– LINZESS® (Iinaclotide) EUTRx prescription
demand growth of 13% year-over-year –
– Remains on track to complete apraglutide NDA
submission in Q1 2025 –
– Maintains Full Year 2024 Financial Guidance
–
Ironwood Pharmaceuticals, Inc. (Nasdaq: IRWD), a GI-focused
healthcare company, today reported its third quarter 2024 results
and recent business performance.
“LINZESS continued to deliver robust prescription demand growth
in the third quarter,” said Tom McCourt, chief executive officer of
Ironwood Pharmaceuticals. “LINZESS extended units and new-to-brand
prescriptions each increased 13% year-over-year, respectively,
reinforcing that patients and health care professionals continue to
choose LINZESS in a growing market. Although LINZESS has faced
pricing headwinds throughout 2024, we are maintaining our full year
financial guidance. With apraglutide, we continue making progress
in preparing the NDA submission and remain on track to complete the
submission in the first quarter of 2025. Our team is focused on
getting apraglutide to market as soon as possible, and we look
forward to providing more updates on our progress in the months
ahead. We believe that, if approved, apraglutide would be the drug
of choice among physicians to treat adult patients with short bowel
syndrome who are dependent on parenteral support.”
Third Quarter 2024 Financial Highlights1 (in thousands,
except for per share amounts)
Q3 2024
Q3 2023
Total revenue
$91,592
$113,739
Total costs and expenses
65,956
73,716
GAAP net income
3,646
13,950
GAAP net income attributable to Ironwood
Pharmaceuticals, Inc.
3,646
15,321
GAAP net income – per share basic
0.02
0.10
GAAP net income – per share diluted
0.02
0.09
Adjusted EBITDA
26,159
49,079
Non-GAAP net income
3,869
21,802
Non-GAAP net income per share – basic
0.02
0.14
Non-GAAP net income per share –
diluted
0.02
0.12
1 Refer to the Reconciliation of GAAP Results to Non-GAAP
Financial Measures table and to the Reconciliation of GAAP Net
Income to Adjusted EBITDA table at the end of this press release.
Refer to Non-GAAP Financial Measures for additional
information.
Third Quarter 2024 Corporate Highlights
U.S. LINZESS
- Prescription Demand: Total LINZESS
prescription demand in the third quarter of 2024 was 54 million
LINZESS capsules, a 13% increase compared to the third quarter of
2023, per IQVIA.
- U.S. Brand Collaboration: LINZESS
U.S. net sales are provided to Ironwood by its U.S. partner, AbbVie
Inc. (“AbbVie”). LINZESS U.S. net sales were $225.5 million in the
third quarter of 2024, a 19% decrease compared to $279.0 million in
the third quarter of 2023. Ironwood and AbbVie share equally in
U.S. brand collaboration profits.
- LINZESS commercial margin was 65% in the third quarter of 2024,
compared to 72% in the third 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, was
$139.6 million in the third quarter of 2024, a decrease compared to
$192.0 million in the third 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 $88.9 million in collaboration revenue in the
third quarter of 2024 related to sales of LINZESS in the U.S.,
compared to $110.1 million for the third quarter of 2023. Third
quarter of 2024 collaboration revenue to Ironwood includes a $5.8
million positive adjustment to reflect Ironwood’s estimate of
LINZESS gross-to-net reserves as of September 30, 2024. See the
U.S. LINZESS Commercial Collaboration table at the end of the press
release.
Pipeline Updates
Apraglutide
- Ironwood is advancing apraglutide, a next-generation, synthetic
glucagon-like peptide-2 (“GLP-2”) analog for short bowel syndrome
(“SBS”) patients dependent on parenteral support (“PS”), a severe
chronic malabsorptive condition. Ironwood believes apraglutide has
the potential to improve the standard of care for adult patients
with SBS who are dependent on PS as the first and only GLP-2 with
once-weekly administration, if approved.
- Ironwood is working to submit a new drug application (“NDA”) to
the U.S. Food and Drug Administration (“FDA”) and marketing
applications to other regulatory agencies for apraglutide for the
treatment of adult patients with SBS who are dependent on PS.
CNP-104
- In the third quarter of 2024, Ironwood received from COUR
Pharmaceutical Development Company, Inc. (“COUR”) the topline data
from COUR’s Phase II clinical study for the treatment of primary
biliary cholangitis. On September 27, 2024, Ironwood notified COUR
of its decision not to exercise the option to acquire an exclusive
license to CNP-104. As a result, the collaboration and license
option agreement between Ironwood and COUR terminated, and Ironwood
retains no rights and has no obligations related to CNP-104.
