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BOSTON--(BUSINESS WIRE)--Nov 3, 2022--
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company, today reported its third quarter 2022 results and recent business performance.
“As we approach the end of the year, I am excited about what we have done to support patients living with gastroenterology diseases and the progress made toward realizing our vision to become the leading GI company in the industry,” said Tom McCourt, chief executive officer of Ironwood. “I am pleased to share that the strong performance of LINZESS continues, and we delivered another quarter of double-digit year-over-year prescription demand growth. For the first time, LINZESS exceeded 1 million total prescriptions in a quarter, a remarkable achievement. We believe there is still a significant opportunity to reach appropriate new adult patients and drive additional prescription growth. We also continued to advance our pipeline programs, highlighted by the exciting positive topline data from the Phase III trial of LINZESS in pediatric patients aged 6 to 17 with functional constipation. The results of this study bring us one step closer to being able to potentially expand the clinical utility of LINZESS to this critical but underserved patient population, as there are currently no FDA approved prescription therapies for the treatment of functional constipation in pediatric patients. Looking ahead, we believe our capabilities in GI, strong balance sheet and disciplined capital allocation continue to position our company for growth.”
Third Quarter 2022 Financial Highlights 1 (in thousands, except for per share amounts) | ||||
|
| 3Q 2022 | 3Q 2021 | |
Total revenues | $108,637 | $103,747 | ||
Total operating expenses | 40,164 | 38,576 | ||
GAAP net income | 50,317 | 55,845 | ||
GAAP net income per share – basic | 0.33 | 0.34 | ||
GAAP net income per share –diluted | 0.28 | 0.34 | ||
Adjusted EBITDA | 68,835 | 65,456 | ||
Non-GAAP net income | 50,166 | 53,608 | ||
Non-GAAP net income per share – basic | 0.33 | 0.33 | ||
Non-GAAP net income per share – diluted | 0.28 | 0.33 |
| 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 2022 Corporate Highlights
U.S. LINZESS
U.S. LINZESS Full Brand Collaboration (in thousands, except for percentages) | Three Months Ended | |
| 2022 | 2021 |
LINZESS U.S. net sales as reported by AbbVie | $261,131 | $252,650 |
AbbVie & Ironwood commercial costs, expenses and other discounts | 68,499 | 66,658 |
Commercial margin | 74% | 74% |
AbbVie & Ironwood R&D Expenses | 7,620 | 9,753 |
Total net profit on sales of LINZESS | 185,012 | 176,239 |
Full brand margin | 71% | 70% |
Pipeline Updates
Pediatric Program
IW-3300
CNP-104
Third Quarter Financial Results
Non-GAAP net income excludes the impact of mark-to-market adjustments on the derivatives related to Ironwood’s 2022 Convertible Notes, restructuring expenses, and the release of the company’s valuation allowance against the majority of deferred tax assets in the second quarter of 2021. See Non-GAAP Financial Measures below.
| 2022 Guidance |
U.S. LINZESS Net Sales Growth | Low single digits % |
Total Revenue | $420 to $430 million |
Adjusted EBITDA 1 | >$250 million |
1 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 from GAAP net income. For purposes of this guidance, Ironwood has assumed that it will not incur material expenses related to business development activities in 2022. |
Non-GAAP Financial Measures
Ironwood presents non-GAAP net income and non-GAAP net income per share to exclude the impact of net gains and losses on derivatives related to Ironwood’s 2022 Convertible Notes that are required to be marked-to-market, restructuring expenses, and the release of the company’s valuation allowance against the majority of deferred tax assets in the second quarter of 2021. Non-GAAP adjustments are further detailed below:
Ironwood also presents adjusted EBITDA, a non-GAAP measure, as well as guidance on adjusted EBITDA. Adjusted EBITDA is calculated by subtracting mark-to-market adjustments on derivatives related to Ironwood’s 2022 Convertible Notes, restructuring expenses, net interest expense, income taxes, depreciation and amortization 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, November 3, 2022 to discuss its third quarter 2022 results and recent business activities. Individuals interested in participating in the call should dial (888) 330-2384 (U.S. and Canada) or (240) 789-2701 (international) using conference ID number and event passcode 4671230. To access the webcast, please visit the Investors section of Ironwood’s website at www.ironwoodpharma.com at least 15 minutes prior to the start of the call to ensure adequate time for any software downloads that may be required. The call will be available for replay via telephone starting at approximately 11:30 a.m. Eastern Time on November 3, 2022 running through 11:59 p.m. Eastern Time on November 17, 2022. To listen to the replay, dial (800) 770-2030 (U.S. and Canada) or (647) 362-9199 (international) using conference ID number 4671230. The archived webcast will be available on Ironwood’s website for 14 days beginning approximately one hour after the call has completed.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD), an S&P SmallCap 600® company, is a leading gastrointestinal (GI) healthcare company on a mission to advance the treatment of GI diseases and redefine the standard of care for GI patients. We are pioneers in the development of LINZESS® (linaclotide), the U.S. branded prescription market leader for adults with irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC). Under the guidance of our seasoned industry leaders, we continue to build upon our history of GI innovation and challenge what has been done before to shape what the future holds. We keep patients at the heart of our R&D and commercialization efforts to reduce the burden of GI diseases and address significant unmet needs.
