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SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549


FORM 10-Q

     
(Mark One)  
[X]   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
 
    For the quarterly period ended September 30, 2002
 
    OR
 
[   ]   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
 
    For the transition period from ________________________ to _________________________

Commission file number 0-26301

United Therapeutics Corporation


(Exact Name of Registrant as Specified in Its Charter)
     
Delaware   52-1984749

 
(State or Other Jurisdiction of
Incorporation or Organization)
  (I.R.S. Employer Identification No.)
 
1110 Spring Street, Silver Spring, MD   20910

 
(Address of Principal Executive Offices)   (Zip Code)

(301) 608-9292


Registrant’s Telephone Number, Including Area Code


(Former Name, Former Address and Former Fiscal Year,
If Changed Since Last Report)

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X]      No [   ]

The number of shares outstanding of the issuer’s common stock, par value $.01 per share, as of November 12, 2002 was 20,918,686.


 

INDEX

             
        Page
       
Part I. FINANCIAL INFORMATION (UNAUDITED)
       
  Item 1.
Financial Statements
       
   
Consolidated Balance Sheets
    1  
   
Consolidated Statements of Operations
    2  
   
Consolidated Statements of Cash Flows
    3  
   
Notes to Consolidated Financial Statements
    4  
  Item 2. Management’s Discussion and Analysis of Financial
Condition and Results of Operations
    10  
  Item 3.
Quantitative and Qualitative Disclosures About Market Risk
    19  
  Item 4.
Controls and Procedures
    19  
Part II. OTHER INFORMATION
       
  Item 6.
Exhibits and Reports on Form 8-K
    19  
SIGNATURES
    20  
 
Certification of Chief Executive Officer
    21  
 
Certification of Chief Financial Officer
    22  


 

PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

UNITED THERAPEUTICS CORPORATION
CONSOLIDATED BALANCE SHEETS

(In thousands, except share and per share data)

                     
        September 30,   December 31,
        2002   2001
       
 
        (Unaudited)        
Assets
               
 
Current assets:
               
   
Cash and cash equivalents
  $ 133,807     $ 24,373  
   
Marketable investments
          31,677  
   
Accounts receivable, net of allowance of $156 for 2002 and $198 for 2001
    11,675       1,452  
   
Interest receivable
    114       2,772  
   
Prepaid expenses
    1,692       917  
   
Inventories
    7,334       6,025  
   
Other current assets
    533       1,787  
 
   
     
 
   
     Total current assets
    155,155       69,003  
 
 
Marketable investments
          116,249  
 
Certificate of deposit
    632       605  
 
Goodwill, net
    7,465       7,465  
 
Other intangible assets, net
    7,209       7,900  
 
Property, plant and equipment, net
    8,585       6,403  
 
Investments in affiliates
    6,396       4,342  
 
Due from affiliates
    433        
 
Note receivable from employee and other assets
    1,598       154  
 
   
     
 
   
     Total assets
  $ 187,473     $ 212,121  
 
   
     
 
Liabilities and Stockholders’ Equity
               
 
Current liabilities:
               
   
Accounts payable
  $ 3,922     $ 6,349  
   
Accounts payable to affiliates
          318  
   
Accrued expenses
    3,787       3,454  
   
Due to affiliates
    1,942       500  
   
Current portion of notes and leases payable
    111       102  
   
Other current liabilities
    34       75  
 
   
     
 
   
     Total current liabilities
    9,796       10,798  
 
 
Notes and leases payable, excluding current portion
    1,781       1,836  
 
Due to affiliates
    1,765       3,079  
 
Other liabilities
    22       9  
 
   
     
 
   
     Total liabilities
    13,364       15,722  
 
   
     
 
 
Stockholders’ equity:
               
   
Preferred stock, par value $.01, 10,000,000 shares authorized, no shares issued
           
   
Series A junior participating preferred stock, par value $ .01, 100,000 authorized, no shares issued
           
   
Common stock, par value $.01, 100,000,000 shares authorized, 21,445,286 and 20,751,820 shares issued at September 30, 2002 and December 31, 2001, respectively, and 20,918,686 and 20,225,220 outstanding at September 30, 2002 and December 31, 2001, respectively
    214       208  
   
Additional paid-in capital
    363,996       365,235  
   
Translation adjustment
    (11 )      
   
Accumulated deficit
    (183,216 )     (162,170 )
   
Treasury stock, 526,600 shares
    (6,874 )     (6,874 )
 
   
     
 
   
     Total stockholders’ equity
    174,109       196,399  
 
   
     
 
   
     Total liabilities and stockholders’ equity
  $ 187,473     $ 212,121  
 
   
     
 

SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.

