U.S. Securities and Exchange Commission
Washington D.C. 20549
FORM 10-QSB
(Mark One)
[x] QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF
THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended: April 30, 1999
[ ] TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF
THE EXCHANGE ACT
Commission File number: 0-19879
BioSpecifics Technologies Corp.
-------------------------------
(Exact name of Small Business Issuer as Specified in Its Charter)
Delaware 11-3054851
-------- ----------
(State of Incorporation) (IRS Employer I.D. Number)
35 Wilbur St.
Lynbrook, NY 11563
------------------
(Address of principal executive offices)
(516) 593-7000
--------------
(Issuer's telephone number, including area code)
Check whether the issuer: (1) has filed all reports required 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 registrant was required to file such
reports), and (2) has been subject to such filing requirements for the past 90
days.
Yes X No__
APPLICABLE ONLY TO CORPORATE ISSUERS:
State the number of shares outstanding of each of the issuer's classes
of common equity, as of the latest practicable date: 4,546,766 shares of Common
--------------------------
Stock, $0.001 par value as of June 1, 1999
- ------------------------------------------
Transitional Small Business Disclosure Format (check one): Yes ____ No x
Page 1 of 12
<PAGE>
INDEX
-----
<TABLE>
<CAPTION>
<S> <C>
Page
----
PART I - FINANCIAL INFORMATION 3
Item 1. Financial Statements 3
Consolidated Financial Statements:
Balance Sheets as of April 30, 1999 (unaudited) and January 31, 1999 3
Statements of Operations for the Three Months Ended April 30, 1999 and 1998
(unaudited) 4
Statements of Cash Flows for the Three Months Ended April 30, 1999 and 1998
(unaudited) 5
Notes to Consolidated Interim Financial Statements (unaudited) 6
Item 2. Management's Discussion and Analysis of Financial Condition and
Results of Operations 7
PART II - OTHER INFORMATION 11
SIGNATURES 12
</TABLE>
Page 2 of 12
<PAGE>
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
BioSpecifics Technologies Corp. and Subsidiaries
Consolidated Balance Sheets
<TABLE>
<CAPTION>
(Unaudited)
April 30, January 31,
ASSETS 1999 1999
-------------- ------------
<S> <C> <C>
Cash and cash equivalents $3,877,007 $5,086,725
Marketable securities 2,767,559 2,102,951
Accounts receivable 1,158,361 1,202,003
Inventory 1,558,757 1,488,525
Deferred tax assets - net 455,351 348,206
Prepaid expenses & other current assets 103,429 135,623
Due from related party 190,425 75,000
-------------- ------------
Total current assets 10,110,889 10,439,033
Property, plant, and equipment - net 665,841 713,716
Due from related parties 170,101 170,101
Other assets 28,811 53,693
-------------- ------------
TOTAL ASSETS $10,975,642 $11,376,543
============== ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $1,123,662 $1,179,900
Notes payable to related parties 12,635 12,510
Income taxes payable - 78,566
Deferred revenue 175,000 175,000
-------------- ------------
Total current liabilities 1,311,297 1,445,976
Minority interest in subsidiaries 258,749 260,849
STOCKHOLDERS' EQUITY
Series A Preferred stock, $.50 par value; 700,000
shares authorized; none outstanding - -
Common stock, $.001 par value; 10,000,000 shares authorized;
4,891,146 shares issued at April 30, 1999 and January 31, 1999 4,891 4,891
Additional paid-in capital 3,734,375 3,734,375
Retained earnings 7,530,049 7,667,141
Accumulated other comprehensive loss (3,448) (3,101)
-------------- ------------
11,265,867 11,403,306
Less: Treasury stock - 344,380 and 310,780 shares, at cost (1,860,271) (1,733,588)
-------------- ------------
Stockholders' equity - net 9,405,596 9,669,718
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $10,975,642 $11,376,543
============= ============
</TABLE>
See accompanying notes to consolidated financial statements.
