<PAGE> 1
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
X Quarterly Report Under Section 13 or 15 (d) of the Securities Exchange
- --- Act of 1934
For the quarterly period ended SEPTEMBER 30, 1996
-------------------
or
Transition Report Pursuant to Section 13 of the Securities Exchange Act
- --- of 1934
For the transition period from to
----------- -------------
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 (I.R.S. Employer
incorporation or organization) Identification Number)
11960 S.W. 144th Street, Miami, FL 33186
------------------------------------------- -----------------------
(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (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 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 24, 1996
----------------------------- ------------------------------------
Common stock $.0001 par value 19,827,771
Page 1 of 12
<PAGE> 2
NOVEN PHARMACEUTICALS, INC.
INDEX TO FORM 10-Q
<TABLE>
<Captiom>
PART I - FINANCIAL INFORMATION Page No.
- ------ --------------------- --------
<S> <C>
Item 1 - Financial Statements
Statements of Operations and Accumulated Deficit
for the three months ended September 30, 1996 and 1995 3
Statements of Operations and Accumulated Deficit
for the nine months ended September 30, 1996 and 1995 4
Balance Sheets as of September 30, 1996 and
December 31, 1995 5
Statements of Cash Flows for the nine months ended
September 30, 1996 and 1995 6
Notes to Financial Statements 7-8
Item 2 - Management's Discussion and Analysis of Financial
Condition and Results of Operations 8-11
PART II - OTHER INFORMATION
- ------- -----------------
Item 6 - Exhibits and Reports on Form 8-K 11
SIGNATURES 12
- ----------
</TABLE>
Page 2
<PAGE> 3
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
- ----------------------------
NOVEN PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND ACCUMULATED DEFICIT
<TABLE>
<CAPTION>
THREE MONTHS ENDED
-------------------------------
SEPTEMBER 30, SEPTEMBER 30,
1996 1995
------------ ------------
<S> <C> <C>
REVENUES:
Product sales $ 5,170,415 $ 2,543,761
License revenue 306,499 366,616
Interest income 303,634 405,313
Other income 0 15,346
------------ ------------
Total revenues 5,780,548 3,331,036
------------ ------------
EXPENSES:
Cost of products sold 2,701,259 1,390,855
Research and development 1,384,247 2,880,340
Marketing, general and administrative 1,130,640 816,777
------------ ------------
Total expenses 5,216,146 5,087,972
------------ ------------
NET INCOME (LOSS) FOR THE PERIOD 564,402 (1,756,936)
ACCUMULATED DEFICIT BEGINNING OF PERIOD (22,500,921) (19,344,210)
------------ ------------
ACCUMULATED DEFICIT END OF PERIOD $(21,936,519) $(21,101,146)
============ ============
NET INCOME (LOSS) PER SHARE $ 0.03 $ (0.09)
============ ============
WEIGHTED AVERAGE SHARES OF COMMON STOCK
AND COMMON STOCK EQUIVALENTS 21,451,911 19,396,327
============ ============
</TABLE>
The accompanying notes are an integral part of this statement.
Page 3
<PAGE> 4
NOVEN PHARMACEUTICALS, INC.
STATEMENTS OF OPERATIONS AND ACCUMULATED DEFICIT
<TABLE>
<CAPTION>
NINE MONTHS ENDED
-------------------------------
SEPTEMBER 30, SEPTEMBER 30,
1996 1995
----------- -------------
<S> <C> <C>
REVENUES:
Product sales $ 15,493,421 $ 3,613,879
License revenue 669,497 1,646,281
Interest income 885,128 1,314,222
Other income 36,250 30,664
------------ ------------
Total revenues 17,084,296 6,605,046
EXPENSES:
Cost of products sold 8,289,637 1,990,946
Research and development 5,743,534 7,886,753
Marketing, general and administrative 2,924,282 2,345,739
------------ ------------
Total expenses $ 16,957,453 12,223,438
------------ ------------
NET INCOME (LOSS) FOR THE PERIOD 126,843 (5,618,392)
ACCUMULATED DEFICIT BEGINNING OF PERIOD (22,063,362) (15,482,754)
------------ ------------
ACCUMULATED DEFICIT END OF PERIOD $(21,936,519) $(21,101,146)
============ ============
NET INCOME (LOSS) PER SHARE $ 0.01 $ (0.29)
============ ============
WEIGHTED AVERAGE SHARES OF COMMON STOCK
AND COMMON STOCK EQUIVALENTS 21,602,070 19,094,110
============ ============
</TABLE>
The accompanying notes are an integral part of this statement.
