SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10 - Q
[X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended September 30, 2000
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the transition period from ______________ to ______________
Commission File Number 1-10352
COLUMBIA LABORATORIES, INC.
(Exact name of Company as specified in its charter)
Delaware 59-2758596
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification No.)
100 North Village Avenue, Suite 32
Rockville Centre, New York 11570
(Address of principal executive offices) (Zip Code)
Company's telephone number, including area code: (516) 766-2847
Indicate by check mark whether the Company (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 Company
was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes X No___
Number of shares of the Common Stock of Columbia Laboratories, Inc.
issued and outstanding as of October 31, 2000: 30,477,782
<PAGE>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
PART 1 - FINANCIAL INFORMATION
Item 1. Financial Statements
The following unaudited, condensed consolidated financial statements of
the Company have been prepared in accordance with the instructions to Form 10-Q
and, therefore, omit or condense certain footnotes and other information
normally included in financial statements prepared in accordance with generally
accepted accounting principles. In the opinion of management, all adjustments
(consisting only of normal recurring accruals) necessary for a fair presentation
of the financial information for the interim periods reported have been made.
Results of operations for the nine months ended September 30, 2000 are not
necessarily indicative of the results for the year ending December 31, 2000.
Except for historical information contained herein, the matters
discussed in this document are forward looking statements made pursuant to the
safe harbor provisions of the Securities Litigation Reform Act of 1995. Such
statements involve risks and uncertainties, including but not limited to
economic, competitive, governmental and technological factors affecting the
Company's operations, markets, products and prices, and other factors discussed
elsewhere in this report.
Page 2 of 17
<PAGE>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
<TABLE>
<CAPTION>
September 30, December 31,
2000 1999
-------------------- --------------------
(Unaudited)
<S> <C> <C>
ASSETS
Current assets-
Cash and cash equivalents $7,823,032 $1,982,085
Accounts receivable, net 2,783,964 1,835,086
Inventories 1,253,781 1,848,816
Prepaid expenses 749,366 468,948
Other current assets 316,201 568,259
-------------------- --------------------
Total current assets 12,926,344 6,703,194
Property and equipment, net 680,428 1,008,553
Intangible assets, net 1,820,688 4,860,212
Other assets 253,578 415,654
-------------------- --------------------
TOTAL ASSETS $15,681,038 $12,987,613
==================== ====================
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY)
Current liabilities-
Accounts payable $1,336,310 $2,089,260
Accrued expenses 886,733 1,072,567
Deferred revenue 100,000 100,000
-------------------- --------------------
Total current liabilities 2,323,043 3,261,827
Convertible subordinated note payable 10,000,000 10,000,000
-------------------- --------------------
TOTAL LIABILITIES 12,323,043 13,261,827
-------------------- --------------------
Stockholders' equity (deficiency)-
Preferred stock, $.01 par value; 1,000,000 shares authorized:
Series A Convertible Preferred Stock, 33 and 923
shares issued and outstanding in 2000 and 1999, respectively -- 9
Series B Convertible Preferred Stock, 1,630
shares issued and outstanding in 2000 and 1999 16 16
Series C Convertible Preferred Stock, 4,110 and 5,260
shares issued and outstanding in 2000 and 1999, respectively 41 53
Common stock, $.01 par value; 100,000,000 shares in 2000 and
40,000,000 shares in 1999 authorized; 30,477,782 and 29,124,686
shares issued and outstanding in 2000 and 1999, respectively 304,778 291,246
Capital in excess of par value 106,076,383 99,575,803
Accumulated deficit (103,009,171) (100,198,848)
Accumulated other comprehensive income (14,052) 57,507
-------------------- --------------------
TOTAL STOCKHOLDERS' EQUITY (DEFICIENCY) 3,357,995 (274,214)
-------------------- --------------------
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIENCY) $15,681,038 $12,987,613
==================== ====================
</TABLE>
See notes to condensed consolidated financial statements
Page 3 of 17
<PAGE>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
<TABLE>
<CAPTION>
Nine Months Ended Three Months Ended
September 30, September 30,
2000 1999 2000 1999
------------------ ------------------ ----------------- ------------------
<S> <C> <C> <C> <C>
NET SALES $ 9,219,872 $ 17,129,968 $ 3,513,917 $ 4,504,390
COST OF GOODS SOLD 3,090,233 4,975,544 990,068 1,350,506
------------------ ------------------ ----------------- ------------------
Gross profit 6,129,639 12,154,424 2,523,849 3,153,884
------------------ ------------------ ----------------- ------------------
