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, 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.
(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.)
2875 NORTHEAST 191 STREET
AVENTURA, FLORIDA 33180
(Address of principal executive offices) (Zip Code)
Company's telephone number, including area code: (305) 933-6089
Indicate by check mark whether the Company (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities Exchange Act of
1934 during the preceding 12 months (or for such shorter period that the Company
was required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days. Yes X No ____
Number of shares of the Common Stock of Columbia Laboratories, Inc.
issued and outstanding as of July 31, 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 six months ended June 30, 1998 are not necessarily
indicative of the results for the year ending December 31, 1998.
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 14
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
JUNE 30, DECEMBER 31,
1998 1997
----------- ------------
(Unaudited)
ASSETS:
Current assets-
Cash and cash equivalents $ 3,398,314 $ 2,256,590
Accounts receivable, net 3,109,100 6,223,842
Inventories 3,199,421 2,252,675
Prepaid expenses 190,849 477,857
-------------- --------------
Total current assets 9,897,684 11,210,964
Property and equipment, net 1,661,770 1,701,136
Intangible assets, net 5,531,999 1,119,697
Other assets 1,184,780 969,955
-------------- --------------
$ 18,276,233 $ 15,001,752
============== ==============
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities-
Accounts payable $ 3,730,954 $ 3,709,368
Accrued expenses 951,248 1,319,400
Deferred revenue 687,344 1,042,638
-------------- --------------
Total current liabilities 5,369,546 6,071,406
-------------- --------------
Convertible Subordinated Note payable 10,000,000 -
Other long-term liabilities 120,473 116,781
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 93,048,987 92,588,038
Accumulated deficit (90,615,487) (84,128,906)
Cumulative translation adjustment 65,842 68,177
-------------- --------------
Total stockholders' equity 2,786,214 8,813,565
-------------- --------------
$ 18,276,233 $ 15,001,752
============== ==============
See notes to condensed consolidated financial statements.
Page 3 of 14
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
SIX MONTHS ENDED THREE MONTHS ENDED
JUNE 30, JUNE 30,
1998 1997 1998 1997
------------ ------------ ---------- --------
NET SALES $ 4,396,712 $3,596,446 $2,124,727 $2,230,565
COST OF GOODS SOLD 2,372,282 2,219,390 966,298 1,194,108
----------- ----------- ------------ ------------
Gross profit 2,024,430 1,377,056 1,158,429 1,036,457
----------- ----------- ----------- ------------
OPERATING EXPENSES:
Selling and distribution 1,757,088 1,496,591 1,119,322 837,489
General and administrative 2,847,161 1,458,960 1,270,608 720,367
Research and development 3,722,493 4,458,775 1,931,384 2,046,223
----------- ----------- ---------- -----------
Total operating expenses 8,326,742 7,414,326 4,321,314 3,604,079
----------- ----------- ----------- -----------
Loss from operations (6,302,312) (6,037,270) (3,162,885) (2,567,622)
----------- ----------- ----------- ----------
OTHER INCOME (EXPENSE):
License fees - 500,000 - -
Interest income 107,883 33,054 65,013 5,746
Interest expense (222,097) (3,059) (188,838) (3,059)
Other, net (70,057) (92,163) (2,448) (30,415)
----------- ----------- ------------ ------------
(184,271) 437,832 (126,273) (27,728)
----------- ----------- ------------ ------------
Net loss $(6,486,583) $(5,599,438) $ (3,289,158) $ (2,595,350)
=========== =========== ============ ============
LOSS PER COMMON SHARE
BASIC AND DILUTED $ (.23) $ (.20) $ (.11) $ (.09)
=========== =========== ============ ============
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING
BASIC AND DILUTED 28,673,000 28,224,000 28,685,000 28,304,000
=========== =========== ============ ============
See notes to condensed consolidated financial statements.
