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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):
November 7, 2024
IRONWOOD PHARMACEUTICALS, INC.
(Exact name of registrant as specified
in its charter)
| Delaware |
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001-34620 |
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04-3404176 |
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| (State
or other jurisdiction |
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(I.R.S.
Employer |
| of incorporation) |
|
(Commission
File Number) |
|
Identification Number) |
| 100 Summer Street, Suite 2300 |
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| Boston, Massachusetts |
|
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|
02110 |
| |
|
|
|
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| (Address of principal |
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| executive offices) |
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(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 November 7, 2024, Ironwood Pharmaceuticals, Inc.
issued a press release containing an update on its recent business activities as well as those for the quarter ended September 30, 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.
(d) 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: November 7, 2024 |
By: |
/s/ Sravan K. Emany |
| |
|
Name: |
Sravan K. Emany |
| |
|
Title: |
Senior Vice President, Chief Operating Officer and Chief Financial Officer |
Exhibit 99.1
Ironwood Pharmaceuticals Reports Third Quarter
2024 Results
– 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
–
BOSTON, Mass., November 7, 2024 — 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.
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)
| | |
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 | | |
| 155,886 | | |
| 158,810 | | |
| 155,240 | |
A reconciliation between diluted net income (loss) per share on a GAAP
basis and on a non-GAAP basis is as follows:
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.
| | |
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.
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Ironwood Pharmaceuticals (NASDAQ:IRWD)
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