- Generated 2017 revenue of $298 million, driven primarily by LINZESS®
(linaclotide) U.S. net sales of $701 million and expansion
of LINZESS commercial margin to 61% -
- On track to advance key pipeline candidates in 2018, including
Phase III trials for IW-3718 and LINZESS and Phase II trials for
praliciguat (IW-1973) and IW-1701 -
- Expect to generate positive cash flow in 4Q 2018 through continued
top-line growth and financial discipline -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology
company, today provided an update on its fourth quarter and full year
2017 results and recent business activities.
"Continued execution in 2017 advanced our vision of building a biotech
company that is grounded in innovation and creating and commercializing
medicines that make a difference in patients' lives," said Peter Hecht,
chief executive officer of Ironwood. "LINZESS continued to strengthen
its branded prescription market leading position, ex-U.S. linaclotide
contribution from our partner Astellas in Japan increased significantly,
DUZALLO® was approved and launched, and we advanced six
exciting mid- and late-stage clinical trials. In 2018, we expect strong
top-line growth through our commercial efforts, the advancement of key
mid- to late-stage clinical trials targeting areas of significant unmet
need such as uncontrolled GERD, diabetic nephropathy, heart failure with
preserved ejection fraction and sickle cell disease, and we expect to
generate positive cash flow in the fourth quarter."
Fourth Quarter and Full Year 2017 and Recent Highlights
Irritable Bowel Syndrome with Constipation
(IBS-C) / Chronic Idiopathic Constipation (CIC)
-
LINZESS. U.S. net sales, as reported by Ironwood's U.S.
collaboration partner Allergan plc, were $194.8 million in the fourth
quarter of 2017, a 12% increase compared to the fourth quarter of
2016, and $701.2 million for the full year 2017, a 12% increase
compared to the full year 2016. Ironwood and Allergan share equally in
brand collaboration profits.
-
LINZESS commercial margin was 71% in the fourth quarter of 2017
compared to 61% in the fourth quarter 2016. For the full year
2017, commercial margin was 61% compared to 58% in 2016.
-
Net profit for the LINZESS U.S. brand collaboration, including
commercial and research and development (R&D) expenses, was $126.5
million in the fourth quarter of 2017, a 41% increase compared to
the fourth quarter of 2016. For the full year 2017, net profit was
$371.8 million, a 29% increase compared to the full year 2016.
-
Total LINZESS prescription volume in the fourth quarter of 2017
included approximately 31 million LINZESS capsules, an 18%
increase in capsules compared to the fourth quarter of 2016, per
IQVIA. For the full year 2017, total prescription volume included
approximately 113 million LINZESS capsules, an 18% increase
compared to the full year 2016, per IQVIA.
-
More than 806,000 total LINZESS prescriptions were filled in the
fourth quarter of 2017, a nearly 12% increase compared to the
fourth quarter of 2016, per IQVIA. For the full year 2017,
approximately 3 million total LINZESS prescriptions were filled, a
nearly 14% increase compared to the full year 2016, per IQVIA.
-
Since the launch of LINZESS in December 2012, greater than 2
million unique patients have filled approximately 10 million
prescriptions, per IQVIA.
-
In January 2018, Ironwood and Allergan reached an agreement with
wholly-owned subsidiaries of Sun Pharmaceutical Industries Ltd. (Sun
Pharma, including its subsidiaries and/or associated companies),
resolving patent litigation brought in response to Sun Pharma's
abbreviated new drug application (ANDA) seeking approval to market a
generic version of LINZESS prior to the expiration of the companies'
patents. Pursuant to the terms of the settlement, Ironwood and
Allergan will grant the wholly-owned subsidiaries of Sun Pharma a
license to market a generic version of LINZESS in the U.S. beginning
on February 1, 2031 (subject to U.S.FDA approval), unless certain
limited circumstances, customary to settlement agreements of this
nature, occur. As a result of the settlement, all Hatch-Waxman
litigation between the companies and Sun Pharma regarding LINZESS
patents has been dismissed.
-
Additional Abdominal Symptom Claims. Abdominal bloating and
discomfort are two highly bothersome symptoms associated with IBS-C.
Ironwood and Allergan expect to advance a single Phase III trial with
LINZESS in 2018 intended to obtain additional abdominal symptom
claims, including bloating and discomfort.
-
Linaclotide Delayed Release. An estimated 20 to 25 million
patients suffer from IBS-mixed and IBS with diarrhea in the U.S.
