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FORM 10-Q
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
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/X/ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD
ENDED JUNE 30, 2000
OR
/ / TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934
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FOR THE TRANSITION PERIOD FROM ______________ TO ______________
COMMISSION FILE NUMBER 1010397
------------------------
PHYSIOMETRIX, INC.
(Exact name of registrant as specified in its charter)
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DELAWARE 77-0248588
(State or other jurisdiction of (IRS Employer identification No.)
incorporation or organization)
Five Billerica Park, N. Billerica, MA 01862-1256
(Address of principal executive offices) (Zip code)
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(978) 670-2422
(Registrant's telephone number, including area code)
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.
ITEM 1--Yes /X/ No / /
ITEM 2--Yes /X/ No / /
The number of shares outstanding of each of the issuer's classes of common stock
as of
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CLASS OUTSTANDING AT JUNE 30, 2000
Common Stock, $.001 par value 8,042,152
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PHYSIOMETRIX, INC.
TABLE OF CONTENTS
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PAGE NO.
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PART I FINANCIAL INFORMATION
ITEM 1 Financial Statements
Balance Sheets as of December 31, 1999 and June 30, 2000.... 3
Statements of Operations for the Three and Six Months ended
June 30, 1999 and 2000.................................... 4
Statements of Cash Flows for the Six Months ended June 30,
1999 and 2000............................................. 5
Notes to Financial Statements............................... 6
Management's Discussion and Analysis of Financial Condition
ITEM 2 and Results of Operations................................. 8
PART II OTHER INFORMATION................................................... 12
SIGNATURES................................................................... 13
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PHYSIOMETRIX, INC.
BALANCE SHEETS
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JUNE 30
DECEMBER 31 2000
1999 (UNAUDITED)
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ASSETS
Current assets:
Cash and cash equivalents................................. $ 1,365,002 $ 1,919,685
Short-term investments.................................... -- 18,724,411
Accounts receivable, net.................................. 41,209 36,150
Inventory................................................. 31,916 607,241
Prepaid expenses.......................................... 115,917 131,237
------------ -----------
Total current assets.................................... 1,554,044 21,418,724
Property, plant and equipment............................... 591,481 630,917
Less allowances for depreciation............................ (382,084) (427,080)
------------ -----------
209,397 203,837
Due from officer............................................ 84,000 84,000
Other assets................................................ 6,318 6,318
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Total assets............................................ $ 1,853,759 $21,712,879
============ ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable.......................................... $ 62,305 $ 217,586
Accrued expenses.......................................... 327,929 418,570
------------ -----------
Total current liabilities............................... 390,234 636,156
Stockholders' equity
Preferred stock: $.001 par value; 10,000,000 shares
authorized:
none issued and outstanding............................. -- --
Common stock: $.001 par value, 50,000,000 shares
authorized; 5,818,383 shares in 1999 and 8,042,152
shares in 2000 issued and outstanding................... 5,818 8,042
Additional paid-in capital.................................. 30,819,965 53,189,515
Deferred compensation....................................... -- (629,180)
Accumulated deficit......................................... (29,362,258) (31,491,654)
------------ -----------
Total stockholders' equity.............................. 1,463,525 21,076,723
------------ -----------
Total liabilities and stockholders' equity.............. $ 1,853,759 $21,712,879
============ ===========
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See accompanying notes
3
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PHYSIOMETRIX, INC.
STATEMENTS OF OPERATIONS
(UNAUDITED)
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THREE MONTHS ENDED SIX MONTHS ENDED
JUNE 30 JUNE 30
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1999 2000 1999 2000
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Revenues..................................... $ 82,230 $ 91,662 $ 200,609 $ 178,904
Costs and expenses:
Cost of goods sold......................... 192,172 252,476 405,243 477,107
Research and development................... 446,813 509,678 982,925 1,440,030
Selling, general and administrative........ 269,945 424,087 516,852 822,157
--------- ----------- ----------- -----------
908,930 1,186,241 1,905,020 2,739,294
--------- ----------- ----------- -----------
Operating loss............................... (826,700) (1,094,579) (1,704,411) (2,560,390)
Interest income.............................. 36,625 314,457 81,480 430,994
--------- ----------- ----------- -----------
Net loss..................................... $(790,075) $ (780,122) $(1,622,931) $(2,129,396)
========= =========== =========== ===========
Net loss per share........................... $ (0.14) $ (0.10) $ (0.28) $ (0.29)
========= =========== =========== ===========
Shares used in computing net loss per common
share...................................... 5,767,149 8,015,075 5,740,591 7,286,544
========= =========== =========== ===========
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See accompanying notes
4
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PHYSIOMETRIX, INC.
