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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 June 30, 2000
Commission file number 0-17254
NOVEN PHARMACEUTICALS, INC.
STATE OF DELAWARE 59-2767632
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(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification Number)
11960 S.W. 144th Street Miami, FL 33186
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(Address of principal executive offices) (Zip Code)
(305) 253-5099
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(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 [ ].
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, 2000
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Common stock $.0001 par value 22,027,668
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NOVEN PHARMACEUTICALS, INC.
INDEX
<TABLE>
<CAPTION>
Page No.
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<S> <C>
PART I - FINANCIAL INFORMATION
Item 1 - Financial Statements
Statements of Operations for the Three and Six Months Ended
June 30, 2000 and 1999 3
Balance Sheets as of June 30, 2000 and December 31, 1999 4
Statements of Cash Flows for the Six Months Ended
June 30, 2000 and 1999 5
Notes to Financial Statements 6-7
Item 2 - Management's Discussion and Analysis of Financial
Condition and Results of Operations 8-10
Item 3 - Quantitative and Qualitative Disclosures About Market Risk 10
PART II - OTHER INFORMATION
Item 4 - Submission of Matters to a Vote of Security Holders 11
Item 6 - Exhibits and Reports on Form 8-K 11
SIGNATURES 12
</TABLE>
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PART I. FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
NOVEN PHARMACEUTICALS, INC.
Statements of Operations
Three and Six Months Ended June 30,
(in thousands, except per share amounts)
(unaudited)
<TABLE>
<CAPTION>
Three Months Six Months
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2000 1999 2000 1999
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<S> <C> <C> <C> <C>
Revenues:
Product sales $10,335 $ 7,437 $19,791 $14,857
License revenue 146 56 293 113
------- ------- ------- -------
Total revenues 10,481 7,493 20,084 14,970
Expenses:
Cost of products sold 4,512 3,361 9,023 6,605
Research and development 3,555 1,485 5,380 3,142
Marketing, general and administrative 2,307 1,743 4,389 3,647
------- ------- ------- -------
Total operating costs and expenses 10,374 6,589 18,792 13,394
------- ------- ------- -------
Income from operations 107 904 1,292 1,576
Equity in earnings of Novogyne 3,253 -- 3,730 --
Interest income, net 267 64 467 116
------- ------- ------- -------
Income before income taxes 3,627 968 5,489 1,692
Provision for income taxes 153 9 188 18
------- ------- ------- -------
Net income $ 3,474 $ 959 $ 5,301 $ 1,674
======= ======= ======= =======
Basic earnings per share $ 0.16 $ 0.05 $ 0.24 $ 0.08
======= ======= ======= =======
Diluted earnings per share $ 0.15 $ 0.05 $ 0.23 $ 0.08
======= ======= ======= =======
Weighted average number of common shares outstanding:
Basic 21,797 21,460 21,740 21,496
======= ======= ======= =======
Diluted 22,895 21,638 22,862 21,673
======= ======= ======= =======
</TABLE>
THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THESE STATEMENTS.
3
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NOVEN PHARMACEUTICALS, INC.
Balance Sheets
(in thousands, except share data)
<TABLE>
<CAPTION>
June 30, 2000 December 31, 1999
(unaudited) (audited)
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<S> <C> <C>
ASSETS
Current Assets:
Cash and cash equivalents $ 18,798 $ 15,338
Accounts receivable (less allowance for doubtful accounts
of $156 in 2000 and $167 in 1999) 4,324 3,048
Due from Novogyne 3,304 3,651
Inventories 5,315 3,578
Prepaid and other current assets 382 415
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32,123 26,030
Property, Plant and Equipment - net 15,186 15,329
Other Assets:
Investment in Novogyne 9,868 8,365
Net deferred income tax asset 5,000 5,000
Patent development costs, net 1,789 1,805
Deposits and other assets 199 359
-------- --------
16,856 15,529
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$ 64,165 $ 56,888
======== ========
LIABILITIES AND SHAREHOLDERS' EQUITY
Current Liabilities:
Accounts payable $ 5,533 $ 5,085
Notes payable - current portion 348 348
Accrued compensation and related liabilities 1,816 2,237
Other accrued liabilities 1,058 1,193
Deferred license revenue - current portion 586 586
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9,341 9,449
Long Term Liabilities:
Notes payable 433 604
Deferred license revenue 7,149 7,442
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16,923 17,495
Shareholders' Equity:
Preferred stock - authorized 100,000 shares of $.01 par
value; no shares issued or outstanding -- --
Common stock - authorized 40,000,000 shares,
par value $.0001 per share; issued and
outstanding 21,916,932 shares at June 30, 2000 and
21,546,271 at December 31, 1999 2 2
Additional paid-in capital 69,162 66,614
Accumulated deficit (21,922) (27,223)
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47,242 39,393
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$ 64,165 $ 56,888
======== ========
</TABLE>
THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THESE STATEMENTS.
