<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 March 31, 1997
--------------
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 April 29, 1997
----- -------------------------------
Common stock $.0001 par value 19,961,284
Page 1 of 12
<PAGE> 2
NOVEN PHARMACEUTICALS, INC.
INDEX TO FORM 10-Q
PART I - FINANCIAL INFORMATION
<TABLE>
<CAPTION>
Page No.
<S> <C>
Item 1 - Financial Statements
Statements of Operations and Accumulated Deficit
for the three months ended March 31, 1997 and 1996 3
Balance Sheets as of March 31, 1997 and
December 31, 1996 4
Statements of Cash Flows for the three months ended
March 31, 1997 and 1996 5
Notes to Financial Statements 6 - 7
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
------------------------------
MARCH 31, MARCH 31,
1997 1996
------------ ------------
<S> <C> <C>
REVENUES:
Product sales $ 1,346,521 $ 5,171,991
License revenue 81,499 106,499
Interest income 221,934 276,035
Other income 31,325 0
------------ ------------
Total revenues 1,681,279 5,554,525
------------ ------------
EXPENSES:
Cost of products sold 593,256 2,891,843
Research and development 2,139,560 2,409,604
Marketing, general and administrative 1,708,072 873,002
------------ ------------
Total expenses 4,440,888 6,174,449
------------ ------------
NET LOSS FOR THE PERIOD (2,759,609) (619,924)
ACCUMULATED DEFICIT BEGINNING OF PERIOD (24,047,315 (22,063,362)
------------ ------------
ACCUMULATED DEFICIT END OF PERIOD $(26,806,924) $(22,683,286)
============ ============
NET LOSS PER SHARE $ (0.14) $ (0.03)
============ ============
WEIGHTED AVERAGE SHARES OF COMMON STOCK
AND COMMON STOCK EQUIVALENTS 19,883,435 19,756,549
============ ============
</TABLE>
The accompanying notes are an integral part of this statement.
Page 3
<PAGE> 4
NOVEN PHARMACEUTICALS, INC.
BALANCE SHEETS
<TABLE>
<CAPTION>
MARCH 31, DECEMBER 31,
1997 1996
------------ ------------
<S> <C> <C>
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 13,636,343 $ 5,456,826
Securities held to maturity 1,967,003 13,692,010
Accounts receivable 3,310,817 3,366,489
Inventories 4,540,769 4,151,020
Prepaid and other current assets 273,566 248,357
------------ ------------
Total current assets 23,728,498 26,914,702
------------ ------------
PROPERTY AND EQUIPMENT, at cost,
net of accumulated depreciation and amortization of
$3,103,531 at March 31, 1997 and $2,873,401 at
December 31, 1996 15,635,206 15,701,474
------------ ------------
OTHER ASSETS:
Patent development costs, net 1,398,775 1,547,434
Deposits and other assets 64,069 65,128
------------ ------------
Total other assets 1,462,844 1,612,562
------------ ------------
TOTAL $ 40,826,548 $ 44,228,738
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable and accrued liabilities $ 1,465,847 $ 2,055,780
------------ ------------
DEFERRED LICENSE REVENUE 6,039,516 6,096,015
------------ ------------
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 - 19,948,948
shares at March 31, 1997 and 19,831,538 shares at
December 31, 1996 1,995 1,983
Additional paid-in capital 60,126,114 60,122,275
Accumulated deficit (26,806,924) (24,047,315)
------------ ------------
Total stockholders' equity 33,321,185 36,076,943
------------ ------------
TOTAL $ 40,826,548 $ 44,228,738
============ ============
</TABLE>
The accompanying notes are an integral part of this statement
Page 4
<PAGE> 5
NOVEN PHARMACEUTICALS, INC.
STATEMENTS OF CASH FLOWS
<TABLE>
<CAPTION>
THREE MONTHS ENDED
------------------------------
MARCH 31, MARCH 31,
1997 1996
------------ ------------
<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ (2,759,609) $ (619,924)
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation and amortization 272,659 335,898
Increase in inventories (389,749) (812,160)
(Increase) decrease in prepaid and other current assets (25,209) 25,241
Decrease in accounts receivable 55,672 233,788
Decrease in accounts payable and accrued
liabilities (589,933) (196,700)
Decrease in deferred license revenue (56,499) (56,499)
------------ ------------
Cash flows used in operating activities (3,492,668) (1,090,356)
------------ ------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Maturity of securities, net 11,725,007 1,951,441
Purchase of fixed assets, net (163,862) (325,999)
Reimbursements (payments) for patent development costs 106,131 (55,300)
Refund of deposits 1,059 0
------------ ------------
Cash flows provided by investing
activities 11,668,335 1,570,142
------------ ------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Sale of common stock 3,850 13,000
------------ ------------
NET INCREASE IN CASH AND CASH EQUIVALENTS 8,179,517 492,786
CASH AND CASH EQUIVALENTS - BEGINNING OF
PERIOD 5,456,826 16,131,263
------------ ------------
CASH AND CASH EQUIVALENTS - END OF PERIOD $ 13,636,343 $ 16,624,049
============ ============
</TABLE>
The accompanying notes are an integral part of this statement.
