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

FORM 10-Q

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

For the quarterly period ended June 30, 2003

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 by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).   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 July 31, 2003

 
Common stock $.0001 par value   22,497,917



 


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
Item 4. Controls and Procedures
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Item 4. Submission of Matters to a Vote of Security Holders
Item 6. Exhibits and Reports on Form 8-K
EX-31.1 CEO CERTIFICATION PURSUANT SECTION 302
EX-31.2 CFO CERTIFICATION PURSUANT SECTION 302
EX-32.1 CEO CERTIFICATION PURSUANT SECTION 906
EX-32.2 CFO CERTIFICATION PURSUANT SECTION 906


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 Six Months Ended June 30, 2003 and 2002   3
         
    Condensed Balance Sheets as of June 30, 2003 and December 31, 2002   4
         
    Condensed Statements of Cash Flows for the Six Months Ended June 30, 2003 and 2002   5
         
    Notes to Unaudited Condensed Financial Statements   6
         
Item 2 -   Management’s Discussion and Analysis of Financial Condition and Results of Operations   14
         
Item 3 -   Quantitative and Qualitative Disclosures About Market Risk   28
         
Item 4 -   Controls and Procedures   28
         
PART II -   OTHER INFORMATION    
         
Item 1 -   Legal Proceedings   30
         
Item 4 -   Submission of Matters to a Vote of Security Holders   30
         
Item 6 -   Exhibits and Reports on Form 8-K   31
         
SIGNATURES       32

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PART I. FINANCIAL INFORMATION

Item 1. Financial Statements

NOVEN PHARMACEUTICALS, INC.

Condensed Statements of Operations
Three and Six Months Ended June 30,
(in thousands, except per share amounts)
(unaudited)
                                   
      Three Months   Six Months
     
 
      2003   2002   2003   2002
     
 
 
 
Revenues:
                               
 
Product revenues — Novogyne
  $ 7,054     $ 8,420     $ 11,215     $ 16,079  
 
Product revenues — third parties
    3,786       6,058       8,743       9,835  
 
   
     
     
     
 
 
Total product revenues
    10,840       14,478       19,958       25,914  
 
License and contract revenues
    1,421       1,678       2,328       2,977  
 
   
     
     
     
 
 
Total revenues
    12,261       16,156       22,286       28,891  
 
Expenses:
                               
 
Cost of products sold
    6,040       6,021       10,325       11,921  
 
Research and development
    2,154       3,313       4,647       6,682  
 
Marketing, general and administrative
    3,293       3,679       7,474       6,612  
 
   
     
     
     
 
 
 
Total expenses
    11,487       13,013       22,446       25,215  
 
   
     
     
     
 
 
Income (loss) from operations
    774       3,143       (160 )     3,676  
Equity in earnings of Novogyne
    3,795       7,132       5,320       8,647  
Interest income, net
    198       195       346       402  
 
   
     
     
     
 
 
Income before income taxes
    4,767       10,470       5,506       12,725  
 
Provision for income taxes
    1,717       3,827       1,983       4,629  
 
   
     
     
     
 
 
Net income
  $ 3,050     $ 6,643     $ 3,523     $ 8,096  
 
   
     
     
     
 
 
Basic earnings per share
  $ 0.14     $ 0.29     $ 0.16     $ 0.36  
 
   
     
     
     
 
 
Diluted earnings per share
  $ 0.13     $ 0.28     $ 0.15     $ 0.34  
 
   
     
     
     
 
Weighted average number of common shares outstanding:
                               
 
Basic
    22,493       22,528       22,536       22,510  
 
   
     
     
     
 
 
 
Diluted
    22,937       23,687       22,928       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)
                       
          June 30, 2003   December 31, 2002
         
 
Assets
               
Current Assets:
               
     
Cash and cash equivalents
  $ 83,789     $ 58,684  
     
Accounts receivable — trade (less allowance for doubtful accounts of $54 in 2003 and $79 in 2002)
    4,172       4,359  
     
Accounts receivable — Novogyne
    5,973       2,581  
     
Inventories
    4,251       5,613  
     
Net deferred income tax asset
    2,000       2,600  
     
Prepaid and other current assets
    1,951       541  
 
   
     
 
 
    102,136       74,378  
Property, plant and equipment, net
    18,195       16,232  
 
Other Assets:
               
     
Investment in Novogyne
    26,353       34,684  
     
Net deferred income tax asset
    19,213       9,831  
     
Patent development costs, net
    1,998       1,996  
     
Deposits and other assets
    381       581  
 
   
     
