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 September 30, 2003
Commission file number 0-17254
NOVEN PHARMACEUTICALS, INC.
| 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
(305) 253-5099
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 [ ].
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act). Yes [X] No [ ].
Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the last practicable date.
| Class | Outstanding at October 31, 2003 | |||
| Common stock $.0001 par value | 22,521,813 | |||
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, 2003 and 2002 | 3 | ||||||
| Condensed Balance Sheets as of September 30, 2003 and December 31, 2002 | 4 | ||||||
| Condensed Statements of Cash Flows for the Nine Months Ended September 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 | 16 | |||||
| Item 3 - | Quantitative and Qualitative Disclosures About Market Risk | 31 | |||||
| Item 4 - | Controls and Procedures | 31 | |||||
| PART II - OTHER INFORMATION | |||||||
| Item 1 - | Legal Proceedings | 32 | |||||
| Item 6 - | Exhibits and Reports on Form 8-K | 33 | |||||
| SIGNATURES | 34 | ||||||
2
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 | ||||||||||||||||
| 2003 | 2002 | 2003 | 2002 | ||||||||||||||
Revenues: |
|||||||||||||||||
Product revenues Novogyne |
$ | 3,938 | $ | 7,604 | $ | 15,153 | $ | 23,683 | |||||||||
Product revenues third parties |
4,045 | 4,610 | 12,788 | 14,445 | |||||||||||||
Total product revenues |
7,983 | 12,214 | 27,941 | 38,128 | |||||||||||||
License and contract revenues |
1,113 | 984 | 3,441 | 3,961 | |||||||||||||
Total revenues |
9,096 | 13,198 | 31,382 | 42,089 | |||||||||||||
Expenses: |
|||||||||||||||||
Cost of products sold |
3,936 | 5,111 | 14,261 | 17,032 | |||||||||||||
Research and development |
1,916 | 2,585 | 6,563 | 9,267 | |||||||||||||
Marketing, general and administrative |
4,791 | 3,492 | 12,265 | 10,104 | |||||||||||||
Total expenses |
10,643 | 11,188 | 33,089 | 36,403 | |||||||||||||
Income (loss) from operations |
(1,547 | ) | 2,010 | (1,707 | ) | 5,686 | |||||||||||
Equity in earnings of Novogyne |
4,529 | 2,010 | 9,849 | 10,657 | |||||||||||||
Interest income, net |
159 | 223 | 505 | 625 | |||||||||||||
Income before income taxes |
3,141 | 4,243 | 8,647 | 16,968 | |||||||||||||
Provision for income taxes |
1,130 | 1,480 | 3,113 | 6,109 | |||||||||||||
Net income |
$ | 2,011 | $ | 2,763 | $ | 5,534 | $ | 10,859 | |||||||||
Basic earnings per share |
$ | 0.09 | $ | 0.12 | $ | 0.25 | $ | 0.48 | |||||||||
Diluted earnings per share |
$ | 0.09 | $ | 0.12 | $ | 0.24 | $ | 0.46 | |||||||||
Weighted average number of common shares outstanding: |
|||||||||||||||||
Basic |
22,506 | 22,549 | 22,526 | 22,523 | |||||||||||||
Diluted |
22,949 | 23,127 | 22,935 | 23,424 | |||||||||||||
The accompanying notes are an integral part of these statements.
3
NOVEN PHARMACEUTICALS, INC.
