Ironwood Pharmaceuticals Reports Fourth Quarter and Full Year 2023 Results; Achieves 2023 Financial Guidance
- None.
- None.
Insights
The reported 7% year-over-year growth in LINZESS® net sales to $1.1 billion and the 10% increase in prescription demand reflect positively on Ironwood Pharmaceuticals' market positioning and revenue generation capabilities. The expansion into the pediatric market for functional constipation could potentially open up new revenue streams and contribute to future growth. The revenue of $443 million, primarily from LINZESS collaboration, indicates a strong reliance on this flagship product, which could pose risks should competition intensify or if there are any regulatory setbacks. The anticipation of the STARS Phase III study results for apraglutide suggests a strategic focus on pipeline development, which is critical for long-term sustainability. Investors should monitor the progress of this pipeline, as success in clinical trials can significantly impact the company's valuation and market share.
Ironwood's focus on gastrointestinal treatments with LINZESS® and the development of apraglutide for short bowel syndrome with intestinal failure (SBS-IF) illustrates their commitment to addressing unmet medical needs. The FDA approval for LINZESS® in pediatric patients is a significant milestone, as it not only expands the patient base but also demonstrates the company's ability to innovate within its specialty. The mention of apraglutide as a potential once-weekly GLP-2 therapy highlights its convenience compared to existing treatments, which could lead to better patient adherence and outcomes. If apraglutide meets its peak sales target of $1 billion, it could substantially impact Ironwood's financials. However, the efficacy and safety data from the upcoming STARS Phase III study will be crucial in determining its market potential and regulatory path forward.
The growth in prescription demand for LINZESS® indicates a strong brand presence and effective marketing within the therapeutic area of IBS-C and chronic idiopathic constipation. The strategic move to target pediatric functional constipation, a previously untapped demographic, suggests a calculated expansion of the target market that could further solidify Ironwood's presence in the GI sector. The projected peak sales for apraglutide and its positioning as the only once-weekly therapy in its class could disrupt the current treatment landscape for SBS-IF. Market analysts should assess the competitive environment, payer receptivity and potential market size for apraglutide, as these factors will be instrumental in realizing the projected sales figures and overall impact on Ironwood's market valuation.
– LINZESS® (Iinaclotide) 2023 U.S. net sales of
– 2023 Ironwood revenue of
– Continues to expect topline results from the STARS Phase III study of apraglutide in patients with short bowel syndrome with intestinal failure (SBS-IF) in March of 2024 –
“In 2023, we made important progress toward realizing our vision to become the leading GI healthcare company in the industry,” said Tom McCourt, chief executive officer of Ironwood. “In its 11th year on market, LINZESS had another terrific year as the leading prescription treatment for adults with IBS-C or chronic idiopathic constipation, with prescription demand increasing a robust
Fourth Quarter and Full Year 2023 Financial Highlights1
(in thousands, except for per share amounts)
|
Q4 2023 |
Q4 2022 |
FY 2023 |
FY 2022 |
||||
Total revenues |
|
|
|
|
||||
Total operating expenses2 |
79,964 |
38,836 |
1,388,165 |
160,259 |
||||
GAAP net income (loss)2 |
(1,745) |
48,867 |
(1,031,559) |
175,065 |
||||
GAAP net income (loss) attributable to Ironwood Pharmaceuticals, Inc.2 |
(1,087) |
- |
(1,002,239) |
- |
||||
GAAP net income (loss) attributable to Ironwood Pharmaceuticals, Inc. per share – basic |
(0.01) |
0.32 |
(6.45) |
1.13 |
||||
