Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — J.P. Morgan 38th Annual Healthcare Conference (January 2020)
57 slides from Ironwood Pharmaceuticals's conference presentation, Jan 13, 2020
Slide 1: J.P. Morgan 38th Annual Healthcare Conference
1 J.P. Morgan 38 th Annual Healthcare Conference Ironwood Pharmaceuticals January 2020
Slide 2: Forward Looking Statements
2 Forward Looking Statements This presentation contains forward - looking statements. Investors are cautioned not to place undue reliance on these forward - look ing statements, including statements about our ability to execute on our vision to become a leader in GI; the mechanisms of action, develo
Slide 3: Ironwood's Vision & Mission
3 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
Slide 4: GI diseases affect approximately 2 in 3 Americans
4 GI diseases affect approximately 1 in every 5 Americans 1 Nearly 2/3 of Americans surveyed reported being burdened by ≥1 GI symptoms per week 2 GI impact to the healthcare system ~$136B 1 • This is more than heart disease (~$113B), trauma ($103B), or mental health ($99B) 1 • >20% of healthcare cos
Slide 5: Ironwood Has Leading GI Capabilities and Expertise
5 Ironwood Has Leading GI Capabilities and Expertise Leading U.S. GI Capabilities GI SCIENCE & CLINICAL DEVELOPMENT Deep understanding of GI diseases; 10 positive phase III linaclotide studies worldwide REGULATORY STRATEGY Led development of new GI patient reported outcome (PRO) measures PARTNERING
Slide 6: Executing on Our Strategy
6 Executing on Our Strategy Deliver sustainable profits Advance late - stage U.S. GI development portfolio Drive LINZESS ® (linaclotide) growth
Slide 7: LINZESS is Now #1 Prescribed Medicine for IBS-C/CIC
7 LINZESS is Now #1 Prescribed Medicine for IBS - C/CIC DRIVE LINZESS GROWTH In 2019: LINZESS Extended Unit Growth 2 Increased LINZESS growth with 13% YOY growth in extended unit prescription demand, vs 12% YOY in 2018 2 Demonstrated positive linaclotide Phase 3b overall abdominal symptom data (bloa
Slide 8: Pipeline Positioned for Two Top-line Data Readouts in 2020
8 Pipeline Positioned for Two Top - line Data Readouts in 2020 Advanced IW - 3718 Phase III trials in refractory GERD (rGERD) and MD - 7246 Phase II trial in GI pain with IBS - D ADVANCE GI PIPELINE In 2019: MD - 7246: Completed patient enrollment in December 2019; top - line data targeted mid - 202
Slide 9: Profit Generation Began Immediately Post Separation
9 Profit Generation Began Immediately Post Separation Delivered GAAP and non - GAAP profitability in first two quarters post - separation 1 DELIVER SUSTAINABLE PROFITS In 2019: Raised FY2019 guidance for total revenue and adjusted EBITDA from continuing operations Restructured debt to lower cash int
Slide 10: 2020: Multiple Catalysts Positioned to Drive Further Growth
10 2020: Multiple Catalysts Positioned to Drive Further Growth Leveraging our momentum in 2020 and beyond 1H 2020 2H 2020 Driving LINZESS Growth Advancing Late - Stage Pipeline Delivering Sustainable Profits Launch full year consumer campaign discussing multiple abd symptoms associated with IBS - C
Slide 11: Advancing a Leading GI Portfolio
11 Advancing a Leading GI Portfolio Three differentiated, durable GI assets positioned for growth and value creation Status of selected key development programs as of January 13, 2020. Represents ongoing phase of development; does not corresp ond to completion of a particular phase. 1) Previously “p
Slide 12: LINZESS Success Generated Substantial Brand Profits for Ironwood