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NOVEN PHARMACEUTICALS, INC.
Statements of Cash Flows
Six Months Ended June 30,
(in thousands)
(unaudited)
<TABLE>
<CAPTION>
2000 1999
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<S> <C> <C>
Cash flows from operating activities:
Net income $ 5,301 $ 1,674
Adjustments to reconcile net income to net
cash (used in) provided by operating activities:
Depreciation and amortization 707 685
Amortization of patent costs 104 104
Recognition of deferred license revenue (293) (113)
Equity in earnings of Novogyne (3,730) --
(Increase) in accounts receivable (1,276) (1,157)
Decrease in due from Novogyne 347 205
(Increase) in inventories (1,737) (201)
Decrease in prepaid and other current assets 33 71
Decrease (Increase) in deposits and other assets 160 (307)
Increase (Decrease) in accounts payable 448 (1,169)
Increase in accrued compensation and related liabilities 360 488
(Decrease) increase in other accrued liabilities (135) 343
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Cash flows provided by operating activities 289 623
Cash flows from investing activities:
Purchase of fixed assets, net (564) (511)
Distribution from Novogyne 2,228 622
Payments for patent development costs (88) (155)
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Cash flows provided by (used in) investing activities
1,576 (44)
Cash flows from financing activities:
Issuance of common stock 1,766 81
Notes payable (171) 1,060
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Cash flows provided by financing activities 1,595 1,141
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Net increase in cash and cash equivalents 3,460 1,720
Cash and cash equivalents - beginning of period 15,338 5,573
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Cash and cash equivalents - end of period $ 18,798 $ 7,293
======== ========
Cash payments for interest were $35 in 2000 and $9 in 1999
Accrued compensation and related liabilities for the years ended December 31,
1999 and 1998 includes bonuses for employees and officers of $782 and $329 that
were settled by issuance of 55,000 and 62,000 shares of common stock during the
quarters ended March 31, 2000 and 1999, respectively.
</TABLE>
THE ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THESE STATEMENTS.
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NOVEN PHARMACEUTICALS, INC.
NOTES TO UNAUDITED FINANCIAL STATEMENTS
1. Basis of Presentation:
In management's opinion, the accompanying unaudited financial
statements of Noven Pharmaceuticals, Inc. ("Noven") contain all
adjustments (consisting of only normal recurring adjustments) necessary
to present fairly the financial position of Noven as of June 30, 2000,
and the results of its operations for the three and six months ended
June 30, 2000 and 1999. The results of operations and cash flows for
the six months ended June 30, 2000 are not necessarily indicative of
the results of operations or cash flows which may be reported for the
remainder of 2000.
The accompanying 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 generally
accepted accounting principles have been condensed or omitted. The
financial statements should be read in conjunction with the financial
statements and the notes to the financial statements included in
Noven's Annual Report on Form 10-K for the year ended December 31,
1999.
The accounting policies followed for interim financial
reporting are the same as those disclosed in Note 1 of the notes to the
financial statements included in Noven's Annual Report on Form 10-K for
the year ended December 31, 1999.
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 healthcare products in the United States and Canada,
including Noven's transdermal estrogen delivery systems marketed under
the brand names Vivelle(R) and Vivelle-Dot(TM). 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 has eliminated 49% of its profit on
products sold to Novogyne that remain in Novogyne's inventory.
Certain amounts presented in the financial statements for
prior periods have been reclassified to the current period's
presentation.
