- Ironwood revenue increased 67% to $66 million in 3Q 2016 over 3Q
2015 -
- Linzess® (linaclotide) U.S. net sales
increased 40% to $164 million in 3Q 2016 over 3Q 2015; net profit for
the brand increased 128% to $82 million in same period -
- Zurampic® (lesinurad) launched in October 2016; Ironwood salesforce
now bringing three products to primary care physicians -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial biotechnology
company, today provided an update on its third quarter 2016 results and
recent business activities.
"Ironwood demonstrated outstanding third quarter performance, including
a 67% increase in revenue year-over-year driven by strong growth in
LINZESS demand. With the launch of ZURAMPIC, our salesforce is now
bringing three products for chronic, debilitating conditions to roughly
30,000 of the highest prescribing primary care physicians in the U.S.,"
said Peter Hecht, chief executive officer of Ironwood. "Over the coming
year, we expect continued revenue and prescription growth and a number
of value-creating milestones, including three additional commercial
launches and at least three Phase II data readouts from our pipeline. We
remain on track to deliver positive cash flow beginning in 2018 and
believe our continued execution and financial discipline will provide
the opportunity for sustained revenue growth and shareholder returns."
Third Quarter 2016 and Recent Highlights
Irritable Bowel Syndrome with Constipation
(IBS-C) / Chronic Idiopathic Constipation (CIC) Franchise
-
LINZESS. U.S. net sales, as provided by Ironwood's U.S.
collaboration partner Allergan plc, were $164.4 million in the third
quarter of 2016, a 40% increase compared to the third quarter of 2015.
Ironwood and Allergan share equally in brand collaboration profits or
losses.
-
Approximately 700,000 total LINZESS prescriptions were filled in
the third quarter of 2016, a 26% increase compared to the third
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 $81.5
million in the third quarter of 2016, a 128% increase compared to
the third quarter of 2015. LINZESS commercial margin was 61% in
the third quarter of 2016, compared to 44% in the third quarter of
2015.
-
Ironwood and Allergan expect to launch a 72 mcg dose of
linaclotide in early 2017 that, if approved by the Food and Drug
Administration (FDA), could increase physician prescribing of
LINZESS among the estimated 35 million adult CIC patients.
-
Linaclotide Colonic Release. Ironwood and Allergan expect data
from the Phase IIb clinical trial later this year. Linaclotide colonic
release is a second-generation guanylate cyclase-C (GC-C) agonist
product candidate that, if approved by the FDA, has the potential to
provide better symptom improvement, including improved abdominal pain
relief in adult IBS-C patients, to expand the IBS-C and CIC markets,
and to extend patent protection for linaclotide to the mid-2030s.
-
In October 2016, Ironwood and Allergan received Paragraph IV
certification notice letters regarding Abbreviated New Drug
Applications (ANDAs) submitted to the FDA by generic drug
manufacturers seeking approval to manufacture, use and sell generic
versions of LINZESS. One of the ANDAs was submitted to the FDA by Teva
Pharmaceuticals USA, Inc. (Teva). Teva contends that the U.S. patents
for LINZESS listed in the FDA's Approved Drugs Product with
Therapeutic Equivalence Evaluations list, commonly known as the Orange
Book, are invalid, unenforceable and/or would not be infringed by
Teva's manufacture, use or sale of a generic version of LINZESS.
Ironwood and Allergan are evaluating filing patent infringement suits
against such generic drug manufacturers. Filing of a patent
infringement suit would trigger a 30-month stay of any approval of the
subject ANDA that will not expire until 2020, unless the court earlier
decides that the relevant patents are invalid, unenforceable and/or
not infringed. LINZESS is currently covered by nine patents listed in
the Orange Book, which expire between 2024 and 2031.
Uncontrolled Gout Franchise
-
ZURAMPIC. In October 2016, Ironwood's clinical sales
specialists began promoting ZURAMPIC for the treatment of
hyperuricemia in patients with uncontrolled gout who are already
taking a xanthine oxidase inhibitor (XOI), such as allopurinol or
Uloric® (febuxostat). Gout is a form of inflammatory arthritis caused
by an underlying metabolic disorder, hyperuricemia - or high levels of
uric acid in the blood. An estimated two million patients in the U.S.
suffer from uncontrolled gout in which traditional first-line XOI
treatment alone is not sufficient to achieve target serum uric acid
(sUA) levels. ZURAMPIC is not recommended for the treatment of
asymptomatic hyperuricemia and should not be used as monotherapy.
