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, 2001
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, Ste 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 July 31, 2001: 31,527,982
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, 2001 are not necessarily
indicative of the results for the year ending December 31, 2001.
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 18
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
CONDENSED CONSOLIDATED BALANCE SHEETS
-------------------------------------
June 30, December 31,
2001 2000
-------------- --------------
(Unaudited)
ASSETS
Current assets-
Cash and cash equivalents $ 6,782,906 $ 7,594,707
Accounts receivable, net 910,748 3,302,801
Inventories 992,346 979,738
Prepaid expenses 870,376 758,603
Other current assets 297,536 325,718
-------------- --------------
Total current assets 9,853,912 12,961,567
Property and equipment, net 403,686 594,516
Intangible assets, net 1,599,071 1,746,815
Other assets 197,318 216,333
-------------- --------------
TOTAL ASSETS $ 12,053,987 $ 15,519,231
============== ==============
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY)
Current liabilities-
Accounts payable $ 993,300 $ 795,508
Accrued expenses 2,716,533 1,129,846
Deferred revenue - 100,000
-------------- --------------
Total current liabilities 3,709,833 2,025,354
Convertible subordinated note payable 10,000,000 10,000,000
-------------- --------------
TOTAL LIABILITIES 13,709,833 12,025,354
-------------- --------------
Stockholders' equity (deficiency)-
Preferred stock, $.01 par value; 1,000,000 shares authorized:
Series A Convertible Preferred Stock, 0 and 33
shares issued and outstanding in 2001 and 2000, respectively - -
Series B Convertible Preferred Stock, 1,630
shares issued and outstanding in 2001 and 2000 16 16
Series C Convertible Preferred Stock, 4,050
shares issued and outstanding in 2001 and 2000 41 41
Common stock, $.01 par value; 100,000,000 authorized
31,093,199 and 30,494,924 shares issued and outstanding
in 2001 and 2000, respectively 310,932 304,949
Capital in excess of par value 109,118,496 105,991,194
Accumulated deficit (111,050,832) (102,801,779)
Accumulated other comprehensive income (34,499) (544)
-------------- --------------
TOTAL STOCKHOLDERS' EQUITY (DEFICIENCY) (1,655,846) 3,493,877
-------------- --------------
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIENCY) $ 12,053,987 $ 15,519,231
============== ==============
See notes to condensed consolidated financial statements
Page 3 of 18
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
-----------------------------------------------
(Unaudited)
-----------
Six Months Ended Three Months Ended
June 30, June 30,
2001 2000 2001 2000
------------- ------------- ------------- -------------
NET SALES $ 1,275,369 $ 5,705,955 $ 427,554 $ 2,716,025
COST OF GOODS SOLD 834,850 2,100,165 368,953 880,317
------------- ------------- ------------- -------------
Gross profit 440,519 3,605,790 58,601 1,835,708
------------- ------------- ------------- -------------
OPERATING EXPENSES:
Selling and distribution 516,909 1,414,589 254,158 601,719
General and administrative 1,932,940 1,844,833 1,172,180 1,056,705
Research and development 3,545,530 2,529,611 1,932,976 1,166,199
Product recall costs 1,500,000 - - -
Corporate restructuring expense 1,000,000 285,000 1,000,000 285,000
------------- ------------- ------------- -------------
Total operating expenses 8,495,379 6,074,033 4,359,314 3,109,623
------------- ------------- ------------- -------------
Income (loss) from operations (8,054,860) (2,468,243) (4,300,713) (1,273,915)
------------- ------------- ------------- -------------
OTHER INCOME (EXPENSE):
Interest income 175,063 135,909 70,219 107,605
