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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, 2002
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.)
220 South Orange Avenue, 2/nd/ Floor
Livingston, New Jersey 07039
(Address of principal executive offices) (Zip Code)
Company's telephone number, including area code: (973) 994-3999
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 November 1, 2002: 35,453,722
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, 2002 are not
necessarily indicative of the results for the year ending December 31, 2002.
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 21
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
September 30, December 31,
2002 2001
----------------- ------------------
(Unaudited)
ASSETS
Current assets-
Cash and cash equivalents $ 4,306,544 $ 4,060,836
Accounts receivable, net 4,495,467 811,648
Inventories 2,130,811 992,453
Prepaid expenses 1,341,981 538,262
Loans receivable, related party 208,363 200,087
----------------- ------------------
Total current assets 12,483,166 6,603,286
Property and equipment, net 886,646 356,634
Intangible assets, net 1,235,841 1,453,281
Other assets 55,083 146,823
----------------- ------------------
TOTAL ASSETS $ 14,660,736 $ 8,560,024
================= ==================
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY)
Current liabilities-
Notes payable - current portion $ 1,246,666 $ -
Accounts payable 1,772,506 630,468
Accrued expenses 3,278,297 1,350,735
----------------- ------------------
Total current liabilities 6,297,469 1,981,203
Notes payable - long-term 10,000,000 10,000,000
----------------- ------------------
TOTAL LIABILITIES 16,297,469 11,981,203
----------------- ------------------
Stockholders' equity (deficiency)-
Preferred stock, $.01 par value; 1,000,000 shares authorized:
Series B Convertible Preferred Stock, 1,130 and 1,630
shares issued and outstanding in 2002 and 2001, respectively 11 16
Series C Convertible Preferred Stock, 3,750
shares issued and outstanding in 2002 and 2001 38 38
Common stock, $.01 par value; 100,000,000 authorized
35,453,722 and 32,752,425 shares issued and outstanding
in 2002 and 2001, respectively 354,537 327,524
Capital in excess of par value 126,711,680 114,917,247
Accumulated deficit (128,763,036) (118,647,406)
Accumulated other comprehensive income (loss) 60,037 (18,598)
----------------- ------------------
TOTAL STOCKHOLDERS' EQUITY (DEFICIENCY) (1,636,733) (3,421,179)
----------------- ------------------
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIENCY) $ 14,660,736 $ 8,560,024
================= ==================
See notes to condensed consolidated financial statements
Page 3 of 21
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Nine Months Ended Three Months Ended
September 30, September 30,
2002 2001 2002 2001
-------------- --------------- -------------- --------------
NET SALES $ 7,072,494 $ 1,993,076 $ 4,040,534 $ 411,354
COST OF GOODS SOLD 3,769,402 1,991,971 1,916,372 675,021
-------------- --------------- -------------- --------------
Gross profit (loss) 3,303,092 1,105 2,124,162 (263,667)
-------------- --------------- -------------- --------------
OPERATING EXPENSES:
Selling and distribution 2,221,096 789,082 1,384,804 272,173
General and administrative 3,507,664 2,980,217 1,232,148 1,067,590
Research and development 3,457,346 4,872,652 1,139,717 1,482,556
Litigation settlement expense 3,960,000 - - -
Product recall costs (449,489) 1,500,000 - -
Corporate restructuring expense - 1,000,000 -
-------------- --------------- -------------- --------------
Total operating expenses 12,696,617 11,141,951 3,756,669 2,822,319
-------------- --------------- -------------- --------------
Loss from operations (9,393,525) (11,140,846) (1,632,507) (3,085,986)
-------------- --------------- -------------- --------------
OTHER INCOME (EXPENSE):
Interest income 33,814 228,453 12,125 53,390
Interest expense (643,445) (566,514) (237,447) (188,838)
Other, net (112,474) (10,653) (21,360) (19,073)
-------------- --------------- -------------- --------------
(722,105) (348,714) (246,682) (154,521)
-------------- --------------- -------------- --------------
Net loss $ (10,115,630) $ (11,489,560) $ (1,879,189) $ (3,240,507)
============== =============== ============== ==============
NET LOSS PER COMMON SHARE:
Basic and diluted $ (0.30) $ (0.38) $ (0.05) $ (0.10)
============== =============== ============== ==============
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING:
Basic and diluted 34,034,284 31,031,883 35,087,980 31,429,067
