- Fourth quarter LINZESS® (linaclotide) net
product sales of
"2013 was a transformational year for Ironwood. LINZESS had a strong
first full year in the market with greater than 200,000 unique adult
patients filling a LINZESS prescription, more than 580,000 total
prescriptions filled, over 50,000 healthcare practitioners gaining
experience with LINZESS, approximately
Fourth Quarter 2013 and Recent Highlights
LINZESS net product sales, as reported by Forest Laboratories, Inc.,
$51.0 millionin the fourth quarter of 2013, an increase of approximately 48% quarter over quarter, and $118.8 millionfor the year ended December 31, 2013.
More than 220,000 LINZESS prescriptions were filled in the fourth
quarter of 2013, resulting in more than 24% growth in total
prescriptions quarter over quarter, and over 580,000 LINZESS
prescriptions were filled in 2013, according to
- In 2013, more than 50,000 healthcare practitioners prescribed LINZESS, including approximately 90% of high prescribing gastroenterologists and approximately 70% of other high prescribing healthcare practitioners, primarily primary care physicians. Physician prescribing continues to increase month over month.
December 2013, approximately 75% of adult irritable bowel syndrome with constipation (IBS-C) or chronic idiopathic constipation (CIC) patients with commercial insurance had unrestricted access to LINZESS and approximately 80% of adult patients with commercial insurance had access to LINZESS at a copay of $30per month or less through formulary coverage or the LINZESS Instant Savings Program.
- Ironwood and Forest continue to explore opportunities to enhance the clinical profile of LINZESS by seeking to expand its utility in its indicated populations, as well as studying linaclotide in additional indications and populations, new formulations and in combination with other products to assess its potential to treat various gastrointestinal (GI) conditions.
Linaclotide (Rest of World)
Almirall, S.A., Ironwood's European partner, continues to launch
CONSTELLA® (linaclotide) in Europe. CONSTELLAis currently available to adult IBS-C patients in nine countries in Europe, including the United Kingdomand Germany.
Ironwoodand AstraZeneca AB continue to enroll patients in a Phase III clinical trial of linaclotide in adult patients with IBS-C in China. The trial is expected to be completed in the first half of 2015.
Astellas Pharma Inc. has completed enrollment in a Phase II
double-blind, placebo-controlled, dose-ranging clinical trial of
linaclotide in adult patients with IBS-C in
Research & Development
- Ironwood is leveraging its strong therapeutic expertise in GI disorders to advance up to seven GI development programs with multiple opportunities to generate proof of concept data over the next 24 months.
- Building on its pioneering research with linaclotide, guanylate cyclase-C (GC-C) and other guanylate cyclases, Ironwood is also advancing a second GC program targeting soluble guanylate cyclase (sGC), a validated mechanism with the potential for broad therapeutic utility and multiple opportunities for product development.
Corporate and Financials
Total Revenues. Revenues were approximately
$5.0 millionin the fourth quarter of 2013. This consisted of $2.9 millionin collaborative arrangements revenue associated with its share of the net profits and losses from the sales of LINZESS in the U.S., $0.5 millionin sales of active pharmaceutical ingredient (API), $1.5 millionin the amortization of deferred revenue associated with consideration received from Ironwood's collaborations with Astellas and AstraZeneca, and $0.1 millionin royalty payments based on sales of CONSTELLAin Europefrom Almirall. For 2013, revenues were approximately $22.9 million. This consisted of $2.9 millionin collaborative arrangements revenue associated with its share of the net profits and losses from the sales of LINZESS in the U.S., $12.2 millionin sales of API, $5.7 millionin the amortization of deferred revenue associated with consideration received from Ironwood's collaborations with Astellas and AstraZeneca, $1.9 millionin milestone payments from Almirall as a result of the commercial launches of CONSTELLAin the U.K.and Germany, and $0.2 millionin royalty payments from Almirall.
Operating Expenses. Operating expenses were approximately
$51.2 millionin the fourth quarter of 2013. This consisted of $22.5 millionin research and development (R&D) expenses, which included approximately $1.9 millionin non-cash share-based compensation expense, and $28.7 millionin selling, general and administrative (SG&A) expenses, which included approximately $2.6 millionin non-cash share-based compensation expense. For 2013, operating expenses were approximately $225.6 millionand consisted of $102.4 millionin research and development expenses, which included approximately $9.2 millionin non-cash share-based compensation expense, and $123.2 millionin SG&A expenses, which included approximately $10.7 millionin non-cash share-based compensation expense.
Collaborative Arrangements Revenue/Collaboration Expense. Ironwood
records its share of the net profits and losses from the sales of
LINZESS in the U.S. on a net basis and presents the settlement
payments as collaborative arrangements revenue or collaboration
expense, as applicable. For the fourth quarter of 2013, Ironwood
recorded the settlement payment from Forest as collaborative
arrangements revenue and no collaboration expense was recorded. For
2013, collaboration expense was
Interest Expense. Interest expense was
$5.3 millionin the fourth quarter of 2013 in connection with the $175 milliondebt financing executed in January 2013. For 2013, interest expense was $21.0 million.
Net Loss. Net loss was
$52.0 million, or $0.43per share, in the fourth quarter of 2013. For 2013, net loss was $272.8 million, or $2.35per share.
Cash Position. Ironwood ended 2013 with approximately
$198 millionof cash, cash equivalents and available-for-sale securities. Ironwood used approximately $42 millionof net cash for operations during the quarter and approximately $273 millionof net cash for operations during the year ended December 31, 2013.
2013 Financial Guidance. Ironwood provided financial guidance
for its 2013 non-linaclotide R&D expenses to be in the range of
$60to $75 million. Total actual non-linaclotide R&D expenses in 2013 were $56.3 million. Additionally, Ironwood provided financial guidance for its 2013 marketing and sales expenses for LINZESS to be in the range of $250to $300 million. Total actual 2013 marketing and sales expenses for LINZESS were $255.5 million.
2014 Financial Guidance. Ironwood expects its 2014 total
operating expenses to be in the range of
$215to $245 million, consisting of $105to $120 millionin R&D expenses and $110to $125 millionin SG&A expenses. Non-linaclotide R&D expenses are expected to be approximately 45% of total R&D expenses. In addition, Ironwood today updated its financial guidance for the Forest and Ironwood total 2014 marketing and sales expenses for LINZESS, which it now expects to be in the range of $240to $270 million.
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 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 up to 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 in young juvenile mice. LINZESS has not been studied in pediatric patients. 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 in
LINZESS® and CONSTELLA® are trademarks owned by
Important Safety Information
WARNING: PEDIATRIC RISK
LINZESS is contraindicated in pediatric patients up to 6 years of age. Use should be avoided in pediatric patients 6 through 17 years of age. In nonclinical studies, administration of a single, clinically relevant adult oral dose of linaclotide caused deaths in young juvenile mice.
- LINZESS is contraindicated in pediatric patients up to 6 years of age.
- LINZESS is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction.
Warnings and Precautions
- LINZESS is contraindicated in pediatric patients up to 6 years of age. In nonclinical studies, deaths occurred within 24 hours in young juvenile mice (1 to 3 week-old mice; approximately equivalent to human pediatric patients less than 2 years of age) following administration of one or two daily oral doses of linaclotide.
- Use of LINZESS should be avoided in pediatric patients 6 through 17 years of age. Linaclotide did not cause deaths in older juvenile mice (approximately equivalent to humans age 12 to 17 years). 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, who should consider dose suspension.
- 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 our
development and commercialization plans for linaclotide and our product
candidates and programs in our pipeline; the anticipated timing of
pre-clinical and clinical developments, including clinical trials (and
their associated results); and our company's financial performance and
results, including our projected 2014 operating expenses (including
certain research and development expenses) and 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, regulatory approvals,
manufacturing, formulation development, intellectual property matters,
efficacy, safety and tolerability, competition in disease states, and
the commercial potential of LINZESS and our product candidates; the risk
that our planned investments do not have the anticipated effect on
LINZESS or our company revenues; 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 our partner, Forest
Laboratories, Inc., 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||$||197,602||$||168,228|
|Accounts receivable, net||3,213||1,487|
|Prepaid expenses and other current assets||6,168||8,026|
|Total current assets||229,128||184,440|
|Property and equipment, net||37,376||37,537|
|Liabilities and Stockholders' Equity|
|Accounts payable and accrued expenses||$||32,037||$||48,561|
|Current portion of capital lease obligations||1,139||261|
|Current portion of deferred rent||2,790||2,735|
|Current portion of deferred revenue||5,074||3,381|
|Total current liabilities||41,040||54,938|
|Capital lease obligations||3,134||308|
|Total stockholders' equity||38,225||144,052|
|Total liabilities and stockholders' equity||$||278,962||$||229,907|
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Three Months Ended
|Cost and expenses:|
|Cost of revenue||533||965||7,203||965|
|Research and development (1)||22,516||28,273||102,378||113,474|
|Selling, general and administrative (1)||28,720||33,274||123,228||92,538|
|Total cost and expenses||51,769||70,880||274,883||223,007|
|Loss from operations||(46,738||)||(43,900||)||(252,002||)||(72,762||)|
|Other income (expense), net||(5,248||)||45||(20,810||)||138|
|Net loss per share—basic and diluted||$||(0.43||)||$||(0.41||)||$||(2.35||)||$||(0.68||)|
|Weighted average number of common shares used in net loss per share —basic and diluted||120,929,271||107,439,026||115,851,875||106,402,639|
(1) Non-cash compensation expenses reflected in the condensed consolidated statements of operations are as follows:
Research and development
Selling, general and administrative
LINZESS U.S. Collaboration Revenue/Expense Calculation1
Three Months Ended
|LINZESS net sales||$||51,044||$||19,227||$||118,753||$||19,227|
|Commercial costs and expenses2 Includes cost of goods sold incurred by Forest as well as selling, general and administrative expenses incurred by Forest and Ironwood that are attributable to the cost-sharing arrangement between the parties.||62,806||39,157||264,751||61,471|
|Net profit (loss) on sales of LINZESS||$||(11,762||)||$||(19,930||)||$||(145,998||)||$||(42,244||)|
|Ironwood's share of net loss||$||(5,881||)||$||(9,965||)||$||(72,999||)||$||(21,122||)|
Ironwood's selling, general and administrative expenses3 Includes Ironwood's selling, general and administrative expenses attributable to the cost-sharing arrangement with Forest.
|Ironwood's collaboration expense||$||—||$||8,368||$||39,160||$||16,030|
|Ironwood's collaborative arrangement revenue||$||2,914||$||—||$||—||$||—|
1 Ironwood collaborates with Forest on the development and
commercialization of linaclotide in
2 Includes cost of goods sold incurred by Forest as well as selling, general and administrative expenses incurred by Forest 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 Forest.
Associate Director, Corporate Communications
Director, Investor Relations
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