Founded in 1998, Ironwood Pharmaceuticals is headquartered in Boston, Massachusetts.
We routinely post information that may be important to investors on our website at www.ironwoodpharma.com. In addition, follow us on Twitter and on LinkedIn.
About LINZESS (linaclotide)
LINZESS® is the #1 prescribed brand in the U.S. for the treatment of adult patients with irritable bowel syndrome with constipation (“IBS-C”) or chronic idiopathic constipation (“CIC”), based on IQVIA data.
LINZESS is a once-daily capsule that helps relieve the abdominal pain, constipation, and overall abdominal symptoms of bloating, discomfort and pain associated with IBS-C, as well as the constipation, infrequent stools, hard stools, straining, and incomplete evacuation associated with CIC. The recommended dose is 290 mcg for IBS-C patients and 145 mcg for CIC patients, with a 72-mcg dose approved for use in CIC depending on individual patient presentation or tolerability. LINZESS should be taken at least 30 minutes before the first meal of the day.
LINZESS is contraindicated in pediatric patients less than 2 years of age. In neonatal mice, linaclotide increased fluid secretion as a consequence of age-dependent elevated GC-C agonism resulting in 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. The safety and effectiveness of LINZESS in patients less than 18 years of age have not been established.
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 the United States, Ironwood and AbbVie co-develop and co-commercialize LINZESS for the treatment of adults with IBS-C or CIC. In Europe, AbbVie markets linaclotide under the brand name CONSTELLA® for the treatment of adults with moderate to severe IBS-C. In Japan, Ironwood's partner, Astellas, markets linaclotide under the brand name LINZESS for the treatment of adults with IBS-C or CIC. Ironwood also has partnered with AstraZeneca for development and commercialization of LINZESS in China, and with AbbVie for development and commercialization of linaclotide in all other territories worldwide.
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment of both irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC).
