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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
Current Report Pursuant to
Section 13 or 15(d) of the
Securities Exchange Act of 1934
Date of Report (Date of Earliest Event Reported):
May 9, 2024
IRONWOOD PHARMACEUTICALS, INC.
(Exact name of registrant as specified
in its charter)
| Delaware |
|
001-34620 |
|
04-3404176 |
| (State
or other jurisdiction |
|
(Commission
File Number) |
|
(I.R.S.
Employer |
| of incorporation) |
|
|
|
Identification Number) |
| 100 Summer Street, Suite 2300 |
|
|
|
|
| Boston, Massachusetts |
|
|
|
02110 |
(Address
of principal
executive
offices) |
|
|
|
(Zip
code) |
(617)
621-7722
(Registrant’s telephone number,
including area code)
Check the appropriate box below if the
Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
| ¨ | Written communications pursuant to Rule 425 under
the Securities Act (17 CFR 230.425) |
| ¨ | Soliciting material pursuant to Rule 14a-12 under
the Exchange Act (17 CFR 240.14a-12) |
| ¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under
the Exchange Act (17 CFR 240.14d-2(b)) |
| ¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under
the Exchange Act (17 CFR 240.13e-4(c)) |
Securities registered pursuant to Section 12(b) of the Act:
| Title of each class |
Trading Symbol(s) |
Name of each exchange on which
registered |
| Class A common stock, $0.001 par value |
IRWD |
Nasdaq Global Select Market |
Indicate by check mark whether the
registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this
chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ¨
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
¨
Item 2.02 Results of Operations and Financial Condition.
On May 9, 2024, Ironwood Pharmaceuticals, Inc.
issued a press release containing an update on its recent business activities as well as those for the quarter ended March 31, 2024.
A copy of the press release is furnished as Exhibit 99.1 and is incorporated herein by reference.
The press release is being furnished pursuant
to Item 2.02 of this Current Report on Form 8-K and shall not be deemed “filed” for purposes of Section 18 of the
Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that Section,
nor shall such document be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange
Act except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
Pursuant to the requirements of the Securities
Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| |
Ironwood Pharmaceuticals, Inc. |
| |
|
|
| Dated: May 9, 2024 |
By: |
/s/
Sravan K. Emany |
| |
|
Name: |
Sravan K. Emany |
| |
|
Title: |
Senior Vice President, Chief
Financial Officer |
Exhibit 99.1
Ironwood Pharmaceuticals Reports First
Quarter 2024 Results
– Reported positive topline results from
global Phase III STARS trial of once-weekly apraglutide in adults with short bowel syndrome with intestinal failure (SBS-IF) –
– Reported positive results from Phase
II exploratory STARGAZE trial of apraglutide in patients with steroid-refractory gastrointestinal acute Graft-versus-Host Disease (SR
GI aGVHD) –
– LINZESS® (Iinaclotide)
EUTRx prescription demand growth of 10% year-over-year –
– Revises FY 2024 financial guidance due
to a LINZESS gross-to-net change in estimate –
BOSTON, Mass., May 9, 2024
— Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused healthcare company,
today reported its first quarter 2024 results and recent business performance.
“In the first quarter of 2024, we made significant advancements
across our portfolio,” said Tom McCourt, chief executive officer of Ironwood. “LINZESS maintained its strong demand momentum,
experiencing a rise in prescription volume by a robust 10% year-over-year, while continuing to generate meaningful cash flow. Particularly
noteworthy during the quarter was the positive Phase III clinical data for apraglutide, which validates its potential as the first and
only once-weekly GLP-2 analog for adult patients with short bowel syndrome who are dependent on parenteral support. The positive results
from the STARS trial, coupled with our proven track record of effective commercial execution, uniquely position Ironwood in the market
and reinforce our belief in the long-term value potential of apraglutide for patients and shareholders. We are working swiftly and plan
to file an NDA as soon as possible for apraglutide for adult SBS patients dependent on parenteral support. In addition, we remain focused
on executing across our strategic priorities by advancing our other GI pipeline assets, driving robust LINZESS demand growth, and delivering
sustained profits and cash flow.”
