-Progress across priority opportunities, including two Phase IIb
trials underway, and lesinurad license establishes new uncontrolled gout
franchise -
- LINZESS® (linaclotide) U.S. net sales
increased ~44% to $137 million in 1Q 2016 compared to 1Q 2015; on track
to exceed $1 billion in net sales by 2020 -
-Ironwood revenue increased 128% to $66 million in 1Q 2016, primarily
driven by continued growth in LINZESS net sales and profitability;
Ironwood on track to achieve positive cash flow in 2018 -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology
company, today provided an update on its first quarter 2016 results and
recent business activities.
"In the first few months of 2016, Ironwood made significant
progress building a top-performing commercial biotech company. We
delivered strong operational performance, advanced a second program into
Phase IIb trials, and executed a license agreement that leverages our
strong commercial capabilities and puts us on track for at least five
U.S. commercial product launches by 2020," said Peter Hecht, chief
executive officer of Ironwood. "The quarter's results also demonstrate
continued strong LINZESS growth: more than 4.5 million prescriptions
have now been filled by more than 1 million patients since launch, and
market research has shown high physician and patient satisfaction with
LINZESS as an effective and safe treatment option for adults suffering
from IBS-C or CIC."
First Quarter 2016 and Recent Highlights
Irritable Bowel Syndrome with Constipation
(IBS-C) / Chronic Idiopathic Constipation (CIC) Franchise
Ironwood estimates its IBS-C/CIC franchise, including LINZESS and
linaclotide colonic release (if approved), which are jointly owned in
the U.S. by Ironwood and Allergan with both companies sharing equally in
any profits or losses, may represent a peak U.S. sales opportunity
exceeding $2 billion, with additional global potential.
-
LINZESS. U.S. net sales, as provided by Allergan, were $137.1
million in the first quarter of 2016, a 44% increase compared to the
first quarter of 2015.
-
Nearly 600,000 total LINZESS prescriptions were filled in the
first quarter of 2016, a 30% increase compared to the first
quarter of 2015, according to IMS Health.
-
Net profit for the LINZESS U.S. brand collaboration, including
commercial and research and development (R&D) expenses, was $58.4
million in the first quarter of 2016.
-
LINZESS commercial margin was 55% in the first quarter of 2016,
compared to 39% in the first quarter of 2015.
-
Ironwood and Allergan launched a new direct to consumer marketing
campaign, and the companies increased LINZESS managed care
coverage and expanded the entry into new market segments including
long term care.
-
Ironwood and Allergan continue to expect to launch a 72 mcg dose
of linaclotide in early 2017, if approved. The companies
anticipate that the 72 mcg dose will accelerate physician
prescribing of LINZESS within the large, heterogeneous adult CIC
patient population.
-
Linaclotide Colonic Release. A Phase IIb clinical trial is
enrolling patients, with data expected in the second half of 2016.
This second-generation guanylate cyclase-C (GC-C) agonist product
candidate has the potential to provide greater and faster abdominal
pain relief in adult IBS-C patients and to expand the IBS-C and CIC
market, if approved.
Refractory Gastroesophageal Reflux Disease
(GERD) Franchise
-
IW-3718. Ironwood initiated a dose-ranging Phase IIb
clinical trial with IW-3718, a wholly-owned asset, for the potential
treatment of refractory GERD. Data from the Phase IIb trial are
expected in 2017. If approved, Ironwood estimates peak sales for
IW-3718 may exceed $2 billion.
Uncontrolled Gout Franchise
On April 26, Ironwood announced that it signed a licensing agreement
with AstraZeneca for the exclusive U.S. rights to all products
containing lesinurad. This includes FDA-approved ZURAMPIC®
(lesinurad 200mg tablets) as well as a fixed-dose combination of lesinurad
and allopurinol, which AstraZeneca plans to submit for FDA regulatory
review in the second half of 2016.
For as many as two million gout patients in the U.S., treatment with a
xanthine oxidase inhibitor (XOI) such as allopurinol to decrease
production of uric acid is not sufficient to achieve treatment goals.
