Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — 41st Annual J.P. Morgan Healthcare Conference (January 2023)
26 slides from Ironwood Pharmaceuticals's conference presentation, Jan 11, 2023
Slide 1: Leading in GI through Growth and Innovation
Leading in GI through Growth and Innovation J.P. Morgan Healthcare Conference | January 11, 2023 Presented by Tom McCourt CEO, Ironwood Pharmaceuticals, Inc. Nasdaq: IRWD
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; our strategy, business, financial position and operations, including
Slide 3: Ironwood Pharmaceuticals: A profitable, GI-focused healthcare company
Ironwood Pharmaceuticals: A profitable, GI-focused healthcare company Our Vision is to be the Leading U.S. GI Healthcare Company Proven Differentiated Focused Success GI Capabilities Priorities Launched LINZESS in 2012, which Led by an experienced team • Maximize LINZESS today is a blockbuster br
Slide 4: Strong execution across our three strategic priorities is positioning our company for future growth
Strong execution across our three strategic priorities is positioning our company for future growth 2022 Highlights 2023 Outlook Maximize LINZESS Expect ~10% Y/Y EUTRx demand growth1 • Continue to invest in LINZESS as a growth brand with targeted promotion Increased market leading TRx share to 4
Slide 5: LINZESS is a growing, market leading brand with a significant opportunity to reach appropriate new patients
LINZESS is a growing, market leading brand with a significant opportunity to reach appropriate new patients Impressive Demand Large Market Opportunity Growth Since Launch LINZESS Extended Unit Growth1 Drivers of Estimated population of pediatric 4,000,000 Continued Growth: ~4-6M patients aged 6-17 w
Slide 6: LINZESS demand is increasing and fueling U.S. net sales and brand profitability
LINZESS demand is increasing and fueling U.S. net sales and brand profitability LINZESS brand profitability (incl. R&D) 2023 LINZESS Expectations $1,200 LINZESS U.S. net sales ~$1B1 in 2022 ~$350M1 High single-digit demand growth $1,000 Ironwood’s share of expected 2022 U.S. LINZESS profits $800 Mai
Slide 7: 2023 is an exciting year for our development programs as we anticipate reaching new clinical milestones
2023 is an exciting year for our development programs as we anticipate reaching new clinical milestones Linaclotide Lifecycle Management Development Assets CNP-104 IW-3300 Pediatric program in FC & IBS-C Primary Biliary Interstitial Cystitis / Cholangitis (PBC) Bladder Pain Syndrome (IC/BPS) • FC af
Slide 8: LINZESS could be the first and only FDA approved Rx therapy to treat functional constipation in pediatric patients aged 6-17
LINZESS could be the first and only FDA approved Rx therapy to treat functional constipation in pediatric patients aged 6-17 Significant unmet patient need and opportunity Positive • Incremental 4-6M addressable patients1 Topline Data • Highly symptomatic condition with patients actively seeking car
Slide 9: CNP-104 introduces a potentially new game-changing therapy to PBC patients
CNP-104 introduces a potentially new game-changing therapy to PBC patients COUR’s proprietary platform combines PDC-E2 with state-of-the-art pharmaceutical nanoparticles to tolerize the immune system and potentially We are excited about CNP-104 eliminate the immune cell bile duct destruction present
Slide 10: Increased corporate development activity is core to our strategy
Increased corporate development activity is core to our strategy Our goal is to identify assets in disease areas primarily managed by gastroenterologists / hepatologists to create the next growth horizon for Ironwood as a leader in GI Transformational M&A opportunities Key Criteria with commercial a
Slide 11: Strong cash flow generation positions Ironwood well to deliver shareholder value
Strong cash flow generation positions Ironwood well to deliver shareholder value Expect 2 ~ Ironwood’s Capital Allocation Priorities strong cash Expect ~ position ($M) 3 continues Maximize LINZESS to grow1 continue to drive growth through commercial innovation and Lifecycle Management + Strengthen a