GAAP net income (loss) attributable to Ironwood Pharmaceuticals, Inc. per share – diluted |
(0.01) |
0.27 |
(6.45) |
0.96 |
||||
Adjusted EBITDA2 |
39,895 |
68,703 |
(884,820) |
251,755 |
||||
Non-GAAP net income (loss)2 |
39 |
48,885 |
(973,788) |
174,883 |
||||
Non-GAAP net income (loss) per share – basic |
(0.00) |
0.32 |
(6.27) |
1.13 |
||||
Non-GAAP net income (loss) per share – diluted |
(0.00) |
0.27 |
(6.27) |
0.96 |
1. |
Refer to the Reconciliation of GAAP Results to Non-GAAP Financial Measures table and to the Reconciliation of GAAP Net Income to Adjusted EBITDA table at the end of this press release. Refer to Non-GAAP Financial Measures for additional information. |
|
2. |
Figures presented for FY 2023 include a one‐time charge of approximately |
Fourth Quarter and Full Year 2023 Corporate Highlights
-
Prescription Demand: Total LINZESS prescription demand in the fourth quarter of 2023 was 50 million LINZESS capsules, a
10% increase compared to the fourth quarter of 2022, per IQVIA. Total prescription demand was 191 million LINZESS capsules for the full year 2023, a10% increase compared to the full year 2022, per IQVIA. -
U.S. Brand Collaboration: LINZESSU.S. net sales are provided to Ironwood by itsU.S. partner, AbbVie Inc. (“AbbVie”). LINZESSU.S. net sales were$274.4 million 5% increase compared to$260.3 million $1,073.2 million 7% increase compared to$1,002.1 million -
Ironwood and AbbVie share equally in
U.S. brand collaboration profits. See the LINZESSU.S. Commercial Collaboration table at the end of the press release.
– LINZESS commercial margin was77% in the fourth quarter of 2023, compared to74% in the fourth quarter of 2022. LINZESS commercial margin was73% for the full year in each of 2023 and 2022. See theU.S. LINZESS Full Brand Collaboration table below and at the end of this press release.
– Net profit for the LINZESSU.S. brand collaboration, net of commercial and research and development (“R&D”) expenses, was$202.5 million $183.8 million U.S. brand collaboration, net of commercial and R&D expenses, was$749.9 million $695.7 million U.S. LINZESS Full Brand Collaboration table below and at the end of this press release.
-
Ironwood and AbbVie share equally in
-
Collaboration Revenue to Ironwood: Ironwood recorded
$114.0 million U.S. , a9% increase compared to$104.8 million $430.5 million 8% increase compared to$398.8 million U.S. LINZESS Commercial Collaboration table at the end of the press release.
(in thousands, except for percentages) |
Three Months Ended December 31, |
Twelve Months Ended December 31, |
||
|
2023 |
2022 |
2023 |
2022 |
LINZESS |
274,356 |
|
1,073,210 |
|
AbbVie & Ironwood commercial costs, expenses and other discounts |
62,903 |
66,879 |
286,045 |
272,757 |
Commercial margin |
|
|
|
|
AbbVie & Ironwood R&D Expenses |
8,980 |
9,684 |
37,250 |
33,684 |
Total net profit on sales of LINZESS |
202,473 |
183,764 |
749,915 |
695,702 |
Full brand margin |
|
|
|
|
- In January 2024, Ironwood announced publication in The Lancet Gastroenterology & Hepatology of new linaclotide Phase III data in children and adolescents aged 6-17 years with functional constipation. The data highlighted additional efficacy endpoints from the company’s pivotal Phase III trial, which formed the basis of the June 2023 U.S. Food and Drug Administration (FDA) approval of linaclotide for the treatment of functional constipation in this population. Additional details can be found here.
- In October 2023, Ironwood presented new data at the 2023 North American Society for Pediatric Gastroenterology, Hepatology & Nutrition (NASPGHAN) Annual Meeting reinforcing the impact of linaclotide on functional constipation in children and adolescents ages 6-17 years-old. The data demonstrated that linaclotide reduces the need for rescue medications in this patient population and further characterized the efficacy and safety profile of linaclotide as the only FDA-approved prescription therapy for this population. Additional details can be found here.