First Quarter 2024 Financial
Highlights1
(in thousands, except for per share amounts)
| | |
Q1 2024 | | |
Q1 2023 | |
| Total revenue2 | |
$ | 74,877 | | |
$ | 104,061 | |
| Total operating expenses | |
| 63,857 | | |
| 43,964 | |
| GAAP net income (loss)2 | |
| (4,162 | ) | |
| 45,714 | |
| GAAP net income (loss) – per share basic2 | |
| (0.03 | ) | |
| 0.30 | |
| GAAP net income (loss) – per share diluted2 | |
| (0.03 | ) | |
| 0.25 | |
| Adjusted EBITDA2 | |
| 12,757 | | |
| 60,383 | |
| Non-GAAP net income (loss) 2 | |
| (2,933 | ) | |
| 45,695 | |
| Non-GAAP net income (loss) per share – basic | |
| (0.02 | ) | |
| 0.30 | |
| Non-GAAP net income (loss) per share – diluted | |
| (0.02 | ) | |
| 0.25 | |
1 Refer to the Reconciliation of GAAP Results
to Non-GAAP Financial Measures table and to the Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA table at the end of this
press release. Refer to Non-GAAP Financial Measures for additional information.
2 Figures presented in Q1 2024 include a $30.0
million reduction to collaborative arrangements revenue due to a LINZESS gross-to-net change in estimate related to the year ended December 31,
2023.
First Quarter 2024 Corporate
Highlights
U.S. LINZESS
| · | Prescription Demand: Total LINZESS prescription demand in the first
quarter of 2024 was 50 million LINZESS capsules, a 10% increase compared to the first quarter of 2023, per IQVIA. |
| · | U.S. Brand Collaboration: LINZESS U.S. net sales are provided to Ironwood
by its U.S. partner, AbbVie Inc. (“AbbVie”). LINZESS U.S. net sales were $256.6 million in the first quarter of 2024, a 3%
increase compared to $250.2 million in the first quarter of 2023. Ironwood and AbbVie share equally in U.S. brand collaboration profits. |
| – | Based on information subsequently provided by AbbVie, Ironwood recorded a $30 million reduction to collaborative arrangements
revenue in its first quarter 2024 financial statements as a result of a LINZESS gross-to-net change in estimate related to the year ended
December 31, 2023. See the LINZESS U.S. Commercial Collaboration table at the end of the press release. |
| – | LINZESS commercial margin, excluding the gross-to-net change in estimate, was 71% in the first quarter of 2024, compared to 73% in
the first 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 excluding the gross-to-net change in estimate, was $175.6 million in the first quarter of 2024, compared to $175.2 million in the
first quarter of 2023. See the U.S. LINZESS Full Brand Collaboration table at the end of this press release. |
| · | Collaboration Revenue to Ironwood: Ironwood recorded $71.7 million
in collaboration revenue in the first quarter of 2024 related to sales of LINZESS in the U.S., a decrease compared to $101.6 million for
the first quarter of 2023, due to a $30.0 million reduction to collaborative arrangements revenue from a LINZESS gross-to-net change in
estimate as noted above. See the U.S. LINZESS Commercial Collaboration table at the end of the press release. |
| · | In
January 2024, Ironwood announced a publication in The Lancet Gastroenterology &
Hepatology of new linaclotide Phase III data in children and adolescents aged 6-17 years
with functional constipation. The data highlighted additional efficacy endpoints from the
company’s pivotal Phase III trial, which formed the basis of the June 2023 U.S.