12 LINZESS Success Generated Substantial Brand Profits for Ironwood IP coverage expected to provide long runway for continued growth 2019 LINZESS U.S. net sales and brand profitability is unaudited, preliminary and based on estimates, and may change as we re cei ve final 2019 data from Allergan plc
Slide 13: Ironwood is Positioned for Long-Term Growth and Value Creation
13 Ironwood is Positioned for Long - Term Growth and Value Creation 1) Lieberman Research Group, GI Patient Landscape study, 2010 2) American Community Survey 2018 (US 18+ population) 3) Lieber man GERD Survey 2010 and 2019 4) My Total Health 2018. 5) AHRI GERD Survey 2018 6) Grundmann O, Yoon SL. I
Slide 14: Proven Leadership Team
14 Proven Leadership Team Mark Mallon Chief Executive Officer Gina Consylman SVP, CFO Halley Gilbert, Esq. SVP, Corporate Development & CAO Thomas McCourt President Michael Shetzline, M.D., Ph.D. Chief Medical Officer Jason Rickard SVP, Operations *No product on this list, except for LINZESS, is aff
Slide 15: Maximizing LINZESS (linaclotide)
15 Maximizing LINZESS ® (linaclotide)
Slide 16: LINZESS Achieved IBS-C/CIC Prescription Market Leadership in 2019
16 LINZESS Achieved IBS - C/CIC Prescription Market Leadership in 2019 50,000 100,000 150,000 200,000 250,000 300,000 350,000 Jan 2019 TRx Feb 2019 TRx Mar 2019 TRx Apr 2019 TRx May 2019 TRx Jun 2019 TRx Jul 2019 TRx Aug 2019 TRx Sep 2019 TRx Oct 2019 TRx IBS - C/CIC Prescription Category 1 LACTULOS
Slide 17: LINZESS is Well Positioned Among Patients, Physicians, Payers
17 LINZESS is Well Positioned Among Patients, Physicians, Payers LINZESS growth driven by strong differentiated clinical profile, high patient and physician satisfaction, and broad payer access Industry - leading payer access 3 (% of preferred access by lives covered) >80% >90% >75% Combined Medicar
Slide 18: Linaclotide is a First-in-Class GC-C Agonist
18 18 Linaclotide is a First - in - Class GC - C Agonist
Slide 19: Linaclotide Works by Regulating Key Hormones in GI Tract
19 Large Intestine 1 - 11 Linaclotide Works by Regulating Key Hormones in GI Tract Busby, R. W., et al. (2010). Eur J Pharmacol 649(1 - 3): 328 - 335.; Evans DF., et al., Gut. 1988 Aug;29(8):1035 - 1041.; Cohen MB, et al. Biochem Biophys Res Commun. 1995;209(3):803 - 808.; Whitaker TL, et al. Gastro
Slide 20: Large Unmet Need Remains: >10M U.S. Adults Suffering and Dissatisfied
20 Large Unmet Need Remains: >10M U.S. Adults Suffering and Dissatisfied 1) Lieberman Research Group, GI Patient Landscape study, 2010 Abdominal & constipation symptoms Irritable bowel syndrome with constipation (IBS - C) and chronic idiopathic constipation (CIC) >40 Million adult patients >10 Milli
Slide 21: IBS-C/CIC Patients Report Frequent and Bothersome Symptoms
21 IBS - C/CIC Patients Surveyed Report Experiencing Frequent and Bothersome Symptoms Kantar Milward Brown LINZESS Tracking Study; Aug 2017 - Feb 2018; general population sample only: ‘Abdominal symptoms’ includes ex periencing abdominal discomfort or pain, stomach cramping, or bloating at least onc
Slide 22: We are Investing in Multiple Opportunities for Continued Growth
22 We are Investing in Multiple Opportunities for Continued Growth Drive volume growth by broadening HCP view of appropriate patient Maintain broad, unrestricted access to pull - through demand Increase patient requests for LINZESS BROAD PAYER ACCESS PATIENT ACTIVATION PHYSICIAN EDUCATION • Continue
Slide 23: Global Linaclotide Partnerships Designed to Enable Access Worldwide
23 Global Linaclotide Partnerships Designed to Enable Access Worldwide Japan Europe & rest of world China (incl. Hong Kong & Macau) • Amended and restated agreement August 2019 • Astellas assumed full responsibility for API manufacturing for Japan • IRWD received $10M upfront payment and will receiv
