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UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

Quarterly Report Under Section 13 or 15 (d) of the Securities Exchange Act of 1934

For the quarterly period ended September 30, 2002

Commission file number 0-17254

NOVEN PHARMACEUTICALS, INC.


(Exact name of registrant as specified in its charter)
     
STATE OF DELAWARE   59-2767632

 
(State or other jurisdiction of
incorporation or organization)
  (I.R.S. Employer
Identification Number)

11960 S.W. 144th Street, Miami, FL 33186


(Address of principal executive offices) (Zip Code)

(305) 253-5099


(Registrant’s telephone number, including area code)

     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   o.

     Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the last practicable date.

     
Class   Outstanding at October 31, 2002

 
Common stock $.0001 par value   22,554,406

 


TABLE OF CONTENTS

PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
Condensed Statements of Operations
Condensed Balance Sheets
Condensed Statements of Cash Flows
Notes to Unaudited Condensed Financial Statements
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 3. Quantitative and Qualitative Disclosure About Market Risk
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Item 4. Controls and Procedures
Item 6. Exhibits and Reports on Form 8-K
Signatures
Certification of Chief Executive Officer
Certification of Chief Financial Officer


Table of Contents

NOVEN PHARMACEUTICALS, INC.

INDEX

             
        Page No.
       
PART I - FINANCIAL INFORMATION
       
 
 
Item 1 – Unaudited Condensed Financial Statements
       
 
   
Condensed Statements of Operations for the Three and Nine Months Ended September 30, 2002 and 2001
    3  
 
   
Condensed Balance Sheets as of September 30, 2002 and December 31, 2001
    4  
 
   
Condensed Statements of Cash Flows for the Nine Months Ended September 30, 2002 and 2001
    5  
 
   
Notes to Unaudited Condensed Financial Statements
    6  
 
 
Item 2 - Management’s Discussion and Analysis of Financial Condition and Results of Operations
    10  
 
 
Item 3 - Quantitative and Qualitative Disclosures About Market Risk
    24  
 
PART II - OTHER INFORMATION
       
 
 
Item 1 - Legal Proceedings
    25  
 
 
Item 4 - Controls and Procedures
    25  
 
 
Item 6 - Exhibits and Reports on Form 8-K
    25  
 
SIGNATURES
    26  
 
CERTIFICATIONS
    27  

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

NOVEN PHARMACEUTICALS, INC.

Condensed Statements of Operations
Three and Nine Months Ended September 30,
(in thousands, except per share amounts)
(unaudited)
                                   
      Three Months   Nine Months
     
 
      2002   2001   2002   2001
     
 
 
 
Revenues:
                               
 
Product sales
  $ 12,317     $ 9,705     $ 39,585     $ 33,569  
 
License revenue
    881       698       2,504       2,117  
 
   
     
     
     
 
 
Total revenues
    13,198       10,403       42,089       35,686  
 
Expenses:
                               
 
Cost of products sold
    5,111       4,982       17,032       15,692  
 
Research and development
    2,585       3,716       9,267       8,353  
 
Marketing, general and administrative
    3,492       3,383       10,104       9,219  
 
   
     
     
     
 
 
Total expenses
    11,188       12,081       36,403       33,264  
 
   
     
     
     
 
Income (loss) from operations
    2,010       (1,678 )     5,686       2,422  
 
Equity in earnings of Novogyne
    2,010       5,278       10,657       9,010  
Interest income, net
    223       398       625       1,499  
 
   
     
     
     
 
Income before income taxes
    4,243       3,998       16,968       12,931  
 
Provision for income taxes
    1,480       1,542       6,109       4,585  
 
   
     
     
     
 
Net income
  $ 2,763     $ 2,456     $ 10,859     $ 8,346  
 
   
     
     
     
 
Basic earnings per share
  $ 0.12     $ 0.11     $ 0.48     $ 0.37  
 
   
     
     
     
 
Diluted earnings per share
  $ 0.12     $ 0.10     $ 0.46     $ 0.35  
 
   
     
     
     
 
Weighted average number of common shares outstanding:
                               
 
Basic
    22,549       22,427       22,523       22,334  
 
   
     
     
     
 
 
Diluted
    23,127       23,542       23,424       23,571  
 
   
     
     
     
 

The accompanying notes are an integral part of these statements.

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NOVEN PHARMACEUTICALS, INC.