Food and Drug Administration (“FDA”) approval of linaclotide for the treatment
of functional constipation in this population. Additional details can be found here. |
Pipeline Updates
Apraglutide
| · | Ironwood is advancing apraglutide, a next-generation, synthetic glucagon-like
peptide-2 (“GLP-2”) analog for short bowel syndrome 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
February 2024, Ironwood announced positive topline results from its pivotal Phase
III clinical trial, STARS, which evaluated the efficacy and safety of once-weekly subcutaneous
apraglutide in reducing PS dependency in adult patients with short bowel syndrome with intestinal
failure (“SBS-IF”). Based on the results from the STARS clinical trial, Ironwood
plans to submit a new drug application and other regulatory filings for apraglutide for use
in adult patients with SBS who are dependent on PS. Additional details on the topline results
can be found here. Data from the Phase III STARS
study was accepted as a late-breaker oral presentation and will be presented on May 21,
2024 at Digestive Disease Week® (DDW) 2024 in Washington D.C. |
| · | In
March 2024, Ironwood announced positive, primary results up to Day 91 for its Phase
II exploratory trial, STARGAZE, to evaluate apraglutide in patients with steroid-refractory
gastrointestinal acute Graft-versus-Host Disease (“SR GI aGvHD”), which evaluated
the safety and tolerability of once-weekly apraglutide in SR GI aGvHD patients treated with
standard of care, including systemic corticosteroids and ruxolitinib. The STARGAZE study
will continue through its two-year endpoint, where apraglutide will be re-evaluated for safety
and efficacy. Additional details can be found here. |
CNP-104
| · | Ironwood has a collaboration and license option agreement with COUR Pharmaceuticals
Development Company, Inc. (“COUR”). This agreement grants Ironwood an option to acquire an exclusive license to research,
develop, manufacture and commercialize, in the U.S., products containing CNP-104 (“CNP-104”), a tolerizing immune modifying
nanoparticle, for the treatment of primary biliary cholangitis (“PBC”), a rare autoimmune disease targeting the liver. If
successful, CNP-104 has the potential to be the first approved disease modifying therapy for PBC. |
| · | COUR is currently conducting a clinical study with CNP-104 evaluating the
safety, tolerability, pharmacodynamic effects and efficacy of CNP-104 in PBC patients. Enrollment is complete and 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. |
First Quarter
2024 Financial Results
| · | Total Revenue. Total revenue in the first quarter of 2024 was $74.9
million, compared to $104.1 million in the first quarter of 2023. |
| – | As noted above, revenue was lower year-over-year primarily due to the $30.0 million LINZESS gross-to-net change in estimate recorded
to collaborative arrangements revenue. |
| – | Total revenue in the first quarter of 2024 consisted of $71.7 million associated with Ironwood’s share of the net profits from
the sales of LINZESS in the U.S., including the $30.0 million reduction, and $3.2 million in royalties and other revenue. Total revenue
in the first quarter of 2023 consisted of $101.6 million associated with Ironwood’s share of the net profits from the sales of LINZESS
in the U.S. and $2.5 million in royalties and other revenue. |
| · | Operating Expenses. Operating expenses in the first quarter of 2024
were $63.9 million, compared to $44.0 million in the first quarter of 2023. |
| – | Operating expenses in the first quarter of 2024 consisted of $37.6 million in selling, general and administrative (“SG&A”)
expenses, $25.8 million in R&D expenses and $0.4 million in restructuring expenses. Operating expenses in the first quarter of 2023
consisted of $31.1 million in SG&A expenses and $12.9 million in R&D expenses. |
| · | Interest Expense. Interest expense was $7.2 million in the first quarter
of 2024, primarily in connection with Ironwood’s convertible senior notes and revolving credit facility. Interest expense was $1.5
million in the first quarter of 2023, in connection with Ironwood’s convertible senior notes. |
| · | Interest and Investment Income. Interest and investment income was
$1.2 million in the first quarter of 2024. Interest and investment income was $7.3 million in the first quarter of 2023. |
| · | Gain on Derivatives. Ironwood recorded a gain on derivatives of an
insignificant amount in the first quarter of 2023, as a result of the change in fair value of its note hedge warrants. Ironwood’s
note hedge warrants terminated unexercised upon expiration in April 2023. |
