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, 1997
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 July 31, 1997: 28,386,319
<PAGE>
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, 1997 are not necessarily
indicative of the results for the year ending December 31, 1997.
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.
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<TABLE>
<CAPTION>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
JUNE 30, DECEMBER 31,
1997 1996
------------ ------------
(Unaudited)
<S> <C> <C>
ASSETS:
Current assets-
Cash and cash equivalents $ 215,422 $ 3,561,794
Accounts receivable, net 1,721,274 1,261,478
Inventories 1,611,070 943,143
Prepaid expenses 178,713 151,400
------------ ------------
Total current assets 3,726,479 5,917,815
Property and equipment, net 1,515,459 1,233,638
Intangible assets, net 1,230,727 1,341,757
Other assets 1,528,892 1,486,887
------------ ------------
$ 8,001,557 $ 9,980,097
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY:
Current liabilities-
Accounts payable $5,208,872 $2,891,502
Accrued expenses 802,865 892,456
Deferred revenue 1,062,925 1,093,524
Estimated liability for returns
and allowances 315,660 320,484
------------ ------------
Total current liabilities 7,390,322 5,197,966
------------ ------------
Other long-term liabilities 112,888 108,693
Stockholders' equity-
Preferred stock, $.01 par value; 1,000,000 shares
authorized;
Series A Convertible Preferred Stock, 973 and
1,323 shares issued and outstanding in 1997
and 1996, respectively 10 13
Series B Convertible Preferred Stock, 1,630
shares issued and outstanding in 1997
and 1996 16 16
Common stock, $.01 par value; 40,000,000 shares
authorized; 28,360,319 and 28,273,672 shares
issued and outstanding in 1997 and 1996,
respectively 283,603 280,716
Capital in excess of par value 90,670,599 89,254,885
Accumulated deficit (90,491,250) (84,891,812)
Cumulative translation adjustment 35,369 29,620
------------ ------------
Total stockholders' equity 498,347 4,673,438
------------ ------------
$ 8,001,557 $ 9,980,097
============ ============
</TABLE>
See note to condensed consolidated financial statements
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<TABLE>
<CAPTION>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
SIX MONTHS ENDED THREE MONTHS ENDED
JUNE 30, JUNE 30,
1997 1996 1997 1996
------------ ------------ ------------ ------------
<S> <C> <C> <C> <C>
NET SALES $3,596,446 $2,405,480 $2,230,565 $1,082,514
COST OF GOODS SOLD 2,219,390 1,272,865 1,194,108 679,470
------------ ------------ ------------ ------------
Gross profit 1,377,056 1,132,615 1,036,457 403,044
------------ ------------ ------------ ------------
OPERATING EXPENSES:
Selling and distribution 1,496,591 1,418,632 837,489 792,462
General and administrative 1,458,960 1,652,454 720,367 771,587
Research and development 4,458,775 5,151,274 2,046,223 2,747,597
------------ ------------ ------------ ------------
Total operating expenses 7,414,326 8,222,360 3,604,079 4,311,646
------------ ------------ ------------ ------------
Loss from operations (6,037,270) (7,089,745) (2,567,622) (3,908,602)
------------ ------------ ------------ ------------
OTHER INCOME (EXPENSE):
License fees 500,000 1,500,000 - -
Interest income 33,054 193,263 5,746 146,222
Interest expense (3,059) (7,121) (3,059) (3,489)
Other, net (92,163) (10,387) (30,415) (7,446)
------------ ------------ ------------ ------------
437,832 1,675,755 (27,728) 135,287
------------ ------------ ------------ ------------
Net loss $ (5,599,438) $ (5,413,990) $ (2,595,350) $ (3,773,315)
============ ============ ============ ============
NET LOSS PER
COMMON SHARE $ (.20) $ (.20) $ (.09) $ (.14)
============ ============ ============ ============
WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 28,224,000 27,176,000 28,304,000 27,868,000
============ ============ ============ ============
</TABLE>
See note to condensed consolidated financial statements
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<TABLE>
<CAPTION>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
SIX MONTHS ENDED JUNE 30,
1997 1996
------------ ------------
<S> <C> <C>
CASH FLOWS FROM OPERATING ACTIVITIES:
Net income (loss) $ (5,599,438) $ (5,413,990)
Adjustments to reconcile net income (loss) to net
cash provided by (used for) operating activities-
Depreciation and amortization 421,983 286,848
Provision for (recovery of) doubtful accounts - (25,000)
Provision (credit) for returns and allowances - (47,461)
Changes in assets and liabilities-
(Increase) decrease in:
Accounts receivable (263,733) 57,076
Inventories (664,946) 123,207
Prepaid expenses 280,773 274,711
Other assets (399,059) 122,761
Increase (decrease) in:
Accounts payable 2,397,036 (1,102,914)
Accrued expenses (355,028) (166,306)
Deferred revenue (10,221) (37,123)
Estimated liability for returns
and allowances (4,824) (10,695)
------------ ------------
Net cash used for operating activities (4,197,457) (5,938,886)
------------ ------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchase of property and equipment (534,799) (261,697)
------------ ------------
CASH FLOWS FROM FINANCING ACTIVITIES:
Repayment of long-term debt - (17,242)