OPERATING EXPENSES:
Selling and distribution 1,773,510 3,005,952 358,921 993,863
General and administrative 3,029,880 3,707,188 1,185,047 932,698
Research and development 3,722,316 4,864,379 1,192,705 1,989,133
------------------ ------------------ ------------------
Total operating expenses 8,525,706 11,577,519 2,736,673 3,915,694
------------------ ------------------ ----------------- ------------------
Income (loss) from operations (2,396,067) 576,905 (212,824) (761,810)
------------------ ------------------ ----------------- ------------------
OTHER INCOME (EXPENSE):
License fees, net of expenses -- 387,500 -- --
Interest income 258,880 101,072 122,971 44,809
Interest expense (566,514) (566,514) (188,838) (188,838)
Corporate restructuring expense (285,000) -- -- --
Other, net 178,378 (44,542) 6,144 (24,344)
------------------ ------------------ ----------------- ------------------
(414,256) (122,484) (59,723) (168,373)
------------------ ------------------ ----------------- ------------------
Income (loss) before income taxes (2,810,323) 454,421 (272,547) (930,183)
Provision for income taxes -- 69,000 -- --
------------------ ------------------ ----------------- ------------------
Net income (loss) ($2,810,323) $385,421 ($272,547) ($930,183)
================== ================== ================= ==================
INCOME (LOSS) PER COMMON AND
POTENTIAL COMMON SHARE:
Basic and Diluted $ (.10) $ -- $ (.01) $ (.03)
================== ================== ================= ==================
WEIGHTED AVERAGE NUMBER OF
COMMON AND POTENTIAL
COMMON SHARES OUTSTANDING:
Basic and Diluted 30,151,000 28,790,000 30,478,000 28,997,000
================== ================== ================= ==================
</TABLE>
Page 4 of 17
<PAGE>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE OPERATIONS
(Unaudited)
<TABLE>
<CAPTION>
Nine Months Ended Three Months Ended
September 30, September 30,
2000 1999 2000 1999
------------------ ----------------- ------------------ ----------------
<S> <C> <C> <C> <C>
NET INCOME (LOSS) ($2,810,323) $385,421 ($272,547) ($930,183)
Other comprehensive income (loss):
Foreign currency translation, net of tax 71,559 (23,432) 22,878 (13,566)
------------------ ----------------- ------------------ ----------------
Comprehensive income (loss) ($2,738,764) $361,989 ($249,669) ($943,749)
================== ================= ================== ================
</TABLE>
See notes to condensed consolidated financial statements
Page 5 of 17
<PAGE>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
<TABLE>
<CAPTION>
Nine Months Ended September 30,
2000 1999
----------------- ----------------
<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss) ($2,810,323) $385,421
Adjustments to reconcile net income (loss) to net
cash used in operating activities-
Depreciation and amortization 582,605 729,520
Issuance of warrants for consulting services 114,387 42,187
Gain on sale of assets (158,629) --
Loss on disposal of fixed assets 47,817 --
Changes in assets and liabilities-
(Increase) decrease in:
Accounts receivable (948,878) (1,016,498)
Inventories 595,035 812,675
Prepaid expenses (280,418) (244,479)
Other assets 414,133 532
Increase (decrease) in:
Accounts payable (752,950) (1,332,866)
Accrued expenses (210,884) (413,360)
Deferred revenue -- (478,150)
----------------- ----------------
Net cash used in operating activities (3,408,105) (1,515,018)
----------------- ----------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from sale of assets 4,119,729 --
Purchase of property and equipment (16,168) (75,647)
Acquisition of licensing rights (525,000) (100,000)
----------------- ----------------
Net cash provided by (used in) investing activities 3,578,561 (175,647)
----------------- ----------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of preferred stock -- 5,770,343
Dividends paid (166,749) (338,692)
Proceeds from exercise of options and warrants 5,891,504 149,375
----------------- ----------------
Net cash provided by financing activities 5,724,755 5,581,026
----------------- ----------------
</TABLE>
(Continued)
Page 6 of 17
<PAGE>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Continued)
<TABLE>
<CAPTION>
Nine Months Ended September 30,
2000 1999
----------------- ----------------
<S> <C> <C>
EFFECT OF EXCHANGE RATE CHANGES ON CASH (54,264) 23,432
----------------- ----------------
NET INCREASE IN CASH
AND CASH EQUIVALENTS 5,840,947 3,913,793
CASH AND CASH EQUIVALENTS,
Beginning of period 1,982,085 315,288
----------------- ----------------
CASH AND CASH EQUIVALENTS,
End of period $7,823,032 $4,229,081
================= ================
</TABLE>
See notes to condensed consolidated financial statements
Page 7 of 17
<PAGE>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
(1) SIGNIFICANT ACCOUNTING POLICIES:
The accounting policies followed for quarterly financial reporting are
the same as those disclosed in Note (1) of the Notes to Consolidated Financial
Statements included in the Company's Annual Report on Form 10-K for the fiscal
year ended December 31, 1999.