Page 4
<PAGE> 5
NOVEN PHARMACEUTICALS, INC.
BALANCE SHEETS
<TABLE>
<CAPTION>
SEPTEMBER 30, DECEMBER 31,
1996 1995
-------------------- ---------------------
<S> <C> <C>
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 10,622,334 $ 16,131,263
Securities held to maturity 11,567,480 7,881,397
Accounts receivable 1,804,340 2,512,561
Inventories 5,287,529 5,069,946
Prepaid and other current assets 62,519 258,220
------------ ------------
Total current assets 29,344,202 31,853,387
------------ ------------
PROPERTY AND EQUIPMENT, at cost,
net of accumulated depreciation and amortization of
$2,651,541 at September 30, 1996 and $1,974,138 at
December 31, 1995 15,677,446 15,532,797
------------ ------------
OTHER ASSETS:
Patent development costs, net 1,375,927 1,218,630
Deposits and other assets 65,138 40,738
------------ ------------
Total other assets 1,441,065 1,259,368
------------ ------------
TOTAL $ 46,462,713 $ 48,645,552
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued liabilities $ 2,132,832 $ 4,293,185
------------ ------------
DEFERRED LICENSE REVENUE 6,152,514 6,322,011
------------ ------------
COMMITMENTS AND CONTINGENCIES
STOCKHOLDERS' EQUITY:
Preferred stock - authorized 100,000 shares of $.01 par
value; no shares issued or outstanding
Common stock - authorized 30,000,000 shares, par value
$.0001 per share; issued and outstanding - 19,827,771
shares at September 30, 1996 and 19,674,144 shares at
December 31, 1995 1,983 1,967
Additional paid-in capital 60,111,903 60,091,751
Accumulated deficit (21,936,519) (22,063,362)
------------ ------------
Total stockholders' equity 38,177,367 38,030,356
------------ ------------
TOTAL $ 46,462,713 $ 48,645,552
============ ============
</TABLE>
The accompanying notes are an integral part of this statement.
Page 5
<PAGE> 6
NOVEN PHARMACEUTICALS, INC.
STATEMENTS OF CASH FLOWS
<TABLE>
<CAPTION>
NINE MONTHS ENDED
----------------------------------
SEPTEMBER 30, SEPTEMBER 30,
1996 1995
------------- -------------
<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss) $ 126,843 $(5,618,392)
Adjustments to reconcile net income (loss) to net
cash used in operating activities:
Depreciation and amortization 767,763 713,835
Increase in inventories (217,583) (2,532,414)
Decrease in prepaid and other current assets 195,701 519,536
Decrease (increase) in accounts receivable 708,221 (1,439,276)
(Decrease) increase in accounts payable and
accrued liabilities (2,160,353) 621,616
Decrease in deferred license revenue (169,497) (169,497)
----------- -----------
Cash flows used in operating activities (748,905) (7,904,592)
----------- -----------
CASH FLOWS FROM INVESTING ACTIVITIES:
(Purchase) maturity of securities, net (3,711,083) 5,918,068
Purchase of fixed assets, net (822,052) (1,500,768)
Payments for patent development costs (247,657) (163,262)
Refund of deposits 600 1,966
----------- -----------
Cash flows provided by (used in) investing
activities (4,780,192) 4,256,004
----------- -----------
CASH FLOWS FROM FINANCING ACTIVITIES:
Sale of common stock 20,168 21,001
----------- -----------
NET DECREASE CASH AND CASH EQUIVALENTS (5,508,929) (3,627,587)
CASH AND CASH EQUIVALENTS - BEGINNING OF
PERIOD 16,131,263 12,070,272
----------- -----------
CASH AND CASH EQUIVALENTS - END OF PERIOD $10,622,334 $ 8,442,685
=========== ===========
</TABLE>
The accompanying notes are an integral part of this statement.
