- Expect > 25% compound annual growth rate (CAGR) for Ironwood revenue between 2016 and 2020 -
- LINZESS® (linaclotide) 2016 U.S. net sales expected to be
- Continued R&D innovation expected to deliver multiple catalysts in 2017 including ≥2 launches, ≥4 data readouts and ≥4 trial initiations -
"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
2016 Accomplishments and Recent Updates:
U.S.net sales, based on estimates provided by Allergan, are expected to be approximately $625 millionfor 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.
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
- 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 millionin cash for operations during 2016, as estimated based on Ironwood's preliminary calculations, a decrease from the less than $50 millionpreviously 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.
- 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
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).
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 millionexpected to be recognized in 2016.
$1 billionin 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
A live webcast of Ironwood's presentation and the question and answer
session at 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
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
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 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.
- 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
More than four million patients are treated with a xanthine oxidase
inhibitor (XOI), either allopurinol or febuxostat, for gout in the
Lesinurad is a URAT1 inhibitor approved by the
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
- 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 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
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.
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
The 2016 LINZESS
LINZESS® and CONSTELLA® are trademarks owned by
Director, Corporate Communications
Director, Investor Relations
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