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Aaipharma Inc · 8-K · For 7/23/03 · EX-99.1

Filed On 7/25/03 1:46pm ET   ·   SEC File 0-21185   ·   Accession Number 950144-3-8896

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  As Of               Filer                 Filing     As/For/On Docs:Pgs              Issuer               Agent

 7/25/03  Aaipharma Inc                     8-K{7,9}    7/23/03    2:16                                     Bowne of Atlanta Inc/FA

Current Report   ·   Form 8-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 8-K         Aaipharma, Inc                                      HTML     15K 
 2: EX-99.1     Press Release Dated July 23,2003                    HTML    103K 


EX-99.1   ·   Press Release Dated July 23,2003


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  PRess Release dated July 23,2003  

 

Exhibit 99.1

     

Image -- aaiPharma Logo

  News
Release
2320 Scientific Park Drive
Wilmington, NC 28405
   

Nasdaq: AAII

     
Contacts:    
Investors:   Media:
William L. Ginna, Jr.   Andrea L. Johnston
EVP & CFO   VP, Corporate Communications
James B. Sloan, Jr.   910-254-7340
SVP, Corporate Finance    
910-254-7000    

aaiPharma Inc. Announces Record 2003 Earnings and Revenues in the
Second Quarter Driven by Pharmaceutical Product Sales

Second Quarter 2003 Highlights

  Revenues Increase 15% over the Prior Year Quarter to $70.8 Million
 
  Pharmaceutical Product Sales Increase to $45.8 Million
 
  Earnings Rise to $0.28 Per Diluted Share, an Increase of 33% over the Second Quarter of 2002
 
  Launched Darvon® Compound 32, the Company’s First Darvon®/Darvocet™ Line Extension

Wilmington, N.C., July 23, 2003 aaiPharma Inc. (Nasdaq:AAII), a science-based specialty pharmaceutical company, today reported financial results for the second quarter ended June 30, 2003.

“Our positive second quarter financial performance was driven by strong revenue growth in our pharmaceutical products division,” stated Dr. Philip S. Tabbiner, President and Chief Executive Officer. “We are very pleased with the strategic and operational milestones we achieved in the first six months of 2003 which reflect our continued focus on our core strategy of being a science-based, specialty pharmaceutical company.”

Financial Results
Total revenues for the second quarter were $70.8 million, representing organic growth of 15% above the $61.4 million recorded in the second quarter of 2002. For the six-month period ended June 30, 2003, revenues increased 26% to $134.8 million, compared with revenues of $107.1 million in the first half of 2002. Net income and earnings per diluted share increased 31% to $8.0 million and 33% to $0.28, respectively, as compared to the second quarter of 2002, driven

 



 

by a continued shift toward higher margin pharmaceutical products. The Company reported net income of $15.1 million for the first half of 2003, or $0.53 per diluted share, an increase of 85% over income before extraordinary loss in the year ago period of $8.2 million, or $0.29 per diluted share.

Gross margin (excluding depreciation) for the second quarter of 2003 improved 12% to $45.2 million, compared with $40.4 million last year. Selling, general and administrative expenses represented 28% of net revenues in the second quarter of 2003, up from 26% in the 2002 quarter, primarily driven by the build-out of our pharmaceutical sales force. Research and development spending was on plan at $5.6 million, or 8% of total revenues for the quarter.

aaiPharma’s strong second quarter product sales reflected market share gains of M.V.I. Pediatric®, increased demand for Brethine® injectable and continued performance in line with expectations for our pain management franchise. Product sales grew organically to $45.8 million, an increase of 32% versus the same period in 2002. Sequentially, product sales were up 14% over the first quarter of 2003. Product sales, including the acquisition of the Darvon®/Darvocet™ family late in the first quarter of 2002, increased 56% to $85.8 million in the first six months of 2003 as compared with the same period in 2002. Product development revenues (royalties and fees) remain in line with management’s expectations at $3.9 million for the second quarter 2003. Development services revenues for the second quarter of 2003 increased to $21.1 million, as compared to $20.3 million in the prior year period, driven primarily by increased demand for our analytical services and contract manufacturing capabilities.

During the second quarter of 2003, the Company paid down an additional $8.5 million of debt, bringing the amount of debt repaid to $17.0 million for the first six months of 2003. By the end of the quarter, the Company again reduced its total leverage ratio as a result of increasing earnings before interest, taxes, depreciation and amortization, and decreasing its debt balance. At June 30, 2003, aaiPharma’s cash position was $8.1 million.

