- Expect >25% compound annual growth rate (CAGR) for Ironwood
revenue between 2016 and 2020 -
- LINZESS® (linaclotide) 2016 U.S. net sales expected to be ~$625M
with >55% commercial margin; on track to exceed $1B by 2020 -
- Continued R&D innovation expected to deliver multiple catalysts
in 2017 including ≥2 launches, ≥4 data readouts and ≥4 trial initiations
- Presentation Monday, Jan. 9 at 12:00 p.m. PT during J.P. Morgan
Healthcare Conference -
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Jan. 8, 2017--
Pharmaceuticals, Inc. (NASDAQ:IRWD) today detailed strong execution
against its strategy of building a top-performing commercial
biotechnology company generating rapid, sustainable, high-margin growth.
The company also outlined future goals and will provide further details
during its presentation at the 35th Annual J.P. Morgan Healthcare
Conference on Monday, January 9, 2017, at 12:00 p.m. Pacific Time / 3:00
p.m. Eastern Time at the Westin St. Francis Hotel in San Francisco.
“Ironwood discovered, developed and commercialized a market-leading
product – which is rare in the biotech industry – and we have now
translated innovation into strong revenue growth and continuing margin
expansion, which is fueling further research and development of
additional innovative product candidates,” said Peter Hecht, chief
executive officer of Ironwood. “This cycle of innovation and value
creation is enabling us to build a top-performing commercial biotech
company and realize our mission of bringing important medicines to
patients and maximizing long-term, per-share cash flows for our fellow
2016 Accomplishments and Recent Updates:
LINZESS U.S. net sales, based on estimates provided by Allergan, are
expected to be approximately $625 million for the full year 2016,
representing estimated growth of more than 35% over 2015 with an
estimated commercial margin of greater than 55%. Ironwood expected
2016 revenue from LINZESS represents an increase of more than 60%
compared to the full year 2015. Final numbers will be provided during
Ironwood’s Fourth Quarter 2016 Investor Update.
Reported topline Phase IIb data for linaclotide colonic release-1
(CR1) supporting advancement into Phase III for irritable bowel
syndrome with constipation (IBS-C) and for linaclotide colonic
release-2 (CR2) supporting further investigation for non-constipation
subtypes of IBS.
In-licensed U.S. rights to lesinurad and launched ZURAMPIC®
(lesinurad) for the treatment of hyperuricemia in patients with
uncontrolled gout who are already taking a xanthine oxidase inhibitor
(XOI); filed for U.S. Food and Drug Administration (FDA) approval of
DUZALLO™ (fixed-dose combination of lesinurad and allopurinol),
which if approved would be the first fixed-dose, dual-mechanism
treatment for patients with uncontrolled gout.
Announced approval, with partner Astellas, of LINZESS as the first
prescription treatment for adults with IBS-C in Japan.
Initiated a Phase IIb clinical trial of IW-3718 for adults with
uncontrolled gastroesophageal reflux disease (GERD).
Advanced sGC stimulators IW-1973 and IW-1701 into Phase II trials in
diabetic hypertension and achalasia, respectively.
Used less than $30 million in cash for operations during 2016, as
estimated based on Ironwood’s preliminary calculations, a decrease
from the less than $50 million previously guided; lowered cost of
capital through debt refinancing. Final 2016 use of cash for
operations will be provided during Ironwood’s Fourth Quarter 2016
Continue strong LINZESS growth and margin expansion, and introduce a
72 mcg dose of linaclotide for adult chronic idiopathic constipation
(CIC) patients, if approved, in early 2017.
Launch at least two products, including LINZESS for adults with IBS-C
in Japan, expected to be launched by Astellas in the first half of
2017, and DUZALLO, if approved for uncontrolled gout, expected to
launch in late 2017.
Generate data from at least four clinical trials, including the
ongoing Phase IIb trial of IW-3718 for uncontrolled GERD, expected
mid-year; the ongoing Phase III trial of LINZESS for CIC in Japan; and
the ongoing Phase II trials of IW-1973 and IW-1701 in diabetic
hypertension and achalasia, respectively.
Initiate at least four clinical studies, including a Phase III trial
of linaclotide CR1 for adults with IBS-C and Phase II trials of
IW-1973 for diabetic nephropathy, resistant hypertension and heart
Greater than 25% Ironwood revenue CAGR between 2016 and 2020,
excluding any current or future revenue recognized in the period
related to milestone payments to Ironwood, including approximately $39
million expected to be recognized in 2016.
Greater than $1 billion in LINZESS annual U.S. net sales; greater than
70% LINZESS commercial margin .
ZURAMPIC/DUZALLO cash flow accretive in 2019 and rapidly expanding
At least two new product launches.
At least five Phase III clinical programs ongoing.
