Ironwood Pharmaceuticals Reports First Quarter 2022 Results; Maintains Full Year 2022 Financial Guidance

– LINZESS^® (Iinaclotide) prescription demand growth increased 11% year-over-year; LINZESS U.S. net sales of $232 million, an increase of 8% year-over-year –

– Total revenue of $98 million; U.S. LINZESS collaboration revenue of $94 million –

– GAAP net income of $39 million and adjusted EBITDA of $58 million; ended Q1 2022 with $593 million in cash and cash equivalents –

BOSTON--(BUSINESS WIRE)--Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today reported its first quarter 2022 results and recent business performance.

“Continuing the growth and momentum from 2021 when LINZESS exceeded $1 billion in U.S. net sales and earned blockbuster status, we believe we are in a strong position to realize our vision of becoming the leading U.S. GI healthcare company,” said Tom McCourt, chief executive officer of Ironwood. “We continue to be excited by the performance of LINZESS, which has delivered another quarter of double-digit prescription demand growth year-over-year. We believe that our focused investments and commitment to reaching new patients will continue to drive demand growth moving forward. Beyond LINZESS, we are making progress with our ongoing clinical trials and remain on track with the previously shared data readout timing. We are also focused on strengthening our pipeline through the in-license or acquisition of innovative GI assets, which we believe will position our company for continued growth.”

First Quarter 2022 Financial Highlights¹

(in thousands, except for per share amounts)

1. Refer to the Reconciliation of GAAP Results to Non-GAAP Financial Measures table and to the Reconciliation of GAAP Net Income to Adjusted EBITDA table at the end of this press release. Refer to Non-GAAP Financial Measures for additional information.

First Quarter 2022 Corporate Highlights

U.S. LINZESS

• Prescription Demand: Total LINZESS prescription demand in the first quarter of 2022 was 41 million LINZESS capsules, an 11% increase compared to the first quarter of 2021, per IQVIA.
• U.S. Brand Collaboration: LINZESS U.S. net sales are provided to Ironwood by its U.S. partner, AbbVie Inc. (“AbbVie”). LINZESS U.S. net sales were $232.3 million in the first quarter of 2022, an 8% increase compared to $215.4 million in the first quarter of 2021.
  • Ironwood and AbbVie share equally in U.S. brand collaboration profits. See the LINZESS U.S. Commercial Collaboration table at the end of the press release.
    – LINZESS commercial margin was 74% in the first quarter of 2022, compared to 73% in the first quarter of 2021. See the U.S. LINZESS Full Brand Collaboration table below and at the end of this press release.
    – Net profit for the LINZESS U.S. brand collaboration, net of commercial and research and development (“R&D”) expenses, was $163.2 million in the first quarter of 2022, compared to $148.4 million in the first quarter of 2021. See U.S. LINZESS Full Brand Collaboration table below and at the end of this press release.
• Collaboration Revenue to Ironwood: Ironwood recorded $94.3 million in collaboration revenue in the first quarter of 2022 related to sales of LINZESS in the U.S., a 10% increase compared to $85.9 million for the first quarter of 2021. See U.S. LINZESS Commercial Collaboration table at the end of the press release.

Pediatric Program

• Ironwood and AbbVie are currently advancing the linaclotide clinical pediatric program to potentially expand the clinical profile of LINZESS (assuming positive data and FDA approval). The functional constipation study in 6 to 17 year-olds is expected to readout in the second half of 2022. Functional Constipation affects an estimated 4 to 6 million 6 to 17 year-olds in the U.S., according to studies published in The Journal of Pediatrics. There are currently no FDA approved prescription pediatric therapies for functional constipation.

IW-3300

• Ironwood is currently advancing IW-3300, a guanylate cyclase-C agonist being developed for the potential treatment of visceral pain conditions, such as interstitial cystitis / bladder pain syndrome (IC/BPS) and endometriosis.
  – IC/BPS affects an estimated 4 to 12 million Americans, according to the Interstitial Cystitis Association. An estimated 4 million reproductive-age women in the U.S. have been diagnosed with endometriosis, according to a study published in Gynecologic and Obstetric Investigation. Both diseases have a limited number of treatment options available. The Phase I clinical program commenced in the first quarter of 2022 to evaluate the safety and tolerability of IW-3300 in healthy volunteers.

