Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — 42nd Annual J.P. Morgan Healthcare Conference 2024
44 slides from Ironwood Pharmaceuticals's conference presentation, Jan 10, 2024
Slide 1: Ironwood Pharmaceuticals: A Leading GI Healthcare Company
Ironwood Pharmaceuticals A Leading GI Healthcare Company NASDAQ: IRWD 1
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: Our vision is to be the leading GI healthcare company
Our vision is to be the leading GI healthcare company focused on advancing the treatment of GI diseases and redefining the standard of care for GI patients 3
Slide 4: Leading the Way in GI Innovation
Leading the Way OUR FOCUSED PRIORITIES: in GI Innovation Maximize LINZESS Ironwood is uniquely positioned to drive value as a GI-focused biotech with Advance GI pipeline multiple 2024 development catalysts Highlighted by apraglutide for SBS-IF1 and CNP-104 for PBC2 and strong LINZESS cash flows expe
Slide 5: $1.5B+ Revenue Potential through the 2030s
Pro Forma Ironwood Long Term Ironwood Today $1.5B+ Revenue (Assuming Apraglutide (LINZESS) and CNP-104 Approval) Potential $1.5B+2 through the peak revenue potential 2030s ~$1.0B2 Apraglutide and CNP-104 have the potential to extend growth through the 2030s $0.4B1 and drive value for patients and sh
Slide 6: Emerging data to create significant momentum
We expect emerging data to create significant momentum as we strive to deliver value for patients and shareholders Discovery Preclinical Phase 1 Phase 2 Phase 3 Marketed IBS-C & Chronic Idiopathic Constipation (CIC) Marketed LINZESS Pediatric Functional Constipation (FC) Ages 6-17 in the U.S.1 Marke
Slide 7: LINZESS
LINZESS The U.S. prescription market leader for adults with Irritable Bowel Syndrome with Constipation (IBS-C) and Chronic Idiopathic Constipation (CIC) 7
Slide 8: Leader in IBS-C and CIC
Impressive LINZESS Demand Growth Leader in Since Launch IBS-C and CIC 4,500,000 20,000 4,000,000 18,000 16,000 3,500,000 LINZESS is a growing, market 3,000,000 14,000 leading, blockbuster brand 12,000 EUTRx Volume NBRx Volume 2,500,000 with a significant opportunity 2,000,000 10,000 to address high
Slide 9: LINZESS is the prescription market leader in the U.S.
LINZESS is the prescription market leader in the U.S. for adults with IBS-C/CIC with a large market opportunity IBS-C/CIC TRx Market Share1 Large Market Opportunity 60% (Combined Branded and Generic Market) LINZESS Estimated population of pediatric 50% 46% ~6M patients aged 6-17 with FC in the U.S.2
Slide 10: First and only FDA approved Rx therapy for pediatric functional constipation
First and only FDA approved Rx therapy to treat pediatric functional constipation for patients ages 6-17 Significant unmet patient need and opportunity • Commercially available as of June 2023 with existing 72 mcg dose for patients aged 6-17 years-old; benefits from existing LINZESS class-leading pa
Slide 11: Apraglutide
Apraglutide Glucagon-like peptide 2 (GLP-2) analog for Short Bowel Syndrome with Intestinal Failure (SBS-IF) 11
Slide 12: Apraglutide advances Ironwood's GI leadership
Apraglutide advances Ironwood’s GI leadership and creates value for patients and shareholders • Apraglutide’s unique pharmacological properties support potential to be the only once weekly GLP-2 for the whole spectrum of SBS-IF patients1 Apraglutide has the potential to establish a new standard of c
Slide 13: SBS-IF
SBS-IF SBS-IF Subtypes Stoma Colon-in-Continuity (CIC) Short Bowel Syndrome with Duodenum Duodenum Jejunocolonic Intestinal Failure (SBS-IF), Jejunum Anastomosis defined by an SBS patient’s Colon dependence on parenteral Stoma (on abdominal surface) Jejunum support, is a severe organ Stoma Bag Adapt
Slide 14: STARS Phase 3 is the largest GLP-2 trial
Topline data expected in STARS Phase 3 March 2024 is the largest Week 24 Week 48 GLP-2 trial Apraglutide weekly dosing administration ever conducted PRIMARY 24-WEEK ENDPOINT in SBS-IF PS volume reduction in aggregate population 164 SECONDARY ENDPOINTS SECONDARY ENDPOINTS SBS-IF patients Aggregate an
Slide 15: Apraglutide has best-in-class potential
Apraglutide Target Product Profile1 Enabled by unique pharmacological properties and development strategy Apragludtide has + PS volume reduction in stoma and CIC patients best-in-class potential + Long half-life supports once-weekly dosing 2,3 + Improved quality of life and symptoms Opportunity to b
Slide 16: Apraglutide has potential to achieve $1B+ in peak net sales
Apraglutide has Apraglutide target product profile potential to SBS-IF Market has the potential to: achieve $1B+ in peak net sales1 Increase utilization $1B+ Apraglutide Net Improve Sales Potential1 Apraglutide target product persistency profile can enable market Current GLP-2 Market 2 Untreated by
Slide 17: CNP-104
CNP-104 Potential disease-modifying therapy for the treatment of Primary Biliary Cholangitis (PBC) 17
Slide 18: CNP-104: a potentially new game-changing therapy for PBC
Encapsulated Disease Proprietary PLGA CNP-104: Specific Antigens nanoparticle with a potentially new PDC-E2 encapsulated game-changing therapy for PBC PDC-E2 Antigen Nanoparticle Platform patients • Well-characterized and • COUR’s platform has shown common PBC autoantigen: clinical proof of technolo