Rapid growth in cash flows; expect to achieve positive cash flow
Ironwood will provide further details during its presentation at the
35th Annual J.P. Morgan Healthcare Conference on Monday, January 9,
2017, at 12:00 p.m. Pacific Time / 3:00 p.m. Eastern Time at the Westin
St. Francis Hotel in San Francisco. The presentation will be followed by
a question and answer session that will begin at 1:30 p.m. Pacific Time
/ 4:30 p.m. Eastern Time. Additional details are expected to be provided
during the company’s Fourth Quarter 2016 Investor Update in February and
its Investor Day on Thursday, March 9, 2017, in Cambridge, Mass.
A live webcast of Ironwood’s presentation and the question and answer
session at the J.P. Morgan Healthcare Conference will be accessible
through the Investors section of the company’s website at www.ironwoodpharma.com.
To access the webcast, please log on to the Ironwood website
approximately 15 minutes prior to the start time to ensure adequate time
for any software downloads that may be required. A replay of the webcast
will be available on Ironwood’s website for 14 days following the
About IBS-C and CIC
Irritable bowel syndrome with constipation (IBS-C) and chronic
idiopathic constipation (CIC) are functional gastrointestinal disorders.
While estimates vary, as many as 13 million adults in the U.S. may
suffer from IBS-C and as many as 35 million adults in the U.S. may
suffer from CIC. IBS-C is generally characterized by hallmark symptoms
of abdominal pain and infrequent bowel movements (less than three times
per week); CIC is generally characterized by infrequent bowel movements
(less than three times per week), but symptoms vary across this broad
and heterogeneous patient population and may also include recurrent
straining, lumpy or hard stools, and/or a sensation that the bowels are
not fully empty. Results derived from responses to a web based survey
commissioned by Forest Pharmaceuticals and Ironwood Pharmaceuticals
suggest that only about half of adult IBS-C sufferers and only 12
percent of CIC sufferers are medically diagnosed. There are few
available prescription treatment options for these conditions.
Linaclotide is a guanylate cyclase‐C (GC‐C) agonist that is thought to
work in two ways based on nonclinical studies. Linaclotide 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. Linaclotide is
marketed by Ironwood and Allergan in the United States as LINZESS®
and is indicated for the treatment of adults with irritable bowel
syndrome with constipation (IBS-C) or chronic idiopathic constipation
(CIC). Linaclotide is marketed by Allergan for the treatment of adults
with moderate to severe IBS-C in Europe under the brand name CONSTELLA®.
Ironwood’s partner Astellas received approval of linaclotide in Japan
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.
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.
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
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 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
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.
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
About Hyperuricemia and Gout
Gout is a highly symptomatic and painful form of inflammatory arthritis
affecting more than nine million people in the U.S. It is caused by an
underlying metabolic disorder, hyperuricemia – high levels of uric acid
in the blood – and can lead to painful flares, characterized by
excruciating pain, inflammation, swelling and tenderness in one or more
joints. Gout has a hereditary component and is not only a lifestyle
disease. While diet and lifestyle changes are important in managing gout
and its comorbidities, they are often not enough to get patient serum
uric acid (sUA) levels to target.
More than four million patients are treated with a xanthine oxidase
inhibitor (XOI), either allopurinol or febuxostat, for gout in the U.S.
Of these, an estimated two million patients are uncontrolled and are not
achieving target serum uric acid (sUA) levels <6 mg/dL as recommended by
the American College of Rheumatology (ACR), despite treatment with an
XOI alone. These patients continue to suffer from flares, and may face
serious long-term consequences that can result from having uncontrolled
sUA levels. ACR guidelines recommend adding a uricosuric agent, like
ZURAMPIC, to an XOI in patients who are not achieving target sUA levels.
Lesinurad is a URAT1 inhibitor approved by the FDA for use in
combination with a xanthine oxidase inhibitor (XOI) for the treatment of
hyperuricemia associated with gout in patients who have not achieved
target serum uric acid (sUA) levels with an XOI alone. Lesinurad is not
recommended for the treatment of asymptomatic hyperuricemia and should
not be used as a monotherapy. XOIs reduce the production of uric acid;
lesinurad increases renal excretion of uric acid by selectively
inhibiting the action of URAT1, the UA transporter responsible for the
majority of renal UA reabsorption. The dual-mechanism combination of
lesinurad plus an XOI (allopurinol or febuxostat) can address both
inefficient excretion and overproduction of UA, thereby lowering sUA
levels. The safety profile and efficacy of lesinurad were established in
three Phase III clinical trials that evaluated a once-daily dose of
lesinurad in combination with the XOI allopurinol or febuxostat compared
to XOI alone. Lesinurad is marketed by Ironwood in the U.S. as ZURAMPIC®;
see the important safety information below for more information.
