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Ironwood Pharmaceuticals Reports Second Quarter 2022 Results; Maintains Full Year Guidance Due to Continued Strength of LINZESS Prescription Demand - LINZESS (Iinaclotide) EUTRx prescription demand

Key Takeaway: Pharmaceuticals Reports Second Quarter 2022 Results; Maintains Full Year Guidance Due to Continued Strength of LINZESS LINZESS (Iinaclotide) EUTRx prescription demand growth in Q2 2022 increased 9% year-over-year - GAAP net income of $37 million and adjusted EBITDA of $56 milli

Full Press Release Details

Pharmaceuticals Reports Second Quarter 2022 Results; Maintains Full Year Guidance Due to Continued Strength of LINZESS
LINZESS (Iinaclotide) EUTRx prescription demand growth in Q2 2022 increased 9% year-over-year -
GAAP net income of $37 million and adjusted EBITDA of $56 million;
ended Q2 2022 with $504 million in cash and cash equivalents -
Completes Board of Directors authorized share repurchase program; repays remaining principal amount of the 2022 Convertible Notes in
Reiterates 2022 guidance of U.S. LINZESS net sales growth of low single digits %, total Ironwood revenue of $420 to $430 million and
adjusted EBITDA of >$250 million -
Mass., August 4, 2022 - Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today reported
its second quarter 2022 results and recent business performance.
made progress towards our goal of becoming the leading GI healthcare company in the U.S., as the positive momentum across our business
continued in the second quarter," said Tom McCourt, chief executive officer of Ironwood. "We are pleased by the year-over-year
double-digit LINZESS prescription demand growth in the first half of 2022, and we believe there is still significant opportunity to reach
appropriate new patients and drive additional growth for the brand. In addition to the commercial success of LINZESS, we continue to
make progress with our ongoing clinical trials. We now expect our Phase 3 pediatric study of linaclotide in 6 to 17 year-olds with functional
constipation to readout in the third quarter of this year and remain on track with the previously shared data readout timing for IW-3300
and CNP-104. We believe our capabilities in GI, strong balance sheet and disciplined capital allocation continue to position our company
for growth moving forward."
Quarter 2022 Financial Highlights1
thousands, except for per share amounts)
2Q 2022 2Q 2021
Total revenues $ 97,231 $ 104,031
Total operating expenses 41,576 38,933
GAAP net income 37,080 391,303
GAAP net income per share - basic 0.24 2.42
GAAP net income per share - diluted 0.21 2.39
Adjusted EBITDA 56,015 65,212
Non-GAAP net income 37,761 56,387
Non-GAAP net income per share - basic 0.24 0.35
Non-GAAP net income per share - diluted 0.21 0.34
Quarter 2022 Corporate Highlights
U.S. LINZESS Full Brand Collaboration (in thousands, except for percentages) Three Months Ended June 30,
2022 2021
LINZESS U.S. net sales as reported by AbbVie $ 248,351 $ 259,252
AbbVie & Ironwood commercial costs, expenses and other discounts 76,363 73,439
Commercial margin 69 % 72 %
AbbVie & Ironwood R&D Expenses 8,214 9,173
Total net profit on sales of LINZESS 163,774 176,640
Full brand margin 66 % 68 %
Quarter Financial Results
net income excludes the impact of mark-to-market adjustments on the derivatives related to Ironwood's 2022 Convertible Notes, restructuring
expenses, and the release of the company's valuation allowance against the majority of deferred tax assets in the second quarter
of 2021. See Non-GAAP Financial Measures below.
2022 Guidance
U.S. LINZESS Net Sales Growth Low single digits %
Total Revenue $420 to $430 million
Adjusted EBITDA 1 >$250 million
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 2022.
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 expenses, 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 below:
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, restructuring expenses, 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.
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, August 4, 2022 to discuss its second quarter 2022 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 August 4, 2022 running through 11:59 p.m. Eastern Time on August 18, 2022. 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), 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.
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, follow us
on Twitter and on LinkedIn.
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:
and CONSTELLA are registered trademarks of Ironwood Pharmaceuticals, Inc. Any other trademarks referred to in this press release
press release contains forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements,
including statements about Ironwood's ability to execute its mission; Ironwood's strategy, business, financial position and
operations; Ironwood's ability to drive growth and profitability; the demand, development, commercial availability and commercial
potential of linaclotide and the drivers, timing, impact and results thereof; Ironwood's continued focused investments and commitment
to reaching new patients to drive prescription demand growth moving forward, which include a clinical pediatric programs in IBS-C and
functional constipation (including the timing and results thereof); the potential indications for, and benefits of, linaclotide; financial
performance and results, and guidance and expectations related thereto, including expectations related to LINZESS U.S. net sales growth,
Last updated: Aug 4, 2022