"During 2011, we were focused on preparing linaclotide for successful
regulatory submissions in the U.S. and
Fourth Quarter and Recent Highlights
February 8, Ironwood was informed that the U.S. Food and Drug Administration(FDA) will not schedule an advisory committee meeting in connection with its review of the New Drug Application (NDA) for linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC). Under the FDA's Prescription Drug User Fee Act (PDUFA), the companies anticipate action by the FDAin June 2012.
Fourteen linaclotide-related abstracts have been accepted for
presentation during the 2012 Digestive Disease Week (DDW) annual
meeting that will be held in
San Diegofrom May 19—22, 2012. One abstract will be discussed in an oral presentation and 13 will be made available through poster presentations.
- Ironwood continues to advance its pipeline, which includes early development candidates and discovery efforts focused on gastrointestinal disease, central nervous system disorders, and respiratory disease.
January 2012, Ironwood announced that it entered into a collaboration, research, and licensing agreement for the development and commercialization of Bionomics' investigational anti-anxiety compound BNC210 (renamed as IW-2143) and other related compounds. Ironwood will be responsible for worldwide development and commercialization of all products incorporating IW-2143 or other licensed compounds, including funding of clinical trials. Over the next 24 months, Bionomics may receive up to $13 millionin research funding and milestone payments, which includes an initial payment of $3 million.
Ironwood ended 2011 with approximately
$164 millionof cash, cash equivalents, and available-for-sale securities. Ironwood used approximately $75 millionof net cash for operations for the year ended December 31, 2011.
February 2012, Ironwood sold 6,037,500 shares of its Class A common stock through a firm commitment, underwritten public offering at a price to the public of $15.09per share. As a result of the offering, Ironwood received aggregate net proceeds, after underwriting discounts and commissions and other estimated offering expenses, of approximately $85 million. Ironwood intends to use these proceeds for general corporate purposes, including to fund expenses related to the expected market launch of linaclotide (if approved).
In February, the
Massachusetts Life Sciences Centerawarded Ironwood tax incentives of $1.8 millionbased upon Ironwood's plan to increase its Massachusetts-based employees by 75 by the end of 2012.
Conference Call Information
Ironwood will host a conference call and webcast at
Linaclotide, an investigational drug, is an agonist of the guanylate
cyclase type-C (GC-C) receptor located on the luminal surface of the
intestine. In preclinical models, linaclotide reduced visceral
hypersensitivity, increased fluid secretion, and accelerated intestinal
transit. The effects on secretion and transit are mediated through
cyclic guanosine monophosphate (cGMP), which is also believed to
modulate the activity of local nerves to reduce pain. Linaclotide is an
orally delivered peptide that acts locally in the gut with no measurable
systemic exposure at therapeutic doses and is intended for once-daily
administration. An issued composition of matter patent for linaclotide
provides protection to 2025 in
About Irritable Bowel Syndrome with Constipation (IBS-C)
IBS-C is a chronic functional gastrointestinal disorder characterized by abdominal pain, abdominal discomfort, and bloating associated with altered bowel habits, and as many as 11 million people in the U.S. suffer from it. IBS-C can have a negative impact on daily living. There are currently few available therapies to treat this disorder.
About Chronic Constipation (CC)
As many as 34 million Americans suffer from symptoms associated with CC and 8.5 million patients have sought treatment. Patients with CC often experience hard and lumpy stools, straining during defecation, a sensation of incomplete evacuation, and fewer than three bowel movements per week, as well as abdominal discomfort and bloating. There is a high rate of dissatisfaction with currently available treatments for CC.
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, the FDA PDUFA target action
date, linaclotide's potential as a treatment for IBS-C or chronic
constipation, the potential clinical trials for IW-2143 and Ironwood's
obligations to make milestone payments and royalties if products
incorporating IW-2143 are successfully developed or commercialized, the
anticipated use of proceeds from Ironwood's recent equity offering, and
the plan to increase
Condensed Consolidated Balance Sheets
|Cash, cash equivalents and available-for-sale securities||$||164,016||$||248,027|
|Accounts receivable, net||652||2,895|
|Prepaid expenses and other current assets||2,899||8,153|
|Total current assets||167,567||259,075|
|Property and equipment, net||33,625||34,369|
|Liabilities and Stockholders' Equity|
|Accounts payable and accrued expenses||$||24,568||$||21,380|
|Current portion of capital lease obligations||233||197|
|Current portion of deferred rent||4,042||2,799|
|Current portion of deferred revenue||36,291||40,050|
|Total current liabilities||65,134||64,426|
|Capital lease obligations||422||393|
|Total stockholders' equity||109,856||159,551|
|Total liabilities and stockholders' equity||$||208,977||$||301,365|
Condensed Consolidated Statements of Operations
(in thousands, except share and per share amounts)
Three Months Ended
|Research and development||24,224||21,266||86,093||77,454|
|General and administrative||14,962||8,301||45,920||27,169|
|Total operating expenses||39,186||29,567||132,013||104,623|
|Loss from operations||(7,032||)||(12,795||)||(66,142||)||(60,766||)|
|Other income (expense), net||58||1,144||1,293||1,411|
Net loss from continuing operations before
|Income tax expense (benefit)||—||—||3||(2,944||)|
|Net loss from continuing operations||(6,974||)||(11,651||)||(64,852||)||(56,411||)|
|Net income from discontinued operations||—||—||—||4,551|
Net income from discontinued operations
Net loss attributable to Ironwood
Net income (loss) per share attributable to
|Net loss per share||$||(0.07||)||$||(0.12||)||$||(0.65||)||$||(0.59||)|
Weighted average number of common shares
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