Ironwood Pharmaceuticals Reports Third Quarter 2024 Results
Ironwood Pharmaceuticals reported Q3 2024 results with total revenue of $91.6M, down from $113.7M in Q3 2023. LINZESS prescription demand grew 13% year-over-year, though U.S. net sales decreased 19% to $225.5M. The company maintains its 2024 financial guidance with expected U.S. LINZESS net sales of $900-950M and total revenue of $350-375M. GAAP net income was $3.6M ($0.02 per share) compared to $15.3M ($0.10 per share) in Q3 2023. The company remains on track to complete apraglutide NDA submission in Q1 2025.
Ironwood Pharmaceuticals ha riportato i risultati del terzo trimestre 2024 con un fatturato totale di $91,6 milioni, in calo rispetto ai $113,7 milioni del terzo trimestre 2023. La domanda per le prescrizioni di LINZESS è aumentata del 13% rispetto all'anno precedente, sebbene le vendite nette negli Stati Uniti siano diminuite del 19%, attestandosi a $225,5 milioni. L'azienda mantiene le sue previsioni finanziarie per il 2024, con vendite nette di LINZESS negli Stati Uniti previste tra $900-950 milioni e un fatturato totale tra $350-375 milioni. Il reddito netto GAAP è stato di $3,6 milioni ($0,02 per azione), rispetto ai $15,3 milioni ($0,10 per azione) del terzo trimestre 2023. L'azienda rimane sulla buona strada per completare la presentazione della NDA per l'apraglutide nel primo trimestre del 2025.
Ironwood Pharmaceuticals informó sobre los resultados del tercer trimestre de 2024, con ingresos totales de $91.6 millones, una disminución respecto a los $113.7 millones en el tercer trimestre de 2023. La demanda de prescripciones de LINZESS creció un 13% interanual, aunque las ventas netas en EE.UU. disminuyeron un 19% a $225.5 millones. La compañía mantiene su orientación financiera para 2024, con ventas netas de LINZESS en EE.UU. esperadas entre $900-950 millones y un ingreso total de $350-375 millones. El ingreso neto GAAP fue de $3.6 millones ($0.02 por acción) en comparación con $15.3 millones ($0.10 por acción) en el tercer trimestre de 2023. La empresa sigue en camino de completar la presentación de la NDA de apraglutide en el primer trimestre de 2025.
아이언우드 제약은 2024년 3분기 결과를 보고하며 총 수익이 9,160만 달러로 2023년 3분기의 1억 1천 370만 달러에서 감소했다고 발표했습니다. LINZESS의 처방 수요는 전년 대비 13% 증가했지만, 미국의 순 매출은 19% 감소하여 2억 2,550만 달러에 달했습니다. 회사는 2024년 재정 가이던스를 유지하며, 미국에서의 LINZESS 순 매출이 9억~9억 5천만 달러, 총 수익이 3억 5천~3억 7천 5백만 달러로 예상하고 있습니다. GAAP 순이익은 360만 달러($0.02 주당)로, 2023년 3분기의 1,530만 달러($0.10 주당)와 비교됩니다. 회사는 2025년 1분기에 apraglutide NDA 제출을 완료할 계획입니다.
Ironwood Pharmaceuticals a annoncé les résultats du troisième trimestre 2024 avec un chiffre d'affaires total de 91,6 millions de dollars, en baisse par rapport à 113,7 millions de dollars au troisième trimestre 2023. La demande de prescriptions de LINZESS a augmenté de 13 % d'une année sur l'autre, bien que les ventes nettes aux États-Unis aient diminué de 19 % pour atteindre 225,5 millions de dollars. L'entreprise maintient ses prévisions financières pour 2024, avec des ventes nettes de LINZESS aux États-Unis attendues entre 900 et 950 millions de dollars et un chiffre d'affaires total de 350 à 375 millions de dollars. Le résultat net GAAP s'élevait à 3,6 millions de dollars (0,02 dollar par action), contre 15,3 millions de dollars (0,10 dollar par action) au troisième trimestre 2023. L'entreprise reste sur la bonne voie pour soumettre la NDA de l'apraglutide au premier trimestre 2025.