ZURAMPIC complements XOI therapy by increasing excretion of uric acid
and is indicated for use in combination with an XOI for the treatment of
hyperuricemia associated with uncontrolled gout. ZURAMPIC is not
recommended for the treatment of asymptomatic hyperuricemia and should
not be used as monotherapy.
The transaction is expected to close in the second quarter of 2016, and
Ironwood expects to launch ZURAMPIC in the middle of the second half of
2016.
Vascular and Fibrotic Franchise
Ironwood is leveraging its pharmacologic expertise in guanylate cyclases
to advance soluble guanylate cyclase (sGC) stimulators for the potential
treatment of vascular and fibrotic diseases. Ironwood believes this
opportunity has the potential to deliver multiple products, a number of
which could generate peak sales exceeding $1 billion if approved. All
vascular and fibrotic assets are wholly-owned by Ironwood. Highlights
during the first quarter and recent period include:
-
IW-1701. Ironwood announced positive top-line results
from a Phase Ia study of IW-1701 and is in the process of initiating a
Phase Ib multiple ascending dose study, with topline data expected in
the second half of 2016.
-
IW-1973. Ironwood is currently enrolling healthy
volunteers in a Phase Ib clinical study with IW-1973 designed to
assess its safety, tolerability, pharmacokinetic profile and
pharmacodynamic effects. Data from this study are expected in the
second half of 2016.
-
Data from pre-clinical and early clinical studies of these
compounds are being presented at several scientific conferences this
spring.
Ironwood expects to initiate multiple Phase II studies with its sGC
stimulators this year.
Additional Programs
Diabetic Gastroparesis
IW-9179. Ironwood previously announced that top-line data
from an exploratory Phase IIa clinical study indicated IW-9179 did not
meaningfully reduce the severity of symptoms in patients with diabetic
gastroparesis and it will discontinue development of IW-9179 for
gastroparesis.
Global Collaborations and Partnerships
Ironwood's strong U.S. commercial organization successfully introduced
LINZESS to the market with its partner Allergan and expects to
commercialize multiple important products in the U.S. over time.
Ironwood expects to out-license ex-U.S. commercialization rights to its
pipeline product candidates. Highlights during the first quarter and
recent period include:
-
Astellas Pharma Inc. filed for approval with the Ministry of Health,
Labor and Welfare to market linaclotide in Japan for IBS-C in adult
patients, which resulted in Ironwood earning a $15 million development
milestone payment, which was received in the first quarter.
-
Ironwood and AstraZeneca AB filed for approval with the China Food and
Drug Administration to market linaclotide in China for the treatment
of adult patients with IBS-C.
-
Ironwood continued co-promoting Allergan's VIBERZI™ (eluxadoline) for
adults suffering from IBS with diarrhea (IBS-D) and Exact Sciences'
Cologuard® noninvasive stool DNA screening test for
colorectal cancer, in the U.S. Both partnerships represent productive
and efficient utilization of Ironwood's commercial capabilities and
continue to generate incremental revenues.
Corporate and Financials
On its second quarter 2016 investor update, following the closing of the
lesinurad transaction, Ironwood expects to update its guidance for total
annual operating expenses for 2016, including both R&D and SG&A expenses.
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. These
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. 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 4:30 p.m. Eastern
Time, on Monday, May 9, to discuss its first quarter of 2016 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 89241099. 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 7:30 p.m.
Eastern Time, on May 9, running through 11:59 p.m. Eastern Time on May
16, 2016. To listen to the replay, dial (855) 859-2056 (U.S. and Canada)
or (404) 537-3406 (international) using conference ID number 89241099.
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 advancing an innovative pipeline of medicines in
multiple areas of significant unmet need, including irritable bowel
syndrome with constipation (IBS-C)/chronic idiopathic constipation
(CIC), vascular and fibrotic diseases, and refractory gastroesophageal
reflux disease, among others. We discovered, developed and are
commercializing linaclotide, the U.S. branded prescription market leader
in the IBS-C/CIC category, and we are applying our proven R&D and
commercial capabilities to advance multiple internally-developed and
externally-accessed product opportunities. 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 first and only guanylate cyclase-C (GC-C) agonist
approved by the FDA and is indicated for the treatment of both irritable
bowel syndrome with constipation (IBS-C) and chronic idiopathic
constipation (CIC) in adults. 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 and incomplete
evacuation associated with CIC. The recommended dose is 290 mcg for
IBS-C patients and 145 mcg for CIC patients. LINZESS should be taken at
least 30 minutes before the first meal of the day.