Slide 24: Advancing Our Late-Stage Pipeline
24 Advancing Our Late - Stage Pipeline
Slide 25: IW-3718
25 IW - 3718 Pioneering an innovative approach designed to treat millions of adult patients suffering from refractory GERD
Slide 26: IW-3718: Opportunity to Bring Relief to Millions of rGERD Patients
26 IW - 3718: Opportunity to Bring Relief to Millions of rGERD Patients Phase III data targeted 2H 2020 1) American Community Survey 2018 (US 18+ population) 2) Lieberman GERD Survey 2010 and 2019 3) My Total Health 2018 4) AHRI GER D Survey 2018 5) Ironwood data; Dickman et al., J Neurogastroentero
Slide 27: ~10M U.S. Adults Estimated to Suffer from rGERD
27 ~10M U.S. Adults Estimated to Suffer from rGERD US Census; Lieberman HCP Survey, 2018; Lieberman GI Patient Landscape Survey, 2010; American Community Survey 2018 (US 18+ po pul ation); Lieberman GERD Survey 2010 and 2019; My Total Health 2018; AHRI GERD Survey 2018 with refractory GERD Gastroeso
Slide 28: Heartburn and Regurgitation are Highly Bothersome Symptoms
28 Heartburn and Regurgitation are Highly Bothersome Symptoms AHRI GERD Burden of Disease survey, 2019 67% 50% 0% 20% 40% 60% 80% 100% Nausea/Vomiting Regurgitation/Acid Taste Heartburn/Burning Chest Pressure/Discomfort Bloating Cough Very/quite a bit bothersome Somewhat Bothersome r GERD Symptom Bu
Slide 29: Bile Acids May be the Missing Link in rGERD
29 Bile Acids May be the Missing Link in rGERD Emerging data in 2019 reinforce the role of bile in rGERD, including its impact on lower esophageal sphincter (LES) impairment and delayed gastric emptying = Bile Acids = Gastric Acid Potential Role of Bile Acids in rGERD Bile + gastric acid induce more
Slide 30: IW-3718: Developing A Potential New Treatment Paradigm
30 IW - 3718: Developing A Potential New Treatment Paradigm Potential to treat root cause of rGERD; IW - 3718 designed to sequester bile acids in stomach over extended period of time via gastric retentive formulation IW - 3718 + PPI PPI ALONE PPIs block gastric acid from refluxing into esophagus, bu
Slide 31: Burden of Disease Underscores the Need for IW-3718
31 † Person depicted is not an actual patient. Lieberman Patient Journey Research, 2019; AHRI GERD Survey, 2018. Burden of Disease Underscores the Need for IW - 3718 Likely to request IW - 3718 (if approved) 60% Dissatisfied with current treatment >70% 75% Have regurgitation 2+ times/week “It feels
Slide 32: Phase 2b Data: IW-3718 Reduction in Heartburn Severity and Regurgitation
32 Phase 2b Data: IW - 3718 1500mg Showed Meaningful Reduction in Heartburn Severity and Regurgitation Frequency of patients treated with IW - 3718 + PPI achieved clinically meaningful reduction in heartburn severity ~53 % IW - 3718 + PPI demonstrated ~55% reduction in regurgitation frequency IW - 3
Slide 33: IW-3718 Phase II Data: Reduction in Regurgitation Frequency
33 IW - 3718 Phase II Data: Reduction in Regurgitation Frequency & Increase in Regurgitation - free Days *P - value obtained from a pairwise comparison versus PBO (PPI alone) in an ANCOVA model with treatment group and esophagitis status as factors and baseline value as covariate. **PBR: pathologic
Slide 34: IW-3718 Pivotal Phase Program Ongoing
34 IW - 3718 Pivotal Phase 3 Program Ongoing Enrollment slower than expected; targeting topline data in 2H 2020 IW - 3718 1500 mg + PPI Placebo + PPI 8 WEEK TREATMENT PERIOD Endpoints • Overall heartburn response – Primary • Defined as ≥45% reduction from baseline in heartburn for at least four out
Slide 35: MD-7246