============== =============== ============== ==============
See notes to condensed consolidated financial statements
Page 4 of 21
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE OPERATIONS
(Unaudited)
Nine Months Ended Three Months Ended
September 30, September 30,
2002 2001 2002 2001
------------- -------------- ---------------- ----------------
NET LOSS $ (10,115,630) $ (11,489,560) $ (1,879,189) $ (3,240,507)
Other comprehensive income (loss):
Foreign currency translation, net of tax (78,635) (3,930) (27,913) (37,885)
------------- -------------- ---------------- ----------------
Comprehensive loss $ (10,194,265) $ (11,493,490) $ (1,907,102) $ (3,278,392)
============= ============== ================ ================
See notes to condensed consolidated financial statements
Page 5 of 21
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
2002 2001
---------------- ----------------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ (10,115,630) $ (11,489,560)
Adjustments to reconcile net (loss) to net
cash used in operating activities-
Depreciation and amortization 455,365 518,497
Isuance of warrants for consulting services - 112,387
Povision for returns and allowances 258,548 156,000
Write-down of inventories 81,029 90,000
Loss on disposal of fixed assets 6,384 4,945
Changes in assets and liabilities-
(Increase) decrease in:
Accounts receivable (3,942,367) 2,037,787
Inventories (1,219,387) (374,386)
Prepaid expenses (803,719) (205,757)
Loans receivable, related parties (8,276) 71,748
Other assets 91,740 31,546
Increase (decrease) in:
Accounts payable 1,142,038 149,576
Accrued expenses 1,927,562 875,789
Deferred revenue - (100,000)
---------------- ----------------
Net cash used in operating activities (12,126,713) (8,121,428)
---------------- ----------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment (771,785) (38,248)
---------------- ----------------
Net cash used in investing activities (771,785) (38,248)
---------------- ----------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock 11,962,067 6,059,405
Issuance of note payable 3,960,000 -
Payment of note payable (2,713,334) -
Dividends paid (140,625) (151,908)
Proceeds from exercise of options and warrants - 41,250
---------------- ----------------
Net cash provided by financing activities 13,068,108 5,948,747
---------------- ----------------
(Continued)
Page 6 of 21
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Continued)
Nine Months Ended June 30,
2002 2001
------------- -------------
EFFECT OF EXCHANGE RATE CHANGES ON CASH 76,098 5,639
------------- -------------
NET INCREASE (DECREASE) IN CASH
AND CASH EQUIVALENTS 245,708 (2,205,290)
CASH AND CASH EQUIVALENTS,
Beginning of period 4,060,836 7,594,707
------------- -------------
CASH AND CASH EQUIVALENTS,
End of period $ 4,306,544 $ 5,389,417
============= =============
See notes to condensed consolidated financial statements
Page 7 of 21
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, 2001.
Prior-year financial statements have been reclassified to conform to the
2002 presentations.
(2) INVENTORIES:
Inventories consist of the following:
September 30, December 31,
2002 2001
-------------- --------------
Finished goods $ 1,331,750 $ 426,206
Raw materials 799,061 566,247
-------------- --------------
$ 2,130,811 $ 992,453
============== ==============
(3) NOTES PAYABLE:
Notes payable consist of:
September 30, December 31,
2002 2001
-------------- --------------
7.125% convertible subordinated
note payable - due March 2005 $ 10,000,000 $ 10,000,000
9.00% note payable - payable
in monthly installments (a) 1,246,667 -
-------------- --------------
11,246,667 10,000,000
Less: current portion (1,246,667) -
-------------- --------------
$ 10,000,000 $ 10,000,000
============== ==============
(a) Promissory note payable in the original amount of $3,960,000 with
interest on the unpaid balance at the fixed rate of 9% per annum. Principal and
interest was to be paid in equal monthly installments of $220,000 of principal
plus accrued interest commencing June 15, 2002. Pursuant to the note, the
Company is obligated to pay down the note by an amount equal to one-third of the
proceeds from the sale by the Company of its equity securities. The Company paid
$1,833,333 (one-third of the $5,500,000 raised by the Company through the sale
of its common stock in July 2002). The payment was applied in reverse order of
payments due. At September 30, 2002, the company is required to make payments of
$220,000 through February 2003 and a final payment of $146,667 in March 2003.
