EX-99.1 2 a06-7157_1ex99d1.htm EXHIBIT 99

Exhibit 99.1

 

1440 Davey Road
Woodridge, Ill. 60517
(Phone) 630.739.6744
(Fax) 630.739.6754
www.advancedlifesciences.com

 

For Immediate Release

Investor Relations Contact: Edward P. Flavin (630) 739-6744 Ex 211

 

Advanced Life Sciences Announces Fourth Quarter and Full Year 2005 Results.

 

WOODRIDGE, IL, March 14, 2005/PRNewswire/: — Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and inflammation, today announced its financial results for the fourth quarter and full year ended December 31, 2005. The net loss for the three months ended December 31, 2005 was $2.6 million or ($.15) per share compared to a net loss of $25.3 million or ($7.29) per share for the three months ended December 31, 2004. The net loss for the full year 2005 was $6.6 million or ($.49) per share compared to a net loss of $27.4 million or ($13.27) per share for 2004. The decrease in the net loss for both periods is due to the $24.5 million in-process research & development charge the Company took in the fourth quarter of 2004, reflecting its establishment of a license agreement with Abbott Laboratories for cethromycin.

 

Michael T. Flavin, Ph.D., chairman and chief executive officer of the Company, noted “Advanced Life Sciences continued to make excellent progress during 2005. We completed our IPO to provide the capital required to advance the clinical development of our lead product, cethromycin and we launched our pivotal phase III clinical trials for cethromycin in the fourth quarter. With the closing of our recent $33.6 million private financing, we have strengthened our financial position and broadened our shareholder base.”

 

The Company ended 2005 with cash, cash equivalents and investments totaling approximately $15.2 million.

 

Operating Expense Analysis 2005 versus 2004:

 

•                  Research and development expense. Total research and development expense decreased 88% to approximately $3.1 million for the twelve months ended December 31, 2005 from approximately $25.7 million for the twelve months ended December 31, 2004. The total expense realized in 2004 of $25.7 million includes an in-process research and development charge totaling approximately $24.5 million related to the cethromycin license. Excluding this non-recurring expense, total research and development expenditures increased by approximately $1.9 million in 2005.

 

•                  General and administrative expense. General and administrative expense increased 96% to approximately $3.2 million for the year ended December 31, 2005 from $1.6 million for the year ended December 31, 2004. Of the approximate $1.6 million increase in administrative expense, approximately $776,000 related to one-time stock option expense and compensation charges paid in connection with the completion of the Company’s IPO.

 

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2005 Operational and Financial Highlights:

 

Advanced Life Sciences is developing cethromycin, a novel once-a-day ketolide antibiotic, in response to the emerging antibiotic resistance observed in the treatment of community acquired pneumonia (CAP). Cethromycin has previously been tested by Abbott in approximately 3,800 human subjects during clinical trials, and the Company has initiated pivotal phase III clinical trials for the treatment of mild-to-moderate CAP.

 

Advanced Life Sciences completed the following activities in 2005:

 

•                  Launched pivotal phase III clinical trials with cethromycin in CAP

 

•                  Received FDA guidance regarding its cethromycin regulatory and development plan

 

•                  Established presence with key thought leaders in the infectious disease field at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) conference

 

•                  Engaged Quintiles as its clinical research organization for cethromycin clinical development

 

•                  Completed tablet manufacturing and clinical site distribution of cethromycin with Cardinal Health

 

•                  Elected Scott Meadow, an experienced healthcare financier, and Richard Reck, formerly a partner with KPMG, to its board of directors. Mr. Meadow was also elected as chairman of the board compensation committee, while Mr. Reck was elected chairman of the board audit committee

 

•                  Raised net proceeds of $28.7 million in its August, 2005 IPO.

 

Advanced Life Sciences recently raised net proceeds of approximately $33.6 million in a private placement in March, 2006. Additionally, the Company engaged Montridge, LLC, a financial healthcare investor relations firm, and continued a comprehensive IR program.