LINZESS is thought to work in two ways based on nonclinical studies.
LINZESS binds to the GC-C receptor locally, within the intestinal
epithelium. Activation of GC-C results 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 placebo-controlled Phase III clinical trials of more than 2,800
adults, LINZESS was shown to reduce abdominal pain in IBS-C patients and
increase bowel movement frequency in both IBS-C patients and CIC
patients. Improvement in abdominal pain and constipation occurred in the
first week of treatment and was maintained throughout the 12-week
treatment period. Maximum effect on abdominal pain was seen at weeks 6-9
and maximum effect on constipation occurred during the first week. When
a subset of LINZESS-treated patients in the trials were switched to
placebo, they reported their symptoms returned toward pretreatment
levels within one week, while placebo-treated patients switched to
LINZESS reported symptom improvements. LINZESS is contraindicated in
pediatric patients under 6 years of age. The use of LINZESS in pediatric
patients 6 through 17 years of age should be avoided. In nonclinical
studies, administration of a single, clinically relevant adult oral dose
of linaclotide caused deaths due to dehydration in young juvenile mice.
The safety and efficacy of LINZESS in pediatric patients under 18 years
of age have not been established. In adults with IBS-C or CIC treated
with LINZESS, the most commonly reported adverse event was diarrhea.
Ironwood and Allergan plc are co-promoting LINZESS in the United States.
Linaclotide is marketed by Allergan for the treatment of adults with
moderate to severe IBS-C in Europe under the brand name CONSTELLA®.
Ironwood also has partnered with Astellas Pharma Inc. for development
and commercialization of linaclotide in Japan and with AstraZeneca AB
for development and commercialization in China.
About CONSTELLA (linaclotide)
Linaclotide is a guanylate cyclase-C receptor agonist (GCCA) with
visceral analgesic and secretory activities. Linaclotide is a 14-amino
acid synthetic peptide structurally related to the endogenous guanylin
peptide family. Both linaclotide and its active metabolite bind to the
guanylate cyclase-C receptor, on the luminal surface of the intestinal
epithelium. Through its action at GC-C, linaclotide has been shown to
reduce visceral pain and increase GI transit in animal models and
increase colonic transit in humans. Activation of GC-C results in an
increase in concentrations of cyclic guanosine monophosphate (cGMP),
both extracellularly and intracellularly. Extracellular cGMP decreases
pain-fiber activity, resulting in reduced visceral pain in animal
models. Intracellular cGMP causes secretion of chloride and bicarbonate
into the intestinal lumen, through activation of the cystic fibrosis
transmembrane conductance regulator (CFTR), which results in increased
intestinal fluid and accelerated transit.
Linaclotide was discovered by scientists at Ironwood and is marketed by
Allergan plc for the treatment of adults with moderate to severe IBS-C
in Europe under the brand name CONSTELLA.
About ZURAMPIC® (lesinurad) 200mg tablets
ZURAMPIC® (lesinurad) works selectively to complement xanthine oxidase
inhibitors (XOIs) in the treatment of 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.
In humans, it does not inhibit OAT1 and OAT3, which are drug
transporters in the kidney associated with drug-drug interactions. 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.
LINZESS Important Safety Information
WARNING: PEDIATRIC RISK
|
LINZESS is contraindicated in pediatric patients under 6 years
of age. In nonclinical studies, administration of a single,
clinically relevant adult oral dose of linaclotide caused deaths
due to dehydration in young juvenile mice. Use of LINZESS should
be avoided in pediatric patients 6 through 17 years of age. The
safety and efficacy of LINZESS has not been established in
pediatric patients under 18 years of age.
|
Contraindications
-
LINZESS is contraindicated in pediatric patients under 6 years of age.
-
LINZESS is contraindicated in patients with known or suspected
mechanical gastrointestinal obstruction.
