UNITED STATES
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 January 31, 2009
or
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE
ACT OF 1934
For the transition period from ___to ___
Commission File Number: 0-11485
ACCELR8 TECHNOLOGY CORPORATION
(Exact name of registrant as specified in its charter)
COLORADO 84-1072256
-------- ----------
(State or other jurisdiction (I.R.S. Employer Identification No.)
of incorporation or organization)
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7000 N Broadway, Bldg. 3-307, Denver, CO 80221
(Address of principal executive offices) (Zip Code)
(303) 863-8088
(Registrant's telephone number, including area code)
(Former name, former address and former fiscal year, if changed
since last report)
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 by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company.
Large accelerated filer [ ] Accelerated filer [ ]
Non-accelerated filer [ ] Smaller reporting company [X]
Indicate by check mark whether the registrant is a shell company (as defined in
Rule 12b-2 of the Exchange Act).
Yes [ ] No [X]
Indicate the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date. 10,226,210
INDEX
Page
PART 1. FINANCIAL INFORMATION
Item 1. Financial Statements
Condensed Balance Sheets January 31, 2009 (unaudited) and
July 31, 2008 3
Condensed Statements of Operations for the three and six
months ended January 31, 2009 and 2008 (unaudited) 4
Condensed Statements of Cash Flows for the six months ended
January 31, 2009 and 2008 (unaudited) 5
Notes to Unaudited Condensed Financial Statements 6-11
Item 2. Management's Discussion and Analysis of Financial Condition
and Results of Operations 12
Item 3. Quantitative and Qualitative Disclosures About Market Risk 20
Item 4. Controls and Procedures 21
Part II. OTHER INFORMATION
Item 1. Legal Proceedings 21
Item 1A. Risk Factors 21
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds 21
Item 3. Defaults Upon Senior Securities 21
Item 4. Submission of Matters to a Vote of Security Holders 21
Item 5. Other Information 22
Item 6. Exhibits 22
SIGNATURES 23
CERTIFICATION OF OFFICERS
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2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
----------------------------
Accelr8 Technology Corporation
Condensed Balance Sheets
ASSETS
January 31, 2009 July 31, 2008
(Unaudited)
Current assets:
Cash and cash equivalents $ 986,857 $ 1,233,100
Accounts receivable 50,000 6,334
Inventory 78,905 97,268
Prepaid expenses and other current assets 24,562 39,338
Total current assets 1,140,324 1,376,040
Property and equipment, net 26,026 37,398
Investments, net 1,055,440 1,067,327
Intellectual property, net (Note 3) 3,246,075 3,346,701
------------ ------------
Total assets $ 5,467,865 $ 5,827,466
============ ============
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities:
Accounts payable $ 98,115 $ 133,628
Accrued compensation and other liabilities 18,455 25,889
Deferred revenue 97,506 112,651
------------ ------------
Total current liabilities 214,076 272,168
Long-term liabilities:
Deferred compensation 1,092,939 1,142,327
------------ ------------
Total liabilities 1,307,015 1,414,495
------------ ------------
Commitments and Contingencies
Shareholders' equity
Common Stock, no par value; 14,000,000 shares authorized;
10,226,210 shares issued and outstanding
13,803,820 13,803,820
Contributed capital 1,048,894 922,586
Accumulated (deficit) (10,418,264) (10,039,835)
Shares held for employee benefit (1,129,110 shares at cost) (273,600) (273,600)
------------ ------------
Total shareholders' equity 4,160,850 4,412,971
------------ ------------
Total liabilities and shareholders' equity $ 5,467,865 $ 5,827,466
============ ============
3
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Accelr8 Technology Corporation
Condensed Statements of Operations
For the Three and Six Months ended January 31, 2009 and 2008
(Unaudited)
3 Months Ended January 31 6 Months Ended January 31
2009 2008 2009 2008
------------ ------------ ------------ ------------
Revenues:
OptiChem(R) revenues $ 14,493 $ 39,058 $ 15,145 $ 53,642
Technical development fees 300,000 -- 600,000 --
Option fees -- 45,455 -- 45,455
License fees 50,000 50,000 50,000 100,000
------------ ------------ ------------ ------------
Total Revenues 364,493 134,513 665,145 199,097
------------ ------------ ------------ ------------
Costs and expenses:
Research and development 194,603 252,109 354,380 521,176
General and administrative 213,714 157,215 464,177 408,282
Amortization 61,753 61,691 123,296 121,737
Marketing and sales 5,663 2,631 6,829 9,143
Depreciation 5,686 12,036 11,372 27,111
Cost of sales -- 7,719 -- 9,032
------------ ------------ ------------ ------------
Total costs and expenses 481,419 493,401 960,054 1,096,481
------------ ------------ ------------ ------------
Loss from operations (116,926) (358,888) (294,909) (897,384)
------------ ------------ ------------ ------------
Other income:
Interest and dividend income 5,154 12,612 14,068 36,278
Unrealized gain (loss) on investments
(42,558) (44,371) (97,588) (18,019)
Gain (loss) on sale of equipment
-- 50,407 -- 51,761
------------ ------------ ------------ ------------