-
Lesinurad-allopurinol fixed-dose combination product. A New
Drug Application (NDA) for the fixed-dose combination of lesinurad
and allopurinol was submitted in October 2016 for review by the FDA.
If approved, Ironwood expects to launch the fixed-dose combination
product by late 2017.
Refractory Gastroesophageal Reflux Disease
(rGERD) Franchise
-
IW-3718. Ironwood continues to enroll patients in a
dose-ranging Phase IIb clinical trial of IW-3718, a wholly-owned asset
being studied as a potential treatment of rGERD. IW-3718 is a novel,
investigational gastric retentive formulation of a bile acid
sequestrant designed to work with a proton pump inhibitor (PPI) to
reduce the detrimental effects of bile and acid on the esophagus. An
estimated 10 million people in the U.S. suffer from rGERD and continue
to experience heartburn symptoms despite treatment with PPIs.
Vascular and Fibrotic Franchise
-
IW-1973. Ironwood initiated a Phase IIa open-label,
placebo-controlled study in patients with Type 2 diabetes and
hypertension. This study is designed to explore the tolerability,
pharmacokinetic and pharmacodynamic effects of IW-1973 across multiple
doses, as well as to explore its effects on biomarkers. Data from this
study are expected in the first quarter of 2017.
-
IW-1701. Data from the IW-1701 Phase Ib multiple
ascending dose study are expected by year-end. Ironwood initiated a
Phase IIa randomized, double-blind, placebo-controlled single-dose
study of IW-1701 designed to evaluate its safety, tolerability,
pharmacokinetics and pharmacodynamics in patients with Type II
achalasia. Data from this study are expected in 2017.
Global Collaborations and Partnerships
-
Linaclotide is currently under review by the Pharmaceuticals and
Medical Devices Agency (PMDA) in Japan for potential approval for the
treatment of adult patients with IBS-C. Under the terms of Ironwood's
license agreement with Astellas Pharma Inc., Ironwood will earn a $15
million development milestone payment upon approval of linaclotide by
the PMDA.
-
Astellas continues to enroll patients in the Phase III clinical
trial of linaclotide in Japan for adults with chronic constipation.
-
Ironwood continues co-promoting Allergan's VIBERZI™ (eluxadoline) in
the U.S. for adults suffering from IBS with diarrhea.
-
Ironwood and Exact Sciences Corp. terminated their agreement for the
U.S. co-promotion of Cologuard®, a noninvasive stool DNA screening
test for colorectal cancer.
Corporate and Financials
-
Collaborative Arrangements Revenue
-
Collaborative arrangements revenue was $66.1 million in the third
quarter of 2016, compared to $39.6 million in the third quarter of
2015. Included in collaborative arrangements revenue was $60.0
million associated with Ironwood's share of the net profits from
the sales of LINZESS in the U.S., up from $34.8 million in the
third quarter of 2015.
-
Operating Expenses
-
Operating expenses were $94.4 million in the third quarter of
2016, compared to $65.8 million in the third quarter of
2015. Operating expenses in the third quarter of 2016 consisted of
$37.5 million in R&D expenses and $45.0 million in selling,
general and administrative (SG&A) expenses, as well as $3.2
million in acquired intangible asset amortization expenses and an
$8.7 million loss on fair value remeasurement of contingent
consideration resulting from Ironwood's U.S. licensing agreement
with AstraZeneca for the exclusive rights to all products
containing lesinurad.
-
Other Expense
-
Interest Expense. Net interest expense was $9.5 million in
the third quarter of 2016, in connection with the $175 million
Linaclotide PhaRMA 11% Note debt financing executed in January
2013 and the approximately $336 million convertible debt financing
executed in June 2015 and due in 2022. Interest expense recorded
in the third quarter of 2016 includes $6.0 million in cash expense
and $3.8 million in non-cash expense. Both the cash and non-cash
components of the 2022 convertible notes are recorded quarterly.
-
In September 2016, Ironwood closed a $150 million debt
refinancing with an annual interest rate of 8.375%. The
transaction is expected to fund on January 5, 2017, with the
net proceeds from this transaction being used to redeem the
remaining principal balance of the existing PhaRMA Notes.
-
Gain/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 in June 2015. A gain on derivatives of
$4.5 million was recorded in the third quarter of 2016.
-
Net Loss
-
GAAP net loss was $33.2 million, or $0.23 per share, in the third
quarter of 2016, compared to $47.4 million, or $0.33 per share, in
the third quarter of 2015.