Ironwood Pharmaceuticals berichtete über die Ergebnisse des dritten Quartals 2024 mit einem Gesamtumsatz von 91,6 Millionen Dollar, ein Rückgang von 113,7 Millionen Dollar im dritten Quartal 2023. Die Nachfrage nach LINZESS-Rezepten wuchs im Jahresvergleich um 13%, während die Nettoumsätze in den USA um 19% auf 225,5 Millionen Dollar sanken. Das Unternehmen hält an seinen finanziellen Prognosen für 2024 fest und erwartet Nettoumsätze von LINZESS in den USA zwischen 900 und 950 Millionen Dollar sowie einen Gesamtumsatz von 350 bis 375 Millionen Dollar. Der GAAP-Nettoeinkommen betrug 3,6 Millionen Dollar (0,02 Dollar pro Aktie) im Vergleich zu 15,3 Millionen Dollar (0,10 Dollar pro Aktie) im dritten Quartal 2023. Das Unternehmen liegt im Zeitplan, die NDA für Apraglutid im ersten Quartal 2025 einzureichen.
- LINZESS prescription demand growth of 13% year-over-year
- Maintained full year 2024 financial guidance
- Commercial margin for LINZESS remained strong at 65%
- Total revenue declined 19.5% to $91.6M from $113.7M YoY
- LINZESS U.S. net sales decreased 19% to $225.5M YoY
- GAAP net income dropped to $3.6M from $15.3M YoY
- Adjusted EBITDA decreased to $26.2M from $49.1M YoY
Insights
The Q3 2024 results show mixed performance with concerning trends. Total revenue declined -19.5% to
Key concerns include declining LINZESS U.S. net sales (
The balance sheet remains stable with
– LINZESS® (Iinaclotide) EUTRx prescription demand growth of
– Remains on track to complete apraglutide NDA submission in Q1 2025 –
– Maintains Full Year 2024 Financial Guidance –
“LINZESS continued to deliver robust prescription demand growth in the third quarter,” said Tom McCourt, chief executive officer of Ironwood Pharmaceuticals. “LINZESS extended units and new-to-brand prescriptions each increased
Third Quarter 2024 Financial Highlights1
(in thousands, except for per share amounts)
|
Q3 2024 |
|
Q3 2023 |
|
Total revenue |
|
|
|
|
Total costs and expenses |
65,956 |
|
73,716 |
|
GAAP net income |
3,646 |
|
13,950 |
|
GAAP net income attributable to Ironwood Pharmaceuticals, Inc. |
3,646 |
|
15,321 |
|
GAAP net income – per share basic |
0.02 |
|
0.10 |
|
GAAP net income – per share diluted |
0.02 |
|
0.09 |
|
Adjusted EBITDA |
26,159 |
|
49,079 |
|
Non-GAAP net income |
3,869 |
|
21,802 |
|
Non-GAAP net income per share – basic |
0.02 |
|
0.14 |
|
Non-GAAP net income per share – diluted |
0.02 |
|
0.12 |
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.
Third Quarter 2024 Corporate Highlights
-
Prescription Demand: Total LINZESS prescription demand in the third quarter of 2024 was 54 million LINZESS capsules, a
13% increase compared to the third quarter of 2023, 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 in the third quarter of 2024, a$225.5 million 19% decrease compared to in the third quarter of 2023. Ironwood and AbbVie share equally in$279.0 million U.S. brand collaboration profits.-
LINZESS commercial margin was
65% in the third quarter of 2024, compared to72% in the third quarter of 2023. See theU.S. LINZESS Full Brand Collaboration table at the end of this press release. -
Net profit for the LINZESS
U.S. brand collaboration, net of commercial and research and development (“R&D”) expenses, was in the third quarter of 2024, a decrease compared to$139.6 million in the third quarter of 2023. See the$192.0 million U.S. LINZESS Full Brand Collaboration table at the end of this press release.