Page 4 of 14
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE OPERATIONS
(Unaudited)
SIX MONTHS ENDED THREE MONTHS ENDED
JUNE 30, JUNE 30,
1998 1997 1998 1997
------------ ------------ ---------- --------
Net loss $(6,486,583) $(5,599,438) $(3,289,158) $(2,595,350)
Other comprehensive income (loss):
Foreign currency translations, net of tax 2,335 (5,749) (3,256) (8,140)
----------- ----------- ----------- -----------
Comprehensive loss $(6,484,248) $(5,605,187) $(3,292,414) $(2,603,490)
=========== =========== =========== ===========
See notes to condensed consolidated financial statements.
Page 5 of 14
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
SIX MONTHS ENDED JUNE 30,
1998 1997
------------ ------------
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ (6,486,583) $(5,599,438)
Adjustments to reconcile net loss to net
cash used in operating activities-
Depreciation and amortization 574,015 421,983
Issuance of warrants and options for
consulting services 333,456 -
Changes in assets and liabilities-
(Increase) decrease in:
Accounts receivable 2,805,611 (263,733)
Inventories (946,748) (664,946)
Prepaid expenses 274,389 280,773
Other assets (314,372) (399,059)
Increase (decrease) in:
Accounts payable 24,217 2,397,036
Accrued expenses (281,808) (359,852)
Deferred revenue (355,295) (10,221)
------------ -----------
Net cash used in operating activities (4,373,118) (4,197,457)
------------ -----------
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of product rights (4,600,000) -
Purchase of property and equipment (238,523) (534,799)
------------ -----------
Net cash used in investing activities (4,838,523) (534,799)
------------ -----------
CASH FLOWS FROM FINANCING ACTIVITIES:
Issuance of note payable 10,000,000 -
Proceeds from exercise of options and warrants 356,188 1,422,793
------------ -----------
Net cash provided by financing activities 10,356,188 1,422,793
------------ -----------
(Continued)
Page 6 of 14
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Continued)
SIX MONTHS ENDED JUNE 30,
1998 1997
------------ ------------
EFFECT OF EXCHANGE RATE CHANGES ON CASH (2,823) (36,909)
------------ ------------
NET INCREASE (DECREASE) IN CASH
AND CASH EQUIVALENTS 1,141,724 (3,346,372)
CASH AND CASH EQUIVALENTS,
beginning of period 2,256,590 3,561,794
------------ ------------
CASH AND CASH EQUIVALENTS,
end of period $ 3,398,314 $ 215,422
============ ============
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Interest paid during the period $ 11,057 $ 7,889
============ ============
SUPPLEMENTAL SCHEDULE OF NONCASH OPERATING AND FINANCING ACTIVITIES:
As of June 30, 1998, dividends on the Series A Preferred Stock of
$120,473 ($3,692 relating to the six months ended June 30, 1998) have been
earned but have not been declared and are included in other long-term
liabilities in the accompanying June 30, 1998 condensed consolidated balance
sheet.
See notes to condensed consolidated financial statements.
Page 7 of 14
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) LOSS PER SHARE:
Basic loss per share is computed by dividing the net loss plus
preferred dividends by the weighted average number of shares of common stock
outstanding during the period. In the computation of diluted loss per share, the
weighted average number of common shares outstanding is adjusted for all
dilutive potential common stock.
For the three and six month periods ending June 30, 1998 and 1997,
there was no difference between basic and diluted loss per common share as all
potential common stock was antidilutive.
Total potential common stock at June 30, 1998, includes Series A and
Series B Convertible Preferred stock convertible into 11,408 and 33,529 shares
of common stock, respectively; outstanding options and warrants to purchase
5,540,027 shares of common stock and a convertible subordinated note due March
15, 2005 which is convertible at the option of the holder into 662,032 shares of
common stock at a conversion rate of $15.105 per share.
(3) CONVERTIBLE SUBORDINATED 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 is convertible into 662,032 shares of common stock at 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 19, 1999.