(2) INVENTORIES:
September 30, December 31,
2000 1999
------------------- -------------------
Finished goods $631,568 $1,029,574
Raw materials 622,213 819,242
------------------- -------------------
$1,253,781 $1,848,816
=================== ===================
(3) SALE OF ASSETS
Effective May 5, 2000, the Company sold various tangible and intangible assets
related to the U.S. rights for Replens for a total of $4.5 million cash.
Additionally, the purchaser agreed to buy up to $500,000 of Replens inventory
from the Company and to pay future royalties of up to $2 million equal to 10% of
future U.S. sales of Replens.
Additionally, effective May 5, 2000, the Company licensed its Legatrin PM,
Legatrin GCM, Vaporizer in a Bottle and Diasorb brands to the same purchaser
mentioned above. Under the terms of these agreements, the Company will receive
license fees equal to 20% of the licensee's net sales of these brands. These
agreements each have five-year terms with provisions for renewal and contain
options that allow the licensee to acquire the brands from the Company.
As of September 30, 2000, the Company has received approximately $408,669 in
royalty and license fees which have been included in net sales in the
accompanying statements of operations.
Page 8 of 17
<PAGE>
(4) INCOME (LOSS) PER COMMON AND COMMON EQUIVALENT SHARE:
The calculation of basic and diluted income (loss) per common and
common equivalent share is as follows:
<TABLE>
<CAPTION>
Nine Months Ended September 30, Three Months Ended September 30,
2000 1999 2000 1999
----------------- ------------------ ----------------- ------------------
<S> <C> <C> <C> <C>
Net income (loss) ($2,810,323) $385,421 ($272,547) ($930,183)
Less: Preferred stock dividends (166,749) (217,035) (51,441) (71,971)
Deduction related to Series C
Convertible Preferred Stock -- (133,320) -- --
----------------- ------------------ ----------------- ------------------
Net income (loss) applicable to
common stock ($2,977,072) $35,066 ($323,988) ($1,002,154)
================= ================== ================= ==================
Basic:
Weighted average number of
common shares outstanding 30,151,000 28,790,000 30,478,000 28,686,000
================= ================== ================= ==================
Basic net income (loss) per common share $ (.10) $ -- $ (.01) $ (.03)
================= ================== ================= ==================
Diluted:
Weighted average number of
common shares outstanding 30,151,000 28,790,000 30,478,000 28,997,000
Weighted average number of
potential common shares -- -- -- --
----------------- ------------------ ================= ==================
Weighted average number of
common and potential shares outstanding 30,151,000 28,790,000 30,478,000 28,997,000
================= ================== ================= ==================
Diluted net income (loss) per
common share $ (.10) $ -- $ (.01) $ (.03)
================= ================== ================= ==================
</TABLE>
Page 9 of 17
<PAGE>
(5) SEGMENT INFORMATION:
The Company and its subsidiaries are engaged in one line of business, the
development and sale of pharmaceutical products and cosmetics. The following
table shows selected unaudited information by geographic area:
<TABLE>
<CAPTION>
Income
Net (Loss) from Identifiable
Sales Operations Assets
------------------ ----------------- ------------------
<S> <C> <C> <C>
As of and for the nine months
ended September 30, 2000-
United States $7,406,177 ($965,601) $8,907,612
Europe 1,813,695 (1,430,466) 6,773,426
------------------ ----------------- ------------------
$9,219,872 ($2,396,067) $15,681,038
================== ================= ==================
As of and for the nine months
ended September 30, 1999-
United States $14,808,968 $4,921,469 $12,112,150
Europe 2,321,000 (4,344,564) 3,578,087
------------------ ----------------- ------------------
$17,129,968 $576,905 $15,690,237
================== ================= ==================
As of and for the three months
ended September 30, 2000-
United States $2,756,769 ($111,031)
Europe 757,148 (101,793)
------------------ -----------------
$3,513,917 ($212,284)
================== =================
As of and for the three months
ended September 30, 1999-
United States $3,743,808 $703,814
Europe 760,582 (1,465,624)
------------------ -----------------
$4,504,390 ($761,810)
================== =================
</TABLE>
Page 10 of 17
<PAGE>
(6) LITIGATION:
In June and July 2000, six class action lawsuits were filed in the United States
District Court for the Southern District of Florida purportedly on behalf of
purchasers of the Company's common stock during the period from November 8, 1999
to June 9, 2000. The complaints allege, among other things, that the Company and
other defendants made materially misleading statements and omissions about the
likely prospects for two of the Company's products. The Company believes that
the lawsuits are without merit and intends to defend the lawsuits vigorously.