Page 8 of 21
(4) SEGMENT INFORMATION:
The Company and its subsidiaries are engaged in one line of
business, the development and sale of pharmaceutical products, medical devices
and cosmetics. The Company sells its products to other pharmaceutical companies
under licensing and supply agreements and to wholesalers and chain drug stores.
The following table shows selected unaudited information by geographic area:
Net Loss from Identifiable
Sales Operations Assets
------------- -------------- -------------
As of and for the nine months
ended September 30, 2002-
United States $ 4,931,670 $ (2,977,387) $ 8,493,699
Europe 2,140,824 (6,416,138) 6,167,037
------------- --------------- -------------
$ 7,072,494 $ (9,393,525) $ 14,660,736
============= =============== =============
As of and for the nine months
ended September 30, 2001-
United States $ 664,943 $ (6,095,666) $ 7,224,202
Europe 1,328,133 (5,045,180) 3,795,898
------------- --------------- -------------
$ 1,993,076 $ (11,140,846) $ 11,020,100
============= =============== =============
As of and for the three months
ended September 30, 2002-
United States $ 3,011,987 $ (1,150,851)
Europe 1,028,547 (481,656)
------------- ---------------
$ 4,040,534 $ (1,632,507)
============= ===============
As of and for the three months
ended September 30, 2001-
United States $ 226,393 $ (2,047,826)
Europe 184,961 (1,038,160)
------------- ---------------
$ 411,354 $ (3,085,986)
============= ===============
Page 9 of 21
(5) LOSS PER COMMON AND COMMON EQUIVALENT SHARE:
The calculation of basic and diluted loss per common and common equivalent share
is as follows:
Nine Months Ended Three Months Ended
September 30, September 30,
2002 2001 2002 2001
-------------- -------------- ------------- --------------
Net loss $ (10,115,630) $ (11,489,560) $ (1,879,189) $ (3,240,507)
Less: Preferred stock dividends (140,625) (151,908) (46,875) (50,625)
-------------- -------------- ------------- --------------
Net loss applicable to
common stock $ (10,256,255) $ (11,641,468) $ (1,926,064) $ (3,291,132)
============== ============== ============= ==============
Basic and diluted:
Weighted average number of
common shares outstanding 34,034,284 31,031,883 35,087,980 31,429,067
============== ============== ============= ==============
Basic and diluted net loss per common share $ (0.30) $ (0.38) $ (0.05) $ (0.10)
============== ============== ============= ==============
(6) LEGAL PROCEEDINGS:
In August 2001, Ares Trading S.A. ("Serono") filed a lawsuit in the Supreme
Court of the State of New York (the "Action") naming the Company as defendant.
The Action set forth claims for an alleged breach of contract for failure to
supply Crinone(R) in accordance with the supply agreement between the parties.
In November 2001, the Company filed counterclaims against Serono. In June 2002,
the Company reached a settlement with Serono. The companies agreed to release
all claims against each other in Serono's suit against the Company and the
Company's counterclaims against Serono. Under the terms of the settlement,
Columbia will have rights to market a second brand of its 8% and 4% progesterone
gel products under the trade name "Prochieve (TM)" to a defined audience of
obstetricians, gynecologists and primary care physicians in the United States.
Following the settlement, Columbia shipped additional Crinone product to Ares
for the U.S. and European markets. Columbia had previously shipped three batches
of Crinone(R) 8% which were used to support the March 8th re-launch by Serono in
the U.S. This product was shipped at no charge to replace recalled product. As
part of the settlement, Columbia gave Ares a note for $3.96 million (currently
$1,246,666) to be paid over an eighteen-month period to cover out of pocket
costs resulting from the recall. This amount is shown as litigation settlement
expense in the "Operating Expenses" section of the Condensed Consolidated
Statements of Operations. For terms of the note, see Note 3 in the Notes to the
Condensed Consolidated Financial Statements. At September 30, 2002, 7% of the
Company's net receivables are from Serono. For the nine months ended September
30, 2002, 33% of the Company's net sales were made to Serono.
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.
(7) PRODUCT RECALL:
On April 5, 2001, the Company announced that it had 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 was initiated
due to an application problem of the gel in the recalled batches. The Company
estimated that the direct out-of-pocket costs related to the recall would cost
approximate $1.5 million, which was recorded in the first quarter of 2001. As a
result of the settlement of the litigation described in Note 6, the Company's
original estimate of the expenses necessary to complete the product recall
exceeded the actual expense by approximately $449,000. This amount is shown as a
reduction in Operating Expenses in the Condensed Consolidated Statement of
Operations.
