Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — Investor Presentation (January 2019)
37 slides from Ironwood Pharmaceuticals's investor presentation, Jan 7, 2019
Slide 1: Forward looking statements
Forward looking statements This presentation contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about expectations and timing regarding Ironwood’s ability to achieve profitability; the development, launch
Slide 2: We aim to grow LINZESS and accelerate U.S. GI development portfolio
WE AIM TO: Grow LINZESS® (linaclotide) and accelerate U.S. GI development portfolio Deliver profits beginning in 2019 (following planned separation) IRONWOOD is building a profitable, GI-focused healthcare company Capitalize on our GI expertise to bring innovative therapies to patients
Slide 3: Seasoned executive team with proven track record in GI businesses
Seasoned executive team with proven track record in building successful GI businesses* 4 Mark Mallon Chief Executive Officer Tom McCourt President Gina Consylman Chief Financial Officer Halley Gilbert Chief Administrative Officer Jason Rickard Senior Vice President, Operations Mike Shetzline Chief M
Slide 4: Capitalizing on our expertise in GI to bring innovative therapies to patients
Capitalizing on our expertise in GI to bring innovative therapies to patients 5 Accelerating LINZESS growth and profitability1 Sources: 1. IQVIA NPA, Dec 2018 Investing in profitable growth beginning in 2019 Driving revenue growth and expanding operating margins Seeking to strengthen balance sheet a
Slide 5: Focused execution on core GI business
Focused execution on core GI business 3 differentiated, durable GI assets positioned for growth and value creation 6 Status of selected key development programs as of January 7, 2019. Represents ongoing phase of development; does not correspond to completion of a particular phase linaclotide MD-7246
Slide 6: LINZESS (linaclotide)
LINZESS® (linaclotide) Market-leading branded prescription product in its class with significant opportunity for continued growth
Slide 7: >10 Million unsatisfied adult patients with IBS-C or CIC actively seeking care
>10 Million unsatisfied adult patients with IBS-C or CIC actively seeking care 8 Source: 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 patients >10
Slide 8: IBS-C and CIC patients experience frequent and bothersome symptoms
9 IBS-C and CIC surveyed patients experience frequent and bothersome symptoms Avg. days per year Bothersome symptoms by severity (%) Extremely / very Somewhat Not very / not at all IBS-C CIC w/o abd symptoms Source: Kantar Milward Brown LINZESS Tracking Study; Aug 2017-Feb 2018; general population s
Slide 9: LINZESS: branded, prescription market leader in its class
2013 2014 2015 2016 2017 2018 2012 LINZESS: branded, prescription market leader in its class ~2.5M unique patients have filled ~13M LINZESS prescriptions to-date since launch1 10 >85% of the time patients are prescribed LINZESS when requested to their HCP5 Sources: 1. IQVIA Patient Tracker, Nov 2018
Slide 10: LINZESS has generated ~$3 billion in U.S. net sales since launch
LINZESS has generated ~$3 billion in U.S. net sales and ~$1 billion in brand profits since launch Strong intellectual property position with coverage expected into 2030 11 50/50 profit share Ironwood’s share of 2018 U.S. LINZESS profits Sources: 2018 LINZESS U.S. net sales and brand profitability is
Slide 11: Investing in multiple opportunities for continued growth
Investing in multiple opportunities for continued growth 12 Drive volume growth by broadening HCP view of appropriate patient Capture Rx PEG patients seeking different treatment options Increase conversion of dissatisfied OTC patients Maintain broad, unrestricted access to pull-through demand Increa
Slide 12: LINZESS DTC campaigns have activated new sources of patients
LINZESS DTC campaigns have consistently activated new sources of patients 13 “Tell me something I don’t know” NEW TO BRAND PATIENTS (000) “Wearing on you” “Feels like a knot” “Keeps coming back” “Tell me something I don’t know” “Yesssss! Linzess” 2018 2012 2018 2017 2016 2015 2014 2013 Source: 1. IQ
