– LINZESS® (linaclotide) U.S. net sales
increased 7% to $205 million in 3Q 2018 vs 3Q 2017 –
– Ironwood revenue of $66 million in 3Q 2018, which includes a $30
million reduction due to LINZESS change in estimate as reported to
Ironwood by Allergan –
– Received Fast Track Designation for praliciguat for potential
treatment of HFpEF –
– On track to complete separation of Ironwood into two independent,
publicly traded companies in first half 2019 –
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Nov. 6, 2018--
Ironwood
Pharmaceuticals, Inc. (Nasdaq: IRWD), a commercial biotechnology
company, today provided an update on its third quarter 2018 results and
recent business activities.
“Ironwood carried operating momentum from the first half of 2018 through
the third quarter, driven by 12% LINZESS demand growth and further
advancement of our five ongoing clinical programs with linaclotide,
IW-3718, olinciguat and praliciguat,” said Peter Hecht, chief executive
officer of Ironwood. “LINZESS is the branded prescription market leader
in its class, driven by our productive investments in marketing,
personal promotion and payer access. LINZESS is a growth brand with
years of expected patent coverage ahead, and we and Allergan are
investing in multiple innovative strategies that we believe represent an
opportunity to drive significant growth going forward.”
Dr. Hecht continued, “We also made progress on our planned separation,
which we believe will better position both companies to bring new
treatment options to patients and unlock value for shareholders.
Following the separation, we expect Ironwood will be a profitable,
leading U.S. GI company. We expect the R&D Co. to harness its expertise
in sGC pharmacology, developing five sGC stimulators tailored for
serious and orphan diseases.”
Third Quarter 2018 and Recent Highlights
Irritable Bowel Syndrome with Constipation
(IBS-C) / Chronic Idiopathic Constipation (CIC)
- U.S. LINZESS® (linaclotide). U.S. net
sales, as reported by Ironwood’s U.S. collaboration partner Allergan
plc, were $204.8 million in the third quarter of 2018, a 7% increase
compared to the third quarter of 2017. Ironwood and Allergan share
equally in U.S. brand collaboration profits.
-
During the third quarter, Allergan reported to Ironwood a $59.3
million negative adjustment to LINZESS net sales relating to the
cumulative difference between Allergan’s previous gross-to-net
estimates during the three years ended December 31, 2015, 2016 and
2017 and actual subsequent payments made. This equates to between
3-4% of LINZESS net sales for each of those annual periods and is
primarily associated with estimated governmental and contractual
rebates, as reported to Ironwood by Allergan.
-
Upon receiving the information from Allergan, Ironwood
recorded a $29.7 million reduction to collaborative
arrangement revenue and accounts receivable in its third
quarter financial statements related to its share of the
adjustment. Ironwood’s collaborative arrangement revenue
related to sales of LINZESS in the U.S. for the third quarter
of 2018 was $52.3 million, down approximately 29% compared to
the third quarter of 2017, driven primarily by this reduction.
-
Going forward, Ironwood expects LINZESS brand-specific
adjustments to be made by Allergan on a more frequent basis to
reduce the potential for multi-year adjustments of this
magnitude.
-
LINZESS commercial margin, excluding the $59.3 million adjustment,
was 69% in the third quarter of 2018 compared to 66% in the third
quarter of 2017. See U.S. Brand Collaboration table below.
-
Net profit for the LINZESS U.S. brand collaboration, net of
commercial and research and development (R&D) expenses and
excluding the $59.3 million adjustment, was $125.5 million in the
third quarter of 2018, a 13% increase compared to the third
quarter of 2017. See U.S. Brand Collaboration table below.
-
Total LINZESS prescription volume in the third quarter of 2018
included approximately 33 million LINZESS capsules, an
approximately 12% increase in capsules compared to the third
quarter of 2017, per IQVIA.
-
More than 830,000 total LINZESS prescriptions were filled in the
third quarter of 2018, an approximately 6% increase compared to
the third quarter of 2017, per IQVIA.
-
Since the launch of LINZESS in December 2012, approximately 2.5
million unique patients have filled approximately 12 million
prescriptions, per IQVIA.
- Linaclotide Additional Abdominal Symptom Claims. In July 2018,
Ironwood and Allergan initiated a randomized, double-blind,
placebo-controlled Phase IIIb trial expected to enroll approximately
600 adult IBS-C patients in the U.S. The trial is designed to evaluate
the efficacy and safety of linaclotide 290 mcg on multiple abdominal
symptoms including pain, bloating and discomfort. Eligible patients
are being randomized to placebo or linaclotide 290 mcg once daily for
12 weeks, followed by a four-week randomized withdrawal period. The
Phase IIIb trial is enrolling faster than expected, and topline data
are now expected in mid-2019.
- MD-7246 (formerly linaclotide delayed release). MD-7246 has the
potential to be an oral, intestinal, non-opioid, pain-relieving agent
for patients in the U.S. suffering from all subtypes of IBS, including
IBS-C, IBS with diarrhea and IBS-mixed. A randomized, double-blind,
placebo-controlled Phase II trial of MD-7246 is expected to initiate
in the first quarter of 2019. This trial is designed to evaluate the
safety, tolerability, and treatment effect on abdominal pain of
MD-7246 in approximately 400 IBS patients.
- LINZESS-Japan. In August 2018, Ironwood and its Japanese
partner Astellas Pharma Inc. announced that LINZESS was approved in
Japan for the additional indication of chronic constipation, and
launched with this indication shortly thereafter. LINZESS was approved
for the treatment of IBS-C in Japan in December 2016 and has been on
the Japanese market since March 2017. Ironwood reported $9.5 million
in sales of linaclotide active pharmaceutical ingredient (API) to
Astellas in the third quarter of 2018.
- Linaclotide-China. Ironwood now expects the China Food and Drug
Administration (CFDA) to complete its review of the marketing
application for linaclotide in China for adult IBS-C patients in early
2019 due to the timing of the CFDA review process. Ironwood is
partnered with AstraZeneca AB for the development and
commercialization of linaclotide in China.