2. Inventories:
The following are the major classes of inventories (in
thousands):
June 30, December 31,
2000 1999
-------- ------------
Finished goods $ 130 $ 125
Work in process 1,078 973
Raw Materials 4,107 2,480
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Total $5,315 $3,578
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3. Income Taxes:
Provisions for income taxes for the six months ended June 30,
2000 and 1999 reflect provisions for the alternative minimum tax.
4. Investment in Novogyne:
Noven shares in the earnings of Novogyne according to an
established formula after satisfaction of an annual preferred return of
$6.1 million to Novartis. Noven's share of earnings increases as
product sales increase, subject to a cap of 49%. Novogyne produced
sufficient income in the first quarter of 2000 to meet Novartis'
preferred return and for Noven to recognize earnings from Novogyne
under the formula.
During the six months ended June 30, 2000 and 1999, Noven
recognized $10.9 million and $5.0 million, respectively, of product
sales to Novogyne, which included $1.8 million and $1.0 million in
royalties, and was reimbursed for $7.3 million and $6.5 million,
respectively, of sales and marketing expenses incurred on behalf of
Novogyne. As of June 30, 2000 and 1999, Noven had amounts due from
Novogyne of $3.3 million and $3.3 million, respectively, representing
products sold to and marketing expenses reimbursable by Novogyne.
During the three months ended June 30, 2000 and 1999, Noven
recognized $4.8 million and $3.0 million, respectively, of product
sales to Novogyne, which included $0.9 million and $0.7 million in
royalties, and was reimbursed for $4.1 million and $3.8 million,
respectively, of sales and marketing expenses incurred on behalf of
Novogyne.
Subject to the approval of Novogyne's management committee,
cash may be distributed quarterly to Novartis and Noven based upon a
contractual formula. In April 2000, Noven received a cash distribution
of $2.2 million from Novogyne based upon the results of operations for
the year ended December 31, 1999, which was recorded as a reduction in
the investment in Novogyne in the second quarter of 2000.
5. Notes Payable:
In May 1999, Noven entered into a Master Finance Lease
Agreement (the "Master Lease") for $1 million with a base lease term of
three or four years depending upon the equipment type. The terms of the
Master Lease include, among other provisions, minimum net worth,
revenue and operating results requirements, as well as certain
financial ratios, measured on a quarterly basis. Transactions under the
Master Lease have been accounted for as financing arrangements.
7
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
The following discussion and analysis should be read in conjunction
with the financial statements, the related notes and management's discussion and
analysis of financial condition and results of operations included in Noven's
Annual Report on Form 10-K for the year ended December 31, 1999 and the
financial statements and related notes included in Item 1 of this Quarterly
Report on Form 10-Q. Except for historical information contained herein, the
matters discussed below are forward looking statements made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995. Such
statements involve risks and uncertainties, including but not limited to
economic, competitive, governmental and technological factors affecting Noven's
operations, markets, products and prices, and other factors. These factors,
which are discussed elsewhere in this report and in the documents filed by Noven
with the Securities and Exchange Commission ("SEC"), may cause Noven's results
to differ materially from the forward looking statements made in this report or
otherwise made by or on behalf of Noven.
Noven recognizes revenues from product sales at the time of shipment.
Noven accrues royalty revenue, which is included in product sales, based on its
best estimates of its licensee's product sales. When no reasonable basis for
estimating exists because the information is not in Noven's control, Noven will
recognize royalty revenue when actual results are available. Because
substantially all of Noven's product sales are to its licensees, Noven's product
sales may fluctuate from quarter to quarter depending on various factors not in
Noven's control, including but not limited to the marketing efforts of each
licensee, inventory requirements of each licensee, the product pricing of each
licensee and the timing of certain royalty reconciliations and payments under
Noven's license agreements. Royalty reconciliations and payments under the
license agreements are generally made once or twice per year for product sales
made in the prior period.
Noven shares in the earnings of Novogyne according to an established
formula after satisfaction of an annual preferred return of $6.1 million to
Novartis. In the first quarter of 2000, Novartis' preferred return was satisfied
for all of 2000. Noven reports its share of Novogyne's earnings as "Equity in
Earnings of Novogyne" on its Statements of Operations.