CNP-104

• In November 2021, Ironwood entered into a collaboration and license option agreement with COUR Pharmaceuticals Development Company, Inc. (“COUR”). This agreement gives Ironwood an option to acquire an exclusive license to research, develop, manufacture and commercialize, in the U.S., products containing CNP-104 Particle (“CNP-104”), a tolerizing immune modifying nanoparticle, for the treatment of primary biliary cholangitis (“PBC”), a rare autoimmune disease targeting the liver. If successful, CNP-104 has the potential to be the first approved PBC disease modifying therapy.
  – In December 2021, the U.S. FDA granted Fast Track Designation to CNP-104.
  – PBC affects an estimated 133,000 people in the U.S, according to a study published in Gastroenterology in 2000. There is currently no approved therapy that addresses the root cause of the autoimmune destruction of the bile ducts in PBC with medical care currently focused on disease management. COUR is currently conducting a clinical study for CNP-104 evaluating the safety, tolerability, pharmacodynamic effects and efficacy of CNP-104 in PBC patients, with a data readout estimated in 2023.

First Quarter Financial Results

• Total Revenues. Total revenues in the first quarter of 2022 were $97.5 million, compared to $88.8 million in the first quarter of 2021.
  – Total revenues in the first quarter of 2022 consisted of $94.3 million associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S. and $3.2 million in royalties and other revenue. Total revenues in the first quarter of 2021 consisted of $85.9 million associated with Ironwood’s share of the net profits from the sales of LINZESS in the U.S., $2.7 million in linaclotide royalties and other revenue, and $0.2 million in sales of linaclotide API.

• Operating Expenses. Operating expenses in the first quarter of 2022 were $39.7 million, compared to $43.4 million in the first quarter of 2021.
  – Operating expenses in the first quarter of 2022 consisted of $28.9 million in selling, general and administrative (“SG&A”) expenses, and $10.8 million in research and development (“R&D”) expenses. Operating expenses in the first quarter of 2021 consisted of $27.7 million in SG&A expenses, $15.5 million in R&D expenses, and $0.3 million in restructuring expenses.

• Interest Expense, net of Interest and Investment Income. Net interest expense was $2.1 million in the first quarter of 2022, primarily in connection with Ironwood’s convertible senior notes. Interest expense recorded in the first quarter of 2022 included $1.8 million in cash expense and $0.5 million in non-cash expense. Net interest expense was $7.4 million in the first quarter of 2021, primarily in connection with Ironwood’s convertible senior notes. Interest expense recorded in the first quarter of 2021 included $1.8 million in cash expense and $5.8 million in non-cash expense. The reduction in non-cash interest expense in the first quarter of 2022 relates to the adoption of ASU No. 2020-06, Debt—Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging— Contracts in Entity’s Own Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”) on January 1, 2022, that impacts the accounting for Ironwood’s convertible senior notes.

• Gain on Derivatives. Ironwood recorded a gain on derivatives of $0.7 million in the first quarter of 2022, as a result of the change in fair value of its convertible note hedges and note hedge warrants. Ironwood recorded a gain on derivatives of $2.4 million in the first quarter of 2021, as a result of the change in fair value of its convertible note hedges and note hedge warrants.

• Income Tax Expense. Ironwood recorded $17.7 million of income tax expense in the first quarter of 2022, the majority of which was non-cash, as Ironwood continues to utilize net operating losses to offset taxable income for federal purposes and in many states. Ironwood recorded $0.4 million of income tax expense in the first quarter of 2021, primarily related to state income taxes in certain states that have temporarily disallowed or only partially allowed the use of net operating losses to offset taxable income. Ironwood maintained a valuation allowance on the majority of its net deferred tax assets until the second quarter of 2021.

• GAAP Net Income. GAAP net income was $38.8 million, or $0.25 per share (basic) and $0.21 per share (diluted), in the first quarter of 2022 compared to GAAP net income of $39.9 million, or $0.25 per share (basic and diluted), in the first quarter of 2021.

