Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — 37th Annual J.P. Morgan Healthcare Conference 2019
37 slides from Ironwood Pharmaceuticals's conference presentation, Jan 8, 2019
Slide 1: J.P. Morgan Healthcare Conference
J.P. Morgan Healthcare Conference JANUARY 7 – 10, 2019
Slide 2: 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 3: Ironwood is building a profitable, GI-focused healthcare company
WE AIM TO: Grow LINZESS® (linaclotide) and accelerate U.S. GI development portfolio Capitalize on our GI expertise to IRONWOOD bring innovative therapies to patients is building a profitable, GI-focused healthcare company Deliver profits beginning in 2019 (following planned separation)
Slide 4: Seasoned executive team with proven track record in building successful GI businesses
Seasoned executive team with proven track record in building successful GI businesses* Mark Mallon Tom McCourt Gina Consylman Chief Executive Officer President Chief Financial Officer Halley Gilbert Jason Rickard Mike Shetzline Chief Administrative Officer Senior Vice President, Chief Medical Office
Slide 5: Capitalizing on our expertise in GI to bring innovative therapies to patients
Capitalizing on our expertise in GI to bring innovative therapies to patients Accelerating LINZESS Advancing late-stage Focusing investments growth and profitability1 development programs for growth & value creation Linaclotide abdominal symptom • Investing in profitable growth 3,000,000 claims (blo
Slide 6: Focused execution on core GI business
Focused execution on core GI business 3 differentiated, durable GI assets positioned for growth and value creation PHASE I PHASE II PHASE III APPROVAL IBS-C or CIC in adults Launched 12/12 linaclotide Abdominal symptoms (bloating, discomfort, pain) linaclotide IBS-C/CIC in pediatrics MD-7246 Abdomin
Slide 7: LINZESS (linaclotide)
LINZESS® (linaclotide) Market-leading branded prescription product in its class with significant opportunity for continued growth
Slide 8: >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 >40 Million patients Irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) >15 Million patients Abdominal & constipation symptoms, actively seeking care, MDs recommend OTC lax majori
Slide 9: IBS-C and CIC surveyed patients experience frequent and bothersome symptoms
IBS-C and CIC surveyed patients experience frequent and bothersome symptoms Avg. days per year Bothersome symptoms by severity (%) Bloating IBS-C CIC + abd symptoms CIC w/o abd symptoms Abdominal discomfort 67 54 Abdominal pain 39 34 38 Stomach cramping 26 22 11 Heartburn / acid reflux 6 Straining E
Slide 10: LINZESS: branded, prescription market leader in its class
LINZESS: branded, prescription market leader in its class ~2.5M unique patients have filled ~13M LINZESS prescriptions to-date since launch1 3,000,000 >80% of surveyed >85% of the time 2,500,000 LINZESS patients patients are highly satisfied with prescribed >80% >85% LINZESS Extended Units TRx 2,000
Slide 11: LINZESS has generated ~$3 billion in U.S. net sales and ~$1 billion in brand profits
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 $800 LINZESS brand profitability LINZESS U.S. net sales ~$760M 50/50 profit share >$220M $600 ~$440M Ironwood’s share $400 of 2018
Slide 12: Investing in multiple opportunities for continued growth
Investing in multiple opportunities for continued growth Drive volume growth by Increase patient requests for Maintain broad, broadening HCP view of LINZESS unrestricted access to appropriate patient • Promotion of new abdominal symptom pull-through demand • Capture Rx PEG patients seeking claims, i
Slide 13: LINZESS DTC campaigns have consistently activated new sources of patients
LINZESS DTC campaigns have consistently activated new sources of patients “Feels like a knot” “Keeps coming back” “Tell me something I “Wearing on you” “Yesssss! Linzess” NEW TO BRAND PATIENTS (000) don’t “Tellknow” me something I don’t know” 2012 2013 2014 2015 2016 2017 2018 13 Source: 1. IQVIA Pa
Slide 14: Positive data in abdominal bloating, discomfort + pain have potential to motivate additional IBS-C 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 ~95% 1x/week BLOATING of IBS-C patients The majority of IBS-C surveyed experience patients surveyed Characterized by
Slide 15: Focused on bringing linaclotide to patients worldwide
Focused on bringing linaclotide to patients worldwide Capturing significant value from ex-U.S. partnerships Europe & rest of world Japan Strong IBS-C launch; CC approved in Aug 2018 Expect ~$70M in 2018 >$285M linaclotide API sales2 total revenue from ex-U.S. partnerships1 China, Hong Kong, & Macau
Slide 16: IW-3718
IW-3718 Pioneering an innovative approach designed to treat millions of patients suffering from persistent GERD
Slide 17: ~10 Million unsatisfied adult patients with persistent GERD actively seeking care
~10 Million unsatisfied adult patients with persistent GERD actively seeking care >45 Million adult patients Gastroesophageal reflux disease (GERD) >20 Million patients Actively seeking care, taking prescription or OTC PPIs >45% Not fully satisfied with treatment ~10 Million patients with persistent
Slide 18: Patients with persistent GERD suffer from frequent, bothersome symptoms despite PPI
Patients with persistent GERD suffer from frequent, bothersome symptoms despite treatment with PPI “It feels like a volcano is erupting in my 85% 50% throat, my chest hurts Of patients surveyed Have damage to the lining experience heartburn of the esophagus, or and I feel liquid and regurgitation 6
Slide 19: Bile acids may be the missing link