STATEMENTS OF CASH FLOWS
(UNAUDITED)
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SIX MONTHS ENDED
JUNE 30
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1999 2000
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OPERATING ACTIVITIES:
Net loss.................................................... $(1,622,931) $ (2,129,396)
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation and amortization............................. 53,473 44,996
Stock compensation........................................ -- 195,095
Changes in operating assets and liabilities:
Accounts receivable..................................... 14,947 5,059
Inventories............................................. -- (575,325)
Prepaid expenses and other assets....................... (25,205) (15,320)
Accounts payable and accrued expenses................... (39,283) 245,922
----------- ------------
Net cash used in operating activities....................... (1,618,999) (2,228,969)
INVESTING ACTIVITIES:
Purchase of equipment....................................... (2,965) (39,436)
Purchase of available-for-sale securities................... -- (32,341,553)
Proceeds from maturity of available-for-sale securities..... -- 13,617,142
----------- ------------
Net cash used in investing activities....................... (2,965) (18,763,847)
FINANCING ACTIVITIES:
Proceeds from issuance of common stock, net................. 32,966 21,547,499
----------- ------------
Net cash provided by financing activities................... 32,966 21,547,499
----------- ------------
Net increase (decrease) in cash and cash equivalents........ (1,588,998) 554,683
Cash and cash equivalents at beginning of period............ 4,589,585 1,365,002
----------- ------------
Cash and cash equivalents at end of period.................. $ 3,000,587 $ 1,919,685
=========== ============
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5
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NOTES TO FINANCIAL STATEMENTS
(UNAUDITED)
NOTE A--BASIS OF PRESENTATION
The accompanying unaudited financial statements have been prepared in
accordance with generally accepted accounting principles for interim financial
information and in accordance with the instructions for Form 10-Q and
Article 10 of Regulation S-X. Accordingly, they do not include all of the
information and footnotes required by generally accepted accounting principles
for complete financial statements. In the opinion of management, all adjustments
(consisting of normal recurring accruals) considered necessary for a fair
presentation have been included.
Operating results for the interim periods presented are not necessarily
indicative of the results that may be expected for the year ended December 31,
2000 or any other interim period. The accompanying financial statements should
be read in conjunction with the audited financial statements for the period
ending December 31, 1999.
NOTE B--ACCOUNTING PRONOUNCEMENTS
In June 1998, SFAS No. 133, "Accounting For Derivative Instruments and
Hedging Activities" was issued which is effective for fiscal year 2001. The
Company believes that the adoption of this statement will not have a material
impact on the Company's financial statement.
In December 1999, the Securities and Exchange Commission (SEC) issued Staff
Accounting Bulletin (SAB) 101, "Revenue Recognition in Financial Statements".
SAB 101 clarifies the SEC staff's views on applying generally accepted
accounting principles to revenue recognition in financial statements. In
March 2000, the SEC issued an amendment, SAB 101A, which deferred the effective
date of SAB 101. In June 2000, the SEC issued an amendment, SAB 101B, which
again deferred the effective date of SAB 101. The Company will adopt SAB 101 in
the fourth quarter of 2000 in accordance with SAB 101B. The adoption of this SAB
is not expected to have a significant impact on the Company's financial
statements.
