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, 1996
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.)
2665 SOUTH BAYSHORE DRIVE
MIAMI, FLORIDA 33133
(Address of principal executive offices) (Zip Code)
Company's telephone number, including area code: (305) 860-1670
Indicate by check mark whether the Company (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the Company
was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes [X] No [ ]
Number of shares of the Common Stock of Columbia Laboratories, Inc.
issued and outstanding as of October 31, 1996: 28,062,628
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
PART 1 - FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
The following unaudited, condensed consolidated financial statements of
the Company have been prepared in accordance with the instructions to Form 10-Q
and, therefore, omit or condense certain footnotes and other information
normally included in financial statements prepared in accordance with generally
accepted accounting principles. In the opinion of management, all adjustments
(consisting only of normal recurring accruals) necessary for a fair presentation
of the financial information for the interim periods reported have been made.
Results of operations for the nine months ended September 30, 1996 are not
necessarily indicative of the results for the year ending December 31, 1996.
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.
2 of 12
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
SEPTEMBER 30, DECEMBER 31,
1996 1995
------------- ------------
(UNAUDITED)
ASSETS:
Current assets-
Cash and cash equivalents $ 6,530,838 $ 1,628,952
Accounts receivable, net 1,857,815 1,266,964
Inventories 980,010 953,913
Prepaid expenses 173,963 213,723
------------- -------------
Total current assets 9,542,626 4,063,552
Property and equipment, net 1,320,752 922,093
Intangible assets, net 1,397,272 1,563,817
Other assets 1,295,190 1,137,208
------------- -------------
$ 13,555,840 $ 7,686,670
============= =============
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities-
Current portion of long-term debt $ - $ 156,751
Accounts payable 2,575,956 3,423,339
Accrued expenses 574,067 956,647
Deferred revenue 1,044,189 1,081,522
Estimated liability for returns
and allowances 349,502 413,899
------------- -------------
Total current liabilities 4,543,714 6,032,158
------------- -------------
Other long-term liabilities 106,025 98,079
Stockholders' equity-
Preferred stock, $.01 par value; 1,000,000 shares
authorized;
Series A Convertible Preferred Stock, 1,323
shares issued and outstanding in 1996
and 1995 13 13
Series B Convertible Preferred Stock, 1,750
shares issued and outstanding in 1996
and 1995 18 18
Common stock, $.01 par value; 40,000,000 shares
authorized; 28,057,628 and 25,982,373 shares
issued and outstanding in 1996 and 1995,
respectively 280,576 259,824
Capital in excess of par value 89,200,254 73,067,014
Accumulated deficit (80,621,690) (71,812,828)
Cumulative translation adjustment 46,930 42,392
------------- -------------
Total stockholders' equity 8,906,101 1,556,433
------------- -------------
$ 13,555,840 $ 7,686,670
============= =============
See note to condensed consolidated financial statements
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COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Nine Months Ended Three Months Ended
September 30, September 30,
1996 1995 1996 1995
------------ ------------ ---------- --------
NET SALES $ 3,731,348 $ 7,970,001 $ 1,325,868 $ 1,886,135
COST OF GOODS SOLD 2,070,992 4,099,040 798,128 902,026
------------ ------------ ------------ ------------
Gross profit 1,660,356 3,870,961 527,740 984,109
------------ ------------ ------------ ------------
OPERATING EXPENSES:
Selling and distribution 2,220,872 2,283,150 802,240 834,687
General and administrative 2,516,189 2,273,295 863,735 701,241
Research and development 8,027,727 4,671,182 2,876,453 1,946,097
------------ ------------ ------------ ------------
Total operating expenses 12,764,788 9,227,627 4,542,428 3,482,025
------------ ------------ ------------ ------------
Loss from operations (11,104,432) (5,356,666) (4,014,688) (2,497,916)
------------ ------------ ------------ ------------
OTHER INCOME (EXPENSE):
License fees 2,018,205 8,054,883 518,205 --
Interest income 299,838 99,167 106,575 58,962
Interest expense (15,819) (166,824) (8,698) (26,074)
Other, net (6,654) 118,221 3,734 5,714
------------ ------------ ------------ ------------
2,295,570 8,105,447 619,816 38,602
------------ ------------ ------------ ------------
Net income (loss) $ (8,808,862) $ 2,748,781 $ (3,394,872) $ (2,459,314)
============ ============ ============ ============
NET INCOME (LOSS) PER
COMMON SHARE $ (.32) $ .11 $ (.12) $ (.10)
============ ============ ============ ============
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 27,463,000 25,326,000 28,031,000 25,726,000
============ ============ ============ ============
See note to condensed consolidated financial statements
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COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Nine Months Ended September 30,
1996 1995
---- ----
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss) $ (8,808,862) $ 2,748,781
Adjustments to reconcile net income (loss) to net
cash provided by (used for) operating activities-
Depreciation and amortization 620,322 385,433