The Company filed an action in the United States District Court for the
Southern District of Florida ("Florida Action") in November 1997 seeking a
declaratory judgment on certain issues related to its relationship with Lake
Consumer Products, Inc. ("Lake") as governed by the contract between the Company
and Lake. Lake filed an action against the Company in the United States District
Court, Northern District of Illinois ("Illinois Action") , for damages alleged
by Lake to have been suffered by it as a result of the FDA's allegations in July
1997 that the Company's nonoxynol-9 product, then marketed by Lake under the
tradename Advantage 24, was not permitted to be sold under the monograph. The
Illinois Action was dismissed by the Illinois Court and transferred to the
Florida Court for consolidation as a counterclaim in the Florida Action. On
March 16, 2000, the Company and Lake settled all outstanding issues in the
consolidated Florida Action by the Company having bought out the contract for
the sum of $1,200,000 ($600,000 in cash and $600,000 in the form of Company
common stock). As a result, the Company reacquired the U.S. rights to the
Advantage product and both parties agreed to have their legal actions dismissed.
The total amount of the settlement plus certain attorney's fees, related solely
to the reacquisition of the product rights, have been capitalized as part of
intangible assets in the accompanying balance sheets.
Page 11 of 17
<PAGE>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITIONS AND RESULTS OF OPERATIONS
Liquidity and Capital Resources
The Company and its representatives from time to time make written or
verbal forward looking statements, including statements contained in this and
other filings with the Securities and Exchange Commission and in the Company's
reports to stockholders, which are made pursuant to the safe harbor provisions
of the Private Securities Litigation Reform Act of 1995. Such statements
include, without limitation, the Company's expectations regarding sales,
earnings or other future financial performance and liquidity, product
introductions, entry into new geographic regions and general optimism about
future operations or operating results. Although the Company believes that its
expectations are based on reasonable assumptions within the bounds of its
knowledge of its business and operations, there can be no assurance that actual
results will not differ materially from its expectations. Factors that could
cause actual results to differ from expectations include, without limitation:
(i) increased competitive activity from companies in the pharmaceutical
industry, some of which have greater resources than the Company; (ii) social,
political and economic risks to the Company's foreign operations, including
changes in foreign investment and trade policies and regulations of the host
countries and of the United States; (iii) changes in the laws, regulations and
policies, including changes in accounting standards, that affect, or will
affect, the Company in the United States and abroad; (iv) foreign currency
fluctuations affecting the relative prices at which the Company and foreign
competitors sell their products in the same market; and (v) the ability of the
Company and third parties, including customers or suppliers, to adequately
address Year 2000 issues. Additional information on factors that may affect the
business and financial results of the Company can be found in filings of the
Company with the Securities and Exchange Commission. All forward-looking
statements should be considered in light of these risks and uncertainties. The
Company assumes no responsibility to update forward-looking statements made
herein or otherwise.
Cash and cash equivalents increased from approximately $1,982,000 at
December 31, 1999 to approximately $7,823,000 at September 30, 2000. The Company
received approximately $5.9 million, from the exercise of outstanding options
and warrants, and $4.5 million from the sale of various tangible and intangible
assets related to the U.S. rights for Replens.
The Company has a worldwide, except for South Africa, license and
supply agreement with Ares-Serono ("Serono") a Swiss pharmaceutical company, to
market Crinone. Under the terms of the agreement, as of September 30, 2000, the
Company has earned $17 million in milestone payments and will continue to
receive additional milestone payments. The Company also supplies Crinone to
Serono at a price equal to 30% of Serono's net selling price
In connection with the 1989 purchase of the assets of Bio-Mimetics,
Inc., which assets consisted of the patents underlying the Company's Bioadhesive
Delivery System, other patent applications and related technology, the Company
pays Bio-Mimetics, Inc. a royalty equal to two percent of the net sales of
products based on the Bioadhesive Delivery System, to an aggregate of $7.5
million. The Company is required to prepay a portion of the remaining royalty
obligation, in cash or stock at the option of the Company, if certain conditions
are met. Through September 30, 2000, the Company has paid approximately $1.8
million in royalty payments.
