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Exhibit 99.1

 

GRAPHIC

GRAPHIC

 

FOR IMMEDIATE RELEASE

 

IRONWOOD PHARMACEUTICALS PROVIDES

SECOND QUARTER 2012 INVESTOR UPDATE

 

CAMBRIDGE, Mass., July 17, 2012 — Ironwood Pharmaceuticals, Inc. (NASDAQ: IRWD) today provided an update on its second quarter 2012 and recent business activities.

 

Second Quarter 2012 and Recent Highlights

 

Linaclotide

 

·                  In April, the U.S. Food and Drug Administration (FDA) notified Ironwood and Forest Laboratories, Inc. that it will require a three-month extension to complete its review of the data supporting the New Drug Application (NDA) for linaclotide for the treatment of irritable bowel syndrome with constipation (IBS-C) and chronic constipation (CC).  FDA action has been extended to September 2012.  Ironwood and Forest continue to plan for a 2012 launch.

 

·                  Ironwood and Forest presented linaclotide-related data in one oral presentation and sixteen poster presentations at the 2012 Digestive Disease Week (DDW) annual meeting held in San Diego from May 19-22, 2012. Included in these presentations were data about the effect of linaclotide on abdominal pain and other symptoms in Phase 3 clinical trials involving patients with IBS- C.

 

·                  Ironwood submitted a Clinical Trial Application (CTA) to China’s State Food and Drug Administration for a Phase 3 trial of linaclotide in patients with IBS-C. The CTA has been accepted for review.

 

·                  As part of the strategy to maximize the utility of linaclotide over time, Ironwood and Forest have initiated a Phase 3b clinical trial to further characterize the effect of linaclotide on abdominal symptoms in patients with chronic constipation.

 

Research & Development

 

·                  Ironwood continues to advance its pipeline, which includes early development candidates and discovery research efforts focused on gastrointestinal disease, central nervous system disorders, respiratory disease, and cardiovascular disease.

 

GRAPHIC

 



 

Corporate

 

·                  Ironwood ended the second quarter of 2012 with approximately $158 million of cash, cash equivalents, and available-for-sale securities. Ironwood used approximately $93 million of cash for operations during the six months ended June 30, 2012.

 

Conference Call Information

 

Ironwood will host a conference call and webcast at 8:30 a.m. Eastern Time, July 17, to discuss its second quarter 2012 and recent business activities. Individuals interested in participating in the call should dial (877) 643-7155 (U.S. and Canada) or (914) 495-8552 (international) using conference ID number 98056073. 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 11:30 a.m. Eastern Time, running through 11:59 p.m. Eastern Time on July 31, 2012. To listen to the replay, dial (855) 859-2056 (U.S. and Canada) or (404) 537-3406 (international) using conference ID number 98056073. 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 a guanylate cyclase-C agonist (GCCA). 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 guanylate cyclase-C agonist (GCCA), 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 submitted NDA 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’s target action date, our development plans for linaclotide in China, and linaclotide’s potential as a treatment for IBS-C or CC. 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 the FDA further extends its review of the linaclotide NDA, 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 issues a complete response letter for linaclotide, China’s State Food and Drug Administration does not grant our request for a Phase 3 clinical trial or we choose not to perform a clinical trial in China, 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 Ironwood Pharmaceuticals’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2012, 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.

 

SOURCE: Ironwood Pharmaceuticals, Inc.

 

Ironwood Pharmaceuticals, Inc.
Media Relations

Lisa Buffington, 617-374-5103

Vice President, Corporate Communications
lbuffington@ironwoodpharma.com

 

Investor Relations

Meredith Kaya, 617-374-5082

Associate Director, Investor Relations

mkaya@ironwoodpharma.com

 



 

Condensed Consolidated Balance Sheets

 

(in thousands)

(unaudited)

 

 

 

June 30,
2012

 

December 31,
2011

 

Assets

 

 

 

 

 

Cash, cash equivalents and available-for-sale securities

 

$

157,653

 

$

164,016

 

Accounts receivable, net

 

2,466

 

652

 

Prepaid expenses and other assets

 

5,964

 

2,899

 

Total current assets

 

166,083

 

167,567

 

Property and equipment, net

 

34,859

 

33,625

 

Other assets

 

7,721

 

7,785

 

Total assets

 

$

208,663

 

$

208,977

 

 

 

 

 

 

 

Liabilities and Stockholders’ Equity

 

 

 

 

 

Accounts payable, net and accrued expenses

 

$

30,749

 

$

24,568

 

Current portion of capital lease obligations

 

277

 

233

 

Current portion of deferred rent

 

4,517

 

4,042

 

Current portion of deferred revenue

 

13,578

 

36,291

 

Total current liabilities

 

49,121

 

65,134

 

Capital lease obligations

 

364

 

422

 

Deferred rent

 

10,832

 

12,435

 

Deferred revenue

 

19,565

 

21,130

 

Total stockholders’ equity

 

128,781

 

109,856

 

Total liabilities and stockholders’ equity

 

$

208,663

 

$

208,977

 

 



 

Condensed Consolidated Statements of Operations

 

(in thousands, except share and per share amounts)

(unaudited)

 

 

 

Three Months Ended
June 30,

 

Six Months Ended
June 30,

 

 

 

2012

 

2011

 

2012

 

2011

 

Revenue

 

$

14,604

 

$

11,262

 

$

26,852

 

$

21,499

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

32,238

 

19,409

 

61,748

 

38,964

 

General and administrative

 

23,200

 

10,805

 

41,574

 

20,029

 

Total operating expenses

 

55,438

 

30,214

 

103,322

 

58,993

 

Loss from operations

 

(40,834

)

(18,952

)

(76,470

)

(37,494

)

Other income (expense), net

 

31

 

108

 

66

 

249

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

$

(40,803

)

$

(18,844

)

$

(76,404

)

$

(37,245

)

 

 

 

 

 

 

 

 

 

 

Net loss per share—basic and diluted

 

$

(0.38

)

$

(0.19

)

$

(0.73

)

$

(0.37

)

Weighted average number of common shares used in net loss per share —basic and diluted

 

107,078,150

 

99,674,969

 

105,414,607

 

99,458,336