| · | Income Tax Expense. Ironwood recorded $9.1 million of income tax expense
in the first 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 $20.1 million of income tax expense in the first 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 Income (Loss). GAAP net loss was $4.2 million, or ($0.03)
per share (basic and diluted), in the first quarter of 2024, which includes a $30.0 million reduction to collaborative arrangements revenue
due to a LINZESS gross-to-net change in estimate, compared to GAAP net income of $45.7 million, or $0.30 per share (basic) and $0.25 per
share (diluted), in the first quarter of 2023. |
| · | Non-GAAP Net Income (Loss). Non-GAAP net loss was $2.9 million, or
($0.02) per share (basic and diluted), in the first quarter of 2024, which includes a $30.0 million reduction to collaborative arrangements
revenue due to a LINZESS gross-to-net change in estimate, compared to non-GAAP net income of $45.7 million, or $0.30 per share (basic)
and $0.25 per share (diluted), in the first quarter of 2023. |
| – | 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 $12.8 million in the first quarter
of 2024, which includes a $30.0 million reduction to collaborative arrangements revenue due to a LINZESS gross-to-net change in estimate,
compared to $60.4 million in the first quarter of 2023. |
| – | Adjusted EBITDA is calculated by subtracting mark-to-market adjustments on derivatives related to Ironwood’s 2022 Convertible
Notes, restructuring expenses, net interest expense, income taxes, depreciation and amortization, and acquisition-related costs, from
GAAP net income. See Non-GAAP Financial Measures below. |
| · | Cash Flow Highlights. Ironwood ended the first quarter of 2024 with
$121.5 million of cash and cash equivalents, compared to $92.2 million of cash and cash equivalents at the end of 2023. |
| – | In the first quarter of 2024, Ironwood repaid $25.0 million of the outstanding principal balance on its revolving credit facility
used to partially finance the VectivBio acquisition. The outstanding principal balance on the revolving credit facility was $275.0 million
as of March 31, 2024. |
| – | Ironwood generated $45.0 million in cash from operations in the first quarter of 2024, compared to $80.2 million in cash from operations
in the first quarter of 2023. |
| · | Ironwood 2024 Financial Guidance. Ironwood has revised its FY 2024
financial guidance due to a LINZESS gross-to-net change in estimate related to the year ended December 31, 2023. Ironwood now expects: |
| |
Prior
2024 Guidance
(February 15, 2024) |
Revised
2024 Guidance2
(May 9, 2024) |
| U.S.
LINZESS Net Sales3 |
Low-single
digits % growth
|
Mid-single
digits % decline |
| Total
Revenue |
$435
to $455 million
|
$405
to $425 million |
| Adjusted
EBITDA1 |
>$150
million
Excludes
potential CNP-104 option exercise |
>$120
million
Excludes
potential CNP-104 option exercise |
1 Adjusted EBITDA is calculated by subtracting restructuring
expenses, net interest expense, income taxes, depreciation and amortization, and acquisition-related costs from GAAP net income. For
purposes of the 2024 guidance, Ironwood has assumed it will not incur material expenses related to business development activities
in 2024 and excludes any costs associated with potential CNP-104 option exercise. Ironwood does not provide guidance on GAAP net income
or a reconciliation of expected adjusted EBITDA to expected GAAP net income because, without unreasonable efforts, it is unable to predict
with reasonable certainty the non-GAAP adjustments used to calculate adjusted EBITDA. These adjustments are uncertain, depend on various
factors and could have a material impact on GAAP net income for the guidance period. Management believes this non-GAAP information is
useful for investors, taken in conjunction with Ironwood’s GAAP financial statements, because it provides greater transparency
and period-over-period comparability with respect to Ironwood’s operating performance. These measures are also used by management
to assess the performance of the business. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute
for or as superior to, measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures
are unlikely to be comparable with non-GAAP information provided by other companies.
2 Based on information provided by AbbVie, Ironwood estimates a $60.0 million LINZESS gross-to-net change related to the year ended December
31, 2023, and has recorded a $30.0 million reduction to collaborative arrangements revenue in its first quarter 2024 financial statements
to reflect this change in estimate.
3 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 $1,073.2 million.
