Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — 40th Annual J.P. Morgan Healthcare Conference (January 2022)
27 slides from Ironwood Pharmaceuticals's conference presentation, Jan 12, 2022
Slide 1: Leading in GI through Growth and Innovation
Leading in GI through Growth and Innovation J.P. Morgan Healthcare Conference January 12, 2022 PRESENTED BY Tom McCourt, CEO Ironwood Pharmaceuticals, Inc.
Slide 2: 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 and mission; our strategy, business, financial position and operations
Slide 3: Ironwood Pharmaceuticals: Emerging as a Leader in GI
Ironwood Pharmaceuticals: (Nasdaq: IRWD) Emerging as a Leader in GI Our Vision is to be the Leading U.S. GI Healthcare Company Blockbuster Brand That is Strengthening Innovative Pipeline Structured for Growth Still Growing for the Future and Sustained Profitability FDA approved in the U.S. in 2012
Slide 4: 2021: We Executed Against Our Three Strategic Priorities
2021: We Executed Against Our Three Strategic Priorities Maximize Strengthen Deliver LINZESS® Innovative Sustained Profits and (linaclotide) GI Pipeline Generate Cash Flow Continue to grow LINZESS demand Focus on serious, organic GI diseases Apply thoughtful and disciplined capital and net sales wit
Slide 5: Our Leadership Team is Ready to Usher in a New Era of Growth and Innovation
Our Leadership Team is Ready to Usher in a New Era of Growth and Innovation TOM MCCOURT JASON RICKARD MIKE SHETZLINE Chief Executive Officer Chief Operating Officer Chief Medical Officer and Head of Research and Development JOHN MINARDO ANDREW DAVIS SRAVAN EMANY Chief Legal Officer Chief Business Of
Slide 6: LINZESS is the #1 Prescribed Branded Treatment in the U.S. for Adult IBS-C / CIC
LINZESS is the #1 Prescribed Branded Treatment in the U.S. for Adult IBS-C / CIC Patients with Continued Growth Opportunities LINZESS Extended Unit Growth1 40M Potential Patients 3,500,000 Adult CIC and IBS-C population in We expect to grow the U.S.3 3,300,000 LINZESS demand through: 3,100,000 Patie
Slide 7: LINZESS Demand is Increasing and Fueling U.S. Net Sales
LINZESS Demand is Increasing and Fueling U.S. Net Sales In 2022, we expect to: LINZESS brand profitability (incl. R&D) $1,200 LINZESS U.S. net sales 50/50 $1,000 ~$1B1 profit share Drive continued double-digit % Rx demand growth $800 ~$7001 (in millions) Refine mix of brand investment and $600 ~$350
Slide 8: We Are Unlocking New Opportunities for the Future of LINZESS and Strengthening Our Pipeline
We Are Unlocking New Opportunities for the Future of FUTURE FORWARD LINZESS (linaclotide) and Strengthening Our Pipeline Linaclotide Lifecycle Management Development Assets CNP-104 IW-3300 Advancing pediatric program in IBS-C & Functional Primary Biliary Cholangitis (PBC) Interstitial Cystitis / Bla
Slide 9: Our Corporate Development Priorities: Deliver Patient Benefit and Shareholder Value
Our Corporate Development Priorities: Deliver Patient Benefit and Shareholder Value In assessing any new potential asset, we seek to: 1 Prioritize diseases that are primarily 2 Focus on organic GI diseases, where 3 Target innovation, via first-in-class managed by mechanisms are or differentiated gas
Slide 10: We Are Prioritizing Serious, Organic GI Diseases Primarily Managed by Gastroenterologists
We Are Prioritizing Serious, Organic GI Diseases Primarily Managed by Gastroenterologists Abdominal Liver Injury / Celiac Disease Pruritis Pain Failure Gut Rare GI Esophageal / Pancreatitis Inflammation Diseases Allergic 10
Slide 11: We Are Updating FY 2021 Financial Guidance and Providing FY 2022 Guidance
We Are Updating FY 2021 Financial Guidance and Providing FY 2022 Guidance Ironwood now expects: Previous 2021 Updated 2021 2022 Guidance Guidance (Nov 2021) Guidance2 LINZESS U.S. net 6% to 8% High end of 6% to 8% Low single digits % sales growth Ironwood revenue $390 – $410 million High end of $390
Slide 12: Ironwood is Leading in GI through Growth and Innovation
Ironwood is Leading in GI through Growth and Innovation FUURE FORWARD Our Strategy: Leading position in the IBS-C / CIC market expected to exceed $1 billion in 2021 LINZESS U.S. net sales, with continued strong prescription demand growth potential1 Maximize LINZESS Highly capable commercial team
Slide 13: Appendix
Appendix
Slide 14: Global Linaclotide Partnerships Designed to Enable Access Worldwide
Global Linaclotide Partnerships Designed to Enable Access Worldwide Rest of world China (incl. Hong Kong & Macau) Japan • LINZESS launched in Japan for • LINZESS launched in China in IBS-C in March 2017 and chronic November 2019 constipation in August 2018 • Chinese National Healthcare Security • LI
Slide 15: LINZESS Achieved All-Time Highs in TRx Volume and Market Share in 2021