Interest expense (377,676) (377,676) (188,838) (188,838)
Other, net 8,420 172,234 (10,792) 179,068
------------- ------------- ------------- -------------
(194,193) (69,533) (129,411) 97,835
------------- ------------- ------------- -------------
Net loss $ (8,249,053) $ (2,537,776) $ (4,430,124) $ (1,176,080)
============= ============= ============= =============
NET LOSS PER COMMON SHARE:
Basic and diluted $ (0.27) $ (0.09) $ (0.14) $ (0.04)
============= ============= ============= =============
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING:
Basic and diluted 30,830,000 29,986,278 30,969,453 30,445,392
============= ============= ============= =============
See notes to condensed consolidated financial statements
Page 4 of 18
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE OPERATIONS
-------------------------------------------------------------
(Unaudited)
-----------
Six Months Ended Three Months Ended
June 30, June 30,
2001 2000 2001 2000
------------- ------------- ------------- -------------
NET LOSS ($8,249,053) ($2,537,776) ($4,430,124) ($1,176,080)
Other comprehensive income (loss):
Foreign currency translation, net of tax 33,955 48,681 7,389 (2,866)
------------- ------------- ------------- -------------
Comprehensive loss ($8,215,098) ($2,489,095) ($4,422,735) ($1,178,946)
============= ============= ============= =============
See notes to condensed consolidated financial statements
Page 5 of 18
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
-----------------------------------------------
(Unaudited)
-----------
Six Months Ended June 30,
2001 2000
----------------- ----------------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss ($8,249,053) ($2,537,776)
Adjustments to reconcile net income (loss) to net
cash used in operating activities-
Depreciation and amortization 336,870 412,490
Issuance of warrants for consulting services 112,387 71,370
Provision for returns and allowances 100,000 -
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 2,292,053 (492,095)
Inventories (12,608) 380,404
Prepaid expenses (111,773) 15,096
Other assets 47,197 385,028
Increase (decrease) in:
Accounts payable 197,792 (269,688)
Accrued expenses 1,586,687 105,982
Deferred revenue (100,000) -
----------------- ----------------
Net cash used in operating activities (3,800,448) (2,077,891)
----------------- ----------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Proceeds from sale of assets - 4,119,729
Purchase of property and equipment (7,987) (5,025)
Acquisition of licensing rights - (525,000)
----------------- ----------------
Net cash provided by (used in) investing activities (7,987) 3,589,704
----------------- ----------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock 3,122,182 -
Dividends paid (101,283) (115,308)
Proceeds from exercise of options and warrants - 5,891,504
----------------- ----------------
Net cash provided by financing activities 3,020,899 5,776,196
----------------- ----------------
(Continued)
Page 6 of 18
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
-----------------------------------------------
(Unaudited)
(Continued)
Six Months Ended June 30,
2001 2000
---------------- ----------------
EFFECT OF EXCHANGE RATE CHANGES ON CASH (24,265) (48,681)
---------------- ----------------
NET INCREASE IN CASH
AND CASH EQUIVALENTS (811,801) 7,239,328
CASH AND CASH EQUIVALENTS,
Beginning of period 7,594,707 1,982,085
---------------- ----------------
CASH AND CASH EQUIVALENTS,
End of period $ 6,782,906 $ 9,221,413
================ ================
See notes to condensed consolidated financial statements
Page 7 of 18
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
-----------------------------------------------
(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, 2000.
