- 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 -
Ironwood 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 shareholders.”
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 Investor Update.
2017 Goals:
- 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 failure (pEF).
2020 Goals:
- 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 commercial margins.
- 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 during 2018.
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 conference.
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.
About linaclotide
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.
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
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.
About lesinurad
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.
About allopurinol
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 renal insufficiency.
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 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, 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.
About IW-3718
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 achalasia.
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.
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 statements.
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
rights reserved.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20170108005047/en/
Ironwood Pharmaceuticals, Inc.Media RelationsTrista Morrison,
617-374-5095Director, Corporate
Communicationstmorrison@ironwoodpharma.comorInvestor
RelationsMeredith Kaya, 617-374-5082Director, Investor
Relationsmkaya@ironwoodpharma.com
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