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– Expects demand for LINZESS® EUTRx prescriptions to grow by higher single-digit percentages in 2024 –
– Expects adjusted EBITDA greater than $150 million by 2024 –
BOSTON, January 8, 2024–(BUSINESS WIRE)–Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a healthcare company focused on the gastrointestinal system, announced its monetary guidance for the Gastrointestinal System. Morgan, which will take place on Wednesday, January 10, 2024 at 11:15 a. m. m. PT / 2:15 p. m. PT). Y.
“The significant progress we’ve made over the past year on our strategic priorities has strengthened our position as a leader in gastrointestinal healthcare,” said Tom McCourt, Ironwood’s president and chief executive officer. “We are on track to reach our net goal of the U. S. We have announced the U. S. sales direction for LINZESS, driven by continued strong demand for prescription drugs, and we continue to be encouraged by the brand’s long-term expansion outlook. In addition, in 2023, we strengthened our gastrointestinal product portfolio with the addition of apraglutide, which we have forever prospects for. Fortune in short bowel syndrome requiring parenteral support, if approved.
“For 2024, we remain committed to maximizing LINZESS, advancing our GI progression process, and generating earnings and cash flow. We expect to achieve another year of higher single-digit percentage for expansion and best-in-class form access, which will drive LINZESS’ net sales expansion in the U. S. At least in 2024. In addition, we expect to generate adjusted EBITDA in excess of $150 million in 2024. We look forward to an exciting and potentially transformative year for Ironwood with several catalysts ahead, as evidenced by early data from our STARS study. The Phase 3 study is expected in March at SBS-IF and the first data from the ongoing Phase 2 study of CNP-104 are expected in the third quarter. Combined with a continued strong expansion in demand for LINZESS, uniquely positions our company to succeed in our quest to be the leader in IG.
Full-year 2023 monetary guidance and full-year 2024 monetary guidance
Ironwood maintains its previous financial guidance for FY 2023 and provides financial guidance for FY 2024.
FY 2023 Guidance
(November 2023)
FY 2024 Guidance
(January 2024)
LINZESS U.S. net sales growth
6% – 8%
One digit %
Single-digit expansion in prescriptions requires compensation through an erosion of mid-to-high single-digit value, primarily due to the elimination of the Medicaid AMP cap.
Total Revenue
Between $435 million and $450 million
$435 million to $455 million
Adjusted EBITDA1
~(900) million dollars
Reflects a one-time fee of approximately $1. 1 billion for the acquisition of VectivBio
>$150 million
Excludes NOC-104 option training
Presentation and webcast of J. P. Morgan Healthcare’s main points
As previously announced, Ironwood will provide a company review at the 42nd Annual J. P. Morgan Healthcare on Wednesday, January 10, 2024 at 11:15 a. m. m. PT / 2:15 p. m. m. PT. Y.
A live audio webcast of Ironwood’s presentation is accessible through the Investors section of the Company’s website at www.ironwoodpharma.com. To access the webcast, please log on to the Ironwood website approximately 15 minutes prior to the start time to ensure adequate time for any software downloads that may be required. A replay of the webcast will be available on Ironwood’s website after the event has completed.
About Ironwood Pharmaceutical
Ironwood Pharmaceuticals (Nasdaq: IRWD), an S
Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts with other operations in Basel, Switzerland.
We posted data that would potentially be a smokescreen for investors on our online page in www. ironwoodpharma. com. Also, stay with us on X and LinkedIn.
About LINZESS (linaclotide)
LINZESS is the number one prescribed logo in the U. S. A study was conducted 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 data from IQVIA.
LINZESS is a once-daily capsule that helps relieve abdominal pain, constipation, and general abdominal symptoms of IBS-C-related bloating, discomfort, and pain, as well as constipation, infrequent bowel movements, hard stools, straining, and related incomplete stools. With CIC. LINZESS relieves constipation in young people and older adolescents aged 6 to 17 years with functional constipation. The dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients, with a dose of 72 mcg approved for use in CIC depending on the presentation or tolerability of each patient. In youth with functional constipation aged 6 to 17 years, the dose is 72 mcg.
LINZESS is not a laxative; It is the first FDA-approved drug in a category called GC-C agonists. LINZESS is a peptide called linaclotide that activates the GC-C receptor in the gut. Activation of GC-C is thought to lead to increased secretion of intestinal fluid. acceleration of transit and decreased activity of pain-sensitive nerves in the intestine. The clinical relevance of the effect on pain fibres has not been established, based on non-clinical studies.
In the US, Ironwood and AbbVie are jointly developing and commercializing 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 partner Astellas markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or CIC. Ironwood has also partnered with AstraZeneca for the development and commercialization of LINZESS in China, and with AbbVie for the progression and commercialization of linaclotide in all other territories around the world.
Important About LINZESS Protection
INDICATIONS AND USE
LINZESS (linaclotide) is indicated for the treatment of irritable bowel syndrome with constipation (IBS-C®) and chronic idiopathic constipation (CIC) in adults and functional constipation (CF) in youth and adolescents 6 to 17 years of age. It is not known whether LINZESS is safe and effective in children younger than 6 years with CF or in children younger than 18 years with IBS-C.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SEVERE DEHYDRATION IN PEDIATRIC PATIENTS YOUNGER THAN 2 YEARS OF AGE
LINZESS is contraindicated in patients younger than 2 years of age. In non-clinical studies in neonatal mice, management of a single, clinically applicable oral dose of linaclotide in adults resulted in death from dehydration.
Contraindications
LINZESS is contraindicated in patients under 2 years of age due to severe dehydration.
LINZESS is contraindicated in patients with or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
LINZESS is contraindicated in patients less than 2 years of age. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated guanylate cyclase (GC-C) agonism, which was associated with increased 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.