In March 1999, the Company entered into a license and supply agreement
with Mipharm SpA under which Mipharm SpA will be the exclusive marketer of the
Company's previously unlicensed women's healthcare products in Italy, Portugal,
Greece and Ireland with a right of first refusal for Spain. Under the terms of
the agreement, the Company received a $462,500 in 1999, net of expenses, and
expects to receive future milestone payments as products are made available by
the Company.
The Company believes that sales and liquidity will increase as Crinone is fully
marketed by Ares-Serono.
Page 12 of 17
<PAGE>
As of September 30, 2000, the Company has outstanding exercisable
options and warrants that, if exercised, would result in approximately $47.0
million of additional capital. However, there can be no assurance that such
options or warrants will be exercised.
Significant expenditures anticipated by the Company in the near future
are concentrated on research and development related to new products. The
Company anticipates it will spend approximately $5.2 million on research and
development in 2000 and an additional $10,000 on property and equipment.
As of September 30, 2000, the Company had available net operating loss
carryforwards of approximately $50 million to offset its future U.S. taxable
income.
In accordance with Statement of Financial Accounting Standards No. 109,
as of September 30, 2000 and December 31, 1999, other assets in the accompanying
consolidated balance sheets include deferred tax assets of approximately $18
million and $17 million, respectively, (comprised primarily of a net operating
loss carryforward) for which a valuation allowance has been recorded since the
realizability of the deferred tax assets are not determinable.
Results of Operations - Nine Months Ended September 30, 2000 versus Nine Months
Ended September 30, 1999
Net sales decreased by approximately $7.9 million from approximately
$17.1 million in 1999 to approximately $9.2 million in 2000. The decrease is
primarily lower Crinone sales ($5.6 million in 2000 versus $10.3 million in
1999)resulting from the transition to the Company's new marketing partner. The
remainder of the sales decrease totaling approximately $3.2 million results from
the Company's sale of the Replens line and the licensing of the other
over-the-counter brands in May 2000.
Gross profit as a percentage of net sales decreased in 2000 to 66% as
compared to 71% in 1999. The lower gross profit in 2000 is the result of the
decrease in Crinone sales which has a higher gross profit.
Selling and distribution expenses decreased by approximately $1,232,000
to approximately $1,774,000 in 2000 from $3,006,000 in 1999. The reduction is
due primarily to the Company's sale of its Replens line and licensing of the
over-the-counter brands resulting in an approximately $528,000 reduction in
advertising and marketing expenses, an approximately $54,000 reduction of broker
expenses, an approximately $128,000 reduction in Replens amortization expense
and an approximately $157,000 reduction in warehousing and freight costs. These
reductions were offset in part with an approximately $121,000 increase in
advertising allowances in 2000 which the Company assumed as a part of the
transaction. Due to the reduction in Crinone sales there was a reduction of
approximately $91,000 in royalties and an approximately $120,000 reduction in
warehousing and freight costs.
General and administrative expenses decreased by approximately $677,000
to approximately $3,030,000 in 2000 compared to approximately $3,707,000 in
1999. The majority of the decrease is the result of a decrease in legal expenses
of approximately $663,000 related to litigation settled in March 2000. This was
offset somewhat, by an increase of $158,000 for patent counsel incurred because
of the filing of several worldwide patents.
Research and development decreased in 2000 by approximately $1,142,000
from approximately $4,864,000 in 1999 to $3,722,000 in 2000. The decrease is
primarily related to decreased stability, manufacturing development and
regulatory expenses totaling approximately $787,000 related to decreased Crinone
production.
Corporate restructure expenses of $285,000 are related to estimated
costs associated with the Company's closing of its corporate and accounting
operations in Florida.
Net license fees of $387,500 in 1999 represent an upfront payment
received in connection with a licensing agreement entered into in March 1999. No
such fees were received in 2000.
Page 13 of 17
<PAGE>
Interest expense related to the convertible subordinated note payable
totaled approximately $567,000 in 2000 and 1999.
In 1999, the Company recorded a $69,000 alternative minimum tax
provision for U.S. federal taxes. No such provision is required in 2000.