Pipeline Updates
Apraglutide
- Ironwood is advancing apraglutide, a next-generation, synthetic glucagon-like peptide-2 (“GLP-2”) analog for short bowel syndrome with intestinal failure (“SBS-IF”), a severe malabsorptive condition. Ironwood believes apraglutide has the potential to be the new standard of care for the treatment of short bowel syndrome dependent on parenteral support, also known as short bowel syndrome with intestinal failure, based on its potency and pharmacologic properties. Ironwood is conducting a Phase III clinical trial, STARS, designed to evaluate clinical benefit for both SBS-IF stoma and colon-in-continuity (“CIC”) patients with the unique convenience of weekly dosing. Topline results are expected in March of 2024.
- In October 2023, Ironwood presented positive final data from the company’s Phase II STARS Nutrition program during United European Gastroenterology (UEG) Week. This multicenter, open-label study of nine patients was designed to evaluate the safety, pharmacokinetics, and efficacy of apraglutide on intestinal absorption in adult patients who have SBS-IF and CIC. Additional details can be found here.
- Ironwood is also conducting an exploratory Phase II clinical trial, STARGAZE, to evaluate apraglutide in patients with steroid-refractory acute Graft versus Host Disease (aGvHD), a life-threatening condition that occurs when immune cells from the donor attack a recipient’s healthy cells after an allogeneic hematopoietic stem cell transplant. Enrollment is completed and data is expected for the STARGAZE Phase II clinical trial in the first quarter of 2024.
CNP-104
-
Ironwood has a collaboration and license option agreement with COUR Pharmaceuticals Development Company, Inc. (“COUR”). This agreement grants Ironwood an option to acquire an exclusive license to research, develop, manufacture and commercialize, in the
U.S. , products containing CNP-104 (“CNP-104”), a tolerizing immune modifying nanoparticle, for the treatment of primary biliary cholangitis (“PBC”), a rare autoimmune disease targeting the liver. If successful, CNP-104 has the potential to be the first approved disease modifying therapy for PBC. - COUR is currently conducting a clinical study with CNP-104 evaluating the safety, tolerability, pharmacodynamic effects and efficacy of CNP-104 in PBC patients, with topline data expected in the third quarter of 2024.
IW-3300
- Ironwood is currently advancing IW-3300, a guanylate cyclase-C agonist being developed for the potential treatment of visceral pain conditions, such as interstitial cystitis / bladder pain syndrome (“IC/BPS”) and endometriosis. Ironwood is continuing the Phase II proof of concept study in IC/BPS.
Fourth Quarter and Full Year 2023 Financial Results
-
Total Revenues. Total revenues in the fourth quarter of 2023 were
$117.6 million $107.2 million $442.7 million $410.6 million -
Total revenues in the fourth quarter of 2023 consisted of
$114.0 million U.S. and$3.6 million $104.8 million U.S. and$2.4 million -
Total revenues for the full year 2023 consisted of
$430.5 million U.S. , and$12.2 million $398.8 million U.S. , and$11.8 million
-
Total revenues in the fourth quarter of 2023 consisted of
-
Operating Expenses. Operating expenses in the fourth quarter of 2023 were
$80.0 million $38.8 million $1,388.2 million $160.3 million -
Operating expenses in the fourth quarter of 2023 consisted of
$38.7 million $35.7 million $5.0 million $0.6 million $28.4 million $10.4 million -
Operating expenses for the full year 2023 consisted primarily of approximately
$1.1 billion $158.3 million $116.1 million $18.3 million $116.0 million $44.3 million
-
Operating expenses in the fourth quarter of 2023 consisted of
-
Interest Expense and Other Financing Costs. Interest expense was
$8.4 million $21.6 million $7.6 million $0.6 million $19.3 million $2.1 million -
Interest expense was
$1.5 million $7.6 million $1.1 million $0.4 million $5.7 million $1.9 million
-
Interest expense was
-
Interest and Investment Income. Interest and investment income was
$1.2 million $19.0 million -
Interest and investment income was
$5.4 million $9.5 million
-
Interest and investment income was
-
Gain (Loss) on Derivatives. Ironwood recorded a loss on derivatives of an insignificant amount in the fourth quarter of 2022, as a result of the change in fair value of its note hedge warrants. For the full year 2022, Ironwood recorded a gain on derivatives of
$0.2 million -
Income Tax Expense. Ironwood recorded
$32.1 million $83.5 million $23.4 million $77.4 million -
GAAP Net Income (Loss) Attributable to Ironwood. GAAP net loss was
$1.1 million $0.01 $48.9 million $0.32 $0.27 $1.0 billion $6.45 $175.1 million $1.13 $0.96 -
Non-GAAP Net Income (Loss). Non-GAAP net income was an insignificant amount, or (
$0.00 $48.9 million $0.32 $0.27 $973.8 million $6.27 $174.9 million $1.13 $0.96 - Non-GAAP net income excludes the impact of mark-to-market adjustments on the derivatives related to Ironwood’s 2022 Convertible Notes, amortization of acquired intangible assets, restructuring expenses and acquisition-related costs, all net of tax effect. See Non-GAAP Financial Measures below.