Page 10 of 21
(8) CORPORATE RESTRUCTURING EXPENSE:
During the second quarter of 2001, the Company's management decided to close the
France office. The Company recorded a restructuring charge for the anticipated
costs associated with closing the office consisting of employee severance
payments and other costs. The cost estimated in the restructuring charge has
been completely used.
(9) RELATED PARTY TRANSACTIONS:
During 1993, the Company loaned an individual, who was an officer, director and
stockholder of the Company, an aggregate of $110,350. These notes bore interest
at 10% per annum and were originally due on or before December 7, 1997, were
subsequently extended through December 7, 1999. At September 30, 2002 and
December 31, 2001, $208,363 and $200,087, respectively, remains outstanding,
from this current officer, director and shareholder, and is included in other
current assets in the accompanying Condensed Consolidated Balance Sheets.
As decribed in the Company's Annual Report on Form 10-K for the fiscal year
ended December 31, 2001, the Company leases a 2,600 square foot business
residence in Paris, France at annual rent of approximately $60,000 per annum.
The leased premises are used exclusively by the same current officer, director
and stockholder mentioned in the preceding paragraph. As of October 1, 2002, the
lease payments are being paid directly by the Company officer. Columbia remains
on the lease, but only as a guarantor. The lease expires in December 2003.
It is the intent of the Company that by December 31, 2002 to have the above
notes repaid to the Company.
(10) AGREEMENTS WITH QUINTILES TRANSNATIONAL CORP.
On July 31, 2002, Columbia Laboratories, Inc. ("Columbia") and Quintiles
Transnational Corp. ("Quintiles") entered into an agreement to commercialize
Columbia's portfolio of women's healthcare products in the United States. Under
the terms of this agreement, Quintiles' commercialization unit, Innovex, will
provide a dedicated team of 55 sales representatives on a three-year,
fee-for-service basis, to commercialize the Company's women's healthcare
products. In a second agreement dated July 31, 2002, Quintiles' strategic
investment group, PharmaBio Development agreed to pay $4.5 million, to be paid
in four equal quarterly installments commencing third quarter 2002 for the right
to receive a 5% royalty on the net sales of Columbia's women's healthcare
products in the United States for five years beginning in the first quarter of
2003. The royalty payments are subject to minimum and maximum amounts. The first
installment of $1,125,000 was received in September 2002 and is included in
Accrued Expenses in the accompanying Balance Sheet. In a third agreement dated
July 31, 2002, PharmaBio Development agreed to purchase 1,121,610 shares of
Columbia's common stock at a purchase price of $4.903667, for aggregate proceeds
to Columbia of $5,500,000.
Page 11 of 21
(11) SUBSEQUENT EVENT
On October 16, 2002, the Company and Ardana Bioscience, Ltd. announced that they
had executed a license and supply agreement for the Company's Striant(TM)
testosterone buccal bioadhesive product in eighteen European countries
(excluding Italy). Under the terms of the agreement, Ardana will market,
distribute and sell Striant(TM). In exchange for these rights, the Company will
receive total payments of $8 million, including $4 million in signature and
milestone fees in the fourth quarter of 2002 ($2 million payable immediately, $1
million payable on December 15, 2002 and $1 million payable upon filing of the
application for regulatory approval in the United Kingdom). Initial regulatory
approval of the U.K. application will be the basis for mutual recognition
applications to be filed in the rest of Europe. Additional milestone payments
totaling $2 million are due upon marketing approvals in major European countries
included in the agreement. A performance payment of $2 million is also due upon
achievement of a certain level of sales. Ardana will purchase its requirements
of product from the Company during the term of the agreement.
Page 12 of 21
Item 2. Management's Discussion And Analysis Of Financial Condition 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, most 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 produce and sell their products in various markets; (v) product
recall due to failure to meet regulatory standards; (vi) failure to develop the
Company products or delay in the development of the Company's product; (vii) the
timely completion of studies and approvals by the FDA and other regulatory
agencies of new products, including Striant(TM), the Company's testosterone
buccal bioadhesive product; (viii) the successful re-launch of Crinone back into
the marketplace; and (ix) the successful launch and marketing of Prochieve(TM),
RepHresh Vaginal Gel(TM) and re-launch of Advantage-S(R) Bioadhesive
Contraceptive Gel. 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.