Warnings and Precautions
Pediatric Risk
-
LINZESS is contraindicated in children under 6 years of age. The
safety and effectiveness of LINZESS in pediatric patients under 18
years of age have not been established. In neonatal mice, increased
fluid secretion as a consequence of GC-C agonism resulted in mortality
within the first 24 hours due to dehydration. Due to increased
intestinal expression of GC-C, children under 6 years of age may be
more likely than older children and adults to develop significant
diarrhea and its potentially serious consequences.
-
Use of LINZESS should be avoided in pediatric patients 6 through 17
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 through 17 years of age.
Diarrhea
-
Diarrhea was the most common adverse reaction of LINZESS-treated
patients in the pooled IBS-C and CIC double-blind placebo-controlled
trials. Severe diarrhea was reported in 2% of LINZESS-treated
patients. The incidence of diarrhea was similar in the IBS-C and CIC
populations.
-
Patients should be instructed to stop LINZESS if severe diarrhea
occurs and to contact their healthcare provider. The healthcare
provider should consider dose suspension and rehydration.
Adverse Reactions
-
In IBS-C clinical trials, the most common adverse reactions in
LINZESS-treated patients (incidence ≥2% and greater than placebo) were
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 clinical trials, the most common adverse reactions in
LINZESS-treated patients (incidence ≥2% and greater than placebo) were
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%).
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, and
evaluate for signs and symptoms of acute uric acid nephropathy.
ZURAMPIC should not be initiated in patients with an eCLcr less than
45 mL/min
-
Cardiovascular events: Major adverse cardiovascular events 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://www.azpicentral.com/zurampic/zurampic.pdf.
VIBERZI Important Safety Information
Contraindications
-
Known or suspected biliary duct obstruction, or sphincter of Oddi
disease or dysfunction; a history of pancreatitis; structural diseases
of the pancreas.
-
Alcoholism, alcohol abuse, alcohol addiction, or drink more than 3
alcoholic beverages per day.
-
Severe hepatic impairment.
-
A history of chronic or severe constipation or sequelae from
constipation, or known or suspected mechanical gastrointestinal
obstruction.
Warnings and Precautions
Sphincter of Oddi Spasm:
-
There is a potential for increased risk of sphincter of Oddi spasm,
resulting in pancreatitis or hepatic enzyme elevation associated with
acute abdominal pain (eg, biliary-type pain) with VIBERZI. These
events were reported in less than 1% of patients receiving VIBERZI in
clinical trials.
-
Patients without a gallbladder are at increased risk. Consider
alternative therapies before using VIBERZI in patients without a
gallbladder and evaluate the benefits and risks of VIBERZI in these
patients.
-
Inform patients without a gallbladder that they may be at increased
risk for symptoms of sphincter of Oddi spasm, such as elevated liver
transaminases associated with abdominal pain or pancreatitis,
especially during the first few weeks of treatment. Instruct patients
to stop VIBERZI and seek medical attention if they experience symptoms
of sphincter of Oddi spasm.
Pancreatitis:
-
There is a potential for increased risk of pancreatitis not associated
with sphincter of Oddi spasm; such events were reported in less than
1% of patients receiving VIBERZI in clinical trials, and the majority
were associated with excessive alcohol intake. All pancreatic events
resolved upon discontinuation of VIBERZI.
-
Instruct patients to avoid chronic or acute excessive alcohol use
while taking VIBERZI. Monitor for new or worsening abdominal pain that
may radiate to the back or shoulder, with or without nausea and
vomiting, associated with elevations of pancreatic enzymes. Instruct
patients to stop VIBERZI and seek medical attention if they experience
symptoms suggestive of pancreatitis.
Adverse Reactions
-
The most commonly reported adverse reactions (incidence > 5% and
greater than placebo) were constipation, nausea, and abdominal pain.