-
Adjusted EBITDA. Adjusted EBITDA was
$39.9 million $68.7 million ( , compared to$884.8) million $251.8 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, and acquisition-related costs, from GAAP net income. See Non-GAAP Financial Measures below.
-
Cash Flow Highlights. Ironwood ended 2023 with
$92.2 million $656.2 million -
In the fourth quarter of 2023 and in the full year of 2023, Ironwood repaid
$25.0 million $100.0 million $300.0 million -
Ironwood generated
$35.8 million $79.2 million $183.4 million $273.8 million
-
In the fourth quarter of 2023 and in the full year of 2023, Ironwood repaid
- Ironwood 2024 Financial Guidance. In 2024, Ironwood continues to expect:
|
2024 Guidance |
|
Low-single digits % |
Total Revenue |
|
Adjusted EBITDA1 |
> 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 income. 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 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. |
Non-GAAP Financial Measures
Ironwood presents non-GAAP net income and non-GAAP net income 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:
- The gains and losses on the derivatives related to Ironwood’s 2022 Convertible Notes were highly variable, difficult to predict and of a size that could have a substantial impact on the company’s reported results of operations in any given period.
- Amortization of acquired intangible assets are non-cash expenses arising in connection with the acquisition of VectivBio and are considered to be non-recurring.
- Restructuring expenses are considered to be a non-recurring event as they are associated with distinct operational decisions. Included in restructuring expenses are costs associated with exit and disposal activities.
- Acquisition-related costs in connection with the acquisition of VectivBio are considered to be non-recurring and include direct and incremental costs associated with the acquisition and integration of VectivBio to the extent such costs were not classified as capitalizable transaction costs attributed to the cost of net assets acquired through acquisition accounting.
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 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, February 15, 2024 to discuss its fourth quarter and full year 2023 results and recent business activities. Individuals interested in participating in the call should dial +1 (888) 596-4144 (
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
Founded in 1998, Ironwood Pharmaceuticals is headquartered in
We routinely post information that may be important to investors on our website at www.ironwoodpharma.com. In addition, follow us on X and on LinkedIn.
About LINZESS (Linaclotide)
LINZESS® is the #1 prescribed brand in the
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
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS® (linaclotide) is indicated for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC) in adults and functional constipation (FC) in children and adolescents 6 to 17 years of age. It is not known if LINZESS is safe and effective in children with FC less than 6 years of age or in children with IBS-C less than 18 years of age.
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LESS THAN 2 YEARS OF AGE
LINZESS is contraindicated in patients less than 2 years of age. In nonclinical studies in neonatal mice, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration. |
Contraindications
- LINZESS is contraindicated in patients less than 2 years of age due to the risk of serious dehydration.
- LINZESS is contraindicated in patients with known 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.
Diarrhea
-
In adults, diarrhea was the most common adverse reaction in LINZESS-treated patients in the pooled IBS-C and CIC double-blind placebo-controlled trials. The incidence of diarrhea was similar in the IBS-C and CIC populations. Severe diarrhea was reported in
2% of 145 mcg and 290 mcg LINZESS-treated patients and in <1% of 72 mcg LINZESS-treated CIC patients. -
In children and adolescents 6 to 17 years of age, diarrhea was the most common adverse reaction in 72 mcg LINZESS-treated patients in the FC double-blind placebo-controlled trial. Severe diarrhea was reported in <
1% of 72 mcg LINZESS treated patients. If severe diarrhea occurs, dosing should be suspended and the patient rehydrated.