Page 3 of 12
<PAGE>
Biospecifics Technologies Corp.
and Subsidiaries
Consolidated Statements of Operations
<TABLE>
<CAPTION>
Unaudited
Three Months Ended
April 30,
1999 1998
------------- -------------
Revenues:
<S> <C> <C>
Net sales $682,728 $1,223,543
Royalties 596,747 484,115
------------- -------------
1,279,475 1,707,658
------------- -------------
Costs and Expenses:
Cost of sales 407,871 546,757
Selling, general and administrative 647,204 429,835
Research and development 505,701 421,818
------------- -------------
1,560,776 1,398,410
------------- -------------
Income (loss) from operations (281,301) 309,248
Other income (expense):
Investment and other income 42,691 61,018
Interest expense (1,090) (1,643)
------------- -------------
41,601 59,375
Income (loss) before taxes and minority interest (239,700) 368,623
Income tax expense (benefit) (100,510) 136,100
------------- -------------
Income (loss) before minority interest (139,190) 232,523
Minority interest in net income (loss) of subsidiaries (2,100) 3,900
------------- -------------
Net income (loss) ($137,090) $228,623
============= =============
Basic net income (loss) per common share ($0.03) $0.05
============= =============
Weighted-average common shares outstanding 4,566,933 4,785,263
============= =============
Diluted net income (loss) per common share ($0.03) $0.05
============= =============
Weighted-average common and dilutive
potential common shares outstanding 4,566,933 4,921,768
============= =============
</TABLE>
See accompanying notes to consolidated
financial statements
Page 4 of 12
<PAGE>
BioSpecifics Technologies Corp.
and Subsidiaries
Consolidated Statements of Cash Flows
<TABLE>
<CAPTION>
(unaudited)
Three months ended
April 30,
CASH FLOWS FROM OPERATING ACTIVITIES: 1999 1998
------------- -------------
<S> <C> <C>
Net income (loss) ($137,090) $228,623
Adjustments to reconcile net income (loss)
to cash provided by (used in) operating activities:
Depreciation and amortization 47,875 47,075
Loss on marketable securities - net 26,104 21,523
Minority interest in income (loss) of subsidiaries (2,100) 3,900
Options issued to third parties - 15,000
Changes in operating assets and liabilities:
Accounts receivable 43,642 62,573
Marketable securities, net (690,712) 310,490
Inventory (70,232) 76,829
Prepaid and other current assets 32,193 (173,233)
Deferred tax assets (107,145) -
Due from related party (115,425) -
Other assets 24,882 18,332
Accounts payable & accruals (56,238) (348,410)
Notes payable to related parties 125 125
Income taxes payable (78,566) 31,729
Accumulated other comprehensive loss (349) 68
------------- -------------
Net cash provided by (used in) operating activities (1,083,036) 294,624
------------- -------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Expenditures for plant, property and equipment - (18,067)
------------- -------------
Net cash used in investing activities - (18,067)
------------- -------------
CASH FLOWS FROM FINANCING ACTIVITIES
Treasury stock purchases (126,682) (60,161)
Proceeds from exercise of stock options - 20,175
------------- -------------
Net cash used in financing activities (126,682) (39,986)
------------- -------------
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (1,209,718) 236,571
CASH AND CASH EQUIVALENTS:
Beginning of Period 5,086,725 4,431,055
------------- -------------
End of Period $3,877,007 $4,667,626
============= =============
Supplemental disclosure of cash flow information:
Cash paid during period for interest $0 $1,743
============= =============
Cash paid during period for income taxes $97,327 $104,371
============= =============
</TABLE>
See accompanying note to consolidated
financial statements
Page 5 of 12
<PAGE>
BIOSPECIFICS TECHNOLOGIES CORP.
NOTES TO CONSOLIDATED INTERIM FINANCIAL STATEMENTS
APRIL 30, 1999
(UNAUDITED)
1. Description of Business and Basis of Presentation
-------------------------------------------------
BioSpecifics Technologies Corp.(the "Company") serves as a holding company for
Advance Biofactures Corporation ("ABC-New York"), Advance Biofactures of
Curacao, N.V.and subsidiaries ("ABC-Curacao"), and Biospecifics Pharma GmbH
("Bio Pharma"), Germany.