Ironwood and Allergan plan to advance a linaclotide delayed release
formulation as a visceral, non-opioid, pain-relieving agent for
patients suffering from all subtypes of IBS. The companies are in
active discussions with the U.S.FDA to advance this program into a
Phase IIb trial.
Uncontrolled Gout
-
DUZALLO (lesinurad and allopurinol) and ZURAMPIC®
(lesinurad). Combined U.S. net sales were $1.6 million in the
fourth quarter of 2017 and $3.1 million for the full year 2017,
including a cumulative adjustment of approximately $0.9 million due to
the transition to the sell-in revenue recognition model.
-
In October 2017, Ironwood began commercializing DUZALLO in the
U.S. as the first FDA-approved fixed-dose combination treatment
that addresses two causes of hyperuricemia in gout,
over-production and under-excretion of serum uric acid, in a
single pill.
-
Nearly 3,000 total DUZALLO and ZURAMPIC prescriptions were filled
in the fourth quarter of 2017, and more than 6,000 total
prescriptions were filled in the full year 2017, per IQVIA.
-
Lesinurad Franchise Strategy. In January 2018, Ironwood
commenced an initiative to evaluate the optimal mix of investments for
its lesinurad franchise, including DUZALLO and ZURAMPIC. As part of
this effort, Ironwood is investing to systemically explore a more
comprehensive marketing mix in select test markets (with paired
controls), while continuing to build market presence across the
country. The data received in 2018 from these test markets are
expected to inform future investments into the lesinurad franchise. As
a result, Ironwood is re-allocating its franchise resources and
commenced a reduction in its field-based workforce, primarily
consisting of field-based sales representatives that promote DUZALLO
or ZURAMPIC in the first position, by approximately 60 employees.
Ironwood's field-based sales representatives that promote LINZESS in
the first position and headquarters-based employees are excluded from
the workforce reduction.
Uncontrolled Gastroesophageal Reflux Disease
(GERD)
-
IW-3718. There are an estimated 10 million Americans who suffer
regularly from symptoms of GERD, such as heartburn and regurgitation,
despite receiving treatment with the current standard of care, proton
pump inhibitors. Ironwood is actively working to advance IW-3718, its
gastric retentive formulation of a bile acid sequestrant for the
potential treatment of uncontrolled GERD, into Phase III trials.
Ironwood continues to expect the trials to begin in the second half of
2018, pending end of Phase II meetings with the U.S.FDA.
Diabetic Nephropathy and Heart Failure with
Preserved Ejection Fraction (HFpEF)
-
Praliciguat (IW-1973). Ironwood is advancing praliciguat, its
lead soluble guanylate cyclase (sGC) stimulator, in Phase II trials
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.
-
Diabetic nephropathy. Ironwood is enrolling approximately
150 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.
-
HFpEF. Ironwood is enrolling approximately 325 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 HFpEF.
-
In December 2017, Ironwood announced top-line results from two
Phase IIa studies designed to study the safety and
pharmacokinetics of praliciguat in patients with type 2 diabetes
and hypertension. Consistent with pre-clinical observations, data
from both studies indicated that treatment with praliciguat led to
blood pressure reductions, improvements in metabolic parameters
(including reductions in fasting plasma glucose, triglyceride and
cholesterol levels), and improvements in markers of endothelial
health in patients who were taking a stable medical regimen to
manage their disease. These studies confirmed a pharmacokinetic
profile of praliciguat that supports evaluation of once-daily
dosing and suggest broad distribution to tissues, offering the
potential for extra-vascular pharmacology. Praliciguat was
generally well-tolerated in both studies.
Sickle Cell Disease and Achalasia
-
IW-1701. Ironwood is advancing IW-1701, its second clinical sGC
stimulator, in Phase II development for the potential treatment of
sickle cell disease and of achalasia. Sickle cell disease is a
debilitating genetic disorder that affects approximately 100,000
Americans and causes red blood cells to become sickle-shaped, reducing
normal red blood cell number. Achalasia is a rare disease with a
prevalence rate of 10/100,000 Americans in which the lower esophagus
does not relax normally, causing dysphagia (swallowing problems),
regurgitation, and chest pain.
