1
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
X Quarterly report pursuant to Section 13 or 15(d) of the Securities
---- Exchange Act of 1934. For the quarterly period ended March 31, 1997.
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: 0-19749
CHEMTRAK INCORPORATED
Delaware 77-0295388
- ------------------------------- -----------------------------------
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
929 E. Arques Avenue, Sunnyvale, CA 94086
-----------------------------------------
(Address of principal executive offices)
Registrant's telephone number, including area code: (408) 773-8156
Securities registered pursuant to Section 12(g) of the Act:
Common Stock $.001 par value
----------------------------
(Title of Class)
Indicate by check mark whether the registrant (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
registrant was required to file such reports), and (2) has been subject to such
filing requirements for the past 90 days.
Yes X No
--- ---
Indicate the number of shares outstanding of each of the issuer's
classes of common stock, as of the latest practicable date.
Class: Common Stock $.001 par value Outstanding at April 30, 1997: 12,685,943
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CHEMTRAK INCORPORATED
INDEX
PAGE NO.
PART I. FINANCIAL INFORMATION
Item 1: Financial Statements
Condensed Balance Sheets as of March 31, 1997 and December 31, 1996 3
Condensed Statements of Operations for the three months ended
March 31, 1997 and 1996 4
Condensed Statements of Cash Flows for the three months ended March 31,
1997 and 1996 5
Notes to Condensed Financial Statements 6
Item 2: Management's Discussion and Analysis of Financial Condition
and Results of Operations 7-10
PART II. OTHER INFORMATION
Item 6: Exhibits and Reports on Form 8-K 11
SIGNATURES 12
EXHIBITS
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3
CHEMTRAK INCORPORATED
CONDENSED BALANCE SHEETS
March 31, 1997 December 31, 1996
--------------- -----------------
(unaudited)
ASSETS
Current assets:
Cash and cash equivalents $ 4,069,000 $ 4,125,000
Short-term investments -- 567,000
Accounts receivable, net 320,000 485,000
Inventories 867,000 540,000
Prepaid expenses and other current assets 159,000 320,000
------------ ------------
Total current assets 5,415,000 6,037,000
Property and equipment, net 2,499,000 2,738,000
Other assets 66,000 66,000
------------ ------------
Total assets $ 7,980,000 $ 8,841,000
============ ============
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 446,000 $ 289,000
Accrued payroll and benefits 244,000 199,000
Other accrued liabilities 894,000 788,000
Accrued royalties 108,000 105,000
------------ ------------
Total current liabilities 1,692,000 1,381,000
Accrued rent 308,000 295,000
Convertible Debentures 800,000 2,135,000
Stockholders' equity:
Common stock 15,000 12,000
Additional paid-in capital 42,813,000 41,375,000
Deferred compensation (45,000) (49,000)
Accumulated deficit (37,603,000) (36,308,000)
------------ ------------
Total stockholders' equity 5,180,000 5,030,000
------------ ------------
Total liabilities and stockholders' equity $ 7,980,000 $ 8,841,000
============ ============
See accompanying notes.
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CHEMTRAK INCORPORATED
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
Three months ended
March 31,
------------------------------------
1997 1996
----------------- -----------------
Net revenues:
Product sales $ 608,000 $ 856,000
Funded research and other revenues 833,000 150,000
---------------- ----------------
Total net revenues 1,441,000 1,006,000
Cost and expenses:
Cost of product sales 704,000 731,000
Research and development 453,000 744,000
Marketing, general and administrative 1,623,000 1,094,000
---------------- ----------------
Total costs and expenses 2,780,000 2,569,000
---------------- ----------------
Operating loss (1,339,000) (1,563,000)
Interest and other income 44,000 67,000
---------------- ----------------
Net loss $ (1,295,000) $ (1,496,000)
================ ================
Net loss per share $ (0.11) $ (0.15)
================ ================
Shares used in calculating per share amounts 12,085,000 9,732,000
================ ================
See accompanying notes.