(2) INVENTORIES:
-----------
June 30, December 31,
2001 2000
----------- -------------
Finished goods $ 275,947 $ 551,650
Raw materials 716,399 428,088
----------- -------------
$ 992,346 $ 979,738
=========== =============
Page 8 of 18
(3) 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:
Net Loss from Identifiable
Sales Operations Assets
------------------ ----------------- ------------------
As of and for the six months
ended June 30, 2001-
United States $ 438,550 ($4,047,840) $ 6,684,551
Europe 836,819 (4,007,000) 5,369,436
------------------ ----------------- ------------------
$1,275,369 ($8,054,840) $12,053,987
================== ================= ==================
As of and for the six months
ended June 30, 2000-
United States $4,649,408 ($1,139,570) $10,989,429
Europe 1,056,547 (1,328,673) 5,795,584
------------------ ----------------- ------------------
$5,705,955 ($2,468,243) $16,785,013
================== ================= ==================
As of and for the three months
ended June 30, 2001-
United States $ 163,964 ($1,488,921)
Europe 263,590 (2,811,792)
------------------ -----------------
$ 427,554 ($4,300,713)
================== =================
As of and for the three months
ended June 30, 2000-
United States $2,236,624 ($994,243)
Europe 479,401 (279,172)
------------------ -----------------
$2,716,025 ($1,273,415)
================== =================
Page 9 of 18
(4) INCOME (LOSS) PER COMMON AND COMMON EQUIVALENT SHARE:
----------------------------------------------------
The calculation of basic and diluted loss per common and common
equivalent share is as follows:
Six Months Ended June 30, Three Months Ended June 30,
2001 2000 2001 2000
----------------- ---------------- ------------- -------------
Net loss ($8,249,053) ($2,537,776) ($4,430,124) ($1,176,080)
Less: Preferred stock dividends (101,283) (115,308) (50,625) (52,904)
----------------- ---------------- ------------- -------------
Net loss applicable to
common stock ($8,350,336) ($2,653,084) ($4,480,749) ($1,228,984)
================= ================ ============= =============
Basic and diluted:
Weighted average number of
common shares outstanding 30,830,000 29,986,278 30,969,453 30,445,392
================= ================ ============= =============
Basic and diluted net loss per common share $ (0.27) $ (0.09) $ (0.14) $ (0.04)
================= ================ ============= =============
(5) LEGAL PROCEEDINGS:
-----------------
In August 2001, Ares Trading S.A. ("Serono") filed an action in the Supreme
Court of the State of New York (the "Action") naming the Company as defendant.
The Action sets forth claims for an alleged breach of contract for failure to
supply Crinone in accordance with the supply agreement between the parties, and
seeks damages and indemnification in the amount of $13 million. The Company
intends to defend the lawsuit vigorously.
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. These lawsuits were later combined into one. The complaints
allege, among other things, that the Company and William Bologna, David Weinberg
and Norman Meier made materially misleading statements and omissions about the
likely prospects for two of the Company's products in violation of the federal
securities law. The Company and the individual defendants have filed a motion to
dismiss the complaint. On May 9, 2001, the complaint was dismissed with
prejudice.
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 covered, are without
any or have little merit or involve such amounts that is disposed of unfavorably
would not have a material adverse effect on the Company.
Page 10 of 18
(6) PRODUCT RECALL:
--------------
On April 5, 2001, the Company announced that it has requested its licensee,
Serono, to voluntarily recall a number of batches of Crinone(R), a progesterone
vaginal gel used in the treatment of infertile women. The recall has been
initiated due to an application problem of the gel, which may change consistency
over time in the recalled batches. Investigations of the problem to date confirm
that there is no safety risk to patients, and that the active ingredient,
progesterone, is still effective, and all other parameters remain within
specification. The Company estimates that the direct out-of-pocket costs related
to the recall will approximate $1.5 million, which was recorded in the first
quarter of 2001. The Company is attempting to recover a portion of the product
recall costs from its trade suppliers, but has not included any potential
recovery, if any, in its estimate.
(7) CORPORATE RESTRUCTURING EXPENSE:
-------------------------------
During the three month period ended June 30, 2001, the Company decided to
discontinue operations in its Paris, France office. The activities conducted in
this office include new product development, coordination of regulatory matters
and clinical research performed outside the United States, production planning,
quality control and assurance and international marketing. It is anticipated
that all operations will cease by December 31, 2001. Certain costs will be
incurred in closing the office. The Company estimates that these costs will
approximate $1 million. Approximately $800,000 will represent the cost of
employment termination in compliance with French employment regulations.