Critical Accounting Policies and Estimates
The Company has identified the policies below as critical to its
business operations and the understanding of its results of operations. For a
detailed discussion on the application of these and other accounting policies,
see Note 1 of the consolidated financial statements included in Item 14 of the
Company's Annual Report on Form 10-K, beginning on page F-11. Note that the
preparation of this Quarterly Report on Form 10-Q requires the Company to make
estimates and assumptions that affect the reported amount of assets and
liabilities, disclosure of contingent assets and liabilities at the date of the
financial statements, and the reported amounts of revenues and expenses during
the reporting period. There can be no assurance that actual results will not
differ from those estimates.
Revenue recognition. The Company's revenue recognition is significant
because revenue is a key component of the Company's results of operations. In
addition, revenue recognition determines the timing of certain expenses, such as
commissions and royalties. Revenue results are difficult to predict, and any
shortfall in revenue or delay in recognizing revenue could cause operating
results to vary significantly from quarter to quarter.
Impairment of intangible assets. The Company periodically evaluates its
intangible assets for potential impairment indicators. Judgments regarding the
existence of impairment indicators are based on legal factors, market condition
and operational performance. Future events could cause the Company to conclude
that impairment factors exist and that certain intangible assets are impaired.
Any resulting impairment loss could have a material adverse impact on results of
operations.
Liquidity and Capital Resources
Cash and cash equivalents increased from $4,060,836 at December 31, 2001
to $4,306,544 at September 30, 2002. During the period, the Company used
$12,126,713 for operating activities. On February 28, 2002, March 13, 2002,
April 23,
Page 13 of 21
2002 and May 14, 2002, the Company sold 277,778 shares (at $3.60 per share),
500,000 shares (at $4.00 per share), 337,079 shares (at $4.45 per share) and
454,545 shares (at $4.40 per share), respectively, of its Common Stock to Acqua
Wellington North American Funds, Ltd. pursuant to the Amended and Restated
Common Stock Purchase Agreement. The prices represented a negotiated discount to
the market price. Gross proceeds were $6,500,000. In connection with the
settlement of litigation in the June 2002, the Company issued a note in the
amount of $3,960,000. The note called for eighteen monthly payments of $220,000
beginning June 15, 2002. In the event that the Company raises capital through
the sale of equity securities subsequent to the settlement, it is required to
pay one-third of the proceeds as a pre-payment of the note in reverse order of
the due dates. Based on the sale of 1,121,610 of the Company's Common Stock for
$5,500,000 on July 31, 2002, together with four paid monthly installments
beginning in June, the Company has paid off $2,713,334 of the note payable.
During the period, the Company spent $771,785 on property and equipment,
primarily for new accounting and materials management software and for the
construction of a dedicated manufacturing suite for its male testosterone buccal
tablet product. The Company also paid $140,625 for dividends to holders of its
Series C preferred stock.
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 third
parties, 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. At November 13, 2002, $9.0 million may be sold pursuant to the
Purchase Agreement.
On July 31, 2002, Columbia Laboratories, Inc. ("Columbia") and Quintiles
Transnational Corp. ("Quintiles") entered into an agreement to commercialize
Columbia's portfolio of women's healthcare products in the United States. Under
the terms of this agreement, Quintiles' commercialization unit, Innovex, will
provide a dedicated team of 55 sales representatives on a three-year,
fee-for-service basis, to commercialize the Company's women's healthcare
products. In a second agreement dated July 31, 2002, Quintiles' strategic
investment group, PharmaBio Development agreed to pay $4.5 million, to be paid
in four equal quarterly installments commencing third quarter 2002 for the right
to receive a 5% royalty on the net sales of Columbia's women's healthcare
products in the United States for five years beginning in the first quarter of
2003. The royalty payments are subject to minimum and maximum amounts. The first
installment of $1,125,000 was received in September 2002. In a third agreement
dated July 31, 2002, PharmaBio Development agreed to purchase 1,121,610 shares
of Columbia's common stock at a purchase price of $4.903667, for aggregate
proceeds to Columbia of $5,500,000.
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, 2002, the Company has paid approximately $2.1
million in royalty payments.
As of September 30, 2002, the Company has outstanding exercisable
options and warrants that, if exercised, would result in approximately $53.6
million of additional capital. However, most of the options and warrants are
exercisable at prices above the market value of the common stock at September
30, 2002 and there can be no assurance that any 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 $4.9 million on research and
development in 2002 and an additional $1,100,000 on property and equipment.