Page 6
<PAGE> 7
NOTES TO FINANCIAL STATEMENTS
1. BASIS OF PRESENTATION
The financial statements of Noven Pharmaceuticals, Inc. (the "Company"),
included herein, do not include all footnote disclosures normally included
in annual financial statements and, therefore, should be read in conjunction
with the Company's financial statements and notes thereto for each of the
three years in the period ended December 31, 1995 included in the Company's
annual report on Form 10-K.
The interim financial statements for the three months and nine months ended
September 30, 1996 are unaudited and, in the opinion of management, reflect
all adjustments (consisting only of normal recurring accruals) necessary for
fair presentation of the balance sheets, statements of operations and cash
flows of the Company. The statements of operations for the three months and
nine months ended September 30, 1996 are not necessarily indicative of the
results to be expected for the year ending December 31, 1996.
2. SUMMARY OF ACCOUNTING POLICIES
The following is a summary of the significant accounting policies
consistently applied in the preparation of the Company's financial
statements:
"INVENTORIES"
Inventories are stated at the lower of cost (first-in, first-out method) or
net realizable value. Inventories at September 30, 1996 related primarily
to the Company's transdermal estrogen delivery system. To date the
Company has not experienced and does not anticipate in the future, any
difficulty acquiring materials necessary to manufacture its transdermal
systems. The following are the major classes of inventory:
<TABLE>
<CAPTION>
September 30, December 31,
1996 1995
---- ----
<S> <C> <C>
Finished goods $2,018,510 $2,226,603
Work in process 649,114 1,262,657
Raw materials 2,619,905 1,580,686
---------- ----------
Total $5,287,529 $5,069,946
========== ==========
</TABLE>
"PROPERTY AND EQUIPMENT"
Property and equipment is recorded at cost. Depreciation is provided over
the estimated useful lives of the assets. Leasehold improvements are
amortized over the life of the lease or the service life of the
improvements, whichever is shorter. The straight-line method of depreciation
is primarily followed for financial purposes.
Page 7
<PAGE> 8
NOTES TO FINANCIAL STATEMENTS
(CONTINUED)
"PATENT DEVELOPMENT COSTS"
Costs, principally legal fees related to the development of patents, are
capitalized and amortized over the lesser of their estimated economic useful
lives or their remaining legal lives.
"EARNINGS PER SHARE"
Earnings per share is based on the weighted average number of shares
including common stock and common stock equivalent shares. Common stock
equivalent shares include outstanding warrants and options (using the
Treasury Stock Method).
3. STOCKHOLDERS' EQUITY
A schedule of the transactions in the common stock and the additional paid
in capital accounts is as follows:
<TABLE>
<CAPTION>
Common Stock Additional
------------ Paid-In
Shares Amount Capital
------ ------ -------
<S> <C> <C> <C>
Balance, January 1, 1996 19,674,144 $1,967 $60,091,751
Issuance of 153,627 shares of
stock pursuant to stock option plan, net 153,627 16 20,152
---------- ------ -----------
Balance, September 30, 1996 19,827,771 $1,983 $60,111,903
========== ====== ===========
</TABLE>
ITEM 2.
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
RESULTS OF OPERATIONS
Total revenues increased approximately $2,450,000 or 74% for the three
month period ended September 30, 1996 from the same period in the prior year
and approximately $10,479,000 or 159% for the comparable nine month period.
This increase in revenues was the result of the increase of approximately
$2,627,000 in sales of the Company's transdermal estrogen delivery system to
its two licensee partners in the third quarter of 1996 and approximately
$11,880,000 in the first nine months of 1996. Revenues from product sales
to Noven's licensing partners will fluctuate from quarter to quarter
depending upon various factors not in Noven's control, including, but not
limited to, the inventory requirements of each
Page 8
<PAGE> 9
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(CONTINUED)
licensing partner at different times throughout the year, possible special
selling efforts undertaken by each licensing partner at different times during
the year, and, in the case of Rhone-Poulenc Rorer, Inc. ("RPR"), the
introduction of the product into new territories. Further, due to the recent
launches of Menorest and Vivelle TM by RPR and Ciba Geigy Corporation ("Ciba
Geigy") respectively, sale trends for these products are not yet apparent.