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CHEMTRAK INCORPORATED
CONDENSED STATEMENTS OF CASH FLOWS
Increase (decrease) in cash and cash equivalents
(unaudited)
Three months ended
March 31,
----------------------------------------
1997 1996
-------------------- ------------------
Operating activities:
Net loss $ (1,295,000) $ (1,496,000)
Adjustment to reconcile net loss to net cash and
cash equivalents used in operating activities:
Interest expense and financing charges
on debentures 79,000 -
Depreciation and amortization 202,000 217,000
Accrued rent 13,000 13,000
Stock option compensation and other - 1,000
Loss on disposal of assets 70,000 -
Changes in operating assets and liabilities:
Accounts receivable 165,000 (500,000)
Inventories (327,000) (361,000)
Prepaid expenses and other current assets 161,000 103,000
Accounts payable 157,000 (17,000)
Accrued payroll and benefits 45,000 57,000
Other accrued liabilities 109,000 249,000
------------------ ------------------
Net cash and cash equivalents
used in operating activities (621,000) (1,734,000)
------------------ ------------------
Investing activities:
Proceeds from available-for-sale securities 567,000 1,499,000
Acquisition of property and equipment, net (33,000) (142,000)
------------------ ------------------
Net cash and cash equivalents provided
by investing activities 534,000 1,357,000
------------------ ------------------
Financing activities:
Proceeds from issuance of common stock 31,000 32,000
------------------ ------------------
Net decrease in cash and cash equivalents (56,000) (345,000)
Cash and cash equivalents at beginning of period 4,125,000 4,251,000
------------------ ------------------
Cash and cash equivalents at end of period $ 4,069,000 $ 3,906,000
================== ==================
Supplemental disclosure of non-cash financing activities
Conversion of convertible debentures and accrued
interest of Common stock $ 1,414,000 $ -
================== ==================
See accompanying notes.
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CHEMTRAK INCORPORATED
NOTES TO CONDENSED FINANCIAL STATEMENTS
March 31, 1997
(unaudited)
Note 1. Basis of Presentation
The accompanying unaudited financial statements include all adjustments
consisting of normal recurring adjustments which the Company's management
believes to be necessary to fairly present the Company's financial position as
of March 31, 1997, and the results of operations for the three months ended
March 31, 1997.
The operating results of the interim periods presented are not
necessarily indicative of the results for the full year. The accompanying
financial statements should be read in conjunction with the financial statements
for the year ended December 31, 1996, included in the ChemTrak Incorporated
Annual Report on Form 10-K for the fiscal year ended December 31, 1996 (the
"Form 10-K"), and the 1996 Annual Report to Stockholders (the "Annual Report").
The information set forth in the accompanying balance sheet as of December 31,
1996, has been derived from the audited balance sheet included in the
above-referenced Form 10-K and Annual Report.
Note 2. Net Loss Per Share
Net loss per share is computed using the weighted number of shares
outstanding. Common equivalent shares from stock options are excluded in the
computation as their effect is antidilutive.
In February 1997, the Financial Accounting Standards Board issued
Statement No. 128, Earnings per Share, which is required to be adopted on
December 31, 1997. At that time, the Company will be required to change the
method currently used to compute loss per share and to restate all prior
periods. Under the new requirements for calculating primary loss per share,
the dilutive effect of stock options will be excluded. The primary loss per
share for the first quarter ended March 31, 1997 and March 31, 1996 would not
change as reported. The impact of Statement 128 is expected to result in a
decrease of fully diluted loss per share for the first quarter ended March 31,
1997 of ($0.01) and no change for the first quarter ended March 31, 1996.
Note 3. Inventories
Inventories are stated at the lower of standard cost (which
approximates actual costs on a first-in, first-out basis) or market. Inventories
consisted of the following:
March 31, 1997 December 31,1996
---------------------- ----------------------
Raw materials................................... $ 398,000 $ 289,000
Work in process................................. 92,000 63,000
Finished goods.................................. 377,000 188,000
---------------------- ----------------------
Total........................................... $ 867,000 $ 540,000
====================== ======================
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CHEMTRAK INCORPORATED
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL
CONDITION AND RESULTS OF OPERATIONS
The following Management's Discussion and Analysis of Financial
Condition and Results of Operations contains forward-looking statements which
involve risks and uncertainties. The Company's actual results could differ
materially from those anticipated in these forward-looking statements as a
result of certain factors, including those set forth in the Company's 10K and
elsewhere in this document.