Provision for (recovery of ) doubtful accounts (8,162) 51,866
Credit for returns and allowances (53,701) (2,012)
Write-off of inventory (55,583) --
Changes in assets and liabilities-
(Increase) decrease in:
Accounts receivable (596,218) (196,914)
Inventories 29,486 (175,516)
Prepaid expenses 62,921 25,004
Other assets (312,242) (129,246)
Increase (decrease) in:
Accounts payable (813,362) (1,321,731)
Accrued expenses (360,793) 94,028
Deferred revenue (37,333) (138,733)
Estimated liability for returns
and allowances (10,697) (21,135)
------------ ------------
Net cash provided by (used for) operating activities (10,344,224) 1,319,825
------------ ------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment (712,810) (52,671)
------------ ------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Repayment of long-term debt (156,752) (91,954)
Proceeds from issuance of common stock 12,205,950 78,147
Proceeds from exercise of options and warrants 3,927,836 1,382,569
------------ ------------
Net cash provided by financing activities 15,977,034 1,368,762
------------ ------------
(Continued)
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COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Continued)
Nine Months Ended September 30,
1996 1995
EFFECT OF EXCHANGE RATE CHANGES ON CASH (18,114) (173,266)
---------- -----------
NET INCREASE IN CASH
AND CASH EQUIVALENTS 4,901,886 2,462,650
CASH AND CASH EQUIVALENTS,
beginning of period 1,628,952 689,749
---------- -----------
CASH AND CASH EQUIVALENTS,
end of period $6,530,838 $ 3,152,399
========== ===========
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Interest paid during the period $ 20,186 $ 24,615
========== ===========
SUPPLEMENTAL SCHEDULE OF NONCASH OPERATING AND FINANCING ACTIVITIES:
During the nine months ended September 30, 1995, the Company issued
1,695,232 shares of Common Stock in payment of long-term debt and accrued
interest totaling $6,339,409. In addition, during the nine months ended
September 30, 1995, the Company issued 95,000 shares of Common Stock in payment
of legal fees totaling $562,500.
As of September 30, 1996, dividends on the Series A Preferred Stock of
$106,025 ($7,946 relating to the nine months ended September 30, 1996) have been
earned but have not been declared and are included in other long-term
liabilities in the September 30, 1996 condensed consolidated balance sheet.
See note to condensed consolidated financial statements
6 of 12
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
NOTE 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, 1995.
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, 1996 are not necessarily
indicative of the results for the year ending December 31, 1996.
7 of 12
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITIONS AND RESULTS OF OPERATIONS
LIQUIDITY AND CAPITAL RESOURCES
Cash and cash equivalents increased from approximately $1.6 million at
December 31, 1995 to approximately $6.5 million at September 30, 1996, primarily
as a result of a private placement in March 1996 of 1,358,000 shares of Common
Stock which raised net proceeds of approximately $12 million, and approximately
$4 million received from the exercise of options and warrants offset by
approximately $10 million of net cash used in operations and approximately
$700,000 used to purchase property and equipment.
In May 1995, the Company entered into a worldwide, except for South
Africa, license and supply agreement with American Home Product Corporation
("AHP") under which the Wyeth-Ayerst division of AHP will market Crinone(R).
Under the terms of the agreement, to date the Company has received $10 million
in milestone payments and will continue to receive additional milestone payments
and a percentage of sales, which sales are expected to commence during late
1996.
In December 1993, the Company entered into an Option and License
Agreement with a French research group based in Marseille, France, pursuant to
which it was granted an option to obtain an exclusive license to the North and
South American rights to a potential AIDS treatment. The potential product has
been granted a Clinical Trials Exemption ("CTX") in the United Kingdom and
clinical trials in humans are now underway. In addition, an Investigational New
Drug Application to start U.S. clinical trials has been approved. The purpose of
these trials is to determine the optimal dosage in late stage seropositive
patients. The option, which must be exercised upon the occurrence of certain
events, expires in December 1998. Upon exercise of the option, the Company will
be required to pay an additional $5 million. If the Company does not exercise
its option upon the occurrence of certain events, the Company's rights to the
option are terminated.
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.
As of September 30, 1996, the Company has outstanding exercisable
options and warrants that, if exercised, would result in approximately $16
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 production commitments and research and development related
to new products. The Company has committed to spend an aggregate of
approximately $1.3 million on additional molding capacity at its suppliers
during 1996 and 1997.
As of September 30, 1996, the Company had available net operating loss
carryforwards of approximately $47 million to offset its future U.S. taxable
income.