Persistent Gastroesophageal Reflux Disease
(GERD)
- IW-3718. Ironwood is currently enrolling patients in two
pivotal Phase III trials to evaluate IW-3718, its gastric retentive
formulation of a bile acid sequestrant for the potential treatment of
persistent GERD. Persistent GERD affects an estimated 10 million
Americans who continue to suffer from heartburn and regurgitation
despite receiving treatment with proton pump inhibitors (PPIs), the
current standard of care.
-
The Phase III trials are identical randomized, double-blind,
placebo-controlled, multicenter trials that target enrolling
approximately 1,320 total patients (660 in each trial) with
persistent GERD who demonstrate evidence of pathological acid
reflux.
-
The primary endpoint of each trial is an overall heartburn
response, defined as a patient who experiences at least a 45%
reduction from baseline in heartburn severity (an improvement
determined to be clinically meaningful based on patient-reported
outcomes in the Phase IIb trial) for at least four out of eight
weeks, including at least one of the last two weeks.
Sickle Cell Disease
Olinciguat. Ironwood is advancing olinciguat, one of its tailored
clinical soluble guanylate cyclase (sGC) stimulators, for the potential
treatment of sickle cell disease. Sickle cell disease is a rare, genetic
disease that affects approximately 100,000 Americans. It causes red
blood cells to “sickle”, or become misshapen, and to more easily
rupture, resulting in nitric oxide depletion and severe complications
including chronic vascular inflammation, painful vaso-occlusive crises,
poor blood flow to organs, pulmonary hypertension, and renal failure.
- Sickle Cell Disease. Ironwood is enrolling patients in a Phase
II multicenter, randomized, double-blind, placebo-controlled,
dose-ranging trial designed to evaluate the safety, tolerability,
pharmacokinetics and pharmacodynamics of once-daily, oral olinciguat
in approximately 88 patients with sickle cell disease. Topline data
are expected in the second half of 2019.
- Achalasia. Ironwood today announces positive data from a small,
exploratory Phase IIa single-dose study in patients with type I or
type II achalasia in which olinciguat demonstrated the expected
pharmacokinetic and pharmacodynamic effects. Data from the Phase IIa
study showed that single doses of olinciguat reduced Integrated
Relaxation Pressure (IRP), a measure of dilation of the lower
esophageal sphincter (LES) during swallowing, relative to baseline.
The reduction in IRP observed in this study provides support for sGC
target engagement. Data also demonstrated a pharmacokinetic profile of
olinciguat supporting once-daily dosing, consistent with findings from
previous Phase I data in healthy volunteers. In the study, olinciguat
was well tolerated and no serious adverse events (SAEs) were reported.
The most common adverse event reported in this trial was mild
dizziness. Ironwood intends to focus its resources on olinciguat in
sickle cell disease, where there is a significant unmet need and the
potential to play a critical role in treating patients. Ironwood will
not pursue additional clinical studies in achalasia at this time.
Diabetic Nephropathy and Heart Failure with
Preserved Ejection Fraction (HFpEF)
- Praliciguat. Ironwood is advancing praliciguat for the
potential treatment of diabetic nephropathy and of HFpEF. Both
diseases affect millions of patients around the world, including an
estimated eight million Americans suffering from diabetic nephropathy
and an estimated three million Americans suffering from HFpEF.
Diabetic nephropathy is the leading cause of end-stage renal disease.
There are few treatment options available to delay the steady decline
of renal function leading to dialysis or kidney transplant. HFpEF is a
highly symptomatic condition with high rates of morbidity and
mortality, with no approved treatments available. Ironwood intends to
out-license praliciguat for development and commercialization to a
global partner before entering Phase III trials.
- Diabetic nephropathy. Ironwood is enrolling patients into a
randomized, double-blind, placebo-controlled, dose-ranging Phase
II trial designed to evaluate the safety and efficacy of
praliciguat in patients with diabetic nephropathy. Topline data
are expected in the second half of 2019.
- HFpEF. In September 2018, the U.S. FDA granted Fast Track
Designation for praliciguat for the treatment of patients with
HFpEF. Ironwood is enrolling patients into a randomized,
double-blind, placebo-controlled Phase II trial designed to
evaluate the safety and efficacy of the high dose arm of
praliciguat in patients with HFpEF. Topline data are expected in
the second half of 2019.
Corporate Updates
- Intent to Separate
-
In May 2018, Ironwood announced its intent to separate into two
independent, publicly traded companies (Ironwood and “R&D Co.”).
The separation is expected to be completed in the first half of
2019 and is anticipated to be tax-free to Ironwood shareholders.
-
Following the separation, Ironwood expects to be profitable
and to focus on building a leading U.S. GI healthcare company.
Ironwood intends to leverage its broad capabilities to advance
a strong GI portfolio, including LINZESS – the branded
prescription market-leading product in its class – and two
potentially highly differentiated, late-stage development
products in IW-3718 and MD-7246.
- R&D Co. expects to harness its deep expertise in cyclic
guanosine monophosphate (cGMP) pharmacology to advance an
innovative sGC stimulator pipeline focused on the treatment of
serious and orphan diseases. At its strategic core are
expected to be five novel sGC stimulator programs tailored to
the tissues most relevant to the diseases they are designed to
treat, including olinciguat, praliciguat, IW-6463, and
late-stage discovery programs targeting serious liver and lung
diseases.
- Lesinurad U.S. Termination
-
In August 2018, Ironwood delivered to AstraZeneca notice of
termination of the U.S. lesinurad license agreement, expected to
be effective 180 days from the notice.
-
Ironwood expects to save $75 million to $100 million in full
year 2019 operating expenses, primarily from SG&A.
-
Following the termination notification, Ironwood initiated a
reduction in its workforce, primarily consisting of
field-based employees. Total costs related to the reduction in
workforce, including severance costs, termination fees, and
other contract-related costs were approximately $7.6 million
during the third quarter.
Financial Results
- Total Revenues
-
Total revenues were $65.7 million in the third quarter of 2018
compared to $86.8 million in the third quarter of 2017.
-
As noted above, revenues were lower year-over-year primarily
due to the $29.7 million change in estimate recorded to
collaborative arrangement revenue as a result of the 2015-2017
LINZESS net sales adjustment, as reported to Ironwood by
Allergan.