-
Sickle Cell Disease. Ironwood is enrolling approximately 80
patients into a multicenter, randomized, double-blind,
placebo-controlled, dose-ranging Phase II trial of IW-1701 in
patients with sickle cell disease. The Phase II trial is designed
to evaluate the safety, tolerability, pharmacokinetics and
pharmacodynamics of IW-1701 in these patients.
-
Achalasia. Ironwood continues to enroll patients into a
randomized, double-blind, placebo-controlled, single-dose Phase
IIa study of IW-1701 in patients with achalasia. This study is
designed to evaluate the safety, tolerability, pharmacokinetics
and pharmacodynamics of IW-1701 in these patients. Data from this
study are expected in 2018.
Global Collaborations and Partnerships
-
Ironwood's partner Astellas is commercializing LINZESS for adults with
IBS-C in Japan. In September 2017, Astellas submitted a Supplemental
New Drug Application with the Pharmaceuticals and Medical Devices
Agency in Japan for approval to market linaclotide for the additional
indication of chronic constipation.
-
Ironwood continues to expect the China Food and Drug Administration to
complete its review of the marketing application for linaclotide in
China for adult IBS-C patients in the first half of 2018. Ironwood is
partnered with AstraZeneca for the development and commercialization
of linaclotide in China.
Corporate and Financials
-
Total Revenues
-
Total revenues were $94.2 million in the fourth quarter of 2017
compared to $87.4 million in the fourth quarter of 2016. Included
in total revenues was $76.6 million associated with Ironwood's
share of the net profits from the sales of LINZESS in the U.S.,
$14.2 million in sales of linaclotide API to Astellas, $1.6
million in ZURAMPIC and DUZALLO product revenue, and $1.8 million
in linaclotide royalties, co-promotion and other revenue.
-
For the full year 2017, total revenues were $298.3 million
compared to $273.9 million in 2016. Included in total revenues was
$258.0 million associated with Ironwood's share of the net profits
from the sales of LINZESS in the U.S., $29.7 million in sales of
linaclotide API to Astellas, $3.1 million in ZURAMPIC and DUZALLO
product revenue, and $7.5 million in linaclotide royalties,
co-promotion and other revenue.
-
For the fourth quarter and full year 2016, revenue included $19.1
million and $39.0 million of milestone related revenue from
Astellas, respectively. These were primarily related to the final
development milestones for the approval of LINZESS for the
treatment of adults with IBS-C in Japan.
-
Operating Expenses
-
Operating expenses were $71.4 million in the fourth quarter of
2017 as compared to $93.8 million in the fourth quarter of
2016. Operating expenses in the fourth quarter of 2017 included
$9.1 million in cost of revenues, $40.1 million in R&D expenses,
$58.0 million in selling, general and administrative (SG&A)
expenses, $3.5 million in acquired intangible assets amortization
expenses, and a $39.2 million gain on fair value remeasurement of
contingent consideration.
-
Operating expenses were $375.7 million for the full year 2017,
compared to $325.8 million for the full year 2016. Operating
expenses for the full year 2017 included $19.1 million in cost of
revenue, $0.3 million in write-down of inventory to net realizable
value and loss on non-cancelable purchase commitments, $148.2
million in R&D expenses, $233.1 million in SG&A expenses, $6.2
million in acquired intangible asset amortization expenses and a
$31.3 million gain on fair value remeasurement of contingent
consideration.
-
The gain in fair value remeasurement of contingent consideration
during the fourth quarter and full year 2017 was primarily due to
a revised lesinurad U.S. net sales forecast with a slower sales
ramp. Contingent consideration at December 31, 2017 relates to
future royalty and milestone payments based on the estimated
future sales of DUZALLO and ZURAMPIC.
-
Other Expense
-
Interest Expense. Net interest expense was $8.6 million in
the fourth quarter of 2017 and $34.3 million for the full year
2017, primarily in connection with the $150 million debt
refinancing funded in January 2017 and the approximately $336
million convertible debt financing funded in June 2015. Interest
expense recorded in the fourth quarter of 2017 includes $5.0
million in cash expense and $4.2 million in non-cash expense.
Interest expense recorded for the full year 2017 includes $20.3
million in cash expense and $16.1 million in non-cash expense.
-
Loss on Derivatives. Ironwood records a gain/loss on
derivatives 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. A loss on
derivatives of $2.1 million and $3.3 million was recorded in the
fourth quarter and the full year 2017, respectively.
-
Loss on Extinguishment of Debt. A $2.0 million write-off
related to the payoff of the Linaclotide PhaRMA 11% Notes was
recognized during the year ended December 31, 2017.