As a result, the net loss for the nine months ended September 30, 2000
was $2,810,323 or $.10 per common share as compared to net income for the nine
months ended September 30, 1999 of $385,421 or $.00 per common share.
Results of Operations - Three Months Ended September 30, 2000 versus Three
Months Ended September 30, 1999
Net sales decreased by approximately $1.0 million from approximately
$4.5 million in 1999 compared to $3.5 million in 2000. The decrease is primarily
the result of decreased sales resulting from the Company's sale of the Replens
line and licensing of the other over-the-counter brands.
Gross profit as a percentage of net sales increased in 2000 to 72% as
compared to 70% in 1999. The divestiture of the over-the-counter products with
their lower gross margins accounted for the improvement.
Selling and distribution expenses decreased by approximately $635,000
to approximately $359,000 in 2000 from $994,000 in 1999. The reduction is due
primarily to the Company's sale of its Replens line and licensing of the
over-the-counter brands resulting in an approximately $247,000 reduction in
advertising and marketing expenses, an approximately $77,000 reduction in
Replens amortization expense and an approximately $91,000 reduction in
warehousing and freight costs.
General and administrative expenses increased by approximately $252,000
to approximately $1,185,000 in 2000 compared to approximately $933,000 in 1999.
The majority of the increase is the result of fees spent to procure worldwide
patent protection on several new patents.
Research and development decreased in 2000 by approximately
$796,000 from approximately $1,989,000 in 1999 to $1,193,000 in 2000. The
decrease is primarily related to decreased stability, manufacturing development
and regulatory expenses totaling approximately $423,000 related to decreased
Crinone production..
Interest expense related to the convertible subordinated note payable
totaled approximately $189,000 in 2000 and 1999.
As a result, the net loss for the three months ended September 30, 2000
was $272,547 or $.01 per common share as compared to the net loss for the three
months ended September 30, 1999 of $930,183 or $.03 per common share.
Page 14 of 17
<PAGE>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
In June and July 2000, six class action lawsuits were filed in the
United States District Court for the Southern District of Florida
purportedly on behalf of purchasers of the Company's common stock
during the period from November 8, 1999 to June 9, 2000. The complaints
allege, among other things, that the Company and other defendants made
materially misleading statements and omissions about the likely
prospects for two of the Company's products. The Company believes that
the lawsuits are without merit and intends to defend the lawsuits
vigorously.
The Company filed an action in the United States District Court for the
Southern District of Florida ("Florida Action") in November 1997
seeking a declaratory judgment on certain issues related to its
relationship with Lake Consumer Products, Inc. ("Lake") as governed by
the contract between the Company and Lake. Lake filed an action against
the Company in the United States District Court, Northern District of
Illinois ("Illinois Action"), for damages alleged by Lake to have been
suffered by it as a result of the FDA's allegations in July 1997 that
the Company's nonoxynol-9 product, then marketed by Lake under the
tradename Advantage 24, was not permitted to be sold under the
monograph. The Illinois Action was dismissed by the Illinois Court and
transferred to the Florida Court for consolidation as a counterclaim in
the Florida Action. On March 16, 2000, the Company and Lake settled all
outstanding issues in the consolidated Florida Action by the Company
having bought out the contract for the sum of $1,200,000 ($600,000 in
cash and $600,000 in the form of Company common stock). As a result,
the Company reacquired the U.S. rights to the Advantage product and
both parties agreed to have their legal actions dismissed.
Other claims and lawsuits have been filed against the Company.
In the opinion of management and counsel, none of these lawsuits are
material and they are all adequately reserved for or covered by
insurance or, if not so covered, are without any or have little merit
or involve such amounts that if disposed of unfavorably would not have
a material adverse effect on the Company.
Item 2. Changes in Securities
None.
Item 3. Defaults upon Senior Securities
None.
Item 4. Submission of Matters to a Vote of Security Holders
None
Item 5. Other Information
None.
Page 15 of 17
<PAGE>
Item 6. Exhibits and Reports on Form 8-K
A. Exhibits
27.1 - Financial Data Schedule (SEC use only)
B. Reports on Form 8-K
None.
Page 16 of 17
<PAGE>
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.
COLUMBIA LABORATORIES, INC.
/S/ DAVID L. WEINBERG
----------------------------------
DAVID L. WEINBERG, Vice President-
Finance and Administration,
Chief Financial Officer
DATE: November 14, 2000
-------------------------
Page 17 of 17
<PAGE>
EXHIBIT INDEX
EXHIBIT NO. DESCRIPTION
----------- -----------
27.1 Financial Data Schedule
