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Ironwood Pharmaceuticals Reports First Quarter 2023 Results; Maintains Full Year 2023 Financial Guidance - LINZESS (Iinaclotide) EUTRx prescription demand growth increased 10% year- over-year; LINZE

Key Takeaway: Ironwood Pharmaceuticals reported its first quarter 2023 results, showing a 10% year-over-year increase in LINZESS prescription demand and achieving net sales of $250 million, an 8% rise from the previous year. The company also reported a GAAP net income of $46 million and an adjusted EBITDA of $60 million. With a robust cash reserve of $740 million, Ironwood remains focused on its pipeline and anticipates a potential pediatric indication for LINZESS in June. The company maintains its financial guidance for 2023, projecting net sales growth of 3% to 5%.

Market Sentiment Analysis

POSITIVE FACTORS

  • LINZESS prescription demand increased by 10% year-over-year.
  • U.S. net sales for LINZESS rose to $250 million, an 8% increase.
  • Ironwood maintains strong financial position with $740 million in cash.
  • Upcoming PDUFA date on June 14 may expand LINZESS's market.

Full Press Release Details

Ironwood Pharmaceuticals
Reports First Quarter 2023 Results; Maintains Full Year 2023
LINZESS (Iinaclotide) EUTRx prescription demand growth increased 10% year-
over-year; LINZESS U.S. net sales of $250 million, an increase of 8%
GAAP net income of $46 million and adjusted EBITDA of $60 million;
ended Q1 2023 with $740 million in cash and cash equivalents -
Mass., May 4, 2023 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused
healthcare company, today reported its first quarter 2023 results and recent business performance.
"We are off to a terrific start
to the year, as the strong momentum of LINZESS continues," said Tom McCourt, chief executive officer of Ironwood. "In the
first quarter, LINZESS prescription demand increased over 10% year-over-year, with LINZESS achieving an all-time high in new-to-brand
patient volume. We look forward to our upcoming June 14th PDUFA date for a potential pediatric functional constipation indication in
children and adolescents ages 6 to 17, which, if approved, would further expand the growth potential of the brand. In addition, we made
progress with our pipeline programs, CNP-104 and IW-3300, and finished the quarter with $740 million of cash and cash equivalents on
our balance sheet. We believe we are well-positioned to maximize LINZESS growth and continue to build an innovative GI portfolio supporting
the next growth horizon for the company."
First Quarter 2023 Financial Highlights1
(in thousands, except for per share
1Q 2023 1Q 2022
Total revenues $ 104,061 $ 97,529
Total operating expenses 43,964 39,683
GAAP net income 45,714 38,801
GAAP net income per share - basic 0.30 0.25
GAAP net income per share -diluted 0.25 0.21
Adjusted EBITDA 60,383 58,201
Non-GAAP net income 45,695 38,071
Non-GAAP net income per share - basic 0.30 0.24
Non-GAAP net income per share - diluted 0.25 0.21
First Quarter 2023 Corporate Highlights
Prescription Demand : Total LINZESS prescription demand in the first quarter of 2023 was 45 million LINZESS capsules, a 10% increase compared to the first quarter of 2022, per IQVIA.
U.S. Brand Collaboration : LINZESS U.S. net sales are provided to Ironwood by its U.S. partner, AbbVie Inc. ("AbbVie"). LINZESS U.S. net sales were $250.2 million in the first quarter of 2023, an 8% increase compared to $232.3 million in the first quarter of 2022.
U.S. LINZESS Full Brand Collaboration Three Months Ended March 31,
(in thousands, except for percentages) 2023 2022
LINZESS U.S. net sales as reported by AbbVie $ 250,214 $ 232,334
AbbVie & Ironwood commercial costs, expenses and other discounts 66,408 61,016
Commercial margin 73 % 74 %
AbbVie & Ironwood R&D Expenses 8,650 8,166
Total net profit on sales of LINZESS 175,156 163,152
Full brand margin 70 % 70 %
First Quarter 2023 Financial Results
Non-GAAP Net Income. Non-GAAP net income was $45.7 million, or $0.30 per share (basic) and
0.25 per share (diluted), in the first quarter of 2023, compared to non-GAAP net income of $38.1 million, or $0.24 per share (basic) and $0.21 (diluted) in the first quarter of 2022.
2023 Guidance
U.S. LINZESS Net Sales Growth 3% to 5%
Total Revenue $420 to $435 million
Adjusted EBITDA 1 >$250 million
1 Adjusted EBITDA is calculated
by subtracting mark-to-market adjustments on derivatives related to Ironwood's 2022 Convertible Notes, restructuring expenses,
net interest expense, income taxes, depreciation and amortization from GAAP net income. For purposes of this guidance, Ironwood has assumed
that it will not incur material expenses related to business development activities in 2023.
Non-GAAP Financial Measures
Ironwood 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. Non-GAAP adjustments are further detailed below:
Ironwood also presents adjusted EBITDA,
a non-GAAP measure, as well as guidance on adjusted EBITDA. Adjusted EBITDA is calculated by subtracting mark-to-market adjustments on
derivatives related to Ironwood's 2022 Convertible Notes, net interest expense, income taxes, depreciation and amortization from
GAAP net income. The adjustments are made on a similar basis as described above related to non-GAAP net income, as applicable.
Management 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.
Ironwood 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.
Conference Call Information
Ironwood will host a conference call
and webcast at 8:30 a.m. Eastern Time on Thursday, May, 4 2023 to discuss its first quarter 2023 results and recent business activities.
Individuals interested in participating in the call should dial (888) 330-2384 (U.S. and Canada) or (240) 789-2701 (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 May 4, 2023,
running through 11:59 p.m. Eastern Time on May 18, 2023. 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.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD),
an S&P SmallCap 600 company, 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.
About 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.
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
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.
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
Warnings and Precautions

Frequently Asked Questions

What were Ironwood's Q1 2023 net sales for LINZESS?

Ironwood reported LINZESS U.S. net sales of $250 million for Q1 2023.

How much cash did Ironwood have at the end of Q1 2023?

Ironwood ended Q1 2023 with $740 million in cash and cash equivalents.

What was the adjusted EBITDA for Ironwood in Q1 2023?

Ironwood's adjusted EBITDA for Q1 2023 was $60 million.

What is LINZESS used to treat?

LINZESS is used for treating IBS-C and chronic idiopathic constipation in adults.

What is the expected U.S. LINZESS net sales growth for 2023?

The expected U.S. LINZESS net sales growth for 2023 is between 3% to 5%.

Last updated: May 4, 2023