35 MD - 7246 Potential oral, non - opioid, pain - relieving agent for patients suffering from abdominal pain associated with certain GI diseases 35
Slide 36: MD-7246: Potential Non-Opioid Treatment for Abdominal Pain
36 MD - 7246: Potential Non - Opioid Treatment for Abdominal Pain Associated with Certain GI Diseases Phase II data in IBS - D targeted mid - 2020 1) IFFGD "IBS Patients: Their Illness Experience and Unmet Needs", 2009. 2) Grundmann O, Yoon SL. Irritable bowel syndrome: e pid emiology, diagnosis and
Slide 37: New, Innovative Treatment Options Needed for Abdominal Pain
37 New, Innovative Treatment Options Needed for Abdominal Pain 1) Grundmann O, Yoon SL. Irritable bowel syndrome: epidemiology, diagnosis and treatment: an update for health - care practitioner s. J Gastroenterol Hepatol. 2010 Apr;25(4):691 - 9 2) US Census Bureau. USA QuickFacts from the US Census
Slide 38: MD-7246 Leverages Linaclotide's Differentiated MoA
38 MD - 7246 Leverages Linaclotide’s Differentiated MoA Initially exploring MD - 7246 in patients with abdominal pain associated with IBS - D Immediate release in stomach LINZESS Ileocecal junction release MD - 7246 (linaclotide) Potential for abdominal pain relief with minimal impact on bowel funct
Slide 39: MD-7246 Demonstrated Decoupling of Abdominal Pain Relief & Bowel Effect
39 MD - 7246 Demonstrated Decoupling of Abdominal Pain Relief & Bowel Effect in Phase II IBS - C trial 1) Abdominal pain responder defined as decrease from baseline of at least 30% in the mean abdominal pain score for at least 9 of 12 weeks of treatment period 2) Complete spontaneous bowel movements
Slide 40: Initial Trial in Abdominal Pain associated with IBS-D
40 Initial Trial in Abdominal Pain associated with IBS - D; Topline Data Targeted Mid - 2020 Primary Endpoints • Change from baseline in abdominal pain at its worst each week • Overall abdominal pain response – Defined as ≥30% reduction from baseline in abdominal pain for at least six out of 12 week
Slide 41: IBS-D Patients Report Frequent & Bothersome Abdominal Symptoms
41 IBS - D Patients Report Suffering Frequent & Bothersome Abdominal Symptoms 1) Irritable Bowel Syndrome in Women: The Unmet Needs A Report from the Society for Women’s Health Research 2) Lembo T,et al. Sy mptoms and visceral perception in patients with pain - predominant irritable bowel syndrome.
Slide 42: Delivering Sustainable Profits
42 Delivering Sustainable Profits
Slide 43: Solid Financial Performance in 2019 YTD
43 $11M in GAAP net income from continuing operations ($0.07/share) $94M in adjusted EBITDA from continuing operations 1 $302M in Ironwood revenues Includes: $274M in Ironwood’s share of net profits from LINZESS U.S. net sales and collaborative arrangements revenue, including $42M in milestone and n
Slide 44: Ironwood is Positioned to Deliver Sustainable Profitability
44 Ironwood is Positioned to Deliver Sustainable Profitability 1) Profitability on a non - GAAP basis based on Adjusted EBITDA from Continuing Operations. 2) Refer to the Reconciliation of GAAP net income from continuing operations to adjusted EBITDA from continuing operations as appearing on page 5
Slide 45: Full Year 2019 Financial Guidance
45 Full Year 2019 Financial Guidance Total Revenue and Adjusted EBITDA from Continuing Operations guidance includes ~$42M in milestone payments from amended ex - U.S. agreements 1) Separation expenses were $6.7 million in the third quarter of 2019. 2) Restructuring expenses were largely incurred dur
Slide 46: Becoming a Leading GI Healthcare Company