-
Total revenues consisted of $52.3 million associated with
Ironwood’s share of the net profits from the sales of LINZESS
in the U.S., including the $29.7 million reduction, $10.3
million in sales of linaclotide API, $1.9 million in
linaclotide royalties, co-promotion and other revenue, and
$1.2 million in ZURAMPIC® (lesinurad) and DUZALLO®
(lesinurad + allopurinol) product revenue.
- Operating Expenses
-
Operating expenses were $234.8 million in the third quarter of
2018, compared to $106.3 million in the third quarter of 2017.
-
Operating expenses were higher year-over-year primarily due to
a $151.8 million non-cash impairment of intangible assets,
partially offset by a $33.5 million non-cash gain on fair
value remeasurement of contingent consideration, both related
to Ironwood’s U.S. lesinurad license agreement with
AstraZeneca.
-
Operating expenses in the third quarter of 2018 also consisted
of $55.2 million in SG&A expenses, $46.8 million in R&D
expenses, $10.3 million in restructuring expenses, $4.6
million in cost of revenues, and $1.2 million in acquired
intangible assets amortization expenses, partially offset by
$1.6 million related to the write-down of inventory to net
realizable value and (settlement) loss on non-cancellable
purchase commitments.
- Other Expense
- Interest Expense. Net interest expense was $8.7 million in
the third quarter of 2018, primarily in connection with the $150
million 8.375% Notes funded in January 2017 and the approximately
$336 million convertible debt financing funded in June 2015.
Interest expense recorded in the third quarter of 2018 includes
$5.0 million in cash expense and $4.5 million in non-cash expense.
- Gain on Derivatives. Ironwood recorded a gain on
derivatives of $3.5 million related to the change in fair value of
the convertible note hedges and note hedge warrants issued in
connection with the convertible debt financing funded in June 2015.
- Net Loss
-
GAAP net loss was $174.4 million, or $1.14 per share, in the third
quarter of 2018, compared to a net loss of $32.3 million, or $0.22
per share, in the third quarter of 2017.
-
Non-GAAP net loss was $58.4 million, or $0.38 per share, in the
third quarter of 2018, compared to $26.7 million, or $0.18 per
share, in the third quarter of 2017. Non-GAAP net loss excludes
the impact of mark-to-market adjustments on the derivatives
related to Ironwood’s convertible debt, the amortization of
acquired intangible assets, the fair value remeasurement of
contingent consideration related to Ironwood’s U.S. lesinurad
license, and the impairment of acquired intangible assets in
connection with Ironwood’s notice of termination of the lesinurad
franchise. See Non-GAAP Financial Measures below.
- Cash Position
-
Ironwood ended the third quarter of 2018 with approximately $161.4
million of cash, cash equivalents and available-for-sale
securities. Ironwood used approximately $26.6 million of cash for
operations during the third quarter of 2018.
- 2018 Financial Guidance
Ironwood continues to expect
in 2018:
-
SG&A expenses to be in the range of $230 million to $250 million;
-
R&D expenses to be in the range of $160 million to $180 million;
-
the combined Ironwood and Allergan total marketing and sales
expenses for LINZESS to be in the range of $230 to $260 million;
and,
-
net interest expense to be less than $40 million.
Ironwood now expects total restructuring costs to be approximately $16
million, versus previous guidance of $18 million to $21 million.
Non-GAAP Financial Measures
Ironwood presents non-GAAP net loss and non-GAAP net loss per share to
exclude the impact of net gains and losses on the derivatives related to
our convertible notes that are required to be marked-to-market, the
amortization of acquired intangible assets, the fair value remeasurement
of contingent consideration associated with Ironwood’s U.S. license
agreement with AstraZeneca for the exclusive rights to all products
containing lesinurad, and the impairment of intangible assets associated
with Ironwood’s subsequent notice of termination of the lesinurad
license agreement. The derivative gains and losses may be 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. The acquired intangible assets are valued as of the
date of acquisition and are amortized over their estimated economic
useful life, and management believes excluding the amortization of
acquired intangible assets provides more consistency with the treatment
of internally developed intangible assets for which research and
development costs were previously expensed. The contingent consideration
balance is remeasured each reporting period, and the resulting change in
fair value impacts the company’s reported results of operations. The
changes in the fair value remeasurement of contingent consideration do
not correlate to the company’s actual cash payment obligations in the
relevant period. Impairment of intangible assets is a non-cash charge
that Ironwood considers to be non-recurring as it is associated with its
notice of termination of the lesinurad franchise. As such, management
believes that excluding the impairment of intangible assets provides
more transparency into Ironwood’s continuing operations. 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 these non-GAAP
financial measures to the most comparable GAAP measures, please refer to
the table at the end of this press release.
Conference Call Information
Ironwood will host a conference call and webcast at 8:30 a.m. Eastern
Time on Tuesday, November 6, 2018 to discuss its third quarter 2018
results and recent business activities. Individuals interested in
participating in the call should dial (877) 643-7155(U.S. and
Canada) or (914) 495-8552 (international) using conference ID number
6878976. To access the webcast, please visit the Investors section of
Ironwood’s website at www.ironwoodpharma.com
at least 15 minutes prior to the start of the call to ensure adequate
time for any software downloads that may be required. The call will be
available for replay via telephone starting at approximately 11:30 a.m.
Eastern Time, on November 6, 2018 running through 11:59 p.m. Eastern
Time on November 13, 2018. To listen to the replay, dial (855) 859-2056
(U.S. and Canada) or (404) 537-3406 (international) using conference ID
number 6878976. The archived webcast will be available on Ironwood’s
website for 14 days beginning approximately one hour after the call has
completed.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (Nasdaq: IRWD) is a commercial biotechnology
company focused on creating medicines that make a difference for
patients, building value for our fellow shareholders, and empowering our
passionate team. We discovered, developed and are commercializing
linaclotide, the U.S. branded prescription market leader for adults with
irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic
constipation (CIC). Our pipeline priorities for linaclotide include a
Phase IIIb trial evaluating its efficacy and safety on multiple
abdominal symptoms, including abdominal bloating, pain, and discomfort
in adult patients with IBS-C, as well as research into a formulation of
linaclotide designed to relieve pain across all IBS subtypes.