Additional costs to be incurred include post-closing rent, fixed asset
write-offs and legal costs. As of June 30, 2001, $173,000 of the total cost has
been paid.
(8) EMPLOYMENT AGREEMENT:
--------------------
In March 2001, the Company entered into a three-year employment agreement with
G. Frederick Wilkinson to serve as President and Chief Executive Officer of the
Company. Pursuant to his employment, Mr. Wilkinson is entitled to a base salary
of $450,000 per year plus a minimum ten percent bonus. Additionally, Mr.
Wilkinson was granted options to purchase 500,000 shares of the Company's common
stock at an exercise price of $5.85 and warrants to purchase 350,000 shares of
the Company's common stock at an exercise price of $8.35. The options and
warrants vest ratably over a four year period.
(9) SUBSEQUENT EVENT:
----------------
On July 23, 2001, the Company completed an offering of 434,783 shares of the
Company's common stock, under the Registration Statement, the base Prospectus
and the related Prospectus Supplement dated July 23, 2001, pursuant to the
Agreement, dated as of July 23, 2001, between the Company and Ridgeway
Investment Limited. The shares of common stock were sold at a price of $6.90 per
share, calculated based on a small negotiated discount to the market price on
July 23, 2001. Gross proceeds before expenses were $3,000,000.
Page 11 of 18
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
-------------------------------------------------
CONDITIONS AND RESULTS OF OPERATIONS
------------------------------------
Forward-Looking Information
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; (v)failure to develop the
Company products or delay in the development of the Company's products and (vi)
the timely completion of studies and approvals by the FDA and other regulatory
agencies. 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.
Liquidity and Capital Resources
Cash and cash equivalents decreased from $7,594,707 at December 31, 2000 to
$6,782,906 at June 30, 2001. Through June 30, 2001, the Company completed two
offerings of its common stock to Ridgeway Investments Limited. The first on
January 31, 2001 for 288,462 shares at a price of $5.20 per share, which
resulted in $1,491,231 after expenses and the second on May 10, 2001 for 304,348
shares at a price of $5.75 per share, which resulted in $1,630,951 after
expenses. The Company used $3,830,588 for operating activities during the first
six months of 2001. The Company also paid $101,283 for dividends to holders of
its Series A and C preferred stocks.
Effective as of February 6, 2001, the Company entered into the Amended and
Restated Common Stock Purchase Agreement with Acqua Wellington to sell up to
$16.5 million of the Common Stock, under the Registration Statement, the
Prospectus, and the related Prospectus Supplement dated February 6, 2001 and
amended on April 13, 2001. Pursuant to the Purchase Agreement, the Company may,
from time to time over the term of the Purchase Agreement and at its sole
discretion, issue and sell to Acqua Wellington up to $16.5 million of the Common
Stock, subject to certain conditions, at a price per share based on the daily
volume weighted average price of the Common Stock over a certain period of time
less a discount ranging from 5% to 7%. In addition, during the period in which
the Company elects to issue and sell shares of the Common Stock to Acqua
Wellington, the Company may also, at its sole discretion, grant Acqua Wellington
a call option at the same discount for the applicable period to purchase
additional shares of the Common Stock up to the applicable amount being sold by
the Company in such period, subject to the overall limit of $16.5 million
described above.
Page 12 of 18
On July 23, 2001, the Company completed an offering of its common stock to
Ridgeway Investment Limited for 434,783 shares at a price of $6.90 per share.
The Company has a worldwide, except for South Africa, license and supply
agreement for Crinone(R) with Serono, a Swiss pharmaceutical company. Under the
terms of the agreement, as of March 31, 2001, the Company has earned $17 million
in milestone payments and may receive additional milestone payments, if certain
conditions are met. The Company 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, 2001, the Company has paid approximately $1.9 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, upfront
payment and expects to receive future milestone payments, as additional products
are made available by the Company.
The Company believes that sales and liquidity will increase as Crinone is
fully marketed by Serono.