Condensed Balance Sheets
(in thousands, except share data)
(unaudited)
                       
          September 30, 2002   December 31, 2001
         
 
Assets
               
Current Assets:
               
     
Cash and cash equivalents
  $ 59,760     $ 49,389  
     
Accounts receivable — trade (less allowance for doubtful accounts of $75 in 2002 and $28 in 2001)
    3,521       1,308  
     
Accounts receivable – Novogyne
    2,328       15,158  
     
Inventories
    7,180       4,324  
     
Net deferred income tax asset
    3,000       4,800  
     
Prepaid and other current assets
    1,032       304  
 
   
     
 
 
    76,821       75,283  
Property, plant and equipment, net
    15,718       15,699  
Other Assets:
               
     
Investment in Novogyne
    30,973       32,043  
     
Net deferred income tax asset
    9,922       10,150  
     
Patent development costs, net
    1,969       2,046  
     
Deposits and other assets
    681       1,007  
 
   
     
 
 
  $ 136,084     $ 136,228  
 
   
     
 
Liabilities and Stockholders’ Equity
               
Current Liabilities:
               
   
Accounts payable
  $ 5,624     $ 5,620  
   
Notes payable — current portion
    8       252  
   
Due to Aventis Pharmaceuticals
          10,000  
   
Accrued compensation and related liabilities
    4,085       1,518  
   
Other accrued liabilities
    2,448       4,169  
   
Deferred license revenue — current portion
    3,526       7,936  
 
   
     
 
 
    15,691       29,495  
Long-Term Liabilities:
               
   
Notes payable
    7       13  
   
Deferred license revenue
    26,801       24,822  
 
   
     
 
 
    42,499       54,330  
Commitments and contingencies
               
Stockholders’ Equity:
               
   
Preferred stock — authorized 100,000 shares of $.01 par value; no shares issued or outstanding
           
   
Common stock — authorized 80,000,000 shares, par value $.0001 per share; issued and outstanding 22,553,006 shares at September 30, 2002 and 22,481,977 at December 31, 2001
    2       2  
   
Additional paid-in capital
    78,222       77,394  
   
Retained earnings
    15,361       4,502  
 
   
     
 
 
    93,585       81,898  
 
   
     
 
 
  $ 136,084     $ 136,228  
 
   
     
 

The accompanying notes are an integral part of these statements.

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NOVEN PHARMACEUTICALS, INC.

Condensed Statements of Cash Flows
Nine Months Ended September 30,
(in thousands)
(unaudited)
                       
          2002   2001
         
 
Cash flows from operating activities:
               
 
Net income
  $ 10,859     $ 8,346  
 
Adjustments to reconcile net income to net cash provided by operating activities:
               
   
Depreciation and amortization
    1,623       1,730  
   
Amortization of patent costs
    231       169  
   
Amortization of non-competition agreement
    300       133  
   
Deferred income tax provision
    2,099       699  
   
Recognition of deferred license revenue
    (2,504 )     (2,117 )
   
Equity in earnings of Novogyne
    (10,657 )     (9,010 )
   
(Increase) decrease in accounts receivable — trade
    (2,213 )     3,341  
   
Decrease (increase) in accounts receivable — Novogyne
    2,830       (1,896 )
   
(Increase) decrease in inventories
    (2,856 )     1,341  
   
(Increase) decrease in prepaid and other current assets
    (728 )     99  
   
Decrease (increase) in deposits and other assets
    26       (1,131 )
   
Increase (decrease) in accounts payable
    4       (368 )
   
Increase (decrease) in accrued compensation and related liabilities
    2,567       (38 )
   
(Decrease) increase in other accrued liabilities
    (1,629 )     4,164  
   
Increase in deferred license revenue
    73       3,500  
 
   
     
 
     
Cash flows provided by operating activities
    25       8,962  
 
Cash flows from investing activities:
               
   
Purchase of property, plant and equipment, net
    (1,642 )     (2,366 )
   
Investment in Novogyne
          (15,680 )
   
Distribution from Novogyne
    11,727       13,080  
   
Payments for patent development costs
    (154 )     (179 )
 
   
     
 
     
Cash flows provided by (used in) investing activities
    9,931       (5,145 )
 
Cash flows from financing activities:
               
   
Issuance of common stock
    665       2,557  
   
Payments on notes payable
    (250 )     (280 )
 
   
     
 
     
Cash flows provided by financing activities
    415       2,277  
 
   
     
 
Net increase in cash and cash equivalents
    10,371       6,094  
 
Cash and cash equivalents, beginning of period
    49,389       40,976  
 
   
     
 
Cash and cash equivalents, end of period
  $ 59,760     $ 47,070  
 
   
     
 

The accompanying notes are an integral part of these statements.

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NOVEN PHARMACEUTICALS, INC.

Notes to Unaudited Condensed Financial Statements

1.    DESCRIPTION OF BUSINESS:

       Noven Pharmaceuticals, Inc. (“Noven”) was incorporated in Delaware in 1987 and is engaged in the research, development, manufacture and marketing of prescription transdermal drug delivery products.
 