 
 
    47,945       47,092  
 
   
     
 
 
  $ 168,276     $ 137,702  
 
   
     
 
Liabilities and Stockholders’ Equity
               
Current Liabilities:
               
   
Accounts payable
  $ 5,251     $ 5,062  
   
Notes payable — current portion
    9       8  
   
Accrued compensation and related liabilities
    2,251       3,549  
   
Other accrued liabilities
    1,405       1,350  
   
Current tax payable
    6,579       713  
   
Deferred contract revenues
    1,429       829  
   
Deferred license revenues — current portion
    10,526       3,525  
 
   
     
 
 
    27,450       15,036  
Long-Term Liabilities:
               
   
Notes payable
          5  
   
Deferred license revenues
    41,656       25,920  
 
   
     
 
 
    69,106       40,961  
Commitments and Contingencies (Note 11)
               
 
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 22,495,942 shares at June 30, 2003 and 22,579,112 at December 31, 2002
    2       2  
   
Additional paid-in capital
    77,264       78,358  
   
Retained earnings
    21,904       18,381  
 
   
     
 
 
    99,170       96,741  
 
   
     
 
 
  $ 168,276     $ 137,702  
 
   
     
 

The accompanying notes are an integral part of these statements.

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NOVEN PHARMACEUTICALS, INC.

Condensed Statements of Cash Flows
Six Months Ended June 30,
(in thousands)
(unaudited)
                         
            2003   2002
           
 
Cash flows from operating activities:
               
 
Net income
  $ 3,523     $ 8,096  
 
Adjustments to reconcile net income to net cash provided by operating activities:
               
   
Depreciation and amortization
    1,146       1,063  
   
Amortization of patent costs
    166       154  
   
Amortization of non-competition agreement
    200       200  
   
Deferred income tax (benefit) expense
    (8,782 )     1,873  
   
Non-cash expense related to issuance of stock to charitable organization
    31        
   
Recognition of deferred contract revenues
    (65 )     (1,354 )
   
Amortization of deferred license revenues
    (2,263 )     (1,623 )
   
Distributed earnings in excess of equity in earnings of Novogyne
    6,660       3,080  
   
Changes in assets and liabilities:
               
     
Decrease (increase) in accounts receivable — trade, net
    187       (4,555 )
     
Increase in accounts receivable — Novogyne
    (3,392 )     (4,323 )
     
Decrease (increase) in inventories
    1,362       (1,340 )
     
Increase in prepaid and other current assets
    (1,410 )     (814 )
     
Decrease in deposits and other assets
          26  
     
Increase in accounts payable
    189       1,602  
     
(Decrease) increase in accrued compensation and related liabilities
    (1,298 )     1,394  
     
Increase in other accrued liabilities
    55       936  
     
Increase in current tax payable
    7,554       161  
     
Increase in deferred contract revenues
    665       58  
     
Increase in deferred license revenues
    25,000        
 
   
     
 
       
Cash flows provided by operating activities
    29,528       4,634  
 
Cash flows from investing activities:
               
 
Purchase of property, plant and equipment, net
    (3,109 )     (873 )
 
Payments for patent development costs
    (168 )     (93 )
 
   
     
 
       
Cash flows used in investing activities
    (3,277 )     (966 )
 
Cash flows from financing activities:
               
 
Issuance of common stock
    147       593  
 
Purchase and retirement of common stock
    (1,289 )      
 
Repayments of notes payable
    (4 )     (249 )
 
   
     
 
       
Cash flows (used in) provided by financing activities
    (1,146 )     344  
 
   
     
 
Net increase in cash and cash equivalents
    25,105       4,012  
 
Cash and cash equivalents, beginning of period
    58,684       49,389  
 
   
     
 
Cash and cash equivalents, end of period
  $ 83,789     $ 53,401  
 
   
     
 

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 advanced transdermal drug delivery technologies and prescription transdermal 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 Noven’s transdermal combination estrogen/progestin delivery system marketed under the brand name CombiPatch®. 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 June 30, 2003, and the results of its operations for the three and six months ended June 30, 2003 and 2002. 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/A for the year ended December 31, 2002 (“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, the risk that MethyPatch® may not be approved by the United States Food and Drug Administration (“FDA”), particularly in light of Noven’s receipt of a “not approvable” letter from the FDA in April 2003, and the risk that Shire Pharmaceuticals Group plc. (“Shire”) may elect to require Noven to repurchase the MethyPatch® rights for $5 million. Accordingly, the results of operations and cash flows for the three and six months ended June 30, 2003 and 2002 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 2003.