LINZESS Achieved All-Time Highs in TRx Volume and Market Share in 2021 LINZESS TRx Volume1 LINZESS TRx Market Share – All-Time High1 80,000 50% LINZESS 75,000 45% All-Time High (43%) Lactulose 40% Molecule (41%) TRx Market Share 70,000 35% 30% Volume 65,000 25% 20% 60,000 15% 55,000 10% Total AMITIZ
Slide 16: Strong LINZESS New-to-brand Volume and 90-Day Prescriptions Are Key Indicators of Future Growth Potential
Strong LINZESS New-to-brand Volume and 90-Day Prescriptions Are Key Indicators of Future Growth Potential LINZESS NBRx Volume Growth1 LINZESS 90-Day Prescription ~20%2 43.0 42.5 500,000 ~16% y/y 42.0 480,000 41.5 Average TRx Fill Size 460,000 NBRx Volume 20.0% Percent 90 Count Quantity3 41.0 18.0% 4
Slide 17: The Natural History of Primary Biliary Cholangitis
The Natural History of Primary Biliary Cholangitis PBC is a chronic inflammatory autoimmune cholestatic liver disease, which when untreated will culminate in end-stage biliary cirrhosis. Current available therapies can slow disease progression but are not curative. Preclinical or Asymptomatic Sympto
Slide 18: CNP-104 is Supported by Established Research and Data Regarding Nanoparticle Platform and Antigen
CNP-104 is Supported by Established Research and Data Regarding (1) the Nanoparticle Delivery Platform and (2) the PDC-E2 Antigen Proprietary PLGA nanoparticle with PDC-E2 encapsulated Nanoparticle Platform PDC-E2 Antigen • COUR’s platform has shown proof of technology in clinical and • Well-charact
Slide 19: Our wholly-owned IW-3300 is Entering Phase I development for visceral pain
Our wholly-owned IW-3300 is Entering Phase I development for potential treatment of visceral pain conditions Opportunity to test the “cross-talk” hypothesis in humans for the first time • Strong pre-clinical data: Stable peptide expected to provide great flexibility in formulation – IW-3300 also dem
Slide 20: In Pre-clinical Model, IW-3300 Reversed Endometriosis-induced Vaginal Hypersensitivity
In Pre-clinical Model, IW-3300 Reversed Endometriosis-induced Vaginal Hypersensitivity 15 Key v o n F r e y V a g in a l W ith d r a w a l T h r e s h o ld (g ) KEY Day 1 Day 5 Day 13 Sham (“normal response) Baseline (ENDO pre-treat.) 10 Vehicle IW-3300, 1 µg/kg IW-3300, 3 µg/kg 5 IW-3300, 10 µg/kg
Slide 21: IW-3300 Demonstrated Pain Relief In Pre-Clinical Model of Bladder Hypersensitivity
IW-3300 Demonstrated Pain Relief In Pre-Clinical Model of Bladder Hypersensitivity 7 Hypersensitive pre-clinical model Sham+vehicle (n=2) *** 6 Sham+IW3300 (n=3) IW-3300 (3 µg/kg/day) reversed radiation-induced chronic bladder hypersensitivity, Average number of withdrawal responses consistently red
Slide 22: We Reported Robust Financial Performance in Q3 2021
We Reported Robust Financial Performance in Q3 2021 $104M $253M Total Revenue U.S. LINZESS Net Sales1 Primarily driven by $100M in U.S. LINZESS 5% Y/Y growth collaboration revenue Primarily driven by 12% Y/Y prescription demand growth partially offset by net price and inventory channel fluctuations
Slide 23: Execution and disciplined investments are leading to a strong cash balance
Execution and disciplined investments are leading to a strong FUTURE FORWARD cash balance that we believe will support future growth Collaborative Arrangement Revenue1 Cash and Cash Equivalents2 Expect $500 Expect $700 >$600 3 ~$410 $400 $380 $382 $600 (millions) $500 (millions) $300 $363 $400 $200
Slide 24: We are Maintaining a Strong Capital Structure
We are Maintaining a Strong Capital Structure Expect to end 2021 with >$600 million in cash and cash equivalents1 Debt Maturity Profile2 $400 $300 Principal in $Ms 0.75% Convertible Notes 1.50% Convertible Notes Conv price: $13.39 Conv price: $13.39 Capped call price: $17.05 Capped call price: $17.0
Slide 25: Q3 2021 Financial Summary
Q3 2021 Financial Summary Reconciliation of GAAP results to non-GAAP financial measures1 Three Months Ended Nine Months Ended September 30, 2021 September 30, 2021 (000s, except per share (000s, except per share amounts) amounts) GAAP net income $ 55,845 $ 487,074 Adjustments: Mark-to-market adjustm
Slide 26: Q3 2021 Financial Summary
Q3 2021 Financial Summary Reconciliation of GAAP net income to adjusted EBITDA Three Months Ended Nine Months Ended September 30, 2021 September 30, 2021 (000s) (000s) GAAP net income1 $ 55,845 $ 487,074 Adjustments: Mark-to-market adjustments on the derivatives related to (2,164) (1,388) convertibl
Slide 27: Q3 2021 Financial Summary
Q3 2021 Financial Summary LINZESS U.S. Brand Collaboration Commercial Profit & Collaboration Revenue1 Ironwood & AbbVie Total Net Profit Three Months Ended Nine Months Ended Three Months Nine Months Ended September 30, 2021 September 30, 2021 Ended September 30, 2021 September 30, 2021 (000s) (000s)
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