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, 2000
--------------
[ ] 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: 4,529,766 shares of Common
Stock, $0.001 par value as of June 1, 2000
Transitional Small Business Disclosure Format (check one):
Yes [ ] No [x]
<PAGE>
INDEX
-----
<TABLE>
<CAPTION>
Page
----
<S> <C>
PART I - FINANCIAL INFORMATION 3
Item 1. Financial Statements 3
Consolidated Financial Statements:
Balance Sheets as of April 30, 2000 (unaudited) and January 31, 2000 3
Statements of Operations for the Three Months Ended April 30, 2000 and 1999 (unaudited) 4
Statements of Cash Flows for the Three Months Ended April 30, 2000 and 1999 (unaudited) 5
Notes to Consolidated Interim Financial Statements (unaudited) 6
Item 2. Management's Discussion and Analysis of Financial Condition and
Condition and Results of Operations 7
PART II - OTHER INFORMATION 10
SIGNATURES 11
</TABLE>
2
<PAGE>
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
<TABLE>
<CAPTION>
BioSpecifics Technologies Corp. and Subsidiaries
Consolidated Balance Sheets
(Unaudited)
April 30, January 31,
ASSETS 2000 2000
------------ ------------
<S> <C> <C>
Cash and cash equivalents $ 4,894,671 $ 4,221,447
Marketable securities 1,046,955 951,398
Accounts receivable 975,618 1,484,326
Inventory 1,948,321 1,779,531
Deferred tax assets - net 739,176 686,206
Prepaid expenses and other current assets 256,271 268,942
............ ............
Total current assets 9,861,012 9,391,850
Property, plant, and equipment - net 1,878,258 1,221,337
Due from related parties 123,780 119,780
Other assets 28,812 28,812
............ ............
TOTAL ASSETS $ 11,891,862 $ 10,761,779
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Accounts payable and accrued expenses $ 1,184,718 $ 1,516,915
Notes payable to related parties 13,135 13,010
Income taxes payable 59,970 3,970
Deferred revenue 1,732,910 45,000
............ ............
Total current liabilities 2,990,733 1,578,895
Minority interest in subsidiaries 271,448 271,448
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, 2000 and January 31, 2000 4,891 4,891
Additional paid-in capital 3,734,375 3,734,375
Retained earnings 7,760,890 7,826,810
Accumulated other comprehensive income 6,577 7,412
............ ............
11,506,733 11,573,488
Less: Treasury stock - 361,380 shares, at cost (1,911,237) (1,911,237)
Notes receivable from chairman (965,815) (750,815)
............ ............
Stockholders' equity 8,629,681 8,911,436
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 11,891,862 $ 10,761,779
============ ============
</TABLE>
See accompanying notes to consolidated financial statements.
3
<PAGE>
Biospecifics Technologies Corp.
and Subsidiaries
Consolidated Statements of Operations
<TABLE>
<CAPTION>
Unaudited
Three Months Ended
April 30,
2000 1999
------------------------ -------------------------
<S> <C> <C>
Revenues:
Net sales $989,805 $682,728
Royalties 449,198 596,747
........................ .........................
1,439,003 1,279,475
------------------------ -------------------------
Costs and Expenses:
Cost of sales 479,787 407,871
Selling, general and administrative 552,327 647,204
Research and development 411,679 505,701
........................ .........................
1,443,793 1,560,776
------------------------ -------------------------
Loss from operations (4,790) (281,301)
Other income (expense):
Investment and other income (loss) (56,515) 42,691
Interest expense (1,583) (1,090)
........................ .........................
(58,098) 41,601
Loss before income taxes and minority interest (62,888) (239,700)
Income tax (expense) benefit (3,030) 100,510
........................ .........................
Loss before minority interest (65,918) (139,190)
Minority interest in net loss of subsidiaries - (2,100)
........................ .........................