       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.

       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.

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3. RECLASSIFICATIONS:

       Certain reclassifications have been made to prior period financial statements to conform to the current year’s presentation.

4. INVENTORIES:

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

                 
    June 30,   December 31,
    2003   2002
   
 
Finished goods
  $ 224     $ 830  
Work in process
    1,746       1,390  
Raw materials
    2,281       3,393  
 
   
     
 
Total
  $ 4,251     $ 5,613  
 
   
     
 

5. REVENUE RECOGNITION:

       Substantially all of Noven’s product revenues were to its licensees, Novogyne, Novartis Pharma AG (“Novartis AG”) and Aventis Pharma AG. Revenues from product sales are recognized at the time of shipment when both title and the risks and rewards of ownership have been transferred to the buyer. Certain of our license agreements provide that the ultimate supply price is based on a percentage of the licensee’s net selling price. Each of those agreements also establishes a fixed minimum supply price per unit that represents the lowest price Noven would receive on sales to the licensee. Noven receives the minimum price at the time of shipment with the possibility of an upward adjustment later when the licensee’s net selling price is known. Revenues under these agreements are recorded at the minimum price. Noven records any upward adjustments to revenues at the time that the information necessary to make the determination is received from the licensee. If the upward adjustments are not determinable, Noven records the adjustments (which historically have not been significant) on a cash basis. These fees are included in product revenues.

       Royalty revenues consist of royalties payable by Novogyne and Novartis AG from sales of Vivelle® and Vivelle-Dot®/Estradot® in the United States and Canada. Noven accrues royalties from Novogyne’s and Novartis AG’s product sales each quarter based on Novogyne’s and Novartis AG’s net sales for that quarter. Royalties are included in product revenues.

       License revenues consist of up-front, milestone and similar payments under license agreements and are recognized when earned under the terms of the applicable agreements. In most cases, license revenues are deferred and recognized over the estimated product life cycle or the length of relevant patents, whichever is shorter.

       Contract revenues consist of contract payments related to research and development projects performed for third parties. The work performed by Noven includes feasibility studies to determine if a specific drug is amenable to transdermal drug delivery, the actual formulation of a

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  specific drug into a transdermal drug delivery system, studies to address the ongoing stability of the drug in a transdermal drug delivery system, and manufacturing of batches of product that can be used in human clinical trials. Noven receives contract payments for the work it performs in the following forms:

       • Nonrefundable up-front payments prior to commencing the work (or certain phases of the work).

       • Additional payments upon completion of additional phases.

       • In some cases, success milestone payments based on achievement of specified performance criteria.

       As prescribed by EITF 00-21 “Accounting for Revenue Arrangements with Multiple Deliverables”, Noven analyzes each contract in order to separate each deliverable into separate units of accounting and then recognizes revenues for those separated units at their fair value, as delivered, based on the proportionate share of the work performed by Noven as it performs the specified acts under the contract. The difference between the amount of the payments received and the amount recognized is recorded as deferred revenues until that amount is earned in accordance with Staff Accounting Bulletin 101, “Revenue Recognition in Financial Statements” (“SAB 101”).

       Milestone payments are recorded when the specified performance criteria are achieved, as determined by the customer. Each contract may have different payment terms. Therefore, the revenues recognized may vary from contract to contract.

       Noven’s revenue recognition policy is in compliance with the requirements of SAB 101.

6. EMPLOYEE STOCK PLANS:

       In accordance with the provisions of Statement of Financial Accounting Standards No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123”), as amended by Statement of Financial Accounting Standards No. 148, “Accounting for Stock-Based Compensation - -Transition and Disclosure” (“SFAS 148”), Noven may elect to continue to apply the provisions of the Accounting Principles Board’s Opinion No. 25, “Accounting for Stock Issued to Employees” (“APB 25”) and related interpretations in accounting for its employee stock option plans, or adopt the fair value method of accounting prescribed by SFAS 123. Noven has elected to continue to account for its stock plans using APB 25, and therefore no stock-based employee compensation cost is reflected in net income, as all options granted under those plans had an exercise price equal to the market value of the underlying common stock on the date of grant.

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       The following table illustrates the effect on net income and earnings per share for the three and six months ended June 30, 2003 and 2002 if Noven had applied the fair value recognition provisions of SFAS 123, as amended by SFAS 148 (in thousands, except per share amounts):

                                 
    Three Months   Six Months
   
 
    2003   2002   2003   2002