Ironwood Pharmaceuticals Reports Second Quarter 2024 Results
– LINZESS® (linaclotide) EUTRx prescription demand growth of 11% year-over-year –
– Plans to pursue apraglutide rolling NDA review; expects to complete submission in the first quarter of 2025 –
– On track 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 –
“We continued to make progress across our portfolio in the second quarter,” said
Second Quarter 2024 Financial Highlights1
(in thousands, except for per share amounts)
|
|
Q2 2024 |
Q2 2023 |
|
Total revenue2 |
|
|
||
Total costs and expenses3 |
69,419 |
1,190,521 |
||
GAAP net loss2,3 |
(860) |
(1,089,478) |
||
GAAP net loss attributable to |
(860) |
(1,062,187) |
||
GAAP net loss – per share basic2,3 |
(0.01) |
(6.84) |
||
GAAP net loss – per share diluted2,3 |
(0.01) |
(6.84) |
||
Adjusted EBITDA2,3 |
27,909 |
(1,034,182) |
||
Non-GAAP net income (loss)2,3 |
1,508 |
(1,041,325) |
||
Non-GAAP net income (loss)per share – basic2,3 |
0.00 |
(6.71) |
||
Non-GAAP net income (loss) per share – diluted2,3 |
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 |
3 Figures presented for the second quarter of 2023 include a one‐time charge of approximately |
Second Quarter 2024 Corporate Highlights
-
Prescription Demand: Total LINZESS prescription demand in the second quarter of 2024 was 52 million LINZESS capsules, an 11% increase compared to the second 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$211.2 million in the second quarter of 2024, a 22% decrease compared to$269.7 million in the second quarter of 2023. Ironwood and AbbVie share equally inU.S. brand collaboration profits.-
LINZESS
U.S. net sales as reported by AbbVie in the second quarter of 2024 reflected the gross-to-net change in estimate related to the year endedDecember 31, 2023 , which Ironwood previously accounted for in the first quarter of 2024 by recording a$30.0 million reduction to collaborative arrangements revenue. -
LINZESS commercial margin, including the gross-to-net change in estimate, was 62% in the second quarter of 2024, compared to 71% in the second quarter of 2023. See the
U.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, and including the gross-to-net change in estimate, was$120.5 million in the second quarter of 2024, a decrease compared to$180.3 million in the second quarter of 2023. See theU.S. LINZESS Full Brand Collaboration table at the end of this press release.
-
LINZESS
-
Collaboration Revenue to Ironwood: Ironwood recorded
$91.4 million in collaboration revenue in the second quarter of 2024 related to sales of LINZESS in theU.S. , compared to$104.8 million for the second quarter of 2023. Second quarter of 2024 collaboration revenue to Ironwood includes a$17.0 million adjustment, 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 endedDecember 31, 2023 , previously recorded by Ironwood in the first quarter of 2024, which was reflected in LINZESSU.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 ofJune 30, 2024 . See theU.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.
-
In
May 2024 , Ironwood presented late-breaking data during the 2024 Digestive Disease Week® (DDW) meeting from its pivotal Phase III clinical trial, STARS, which evaluated the efficacy and safety of once-weekly subcutaneous apraglutide in adult patients with short bowel syndrome with intestinal failure (“SBS-IF”). These findings build on the positive topline data that Ironwood previously announced inFebruary 2024 . Additional details from the late-breaking presentation can be found here.-
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
-
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 theU.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. Topline data is 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.
Second Quarter 2024 Financial Results
-
Total Revenue. Total revenue in the second quarter of 2024 was
$94.4 million , compared to$107.4 million in the second quarter of 2023.- As noted above, revenue was lower year-over-year, primarily due to the decrease in collaborative arrangements revenue.
-
Total revenue in the second quarter of 2024 consisted of
$91.4 million associated with Ironwood’s share of the net profits from the sales of LINZESS in theU.S. , and$3.0 million in royalties and other revenue. Total revenue in the second quarter of 2023 consisted of$104.8 million associated with Ironwood’s share of the net profits from the sales of LINZESS in theU.S. and$2.6 million in royalties and other revenue.
-
Operating Expenses. Operating expenses in the second quarter of 2024 were
$69.4 million , compared to$1,190.5 million in the second quarter of 2023, which included a one-time charge of$1,090.4 million of acquired in-process research and development (“IPR&D”) from the acquisition ofVectivBio .-
Operating expenses in the second quarter of 2024 consisted of
$37.0 million in selling, general and administrative (“SG&A”) expenses,$30.4 million in R&D expenses and$2.1 million in restructuring expenses. Operating expenses in the second quarter of 2023 consisted of$52.5 million in SG&A expenses and$34.6 million in R&D expenses,$13.0 million in restructuring expenses and approximately$1.1 billion in acquired IPR&D from the acquisition ofVectivBio .