-
Net Income (loss)
-
GAAP net income was $12.1 million, or $0.08 per share, in the
fourth quarter of 2017, compared to a net loss of $13.5 million,
or $(0.09) per share, in the fourth quarter of 2016. For the full
year 2017, GAAP net loss was $116.9 million, or $(0.78) per share,
as compared to $81.7 million, or $0.56 per share, in 2016.
-
Non-GAAP net loss was $21.6 million, or $(0.14) per share, in the
fourth quarter of 2017, compared to $17.7 million, or $(0.12) per
share, in the fourth quarter of 2016. For the full year 2017,
Non-GAAP net loss was $138.7 million, or $(0.93) per share, as
compared to $79.0 million, or $(0.55) per share, in 2016. Non-GAAP
net loss excludes the impact of mark-to-market adjustments on the
derivatives related to Ironwood's convertible debt, as well as the
amortization of acquired intangible assets and the fair value
remeasurement of contingent consideration related to Ironwood's
U.S. lesinurad license. See Non-GAAP Financial Measures below.
-
Cash Position
-
Ironwood ended 2017 with approximately $221 million of cash, cash
equivalents and available-for-sale securities. Ironwood used
approximately $9 million of cash for operations during the fourth
quarter of 2017 and approximately $100 million during the full
year 2017, as compared to approximately $19 million during the
fourth quarter of 2016 and approximately $25 million during the
full year 2016.
-
Performance against 2017 Financial Guidance
-
Total 2017 R&D expenses were $148.2 million.
-
2017 R&D expenses were guided to be in the low- to middle-end
of the $145 million to $160 million range.
-
Total 2017 SG&A expenses were $233.1 million.
-
2017 SG&A expenses were guided to be in the low- to middle-end
of the $235 million to $250 million range.
-
Combined Ironwood and Allergan total 2017 LINZESS marketing and
sales expenses were $254.2 million.
-
Ironwood and Allergan total 2017 marketing and sales expenses
for LINZESS were guided to be in the middle of the $250
million to $280 million range.
-
Ironwood used $99.6 million in cash for operations for the full
year 2017.
-
Ironwood guided to use less than $110 million in cash for
operations in 2017.
-
2017 net interest expense was $34.3 million.
-
2017 net interest expense was guided to be approximately $40
million.
-
2018 Financial Guidance
Non-GAAP Financial Measures
The company 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, as
well as the amortization of acquired intangible assets and 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. 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. 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 Thursday, February 15, 2018 to discuss its fourth quarter and
full year 2017 results and recent business activities. Individuals
interested in participating in the call should dial (877) 643-7155 (U.S.
and Canada) or (914) 495-8554 (international) using conference ID number
8489758. 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 February 15, 2018 running through 11:59 p.m. Eastern
Time on February 22, 2018. To listen to the replay, dial (855) 859-2056
(U.S. and Canada) or (404) 537-3406 (international) using conference ID
number 8489758. 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 are commercializing two innovative primary care
products: linaclotide, the U.S. branded prescription market leader for
adults with irritable bowel syndrome with constipation (IBS-C) or
chronic idiopathic constipation (CIC), and lesinurad, which is approved
to be taken with a xanthine oxidase inhibitor (XOI), or as a fixed-dose
combination with allopurinol, for the treatment of hyperuricemia
associated with gout. We are also advancing a pipeline of innovative
product candidates in areas of significant unmet need, including
uncontrolled gastroesophageal reflux disease, diabetic nephropathy,
heart failure with preserved ejection fraction, achalasia 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 million unique patients have filled approximately 10
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. 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 development, launch,
commercial availability and commercial potential of linaclotide,
lesinurad, our product candidates and the other products that we promote
and the drivers, timing, impact and results thereof; market size,
prevalence, growth and opportunity, including peak sales (and drivers
thereof) and the growth in and potential demand for linaclotide,
lesinurad and our product candidates, as well as their potential impact
on applicable markets; the potential indications for, and benefits of,
linaclotide, lesinurad and our product candidates; the anticipated
timing of preclinical, clinical and regulatory developments and the
design, timing and results of clinical and preclinical studies; the
potential for, and timing of, regulatory submissions and approvals for
linaclotide, lesinurad and our product candidates; partnering strategy
and discussions; business strategy and investments (and evaluations
thereof), structure and operations; the cause, size, timing and impact
of Ironwood's reduction in workforce and related activities; expected
periods of patent exclusivity, durability and life of the respective
patent portfolios for linaclotide, lesinurad and our product candidates;
the strength of the intellectual property protection for linaclotide,
lesinurad and our product candidates and our intentions and efforts to
protect such intellectual property; and our financial performance and
results, and guidance and expectations related thereto (including the
drivers and timing thereof), including expectations related to a rapidly
growing top-line, the exercise of capital discipline, maximizing
long-term per-share cash flows for shareholders, Ironwood revenue CAGR,
commercial margin, net price increase, positive cash flow and positive
cash flow from operations, LINZESS U.S. net sales, ex-U.S. revenue
(including API revenue), allocation of capital, R&D, SG&A and marketing
and sales expenses, net interest expense and cash used for operations.
