AKELA Pharma Reports Third Quarter 2009 Financial and Operating Results |
Austin, Texas, November 16, 2009 – Akela Pharma Inc. (TSX: AKL), and its wholly owned subsidiary, PharmaForm, today announced financial results for the three and nine months ended September 30, 2009. The company also highlighted several recent operational achievements:
2009 Third Quarter Operational Highlights
- Akela announced a change in leadership with the appointment of Greg McKee to the position of president and chief executive officer and Robert Rieder to the position of chairman of the board of directors. Both Mr. McKee and Mr. Rieder join the company as a result of Akela’s acquisition of Nventa Biopharmaceuticals Corporation in May 2009.
- Akela announced a comprehensive corporate restructuring designed to achieve several operational objectives. In an effort to preserve resources essential to Akela’s Fentanyl TAIFUN® program, and to optimize the infrastructure required to support its PharmaForm clients, the company reduced its head count by 32 employees to a workforce of 65. Akela’s operational headquarters have been centralized in Austin, Texas, and several of the company’s international operations are in the process of being closed.
- Subsequent to the end of the third quarter, Akela and PharmaForm announced the addition of aqueous and solvent spray drying to its portfolio of bioavailability enhancement solutions. A widely used processing technology, spray drying offers a number of benefits to optimize drug formulation, including enhanced bioavailability of poorly soluble compounds, higher drug loading and predictable scale-up. In addition to the new spray drying capability, PharmaForm’s comprehensive bioavailability enhancement technologies include hot-melt extrusion, solvent-based fluid bed processing and liquid filled hard capsules.
2009 Third Quarter Financial Highlights
Total consolidated revenues for the third quarter of 2009 were $3.1 million, including $2.2 million of contract services, as compared to $4.2 million, including $3.4 million of contract services, for the same period during the previous year. Revenues during the third quarter of 2009 were adversely impacted by the limited ability of our clients in the pharmaceutical and biotech industry to secure funding. Over the last several months business development has been restructured and expanded. Direct sales and marketing efforts have diversified our client portfolio, fostered collaborative ventures with other pharmaceutical companies and have focused on securing longer term supply arrangements with some of our larger existing and potential customers.
Consolidated net loss for the third quarter of 2009 was $3.2 million, or ($0.10) per share, versus $3.9 million, or ($0.18) per share, for the third quarter of 2008. Results for the current quarter reflect a $0.5 million charge associated with Akela’s recently announced corporate restructuring. Excluding this one time charge, Akela’s consolidated net loss was $2.7 million or ($0.09) per share.
The company had a cash balance of $0.8 million as of September 30, 2009 compared with $2.3 million as of December 31, 2008.
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. Akela’s pipeline also includes a growth hormone releasing hormone (GHRH), which is being developed for frailty and wasting in chronic renal disease.
Akela’s common shares trade on The Toronto Stock Exchange (“TSX”) under the symbol “AKL” with 30.9 million shares outstanding.
About PharmaForm:
PharmaForm, a wholly owned subsidiary of Akela Pharma Inc., is a leading specialty contract service provider in the area of pharmaceutical dosage form development and manufacturing, specializing in controlled release and bioavailability enhancement technologies, such as hot melt extrusion, liquid filled capsules, solvent-based fluid bed processing 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.
The audit committee of the company has reviewed and approved the contents of this press release. Summary financial statements are attached below. The full financial statements and MD&A for the nine months ended September 30, 2009 can be found on SEDAR at http://www.sedar.com.
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 trail 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.
For further information please contact:
Akela Pharma
Greg McKee
President and Chief Executive Officer
Tel: 512-834-0449
Vida Communication
Tim Brons (media)
415-675-7402
tbrons@vidacommunication.com
Stephanie Diaz (investors)
415-675-7401
mailto:sdiaz@vidacommunication.com
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