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 March 31, 1998
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.
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(Exact name of Company as specified in its charter)
DELAWARE 59-2758596
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(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 April 30, 1998: 28,684,687
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 three months ended March 31, 1998 are not
necessarily indicative of the results for the year ending December 31, 1998.
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COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
MARCH 31, DECEMBER 31,
1998 1997
------------ ------------
(Unaudited)
ASSETS:
Current assets-
Cash and cash equivalents $ 12,517,036 $ 2,256,590
Accounts receivable, net 1,577,485 6,223,842
Inventories 2,205,355 2,252,675
Prepaid expenses 382,601 477,857
------------ ------------
Total current assets 16,682,477 11,210,964
Property and equipment, net 1,640,914 1,701,136
Intangible assets, net 1,064,182 1,119,697
Other assets 1,188,181 969,955
------------ ------------
$ 20,575,754 $ 15,001,752
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities-
Accounts payable $ 3,048,357 $ 3,709,368
Accrued expenses 747,738 1,319,400
Deferred revenue 687,344 1,042,638
------------ ------------
Total current liabilities 4,483,439 6,071,406
------------ ------------
Note payable 10,000,000 --
Other long-term liabilities 118,627 116,781
Stockholders' equity-
Preferred stock, $.01 par value; 1,000,000 shares
authorized;
Series A Convertible Preferred Stock, 923
shares issued and outstanding in 1998
and 1997 9 9
Series B Convertible Preferred Stock, 1,630
shares issued and outstanding in 1998
and 1997 16 16
Common stock, $.01 par value; 40,000,000 shares
authorized; 28,684,687 and 28,623,187 shares
issued and outstanding in 1998 and 1997,
respectively 286,847 286,231
Capital in excess of par value 92,941,714 92,588,038
Accumulated deficit (87,326,331) (84,128,906)
Cumulative translation adjustment 71,433 68,177
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Total stockholders' equity 5,973,688 8,813,565
------------ ------------
$ 20,575,754 $ 15,001,752
============ ============
See notes to condensed consolidated financial statements
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COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
THREE MONTHS ENDED MARCH 31,
1998 1997
------------ ------------
NET SALES $ 2,271,985 $ 1,365,881
COST OF GOODS SOLD 1,405,984 1,025,282
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Gross profit 866,001 340,599
------------ ------------
OPERATING EXPENSES:
Selling and distribution 637,766 659,102
General and administrative 1,576,553 738,593
Research and development 1,791,109 2,412,552
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Total operating expenses 4,005,428 3,810,247
------------ ------------
Loss from operations (3,139,427) (3,469,648)
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OTHER INCOME (EXPENSE):
License fees -- 500,000
Interest income 42,870 27,308
Interest expense (33,259) --
Other, net (67,609) (61,748)
------------ ------------
(57,998) 465,560
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Net loss $ (3,197,425) $ (3,004,088)
============ ============
NET LOSS PER COMMON SHARE $ (.11) $ (.11)
============ ============
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 28,660,000 28,142,000
============ ============
See notes to condensed consolidated financial statements
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COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
THREE MONTHS ENDED MARCH 31,
1998 1997
------------ ------------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ (3,197,425) $ (3,004,088)
Adjustments to reconcile net loss to net
cash used for operating activities-
Depreciation and amortization 238,215 206,951
Issuance of warrants for consulting services 44,877 --
Changes in assets and liabilities- (Increase) decrease in:
Accounts receivable 4,333,254 360,478
Inventories 47,319 (210,855)
Prepaid expenses 217,427 143,916
Other assets (271,308) (445,793)
Increase (decrease) in:
Accounts payable (647,591) 152,525
Accrued expenses (421,444) (392,858)
Deferred revenue (355,295) 240,999
------------ ------------
Net cash used for operating activities (11,971) (2,948,725)
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CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment (75,856) (103,136)
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CASH FLOWS FROM FINANCING ACTIVITIES:
Issuance of note payable 10,000,000 --
Proceeds from exercise of options and warrants 356,138 925,980
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Net cash provided by financing activities 10,356,138 925,980
