Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — Q3 2023 Earnings Presentation
22 slides from Ironwood Pharmaceuticals's earnings presentation, Nov 9, 2023
Slide 1: Ironwood Q3 2023 Investor Update
Ironwood Q3 2023 Investor Update November 9, 2023
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: Introduction
Introduction Matt Roache
Slide 4: Today's Agenda
Today’s Agenda • Introduction Matt Roache, Director, Investor Relations • Overview Tom McCourt, Chief Executive Officer • Pipeline Update Mike Shetzline, M.D., Ph.D., Chief Medical Officer • Commercial Update, Q3 2023 Financial Highlights and 2023 Guidance Sravan Emany, Chief Financial Officer 4
Slide 5: Overview
Overview Tom McCourt
Slide 6: Progress across our strategic priorities positions us for success in GI
We believe the progress made across our strategic priorities positions us for success in our mission to be the leader in GI Maximize Strengthen and Progress Deliver Sustained Profits LINZESS Innovative GI Portfolio and Generate Cash Flow Continue to grow LINZESS demand Focus on serious, organic GI d
Slide 7: Pipeline Update
Pipeline Update Mike Shetzline
Slide 8: Short Bowel Syndrome with Intestinal Failure is a rare, chronic and debilitating condition
Short Bowel Syndrome with Intestinal Failure (SBS-IF) is a rare, chronic and debilitating condition with severe consequences SBS-IF Subtypes: Stoma Colon-in-Continuity (CIC) Duodenum Duodenum Jejunocolonic Anastomosis Jejunum Colon Stoma (on abdominal surface) Jejunum Adapted from: Stoma Bag Jeppese
Slide 9: STARS Nutrition is the first dedicated Phase 2 in colon-in-continuity patients
STARS Nutrition is the first-ever dedicated Phase 2 in colon-in- continuity (CIC) patients GI, gastrointestinal; aGvHD, acute graft-versus-host disease; PK, pharmacokinetics; RR, response rate; DOR,Supplemental study toSS, duration of response; demonstrate and quantify systemic steroids; absorption
Slide 10: STARS Nutrition: PS volume reduction statistically significant at week 24, maintained at week 52
STARS Nutrition: PS volume reduction reached a statistically significant 40% at week 24 and the effect was maintained with a 52% volume reduction at week 52 No PS changes allowed until 4W 48-week PS reduction phase Weekly PS volume from Baseline 0 –15 p=0.004 p=0.0007 –22 –31 Percentage change in –4
Slide 11: STARS Nutrition: All patients were clinical responders
STARS Nutrition: All patients were clinical responders, achieving a PS volume reduction of at least 20% 9/9 7/9 100% 100% 100% 100% 100% 100% 89% 89% 90% 80% 78% 78% 70% 60% 56% 50% 3/9 40% 33% 33% 30% 20% 10% 0% 0% 0% 11 PS = Parenteral Support
Slide 12: STARS Phase 3 is the largest GLP-2 trial ever conducted in SBS-IF
STARS Phase 3 is the largest GLP-2 trial ever conducted in Top-line results SBS-IF anticipated March 2024 Anatomy-specific Stoma and CIC stratification P R I M A RY E N D P O I N T PS volume reduction in overall population S E C O N D A RY E N D P O I N T S S E C O N D A RY ENDPOINTS 164 SBS-IF pati
Slide 13: Our GI pipeline includes near-term development catalysts
Our GI pipeline includes near-term development catalysts to drive shareholder value Anticipated Near-term Discovery Preclinical Phase 1 Phase 2 Phase 3 Marketed Milestones / Catalysts IBS-C & Chronic Idiopathic Marketed LINZESS Constipation Pediatric Functional Marketed Constipation Ages 6-17 in the
Slide 14: Commercial Update, Q3 2023 Financial Highlights and 2023 Guidance
Commercial Update, Q3 2023 Financial Highlights and 2023 Guidance Sravan Emany
Slide 15: Continued strong LINZESS demand growth in Q3
Continued strong LINZESS demand growth in Q3, supported by robust new-to-brand prescription volume Q3 2023 LINZESS Total EUTRx Demand1 LINZESS NBRx Volume / Growth Y/Y2 17,000,000 170,000 +16% Y/Y 18% +8% Y/Y in Q3 2023 16% 16,000,000 160,000 14% 15,000,000 150,000 12% EUTRx Volume 14,000,000 10% 14
Slide 16: Q3 2023 financial performance
Q3 2023 financial performance $279M $114M LINZESS U.S. Net Sales1 Total Ironwood Revenues LINZESS U.S. net sales growth of 7%, driven by strong Primarily driven by $110M in U.S. LINZESS prescription demand growth of 8% collaboration revenue LINZESS commercial margin: 72%1 $14M $49M GAAP Net Income A
Slide 17: We are maintaining our FY 2023 guidance
We are maintaining our FY 2023 guidance FY 2023 Guidance LINZESS U.S. 6% – 8% net sales growth Ironwood revenue $435 – $450 million Adjusted EBITDA1 ~($900) million2 Includes ~$1.1 billion one-time charge from acquisition of VectivBio 1 Adjusted EBITDA is calculated by subtracting mark-to-market adj
Slide 18: Q3 2023 Financial Summary
Q3 2023 Financial Summary Reconciliation of GAAP results to non-GAAP financial measures (page 1) Three Months Ended Nine Months Ended September 30, 2023 September 30, 2023 (000s, except per share (000s, except per share amounts) amounts) GAAP net income (loss)1,2 $13,950 ($1,029,814) Adjustments: Ma
Slide 19: Q3 2023 Financial Summary
Q3 2023 Financial Summary Reconciliation of GAAP results to non-GAAP financial measures (page 2) Three Months Ended Nine Months Ended September 30, 2023 September 30, 2023 (000s, except per share (000s, except per share amounts) amounts) GAAP net income (loss) attributable to Ironwood per share – di
Slide 20: Q3 2023 Financial Summary
Q3 2023 Financial Summary Reconciliation of GAAP net income (loss) to adjusted EBITDA Three Months Ended Nine Months Ended September 30, 2023 September 30, 2023 (000s) (000s) GAAP net income (loss)1,2 $13,950 ($1,029,814) Adjustments: Mark-to-market adjustments on the derivatives related to 0 (19) c
Slide 21: Q3 2023 Financial Summary
Q3 2023 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, 2023 September 30, 2023 September 30, 2023 September 30, 2023 (000s) (000s)
Slide 22: Thank You
Thank You
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