OVERVIEW
ChemTrak began marketing the AccuMeter(R) Cholesterol Test to the
United States physicians office market in May 1991, following receipt of
clearance from the FDA, and to the international consumer retail and physicians'
office laboratory market in October 1991. In March 1993, the Company received
clearance from the FDA for the United States consumer retail market. In January
1994, the Company began marketing the AccuMeter(R) Cholesterol Self-Test through
United States consumer catalogs and signed a license and supply agreement with
Direct Access Diagnostics ("DAD"), a Johnson & Johnson company, to market the
Company's Total Cholesterol Test to over-the-counter retail outlets in North
America. In December the Company regained the exclusive rights to market its
Total Cholesterol Test in the United States retail market and relaunched it in
January 1996 under the trade name of CholesTrak(R).
In March 1997, ChemTrak announced its entry into the colorectal disease
testing market with the introduction of its ColoCARE(R) home test to detect the
early warning signs of colorectal disease. The Company began shipments of
ColoCARE(R) during the first quarter of 1997.
In July 1996, the Company received clearance from the FDA to market its
first test for infectious diseases, the H. pylori test for use in the
physicians' office laboratory market. The first shipment to Astra Merck, as part
of the 1995 agreement, is expected to be delivered in the second quarter of
1997.
In January of 1997, ChemTrak announced a pan-European license with
Selfcare Inc. of Waltham, Massachusetts to market the AWARE(TM) home HIV test
service in Europe. As part of the agreement Selfcare will pay for the cost of
regulatory submissions in each of the countries of Europe. Selfcare, does
however, have the option to terminate the agreement if the FDA does not approve
ChemTrak's AWARE(TM) home HIV test service in 1997. In 1995, the Company
acquired technology and filed with the FDA its pre-market approval application
("PMA") for the Company's AWARE(TM) home HIV test service. The Company
anticipates FDA approval for the AWARE(TM) home HIV test service during 1997.
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As of March 31, 1997, ChemTrak had an accumulated deficit of
approximately $37,603,000. The ability of the Company to achieve profitability
is highly dependent upon numerous factors including, but not limited to, the
Company's ability to directly market and distribute its cholesterol, H. Pylori,
and colorectal products in the United States, successful completion of the
Company's regulatory approval process to market products under development, and
the Company's ability to provide product in sufficient, cost effective
quantities. Due to the uncertainty of these factors, it is difficult to reliably
predict when such profitability may occur, if at all. Until such time as it
achieves profitability, the Company is likely to require additional capital to
finance its operations.
The development and marketing of consumer medical devices is capital
intensive. The Company has funded its operations to date through product sales
and public and private equity and debt financings. The Company will require
substantial additional funding in order to complete the development and
marketing activities in which it is currently engaging, and to launch these
products in the consumer marketplace. The Company intends to seek additional
funding through collaborative agreements with corporate partners or through
additional equity or debt financings. There can be no assurance that the Company
will be able to enter into such arrangements on acceptable terms, or at all.
The Company has historically experienced significant fluctuations in
its operating results and anticipates that these fluctuations may continue. The
market price of the shares of the Company's common stock, like that of other
emerging medical technology companies, has been highly volatile. Various factors
including, but not limited to, fluctuations in the Company's operating results,
technical and regulatory developments, and general market and economic factors,
may have a significant effect on the market price of the Company's common stock.
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RESULTS OF OPERATIONS
NET REVENUES
Total net revenues increased to $1,441,000 for the three months ended
March 31, 1997 from $1,006,000 for the three months ended March 31, 1996.