We are also advancing a pipeline of innovative product candidates in
areas of significant unmet need, including persistent gastroesophageal
reflux disease, diabetic nephropathy, heart failure with preserved
ejection fraction and sickle cell disease. Ironwood was founded in 1998
and is headquartered in Cambridge, Mass. For more information, please
visit www.ironwoodpharma.com
or www.twitter.com/ironwoodpharma;
information that may be important to investors will be routinely posted
in both these locations.
About LINZESS (linaclotide)
LINZESS® is the #1 prescribed brand for the treatment of adult patients
with irritable bowel syndrome with constipation (IBS-C) and chronic
idiopathic constipation (CIC), based on IQVIA data. Since its FDA
approval in August of 2012 and subsequent launch in December 2012,
greater than 2.2 million unique patients have filled approximately 12.2
million prescriptions for LINZESS, according to IQVIA.
LINZESS is a once-daily capsule that helps relieve the abdominal pain
and constipation associated with IBS-C, as well as the constipation,
infrequent stools, hard stools, straining, and incomplete evacuation
associated with CIC. The recommended dose is 290 mcg for IBS-C patients
and 145 mcg for CIC patients, with a 72 mcg dose approved for use in CIC
depending on individual patient presentation or tolerability. LINZESS
should be taken at least 30 minutes before the first meal of the day.
LINZESS is contraindicated in pediatric patients less than 6 years of
age. The safety and effectiveness of LINZESS in pediatric patients less
than 18 years of age have not been established. In neonatal mice,
linaclotide increased fluid secretion as a consequence of GC-C agonism
resulting in mortality within the first 24 hours due to dehydration. Due
to increased intestinal expression of GC-C, patients less than 6 years
of age may be more likely than patients 6 years of age and older to
develop severe diarrhea and its potentially serious consequences. In
adults with IBS-C or CIC treated with LINZESS, the most commonly
reported adverse event was diarrhea.
LINZESS is not a laxative; it is the first medicine approved by the FDA
in a class called guanylate cyclase-C (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 Allergan plc co-develop and
co-commercialize LINZESS for the treatment of adults with IBS-C or CIC.
In Europe, Allergan 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
linaclotide in China, and with Allergan for development and
commercialization of linaclotide in all other territories worldwide.
About ZURAMPIC (lesinurad) 200mg tablets
ZURAMPIC (lesinurad) works in combination with xanthine oxidase
inhibitors (XOIs) to treat hyperuricemia associated with uncontrolled
gout. ZURAMPIC is not recommended for the treatment of asymptomatic
hyperuricemia and should not be used as monotherapy. XOIs reduce the
production of uric acid; ZURAMPIC increases the excretion of uric acid.
Together, the combination of ZURAMPIC and an XOI provides a dual
mechanism of action that both decreases production and increases
excretion of uric acid, thereby lowering serum uric acid (sUA) levels in
patients who have not achieved target serum uric acid levels with XOI
treatment alone. ZURAMPIC selectively inhibits the function of
transporter proteins uric acid transporter 1 (URAT1) and organic anion
transporter 4 (OAT4), involved in uric acid reabsorption in the kidney.
The safety and efficacy of ZURAMPIC was established in three Phase III
clinical trials that evaluated a once-daily dose of ZURAMPIC in
combination with the XOI allopurinol or febuxostat compared to XOI
alone. The boxed warning for ZURAMPIC states that acute renal failure
has occurred with ZURAMPIC and was more common when ZURAMPIC was given
alone and reinforces that ZURAMPIC should be used in combination with an
XOI.
About DUZALLO (lesinurad and allopurinol)
DUZALLO (lesinurad and allopurinol) is a once-daily oral therapy that
contains lesinurad 200 mg plus allopurinol 300 mg; it is also available
in a lesinurad 200 mg plus allopurinol 200 mg dosage. DUZALLO is
approved by the FDA as a once-daily oral treatment for hyperuricemia
associated with gout in patients who have not achieved target serum uric
acid (sUA) levels with a medically appropriate daily dose of allopurinol
alone. DUZALLO is not recommended for the treatment of asymptomatic
hyperuricemia. Allopurinol is an XOI whose action differs from that of
uricosuric agents such as lesinurad. Allopurinol reduces the production
of uric acid (UA); lesinurad increases renal excretion of UA by
selectively inhibiting the action of URAT1, the UA transporter
responsible for the majority of renal UA reabsorption. The
dual-mechanism combination of DUZALLO can address both inefficient
excretion and overproduction of UA, thereby lowering sUA levels. DUZALLO
should be taken in the morning with food and water, and patients should
be advised to stay well hydrated when taking DUZALLO (about 2 liters of
liquid a day).
LINZESS Important Safety Information
INDICATIONS AND USAGE
LINZESS (linaclotide) is indicated in adults for the treatment of both
irritable bowel syndrome with constipation (IBS-C) and chronic
idiopathic constipation (CIC).
IMPORTANT SAFETY INFORMATION
WARNING: RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS LINZESS is contraindicated in patients less than 6 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. Use of LINZESS should be avoided in
patients 6 years to less than 18 years of age. The safety and
effectiveness of LINZESS have not been established in patients
less than 18 years of age.
|
Contraindications
-
LINZESS is contraindicated in patients less than 6 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
Pediatric Risk
-
LINZESS is contraindicated in patients less than 6 years of age. The
safety and effectiveness of LINZESS in patients less than 18 years of
age have not been established. In neonatal mice, linaclotide increased
fluid secretion as a consequence of GC-C agonism resulting in
mortality within the first 24 hours due to dehydration. Due to
increased intestinal expression of GC-C, patients less than 6 years of
age may be more likely than patients 6 years of age and older to
develop severe diarrhea and its potentially serious consequences.