Common Adverse Reactions (incidence ≥
- In IBS-C or CIC adult patients: diarrhea, abdominal pain, flatulence, and abdominal distension.
- In FC pediatric patients: 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. Any other trademarks referred to in this press release are the property of their respective owners. All rights reserved.
Forward-Looking Statements
This 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 on its mission; Ironwood’s strategy, business, financial position and operations; Ironwood’s ability to drive growth and profitability; the commercial potential of LINZESS; our financial performance and results, and guidance and expectations related thereto; LINZESS prescription demand growth, LINZESS
Condensed Consolidated Balance Sheets |
|||||||
(In thousands) |
|||||||
(unaudited) |
|||||||
December 31, 2023 |
December 31, 2022 |
||||||
Assets |
|
|
|||||
Cash and cash equivalents |
$ |
92,154 |
|
$ |
656,203 |
||
Accounts receivable, net |
|
129,122 |
|
|
115,458 |
||
Prepaid expenses and other current assets |
|
12,012 |
|
|
7,715 |
||
Restricted cash |
|
- |
|
|
1,250 |
||
Total current assets |
|
233,288 |
|
|
780,626 |
||
Restricted cash, net of current portion |
|
- |
|
|
485 |
||
Accounts receivable, net of current portion |
|
- |
|
|
14,589 |
||
Property and equipment, net |
|
5,585 |
|
|
6,288 |
||
Operating lease right-of-use assets |
|
12,586 |
|
|
14,023 |
||
Intangible assets, net |
|
3,682 |
|
|
- |
||
Deferred tax assets |
|
212,324 |
|
|
283,661 |
||
Other assets |
|
3,608 |
|
|
847 |
||
Total assets |
$ |
471,073 |
|
$ |
1,100,519 |
||
Liabilities and Stockholders’ Equity |
|
|
|||||
Accounts payable |
$ |
7,830 |
|
$ |
483 |
||
Accrued research and development costs |
|
21,331 |
|
|
5,258 |
||
Accrued expenses and other current liabilities |
|
44,254 |
|
|
16,700 |
||
Current portion of operating lease liabilities |
|
3,126 |
|
|
3,065 |
||
Current portion on convertible senior notes |
|
199,560 |
|
|
- |
||
Note hedge warrants |
|
- |
|
|
19 |
||
Total current liabilities |
|
276,101 |
|
|
25,525 |
||
Operating lease liabilities, net of current portion |
|
14,543 |
|
|
16,599 |
||
Convertible senior notes, net of current portion |
|
198,309 |
|
|
396,251 |
||
Revolving credit facility |
|
300,000 |
|
|
- |
||
Other liabilities |
|
28,415 |
|
|
9,766 |
||
Total stockholders’ equity (deficit) |
|
(346,295 |
) |
|
652,378 |
||
Total liabilities and stockholders’ equity (deficit) |
$ |
471,073 |
|
$ |
1,100,519 |
||
Condensed Consolidated Statements of Income |
||||||||||||||||
(In thousands, except per share amounts) |
||||||||||||||||
(unaudited) |
||||||||||||||||
|
Three Months Ended December 31, |
|
Twelve Months Ended December 31, |
|||||||||||||
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|||||||||
Revenues |
|
|
|
|
||||||||||||
Collaborative arrangements revenue |
$ |
117,553 |
|
$ |
107,199 |
|
$ |
442,735 |
|
$ |
410,596 |
|
||||
Total revenues |
|
117,553 |
|
|
107,199 |
|
|
442,735 |
|
|
410,596 |
|
||||
Operating expenses: |
|
|
|
|
||||||||||||
Research and development |
|
35,676 |
|
|
10,446 |
|
|