RESULTS OF OPERATIONS
SIX MONTHS ENDED JUNE 30, 2000 COMPARED TO SIX MONTHS ENDED JUNE 30, 1999
Total revenues for the six months ended June 30, 2000 were $20.1
million, an increase of $5.1 million, or 34%, over the same period in the prior
year. The increase was attributable to increased sales of Estalis(R),
Vivelle-Dot(TM) and Vivelle(R), partially offset by lower sales of
CombiPatch(TM) in the United States.
Gross profit (product sales less cost of products sold) for the six
months ended June 30, 2000 was $10.8 million (54% of product sales), compared to
$8.3 million (56% of product sales) for the same period in the prior year. The
decrease in gross margins resulted primarily from the elimination of 49% of
Noven's profit on product sold to Novogyne that remained in Novogyne's inventory
at June 30, 2000. This profit will be recognized by Noven at the time such
inventory is sold by Novogyne. The inventory increase at Novogyne was the result
of an inventory build up in anticipation of an increase in product demand.
8
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Research and development expenses increased approximately $2.2 million,
or 71%, for the six months ended June 30, 2000 compared to the same period in
the prior year, primarily resulting from increased clinical study expenses.
Noven expects a significant increase in research and development expenses in the
remainder of 2000, primarily related to clinical studies associated with Noven's
methylphenidate transdermal delivery system. The future level of research and
development expenditure will depend on, among other things, the status of
products under development and the outcome of clinical trials, strategic
decisions by management, the consummation of new license agreements and Noven's
liquidity.
Marketing, general and administrative expenses increased approximately
$0.7 million, or 20%, for the six months ended June 30, 2000 compared to the
same period in the prior year. This increase primarily resulted from an increase
in staffing and associated office expenses.
For the six months ended June 30, 2000, Noven reported Equity in
Earnings of Novogyne of $3.7 million; Noven reported no such equity in earnings
for the same period in the prior year. In the first half of 2000, Novogyne had
revenues of $29.0 million, an increase of 75% over the same period in the prior
year. A significant portion of this increase came from increased sales of
Vivelle-Dot(TM), which was launched in the second quarter of 1999. In the first
half of 2000, Novogyne had net income of $15.5 million, a 200% increase over the
same period in the prior year.
Provision for income taxes for the six months ended June 30, 2000
reflects a provision for the alternative minimum tax. Noven will continue to
evaluate the appropriateness of recording an additional tax benefit which would
result in an increase in the Net Deferred Income Tax Asset.
THREE MONTHS ENDED JUNE 30, 2000 COMPARED TO THREE MONTHS ENDED JUNE 30, 1999
Total revenues for the three months ended June 30, 2000 were $10.5
million, an increase of $3.0 million, or 40%, over the same period in the prior
year. The increase was primarily attributable to increased sales of Estalis(R),
Vivelle-Dot(TM) and Vivelle(R), partially offset by lower sales of
CombiPatch(TM) in the United States.
Gross profit (product sales less cost of products sold) for the three
months ended June 30, 2000 was $5.8 million (56% of product sales) compared to
$4.1 million (55% of product sales) for the same period in the prior year. The
increase in gross margin resulted primarily from an increase in manufacturing
volume, partially offset by the elimination of 49% of Noven's profit on product
sold to Novogyne that remains in Novogyne's inventory at June 30, 2000.
Research and development expenses increased approximately $2.1 million,
or 139%, for the three months ended June 30, 2000 compared to the same period in
the prior year, primarily resulting from clinical study expenses associated with
Noven's methylphenidate transdermal delivery system.
Marketing, general and administrative expenses increased approximately
$0.6 million, or 32%, for the three months ended June 30, 2000 compared to the
same period in the prior year. This increase primarily resulted from an increase
in staffing and associated office expenses.
For the three months ended June 30, 2000, Noven reported Equity in
Earnings of Novogyne of $3.3 million; Noven reported no such equity in earnings
for the same period in the prior year. For the three months ended June 30, 2000,
Novogyne had revenues of $15.8 million, an increase of 162% over the same period
in the prior year. A significant portion of this increase came from increased
sales of Vivelle-Dot(TM), which was launched in the second quarter of 1999. For
the three months
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ended June 30, 2000, Novogyne had net income of $8.2 million, a 277% greater
than the same period in the prior year.
