Ironwood Pharmaceuticals, Inc. · NASDAQ:IRWD
Ironwood Pharmaceuticals — J.P. Morgan Healthcare Conference 2021
42 slides from Ironwood Pharmaceuticals's conference presentation, Jan 11, 2021
Slide 1: J.P. Morgan Healthcare Conference
J.P. Morgan Healthcare Conference January 11, 2021 Exhibit 99.1
Slide 2: Forward-looking statements
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 to become the leading U . S . GI healthcare company ; the Company’s strategy, business,
Slide 3: Ironwood: Leading in GI through Growth and Innovation
Ironwood: Leading in GI through Growth and Innovation
Slide 4: Vision and Mission: Leading U.S. GI Healthcare Company
To Become the Leading U.S. Gastrointestinal Healthcare Company 4 To advance the treatment of GI diseases and redefine the standard of care for GI patients OUR VISION OUR MISSION
Slide 5: Disciplined Execution in 2020 Positions Ironwood for 2021
Disciplined Execution in 2020 Positions Ironwood for 2021 and Beyond 5 x New - to - brand Rx demand achieved all time highs in 2H 2020 3 x Launched new virtual detailing capability and initiated use of new telehealth platform on Linzess.com x Expanded strategy to include external commercial & earlie
Slide 6: LINZESS Performance Resilient in 2020 despite COVID-19
LINZESS Performance Was Resilient in 2020, despite COVID - 19 Pandemic 6 LINZESS Net Sales Growth 2 LINZESS Extended Unit Growth 1 1) IQVIA NPA Dec 2020 2) 4Q 2020 LINZESS U.S. net sales is unaudited, preliminary and based on estimates, and may change as w e r eceive final 2020 data from AbbVie Inc.
Slide 7: We Assessed Value-Creation Potential of Strategic Options
7 Advancing innovative treatments for GI diseases Supported by strong LINZESS business, growth in profits, GI expertise and high unmet needs Pursuing broader range of smaller on - market GI assets Expands opportunities, but limited durability & less innovative We Assessed the Value - Creation Potent
Slide 8: Our Path Forward: Advancing Innovative Treatments for GI Diseases
We have a refreshed focus in areas of high unmet need where gastroenterologists play the primary role in treating patients ▪ Strengthen GI portfolio with a focus on serious, organic GI diseases and other prioritized criteria focused on value creation Build Innovative GI Pipeline Our Path Forward: Ad
Slide 9: Focused on Delivering Shareholder Value
Maximize LINZESS Seek to drive net sales growth via commercial innovation and lifecycle management 9 We are Focused on Delivering Shareholder Value Seeking to Allocate Capital to Highest Return Opportunities Total Shareholder Return Build Innovative GI Pipeline Leverage external innovation in effort
Slide 10: Ironwood Leading through Growth and Innovation
$23 $76 $150 $274 $298 $347 $428 2013 2014 2015 2016 2017 2018 2019 Total Ironwood Revenue (in millions) 1 1) Ironwood revenues are generated primarily through its collaborative arrangements and license agreements related to linaclo tid e, as well as co - promotion arrangements in the U.S. 10 Ironwo
Slide 11: Maximize LINZESS
Maximize LINZESS
Slide 12: LINZESS is the Prescription Market Leader in IBS-C/CIC
Sustained growth since launch in 2012 LINZESS is the Prescription Market Leader in IBS - C / CIC Category in Rx Demand IBS - C / CIC Market Share ~40% HCP / Patient Satisfaction Oct 2020 MMIT, AbbVie Oct 2020 MM Dashboard SRI “LINZESS ATU” 2020; Brado “LINZESS Patient Journey” July 2020 IQVIA RAPID
Slide 13: LINZESS Maintained Strong Demand Growth and Market Share
1) IQVIA NPA Weekly, Dec 2020 2) IQVIA RAPID Weekly Market without PEG, Dec 2020 LINZESS Maintained Strong Demand Growth and Nearly 40% IBS - C / CIC Market Share in 2020 2 13 LINZESS Y/Y Total Rx Demand 1 2020 IBS - C/CIC Market Share 2 1,900,000 2,100,000 2,300,000 2,500,000 2,700,000 2,900,000 3,
Slide 14: Strong New-to-brand Volume and 90-Day Prescriptions
1) Other Branded Products: Amitiza , Trulance, Motegrity, and Zelnorm . 2) IQVIA Monthly Patient Insights. 3) IQVIA Weekly NPA Nov 2019 vs Nov 2020 4) IQVIA Monthly NPA FY 2018, FY 2019, and FY 2020 (through 11/30/2020) Strong LINZESS New - to - brand Volume and 90 - Day Prescriptions Are Key Indica
Slide 15: LINZESS U.S. Net Sales and Profitability
*2020 LINZESS U.S. net sales and brand profitability (and Ironwood’s share of 2020 U.S. LINZESS profits) are unaudited, preli min ary and based on estimates, and may change as we receive final 2020 data from AbbVie, Inc. and as we and AbbVie complete the preparation of our respective 2020 financial