Please see full Prescribing Information for VIBERZI: http://www.allergan.com/assets/pdf/viberzi_pi
LINZESS® and CONSTELLA® are trademarks owned by Ironwood
Pharmaceuticals, Inc. 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 and
commercial potential of linaclotide, lesinurad, our product candidates
and the other products that we promote and the drivers, timing, impact
and results thereof; the benefits anticipated from the addition of the
gout franchise to Ironwood's portfolio; the timing of the closing of the
lesinurad transaction; market size, growth and opportunity, including
peak sales and the 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; expected periods of patent
exclusivity; the strength of the intellectual property protection for
linaclotide, lesinurad and our product candidates; potential business
development activity and the timing and impact thereof; our potential
for rapid, sustainable, high-margin growth; and 2016 financial
performance and results, and guidance and expectations related thereto,
including expectations regarding the need for future financings, cash
flows (including cash use for operations), LINZESS profitability,
operating expenses, revenue growth, operating leverage, commercial
margin and LINZESS net sales and marketing and sales expense, net
interest expense, and the timing of providing updated financial
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 the risk that the lesinurad transaction does not
close or is delayed; the risk that we are unable to successfully
integrate lesinurad into our existing business or are unable to realize
the anticipated benefits of the lesinurad transaction; those related to
the effectiveness of 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 authorities; the risk that we may
never get sufficient patent protection for linaclotide and our product
candidates; 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 LINZESS, within the
guided ranges; and the risks listed under the heading "Risk Factors" and
elsewhere in Ironwood's Annual Report on Form 10-K for the year
ended December 31, 2015, 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)
|
|
|
|
|
|
March 31, 2016
|
|
|
December 31, 2015
|
Assets
|
|
|
|
|
|
|
|
Cash, cash equivalents and available-for-sale securities
|
|
|
|
$
|
434,452
|
|
|
$
|
439,394
|
Accounts receivable, net
|
|
|
|
53,018
|
|
|
54,518
|
Prepaid expenses and other current assets
|
|
|
|
7,731
|
|
|
6,293
|
Restricted cash, current portion
|
|
|
|
500
|
|
|
-
|
Total current assets
|
|
|
|
495,701
|
|
|
500,205
|
Property and equipment, net
|
|
|
|
19,446
|
|
|
21,075
|
Convertible note hedges
|
|
|
|
77,688
|
|
|
86,466
|
Other assets
|
|
|
|
10,490
|
|
|
11,375
|
Total assets
|
|
|
|
$
|
603,325
|
|
|
$
|
619,121
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
|
|
Accounts payable, accrued expenses and other current liabilities
|
|
|
|
$
|
30,431
|
|
|
$
|
36,135
|
Current portion of capital lease obligations
|
|
|
|
2,447
|
|
|
2,631
|
Current portion of deferred rent
|
|
|
|
7,684
|
|
|
5,544
|
Current portion of deferred revenue
|
|
|
|
9,309
|
|
|
7,191
|
Current portion of long-term debt
|
|
|
|
28,242
|
|
|
24,964
|
Total current liabilities
|
|
|
|
78,113
|
|
|
76,465
|
Capital lease obligations
|
|
|
|
253
|
|
|
306
|
Deferred rent
|
|
|
|
7,131
|
|
|
6,395
|
Deferred revenue
|
|
|
|
-
|
|
|
1,798
|
Other liabilities
|
|
|
|
10,120
|
|
|
10,120
|
Note hedge warrants
|
|
|
|
68,193
|
|
|
75,328
|
Convertible notes
|
|
|
|
223,908
|
|
|
220,620
|
Long-term debt
|
|
|
|
124,672
|
|
|
132,964
|
Total stockholders' equity
|
|
|
|
90,935
|
|
|
95,125
|
Total liabilities and stockholders' equity
|
|
|
|
$
|
603,325
|
|
|
$
|
619,121
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Operations