In accordance with Statement of Financial Accounting Standards No. 109,
as of September 30, 1996, other assets in the accompanying condensed
consolidated balance sheet includes a deferred tax asset of approximately $17
million (consisting primarily of a net operating loss carryforward) which has
been fully reserved as its ultimate realizability is not assured.
8 of 12
RESULTS OF OPERATIONS - NINE MONTHS ENDED SEPTEMBER 30, 1996 VERSUS NINE MONTHS
ENDED SEPTEMBER 30, 1995
Sales have decreased in 1996 as compared to 1995 due to the fact that
Warner-Lambert did not order Replens(R) during the first nine months of 1996,
combined with the fact that 1995 sales included the initial stocking of Legatrin
PM(R). While the strategic alliance agreements in the United States and abroad
have not produced desired unit sales as quickly as planned, the Company believes
it has established effective working relationships with its partners which the
Company believes form a solid foundation to build sales of Replens and the other
products in the development pipeline. However, the Company is exploring
alternatives to such strategic alliances where appropriate. In addition, upon
granting of the European multistate licenses, Replens should become a
reimbursable product in certain countries. The Company believes that sales of
Replens in Europe should increase once the licenses are granted. The Company's
success is dependent to a great extent on the marketing efforts of its strategic
alliance partners, which the Company has limited ability to influence.
Gross profit as a percentage of sales decreased in 1996 as compared to
1995 primarily as a result of a change in product mix sold. Specifically, 1995
sales included approximately $600,000 of revenue from a research agreement which
agreement had a higher gross profit than that earned on the sale of the
Company's pharmaceutical products. No similar revenue was recorded in 1996.
Research and development expenditures have increased in 1996 as
compared to 1995 primarily as a result of costs incurred in connection with the
pivotal studies required for filing the New Drug Applications for Crinone in the
United States.
License fees represent milestone payments received in connection with
the licensing agreement with AHP.
Interest income increased in 1996 as compared to 1995 as a result of
the interest earned on the monies received in the private placement completed in
March 1996.
Interest expense decreased in 1996 as compared to 1995 as a result of
the repayment of long-term debt during 1995.
As a result, the net loss for 1996 was $8,808,862 or $.32 per share as
compared to net income in 1995 of $2,748,781 or $.11 per common share.
RESULTS OF OPERATIONS - THREE MONTHS ENDED SEPTEMBER 30, 1996 VERSUS
THREE MONTHS ENDED SEPTEMBER 30, 1995
Sales have decreased in 1996 as compared to 1995 due to the fact that
Warner-Lambert did not order Replens(R) during the third quarter of 1996. While
the strategic alliance agreements in the United States and abroad have not
produced desired unit sales as quickly as planned, the Company believes it has
established effective working relationships with its partners which the Company
believes form a solid foundation to build sales of Replens and the other
products in the development pipeline. However, the Company is exploring
alternatives to such strategic alliances where appropriate. In addition, upon
granting of the European multistate licenses, Replens should become a
reimbursable product in certain countries. The Company believes that sales of
Replens in Europe should increase once the licenses are granted. The Company's
success is dependent to a great extent on the marketing efforts of its strategic
alliance partners, which the Company has limited ability to influence.
9 of 12
Gross profit as a percentage of sales decreased in 1996 as compared to
1995 primarily as a result of a change in product mix sold.
Research and development expenditures have increased in 1996 as
compared to 1995 primarily as a result of costs incurred in connection with the
pivotal studies required for filing the New Drug Applications for Crinone in the
United States.
Interest income increased in 1996 as compared to 1995 as a result of
the interest earned on the monies received in the private placement completed in
March 1996.
Interest expense decreased in 1996 as compared to 1995 as a result of
the repayment of long-term debt during 1995.
As a result, the net loss for 1996 was $3,394,872 or $.12 per share as
compared to a net loss in 1995 of $2,459,314 or $.10 per common share.
10 of 12
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
PART II - OTHER INFORMATION
ITEM 1. LEGAL PROCEEDINGS
Certain claims and complaints have been filed or are pending
against the Company with respect to various matters. In the opinion of
management and counsel, all such matters are 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
As of November 12, 1996, dividends on the Series A Preferred Stock
of $107,272 have been earned but have not been declared.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
The annual meeting of stockholders of the Company was held on
October 2, 1996 for the purpose of electing seven directors, ratifying
the appointment of Arthur Andersen LLP as independent public
accountants for the Company and approving the Columbia Laboratories,
Inc. 1996 Long-term Performance Plan.
ITEM 5. OTHER INFORMATION
None.
ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K
None.
11 of 12
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/ MARGARET J. ROELL
-----------------------------------
MARGARET J. ROELL, Vice President-
Finance and Administration,
Chief Financial Officer
DATE: NOVEMBER 13, 1996