Condensed Balance Sheets
(in thousands, except share data)
(unaudited)
| September 30, 2003 | December 31, 2002 | ||||||||
Assets |
|||||||||
Current Assets: |
|||||||||
Cash and cash equivalents |
$ | 86,913 | $ | 58,684 | |||||
Accounts receivable trade (less allowance for doubtful
accounts of $84 in 2003 and $79 in 2002) |
3,283 | 4,359 | |||||||
Accounts receivable Novogyne |
4,243 | 2,581 | |||||||
Inventories |
5,194 | 5,613 | |||||||
Net deferred income tax asset |
5,400 | 2,600 | |||||||
Prepaid income taxes and other current assets |
5,716 | 541 | |||||||
| 110,749 | 74,378 | ||||||||
Property, plant and equipment, net |
18,418 | 16,232 | |||||||
Other Assets: |
|||||||||
Investment in Novogyne |
25,968 | 34,684 | |||||||
Net deferred income tax asset |
9,646 | 9,831 | |||||||
Patent development costs, net |
1,979 | 1,996 | |||||||
Deposits and other assets |
281 | 581 | |||||||
| 37,874 | 47,092 | ||||||||
| $ | 167,041 | $ | 137,702 | ||||||
Liabilities and Stockholders Equity |
|||||||||
Current Liabilities: |
|||||||||
Accounts payable |
5,709 | 5,062 | |||||||
Notes payable current portion |
7 | 8 | |||||||
Accrued compensation and related liabilities |
3,454 | 3,549 | |||||||
Other accrued liabilities |
1,953 | 1,578 | |||||||
Allowance for returns |
1,975 | 485 | |||||||
Deferred contract revenues |
1,301 | 829 | |||||||
Deferred license revenues current portion |
20,526 | 3,525 | |||||||
| 34,925 | 15,036 | ||||||||
Long-Term Liabilities: |
|||||||||
Notes payable |
| 5 | |||||||
Deferred license revenues |
30,774 | 25,920 | |||||||
| 65,699 | 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 22,517,430 shares at September 30, 2003
and 22,579,112 at December 31, 2002 |
2 | 2 | |||||||
Additional paid-in capital |
77,425 | 78,358 | |||||||
Retained earnings |
23,915 | 18,381 | |||||||
| 101,342 | 96,741 | ||||||||
| $ | 167,041 | $ | 137,702 | ||||||
The accompanying notes are an integral part of these statements.
4
NOVEN PHARMACEUTICALS, INC.
Condensed Statements of Cash Flows
Nine Months Ended September 30,
(in thousands)
(unaudited)
| 2003 | 2002 | |||||||||||
Cash flows from operating activities: |
||||||||||||
Net income |
$ | 5,534 | $ | 10,859 | ||||||||
Adjustments to reconcile net income to net cash
provided by operating activities: |
||||||||||||
Depreciation and amortization |
1,683 | 1,623 | ||||||||||
Amortization of patent costs |
252 | 231 | ||||||||||
Amortization of non-competition agreement |
300 | 300 | ||||||||||
Deferred income tax (benefit) expense |
(2,615 | ) | 2,099 | |||||||||
Non-cash expense related to issuance of stock
to charitable organization |
31 | | ||||||||||
Recognition of deferred contract revenues |
(296 | ) | (1,457 | ) | ||||||||
Recognition of deferred license revenues |
(3,145 | ) | (2,504 | ) | ||||||||
Distributed earnings in excess of equity in earnings of Novogyne |
7,045 | 1,070 | ||||||||||
Changes in operating assets and liabilities: |
||||||||||||
Decrease (increase) in accounts receivable trade, net |
1,076 | (2,213 | ) | |||||||||
(Increase) decrease in accounts receivable Novogyne |
(1,662 | ) | 2,830 | |||||||||
Decrease (increase) in inventories |
419 | (2,856 | ) | |||||||||
Increase in prepaid income taxes and other current assets |
(3,504 | ) | (728 | ) | ||||||||
Decrease in deposits and other assets |
| 26 | ||||||||||
Increase in accounts payable |
647 | 4 | ||||||||||
(Decrease) increase in accrued compensation and related liabilities |
(95 | ) | 2,567 | |||||||||
Increase (decrease) in other accrued liabilities |
442 | (304 | ) | |||||||||
Increase in allowance for returns |
1,490 | | ||||||||||
Increase in deferred contract revenues |
768 | 132 | ||||||||||
Increase in deferred license revenues |
25,000 | 73 | ||||||||||
Cash flows provided by operating activities |
33,370 | 11,752 | ||||||||||
Cash flows from investing activities: |
||||||||||||
Purchase of property, plant and equipment, net |
(3,869 | ) | (1,642 | ) | ||||||||
Payments for patent development costs |
(235 | ) | (154 | ) | ||||||||
Cash flows used in investing activities |
(4,104 | ) | (1,796 | ) | ||||||||
Cash flows from financing activities: |
||||||||||||
Issuance of common stock |
258 | 665 | ||||||||||
Purchase and retirement of common stock |
(1,289 | ) | | |||||||||
Repayments of notes payable |
(6 | ) | (250 | ) | ||||||||
Cash flows (used in) provided by financing activities |
(1,037 | ) | 415 | |||||||||
Net increase in cash and cash equivalents |
28,229 | 10,371 | ||||||||||
Cash and cash equivalents, beginning of period |
58,684 | 49,389 | ||||||||||
Cash and cash equivalents, end of period |
$ | 86,913 | $ | 59,760 | ||||||||
The accompanying notes are an integral part of these statements.