• Non-GAAP Net Income. Non-GAAP net income was $38.1 million, or $0.24 per share (basic) and $0.21 per share (diluted), in the first quarter of 2022, compared to non-GAAP net income of $37.8 million, or $0.24 per share (basic and diluted), in the first quarter of 2021.
  – Non-GAAP net income excludes the impact of mark-to-market adjustments on the derivatives related to Ironwood’s 2022 Convertible Notes and restructuring expenses. See Non-GAAP Financial Measures below.

• Adjusted EBITDA. Adjusted EBITDA was $58.2 million in the first quarter of 2022, compared to $46.1 million in the first quarter of 2021.
  – Adjusted EBITDA is calculated by subtracting mark-to-market adjustments on derivatives related to Ironwood’s 2022 Convertible Notes, restructuring expenses, net interest expense, income taxes, depreciation and amortization from GAAP net income. See Non-GAAP Financial Measures below.

• Cash Flow Statement and Balance Sheet Highlights. Ironwood ended the first quarter of 2022 with $593.4 million of cash and cash equivalents, compared to $620.1 million of cash and cash equivalents at the end of 2021.
  – Ironwood generated $64.1 million in cash from operations in the first quarter of 2022, compared to $73.7 million in cash from operations in the first quarter of 2021.
  – Ironwood used $92.5 million of cash to repurchase shares of its common stock in the first quarter of 2022.

• Ironwood 2022 Financial Guidance. In 2022, Ironwood continues to expect:

¹ Adjusted EBITDA is calculated by subtracting mark-to-market adjustments on derivatives related to Ironwood’s 2022 Convertible Notes, restructuring expenses, net interest expense, income taxes, depreciation and amortization from GAAP net income. For purposes of this guidance, Ironwood has assumed that it will not incur material expenses related to business development activities in 2022.

Non-GAAP Financial Measures

Ironwood presents non-GAAP net income and non-GAAP net income per share to exclude the impact of net gains and losses on derivatives related to Ironwood’s 2022 Convertible Notes that are required to be marked-to-market, restructuring expenses, and the release of the company’s valuation allowance against the majority of deferred tax assets in the second quarter of 2021. Non-GAAP adjustments are further detailed below:

• The gains and losses on the derivatives related to Ironwood’s 2022 Convertible Notes may be highly variable, difficult to predict and of a size that could have a substantial impact on the company’s reported results of operations in any given period.
• Restructuring expenses are considered to be a non-recurring event as they are associated with distinct operational decisions. Included in restructuring expenses are costs associated with exit and disposal activities.
• The income tax benefit associated with the valuation allowance release in the second quarter of 2021 was a non-cash, non-recurring accounting recognition event, and does not affect the company’s ability to utilize its historical net operating losses and tax credit carryforwards to offset future taxable income.

Ironwood also presents adjusted EBITDA, a non-GAAP measure, as well as guidance on adjusted EBITDA. Adjusted EBITDA is calculated by subtracting mark-to-market adjustments on derivatives related to Ironwood’s 2022 Convertible Notes, restructuring expenses, net interest expense, income taxes, depreciation and amortization from GAAP net income. The adjustments are made on a similar basis as described above related to non-GAAP net income, as applicable.

Management believes this non-GAAP information is useful for investors, taken in conjunction with Ironwood’s GAAP financial statements, because it provides greater transparency and period-over-period comparability with respect to Ironwood’s operating performance. These measures are also used by management to assess the performance of the business. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be comparable with non-GAAP information provided by other companies. For a reconciliation of non-GAAP net income and non-GAAP net income per share to GAAP net income and GAAP net income per share, respectively, and for a reconciliation of adjusted EBITDA to GAAP net income, please refer to the tables at the end of this press release.

Ironwood does not provide guidance on GAAP net income or a reconciliation of expected adjusted EBITDA to expected GAAP net income because, without unreasonable efforts, it is unable to predict with reasonable certainty the non-GAAP adjustments used to calculate adjusted EBITDA. These adjustments are uncertain, depend on various factors and could have a material impact on GAAP net income for the guidance period.