Total other income (37,404) 18,648 (83,520) 70,020
------------ ------------ ------------ ------------
Net loss $ (154,330) $ (340,240) $ (378,429) $ (827,364)
============ ============ ============ ============
Net loss per share:
Basic and diluted net loss per share
$ (.02) $ (.03) $ (.04) $ (.08)
============ ============ ============ ============
Weighted average shares outstanding
10,226,210 9,971,210 10,226,210 9,971,210
============ ============ ============ ============
4
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Condensed Statements of Cash Flows
For the Six Months Ended January 31, 2009 and 2008
(Unaudited)
2009 2008
----------- -----------
Cash flows from operating activities:
Net loss $ (378,429) $ (827,364)
Adjustments to reconcile net (loss) to net
cash (used in) operating activities:
Depreciation 11,372 27,111
Amortization 123,296 121,737
Fair value of stock options granted for services
126,308 38,058
Unrealized holding (gain) loss on investments
97,588 18,019
Reinvested earnings - interest and dividends (10,701) (15,836)
(Gain) on sale of fixed assets 0 (51,761)
(Increase) decrease in assets:
Accounts receivable (43,666) (5,625)
Inventory 18,363 7,795
Prepaid expense and other 14,776 5,238
Increase (decrease) in liabilities:
Accounts payable (35,513) 58,817
Accrued liabilities (7,434) (5,894)
Deferred revenue (15,145) 130,728
Deferred compensation (49,388) 38,058
----------- -----------
Net cash (used in) operating activities (148,573) (460,919)
----------- -----------
Cash flows from investing activities:
Sales proceeds - fixed assets 0 70,000
Purchases of equipment and patents (22,670) (49,134)
Contribution to deferred compensation trust (75,000) (75,000)
----------- -----------
Net cash used in investing activities (97,670) (54,134)
----------- -----------
Decrease in cash and cash equivalents (246,243) (515,053)
Beginning balance 1,233,100 1,393,669
----------- -----------
Ending balance $ 986,857 $ 878,616
=========== ===========
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5
Note 1. Basis of Presentation
The financial statements included herein have been prepared by Accelr8
Technology Corporation (the "Company") without audit, pursuant to the rules and
regulations of the United States Securities and Exchange Commission ("SEC").
Certain information and footnote disclosures normally included in the financial
statements prepared in accordance with generally accepted accounting principles
have been condensed or omitted as allowed by such rules and regulations. The
Company believes that the disclosures are adequate to make the information
presented not misleading. These financial statements should be read in
conjunction with our annual audited financial statements dated July 31, 2008,
included in our annual report on Form 10-KSB as filed with the SEC. Management
believes that the accompanying unaudited financial statements are prepared in
conformity with generally accepted accounting principles, which require the use
of management estimates, and contain all adjustments (including normal recurring
adjustments) necessary to present fairly the operations and cash flows for the
periods presented. The results of operations for the three months and six months
ended January 31, 2009 may not be indicative of the results of operations for
the year ended July 31, 2009.
Note 2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with accounting principles
generally accepted in the United States of America requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities as of the date
of the financial statements and the reported amounts of revenues and expenses
during the reporting period. Actual results could differ from those estimates.
Concentration of Credit Risk
Financial instruments that potentially subject the Company to concentrations of
credit risk consist primarily of cash equivalents, accounts receivable, and
notes receivable, including receivables from major customers. The Company grants
credit to domestic and international clients in various industries. Exposure to
losses on accounts receivable is principally dependent on each client's
financial position. The Company performs ongoing credit evaluations of its
clients' financial condition.
Estimated Fair Value of Financial Instruments
The carrying amounts of cash and cash equivalents, investments and other
long-term liabilities approximates fair value at January 31, 2009 and July 31,
2008. The carrying value of all other financial instruments potentially subject
to valuation risk, principally consisting of accounts receivable and accounts
payable, also approximate fair value.
6
Income Taxes
The Company adopted the provisions of Financial Accounting Standards Board
("FASB") Interpretation No. 48 ("FIN 48") "Accounting for Uncertainty in Income
Taxes," on August 1, 2007. The adoption of FIN 48 resulted in no adjustment to
opening retained earnings. The Company has no unrecognized tax benefits. Should
the Company determine that any penalty and interest be accrued as a result of
current or future tax positions taken on its returns, such penalties and
interest will be accrued in its financial statements as other non-interest
expense and as interest expense during the period in which such determination is
made.
