Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — Q1 2019 Earnings Presentation
23 slides from Ironwood Pharmaceuticals's earnings presentation, May 2, 2019
Slide 1: Ironwood 1Q 2019 Investor Update
Ironwood 1Q 2019 Investor Update May 2, 2019
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 the development, launch, commercial availability and commercial potential of linaclotide, our other product
Slide 4: Today's Agenda
Today’s Agenda • Introduction Meredith Kaya, VP Investor Relations & Communications • 1Q 2019 Overview Mark Mallon, Chief Executive Officer • Commercial Highlights Tom McCourt, President • Development Highlights Mike Shetzline, M.D., Ph.D., Chief Medical Officer • Financial Highlights & Guidance Gin
Slide 5: 1Q 2019 Overview
1Q 2019 Overview Mark Mallon
Slide 6: Ironwood is dedicated to making a difference for patients living with GI diseases
WE AIM TO: Accelerate LINZESS® (linaclotide) growth Advance late-stage U.S. GI development portfolio IRONWOOD is dedicated to making a difference for Deliver profits beginning in 20191 patients living with GI diseases 1. Based on adjusted EBITDA from continuing operations
Slide 7: Commercial Highlights
Commercial Highlights Tom McCourt
Slide 8: Double-digit LINZESS demand growth and New to Brand growth in 1Q 2019
Double-digit LINZESS demand growth and New to Brand (NTB) growth in 1Q 2019 Extended Unit Growth up 14% yoy in 1Q 20191 New to Brand Growth up 15% yoy in Q1 20191 31,000,000 15% 110,000 20% 30,000,000 14% 14% 105,000 15% 15% 13% 29,000,000 Total New to Brand Rx Total Extended Units 12% 28,000,000 10
Slide 9: LINZESS market share grew significantly more vs other branded products
LINZESS market share grew significantly more vs other branded products in the category 60 1 IBS-C / CIC Market Share 50 40 +16 +14 Share Points 30 20 -36 +5 10 +1 0 LINZESS AMITIZA TRULANCE OTHER PEG GENERIC Rx LAXATIVES Sharepoints 2018-Q1 Sharepoints 2019-Q1 9 Source: 1. IQVIA NPA, March 2019
Slide 10: LINZESS DTC campaigns have consistently activated new sources of patients
LINZESS DTC campaigns have consistently activated new sources of patients New DTC campaign launched April 2019 “Feels like a knot” “Keeps coming back” “Tell me something I “Wearing on you” “Yesssss! Linzess” “I’m doing it all!” NEW TO BRAND PATIENTS (000) don’t know” “Tell me something I don’t know”
Slide 11: Phase III data in abdominal pain, bloating + discomfort have potential to motivate additional IBS-C patients
Phase III data (if positive) in abdominal pain, bloating + discomfort have potential to motivate additional IBS-C patients Opportunity to communicate LINZESS impact on additional abdominal symptoms ~95% 1x/week of IBS-C patients The majority of IBS-C surveyed reported patients surveyed experiencing
Slide 12: Development Highlights
Development Highlights Mike Shetzline, M.D., Ph.D.
Slide 13: IW-3718 Phase III program in persistent GERD
IW-3718 Phase III program seeking to demonstrate improved heartburn & regurgitation in patients with persistent GERD Top line data expected 2H 2020 Placebo IW-3718 + PPI 1500 mg + PPI 8 WEEK TREATMENT PERIOD Endpoints • Overall heartburn response - Primary Patients - Defined as ≥45% reduction from b
Slide 14: MD-7246 Phase IIb trial in abdominal pain with IBS-D
MD-7246 Phase IIb trial being evaluated as non-opioid, pain- relieving agent for patients suffering from abdominal pain with IBS-D On track to initiate Phase IIb trial in May 2019 MD-7246 MD-7246 MD-7246 Placebo 300 mg 600 mg 1200 mg 12 WEEK TREATMENT PERIOD Primary Endpoints • Change from baseline
Slide 15: >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 16: Financial Highlights & 2019 Financial Guidance
Financial Highlights & 2019 Financial Guidance Gina Consylman
Slide 17: 1Q 2019 financial performance
1Q 2019 financial performance $68.7M $123.1M in Ironwood revenues in total operating expenses (incl. $66.2M in collaboration revenue and $2.6M (incl. $54.0M in R&D, $64.7M in SG&A, $3.3M in in linaclotide API sales) restructuring, $1.0M in cost of revenues) ($59.3M) ($40.5M) in GAAP net loss ($0.38/
Slide 18: 2019 financial guidance
2019 financial guidance Ironwood expects Total revenue $370 – $390 million Net interest expense ~$35 million Separation expenses1 $30 – $40 million Restructuring expenses $3 – $4 million (new) Adjusted EBITDA from continuing operations2 >$65 million (new) LINZESS net sales growth Low-to-mid single d
Slide 19: Ironwood is dedicated to making a difference for patients living with GI diseases
WE AIM TO: Accelerate LINZESS® (linaclotide) growth Advance late-stage U.S. GI development portfolio IRONWOOD is dedicated to making a difference for Deliver profits beginning in 20191 patients living with GI diseases 1. Based on adjusted EBITDA from continuing operations
Slide 20: Thank You!
Thank You ~ \ q ronwoo
Slide 21: 1Q 2019 Financial Summary
1Q 2019 Financial Summary Condensed Consolidated Statement of Operations (unaudited) Three Months Ended March 31, 2019 (000s, except per share amounts) Revenue $ 68,730 Cost and expenses: Cost of revenue 1,043 Research and development 53,990 Selling, general and administrative 64,741 Restructuring e
Slide 22: 1Q 2019 Financial Summary
1Q 2019 Financial Summary Reconciliation of GAAP Results to Non-GAAP Financial Measures Three Months Ended March 31, 2019 (000s, except per share amounts) Reconciliation of GAAP Results to Non-GAAP Financial Measures GAAP net loss $ (59,284) Adjustments: Mark-to-market adjustments on the derivatives
Slide 23: 1Q 2019 Financial Summary
1Q 2019 Financial Summary LINZESS U.S. Brand Collaboration Commercial Profit & Collaboration Revenue1 Ironwood & Allergan Total Net Profit Three Months Ended March 31, 2019 Three Months Ended March 31, 2019 (000s) (000s) LINZESS U.S. net product sales $ 161,348 LINZESS U.S. net product sales $ 161,3
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