Page 5
<PAGE> 6
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, 1996
included in the Company's annual report on Form 10-K.
The interim financial statements for the three months ended March 31,
1997 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 ended March 31, 1997 are not necessarily indicative of the
results to be expected for the year ending December 31, 1997.
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 March 31, 1997 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>
March 31, December 31,
1997 1996
------------ -------------
<S> <C> <C>
Finished goods $ 1,963,660 $ 1,399,858
Work in process 404,528 491,014
Raw materials 2,172,581 2,260,148
------------ -------------
Total $ 4,540,769 $ 4,151,020
============ =============
</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 6
<PAGE> 7
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.
"LOSS PER SHARE"
Loss per share is based on the weighted average number of shares
outstanding.
"NEW ACCOUNTING STANDARDS"
In February 1997, the Financial Accounting Standards Board issued
Statement of Financial Accounting Standard (SFAS) No. 128, "Earnings per
Share." The statement is effective for financial statements for periods
ending after December 15, 1997, and changes the method in which earnings
per share will be determined. Adoption of this statement by the Company
will not have a material impact on earnings per share.
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, 1997 19,831,538 $ 1,983 $60,122,275
Issuance of 117,410 shares of
stock pursuant to stock option plan, net 117,410 12 3,839
---------- ------- -----------
Balance, March 31, 1997 19,948,948 $ 1,995 $60,126,114
========== ======= ===========
</TABLE>
Page 7
<PAGE> 8
ITEM 2.
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
GENERAL
From inception (1987) through 1994, the Company primarily engaged in the
research and development of transdermal drug delivery systems. During this
period, the Company's revenues were principally generated by license fees,
milestone payments pursuant to various license agreements and interest earned
on funds raised through the sale of its common stock. In 1995, due to the
receipt of regulatory approvals for its transdermal estrogen delivery system, a
significant portion of the Company's revenues were derived from the sale of
this product to the Company's two licensing partners. In 1996, revenues from
the sale of these products increased substantially as the Company's licensing
partners initiated marketing and distribution. Noven expects that revenues from
product sales to its licensing partners will fluctuate from quarter to quarter
and year to year depending upon various factors not in Noven's control,
including, but not limited to, the inventory requirements of each 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. the introduction of the
product into new territories.
Noven experienced fluctuations in sales of its transdermal estrogen delivery
systems, Vivelle(TM) and MENOREST, to its licensing partners from the first
three quarters to the last quarter of 1996 and the first quarter of 1997, when
sales to these licensing partners declined. Although in-market sales of Noven's
transdermal estrogen delivery system continue to increase on a global basis, it
is anticipated that inventory balancing by the Company's licensing partners will
result in significantly lower levels of reorders during the second quarter of
1997, causing continued losses. After this circumstance has been corrected,
Noven expects that product sales to its licensing partners will significantly
increase in the second half of 1997.
Noven also expects to generate revenues in 1997 from licensing agreements with
respect to products under development, although such revenues will fluctuate
from period to period depending upon such factors as the number of new
agreements finalized, timely achievement of milestones and strategic decisions
affecting self-funding of products.
Finally, during calendar year 1996, the Company commenced the marketing of its
DentiPatch(TM) system. It is anticipated that significant revenues will be
generated from the sale of this product commencing in the second half of 1997.
RESULTS OF OPERATIONS
Total revenues decreased approximately $3,873,000 or 70% for the three month
period ended March 31, 1997 from the same period in the prior year. This
decrease in revenues was the result of the decrease of approximately $3,825,000
in sales of the Company's transdermal estrogen delivery system to its two
licensing partners. Royalties from transdermal estrogen delivery system are
included in products sales. Interest income decreased approximately $54,000 or
20% for the three month period of 1997 primarily due to lower average balances
in securities.