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
Warnings and Precautions
Pediatric Risk
Diarrhea
Common Adverse Reactions (incidence ≥2% and greater than placebo)
Please see full Prescribing Information including Boxed Warning: http://www.allergan.com/assets/pdf/linzess_pi
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 its mission; Ironwood’s strategy, business, financial position and operations; Ironwood’s ability to drive growth and profitability; the demand, development, commercial availability and commercial potential of linaclotide and the drivers, timing, impact and results thereof; Ironwood’s continued focused investments and commitment to reaching new patients to drive prescription demand growth moving forward; the potential indications for, and benefits of, linaclotide; financial performance and results, and guidance and expectations related thereto, including expectations related to LINZESS U.S. net sales growth, total revenue and adjusted EBITDA in 2022; Ironwood’s plans to maximize LINZESS growth via commercial innovation and lifecycle management; the progress of our ongoing clinical trials and the timing of related data readouts; the plan and timing to submit an sNDA to the FDA for a potential indication in functional constipation in pediatric patients aged 6-17; the potential of IW-3300 as a treatment of visceral pain conditions and the size of the IC/BPS and endometriosis populations; the size of estimated U.S. population affected by PBC; and the potential of CNP-104 to be the first PBC disease modifying therapy. These forward-looking statements speak only as of the date of this press release, and Ironwood undertakes no obligation to update these forward-looking statements. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include those related to the effectiveness of development and commercialization efforts by us and our partners; preclinical and clinical development, manufacturing and formulation development of linaclotide, CNP-104 and our product candidates; the risk that clinical programs and studies may not progress or develop as anticipated, including that studies are delayed or discontinued for any reason, such as safety, tolerability, enrollment, manufacturing, economic or other reasons; the risk that findings from our completed nonclinical and clinical studies may not be replicated in later studies; the risk that we or our partners are unable to obtain, maintain or manufacture sufficient LINZESS or our product candidates, or otherwise experience difficulties with respect to supply or manufacturing; the efficacy, safety and tolerability of linaclotide and our product candidates; the risk that the therapeutic opportunities for LINZESS or our product candidates are not as we expect; decisions by regulatory and judicial authorities; the risk we may never get additional patent protection for linaclotide and other product candidates, that patents for linaclotide or other products may not provide adequate protection from competition, or that we are not able to successfully protect such patents; the risk that we are unable to manage our expenses or cash use, or are unable to commercialize our products as expected; the risk that we may elect to not exercise our option to acquire the exclusive license for CNP-104; the risk that the development of either our clinical pediatric programs in IBS-C and functional constipation in 6 to 17 year-olds, CNP-104 and/or IW-3300 is not successful or that any of our product candidates is not successfully commercialized; outcomes in legal proceedings to protect or enforce the patents relating to our products and product candidates, including abbreviated new drug application litigation; the risk that financial and operating results may differ from our projections; developments in the intellectual property landscape; challenges from and rights of competitors or potential competitors; the risk that our planned investments do not have the anticipated effect on our company revenues; developments in accounting guidance or practice; Ironwood’s or AbbVie’s accounting practices, including reporting and settlement practices as between Ironwood and AbbVie; the risk that we are unable to manage our expenses or cash use, or are unable to commercialize our products as expected; the impact of the COVID-19 pandemic; and the risks listed under the heading “Risk Factors” and elsewhere in Ironwood’s Annual Report on Form 10-K for the year ended December 31, 2021, and in our subsequent Securities and Exchange Commission filings.
