Ironwood Pharmaceuticals Announces Leadership Updates

– Thomas McCourt named permanent CEO and appointed to Ironwood Board of Directors –

– Gina Consylman to step down as SVP, CFO effective July 2, 2021 –

BOSTON–(BUSINESS WIRE)–Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today announced that the Board of Directors named Thomas McCourt, who has served as president and interim chief executive officer since March 12, 2021, as permanent chief executive officer. Mr. McCourt has also been appointed to serve on Ironwood’s Board. With the appointment of Mr. McCourt, the Board is now comprised of 11 directors.

Ironwood also announced that Gina Consylman plans to step down as senior vice president and chief financial officer, effective July 2, 2021, in order to pursue another leadership opportunity at a rare disease biotechnology company. Ms. Consylman’s resignation is not due to any disagreement with Ironwood on any matter relating to the Company’s financial reporting. Ironwood plans to initiate a search for Ms. Consylman’s permanent successor and intends to name an interim chief financial officer if a permanent successor has not yet been appointed by the date of Ms. Consylman’s departure.

“Following a comprehensive search process, the Board unanimously determined that Tom is the ideal person to lead Ironwood forward,” said Julie McHugh, chair of Ironwood’s Board. “Tom has been an exceptional leader as Ironwood has continued to execute on its strategy. We are fortunate to have an executive with his experience, deep knowledge of the company, and commitment to our patients and people. I look forward to working with him – along with our entire senior leadership team – as we focus on creating value for our shareholders.”

Ms. McHugh continued, “On behalf of the Board and everyone at Ironwood, I would also like to thank Gina for her outstanding leadership and significant contributions over the past seven years. She played an instrumental role in several highly strategic transactions, including our business separation in 2019 and launching the new GI-focused Ironwood as an independent company, and has helped the company to achieve its financial objectives. We appreciate Gina’s commitment to ensuring a seamless transition and we wish her all the best.”

Mr. McCourt said, “I am honored to be named permanent CEO and thank Julie and the Board for their guidance and support over the past several months. We have made steady progress on many of our key objectives, including the continued growth of LINZESS® (linaclotide) and building a strong financial position. I have great confidence in the exciting opportunities ahead for Ironwood and look forward to working with our exceptional team as we execute our strategy of maximizing LINZESS, building an innovative GI development portfolio and delivering sustained profits and generating cash.”

Mr. McCourt added, “I join Julie in expressing my thanks to Gina for her leadership and commitment to Ironwood. She built a strong and effective finance organization, and today, Ironwood is proud to have delivered two years of profitability, supported by a robust balance sheet and strong cash flows. She has been a trusted partner to me, and I know she will see continued success in her next role.”

“It has been a privilege to work at this incredible company since 2014,” said Ms. Consylman. “While decisions like this are never easy, I look forward to taking on new challenges and expanding my skill set in the next phase of my career. I leave with confidence knowing that we have a talented and dedicated finance team and a solid foundation in place to continue building on our positive momentum and delivering enhanced value for patients and shareholders. I plan to work closely with Tom and the leadership team to facilitate a smooth transition.”

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 6 years of age. The safety and effectiveness of LINZESS in pediatric patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of guanylate cyclase-C (GC-C) agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences. In adults with IBS-C or CIC treated with LINZESS, the most commonly reported adverse event was diarrhea.

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

WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS

LINZESS is contraindicated in patients less than 6 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. Use of LINZESS should be avoided in patients 6 years to less than 18 years of age. The safety and effectiveness of LINZESS have not been established in patients less than 18 years of age.

Contraindications

LINZESS is contraindicated in patients less than 6 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 6 years of age. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established. In neonatal mice, linaclotide increased fluid secretion as a consequence of GC-C agonism resulting in mortality within the first 24 hours due to dehydration. Due to increased intestinal expression of GC-C, patients less than 6 years of age may be more likely than patients 6 years of age and older to develop severe diarrhea and its potentially serious consequences.
Use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age. Although there were no deaths in older juvenile mice, given the deaths in young juvenile mice and the lack of clinical safety and efficacy data in pediatric patients, use of LINZESS should be avoided in pediatric patients 6 years to less than 18 years of age.

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.

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.

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 anticipated leadership updates, management transition plans, the company’s intent to initiate a search for a permanent CFO and to name an interim CFO if a permanent successor has not yet been appointed by the date of Ms. Consylman’s departure, Ironwood’s business strategy, the strength of Ironwood’s financial position and operations, progress and ability to execute on its strategy and mission, and the demand and growth of LINZESS, as well as statements about the timing of any of the foregoing. Each forward‐looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. These forward-looking statements speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements. Applicable risks and uncertainties include those related to the possibility that the leadership transitions do not occur as anticipated for any reason or on the expected timing; our ability to effectively advance our strategy; the effectiveness of development and commercialization efforts by us and our partners; preclinical and clinical development, manufacturing and formulation development of linaclotide and our product candidates; the risk that clinical programs and studies may not progress or develop as anticipated, including that studies are delayed or discontinued for any reason, such as safety, tolerability, enrollment, manufacturing, economic or other reasons; the risk that findings from our completed nonclinical and clinical studies may not be replicated in later studies; the risk that we or our partners are unable to obtain, maintain or manufacture sufficient LINZESS or our product candidates, or otherwise experience difficulties with respect to supply or manufacturing; the efficacy, safety and tolerability of linaclotide and our product candidates; the risk that the therapeutic opportunities for LINZESS or our product candidates are not as we expect; decisions by regulatory and judicial authorities; the risk that we may never get sufficient patent protection for linaclotide and other product candidates, that patents for linaclotide or other products may not provide adequate protection from competition, or that we are not able to successfully protect such patents; developments in the intellectual property landscape; challenges from and rights of competitors or potential competitors; the risk that our planned investments do not have the anticipated effect on our company revenues; the risk that we are unable to manage our expenses or cash use, or are unable to commercialize our products as expected; the impact of the COVID-19 pandemic; and the risks listed under the heading “Risk Factors” and elsewhere in Ironwood’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, and in our subsequent SEC filings.