-
Operating expenses in the second quarter of 2024 consisted of
-
Interest Expense. Interest expense was
$7.5 million in the second quarter of 2024, primarily in connection with Ironwood’s convertible senior notes and revolving credit facility. Interest expense was$1.8 million in the second quarter of 2023, in connection with Ironwood’s convertible senior notes and revolving credit facility. -
Interest and Investment Income. Interest and investment income was
$1.4 million in the second quarter of 2024. Interest and investment income was$8.8 million in the second quarter of 2023. -
Income Tax Expense. Ironwood recorded
$19.7 million of income tax expense in the second 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$13.3 million of income tax expense in the second 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. -
GAAP Net Loss Attributable to Ironwood. GAAP net loss attributable to Ironwood was
($0.9) million , or ($0.01 ) per share (basic and diluted) in the second quarter of 2024, compared to GAAP net loss attributable to Ironwood of($1,062.2) million , or ($6.84 ) per share (basic and diluted) in the second quarter of 2023, which included a one-time charge of($1,090.4) million of acquired IPR&D from the acquisition ofVectivBio . -
Non-GAAP Net Income (Loss). Non-GAAP net income was
$1.5 million , or$0.00 per share (basic and diluted), in the second quarter of 2024, compared to non-GAAP net loss of($1,041.3) million , or ($6.71 ) per share (basic and diluted), in the second quarter of 2023, which included a one-time charge of($1,090.4) million of acquired IPR&D from the acquisition ofVectivBio .- Non-GAAP net income (loss) 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
$27.9 million in the second quarter of 2024, compared to($1,034.2) million in the second quarter of 2023, which included a one-time charge of($1,090.4) million of acquired IPR&D from the acquisition ofVectivBio .- 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 second quarter of 2024 with
$105.5 million of cash and cash equivalents, compared to$92.2 million of cash and cash equivalents at the end of 2023.-
In the second quarter of 2024, Ironwood repaid the aggregate principal amount of the 2024 Convertible Notes of approximately
$200.0 million upon maturity, using$50.0 million of cash on hand and drawing$150.0 million from its revolving credit facility. The outstanding principal balance on the revolving credit facility was$425.0 million as ofJune 30, 2024 . -
Ironwood generated
$33.5 million in cash from operations in the second quarter of 2024, compared to$35.0 million in cash from operations in the second quarter of 2023.
-
In the second quarter of 2024, Ironwood repaid the aggregate principal amount of the 2024 Convertible Notes of approximately
- Ironwood 2024 Financial Guidance. Ironwood has revised its FY 2024 financial guidance due to continued LINZESS pricing pressure as a result of higher-than-expected Medicaid utilization trends for FY 2024. Ironwood now expects:
|
Prior 2024 Guidance
|
Revised 2024 Guidance
|
|
Mid-single digits % decline2 |
|
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 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 |
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 ofVectivBio 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 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
About
Founded in 1998,
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 ≥2% and greater than placebo)
- 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
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) |
||||||
|
|
|
|
|||
Assets |
|
|
|
|||
Cash and cash equivalents |
|
$ |
105,524 |
$ |
92,154 |
|
Accounts receivable, net |
|
|
58,108 |
|
129,122 |
|
Prepaid expenses and other current assets |
|
|
14,548 |
|
12,012 |
|
Total current assets |
|
|
178,180 |
|
233,288 |
|
Property and equipment, net |
|
|
5,068 |
|
5,585 |
|
Operating lease right-of-use assets |
|