Slide 12: We are updating FY 2022 financial guidance and providing FY 2023 guidance
We are updating FY 2022 financial guidance and providing FY 2023 guidance Previous 2022 Updated 2022 2023 Guidance Guidance (Nov 2022) Guidance2 LINZESS U.S. Low single digits % ~0% 3% – 5% net sales growth Ironwood revenue $420 – $430 million ~$411 million $420 – $435 million Adjusted EBITDA1 >$250
Slide 13: IRWD: Well-positioned to deliver shareholder value
IRWD: Well-positioned to deliver shareholder value Leading position in the adult IBS-C / CIC market with over $1 billion in 2022 Our Strategic Priorities: LINZESS U.S. net sales1, with continued strong prescription demand growth potential1 Well-positioned to expand clinical profile of LINZESS with p
Slide 14: Appendix
Appendix
Slide 15: 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 • As
Slide 16: LINZESS Achieved All-Time Highs in TRx Volume and Market Share in 2022
LINZESS Achieved All-Time Highs in TRx Volume and Market Share in 2022 LINZESS TRx Volume – All-Time High1 LINZESS TRx Market Share – All-Time High1 85,000 50% LINZESS 80,000 45% All-Time High (44%) TRx Market Share Lactulose 40% Molecule (41%) 75,000 Volume 35% 70,000 30% 25% 65,000 20% 15% 60,000
Slide 17: 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 ~21%2 44 +9% Y/Y 43 140,000 42 41 Average TRx fill size 135,000 40 39 3 130,000 38 37 125,000 36 35 120,000 34 Q3 2021 Q3 2022 17 . 1 IQVI
Slide 18: The natural history of Primary Biliary Cholangitis (PBC)
The natural history of Primary Biliary Cholangitis (PBC) 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
Slide 19: IW-3300: We are continuing Phase II POC study start up activities in IC/BPS
IW-3300: We are continuing Phase II POC study start up activities in IC/BPS 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 demonstrated pain relief in bladder pre-c
Slide 20: IW-3300 proof of concept study overview
IW-3300 proof of concept study overview Pain associated with interstitial cystitis/bladder pain syndrome (IC/BPS) Study Plan Concept Trial Design Randomized, double-blind, Placebo-controlled design IC/BPS patients Patient Selection Moderate to severe baseline pain based on 11-point numeric rating sc
Slide 21: 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 21
Slide 22: Q3 2022 financial performance
Q3 2022 financial performance $261M $109M U.S. LINZESS Net Sales1 Total Ironwood Revenues 3% Y/Y growth Primarily driven by $105M in U.S. LINZESS Strong LINZESS prescription demand growth was partially collaboration revenue offset by net price erosion LINZESS commercial margin: 74%1 $50M $69M GAAP N
Slide 23: We are maintaining a strong capital structure
We are maintaining a strong capital structure Expect to end 2022 with ~$650 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 24: Q3 2022 financial summary
Q3 2022 financial summary Reconciliation of GAAP results to non-GAAP financial measures1 Three Months Ended Nine Months Ended September 30, 2022 September 30, 2022 (000s, except per share (000s, except per share amounts) amounts) GAAP net income $ 50,317 $ 126,198 Adjustments: Mark-to-market adjustm
Slide 25: Q3 2022 financial summary
Q3 2022 financial summary Reconciliation of GAAP net income to adjusted EBITDA Three Months Ended Nine Months Ended September 30, 2022 September 30, 2022 (000s) (000s) GAAP net income1 $ 50,317 $ 126,198 Adjustments: Mark-to-market adjustments on the derivatives related to (151) (200) convertible no
Slide 26: Q3 2022 financial summary
Q3 2022 financial summary LINZESS U.S. Brand Collaboration Commercial Profit & Collaboration Revenue1 Ironwood & AbbVie Total Net Profit Three Months Ended Nine Months Ended Three Months Ended Nine Months Ended September 30, 2022 September 30, 2022 September 30, 2022 September 30, 2022 (000s) (000s)
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