------------ ------------
(Continued)
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COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Continued)
THREE MONTHS ENDED MARCH 31,
1998 1997
------------ ------------
EFFECT OF EXCHANGE RATE CHANGES ON CASH (7,865) (14,798)
------------ ------------
NET INCREASE (DECREASE) IN CASH
AND CASH EQUIVALENTS 10,260,446 (2,140,679)
CASH AND CASH EQUIVALENTS,
beginning of period 2,256,590 3,561,794
------------ ------------
CASH AND CASH EQUIVALENTS,
end of period $ 12,517,036 $ 1,421,115
============ ============
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Interest paid during the period $ 6,341 $ 4,386
============ ============
SUPPLEMENTAL SCHEDULE OF NONCASH OPERATING AND FINANCING ACTIVITIES:
As of March 31, 1998, dividends on the Series A Preferred Stock of
$118,627 ($1,846 relating to the three months ended March 31, 1998) have been
earned but have not been declared and are included in other long-term
liabilities in the March 31, 1998 condensed consolidated balance sheet.
See notes to condensed consolidated financial statements
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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, 1997.
(2) NOTE PAYABLE
On March 16, 1998, the Company issued to an institutional investor a
$10 million convertible subordinated note due March 15, 2005. The note bears
interest at 7 1/8% which is payable semi-annually on March 1 and September 1.
The note was originally convertible into 628,931 shares of the Company's common
stock; however, based on a one-time reset provision, the note is convertible
into 662,032 shares of common stock or a price equal to $15.105 per share. The
Company also granted certain registration rights to the investor, under which
the earliest the shares underlying the note could be registered would be March
16, 1999.
(3) SUBSEQUENT EVENT
On April 1, 1998, the Company and the Warner-Lambert Company signed an
agreement terminating their December 1991 license and supply agreement under
which the Warner-Lambert Company had distributed Replens, a vaginal moisturizer
which had been developed by the Company. Under the terms of the termination
agreement, the Company agreed to pay $4.6 million for the right to reaquire the
product Replens, effective on April 9, 1998. The $4.6 million cost will be
capitalized and amortized over a 15 year period.
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COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITIONS AND RESULTS OF OPERATIONS
LIQUIDITY AND CAPITAL RESOURCES
Management's Discussion and Analysis of Financial Conditions and
Results of Operations contains forward-looking statements which are made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. These forward-looking statements involve risks and
uncertainties that could cause actual results to differ materially from the
forward-looking statements. 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.
Cash and cash equivalents increased from approximately $2.3 million at
December 31, 1997 to approximately $12.5 million at March 31, 1998 . The Company
received $9.7 million, net of expenses, from the issuance of a note to an
institutional investor (see note 2 to unaudited condensed consolidated financial
statements), and approximately $356,000 from the exercise of options and
warrants.
In May 1995, the Company entered into a worldwide, except for South
Africa, license and supply agreement with American Home Products Corporation
("AHP") under which the Wyeth-Ayerst Laboratories division of AHP will market
Crinone. Under the terms of the agreement, as of March 31, 1998, the Company has
earned $17 million in milestone payments and will continue to receive additional
milestone payments. The Company also supplies Crinone to AHP at a price equal to
30% of AHP's net selling price.
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. In May 1996, this agreement
was amended such that the Company now has the right to obtain an exclusive
license to the worldwide rights. A phase I/II clinical trial in humans is now
underway in the U.S. The purpose of this trial is to determine the optimal
dosage of SPC3 in late stage seropositive patients. The options, which must be
exercised upon the occurrence of certain events, expire in December 1998.Upon
exercise of the options, the Company will be required to pay an additional $7
million. If the Company does not exercise its options upon the occurrence of
certain events, the Company's rights to the options 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
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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 March 31, 1998, the Company has paid approximately $1.2 million
in royalty payments.
