Ironwood Pharmaceuticals gets Nasdaq deficiency notice over late 2024 Form 10-K

Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD) received a Nasdaq notification letter dated March 21, 2025. The letter says the company is not in compliance with Nasdaq's timely filing rule because it has not yet filed its annual report on Form 10-K for the year ended December 31, 2024. Ironwood disclosed the letter in a Form 8-K filed March 27, 2025, and in a press release issued the same day.

What Nasdaq requires

The notice cites Nasdaq Listing Rule 5250(c)(1), which requires listed companies to file all required periodic reports with the Securities and Exchange Commission on time. Ironwood has 60 calendar days from the date of the notice, or until May 20, 2025, to submit a plan to regain compliance. If Nasdaq accepts that plan, it may grant up to 180 calendar days from the prescribed due date of the 2024 report, or until September 1, 2025, to file it.

The 8-K says the notice has no immediate effect on the listing. The press release calls the notice "standard practice in the event of a delayed periodic financial report filing." Both documents describe a filing that is late, but neither gives a date for it. The company says only that it plans to file the 2024 report as soon as practicable and expects to regain compliance.

Neither the 8-K nor the press release explains why the report is late.

A single product carries the company

Ironwood, founded in 1998, is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland, according to the press release. Its commercial business rests on LINZESS (linaclotide). The company's annual report for 2023, filed February 16, 2024, says it recognized $430.5 million in collaborative arrangements revenue from U.S. sales of LINZESS in 2023, an increase of $31.7 million from 2022. LINZESS is approved for adults with irritable bowel syndrome with constipation and for chronic idiopathic constipation, and for pediatric patients ages 6-17 with functional constipation. AbbVie Inc. handles the product in most territories, AstraZeneca AB in China and Astellas Pharma Inc. in Japan.

That concentration is a risk. The annual report says Ironwood and AbbVie have received Paragraph IV certification notices from generic drug makers seeking to sell generic versions of linaclotide. The company has sued generic filers, and the report warns that an at-risk launch by a generic maker could cut revenue for a product in a short period. In May 2021, Ironwood and AbbVie settled with Teva and agreed to let Teva market a generic 72 mcg version beginning March 31, 2029, subject to FDA approval. The report says the companies have settled with the filers of all known generic applications to date.

Debt, losses and the pipeline

The 2023 report says Ironwood borrowed $400.0 million under a new revolving credit facility to help fund its 2023 acquisition of VectivBio Holding AG. It also says the company incurred net losses in each year from its 1998 inception until the year ended December 31, 2019, and that its accumulated deficit was approximately $1.7 billion as of December 31, 2023. The company says it expects to keep incurring substantial expenses.

Its lead development program is apraglutide, a long-acting GLP-2 analog for short bowel syndrome patients who depend on parenteral support. The 2023 report describes a Phase III trial, STARS, in adults with SBS-IF, and says topline results were expected in March 2024. The report also describes a Phase II study in steroid-refractory acute graft-versus-host disease, with data expected later. Neither the 8-K nor the press release mentions apraglutide results or the trial timeline.

What comes next

The company's stated next steps are the Nasdaq plan, due May 20, 2025, and the 2024 Form 10-K, which has no filing date. If Nasdaq accepts a plan, the latest compliance date would be September 1, 2025. Gregory Martini, Senior Vice President, Chief Financial Officer, signed the 8-K, and the press release lists him as the company contact, and Stephanie Ascher of Precision AQ as the investor contact.

A late annual report from a company that depends on one product, with no filing date attached, leaves the 2024 numbers unknown until the company files them.

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