IW-3300
- Ironwood is advancing IW-3300, a guanylate cyclase-C agonist
for the potential treatment of visceral pain conditions, such as
interstitial cystitis / bladder pain syndrome (“IC/BPS”) and
endometriosis. Ironwood has decided to end further recruitment for
the Phase II proof of concept study in IC/BPS and analyze the data
once all currently enrolled patients complete the full 12-week
study assessment, which will inform the next steps on the
program.
Revolving Credit Facility
- In September 2024, Ironwood entered into a first amendment to
its revolving credit agreement to, among other things, increase the
quantum of the revolving credit facility from $500.0 million to
$550.0 million, extend the maturity date, and increase Ironwood’s
permitted maximum consolidated secured net leverage ratio.
Additional details can be found in Ironwood’s Form 8-K filing dated
September 30, 2024.
Third Quarter 2024 Financial Results
- Total Revenue. Total revenue in the third quarter of
2024 was $91.6 million, compared to $113.7 million in the third
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 third quarter of 2024 consisted of $88.9
million associated with Ironwood’s share of the net profits from
the sales of LINZESS in the U.S., and $2.7 million in royalties and
other revenue. Total revenue in the third quarter of 2023 consisted
of $110.1 million associated with Ironwood’s share of the net
profits from the sales of LINZESS in the U.S. and $3.6 million in
royalties and other revenue.
- Total Costs and Expenses. Total costs and expenses in
the third quarter of 2024 were $66.0 million, compared to $73.7
million in the third quarter of 2023.
- Total costs and expenses in the third quarter of 2024 consisted
of $36.1 million in selling, general and administrative
(“SG&A”) expenses, $29.8 million in R&D expenses and an
insignificant amount in restructuring expenses. Total costs and
expenses in the third quarter of 2023 consisted of $36.0 million in
SG&A expenses, $33.0 million in R&D expenses and $4.7
million in restructuring expenses.
- Interest Expense. Interest expense was $9.4 million in
the third quarter of 2024, in connection with Ironwood’s
convertible senior notes and revolving credit facility. Interest
expense was $9.8 million in the third quarter of 2023, in
connection with Ironwood’s convertible senior notes and revolving
credit facility.
- Interest and Investment Income. Interest and investment
income was $1.2 million in the third quarter of 2024. Interest and
investment income was $1.7 million in the third quarter of
2023.
- Income Tax Expense. Ironwood recorded $13.7 million of
income tax expense in the third quarter of 2024, the majority of
which was non-cash, as Ironwood continues to utilize net operating
losses to offset taxable income for federal purposes and in many
states. Ironwood recorded $18.0 million of income tax expense in
the third quarter of 2023, the majority of which was non-cash, as
Ironwood continued to utilize net operating losses to offset
taxable income for federal purposes and in many states.
- GAAP Net Income Attributable to Ironwood. GAAP net
income attributable to Ironwood was $3.6 million, or $0.02 per
share (basic and diluted) in the third quarter of 2024, compared to
GAAP net income of $15.3 million, or $0.10 per share (basic) and
$0.09 per share (diluted) in the third quarter of 2023.
- Non-GAAP Net Income. Non-GAAP net income was $3.9
million, or $0.02 per share (basic and diluted), in the third
quarter of 2024, compared to non-GAAP net income of $21.8 million,
or $0.14 per share (basic) and $0.12 diluted in the third 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 $26.2 million in
the third quarter of 2024, compared to $49.1 million in the third
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 loss. See Non-GAAP Financial Measures below.
- Cash Flow Highlights. Ironwood ended the third quarter
of 2024 with $88.2 million of cash and cash equivalents, compared
to $92.2 million of cash and cash equivalents at the end of 2023.
- In the third quarter of 2024, Ironwood repaid $25.0 million of
the outstanding principal balance on its revolving credit facility.
The outstanding principal balance on the revolving credit facility
was $400.0 million as of September 30, 2024.
- Ironwood generated $9.9 million in cash from operations in the
third quarter of 2024, compared to $32.5 million in cash from
operations in the third quarter of 2023.
- Ironwood 2024 Financial Guidance. Ironwood continues to
expect:
2024 Guidance
(November 7, 2024)
U.S. LINZESS Net Sales
$900 - $950 million
Total Revenue
$350 - $375 million
Adjusted EBITDA1
>$75 million
1 Adjusted EBITDA is calculated by subtracting restructuring
expenses, net interest expense, income taxes, depreciation and
amortization, and acquisition-related costs from GAAP net income.