Slide 16: On Track to Exceed $1 Billion in LINZESS Net Sales
~75% >90% ~70% Communicating Overall Abdominal Symptom Data x FDA approved LINZESS sNDA for overall IBS - C abdominal symptoms x Full refresh of consumer campaign expected spring 2021 Enhancing HCP / Patient Experience x Expand hybrid selling model leveraging in - person & virtual technologies x Adv
Slide 17: Innovating Our Commercial Strategy to Align to Customer Needs
Innovating Our Commercial Strategy to Align to Customer Needs 17 Expanding Hybrid Selling Model Advancing Telehealth Initiatives x Making virtual selling a more permanent component of overall selling model x Surveyed HCPs currently estimate ~2/3 of rep interactions are remote and ~30% of future inte
Slide 18: OTC/Rx Laxative Market Remains Largest Opportunity
18 1) Chey, W. et al “Frequency and Bothersomeness of Symptoms, Health Care Seeking Behavior and Satisfaction with Therapy in IBS - C Patients Meeting ROME II Criteria: Results of a Population Based Survey”; Hoch, R, et al "Title: Symptom Frequency, Health Care Seeking Behavior, and Satisfaction wit
Slide 19: Linaclotide Improves Abdominal Pain in Phase III Trials
1) Results from two Phase III clinical trials with identical designs comparing LINZESS 290 mcg vs placebo for 12 weeks. The d ata above represent a prespecified secondary endpoint in individual trials. Trial 1: Trt Diff 12.7%, 95% CI (5.8%, 19.5%). Trial 2: Trt Diff 14.4%, 95% CI (7.6%, 21.1%). 2) A
Slide 20: Lifecycle Management Efforts Play Critical Role in LINZESS Growth
Ongoing Complete Assessing Additional Opportunities Lifecycle Management Efforts Expected to Play Critical Role in Future LINZESS Growth Potential 20 x LINZESS 290 mcg Overall Abdominal Symptom data and sNDA approval for adults with IBS - C x LINZESS 72 mcg dose approval for adults with CIC x Approv
Slide 21: Global LINZESS partnerships: Japan, China, Rest of world
Japan Rest of world China (incl. Hong Kong & Macau) • LINZESS launched in Japan for IBS - C in March 2017 and chronic constipation in August 2018 • LINZESS net sales for six months ended 9/30/20 (as reported by Astellas) were ~¥3.1B, up 13% Y/Y • Astellas has exclusive rights to develop, manufacture
Slide 22: Build an Innovative Pipeline
Build an Innovative Pipeline
Slide 23: High Unmet Need within GI
1) National Institutes of Health, U.S. Department of Health and Human Services. Opportunities and Challenges in Digestive Diseas es Research: Recommendations of the National Commission on Digestive Diseases. Bethesda, MD: National Institutes of Health; 2009. NIH Publication 08 – 6514 ; 2) Peery AF e
Slide 24: Identified >100 GI Assets in >25 Prioritized Disease Areas
We Have Identified >100 GI Assets in >25 Prioritized Disease Areas, Including: 24 Prioritizing Serious, Organic GI Diseases Abdominal Pain Pruritis Celiac Disease Liver Injury / Failure Pancreatitis Esophageal / Allergic Mucositis / Gut Inflammation Rare GI Diseases Note: Organic GI diseases have me
Slide 25: Guided by Clear Principles
Prioritize diseases that are primarily managed by gastroenterologists Focus on organic GI diseases , where mechanisms are well understood Target innovation, via first - in - class or differentiated opportunities Explore innovative, earlier - stage clinical assets and late - stage / commercial assets
Slide 26: Advancing IW-3300 into Phase I Development
• Strong pre - clinical data: Stable peptide expected to provide great flexibility in formulation – IW - 3300 reversed endometriosis - induced vaginal hypersensitivity in a pre - clinical vaginal distension model – IW - 3300 also demonstrated pain relief in bladder pre - clinical hypersensitivity mo
Slide 27: IW-3300 Pre-clinical Endometriosis Model Data
KEY Sham (“normal response) Baseline (ENDO pre - treat.) Vehicle IW - 3300, 1 µg/kg IW - 3300, 3 µg/kg IW - 3300, 10 µg/kg S h a m B L E N D O B L V e h i c l e - D a y 1 - 1 h 3 3 0 0 a t 1 u g / k g - D a y 1 - 1 h 3 3 0 0 a t 3 u g / k g - D a y 1 - 1 h 3 3 0 0 a t 1 0 u g / k g - D a y 1 - 1 h V
Slide 28: IW-3300 Demonstrates Pain Relief in Bladder Hypersensitivity Model
IW 3300 Demonstrates Pain Relief In Pre - Clinical Model of Bladder Hypersensitivity 0 1 2 3 4 5 6 7 0.16 0.4 1 2 4 8 15 Sham+vehicle (n=2) Sham+IW3300 (n=3) 40Gy+vehicle (n=4) 40Gy+IW3300 (n=5) IW - 3300 (3 µg/kg/day) reversed radiation - induced chronic bladder hypersensitivity, consistently reduc