Non-GAAP Financial Measures
Ironwood presents non-GAAP net income and non-GAAP net income per share
to exclude the impact, net of tax effects, of net gains and losses on derivatives related to Ironwood’s 2022 Convertible Notes that
are required to be marked-to-market, amortization of acquired intangible assets, restructuring expenses, and acquisition-related costs.
Non-GAAP adjustments are further detailed below:
| · | The gains and losses on the derivatives related to Ironwood’s 2022
Convertible Notes were highly variable, difficult to predict and of a size that could have a substantial impact on the company’s
reported results of operations in any given period. |
| · | Amortization of acquired intangible assets are non-cash expenses arising
in connection with the acquisition of VectivBio and are considered to be non-recurring. |
| · | Restructuring expenses are considered to be a non-recurring event as they
are associated with distinct operational decisions. Included in restructuring expenses are costs associated with exit and disposal activities. |
| · | Acquisition-related costs in connection with the acquisition of VectivBio
are considered to be non-recurring and include direct and incremental costs associated with the acquisition and integration of VectivBio
to the extent such costs were not classified as capitalizable transaction costs attributed to the cost of net assets acquired through
acquisition accounting. |
Ironwood also presents adjusted EBITDA, a non-GAAP measure, as well
as guidance on adjusted EBITDA. Adjusted EBITDA is calculated by subtracting mark-to-market adjustments on derivatives related to Ironwood’s
2022 Convertible Notes, restructuring expenses, net interest expense, income taxes, depreciation and amortization, and acquisition-related
costs from GAAP net income. The adjustments are made on a similar basis as described above related to non-GAAP net income, as applicable.
Management believes this non-GAAP information is useful for investors,
taken in conjunction with Ironwood’s GAAP financial statements, because it provides greater transparency and period-over-period
comparability with respect to Ironwood’s operating performance. These measures are also used by management to assess the performance
of the business. Investors should consider these non-GAAP measures only as a supplement to, not as a substitute for or as superior to,
measures of financial performance prepared in accordance with GAAP. In addition, these non-GAAP financial measures are unlikely to be
comparable with non-GAAP information provided by other companies. For a reconciliation of non-GAAP net income and non-GAAP net income
per share to GAAP net income and GAAP net income per share, respectively, and for a reconciliation of adjusted EBITDA to GAAP net income,
please refer to the tables at the end of this press release.
Ironwood does not provide guidance on GAAP net income or a reconciliation
of expected adjusted EBITDA to expected GAAP net income because, without unreasonable efforts, it is unable to predict with reasonable
certainty the non-GAAP adjustments used to calculate adjusted EBITDA. These adjustments are uncertain, depend on various factors
and could have a material impact on GAAP net income for the guidance period.
Conference Call Information
Ironwood will host a conference call
and webcast at 8:30 a.m. Eastern Time on Thursday, May 9, 2024 to discuss its first quarter 2024 results and recent business
activities. Individuals interested in participating in the call should dial (888) 596-4144 (U.S. and Canada) or (646) 968-2525 (international)
using conference ID number and event passcode 3416473. 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 May 9,
2024, running through 11:59 p.m. Eastern Time on May 23, 2024. To listen to the replay, dial (800) 770-2030 (U.S. and
Canada) or (609) 800-9909 (international) using conference ID number 3416473. The archived webcast will be available on Ironwood’s
website for 1 year 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).
LINZESS is also approved for the treatment of functional constipation in pediatric patients ages 6-17 years-old. Ironwood is also advancing
apraglutide, a next-generation, long-acting synthetic GLP-2 analog being developed for rare gastrointestinal diseases, including short
bowel syndrome with intestinal failure (SBS-IF) as well as several earlier stage assets. Building upon our history of GI innovation, 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, with a site in Basel, Switzerland.
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 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. LINZESS relieves constipation in children and adolescents
aged 6 to 17 years with functional constipation. 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. In children with functional
constipation aged 6 to 17 years, the recommended dose is 72 mcg.