Page 14 of 21
As of September 30, 2002, the Company had available net operating loss
carryforwards of approximately $59.4 million to offset its future U.S. taxable
income.
In accordance with Statement of Financial Accounting Standards No. 109,
as of September 30, 2002 and December 31, 2001, other assets in the accompanying
consolidated balance sheets include deferred tax assets of approximately $21
million, (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, 2002 versus Nine Months
Ended September 30, 2001
Net sales increased by approximately $5,079,000 from approximately
$1,993,000 in 2001 to approximately $7,072,000 in 2002. The increase resulted
from the introduction of Prochieve(TM) 8% in September 2002 and the increase in
Crinone(R) sales from approximately $528,000 in 2001 to $2,345,000 in 2002.
Because of the recall of Crinone(R) in April 2001 and its subsequent
re-introduction into the market in March 2002, the Company recorded no
Crinone(R) sales from March 2001 until May 2002.
Gross profit as a percentage of net sales was 47% in 2002 as compared to
0% in 2001. The higher gross profit percentage in 2002 is the result of the
introduction of Prochieve(TM) 8% and increased Crinone(R) and Advantage-S(R)
sales.
Selling and distribution expenses increased by approximately $1,432,000
in 2002, from approximately $789,000 in 2001 to approximately $2,221,000 in
2002. The increase is due primarily to marketing expenses and sales force costs
associated with Prochieve(TM) 8% and market intelligence studies for the
Company's male testosterone product, Striant(TM).
General and administrative expenses increased by approximately $528,000
to approximately $3,508,000 in 2002 compared to approximately $2,980,000 in
2001. The increase was the result of the hiring of additional administrative
personnel subsequent to the third quarter of 2001 and legal expense incurred as
the result of litigation commenced in August 2001 and concluded in June 2002.
Research and development expense decreased in 2002 by approximately
$1,416,000 from approximately $4,873,000 in 2001 to $3,457,000 in 2002. The
decrease is primarily related to the costs associated with the Company's Phase
III trials for Striant(TM), its male testosterone product, which started to
conclude in the 2002 first quarter. Reductions resulting from the downsizing of
the Company's Paris office also contributed to the decrease.
Litigation settlement expense in 2002 represents the amount the Company
agreed to pay Ares Trading S.A. to settle the litigation that followed the
recall of Crinone(R) in April 2001.
Product recall costs in 2001 represented an estimate of the Company's
direct out-of-pocket costs related to the voluntary recall of Crinone(R). In
2002, the remaining unused accrual was reversed.
Corporate restructuring cost, of $1,000,000, in 2001, represented an
estimate of the costs associated with downsizing the Company's presence outside
the United States. The entire estimate has been used.
Interest income in 2002 was approximately $33,814 compared to
approximately $228,000 in 2001. The decrease resulted from a reduction in cash
available for investing.
Interest expense, primarily related to the convertible subordinated note
payable, totaled approximately $643,000 in 2002 as compared to approximately
$567,000 in 2001.
As a result, the net loss for the nine months ended September 30, 2002
was $10,115,630 or $(.30) per common share as compared to the net loss for the
nine months ended September 30, 2001 of $11,489,560 or $(.38) per common share.
Page 15 of 21
Results of Operations - Three Months Ended September 30, 2002 versus Three
Months Ended September 30, 2001
Net sales increased by approximately $3,630,000 from approximately
$411,000 in 2001 to approximately $4,041,000 in 2002. The increase resulted from
the introduction of Prochieve(TM) 8% in September 2002 and the increase in
Crinone(R) sales from approximately $0.0 in 2001 to $636,000 in 2002. Because of
the recall of Crinone(R) in April 2001 and its subsequent re-introduction into
the market in March 2002, the Company recorded no Crinone(R) sales from March
2001 until May 2002.
Gross profit as a percentage of net sales was 53% in 2002 as compared to
a negative 64% in 2001. The higher gross profit percentage in 2002 is the result
of Prochieve(TM) 8% and Crinone(R) sales.
Selling and distribution expenses in 2002 increased by approximately
$1,113,000, from $272,000 in 2001 to approximately $1,385,000 in 2002. The
increase is due primarily to marketing expenses and sales force costs associated
with Prochieve(TM) 8% and to market intelligence studies for the Company's male
testosterone product, Striant(TM).