Business Highlights
Subsequent to the end of the second quarter, on July 17, 2003, aaiPharma announced the acquisition of a unique Darvocet™ line extension from Athlon Pharmaceuticals. Upon FDA approval, which is expected before the end of this year, this unique line extension is expected to be the only propoxyphene napsylate/acetaminophen combination product on the market offering this particular dose combination. The total propoxyphene market, generic and branded, is valued at more than $500 million, according to 2002 Verispan data. This new, unique Darvocet™ line extension is expected to add substantial value to aaiPharma’s growing pain management franchise.

On June 24, 2003, aaiPharma launched its first line extension of the Darvon®/Darvocet™ family, Darvon® Compound 32 (propoxyphene hydrochloride, aspirin and caffeine). Darvon® Compound 32 offers a lower dose (i.e., 32 mg of propoxyphene) alternative to Darvon® Compound 65 (i.e., 65 mg of propoxyphene), providing physicians with more options and increased titration flexibility to aid in the management of headache pain.

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“In the last fifteen months since we acquired the Darvon®/Darvocet™ franchise from Eli Lilly & Company, we have successfully executed our strategy to grow the prescription volume for the semi-exclusive products and slow the decline of the genericized portion of the franchise while also progressing with the development of key line extensions to the portfolio,” indicated Dr. Tabbiner. “Furthermore, we remain on track to launch another Darvon® line extension, separate from the recently announced Darvocet™ acquisition, before the end of this year. We believe that these factors, coupled with our continued sales force expansion and targeted pain management promotional campaigns, substantiate continued revenue growth for the Darvon®/Darvocet™ brand family, consistent with our strategic objectives.”

On June 25, 2003, the Company filed a supplemental new drug application (SNDA) for Brethine® Ampuls with the U.S. Food and Drug Administration (FDA) seeking approval for a new and safer vial presentation of injectable Brethine® and certification of aaiPharma’s sterile manufacturing facility in Charleston, South Carolina as an alternate production site for the product.

On April 16, 2003, aaiPharma announced the acquisition of the exclusive rights to a parenterally administered methadone product, formerly branded as Dolophine® Hydrochloride Injection, from Roxane Laboratories, Inc. The Company remains on plan for re-branding this product under a new trade name and launching it in 2003. This acquisition expands aaiPharma’s pain management product offerings into the severe pain, Schedule II class of pain products while also complementing its existing portfolio of hospital-based injectable products.

Outlook
The Company updated financial guidance for the 2003 third quarter by stating that earnings per diluted share are expected to be in the range of $0.28 to $0.30.

aaiPharma management will conduct a conference call to review the financial results for the second quarter of 2003 tomorrow, Thursday, July 24, 2003 at 8:00 a.m., Eastern Daylight Time. A simultaneous web cast of the call for interested investors and others may be accessed by visiting aaiPharma’s website at www.aaipharma.com. Presentation slides will accompany the web cast and will be available for viewing just prior to the web cast. A replay of the web cast will be available on this website shortly after the call through 5:00 p.m. on August 6, 2003.

About aaiPharma
aaiPharma Inc. is a science-based specialty pharmaceutical company with more than 23 years of drug development experience. Focusing on targeted therapeutic areas, the Company markets a growing portfolio of established branded products and applies innovative technologies to increase the commercial potential of these products. At the same time, aaiPharma’s research and development organization is developing a pipeline of products to position the Company for near-term and long-term growth in its targeted therapeutic areas. In addition to developing and marketing its own line of proprietary pharmaceutical products, aaiPharma continues to be a leader in providing contract pharmaceutical development services through its AAI Development Services division. For more information on the Company, please visit us on the web at www.aaipharma.com.