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; the
risk that findings from our completed nonclinical and clinical studies
may not be replicated in later studies; efficacy, safety and
tolerability of linaclotide, lesinurad and our product candidates;
decisions by regulatory and judicial authorities; the risk that we are
unable to successfully commercialize lesinurad or realize the
anticipated benefits of the lesinurad transaction; the risk that we may
never get sufficient patent protection for linaclotide, lesinurad and
our 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, linaclotide, lesinurad or our 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 September 30, 2017, 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)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
December 31, 2017
|
|
|
|
December 31, 2016
|
Assets
|
|
|
|
|
|
|
|
|
Cash, cash equivalents and available-for-sale securities
|
|
|
|
$
|
221,416
|
|
|
|
$
|
305,216
|
Accounts receivable, net
|
|
|
|
82,157
|
|
|
|
64,854
|
Inventory
|
|
|
|
735
|
|
|
|
1,081
|
Prepaid expenses and other current assets
|
|
|
|
7,288
|
|
|
|
9,030
|
Total current assets
|
|
|
|
311,596
|
|
|
|
380,181
|
Property and equipment, net
|
|
|
|
17,274
|
|
|
|
20,512
|
Convertible note hedges
|
|
|
|
108,188
|
|
|
|
132,521
|
Intangible assets, net
|
|
|
|
159,905
|
|
|
|
166,119
|
Goodwill |
|
|
|
785
|
|
|
|
785
|
Other assets
|
|
|
|
7,926
|
|
|
|
9,703
|
Total assets
|
|
|
|
$
|
605,674
|
|
|
|
$
|
709,821
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
|
|
|
Accounts payable, accrued expenses and other current liabilities
|
|
|
|
$
|
61,508
|
|
|
|
$
|
62,941
|
Current portion of capital lease obligations
|
|
|
|
4,077
|
|
|
|
6,227
|
Current portion of deferred rent
|
|
|
|
195
|
|
|
|
7,719
|
Current portion of contingent consideration
|
|
|
|
247
|
|
|
|
14,244
|
Total current liabilities
|
|
|
|
66,027
|
|
|
|
91,131
|
Capital lease obligations
|
|
|
|
-
|
|
|
|
82
|
Deferred rent, net of current portion
|
|
|
|
5,449
|
|
|
|
557
|
Other liabilities
|
|
|
|
5,060
|
|
|
|
8,190
|
Contingent consideration, net of current portion
|
|
|
|
31,011
|
|
|
|
63,416
|
Note hedge warrants
|
|
|
|
92,188
|
|
|
|
113,237
|
Convertible notes
|
|
|
|
249,193
|
|
|
|
234,243
|
Long-term debt
|
|
|
|
146,898
|
|
|
|
132,249
|
Total stockholders' equity
|
|
|
|
9,848
|
|
|
|
66,716
|
Total liabilities and stockholders' equity
|
|
|
|
$
|
605,674
|
|
|
|
$
|
709,821
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
|
|
Twelve Months Ended December 31,
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
2017
|
|
|
|
2016
|
Total revenues
|
|
|
|
$
|
94,208
|
|
|
|
|
$
|
87,459
|
|
|
|
|
$
|
298,276
|
|
|
|
|
$
|
273,957
|
|
Cost and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenues, excluding amortization of acquired intangible
assets
|
|
|
|
|
9,126
|
|
|
|
|
|
2,242
|
|
|
|
|
|
19,406
|
|
|
|
|
|
2,242
|
|
Research and development
|
|
|
|
|
40,117
|
|
|
|
|
|
38,442
|
|
|
|
|
|
148,228
|
|
|
|
|
|
139,492
|
|
Selling, general and administrative
|
|
|
|
|
57,953
|
|
|
|
|
|
55,208
|
|
|
|
|