-
Non-GAAP net loss was $25.9 million, or $0.18 per share, in the
third quarter of 2016, compared to $36.1 million, or $0.25 per
share, in the third quarter of 2015. 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 the third quarter of 2016 with $320 million of
cash, cash equivalents and available-for-sale securities, a
decrease of $5 million from the end of the second quarter of 2016.
Cash used in operations was $645,000 in the third quarter of 2016.
-
2016 Financial Guidance
-
Ironwood now expects to use less than $50 million in cash for
operations in 2016, down from previous guidance of less than $70
million.
-
Ironwood continues to expect:
-
R&D expenses to be within a range of $140 million to $150
million,
-
SG&A expenses to be within a range of $170 million to $180
million,
-
amortization of intangible assets to be $8 million (not
applicable prior to the U.S. lesinurad license), and
-
combined Allergan and Ironwood total 2016 LINZESS marketing
and sales expenses to be in the mid to higher end of $230
million to $260 million.
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. licensing 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 at the time 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. The company has presented non-GAAP
net loss and non-GAAP net loss per share in prior calendar quarters, and
this is the first calendar quarter in which the company has contingent
consideration that is excluded from such non-GAAP financial measures.
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, November 3, to discuss its third 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
98682158. 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 3, running through 11:59 p.m. Eastern Time on
November 10, 2016. To listen to the replay, dial (855) 859-2056 (U.S.
and Canada) or (404) 537-3406 (international) using conference ID number
98682158. 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 a pipeline of innovative medicines in
areas of significant unmet need, including irritable bowel syndrome with
constipation (IBS-C)/chronic idiopathic constipation (CIC), uncontrolled
gout, refractory gastroesophageal reflux disease, and vascular and
fibrotic diseases. 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.
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 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
ZURMAPIC. 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 of Ironwood Pharmaceuticals, Inc.
and ZURAMPIC® is a trademark 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 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, 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; milestone and royalty payments;
expected periods of patent exclusivity; the strength of the intellectual
property protection for linaclotide, lesinurad and our product
candidates and our intentions and efforts to protect such intellectual
property; ANDAs filed by generic drug manufacturers and potential FDA
approval thereof, and associated patent infringement suits that we may
file or other action that we may take against such companies, and the
timing thereof; expectations regarding the issuance of our 8.375% notes
due 2026 and the redemption of our 11% PhaRMA Notes, and the timing
thereof; our potential for rapid, sustainable, high-margin growth and
shareholder returns; 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), profitability, operating expenses (including R&D
expenses, SG&A expenses and amortization of intangible assets), LINZESS
marketing and sales expense, revenue growth, operating leverage,
commercial margin, net sales and cash flow accretion. 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 we are unable to successfully integrate lesinurad into our
existing business, commercialize lesinurad or 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; our reliance on AstraZeneca to provide critical support