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UNITED THERAPEUTICS CORPORATION
CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except share and per share data)
(UNAUDITED)

                                     
        Three months ended September 30,   Nine months ended September 30,
       
 
        2002   2001   2002   2001
       
 
 
 
Revenues:
                               
 
Product sales
  $ 4,358     $ 505     $ 15,599     $ 1,729  
 
Service sales
    770       572       2,499       1,746  
 
Service sales to affiliates
          186             541  
 
Grant revenue
          53             96  
 
   
     
     
     
 
   
Total revenue
    5,128       1,316       18,098       4,112  
 
Operating expenses:
                               
 
Research and development
    6,640       8,014       18,423       26,080  
 
General and administrative
    2,580       3,378       8,108       10,374  
 
Sales and marketing
    1,170       963       2,499       2,696  
 
Cost of product sales
    833       535       2,724       1,094  
 
Cost of service sales
    442       324       1,234       1,295  
 
   
     
     
     
 
   
Total operating expenses
    11,665       13,214       32,988       41,539  
 
   
Loss from operations
    (6,537 )     (11,898 )     (14,890 )     (37,427 )
 
Other income (expense)
                               
 
Interest income
    537       2,186       4,396       7,924  
 
Interest expense
    (25 )     (31 )     (90 )     (125 )
 
Equity loss in affiliate
    (7 )     (107 )     (151 )     (261 )
 
Other, net
    65       39       10       28  
 
Write-down of investment in affiliate
    (2,893 )           (2,893 )      
 
Loss on marketable investments
    (3,328 )           (7,428 )      
 
   
     
     
     
 
   
Total other income (expense)
    (5,651 )     2,087       (6,156 )     7,566  
 
   
     
     
     
 
 
Net loss before income tax
    (12,188 )     (9,811 )     (21,046 )     (29,861 )
 
Income tax
                       
 
   
     
     
     
 
Net loss
  $ (12,188 )   $ (9,811 )   $ (21,046 )   $ (29,861 )
 
   
     
     
     
 
 
Net loss per common share – basic and diluted
  $ (0.58 )   $ (0.48 )   $ (1.02 )   $ (1.47 )
 
   
     
     
     
 
Weighted average number of common shares outstanding – basic and diluted
    20,899,094       20,250,167       20,550,978       20,306,124  
 
   
     
     
     
 

SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.

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UNITED THERAPEUTICS CORPORATION
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(UNAUDITED)

                       
          Nine months ended September 30,
         
          2002   2001
         
 
Cash flows from operating activities:
               
 
Net loss
  $ (21,046 )   $ (29,861 )
 
Adjustments to reconcile net loss to net cash used in operating activities:
               
     
Depreciation and amortization
    1,532       2,115  
     
Provision for (reduction in) doubtful accounts receivable
    (46 )     331  
     
Loss on disposal of equipment
          16  
     
Stock options granted to consultants
    228       742  
     
Amortization of premium/discounts on investments
    1,113       42  
     
Reserve for inventory obsolescence
    495        
     
Equity loss in affiliate
    151       262  
     
Loss on marketable investments
    7,428        
     
Write-down of investment in affiliate
    2,893        
 
Changes in operating assets and liabilities:
               
     
Accounts receivable
    (10,177 )     (409 )
     
Interest receivable
    2,658       (1,617 )
     
Inventories
    (2,195 )     (1,443 )
     
Prepaid expenses
    (776 )     (70 )
     
Note receivable and other assets
    (1,855 )     (707 )
     
Accounts payable
    (2,427 )     (981 )
     
Due to/from affiliates
    (809 )     198  
     
Accrued expenses
    333       25  
     
Other liabilities
    (28 )     (165 )
 
   
     
 
     
Net cash used in operating activities
    (22,528 )     (31,522 )
 
Cash flows from investing activities:
               
   
Purchases of property, plant and equipment
    (2,644 )     (436 )
   
Proceeds from disposals of property, plant and equipment
    1       25  
   
Investment in AltaRex
    (4,913 )      
   
Purchases of marketable investments
    (1,218 )     (102,444 )
   
Sales and maturities of marketable investments
    140,576       22,779  
 
   
     
 
     
Net cash provided by (used in) investing activities
    131,802       (80,076 )
 
Cash flows from financing activities:
               
   
Proceeds from the exercise of stock options
    206       6  
   
Payments to repurchase common stock
          (2,802 )
   
Principal payments on notes payable
    (15 )     (13 )
   
Principal payments on capital lease obligations
    (31 )     (49 )
 
   
     
 
     
Net cash provided by (used in) financing activities
    160       (2,858 )
 
   
Net increase (decrease) in cash and cash equivalents
    109,434       (114,456 )
 
   
Cash and cash equivalents, beginning of period
    24,373       200,935  
 
   
     
 
   
Cash and cash equivalents, end of period
  $ 133,807     $ 86,479  
 
   
     
 
Supplemental schedule of cash flow information:
               
   
Cash paid for interest
  $ 101     $ 129  
 
   
     
 
   
Noncash investing and financing activities - Equipment acquired under a capital lease
  $     $ 115  
 
   
     
 

SEE ACCOMPANYING NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.