The Company files federal and state income tax returns. These returns are
subject to examination by taxing authorities for all tax years after 2002.
Note 3. Recently Issued Accounting Pronouncements
In December 2007, the FASB issued FAS 160 which changes the accounting and
reporting for minority interests. Minority interests will be recharacterized as
noncontrolling interests and will be reported as a component of equity separate
from the parent's equity, and purchases or sales of equity interests that do not
result in a change in control will be accounted for as equity transactions.
In addition, net income attributable to the noncontrolling interest will be
included in consolidated net income on the face of the income statement and,
upon a loss of control, the interest sold, as well as any interest retained,
will be recorded at fair value with any gain or loss recognized in earnings. FAS
160 is effective for annual periods beginning on or after December 15, 2008. The
Company does not expect the adoption of FAS 160 to have an effect on its
financial statements.
In December 2007, the FASB issued SFAS 141(revised 2007), Business Combinations
("SFAS 141R"). SFAS 141R will significantly change the accounting for business
combinations in a number of areas including the treatment of contingent
consideration, contingencies, acquisition costs, intellectual property research
& development and restructuring costs. In addition, under SFAS 141R, changes in
deferred tax asset valuation allowances and acquired income tax uncertainties in
a business combination after the measurement period will impact income tax
expense. SFAS 141R is effective for fiscal years beginning after December 15,
2008. The Company has not yet determined the impact, if any, of SFAS 141R on its
financial statements.
In April 2008, the FASB issued Staff Position FAS 142-3, "Determination of the
Useful Life of Intangible Assets" ("FSP FAS 142-3") which amends the factors an
entity should consider in developing renewal or extension assumptions used to
determine the useful life of a recognized intangible asset under FAS No. 142,
"Goodwill and Other Intangible Assets" ("FAS No. 142"). FSP FAS 142-3 applies to
intangible assets that are acquired individually or with a group of assets and
7
intangible assets acquired in both business combinations and asset acquisitions.
It removes a provision under FAS No. 142, requiring an entity to consider
whether a contractual renewal or extension clause can be accomplished without
substantial cost or material modifications of the existing terms and conditions
associated with the asset. Instead, FSP FAS 142-3 requires that an entity
consider its own experience in renewing similar arrangements. An entity would
consider market participant assumptions regarding renewal if no such relevant
experience exists. FSP FAS 142-3 is effective for year ends beginning after
December 15, 2008 with early adoption prohibited. We have not yet determined the
effect, if any, of the adoption of this statement on our financial condition or
results of operations.
Note 4. Intellectual Property
Intellectual property consisted of the following:
January 31, 2009 July 31, 2008
---------------- -------------
OptiChem(R) Technologies $ 4,454,538 $ 4,454,538
Patents 434,302 411,632
Trademarks 49,019 49,019
----------- -----------
Total intellectual property 4,937,859 4,915,189
Accumulated amortization (1,691,784) (1,568,488)
Net intellectual property $ 3,246,075 $ 3,346,701
=========== ===========
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Intellectual properties are recorded at cost and are being amortized on a
straight-line basis over their estimated useful lives of 20 years, which
approximates the patent and patent application life of the OptiChem(R)
technologies. Amortization expense was $123,296 and $121,737, respectively, for
the six months ended January 31, 2009 and 2008.
The Company routinely evaluates the recoverability of its long-lived assets
based upon estimated future cash flows from or estimated fair value of such
long-lived assets. If in management's judgment, the anticipated undiscounted
cash flows or estimated fair value are insufficient to recover the carrying
amount of the long-lived asset, the Company will determine the amount of the
impairment, and the value of the asset will be written down. Management believes
that the fair value of the technology exceeds the carrying value. However, it is
possible that future impairment testing may result in intangible asset
write-offs, which could adversely affect the Company's financial condition and
results of operations.
Note 5. Research and Option Agreement and License and Supply Agreements
Effective May 16, 2008, the Company and Becton, Dickinson and Company
("BD") entered into a Research and Option Agreement (the "Agreement").
The Agreement provides for the establishment of a research program until
October 31, 2009 whereby BD will fund certain research work by the Company
relating to the Company's BACcel(TM) rapid pathogen diagnostics platform (the
8
"BACcel(TM) Platform"). The research program includes mutually agreed upon
milestones to support BD's product development planning. Under the terms of the
Agreement, in connection with the research program, the Company will receive
certain periodic payments from BD between the date of the Agreement and July 1,
2009.
The Agreement also grants BD an option to acquire for an upfront payment an
exclusive license (the "Exclusive License") from the Company for certain
know-how and patent rights relating to the BACcel (TM) Platform. The Exclusive
License also provides for the Company to receive royalty payments on worldwide
sales. The Exclusive License contains certain diligence requirements for BD to
develop and commercialize such products. If BD exercises the option but fails to
meet certain terms of the Exclusive License, the Company has the option to
convert the Exclusive License to a non-exclusive license. If BD does not
exercise the Exclusive License Accelr8 will receive a non-exclusive license from
BD for certain intellectual property.
