- LINZESS® (linaclotide) U.S. net sales of
- Total LINZESS prescriptions increased approximately 56% in second quarter 2015 compared to second quarter 2014 -
- Advanced innovative pipeline, including positive top-line Phase I data with sGC stimulator IW-1973 -
- Entered agreement with Allergan to co-promote VIBERZI™ (eluxadoline) for IBS-D -
"Ironwood made substantial progress in the second quarter of 2015, with
continued strong performance for each of our key value drivers -
LINZESS, our innovative pipeline and our strong commercial
Second Quarter 2015 and Recent Highlights
LINZESS U.S. net sales, as provided by Allergan plc, were
$112.1 millionin the second quarter of 2015, an approximately 79% increase compared to the second quarter of 2014.
More than 510,000 total LINZESS prescriptions were filled in the
second quarter of 2015, an approximately 56% increase compared to the
second quarter of 2014, and nearly three million LINZESS prescriptions
have been filled since the product's launch in
December 2012, according to IMS Health.
Net profit for the LINZESS brand collaboration in the U.S., including
commercial costs and expenses and research and development (R&D)
$15.0 millionin the second quarter of 2015. LINZESS U.S. net profit is shared equally with Allergan.
- Approximately 140,000 healthcare practitioners have prescribed LINZESS to more than 760,000 unique patients since the product's launch, according to IMS Health.
More than 70% of people with commercial insurance or
Medicare Part Dplans had unrestricted access to LINZESS as of May 2015. Additionally, as of June 2015, more than 75% of people with commercial insurance had access to LINZESS for a co-pay of $30or less through formulary coverage or the LINZESS Instant Savings Program.
Research & Development
Ironwood continues to advance its innovative pipeline. The company now
expects up to 12 ongoing clinical studies in 2015, including four
Ironwood studies and eight with its partners. In addition, Ironwood
expects five clinical data readouts in 2015, including the already
reported positive top-line data from the IW-3718 Phase IIa study, the
linaclotide Phase III trial for
Ironwood and Allergan continue to evaluate opportunities to strengthen
the clinical utility of linaclotide in its indicated patient
population, as well as to develop and seek approval of linaclotide in
additional indications, patient populations and formulations.
Development highlights during the second quarter and recent period
Completed enrollment in the Phase III clinical trial assessing the
efficacy and safety of a once-daily 72 mcg dose of linaclotide in
adult patients with chronic idiopathic constipation (CIC). Data
from this trial are expected in the fourth quarter of 2015 and a
supplemental new drug application is expected to be submitted to
U.S. Food and Drug Administration(FDA) in the first half of 2016. If approved, the 72 mcg dose should accelerate the expansion of LINZESS use within adult CIC patients by providing physicians an additional dosing option for this large and diverse population.
- Completed enrollment in the Phase II clinical study evaluating linaclotide for the treatment of adults suffering from opioid-induced constipation. Data from this study are expected in the fourth quarter of 2015.
- Finalizing preparations for a Phase IIb clinical study to evaluate two linaclotide colonic release formulations in adult patients with irritable bowel syndrome with constipation (IBS-C). The Phase IIb study is expected to initiate in the fourth quarter of 2015 with data anticipated in the second half of 2016.
FDAto advance plans to evaluate linaclotide in the pediatric population. Two Phase II studies are expected to initiate in the fourth quarter of 2015, one in IBS-C patients aged 7 to 17 years old and the other in patients with functional constipation aged 6 to 17 years old.
- Completed enrollment in the Phase III clinical trial assessing the efficacy and safety of a once-daily 72 mcg dose of linaclotide in adult patients with chronic idiopathic constipation (CIC). Data from this trial are expected in the fourth quarter of 2015 and a supplemental new drug application is expected to be submitted to the
Ironwood continues to advance its pipeline of gastrointestinal (GI)
product candidates and its soluble guanylate cyclase (sGC) program.
Development highlights during the second quarter and recent period
- Advanced IW-1973 and IW-1701, the first two candidates from the sGC stimulator platform. sGC is a key regulator of blood flow, fibrosis and inflammation in nearly every tissue throughout the human body. Ironwood is developing an innovative and proprietary chemical series of pharmacologically distinct sGC stimulators targeting severe cardiovascular and fibrotic diseases. Ironwood reported positive top-line data from the Phase Ia clinical study of IW-1973, Ironwood's first sGC stimulator. In the study, IW-1973 demonstrated cardiovascular pharmacodynamic effects, extensive tissue distribution, proof of mechanism for sGC stimulation, and a dose range that was well tolerated in healthy volunteers. No serious adverse events were reported. Ironwood intends to initiate a Phase Ib multiple ascending dose study of IW-1973 in the fourth quarter of 2015. The company expects to initiate a Phase I clinical study with its second sGC stimulator, IW-1701, in the fourth quarter of 2015.