Page 8
<PAGE> 9
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(CONTINUED)
Cost of product sold decreased approximately $2,299,000 or 79% for the three
month period ended March 31, 1997 from the same period in the prior year. The
gross margin percentage was 56% for the first quarter of 1997 as compared to
44% for the same period of the prior year. The gross margins vary depending on
the amount of product sold to each licensing partner and manufacturing
efficiencies including those relating to production volumes and in the first
quarter of 1997 was favorably impacted by the sale of the DentiPatch product.
Research and development expenses decreased approximately $270,000 or 11% for
the three month period ended March 31, 1997 from the same period in the prior
year. The decrease in research and development expenses from 1996 to 1997 was
attributable to less process development activity and a reduced amount of cost
associated with the validation of manufacturing equipment and facilities. In
1997 research and development expenses for new product development continued at
the same rate as in 1996. New product development included work related to
transoral delivery systems in the areas of glucose metabolism, hormone
deficiency and cardiovascular disease, in addition to transdermal delivery
systems for NSAIDs and other widely sold drugs. Marketing, general and
administrative expenses increased approximately $835,000 or 96% for the three
month period ended March 31, 1997 from the same period in the prior year. 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.
LIQUIDITY AND CAPITAL RESOURCES
The Company has historically financed its operations through public offerings
of common stock, including the exercise of warrants issued in connection with
the first such offerings, private placements of its equity securities, license
and contract revenues, and interest income. However, since the launch of its
first commercial product in 1995, the Company's operations have been
principally financed increasingly by revenues from the sale of its transdermal
estrogen delivery system to its licensing partners. The Company has neither
utilized debt nor has it engaged in significant commercial lease transactions
to finance its operations.
Net cash used in operating activities for the three months ended March 31, 1997
was approximately $3,493,000 compared to approximately $1,090,000 for the three
months ended March 31, 1996. Cash used in 1997 was primarily due to decreases
in accounts payable and accrued liabilities, along with the net operating loss
and increases in inventories. In 1996 net cash used by operating activities was
primarily attributable to decreases in accounts payable and accrued liabilities
along with the net operating loss and increases in inventories, partially
offset by decreases in accounts receivable.
During the three months ended March 31, 1997 the Company's investing activities
provided approximately $11,700,000 compared to approximately $1,570,000 for the
three months ended March 31, 1996. Net cash provided during 1997 in investing
activities resulted primarily from the sale of securities held to maturity to
finance operating activities and reimbursement of patent cost partially offset
by capital expenditures for commercial manufacturing equipment and improvements
at the new manufacturing site. Net cash provided
Page 9
<PAGE> 10
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(CONTINUED)
in 1996, resulted primarily from the sale of securities held to maturity to
finance operating activities, partially offset by capital expenditures for
manufacturing equipment, buildup of manufacturing facilities and investments in
patents. As of March 31, 1997 the Company had commitments for capital
expenditures of approximately $50,000.
Net cash provided by financing activities of $4,000 and $13,000 for three
months ended March 31, 1997 and 1996 respectively, resulted form the exercise
of options in the employee stock option plan.
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 Novartis, 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.
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.
Page 10
<PAGE> 11
MANAGEMENT'S DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
(CONTINUED)
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
Item 6. Exhibits and Reports on Form 8-K
None
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: May 14, 1997 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
<S> <C>
<PERIOD-TYPE> 3-MOS
<FISCAL-YEAR-END> DEC-31-1997
<PERIOD-START> JAN-01-1997
<PERIOD-END> MAR-31-1997
<CASH> 13,636,343
<SECURITIES> 1,967,003
<RECEIVABLES> 3,310,817
<ALLOWANCES> 0
<INVENTORY> 4,540,769
<CURRENT-ASSETS> 23,728,498
<PP&E> 18,738,737
<DEPRECIATION> 3,103,531
<TOTAL-ASSETS> 40,826,548
<CURRENT-LIABILITIES> 1,465,847
<BONDS> 0
0
0
<COMMON> 1,995
<OTHER-SE> 33,319,190
<TOTAL-LIABILITY-AND-EQUITY> 40,826,548
<SALES> 1,346,521
<TOTAL-REVENUES> 1,681,279
<CGS> 593,256
<TOTAL-COSTS> 593,256
<OTHER-EXPENSES> 2,139,560
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (2,759,609)
<INCOME-TAX> 0
<INCOME-CONTINUING> (2,759,609)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (2,759,609)
<EPS-PRIMARY> (.14)
<EPS-DILUTED> (.14)
</TABLE>