|
11,823 |
|
12,586 |
|
Intangible assets, net |
|
|
3,273 |
|
3,682 |
|
Deferred tax assets |
|
|
193,019 |
|
212,324 |
|
Other assets |
|
|
4,257 |
|
3,608 |
|
Total assets |
|
$ |
395,620 |
$ |
471,073 |
|
Liabilities and stockholders’ equity |
|
|
|
|||
Accounts payable |
|
$ |
3,227 |
$ |
7,830 |
|
Accrued research and development costs |
|
|
6,720 |
|
21,331 |
|
Accrued expenses and other current liabilities |
|
|
32,406 |
|
44,254 |
|
Current portion of operating lease liabilities |
|
|
3,157 |
|
3,126 |
|
Current portion on convertible senior notes |
|
|
- |
|
199,560 |
|
Total current liabilities |
|
|
45,510 |
|
276,101 |
|
Operating lease liabilities, net of current portion |
|
|
13,452 |
|
14,543 |
|
Convertible senior notes, net of current portion |
|
|
198,647 |
|
198,309 |
|
Revolving credit facility |
|
|
425,000 |
|
300,000 |
|
Other liabilities |
|
|
34,738 |
|
28,415 |
|
Total stockholders’ deficit |
|
|
(321,727) |
|
(346,295) |
|
Total liabilities and stockholders’ deficit |
|
$ |
395,620 |
$ |
471,073 |
Condensed Consolidated Statements of Income (Loss) |
|||||||||||
(In thousands, except per share amounts) |
|||||||||||
(unaudited) |
|||||||||||
|
Three Months Ended
|
|
Six Months Ended
|
||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||
Total revenues1 |
$ |
94,396 |
$ |
107,382 |
$ |
169,273 |
$ |
211,443 |
|||
Collaborative arrangements revenue1 |
94,396 |
|
107,382 |
|
169,273 |
|
211,443 |
||||
Costs and expenses: |
|
|
|
|
|||||||
Research and development |
30,388 |
|
34,577 |
|
56,203 |
47,424 |
|||||
Selling, general and administrative |
36,964 |
|
52,484 |
|
74,569 |
|
83,601 |
||||
Restructuring |
|
2,067 |
|
13,011 |
|
2,504 |
|
13,011 |
|||
Acquired in-process research and development |
|
- |
|
1,090,449 |
|
- |
|
1,090,449 |
|||
Total costs and expenses2 |
|
69,419 |
|
1,190,521 |
|
133,276 |
|
1,234,485 |
|||
Income (loss) from operations |
|
24,977 |
|
(1,083,139) |
|
35,997 |
|
(1,023,042) |
|||
Other income (expense): |
|
|
|
|
|||||||
Interest expense and other financing costs |
(7,470) |
|
(1,840) |
|
(14,701) |
(3,367) |
|||||
Interest and investment income |
1,369 |
|
8,757 |
|
2,538 |
|
16,029 |
||||
Gain on derivatives |
|
- |
|
- |
|
- |
|
19 |
|||
Other income (expense), net |
|
(6,101) |
|
6,917 |
|
(12,163) |
|
12,681 |
|||
Income (loss) before income taxes |
|
18,876 |
|
(1,076,222) |
|
23,834 |
|
(1,010,361) |
|||
Income tax expense |
|
(19,736) |
|
(13,256) |
|
(28,856) |
|
(33,403) |
|||
GAAP net loss1,2 |
|
(860) |
|
(1,089,478) |
|
(5,022) |
|
(1,043,764) |
|||
Less: GAAP net loss attributable to noncontrolling interests |
|
- |
|
(27,291) |
|
- |
|
(27,291) |
|||
GAAP net loss attributable to |
$ |
(860) |
$ |
(1,062,187) |
$ |
(5,022) |
$ |
(1,016,473) |
|||
|
|
|
|
|
|||||||
GAAP net loss per share—basic |
$ |
(0.01) |
$ |
(6.84) |
$ |
(0.03) |
$ |
(6.56) |
|||
|
|
|
|
|
|||||||
GAAP net loss per share—diluted |
$ |
(0.01) |
$ |
(6.84) |
$ |
(0.03) |
$ |
(6.56) |
_________________ |
1 Figures presented for the three and six months ended |
2 Figures presented for the three and six months ended |
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
|
|
Six Months Ended
|
||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|||||
GAAP net loss1,2 |
$ |
(860) |
$ |
(1,089,478) |
$ |
(5,022) |
$ |
(1,043,764) |
||||
Adjustments: |
|
|
|
|
||||||||
Mark-to-market adjustments on the derivatives related to convertible notes, net |
|
- |
|
|
- |
|
|
- |
|
|
(19) |
|
Amortization of acquired intangible assets |
|
204 |
|
|
4 |
|
|
409 |
|
|
4 |
|
Restructuring expenses |
|
2,067 |
|
|
13,011 |
|
|
2,504 |
|
|
13,011 |
|
Acquisition-related costs |
|
359 |
|
|
35,681 |
|
|
1,146 |
|
|
35,681 |
|
Tax effect of adjustments |
(262) |
|
|
(543) |
|
|
(461) |
|
|
(543) |
||
Non-GAAP net income (loss)1,2 |
$ |
1,508 |
$ |
(1,041,325) |
$ |
(1,424) |
$ |
(995,630) |
A reconciliation between basic and diluted net income (loss) per share on a GAAP basis and on a non-GAAP basis is as follows:
