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AKELA PHARMA REPORTS RESULTS FOR THE THIRD QUARTER OF FISCAL 2010

^{Published on 2010-11-15 04:05:45 - Market Wire}
 

AUSTIN, TX, Nov. 15 /CNW/ - Akela Pharma, Inc. ("Akela"), (TSX: AKL), a leader in the development of therapeutics for the treatment of pain, and the company's wholly owned subsidiary, PharmaForm, today announced its financial results for the three and nine months ended September 30, 2010.

Akela's net income for the three months ending September 30, 2010 was $0.1 million, as compared to a net loss of $3.2 million, for the same period in 2009. 

2010 Third Quarter Financial Highlights

• Consolidated net income for the third quarter of 2010 was $0.1 million, or nil per share, versus a consolidated net loss of $3.2 million, or ($0.10) per share, for the third quarter of 2009. 
• Total consolidated revenues for the third quarter of 2010 were $4.0 million, including $3.1 million of contract services, as compared to $3.1 million, including $2.2 million of contract services, for the same period during the previous year. 
• Consolidated results for the third quarter of 2010 and 2009 include $0.8 million and $0.9 million in non-cash unrealized foreign exchange losses, respectively. The third quarter of 2009 also reflects $0.5 million in restructuring charges. Excluding the effects of non-cash unrealized foreign exchange losses and restructuring charges, Akela's consolidated net income for the third quarter of 2010 was $0.9 million or $0.03 per share as compared to a loss of $1.8 million or ($0.06) per share for the third quarter of 2009.

2010 Third Quarter Operational Highlights

• On August 6, 2010 the Company received a $1.8 million milestone payment for achieving a near term development milestone of the Fentanyl TAIFUN® inhaler. The milestone payment from Teikoku Seiyaku Co. Ltd., was made under our Fentanyl TAIFUN® license and co-development agreement.
• Direct costs declined to $1.3 million for the three months ended September 30, 2010 from $2.8 million during the previous year primarily as a result of the Company's restructuring initiatives started in 2009.
• During the third quarter of 2010, the Company achieved positive cash flow from operations of approximately $1.9 million. 
• During the nine months ended September 30, 2010, management's cost containment and debt reduction efforts have affected a $1.3 million reduction in the Company's total outstanding liabilities.

Other Highlights

• On October 29, 2010, Akela was awarded through the United States Qualifying Therapeutic Discovery Grant Program federal grants of $0.5 million toward the continuation of Akela's research and development programs.

About Akela Pharma Inc.

Akela Pharma is a drug development company with its lead product, Fentanyl TAIFUN®, being developed for the treatment of breakthrough cancer pain. Fentanyl TAIFUN® is a fast-acting fentanyl formulation delivered using the company's TAIFUN® multi-dose dry powder inhaler platform.

About PharmaForm

PharmaForm, Akela's wholly owned subsidiary, is a leading specialty contract service provider in the area of pharmaceutical dosage form development and clinical and small scale commercial manufacturing, specializing in controlled release and bioavailability enhancement technologies, such as hot melt extrusion, liquid filled capsules, and spray drying. Through its diverse offerings, PharmaForm solutions help pharmaceutical and biotechnology clients reach their development targets, reduce development costs and accelerate time-to-market.

Akela's common shares trade on The Toronto Stock Exchange ("TSX") under the symbol "AKL" with 32 million shares outstanding.

This press release contains statements which may constitute forward-looking information under applicable Canadian securities legislation or forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1955. Such forward-looking statements or information may include financial and other projections as well as statements regarding the company's future plans, objectives, performance, revenues, growth, profits, operating expenses or the company's underlying assumptions. The words "may", "would", "could", "will", "likely", "expect", anticipate", "intend", "plan", "forecast", "project", "estimate" and "believe" or other similar words and phrases may identify forward-looking statements or information. Persons reading this press release are cautioned that such statements or information are only expectations, and that the company's actual future results or performance may be materially different.

Forward-looking statements or information in this press release include, but are not limited to, statements or information concerning our ongoing drug development programs and collaborations as well as the possible receipt of future payments upon achievement of milestones.

Such forward-looking statements or information involve known and unknown risks, uncertainties and other factors that may cause our actual results, events or developments to be materially different from results, events or developments expressed or implied by such forward-looking statements or information. Such factors include, among others, the possibility that risks associated with requirements for approvals by government agencies such as the FDA before products can be tested in clinical trials; the possibility that such government agency approvals will not be obtained in a timely manner or at all or will be conditioned in a manner that would impair our ability to advance development; risks associated with the requirement that a drug candidate be found safe and effective after extensive clinical trials; our dependence on suppliers, collaborative partners and other third parties and the prospects and timing for negotiating supply agreements, corporate collaborations or licensing arrangements; our ability to attract and retain key personnel; and other factors as described in detail in our filings with the Canadian securities regulatory authorities at [ http:www.sedar.com ].

Assumptions underlying our expectations regarding forward-looking statements or information contained in this press release include, among others, that future clinical trial results will be favorable; that our drug candidate will treat target diseases as intended; that we will raise enough capital, on reasonable terms and in a timely manner; that we will retain our key personnel; that we will obtain the necessary regulatory approvals.

In the event that any of these assumptions prove to be incorrect, or in the event that we are impacted by any of the risks identified above, we may not be able to continue in our business as planned.

For a complete discussion of the assumptions, risks and uncertainties related to our business, you are encouraged to review our filings with Canadian securities regulatory authorities, filed on SEDAR at [ http://www.sedar.com ].

All forward-looking statements and information made herein are based on our current expectations as of the date hereof and we disclaim any intention or obligation to revise or update such forward-looking statements and information to reflect subsequent events or circumstances, except as required by law.

AKELA PHARMA INC.
Consolidated Balance Sheets
(Unaudited)

September 30, 2010 and December 31, 2009
(in thousands of US dollars)

AKELA PHARMA INC.
Consolidated Statements of Operations and Comprehensive Loss
(Unaudited)

Periods ended September 30, 2010 and 2009
(in thousands of US dollars, except share and per share data unless otherwise noted)

AKELA PHARMA INC.
Consolidated Statements of Cash Flows
(Unaudited)

Periods ended September 30, 2010 and 2009
(in thousands of US dollars)

%SEDAR: 00003466E