|
233,123
|
|
|
|
|
|
173,281
|
|
Amortization of acquired intangible assets
|
|
|
|
|
3,476
|
|
|
|
|
|
(3,297
|
)
|
|
|
|
|
6,214
|
|
|
|
|
|
981
|
|
(Gain) loss on fair value remeasurement of contingent consideration
|
|
|
|
|
(39,229
|
)
|
|
|
|
|
1,164
|
|
|
|
|
|
(31,310
|
)
|
|
|
|
|
9,831
|
|
Total cost and expenses
|
|
|
|
|
71,443
|
|
|
|
|
|
93,759
|
|
|
|
|
|
375,661
|
|
|
|
|
|
325,827
|
|
Income (Loss) from operations
|
|
|
|
|
22,765
|
|
|
|
|
|
(6,300
|
)
|
|
|
|
|
(77,385
|
)
|
|
|
|
|
(51,870
|
)
|
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net
|
|
|
|
|
(8,587
|
)
|
|
|
|
|
(9,308
|
)
|
|
|
|
|
(34,259
|
)
|
|
|
|
|
(37,984
|
)
|
(Loss) gain on derivatives
|
|
|
|
|
(2,093
|
)
|
|
|
|
|
2,103
|
|
|
|
|
|
(3,284
|
)
|
|
|
|
|
8,146
|
|
Loss on extinguishment of debt
|
|
|
|
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
(2,009
|
)
|
|
|
|
|
-
|
|
Other expense, net
|
|
|
|
|
(10,680
|
)
|
|
|
|
|
(7,205
|
)
|
|
|
|
|
(39,552
|
)
|
|
|
|
|
(29,838
|
)
|
GAAP net income (loss)
|
|
|
|
|
12,085
|
|
|
|
|
|
(13,505
|
)
|
|
|
|
|
(116,937
|
)
|
|
|
|
|
(81,708
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net income (loss) per share—basic and diluted
|
|
|
|
$
|
0.08
|
|
|
|
|
$
|
(0.09
|
)
|
|
|
|
$
|
(0.78
|
)
|
|
|
|
$
|
(0.56
|
)
|
|
|
|
|
Three Months Ended December 31,
|
|
|
|
Twelve Months Ended December 31,
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
2017
|
|
|
|
2016
|
Non-GAAP net loss
|
|
|
|
$
|
(21,575
|
)
|
|
|
|
$
|
(17,741
|
)
|
|
|
|
$
|
(138,749
|
)
|
|
|
|
$
|
(79,042
|
)
|
Non-GAAP net loss per share (basic and diluted)
|
|
|
|
$
|
(0.14
|
)
|
|
|
|
$
|
(0.12
|
)
|
|
|
|
$
|
(0.93
|
)
|
|
|
|
$
|
(0.55
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares used
|
|
|
|
|
149,877
|
|
|
|
|
|
146,274
|
|
|
|
|
|
148,993
|
|
|
|
|
|
144,928
|
|
in net loss per share — basic and diluted
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 December 31,
|
|
|
|
Twelve Months Ended December 31,
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
2017
|
|
|
|
2016
|
GAAP net income (loss)
|
|
|
|
$
|
12,085
|
|
|
|
|
$
|
(13,505
|
)
|
|
|
|
$
|
(116,937
|
)
|
|
|
|
$
|
(81,708
|
)
|
Adjustments:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mark-to-market adjustments on the derivatives related to convertible
notes, net
|
|
|
|
|
2,093
|
|
|
|
|
|
(2,103
|
)
|
|
|
|
|
3,284
|
|
|
|
|
|
(8,146
|
)
|
Amortization of intangible assets
|
|
|
|
|
3,476
|
|
|
|
|
|
(3,297
|
)
|
|
|
|
|
6,214
|
|
|
|
|
|
981
|
|
(Gain) loss fair value remeasurement of contingent consideration
|
|
|
|
|
(39,229
|
)
|
|
|
|
|
1,164
|
|
|
|
|
|
(31,310
|
)
|
|
|
|
|
9,831
|
|
Non-GAAP net loss
|
|
|
|
$
|
(21,575
|
)
|
|
|
|
$
|
(17,741
|
)
|
|
|
|
$
|
(138,749
|
)
|
|
|
|
$
|
(79,042
|
)
|
A reconciliation between diluted net loss per share on a GAAP
basis and on a non-GAAP basis is as follows:
|
|
|
|
|
|
Three Months Ended December 31,
|
|
|
|
Twelve Months Ended December 31,
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
2017
|
|
|
|
2016
|
GAAP net income (loss) per share - Basic and Diluted
|
|
|
|
$
|
0.08
|
|
