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 June 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.)
2875 Northeast 191st Street, Ste 400
Aventura, Florida 33180
(Address of principal executive offices) (Zip Code)
Company's telephone number, including area code: (305) 933-6089
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 July 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 six months ended June 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>
June 30, December 31,
2000 1999
------------- -------------
<S> <C> <C>
ASSETS
Current assets-
Cash and cash equivalents $ 9,221,413 $ 1,982,085
Accounts receivable, net 2,327,181 1,835,086
Inventories 1,468,412 1,848,816
Prepaid expenses 453,852 468,948
Other current assets 316,201 568,259
------------- -------------
Total current assets 13,787,059 6,703,194
Property and equipment, net 820,710 1,008,553
Intangible assets, net 1,894,560 4,860,212
Other assets 282,684 415,654
------------- -------------
TOTAL ASSETS $ 16,785,013 $ 12,987,613
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY)
Current liabilities-
Accaounts payable $ 1,819,572 $ 2,089,260
Accrued expenses 1,203,599 1,072,567
Deferred revenue 100,000 100,000
------------- -------------
Total current liabilities 3,123,171 3,261,827
Convertible subordinated note payable 10,000,000 10,000,000
------------- -------------
TOTAL LIABILITIES 13,123,171 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 106,084,808 99,575,803
Accumulated deficit (102,736,627) (100,198,848)
Accumulated other comprehensive income 8,826 57,507
------------- -------------
TOTAL STOCKHOLDERS' EQUITY (DEFICIENCY) 3,661,842 (274,214)
------------- -------------
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIENCY) $ 16,785,013 $ 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>
Six Months Ended Three Months Ended
June 30, June 30,
2000 1999 2000 1999
------------------ ------------------ ----------------- ------------------
<S> <C> <C> <C> <C>
NET SALES $5,705,955 $12,625,578 $2,716,025 $7,159,117
COST OF GOODS SOLD 2,100,165 3,625,038 880,317 1,848,197
------------------ ------------------ ----------------- ------------------
Gross profit 3,605,790 9,000,540 1,835,708 5,310,920
------------------ ------------------ ----------------- ------------------
OPERATING EXPENSES:
Selling and distribution 1,414,589 2,012,089 601,719 1,154,262
General and administrative 1,844,833 2,774,490 1,056,705 1,289,892
Research and development 2,529,611 2,875,246 1,166,199 1,485,170
------------------ ------------------ ----------------- ------------------
Total operating expenses 5,789,033 7,661,825 2,824,623 3,929,324
------------------ ------------------ ----------------- ------------------
Income (loss) from operations (2,183,243) 1,338,715 (988,915) 1,381,596
------------------ ------------------ ----------------- ------------------
OTHER INCOME (EXPENSE):
License fees, net of expenses - 387,500 - -
Interest income 135,909 56,263 107,605 25,768
Interest expense (377,676) (377,676) (188,838) (188,838)
Corporate restructuring expense (285,000) - (285,000) -
Other, net 172,234 (20,198) 179,068 968
------------------ ------------------ ----------------- ------------------
(354,533) 45,889 (187,165) (162,102)
------------------ ------------------ ----------------- ------------------
Income (loss) before income taxes (2,537,776) 1,384,604 (1,176,080) 1,219,494
Provision for income taxes - 69,000 - 44,000
------------------ ------------------ ----------------- ------------------
Net income (loss) ($2,537,776) $1,315,604 ($1,176,080) $1,175,494
================== ================== ================= ==================
INCOME (LOSS) PER COMMON AND
POTENTIAL COMMON SHARE:
Basic $ (.09) $ .04 $ (.04) $ .03
================== ================== ================= ==================
Diluted $ (.09) $ .04 $ (.04) $ .03
================== ================== ================= ==================
WEIGHTED AVERAGE NUMBER OF
COMMON AND POTENTIAL
COMMON SHARES OUTSTANDING:
Basic 29,986,278 28,685,000 30,445,392 28,686,000
================== ================== ================= ==================
Diluted 29,986,278 29,474,000 30,445,392 29,881,000
================== ================== ================= ==================
</TABLE>
See notes to condensed consolidated financial statements
Page 4 of 17
<PAGE>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE OPERATIONS
(Unaudited)
<TABLE>
<CAPTION>
Six Months Ended Three Months Ended
June 30, June 30,
2000 1999 2000 1999
----------------- ---------------- ------------------ ----------------
<S> <C> <C> <C> <C>
NET INCOME (LOSS) ($2,537,776) $1,315,604 ($1,176,080) $1,175,494
Other comprehensive income (loss):
Foreign currency translation, net of tax 48,681 (9,373) (2,866) (47,663)
----------------- ---------------- ------------------ ----------------
Comprehensive income (loss) ($2,489,095) $1,306,231 ($1,178,946) $1,127,831
================= ================ ================== ================
</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>
Six Months Ended June 30,
2000 1999
----------------- ----------------
<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss) ($2,537,776) $1,315,604
Adjustments to reconcile net income (loss) to net
cash used in operating activities-
Depreciation and amortization 412,490 498,235
Issuance of warrants for consulting services 71,370 25,398
Gain on sale of assets (158,629) -
Loss on disposal of fixed assets 9,927 -
Changes in assets and liabilities-
(Increase) decrease in:
Accounts receivable (492,095) (3,255,718)
Inventories 380,404 647,199
Prepaid expenses 15,096 (162,284)
Other assets 385,028 7,931
Increase (decrease) in:
Accounts payable (269,688) (1,313,339)
Accrued expenses 105,982 (184,300)