Slide 13: Positive data in abdominal bloating, discomfort and pain could motivate additional patients
Positive data in abdominal bloating, discomfort + pain have potential to motivate additional IBS-C patients Opportunity to address key unmet need and increase LINZESS patient requests Source: 1. GfK “IBS in America”, 2016. 2. Lieberman GI Patient Landscape Survey, 2010. 3. Galileo Patient Explorator
Slide 14: Capturing significant value from ex-U.S. partnerships
Focused on bringing linaclotide to patients worldwide Capturing significant value from ex-U.S. partnerships 15 Sources: 1. As of 9/30/18; 2. 2018 revenue from linaclotide API sales to Astellas is unaudited, preliminary and based on estimates, and may change as we complete the preparation of our 2018
Slide 15: IW-3718 for persistent GERD
IW-3718 Pioneering an innovative approach designed to treat millions of patients suffering from persistent GERD
Slide 16: ~10 Million unsatisfied adult patients with persistent GERD
~10 Million unsatisfied adult patients with persistent GERD actively seeking care 17 Source: US Census; Lieberman HCP Survey, 2018; Lieberman GI Patient Landscape Survey, 2010 with persistent GERD Gastroesophageal reflux disease (GERD) >45 Million adult patients ~10 Million patients >20 Million pati
Slide 17: Persistent GERD patients suffer frequent, bothersome symptoms despite PPI
Patients with persistent GERD suffer from frequent, bothersome symptoms despite treatment with PPI Of patients surveyed experience heartburn and regurgitation 6 days per week3 85% Have damage to the lining of the esophagus, or erosive esophagitis3,5 50% More ER visits than PPI responsive patients4 3
Slide 18: Bile acids may be the missing link
Bile acids may be the missing link 19 DISEASED GI = Bile Acids = Gastric Acid Sources: 1. McQuaid et al, Aliment Pharmacol Ther 2011; 34: 146–165; 2. Bachir et al, Southern Medical Journal. 1981; 74(9): 1072–1074; 3. Duggan et al., Carcinogenesis 2010; 31(5): 936–945; 4. Tack et al., Am J Gastro 200
Slide 19: IW-3718: Opportunity to establish new treatment paradigm
IW-3718: Opportunity to establish new treatment paradigm for patients with persistent GERD Offers complementary mechanism with PPI, designed to sequester bile acids in stomach over extended period of time 20 IW-3718 designed to sequester bile acids in the stomach to reduce bile exposure in the esoph
Slide 20: Strong Phase IIb results propel IW-3718 into Phase III
Strong Phase IIb results propel IW-3718 into pivotal Phase III program of patients treated with IW-3718 + PPI reported clinically meaningful reduction in heartburn severity ~53% 21 IW-3718 + PPI demonstrated reduction in regurgitation frequency IW-3718 + PPI effect even more pronounced in patients w
Slide 21: IW-3718 Phase II reduced regurgitation frequency
IW-3718 Phase II data showed reduction in regurgitation frequency & improvement in regurgitation-free days 22 *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: patholog
Slide 22: Phase III pivotal program design
Phase III pivotal program seeking to demonstrate improved heartburn & regurgitation in patients with persistent GERD Patients 23 Adult patients with GERD who continue to have persistent symptoms while receiving current standard of care (PPI) therapy ~1320 GERD patients, 2 identical trials Endpoints
Slide 23: Opportunity to transform standard of care
Opportunity to transform standard of care Seeking to bring relief to millions of persistent GERD patients with IW-3718 24 ~10M U.S. (>60M global) patients suffer from GERD despite optimized PPI therapy1,2,6 Over 50% have esophageal erosions3 3x more ER visits than PPI-responsive patients4 Limited tr
Slide 24: MD-7246 for IBS abdominal pain
MD-7246 Advancing a potential oral, intestinal, pain-relieving agent for patients suffering from IBS 25
Slide 25: >50 million patients report recurring abdominal pain
>50 million patients report suffering from recurring abdominal pain across several GI disorders 26 ~80% of IBS patients report suffering from continuous or frequent abdominal pain3 >50 MILLION3 POTENTIAL FUTURE INDICATIONS IBS-C3,4 IBS-mixed3,4 Functional abdominal pain4 Large suffering population C