Condensed Consolidated Balance Sheets (In thousands) (unaudited) | |||||||||
September 30, | December 31, | ||||||||
Assets |
|
|
|
|
| ||||
Cash and cash equivalents |
| $ |
| 574,188 | $ |
| 620,129 |
| |
Accounts receivable, net |
|
| 116,545 |
| 114,042 |
|
| ||
Prepaid expenses and other current assets |
|
| 7,011 |
| 8,689 |
|
| ||
Restricted cash, short-term |
|
| 1,250 |
| 1,250 |
|
| ||
Convertible note hedges |
|
| - |
| 1,115 |
|
| ||
Total current assets |
|
| 698,994 |
| 745,225 |
|
| ||
Restricted cash, net of current portion |
|
| 485 |
| 485 |
|
| ||
Accounts receivable, net of current portion |
|
| 14,439 |
| 23,998 |
|
| ||
Property and equipment, net |
|
| 6,660 |
| 7,575 |
|
| ||
Operating lease right-of-use assets |
|
| 14,365 |
| 15,350 |
|
| ||
Deferred tax assets |
|
| 304,538 |
| 333,294 |
|
| ||
Other assets |
|
| 863 |
| 1,000 |
|
| ||
Total assets |
| $ | 1,040,344 | $ | 1,126,927 |
|
| ||
Liabilities and Stockholders’ Equity |
|
|
|
|
| ||||
Accounts payable |
| $ |
| 795 | $ |
| 935 |
| |
Accrued research and development costs |
|
| 5,673 |
| 15,896 |
|
| ||
Accrued expenses and other current liabilities |
|
| 17,598 |
| 23,566 |
|
| ||
Current portion of operating lease liabilities |
|
| 3,050 |
| 3,127 |
|
| ||
Current portion of convertible senior notes |
|
| - |
| 116,858 |
|
| ||
Note hedge warrants |
|
| 1 |
| 1,316 |
|
| ||
Total current liabilities |
|
| 27,117 |
| 161,698 |
|
| ||
Convertible senior notes, net of current portion |
|
| 395,850 |
| 337,333 |
|
| ||
Operating lease liabilities, net of current portion |
|
| 17,087 |
| 18,484 |
|
| ||
Other liabilities |
|
| 9,227 |
| 3,501 |
|
| ||
Total stockholders’ equity |
|
| 591,063 |
| 605,911 |
|
| ||
Total liabilities and stockholders’ equity |
| $ | 1,040,344 | $ | 1,126,927 |
|
|
Condensed Consolidated Statements of Income (In thousands, except per share amounts) (unaudited) | |||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||
Revenues |
|
|
|
| |||||||||||
Collaborative arrangements revenue | $ | 108,637 |
| $ | 103,747 |
| $ | 303,397 |
| $ | 295,798 |
| |||
Sale of active pharmaceutical ingredient |
| - |
|
| - |
|
| - |
|
| 825 |
| |||
Total revenues |
| 108,637 |
|
| 103,747 |
|
| 303,397 |
|
| 296,623 |
| |||
Operating expenses: |
|
|
|
| |||||||||||
Research and development |
| 11,545 |
|
| 10,907 |
|
| 33,819 |
|
| 38,554 |
| |||
Selling, general and administrative |
| 28,619 |
|
| 27,742 |
|
| 87,604 |
|
| 82,446 |
| |||
Restructuring expenses |
| - |
|
| (73 | ) |
| - |
|
| (44 | ) | |||
Total operating expenses |
| 40,164 |
|
| 38,576 |
|
| 121,423 |
|
| 120,956 |
| |||
Income from operations |
| 68,473 |
|
| 65,171 |
|
| 181,974 |
|
| 175,667 |
| |||
Other (expense) income: |
|
|
|
| |||||||||||
Interest expense |
| (1,524 | ) |
| (7,841 | ) |
| (6,072 | ) |
| (23,199 | ) | |||
Interest and investment income |
| 2,807 |
|
| 178 |
|
| 4,055 |
|
| 546 |
| |||
Gain on derivatives |
| 151 |
|
| 2,164 |
|
| 200 |
|
| 1,388 |
| |||
Other expense, net |
| 1,434 |
|
| (5,499 | ) |
| (1,817 | ) |
| (21,265 | ) | |||
Income before income taxes |
| 69,907 |
|
| 59,672 |
|
| 180,157 |
|
| 154,402 |
| |||
Income tax (expense) benefit |
| (19,590 | ) |
| (3,827 | ) |
| (53,959 | ) |
| 332,672 |
| |||
GAAP net income | $ | 50,317 |
| $ | 55,845 |
| $ | 126,198 |
| $ | 487,074 |
| |||
|
|
|
|
| |||||||||||
GAAP net income per share—basic | $ | 0.33 |
| $ | 0.34 |
| $ | 0.82 |
| $ | 3.01 |
| |||
|
|
|
|
| |||||||||||
GAAP net income per share—diluted | $ | 0.28 |
| $ | 0.34 |
| $ | 0.69 |