In March 2000, the FASB issued Interpretation No. 44, "ACCOUNTING FOR
CERTAIN TRANSACTIONS INVOLVING STOCK COMPENSATION" (the Interpretation). This
Interpretation clarifies how companies should apply the Accounting Principles
Board's Opinion No. 25, "ACCOUNTING FOR STOCK ISSUED TO EMPLOYEES". The
Interpretation will be applied prospectively to new awards, modifications to
outstanding awards, and changes in employee status on or after July 1, 2000,
except as follows: the definition of an employee applies to awards granted after
December 15, 1998; the Interpretation applies to modifications that reduce the
exercise price of an award after December 15, 1998; and the Interpretation
applies to modifications that add a reload feature to an award made after
January 12, 2000. At the present time, there are no awards granted by the
Company which would result in an adjustment at July 1, 2000 as a result of this
Interpretation.
NOTE C--STOCKHOLDERS' EQUITY
On February 29, 2000, the Company closed a private placement of common stock
and warrants totalling $21.5 million in net proceeds less offering costs to the
Company. The Company issued 2,080,340 shares of common stock at $10.80 and
warrants to purchase 624,102 shares of common stock at $14.04 per share.
6
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NOTES TO FINANCIAL STATEMENTS
(UNAUDITED) (CONTINUED)
NOTE D--INVENTORIES
Inventory is recorded at the lower of cost (first-in, first-out) or market,
and consists of the following:
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DECEMBER 31, JUNE 30,
1999 2000
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Raw materials......................................... $28,743 $605,646
Finished goods........................................ 3,173 1,595
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$31,916 $607,241
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF
FINANCIAL CONDITION AND RESULTS OF OPERATIONS
RESULTS OF OPERATIONS
The following discussion of the financial condition and results of
operations of Physiometrix, Inc. should be read in conjunction with the
Financial Statements and related Notes thereto included elsewhere in this
Form 10-Q. This Form 10-Q contains certain forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of the
Securities Exchange Act of 1934. Actual events or results may differ materially
from those projected in the forward-looking statements as a result of the
factors described herein and other risks detailed from time to time in the
Company's SEC reports, including its annual report on Form 10-K for the year
ended December 31, 1999. Such forward-looking statements include, but are not
limited to, statements concerning (i) business strategy; (ii) products under
development; (iii) other products; (iv) marketing and distribution;
(v) research and development; (vi) manufacturing; (vii) competition;
(viii) government regulation especially as it relates to FDA approvals;
(ix) third-party reimbursement (x) operating and capital requirements and
(xi) clinical trials.
OVERVIEW
Since its inception in January 1990, Physiometrix has been engaged primarily
in the design and development and more recently the manufacture and sale of
noninvasive, advanced medical products. The Company's products which incorporate
proprietary materials and electronics technology are used in neurological
monitoring applications. The Company's initial products are its e-Net headpiece
and disposable HydroDot biosensors and custom electronics, which are packaged as
the HydroDot NeuroMonitoring System. The Company also has two additional
neurological monitoring products, the Equinox EEG System which was commercially
introduced in February 1997 and discontinued in June 1998 and the Patient State
Analyzer (PSA), which received FDA 510(k) approval on June 30, 2000. The Company
expects to begin shipments to customers in the 3rd quarter through Baxter
Healthcare Corporation, our exclusive U.S. distribution partner.
Physiometrix has a limited history of operations and has experienced
significant operating losses since its inception. As of June 30, 2000, the
Company had an accumulated deficit of approximately $31.5 million. The HydroDot
NeuroMonitoring System is currently the Company's principal commercial product.
The Company anticipates that its operating results will fluctuate on a quarterly
basis for the foreseeable future due to several factors, including actions
relating to regulatory and reimbursement matters, the extent to which the
Company's products gain market acceptance, introduction of alternative means for
neurophysiological monitoring and competition. Results of operations will also
be affected by the progress of clinical trials and in house development
activities, and the extent to which the Company establishes distribution
channels for its products domestically and internationally. There can be no
assurance the Company will achieve significant commercial revenues or
profitability.
THREE MONTHS ENDED JUNE 30, 2000 AND 1999
REVENUES
Revenues increased 11% to $92,000 for the three months ended June 30, 2000
from $82,000 for the three months ended June 30, 1999. This increase is
primarily the result of a higher sales volume of the Company's HydroDot
NeuroMonitoring products. The Company intends to either license the HydroDot
NeuroMonitoring technology to another company or transition out of the business
by the end of 2000.