For purposes of the 2024 guidance, Ironwood has assumed it will not
incur material expenses related to business development activities
in 2024. Ironwood does not provide guidance on GAAP net income or a
reconciliation of expected adjusted EBITDA to expected GAAP net
income because, without unreasonable efforts, it is unable to
predict with reasonable certainty the non-GAAP adjustments used to
calculate adjusted EBITDA. These adjustments are uncertain, depend
on various factors and could have a material impact on GAAP net
income for the guidance period. Management believes this non-GAAP
information is useful for investors, taken in conjunction with
Ironwood’s GAAP financial statements, because it provides greater
transparency and period-over-period comparability with respect to
Ironwood’s operating performance. These measures are also used by
management to assess the performance of the business. Investors
should consider these non-GAAP measures only as a supplement to,
not as a substitute for or as superior to, measures of financial
performance prepared in accordance with GAAP. In addition, these
non-GAAP financial measures are unlikely to be comparable with
non-GAAP information provided by other companies.
Non-GAAP Financial Measures
Ironwood presents non-GAAP net income (loss) and non-GAAP net
income (loss) per share to exclude the impact, net of tax effects,
of net gains and losses on derivatives related to Ironwood’s 2022
Convertible Notes that are required to be marked-to-market,
amortization of acquired intangible assets, restructuring expenses,
and acquisition-related costs. Non-GAAP adjustments are further
detailed below:
- The gains and losses on the derivatives related to Ironwood’s
2022 Convertible Notes were highly variable, difficult to predict
and of a size that could have a substantial impact on the company’s
reported results of operations in any given period.
- Amortization of acquired intangible assets are non-cash
expenses arising in connection with the acquisition of VectivBio
and are considered to be non-recurring.
- Restructuring expenses are considered to be a non-recurring
event as they are associated with distinct operational decisions.
Restructuring expenses include costs associated with exit and
disposal activities.
- Acquisition-related costs in connection with the acquisition of
VectivBio are considered to be non-recurring and include direct and
incremental costs associated with the acquisition and integration
of VectivBio to the extent such costs were not classified as
capitalizable transaction costs attributed to the cost of net
assets acquired through acquisition accounting.
Ironwood also presents adjusted EBITDA, a non-GAAP measure, as
well as guidance on adjusted EBITDA. Adjusted EBITDA is calculated
by subtracting mark-to-market adjustments on derivatives related to
Ironwood’s 2022 Convertible Notes, restructuring expenses, net
interest expense, income taxes, depreciation and amortization, and
acquisition-related costs from GAAP net income. The adjustments are
made on a similar basis as described above related to non-GAAP net
income (loss), as applicable.
Management believes this non-GAAP information is useful for
investors, taken in conjunction with Ironwood’s GAAP financial
statements, because it provides greater transparency and
period-over-period comparability with respect to Ironwood’s
operating performance. These measures are also used by management
to assess the performance of the business. Investors should
consider these non-GAAP measures only as a supplement to, not as a
substitute for or as superior to, measures of financial performance
prepared in accordance with GAAP. In addition, these non-GAAP
financial measures are unlikely to be comparable with non-GAAP
information provided by other companies. For a reconciliation of
non-GAAP net income (loss) and non-GAAP net income (loss) per share
to GAAP net income and GAAP net income per share, respectively, and
for a reconciliation of adjusted EBITDA to GAAP net income, please
refer to the tables at the end of this press release.
Ironwood does not provide guidance on GAAP net income or a
reconciliation of expected adjusted EBITDA to expected GAAP net
income because, without unreasonable efforts, it is unable to
predict with reasonable certainty the non-GAAP adjustments used to
calculate adjusted EBITDA. These adjustments are uncertain, depend
on various factors and could have a material impact on GAAP net
income for the guidance period.
Conference Call Information
Ironwood will host a conference call and webcast at 8:30 a.m.
Eastern Time on Thursday, November 7, 2024 to discuss its third
quarter 2024 results and recent business activities. Individuals
interested in participating in the call should dial (888) 596-4144
(U.S. and Canada) or (646) 968-2525 (international) using
conference ID number and event passcode 2530602. To access the
webcast, please visit the Investors section of Ironwood’s website
at www.ironwoodpharma.com. The call will be available for replay
via telephone starting at approximately 11:30 a.m. Eastern Time on
November 7, 2024, running through 11:59 p.m. Eastern Time on
November 21, 2024. To listen to the replay, dial (800) 770-2030
(U.S. and Canada) or (609) 800-9909 (international) using
conference ID number 2530602. 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; that
the increase in LINZESS extended units and new-to-brand
prescriptions is reinforcing that patients and health care
professionals continue to choose LINZESS in a growing market; our
plan to and the expected timing to complete the NDA submission; our
plan to on getting apraglutide to market as soon as possible, our
belief that if apraglutide is approved, it would be the drug of
choice among physicians to treat adult patients with SBS who are
dependent on PS; our plan to submit an NDA and marketing
applications to other regulatory agencies for apraglutide. 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, 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 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 that apraglutide will not be approved by the FDA or other
regulatory agencies; 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 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.