 

2006 Financial and Operational Guidance:

 

The Company anticipates the following upcoming milestones in the clinical development of cethromycin:

 

•                  Completion of pivotal phase III clinical trials in 2006

 

•                  Submission of NDA for the CAP indication in the first quarter of 2007

 

•                  Advancement of discussions with potential commercial partners for cethromycin.

 

Advanced Life Sciences expects to invest between $22 million and $25 million in the cethromycin program and supporting operations over 2006. The Company anticipates cash requirements of between $3.5 million and $4 million for first quarter 2006 operating activities. With the current cash on hand, the Company believes it has sufficient financial resources to complete the cethromycin clinical trial program in CAP and file its NDA with the FDA. Advanced Life Sciences is on track to initiate 200 clinical sites in the Northern and Southern Hemispheres to recruit 1,000 total subjects in its pivotal phase III CAP clinical trials for cethromycin during 2006.

 

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Conference Call Details:

 

Advanced Life Sciences will host a conference call and live webcast at 10:00 a.m. Eastern Time on Wednesday, March 15, 2006 to discuss the Company’s fourth quarter financial results.

 

The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of Advanced Life Sciences’ corporate website at www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 800-322-2803 (domestic) or 617-614-4925 (international). The passcode for the conference call is 38767589. A telephone replay of the call will also be available for 48 hours. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 53133563.

 

About Advanced Life Sciences

 

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and inflammation. The Company’s lead candidate, cethromycin, is a novel once-a-day ketolide antibiotic in late-stage clinical development for the treatment of respiratory tract infections including CAP.

 

Forward-Looking Statements

 

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements.  These risks and uncertainties include, among others, those relating to technology and product development, market acceptance, government regulation and regulatory approval processes, intellectual property rights and litigation, dependence on collaborative relationships, ability to obtain financing, competitive products, industry trends and other risks identified in Advanced Life Sciences’ filings with the Securities and Exchange Commission.  Advanced Life Sciences undertakes no obligation to update or alter these forward-looking statements as a result of new information, future events or otherwise.

 

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ADVANCED LIFE SCIENCES HOLDINGS, INC. AND SUBSIDIARY

(A Development Stage Company)

 

CONSOLIDATED BALANCE SHEETS

 

 

 

Year ended December 31,

 

 

 

2005

 

2004

 

ASSETS

 

 

 

 

 

 

 

 

 

 

 

CURRENT ASSETS:

 

 

 

 

 

Cash & cash equivalents

 

$

4,749,932

 

$

194,555

 

Investments - available for sale

 

10,475,000

 

—

 

Accounts receivable - related party

 

6,160

 

24,868

 

Clinical trials supplies

 

—

 

533,333

 

Prepaid insurance

 

362,241

 

—

 

Prepaid expenses and other

 

118,263

 

25,806

 

 

 

 

 

 

 

Total current assets

 

15,711,596

 

778,562

 

 

 

 

 

 

 

FURNITURE AND EQUIPMENT:

 

 

 

 

 

Furniture and fixtures

 

147,275

 

139,005

 

Laboratory equipment

 

142,928

 

142,928

 

Computer equipment

 

111,884

 

79,146

 

Leasehold improvements

 

40,646

 

40,646

 

Construction in-progress

 

75,887

 

—

 

 

 

 

 

 

 

Total furniture and equipment—at cost

 

518,620

 

401,725

 

Less accumulated depreciation

 

(267,372

)

(180,807

)

 

 

 

 

 

 

Furniture and equipment—net

 

251,248

 

220,918

 

 

 

 

 

 

 

OTHER LONG-TERM ASSETS:

 

 

 

 

 

Deferred financing costs

 

53,004

 

15,000

 

Other assets

 

6,062

 

1,452

 

 

 

 

 

 

 

Total other long-term assets

 

59,066

 

16,452

 

 

 

 

 

 

 

TOTAL ASSETS

 

$

16,021,910

 

$

1,015,932

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

 

 

 

CURRENT LIABILITIES:

 

 

 

 

 

Accounts payable

 

$

294,816

 

