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Adolor Corporation Reports Second Quarter 2008 Financial Results

2008-08-05 15:43:00

Adolor Corporation Reports Second Quarter 2008 Financial Results

EXTON, Pa.–(EMWNews)–Adolor Corporation (Nasdaq:ADLR) today reported financial results for

the three and six months ended June 30, 2008.

For the three-month period ended June 30, 2008, the company reported net

income of $7.5 million, or $0.16 per basic and diluted share, compared

to a net loss of $11.6 million, or $0.25 per basic and diluted share,

for the same period in 2007. For the six-month period ended June 30,

2008, the company reported a net loss of $1.6 million, or $0.03 per

basic and diluted share, compared to a net loss of $24.8 million, or

$0.54 per basic and diluted share, for the same period in 2007. Results

for 2008 were favorably impacted by the receipt of a $20.0 million

milestone payment from Glaxo Group Limited (Glaxo), which was earned

upon approval of Entereg® (alvimopan) by the

U. S. Food and Drug Administration (FDA) in the second quarter of 2008.

The second quarter was highlighted by the FDA

approval of Entereg for the management of postoperative ileus in bowel

resection patients, said Michael R.

Dougherty, president and chief executive officer of Adolor Corporation. We

are delighted with the initial interest of the hospital community in

Entereg, and the receptivity to the E.A.S.E.

Program, with over 600 hospitals registered to date.

Mr. Dougherty continued, Following a

productive meeting with the FDA in June, we were pleased to announce

that the FDA lifted the clinical hold on the development of Entereg for

opioid bowel dysfunction. We await GSKs

determination as to their continued involvement in the program. There

remains a large, unmet need in treatment options for the many patients

suffering from this debilitating condition.

Contract revenues were $27.0 million and $1.8 million for the three

months ended June 30, 2008 and 2007, respectively, and were $33.2

million and $3.6 million for the six months ended June 30, 2008 and

2007, respectively. The increase in contract revenues for the

three-month and six-month periods ended June 30, 2008 was due primarily

to the $20.0 million milestone payment upon FDA approval of Entereg and

the inclusion of contract revenues from our collaboration with Pfizer,

Inc.

Research and development expenses were $13.3 million and $9.9 million

for the three months ended June 30, 2008 and 2007, respectively, and

were $24.7 million and $21.5 million for the six months ended June 30,

2008 and 2007, respectively. The increase in expenses for the

three-month and six-month periods ended June 30, 2008 was principally

related to increased development and clinical trial expenses under the

Delta program and other research programs.

Marketing, general and administrative expenses were $7.2 million and

$5.5 million for the three months ended June 30, 2008 and 2007,

respectively, and were $12.8 million and $11.3 million for the six

months ended June 30, 2008 and 2007, respectively. Marketing, general

and administrative expense increases were principally the result of

increased expenses associated with the launch of Entereg.

As of June 30, 2008, the Company had $161.3 million in cash, cash

equivalents and short-term investments.

About Adolor Corporation

Adolor Corporation (Nasdaq:ADLR) is a biopharmaceutical company

specializing in the discovery, development and commercialization of

novel prescription pain management products. By applying its knowledge

and expertise in pain management, along with ingenuity, Adolor is

seeking to make a positive difference for patients, caregivers and the

medical community. For more information, visit www.adolor.com.

This release and oral statements made with respect to information

contained in this release, may constitute forward-looking statements

within the meaning of the Private Securities Litigation Reform Act of

1995. Such forward-looking statements include those which express

plan, anticipation, intent, contingency, goals, targets or future

development and/or otherwise are not statements of historical fact. These

statements are based upon management’s current expectations and are

subject to risks and uncertainties, known and unknown, which could cause

actual results and developments to differ materially from those

expressed or implied in such statements. Such known risks and

uncertainties relate to, among other factors: the risk that hospitals

even though registered in the E.A.S.E. Program do not order ENTEREG; the

risk that ENTEREG may not be a commercial success; the

uncertainty of market acceptance of ENTEREG, including acceptance by

hospitals, physicians, payors or the medical community; the risk that

the Risk Evaluation and Mitigation Strategy or REMS, including the

registration of hospitals could materially adversely affect the

commercial prospects for ENTEREG or negatively impact the uptake of

ENTEREG; the risks associated with government regulations relating to

marketing and selling pharmaceutical products; the risk of product

liability claims; the risks of reliance on third party manufacturers;