116,085 |
|
|
44,265 |
|
||||
Selling, general and administrative |
|
38,667 |
|
|
28,390 |
|
|
158,314 |
|
|
115,994 |
|
||||
Restructuring expenses |
|
621 |
|
|
- |
|
|
18,317 |
|
|
- |
|
||||
Acquired in-process research and development |
|
5,000 |
|
|
- |
|
|
1,095,449 |
|
|
- |
|
||||
Total operating expenses |
|
79,964 |
|
|
38,836 |
|
|
1,388,165 |
|
|
160,259 |
|
||||
Income (loss) from operations |
|
37,589 |
|
|
68,363 |
|
|
(945,430 |
) |
|
250,337 |
|
||||
Other income (expense): |
|
|
|
|
||||||||||||
Interest expense and other financing costs |
|
(8,423 |
) |
|
(1,526 |
) |
|
(21,629 |
) |
|
(7,598 |
) |
||||
Interest and investment income |
|
1,194 |
|
|
5,446 |
|
|
18,971 |
|
|
9,501 |
|
||||
Gain on derivatives |
|
- |
|
|
(18 |
) |
|
19 |
|
|
182 |
|
||||
Other income (expense), net |
|
(7,229 |
) |
|
3,902 |
|
|
(2,639 |
) |
|
2,085 |
|
||||
Income (loss) before income taxes |
|
30,360 |
|
|
72,265 |
|
|
(948,069 |
) |
|
252,422 |
|
||||
Income tax expense |
|
(32,105 |
) |
|
(23,398 |
) |
|
(83,490 |
) |
|
(77,357 |
) |
||||
GAAP net income (loss) |
|
(1,745 |
) |
|
48,867 |
|
|
(1,031,559 |
) |
|
175,065 |
|
||||
Less: GAAP net income (loss) attributable to noncontrolling interests |
|
(658 |
) |
|
- |
|
|
(29,320 |
) |
|
- |
|
||||
GAAP net income (loss) attributable to Ironwood Pharmaceuticals, Inc. |
$ |
(1,087 |
) |
$ |
48,867 |
|
$ |
(1,002,239 |
) |
$ |
175,065 |
|
||||
|
|
|
|
|
||||||||||||
GAAP net income (loss) attributable to Ironwood Pharmaceuticals, Inc. per share—basic |
$ |
(0.01 |
) |
$ |
0.32 |
|
$ |
(6.45 |
) |
$ |
1.13 |
|
||||
|
|
|
|
|
||||||||||||
GAAP net income (loss) attributable to Ironwood Pharmaceuticals, Inc. per share—diluted |
$ |
(0.01 |
) |
$ |
0.27 |
|
$ |
(6.45 |
) |
$ |
0.96 |
|
||||
Reconciliation of GAAP Results to Non-GAAP Financial Measures |
|||||||||||||||
(In thousands, except per share amounts) (unaudited) |
|||||||||||||||
A reconciliation between net income (loss) on a GAAP basis and on a non-GAAP basis is as follows: |
|||||||||||||||
|
Three Months Ended
|
|
Twelve Months Ended
|
||||||||||||
|
2023 |
|
2022 |
|
2023 |
|
2022 |
||||||||
GAAP net income (loss)1 |
$ |
(1,745 |
) |
$ |
48,867 |
$ |
(1,031,559 |
) |
$ |
175,065 |
|
||||
Adjustments: |
|
|
|
||||||||||||
Mark-to-market adjustments on the derivatives related to convertible notes, net |
|
- |
|
|
18 |
|
(19 |
) |
|
(182 |
) |
||||
Amortization of acquired intangible assets |
|
207 |
|
|
- |
|
418 |
|
|
- |
|
||||
Restructuring expenses |
|
621 |
|
|
- |
|
18,317 |
|
|
- |
|
||||
Acquisition-related costs |
|
1,173 |
|
|
- |
|
40,718 |
|
|
- |
|
||||
Tax effect of adjustments |
|
(217 |
) |
|
- |
|
(1,663 |
) |
|
- |
|
||||
Non-GAAP net income (loss)1 |
$ |
39 |
|
$ |
48,885 |
$ |
(973,788 |
) |
$ |
174,883 |
|||||
____________________________________ |
1 GAAP and non-GAAP net loss for twelve months ended December 31, 2023 include a one-time charge of approximately |
| A reconciliation between basic net income (loss) per share on a GAAP basis and on a non-GAAP basis is as follows: | ||||||||||||||
Three Months Ended
|
|
Twelve Months Ended