Condensed Consolidated Balance
Sheets
(In thousands)
(unaudited)
September 30,
2024
December 31,
2023
Assets
Cash and cash equivalents
$
88,211
$
92,154
Accounts receivable, net
76,202
129,122
Prepaid expenses and other current
assets
14,191
12,012
Total current assets
178,604
233,288
Property and equipment, net
4,795
5,585
Operating lease right-of-use assets
11,430
12,586
Intangible assets, net
3,067
3,682
Deferred tax assets
185,338
212,324
Other assets
6,285
3,608
Total assets
$
389,519
$
471,073
Liabilities and stockholders’
equity
Accounts payable
$
3,236
$
7,830
Accrued research and development costs
9,408
21,331
Accrued expenses and other current
liabilities
33,566
44,254
Current portion of operating lease
liabilities
3,173
3,126
Current portion on convertible senior
notes
-
199,560
Total current liabilities
49,383
276,101
Operating lease liabilities, net of
current portion
12,882
14,543
Convertible senior notes, net of current
portion
198,817
198,309
Revolving credit facility
400,000
300,000
Other liabilities
39,771
28,415
Total stockholders’ deficit
(311,334
)
(346,295
)
Total liabilities and stockholders’
deficit
$
389,519
$
471,073
Condensed Consolidated
Statements of Income (Loss)
(In thousands, except per
share amounts)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
Total revenues
$
91,592
$
113,739
$
260,865
$
325,182
Collaborative arrangements revenue
91,592
113,739
260,865
325,182
Costs and expenses:
Research and development
29,827
32,985
86,030
80,409
Selling, general and administrative
36,113
36,046
110,682
119,647
Restructuring
16
4,685
2,520
17,696
Acquired in-process research and
development
-
-
-
1,090,449
Total costs and expenses1
65,956
73,716
199,232
1,308,201
Income (loss) from operations
25,636
40,023
61,633
(983,019
)
Other income (expense):
Interest expense and other financing
costs
(9,419
)
(9,839
)
(24,120
)
(13,206
)
Interest and investment income
1,152
1,748
3,690
17,777
Gain on derivatives
-
-
-
19
Other income (expense), net
(8,267
)
(8,091
)
(20,430
)
4,590
Income (loss) before income taxes
17,369
31,932
41,203
(978,429
)
Income tax expense
(13,723
)
(17,982
)
(42,579
)
(51,385
)
GAAP net income (loss)1
3,646
13,950
(1,376
)
(1,029,814
)
Less: GAAP net loss attributable to noncontrolling interests
-
(1,371
)
-
(28,662
)
GAAP net income (loss) attributable to
Ironwood Pharmaceuticals, Inc.
$
3,646
$
15,321
$
(1,376
)
$
(1,001,152
)
GAAP net income (loss) per share—basic
$
0.02
$
0.10
$
(0.01
)
$
(6.45
)
GAAP net income (loss) per
share—diluted
$
0.02
$
0.09
$
(0.01
)
$
(6.45
)
____________________ 1 Figures presented for the nine months
ended September 30, 2023 include a one-time charge of approximately
$1.1 billion related to acquired IPR&D from the acquisition of
VectivBio in the second quarter of 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
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP net income (loss)1
$
3,646
$
13,950
$
(1,376
)
$
(1,029,814
)
Adjustments:
Mark-to-market adjustments on the
derivatives related to convertible notes, net
-
-
-
(19
)
Amortization of acquired intangible
assets
207
207
616
211
Restructuring expenses
16
4,685
2,520
17,696
Acquisition-related costs
-
3,864
1,146
39,545
Tax effect of adjustments
-
(904
)
(461
)
(1,447
)
Non-GAAP net income (loss)1
$
3,869
$
21,802
$
2,445
$
(973,828
)
A reconciliation between basic net income (loss) per share on a
GAAP basis and on a non-GAAP basis is as follows:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP net income (loss) attributable to
Ironwood Pharmaceuticals, Inc. per share – basic
$
0.02
$
0.10
$
(0.01
)
$
(6.45
)
Plus: Net income (loss) per share
attributable to noncontrolling interests – basic
-
(0.01
)
-
(0.18
)
Adjustments to GAAP net income per share
(as detailed above)
-
0.05
0.02
0.36
Non-GAAP net income (loss) per share –
basic
$
0.02
$
0.14
$
0.01
$
(6.27
)
Weighted average number of common shares
used to calculate net income (loss) per share — basic
159,706
158,810
155,886
155,240
____________________ 1 Figures presented for the nine months
ended September 30, 2023, include a one-time charge of
approximately $1.1 billion related to acquired IPR&D from the
acquisition of VectivBio in the second quarter of 2023.