-
LINZESS commercial margin was
-
Collaboration Revenue to Ironwood: Ironwood recorded
in collaboration revenue in the third quarter of 2024 related to sales of LINZESS in the$88.9 million U.S. , compared to for the third quarter of 2023. Third quarter of 2024 collaboration revenue to Ironwood includes a$110.1 million positive adjustment to reflect Ironwood’s estimate of LINZESS gross-to-net reserves as of September 30, 2024. See the$5.8 million U.S. LINZESS Commercial Collaboration table at the end of the press release.
Pipeline Updates
Apraglutide
-
Ironwood is advancing apraglutide, a next-generation, synthetic glucagon-like peptide-2 (“GLP-2”) analog for short bowel syndrome (“SBS”) patients dependent on parenteral support (“PS”), a severe chronic malabsorptive condition. Ironwood believes apraglutide has the potential to improve the standard of care for adult patients with SBS who are dependent on PS as the first and only GLP-2 with once-weekly administration, if approved.
-
Ironwood is working to submit a new drug application (“NDA”) to the
U.S. Food and Drug Administration (“FDA”) and marketing applications to other regulatory agencies for apraglutide for the treatment of adult patients with SBS who are dependent on PS.
-
Ironwood is working to submit a new drug application (“NDA”) to the
CNP-104
- In the third quarter of 2024, Ironwood received from COUR Pharmaceutical Development Company, Inc. (“COUR”) the topline data from COUR’s Phase II clinical study for the treatment of primary biliary cholangitis. On September 27, 2024, Ironwood notified COUR of its decision not to exercise the option to acquire an exclusive license to CNP-104. As a result, the collaboration and license option agreement between Ironwood and COUR terminated, and Ironwood retains no rights and has no obligations related to CNP-104.
IW-3300
-
Ironwood is advancing IW-3300, a guanylate cyclase-C agonist for the potential treatment of visceral pain conditions, such as interstitial cystitis / bladder pain syndrome (“IC/BPS”) and endometriosis.
Ironwood has decided to end further recruitment for the Phase II proof of concept study in IC/BPS and analyze the data once all currently enrolled patients complete the full 12-week study assessment, which will inform the next steps on the program.
Revolving Credit Facility
-
In September 2024, Ironwood entered into a first amendment to its revolving credit agreement to, among other things, increase the quantum of the revolving credit facility from
to$500.0 million , extend the maturity date, and increase Ironwood’s permitted maximum consolidated secured net leverage ratio. Additional details can be found in Ironwood’s Form 8-K filing dated September 30, 2024.$550.0 million
Third Quarter 2024 Financial Results
-
Total Revenue. Total revenue in the third quarter of 2024 was
, compared to$91.6 million in the third quarter of 2023.$113.7 million - As noted above, revenue was lower year-over-year, primarily due to the decrease in collaborative arrangements revenue.
