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, 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, 2nd 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 August 1, 2002: 35,453,722
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, 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 17
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
CONDENSED CONSOLIDATED BALANCE SHEETS
-------------------------------------
June 30, December 31,
2002 2001
----------------- --------------
(Unaudited)
ASSETS
Current assets-
Cash and cash equivalents $ 3,471,101 $ 4,060,836
Accounts receivable, net 2,777,105 811,648
Inventories 1,639,318 992,453
Prepaid expenses 1,015,569 538,262
Loans receivable, related party 206,414 200,087
----------------- --------------
Total current assets 9,109,507 6,603,286
Property and equipment, net 718,335 356,634
Intangible assets, net 1,308,343 1,453,281
Other assets 126,112 146,823
----------------- --------------
TOTAL ASSETS $ 11,262,297 $ 8,560,024
================= ==============
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY)
Current liabilities-
Notes payable - current portion $ 2,640,000 $ -
Accounts payable 1,914,425 630,468
Accrued expenses 846,454 1,350,735
----------------- --------------
Total current liabilities 5,400,879 1,981,203
Notes payable - long-term 11,100,000 10,000,000
----------------- --------------
TOTAL LIABILITIES 16,500,879 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
34,332,112 and 32,752,425 shares issued and outstanding
in 2002 and 2001, respectively 343,321 327,524
Capital in excess of par value 121,269,771 114,917,247
Accumulated deficit (126,883,847) (118,647,406)
Accumulated other comprehensive income (loss) 32,124 (18,598)
----------------- --------------
TOTAL STOCKHOLDERS' EQUITY (DEFICIENCY) (5,238,582) (3,421,179)
----------------- --------------
TOTAL LIABILITIES AND STOCKHOLDERS'
EQUITY (DEFICIENCY) $ 11,262,297 $ 8,560,024
----------------- --------------
See notes to condensed consolidated financial statements
page 3 of 17
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
-----------------------------------------------
(Unaudited)
---------
Six Months Ended Three Months Ended
June 30, June 30,
2002 2001 2002 2001
------------------ ---------------- -------------- ---------------
NET SALES $ 2,717,770 $ 1,275,369 $ 2,225,378 $ 427,554
COST OF GOODS SOLD 1,538,840 1,010,597 671,977 485,131
--------------- -------------- ------------- ------------
Gross profit (loss) 1,178,930 264,772 1,553,401 (57,577)
--------------- -------------- ------------- ------------
OPERATING EXPENSES:
Selling and distribution 836,292 516,909 469,242 254,158
General and administrative 2,275,516 1,912,627 1,091,586 1,151,867
Research and development 2,317,629 3,390,096 1,079,264 1,837,111
Litigation settlement expense 3,960,000 - 3,960,000 -
Product recall costs (449,489) 1,500,000 (449,489) -
Corporate restructuring expense - 1,000,000 1,000,000
--------------- -------------- ------------- ------------
Total operating expenses 8,939,948 8,319,632 6,150,603 4,243,136
--------------- -------------- ------------- ------------
Loss from operations (7,761,018) (8,054,860) (4,597,202) (4,300,713)
--------------- -------------- ------------- ------------
OTHER INCOME (EXPENSE):
Interest income 21,689 175,063 11,192 70,219
Interest expense (405,998) (377,676) (217,159) (188,838)
Other, net (91,114) 8,420 (52,329) (10,792)
--------------- -------------- ------------- ------------
(475,423) (194,193) (258,296) (129,411)
--------------- -------------- ------------- ------------
Net loss ($ 8,236,441) ($ 8,249,053) $ (4,855,498) $ (4,430,124)
=============== ============== ============= ============
NET LOSS PER COMMON SHARE:
Basic and diluted $ (0.25) $ (0.27) $ (0.14) $ (0.14)
=============== ============== ============= ============
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING:
Basic and diluted 33,498,703 30,830,000 34,034,705 30,969,453
=============== ============== ============= ============
See notes to condensed consolidated financial statements
page 4 of 17
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
-----------------------------------------------
(Unaudited)
---------
Six Months Ended Three Months Ended
June 30, June 30,
2002 2001 2002 2001
----------- ----------- ----------- -----------
NET LOSS ($8,236,441) ($8,249,053) $(4,855,498) $(4,430,124)
Other comprehensive income (loss):
Foreign currency translation, net of tax (50,722) 33,955 (62,631) 7,389
----------- ----------- ----------- -----------
Comprehensive loss ($8,287,163) ($8,215,098) $(4,918,129) $(4,422,735)
=========== =========== =========== ===========
page 5 of 17
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
-----------------------------------------------
(Unaudited)
---------
Six Months Ended June 30,
2002 2001
--------------- --------------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss ($ 8,236,441) ($ 8,249,053)