-
Use of LINZESS should be avoided in pediatric patients 6 years to less
than 18 years of age. Although there were no deaths in older juvenile
mice, given the deaths in young juvenile mice and the lack of clinical
safety and efficacy data in pediatric patients, use of LINZESS should
be avoided in pediatric patients 6 years to less than 18 years of age.
Diarrhea
-
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. If severe diarrhea occurs, dosing should be suspended and
the patient rehydrated.
Common Adverse Reactions (incidence ≥2% and greater than placebo)
-
In IBS-C clinical trials: diarrhea (20% vs 3% placebo), abdominal pain
(7% vs 5%), flatulence (4% vs 2%), headache (4% vs 3%), viral
gastroenteritis (3% vs 1%) and abdominal distension (2% vs 1%).
-
In CIC trials of a 145 mcg dose: diarrhea (16% vs 5% placebo),
abdominal pain (7% vs 6%), flatulence (6% vs 5%), upper respiratory
tract infection (5% vs 4%), sinusitis (3% vs 2%) and abdominal
distension (3% vs 2%). In a CIC trial of a 72 mcg dose: diarrhea (19%
vs 7% placebo) and abdominal distension (2% vs <1%).
Please see full Prescribing Information including Boxed Warning: http://www.allergan.com/assets/pdf/linzess_pi
ZURAMPIC Important Safety Information and Limitations of Use
|
WARNING: RISK OF ACUTE RENAL FAILURE MORE COMMON WHEN USED
WITHOUT A XANTHINE OXIDASE INHIBITOR (XOI)
- Acute renal failure has occurred with ZURAMPIC and was more
common when ZURAMPIC was given alone
- ZURAMPIC should be used in combination with an XOI
|
Contraindications:
-
Severe renal impairment (eCLcr less than 30 mL/min), end-stage renal
disease, kidney transplant recipients, or patients on dialysis
-
Tumor lysis syndrome or Lesch-Nyhan syndrome
Warnings and Precautions:
- Renal events: Adverse reactions related to renal function have
occurred after initiating ZURAMPIC. A higher incidence was observed at
the 400-mg dose, with the highest incidence occurring with monotherapy
use. Monitor renal function at initiation and during therapy with
ZURAMPIC, particularly in patients with eCLcr below 60 mL/min or with
serum creatinine elevations 1.5 to 2 times the pre-treatment value,
and evaluate for signs and symptoms of acute uric acid nephropathy.
Interrupt treatment with ZURAMPIC if serum creatinine is elevated to
greater than 2 times the pre-treatment value or if there are symptoms
that may indicate acute uric acid nephropathy. ZURAMPIC should not be
restarted without another explanation for the serum creatinine
abnormalities. ZURAMPIC should not be initiated in patients with an
eCLcr less than 45 mL/min.
- Cardiovascular events: In clinical trials, major adverse
cardiovascular events (defined as cardiovascular deaths, non-fatal
myocardial infarctions, or non-fatal strokes) were observed with
ZURAMPIC. A causal relationship has not been established.
Adverse Reactions:
-
Most common adverse reactions with ZURAMPIC (in combination with an
XOI and more frequently than on an XOI alone) were headache,
influenza, blood creatinine increased, and gastroesophageal reflux
disease
Indication and Limitations of Use for ZURAMPIC
ZURAMPIC is a URAT1 inhibitor indicated in combination with an XOI for
the treatment of hyperuricemia associated with gout in patients who have
not achieved target serum uric acid levels with an XOI alone.
-
ZURAMPIC is not recommended for the treatment of asymptomatic
hyperuricemia
-
ZURAMPIC should not be used as monotherapy
Please see full Prescribing Information, including Boxed Warning,
at: http://irwdpi.com/zurampic/ZURAMPIC_PI_and_Medguide_2017.pdf#page=1
DUZALLO Important Safety Information
|
WARNING: RISK OF ACUTE RENAL FAILURE
- Acute renal failure has occurred with lesinurad, one of the
components of DUZALLO
|
Contraindications:
-
Severe renal impairment (estimated creatinine clearance [eCLcr] < 30
mL/min), end-stage renal disease, kidney transplant recipients, or
patients on dialysis
-
Tumor lysis syndrome or Lesch-Nyhan syndrome
-
Known hypersensitivity to allopurinol, including previous occurrence
of skin rash
Warnings and Precautions:
- Renal events: Adverse reactions related to renal function,
including acute renal failure, can occur after initiating DUZALLO.