|
||||||||||||
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|||||||
GAAP net income (loss) attributable to Ironwood Pharmaceuticals, Inc. per share – basic |
$ |
(0.01 |
) |
$ |
0.32 |
$ |
(6.45 |
) |
$ |
1.13 |
||||
Plus: GAAP net income (loss) attributable to noncontrolling interests – basic |
|
(0.00 |
) |
|
- |
|
(0.19 |
) |
|
- |
||||
|
|
|
|
|
||||||||||
Adjustments to GAAP net income (loss) per share (as detailed above) |
|
0.01 |
|
|
- |
|
0.37 |
|
|
- |
||||
Non-GAAP net income (loss) per share – basic |
$ |
(0.00 |
) |
$ |
0.32 |
$ |
(6.27 |
) |
$ |
1.13 |
||||
Weighted average number of common shares used to calculate net income (loss) per share — basic |
|
156,014 |
|
|
153,337 |
|
155,435 |
|
|
154,366 |
||||
A reconciliation between diluted net income (loss) per share on a GAAP basis and on a non-GAAP basis is as follows: |
||||||||||||||
|
Three Months Ended
|
|
Twelve Months Ended
|
|||||||||||
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|||||||
GAAP net income (loss) attributable to Ironwood Pharmaceuticals, Inc. per share – diluted |
$ |
(0.01 |
) |
$ |
0.27 |
$ |
(6.45 |
) |
$ |
0.96 |
||||
Plus: GAAP net income (loss) attributable to noncontrolling interests – diluted |
(0.00 |
) |
- |
|
(0.19 |
) |
|
- |
||||||
|
|
|
|
|
||||||||||
Adjustments to GAAP net income (loss) per share (as detailed above) |
|
0.01 |
|
|
- |
|
0.37 |
|
|
- |
||||
Non-GAAP net income (loss) per share – diluted |
$ |
(0.00 |
) |
$ |
0.27 |
$ |
(6.27 |
) |
$ |
0.96 |
||||
Weighted average number of common shares used to calculate net income (loss) per share — diluted |
|
156,014 |
|
|
185,188 |
|
155,435 |
|
|
186,312 |
||||
Reconciliation of GAAP Net Income to Adjusted EBITDA |
||||||||||||||||
(In thousands) |
||||||||||||||||
(unaudited) |
||||||||||||||||
A reconciliation of GAAP net income (loss) to adjusted EBITDA: |
||||||||||||||||
|
Three Months Ended
|
|
Twelve Months Ended
|
|||||||||||||
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|||||||||
GAAP net income (loss)1 |
$ |
(1,745 |
) |
$ |
48,867 |
|
$ |
(1,031,559 |
) |
$ |
175,065 |
|
||||
Adjustments: |
|
|
|
|||||||||||||
Mark-to-market adjustments on the derivatives related to convertible notes, net |
|
- |
|
|
18 |
|
|
(19 |
) |
|
(182 |
) |
||||
Restructuring expenses |
|
621 |
|
|
- |
|
|
18,317 |
|
|
- |
|
||||
Interest expense |
|
8,423 |
|
|
1,526 |
|
|
21,629 |
|
|
7,598 |
|
||||
Interest and investment income |
|
(1,194 |
) |
|
(5,446 |
) |
|
(18,971 |
) |
|
(9,501 |
) |
||||
Income tax expense |
|
32,105 |
|
|
23,398 |
|
|
83,490 |
|
|
77,357 |
|
||||
Depreciation and amortization |
|
512 |
|
|
340 |
|
|
1,575 |
|
|
1,418 |
|
||||
Acquisition-related costs |
|
1,173 |
|
|
|
40,718 |
|
|
||||||||
Adjusted EBITDA1 |
$ |
39,895 |
|
$ |
68,703 |
|
$ |
(884,820 |
) |
$ |
251,755 |
|||||
____________________________________ |
1 GAAP net loss and adjusted EBITDA for twelve months ended December 31, 2023 includes a one-time charge of approximately |
Revenue/Expense Calculation |
||||||||||||||||
(In thousands) |
||||||||||||||||
(unaudited) |
||||||||||||||||
|
Three Months Ended
