Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — FY2019 Earnings Presentation
30 slides from Ironwood Pharmaceuticals's earnings presentation, Feb 13, 2020
Slide 1: Ironwood 4Q and FY 2019 Earnings
Ironwood 4Q and FY 2019 Earnings February 13, 2020 1
Slide 2: Introduction
Introduction Meredith Kaya
Slide 3: Safe Harbor Statement
Safe Harbor Statement This presentation contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about our ability to execute on our vision to become a leader in GI; our ability to execute on our strategy, incl
Slide 4: Today's Agenda
Today’s Agenda • Introduction Meredith Kaya, VP Strategy, Investor Relations & Communications • Overview Mark Mallon, Chief Executive Officer • GI Portfolio Highlights Tom McCourt, President • MD-7246 Clinical Program Mike Shetzline, Chief Medical Officer • 2019 Financial Highlights & 2020 Guidance
Slide 5: 4Q and Full Year 2019 Overview
4Q and Full Year 2019 Overview Mark Mallon
Slide 6: Become the Leading U.S. Gastrointestinal Healthcare Company
IRONWOOD’S VISION & MISSION Become the Leading U.S. Gastrointestinal Healthcare Company We are dedicated to advancing the treatment of GI diseases and redefining the standard of care for millions of GI patients 6
Slide 7: Executing on Our Strategy
Executing on Our Strategy Drive LINZESS® Advance late-stage Deliver (linaclotide) growth U.S. GI development sustainable profits portfolio Delivered FY 2019 U.S. net sales of Completed enrollment in MD-7246 FY 2019 GAAP net income from $803 million1, driven by 14% demand Phase II trial; toplin
Slide 8: 2020: Multiple Catalysts Positioned to Drive Further Growth
2020: Multiple Catalysts Positioned to Drive Further Growth Leveraging our momentum in 2020 and beyond WE EXPECT: 1H 2020 2H 2020 Driving Settled outstanding Launch full year consumer campaign discussing multiple abd symptoms Additional overall abd symptom data to be added to LINZESS label ANDA liti
Slide 9: Ironwood Positioned for Long-Term Growth and Value Creation
Ironwood Positioned for Long-Term Growth and Value Creation IW-3718 and MD-7246 represent significant commercial opportunities, if approved Total Ironwood Revenue8 ~10M IBS-C / CIC U.S. adults1 >$1 Billion U.S. net sales opportunity IW-3718 MD-7246 (if approved) ~8-10M rGERD U.S. adults2,3,4,5 + (if
Slide 10: Commercial and Development Highlights
Commercial and Development Highlights Tom McCourt
Slide 11: Strong LINZESS Performance Driven by Double-Digit Demand Growth
Strong LINZESS Performance Driven by Double-Digit Demand Growth LINZESS Extended Unit Growth1 Delivered 4Q 2019 LINZESS U.S. net sales of 2,900,000 2019 $231M; 2019 total LINZESS U.S. net sales of $803M2 2,700,000 2,500,000 Generated 13% yoy growth in 4Q 2019 prescription demand; 14% yoy growth in F
Slide 12: LINZESS is Now #1 Prescribed Medicine for IBS-C/CIC
LINZESS is Now #1 Prescribed Medicine for IBS-C/CIC IBS-C/CIC Prescription Category in US1 350,000 300,000 250,000 LACTULOSE 200,000 TRx 150,000 100,000 AMITIZA 50,000 TRULANCE MOTEGRITY 0 ZELNORM 2019-Jan 2019-Feb 2019-Mar 2019-Apr 2019-May 2019-Jun 2019-Jul 2019-Aug 2019-Sep 2019-Oct 2019-Nov 2019
Slide 13: Substantial Brand Profits To-Date; Significant Growth Potential
Substantial Brand Profits To-Date; Significant Growth Potential IP coverage expected to provide long runway for continued growth 2020 LINZESS Guidance: We expect: LINZESS total brand profitability 803M 50/50 Rx demand growth driven by $800 LINZESS U.S. net sales profit share overall abdominal sympto
Slide 14: IW-3718: Opportunity to Bring Relief to Millions of rGERD Patients
IW-3718: Opportunity to Bring Relief to Millions of rGERD Patients Phase III data targeted in second half of 2020 Compelling Bile Established High Unmet Need 1st In Class MOA Acid Story GI Leadership • ~8-10M U.S. adults suffer • Bile acids play a • IW-3718 is designed to target • GI category leader
Slide 15: MD-7246: Opportunity for Oral, Non-opioid, Pain-relieving Agent
MD-7246: Opportunity for Oral, Non-opioid, Pain-relieving Agent for Patients with Abdominal Pain associated with Certain GI Diseases >50 MILLION AMERICANS IBS with diarrhea Diverticular Functional IBS-C3,4 IBS-mixed3,4 IBD (IBS-D) disease abdominal pain5 POTENTIAL FUTURE INDICATIONS ~16M1,2 POTENTIA