Proceeds from issuance of common stock - 12,205,950
Proceeds from exercise of options and warrants 1,422,793 3,139,755
------------ ------------
Net cash provided by financing activities 1,422,793 15,328,463
------------ ------------
</TABLE>
(Continued)
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<TABLE>
<CAPTION>
COLUMBIA LABORATORIES, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
(Continued)
SIX MONTHS ENDED JUNE 30,
1997 1996
------------- -----------
<S> <C> <C>
EFFECT OF EXCHANGE RATE CHANGES ON CASH (36,909) (20,865)
------------- -----------
NET INCREASE (DECREASE) IN CASH
AND CASH EQUIVALENTS (3,346,372) 9,107,015
CASH AND CASH EQUIVALENTS,
beginning of period 3,561,794 1,628,952
------------- -----------
CASH AND CASH EQUIVALENTS,
end of period $ 215,422 $10,735,967
============= ===========
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION:
Interest paid during the period $ 7,889 $ 7,835
============= ===========
</TABLE>
SUPPLEMENTAL SCHEDULE OF NONCASH OPERATING AND FINANCING ACTIVITIES:
As of June 30, 1997, dividends on the Series A Preferred Stock of
$112,888 ($4,195 relating to the six months ended June 30, 1997) have been
earned but have not been declared and are included in other long-term
liabilities in the June 30, 1997 condensed consolidated balance sheet.
See note to condensed consolidated financial statements
6 of 12
<PAGE>
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, 1996.
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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
Cash and cash equivalents decreased from approximately $3.6 million at
December 31, 1996 to approximately $215,000 at June 30, 1997, primarily as a
result of approximately $4.2 million of net cash used in operations and
approximately $535,000 used to purchase property and equipment offset by
approximately $1.4 million received 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 division of AHP will market Crinone. Under
the terms of the agreement, as of August 12, 1997, the Company has received
$14.5 million in milestone payments and will continue to receive additional
milestone payments and a percentage of sales, which sales began late in the
second quarter of 1997.
In July 1996, Columbia submitted a New Drug Application ("NDA") to the
U.S. Food and Drug Administration ("FDA") for clearance to market Crinone as a
hormonal therapy for patients with secondary amenorrhea (loss of menstrual
period). In November 1996, the Company submitted a second NDA for clearance to
market Crinone for use in Assisted Reproductive Technologies ("ART") procedures,
including in-vitro fertilization, ovum donation and stimulated cycles. The FDA
granted the ART filing a priority review. In addition, in February 1997, the FDA
approved the Company's Treatment Protocol under its Investigational New Drug
Application ("IND") for the use of Crinone in assisted fertility procedures. As
a result, through leads generated by the Wyeth-Ayerst institutional sales force,
Columbia has begun distributing Crinone to leading infertility clinics
throughout the United States.
On May 13, 1997, the Company received U.S. marketing approval for
Crinone from the FDA for use as a progesterone supplementation or replacement as
part of an Assisted Reproductive Technology (ART) treatment for infertile women
with progesterone deficiency.
On July 31, 1997, the Company received U.S. marketing approval for
Crinone from the FDA for the treatment of secondary amenorrhea (loss of
menstrual period). In connection herewith, the Company has received a $3 million
milestone payment from Wyeth-Ayerst. In addition, on July 30, 1997, the Company
received approval to market Crinone in Mexico. As a result of this approval, the
Company received an additional $1 million milestone payment from Wyeth-Ayerst.
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 Columbia 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
8 of 12
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certain conditions are met.
The Company believes that sales and liquidity will increase since
Crinone has been approved by the FDA and other regulatory authorities and
Wyeth-Ayerst is beginning to launch the product. The foregoing is a forward
looking statement which could be impacted by when other approvals are received,
when Wyeth-Ayerst launches the product throughout the world, the marketing
support Wyeth-Ayerst gives to the product and the ultimate acceptance of Crinone
by the consumers, all of which the Company has limited ability to influence.
As of August 12, 1997, the Company has shipped approximately $7 million
of Crinone to Wyeth-Ayerst. The Company receives payments for these shipments
within 30 days of shipment. In addition, in connection with the additional FDA
approval on July 31, 1997 and the Mexican approval on July 30, 1997, the Company
has received $4 million in additional milestone payments from Wyeth-Ayerst.
As of June 30, 1997, 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 $100,000 on additional equipment at its suppliers during 1997.
As of June 30, 1997, the Company had available net operating loss
carryforwards of approximately $50 million to offset its future U.S. taxable
income.