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 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 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 U.S.
net sales growth, total revenue and adjusted EBITDA in 2024; our plan to file an NDA for apraglutide as soon as possible and apraglutide's
potential, if approved, to be the first and only once-weekly GLP-2 analog for adult SBS patients who are dependent on PS; our belief that
the positive results from the STARS Phase III trial, coupled with our proven track record of effective commercial execution, position
Ironwood uniquely in the market and reinforce our belief in the long-term value potential of apraglutide for patients and shareholders;
our plan to file an NDA for apraglutide for adult SBS patients dependent on PS as soon as possible; and the timing of topline data for
CNP-104 and that, if successful, CNP-104 has the potential to be the first approved disease modifying therapy for PBC. 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, apraglutide,
CNP-104, IW-3300, and our other product candidates; the risk of uncertainty relating to pricing and reimbursement policies in the
U.S., which, if not favorable for our products, could hinder or prevent our products’ commercial success; the risk that clinical
programs and studies, including for linaclotide pediatric programs, apraglutide, CNP-104 and IW-3300, 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 studies and clinical trials may not be replicated in later trials
and earlier-stage clinical trials may not be predictive of the results we may obtain in later-stage clinical trials or of the likelihood
of regulatory approval; the risk of competition or that new products may emerge that provide different or better alternatives for treatment
of the conditions that our products are approved to treat; the risk that we are unable to execute on our strategy to in-license externally
developed products or product candidates; the risk that we are unable to successfully partner with other companies to develop and commercialize
products or product candidates; the risk that healthcare reform and other governmental and private payor initiatives may have an adverse
effect upon or prevent our products’ or product candidates’ commercial success; the efficacy, safety and tolerability of linaclotide
and our product candidates; the risk that the commercial and therapeutic opportunities for LINZESS, apraglutide or our other product candidates
are not as we expect; decisions by regulatory and judicial authorities; the risk we may never get additional patent protection for linaclotide,
apraglutide and other product candidates, that patents for linaclotide, apraglutide 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 the development of any of our linaclotide pediatric programs,
apraglutide, CNP-104 and/or IW-3300 is not successful or that any of our product candidates does not receive regulatory approval or 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 our
indebtedness could adversely affect our financial condition or restrict our future operations; and the risks listed under the heading
“Risk Factors” and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2023, and in our
subsequent Securities and Exchange Commission filings.
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
Condensed Consolidated Balance Sheets
(In thousands)
(unaudited)
| | |
March 31,
2024 | | |
December 31,
2023 | |
| Assets | |
| | | |
| | |
| Cash and cash equivalents | |
$ | 121,540 | | |
$ | 92,154 | |
| Accounts receivable, net | |
| 72,015 | | |
| 129,122 | |
| Prepaid expenses and other current assets | |
| 14,619 | | |
| 12,012 | |
| Total current assets | |
| 208,174 | | |
| 233,288 | |
| Property and equipment, net | |
| 5,288 | | |
| 5,585 | |
| Operating lease right-of-use assets | |
| 12,208 | | |
| 12,586 | |
| Intangible assets, net | |
| 3,478 | | |
| 3,682 | |
| Deferred tax assets | |
| 206,273 | | |
| 212,324 | |
| Other assets | |
| 3,398 | | |
| 3,608 | |
| Total assets | |
$ | 438,819 | | |
$ | 471,073 | |