Renal function should be evaluated prior to initiation of DUZALLO and
periodically thereafter, as clinically indicated. More frequent renal
function monitoring is recommended in patients with eCLcr < 60 mL/min
or with serum creatinine elevations 1.5 to 2 times the value when
lesinurad treatment was initiated. DUZALLO should not be initiated in
patients with an eCLcr < 45 mL/min. Interrupt treatment with DUZALLO
if serum creatinine is elevated to > 2 times the pretreatment value or
if there are symptoms that may indicate acute uric acid nephropathy,
including flank pain, nausea, or vomiting. DUZALLO should not be
restarted without another explanation for the serum creatinine
abnormalities
- Skin rash and hypersensitivity: Skin rash is a frequently
reported adverse event in patients taking allopurinol. In some
instances, a skin rash may be followed by more severe hypersensitivity
reactions associated with exfoliation, fever, lymphadenopathy,
arthralgia, and/or eosinophilia including Stevens-Johnson syndrome and
toxic epidermal necrolysis. Associated vasculitis and tissue response
may be manifested in various ways including hepatitis, renal
impairment, seizures, and on rare occasions, death. Hypersensitivity
reactions to allopurinol may be increased in patients with decreased
renal function who are receiving thiazide diuretics and DUZALLO
concurrently. DUZALLO should be discontinued immediately at the first
appearance of skin rash or other signs that may indicate an allergic
reaction, and additional medical care should be provided as needed
- Hepatotoxicity: A few cases of reversible clinical
hepatotoxicity have been reported in patients taking allopurinol and,
in some patients, asymptomatic rises in serum alkaline phosphatase or
serum transaminase have been observed. If anorexia, weight loss, or
pruritus develops in patients taking DUZALLO, evaluation of liver
function should be performed. In patients with preexisting liver
disease, periodic liver function tests are recommended
- Cardiovascular events: In clinical trials, major adverse
cardiovascular events (defined as cardiovascular deaths, nonfatal
myocardial infarctions, and nonfatal strokes) were observed with
DUZALLO. A causal relationship has not been established
- Bone marrow depression: Bone marrow depression has been
reported in patients receiving allopurinol, most of whom received
concomitant drugs with the potential for causing this reaction. This
has occurred as early as 6 weeks to as long as 6 years after the
initiation of allopurinol therapy. Rarely, a patient may develop
varying degrees of bone marrow depression, affecting one or more cell
lines, while receiving allopurinol alone. Patients taking allopurinol
and mercaptopurine or azathioprine require a reduction in dose to
approximately one-third to one-fourth of the usual dose of
mercaptopurine or azathioprine
- Increase in prothrombin time: It has been reported that
allopurinol prolongs the half-life of dicumarol, a coumarin
anticoagulant. The prothrombin time should be reassessed periodically
in patients receiving coumarin anticoagulants (dicumarol, warfarin)
concomitantly with DUZALLO
- Drowsiness: Occasional occurrence of drowsiness was reported in
patients taking allopurinol. Patients should be alerted to the need
for caution when engaging in activities where alertness is mandatory
Adverse Reactions:
-
The most common adverse reactions in controlled studies (occurring in
2% or more of patients on lesinurad in combination with allopurinol
and at least 1% greater than observed in patients on allopurinol
alone) were headache, influenza, blood creatinine increased, and
gastroesophageal reflux disease
-
The most common adverse reactions identified during post-approval use
of allopurinol are skin rash, nausea, and diarrhea
Indication and Limitations of Use:DUZALLO, a combination of
lesinurad, a URAT1 inhibitor, and allopurinol, a xanthine oxidase
inhibitor, is indicated for the treatment of hyperuricemia associated
with gout in patients who have not achieved target serum uric acid
levels with a medically appropriate daily dose of allopurinol alone.
-
DUZALLO is not recommended for the treatment of asymptomatic
hyperuricemia
Please see full Prescribing Information, including Boxed, at https://www.irwdpi.com/duzallo/DuzalloPIandMedguide2017.pdf#page=1
LINZESS® and CONSTELLA® are registered trademarks of Ironwood
Pharmaceuticals, Inc., and ZURAMPIC® and DUZALLO®are
registered trademarks of AstraZeneca AB. Any other trademarks referred
to in this press release are the property of their respective owners.
All rights reserved.
This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including statements about the proposed separation of our
operations into two independent, publicly traded companies, including
the status, completion and timing of the separation; the business and
operations of Ironwood and R&D Co. and any benefits or costs of the
separation, including the tax treatment; the timing of effectiveness of
the termination of the lesinurad license agreement and the transition of
lesinurad operations; the financial profiles and capital structures of
Ironwood and R&D Co.; expectations and timing regarding Ironwood’s
ability to achieve profitability; expectations regarding R&D Co.’s
market, products, development and commercialization plans and ability to
develop its pipeline; the development, launch, commercial availability
and commercial potential of our products, product candidates and the
other products that we promote and the drivers, timing, impact and
results thereof; market size, commercial potential, prevalence, and the
growth in, and potential demand for, our products and product
candidates, as well as their potential impact on applicable markets; the
potential indications for, and benefits of, our products and product
candidates; the anticipated timing of preclinical, clinical and
regulatory developments and the design, timing, size and results of
clinical and preclinical studies; expected periods of patent
exclusivity, durability and life of the patent portfolios for our
products and product candidates; the strength of the intellectual
property protection for our products and product candidates; and our
financial performance and results, and guidance and expectations related
thereto (including the drivers and timing thereof), including
expectations related to the allocation of capital, LINZESS net price,
LINZESS brand-specific adjustments, LINZESS U.S. net sales, ex-U.S.
revenue (including API revenue), R&D, SG&A and marketing and sales
expenses, net interest expense, total restructuring costs, the
non-recurrence of impairment charges to intangible assets and plans to
revise cash guidance.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 possibility that we
may not complete the separation of our business on the terms or timeline
currently contemplated, if at all, achieve the expected benefits of the
separation, and that the separation could harm our business, results of
operations and financial condition; the risk that the transaction might
not be tax-free; the risk that we may be unable to make, on a timely or
cost-effective basis, the changes necessary to operate as independent
companies; R&D Co.’s lack of independent operating history and the risk
that its accounting and other management systems may not be prepared to
meet the financial reporting and other requirements of operating as an
independent public company; the risk that a separation may adversely
impact our ability to attract or retain key personnel; the risk that we
may experience difficulties in implementing or negative effects from the
reduction in workforce, such as claims arising out of the reduction;
risks related to the difficulty of predicting the financial impact or
timing of our reduction in workforce; the effectiveness of development
and commercialization efforts by us and our partners; preclinical and
clinical development, manufacturing and formulation development; the
risk that findings from our completed nonclinical and clinical studies
may not be replicated in later studies; efficacy, safety and
tolerability of our products and product candidates; decisions by
regulatory and judicial authorities; the risk that we may never get
sufficient patent protection for our products and product candidates or
that we are not able to successfully protect such patents; the outcomes
in legal proceedings to protect or enforce the patents relating to our
products and product candidates, including ANDA litigation; 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,
our products or product candidates; the risk that we are unable to
manage our operating expenses or cash use for operations, or are unable
to commercialize our products, within the guided ranges or otherwise as
expected; and the risks listed under the heading "Risk Factors" and
elsewhere in Ironwood's Quarterly Report on Form 10-Q for the quarter
ended June 30, 2018, and in our subsequent SEC filings. These
forward-looking statements (except as otherwise noted) speak only as of
the date of this press release, and Ironwood undertakes no obligation to
update these forward-looking statements. Further, Ironwood considers the
net profit for the U.S. LINZESS brand collaboration with Allergan in
assessing the product's performance and calculates it based on inputs
from both Ironwood and Allergan. This figure should not be considered a
substitute for Ironwood's GAAP financial results. An explanation of our
calculation of this figure is provided in the U.S. LINZESS Brand
Collaboration table and related footnotes accompanying this press
release.