| $ | 2.97 |
|
Reconciliation of GAAP Results to Non-GAAP Financial Measures | ||||||||||||||||
(In thousands, except per share amounts) (unaudited) | ||||||||||||||||
| ||||||||||||||||
A reconciliation between net income on a GAAP basis and on a non-GAAP basis is as follows: | ||||||||||||||||
| Three Months Ended | Nine Months Ended |
| |||||||||||||
| 2022 | 2021 |
| 2022 |
| 2021 |
|
| ||||||||
GAAP net income | $ | 50,317 |
| $ | 55,845 |
| $ | 126,198 |
| $ | 487,074 |
|
| |||
Adjustments: |
|
|
|
| ||||||||||||
Mark-to-market adjustments on the derivatives related to convertible notes, net |
| (151 | ) |
| (2,164 | ) |
| (200 | ) |
| (1,388 | ) |
| |||
Restructuring expenses |
| - |
|
| (73 | ) |
| - |
|
| (44 | ) |
| |||
Valuation allowance release |
| - |
|
| - |
|
| - |
|
| (337,800 | ) |
| |||
Non-GAAP net income | $ | 50,166 |
| $ | 53,608 |
| $ | 125,998 |
| $ | 147,842 |
|
|
A reconciliation between basic net income per share on a GAAP basis and on a non-GAAP basis is as follows:
| Three Months Ended | Nine Months Ended | ||||||||||||
| 2022 | 2021 | 2022 | 2021 | ||||||||||
GAAP net income per share –basic | $ | 0.33 | $ | 0.34 |
| $ | 0.82 | $ | 3.01 |
| ||||
Adjustments to GAAP net income per share (as detailed above) |
| - |
| (0.01 | ) |
| - |
| (2.10 | ) | ||||
Non-GAAP net income per share –basic | $ | 0.33 | $ | 0.33 |
| $ | 0.82 | $ | 0.91 |
| ||||
Weighted average number of common shares used to calculate | 153,066 | 162,742 | 154,713 | 161,892 |
A reconciliation between diluted net income per share on a GAAP basis and on a non-GAAP basis is as follows:
| Three Months Ended | Nine Months Ended | ||||||||||||
| 2022 | 2021 | 2022 | 2021 |
| |||||||||
GAAP net income per share –diluted | $ | 0.28 | $ | 0.34 |
| $ | 0.69 | $ | 2.97 |
| ||||
Adjustments to GAAP net income per share (as detailed above) |
| - |
| (0.01 | ) |
| - |
| (2.07 | ) | ||||
Non-GAAP net income per share –diluted | $ | 0.28 | $ | 0.33 |
| $ | 0.69 | $ | 0.90 |
| ||||
Weighted average number of common shares used to calculate net income per share — diluted 1 |
| 184,465 |
| 165,242 |
|
| 186,504 |
| 163,930 |
|
_________________________________
1 Following the adoption of ASU 2020-06 on January 1, 2022, the dilutive impact of Ironwood’s convertible senior notes is determined using the if-converted method. As a result of this change, the weighted average number of common shares used to calculate diluted net income per share includes approximately 29.9 million shares related to the assumed conversion of the 2024 and 2026 convertible senior notes. Under the modified retrospective transition method elected by the Company in connection with the adoption of ASU 2020-06, diluted earnings per share for prior fiscal periods is not required to be restated. |
| Reconciliation of GAAP Net Income to Adjusted EBITDA | |||||||||||||||
(In thousands) | |||||||||||||||
(unaudited) | |||||||||||||||
A reconciliation of GAAP net income to adjusted EBITDA: | |||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||||||
GAAP net income | $ | 50,317 |
| $ | 55,845 |
| $ | 126,198 |
| $ | 487,074 |
| |||
Adjustments: |
|
|
| ||||||||||||
Mark-to-market adjustments on the derivatives related to convertible notes, net |
| (151 | ) |
| (2,164 | ) |
| (200 | ) |
| (1,388 | ) | |||
Restructuring expenses |
| - |
|
| (73 | ) |
| - |
|
| (44 | ) | |||
Interest expense |
| 1,524 |
|
| 7,841 |
|
| 6,072 |
|
| 23,199 |
| |||
Interest and investment income |
| (2,807 | ) |
| (178 | ) |
| (4,055 | ) |
| (546 | ) | |||
Income tax expense (benefit) |
| 19,590 |
|
| 3,827 |
|
| 53,959 |
|
| (332,672 | ) | |||
Depreciation and amortization |
| 362 |
|
| 358 |
|
| 1,078 |
|
| 1,164 |
| |||
Adjusted EBITDA | $ | 68,835 |
| $ | 65,456 |
| $ | 183,052 |
| $ | 176,787 |
|
U.S. LINZESS Commercial Collaboration 1 Revenue/Expense Calculation (In thousands) (unaudited) | ||||||||||||||||
|
|
|
|
|
| |||||||||||
| Three Months Ended | Nine Months Ended |
| |||||||||||||
| 2022 | 2021 | 2022 | 2021 |
| |||||||||||