| Liabilities and stockholders’ equity | |
| | | |
| | |
| Accounts payable | |
$ | 6,222 | | |
$ | 7,830 | |
| Accrued research and development costs | |
| 11,880 | | |
| 21,331 | |
| Accrued expenses and other current liabilities | |
| 31,398 | | |
| 44,254 | |
| Current portion of operating lease liabilities | |
| 3,142 | | |
| 3,126 | |
| Current portion on convertible senior notes | |
| 199,800 | | |
| 199,560 | |
| Total current liabilities | |
| 252,442 | | |
| 276,101 | |
| Operating lease liabilities, net of current portion | |
| 14,004 | | |
| 14,543 | |
| Convertible senior notes, net of current portion | |
| 198,477 | | |
| 198,309 | |
| Revolving credit facility | |
| 275,000 | | |
| 300,000 | |
| Other liabilities | |
| 29,414 | | |
| 28,415 | |
| Total stockholders’ deficit | |
| (330,518 | ) | |
| (346,295 | ) |
| Total liabilities and stockholders’ deficit | |
$ | 438,819 | | |
$ | 471,073 | |
Condensed Consolidated Statements of Income
(Loss)
(In thousands, except per share amounts)
(unaudited)
| | |
Three Months Ended
March 31, | |
| | |
2024 | | |
2023 | |
| Total revenue1 | |
| 74,877 | | |
| 104,061 | |
| Collaborative arrangements revenue1 | |
| 71,700 | | |
| 101,600 | |
| Operating expenses: | |
| | | |
| | |
| Research and development | |
| 25,815 | | |
| 12,847 | |
| Selling, general and administrative | |
| 37,605 | | |
| 31,117 | |
| Restructuring expenses | |
| 437 | | |
| - | |
| Total operating expenses | |
| 63,857 | | |
| 43,964 | |
| Income from operations | |
| 11,020 | | |
| 60,097 | |
| Other income (expense): | |
| | | |
| | |
| Interest expense and other financing costs | |
| (7,231 | ) | |
| (1,527 | ) |
| Interest and investment income | |
| 1,169 | | |
| 7,272 | |
| Gain on derivatives | |
| - | | |
| 19 | |
| Other income (expense), net | |
| (6,062 | ) | |
| 5,764 | |
| Income before income taxes | |
| 4,958 | | |
| 65,861 | |
| Income tax expense | |
| (9,120 | ) | |
| (20,147 | ) |
| GAAP net income (loss)1 | |
$ | (4,162 | ) | |
$ | 45,714 | |
| | |
| | | |
| | |
| GAAP net income (loss) per share—basic1 | |
($ | 0.03 | ) | |
$ | 0.30 | |
| | |
| | | |
| | |
| GAAP net income (loss) per share—diluted1 | |
($ | 0.03 | ) | |
$ | 0.25 | |
1
Figures presented in Q1 2024 reflect a $30.0 million reduction to collaborative arrangements revenue due to a LINZESS gross-to-net change
in estimate related to the year ended December 31, 2023.
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
March 31, | |
| | |
2024 | | |
2023 | |
| GAAP
net income (loss)1,2 | |
$ | (4,162 | ) | |
$ | 45,714 | |
| Adjustments: | |
| | | |
| | |
| Mark-to-market adjustments on the derivatives related to convertible notes, net | |
| - | | |
| (19 | ) |
| Amortization of acquired intangible assets | |
| 204 | | |
| - | |
| Restructuring expenses | |
| 437 | | |
| - | |
| Acquisition-related costs | |
| 787 | | |
| - | |
| Tax effect of adjustments | |
| (199 | ) | |
| - | |
| Non-GAAP net income (loss)1,2 | |
$ | (2,933 | ) | |
$ | 45,695 | |
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
March 31, | |
| | |
2024 | | |
2023 | |
| GAAP net income (loss) – basic | |
$ | (0.03 | ) | |
$ | 0.30 | |
| Adjustments to GAAP net income (loss) per share (as detailed above) | |
| 0.01 | | |
| (0.00 | ) |
| Non-GAAP net income (loss) per share – basic | |
$ | (0.02 | ) | |
$ | 0.30 | |
| Weighted average number of common shares used to calculate net income (loss) per share — basic | |
| 157,700 | | |
| 154,452 | |
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
March 31, | |
| | |
2024 | | |
2023 | |
| GAAP net income (loss) per share – diluted | |
$ | (0.03 | ) | |
$ | 0.25 | |
| Adjustments to GAAP net income (loss) per share (as detailed
above) | |
| 0.01 | | |
| (0.00 | ) |
| Non-GAAP net income (loss) per share – diluted | |
$ | (0.02 | ) | |
$ | 0.25 | |
Weighted average number of common shares used to calculate net income (loss) per share — diluted
| |
| 157,700 | | |
| 186,680 | |
1
Q1 2024 GAAP and non-GAAP net loss reflect costs associated with the acquisition of VectivBio in the second quarter of 2023.