Diarrhoea
In adults, diarrhoea was the most common adverse reaction in patients treated with LINZESS in the combined, double-blind, placebo-controlled trials of IBS-C and CIC. The occurrence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in 2% of patients treated with LINZESS 145 mcg and 290 mcg and in <1% of patients with CIC treated with LINZESS 72 mcg.
In children and adolescents 6 to 17 years of age, diarrhea was the most common adverse reaction in patients treated with 72 mcg of LINZESS in the double-blind, placebo-controlled CF trial. Severe diarrhea was reported in <1% of patients treated with LINZESS 72 mcg. In case of severe diarrhoea, treatment should be discontinued and the patient rehydrated.
Common adverse reactions (incidence ≥ 2% and higher than placebo)
In patients with IBS-C or CIC: diarrhea, abdominal pain, flatulence, and bloating.
In pediatric patients with CF: diarrhea.
Please see full Prescribing Information including Boxed Warning: https://www.rxabbvie.com/pdf/linzess_pi.pdf
LINZESS® and CONSTELLA® are registered trademarks of Ironwood Pharmaceuticals, Inc. All other trademarks mentioned in this press are the assets of their respective owners. All rights reserved.
Forward-Looking Statements
This press release includes s. Investors are cautioned not to place undue reliance on forward-looking statements, which add information about Ironwood’s ability to achieve its mission; Ironwood’s strategy, business, monetary condition and operations; Ironwood’s ability to drive expansion and ability to generate profits; the call, progression, availability of advertising and prospective advertising of linaclotide, adding new opportunities and maintaining access to the first class formulary for LINZESS, as well as the drivers, timing, effect and effects thereof; prospective indications and benefits of linaclotide; our functionality and monetary effects, and similar guidance and expectations; The LINZESS prescription requires expansion, the expansion of LINZESS’s US net sales, overall earnings and adjusted EBITDA in 2023 and 2024; prospective advertising of apraglutide; Ironwood’s anticipation of achieving new clinical progression milestones in 2024 and confidence that Ironwood is well positioned for long-term expansion. These forward-looking statements speak only as of the date of this press release and Ironwood assumes no legal responsibility to update them. Each forward-looking view is subject to threats and uncertainties that may also cause actual effects to differ materially from those expressed or implied by such matrix. Applicable threats and uncertainties come with those similar to the effectiveness of our and our partners’ promotional and advertising efforts. ; preclinical and clinical progression, production and formulation progression of linaclotide, apraglutide, CNP-104, IW-3300 and our product applicants; the threat that the clinical systems and studies, including the pediatric program of linaclotide, apraglutide, IW-3300 and CNP-104, will not advance or expand as planned, adding that the studies would possibly be delayed or suspended for any reason, such as defense, tolerance, registration, production, economic or other reasons; the threat that the effects of our completed clinical and non-clinical studies may not be replicated in future studies; the risk that the peripheral T-mobile immune reactions demonstrated in patients treated with CNP-104 will not help the mechanistic rationale for CNP-104 or be predictive of the initial insights from the clinical study of CNP-104 in patients with biliary cholangitis number one. From a clinical point of view, the relevance of such an immune reaction of T cells has not been sufficiently established; the threat that we or our partners will be unable to download, maintain or manufacture sufficient LINZESS or our product applicants, or otherwise experience sourcing or production difficulties; the efficacy, defense and tolerability of linaclotide and our applicant products; the threat that advertising and curation opportunities for LINZESS or our product applicants may not be what we expect; decisions of regulatory and judicial authorities; the threat that we may never discharge further patent protections for linaclotide and other product applicants, that the patents for linaclotide or other products may not provide good enough protection against competition, or that we may not be able to protect those patents effectively; the threat that we will not be able to manage our expenses or use of cash, or that we will not be able to advertise our products as planned; the threat that progression of any of our pediatric systems for linaclotide, apraglutide, CNP-104 and/or IW-3300 will fail or that any of our product applicants will not be effectively advertised under legal proceedings to protect or enforce patents related to our products and product applicants, adding abbreviated litigation related to new drug applications; the threat that monetary and operational effects will differ from our projections; progressions in the landscape of intellectual assets; demand situations and rights of competition or potential competition; the threat that our planned investments may not have the desired effect on the earnings of our business; adjustments in accounting rules or practices; The accounting practices of Ironwood or AbbVie, including the reporting practices and agreements between Ironwood and AbbVie; the threat that we will not be able to manage our expenses or use of cash, or that we will not be able to advertise our products as planned; the effect of the COVID-19 pandemic; and the threats indexed in “Risk Factors” and elsewhere in our Annual Report on Form 10-K for the fiscal year ended December 31, 2022, in our Quarterly Reports on Form 10-Q for the quarters ended on June 30, 2023 and September. December 30, 2023, as well as in our upcoming filings with the Securities and Exchange Commission.
______________________________
1 Adjusted EBITDA is calculated by subtracting mark-to-market adjustments on derivatives related to our 2022 Convertible Notes, restructuring expenses, net interest expense, income taxes, depreciation and amortization, and acquisition-related costs from GAAP net income. For purposes of the 2024 guidance, we have assumed that Ironwood will not incur material expenses related to business development activities in 2024. 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. 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. Full year 2023 adjusted EBITDA guidance reflects 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. Full year 2024 adjusted EBITDA guidance also excludes any costs associated with a potential CNP-104 option exercise.
See the issue on businesswire. com: https://www. businesswire. com/news/home/20240108603865/en/
Contacts
Investors:
Greg Martini, 617-374-5230gmartini@ironwoodpharma. com
Matt Roache, 617-621-8395mroache@ironwoodpharma. com
Media:
Beth Calitri, 978-417-2031bcalitri@ironwoodpharma. com