Slide 16: MD-7246 Clinical Program
MD-7246 Clinical Program Mike Shetzline
Slide 17: MD-7246 Demonstrated Decoupling of Abdominal Pain Relief & Bowel Effect
MD-7246 Demonstrated Decoupling of Abdominal Pain Relief & Bowel Effect in Previous Phase II IBS-C trial Abdominal pain: CSBM2 rate: change from baseline 9/12 week responders (%)1 – overall treatment period 35 2.5 30 31.8 31.8 2 2.1 LS mean change Responders (%) 25 …With limited from baseline 20 1.5
Slide 18: Completed Phase II Trial Enrollment; Topline Data Targeted Mid-2020
Completed Phase II Trial Enrollment; Topline Data Targeted Mid-2020 MD- MD- MD- Placebo 7246 7246 7246 300 mcg 600 mcg 1200 mcg 12-WEEK TREATMENT PERIOD Study Design Primary Endpoints • Multicenter, randomized, double-blind, • Overall abdominal pain response placebo-controlled, dose-range-finding –
Slide 19: 2019 Financial Performance and 2020 Guidance
2019 Financial Performance and 2020 Guidance Gina Consylman
Slide 20: Profit Generation Began Immediately Post Separation
Profit Generation Began Immediately Post Separation Delivered GAAP and non-GAAP profitability in first three quarters post-separation1 In 2019: Separation (4/1/19) Exceeded revised guidance for top-line revenue and adjusted EBITDA from continuing operations2,3 GAAP Net Profit ($ Millions) $60 $48 $4
Slide 21: Fourth Quarter and Full Year 2019 Financial Highlights
Fourth Quarter and Full Year 2019 Financial Highlights1 Three Months Ended December 31, Twelve Months Ended December 31, ($ Millions, except per share amounts) 2019 2018 2019 2018 Collaborative arrangements revenue $105.7 $84.4 $379.7 $272.8 Product revenue -- $0.5 -- $3.4 Revenue from sales of API
Slide 22: Strong Financial Performance in 2019
Strong Financial Performance in 2019 $428M $177M in Ironwood revenues in total cash and Primarily Includes: cash equivalents $379M in collaborative arrangements revenue, including $42M in milestone and non-contingent payments from amended ex-U.S. agreements $49M in linaclotide API sales $59M $148M i
Slide 23: Full Year 2020 Financial Guidance
Full Year 2020 Financial Guidance Ironwood expects: FY2020 Guidance LINZESS U.S. net sales growth Mid-single digit % increase Total Ironwood revenue $360 – 380 million Adjusted EBITDA1 >$105 million 1) Adjusted EBITDA is calculated by subtracting net interest expense, taxes, depreciation, amortizati
Slide 24: Capital Allocation Priorities Aligned with Corporate Strategy
Capital Allocation Priorities Aligned with Corporate Strategy Advancing GI portfolio – LINZESS, IW-3718, MD-7246 Delivering sustainable profits and paying down debt Pursuing external GI opportunities 24
Slide 25: Executing on Our Strategy
Executing on Our Strategy Drive LINZESS® Advance late-stage Deliver (linaclotide) growth U.S. GI development sustainable profits portfolio 25 25
Slide 26: Thank You
Thank You “ \ ro d Nwoo
Slide 27: 4Q and FY 2019 financial summary
4Q and FY 2019 financial summary Reconciliation of GAAP results to non-GAAP financial measures1 Three Months Ended Twelve Months Ended December 31, 2019 December 31, 2019 (000s, except per share (000s, except per share Reconciliation of GAAP Results to Non-GAAP Financial Measures amounts) amounts) G
Slide 28: 4Q and FY 2019 financial summary
4Q and FY 2019 financial summary Reconciliation of GAAP net income from continuing operations to adjusted EBITDA from continuing operations Three Months Ended Twelve Months Ended December 31, 2019 December 31, 2019 (000s, except per share amounts) (000s, except per share amounts) GAAP net income fro
Slide 29: 4Q and FY 2019 financial summary
4Q and FY 2019 financial summary LINZESS U.S. Brand Collaboration Commercial Profit & Collaboration Revenue1 Ironwood & Allergan Total Net Profit Twelve Months Twelve Months Three Months Ended Three Months Ended Ended Ended December 31, 2019 December 31, 2019 December 31, 2019 December 31, 2019 (000
Slide 30: Outperforming 2019 financial guidance
Outperforming 2019 financial guidance 2019 Results Revised 2019 Guidance Original 2019 Guidance Total revenue $428 million $410 – $420 million $370 – $390 million Net interest expense $34 million Unchanged ~$35 million Separation expenses1 $32 million ~$30 million $30 – $40 million Restructuring exp
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