Adjustments to reconcile net income (loss) to net
cash used in operating activities-
Depreciation and amortization 330,547 336,870
Issuance of warrants for consulting services - 112,387
Provision for returns and allowances 40,000 100,000
Changes in assets and liabilities-
(Increase) decrease in:
Accounts receivable (2,005,457) 2,292,053
Inventories (646,865) (12,608)
Prepaid expenses (477,307) (111,773)
Loans receivable, related parties (6,327) 28,182
Other assets 20,710 19,015
Increase (decrease) in:
Accounts payable 1,283,957 197,792
Accrued expenses (504,281) 1,586,687
Deferred revenue - (100,000)
------------- ------------
Net cash used in operating activities 10,201,464) (3,800,448)
------------- -----------
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment (544,643) (7,987)
------------- -----------
Net cash used in investing activities (544,643) (7,987)
------------- -----------
CASH FLOWS FROM FINANCING ACTIVITIES:
Proceeds from issuance of common stock 6,462,067 3,122,182
Issuance of note payable 3,960,000 -
Payment of note payable (220,000) -
Dividends paid (93,750) (101,283)
------------- -----------
Net cash provided by financing activities 10,108,317 3,020,899
------------- -----------
(Continued)
page 6 of 17
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
-----------------------------------------------
(Unaudited)
---------
(Continued)
Six Months Ended June 30,
2002 2001
-------------- -------------
EFFECT OF EXCHANGE RATE CHANGES ON CASH 48,055 (24,265)
-------------- -------------
NET INCREASE (DECREASE) IN CASH
AND CASH EQUIVALENTS (589,735) (811,801)
CASH AND CASH EQUIVALENTS,
Beginning of period 4,060,836 7,594,707
-------------- -------------
CASH AND CASH EQUIVALENTS,
End of period $ 3,471,101 $ 6,782,906
============== =============
See notes to condensed consolidated financial statements
page 7 of 17
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:
June 30, December 31,
2002 2001
------------- -------------
Finished goods $ 898,391 $ 426,206
Raw materials 740,927 566,247
------------- -------------
$ 1,639,318 $ 992,453
============= =============
(3) NOTES PAYABLE:
- -----------------
Notes payable Consist of:
June 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) 3,740,000 -
------------ ------------
13,740,000 10,000,000
Less: current portion (2,640,000) -
------------ ------------
$ 11,100,000 $ 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 shall be paid in equal monthly installments of $220,000 of
principal plus accrued interest commencing June 15, 2002 and continuing
thereafter with a final payment of all unpaid principal and interest on
November 15, 2003.
page 8 of 17
(4) 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, 2002-
United States $1,919,683 $(1,826,536) $ 5,340,203
Europe 798,087 (5,934,482) 5,922,094
---------- ----------- -------------
$2,717,770 $(7,761,018) $ 11,262,297
========== =========== =============
As of and for the six months
ended June 30, 2001-
United States $ 438,550 $(4,047,860) $ 6,684,551
Europe 836,819 (4,007,000) 5,369,436
---------- ----------- -------------
$1,275,369 $(8,054,860) $ 12,053,987
========== =========== =============
As of and for the three months
ended June 30, 2002-
United States $1,706,497 $ 1,137
Europe 518,881 (4,598,339)
---------- -----------
$2,225,378 $(4,597,202)
========== ===========
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)
========== ===========
page 9 of 17
(5) 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 Three Months Ended
June 30, June 30,
2002 2001 2002 2001
---------- ---------- ------------- --------------
Net loss ($8,236,441) ($8,249,053) $ (4,855,498) $ (4,430,124)
Less: Preferred stoc (93,750) (101,283) (46,875) (50,625)
---------- ---------- ------------- --------------
Net loss applicable to
common stock ($8,330,191) ($8,350,336) $ (4,902,373) $ (4,480,749)
========== ========== ============= ==============
Basic and diluted:
Weighted average number of
common shares outstanding 33,498,703 30,830,000 34,034,705 30,969,453
========== ========== ============= ==============
Basic and diluted net loss
per common share $ (0.25) $ (0.27) $ (0.14) $ (0.14)
========== ========== ============= ==============
(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 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 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 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 June 30, 2002, 62% of the Company's net receivables are
from Serono. For the six months ended June 30, 2002, 63% 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, 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 Statements of
Operations.
page 10 of 17
(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. As of June 30, 2002, approximately $924,000 of costs
had been paid. The remaining $76,000 of costs is reflected in the accompanying
financial statements under the caption Accrued Expenses.