As of June 30, 2001, the Company has outstanding exercisable options and
warrants that, if exercised, would result in approximately $50.8 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 $8.0 million on research and development
in 2001 and an additional $40,000 on property and equipment.
As of June 30, 2001, the Company had available net operating loss
carryforwards of approximately $53.4 million to offset its future U.S. taxable
income.
In accordance with Statement of Financial Accounting Standards No. 109, as
of June 30, 2001 and December 31, 2000, other assets in the accompanying
consolidated balance sheets include deferred tax assets of approximately $19
million and $18 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, 2001 versus Six Months Ended
June 30, 2000
Net sales decreased by approximately $4.4 million from approximately $5.7
million in 2000 compared to $1.3 million in 2001. The decrease is primarily the
result of decreased Crinone sales of approximately $2.4 million in 2001 from
approximately $2.9 million in 2000 to approximately $539,000 in 2001 as result
of the voluntary recall of Crinone. No sales of Crinone were recorded from March
through June 30, 2001. The remainder of the decrease in sales totaling
approximately $1.5 million is the result of the Company's sale of the Replens
line and licensing of the other over-the-counter brands in May 2000.
Gross profit as a percentage of net sales decreased in 2001 to 34% as
compared to 63% in 2000. The lower gross profit percentage in 2001 is the result
of the decrease in Crinone sales, which has a higher gross profit.
Page 13 of 18
Selling and distribution expenses decreased by approximately $898,000 in
2001 to approximately $517,000 in 2001 from $1,415,000 in 2000. The reduction is
due primarily to the Company's sale of its Replens line and licensing of the
over-the-counter brands, in May 2000, resulting in an approximately $442,000
reduction in advertising and marketing expenses, an approximately $108,000
reduction in broker expenses, an approximately $102,000 reduction in Replens
amortization expense and an approximately $137,000 reduction in warehousing and
freight costs. Because of the reduction in Crinone sales, there was a reduction
of approximately $57,000 in royalties.
General and administrative expenses increased by approximately $88,000 in
2001 to approximately $1,933,000 in 2001 compared to approximately $1,845,000 in
2000. The majority of the increase is the result of an increase in salaries
associated with the hiring of additional management personnel in 2001 and an
increase in patent legal fees.
Research and development increased in 2001 by approximately $1,016,000 from
approximately $2,530,000 in 2000 to $3,546,000 in 2001. The increase is
primarily related to the costs associated with the Company's Phase III trials
for its male testosterone product.
Product recall costs in 2001 represent an estimate of the Company's direct
out-of-pocket costs related to the voluntary recall of Crinone.
Restructuring costs in 2001, of $1,000,000, represent an estimate of the
costs of downsizing the Company's presence outside the United States.
Restructuring costs in 2000, 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 $378,000 in 2001 and 2000.
As a result, the net loss for the six months ended June 30, 2001 was
$8,259,053 or $(.27) per common share as compared to the net loss for the six
months ended June 30, 2000 of $2,537,776 or $(.09) per common share.
Results of Operations - Three Months Ended June 30, 2001 versus Three Months
Ended June 30, 2000
Net sales decreased by approximately $2.3 million from approximately $2.7
million in 2000 compared to $428,000 in 2001. The decrease is primarily the
result of decreased Crinone sales of approximately $1.7 million in 2001 from
approximately $1.7 million in 2000 to $0.0 in 2001 as result of the voluntary
recall of Crinone. No sales of Crinone were recorded in the three months ended
June 30, 2001. The remainder of the decrease in sales totaling approximately
$600,000 is the result of the Company's sale of the Replens line and licensing
of the other over-the-counter brands in May 2000.
Gross profit as a percentage of net sales decreased in 2001 to 14% as
compared to 68% in 2000. The lower gross profit percentage in 2001 is the result
of the decrease in Crinone sales, which has a higher gross profit.