|
|
|
$
|
(0.09
|
)
|
|
|
|
$
|
(0.78
|
)
|
|
|
|
$
|
(0.56
|
)
|
Adjustments to GAAP net loss per share (as detailed above)
|
|
|
|
|
(0.22
|
)
|
|
|
|
|
(0.03
|
)
|
|
|
|
|
(0.15
|
)
|
|
|
|
|
0.02
|
|
Non-GAAP net loss per share - basic and diluted1 Numbers
may not add due to rounding
|
|
|
|
$
|
(0.14
|
)
|
|
|
|
$
|
(0.12
|
)
|
|
|
|
$
|
(0.93
|
)
|
|
|
|
$
|
(0.55
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
U.S. LINZESS Brand Collaboration1
Revenue/Expense Calculation
(In thousands)
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended December 31,
|
|
|
|
Twelve Months Ended December 31,
|
|
|
|
|
2017
|
|
|
|
2016
|
|
|
|
2017
|
|
|
|
2016
|
LINZESS U.S. net sales
|
|
|
|
$
|
194,790
|
|
|
|
|
$
|
173,575
|
|
|
|
|
$
|
701,170
|
|
|
|
|
$
|
625,555
|
|
Commercial costs and expenses2
|
|
|
|
|
56,023
|
|
|
|
|
|
67,397
|
|
|
|
|
|
271,197
|
|
|
|
|
|
265,238
|
|
Commercial profit on sales of LINZESS
|
|
|
|
$
|
138,767
|
|
|
|
|
$
|
106,178
|
|
|
|
|
$
|
429,973
|
|
|
|
|
$
|
360,317
|
|
Commercial Margin3
|
|
|
|
|
71
|
%
|
|
|
|
|
61
|
%
|
|
|
|
|
61
|
%
|
|
|
|
|
58
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ironwood's share of net profit
|
|
|
|
$
|
69,384
|
|
|
|
|
$
|
53,089
|
|
|
|
|
$
|
214,987
|
|
|
|
|
$
|
180,159
|
|
Ironwood's selling, general and administrative expenses4
|
|
|
|
|
7,190
|
|
|
|
|
|
9,674
|
|
|
|
|
|
41,251
|
|
|
|
|
|
35,197
|
|
Profit share adjustment5 |
|
|
|
|
-
|
|
|
|
|
|
-
|
|
|
|
|
|
1,677
|
|
|
|
|
|
2,370
|
|
Ironwood's collaborative arrangement revenue
|
|
|
|
$
|
76,574
|
|
|
|
|
$
|
62,763
|
|
|
|
|
$
|
257,915
|
|
|
|
|
$
|
217,726
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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 December 31, 2017, net profit for the U.S. LINZESS brand
collaboration with Allergan was $126.5 million, calculated by
subtracting $56.0 million in commercial costs and expenses and $12.3
million in research and development expenses, from LINZESS U.S. net
sales of $194.8 million. For the full year 2017, net profit for the U.S.
LINZESS brand collaboration with Allergan was $371.8 million, calculated
by subtracting $271.2 million in commercial costs and expenses and $58.2
million in research and development expenses, from LINZESS U.S. net
sales of $701.2 million.
2 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.
3 Commercial
margin is defined as commercial profit on sales of LINZESS as a percent
of total LINZESS U.S. net sales.
4 Includes Ironwood's
selling, general and administrative expenses attributable to the
cost-sharing arrangement with Allergan.
5 Ironwood or
Allergan may recognize additional revenue or incur additional expenses
resulting in an adjustment to the company's share of the net profits as
stipulated by the collaboration agreement.
View source version on businesswire.com: http://www.businesswire.com/news/home/20180215005322/en/
Ironwood Pharmaceuticals, Inc.
Meredith Kaya, 617-374-5082
Vice
President, Investor Relations and Corporate Communications
mkaya@ironwoodpharma.com
Source: Ironwood Pharmaceuticals, Inc.
News Provided by Acquire Media