The Company, through its subsidiaries, is engaged in the business of producing
and licensing for sale by others a fermentation derived enzyme named Collagenase
ABC (the "product") which is approved by the U.S. Food and Drug Administration
("FDA"), and researching and developing additional products derived from this
enzyme for potential use as pharmaceuticals. The product is used principally as
a topical debridement treatment for dermal ulcers. The Company currently derives
all or substantially all revenues through a license agreement with a U.S.
pharmaceutical company, Knoll Pharmaceutical Company ("KPC"). Sales of the
product have been principally to KPC during the three months ended April 30,
1999 and 1998. The license with KPC expires in 2003. The non renewal of the
license agreement by KPC could have a material adverse impact on the financial
condition of the Company unless the Company secures other licensees. In the
event that KPC were to cancel the license agreement for cause, the financial
condition of the Company would be materially adversely affected unless the
Company were to find a similar licensee in the United States. The Company has
licensing agreements with a number of foreign companies, some of which are
marketing the product and others of which will attempt to market the product or
products in development in licensed territories when permitted by local
governmental authorities. See "Liquidity, Capital Resources, and Changes in
Financial Condition" with respect to issues raised by the FDA.
2. Interim Financial Statements
----------------------------
In the opinion of management, the accompanying consolidated financial statements
of the Company reflect all adjustments necessary to present fairly, in all
material respects, the Company's balance sheet as of April 30, 1999, the
statements of income for the three months ended April 30, 1999 and 1998, and
statements of cash flows for the three months ended April 30, 1999 and 1998. The
results of operations for interim periods are not necessarily indicative of the
results to be expected for an entire fiscal year, and the results for the
current interim period are not necessarily indicative of results to be expected
in other interim periods. These interim financial statements should be read in
conjunction with the Company's Form 10-KSB for the fiscal year ended January 31,
1999.
3. Net Income (loss) per Share
---------------------------
Basic earnings (loss) per share ("EPS") excludes dilution and is computed by
dividing earnings (loss) available to common stockholders by the
weighted-average number of common shares outstanding for the period. Diluted EPS
reflects the dilution that would occur if common stock equivalents were
exercised or converted into common stock or resulted in the issuance of common
stock that then shared in the earnings of the Company.
Page 6 of 12
<PAGE>
Dilutive common stock options and warrants, representing 136,505 shares of
common stock, are included in the diluted EPS calculation using the treasury
stock method for the three months ended April 30, 1998. As a result of the net
loss for the three months ended April 30, 1999, common stock options and
warrants have not been included in the diluted EPS calculation, as their effect
would have been antidilutive.
Item 2: MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
RESULTS OF OPERATIONS
- ---------------------
Safe Harbor Statement Under the Private Securities Litigation Reform Act of 1995
- --------------------------------------------------------------------------------
Information provided by the Company or statements contained in this report or
made by its employees, if not historical, is forward-looking information which
involves uncertainties and risk. The Company cautions readers that important
factors may affect the Company's actual results and could cause such results to
differ materially from forward-looking statements made by or on behalf of the
Company. Such factors include, but are not limited to, changing market
conditions, the impact of competitive products and pricing, the timely
development, approval by the FDA and foreign health authorities, and market
acceptance, of the Company's products in development, the Company's dependence
on KPC, and other risks detailed herein and in other filings the Company makes
with the Securities and Exchange Commission. Further, any forward-looking
statement or statements speak only as of the date on which such statements were
made, and the Company undertakes no obligation to update any forward-looking
statement or statements to reflect events or circumstances after the date on
which such statement or statements were made.
The Company incorporates by reference the Management's Discussion and Analysis
of Financial Condition and Results of Operations set forth in its Form 10-KSB
for the fiscal year ended January 31, 1999.