License revenues decreased approximately $60,000 or 16% for the three month
period ended September 30, 1996 from the same period in the prior year
and approximately $977,000 or 59% for the comparable nine month period.
The Company believes that license revenues will fluctuate from period to period
depending on contributing factors which include, but are not limited to, future
success in finalizing new collaborative agreements, timely achievement of
milestones and strategic decisions on self-funding certain projects. Interest
income decreased approximately $102,000 or 25% for the third quarter of 1996 and
decreased approximately $429,000 or 33% for the first nine months of 1996
primarily due to lower average balances in securities.
Cost of product sold increased approximately $1,310,000 or 94% for the three
month period ended September 30, 1996 from the same period in the prior year
and approximately $6,299,000 or 316% for the comparable nine month period. The
gross margin percentage was 48% for the third quarter of 1996 as compared to
45% for the same period of the prior year and was 46% for the first nine months
of 1996 as compared to 45% in the same period of the prior year. The gross
margins vary depending on the amount of product sold to each licensee partner
and manufacturing efficiencies including those relating to production volumes.
Research and development expenses decreased approximately $1,496,000 or 52% for
the three month period ended September 30, 1996 from the same period in the
prior year and approximately $2,143,000 or 27% for the comparable nine month
period. The decrease in research and development expenses from 1995 to 1996
was attributable to less process development activity and a reduced amount of
cost associated with the validation of manufacturing equipment and facilities.
In 1996 research and development expenses for new product development continued
at the same rate as in 1995. New product development included work related to
the transoral dental anesthetic system (DentiPatch TM), an
estrogen/progestogen combination delivery system, a second generation estrogen
delivery system, a transdermal system delivering a nonsteroidal
anti-inflammatory drug, an albuterol delivery system and a nicotine delivery
system. Marketing, general and administrative expenses increased approximately
$314,000 or 38% for the three month period ended September 30, 1996 from the
same period in the prior year and approximately $579,000 or 25% for the
comparable nine month period. The increase in marketing, general and
administrative expenses was primarily due to initial marketing expenses to
support the launch of the DentiPatch system, increases in staffing and
associated office expenses.
Page 9
<PAGE> 10
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(CONTINUED)
LIQUIDITY AND CAPITAL RESOURCES
Since its inception, the Company has funded its operations through equity
offerings, license and contract revenue, interest income and beginning in 1995,
product sales. During the first nine months of 1996, the Company had an
operating profit. As of September 30, 1996 and December 31, 1995, the Company
had cash, cash equivalents, and securities totaling approximately $22,190,000
and $24,010,000 respectively. This decrease was primarily the result of a
decrease in accounts payable and accrued liabilities of approximately
$2,160,000 and an approximate investment of $1,070,000 in fixed assets and
patents, offset by net income before depreciation and amortization of $890,000.
As of September 30, 1996 the Company had commitments for capital expenditures
of approximately $135,000. The Company's future capital requirements depend
upon numerous factors, including (i) the progress of its product development
programs, (ii) the time required to obtain government regulatory approvals of
products in development, (iii) the resources that the Company devotes to the
development of self-funded products, proprietary manufacturing methods,
advanced technologies and a marketing and sales administration infrastructure,
(iv) the ability of the Company to obtain additional license agreements and to
manufacture products pursuant to those agreements and (v) the demand for its
products.
The Company expects to incur additional costs related to product development
activities, increased marketing, general and administrative expenses and the
completion of its manufacturing facilities. Although the Company believes
that existing cash, anticipated contract and manufacturing revenues will be
adequate for the foreseeable future, circumstances could arise which may result
in a desire to raise additional capital. There can be no assurance that such
capital will be available on acceptable terms, or at all.
