Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — 37th Annual J.P. Morgan Healthcare Conference (January 2019)
23 slides from Ironwood Pharmaceuticals's conference presentation, Jan 8, 2019
Slide 1: J.P. Morgan Healthcare Conference
A COMMERCIAL BIOTECHNOLOGY COMPANY J.P. Morgan Healthcare Conference January 8, 2019
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 the status, structure, completion and timing of the proposed separation of our operations into two independ
Slide 3: TODAY Ironwood is LINZESS and seven differentiated drug development candidates
TODAY Ironwood is LINZESS® (linaclotide) and seven differentiated drug development candidates GI sGC LINZESS / CONSTELLA® (linaclotide) Olinciguat Approved for treatment of adults with IBS-C or CIC Sickle cell disease (Phase II) Additional abdominal symptom claims (bloating, discomfort, pain) (Phase
Slide 4: New Ironwood and Cyclerion: pivotal moment to grow two industry-leading companies
New Ironwood and Cyclerion: pivotal moment to grow two industry-leading companies and unlock shareholder value Ironwood Today expected to: LINZESS / CONSTELLA Build a leading GI franchise GI IW-3718 Accelerate growth of LINZESS® and advance GI development programs MD-7246 Deliver profits begin
Slide 5: Opportunity to unleash two valuable industry leaders
Opportunity to unleash two valuable industry leaders We believe the planned separation will create, among other things: 1 Differentiated, innovative and productive market leaders 2 Management, boards and capabilities matched to the opportunities 3 Tailored capital structures and capital allocation a
Slide 6: Separation: on track to launch 1H 2019
Separation: on track to launch 1H 2019 • Mark Mallon to be Ironwood CEO effective upon separation Right leadership, • Peter Hecht to be Cyclerion CEO right time • Experienced leadership teams complemented with new skills • Expect non-overlapping boards; boards (including new Chairs) expected to be a
Slide 7: Mark Mallon
Mark Mallon NEW Ironwood CEO (effective upon separation)
Slide 8: Ironwood is building a profitable, GI-focused healthcare company
WE AIM TO: Grow LINZESS® (linaclotide) and accelerate U.S. GI development portfolio Capitalize on our GI expertise to IRONWOOD bring innovative therapies to patients is building a profitable, GI-focused healthcare company Deliver profits beginning in 2019 (following planned separation)
Slide 9: Seasoned executive team with proven track record in building successful GI businesses
Seasoned executive team with proven track record in building successful GI businesses* Mark Mallon Tom McCourt Gina Consylman Chief Executive Officer President Chief Financial Officer Halley Gilbert Jason Rickard Mike Shetzline Chief Administrative Officer Senior Vice President, Chief Medical Office
Slide 10: Capitalize on GI expertise to accelerate LINZESS, advance GI portfolio and strengthen financials
Capitalize on GI expertise to accelerate LINZESS, advance GI portfolio and strengthen financials Accelerating LINZESS growth and profitability1 3,000,000 2,500,000 2,000,000 1,500,000 1,000,000 500,000 0 2012 2013 2014 2015 2016 2017 2018 Sources: 1. IQVIA NPA, Dec 2018
Slide 11: LINZESS has generated ~$3 billion in U.S. net sales and ~$1 billion in brand profits
LINZESS has generated ~$3 billion in U.S. net sales and ~$1 billion in brand profits since launch Strong intellectual property position with coverage expected into 2030 $800 LINZESS brand profitability LINZESS U.S. net sales ~$760M 50/50 profit share >$220M $600 ~$440M Ironwood’s share $400 of 2018
Slide 12: Investing in multiple opportunities for continued growth
Investing in multiple opportunities for continued growth Drive volume growth by Increase patient requests for Maintain broad, broadening HCP view of LINZESS unrestricted access to appropriate patient • Promotion of new abdominal symptom pull-through demand • Capture Rx PEG patients seeking claims, i
Slide 13: Capitalize on GI expertise to accelerate LINZESS, advance GI portfolio and strengthen financials
Capitalize on GI expertise to accelerate LINZESS, advance GI portfolio and strengthen financials Accelerating LINZESS Advancing late-stage growth and profitability1 development programs Linaclotide abdominal symptom 3,000,000 claims (bloating, discomfort, pain) • Phase III data expected mid-2019 2,5
Slide 14: Capitalize on GI expertise to accelerate LINZESS, advance GI portfolio and strengthen financials
Capitalize on GI expertise to accelerate LINZESS, advance GI portfolio and strengthen financials Accelerating LINZESS Advancing late-stage Focusing investments growth and profitability1 development programs for growth & value creation Linaclotide abdominal symptom • Investing in profitable growth 3,
Slide 15: Creating breakthrough treatments for patients with serious and orphan diseases by harnessing the power of sGC
Creating breakthrough treatments for patients with serious and orphan diseases by harnessing the power of sGC
Slide 16: 2019 launch year expectations
2019 launch year expectations 5 Differentiated programs 4 Clinical studies ongoing 3 Phase 2 readouts 2 New tissue-tailored development candidates 1 Great company launch
Slide 17: 5 programs: on track to deliver clinical data readouts in 2019
5 programs: on track to deliver 4 clinical data readouts in 2019 including 3 Phase 2 studies, and 2 new drug candidates Distinctive pharmacology: differentiated, tissue- targeted compounds tailored for intended diseases Powerful pathway: nitric oxide-sGC pathway is clinically validated with signific
Slide 18: 4 clinical data readouts in 2019 on differentiated compounds
4 clinical data readouts in 2019 on differentiated compounds Product* Discovery IND Enabling Phase 1 Phase 2 Phase 3 Status and Anticipated Next Milestones Vascular sGC Stimulator - Top line data expected in 2H2019 Olinciguat Sickle Cell Disease - Granted Orphan Drug Designation by the US FDA - Worl
Slide 19: Tailoring proven, powerful pharmacology for treatment of serious diseases
Tailoring proven, powerful pharmacology for treatment of serious diseases A powerful pathway… …that Cyclerion is working to harness • Nitric oxide (NO) signaling plays a • Growing understanding of NO pathway role in central role in physiologic regulation health and disease • Discovery of NO signalin
Slide 20: NO-cGMP signaling regulates multiple aspects of physiology
NO-cGMP signaling regulates multiple aspects of physiology sGC stimulators: differentiated mechanism to modulate NO- cGMP pathway signaling • Act synergistically with the NO signaling system: same time and same locations in body vs. acting independently of NO signaling • Increase overall pathway sig
Slide 21: Cyclerion Leadership
Cyclerion Leadership Brian Cali, PhD - Head of IR and Corp Comms • >20 years enterprise leadership—cofounder of Microbia/IRWD • Led preclinical R&D, R&D strategy, in licensing, program leadership and portfolio management Mark Currie, PhD - President • Extensive research in cGMP signaling pathways an
Slide 22: New Ironwood and Cyclerion: pivotal moment to grow two industry-leading companies
New Ironwood and Cyclerion: pivotal moment to grow two industry-leading companies and unlock shareholder value Ironwood Today expected to: LINZESS / CONSTELLA Build a leading GI franchise GI IW-3718 Accelerate growth of LINZESS® and advance GI development programs MD-7246 Deliver profits begin
Slide 23: A Commercial Biotechnology Company
A COMMERCIAL BIOTECHNOLOGY COMPANY
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