|
|
Twelve Months Ended
|
|||||||||||||
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|||||||||
LINZESS |
$ |
274,356 |
|
$ |
260,327 |
|
$ |
1,073,210 |
|
$ |
1,002,143 |
|
||||
AbbVie & Ironwood commercial costs, expenses and other discounts3 |
|
62,903 |
|
|
66,879 |
|
|
286,045 |
|
|
272,757 |
|
||||
Commercial profit on sales of LINZESS |
$ |
211,453 |
|
$ |
193,448 |
|
$ |
787,165 |
|
$ |
729,386 |
|
||||
Commercial Margin4 |
|
77 |
% |
|
74 |
% |
|
73 |
% |
|
73 |
% |
||||
|
|
|
|
|||||||||||||
|
|
|
|
|||||||||||||
Ironwood’s share of net profit |
|
105,727 |
|
|
96,724 |
|
|
393,583 |
|
|
364,693 |
|
||||
Reimbursement for Ironwood’s commercial expenses |
|
8,260 |
|
|
8,048 |
|
|
36,875 |
|
|
34,074 |
|
||||
Ironwood’s collaborative arrangement revenue |
$ |
113,987 |
|
$ |
104,772 |
|
$ |
430,458 |
|
$ |
398,767 |
|
||||
____________________________________ |
1 Ironwood collaborates with AbbVie on the development and commercialization of linaclotide in |
2 LINZESS net sales are recognized using AbbVie’s revenue recognition accounting policies and reporting conventions. As a result, certain rebates and discounts are classified as LINZESS |
3 Includes certain discounts recognized and cost of goods sold incurred by AbbVie; also includes commercial costs incurred by AbbVie and Ironwood that are attributable to the cost-sharing arrangement between the parties. |
4 Commercial margin is defined as commercial profit on sales of LINZESS as a percent of total LINZESS |
| US LINZESS Full Brand Collaboration1 | ||||||||||||
Revenue/Expense Calculation |
||||||||||||
(In thousands) |
||||||||||||
(unaudited) |
||||||||||||
|
Three Months Ended
|
|
Twelve Months Ended
|
|||||||||
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|||||
LINZESS |
$ |
274,356 |
$ |
260,327 |
$ |
1,073,210 |
$ |
1,002,143 |
||||
AbbVie & Ironwood commercial costs, expenses and other discounts3 |
|
62,903 |
|
66,879 |
|
286,045 |
|
272,757 |
||||
AbbVie & Ironwood R&D Expenses4 |
|
8,980 |
|
9,684 |
|
37,250 |
|
33,684 |
||||
Total net profit on sales of LINZESS |
$ |
202,473 |
$ |
183,764 |
$ |
749,915 |
$ |
695,702 |
||||
____________________________________ |
1 Ironwood collaborates with AbbVie on the development and commercialization of linaclotide in |
2 LINZESS net sales are recognized using AbbVie’s revenue recognition accounting policies and reporting conventions. As a result, certain rebates and discounts are classified as LINZESS |
3 Includes certain discounts recognized and cost of goods sold incurred by AbbVie; also includes commercial costs incurred by AbbVie and Ironwood that are attributable to the cost-sharing arrangement between the parties. |
4 R&D expenses related to LINZESS in the |
View source version on businesswire.com: https://www.businesswire.com/news/home/20240215798096/en/
Investors:
Greg Martini, 617-374-5230
gmartini@ironwoodpharma.com
Matt Roache, 617-621-8395
mroache@ironwoodpharma.com
Media:
Beth Calitri, 978-417-2031
bcalitri@ironwoodpharma.com
Source: Ironwood Pharmaceuticals, Inc.
FAQ
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