(4) REACQUISITION OF PRODUCT RIGHTS:
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 reacquire the
product Replens, effective on April 9, 1998. The $4.6 million cost has been
capitalized and is being amortized over a 15 year period, which represents the
remaining years on the terminated December 1991 license and the patent
underlying the product.
(5) RECENT ACCOUNTING PRONOUNCEMENTS:
In June 1997, the Financial Accounting Standards Board (FASB) issued
Statement of Financial
Page 8 of 14
Accounting Standards ("SFAS") No. 130, "Reporting Comprehensive Income". The
Company adopted SFAS 130 on January 1, 1998. The SFAS 130 establishes standards
for reporting and display of comprehensive income and its components in a full
set of financial statements. Comprehensive income is defined as the change in
equity during the financial reporting period of a business enterprise resulting
from non-owned sources. Accordingly, the Company has included "Condensed
Consolidated Statements of Comprehensive Operations" as part of its financial
statements.
SFAS No. 131, "Disclosures about Segments of an Enterprise and Related
Information", was also issued by the FASB in June 1997. This statement
establishes standards for reporting information about operating segments in
annual financial statements and requires reporting of selected information about
operating segments in interim financial reports issued to shareholders. It also
establishes standards for related disclosures about products and services,
geographic areas and major customers. The Company will adopt SFAS 131 effective
December 31, 1998.
SFAS No. 133, "Accounting for Derivative Instruments and Hedging
Activities", is effective for fiscal years ending after June 15, 1999. This
statement established accounting and reporting standards that require that every
derivative instrument be recorded in the balance sheet as either an asset or a
liability at its fair value. The Company has adopted SFAS 133 for the three
months ended June 30, 1998. The adoption of this statement did not have a
material impact on the Company's consolidated financials position since the
Company does not presently have any derivative or hedging type instruments, as
defined by SFAS 133.
Page 9 of 14
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 $3.4 million at June 30, 1998 . The Company
received $9.7 million, net of expenses, from the issuance of a note to an
institutional investor (see note 3 to unaudited condensed consolidated financial
statements), and approximately $356,000 from the exercise of options and
warrants. The Company paid $4.6 million in April 1997 to the Warner-Lambert
Company to reacquire the rights to the product Replens (see note 4 to unaudited
condensed consolidated financial statements) and used $4.4 million for operating
activities.
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 June 30, 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 ("SPC3"). 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
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, 1998, the Company has paid approximately $1.3 million
in royalty payments.
Page 10 of 14
As of June 30, 1998, the Company has outstanding exercisable options
and warrants that, if exercised, would result in approximately $52 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 $300,000 on production equipment at its
suppliers.
As of June 30, 1998, the Company had available net operating loss
carryforwards of approximately $48 million to offset its future U.S. taxable
income.
In accordance with Statement of Financial Accounting Standards No.
109, as of June 30, 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 - SIX MONTHS ENDED JUNE 30, 1998 VERSUS SIX MONTHS ENDED
JUNE 30, 1997
Net sales increased in 1998 by $800,266 or 22% as compared to 1997
because of the Company's repurchase of the rights to the product Replens in
April 1998 and its subsequent marketing of the product directly to wholesalers
and chain drugstores. Since the Company's gross profit on Replens sales is much
greater when it sells directly to wholesalers and chain drugstores than under
the terminated Replens licensing agreement, gross profit as a percentage of net
sales increased to 46% in 1998 from 38% in 1997.
Selling and distribution expenses increased by $260,497 or 17% in 1998
compared to 1997. This increase was due principally to the Company's marketing
of Replens
General and administrative expenses increased by $1,388,201 or 95% in
1998 compared to 1997. The principal reasons were a $607,000 increase in
investor / public relations expenses including $230,000 for Crinone media
promotion and $378,000 for investor relations, of which $252,000 represented the
value of stock options and warrants granted to non-employees; a $434,000
increase in legal expense, of which $260,000 was related to FDA affairs; a
$139,000 increase in salary expense; and a $60,000 increase in insurance
expense.