- Finalizing preparations for the IW-3718 dose-ranging Phase IIb study for the potential treatment of refractory GERD, which is expected to initiate in early 2016.
- Continued enrollment in the Phase IIa clinical study evaluating the ability of IW-9179 to provide relief of diabetic gastroparesis symptoms. IW-9179 is a guanylate cyclase-C (GC-C) agonist designed to target the upper GI tract. Data from this study are expected in the first half of 2016.
Global Partnerships for Linaclotide
Ironwoodand AstraZeneca AB reported positive top-line data from a Phase III clinical trial of linaclotide in adults with IBS-C for China. In this trial, linaclotide met all primary and secondary endpoints with statistical significance, including multiple abdominal and constipation symptoms. The most common adverse event reported in linaclotide-treated patients was diarrhea. The companies intend to file in early 2016 for China Food and Drug Administrationapproval to market linaclotide.
Astellas Pharma Inc. completed enrollment in its Phase III clinical
trial of linaclotide in adult patients with IBS-C for
Japan, and expects to complete the trial in 2016. In addition, Astellas also continues to enroll patients in its Phase II clinical study of linaclotide in adult patients with chronic constipation for Japan, and expects to complete the Phase II study in 2016.
Almirall, S.A. continues to commercialize CONSTELLA® (linaclotide) in
Europe, where it is approved for adult patients with moderate to severe IBS-C and is available in 12 European countries, including the United Kingdom, Italyand Spain.
Ironwoodand Exact Sciences Corp. are co-promoting Exact Sciences' Cologuard®, the first and only FDA-approved noninvasive stool DNA screening test for colorectal cancer. Ironwood's clinical sales specialists began promoting Cologuard in April 2015. As of mid-July 2015, approximately 3,000 healthcare practitioners on whom the Ironwood clinical sales specialists have called have ordered a Cologuard test kit, as provided by Exact Sciences.
- Ironwood and Allergan entered an agreement for the U.S. co-promotion of VIBERZI™ (eluxadoline), Allergan's new treatment for adults suffering from irritable bowel syndrome with diarrhea (IBS-D). Under the terms of the agreement, Ironwood's clinical sales specialists will detail VIBERZI to the approximately 25,000 health care practitioners to whom they currently detail LINZESS and Cologuard®. LINZESS will remain the first-position product for the Ironwood sales team. Ironwood's promotional efforts will be compensated based on the volume of calls delivered by Ironwood's sales force, as well as agreed upon performance metrics. There will be no incremental investment on the part of Ironwood. Allergan will be responsible for all other costs relating to the commercialization of VIBERZI.
Corporate and Financials
Collaborative Arrangements Revenue. Collaborative arrangements
revenue was approximately
$27.7 millionin the second quarter of 2015 compared to approximately $6.8 millionin the second quarter of 2014. Revenue consisted of approximately $24.3 millionin revenue associated with Ironwood's share of the net profits and losses from the sales of LINZESS in the U.S., as well as approximately $3.4 millionin amortization of deferred revenue associated with consideration received from Ironwood's collaboration with Astellas, revenue recognized in connection with the collaboration with AstraZeneca, royalty payments based on sales of linaclotide in territories outside of the U.S., and revenues associated with Ironwood's co-promotion agreement with Exact Sciences Corp.
Cost of revenue. Cost of revenue is recognized upon shipment of
linaclotide API to certain licensing partners outside of the U.S.
Allergan records costs associated with linaclotide API in the
U.S. Cost of revenue was approximately
$8.2 millionin the second quarter of 2015 as compared to $10.5 million in the second quarter of 2014. Cost of revenue in the second quarter of 2015 was primarily due to a write-down of existing linaclotide API as well as a charge for excess purchase commitments, primarily attributable to a lengthened approval timeline in Chinaas a result of recent regulatory changes made by the China Food and Drug Administrationand lower projected sales in the European market.
Operating Expenses. Operating expenses were approximately
$61.6 millionin the second quarter of 2015 as compared to approximately $51.4 millionin the second quarter of 2014. Operating expense run-rate remains in-line with Ironwood's full year 2015 guidance. Operating expenses in the second quarter of 2015 consisted of approximately $28.6 millionin R&D expenses, and approximately $33.0 millionin selling, general and administrative (SG&A) expenses. Non-cash share-based compensation expenses recorded in R&D and SG&A expenses in the second quarter of 2015 were approximately $2.7 millionand $4.2 million, respectively.
Interest Expense. Interest expense was approximately
$5.9 millionin the second quarter of 2015, as compared to approximately $5.3 millionin the second quarter of 2014, in connection with the $175 milliondebt financing executed in January 2013and the approximately $336 millionconvertible debt financing executed in June 2015.