Conference Call Information

Ironwood will host a conference call and webcast at 8:30 a.m. Eastern Time on Thursday, May 5, 2022 to discuss its first quarter 2022 results and recent business activities. Individuals interested in participating in the call should dial (888) 330-2384 (U.S. and Canada) or (240) 789-2701 (international) using conference ID number and event passcode 4671230. To access the webcast, please visit the Investors section of Ironwood’s website at www.ironwoodpharma.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required. The call will be available for replay via telephone starting at approximately 11:30 a.m. Eastern Time on May 5, 2022 running through 11:59 p.m. Eastern Time on May 19, 2022. To listen to the replay, dial (800) 770-2030 (U.S. and Canada) or (647) 362-9199 (international) using conference ID number 4671230. The archived webcast will be available on Ironwood’s website for 14 days beginning approximately one hour after the call has completed.

About Ironwood Pharmaceuticals

Ironwood Pharmaceuticals (Nasdaq: IRWD) is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Under the guidance of our seasoned industry leaders, we continue to build upon our history of GI innovation and challenge what has been done before to shape what the future holds. We keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.

Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts.

We routinely post information that may be important to investors on our website at www.ironwoodpharma.com. In addition, follow us on Twitter and on LinkedIn.

About LINZESS (linaclotide)

LINZESS® is the #1 prescribed brand in the U.S. for the treatment of adult patients with irritable bowel syndrome with constipation (“IBS-C”) or chronic idiopathic constipation (“CIC”), based on IQVIA data.

LINZESS is a once-daily capsule that helps relieve the abdominal pain, constipation, and overall abdominal symptoms of bloating, discomfort and pain associated with IBS-C, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with CIC. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients, with a 72-mcg dose approved for use in CIC depending on individual patient presentation or tolerability. LINZESS should be taken at least 30 minutes before the first meal of the day.

LINZESS is contraindicated in pediatric patients less than 2 years of age. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated GC-C agonism resulting in mortality within the first 24 hours due to dehydration. There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established.

LINZESS is not a laxative; it is the first medicine approved by the FDA in a class called GC-C agonists. LINZESS contains a peptide called linaclotide that activates the GC-C receptor in the intestine. Activation of GC-C is thought to result in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established.

In the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS for the treatment of adults with IBS-C or CIC. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood's partner, Astellas, markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or CIC. Ironwood also has partnered with AstraZeneca for development and commercialization of LINZESS in China, and with AbbVie for development and commercialization of linaclotide in all other territories worldwide.

LINZESS Important Safety Information

INDICATIONS AND USAGE

LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).

IMPORTANT SAFETY INFORMATION

Contraindications

• LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.
• LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.

Warnings and Precautions

Pediatric Risk

• LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated GC-C agonism resulting in mortality within the first 24 hours due to dehydration. There was no age-dependent trend in GC-C intestinal expression in a clinical study of children 2 to less than 18 years of age; however, there are insufficient data available on GC-C intestinal expression in children less than 2 years of age to assess the risk of developing diarrhea and its potentially serious consequences in these patients. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established.

Diarrhea

• Diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of 145 mcg and 290 mcg LINZESS-treated patients, and in <1% of 72 mcg LINZESS-treated CIC patients. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.

Common Adverse Reactions (incidence ≥2% and greater than placebo)

• In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain (7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
• In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo), abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal distension (3% vs 2%). In a CIC trial of a 72 mcg dose: diarrhea (19% vs 7% placebo) and abdominal distension (2% vs <1%).

Please see full Prescribing Information including Boxed Warning: http://www.allergan.com/assets/pdf/linzess_pi

LINZESS® and CONSTELLA® are registered trademarks of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved.

Forward-Looking Statements

This press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, including statements about Ironwood’s ability to execute its mission; Ironwood’s strategy, business, financial position and operations; Ironwood’s ability to drive growth and profitability; the demand, development, commercial availability and commercial potential of linaclotide and the drivers, timing, impact and results thereof; Ironwood’s continued focused investments and commitment to reaching new patients to drive prescription demand growth moving forward, which include a clinical pediatric programs in IBS-C and functional constipation (including the timing and results thereof); the size of estimated 6 to 17 year-olds population in the U.S. affected functional constipation; the potential indications for, and benefits of, linaclotide; financial performance and results, and guidance and expectations related thereto, including expectations related to LINZESS U.

Investors:
Greg Martini, 617-374-5230
gmartini@ironwoodpharma.com

Matt Roache, 617-621-8395
mroache@ironwoodpharma.com

Media:
Beth Calitri, 978-417-2031
bcalitri@ironwoodpharma.com