-
Total revenue in the third quarter of 2024 consisted of
associated with Ironwood’s share of the net profits from the sales of LINZESS in the$88.9 million U.S. , and in royalties and other revenue. Total revenue in the third quarter of 2023 consisted of$2.7 million associated with Ironwood’s share of the net profits from the sales of LINZESS in the$110.1 million U.S. and in royalties and other revenue.$3.6 million
-
Total Costs and Expenses. Total costs and expenses in the third quarter of 2024 were
, compared to$66.0 million in the third quarter of 2023.$73.7 million -
Total costs and expenses in the third quarter of 2024 consisted of
in selling, general and administrative (“SG&A”) expenses,$36.1 million in R&D expenses and an insignificant amount in restructuring expenses. Total costs and expenses in the third quarter of 2023 consisted of$29.8 million in SG&A expenses,$36.0 million in R&D expenses and$33.0 million in restructuring expenses.$4.7 million
-
Total costs and expenses in the third quarter of 2024 consisted of
-
Interest Expense. Interest expense was
in the third quarter of 2024, in connection with Ironwood’s convertible senior notes and revolving credit facility. Interest expense was$9.4 million in the third quarter of 2023, in connection with Ironwood’s convertible senior notes and revolving credit facility.$9.8 million -
Interest and Investment Income. Interest and investment income was
in the third quarter of 2024. Interest and investment income was$1.2 million in the third quarter of 2023.$1.7 million -
Income Tax Expense. Ironwood recorded
of income tax expense in the third quarter of 2024, the majority of which was non-cash, as Ironwood continues to utilize net operating losses to offset taxable income for federal purposes and in many states. Ironwood recorded$13.7 million of income tax expense in the third quarter of 2023, the majority of which was non-cash, as Ironwood continued to utilize net operating losses to offset taxable income for federal purposes and in many states.$18.0 million -
GAAP Net Income Attributable to Ironwood. GAAP net income attributable to Ironwood was
, or$3.6 million per share (basic and diluted) in the third quarter of 2024, compared to GAAP net income of$0.02 , or$15.3 million per share (basic) and$0.10 per share (diluted) in the third quarter of 2023.$0.09 -
Non-GAAP Net Income. Non-GAAP net income was
, or$3.9 million per share (basic and diluted), in the third quarter of 2024, compared to non-GAAP net income of$0.02 , or$21.8 million per share (basic) and$0.14 diluted in the third quarter of 2023.$0.12 - 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
in the third quarter of 2024, compared to$26.2 million in the third quarter of 2023.$49.1 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 loss. See Non-GAAP Financial Measures below.
-
Cash Flow Highlights. Ironwood ended the third quarter of 2024 with
of cash and cash equivalents, compared to$88.2 million of cash and cash equivalents at the end of 2023.$92.2 million -
In the third quarter of 2024, Ironwood repaid
of the outstanding principal balance on its revolving credit facility. The outstanding principal balance on the revolving credit facility was$25.0 million as of September 30, 2024.$400.0 million -
Ironwood generated
in cash from operations in the third quarter of 2024, compared to$9.9 million in cash from operations in the third quarter of 2023.$32.5 million
-
In the third quarter of 2024, Ironwood repaid
- Ironwood 2024 Financial Guidance. Ironwood continues to expect:
|
2024 Guidance (November 7, 2024) |
|
|
Total Revenue |
|
Adjusted EBITDA1 |