Three months ended April 30, 1999 and 1998
- ------------------------------------------
Net Sales - Net sales of Collagenase ABC for the three months ended April 30,
1999 and 1998 were $682,728 and $1,223,543, respectively, a decrease of $540,815
or 44%. Sales of Collagenase ABC to KPC and foreign licensees were lower during
the three months ended April 30, 1999 versus 1998 due to the timing of
licensees' orders.
Royalties - Royalties for the three months ended April 30, 1999 and 1998 were
$596,747 and $484,115, respectively, an increase of $112,632 or 23%. The
increase was due to higher after-market sales of Collagenase ointment
(Collagenase Santyl(R)) in the United States by KPC during the 2000 first fiscal
quarter, as reported to the Company by KPC.
Page 7 of 12
<PAGE>
Cost of Sales - Cost of sales for the three months ended April 30, 1999 and 1998
were $407,871 and $546,757 respectively, a decrease of $138,886 or 25%, due to
lower net sales. The Company's cost of sales margin was higher during the three
months ended April 30, 1999 versus 1998 as a result of the allocation of fixed
production costs to the lower sales volume.
Selling, general and administrative - Selling, general and administrative
("SG&A") expenses for the three months ended April 30, 1999 and 1998 were
$647,204 and $429,835, respectively, an increase of $217,369 or 51%. During the
quarter ended April 30, 1999, the Company engaged consultants to assist in
responding to inspectional observations ("483's") from FDA inspectors, the cost
of which are included in SG&A. In addition, production lab personnel were highly
involved in the response effort as well, resulting in a significant level of
production inactivity. Those costs, approximating $120,000 usually allocated to
production are included in SG&A. The Company anticipates that there will be
considerable consultation costs and involvement of its lab personnel, in
responding to the 483s, into the foreseeable future. See "Liquidity, Capital
Resources, and Changes in Financial Condition".
Research and development - Research and development ("R&D") expense for the
three months ended April 30, 1999 and 1998 were $505,701 and $421,818
respectively, representing an increase of $83,883 or 20%. The Company is
sponsoring U.S. clinical trials of its injectable collagenase for two disease
conditions. The Company is focusing its R&D on these potential indications. The
Company expects its current year (fiscal 2000) R&D expense to exceed that of
last year.
Other income, net - Other income, net for the three months ended April 30, 1999
and 1998 was $41,601 and $59,375 respectively. The decrease of $17,774 or 30%
was primarily attributable to fluctuations in interest rates which affect the
fair value of the Company's trading securities.
Income tax expense (benefit) - The income tax expense (benefit) for the three
months ended April 30, 1999 and 1998 was $(100,510) and $136,100, respectively.
The Company recorded a tax benefit for the three months ended April 30, 1999
partially as a result of its pretax loss. In addition, the Company generated
additional orphan drug credits as a result of continued research expenditures
for Dupuytren's and Peyronie's diseases. The benefit is available as a
carryback/carryforward against income taxes paid in prior/future periods.
LIQUIDITY, CAPITAL RESOURCES AND CHANGES IN FINANCIAL CONDITION
- ---------------------------------------------------------------
The Company's primary source of working capital is from operations, which
includes sales of product, royalties, and new license fees. At April 30, 1999,
the Company had working capital of approximately $8.7 million which includes
cash and cash equivalents, and marketable securities of approximately $6.6
million. Net cash used in operating activities during the quarter ended April
30, 1999 was approximately $1.1 million, primarily for purchases of trading
marketable securities.