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Forward Looking Statements
Information in this press release contains certain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities and Exchange Act of 1934, including the statements by Dr. Tabbiner and those pertaining to the Company’s plans and expectations as to earnings and revenues outlooks for the Company, for the Darvon®/Darvocet™ brand family, and for its product development segment, and as to the Company’s future sales force expansion, targeted pain management promotional campaigns, launch plans for the acquired methadone product and for an additional Darvon® line extension later in 2003, uniqueness of the acquired Darvocet™ product’s dose combination, commercial and medical value of the acquired Darvocet™ product, the acquired methadone product and Darvon® Compound 32 to the medical and patient communities and to the Company’s branded pain management product portfolio, requested approvals in its regulatory filings with the FDA, and development, commercialization, commercial potential and growth of products and line extensions in the Company’s pipeline and its product portfolio. The “forward-looking statements” herein involve risks and uncertainties that could cause actual results to differ materially, including, without limitation, risks and uncertainties pertaining to the Company’s ability to timely and successfully find, acquire, finance, develop, improve, enhance, obtain timely regulatory approval for, maximize the value of, extend product life cycles of, conduct successful research on, renew marketing of, and sell, on a commercially profitable basis, pharmaceutical products without adversely affecting its client relationships or business opportunities and without future litigation or resulting damages or injunctive relief; the Company’s ability to obtain, use, enforce, defend and license valid and commercially valuable patents; the Company’s ability to obtain and enforce existing and future contracts with major pharmaceutical companies for significant royalties and other consideration; the effect of possible future acquisitions, dispositions and other strategic transactions involving the Company; and the commercial success of the Company’s contemplated products. Additional factors that may cause the actual results to differ materially are discussed in aaiPharma’s recent filings with the Securities and Exchange Commission, including, but not limited to, its Annual Report on Form 10-K filed on March 28, 2003, including its Exhibit 99.1 and other exhibits; its Form 10-Q filed on May 15, 2003; its Form 8-Ks; and its other periodic filings.

Darvon®, Darvocet-N®, M.V.I. Pediatric®, M.V.I.® and Brethine® are registered trademarks, and Azasan™ and Darvocet™ are trademarks, of aaiPharma Inc.

Dolophine® is a registered trademark of Roxane Laboratories.

Tables to Follow –

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aaiPharma Inc.
Consolidated Statements of Operations
(In thousands, except per share amounts)

                                         
            Three Months Ended   Six Months Ended
            June 30,   June 30,
           
 
            2003   2002   2003   2002
           
 
 
 
Product sales
  $ 45,752     $ 34,673     $ 85,760     $ 54,850  
Product development (royalties & fees)
    3,897       6,469       7,707       8,604  
Development services
    21,102       20,305       41,314       43,613  
 
   
     
     
     
 
 
Total revenues
    70,751       61,447       134,781       107,067  
 
   
     
     
     
 
Operating costs and expenses:
                               
 
Direct costs (excluding depreciation):
                               
     
Product sales
    13,201       8,335       23,152       16,140  
     
Development services
    12,377       12,756       24,381       26,301  
 
   
     
     
     
 
       
Total direct costs
    25,578       21,091       47,533       42,441  
 
Selling expenses
    8,201       5,710       15,935       9,984  
 
General and administrative expenses
    11,289       10,161       21,318       18,919  
 
Depreciation and amortization
    2,711       2,671       5,362       4,472  
 
Research and development
    5,588       5,486       10,074       9,864  
 
   
     
     
     
 
 
    53,367       45,119       100,222       85,680  
 
   
     
     
     
 
   
Income from operations
    17,384       16,328       34,559       21,387  
Other income (expense):
                               
 
Interest, net
    (4,931 )     (6,553 )     (10,481 )     (8,376 )
 
Other, net
    226       69       143       203  
 
   
     
     
     
 
 
    (4,705 )     (6,484 )     (10,338 )     (8,173 )
 
   
     
     
     
 
Income before income taxes and extraordinary loss
    12,679       9,844       24,221       13,214  
Provision for income taxes
    4,691       3,740       9,077       5,021  
 
   
     
     
     
 
Income before extraordinary loss
    7,988       6,104       15,144       8,193  
Extraordinary loss, net of a tax benefit of $2,714
                      (5,339 )
Net income
  $ 7,988     $ 6,104     $ 15,144     $ 2,854  
 
   
     
     
     
 
Basic earnings (loss) per share:
                               
 
Income before extraordinary loss
  $ 0.29     $ 0.22     $ 0.55     $ 0.30  
 
Extraordinary loss
                      (0.20 )
 
   
     
     
     
 
Net income
  $ 0.29     $ 0.22     $ 0.55     $ 0.10  
 
   
     
     
     
 
Weighted average shares outstanding
    27,621       27,365       27,590       27,236  
 
   
     
     
     
 
Diluted earnings (loss) per share:
                               
 
Income before extraordinary loss
  $ 0.28     $ 0.21     $ 0.53     $ 0.29  
 
Extraordinary loss
                      (0.19 )
 
   
     
     
     
 
Net income
  $ 0.28     $ 0.21     $ 0.53     $ 0.10  
 
   
     
     
     
 
Weighted average shares outstanding
    28,488       28,565       28,442       28,580  
 
   
     