General and administrative expenses increased by approximately $164,000
to approximately $1,232,000 in 2002 compared to approximately $1,068,000 in
2001. The increase was the result of the hiring of additional administrative
personnel subsequent to the third quarter of 2001.
Research and development expense decreased in 2002 by approximately
$343,000 from approximately $1,483,000 in 2001 to $1,140,000 in 2002. The
decrease is primarily related to the costs associated with the Company's Phase
III trials for Striant(TM), its male testosterone product, which started to
conclude in the 2002 first quarter. Reductions resulting from the downsizing of
the Company's Paris office also contributed to the decrease.
Interest income in 2002 was approximately $12,000 compared to
approximately $53,000 in 2001. The decrease resulted from a reduction in cash
available for investing.
Interest expense, primarily related to the convertible subordinated note
payable, totaled approximately $237,000 in 2002 as compared to $189,000 in 2001.
As a result, the net loss for the three months ended September 30, 2002
was $1,879,189 or $(.05) per common share as compared to the net loss for the
three months ended September 30, 2001 of $3,240,507 or $(.10) per common share.
Item 3. Quantitative And Qualitative Disclosures About Market Risk
The Company does not believe that it has material exposure to market
rate risk. The Company has only a fixed rate debt obligation that comes due in
2005. The Company may, however, require additional financing to fund future
obligations and no assurance can be given that the terms of future sources of
financing will not expose the Company to material market risk.
Item 4. Disclosure Controls And Procedures
The Company maintains disclosure controls and procedures that are
designed to ensure that information required to be disclosed in the Company's
filings under the Securities Exchange Act of 1934 is recorded, processed,
summarized and reported within the periods specified in the rules and forms of
the Securities and Exchange Commission. Such information is accumulated and
communicated to the Company's management, including its Chief Executive Officer
and Chief Financial Officer, as appropriate, to allow timely decisions regarding
required disclosure. The Company's management, including the Chief Executive
Officer and the Chief Financial Officer, recognizes that any set of controls and
procedures, no matter how well designed and operated, can provide only
reasonable assurance of achieving the desired control objectives.
Within 90 days prior to the filing date of this quarterly report on Form
10-Q, the Company has carried out an evaluation, under the supervision and with
the participation of the Company's management, including the Company's
Page 16 of 21
Chief Executive Officer and the Company's Chief Financial Officer, of the
effectiveness of the design and operation of the Company's disclosure controls
and procedures. Based on such evaluation, the Company's Chief Executive Officer
and Chief Financial Officer concluded that the Company's disclosure controls and
procedures are effective.
In March 2002, the Company installed SAP software for its financial and
materials management applications. Other than this, there have been no
significant changes in the Company's internal controls or in other factors that
could significantly affect the internal controls subsequent to the date of their
evaluation in connection with the preparation of this quarterly report on Form
10-Q.
Page 17 of 21
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
In August 2001, Ares Trading S.A. ("Serono") filed a lawsuit in the
Supreme Court of the State of New York (the "Action") naming the Company as
defendant. The Action set forth claims for an alleged breach of contract for
failure to supply Crinone(R) in accordance with the supply agreement between the
parties. In November 2001, the Company filed counterclaims against Serono. In
June 2002, the Company reached a settlement with Serono. The companies agreed to
release all claims against each other in Serono's suit against the Company and
the Company's counterclaims against Serono. Under the terms of the settlement,
Columbia will have rights to market a second brand of its 8% and 4% progesterone
gel products under the trade name "Prochieve (TM)" to a defined audience of
obstetricians, gynecologists and primary care physicians in the United States.
Columbia will immediately ship additional Crinone(R) product to Ares for the
U.S. and initiate shipments for the European markets. Columbia had previously
shipped three batches of Crinone(R) 8% which were used to support the March
8/th/ re-launch by Serono in the U.S. This product was shipped at no charge to
replace recalled product. As part of the settlement, Columbia has given Ares a
note for $3.96 million to be paid over an eighteen-month period to cover out of
pocket costs resulting from the recall.
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.
Item 6. Exhibits and Reports on Form 8-K
A. Exhibits
99.1 -- Certification Pursuant to 18 U.S.C. Section 1350, as
Adopted Pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002, filed herewith.
99.2 -- Certification Pursuant to 18 U.S.C. Section 1350, as
Adopted Pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002, filed herewith.