Net loss ($65,918) ($137,090)
======================== =========================
Basic net loss per common share ($0.01) ($0.03)
======================== =========================
Weighted-average common shares outstanding 4,529,766 4,566,933
======================== =========================
Diluted net loss per common share ($0.01) ($0.03)
======================== =========================
Weighted-average common and dilutive
potential common shares outstanding 4,529,766 4,566,933
======================== =========================
</TABLE>
See accompanying notes to consolidated financial statements
4
<PAGE>
BioSpecifics Technologies Corp. and Subsidiaries
Consolidated Statements of Cash Flows
<TABLE>
<CAPTION>
(unaudited)
Three Months Ended
April 30,
CASH FLOWS FROM OPERATING ACTIVITIES: 2000 1999
------------------------- -------------------------
<S> <C> <C>
Net loss ($65,918) ($137,090)
Adjustments to reconcile net loss
to net cash provided by (used in) operating activities:
Depreciation and amortization 37,292 47,875
Loss on marketable securities - net 141,938 26,104
Minority interest in loss of subsidiaries - (2,100)
Changes in operating assets and liabilities:
Accounts receivable 508,708 43,642
Marketable securities, net (237,495) (690,712)
Inventory (168,790) (70,232)
Prepaid expenses and other current assets 12,671 33,693
Deferred taxes (52,970) (107,145)
Other assets - 24,882
Accounts payable and accrued expenses (332,197) (56,238)
Notes payable to related parties 125 125
Income taxes payable 56,000 (78,566)
Deferred revenue 1,687,910 -
Accumulated other comprehensive loss (835) (349)
......................... .........................
Net cash provided by (used in) operating activities 1,586,439 (966,111)
------------------------- -------------------------
CASH FLOWS FROM INVESTING ACTIVITIES:
Increase in notes receivable from chairman (215,000) (115,425)
Increase in due from related parties (4,000) (1,500)
Expenditures for plant, property and equipment (694,215) -
......................... .........................
Net cash used in investing activities (913,215) (116,925)
------------------------- -------------------------
CASH FLOWS FROM FINANCING ACTIVITIES
Treasury stock purchases - (126,682)
......................... .........................
Net cash used in financing activities - (126,682)
------------------------- -------------------------
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 673,224 (1,209,718)
CASH AND CASH EQUIVALENTS:
Beginning of Period 4,221,447 5,086,725
......................... .........................
End of Period $4,894,671 $3,877,007
========================= =========================
Supplemental disclosure of cash flow information:
Cash paid during period for interest $1,583 $1,092
========================= =========================
Cash paid during period for income taxes $82,847 $97,327
========================= =========================
</TABLE>
See accompanying note to consolidated financial statements
5
<PAGE>
BIOSPECIFICS TECHNOLOGIES CORP.
NOTES TO CONSOLIDATED INTERIM FINANCIAL STATEMENTS
APRIL 30, 2000
(UNAUDITED)
1. Description of Business and Basis of Presentation
-------------------------------------------------
The accompanying consolidated financial statements include the accounts of
BioSpecifics Technologies Corp. (the "Company"), its majority-owned
subsidiaries, Advance Biofactures Corp. ("ABC - New York") and Advance
Biofactures of Curacao N.V. ("ABC - Curacao") and its wholly-owned subsidiary,
Biospecifics Pharma GmbH ("Bio Pharma") of Germany. All significant intercompany
transactions and balances have been eliminated in consolidation.
The Company produces a fermentation-derived enzyme named Collagenase ABC (the
"product" or "enzyme") which is licensed by the U.S. Food and Drug
Administration (the "FDA"). The Company operates a production facility in
Lynbrook, New York (the "Lynbrook Plant or Facility") and in Curacao,
Netherlands Antilles (the "Curacao Plant or Facility"). The Company is also
researching and developing additional products derived from this enzyme for
potential use as pharmaceuticals.
The Company derives most of its net sales of product revenues and all of its
royalty revenues from one customer, Knoll Pharmaceutical Company ("KPC"). KPC
acts as the Company's contract manufacturer by compounding the product into
Collagenase Santyl(R) (Santyl(R)), an ointment used to treat various types of
skin wounds, particularly chronic dermal ulcers and severely burned areas. The
Company and KPC are parties to a licensing agreement expiring in August 2003
providing KPC with exclusive rights to market Santyl(R) ointment in North
America in exchange for purchases of the product and royalties on KPC's
Santyl(R) sales to distributors. The license agreement has an automatic ten-year
renewal clause unless KPC elects not to renew the agreement. The rest of the
Company's revenues come from product sales to pharmaceutical companies in Brazil
and India.
On January 31, 2000, pursuant to a sublicense and assignment agreement, to which
ABC is not a party, KPC sublicensed its rights to Smith & Nephew, Inc. ("S&N")
with the consent of ABC. Under the sublicense, KPC will continue to purchase the
product from the Company and manufacture the ointment. S&N will market the
ointment. In connection with the sublicense, the Company entered into several
agreements with KPC and S&N.