The Company believes that sales and liquidity will increase as Crinone
is fully marketed by Wyeth-Ayerst.
As of March 31, 1998, the Company has outstanding exercisable options
and warrants that, if exercised, would result in approximately $35 million of
additional capital. However, there can be no assurance that such options or
warrants will be exercised.
Significant expenditures anticipated by the Company in the near future
are concentrated on research and development related to new products. The
Company anticipates it will spend approximately $10.1 million on research and
development in 1998 and an additional $200,000 on production equipment at its
suppliers.
As of March 31, 1998, the Company had available net operating loss
carryforwards of approximately $46 million to offset its future U.S. taxable
income.
In accordance with Statement of Financial Accounting Standards No. 109,
as of March 31, 1998 and December 31, 1997, other assets in the accompanying
consolidated balance sheets include deferred tax assets of approximately $17
million and $16 million, respectively, (comprised primarily of a net operating
loss carryforward) which have been fully reserved as their ultimate
realizability is not assured.
RESULTS OF OPERATIONS - THREE MONTHS ENDED MARCH 31, 1998 VERSUS THREE MONTHS
ENDED MARCH 31, 1997
Net sales increased by approximately $906,000 in 1998 as compared to
1997. Crinone, which was not sold in the first quarter of 1997 accounted for
$547,000 of the increase. As a result of the change in product mix, gross profit
as a percentage of sales increased in 1998 as compared to 1997 from 25% to 38%.
Selling and distribution expenses remained relatively constant in 1998
as compared to 1997. The Company's strategic alliance partners are responsible
for all marketing and distribution costs of Crinone and Replens in their
territories. There can be no assurance that any of the companies with whom the
Company has entered into these agreements will aggressively or successfully
market the products. 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.
General and administrative expenses increased to approximately
$1,577,000 in 1998 from $739,000 in 1997. Of the $838,000 increase, $470,000
resulted from one-time public relations fees incurred in connection with the
launch of Crinone 4% and expenses related to FDA regulatory affairs.
Research and development expenses decreased by approximately $621,000
from $2,412,000 in 1997 to $1,791,000 in 1998 as major clinical studies related
to Crinone were completed in 1997.
License fees in 1997 represent upfront and milestone payments received
in connection with the licensing agreement with AHP.
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Interest expense increased in 1998 as a result of the $10 million note
bearing interest at 7 1/8% issued by the Company on March 16, 1998 to an
institutional investor.
As a result, the net loss for 1998 was $3,197,425 or $.11 per common
share as compared to a net loss in 1997 of $3,004,088 or $.11 per common share.
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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 May 8, 1998, dividends on the Series A Preferred Stock
of $119,396 have been earned but have not been declared.
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
Exhibits
10.12 - Convertible Note Purchase Agreement, 7 1/8% Convertible
Subordinated Note due March 15, 2005 and Registration Rights
Agreement all dated as of March 16, 1998 between the Company
and SBC Warburg Dillon Read Inc.
10.13 - Termination Agreement dated as of April 1, 1998 between the
Company and the Warner-Lambert Company.
Reports on Form 8-K
None.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
COLUMBIA LABORATORIES, INC.
/s/ DAVID L. WEINBERG
-----------------------------
DAVID L. WEINBERG, Vice President-
Finance and Administration,
Chief Financial Officer
DATE: MAY 8, 1998
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INDEX TO EXHIBITS
10.12 - Convertible Note Purchase Agreement, 7 1/8% Convertible Subordinated
Note due March 15, 2005 and Registration Rights Agreement all dated as
of March 16, 1998 between the Company and SBC Warburg Dillon Read Inc.
10.13 - Termination Agreement dated as of April 1, 1998 between the Company
and the Warner-Lambert Company.
27 - Financial Data Schedule.