(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, which bore
interest at 10% per annum and which were due on or before December 7, 1997, were
subsequently extended through December 7, 1999. At June 30, 2002 and December
31, 2001, $206,414 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 described 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. The leased
premises are used exclusively by the same current officer, director and
stockholder mentioned in the preceding paragraph.
It is the intent of the Company that by December 31, 2002 to have the above
notes repaid to the Company and to terminate the lease obligation or have it
assumed by the individual mentioned in the preceding paragraphs.
(10) SUBSEQUENT EVENTS:
-----------------
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. 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.
On August 9, 2002, the Company announced that it had submitted a new drug
application to the Food and Drug Administration for a testosterone buccal
bioadhesive product.
page 11 of 17
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, 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 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, RepHresh
Vaginal Gel and Advantage-S. 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 decreased from $4,060,836 at December 31,
2001 to $3,471,101 at June 30, 2002. During the period, the Company used
$10,221,293 for operating activities. On February 28, 2002, March 13, 2002,
April 23,
page 12 of 17
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 calls 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. During the period, the Company spent $544,643 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 $ 93,750 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 August 14, 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. 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 June 30, 2002, the Company has paid approximately $2.0 million
in royalty payments.
As of June 30, 2002, the Company has outstanding exercisable options
and warrants that, if exercised, would result in approximately $53.7 million of
additional capital. However, most of the options and warrants are exercisable at
prices above the market value of the stock at June 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 $4.2 million on research and
development in 2002 and an additional $1,100,000 on property and equipment.
As of June 30, 2002, the Company had available net operating loss
carryforwards of approximately $58.5 million to offset its future U.S. taxable
income.
In accordance with Statement of Financial Accounting Standards No. 109,
as of June 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
page 13 of 17
realizability of the deferred tax assets are not determinable.
RESULTS OF OPERATIONS - SIX MONTHS ENDED JUNE 30, 2002 VERSUS SIX MONTHS ENDED
JUNE 30, 2001
Net sales increased by approximately $1,443,000 from approximately
$1,275,000 in 2001 to approximately $2,718,000 in 2002. The increase resulted
from the increase in Crinone sales from approximately $528,000 in 2001 to
$1,709,000 in 2002. Because of the recall of Crinone in April 2001 and its
subsequent re-introduction into the market in March 2002, the Company recorded
no Crinone sales from March 2001 until May 2002. In addition, Advantage-S sales
also increased by approximately $198,000 in the current period.
Gross profit as a percentage of net sales was 43% in 2002 as compared
to 21% in 2001. The higher gross profit percentage in 2002 is the result of
increased Crinone and Advantage-S sales, which helped to absorb fixed overhead
costs.
Selling and distribution expenses increased by approximately $319,000
in 2002, from approximately $517,000 in 2001 to approximately $836,000 in 2002.
The increase is due primarily to market intelligence studies for the Company's
male testosterone product.
General and administrative expenses increased by approximately $363,000
to approximately $2,276,000 in 2002 compared to approximately $1,913,000 in
2001. The increase was the result of the hiring of additional management
personnel subsequent to the first 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
$1,072,000 from approximately $3,390,000 in 2001 to $2,318,000 in 2002. The
decrease is primarily related to the costs associated with the Company's Phase
III trials for 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 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. 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. At June 30, 2002, approximately $76,000 of the estimate
remains unused and is included in Accrued Expenses.
Interest income in 2002 was approximately $22,000 compared to
approximately $175,000 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 $406,000 in 2002 as compared to
approximately $378,000 in 2001.
As a result, the net loss for the six months ended June 30, 2002 was
$8,236,441 or $(.25) per common share as compared to the net loss for the six
months ended June 30, 2001 of $8,249,053 or $(.27) per common share.
page 14 of 17
RESULTS OF OPERATIONS - THREE MONTHS ENDED JUNE 30, 2002 VERSUS THREE MONTHS
ENDED JUNE 30, 2001
Net sales increased by approximately $1,797,000 from approximately
$428,000 in 2001 to approximately $2,225,000 in 2002. The increase resulted from
the increase in Crinone sales from approximately $0.0 in 2001 to $1,709,000 in
2002. Because of the recall of Crinone in April 2001 and its subsequent
re-introduction into the market in March 2002, the Company recorded no Crinone
sales from March 2001 until May 2002. In addition, Advantage-S sales increased
by approximately $206,000 in the current period.