These included an agreement allocating responsibility under the KPC Agreement
among ABC, KPC, and S&N for both the sublicense and license period. Another
agreement imparts certain obligations upon ABC to address the FDA issues
concerning the Curacao and Lynbrook manufacturing facilities. (See "Liquidity,
Capital Resources, and Changes in Financial Condition".) KPC will assign its
license rights in the KPC Agreement to S&N in the event of FDA approval of a
compliance program being undertaken by ABC. If the license rights are assigned
to S&N, the KPC agreement will be automatically extended at that time until
2013.
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, 2000, the
statements of income for the three months ended April 30, 2000 and 1999, and
statements of cash flows for the three months ended April 30, 2000 and 1999. 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,
2000.
6
<PAGE>
3. Net loss per share
------------------
Basic loss per share ("EPS") excludes dilution and is computed by dividing 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. As a result of the net loss for the three months ended April 30, 2000
and 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, are forward looking information, which
involve 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, government regulation,
the ability of the Company to complete the renovation of its production
facilities and comply with the Form 483 and FDA Letter, the Company's estimate
that its inventory of product is sufficient until the renovated facilities can
produce again, changing market conditions, the impact of competitive products
and pricing, the timely development and approval by the FDA and foreign health
authorities of potential products, market acceptance of the Company's potential
products, 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, 2000.
Three months ended April 30, 2000 and 1999
------------------------------------------
Net Sales - Net sales of Collagenase ABC for the three months ended April 30,
2000 and 1999 were $989,805 and $682,728, respectively, an increase of $307,077
or 45%. Sales of Collagenase ABC to KPC and foreign licensees were higher during
the three months ended April 30, 2000 versus 1999 due to the timing of
licensees' orders.
Royalties - Royalties for the three months ended April 30, 2000 and 1999 were
$449,198 and $596,747, respectively, a decrease of $147,549 or 25%. The decrease
was due to lower after-market sales of Collagenase ointment (Collagenase
Santyl(R)) in the United States by Smith & Nephew during the 2000 first fiscal
quarter, as reported to the Company by KPC. During the fourth quarter of
calendar 1999, KPC initiated a sales promotion for Collagenase Santyl(R).
Wholesalers responded by buying at record levels. As a result, wholesalers
purchased less during the subsequent period; the three months ended April 30,
2000.
7
<PAGE>
Cost of Sales - Cost of sales for the three months ended April 30, 2000 and 1999
were $479,787 and $407,871, respectively, an increase of $71,916 or 18%, due to
higher net sales. The Company's gross profit margin was higher during the three
months ended April 30, 2000 versus 1999 as a result of the allocation of fixed
production costs to higher production activity in the 2000 period versus 1999.
Selling, general and administrative - Selling, general and administrative
("SG&A") expenses for the three months ended April 30, 2000 and 1999 were
$552,327 and $647,204, respectively, a decrease of $94,877 or 16%. During the
quarter ended April 30, 1999, the Company's use of consultants to assist in
responding to inspectional observations ("483's") from FDA inspectors, was
higher than in the 2000 period, the cost of which are included in SG&A in both
periods. In addition, production lab personnel were highly involved in the
response effort as well, resulting in a significant level of production
inactivity in the 1999 activity. Those costs, approximating $120,000 usually
allocated to production, were 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, 2000 and 1999 were $411,679 and $505,701
respectively, representing a decrease of $94,022 or 19%. 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.
During the 1999 period, there was greater clinical activity, hence greater
costs, than in the 2000 period.
Other income (loss), net - Other income (loss), net for the three months ended
April 30, 2000 and 1999 was $(58,098) and $41,601 respectively. The decrease of
$99,699 was attributable to the decrease in the market value of the Company's
investments in equity securities held as trading securities.
Income tax (expense) benefit - The income tax (expense) benefit for the three
months ended April 30, 2000 and 1999 was $(3,030) and $100,510 respectively. The
2000 period expense represents current tax liabilities for foreign income taxes,
partially offset by an increase in deferred tax assets, principally relating to
net operating loss carryback credits. 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. The Company enjoyed a 2% tax rate ("tax holiday")
applicable to pre-tax earnings from operations of its subsidiary in Curacao. The
tax holiday expired December 31, 1999. The Company has requested an extension of
the tax holiday but has not yet been informed of the Curacao government's
decision. If the tax holiday is not extended, the tax rate applicable to pre-tax
earnings from operations there could go up to 30%. There can be no assurance the
Curacao government will extend the tax holiday. During the period ended April
30, 2000, the provision for taxes attributable to the earnings of the Curacao
subsidiary were taken at a 16% rate, pending the outcome of the government's
decision.