Page 18 of 21
B. Reports on Form 8-K
On July 31, 2002, the Company filed a form 8-K in which it reported (a) the
sale of 1,121,610 shares of its common stock to PharmaBio Development Inc.,
(b) an agreement under which PharmaBio Development Inc. will pay Columbia
$4.5 million in four equal quarterly installments commencing third quarter
2002 in return for a 5% royalty on the net sales of Columbia's women's
healthcare products in the United states for five years beginning in the
first quarter of 2003, and (c) an agreement with Innovex under which
Innovex will provide Columbia with a dedicated team of 55 sales
representatives, under a three-year, fee-for-service basis, to
commercialize Columbia's women's healthcare products. PharmaBio Development
inc. and Innovex are affiliates of Quintiles Transnational Corp.
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 Chief Financial Officer
DATED: November 13, 2002
Page 19 of 21
CERTIFICATIONS
I, Fred Wilkinson, Chief Executive Officer of the Company, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Columbia Laboratories,
Inc.;
2. Based on my knowledge, this quarterly report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this quarterly
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this quarterly report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this quarterly report;
4. The registrant's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this quarterly report is being prepared;
b) evaluated the effectiveness of the registrant's disclosure controls and
procedures as of a date within 90 days prior to the filing date of this
quarterly report (the "Evaluation Date"); and
c) presented in this quarterly report our conclusions about the effectiveness of
the disclosure controls and procedures based on our evaluation as of the
Evaluation Date;
5. The registrant's other certifying officer and I have disclosed, based on our
most recent evaluation, to the registrant's auditors and the audit committee of
registrant's board of directors:
a) all significant deficiencies in the design or operation of internal controls
which could adversely affect the registrant's ability to record, process,
summarize and report financial data and have identified for the registrant's
auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant's internal controls; and
6. The registrant's other certifying officer and I have indicated in this
quarterly report whether or not there were significant changes in internal
controls or in other factors that could significantly affect internal controls
subsequent to the date of our most recent evaluation, including any corrective
actions with regard to significant deficiencies and material weaknesses.
Date: November 13, 2002
/s/ Fred Wilkinson
------------------
Fred Wilkinson
Chief Executive Officer
Page 20 of 21
I, David L. Weinberg, Chief Financial Officer of the Company, certify that:
1. I have reviewed this quarterly report on Form 10-Q of Columbia Laboratories,
Inc.;
2. Based on my knowledge, this quarterly report does not contain any untrue
statement of a material fact or omit to state a material fact necessary to make
the statements made, in light of the circumstances under which such statements
were made, not misleading with respect to the period covered by this quarterly
report;
3. Based on my knowledge, the financial statements, and other financial
information included in this quarterly report, fairly present in all material
respects the financial condition, results of operations and cash flows of the
registrant as of, and for, the periods presented in this quarterly report;
4. The registrant's other certifying officer and I are responsible for
establishing and maintaining disclosure controls and procedures (as defined in
Exchange Act Rules 13a-14 and 15d-14) for the registrant and we have:
a) designed such disclosure controls and procedures to ensure that material
information relating to the registrant, including its consolidated subsidiaries,
is made known to us by others within those entities, particularly during the
period in which this quarterly report is being prepared;
b) evaluated the effectiveness of the registrant's disclosure controls and
procedures as of a date within 90 days prior to the filing date of this
quarterly report (the "Evaluation Date"); and
c) presented in this quarterly report our conclusions about the effectiveness of
the disclosure controls and procedures based on our evaluation as of the
Evaluation Date;
5. The registrant's other certifying officer and I have disclosed, based on our
most recent evaluation, to the registrant's auditors and the audit committee of
registrant's board of directors:
a) all significant deficiencies in the design or operation of internal controls
which could adversely affect the registrant's ability to record, process,
summarize and report financial data and have identified for the registrant's
auditors any material weaknesses in internal controls; and
b) any fraud, whether or not material, that involves management or other
employees who have a significant role in the registrant's internal controls; and
6. The registrant's other certifying officer and I have indicated in this
quarterly report whether or not there were significant changes in internal
controls or in other factors that could significantly affect internal controls
subsequent to the date of our most recent evaluation, including any corrective
actions with regard to significant deficiencies and material weaknesses.
Date: November 13, 2002
/s/ David L. Weinberg
---------------------
David L. Weinberg
Chief Financial Officer
Page 21 of 21
Exhibit Index
Exhibit Number Description
99.1 - Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, filed herewith.
99.2 - Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002, filed herewith.