8
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COST OF GOODS SOLD
Cost of goods sold increased 31% to $252,000 for the three months ended
June 30, 2000 from $192,000 for the three months ended June 30, 1999. This was
primarily due to increased labor costs during the period.
GROSS MARGIN
The negative gross profit margin results from the level of headcount and
overhead required in the quality assurance and manufacturing group. The gross
margin produced by the HydroDot NeuroMonitoring business does not provide enough
sales volume to cover these fixed expenses. Gross margin percentage related to
the HydroDot NeuroMonitoring business in 2000 was slightly lower in percentage
terms compared with gross margin produced in 1999. Pricing of the product did
not change in 2000, but material costs of inventory were slightly higher
comparable to 1999. The Company intends to either license the HydroDot
NeuroMonitoring technology to another company or transition out of the business
by the end of 2000.
RESEARCH AND DEVELOPMENT EXPENSES
Research and development expenses consisting principally of salaries,
consulting fees, and clinical trial expenses increased 14% to $510,000 for the
three months ended June 30, 2000 from $447,000 for the three months ended
June 30, 1999. This increase is primarily the result of outside consulting
related to the continued development of the PSA4000 and stock option
compensation expense.
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES
Selling, general and administrative expenses increased 57% to $424,000 for
the three months ended June 30, 2000 from $270,000 for the three months ended
June 30, 1999. This increase is due to expenses related to relisting on the
Nasdaq National Market, costs associated with an increased effort in the
investor relations area as well as marketing expenses incurred as the Company
approaches the commercialization of the PSA4000.
INTEREST INCOME AND EXPENSE:
Interest income increased to $314,000 for the three months ended June 30,
2000 from $37,000 for the three months ended June 30, 1999. This was due to a
higher average cash balance in 2000 versus 1999 as a result of a private
placement of the Company's common stock during the first quarter of 2000 which
raised $21.5 million in net proceeds.
SIX MONTHS ENDED JUNE 30, 2000 AND 1999
REVENUES
Revenues decreased 11% to $179,000 for the six months ended June 30, 2000
from $201,000 for the six months ended June 30, 1999. This decrease is primarily
the result of a lower sales volume of the Company's HydroDot NeuroMonitoring
products. The Company intends to either license the HydroDot NeuroMonitoring
technology to another company or transition out of the business by the end of
2000.
COST OF GOODS SOLD
Cost of goods sold increased 18% to $477,000 for the six months ended
June 30, 2000 from $405,000 for the six months ended June 30, 1999. This
increase was primarily due to increased labor costs during the period.
9
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GROSS MARGIN
The negative gross profit margin results from the level of headcount and
overhead required in the quality assurance and manufacturing group. The gross
margin produced by the HydroDot NeuroMonitoring business does not provide enough
sales volume to cover these fixed expenses. Gross margin related to the HydroDot
NeuroMonitoring business in 2000 was slightly higher in percentage terms
compared with gross margin produced in 1999. Pricing of the product did not
change in 2000, but material costs of inventory were slightly higher comparable
to 1999. The Company intends to either license the technology to another company
or transition out of the business by the end of 2000.
RESEARCH AND DEVELOPMENT EXPENSES
Research and development expenses consisting principally of salaries,
consulting fees, and clinical trial expenses increased 47% to $1,440,000 for the
six months ended June 30, 2000 from $983,000 for the six months ended June 30,
1999. This increase is primarily the result of outside consulting related to the
analysis of the data from the prospective study of the PSA, stock compensation
expense and continued development. The Company filed a 510(k) submission to the
FDA on March 31, 2000 and received 510(k) approval for the PSA on June 30, 2000.
SELLING, GENERAL AND ADMINISTRATIVE EXPENSES
Selling, general and administrative expenses increased 59% to $822,000 for
the six months ended June 30, 2000 from $517,000 for the six months ended
June 30, 1999. This increase is due to expenses related to relisting on the
Nasdaq National Market, costs associated with an increased effort in the
investor relations area as well as marketing expenses incurred as the Company
approaches the commercialization of the PSA4000.