> |
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. 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 (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:
- 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. Restructuring expenses include 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 (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 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, November 7, 2024 to discuss its third quarter 2024 results and recent business activities. Individuals interested in participating in the call should dial (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 within the meaning of the Private Securities Litigation Reform Act of 1995. 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) |
||||||||
|
|
|
|
|
||||
|
|
September 30, 2024 |
|
December 31, 2023 |
||||
Assets |
|
|
|
|||||
Cash and cash equivalents |
|
$ |
88,211 |
|
$ |
92,154 |
|
|
Accounts receivable, net |
|
|
76,202 |
|
|
129,122 |
|
|
Prepaid expenses and other current assets |
|
|
14,191 |
|
|
12,012 |
|
|
Total current assets |
|
|
178,604 |
|
|
233,288 |
|
|
Property and equipment, net |
|
|
4,795 |
|
|
5,585 |
|
|
Operating lease right-of-use assets |
|
|
11,430 |
|
|
12,586 |
|
|
Intangible assets, net |
|
|
3,067 |
|
|
3,682 |
|
|
Deferred tax assets |
|
|
185,338 |
|
|
212,324 |
|
|
Other assets |
|
|
6,285 |
|
|
3,608 |
|
|
Total assets |
|
$ |
389,519 |
|
$ |
471,073 |
|
|
Liabilities and stockholders’ equity |
|
|
|
|||||
Accounts payable |
|
$ |
3,236 |
|
$ |
7,830 |
|
|
Accrued research and development costs |
|
|
9,408 |
|
|
21,331 |
|
|
Accrued expenses and other current liabilities |
|
|
33,566 |
|
|
44,254 |
|
|
Current portion of operating lease liabilities |
|
|
3,173 |
|
|
3,126 |
|
|
Current portion on convertible senior notes |
|
|
- |
|
|
199,560 |
|
|
Total current liabilities |
|
|
49,383 |
|
|
276,101 |
|
|
Operating lease liabilities, net of current portion |
|
|
12,882 |
|
|
14,543 |
|
|
Convertible senior notes, net of current portion |
|
|
198,817 |
|
|
198,309 |
|
|
Revolving credit facility |
|
|
400,000 |
|
|
300,000 |
|
|
Other liabilities |
|
|
39,771 |
|
|
28,415 |
|
|
Total stockholders’ deficit |
|
|
(311,334 |
) |
|
(346,295 |
) |
|
Total liabilities and stockholders’ deficit |
|
$ |
389,519 |
|
$ |
471,073 |
|
Condensed Consolidated Statements of Income (Loss) (In thousands, except per share amounts) (unaudited) |
||||||||||||||||
|
|
|
|
|
||||||||||||
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||||||
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
Total revenues |
$ |
91,592 |
|
$ |
113,739 |
|
$ |
260,865 |
|
$ |
325,182 |
|
||||
Collaborative arrangements revenue |
|
91,592 |
|
113,739 |
260,865 |
325,182 |
||||||||||
Costs and expenses: |
|
|
|
|
||||||||||||
Research and development |
|
29,827 |
|
32,985 |
86,030 |
80,409 |
||||||||||
Selling, general and administrative |
|
36,113 |
|
|
36,046 |
|
110,682 |
119,647 |
||||||||
Restructuring |
|
16 |
|
|
4,685 |
|
|
2,520 |
|
|
17,696 |
|
||||
Acquired in-process research and development |
|
- |
|
|
- |
|
|
- |
|
|
1,090,449 |
|
||||
Total costs and expenses1 |
|
65,956 |
|
|
73,716 |
|
|
199,232 |
|
|
1,308,201 |
|
||||
Income (loss) from operations |
|
25,636 |
|
|
40,023 |
|
|
61,633 |
|
|
(983,019 |
) |
||||
Other income (expense): |
|
|
|
|
||||||||||||
Interest expense and other financing costs |
|
(9,419 |
) |
(9,839 |
) |
(24,120 |
) |
(13,206 |
) |
|||||||
Interest and investment income |
|
1,152 |
|
1,748 |
3,690 |
17,777 |
||||||||||
Gain on derivatives |
|
- |
|
|
- |
|
|
- |
|
|
19 |
|
||||