3


 

UNITED THERAPEUTICS CORPORATION
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
SEPTEMBER 30, 2002
(UNAUDITED)

1.    ORGANIZATION AND BUSINESS DESCRIPTION

     United Therapeutics Corporation (United Therapeutics) is a biotechnology company focused on the development and commercialization of unique therapeutics to treat chronic and life-threatening diseases. United Therapeutics is active in three therapeutic areas – cardiovascular medicine, infectious disease and oncology – with five therapeutic platforms – prostacyclin analogs, arginine formulations, telemedicine, monoclonal antibody immunotherapy and glycobiology antiviral agents. United Therapeutics was incorporated on June 26, 1996 under the laws of the State of Delaware and has four wholly owned subsidiaries: Lung Rx, Inc., Unither Pharmaceuticals, Inc. (UPI), Unither Telemedicine Services Corp. (UTSC), and United Therapeutics Europe, Ltd.

     On May 21, 2002, the U. S. Food and Drug Administration (FDA) approved Remodulin® (treprostinil sodium) Injection for the treatment of pulmonary arterial hypertension in patients with NYHA class II-IV symptoms to diminish symptoms associated with exercise. United Therapeutics agreed with the FDA that it would perform a post-marketing phase IV clinical study to further assess the clinical benefits of Remodulin. The phase IV study will commence in late 2002 and must be completed within 24 months from the May 2002 approval. Continued FDA approval is conditioned on the completion and outcome of the phase IV study. On October 7, 2002, the Canadian Therapeutics Products Directorate approved Remodulin for long term subcutaneous treatment of pulmonary arterial hypertension in NYHA class III and IV patients who did not respond adequately to conventional therapy. On October 31, 2002, the Israeli Ministry of Health, Drug Registration Department, approved Remodulin for the treatment of primary pulmonary arterial hypertension and pulmonary arterial hypertension associated with connective tissue disorders. Remodulin marketing applications are under review in France, Australia and Switzerland, with additional European filings to follow approval in France. Additionally, United Therapeutics is planning pre-pivotal studies of Remodulin in critical limb ischemia to commence in late 2002.

     As of October 31, 2002, approximately 500 patients receive Remodulin therapy worldwide, of which approximately 70% are reimbursable patients. Virtually all of the currently non-reimbursable patients reside in countries where Remodulin is not yet approved. Non-reimburseable patients are those patients who do not yet pay for Remodulin. Remodulin is sold and marketed to reimbursable patients in the U.S. by Priority Healthcare Corporation and Accredo Therapeutics, Inc. United Therapeutics is the manufacturer of Remodulin and sells Remodulin in bulk shipments to these distributors. The timing and extent of United Therapeutics’ sales of Remodulin are based on the timing and extent of these bulk orders from distributors. Sales of Remodulin and Remodulin delivery pumps and supplies are recognized as revenue when delivered to the distributors.

2.    BASIS OF PRESENTATION

     The consolidated financial statements included herein have been prepared, without audit, pursuant to Regulation S-X promulgated by the Securities and Exchange Commission. Certain information and footnote disclosures normally included in consolidated financial statements prepared in accordance with accounting principles generally accepted in the United States have been condensed or omitted pursuant to such rules and regulations. These consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto contained in United Therapeutics’ Annual Report on Form 10-K/A for the year ended December 31, 2001 as filed with the Securities and Exchange Commission.

     In the opinion of United Therapeutics’ management, the accompanying unaudited consolidated financial statements contain all adjustments which are of a normal recurring nature necessary to present fairly its financial

4


 

position as of September 30, 2002 and its results of operations and its cash flows for the three and nine-month periods ended September 30, 2002 and 2001. Interim results are not necessarily indicative of results for an entire year.

3.    MARKETABLE INVESTMENTS

     United Therapeutics’ marketable investments, mainly corporate and federally sponsored debt securities and certificates of deposit, were historically considered held-to-maturity securities due to United Therapeutics’ ability and intent to hold those investments until maturity. Held-to-maturity investments are recorded at amortized cost in the balance sheet. The portfolio consisted of over 100 issues and had a weighted average maturity of approximately 1.6 years. In March 2002, United Therapeutics reported a $538,000 write-down due to an other-than-temporary decline in value of one of its marketable investments. In June 2002, as a result of adverse changes in the bond markets, United Therapeutics began reassessing its investment program. As a result of this reassessment, United Therapeutics decided to liquidate all marketable debt securities in the portfolio and invest the proceeds in money market funds, commercial paper and federal instruments. The entire investment portfolio was sold in July 2002. A write-down of investments totaling approximately $3.6 million was necessary to adjust the value of United Therapeutics’ marketable investments to their fair market value based on quoted market prices at June 30, 2002. In July 2002, United Therapeutics recorded an additional realized loss of approximately $3.3 million as a result of the liquidation of the investment portfolio.

4.    INVENTORIES

     Inventories are accounted for under the first-in, first-out method. At September 30, 2002 and December 31, 2001, inventories consisted of the following (in thousands):