754 1742 1836
200 400 600 800 1,000 1,200 1,400 1,600 1,800 2,000 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
TRx Volume
Trulance Weekly TRx Volume
Source: QuintilesIMS
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Corporate Presentation I August 9, 2017
TR TRULAN ULANCE CE NEW NEW-TO TO-BR BRAND ND MARKE MARKET T SHARE SHARE AT T 12 12% % AMONG AMONG GAST GASTROENT OENTER EROLOGISTS OGISTS
Source: QuintilesIMS
31.8% 22.5% 66.9% 65.4% 12.7% 12.0% 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 Prescription Market Share
NBRx Market Share Among Gastroenterologists
Amitiza Brand Linzess Brand Linzess 72mcg Trulance 3mg
LAUNCH
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Corporate Presentation I August 9, 2017
TR TRULAN ULANCE CE PRE PRESCR SCRIB IBERS ERS HA HAVE VE INCREASED INCREASED AN AN AVER VERAGE GE OF OF 14 140% MONT 0% MONTH-OVER ER-MONT ONTH H SINCE SINCE LA LAUNCH UNCH
257 1,145 2,427 3,768 1,000 2,000 3,000 4,000 5,000 March April May June Cumulative Trulance Prescribers
Source: QI XPT, launch through w/e 6/30/17
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Corporate Presentation I August 9, 2017
TR TRULAN ULANCE CE SOUR SOURCE CE OF B OF BUSINE USINESS SS (BRAN (BRANDED ED MARKE MARKET)
44% Rx convert 51% New therapy starts
5% Add On
Trulance NRx Breakdown
- 51% of Trulance NRx were new branded
Rx therapy starts
- 45% of Trulance patients have converted
from other Rx treatments
- Majority coming from Linzess
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Source: Weeks ending 3/17 – 6/30, QIMS XPD
Corporate Presentation I August 9, 2017
- Positive early launch signals
- 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
OPT OPTIMIZ IMIZING ING THE THE VAL ALUE UE OF TR OF TRULAN ULANCE CE
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