services related to lesinurad; 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 or that we are not able to successfully protect such
patents; 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; 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, 2016, 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, 2016
|
|
|
December 31, 2015
|
Assets
|
|
|
|
|
|
|
Cash, cash equivalents and available-for-sale securities
|
|
|
$
|
319,873
|
|
|
$
|
439,394
|
Accounts receivable, net
|
|
|
53,715
|
|
|
54,518
|
Prepaid expenses and other current assets
|
|
|
9,216
|
|
|
6,293
|
Total current assets
|
|
|
382,804
|
|
|
500,205
|
Property and equipment, net
|
|
|
18,842
|
|
|
21,075
|
Convertible note hedges
|
|
|
137,302
|
|
|
86,466
|
Intangible assets, net and goodwill
|
|
|
183,371
|
|
|
-
|
Other assets
|
|
|
9,659
|
|
|
11,375
|
Total assets
|
|
|
$
|
731,978
|
|
|
$
|
619,121
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
|
Accounts payable, accrued expenses and other current liabilities
|
|
|
$
|
56,849
|
|
|
$
|
36,135
|
Current portion of capital lease obligations
|
|
|
3,525
|
|
|
2,631
|
Current portion of deferred rent
|
|
|
7,821
|
|
|
5,544
|
Current portion of deferred revenue
|
|
|
4,127
|
|
|
7,191
|
Current portion of long-term debt
|
|
|
8,405
|
|
|
24,964
|
Current portion of contingent consideration
|
|
|
14,578
|
|
|
-
|
Total current liabilities
|
|
|
95,305
|
|
|
76,465
|
Capital lease obligations
|
|
|
141
|
|
|
306
|
Deferred rent
|
|
|
2,490
|
|
|
6,395
|
Deferred revenue
|
|
|
-
|
|
|
1,798
|
Other liabilities
|
|
|
10,120
|
|
|
10,120
|
Contingent consideration
|
|
|
81,682
|
|
|
-
|
Note hedge warrants
|
|
|
120,121
|
|
|
75,328
|
Convertible notes
|
|
|
230,717
|
|
|
220,620
|
Long-term debt
|
|
|
131,944
|
|
|
132,964
|
Total stockholders' equity
|
|
|
59,458
|
|
|
95,125
|
Total liabilities and stockholders' equity
|
|
|
$
|
731,978
|
|
|
$
|
619,121
|
|
|
|
|
|
|
|
|
|
|
Condensed Consolidated Statements of Operations
|
(In thousands, except per share amounts)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
|
|
|
2016
|
|
|
|
|
2015
|
|
|
|
|
2016
|
|
|
|
|
2015
|
|
Collaborative arrangements revenue
|
|
|
$
|
66,106
|
|
|
|
$
|
39,572
|
|
|
|
$
|
186,498
|
|
|
|
$
|
96,248
|
|
Cost and expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of revenue, excluding amortization of acquired
intangible asset
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
|
—
|
|
|
|
|
12
|
|
Write-down of inventory to net realizable value and loss on
non-cancellable purchase commitments
|
|
|
|
—
|
|
|
|
|
9,488
|
|
|
|
|
—
|
|
|
|
|
17,638
|
|
Research and development
|
|
|
|
37,526
|
|
|
|
|
25,830
|
|
|
|
|
101,050
|
|
|
|
|
81,119
|
|
Selling, general and administrative
|
|
|
|
44,987
|
|
|
|
|
30,439
|
|
|
|
|
118,073
|
|
|
|
|
93,740
|
|
Amortization of acquired intangible asset
|
|
|
|
3,213
|
|
|
|
|
—
|
|
|
|
|
4,278
|
|
|
|
|
—
|
|
Loss on fair value remeasurement of contingent consideration
|
|
|
|
8,667
|
|
|
|
|
—
|
|
|
|
|
8,667
|
|
|
|
|
—
|
|
Total cost and expenses
|
|
|
|
94,393
|
|
|
|
|
65,757
|
|
|
|
|
232,068
|
|
|
|
|
192,509
|
|
Loss from operations
|
|
|
|
(28,287
|
)
|
|
|
|
(26,185
|
)
|
|
|
|
(45,570
|
)
|
|
|
|
(96,261
|
)
|
Other (expense) income:
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense, net
|
|
|
|
(9,458
|
)
|
|
|
|
(9,865
|
)
|
|
|
|
(28,676
|
)
|
|
|
|
(20,823
|
)
|
Gain (loss) on derivatives
|
|
|
|
4,541
|
|
|
|
|
(11,340
|
)
|
|
|
|
6,043
|
|
|
|
|
(11,548
|
)
|
Other expense, net
|
|
|
|
(4,917
|
)
|
|
|
|
(21,205
|
)
|
|
|
|
(22,633
|
)
|
|
|
|
(32,371
|
)
|
GAAP net loss
|
|
|
$
|
(33,204
|
)
|
|
|
$
|
(47,390
|
)
|
|
|
$
|
(68,203
|
)
|
|
|
$
|
(128,632
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GAAP net loss per share—basic and diluted
|
|
|
$
|
(0.23
|
)
|
|
|
$
|
(0.33
|
)
|
|
|
$
|
(0.47
|
)
|
|
|
$
|
(0.91
