CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its
fourth quarter 2011 and recent business activities.
"During 2011, we were focused on preparing linaclotide for successful
regulatory submissions in the U.S. and Europe, and we continue to put
all of the elements in place for a successful product launch while these
submissions are under review, including our recent capital raise of $85
million to strengthen our balance sheet," said Michael Higgins,
Ironwood's chief operating officer and chief financial officer. "We
believe that linaclotide's product profile is highly appealing for both
therapy-seeking patients and physicians and we are committed to a
successful product launch, if approved."
Fourth Quarter and Recent Highlights
Linaclotide
-
On 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 FDA in 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 Diego from May 19—22, 2012. One
abstract will be discussed in an oral presentation and 13 will be made
available through poster presentations.
Pipeline
-
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.
-
In 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 million in research
funding and milestone payments, which includes an initial payment of
$3 million.
Corporate
-
Ironwood ended 2011 with approximately $164 million of cash, cash
equivalents, and available-for-sale securities. Ironwood used
approximately $75 million of net cash for operations for the year
ended December 31, 2011.
-
In 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 $15.09 per 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 Center awarded Ironwood
tax incentives of $1.8 million based 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 4:30 p.m. Eastern
Time today to discuss its business activities, including its commercial
strategy for linaclotide. Individuals interested in participating in the
call should dial (888) 208-1812 (U.S. and Canada) or (719) 457-2702
(international) using conference ID number 3679648. To access the
webcast, please visit the Investors section of Ironwood's website at www.ironwoodpharma.com
at least 15 minutes prior to the start of the call to ensure adequate
time for any software downloads that may be required. The call will be
available for replay via telephone starting today at approximately 7:30
p.m. Eastern Time, running through 11:59 p.m. Eastern Time on March 13,
2012. To listen to the replay, dial (888) 203-1112 (U.S. and Canada) or
(719) 457-0820 (international) using conference ID number 3679648. The
archived webcast will be available on Ironwood's website for 14 days
beginning approximately one hour after the call.
About Linaclotide
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 the United States. Ironwood and Forest
plan to co-promote linaclotide in the United States. Ironwood has
out-licensed linaclotide to Almirall for European development and
commercialization, and to Astellas Pharma Inc. for development and
commercialization in Japan, Indonesia, Korea, the Philippines, Taiwan,
and Thailand.
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.
About Ironwood Pharmaceuticals
Ironwood Pharmaceuticals (NASDAQ: IRWD) is an entrepreneurial
pharmaceutical company dedicated to the art and science of great
drugmaking. Linaclotide, Ironwood's GC-C agonist, is an investigational
drug for the treatment of irritable bowel syndrome with constipation
(IBS-C) and chronic constipation (CC). The efficacy portion of
linaclotide's development program has been completed and supports the
recently submitted NDA submission for both indications, as well as the
MAA submission in Europe for the IBS-C indication. Ironwood also has a
growing pipeline of additional drug candidates in earlier stages of
development. Ironwood is located in Cambridge, Mass. To learn more,
visit www.ironwoodpharma.com.
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 Massachusetts-based employees in 2012. 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 risks that serious adverse events arise in patients that are deemed
to be definitely or probably related to linaclotide treatment, the
incidence or severity of diarrhea in patients treated with linaclotide
is higher than expected, the FDA recommends modifications to the
proposed label for linaclotide or issues a complete response letter for
linaclotide, the goals of the Bionomics collaboration are never
satisfied or take longer than anticipated to achieve, Ironwood chooses
not to develop or commercialize a product incorporating IW-2143,
advancements in our development pipeline do not proceed as expected,
Ironwood chooses to apply the proceeds from its recent equity offering
in a different manner, and we are unable to or choose not to hire
additional employees at the anticipated rate, as well as risks related
to the difficulty of predicting regulatory approvals and the acceptance
of and demand for new pharmaceutical products. Applicable risks also
include those that are listed in our Quarterly Report on Form 10-Q for
the quarter ended September 30, 2011, in addition to the risk factors
that are listed from time to time in Ironwood Pharmaceuticals' Annual
Reports on Form 10-K, Quarterly Reports on Form 10-Q, and any subsequent
SEC filings. We undertake no obligation to update these forward-looking
statements to reflect events or circumstances occurring after this press
release. These forward-looking statements speak only as of the date of
this press release. All forward-looking statements are qualified in
their entirety by this cautionary statement.
|
Condensed Consolidated Balance Sheets
(in thousands)
(unaudited)
|
|
|
|
|
December 31,
2011
|
|
|
|
December 31,
2010
|
Assets
|
|
|
|
|
|
|
|
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
|
Other assets
|
|
|
|
7,785
|
|
|
|
|
7,921
|
Total assets
|
|
|
$
|
208,977
|
|
|
|
$
|
301,365
|
|
|
|
|
|
|
|
|
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
|
Deferred rent
|
|
|
|
12,435
|
|
|
|
|
14,612
|
Deferred revenue
|
|
|
|
21,130
|
|
|
|
|
62,383
|
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)
(unaudited)
|
|
|
|
|
|
Three Months Ended
December 31,
|
|
|
|
Year Ended
December 31,
|
|
|
|
|
|
2011
|
|
|
|
2010
|
|
|
|
|
|
2011
|
|
|
|
2010
|
|
Revenue
|
|
|
|
$
|
32,154
|
|
|
$
|
16,772
|
|
|
|
|
$
|
65,871
|
|
|
$
|
43,857
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
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)
|
|
|
|
|
(6,974
|
)
|
|
|
(11,651
|
)
|
|
|
|
|
(64,849
|
)
|
|
|
(59,355
|
)
|
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 loss
|
|
|
|
|
(6,974
|
)
|
|
|
(11,651
|
)
|
|
|
|
|
(64,852
|
)
|
|
|
(51,860
|
)
|
Net income from discontinued operations attributable to
noncontrolling interest
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
(1,121
|
)
|
Net loss attributable to Ironwood Pharmaceuticals, Inc.
|
|
|
|
$
|
(6,974
|
)
|
|
$
|
(11,651
|
)
|
|
|
|
$
|
(64,852
|
)
|
|
$
|
(52,981
|
)
|
Net income (loss) per share attributable to Ironwood
Pharmaceuticals, Inc.—basic and diluted:
|
|
|
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
|
|
$
|
(0.07
|
)
|
|
$
|
(0.12
|
)
|
|
|
|
$
|
(0.65
|
)
|
|
$
|
(0.63
|
)
|
Discontinued operations
|
|
|
|
|
—
|
|
|
|
—
|
|
|
|
|
|
—
|
|
|
|
0.04
|
|
Net loss per share
|
|
|
|
$
|
(0.07
|
)
|
|
$
|
(0.12
|
)
|
|
|
|
$
|
(0.65
|
)
|
|
$
|
(0.59
|
)
|
Weighted average number of common shares used in net
income (loss) per share attributable to Ironwood
Pharmaceuticals, Inc.—basic and diluted
|
|
|
|
|
100,394,800
|
|
|
|
98,615,754
|
|
|
|
|
|
99,874,790
|
|
|
|
89,653,364
|
|
Corporate Inquiries:
Ironwood Pharmaceuticals
Susan
Brady, 617-621-8304
[email protected]
Source: Ironwood Pharmaceuticals, Inc.
News Provided by Acquire Media