FORWARD LOOKING STATEMENTS
From time to time, Noven may publish forward looking statements relating to
such matters as anticipated financial performance, business prospects,
technological developments, new products, usage and development activities and
some other matters. The words "may", "will", "expect", "anticipate",
"continue", "estimate", "project", "intend" and similar expressions are
intended to identify such forward looking statements. The Private Securities
Litigation Reform Act of 1995 provides a safe harbor for forward looking
statements. In order to comply with the terms of the safe harbor, Noven notes
that a variety of factors could cause its actual results and experience to
differ materially from anticipated results and other expectations expressed by
Noven's forward looking statements. The risks and uncertainties that may
effect the operations, performance, development and results of Noven's
business, include the following:
1. Dependence upon RPR and Ciba Geigy, its two licensing
partners, with respect to (i) the commercialization and marketing of certain
transdermal hormonal products and (ii) obtaining regulatory approval of
certain other transdermal hormonal products.
Page 10
<PAGE> 11
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(CONTINUED)
2. Uncertainties regarding (i) the market share for Noven's transdermal
hormonal products which can be captured by Noven's licensing partners, and (ii)
the market for DentiPatch TM product and Noven's ability to successfully
establish and effectuate a marketing program.
3. Unanticipated difficulties associated with the manufacturing process
of Menorest and Vivelle TM for its licensing partners as well as its
DentiPatch TM product, that could result in delays in delivery and shortages
of product.
4. Competition from other entities engaged in transdermal and/or
transoral research, development, manufacturing and marketing, as well as other
entities engaged in alternative drug delivery technologies.
5. Difficulties associated with (i) identifying appropriate licensing
partners capable of meeting the financial requirements of research and
development and/or marketing new products, and (ii) consummating satisfactory
licensing agreements.
6. The time required to obtain regulatory approval of products and its
associated expenses.
7. The possible exposure to product liability suits in excess of
insurance policy limits or excluded from insurance coverage.
Readers are cautioned not to place undue reliance on forward looking statements
when made, which speak only as of the date made. Noven undertakes no
obligation to publicly release the results of any revision of these forward
looking statements to reflect events or circumstances after the date they are
made or to reflect the occurrence of unanticipated events. Also, unless
expressly stated, Noven does not adopt projections, forecasts or other forward
looking statements which may be disseminated from time to time by analysts and
others.
PART II - OTHER INFORMATION
<TABLE>
<CAPTION>
Item 6. Exhibits and Reports on Form 8-K
- ------- --------------------------------
<S> <C>
None
</TABLE>
Page 11
<PAGE> 12
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.
(Registrant)
Date: November 13,1996 By: S/ Steven Sablotsky
------------------- ------------------------------------
Steven Sablotsky, Chairman of the
Board and President
By: S/ William A. Pecora
------------------------------------
William A. Pecora
Chief Financial Officer
Page 12
<TABLE> <S> <C>
<ARTICLE> 5
<LEGEND>
THIS SCHEDULE CONTAINS SUMMARY FINANCIAL INFORMATION EXTRACTED FROM THE
FINANCIAL STATEMENTS OF NOVEN PHARMACEUTICALS INC. FOR THE NINE MONTHS ENDED
SEPTEMBER 30, 1996, AND IS QUALIFIED IN ITS ENTIRETY BY REFERENCE TO SUCH
FINANCIAL STATEMENTS.
</LEGEND>
<S> <C>
<PERIOD-TYPE> 9-MOS
<FISCAL-YEAR-END> DEC-31-1996
<PERIOD-START> JAN-01-1996
<PERIOD-END> SEP-30-1996
<CASH> 10,622,334
<SECURITIES> 11,567,480
<RECEIVABLES> 1,804,340
<ALLOWANCES> 0
<INVENTORY> 5,287,529
<CURRENT-ASSETS> 29,344,202
<PP&E> 18,328,987
<DEPRECIATION> 2,651,541
<TOTAL-ASSETS> 46,462,713
<CURRENT-LIABILITIES> 2,132,832
<BONDS> 0
1,983
0
<COMMON> 0
<OTHER-SE> 39,175,384
<TOTAL-LIABILITY-AND-EQUITY> 46,462,713
<SALES> 15,493,421
<TOTAL-REVENUES> 17,084,296
<CGS> 8,289,637
<TOTAL-COSTS> 8,289,637
<OTHER-EXPENSES> 5,743,534
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> 126,843
<INCOME-TAX> 0
<INCOME-CONTINUING> 126,843
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 126,843
<EPS-PRIMARY> .01
<EPS-DILUTED> .01
</TABLE>
