Full Press Release Details
Ironwood Pharmaceuticals
Reports Second Quarter 2024 Results
(Iinaclotide) EUTRx prescription demand growth of 11% year-over-year -
to pursue apraglutide rolling NDA review; expects to complete submission in the first quarter of 2025 -
to deliver CNP-104 topline results in the third quarter of 2024 -
- Revises FY 2024 financial guidance due
to continued LINZESS pricing pressure associated with higher-than-expected Medicaid utilization trends -
BOSTON, Mass., August 8, 2024
- Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today reported its second
quarter 2024 results and recent business performance.
"We continued to make progress across our portfolio in the second
quarter," said Tom McCourt, chief executive officer of Ironwood Pharmaceuticals. "LINZESS prescription demand and new-to-brand
growth remain robust, increasing 11% and 15% year-over-year in Q2, respectively. While demand is up, LINZESS continues to experience pricing
headwinds driven by higher-than-expected Medicaid utilization trends. Even with continued LINZESS pricing pressure, we believe we are
in a fortunate position with meaningful cash flow generation from LINZESS and a capital structure to support the continued execution of
our strategic priorities. Beyond LINZESS, we have continued to receive positive feedback from physicians, key opinion leaders, and patient
advocacy partners on apraglutide's clinical profile. This positive feedback supports our belief that, if approved, apraglutide would
be the drug of choice among physicians to treat adult patients with short bowel syndrome who are dependent on parenteral support, based
on its demonstrated efficacy, tolerability and once-weekly dosing convenience. In addition, we look forward to providing an update on
CNP-104 later this quarter, which will inform a decision on our option to acquire an exclusive license from COUR for CNP-104 in the U.S."
Financial Highlights1
(in thousands, except for per share amounts)
| Q2 2024 | Q2 2023 | |||||||
| Total revenue 2 | $ | 94,396 | $ | 107,382 | ||||
| Total costs and expenses 3 | 69,419 | 1,190,521 | ||||||
| GAAP net loss 2,3 | (860 | ) | (1,089,478 | ) | ||||
| GAAP net loss attributable to Ironwood Pharmaceuticals, Inc . 2,3 | (860 | ) | (1,062,187 | ) | ||||
| GAAP net loss - per share basic 2,3 | (0.01 | ) | (6.84 | ) | ||||
| GAAP net loss - per share diluted 2,3 | (0.01 | ) | (6.84 | ) | ||||
| Adjusted EBITDA 2,3 | 27,909 | (1,034,182 | ) | |||||
| Non-GAAP net income (loss) 2,3 | 1,508 | (1,041,325 | ) | |||||
| Non-GAAP net income (loss) per share - basic 2,3 | 0.00 | (6.71 | ) | |||||
| Non-GAAP net income (loss) per share - diluted 2,3 | 0.00 | (6.71 | ) |
1 Refer to the Reconciliation of GAAP Results
to Non-GAAP Financial Measures table and to the Reconciliation of GAAP Net Loss to Adjusted EBITDA table at the end of this press release.
Refer to Non-GAAP Financial Measures for additional information.
2 Figures presented for the second quarter of
2024 include a $17.0 million adjustment to collaborative arrangements revenue, driven by a $30.0 million increase to collaborative arrangements
revenue as a result of a gross-to-net change in estimate related to the year ended December 31, 2023, previously recorded by Ironwood
in the first quarter of 2024, which was reflected in LINZESS U.S. net sales as reported by AbbVie in the second quarter of 2024. This
was partially offset by a $13.0 million reduction to collaborative arrangements revenue in the second quarter of 2024, to reflect Ironwood's
estimate of LINZESS gross-to-net reserves as of June 30, 2024.
3 Figures presented for the second quarter of
2023 include a one-time charge of approximately $1.1 billion related to acquired in-process research and development from the acquisition
of VectivBio in the second quarter of 2023.
Corporate Highlights
2024 Financial Results
| Prior 2024 Guidance (May 9, 2024) | Revised 2024 Guidance (August 8, 2024) | |||
| U.S. LINZESS Net Sales | Mid-single digits % decline 2 | $900 - $950 million | ||
| Total Revenue | $405 - $425 million | $350 - $375 million | ||
| Adjusted EBITDA 1 | >$120 million Excludes potential CNP-104 option exercise | >$75 million Excludes potential CNP-104 option exercise |
1 Adjusted EBITDA is calculated by subtracting restructuring
expenses, net interest expense, income taxes, depreciation and amortization, and acquisition-related costs from GAAP net loss. For purposes
of the 2024 guidance, Ironwood has assumed it will not incur material expenses related to business development activities in 2024
and excludes any costs associated with potential CNP-104 option exercise. Ironwood does not provide guidance on GAAP net loss or a reconciliation
of expected adjusted EBITDA to expected GAAP net loss 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 loss for the guidance period. 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.
2 2024 U.S. LINZESS Net Sales guidance presented as year-over-year
change relative to 2023 U.S. LINZESS Net Sales as reported by AbbVie of $1,073.2 million.
Non-GAAP Financial Measures
Ironwood presents non-GAAP net income (loss) and non-GAAP net income
(loss) per share to exclude the impact, net of tax effects, of net gains and losses on derivatives related to Ironwood's 2022 Convertible
Notes that are required to be marked-to-market, amortization of acquired intangible assets, restructuring expenses, and acquisition-related
costs. 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, restructuring expenses, net interest expense, income taxes, depreciation and amortization, and acquisition-related
costs from GAAP net loss. The adjustments are made on a similar basis as described above related to non-GAAP net income (loss), 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 (loss) and non-GAAP net
income (loss) per share to GAAP net loss and GAAP net loss per share, respectively, and for a reconciliation of adjusted EBITDA to GAAP
net loss, please refer to the tables at the end of this press release.
Ironwood does not provide guidance on GAAP net loss or a reconciliation
of expected adjusted EBITDA to expected GAAP net loss 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 loss for the guidance period.
Conference Call Information
Ironwood will host a conference
call and webcast at 8:30 a.m. Eastern Time on Thursday, August 8, 2024 to discuss its second quarter 2024 results and recent
business activities. Individuals interested in participating in the call should dial (888) 596-4144 (U.S. and Canada) or (646) 968-2525
(international) using conference ID number and event passcode 2530602. To access the webcast, please visit the Investors section of Ironwood's
website at www.ironwoodpharma.com. The call will be available for replay via telephone starting
at approximately 11:30 a.m. Eastern Time on August 8, 2024, running through 11:59 p.m. Eastern Time on August 22,
2024. To listen to the replay, dial (800) 770-2030 (U.S. and Canada) or (609) 800-9909 (international) using conference ID number 2530602.
The archived webcast will be available on Ironwood's website for 1 year 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).
LINZESS is also approved for the treatment of functional constipation in pediatric patients ages 6-17 years-old. Ironwood is also advancing
apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short
bowel syndrome with intestinal failure (SBS-IF) as well as several earlier stage assets. Building upon our history of GI innovation, we
keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet
Founded in 1998, Ironwood
Pharmaceuticals is headquartered in Boston, Massachusetts, with a site in Basel, Switzerland.
routinely post information that may be important to investors on our website at www.ironwoodpharma.com.
About LINZESS (Linaclotide)
LINZESS 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.
LINZESS 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