Ironwood Pharmaceuticals Reports Third Quarter 2021 Results and Provides Corporate Development Update - LINZESS (Iinaclotide) prescription demand growth increased 12% year-over-year; LINZESS U.S. ne

Ironwood Pharmaceuticals

Reports Third Quarter 2021 Results and Provides Corporate Development Update

LINZESS (Iinaclotide) prescription demand growth increased 12% year-over-year;

LINZESS U.S. net sales of $253 million,

an increase of 5% year-over-year -

revenue of $104 million; U.S. LINZESS collaboration revenue of $100 million -

GAAP net income of $56 million and adjusted EBITDA of $65 million;

ended Q3 2021 with $574 million in cash and cash equivalents -

pipeline by entering into an option agreement with COUR Pharmaceuticals Development Company, Inc. to acquire an exclusive

license to develop and commercialize, in the U.S., CNP-104 for the treatment of primary biliary cholangitis

Mass., November 4, 2021 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today

reported financial results for third quarter 2021.

"We remain highly confident we are well

on our way to achieving our vision of becoming the country's leading GI healthcare company, as evidenced by another stellar quarter

of performance and profitability," said Tom McCourt, chief executive officer of Ironwood. "It's remarkable that

since the launch of our best-selling IBS-C and CIC product in 2012, LINZESS continues as a powerhouse brand; experiencing accelerated

demand and widespread acceptance in the GI community. We're also pleased to expand our pipeline and development program through

the option agreement with COUR Pharmaceuticals to acquire an exclusive license for CNP-104, in the U.S., for the treatment of primary

biliary cholangitis, a rare autoimmune disease targeting the liver. This agreement highlights our focus on prudently allocating capital

to value enhancing opportunities while simultaneously continuing to deliver sustainable profits and cash flow."

Third Quarter 2021 Financial Highlights1

(in thousands, except for per share amounts)

Third Quarter 2021 Corporate Highlights

PBC is a rare autoimmune disease targeting the liver that

affects an estimated 133,000 people in the U.S. COUR expects to initiate a clinical trial for CNP-104 in 2021 to evaluate the

safety, tolerability, pharmacodynamic effects and efficacy of CNP-104 in PBC patients.

Ironwood will pay COUR approximately $20 million in upfront

and near-term payments associated with COUR's clinical trial for CNP-104. After reviewing the data from such clinical trial, if

Ironwood exercises its option, COUR will be eligible to receive up to an additional $475 million, inclusive of an option exercise payment

and commercial milestones and royalties in the high single digits to low double digits percentage of the aggregated annual net sales

in the U.S. of products containing CNP-104.

For more details on the agreement between Ironwood and

COUR, please reference the press release here.

Quarter Financial Results

2021, Ironwood continues to expect:

Adjusted EBITDA is calculated by subtracting net interest expense, income taxes, depreciation, amortization, mark-to-market adjustments

on derivatives related to Ironwood's 2022 Convertible Notes and restructuring expenses from GAAP net income.

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 expense, 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

also presents adjusted EBITDA, a non-GAAP measure, as well as guidance on adjusted EBITDA. Adjusted EBITDA is calculated by subtracting

net interest expense, income taxes, depreciation, amortization, mark-to-market adjustments on derivatives related to Ironwood's

2022 Convertible Notes and restructuring expenses from GAAP net income. The adjustments are made on a similar basis as described above

related to non-GAAP net income, as applicable.

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.

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.

will host a conference call and webcast at 8:30 a.m. Eastern Time on Thursday, November 4, 2021 to discuss its third quarter 2021 results

and recent business activities. Individuals interested in participating in the call should dial (888) 330-3181 (U.S. and Canada) or (646)

960-0699 (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 November 4, 2021 running through 11:59 p.m. Eastern Time on November 18, 2021. 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.

Ironwood Pharmaceuticals

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.

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

routinely post information that may be important to investors on our website at www.ironwoodpharma.com. In addition,

LINZESS (linaclotide)

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.

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

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.

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.

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.

Important Safety Information

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

Adverse Reactions (incidence 2% and greater than placebo)

see full Prescribing Information including Boxed Warning: