– LINZESS® (linaclotide) expanded IBS-C/CIC
branded prescription market leadership in 2Q 2017 with 19% growth
in volume year-over-year and $168 million in U.S. net sales –
– Positive IW-3718 Phase IIb top-line data in
uncontrolled GERD support advancement into Phase III –
– Multiple additional catalysts expected in 2H
2017, including DUZALLO® (lesinurad and allopurinol) approval and
launch, three mid-stage data readouts and four mid- to late-stage
trial initiations –
Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD), a commercial
biotechnology company, today provided an update on its second
quarter 2017 results and recent business activities.
“Our performance in the first half of 2017 reinforces the
potential for our commercial products and mid- to late-stage
pipeline to efficiently grow large consumer-driven patient
categories and help millions of patients for years to come,” said
Peter Hecht, chief executive officer of Ironwood. “We expect
LINZESS and DR1, if approved, to coexist as leading products and
grow the IBS-C/CIC category into the 2030s. IW-3718, if approved,
has the opportunity to build and grow the uncontrolled GERD market,
and is a strong fit with our U.S. commercial capabilities. These
assets, combined with DUZALLO, DR2 and our sGC stimulators,
position us well to continue to deliver new medicines to patients
and accelerate high-margin growth for our fellow shareholders.”
Second Quarter 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 $167.8
million in the second quarter of 2017, a 12% increase compared to
the second quarter of 2016. Ironwood and Allergan share equally in
brand collaboration profits.
- Total LINZESS prescription volume in
the second quarter of 2017 included over 28 million LINZESS
capsules, a 19% increase in capsules compared to the second quarter
of 2016, per QuintilesIMS.
- Levels of inventory held in the channel
were lower in the second quarter of 2017 compared to the second
quarter of 2016, resulting in lower year-over-year growth in
LINZESS net sales compared to LINZESS prescription volume. If
inventory remains at these levels, we expect there will continue to
be a gap between growth in LINZESS net sales and growth in LINZESS
prescription volume for the balance of 2017.
- More than 750,000 total LINZESS
prescriptions were filled in the second quarter of 2017, a 15%
increase compared to the second quarter of 2016, per
QuintilesIMS.
- Since the launch of LINZESS in December
2012, greater than 1.5 million unique patients have filled more
than 8 million prescriptions, per QuintilesIMS.
- Net profit for the LINZESS U.S. brand
collaboration, including commercial and research and development
(R&D) expenses, was $72.2 million in the second quarter of
2017, a 24% increase compared to the second quarter of 2016.
- LINZESS commercial margin was 52% in
both the second quarter of 2017 and of 2016.
- Ironwood received a U.S. patent
covering a component of LINZESS as well as formulations comprising
linaclotide and this component. The patent extends the LINZESS
patent portfolio into 2033.
- Linaclotide Delayed Release-1 (DR1).
Ironwood and Allergan are evaluating DR1 in adult patients with
IBS-C. The companies are engaging with the U.S. Food and Drug
Administration (FDA) to discuss Phase III development plans, with
Phase III IBS-C trials expected to begin in the second half of
2017.
- Linaclotide Delayed Release-2 (DR2).
Ironwood and Allergan are evaluating DR2 for the potential to treat
patients with disorders where lower abdominal pain is a predominant
symptom, such as non-constipated subtypes of IBS. The companies
plan to engage with the FDA to discuss advancing DR2 into Phase IIb
dose-ranging clinical trials, expected to begin in 2018.
Uncontrolled Gout
- ZURAMPIC® (lesinurad). In October 2016,
Ironwood began commercializing ZURAMPIC in the U.S. 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). ZURAMPIC is not recommended
for the treatment of asymptomatic hyperuricemia and should not be
used as monotherapy.
- ZURAMPIC U.S. net sales were $0.5
million in the second quarter of 2017.
- Approximately 1,500 total ZURAMPIC
prescriptions were filled in the second quarter of 2017, per
QuintilesIMS.
- DUZALLO. The DUZALLO New Drug
Application (NDA) for the treatment of hyperuricemia in patients
with uncontrolled gout is currently under FDA review. If approved,
DUZALLO is expected to be commercially available early in the
fourth quarter of 2017 and would be the first fixed-dose,
combination treatment of hyperuricemia in patients with
uncontrolled gout.
Uncontrolled Gastroesophageal Reflux
Disease (GERD)
- IW-3718. IW-3718 is a wholly-owned
asset being developed for the potential treatment of uncontrolled
GERD. In July 2017, Ironwood announced positive top-line data from
a Phase IIb clinical trial of IW-3718 in adult patients with
uncontrolled GERD. The trial met its primary endpoint, indicating
that twice-daily, oral dosing of IW-3718 1500 mg plus a proton pump
inhibitor (PPI) significantly reduced heartburn severity in
patients by 58.0% compared to 46.0% in patients treated with a PPI
alone. Further, 52.9% of patients treated with IW-3718 1500 mg plus
a PPI achieved a clinically meaningful reduction in heartburn
severity, based on patient-reported outcome measures. In the study,
IW-3718 1500 mg plus a PPI also showed a 55.4% reduction in
regurgitation frequency compared to 37.9% in patients treated with
a PPI alone. IW-3718 1500 mg was well tolerated in the trial; the
most common adverse event reported overall was constipation.
Ironwood plans to have end of Phase II meetings with the FDA, after
which the company expects to advance IW-3718 1500 mg into Phase III
development in the second half of 2018.
Vascular and Fibrotic
Diseases
- IW-1973. Ironwood expects to initiate
Phase II trials of IW-1973 during the second half of 2017 in three
disease states: heart failure with preserved ejection fraction,
diabetic nephropathy, and resistant hypertension.
- Data from two Phase IIa studies with
IW-1973 in diabetic patients with hypertension are expected in the
second half of 2017. The first study is designed to evaluate the
effect of IW-1973 on endothelial function and explores its effects
on biomarkers. The second study is a fourteen-day study designed to
evaluate the tolerability and blood pressure effects of
IW-1973.
- IW-1701. Ironwood is enrolling patients
with Type II achalasia in a Phase IIa randomized, double-blind,
placebo-controlled single-dose study of IW-1701. 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 the second half of 2017.
Global Collaborations and
Partnerships
- Ironwood continues to co-promote
Allergan’s VIBERZI® (eluxadoline) in the U.S. for adults suffering
from IBS with diarrhea.
- Ironwood’s partner, Astellas Pharma
Inc., is commercializing LINZESS for adults with IBS-C in Japan.
Astellas also plans to submit a Supplemental New Drug Application
with the Pharmaceuticals and Medical Devices Agency in Japan in the
second half of 2017 for potential approval for the treatment of
chronic constipation.
- Ironwood expects the China Food and
Drug Administration to complete its review of the filing for
approval to market linaclotide in China for adult IBS-C patients in
the first quarter of 2018. Ironwood is partnered with AstraZeneca
AB for development and commercialization of linaclotide in
China.
Corporate and Financials
- Total Revenues
- Total revenues were $65.1 million in
the second quarter of 2017 compared to $54.4 million in the second
quarter of 2016. Included in total revenues was $56.3 million
associated with Ironwood’s share of the net profits from the sales
of LINZESS in the U.S., as well as sales of linaclotide API,
linaclotide royalties, co-promotion revenue and ZURAMPIC
revenue.
- Operating Expenses
- Operating expenses were $106.1 million
in the second quarter of 2017 as compared to $69.7 million in the
second quarter of 2016. Operating expenses in the second
quarter of 2017 consisted of $3.5 million in cost of revenues,
$37.3 million in R&D expenses, $57.8 million in selling,
general and administrative (SG&A) expenses, $0.1 million in
write-down of lesinurad commercial supply to net realizable value,
$0.4 million in acquired intangible asset amortization expenses,
and a $6.9 million loss on fair value remeasurement of contingent
consideration.
- Contingent consideration and
amortization of acquired intangible assets relate to Ironwood’s
licensing agreement with AstraZeneca for the
exclusive U.S. rights to all products containing
lesinurad.
- Other Expense
- Interest Expense. Net interest
expense was $8.6 million in the second quarter of 2017, primarily
in connection with the $150 million 8.375% Notes funded in January
2017 and the approximately $336 million convertible debt financing
funded in June 2015. Interest expense recorded in the second
quarter of 2017 includes $5.0 million in cash expense and $4.0
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 gain on derivatives of $5.3 million was recorded in the
second quarter of 2017.
- Net Loss
- GAAP net loss was $44.2 million, or
$0.30 per share, in the second quarter of 2017, compared to $21.7
million, or $0.15 per share, in the second quarter of 2016.
- Non-GAAP net loss was $42.2 million, or
$0.28 per share, in the second quarter of 2017, compared to $23.8
million, or $0.16 per share, in the second quarter of 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 the second quarter of
2017 with $272.9 million of cash, cash equivalents and
available-for-sale securities. Ironwood used approximately $31.3
million of cash for operations during the second quarter of
2017.
- 2017 Financial Guidance
- Ironwood continues to expect:
- R&D expenses to be in the range of
$145 million to $160 million.
- SG&A expenses to be in the range of
$235 million to $250 million.
- the combined Allergan and Ironwood
total 2017 marketing and sales expenses for LINZESS to be in the
range of $250 million to $280 million.
- net interest expense to be
approximately $40 million.
- to use less than $100 million in cash
for operations in 2017.
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 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 4:30 p.m.
Eastern Time on Thursday, August 3, 2017 to discuss its second
quarter of 2017 results and recent business activities. Individuals
interested in participating in the call should dial (877) 643-7155
(U.S. and Canada) or (914) 495-8552 (international) using
conference ID number 51693981. 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
August 3, 2017 running through 11:59 p.m. Eastern Time on August
10, 2017. To listen to the replay, dial (855) 859-2056 (U.S. and
Canada) or (404) 537-3406 (international) using conference ID
number 51693981. 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) for the treatment
of hyperuricemia associated with uncontrolled gout. We are also
advancing a pipeline of internally and externally generated
innovative product candidates in areas of significant unmet need,
including uncontrolled gastroesophageal reflux disease and vascular
and fibrotic diseases. 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 QuintilesIMS
data. Since its FDA approval in August of 2012 and subsequent
launch in December 2012, greater than 1.5 million unique patients
have filled more than 8 million prescriptions for LINZESS,
according to QuintilesIMS.
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 if 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.
LINZESS Important Safety Information
INDICATIONS AND USAGELINZESS (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 PrecautionsPediatric 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 USEDWITHOUT 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://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 PrecautionsSphincter 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® and DUZALLO® are 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 (including pipeline catalysts); 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 (including engaging with the FDA
and defining primary and secondary endpoints); the potential for,
and timing of, regulatory submissions and approvals for
linaclotide, lesinurad and our product candidates; expected periods
of patent exclusivity and life of the respective patent portfolios
for linaclotide, lesinurad and our product candidates; commercial
strategy, including market development, the potential for broad
access and reimbursement, refreshing our DTC campaign, fit within
our U.S. commercial capabilities, and intentions related to
commercializing IW-3718 within and outside the U.S.;
comparisons related to net sales and volume; the strength of the
intellectual property protection for linaclotide, lesinurad and our
product candidates and our intentions and efforts to protect such
intellectual property; our potential for sustainable, high-margin
growth and shareholder returns; and our financial performance and
results, and guidance and expectations related thereto (including
the drivers and timing thereof), including expectations related to
Ironwood revenue CAGR and revenue growth,
LINZESS U.S. net sales, growth and net price, 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; 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 are unable to successfully integrate lesinurad into our
existing business, commercialize lesinurad or realize the
anticipated benefits of the lesinurad transaction; 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; 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 March 31,
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)
June 30,2017
December 31, 2016
Assets Cash, cash equivalents and available-for-sale
securities $ 272,895 $ 305, 216 Accounts receivable, net 60,357
64,854 Inventory - 1,081 Prepaid expenses and other current assets
8,235 9,030 Total current assets 341,487 380,181 Property and
equipment, net 17,854 20,512 Convertible note hedges 171,880
132,521 Intangible assets, net 165,278 166,119 Goodwill 785 785
Other assets 7,795 9,703 Total assets $ 705,079 $ 709,821
Liabilities and Stockholders’ Equity Accounts payable,
accrued expenses and other current liabilities $ 59,461 $ 62,941
Current portion of capital lease obligations 5,097 6,227 Current
portion of deferred rent 205 7,719 Current portion of deferred
revenue 225 - Current portion of contingent consideration 14,985
14,244 Total current liabilities 79,973 91,131 Capital lease
obligations - 82 Deferred rent, net of current portion 3,515 557
Other liabilities 8,190 8,190 Contingent consideration, net of
current portion 71,213 63,416 Note hedge warrants 149,458 113,237
Convertible notes 241,544 234,243 Long-term debt 146,316 132,249
Total stockholders’ equity 4,870 66,716
Total liabilities and
stockholders’ equity $ 705,079 $ 709,821
Condensed Consolidated Statements of
Operations
(In thousands, except per share
amounts)
(unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2017 2016 2017
2016 Total revenues $ 65,077 $ 54,350 $
117,243 $ 120,392 Cost and expenses: Cost of revenues, excluding
amortization of acquired intangible asset 3,502 - 4,033 -
Write-down of lesinurad commercial supply to net realizable value
96 - 96 - Research and development 37,344 31,682 71,046 63,524
Selling, general and administrative 57,792 36,918 113,396 73,086
Amortization of acquired intangible asset 421 1,065 841 1,065 Loss
on fair value remeasurement of contingent consideration
6,933 - 8,547 -
Total cost and expenses 106,088 69,665
197,959 137,675 Loss from operations
(41,011 ) (15,315 ) (80,716 ) (17,283 ) Other (expense) income:
Interest expense, net (8,550 ) (9,532 ) (17,138 ) (19,218 ) Loss on
extinguishment of debt - - (2,009 ) - Gain on derivatives
5,337 3,145 3,138 1,502
Other expense, net (3,213 ) (6,387 )
(16,009 ) (17,716 ) GAAP net loss $ (44,224 ) $ (21,702 ) $
(96,725 ) $ (34,999 ) GAAP net loss per share—basic and
diluted $ (0.30 ) $ (0.15 ) $ (0.65 ) $ (0.24 )
Three Months Ended
June 30,
Six Months Ended
June 30,
2017 2016 2017
2016 Non-GAAP net loss $ (42,207 ) $ (23,782 )
$ (90,475 ) $ (35,436 ) Non-GAAP net loss per share (basic and
diluted) $ (0.28 ) $ (0.16 ) $ (0.61 ) $ (0.25 )
Weighted average number of common shares
used in net loss
per share — basic and diluted
148,778
144,642
148,285
144,118
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
June 30,
Six Months Ended
June 30,
2017 2016 2017
2016 GAAP net loss $ (44,224 ) $ (21,702 ) $
(96,725 ) $ (34,999 ) Adjustments: Mark-to-market adjustments on
the derivatives related to convertible notes, net (5,337 ) (3,145 )
(3,138 ) (1,502 ) Amortization of intangible asset 421 1,065 841
1,065 Fair value remeasurement of contingent consideration
6,933 - 8,547 -
Non-GAAP net loss $ (42,207 ) $ (23,782 ) $ (90,475 ) $ (35,436 )
A reconciliation between diluted net loss per share on a GAAP
basis and on a non-GAAP basis is as follows:
Three Months Ended
June 30,
Six Months Ended
June 30,
2017 2016 2017
2016 GAAP net loss per share – Basic and
Diluted $ (0.30 ) $ (0.15 ) $ (0.65 ) $ (0.24 ) Adjustments to GAAP
net loss per share (as detailed above) 0.01
(0.01 ) 0.04 (0.01 )
Non-GAAP net loss per share – basic and
diluted1
$ (0.28 ) $ (0.16 ) $ (0.61 ) $ (0.25 )
1 Numbers may not add due to rounding.
U.S. LINZESS Brand
Collaboration1
Revenue/Expense Calculation
(In thousands)
(unaudited)
Three Months Ended
June 30,
Six Months Ended
June 30,
2017 2016 2017
2016 LINZESS U.S. net sales $ 167,833 $
150,464 $ 315,448 $ 287,601
Commercial costs and expenses2
80,211 71,556 151,140 133,705 Commercial profit on sales of LINZESS
$ 87,622 $ 78,908 $ 164,308 $ 153,896
Commercial Margin3
52% 52% 52% 54% Ironwood’s share of net profit $ 43,811 $
39,454 $ 82,154 $ 76,948
Ironwood’s selling, general and
administrative expenses4
12,496 8,879 23,605 18,032 Ironwood’s collaborative arrangement
revenue $ 56,307 $ 48,333 $ 105,759 $ 94,980
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 June 30, 2017, net profit for
the U.S. LINZESS brand collaboration with Allergan was $72.2
million, calculated by subtracting $80.2 million in commercial
costs and expenses and $15.4 million in research and development
expenses, from LINZESS U.S. net sales of $167.8 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170803006233/en/
Ironwood Pharmaceuticals, Inc.Meredith Kaya, 617-374-5082Senior
Director, Investor Relations and Corporate
Communicationsmkaya@ironwoodpharma.com
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