Net Loss. Net loss was approximately
$48.0 million, or $0.34per share, in the second quarter of 2015, as compared to approximately $60.4 million, or $0.44per share, in the second quarter of 2014.
Cash Position. Ironwood ended the second quarter of 2015 with
$493 millionof cash, cash equivalents and available-for-sale securities. Ironwood used approximately $26 millionof cash for operations during the second quarter of 2015, as compared to approximately $36 millionin the second quarter of 2014.
Convertible Debt Offering. In
June 2015, Ironwood issued approximately $335.7 millionin aggregate principal of 2.25% Convertible Senior Notes. These notes include a seven-year maturity and an initial equivalent conversion price of $16.58per share. As part of the offering, Ironwood also entered into certain derivative arrangements that effectively increased the equivalent conversion price to $21.50per share. Aggregate net proceeds, after the purchase of the convertible note hedge, underwriting discounts and other offering expenses, were approximately $303.0 million.
2015 Financial Guidance.
Ironwood continues to expect its 2015 total operating expenses to
be in the range of
$220 millionto $250 million, which includes $105 millionto $120 millionin R&D expenses and $115 millionto $130 millionin SG&A expenses.
Ironwood continues to expect combined Allergan and Ironwood total
2015 marketing and sales expenses for LINZESS to be in the range
$230 millionto $260 million.
- Ironwood continues to expect its 2015 total operating expenses to be in the range of
Conference Call Information
Ironwood will host a conference call and webcast at
About LINZESS (linaclotide)
LINZESS® is the first and only guanylate cyclase-C (GC-C) agonist
approved by the
LINZESS is thought to work in two ways based on nonclinical studies. LINZESS binds to the GC-C receptor locally, within the intestinal epithelium. Activation of GC-C results in increased intestinal fluid secretion and accelerated transit and a decrease in the activity of pain-sensing nerves in the intestine. The clinical relevance of the effect on pain fibers, which is based on nonclinical studies, has not been established.
In placebo-controlled Phase III clinical trials of more than 2,800 adults, LINZESS was shown to reduce abdominal pain in IBS-C patients and increase bowel movement frequency in both IBS-C patients and CIC patients. Improvement in abdominal pain and constipation occurred in the first week of treatment and was maintained throughout the 12-week treatment period. Maximum effect on abdominal pain was seen at weeks 6-9 and maximum effect on constipation occurred during the first week. When a subset of LINZESS-treated patients in the trials were switched to placebo, they reported their symptoms returned toward pretreatment levels within one week, while placebo-treated patients switched to LINZESS reported symptom improvements. LINZESS is contraindicated in pediatric patients under 6 years of age. The use of LINZESS in pediatric patients 6 through 17 years of age should be avoided. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths due to dehydration in young juvenile mice. The safety and efficacy of LINZESS in pediatric patients under 18 years of age have not been established. In adults with IBS-C or CIC treated with LINZESS, the most commonly reported adverse event was diarrhea.
Linaclotide is a guanylate cyclase-C receptor agonist (GCCA) with visceral analgesic and secretory activities. Linaclotide is a 14-amino acid synthetic peptide structurally related to the endogenous guanylin peptide family. Both linaclotide and its active metabolite bind to the guanylate cyclase-C receptor, on the luminal surface of the intestinal epithelium. Through its action at GC-C, linaclotide has been shown to reduce visceral pain and increase GI transit in animal models and increase colonic transit in humans. Activation of GC-C results in an increase in concentrations of cyclic guanosine monophosphate (cGMP), both extracellularly and intracellularly. Extracellular cGMP decreases pain-fiber activity, resulting in reduced visceral pain in animal models. Intracellular cGMP causes secretion of chloride and bicarbonate into the intestinal lumen, through activation of the cystic fibrosis transmembrane conductance regulator (CFTR), which results in increased intestinal fluid and accelerated transit.