5
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 womens prescription healthcare products in the United States and Canada. These products include Novens transdermal estrogen delivery systems marketed under the brand names Vivelle® and Vivelle-Dot® and Novens 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 Novogynes 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 managements 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, 2003, and the results of its operations for the three and nine months ended September 30, 2003 and 2002. Novens business is subject to numerous risks and uncertainties including, but not limited to, those set forth in Novens Annual Report on Form 10-K/A for the year ended December 31, 2002 (Form 10-K), and in Item 2 Managements Discussion and Analysis of Financial Condition and Results of Operations of this quarterly report on Form 10-Q. Accordingly, the results of operations and cash flows for the three and nine months ended September 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 Novens 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 Novens Form 10-K and in Note 5 Revenue Recognition. |
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3. RECLASSIFICATIONS:
| Certain reclassifications have been made to prior period financial statements to conform to the current years presentation. |
4. INVENTORIES:
| The following are the major classes of inventories (in thousands): |
| September 30, | December 31, | |||||||
| 2003 | 2002 | |||||||
Finished goods |
$ | 824 | $ | 830 | ||||
Work in process |
1,905 | 1,390 | ||||||
Raw materials |
2,465 | 3,393 | ||||||
Total |
$ | 5,194 | $ | 5,613 | ||||
5. REVENUE RECOGNITION:
| Substantially all of Novens product revenues were to its licensees, Novogyne, Novartis Pharma AG and its affiliates (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 licensees net selling price. Each of those agreements also establishes a fixed minimum supply price per unit that represents the lowest price Noven could 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 licensees net selling price is known. Revenues under these agreements are recorded at the minimum price at the time of shipment. 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 amounts 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 Novogynes and Novartis AGs product sales each quarter based on Novogynes and Novartis AGs 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 specific drug into a transdermal drug delivery system, studies to address the ongoing stability of |
7
| 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; and | ||
| | 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. If each deliverable does not qualify as a separate unit of accounting, the deliverables are combined and the amounts under the contract are allocated to the combined deliverables. The appropriate recognition of revenue is then determined for the combined deliverables as a single unit of accounting. 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 timing of revenue recognition may vary from contract to contract. | |
| Revenues are net of an allowance for returns. Noven establishes allowances for returns for product that has been recalled or that it believes is probable of being recalled. The methodology used by Noven to estimate product recall returns is based on the distribution and expiration dates of the affected product and overall trade inventory levels. These estimates are based on currently available information, and the ultimate outcome may be significantly different than the amounts estimated given the subjective nature and complexities inherent in this area and in the pharmaceutical industry. | |
| Novens 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 Boards 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. |
8
| The following table illustrates the effect on net income and earnings per share for the three and nine months ended September 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 | Nine Months | ||||||||||||||||
| 2003 | 2002 | 2003 | 2002 | ||||||||||||||
Net income: |
|||||||||||||||||
As reported |
$ | 2,011 | $ | 2,763 | $ | 5,534 | $ | 10,859 | |||||||||
Total stock-based employee
compensation expense determined
under fair value based method for all
awards, net of related tax effects |
(1,138 | ) | (1,270 | ) | (3,247 | ) | (3,499 | ) | |||||||||
Pro forma |
$ | 873 | $ | 1,493 | $ | 2,287 | $ | 7,360 | |||||||||
Basic earnings per share: |
|||||||||||||||||