Product sales decreased to $608,000 in the three months ended March 31, 1997
from $856,000 in the three months ended March 31, 1996, primarily due to the
initial stocking orders placed in 1996. Funded research and other revenues
increased to $833,000 for the three months ended March 31, 1997 from $150,000
for the three months ended March 31, 1996. The increase is due to a milestone
payment from Astra Merck, who will market ChemTrak's H. pylori test as HpChek.
The Company also received a license fee from Selfcare, Inc. of Waltham, Mass.
for the Pan-European licensing and distribution agreement for marketing the
AWARE home HIV test service.
COST OF PRODUCT SALES
For the three months ended March 31, 1997, the cost of product sales
decreased to $704,000 from $731,000 for the three months ended March 31, 1996.
The decrease was principally due to the decrease in product sales volume.
Product gross margin as a percentage of product sales decreased to a
negative 16% on the three months ending March 31, 1997 from 15% for the same
period in 1996. This decrease was due to decreased product revenues.
RESEARCH AND DEVELOPMENT
Research and development expenses decreased to $453,000 in the three
months ended March 31, 1997 from $744,000 for the three months ended March 31,
1996 primarily due to fewer clinical studies, reduction in use of supplies and a
departmental reorganization.
MARKETING, GENERAL AND ADMINISTRATION
Marketing, general and administration expenses increased to $1,623,000
for the three months ended March 31, 1997 from $1,094,000 for the three months
ended March 31, 1996, primarily due to selling and advertising expenses
associated with the Company's CholesTrak(R) total cholesterol test.
INTEREST AND OTHER INCOME, NET
Interest and other income decreased to $44,000 in the three months
ended March 31, 1997 from $67,000 for the three months ended March 31, 1996. The
decrease was primarily due to reduced levels of short term investments.
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LIQUIDITY AND CAPITAL RESOURCES
From August 1985 through January 1992 the Company was financed through
private placements of equity securities. In February 1992, the Company completed
its initial public offering, raising approximately $23,500,000 net of issuance
costs.
At March 31, 1997, the Company had approximately $4,069,000 in cash and
short-term investments.
The Company had convertible debentures outstanding of $800,000 at March
31, 1997.
The Company believes that its existing capital resources, together with
internally generated funds and funded research, will need to be augmented by
funds received through collaboration agreements or equity or debt financing to
complete the development and marketing activities in which it is currently
engaging, and to launch these products in the consumer marketplace at least
through the end of 1997. If such funding cannot be obtained, the Company will
implement cost cutting measures to ensure the continuity of operations at least
to the end of 1997. The Company's success is dependent on its ability to achieve
profitable operations, reduce discretionary operating expenses and to obtain
additional funds to support its operations. There can be no assurance that the
Company will achieve profitable operations or successfully reduce discretionary
expenses by a sufficient amount on a timely basis or that additional funds will
be available when and as required by the Company on acceptable terms or at all.
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CHEMTRAK INCORPORATED
PART II. OTHER INFORMATION
Item 6. Exhibits and Reports on Form 8-K
a) Exhibits
10.39 Distribution Agreement between ChemTrak and Helena
Laboratories (Canada) Ltd. dated February 27, 1997.
11.1 Statement re: computation of income (loss) per
share
27.1 Financial Statement Schedule
b) Reports on Form 8-K
None
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CHEMTRAK INCORPORATED
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as
amended, the registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
Date: May 14, 1997 CHEMTRAK INCORPORATED
/s/ Edward F. Covell
---------------------------------------------
Edward F. Covell
President and Chief Executive Officer
(Principal Executive Officer)
/s/ Donald V. Fluken
---------------------------------------------
Donald V. Fluken
Chief Financial Officer
(Principal Financial and Accounting Officer)
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EXHIBIT INDEX
EXHIBIT
NO. DESCRIPTION
- -------- -----------
10.39 Distribution Agreement between ChemTrak and Helena
Laboratories (Canada) Ltd. dated
11.1 Statement re: computation of income (loss) per
share
27.1 Financial Statement Schedule