Other income (expense), net |
|
(8,267 |
) |
|
(8,091 |
) |
|
(20,430 |
) |
|
4,590 |
|
||||
Income (loss) before income taxes |
|
17,369 |
|
|
31,932 |
|
|
41,203 |
|
|
(978,429 |
) |
||||
Income tax expense |
|
(13,723 |
) |
|
(17,982 |
) |
|
(42,579 |
) |
|
(51,385 |
) |
||||
GAAP net income (loss)1 |
|
3,646 |
|
|
13,950 |
|
|
(1,376 |
) |
|
(1,029,814 |
) |
||||
Less: GAAP net loss attributable to noncontrolling interests |
|
- |
|
|
(1,371 |
) |
|
- |
|
|
(28,662 |
) |
||||
GAAP net income (loss) attributable to Ironwood Pharmaceuticals, Inc. |
$ |
3,646 |
|
$ |
15,321 |
|
$ |
(1,376 |
) |
$ |
(1,001,152 |
) |
||||
|
|
|
|
|
||||||||||||
GAAP net income (loss) per share—basic |
$ |
0.02 |
|
$ |
0.10 |
|
$ |
(0.01 |
) |
$ |
(6.45 |
) |
||||
|
|
|
|
|
||||||||||||
GAAP net income (loss) per share—diluted |
$ |
0.02 |
|
$ |
0.09 |
|
$ |
(0.01 |
) |
$ |
(6.45 |
) |
____________________
1 Figures presented for the nine months ended September 30, 2023 include a one-time charge of approximately
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 September 30, |
|
Nine Months Ended September 30, |
||||||||||||
|
|
2024 |
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
GAAP net income (loss)1 |
$ |
3,646 |
$ |
13,950 |
|
$ |
(1,376 |
) |
$ |
(1,029,814 |
) |
||||
Adjustments: |
|
|
|
|
|||||||||||
Mark-to-market adjustments on the derivatives related to convertible notes, net |
|
- |
|
- |
|
|
- |
|
|
(19 |
) |
||||
Amortization of acquired intangible assets |
|
207 |
|
207 |
|
|
616 |
|
|
211 |
|
||||
Restructuring expenses |
|
16 |
|
4,685 |
|
|
2,520 |
|
|
17,696 |
|
||||
Acquisition-related costs |
|
- |
|
3,864 |
|
|
1,146 |
|
|
39,545 |
|
||||
Tax effect of adjustments |
|
- |
|
(904 |
) |
|
(461 |
) |
|
(1,447 |
) |
||||
Non-GAAP net income (loss)1 |
$ |
3,869 |
$ |
21,802 |
|
$ |
2,445 |
|
$ |
(973,828 |
) |
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 September 30, |
|
Nine Months Ended September 30, |
||||||||||||
|
|
2024 |
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
GAAP net income (loss) attributable to Ironwood Pharmaceuticals, Inc. per share – basic |
$ |
0.02 |
$ |
0.10 |
|
$ |
(0.01 |
) |
$ |
(6.45 |
) |
||||
Plus: Net income (loss) per share attributable to noncontrolling interests – basic |
|
- |
|
(0.01 |
) |
|
- |
|
|
(0.18 |
) |
||||
Adjustments to GAAP net income per share (as detailed above) |
|
- |
|
0.05 |
|
|
0.02 |
|
|
0.36 |
|
||||
Non-GAAP net income (loss) per share – basic |
$ |
0.02 |
$ |
0.14 |
|
$ |
0.01 |
|
$ |
(6.27 |
) |
||||
Weighted average number of common shares used to calculate net income (loss) per share — basic |
|
159,706 |
|
158,810 |
|
|
155,886 |
|
|
155,240 |
|
____________________
1 Figures presented for the nine months ended September 30, 2023, include a one-time charge of approximately
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 September 30, |
|
Nine Months Ended September 30, |
||||||||||||
|
|
2024 |
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
GAAP net income (loss) attributable to Ironwood Pharmaceuticals, Inc. per share – diluted |
$ |
0.02 |
$ |
0.09 |
|
$ |
(0.01 |
) |
$ |
(6.45 |
) |
||||
Plus: Net income (loss) per share attributable to noncontrolling interests – diluted |
|
- |
|
(0.01 |
) |
|
- |
|
|
(0.18 |
) |
||||
Adjustments to GAAP net income per share (as detailed above) |
|
- |
|
0.04 |
|
|
0.02 |
|
|
0.36 |
|
||||
Non-GAAP net income (loss) per share – diluted |
$ |
0.02 |
$ |
0.12 |
|
$ |
0.01 |
|
$ |
(6.27 |
) |
||||
Weighted average number of common shares used to calculate net income (loss) per share — diluted |
|
160,232 |
|
186,891 |
|
|