|
Three Months Ended
|
|
Six Months Ended
|
||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||
GAAP net loss attributable to |
$ |
(0.01) |
$ |
(6.84) |
$ |
(0.03) |
$ |
(6.56) |
|||
Plus: Net income (loss) per share attributable to noncontrolling interests |
|
- |
|
(0.18) |
|
- |
|
(0.18) |
|||
Adjustments to GAAP net income (loss) per share (as detailed above) |
|
0.01 |
|
0.31 |
|
0.02 |
|
0.31 |
|||
Non-GAAP net income (loss) per share– basic and diluted |
$ |
0.00 |
$ |
(6.71) |
$ |
(0.01) |
$ |
(6.43) |
|||
Weighted average number of common shares used to calculate net loss per share — basic and diluted |
159,014 |
155,367 |
158,357 |
154,912 |
_________________ |
1 Figures presented for the three and six months ended |
2 Figures presented for the three and six months ended |
Reconciliation of GAAP Net Loss to Adjusted EBITDA |
||||||||||||
(In thousands) |
||||||||||||
(unaudited) |
||||||||||||
A reconciliation of GAAP net loss to adjusted EBITDA: |
||||||||||||
|
Three Months Ended
|
|
Six Months Ended
|
|||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|||||
GAAP net loss1,2 |
$ |
(860) |
$ |
(1,089,478) |
$ |
(5,022) |
|
$ |
(1,043,764) |
|||
Adjustments: |
|
|
|
|
|
|
|
|||||
Mark-to-market adjustments on the derivatives related to convertible notes, net |
- |
|
- |
- |
|
(19) |
||||||
Restructuring expenses |
|
2,067 |
|
13,011 |
|
2,504 |
|
|
13,011 |
|||
Interest expense |
|
7,470 |
|
1,840 |
|
14,701 |
|
|
3,367 |
|||
Interest and investment income |
|
(1,369) |
|
(8,757) |
|
(2,538) |
|
|
(16,029) |
|||
Income tax expense |
|
19,736 |
|
13,256 |
|
28,856 |
|
|
33,403 |
|||
Depreciation and amortization |
|
506 |
|
265 |
|
1,019 |
|
|
551 |
|||
Acquisition-related costs |
|
359 |
|
35,681 |
|
1,146 |
|
35,681 |
||||
Adjusted EBITDA1,2 |
$ |
27,909 |
$ |
(1,034,182) |
$ |
40,666 |
$ |
(973,799) |
_________________ | ||||
1 Figures presented for the three and six months ended |
||||
2 Figures presented for the three and six months ended |
|
|||||||||||
Revenue/Expense Calculation |
|||||||||||
(In thousands) |
|||||||||||
(unaudited) |
|||||||||||
|
|
|
|
|
|||||||
|
Three Months Ended
|
|
Six Months Ended
|
||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
||||
LINZESS |
$ |
211,183 |
$ |
269,686 |
$ |
467,783 |
$ |
519,900 |
|||
AbbVie & Ironwood commercial costs, expenses and other discounts3 |
|
80,950 |
|
78,998 |
|
154,312 |
|
145,406 |
|||
Commercial profit on sales of LINZESS |
$ |
130,233 |
$ |
190,688 |
$ |
313,471 |
$ |
374,494 |
|||
Commercial Margin 4 |
|
62% |
|
71% |
|
67% |
|
72% |
|||
|
|
|
|
||||||||
|
|
|
|
||||||||
Ironwood’s share of net profit |
|
65,117 |
|
95,344 |
|
156,736 |
|
187,247 |
|||
Reimbursement for Ironwood’s commercial expenses |
|
9,298 |
|
9,407 |
|
19,394 |
|
19,135 |
|||
Adjustment for Ironwood’s estimate of LINZESS gross-to-net reserves |
|
17,000 |
|
- |
|
(13,000) |
|
- |
|||
Ironwood’s |
$ |
91,415 |
$ |
104,751 |
$ |
163,130 |
$ |
206,382 |
_________________ | |||||||||||
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 and six months ended |
US LINZESS Full Brand Collaboration1 |
||||||||||||
Revenue/Expense Calculation |
||||||||||||
(In thousands) |
||||||||||||
(unaudited) |
||||||||||||
|
Three Months Ended
|
|
Six Months Ended
|
|||||||||
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|||||
LINZESS |
$ |
211,183 |
$ |
269,686 |
$ |
467,783 |
$ |
519,900 |
||||
AbbVie & Ironwood commercial costs, expenses and other discounts3 |
|
80,950 |
|
78,998 |
|
154,312 |
|
145,406 |
||||
AbbVie & Ironwood R&D Expenses4 |
|
9,736 |
|
10,356 |
|
17,372 |
|
19,006 |
||||
Total net profit on sales of LINZESS |
$ |
120,497 |
$ |
180,332 |
$ |
296,099 |
$ |
355,488 |
_________________ | ||||||||||||
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/20240808744786/en/
Investors:
gmartini@ironwoodpharma.com
mroache@ironwoodpharma.com
Media:
bcalitri@ironwoodpharma.com
Source: