CAMBRIDGE, Mass.--(BUSINESS WIRE)--
Ironwood
Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its
third quarter 2011 and recent business activities.
Third Quarter 2011 and Recent Highlights
Linaclotide
-
At the end of September, Ironwood's European partner, Almirall, S.A.,
submitted a Market Authorization Application (MAA) for linaclotide to
the European Medicines Agency (EMA) for the treatment of irritable
bowel syndrome with constipation (IBS-C). The submission includes
efficacy and safety data from a Phase 3 program that comprised two
double-blind placebo-controlled clinical trials measured against the
endpoints required by the EMA and two open-label long-term safety
studies. A total of more than 1,600 patients with IBS-C received a
once-daily dose of either linaclotide or placebo across the two Phase
3 clinical trials. Additionally, over 3,200 patients have enrolled in
the ongoing open-label long term safety studies, and more than 2,000
of those patients have received linaclotide for at least 12 months.
-
In October, the U.S. Food and Drug Administration (FDA) accepted for
review the New Drug Application (NDA) submitted by Ironwood and its
U.S. partner, Forest Laboratories, Inc., for linaclotide for the
treatment of IBS-C and chronic constipation (CC). With a standard
10-month review timeline, the FDA Prescription Drug User Fee Act
(PDUFA) target action date is expected to occur in June 2012.
Pipeline
-
Ironwood continues to advance its pipeline, which includes product
candidates and research efforts focused on gastrointestinal disease,
pain and inflammation, respiratory disease, and cardiovascular disease.
Corporate
-
Ironwood ended the third quarter of 2011 with approximately $175
million of cash, cash equivalents, and available-for-sale securities.
Ironwood used approximately $68 million of cash for operations for the
nine months ended September 30, 2011. Based on its current operating
plan, Ironwood continues to target ending fiscal year 2011 with
greater than $150 million of cash, cash equivalents, and
available-for-sale securities.
Conference Call Information
Ironwood will host a conference call and webcast at 4:30 p.m. Eastern
Time, November 7, to discuss its business activities, including its
commercial strategy for linaclotide. Individuals interested in
participating in the call should dial (888) 663-2242 (U.S. and Canada)
or (913) 312-1516 (international) using conference ID number 3637845. 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 November
21, 2011. To listen to the replay, dial (888) 203-1112 (U.S. and Canada)
or (719) 457-0820 (international) using conference ID number 3637845.
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, and our targeted cash-on-hand for the end of 2011. 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 convenes an advisory committee that
does not recommend approval of linaclotide or that recommends
modifications to the proposed label for linaclotide, the FDA issues a
complete response letter for linaclotide, and advancements in our
development pipeline do not proceed as expected, 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 June 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.
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|
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Condensed Consolidated Balance Sheets
|
|
|
|
(in thousands)
|
|
(unaudited)
|
|
|
|
|
|
|
|
|
|
September 30,
2011
|
|
December 31,
2010
|
|
Assets
|
|
|
|
|
|
Cash, cash equivalents and available-for-sale securities
|
|
$
|
175,129
|
|
$
|
248,027
|
|
Accounts receivable, net
|
|
|
741
|
|
|
2,895
|
|
Prepaid expenses and other assets
|
|
|
2,896
|
|
|
8,153
|
|
Total current assets
|
|
|
178,766
|
|
|
259,075
|
|
Property and equipment, net
|
|
|
32,875
|
|
|
34,369
|
|
Other assets
|
|
|
7,839
|
|
|
7,921
|
|
Total assets
|
|
$
|
219,480
|
|
$
|
301,365
|
|
|
|
|
|
|
|
Liabilities and Stockholders' Equity
|
|
|
|
|
|
Accounts payable and accrued expenses
|
|
$
|
19,266
|
|
$
|
21,380
|
|
Current portion of capital lease obligations
|
|
|
228
|
|
|
197
|
|
Current portion of deferred rent
|
|
|
3,707
|
|
|
2,799
|
|
Current portion of deferred revenue
|
|
|
47,647
|
|
|
40,050
|
|
Total current liabilities
|
|
|
70,848
|
|
|
64,426
|
|
Capital lease obligations
|
|
|
481
|
|
|
393
|
|
Deferred rent
|
|
|
13,308
|
|
|
14,612
|
|
Deferred revenue
|
|
|
21,913
|
|
|
62,383
|
|
Total stockholders' equity
|
|
|
112,930
|
|
|
159,551
|
|
Total liabilities and stockholders' equity
|
|
$
|
219,480
|
|
$
|
301,365
|
|
|
|
|
|
Condensed Consolidated Statements of Operations
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(in thousands, except share and per share amounts)
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(unaudited)
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|
|
|
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Three Months Ended
September 30,
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Nine Months Ended
September 30,
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2011
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2010
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|
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2011
|
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|
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2010
|
|
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Revenue
|
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$
|
12,218
|
|
|
$
|
9,059
|
|
|
$
|
33,717
|
|
|
$
|
27,085
|
|
|
Operating expenses:
|
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|
|
|
|
|
|
|
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Research and development
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|
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22,905
|
|
|
|
18,742
|
|
|
|
61,869
|
|
|
|
56,188
|
|
|
General and administrative
|
|
|
10,929
|
|
|
|
6,482
|
|
|
|
30,958
|
|
|
|
18,868
|
|
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Total operating expenses
|
|
|
33,834
|
|
|
|
25,224
|
|
|
|
92,827
|
|
|
|
75,056
|
|
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Loss from operations
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|
|
(21,616
|
)
|
|
|
(16,165
|
)
|
|
|
(59,110
|
)
|
|
|
(47,971
|
)
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Other income (expense), net
|
|
|
986
|
|
|
|
107
|
|
|
|
1,235
|
|
|
|
267
|
|
|
Net loss from continuing operations before income tax expense
(benefit)
|
|
|
(20,630
|
)
|
|
|
(16,058
|
)
|
|
|
(57,875
|
)
|
|
|
(47,704
|
)
|
|
Income tax expense (benefit)
|
|
|
3
|
|
|
|
(2,944
|
)
|
|
|
3
|
|
|
|
(2,944
|
)
|
|
Net loss from continuing operations
|
|
|
(20,633
|
)
|
|
|
(13,114
|
)
|
|
|
(57,878
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)
|
|
|
(44,760
|
)
|
|
Net income from discontinued operations
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|
|
—
|
|
|
|
6,367
|
|
|
|
—
|
|
|
|
4,551
|
|
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Net loss
|
|
|
(20,633
|
)
|
|
|
(6,747
|
)
|
|
|
(57,878
|
)
|
|
|
(40,209
|
)
|
|
Net income from discontinued operations attributable to
noncontrolling interest
|
|
|
—
|
|
|
|
(1,523
|
)
|
|
|
—
|
|
|
|
(1,121
|
)
|
|
Net loss attributable to Ironwood
Pharmaceuticals, Inc.
|
|
$
|
(20,633
|
)
|
|
$
|
(8,270
|
)
|
|
$
|
(57,878
|
)
|
|
$
|
(41,330
|
)
|
|
Net income (loss) per share attributable to Ironwood
Pharmaceuticals, Inc.—basic and diluted:
|
|
|
|
|
|
|
|
|
|
Continuing operations
|
|
$
|
(0.21
|
)
|
|
$
|
(0.13
|
)
|
|
$
|
(0.58
|
)
|
|
$
|
(0.52
|
)
|
|
Discontinued operations
|
|
|
—
|
|
|
|
0.05
|
|
|
|
—
|
|
|
|
0.04
|
|
|
Net loss per share
|
|
$
|
(0.21
|
)
|
|
$
|
(0.08
|
)
|
|
$
|
(0.58
|
)
|
|
$
|
(0.48
|
)
|
|
Weighted average number of common shares used in net income (loss)
per share attributable to Ironwood Pharmaceuticals, Inc.—basic and
diluted
|
|
|
100,174,100
|
|
|
|
97,925,657
|
|
|
|
99,699,545
|
|
|
|
86,633,080
|
|
Corporate Inquiries:
Ironwood Pharmaceuticals
Susan
Brady, 617-621-8304
sbrady@ironwoodpharma.com
Source: Ironwood Pharmaceuticals, Inc.
News Provided by Acquire Media