46 Becoming a Leading GI Healthcare Company 2020 Catalysts 2019 Execution Ironwood Priorities 1. Drive LINZESS Growth 2. Advance Late - Stage GI Portfolio 3. Deliver Sustainable Profits • Increased LINZESS growth: • 13% growth YOY in Rx demand vs 12% growth YOY in 2018 1 • Advanced GI Pipeline: • MD
Slide 47: Appendix
47 Appendix
Slide 48: PPIs Improved Heartburn by ~11% over H2s in Non-erosive GERD
48 Data Showed that PPIs Improved Heartburn by ~11% over H2s in Non - erosive GERD and ~24% in Erosive GERD 0 0.5 1 1.5 2 2.5 3 Ran 150 BID Lan 15 QD Lan 30 QD Baseline Week 8 Change Heartburn severity (0 - 3) 11.1 % 0 10 20 30 40 50 60 70 80 90 100 Ran 150 BID OME 20 QD Heartburn relief Heartburn r
Slide 49: IW-3718 1500 mg + PPI Reduction in Heartburn Severity vs PPI Alone
49 IW - 3718 1500 mg + PPI Demonstrated Clinically Meaningful Reduction in Heartburn Severity vs PPI Alone in Phase IIb Trial -60 -50 -40 -30 -20 -10 0 BL 1 2 3 4 5 6 7 8 LS mean % change from baseline Treatment week Heartburn severity: % change from baseline by week IW - 3718 + PPI - 58.0% p=0.04 P
Slide 50: GERD Regarded as Important Therapeutic Category
50 GERD Regarded as Important Therapeutic Category 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 H2 ANTAGONISTS PROTON PUMP INHIBITORS (PPIs) U.S. Peak H2 Sales ~$4B 1 U.S. Peak PPI Sales ~$14B 2 1) QuintilesIMS Dec - 2009 2) QuintilesIMS Dec 2009 3) Liebe
Slide 51: Reconciliation of GAAP Results to Non-GAAP Financial Measures
Reconciliation of GAAP Results to Non - GAAP Financial Measures Three Months Ended June 30, 2019 (000s, except per share amounts) GAAP net income $ 12,283 Adjustments: Mark - to - market adjustments on the derivatives related to convertible notes , net 672 Restructuring expenses 490 Separation expen
Slide 52: 3Q 2019 Financial Summary
52 3Q 2019 Financial Summary Reconciliation of GAAP results to non - GAAP financial measures (unaudited) Three Months Ended September 30, 2019 (000s, except per share amounts) GAAP net income $20,648 Adjustments: Mark - to - market adjustments on the derivatives related to convertible notes , net 4,
Slide 53: 3Q 2019 Financial Summary: Adjusted EBITDA Reconciliation
53 3Q 2019 Financial Summary Reconciliation of GAAP net income from continuing operations to adjusted EBITDA from continuing operations 1 (unaudited) Three Months Ended September 30, 2019 Nine Months Ended September 30, 2019 (000s, except per share amounts) (000s, except per share amounts) GAAP net
Slide 54: 3Q 2019 Financial Summary: LINZESS U.S. Brand Collaboration
54 3Q 2019 Financial Summary LINZESS U.S. Brand Collaboration Commercial Profit & Collaboration Revenue 1 Ironwood & Allergan Total Net Profit Three Months Ended September 30, 2019 (000s) LINZESS U.S. net product sales $ 214,743 Allergan & Ironwood commercial costs and expenses 63,870 Commercial pro
Slide 55: Patients Continue to Suffer Despite Standard of Care Treatment
55 Patients Continue to Suffer Despite Standard of Care Treatment 0% 10% 20% 30% 40% 50% 60% 70% 80% Overall PPI Standard Dose PPI Double Dose PPI HCP Stated Literature/KOL % of Patients with persistent symptoms while on PPI Persistent Symptoms Despite PPI Therapy by PPI Dosing Regimen Lieberman HCP
Slide 56: Linaclotide Effect on Abdominal Pain Recognized by Scientific Community
56 Linaclotide Effect on Abdominal Pain Recognized by Scientific Community
Slide 57: Strengthened Balance Sheet by Restructuring Debt
57 Strengthened Balance Sheet by Restructuring Debt Raised $400M in convertible debt to pay - off remaining balance of 8.375% Notes and ~$215M of existing 2022 Convertible Notes Lowers Cash Interest Expense Over Next Few Years Improves Debt Maturity Profile Increases Cash Generation to Enable Invest
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