|
Condensed Consolidated Balance Sheets
|
(In thousands)
|
(unaudited)
|
|
|
September 30, 2018
|
|
December 31, 2017
|
Assets |
|
|
|
|
Cash, cash equivalents and available-for-sale securities
|
|
$
|
161,398
|
|
$
|
221,416
|
Accounts receivable, net
|
|
65,375
|
|
82,157
|
Inventory, net
|
|
76
|
|
735
|
Prepaid expenses and other current assets
|
|
21,699
|
|
7,288
|
Total current assets
|
|
248,548
|
|
311,596
|
Restricted cash
|
|
7,676
|
|
7,056
|
Property and equipment, net
|
|
16,161
|
|
17,274
|
Convertible note hedges
|
|
142,774
|
|
108,188
|
Intangible assets, net
|
|
-
|
|
159,905
|
Goodwill
|
|
785
|
|
785
|
Other assets
|
|
708
|
|
870
|
Total assets
|
|
$
|
416,652
|
|
$
|
605,674
|
Liabilities and Stockholders’ (Deficit) Equity |
|
|
|
|
Accounts payable, accrued expenses and other current liabilities
|
|
$
|
59,378
|
|
$
|
61,508
|
Capital lease obligations
|
|
171
|
|
4,077
|
Current portion of deferred rent
|
|
247
|
|
195
|
Current portion of long- term debt
|
|
39,191
|
|
-
|
Current portion of contingent consideration
|
|
74
|
|
247
|
Deferred revenue
|
|
13,521
|
|
-
|
Total current liabilities
|
|
112,582
|
|
66,027
|
Deferred rent, net of current portion
|
|
6,113
|
|
5,449
|
Other liabilities
|
|
2,530
|
|
5,060
|
Contingent consideration, net of current portion
|
|
-
|
|
31,011
|
Note hedge warrants
|
|
122,778
|
|
92,188
|
Convertible notes
|
|
261,355
|
|
249,193
|
Long-term debt
|
|
108,589
|
|
146,898
|
Total stockholders’ (deficit) equity
|
|
(197,295)
|
|
9,848
|
Total liabilities and stockholders’ (deficit) equity |
|
$
|
416,652
|
|
$
|
605,674
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Operations
|
(In thousands, except per share amounts)
|
(unaudited)
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
2018 |
|
|
2017 |
|
2018 |
|
2017 |
Total revenues
|
|
$65,686
|
|
$86,825
|
|
$215,947
|
|
$ 204,068
|
Cost and expenses:
|
|
|
|
|
|
|
|
|
Cost of revenues, excluding amortization of acquired intangible
assets
|
|
4,616
|
|
6,080
|
|
11,288
|
|
10,113
|
Write-down of inventory to net realizable value and (settlement)
loss on non-cancellable purchase commitments
|
|
(1,589)
|
|
71
|
|
247
|
|
167
|
Research and development
|
|
46,794
|
|
37,065
|
|
122,231
|
|
108,111
|
Selling, general and administrative
|
|
55,248
|
|
61,774
|
|
183,112
|
|
175,170
|
Amortization of acquired intangible assets
|
|
1,159
|
|
1,897
|
|
8,111
|
|
2,738
|
(Gain) loss on fair value remeasurement of contingent consideration
|
|
(33,519)
|
|
(628)
|
|
(31,045)
|
|
7,919
|
Restructuring expenses
|
|
10,282
|
|
-
|
|
15,096
|
|
-
|
Impairment of intangible assets
|
|
151,794
|
|
-
|
|
151,794
|
|
-
|
Total cost and expenses
|
|
234,785
|
|
106,259
|
|
460,834
|
|
304,218
|
Loss from operations
|
|
(169,099)
|
|
(19,434)
|
|
(244,887)
|
|
(100,150)
|
Other (expense) income:
|
|
|
|
|
|
|
|
|
Interest expense, net
|
|
(8,741)
|
|
(8,534)
|
|
(25,984)
|
|
(25,672)
|
Gain (loss) on derivatives
|
|
3,489
|
|
(4,329)
|
|
3,996
|
|
(1,191)
|
Loss on extinguishment of debt
|
|
-
|
|
-
|
|
-
|
|
(2,009)
|
Other expense, net
|
|
(5,252)
|
|
(12,863)
|
|
(21,988)
|
|
(28,872)
|
GAAP net loss
|
|
$(174,351)
|
|
$(32,297)
|
|
$(266,875)
|
|
$ (129,022)
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share—basic and diluted
|
|
$(1.14)
|
|
$(0.22)
|
|
$(1.75)
|
|
$(0.87)
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended September 30,
|
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
Non-GAAP net loss
|
|
$(58,406)
|
|
$(26,699)
|
|
$(142,011)
|
|
$(117,174)
|
Non-GAAP net loss per share (basic and diluted)
|
|
$(0.38)
|
|
$(0.18)
|
|
$(0.93)
|
|
$(0.79)
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares used in net loss per
share — basic and diluted
|
|
153,227
|
|
149,502
|
|
152,143
|
|
148,695
|
|
|
|
|
|
|
|
|
|
|
Reconciliation of GAAP Results to Non-GAAP Financial Measures
|
(In thousands, except per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
A reconciliation between net loss on a GAAP basis and on a
non-GAAP basis is as follows:
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30,
|
|
Nine Months Ended, September 30,
|
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
GAAP net loss
|
|
$(174,351)
|
|
$(32,297)
|
|
$(266,875)
|
|
$ (129,022)
|
Adjustments:
|
|
|
|
|
|
|
|
|
Mark-to-market adjustments on the derivatives related to convertible
notes, net
|
|
(3,489)
|
|
4,329
|
|
(3,996)
|
|
1,191
|
Amortization of intangible assets
|
|
1,159
|
|
1,897
|
|
8,111
|
|
2,738
|
Fair value remeasurement of contingent consideration
|
|
(33,519)
|
|
(628)
|
|
(31,045)
|
|
7,919
|
Impairment of intangible assets
|
|
151,794
|
|
-
|
|
151,794
|
|
-
|
Non-GAAP net loss
|
|
$(58,406)
|
|
$(26,699)
|
|
$(142,011)
|
|
$ (117,174)
|
|
|
|
|
|
|
|
|
|
|
A reconciliation between diluted net 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,
|
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
GAAP net loss per share – Basic and Diluted
|
|
$(1.14)
|
|
$(0.22)
|
|
$(1.75)
|
|
$(0.87)
|
Adjustments to GAAP net loss per share (as detailed above)
|
|
0.76
|
|
0.04
|
|
0.82
|
|
0.08
|
Non-GAAP net loss per share – basic and diluted
|
|
$(0.38)
|
|
$(0.18)
|
|
$(0.93)
|
|
$(0.79)
|
|