Page 8 of 12
<PAGE>
In January and March of 1999, the Company was issued a List of Inspectional
Observations ("483s") from FDA inspectors, citing numerous inspectional
observations relating to deficiencies in the Company's "good manufacturing
practice" at its Lynbrook, New York and Curacao, Netherlands Antilles
facilities, respectively. In addition, on May 10, 1999, the Company received a
letter from the FDA (the "FDA Letter") citing certain inspectional observations
relating to deficiencies at its Lynbrook, New York facility, Curacao,
Netherlands Antilles facility, and contract manufacturing facility. The FDA
Letter advised the Company that the FDA will institute formal proceedings to
revoke the Company's license to manufacture Collagenase Santyl(R) Ointment
unless the Company provides satisfactory assurances to the FDA, including
submitting to the FDA a detailed, comprehensive plan of corrective action within
30 days, and undertakes significant remedial action to address the observations
listed in the 483s and the FDA Letter, and otherwise demonstrates compliance
with applicable regulatory requirements. As discussed with the FDA, the Company
provided the FDA with its plan of corrective action on June 17, 1999. The
Company has a July 1, 1999 meeting scheduled with the FDA to discuss the plan of
corrective action. The Company has hired outside consultants, has employed
additional staff for the Quality Control department, and will continue to seek
to employ additional staff for the Quality Control and Quality Assurance
departments to assist in further developing and executing the plan of corrective
action, and is taking steps to reorganize the Quality Control and Quality
Assurance departments.
With regard to an agreement with KPC, pursuant to which KPC will continue to
produce Santyl(R) Ointment from collagenase enzyme provided by the Company after
April 23, 1999, in the event the FDA does not permit the Company to release such
ointment prepared by KPC, the Company would be liable to reimburse KPC an amount
estimated by the Company to be approximately $500,000 for the material and
direct labor manufacturing costs of such ointment lots. Such a charge would
apply to fiscal year 2000, and may have a material adverse effect on fiscal 2000
results.
The Company plans to invest between $1.5 million and $2.0 million in new
equipment at its Lynbrook, New York, and Curacao, Netherlands Antilles
facilities. This investment is intended to address pertinent observations in the
483s and the FDA Letter and position the Company to ensure the efficiency of its
production process. The Company estimates it could spend between $500,000 to
$800,000 for professional fees and other expenses in connection with the
remediation of the FDA's deficiency observations.
In view of the Company's working capital position and anticipated future
profitable operations, although there can be no assurance, management believes
that the Company has sufficient liquidity and capital resources to meet its
immediate operating needs. The Company believes that cash on hand and cash
provided by operations will be sufficient to meet its cash needs on an ongoing
basis. However, if the Company is unable to address and remedy the observations
listed in the 483s and the FDA Letter, it will be required to suspend or
terminate operations. Due to the uncertainty of the outcome of the FDA issue,
the Company's independent auditors, KPMG LLP, have noted in their report on the
Company's consolidated financial statements as of and for the year ended January
31, 1999 that the FDA Letter raises substantial doubt about the Company's
ability to continue as a going concern.
Page 9 of 12
<PAGE>
Year 2000 Compliance
- --------------------
The Company is preparing its computer systems and hardware to contend with the
issues related to the year 2000 ("Year 2000"). The Year 2000 issue results from
computer programs being written using two digits rather than four to define the
applicable year and to assume that the first two digits of a year were 19. As
the year 2000 approaches, systems using such programs may recognize a date
ending in "00" as the year 1900 rather than the year 2000, and so may not
accurately process certain date-based information. To the extent that the
Company's software applications contain source code that is unable to interpret
appropriately the upcoming calendar year 2000 and beyond, some level of
modification or replacement of such applications will be necessary to avoid
system failures and the temporary inability to process transactions or engage in
other normal business activities.
The initial phase of the Company's preparation for the Year 2000 consists of
assessment and planning. The assessment phase includes the assessment of all
computer hardware, software, systems and processes ("IT systems") and
non-information technology systems and other equipment containing embedded
microprocessor technology ("non-IT systems").
The Company believes that all of its mission-critical computer programs and
hardware are currently Year 2000 compliant. The Company has also assessed the
risk relating to manufacturing equipment which may be impacted by the Year 2000
issue. The Company believes that its manufacturing equipment will not be
affected by the Year 2000 issue because its manufacturing equipment's embedded
chips and software programs, if any, are not date critical. In addition to the
assessment of the IT systems and non-IT systems, the Company has identified
relationships with third parties, including customers, vendors, suppliers and
service providers, which the Company believes are critical to its business
operations. The Company has one significant customer, which represents
approximately 90% of its fiscal 1999 revenues. The Company is in the process of
determining the extent to which these third parties are addressing their Year
2000 compliance issues. Based on its assessment to date of the Year 2000
readiness of its key customers, suppliers, including vendors, service providers
and other third parties on which it relies for business operations, the Company
believes that these third parties are taking action related to the Year 2000.