2
Q1 2024 GAAP and non-GAAP net loss reflect a $30.0 million reduction to collaborative arrangements revenue due to a LINZESS gross-to-net
change in estimate related to the year ended December 31, 2023.
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
March 31, | |
| | |
2024 | | |
2023 | |
| GAAP net income (loss)1,2 | |
$ | (4,162 | ) | |
$ | 45,714 | |
| Adjustments: | |
| | | |
| | |
| Mark-to-market adjustments on the derivatives related to convertible notes, net | |
| - | | |
| (19 | ) |
| Restructuring expenses | |
| 437 | | |
| - | |
| Interest expense | |
| 7,231 | | |
| 1,527 | |
| Interest and investment income | |
| (1,169 | ) | |
| (7,272 | ) |
| Income tax expense | |
| 9,120 | | |
| 20,147 | |
| Depreciation and amortization | |
| 513 | | |
| 286 | |
| Acquisition-related costs | |
| 787 | | |
| - | |
| Adjusted EBITDA1,2 | |
$ | 12,757 | | |
$ | 60,383 | |
1
Q1 2024 GAAP net loss and adjusted EBITDA reflect costs associated with the acquisition of VectivBio in the second quarter of 2023.
2
Q1 2024 GAAP net loss and adjusted EBITDA reflect a $30.0 million reduction to collaborative arrangements revenue due to a LINZESS gross-to-net
change in estimate related to the year ended December 31, 2023.
U.S. LINZESS Commercial Collaboration1
Revenue/Expense Calculation
(In thousands)
(unaudited)
| | |
Three Months Ended
March 31, | |
| | |
2024 | | |
2023 | |
| LINZESS U.S. net sales as reported by AbbVie2 | |
$ | 256,600 | | |
$ | 250,214 | |
| AbbVie &
Ironwood commercial costs, expenses and other discounts3 | |
| 73,362 | | |
| 66,408 | |
| Commercial profit on sales of LINZESS | |
$ | 183,238 | | |
$ | 183,806 | |
| Commercial Margin4 | |
| 71 | % | |
| 73 | % |
| | |
| | | |
| | |
| Ironwood’s share of net profit | |
| 91,619 | | |
| 91,903 | |
| Reimbursement for Ironwood’s commercial expenses | |
| 10,096 | | |
| 9,728 | |
| Ironwood’s portion of gross-to-net change in estimate5 | |
| (30,000 | ) | |
| - | |
| Ironwood’s collaborative arrangements revenue | |
$ | 71,715 | | |
$ | 101,631 | |
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.
5
Based on information provided by AbbVie, Ironwood estimates a $60.0 million LINZESS gross-to-net change related to the year ended December
31, 2023, and has recorded a $30.0 million reduction to collaborative arrangements revenue in its first quarter 2024 financial statements
to reflect this change in estimate.
US LINZESS Full Brand Collaboration1
Revenue/Expense Calculation
(In thousands)
(unaudited)
| | |
Three Months Ended
March 31, | |
| | |
2024 | | |
2023 | |
| LINZESS U.S. net sales as reported by AbbVie2 | |
$ | 256,600 | | |
$ | 250,214 | |
| AbbVie & Ironwood commercial costs, expenses and other discounts3 | |
| 73,362 | | |
| 66,408 | |
| AbbVie &
Ironwood R&D Expenses4 | |
| 7,636 | | |
| | |
| Total net profit on sales of LINZESS5 | |
$ | 175,602 | | |
$ | 175,156 | |
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.
5 Total net profit on sales of LINZESS does not reflect
the estimated gross-to-net change related to the year ended December 31, 2023.
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Ironwood Pharmaceuticals (NASDAQ:IRWD)
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From Nov 2024 to Dec 2024
Ironwood Pharmaceuticals (NASDAQ:IRWD)
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From Dec 2023 to Dec 2024