In accordance with Statement of Financial Accounting Standards ('SFAS')
No. 109, as of June 30, 1997 and December 31, 1996, other assets in the
accompanying consolidated balance sheet include deferred tax assets of
approximately $18 million and $17 million, respectively, (comprised primarily of
a net operating loss carryforward) which have been fully reserved as their
ultimate realizability is not assured.
In February 1997, the Financial Accounting Standards Board issued SFAS
No. 128, "Earnings Per Share". SFAS No. 128 which supercedes the previous
standard (Accounting Principles Board Opinion No. 15), modifies the methodology
for calculating earnings per share, and is effective for periods ending after
December 15, 1997; early adoption is not permitted. Upon adoption of SFAS No.
128 in the annual consolidated financial statements for the year ending December
31, 1997, the Company will be required to restate previously reported earnings
(loss) per share data to conform with the requirements of SFAS No. 128. Had the
provisions of SFAS No. 128 been applicable to the accompanying condensed
consolidated financial statements, basic and diluted earnings per share, as
calculated in accordance with the provisions of SFAS No. 128, would not have
been different than the loss per share amounts reported herein.
RESULTS OF OPERATIONS - SIX MONTHS ENDED JUNE 30, 1997 VERSUS SIX MONTHS ENDED
JUNE 30, 1996
Net sales increased in 1997 as compared to 1996 because of the first
shipment of Crinone to Wyeth-Ayerst. In addition, the product mix of other
products sold changed significantly from 1996 to 1997. As a result, gross profit
as a percentage of sales decreased in 1997 as compared to 1996.
Selling and distribution expenses remained relatively constant in 1997
as compared to 1996. The Company's strategic alliance partners are responsible
for all marketing and distribution costs of Crinone, Advantage 24 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.
9 of 12
<PAGE>
Research and development expenditures have decreased in 1997 as
compared to 1996 because 1996 amounts include costs incurred in connection with
the pivotal studies required for filing the New Drug Applications for Crinone in
the United States. The Company submitted two NDA's for Crinone during the second
half of 1996.
License fees represent upfront and milestone payments received in
connection with the licensing agreement with AHP.
Interest income was greater in 1996 as a result of interest earned on
the monies received in the private placement completed in March 1996.
As a result, the net loss for 1997 was $5,599,438 or $.20 per share as
compared to a net loss in 1996 of $5,413,990 or $.20 per common share.
RESULTS OF OPERATIONS - THREE MONTHS ENDED JUNE 30, 1997 VERSUS THREE MONTHS
ENDED JUNE 30, 1996
Net sales increased in 1997 as compared to 1996 because of the first
shipment of Crinone to Wyeth-Ayerst. In addition, the product mix of other
products sold changed significantly from 1996 to 1997. As a result, gross profit
as a percentage of sales increased in 1997 as compared to 1996.
Research and development expenditures have decreased in 1997 as
compared to 1996 because 1996 amounts include costs incurred in connection with
the pivotal studies required for filing the New Drug Applications for Crinone in
the United States. The Company submitted two NDA's during the second half of
1996.
Interest income was greater in 1996 as a result of interest earned on
the monies received in the private placement completed in March 1996.
As a result, the net loss for 1997 was $2,595,350 or $.09 per share as
compared to a net loss in 1996 of $3,773,315 or $.14 per common share.
10 of 12
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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 August 12, 1997, dividends on the Series A Preferred Stock of
$113,776 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
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/ MARGARET J. ROELL
----------------------------------
MARGARET J. ROELL, Vice President-
Finance and Administration,
Chief Financial Officer
DATE: August 12, 1997
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EXHIBIT INDEX
EXHIBIT
NUMBER DESCRIPTION
- ------- -----------
27 Financial Data Schedule
<TABLE> <S> <C>
<ARTICLE> 5
<S> <C>
<PERIOD-TYPE> 6-MOS
<FISCAL-YEAR-END> DEC-31-1997
<PERIOD-END> JUN-30-1997
<CASH> 215,422
<SECURITIES> 0
<RECEIVABLES> 1,818,550
<ALLOWANCES> 97,276
<INVENTORY> 1,611,070
<CURRENT-ASSETS> 3,726,479
<PP&E> 2,979,985
<DEPRECIATION> 1,464,526
<TOTAL-ASSETS> 8,001,557
<CURRENT-LIABILITIES> 7,390,322
<BONDS> 0
0
26
<COMMON> 283,603
<OTHER-SE> 214,718
<TOTAL-LIABILITY-AND-EQUITY> 8,001,557
<SALES> 3,596,446
<TOTAL-REVENUES> 3,596,446
<CGS> 2,219,390
<TOTAL-COSTS> 2,219,390
<OTHER-EXPENSES> 7,414,326
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 0
<INCOME-PRETAX> (5,599,438)
<INCOME-TAX> 0
<INCOME-CONTINUING> (5,599,438)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> (5,599,438)
<EPS-PRIMARY> (.20)
<EPS-DILUTED> (.20)
</TABLE>