----------------- ----------------
Net cash used in operating activities (2,077,891) (2,421,274)
----------------- ----------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from sale of assets 4,119,729 -
Purchase of property and equipment (5,025) (55,456)
Acquisition of licensing rights (525,000) (100,000)
----------------- ----------------
Net cash provided by (used in) investing activities 3,589,704 (155,456)
----------------- ----------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of preferred stock - 5,789,639
Dividends paid (115,308) (266,721)
Proceeds from exercise of options and warrants 5,891,504 26,875
----------------- ----------------
Net cash provided by financing activities 5,776,196 5,549,793
----------------- ----------------
</TABLE>
(Continued)
Page 6 of 17
<PAGE>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Continued)
<TABLE>
<CAPTION>
Six Months Ended June 30,
2000 1999
---------------- ----------------
<S> <C> <C>
EFFECT OF EXCHANGE RATE CHANGES ON CASH (48,681) 9,866
---------------- ----------------
NET INCREASE IN CASH
AND CASH EQUIVALENTS 7,239,328 2,982,929
CASH AND CASH EQUIVALENTS,
Beginning of period 1,982,085 315,288
---------------- ----------------
CASH AND CASH EQUIVALENTS,
End of period $9,221,413 $3,298,217
================ ================
</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:
June 30, December 31,
2000 1999
------------------- -------------------
Finished goods $838,295 $1,029,574
Raw materials 630,117 819,242
------------------- -------------------
$1,468,412 $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 June 30, 2000, the Company has received approximately $169,000 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>
Six Months Ended March 31, Three Months Ended June 30,
2000 1999 2000 1999
------------------ ----------------- ------------------ ----------------
<S> <C> <C> <C> <C>
Net income (loss) ($2,537,776) $1,315,604 ($1,176,080) $1,175,494
Less: Preferred stock dividends (115,308) (145,064) (52,904) (85,096)
Deduction related to Series C
Convertible Preferred Stock - (133,320) - (133,320)
------------------ ----------------- ------------------ ----------------
Net income (loss) applicable to
common stock ($2,653,084) $1,037,220 ($1,228,984) $957,078
================== ================= ================== ================
Basic:
Weighted average number of
common shares outstanding 29,986,278 28,685,000 30,445,392 28,686,000
================== ================= ================== ================
Basic net income (loss) per common share $ (.09) $ .04 $ (.04) $ .03
================== ================= ================== ================
Diluted:
Weighted average number of
common shares outstanding 29,986,278 28,685,000 30,445,392 28,686,000
Weighted average number of
potential common shares - 789,000 - 1,195,000
------------------ ----------------- ================== ================
Weighted average number of
common and potential shares outstanding 29,986,278 29,474,000 30,445,392 29,881,000
================== ================= ================== ================
Diluted net income (loss) per
common share $ (.09) $ .04 $ (.04) $ .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 six months
ended June 30, 2000-
United States $4,649,408 ($854,570) $10,989,429
Europe 1,056,547 (1,328,673) 5,795,584
------------------ ----------------- ------------------
$5,705,955 ($2,183,243) $16,785,013
================== ================= ==================
As of and for the six months
ended June 30, 1999-
United States $11,065,160 $4,217,655 $12,091,114
Europe 1,560,418 (2,878,940) 5,194,457
------------------ ----------------- ------------------
$12,625,578 $1,338,715 $17,285,571
================== ================= ==================
As of and for the three months
ended June 30, 2000-
United States $2,236,624 ($709,743)
Europe 479,401 (279,172)
------------------ -----------------
$2,716,025 ($988,915)
================== =================
As of and for the three months
ended June 30, 1999-
United States $6,566,273 $2,989,092
Europe 592,844 (1,607,496)
------------------ -----------------
$7,159,117 $1,381,596
================== =================
</TABLE>
(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
Page 10 of 17
<PAGE>
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 $9,221,000 at June 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 June 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 June 30, 2000, the Company has paid approximately $1.7 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.
As of June 30, 2000, the Company has outstanding exercisable options
and warrants that, if exercised, would
Page 12 of 17
<PAGE>
result in approximately $46.3 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 $6 million on research and
development in 2000 and an additional $100,000 on property and equipment.
As of June 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 June 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 - Six Months Ended June 30, 2000 versus Six Months Ended
June 30, 1999
Net sales decreased by approximately $6.9 million from approximately
$12.6 million in 1999 compared to $5.7 million in 2000. The decrease is
primarily the result of decreased Crinone sales of approximately $5.6 million in
2000 from approximately $8.5 million in 1999 to approximately $2.9 million in
2000 as result of Ares-Serono's transition to marketing Crinone in the U.S and
abroad. The remainder of the decrease in sales totaling approximately $1.2
million is the result of 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 decreased in 2000 to 63% as
compared to 71% in 1999. The lower gross profit in 2000 is the result of the
decrease in Crinone sales in which has a higher gross profit.