However, the Company has limited ability to test and control such third parties'
Year 2000 readiness, and it cannot provide assurance that failure of such third
parties to address the Year 2000 issue will not cause an interruption of the
Company's business. The Company will continue to monitor the progress of these
third parties in resolving Year 2000 issues. The cost of ensuring Year 2000
compliance is not expected to be material. The Company believes that under a
worst-case scenario, it could continue its normal business activities on a
manual basis, however, the Company believes its internal computer systems will
be Year 2000 compliant. With respect to potential Year 2000 failures of its
vendors and suppliers, the Company plans to mitigate this risk by purchasing and
storing critical raw materials used in the production process in advance, which
the Company believes will enable it to continue normal operations for several
months.
Page 10 of 12
<PAGE>
There can be no assurance that the Company will fully achieve Year 2000
compliance in a timely manner, that the Company will not have to increase
significantly its expenditures relating to any such non-compliance, or that its
business will not be materially adversely affected by any such non-compliance.
New Reporting Standard
- ----------------------
In June 1998, the Financial Accounting Standards Board issued SFAS No. 133,
"Accounting for Derivative Instruments and Hedging Activities", which is
effective for all fiscal quarters of fiscal years beginning after June 15, 2000.
Management does not believe the adoption of this statement will have a material
effect on the Company's consolidated financial statements. This statement will
not be adopted until February 1, 2001, the start of fiscal year 2002.
PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
See "Management's Discussion and Analysis of Financial Condition and Results of
Operations - Liquidity, Capital Resources, and Change in Financial Condition."
Page 11 of 12
<PAGE>
SIGNATURES
In accordance with Section 13 or 15(d) of the Securities Exchange Act
of 1934, the Registrant caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
BioSpecifics Technologies Corp.
(Registrant)
Date: June 21, 1999
-------------
By:/s/ Edwin H. Wegman
-------------------
Edwin H. Wegman
Chairman, President, and
Chief Executive Officer
Date: June 21, 1999
-------------
By: /s/ Albert Horcher
------------------
Albert Horcher
Secretary, Treasurer and Principal Financial
and Chief Accounting Officer
Page 12 of 12
<TABLE> <S> <C>
<ARTICLE> 5
<MULTIPLIER> 1
<S> <C>
<PERIOD-TYPE> 3-mos
<FISCAL-YEAR-END> JAN-31-2000
<PERIOD-START> FEB-01-1999
<PERIOD-END> APR-30-1999
<CASH> 3,877,077
<SECURITIES> 2,767,559
<RECEIVABLES> 1,158,361
<ALLOWANCES> 0
<INVENTORY> 1,558,757
<CURRENT-ASSETS> 103,429
<PP&E> 3,160,064
<DEPRECIATION> 2,494,223
<TOTAL-ASSETS> 10,975,642
<CURRENT-LIABILITIES> 1,123,662
<BONDS> 0
0
0
<COMMON> 4,891
<OTHER-SE> 11,264,424
<TOTAL-LIABILITY-AND-EQUITY> 10,975,642
<SALES> 1,279,475
<TOTAL-REVENUES> 1,279,475
<CGS> 407,871
<TOTAL-COSTS> 407,871
<OTHER-EXPENSES> 505,701
<LOSS-PROVISION> 0
<INTEREST-EXPENSE> 1,090
<INCOME-PRETAX> (239,700)
<INCOME-TAX> (100,510)
<INCOME-CONTINUING> (137,090)
<DISCONTINUED> 0
<EXTRAORDINARY> 0
<CHANGES> 0
<NET-INCOME> 0
<EPS-BASIC> (.03)
<EPS-DILUTED> (.03)
</TABLE>