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, 2000,
the Company had working capital of approximately $6.9 million which includes
cash and cash equivalents, and marketable securities of approximately $5.9
million. Net cash provided by operating activities during the quarter ended
April 30, 2000 was approximately $1.6 million, primarily due to an increase of
$1.7 million in deferred revenue. KPC agreed to pay the Company in advance for a
portion of its planned purchases of the enzyme in calendar 2000 as part of the
agreement between the Company and KPC concerning KPC's sublicense of its
exclusive marketing rights to S&N. The advance payment was received during the
three months ended April 30, 2000.
8
<PAGE>
In 1999, the Company was issued a list of inspectional observations made by the
FDA in Form 483 citing numerous deficiencies in the Company's compliance with
FDA regulations at its manufacturing plants in Lynbrook and Curacao and at KPC's
contract manufacturing facility. The FDA advised the Company that they would
revoke the Company's license to manufacture the enzyme and ointment unless the
Company could immediately provide satisfactory assurance to the FDA (including
submitting a comprehensive plan of corrective action) addressing the FDA's
observations and otherwise demonstrate compliance with the applicable
regulations. The Company responded to the FDA by submitting a comprehensive plan
of corrective action providing for (i) the renovation of the Lynbrook and
Curacao manufacturing plants, (ii) the reorganization of the Company's quality
control and quality assurance departments, (iii) an upgrade of quality control
standards and procedures and (iv) the hiring of additional personnel in the
quality control and quality assurance departments. The Company has retained an
outside consulting firm with expertise in FDA regulatory compliance matters to
assist in developing and implementing the corrective action plan.
The Company started renovating the Curacao plant in March 2000 and as a result
suspended the production of enzyme at that location. The Curacao plant will not
resume the production of enzyme until construction is complete, the plant is
validated and the FDA permits the Company to resume operations and approves the
product itself. The Company also voluntarily suspended the production of enzyme
at its Lynbrook facility, although final-stage production and testing continue
there. Renovations at the Lynbrook facility are planned to begin in the second
quarter of calendar 2000. In anticipation of the renovations and suspension of
manufacturing operations, the Company accumulated an inventory of the product
which it estimates KPC can use to contract manufacture Santyl(R) into the second
quarter of calendar 2001. In the opinion of the Company, this would permit KPC
to supply S&N with Santyl(R) through the second quarter of calendar 2002.
Management estimates that the Company will spend approximately $3.5 million to
remediate both plants. Approximately $1.1 million has been spent through April
2000 on new equipment. In addition, the Company incurred consulting fees and
other expenses of approximately $1 million through January 31, 2000 and believes
it will incur additional expenses of approximately $600,000 during the fiscal
year ended January 31, 2001. The Company believes that the plant remediation
program and changes in the Company's quality control policies and procedures
outlined in the corrective plan will adequately address the FDA's concerns.
Management also believes that the capital-spending plan will modernize the
Company's facilities and improve operational efficiency.
A supplement to ABC's Establishment License will have to be approved by the FDA
after the renovation before any additional enzyme produced at the Curacao
facility can be used by KPC. As part of the approval process for the supplement,
the FDA may conduct an inspection of the Curacao facility. The Company currently
estimates that either one or both the Curacao and Lynbrook facilities could be
back in production by the fourth quarter of calendar 2000 and have enzyme
available for KPC during the third quarter of calendar 2001. Due to the
uncertainty of the FDA approval process however, there can be no assurances that
target dates will be met.
Although the Company believes that it has made considerable progress in
addressing the FDA concerns addressed in the Form 483 and the FDA Letter, if the
Company is unable to further address these matters in a timely manner, there may
be delays in the delivery of product produced in the renovated facilities to KPC
for use to contract manufacture Collagenase Santyl(R) Ointment. Such delays
could have a material adverse effect on the Company's future operating results.
The accompanying consolidated financial statements have been prepared on a going
concern basis, which contemplates the realization of assets and the incurrence
of liabilities in the normal course of business. The Company believes it has
adequate financial resources needed to take corrective action and continue its
operations.
9
<PAGE>
PART II - OTHER INFORMATION
Item 1. Legal Proceedings.
None.
10
<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 15, 2000
-------------
By: /s/ Edwin H. Wegman
-------------------------
Edwin H. Wegman
Chairman, President, and
Chief Executive Officer
Date: June 15, 2000
-------------
By: /s/ Albert Horcher
-------------------------
Albert Horcher
Secretary, Treasurer and Principal Financial
and Chief Accounting Officer
11