       Noven and Novartis Pharmaceuticals Corporation (“Novartis”) entered into a joint venture, Vivelle Ventures LLC (d/b/a Novogyne Pharmaceuticals) (“Novogyne”), effective May 1, 1998, to market and sell women’s prescription healthcare products in the United States and Canada. These products include Noven’s transdermal estrogen delivery systems marketed under the brand names Vivelle® and Vivelle-Dot® and, effective March 30, 2001, Noven’s transdermal combination estrogen/progestin delivery system marketed under the brand name CombiPatch®. Novogyne’s rights to CombiPatch® were acquired from Aventis Pharmaceuticals, the U.S. pharmaceuticals business of Aventis Pharma, AG (“Aventis”), in March 2001 in a series of transactions involving Noven, Novogyne, Novartis and Aventis. Noven accounts for its 49% investment in Novogyne under the equity method and reports its share of Novogyne’s earnings as “Equity in earnings of Novogyne” on its Statements of Operations. Noven defers the recognition of 49% of its profit on products sold to Novogyne until the products are sold by Novogyne.

2.    BASIS OF PRESENTATION:

       In management’s opinion, the accompanying unaudited condensed financial statements of Noven contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly, in all material respects, the financial position of Noven as of September 30, 2002, and the results of its operations for the three and nine months ended September 30, 2002 and 2001. Noven’s business is subject to numerous risks and uncertainties including, but not limited to, those set forth in Noven’s Annual Report on Form 10-K for the year ended December 31, 2001 (“Form 10-K”) as well as the risk that the results of recent and ongoing studies on the adverse health effects of certain forms of hormone replacement therapy (“HRT”) may result in lower sales by Noven or Novogyne in future periods and the risk that the increase in inventory levels at Novogyne and Novogyne’s trade customers may have a further material adverse impact on Noven’s liquidity, results of operations and business. Accordingly, the results of operations and cash flows for the three and nine months ended September 30, 2002 and 2001 are not, and should not be construed as, necessarily indicative of the results of operations or cash flows which may be reported for the remainder of 2002.

       The accompanying unaudited condensed financial statements have been prepared pursuant to the rules and regulations of the Securities and Exchange Commission for reporting on Form 10-Q. Pursuant to such rules and regulations, certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America have been condensed or omitted. The unaudited condensed financial statements should be read in conjunction with the financial statements and the notes to the financial statements included in Noven’s Form 10-K.

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       The accounting policies followed for interim financial reporting are the same as those disclosed in Note 2 of the notes to the financial statements included in Noven’s Form 10-K.

3.    INVENTORIES:

       The following are the major classes of inventories (in thousands):

                 
    September 30,   December 31,
    2002   2001
   
 
Finished goods
  $ 1,742     $ 458  
Work in process
    2,462       1,140  
Raw materials
    2,976       2,726  
 
   
     
 
Total
  $ 7,180     $ 4,324  
 
   
     
 

4.    CASH FLOW INFORMATION:

       Cash payments for income taxes were $4.8 million in 2002 and $0.9 million in 2001. Cash payments for interest were $14,000 in 2002 and $29,000 in 2001.
 
       In connection with the CombiPatch® transaction consummated in March 2001, a final $10.0 million quarterly installment of the purchase price was paid by Novogyne directly to Aventis in March 2002.
 
       Noven recorded $0.2 million and $1.3 million in income tax benefits to additional paid-in capital for the nine months ended September 30, 2002 and 2001, respectively, which were derived from the exercise of non-qualified stock options and disqualifying dispositions of incentive stock options.

5.    LICENSE AGREEMENTS:

       In the fourth quarter of 2001, Noven received a $5.0 million milestone payment from Novartis Pharma AG (“Novartis AG”) under the Estradot® license agreement even though the regulatory approval that was to trigger the milestone payment had not yet been received. Novartis AG received the applicable regulatory approval in the first quarter of 2002. Accordingly, the $5.0 million payment was deferred at December 31, 2001 and is being recognized as license revenue beginning in the first quarter of 2002 through the fourth quarter of 2010.

6.    INVESTMENT IN NOVOGYNE:

       Noven shares in the earnings of Novogyne, after satisfaction of an annual preferred return of $6.1 million to Novartis, according to an established formula. Noven’s share of Novogyne’s earnings increases as Novogyne’s product sales increase, subject to a cap of 49%. Novogyne produced sufficient income in the first quarters of 2002 and 2001 to meet Novartis’ annual preferred return for those years and for Noven to recognize earnings from Novogyne under the formula.

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       During the three and nine months ended September 30, 2002 and 2001, Noven had the following transactions with Novogyne (in thousands):

                                 
    Three Months   Nine Months
   
 
    2002   2001   2002   2001
   
 
 
 
Revenue:
                               
Trade product
  $ 5,583     $ 2,895     $ 16,187     $ 6,981  
Sample product and other
    1,213       90       3,906       1,667  
Royalty
    808       1,320       3,590       3,086  
 
   
     
     
     
 
 
  $ 7,604     $ 4,305     $ 23,683     $ 11,734  
 
   
     
     
     
 
Reimbursed expenses:
                               
Services
  $ 4,750     $ 5,016     $ 14,193     $ 11,970  
Product specific marketing
    1,970       2,455       6,155       4,294  
 
   
     
     
     
 
 
  $ 6,720