|
(In thousands, except per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
2016
|
|
|
|
2015
|
Collaborative arrangements revenue
|
|
|
$
|
66,042
|
|
|
|
$
|
28,932
|
|
Cost and expenses:
|
|
|
|
|
|
|
|
Cost of revenue
|
|
|
|
—
|
|
|
|
|
12
|
|
Research and development
|
|
|
|
31,842
|
|
|
|
|
26,641
|
|
Selling, general and administrative
|
|
|
|
36,168
|
|
|
|
|
30,346
|
|
Total cost and expenses
|
|
|
|
68,010
|
|
|
|
|
56,999
|
|
Loss from operations
|
|
|
|
(1,968
|
)
|
|
|
|
(28,067
|
)
|
Other (expense) income:
|
|
|
|
|
|
|
|
Interest expense, net
|
|
|
|
(9,686
|
)
|
|
|
|
(5,155
|
)
|
Loss on derivatives
|
|
|
|
(1,643
|
)
|
|
|
|
—
|
|
Other expense, net
|
|
|
|
(11,329
|
)
|
|
|
|
(5,155
|
)
|
GAAP net loss
|
|
|
$
|
(13,297
|
)
|
|
|
$
|
(33,222
|
)
|
|
|
|
|
|
|
|
|
GAAP net loss per share—basic and diluted
|
|
|
$
|
(0.09
|
)
|
|
|
$
|
(0.24
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended March 31,
|
|
|
|
|
2016
|
|
|
|
2015
|
Non-GAAP net loss
|
|
|
$
|
(11,654
|
)
|
|
|
$
|
(33,222
|
)
|
Non-GAAP net loss per share —basic and diluted
|
|
|
$
|
(0.08
|
)
|
|
|
$
|
(0.24
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares used in net loss per
share — basic and diluted
|
|
|
|
143,593
|
|
|
|
|
141,278
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
March 31,
|
|
|
|
|
2016
|
|
|
|
2015
|
GAAP net loss
|
|
|
$
|
(13,297
|
)
|
|
|
$
|
(33,222
|
)
|
Adjustments:
|
|
|
|
|
|
|
Mark-to-market adjustments on the derivatives related to
convertible notes, net
|
|
|
|
1,643
|
|
|
|
|
—
|
|
Non-GAAP net loss
|
|
|
$
|
(11,654
|
)
|
|
|
$
|
(33,222
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
A reconciliation between diluted net loss per share on a GAAP
basis and on a non-GAAP basis is as follows:
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
|
2016
|
|
|
|
2015
|
GAAP net loss per share - basic and diluted
|
|
|
$
|
(0.09
|
)
|
|
|
$
|
(0.24
|
)
|
Adjustments to GAAP net loss per share (as detailed above)
|
|
|
|
0.01
|
|
|
|
|
—
|
|
Non-GAAP net loss per share - basic and diluted
|
|
|
$
|
(0.08
|
)
|
|
|
$
|
(0.24
|
)
|
|
|
|
|
|
|
|
|
U.S. LINZESS Brand Collaboration(1)
|
Revenue/Expense Calculation
|
(In thousands)
|
(unaudited)
|
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2016
|
|
|
|
2015
|
LINZESS U.S. net sales
|
|
|
$
|
137,137
|
|
|
|
$
|
95,489
|
|
Commercial costs and expenses2
|
|
|
|
62,149
|
|
|
|
|
58,151
|
|
Net profit on sales of LINZESS
|
|
|
$
|
74,988
|
|
|
|
$
|
37,338
|
|
Commercial Margin3
|
|
|
|
55
|
|
|
%
|
|
39
|
%
|
|
|
|
|
|
Ironwood's share of net profit
|
|
|
$
|
37,494
|
|
|
|
$
|
18,669
|
|
Ironwood's selling, general and administrative expenses4
|
|
|
|
9,153
|
|
|
|
|
7,688
|
|
Profit share adjustment5 |
|
|
|
—
|
|
|
|
|
(1,220
|
)
|
Ironwood's collaborative arrangement revenue
|
|
|
$
|
46,647
|
|
|
|
$
|
25,137
|
|
|
|
|
|
|
|
|
|
|
|
|
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 March 31, 2016, net profit for the U.S. LINZESS brand
collaboration with Allergan was $58.4 million, calculated by subtracting
$62.1 million in commercial costs and expenses and $16.6 million in
research and development expenses, from LINZESS U.S. net sales of $137.1
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 net 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 incur additional expenses related
to certain contractual obligations, 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/20160509006518/en/
Ironwood Pharmaceuticals
Media Relations
Trista
Morrison, 617-374-5095
Director, Corporate Communications
tmorrison@ironwoodpharma.com
or
Mary
T. Conway, 617-768-2628
Investor Relations
maconway@ironwoodpharma.com
Source: Ironwood Pharmaceuticals, Inc.
News Provided by Acquire Media