$

255,880

 

Accrued expenses

 

240,761

 

185,348

 

Accrued interest payable

 

5,334

 

4,319

 

Licenses payable

 

—

 

14,000,000

 

Notes payable, net of $11,766 debt discount

 

—

 

2,238,234

 

Short-term lease payable

 

14,114

 

12,070

 

 

 

 

 

 

 

Total current liabilities

 

555,025

 

16,695,851

 

 

 

 

 

 

 

Long-term lease payable

 

13,166

 

27,279

 

Accrued interest payable - related party

 

765,514

 

566,603

 

Grant payable

 

500,000

 

—

 

Notes payable - net of $22,532 debt discount

 

3,892,468

 

—

 

Notes payable - related party

 

2,000,000

 

2,000,000

 

 

 

 

 

 

 

Total liabilities

 

7,726,173

 

19,289,733

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY:

 

 

 

 

 

Common stock, $0.01 par value—December 31, 2005: 60,000,000 shares authorized;
17,990,322 issued and outstanding; December 31, 2004:
10,604,584 shares issued and outstanding;

 

179,903

 

106,046

 

Series A preferred stock of Advanced Life Sciences Inc., no par value—
250,000 shares authorized, issued and outstanding

 

—

 

—

 

Additional paid-in capital

 

54,834,373

 

21,894,446

 

Deficit accumulated during the development stage

 

(46,718,539

)

(40,274,293

)

 

 

 

 

 

 

Total stockholders’ equity (deficit)

 

8,295,737

 

(18,273,801

)

 

 

 

 

 

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY

 

$

16,021,910

 

$

1,015,932

 

 


 

CONSOLIDATED STATEMENTS OF OPERATIONS

 

 

 

Three months ended December 31,

 

Twelve months ended December 31,

 

 

 

2005

 

2004

 

2005

 

2004

 

 

 

 

 

 

 

 

 

 

 

Revenue and Other Income:

 

 

 

 

 

 

 

 

 

Management fees

 

$

8,358

 

$

61,824

 

$

61,239

 

$

271,644

 

Grant

 

60,212

 

 

 

60,212

 

38,136

 

Royalty—related party

 

—

 

—

 

—

 

10,000

 

 

 

 

 

 

 

 

 

 

 

Total revenue and other income

 

68,570

 

61,824

 

121,451

 

319,780

 

 

 

 

 

 

 

 

 

 

 

Expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

1,516,867

 

24,788,749

 

3,121,616

 

25,661,868

 

Selling, general and administrative

 

1,159,751

 

451,039

 

3,237,997

 

1,649,953

 

 

 

 

 

 

 

 

 

 

 

Total expenses

 

2,676,618

 

25,239,788

 

6,359,613

 

27,311,821

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

(2,608,048

)

(25,177,964

)

(6,238,162

)

(26,992,041

)

 

 

 

 

 

 

 

 

 

 

Interest income

 

(174,504

)

—

 

(272,216

)

—

 

Interest expense

 

138,126

 

52,354

 

478,300

 

194,877

 

 

 

 

 

 

 

 

 

 

 

Net other (income) expense

 

(36,378

)

52,354

 

206,084

 

194,877

 

 

 

 

 

 

 

 

 

 

 

Net loss

 

(2,571,670

)

(25,230,318

)

(6,444,246

)

(27,186,918

)

 

 

 

 

 

 

 

 

 

 

Less accumulated preferred dividends for the period

 

43,750

 

43,750

 

175,000

 

175,000

 

 

 

 

 

 

 

 

 

 

 

Net loss available to common shareholders

 

$

(2,615,420

)

$

(25,274,068

)

$

(6,619,246

)

$

(27,361,918

)

 

 

 

 

 

 

 

 

 

 

Basic net loss per share available to common shareholders

 

$

(0.15

)

$

(7.29

)

$

(0.49

)

$

(13.27

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Weighted average number common shares
outstanding- basic and diluted

 

17,990,322

 

3,468,835

 

13,610,694

 

2,062,351