Gross profit as a percentage of net sales was 70% in 2002 as compared
to a negative 13% in 2001. The higher gross profit percentage in 2002 is the
result of increased Crinone and Advantage-S sales, which helped to absorb fixed
overhead costs.
Selling and distribution expenses increased by approximately $215,000
in 2002, from $254,000 in 2001 to approximately $469,000 in 2002. The increase
is due primarily to market intelligence studies for the Company's male
testosterone product.
General and administrative expenses decreased by approximately $60,000
to approximately $1,092,000 in 2002 compared to approximately $1,152,000 in
2001.
Research and development expense decreased in 2002 by approximately
$758,000 from approximately $1,837,000 in 2001 to $1,079,000 in 2002. The
decrease is primarily related to the costs associated with the Company's Phase
III trials for 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 in April 2001.
Product recall costs in 2002 represents the reversal of the unused
estimate of the Company's direct out-of-pocket costs related to the voluntary
recall of Crinone, which was accrued in the first quarter of 2001.
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. At June 30, 2002, $76,000 of the estimate remains unused and
is included in Accrued Expenses.
Interest income in 2002 was approximately $11,000 compared to
approximately $70,000 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 $217,000 in 2002 as compared to $189,000 in
2001.
As a result, the net loss for the three months ended June 30, 2002 was
$4,855,498 or $(.14) per common share as compared to the net loss for the three
months ended June 30, 2001 of $4,430,124 or $(.14) per common share.
page 15 of 17
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
--------------------------------------------
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 in accordance with the supply agreement between the
parties. In November 2001, the Company filed counterclaims against Serono
alleging, among other things, breach of contract by Serono for its failure to
re-launch Crinone into the market after new batches of Crinone were manufactured
under a revalidation protocol and shipped to 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 product to Ares for the U.S. and initiate
shipments for the European markets Columbia had previously shipped three batches
of Crinone 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 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
- ------------------------------------------------------------
The 2002 annual meeting of shareholders was held on May 9, 2002 for the
purpose of electing eight directors. James J. Apostolakis, William J.
Bologna, Jean Carvais, M.D., Max Link, Ph.D., Denis O'Donnell, M.D.,
Selwyn Oskowitz, M.D., Robert Strauss and Fred Wilkinson were all
elected, with each nominee receiving at least 28,801,595 votes out of a
possible 33,563,732 votes. Also approved by a majority of those voting
was a proposal to ratify the selection of Goldstein Golub Kessler as
independent auditor for the current year.
Item 5. Other Information
- --------------------------
None.
page 16 of 17
Item 6. Exhibits and Reports on Form 8-K
- -----------------------------------------
A. Exhibits
10.31 -- Semi-Exclusive Supply Agreement dated May
7, 2002 between the Company and Mipharm
S.p.A.
10.32 -- Amended and Restated Licence and Supply
Agreement dated June 4, 2002 between the
Company and Ares Trading S.A.
10.33 -- Marketing License Agreement dated June 4,
2002 between the Company and Ares Trading
S.A. and Serono, Inc.
10.34 -- Master Services Agreement dated July 31,
2002 between the Company and Innovex LP
10.35 -- Stock Purchase Agreement dated July 31,
2002 By and Between Columbia
Laboratories, Inc. and PharmaBio
Development Inc.
10.36 -- Investment and Royalty Agreement dated
July 31, 2002 between the Company and
PharmaBio Development Inc.
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.
B. Reports on Form 8-K
On April 25, 2002, the Company filed a form 8-K in which it reported
the sale of 337,079 shares of its common stock to Acqua Wellington
North American Equities Fund.
On May 16, 2002, the Company filed a form 8-K in which it reported the
sale of 454,545 shares of its common stock to Acqua Wellington North
American Equities Fund.
On June 5, 2002, the Company filed a form 8-K in which it reported the
settlement of litigation with Ares Trading S.A.
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
DATE: August 14, 2002
page 17 of 17
Exhibit Index
Exhibit
Number Description
- ------------- -----------
10.31 Semi-Exclusive Supply Agreement
10.32 Amended and Restated License And Supply Agreement
10.33 Marketing License Agreement
10.34 Master Services Agreement
10.35 Stock Purchase Agreement
10.36 Investment and Royalty Agreement
99.1 Certification, Fred Wilkinson
99.2 Certification, David L. Weinberg