Ironwood Pharma (IRWD) Provides Update on Impact of COVID-19

Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a GI-focused healthcare company, today provided an update on certain impacts of COVID-19 on its business and the actions it is taking to mitigate the spread of this virus and help protect the safety and well-being of its employees, healthcare providers, patients and broader communities.

“In the face of the COVID-19 pandemic, we are taking important steps in an effort to help slow the spread of this virus, prioritize the health and safety of our colleagues and communities, and promote business continuity,” said Mark Mallon, chief executive officer of Ironwood. “Ironwood is focused on our mission of advancing the treatment of GI diseases and redefining the standard of care for millions of patients. We entered 2020 in a strong position and are closely monitoring the COVID-19 situation, evaluating our preparedness, and implementing plans to help address the evolving circumstances in an effort to support the long-term value of our business.”

Protecting Ironwood Colleagues and Communities

Since March 16, Ironwood employees, including customer-facing employees, have been working remotely. Ironwood has suspended all in-person interactions with customers, including visits to physician offices, clinics and hospitals. Customer-facing employees are providing support virtually through telephone and web-based technologies. Additionally, all work-related travel has been discontinued.

Ironwood is following guidance from the U.S. Centers for Disease Control and Prevention (CDC) and will continue to assess when it is appropriate for employees to return to normal work practices.

Maintaining U.S. LINZESS® (linaclotide) Manufacturing and Supply Chain Continuity

In collaboration with our partner Allergan plc, Ironwood is focused on maintaining the availability of LINZESS for adult patients suffering from irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation. As of the date of this press release, COVID-19 has not caused significant disruptions to manufacturing operations nor supply of LINZESS in the U.S. Ironwood and Allergan believe there is sufficient supply of LINZESS on hand to meet U.S. commercial needs at this time and continue to closely monitor the situation.

As a reminder, Ironwood’s ex-U.S. partners are responsible for the development, manufacturing and commercialization of linaclotide in their respective territories.

Continuing Clinical Development of GI Pipeline Candidates

Ironwood is monitoring the ongoing clinical trials for MD-7246 and IW-3718 to assess the impact of COVID-19. The current status is as follows:

• MD-7246: The Phase II clinical trial with MD-7246 for the treatment of abdominal pain associated with IBS with diarrhea completed patient dosing. Ironwood continues to target top-line data in mid-2020.
• IW-3718: The COVID-19 pandemic is impacting enrollment of new patients into the Phase III clinical trials with IW-3718 for the treatment of refractory gastroesophageal reflux disease (GERD) due primarily to certain sites suspending enrollment and lower patient participation. As of the date of this press release, nearly 70% of patients have been enrolled into the trials; most of the patients already enrolled are continuing in the trials. Ironwood is no longer guiding for top-line data in the second half of 2020. The company is assessing the situation and plans to provide an update on timing when it has more clarity.

Financial Outlook

Ironwood is currently evaluating the impact of COVID-19 on its 2020 financial guidance and expects to provide more detail, to the extent practicable, in connection with its first quarter 2020 earnings update.

Ironwood first communicated its 2020 financial guidance on February 13, 2020 in connection with its fourth quarter and full year 2019 earnings update. The company then reiterated its guidance on March 12, 2020 during the Barclays Global Healthcare Conference. As noted during the Barclays conference, Ironwood’s guidance did not reflect any potential impact from COVID-19.

Ironwood ended 2019 in a strong financial position. The company reported $177 million of cash and cash equivalents as of December 31, 2019 and generated $27.6 million in cash from operations during the fourth quarter of 2019. Ironwood also restructured its debt in August 2019, lowering cash interest payments over the next few years and extending debt maturities through as late as 2026. Ironwood’s earliest debt maturity is in 2022.

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