     
     
 

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aaiPharma Inc.
Consolidated Balance Sheets
(In thousands)

                     
        June 30,   December 31,
        2003   2002
       
 
ASSETS
               
Current assets:
               
 
Cash and cash equivalents
  $ 8,132     $ 6,532  
 
Accounts receivable, net
    39,438       29,467  
 
Work-in-progress
    12,249       10,515  
 
Inventories
    15,349       17,004  
 
Prepaid and other current assets
    7,613       7,633  
 
   
     
 
   
Total current assets
    82,781       71,151  
Property and equipment, net
    55,968       53,125  
Goodwill, net
    211,759       210,792  
Intangibles, net
    88,168       89,078  
Other assets
    13,318       16,179  
 
   
     
 
   
Total assets
  $ 451,994     $ 440,325  
 
   
     
 
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities:
               
 
Current maturities of long-term debt
  $ 6,553     $ 5,921  
 
Accounts payable
    17,309       17,671  
 
Customer advances
    18,726       15,051  
 
Accrued wages and benefits
    7,263       6,718  
 
Interest payable
    5,026       5,232  
 
Other accrued liabilities
    6,625       5,201  
 
   
     
 
   
Total current liabilities
    61,502       55,794  
Long-term debt, less current portion
    259,271       277,899  
Other liabilities
    13,512       7,182  
Stockholders’ equity:
               
 
Common stock
    28       27  
 
Paid-in capital
    80,140       79,049  
 
Retained earnings
    35,736       20,592  
 
Accumulated other comprehensive income (loss)
    1,805       (218 )
 
   
     
 
   
Total stockholders’ equity
    17,709       99,450  
 
   
     
 
   
Total liabilities and stockholders’ equity
  $ 451,994     $ 440,325  
 
   
     
 

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aaiPharma Inc.
Consolidated Statements of Cash Flows
(In thousands)

                       
          Six Months Ended
          June 30,
         
          2003   2002
         
 
Cash flows from operating activities:
               
 
Income before extraordinary loss
  $ 15,144     $ 8,193  
 
Adjustments to reconcile income before extraordinary loss to net cash provided by (used in) operating activities:
               
   
Depreciation and amortization
    5,362       4,472  
   
Other
    (78 )     117  
   
Changes in operating assets and liabilities:
               
     
Accounts receivable, net
    (9,735 )     (13,427 )
     
Work-in-progress
    (1,319 )     (761 )
     
Inventories
    1,718       (275 )
     
Prepaid and other assets
    1,038       (12,970 )
     
Accounts payable
    (527 )     (32 )
     
Customer advances
    3,437       3,413  
     
Interest payable
    (206 )     6,245  
     
Accrued wages and benefits and other accrued liabilities
    5,898       (104 )
 
   
     
 
Net cash provided by (used in) operating activities
    20,732       (5,129 )
 
   
     
 
Cash flows from investing activities:
               
 
Purchases of property and equipment
    (6,482 )     (4,402 )
 
Purchase of property and equipment previously leased
          (14,145 )
 
Proceeds from sales of property and equipment
    389        
 
Acquisitions
    (600 )     (211,997 )
 
Other
    (287 )     (151 )
 
   
     
 
Net cash used in investing activities
    (6,980 )     (230,695 )
 
   
     
 
Cash flows from financing activities:
               
 
Proceeds from long-term borrowings
          248,755  
 
Payments on long-term borrowings
    (17,000 )     (18,400 )
 
Proceeds from interest rate swap, net
    2,678        
 
Issuance of common stock
    1,091       3,031  
 
Other
    1,018       170  
 
   
     
 
Net cash (used in) provided by financing activities
    (12,213 )     233,556  
 
   
     
 
Net increase (decrease) in cash and cash equivalents
    1,539       (2,268 )
Effect of exchange rate changes on cash
    61       109  
Cash and cash equivalents, beginning of period
    6,532       6,371  
 
   
     
 
Cash and cash equivalents, end of period
  $ 8,132     $ 4,212  
 
   
     
 

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Dates Referenced Herein   and   Documents Incorporated By Reference

This 8-K Filing   Date   Other Filings
3/28/0310-K
4/16/03
5/15/0310-Q, DEF 14A, PRE 14A
6/24/03
6/25/03
6/30/0310-Q, 10-Q/A
7/17/03
For The Period Ended7/23/03
7/24/03
Filed On / Filed As Of7/25/03
8/6/03425, 8-K
12/31/0310-K, 5, NT 10-K
 
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