INTEREST INCOME:
Interest income increased to $431,000 for the six months ended June 30, 2000
from $82,000 for the six months ended June 30, 1999. This was due to a higher
average cash balance in 2000 versus 1999 as a result of a private placement of
the Company's common stock during the first quarter of 2000 which raised
$21.5 million in net proceeds.
LIQUIDITY AND CAPITAL RESOURCES
At quarter ended June 30, 2000, the Company's cash, cash equivalents and
short-term investments were $20,644,000 as compared to $1,365,000 at year ended
December 31, 1999.
The Company's operating activities used cash of $2,229,000 in the six months
ended June 30, 2000 as compared to $1,619,000 in the six months ended June 30,
1999. The increase in net cash used in 2000 compared to 1999 was primarily the
result of the increased net loss of the Company along with an increased
investment in inventory as the company prepares for the commercial launch of the
PSA4000. These increases were partially offset by an increase in accounts
payable and accrued expenses as well as stock option compensation expense.
Net cash used in investing activities in the six months ended June 30, 2000
was $18,764,000, as compared with $2,965 used in the six months ended June 30,
1999. The increase was due to the short term investments made by the Company as
a result of the $21.5 million in net proceeds raised in the private placement of
the Company's common stock during the first quarter of 2000.
The Company's financing activities provided cash of $21,547,000 in the six
months ended June 30, 2000 as compared to $33,000 in the six months ended
June 30, 1999. During the first quarter of 2000, the Company completed a private
placement of common stock that raised $21.5 million in net proceeds.
10
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The Company's principal source of liquidity at June 30, 2000 consists of
cash, cash equivalents and short term investments in the amount of
$20.6 million. On February 29, 2000, the Company issued common stock totalling
$21.5 million in net proceeds to the company. On June 12, 2000, the Company's
stock was relisted on the Nasdaq National Market. The Company believes it has
the necessary cash and cash equivalents on hand to fund its operations for more
than a year from June 30, 2000.
The Company believes that the success of the PSA is the most critical
component to the Company's ability to become profitable. The Company completed
its pivotal study for the PSA on January 5, 2000. A 510(k) was submitted to the
FDA on March 31, 2000 for the PSA and the Company received FDA 510(k) approval
for the PSA4000 on June 30, 2000. The Company's plan for 2000 is to commercially
launch the PSA during the third quarter. The Company signed a distribution
agreement with Baxter Healthcare Corporation for the PSA on May 31, 2000 for
exclusive distribution rights in the United States.
The Company has one commercial competitor for the PSA. The Company believes
it will be able to successfully compete with them in the marketplace.
11
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PHYSIOMETRIX, INC.
JUNE 30, 2000
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PART II Other Information
ITEM 1 Legal Proceedings:
Not applicable.
ITEM 2 Changes in Securities:
Not applicable.
ITEM 3 Defaults upon Senior Securities:
Not applicable.
ITEM 4 Submission of matters to a vote of security holders:
On June 1, 2000, the company held its annual meeting of
shareholders. The following items were submitted for a vote of
the shareholders.
Election of Christopher Mitchell as a class I director. For:
5,387,013
Against: 3,750
Abstain: 0
Ratification of Ernst & Young as independent auditors for the
year ended December 31, 2000.
For: 5,389,763
Against: 350
Abstain: 650
ITEM 5 Other information:
None.
ITEM 6 Exhibits and reports on Form 8-K:
(a) Exhibits
10.8 Strategic Alliance and Exclusive Distribution Agreement
dated
May 31, 2000 by and between The Company and Baxter
Healthcare Corporation.
27.1 Financial Data Schedule
(b) Reports on Form 8-K--None
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JUNE 30, 2000
SIGNATURE
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.
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PHYSIOMETRIX, INC.
BY: /S/ JOHN A. WILLIAMS
-----------------------------------------
John A. Williams
DATE: AUGUST 14, 2000 PRESIDENT, CHIEF EXECUTIVE OFFICER
BY: /s/ DANIEL W. MUEHL
-----------------------------------------
Daniel W. Muehl
VICE PRESIDENT AND CHIEF FINANCIAL OFFICER
(PRINCIPAL FINANCIAL AND ACCOUNTING
OFFICER)
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