Selling and distribution expenses decreased by approximately $348,000 in
2001 to approximately $254,000 in 2001 from $602,000 in 2000. The reduction is
due primarily to the Company's sale of its Replens line and licensing of the
over-the-counter brands, in May 2000, resulting in an approximately $171,000
reduction in advertising and marketing expenses, an approximately $33,000
reduction in broker expenses, an approximately $26,000 reduction in Replens
amortization expense and an approximately $52,000 reduction in warehousing and
freight costs. Because of the reduction in Crinone sales, there was a reduction
of approximately $36,000 in royalties
Page 14 of 18
General and administrative expenses increased by approximately $115,000 in
2001 to approximately $1,172,000 in 2001 compared to approximately $1,057,000 in
2000. The majority of the increase is the result of an increase in salaries
associated with the hiring of additional management personnel in 2001 and an
increase in legal patent fees.
Research and development increased in 2001 by approximately $767,000 from
approximately $1,166,000 in 2000 to $1,933,000 in 2001. The increase is
primarily related to the costs associated with the Company's Phase III trials
for its male testosterone product.
Restructuring costs in 2001, of $1,000,000, represent an estimate of the
costs of downsizing the Company's presence outside of the United States.
Restructuring costs, in 2000, 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 2001 and 2000.
As a result, the net loss for the three months ended June 30, 2001 was
$4,430,124 or $(.14) per common share as compared to the net loss for the three
months ended June 30, 2000 of $1,176,080 or $(.04) per common share.
Page 15 of 18
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
PART II - OTHER INFORMATION
---------------------------
Item 1. Legal Proceedings
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In August 2001, Ares Trading S.A. ("Serono") filed an action in the
Supreme Court of the State of New York (the "Action") naming the
Company as defendant. The Action sets forth claims for an alleged
breach of contract for failure to supply Crinone in accordance with the
supply agreement between the parties, and seeks damages and
indemnification in the amount of $13 million. The Company intends to
defend the lawsuit vigorously.
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. These lawsuits
were later combined into one. The complaints allege, among other
things, that the Company and William Bologna, David Weinberg and Norman
Meier made materially misleading statements and omissions about the
likely prospects for two of the Company's products in violation of the
federal securities law. The Company and the individual defendants have
filed a motion to dismiss the complaint. On May 9, 2001, the complaint
was dismissed with prejudice.
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 covered, are without any or have little merit or involve such
amounts that is disposed of unfavorably would not have a material
adverse effect on the Company.
Item 2. Changes in Securities
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None.
Item 3. Defaults upon Senior Securities
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None.
Item 4. Submission of Matters to a Vote of Security Holders
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The 2001 annual meeting of shareholders was held on June 14, 2001 for
the purpose of electing the following ten directors (with each nominee
receiving at least 23,895,727 votes out of a possible 30,788,851
votes): James J. Apostolakis, William J. Bologna, Jean Carvais, M.D.,
Dominique de Ziegler, M.D., John W. Gildea, Max Link, Ph.D., Denis
O'Donnell, M.D., Selwyn Oskowitz, M.D., Robert C. Strauss and Fred
Wilkinson. Also approved by a majority of those voting was 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 six million and a proposal to ratify the selection of Goldstein
Golub Kessler, LLP as independent auditors for the current year.
Page 16 of 18
Item 5. Other Information
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None.
Item 6. Exhibits and Reports on Form 8-K
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A. Exhibits
None.
B. Reports on Form 8-K
On April 6, 2001, the Company filed a form 8-K in which it
reported that it had requested its licensee, Serono, to
voluntarily recall a number of batches of Crinone, a progesterone
vaginal gel used in the treatment of infertile women.
On May 14, 2001, the Company filed a form 8-K in which it
reported the completion of an offering of 304,348 shares of its
common stock to Ridgeway Investment Limited.
Page 17 of 18
SIGNATURES
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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, 2001
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