Linaclotide was discovered by scientists at Ironwood and is marketed by
Almirall, S.A. for the treatment of adults with moderate to severe IBS-C
LINZESS® and CONSTELLA® are trademarks owned by
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.frx.com/pi/linzess_pi.pdf
This press release contains forward-looking statements. Investors are
cautioned not to place undue reliance on these forward-looking
statements, including, but not limited to, statements about development,
launch and commercialization plans for linaclotide and our product
candidates; commercial efforts for linaclotide and the other products
that we promote and the drivers, timing, impact and results thereof;
market size, growth and opportunity, and potential demand for
linaclotide, our product candidates and the other products that we
promote, as well as their potential impact on applicable markets; the
potential indications for, and benefits of, linaclotide and our product
candidates; the anticipated timing of pre-clinical, clinical and
regulatory developments; the design, timing and results of clinical and
pre-clinical studies; the timing of filings with regulatory authorities;
expected periods of patent exclusivity; the strength of the intellectual
property protection for our product and product candidates; potential
business development activity and the timing and impact thereof;
profitability of the U.S. LINZESS brand collaboration with Allergan plc;
and our company's financial performance and results, and guidance and
expectations related thereto, including our projected 2015 operating
expenses, revenue growth, operating leverage, and 2015 marketing and
sales expense for LINZESS. 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, but are not limited to, those related
to pre-clinical and clinical development, manufacturing, and formulation
development; the risk that findings from our completed nonclinical and
clinical studies may not be replicated in later studies; decisions made
by U.S. regulatory authorities, the U.S. Patent and Trademark Office and
their foreign counterparts; the risk that we may never get sufficient
patent protection for linaclotide and our product candidates;
intellectual property rights of competitors or potential competitors;
efficacy, safety and tolerability of linaclotide and our product
candidates; competition in disease states; the commercial potential of
linaclotide, our product candidates and the other products that we
promote; the risk that our planned investments do not have the
anticipated effect on our company revenues, linaclotide or our product
candidates; the risk that we are unable to identify and execute on
business development opportunities in a cost-effective and timely manner
or that such opportunities do not have the impact expected; the risk
that we are unable to manage our operating expenses over the year due to
foreseeable or unforeseeable events or occurrences; and the risk that we
and Allergan are unable to commercialize LINZESS within the guided range
of expenses. Applicable risks also include those that are listed under
the heading "Risk Factors" and elsewhere in Ironwood's Quarterly Report
on Form 10-Q for the quarter ended
Condensed Consolidated Balance Sheets
|Cash, cash equivalents and available-for-sale securities||$||493,315||$||248,334|
|Accounts receivable, net||27,049||25,839|
|Prepaid expenses and other current assets||6,595||9,180|
|Total current assets||526,959||288,307|
|Property and equipment, net||25,017||29,826|
|Convertible note hedges||90,314||-|
|Liabilities and Stockholders' Equity|
|Accounts payable and accrued expenses||$||31,125||$||35,948|
|Current portion of capital lease obligations||1,203||1,152|
|Current portion of deferred rent||5,009||4,992|
|Current portion of deferred revenue||7,191||7,191|
|Current portion of PhaRMA notes payable||17,571||11,258|
|Total current liabilities||62,099||60,541|
|Capital lease obligations||1,959||2,571|
|Note hedge warrants||69,456||-|
|PhaRMA notes payable||147,793||158,147|
|Total stockholders' equity||140,283||88,552|
|Total liabilities and stockholders' equity||$||653,941||$||329,322|
Condensed Consolidated Statements of Operations
(In thousands, except per share amounts)
Three Months Ended
Six Months Ended
|Cost and expenses:|
|Cost of revenue||8,150||10,518||8,162||12,442|
|Research and development (1)||28,648||22,142||55,289||49,286|
|Selling, general and administrative (1)||32,955||29,299||63,301||59,223|
|Total cost and expenses||69,753||61,959||126,752||120,951|
|Loss from operations||(42,009||)||(55,119||)||(70,076||)||(99,506||)|
|Other expense, net||(6,011||)||(5,238||)||(11,166||)||(10,477||)|
|Net loss per share—basic and diluted||$||(0.34||)||$||(0.44||)||$||(0.57||)||$||(0.82||)|
|Weighted average number of common shares used in net loss per share —basic and diluted||142,098||138,315||141,690||134,053|
|(1) Non-cash compensation expenses reflected in the condensed consolidated statements of operations are as follows:|
|Research and development||$||2,691||$||2,271||$||4,745||$||4,961|
|Selling, general and administrative||$||4,212||$||3,741||$||7,584||$||7,125|
U.S. LINZESS Brand Collaboration1
Three Months Ended
Six Months Ended
|LINZESS U.S. net sales||$||112,062||$||62,746||$||207,551||$||123,558|
Commercial costs and expenses2
|Net profit (loss) on sales of LINZESS||$||34,222||$||(16,678||)||$||71,560||$||(15,782||)|
|Ironwood's share of net profit (loss)||$||17,111||$||(8,339||)||$||35,780||$||(7,891||)|
Ironwood's selling, general and administrative expenses3
|Profit share adjustment4||$||(1,150||)||$||2,311||$||(2,370||)||$||2,311|
|Ironwood's collaborative arrangement revenue||$||24,275||$||1,778||$||49,412||$||10,225|
1 Ironwood collaborates with Allergan on the development and
commercialization of linaclotide in
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 Includes Ironwood's selling, general and administrative expenses attributable to the cost-sharing arrangement with Allergan.
4 Ironwood or Allergan may incur additional expenses related to certain contractual obligations, resulting in an adjustment to the company's share of the net profits as stipulated by the collaboration agreement.
Director, Corporate Communications
Director, Investor Relations
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