the risk of competitive products; the risk that Glaxo terminates the

collaboration agreement with respect to OBD; the risk that a protocol in

OBD is not submitted to the FDA; the risk that clinical development of

alvimopan in OBD does not continue; the risk that ENTEREG may not be

approved in OBD or any indication other than the FDA approved indication

in bowel resection surgery; the risk that filing targets for regulatory

submissions are not met; the risk that the results of other clinical

trials of Adolor’s drug products and drug product candidates, including

ENTEREG, are not positive or do not support safety or efficacy; the

costs, delays and uncertainties inherent in scientific research, drug

development, clinical trials and the regulatory approval process; the

changing regulatory environment; risks associated with intellectual

property protection for Adolors products and

third party intellectual property; Adolor’s history of operating losses

since inception and its need for additional funds to operate its

business; Adolor’s reliance on its collaborators, including Glaxo, in

connection with the development and commercialization of ENTEREG; market

acceptance of Adolor’s products, if regulatory approval is achieved;

competition; and securities litigation.

Further information about these and other relevant risks and

uncertainties may be found in Adolor’s Reports on Form 8-K, 10-Q and

10-K filed with the U.S. Securities and Exchange Commission. Adolor

urges you to carefully review and consider the disclosures found in its

filings which are available in the SEC EDGAR database at http://www.sec.gov

and from Adolor at http://www.adolor.com.

Given the uncertainties affecting pharmaceutical companies in the

development stage, you are cautioned not to place undue reliance on any

such forward-looking statements, any of which may turn out to be wrong

due to inaccurate assumptions, unknown risks, uncertainties or other

factors. Adolor undertakes no obligation to (and expressly

disclaims any such obligation to) publicly update or revise the

statements made herein or the risk factors that may relate thereto

whether as a result of new information, future events, or otherwise.

This press release is available on the website http://www.adolor.com.

[Financial data table follows]

ADOLOR CORPORATION

STATEMENTS OF OPERATIONS DATA

(Unaudited)

 

 

THREE MONTHS
ENDED JUNE 30,

SIX MONTHS
ENDED JUNE 30,

 

2008

 

2007

2008

 

2007

 

REVENUES

Contract revenues

$ 26,964,318

$ 1,805,619

$ 33,175,342

$ 3,626,622

 

OPERATING EXPENSES

Research and development

13,262,176

9,935,998

24,683,248

21,509,015

Marketing, general and administrative

7,224,664

5,524,812

12,773,194

11,342,114

 

Total operating expenses

20,486,840

15,460,810

37,456,442

32,851,129

 

Income (loss) from operations

6,477,478

(13,655,191)

(4,281,100)

(29,224,507)

Interest income and other, net

1,008,015

2,060,521

2,711,034

4,421,386

Net income (loss)

$7,485,493

($11,594,670)

($1,570,066)

($24,803,121)

 

Basic net income (loss) per share

$0.16

($0.25)

($0.03)

($0.54)

 

Diluted net income (loss) per share

$0.16

($0.25)

($0.03)

($0.54)

 

 

 

BALANCE SHEET DATA

(Unaudited)

 

JUNE 30,
2008

 

DECEMBER 31,
2007

 

Cash, cash equivalents and short-term investments

$ 161,312,665

$ 167,189,499

Working capital

141,366,954

147,543,363

Total assets

172,352,959

178,676,652

Total stockholders’ equity

114,119,136

112,353,478

Adolor Corporation
Stephen W. Webster
Senior

Vice President, Finance and CFO
484-595-1500
or
Sam

Brown, Inc. (media)
Mike Beyer, 773-463-4211

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Blake Masterson

Freelance Writer, Journalist and Father of 5

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