|
|
|
|
|
|
|
|
|
U.S. LINZESS Brand Collaboration1
Revenue/Expense Calculation
(In thousands)
(unaudited)
|
|
|
|
Three Months Ended September 30,
|
|
|
2018 excluding Net Sales Adjustment
|
|
Net Sales Adjustment2
|
|
2018 |
|
2017 |
LINZESS U.S. net sales
|
|
$204,815
|
|
$(59,326)
|
|
$145,489
|
|
$190,932
|
Commercial costs and expenses3
|
|
62,798
|
|
-
|
|
62,798
|
|
64,034
|
Commercial profit on sales of LINZESS
|
|
$142,017
|
|
$(59,326)
|
|
$82,691
|
|
$126,898
|
Commercial Margin4
|
|
69% |
|
|
|
57%
|
|
66% |
|
|
|
|
|
|
|
|
|
Ironwood’s share of net profit
|
|
|
|
|
|
$41,346
|
|
$63,449
|
Ironwood’s selling, general and administrative expenses5 |
|
|
|
|
|
10,915
|
|
10,456
|
Profit share adjustment
|
|
|
|
|
|
-
|
|
1,677
|
Ironwood’s collaborative arrangement revenue
|
|
|
|
|
|
$52,261
|
|
$75,582
|
1 Ironwood collaborates with Allergan 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. For the three months
ended September 30, 2018, net profit for the U.S. LINZESS brand
collaboration with Allergan was $66.2 million, calculated by subtracting
$62.8 million in commercial costs and expenses and $16.5 million in
research and development expenses, from LINZESS U.S. net sales of $145.5
million (which includes an approximately $59.3 million negative
adjustment to LINZESS net sales which was reported to Ironwood by
Allergan). Net brand profit of $66.2 million for the three months ended
September 30, 2018, excluding the approximately $59.3 million negative
adjustment to LINZESS net sales, would have been $125.5 million.
2 During the three months ended September 30, 2018, Allergan
reported to Ironwood an approximately $59.3 million negative adjustment
to LINZESS net sales. Such adjustment relates to the cumulative
difference between certain previously estimated LINZESS gross-to-net
sales reserves and allowances made by Allergan during the years ended
December 31, 2015, 2016 and 2017, and actual subsequent payments made.
This adjustment is primarily associated with estimated governmental and
contractual rebates, as reported by Allergan. Upon receiving the
information from Allergan, Ironwood recorded a $29.7 million reduction
to collaborative arrangement revenue and accounts receivable in its
third quarter 2018 financial statements related to its share of the
adjustment.
3 Includes cost of goods sold incurred by Allergan as well as
selling, general and administrative expenses incurred by Allergan 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 reported by Allergan, as a percent of total LINZESS U.S.
net sales.
5 Includes Ironwood’s selling, general and administrative
expenses attributable to the cost-sharing arrangement with Allergan.
|
U.S. LINZESS Brand Collaboration1
Revenue/Expense Calculation
(In thousands)
|
|
|
|
Nine Months Ended September 30,
|
|
|
2018 excluding Net Sales Adjustment
|
|
Net Sales Adjustment2
|
|
2018 |
|
2017 |
LINZESS U.S. net sales
|
|
$555,975
|
|
$(59,326)
|
|
$496,649
|
|
$506,380
|
Commercial costs and expenses3
|
|
198,411
|
|
-
|
|
198,411
|
|
215,174
|
Commercial profit on sales of LINZESS
|
|
$357,564
|
|
$(59,326)
|
|
$298,238
|
|
$291,206
|
Commercial Margin4
|
|
64% |
|
|
|
60% |
|
58% |
|
|
|
|
|
|
|
|
|
Ironwood’s share of net profit
|
|
|
|
|
|
$149,119
|
|
$ 145,603
|
Ironwood’s selling, general and administrative expenses5
|
|
|
|
|
|
33,556
|
|
34,061
|
Profit share adjustment
|
|
|
|
|
|
-
|
|
1,677
|
|
|
|
|
|
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Ironwood’s collaborative arrangement revenue
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$182,675
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$181,341
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1 Ironwood collaborates with Allergan 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.
2 During the three months ended September 30, 2018, Allergan
reported to Ironwood an approximately $59.3 million negative adjustment
to LINZESS net sales. Such adjustment relates to the cumulative
difference between certain previously estimated LINZESS gross-to-net
sales reserves and allowances made by Allergan during the years ended
December 31, 2015, 2016 and 2017, and actual subsequent payments made.
This adjustment is primarily associated with estimated governmental and
contractual rebates, as reported by Allergan. Upon receiving the
information from Allergan, Ironwood recorded a $29.7 million reduction
to collaborative arrangement revenue and accounts receivable in its
third quarter 2018 financial statements related to its share of the
adjustment.
3 Includes cost of goods sold incurred by Allergan as well as
selling, general and administrative expenses incurred by Allergan 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 reported by Allergan, as a percent of total LINZESS U.S.
net sales.
5 Includes Ironwood’s selling, general and administrative
expenses attributable to the cost-sharing arrangement with Allergan.
View source version on businesswire.com: https://www.businesswire.com/news/home/20181106005528/en/
Source: Ironwood Pharmaceuticals, Inc.
Ironwood Pharmaceuticals, Inc.
Meredith Kaya, 617-374-5082
Vice
President, Investor Relations and Corporate Communications
mkaya@ironwoodpharma.com