BOSTON–(BUSINESS WIRE)–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.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is a GI healthcare company dedicated to advancing the treatment of GI diseases and redefining the standard of care for millions of GI patients. We discovered, developed and are commercializing linaclotide, the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC).
We are also advancing two late-stage, first-in-category GI product candidates: IW-3718 is a gastric retentive formulation of a bile acid sequestrant being developed for the potential treatment of refractory gastroesophageal reflux disease, and MD-7246 is a delayed-release formulation of linaclotide that is being evaluated as an oral, intestinal, non-opioid, pain-relieving agent for patients suffering from abdominal pain associated certain GI diseases.
Ironwood was founded in 1998 and is headquartered in Boston, Mass. For more information, please visit our website at www.ironwoodpharma.com or www.twitter.com/ironwoodpharma; information that may be important to investors will be routinely posted in both these locations.
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 initiatives to address the impact of, and response to, the COVID-19 pandemic, and the ability of such initiatives to support the long-term value of our business; the sufficiency of supply of LINZESS; the development, commercial availability and commercial potential of linaclotide and our other product candidates; the anticipated timing of clinical developments and the timing and results of clinical studies, including with respect the impact of COVID-19 on our IW-3718 Phase III clinical trials and the ability of patients already enrolled to continue in the trials and the anticipated timing of top-line data from our MD-7246 Phase II trial; the expected timing of guidance on our financial outlook and top-line data from our IW-3718 Phase III clinical trials; and the assessment and timing of our employees returning to normal work practices. The forward-looking statements in this press release speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements. 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. Applicable risks and uncertainties include those related to the effectiveness of development and commercialization efforts by us and our partners; preclinical and clinical development and manufacturing and formulation development; the risk that our 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, including due to the impacts of the COVID-19 pandemic; 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 other product candidates; 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; the risk that we are unable to manage our expenses or cash use, or are unable to commercialize our products as expected; and the risks listed under the heading “Risk Factors” and elsewhere in Ironwood’s Annual Report on Form 10-K for the year ended December 31, 2019, and in our subsequent SEC filings. In addition, the COVID-19 pandemic and the associated containment efforts have had a serious adverse impact on the economy, the severity and duration of which are uncertain. Government stabilization efforts will only partially mitigate the consequences. The extent and duration of the impact on our business and operations is highly uncertain, and that impact includes effects on our sales and marketing, manufacturing and supply chain, and clinical trial operations. Factors that will influence the impact on our business and operations include the duration and extent of the pandemic, the extent of imposed or recommended containment and mitigation measures, and the general economic consequences of the pandemic. The pandemic could have a material adverse impact on our business, operations and financial results for an extended period of time.
LINZESS® is a registered trademark of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this presentation are the property of their respective owners. All rights reserved.
Contacts
Investors and Media:
Meredith Kaya, 617-374-5082
mkaya@ironwoodpharma.com
Media:
Beth Calitri, 978-417-2031
bcalitri@ironwoodpharma.com