Slide 19: CNP-104 has the potential to be the first PBC disease-modifying therapy
CNP-104 has the potential Expect topline data from to be the first PBC Phase 2 study in Q3 2024 disease-modifying therapy CNP-104 targets the root Initial assessment Ironwood maintains an cause of PBC; there are no provided evidence of option to exclusively license therapies on the market favorable
Slide 20: Financial Guidance
Financial Guidance Wlronwood’
Slide 21: On track for FY 2023 guidance; initial FY 2024 guidance
We are on track to deliver on our FY 2023 financial guidance and are providing initial FY 2024 guidance FY 2023 Guidance FY 2024 Guidance (November 2023) (January 2024) LINZESS U.S. 6% – 8% Low-single digits % net sales growth High-single digit prescription demand growth offset by mid to high-single
Slide 22: 2024 has the potential to be transformational
2024 has the potential to be OUR FOCUSED PRIORITIES: transformational Maximize LINZESS for Ironwood Ironwood is uniquely positioned to drive Advance GI pipeline value as a GI-focused biotech with Highlighted by apraglutide for SBS-IF1 and CNP-104 for PBC2 multiple 2024 development catalysts and stro
Slide 23: Appendix: Apraglutide SBS-IF
Appendix Apraglutide SBS-IF 23
Slide 24: STARS Nutrition: first dedicated Phase 2 in SBS with CIC
STARS Nutrition is the first-ever dedicated Phase 2 in adult patients with short bowel syndrome and colon-in-continuity (CIC) • Study to demonstrate and quantify absorption benefits in CIC GI, gastrointestinal; aGvHD, acute graft-versus-host disease; PK, pharmacokinetics; RR, response rate; DOR, dur
Slide 25: STARS Nutrition: PS volume reduction
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 26: STARS Nutrition: all patients were clinical responders
STARS Nutrition: All patients were clinical responders, achieving a PS volume reduction of at least 20% at week 52 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% 26
Slide 27: Appendix: Apraglutide GVHD
Appendix Apraglutide GVHD Wlronwood’
Slide 28: Acute GvHD is a life-threatening condition
Acute GvHD is a life-threatening condition resulting from allogeneic hematopoietic stem cell transplant (HSCT)1 Significant unmet need for non-immunosuppressive treatments with greater efficacy and durability Allogeneic HSCT Acute GvHD Steroid-Refractory aGvHD Bone marrow Donor immune cells ~50% mor
Slide 29: Strong therapeutic rationale for a GLP-2 treatment
Strong therapeutic rationale for a GLP-2 treatment to protect and regenerate the GI tract GLP-2 can restore GI function and reduce the need for immunosuppressive treatment GI damage from Results in…1,2 conditioning, HSCT Physiological properties and GvHD1,2 of GLP-23 • Reduced intestinal barrier fun
Slide 30: First-In-Class Phase 2 exploratory study in GvHD
First-In-Class Phase 2 exploratory Data study in graft vs. host disease (GvHD) anticipated Q1 2024 Study designed to inform next steps towards pivotal study STUDY OBJECTIVES Safety and tolerability; PK; efficacy measures including response rate, duration of response, survival-related outcomes Patien
Slide 31: Appendix: CNP-104
Appendix CNP-104 Wlronwood’
Slide 32: CNP-104: Phase 2 proof of concept study in PBC
CNP-104: Phase 2 proof of concept study in Expect Primary Biliary Cholangitis (PBC) top-line data in Q3 2024 CNP-104 has potential for accelerated approval pathway with proof of concept STUDY OBJECTIVES Safety, tolerability, pharmacodynamics (PD), and efficacy of two doses of CNP-104 45 patients wit
Slide 33: Appendix: IW-3300
Appendix IW-3300 Wlronwood’
Slide 34: IW-3300: Phase 2 Proof of Concept Study in IC/BPS
IW-3300: Phase 2 Proof of Concept Study in IC/BPS Opportunity to test “cross-talk” hypothesis in humans for the first time STUDY OBJECTIVES Safety, tolerability, and efficacy in patients with IC/BPS 300 patients with Interstitial Cystitis / Bladder Pain Syndrome (IC/BPS) PRIMARY ENDPOINT Change from
Slide 35: IW-3300: GC-C agonist for visceral pain conditions
IW-3300: GC-C agonist for visceral pain conditions • Strong pre-clinical evidence combined with sound scientific & commercial rationale supports POC study to explore potential impact of IW-3300 on chronic visceral pain outside of GI tract • Strong pre-clinical data: – IW-3300 demonstrated pain relie
Slide 36: Appendix: LINZESS
Appendix LINZESS Wlronwood’
Slide 37: 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 38: LINZESS continues to generate strong brand profits
LINZESS continues to $1,200 LINZESS brand profitability (incl. R&D) ~$1.1B1 in 2023 generate strong $1,000 LINZESS U.S. net sales brand profits $800 ~$375M1 Ironwood’s share (in millions) of expected 2023 U.S. LINZESS profits LINZESS demand is $600 increasing and fueling U.S. $400 net sales and bran
Slide 39: Appendix: Financials
Appendix Financials Wlronwood’
Slide 40: 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 41: 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 42: 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 43: Q3 2023 Financial Summary: Adjusted EBITDA reconciliation
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 44: Q3 2023 Financial Summary: LINZESS collaboration
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)
Ironwood Pharmaceuticals — 42nd Annual J.P. Morgan Healthcare Conference 2024 on 6ix