158,810 |
|
|
155,240 |
|
Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA (In thousands) (unaudited) |
||||||||||||||||
|
|
|
|
|
|
|
||||||||||
A reconciliation of GAAP net income (loss) to adjusted EBITDA: |
||||||||||||||||
|
|
|
|
|
|
|
||||||||||
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||||||
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
GAAP net income (loss)1 |
$ |
3,646 |
|
|
$ |
13,950 |
|
|
$ |
(1,376 |
) |
|
$ |
(1,029,814 |
) |
|
Adjustments: |
|
|
|
|
|
|||||||||||
Mark-to-market adjustments on the derivatives related to convertible notes, net |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
(19 |
) |
|
Restructuring expenses |
|
16 |
|
|
|
4,685 |
|
|
|
2,520 |
|
|
|
17,696 |
|
|
Interest expense |
|
9,419 |
|
|
|
9,839 |
|
|
|
24,120 |
|
|
|
13,206 |
|
|
Interest and investment income |
|
(1,152 |
) |
|
|
(1,748 |
) |
|
|
(3,690 |
) |
|
|
(17,777 |
) |
|
Income tax expense |
|
13,723 |
|
|
|
17,982 |
|
|
|
42,579 |
|
|
|
51,385 |
|
|
Depreciation and amortization |
|
507 |
|
|
|
507 |
|
|
|
1,526 |
|
|
|
1,063 |
|
|
Acquisition-related costs |
|
- |
|
|
|
3,864 |
|
|
|
1,146 |
|
|
|
39,545 |
|
|
Adjusted EBITDA1 |
$ |
26,159 |
|
|
$ |
49,079 |
|
|
$ |
66,825 |
|
|
$ |
(924,715 |
) |
____________________
1 Figures presented for the nine months ended September 30, 2023, include a one-time charge of approximately
Revenue/Expense Calculation (In thousands) (unaudited) |
||||||||||||||||
|
|
|
|
|
|
|
|
|
||||||||
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
||||||||||||
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
LINZESS |
$ |
225,537 |
|
$ |
278,954 |
|
$ |
693,320 |
|
$ |
798,854 |
|
||||
AbbVie & Ironwood commercial costs, expenses and other discounts3 |
|
78,499 |
|
|
77,736 |
|
|
232,811 |
|
|
223,142 |
|
||||
Commercial profit on sales of LINZESS |
$ |
147,038 |
|
$ |
201,218 |
|
$ |
460,509 |
|
$ |
575,712 |
|
||||
Commercial Margin4 |
|
65 |
% |
|
72 |
% |
|
66 |
% |
|
72 |
% |
||||
|
|
|
|
|||||||||||||
|
|
|
|
|||||||||||||
Ironwood’s share of net profit |
|
73,519 |
|
|
100,609 |
|
|
230,255 |
|
|
287,856 |
|
||||
Reimbursement for Ironwood’s commercial expenses |
|
9,567 |
|
|
9,480 |
|
|
28,961 |
|
|
28,615 |
|
||||
Adjustment for Ironwood’s estimate of LINZESS gross-to-net reserves |
|
5,800 |
|
|
- |
|
|
(7,200 |
) |
|
- |
|
||||
Ironwood’s |
$ |
88,886 |
|
$ |
110,089 |
|
$ |
252,016 |
|
$ |
316,471 |
|
____________________
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
5 Figures presented for the three months and nine months ended September 30, 2024 include a
US LINZESS Full Brand Collaboration1 Revenue/Expense Calculation (In thousands) (unaudited) |
||||||||||||
|
|
|
||||||||||
|
Three Months Ended September 30, |
Nine Months Ended September 30, |
||||||||||
|
2024 |
2023 |
2024 |
2023 |
||||||||
LINZESS |
$ |
225,537 |
$ |
278,954 |
$ |
693,320 |
$ |
798,854 |
||||
AbbVie & Ironwood commercial costs, expenses and other discounts3 |
|
78,499 |
|
77,736 |
|
232,811 |
|
223,142 |
||||
AbbVie & Ironwood R&D Expenses4 |
|
7,451 |
|
9,264 |
|
24,823 |
|
28,270 |
||||
Total net profit on sales of LINZESS |
$ |
139,587 |
$ |
191,954 |
$ |
435,686 |
$ |
547,442 |
____________________
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 Expenses related to LINZESS in the
View source version on businesswire.com: https://www.businesswire.com/news/home/20241107549223/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
What was Ironwood Pharmaceuticals (IRWD) revenue in Q3 2024?
What was LINZESS prescription growth for IRWD in Q3 2024?
What is Ironwood's (IRWD) 2024 revenue guidance?