LINZESS U.S. net sales as reported by AbbVie 2 | $ | 261,131 |
| $ | 252,650 |
| $ | 741,816 |
| $ | 727,301 |
|
| |||
AbbVie & Ironwood commercial costs, expenses and other discounts 3 |
| 68,499 |
|
| 66,658 |
|
| 205,878 |
|
| 197,608 |
|
| |||
Commercial profit on sales of LINZESS | $ | 192,632 |
| $ | 185,992 |
| $ | 535,938 |
| $ | 529,693 |
|
| |||
Commercial Margin4 |
| 74 | % |
| 74 | % |
| 72 | % |
| 73 | % |
| |||
|
|
|
|
| ||||||||||||
|
|
|
|
| ||||||||||||
Ironwood’s share of net profit |
| 96,316 |
|
| 92,996 |
|
| 267,969 |
|
| 264,846 |
|
| |||
Reimbursement for Ironwood’s commercial expenses |
| 8,908 |
|
| 7,397 |
|
| 26,026 |
|
| 21,803 |
|
| |||
Ironwood’s collaborative arrangement revenue 2 | $ | 105,224 |
| $ | 100,393 |
| $ | 293,995 |
| $ | 286,649 |
|
|
______________________________
| 1 Ironwood collaborates with AbbVie on the development and commercialization of linaclotide in North America. Under the terms of the collaboration agreement, Ironwood receives 50% of the net profits and bears 50% of the net losses from the commercial sale of LINZESS in the U.S. The purpose of this table is to present calculations of Ironwood’s share of net profit (loss) generated from the sales of LINZESS in the U.S. and Ironwood’s collaboration revenue/expense; however, the table does not present the research and development expenses related to LINZESS in the U.S. that are shared equally between the parties under the collaboration agreement. Please refer to the table at the end of this press release for net profit for the U.S. LINZESS brand collaboration with AbbVie. |
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 U.S. commercial costs, expenses and other discounts within Ironwood’s calculation of collaborative arrangements revenue. |
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 U.S. net sales. |
US LINZESS Full Brand Collaboration 1 Revenue/Expense Calculation (In thousands) (unaudited) | |||||||||||
| Three Months Ended | Nine Months Ended | |||||||||
| 2022 | 2021 | 2022 | 2021 | |||||||
LINZESS U.S. net sales as reported by AbbVie 2 | $ | 261,131 | $ | 252,650 | $ | 741,816 | $ | 727,301 | |||
AbbVie & Ironwood commercial costs, expenses and other discounts 3 |
| 68,499 |
| 66,658 |
| 205,878 |
| 197,608 | |||
AbbVie & Ironwood R&D Expenses 4 |
| 7,620 |
| 9, 753 |
| 24,000 |
| 28,400 | |||
Total net profit on sales of LINZESS | $ | 185,012 | $ | 176,239 | $ | 511,938 | $ | 501,293 |
______________________________
1 Ironwood collaborates with AbbVie on the development and commercialization of linaclotide in North America. Under the terms of the collaboration agreement, Ironwood receives 50% of the net profits and bears 50% of the net losses from the commercial sale of LINZESS in the U.S. The purpose of this table is to present calculations of the total net profit (loss) generated from the sales of LINZESS in the U.S., including the commercial costs and expenses and the research and development expenses related to LINZESS in the U.S. that are shared equally between the parties under the collaboration agreement. |
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 U.S. commercial costs, expenses and other discounts within Ironwood’s calculation of collaborative arrangements revenue. |
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 U.S. are shared equally between Ironwood and AbbVie under the collaboration agreement. |
View source version on businesswire.com:https://www.businesswire.com/news/home/20221103005098/en/
CONTACT: Investors:
Greg Martini, 617-374-5230
gmartini@ironwoodpharma.comMatt Roache, 617-621-8395
mroache@ironwoodpharma.comMedia:
Beth Calitri, 978-417-2031
bcalitri@ironwoodpharma.com
KEYWORD: MASSACHUSETTS UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: RESEARCH FDA CLINICAL TRIALS OTHER HEALTH BIOTECHNOLOGY GENERAL HEALTH PHARMACEUTICAL HEALTH SCIENCE OTHER SCIENCE
SOURCE: Ironwood Pharmaceuticals, Inc.
Copyright Business Wire 2022.
PUB: 11/03/2022 07:01 AM/DISC: 11/03/2022 07:03 AM
http://www.businesswire.com/news/home/20221103005098/en