Allopurinol is a xanthine oxidase inhibitor. Allopurinol’s action
differs from that of uricosuric agents such as lesinurad. Allopurinol
reduces both the serum and urinary uric acid levels by inhibiting the
formation of uric acid. The most frequent adverse reaction to
allopurinol is skin rash. Skin reactions can be severe and sometimes
fatal. The incidence of skin rash may be increased in the presence of
ZURAMPIC Important Safety Information
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
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.
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
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
ZURAMPIC should not be used as monotherapy
Please see full Prescribing Information, including Boxed WARNING, http://www.azpicentral.com/zurampic/zurampic.pdf
About Uncontrolled Gastroesophageal Reflux Disease
An estimated 45 million Americans have gastroesophageal reflux disease
(GERD), an estimated 10 million of whom are thought to suffer from the
uncontrolled form of the condition, meaning they continue to experience
symptoms such as heartburn and regurgitation despite receiving the
current standard of care treatment with a proton pump inhibitor (PPI).
While PPIs suppress production of stomach acid, research suggests reflux
of bile from the intestine into the stomach and esophagus may play a
role in the ongoing symptoms of uncontrolled GERD. There are few
FDA-approved treatment options for these patients. If left untreated,
uncontrolled GERD can lead to serious complications including Barrett’s
esophagus and, in rare instances, esophageal cancer.
IW-3718 is a novel, investigational gastric retentive formulation of a
bile acid sequestrant, developed by Ironwood using the proprietary
Acuform® drug delivery technology licensed from Depomed, Inc. IW-3718 is
designed to remain in the stomach and duodenum (upper small intestine)
over an extended period of time and to work in combination with a PPI to
reduce the detrimental effects of bile and acid on the esophagus.
About Ironwood’s sGC Program
Soluble guanylate cyclase (sGC), a central component of the nitric oxide
(NO)-sGC-cGMP pathway, plays an important role in regulating diverse
physiological processes such as blood flow, inflammation, fibrosis, and
metabolism. Dysregulation of sGC may play a role in multiple vascular
and fibrotic diseases with high unmet need such as diabetic nephropathy,
resistant hypertension, heart failure, achalasia, sickle cell disease
and vascular dementia. Ironwood established its expertise in this
signaling pathway through the discovery and development of linaclotide,
a guanylate cyclase C (GC-C) agonist. Stimulation of sGC is a clinically
validated approach, and Ironwood leveraged its GC-C expertise to
discover and develop multiple sGC stimulators. IW-1973 is currently
being studied in diabetic hypertension and IW-1701 is being studied in
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
information that may be important to investors will be routinely posted
in both these locations.
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,
introduction and commercial potential of linaclotide, lesinurad, our
product candidates (including expectations related to the introduction
of LINZESS 72 mcg dose and launch of DUZALLO) and the other products
that we promote and the drivers, timing, impact and results thereof;
expectations concerning the timing of when we will become cash flow
positive; 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 and our intentions and efforts to protect such
intellectual property; our potential for rapid, sustainable, high-margin
growth and shareholder returns; expectations related to driving
productive, high-margin business; and our financial performance and
results, and guidance and expectations related thereto, including
expectations related to net product sales, Ironwood revenue CAGR,
Ironwood revenue from LINZESS and cash used for operations, milestone
revenue, LINZESS U.S. net sales, commercial margin and commercial costs,
cash flow accretion and margin expansion. 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 or otherwise as expected; and the risks listed under the
heading "Risk Factors" and elsewhere in Ironwood's Quarterly Report on
Form 10-Q for the quarter ended September 30, 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
The 2016 LINZESS U.S. net sales and commercial margin, as well as the
2016 Ironwood revenue from LINZESS, milestone revenue, and cash used for
operations information is preliminary and based on estimates, and may
change as we receive final 2016 data from Allergan, and as we and
Allergan complete the preparation of our respective 2016 financial
statements. LINZESS U.S. net sales are reported by Allergan and LINZESS
commercial costs incurred by each of us and Allergan are reported in our
respective financial statements. Further, LINZESS U.S. commercial margin
is defined as commercial profit on sales of LINZESS as a percent of
total LINZESS U.S. net sales. Commercial profit on sales of LINZESS is
equal to LINZESS U.S. net sales less (a) cost of goods sold incurred by
Allergan and (b) selling, general and administrative expenses incurred
by us and Allergan that are attributable to the cost-sharing arrangement
between us. The 2016 LINZESS U.S. commercial margin presented assumes
commercial costs within our previously guided range.
LINZESS® and CONSTELLA® are trademarks owned by Ironwood
Pharmaceuticals, Inc. and ZURAMPIC® and DUZALLOTM are
trademarks owned by AstraZeneca AB. Any other trademarks referred to in
this press release are the property of their respective owners. All
View source version on businesswire.com: http://www.businesswire.com/news/home/20170108005047/en/
Source: Ironwood Pharmaceuticals, Inc.
Ironwood Pharmaceuticals, Inc.
Director, Corporate Communications
Meredith Kaya, 617-374-5082