Slide 26: IBS-D patients suffer from frequent and bothersome abdominal symptoms
Sources: 1. Irritable Bowel Syndrome in Women: The Unmet Needs A Report from the Society for Women’s Health Research 2. Lembo T,et al. Symptoms and visceral perception in patients with pain-predominant irritable bowel syndrome. Am J Gastroenterol.1999;94:1320-1326 3. IBS Patients:Their illness Exper
Slide 27: Treatment potential of MD-7246
Treatment potential of MD-7246 Treating abdominal pain alone with minimal effect on bowel function Immediate release in stomach LINZESS Ileocecal junction release MD-7246 Potential for strong abdominal pain relief only Effective relief of abdominal pain
Slide 28: MD-7246 decoupled abdominal pain relief and bowel effect in Phase II
CSBM2 rate: change from baseline – overall treatment period Abdominal pain: 9/12 week responders (%)1 MD-7246 demonstrated a decoupling of abdominal pain relief and bowel effect in Phase II IBS-C trial 29 RESPONDERS (%) Source: 1. Abdominal pain responder defined as decrease from baseline of at leas
Slide 29: 3Q 2018 Financial performance & FY2018 financial guidance
3Q 2018 Financial performance & FY2018 financial guidance
Slide 30: YTD 2018 financial performance
YTD 2018 financial performance (as of 9/30/18) Refer to the Reconciliation of GAAP Results to Non-GAAP Financial Measures appearing on slide 37 of this presentation 31 in Ironwood revenues Includes: $182.7M in Ironwood’s share of net profits from LINZESS U.S. net sales (including $29.7M reduction du
Slide 31: Financial guidance
Financial guidance Ironwood expects in 2018 32 SG&A expenses R&D expenses Total LINZESS marketing & sales expenses (IRWD + AGN) Net interest expense $230 - $250 million $160 – $180 million $230 - $260 million <$40 million Total restructuring expenses (including 2018 workforce reductions) ~$16 millio
Slide 32: Financial guidance
Financial guidance Ironwood expects in 2018 SG&A expenses R&D expenses Total LINZESS marketing & sales expenses (IRWD + AGN) Net interest expense Total restructuring expenses (including 2018 workforce reductions) Ironwood now expects Total separation expenses (2018 & 2019) $230 - $250 million $160 —
Slide 33: Symptom relief in millions of patients resulted in multiple blockbuster brands
Improving symptom relief in millions of suffering patients resulted in multiple blockbuster brands GERD proven to be extremely important therapeutic category 34 Source: 1. QuintilesIMS Dec-2009 2. QuintilesIMS Dec 2009 3. Lieberman GI Patients Landscape survey, 2010 4. U.S. Census, 2015 U.S. Peak H2
Slide 34: PPIs improved heartburn over H2s in non-erosive and erosive GERD
Data showed that PPIs improved heartburn by ~11% over H2s in non-erosive GERD and ~24% in erosive GERD 35 Heartburn severity (0-3) Heartburn relief *Adapted from JE Ritcher et al Arch Intern Med 2000;160:1803-1809 Pain severity (0-3) 0=none, 1=mild, 2=moderate, 3=severe. **Adapted from S. Sandmark e
Slide 35: IW-3718 + PPI reduced heartburn severity vs PPI alone
IW-3718 1500 mg + PPI demonstrated clinically meaningful reduction in heartburn severity vs PPI alone IW-3718 + PPI -58.0% p=0.04 PPI alone -46.0% 36 -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
Slide 36: 1Q-3Q 2018 Financial Summary: Reconciliation of GAAP to Non-GAAP
Nine Months Ended September 30, 2018 (000s, except per share amounts) GAAP net loss $ (266,875) Adjustments: Mark-to-market adjustments on the derivatives related to convertible notes, net (3,996) Amortization of acquired intangible assets 8,111 Fair value remeasurement of contingent consideration (
Slide 37: 1Q-3Q 2018 Financial Summary
1Q-3Q 2018 Financial Summary Reconciliation of GAAP Results to Non-GAAP Financial Measures Nine Months Ended September 30, 2018 (000s, except per share amounts) GAAP net loss. $ (266,875) Adjustments: Mark-to-market adjustments on the derivatives related to convertible notes, net. (3,996) ‘Amortizat
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