Selling and distribution expenses decreased by approximately $597,000
in 2000 to approximately $1,415,000 in 2000 from $2,012,000 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 $362,000
reduction in advertising and marketing expenses, an approximately $56,000
reduction broker expenses, an approximately $51,000 reduction in Replens
amortization expense and an approximately $67,000 reduction in warehousing and
freight costs. These reductions were offset in part with an approximately
$185,000 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 $113,000 in royalties and an approximately $64,000
reduction in warehousing and freight costs.
General and administrative expenses decreased by approximately $929,000
in 2000 to approximately $1,845,000 in 2000 compared to approximately $2,774,000
in 1999. The majority of the decrease is the result of a decrease in legal
expenses of approximately $781,000 related to litigation settled in March 2000.
Research and development decreased in 2000 by approximately $345,000
from approximately $2,875,000 in 1999 to $2,530,000 in 2000. The decrease is
primarily related to decreased stability and regulatory expenses totaling
approximately $356,000 related to decreased Crinone production.
Corporate restructure expenses of $285, 000 relate 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.
Interest expense related to the convertible subordinated note payable
totaled approximately $378,000 in 2000 and 1999.
Page 13 of 17
<PAGE>
In 2000, 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 six months ended June 30, 2000 was
$2,537,776 or $(.09) per common share as compared to a net income for the six
months ended June 30, 1999 of $1,315,604 or $.04 per common share.
Results of Operations - Three Months Ended June 30, 2000 versus Three Months
Ended June 30, 1999
Net sales decreased by approximately $4.4 million from approximately
$7.2 million in 1999 compared to $2.7 million in 2000. The decrease is primarily
the result of decreased Crinone sales of approximately $3.6 million in 2000 from
approximately $5.3 million in 1999 to approximately $1.7 million in 2000 as
result of Ares-Serono's transition to marketing Crinone in the U.S and abroad.
The remainder of the decrease in sales totaling approximately $1 million is the
result of 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 decreased in 2000 to 68% as
compared to 74% in 1999. The lower gross profit in 2000 is the result of the
decrease in Crinone sales in which has a higher gross profit.
Selling and distribution expenses decreased by approximately $552,000
in 2000 to approximately $602,000 in 2000 from $1,154,000 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 $326,000 reduction in
advertising and marketing expenses, an approximately $41,000 reduction broker
expenses, an approximately $51,000 reduction in Replens amortization expense and
an approximately $49,000 reduction in warehousing and freight costs. Due to the
reduction in Crinone sales there was a reduction of approximately $70,000 in
royalties and an approximately $46,000 reduction in warehousing and freight
costs.
General and administrative expenses decreased by approximately $233,000
in 2000 to approximately $1,057,000 in 2000 compared to approximately $1,290,000
in 1999. The majority of the decrease is the result of a decrease in legal
expenses of approximately $68,000 related to litigation settled in March 2000
and approximately $76,000 in reduction in insurance expenses.
Research and development decreased in 2000 by approximately $319,000
from approximately $1,485,000 in 1999 to $1,166,000 in 2000. The decrease is
primarily related to decreased stability and regulatory expenses totaling
approximately $123,000 related to decreased Crinone production.
Corporate restructure expenses of $285,000 relate to estimated costs
associated with the Company's closing of its corporate and accounting operations
in Florida.
Interest expense related to the convertible subordinated note payable
totaled approximately $189,000 in 2000 and 1999.
In 2000, the Company recorded a $44,000 alternative minimum tax
provision for U.S. federal taxes. No such provision is required in 2000.
As a result, the net loss for the three months ended June 30, 2000 was
$1,176,080 or $(.04) per common share as compared to a net income for the three
months ended June 30, 1999 of $1,175494 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
The 2000 annual meeting of shareholders was held on May 31, 2000 for
the purpose of electing the following eight directors (with each
nominee receiving at least 27,058,906 votes out of a possible
30,466,863 votes): James J. Apostolakis, William J. Bologna, Jean
Carvais, M.D., Dominique de Ziegler, M.D., Norman M. Meier, Denis
O'Donnell, M.D., Selwyn Oskowitz, M.D. and Robert C. Strauss. Also
approved by a majority of those voting was a proposal to amend the
Certificate of Incorporation of the Company to increase from 40 million
to 100 million the aggregate number of authorized shares of the
Company's common stock and a proposal to amend the Company's 1996
Long-Term Performance Plan (the "Plan") in order to increase the number
of authorized shares available under the Plan to four million and to
amend certain other provisions of the Plan.
Page 15 of 17
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Item 5. Other Information
None.
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: August 14, 2000
Page 17 of 17
<PAGE>
INDEX TO EXHIBITS
EXHIBIT
NUMBERS
-------
27.1 - Financial Data Schedule