A reconciliation between diluted net income (loss) per share on
a GAAP basis and on a non-GAAP basis is as follows:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP net income (loss) attributable to
Ironwood Pharmaceuticals, Inc. per share – diluted
$
0.02
$
0.09
$
(0.01
)
$
(6.45
)
Plus: Net income (loss) per share
attributable to noncontrolling interests – diluted
-
(0.01
)
-
(0.18
)
Adjustments to GAAP net income per share
(as detailed above)
-
0.04
0.02
0.36
Non-GAAP net income (loss) per share –
diluted
$
0.02
$
0.12
$
0.01
$
(6.27
)
Weighted average number of common shares
used to calculate net income (loss) per share — diluted
160,232
186,891
158,810
155,240
Reconciliation of GAAP Net
Income (Loss) to Adjusted EBITDA
(In thousands)
(unaudited)
A reconciliation of GAAP net
income (loss) to adjusted EBITDA:
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
GAAP net income (loss)1
$
3,646
$
13,950
$
(1,376
)
$
(1,029,814
)
Adjustments:
Mark-to-market adjustments on the
derivatives related to convertible notes, net
-
-
-
(19
)
Restructuring expenses
16
4,685
2,520
17,696
Interest expense
9,419
9,839
24,120
13,206
Interest and investment income
(1,152
)
(1,748
)
(3,690
)
(17,777
)
Income tax expense
13,723
17,982
42,579
51,385
Depreciation and amortization
507
507
1,526
1,063
Acquisition-related costs
-
3,864
1,146
39,545
Adjusted EBITDA1
$
26,159
$
49,079
$
66,825
$
(924,715
)
____________________ 1 Figures presented for the nine months
ended September 30, 2023, include a one-time charge of
approximately $1.1 billion related to acquired IPR&D from the
acquisition of VectivBio in the second quarter of 2023.
U.S. LINZESS Commercial
Collaboration1
Revenue/Expense
Calculation
(In thousands)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
LINZESS U.S. net sales as reported by
AbbVie2
$
225,537
$
278,954
$
693,320
$
798,854
AbbVie & Ironwood commercial costs,
expenses and other discounts3
78,499
77,736
232,811
223,142
Commercial profit on sales of LINZESS
$
147,038
$
201,218
$
460,509
$
575,712
Commercial Margin4
65
%
72
%
66
%
72
%
Ironwood’s share of net profit
73,519
100,609
230,255
287,856
Reimbursement for Ironwood’s commercial
expenses
9,567
9,480
28,961
28,615
Adjustment for Ironwood’s estimate of
LINZESS gross-to-net reserves
5,800
-
(7,200
)
-
Ironwood’s U.S. collaborative arrangements
revenue5
$
88,886
$
110,089
$
252,016
$
316,471
____________________ 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 Figures presented for the three
months and nine months ended September 30, 2024 include a $5.8
million increase and $7.2 million reduction to collaborative
arrangement revenues, respectively, as a result of an adjustment
recorded for Ironwood’s estimate of LINZESS gross-to-net reserves
as of September 30, 2024.
US LINZESS Full Brand
Collaboration1
Revenue/Expense
Calculation
(In thousands)
(unaudited)
Three Months Ended
September 30,
Nine Months Ended
September 30,
2024
2023
2024
2023
LINZESS U.S. net sales as reported by
AbbVie2
$
225,537
$
278,954
$
693,320
$
798,854
AbbVie & Ironwood commercial costs,
expenses and other discounts3
78,499
77,736
232,811
223,142
AbbVie & Ironwood R&D
Expenses4
7,451
9,264
24,823
28,270
Total net profit on sales of LINZESS
$
139,587
$
191,954
$
435,686
$
547,442
____________________ 1 Ironwood collaborates with AbbVie on the
development and commercialization of linaclotide in 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 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/20241107549223/en/
Investors: Greg Martini, 617-374-5230
gmartini@ironwoodpharma.com
Matt Roache, 617-621-8395 mroache@ironwoodpharma.com
Media: Beth Calitri, 978-417-2031
bcalitri@ironwoodpharma.com
Ironwood Pharmaceuticals (NASDAQ:IRWD)
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Ironwood Pharmaceuticals (NASDAQ:IRWD)
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