Research and development expenditures decreased by $736,282 or 17% in
1998 compared to 1997 as the result of the wind down of Crinone studies. Crinone
approvals were received in the United States in May 1997 and July 1997.
License fees in 1997 represented milestone payments received in
connection with the licensing agreement with AHP.
Interest income was $107,883 in 1998 compared to $33,054 in 1997 and
resulted from interest earned on the money received from the issuance of the $10
million note in March 1998 and after paying $4.6 million to reacquire the rights
to the product Replens in April.
Page 11 of 14
Interest expense increased in 1998 to $222,097 from $3,059 in 1997 as
the result of the $10 million note bearing interest at 7 1/8% issued by the
Company in March 1998 to an institutional investor.
As a result, the net loss for the six months ended June 30, 1998 was
$6,486,583 or $.23 per share compared to a net loss of $5,599,438 or $.20 per
share for the six months ended June 30, 1997.
RESULTS OF OPERATIONS - THREE MONTHS ENDED JUNE 30, 1998 VERSUS THREE MONTHS
ENDED JUNE 30, 1997
Net sales decreased in 1998 from 1997 by $105,838 or 5%. In 1997, the
Company had shipped $957,000 of Crinone 8% to Wyeth-Ayerst for sale in the
United States. No similar order took place in 1998. However, foreign Crinone 8%
sales in 1998 amounting to approximately $252,000 and sales of Replens after the
product repurchase almost offset the lack of U.S. Crinone sales by the Company.
Gross profit as a percentage of net sales improved to 55% in 1998 from 46% in
1997.
Selling and distribution expenses increased by $281,833 or 34% in 1998
compared to 1997. This increase was due almost entirely to the Company's
marketing of Replens.
General and administrative expenses increased by $550,241 or 76% in
1998 compared to 1997. The principal reasons for the increase were a $183,000
increase in investor / public relations expense, of which $117,000 represented
the value of stock options and warrants granted to non-employees; a $145,000
increase in legal expense; a $76,000 increase in salary expense; and a $35,000
increase in insurance expense.
Research and development expenses decreased by $114,839 or 6% in 1998
compared to 1997 as the result of the wind down of Crinone studies. Crinone
approvals were received in the United States in May 1997 and July 1997.
Interest income was $65,013 in 1998 compared to $5,746 in 1997 and
resulted from interest earned on the money received from the issuance of the $10
million note in March 1998 and after paying $4.6 million to reacquire the rights
to the product Replens in April 1998.
Interest expense increased in 1998 to $188,838 from $3,059 in 1997 as
the result of the issuance in March 1998 of the $10 million note which bears
interest at the rate of 7 1/8%.
As a result, the net loss for the three months ended June 30, 1998 was
$3,289,158 or $.11 per share compared to a net loss of $2,595,350 or $.09 per
share for the three months ended June 30, 1997.
IMPACT OF THE YEAR 2000
The Company has assessed and continues to assess the impact of the year
2000 issue on its operations, including the development and implementation of
project plans and cost estimates required to make its information system
infrastructure Year 2000 compliant. Based on existing information, the Company
believes the anticipated spending necessary to become Year 2000 compliant will
not have a material effect on the financial position, cash flows or results of
operations of the Company, nor will the Year 2000 issues cause any material
adverse effect on the future business operations of the Company.
Page 12 of 14
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 August 12, 1998, dividends on the Series A Preferred Stock of
$120,473 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
A. Exhibits
27. Financial Data Schedule
B. Reports on Form 8-K
None.
Page 13 of 14
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: AUGUST 14, 1998
Page 14 of 14
EXHIBIT INDEX
EXHIBIT DESCRIPTION
- ------- -----------
27 Financial Data Schedule