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
|
|
|
2016
|
|
|
2015
|
|
|
|
|
2016
|
|
|
2015
|
|
Non-GAAP net loss
|
|
|
$
|
(25,865
|
)
|
$
|
(36,050
|
)
|
|
|
$
|
(61,301
|
)
|
$
|
(117,084
|
)
|
Non-GAAP net loss per share (basic and diluted)
|
|
|
$
|
(0.18
|
)
|
$
|
(0.25
|
)
|
|
|
$
|
(0.42
|
)
|
$
|
(0.83
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of common shares used in net loss per
share — basic and diluted
|
|
|
|
145,180
|
|
|
145,180
|
|
|
|
|
144,474
|
|
|
141,954
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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,
|
|
|
|
|
2016
|
|
|
2015
|
|
|
|
|
2016
|
|
|
2015
|
|
GAAP net loss
|
|
|
$
|
(33,204
|
)
|
$
|
(47,390
|
)
|
|
|
$
|
(68,203
|
)
|
$
|
(128,632
|
)
|
Adjustments:
|
|
|
|
|
|
|
|
|
Mark-to-market adjustments on the derivatives related to convertible
notes, net
|
|
|
|
(4,541
|
)
|
|
11,340
|
|
|
|
|
(6,043
|
)
|
|
11,548
|
|
Amortization of acquired intangible asset
|
|
|
|
3,213
|
|
|
—
|
|
|
|
|
4,278
|
|
|
—
|
|
Fair value remeasurement of contingent consideration
|
|
|
|
8,667
|
|
|
—
|
|
|
|
|
8,667
|
|
|
—
|
|
Non-GAAP net loss
|
|
|
$
|
(25,865
|
)
|
$
|
(36,050
|
)
|
|
|
$
|
(61,301
|
)
|
$
|
(117,084
|
)
|
A reconciliation between diluted net loss per share on a GAAP basis and
on a non-GAAP basis is as
follows:
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,
|
|
|
|
|
2016
|
|
|
|
|
2015
|
|
|
|
|
2016
|
|
|
|
|
2015
|
|
GAAP net loss per share - basic and diluted
|
|
|
$
|
(0.23
|
)
|
|
|
$
|
(0.33
|
)
|
|
|
$
|
(0.47
|
)
|
|
|
$
|
(0.91
|
)
|
Adjustments to GAAP net loss per share (as detailed above)
|
|
|
|
0.05
|
|
|
|
|
0.08
|
|
|
|
|
0.05
|
|
|
|
|
0.08
|
|
Non-GAAP net loss per share - basic and diluted
|
|
|
$
|
(0.18
|
)
|
|
|
$
|
(0.25
|
)
|
|
|
$
|
(0.42
|
)
|
|
|
$
|
(0.83
|
)
|
|
U.S. LINZESS Brand Collaboration1
|
Revenue/Expense Calculation
|
|
|
|
|
|
|
|
(In thousands)
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended
September 30,
|
|
|
Nine Months Ended
September 30,
|
|
|
|
|
2016
|
|
|
|
|
2015
|
|
|
|
|
2016
|
|
|
|
|
2015
|
|
LINZESS U.S. net sales
|
|
|
$
|
164,379
|
|
|
|
$
|
117,492
|
|
|
|
$
|
451,980
|
|
|
|
$
|
325,043
|
|
Commercial costs and expenses2
|
|
|
|
64,136
|
|
|
|
|
65,282
|
|
|
|
|
197,841
|
|
|
|
|
201,273
|
|
Commercial profit on sales of LINZESS
|
|
|
$
|
100,243
|
|
|
|
$
|
52,210
|
|
|
|
$
|
254,139
|
|
|
|
$
|
123,770
|
|
Commercial Margin3
|
|
|
|
61
|
%
|
|
|
|
44
|
%
|
|
|
|
56
|
%
|
|
|
|
38
|
%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ironwood's share of net profit
|
|
|
$
|
50,122
|
|
|
|
$
|
26,105
|
|
|
|
$
|
127,070
|
|
|
|
$
|
61,885
|
|
Ironwood's selling, general and administrative expenses4
|
|
|
|
7,491
|
|
|
|
|
8,645
|
|
|
|
|
25,523
|
|
|
|
|
24,647
|
|
Profit share adjustment5 |
|
|
|
2,370
|
|
|
|
|
—
|
|
|
|
|
2,370
|
|
|
|
|
(2,370
|
)
|
Ironwood's collaborative arrangement revenue
|
|
|
$
|
59,983
|
|
|
|
$
|
34,750
|
|
|
|
$
|
154,963
|
|
|
|
$
|
84,162
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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, 2016, net profit for the U.S. LINZESS brand
collaboration with Allergan was $81.5 million, calculated by subtracting
$64.1 million in commercial costs and expenses and $18.7 million in
research and development expenses, from LINZESS U.S. net sales of $164.3
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.
3Commercial margin is defined as commercial profit on sales
of LINZESS as a percent of total LINZESS U.S. net sales.
4Includes 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/20161103005455/en/
Ironwood Pharmaceuticals, Inc.
Media Relations
Trista
Morrison, 617-374-5095
Director, Corporate Communications
[email protected]
or
Investor
Relations
Meredith Kaya, 617-374-5082
Director, Investor
Relations
[email protected]
Source: Ironwood Pharmaceuticals, Inc.
News Provided by Acquire Media