Slide 29: Highly Skilled Management Team and Board of Directors
Strengthened our leadership in 2019 - 2020 with development, commercial and business expertise GI Development and Commercial Leadership Board of Directors Management Team x Strengthened development leadership with GI experts x Commercial leadership has directly contributed to creation of multiple $5
Slide 30: Leading GI Capabilities and Expertise
GI SCIENCE & CLINICAL DEVELOPMENT Deep understanding of GI diseases; >10 pivotal linaclotide studies REGULATORY STRATEGY Led development of new GI patient reported outcome (PRO) measures PARTNERING CAPABILITIES Multiple global GI partnerships and collaborations SALES EXCELLENCE Highly experienced, a
Slide 31: Deliver Sustained Profits and Generate Cash Flow
Deliver Sustained Profits and Generate Cash Flow
Slide 32: Strong Financial Performance in 3Q 2020
Demonstrated Strong Financial Performance in 3Q 2020 $34M GAAP Net Income $0.22/share – basic $0.21/share – diluted $47M Adjusted EBITDA 3 $103M Total Ironwood Revenues Primarily driven by $100M in U.S. LINZESS collaboration revenue 18% Y/Y growth in U.S. LINZESS collaboration revenue $241M U.S. LIN
Slide 33: Strong Execution Puts Ironwood in Strong Financial Position
Strong Execution and Disciplined Investments Puts Ironwood in Strong Financial Position Total revenues and cash continued to grow in 2020 behind LINZESS strength and disciplined capital allocation 33 $177 $231 $253 $308 ~ $350 3 $0 $50 $100 $150 $200 $250 $300 $350 $400 4Q19 1Q20 2Q20 3Q20 4Q20 (mil
Slide 34: 3Q 2020 Was 6th Consecutive Quarter of Profitability
($203) $11 $63 ($250) ($200) ($150) ($100) ($50) $0 $50 $100 2018 2019 2020 ($ in millions) GAAP Net Income from Continuing Operations, 1Q – 3Q, 2018, 2019 and 2020 1) Refer to the 3Q 2020 Reconciliation of GAAP results to non - GAAP financial measures table on slide 39 of this presentation Cyclerio
Slide 35: Maintaining a Strong Capital Structure
1) 2020 cash and cash equivalents is unaudited, preliminary and based on estimates and may change as we receive final 2020 da ta and complete the preparation of our 2020 financial statements. 2) Due dates of aggregate principal amounts of convertible senior notes outstanding as of 9/30/20 $121 $200
Slide 36: 2021 Guidance
1) Adjusted EBITDA is calculated by subtracting net interest expense, taxes, depreciation, amortization, mark - to - market adjustme nts on derivatives related to Ironwood’s 2022 Convertible Notes, and restructuring expenses from GAAP income from continuing operations, net of income taxes. Ironwood
Slide 37: Ironwood is Leading through Growth and Innovation
$23 $76 $150 $274 $298 $347 $428 2013 2014 2015 2016 2017 2018 2019 Total Ironwood Revenue (in millions) 1 1) Ironwood revenues are generated primarily through its collaborative arrangements and license agreements related to linaclo tid e, as well as co - promotion arrangements in the U.S. 37 Ironwo
Slide 38: Appendix
Appendix 38
Slide 39: 3Q 2020 Financial Summary
3Q 2020 Financial Summary Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 (000s, except per share amounts) (000s, except per share amounts) GAAP net income $ 34,423 $ 62,972 Adjustments: Mark - to - market adjustments on the derivatives related to convertible notes , net 2
Slide 40: 3Q 2020 Financial Summary: Adjusted EBITDA
3Q 2020 Financial Summary Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 (000s) (000s) GAAP income from continuing operations, net of income taxes 1 $ 34,423 $ 62,972 Adjustments: Mark - to - market adjustments on the derivatives related to convertible notes , net 2,616 6
Slide 41: 3Q 2020 Financial Summary: LINZESS U.S. Brand Collaboration
3Q 2020 Financial Summary LINZESS U.S. Brand Collaboration Three Months Ended September 30, 2020 Nine Months Ended September 30, 2020 (000s) (000s) LINZESS U.S. net product sales $ 241,124 $ 652,891 AbbVie & Ironwood commercial costs, expenses and other discounts 2 52,939 162,833 AbbVie & Ironwood R
Slide 42: LINZESS Net Sales Historical Reconciliation
LINZESS Net Sales Historical Reconciliation (all amounts below in $000s) Three Months Ended March 31, 2019 Three Months Ended June 30, 2019 Three Months Ended September 30, 2019 Three Months Ended December 31, 2019 Year Ended December 31, 2019 Three Months Ended March 31, 2020 Net Sales as previousl
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