LIQUIDITY AND CAPITAL RESOURCES
As of June 30, 2000 and December 31, 1999, Noven had $18.8 million and
$15.3 million, respectively, in cash and cash equivalents.
Net cash of approximately $0.3 million was provided by operating
activities during the first six months of 2000, compared to approximately $0.6
million provided by operating activities during the same period in the prior
year. Equity in Earnings of Novogyne, a non-cash item, constituted $3.7 million
of Noven's $5.3 million net income in the 2000 period. The remaining net income
was mostly offset by increases in raw material inventory and accounts
receivable.
Net cash of approximately $1.6 million was provided by investing
activities during the first six months of 2000, compared to approximately
$44,000 used in investing activities during the same period of the prior year.
Net cash provided by investing activities during 2000 and 1999 resulted from
distributions from Novogyne, partially offset by the purchase of fixed assets
and payment of patent development costs.
Net cash of approximately $1.6 million was provided by financing
activities during the first six months of 2000, compared to approximately $1.1
million provided by financing activities during the same period of the prior
year. The increase in the 2000 period resulted from the issuance of common stock
in connection with the exercise of stock options.
Noven's principal sources of short term liquidity are existing cash and
cash generated from product sales, fees and royalties under license agreements
and distributions from Novogyne, which Noven believes will be sufficient to meet
its operating needs and anticipated capital requirements over the short term. In
April 2000, Noven received a cash distribution of $2.2 million from Novogyne
based upon the results of operations for the year ended December 31, 1999. For
the long term, Noven intends to utilize funds derived from these sources, as
well as funds generated through sales of products under development. Noven
expects that such funds will be comprised of payments received pursuant to
future licensing arrangements, as well as Noven's direct sales of its own
products. Noven expects that its cash requirements will continue to increase,
primarily as a result of expected increases in expenditures associated with
clinical studies for products under development. There can be no assurance that
Noven will successfully complete the development of such products, that Noven
will obtain regulatory approval for any such products, that any approved product
may be produced in commercial quantities, at reasonable costs, and be
successfully marketed, or that Noven will successfully negotiate future
licensing arrangements. To the extent that capital requirements exceed available
capital, Noven will seek alternative sources of financing to fund its
operations. Other than the Master Lease, Noven has no credit facility. Noven is
pursuing financing alternatives, which include a revolving credit facility, and
expects to complete a financing arrangement in the near future. No assurance can
be given that alternative financing will be available, if at all, in a timely
manner, on favorable terms. If Noven is unable to obtain satisfactory
alternative financing, Noven may be required to delay or reduce its proposed
expenditures, including expenditures for research and development, in order to
meet its future cash requirements.
10
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ITEM 3. QUANTITATIVE AND QUALITATIVE DISCLOSURE ABOUT MARKET RISK.
Noven does not believe that it has material exposure to market risk.
Noven has no material debt obligations. Noven may, however, obtain financing in
the future and no assurance can be given that the terms of future sources of
financing will not expose Noven to material market risk.
PART II - OTHER INFORMATION
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
Annual Meeting of Shareholders held on June 6, 2000.
(i) Election of Directors
FOR AGAINST
---------- -------
Sheldon H. Becher 17,294,876 153,615
Sidney Braginsky 17,294,876 153,615
Rodolfo C. Bryce 17,294,876 153,615
John G. Clarkson, M.D. 17,294,876 153,615
Lawrence J. DuBow 17,294,876 153,615
Steven Sablotsky 17,294,876 153,615
Robert C. Strauss 17,294,876 153,615
(ii) The ratification of the appointment of Deloitte & Touche LLP
as Noven's independent certified public accountants for 2000
was approved by an affirmative vote of 17,329,621 shares to a
negative vote of 107,590 shares, with 11,280 shares
abstaining.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
(a) EXHIBITS
27 Financial Data Schedule
(b) REPORTS ON FORM 8-K
No reports on Form 8-K were filed by the Registrant during the three
months ended June 30, 2000.
11
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
NOVEN PHARMACEUTICALS, INC.
Date: August 11, 2000 By: /s/ James B. Messiry
---------------- -----------------------------
James B. Messiry
Vice President and
Chief Financial Officer
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EXHIBITS
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27 Financial Data Schedule
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