Bile acids may be the missing link 50 Inflammation 350 % with Symptoms 40 300 Gastric Acid 250 30 IL8 (pg/ml) 200 vehicle 20 150 Bile + Bile acid Gastric Acid 100 10 50 0 0 0 4 8 12 24 Esophageal exposure to bile acids Bile acids damage esophageal tissue: may triggers a strong symptomatic response1,
Slide 20: IW-3718: Opportunity to establish new treatment paradigm for persistent GERD
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 PPI ALONE IW-3718 + PPI PPIs block IW-3718 gastric acid from designed to refluxing into sequest
Slide 21: Strong Phase IIb results propel IW-3718 into pivotal Phase III program
Strong Phase IIb results propel IW-3718 into pivotal Phase III program • IW-3718 + PPI demonstrated reduction in ~53% regurgitation frequency of patients treated • IW-3718 + PPI effect even more pronounced in patients with erosive esophagitis with IW-3718 + PPI reported clinically • Encouraging safe
Slide 22: IW-3718 Phase II data showed reduction in regurgitation frequency
IW-3718 Phase II data showed reduction in regurgitation frequency & improvement in regurgitation-free days Regurgitation: % change from baseline by week % of Regurgitation-free Patients** (Phase IIb) 0 (Phase IIa) Δ =17.5% 40 34.1 LS Mean % change from baseline -10 Wk 8 1500mg v PBO 35 33.3 Nominal
Slide 23: Phase III pivotal program seeking to demonstrate improved heartburn & regurgitation
Phase III pivotal program seeking to demonstrate improved heartburn & regurgitation in patients with persistent GERD Placebo IW-3718 + PPI 1500 mg + PPI 8 WEEK TREATMENT PERIOD Endpoints • Overall heartburn response - Primary Patients - Defined as ≥45% reduction from baseline in heartburn for at lea
Slide 24: 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 Compelling bile Established GI High unmet need 1st in class MOA acid story leadership • ~10M U.S. (>60M global) • Bile acids play a • IW-3718 is designed to • GI category patients s
Slide 25: MD-7246
MD-7246 Advancing a potential oral, intestinal, pain- relieving agent for patients suffering from IBS 25
Slide 26: >50 million patients report suffering from recurring abdominal pain across several GI disorders
>50 million patients report suffering from recurring abdominal pain across several GI disorders >50 MILLION3 IBS with Diverticular Functional IBS-C3,4 IBS-mixed3,4 IBD diarrhea (IBS-D) disease abdominal pain4 POTENTIAL FUTURE INDICATIONS ~16M1,2 POTENTIAL FUTURE INDICATIONS ~80% of IBS patients Plan
Slide 27: IBS-D patients suffer from frequent and bothersome abdominal symptoms
IBS-D patients suffer from frequent and bothersome abdominal symptoms >80% 80% ~70% of surveyed patients of patients report report ABD PAIN as report IBS-D symptoms experiencing the most important as somewhat to abdominal pain symptom that needs to extremely severe1,2 every week2 improve3 Patient ex
Slide 28: Treatment potential of MD-7246
Treatment potential of MD-7246 Treating abdominal pain alone with minimal effect on bowel function LINZESS MD-7246 Immediate release in stomach Ileocecal junction release Effective relief of Potential for abdominal pain strong abdominal pain relief only
Slide 29: MD-7246 demonstrated a decoupling of abdominal pain relief and bowel effect in Phase II
MD-7246 demonstrated a decoupling of abdominal pain relief and bowel effect in Phase II IBS-C trial Abdominal pain: 9/12 week CSBM2 rate: change from baseline responders (%)1 – overall treatment period 35 2.5 30 31.8 31.8 2 LS MEAN CHANGE RESPONDERS (%) 2.1 FROM BASELINE 25 …With limited 20 1.5 impa
Slide 30: 3Q 2018 Financial performance & FY2018 financial guidance
3Q 2018 Financial performance & FY2018 financial guidance
Slide 31: YTD 2018 financial performance (as of 9/30/18)
YTD 2018 financial performance (as of 9/30/18) $215.9M $460.8M in Ironwood revenues in total operating expenses (incl. $122.2M in R&D & $183.1M in SG&A) Includes: $182.7M in Ironwood’s share of net profits from Higher year-over-year LINZESS U.S. net sales (including $29.7M primarily due to $151.8M i
Slide 32: Financial guidance
Financial guidance Ironwood expects in 2018 SG&A expenses $230 - $250 million R&D expenses $160 – $180 million Total LINZESS marketing & sales expenses (IRWD + AGN) $230 - $260 million Net interest expense <$40 million Total restructuring expenses (including 2018 workforce reductions) ~$16 million I
Slide 33: Thank you
THANK YOU W lronwood.
Slide 34: GERD proven to be extremely important therapeutic category
GERD proven to be extremely important therapeutic category Improving symptom relief in millions of suffering patients resulted in multiple blockbuster brands U.S. Peak PPI Sales ~$14B2 U.S. Peak H2 Sales ~$4B1 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Slide 35: Data showed that PPIs improved heartburn over H2s
Data showed that PPIs improved heartburn by ~11% over H2s in non-erosive GERD and ~24% in erosive GERD Heartburn severity Heartburn response Non-erosive GERD* Erosive GERD** Heartburn severity (0-3) 3 100 11.1% 90 24% 2.5 80 Heartburn relief 70 2 60 1.5 50 40 1 30 20 0.5 10 0 0 Ran 150 BID Lan 15 QD
Slide 36: IW-3718 1500 mg + PPI demonstrated clinically meaningful reduction in heartburn severity
IW-3718 1500 mg + PPI demonstrated clinically meaningful reduction in heartburn severity vs PPI alone Heartburn severity: % change from baseline by week 0 -10 LS mean % change from baseline -20 -30 -40 PPI alone -46.0% -50 IW-3718 + PPI -60 -58.0% BL 1 2 3 4 5 6 7 8 p=0.04 Treatment week 36
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) Amortization
Ironwood Pharmaceuticals — 37th Annual J.P. Morgan Healthcare Conference 2019 on 6ix