Pursuant to the Agreement, from the date of the Agreement until October 31,
2009, the Company agreed not to engage in or participate in any discussions or
negotiations with parties other than BD for the joint development of, licensing
of or intellectual property relating to the BACcel(TM) Platform.
Unless earlier terminated pursuant to the terms of the Agreement, the
Agreement shall terminate upon the Exclusive License Agreement or the
non-exclusive license from BD to the Company coming into effect.
On November 24, 2007 the Company extended the non-exclusive Slide H license
for three more years, to expire on November 23, 2010. Terms of the extended
license are similar to those of the original license, which is $100,000, $50,000
for a prepaid license and $50,000 in prepaid royalties. The Company granted
another royalty-bearing license to Schott Jenaer Glas GmbH for Streptavidin
slides (Slide HS) for two years that expires on December 31, 2008. The terms
were $100,000; $50,000 for a prepaid license and $50,000 in prepaid royalties.
The Company entered into an exclusive seven-year license with NanoString
Technologies Inc. on October 5, 2007. The license grants to NanoString the right
to apply OptiChem(R) coatings to NanoString's proprietary molecular detection
products. Pursuant to the license agreement, NanoString paid the Company a
non-refundable fee of $100,000 of which $50,000 was credited against future
royalties. Under the royalty-bearing license, NanoString is to pay the Company a
royalty at the rate of eight percent (8%) of net sales for sales up to $500,000
of NanoString licensed products. The royalty rate on the second $500,000 of net
sales is six percent (6%), and the royalty thereafter is four percent (4%).
Royalties of $652 were earned during the three months ended October 31, 2008.
On November 24, 2007 the Company extended the non-exclusive Slide H license
with Schott Jenaer Glas GmbH for three more years, to expire on November 23,
2010. Terms of the extended license are similar to those of the original
9
license, which is $100,000, $50,000 for a prepaid license and $50,000 in prepaid
royalties. On January 9, 2009 the Company extended the non-exclusive Slide H
license with Schott Jenaer Glas GmbH for one additional year, from November 24,
2010 to November 24, 2011, for which we received $50,000 in prepaid royalties at
the same royalty rate (6%). The Company had also granted another royalty-bearing
license to Schott Jenaer Glas GmbH for Streptavidin slides (Slide HS) for two
years that expired on December 31, 2008. The Company entered into an exclusive
seven-year license with NanoString Technologies Inc. on October 5, 2007. The
license grants to NanoString the right to apply OptiChem(R) coatings to
NanoString's proprietary molecular detection products. Pursuant to the license
agreement, NanoString paid the Company a non-refundable fee of $100,000 of which
$50,000 was credited against future royalties for a Slide H extension. Under the
royalty-bearing license, NanoString is to pay the Company a royalty at the rate
of eight percent (8%) of net sales for sales up to $500,000 of NanoString
licensed products. The royalty rate on the second $500,000 of net sales is six
percent (6%), and the royalty thereafter is four percent (4%).
Note 6. Employee Stock Based Compensation
On January 31, 2009, there were Common Stock options outstanding at prices
ranging from $1.45 to $4.50 with expiration dates between May 6, 2009 and
October 28, 2018. For the three months ended January 31, 2009 and 2008, stock
options exercisable into 1,180,000 and 987,500 shares of Common Stock,
respectively, were not included in the computation of diluted earnings per share
because their effect was antidilutive.
For the quarters ended January 31, 2009 and 2008, the Company accounted for
stock based compensation to employees and directors using SFAS No. 123 (revised
2004), "Share-Based Payment" (SFAS 123R), which replaces SFAS 123 and supersedes
APB Opinion No. 25. SFAS 123R requires all share-based payments to employees,
including grants of employee stock options, to be recognized in the financial
statements based on their fair values. Under SFAS 123R, we apply the standard to
new awards, and to awards modified, repurchased, or cancelled after the required
effective date. Additionally, compensation cost for the unvested portion of
awards outstanding as of the effected date of SFAS 123R are recognized as
compensation expense as the requisite service is rendered after the required
effective date.
The fair value of options granted under the stock option agreements and
stock-based compensation plans are estimated on the date of grant using the
Black-Scholes option pricing model with the following weighted-average
assumptions used for grants for the three months and six months ended January
31, 2009 and January 1, 2008: no dividend yield; risk free interest rate of 4%
to 5%; expected life of 3-10 years; and expected volatility of 66% to 51%. The
weighted average remaining contractual life of options outstanding at January
31, 2009 and 2008 was 4.50 and 4.11 years.
As of January 31, 2009, the total unrecognized share-based compensation cost
related to unvested stock options was approximately $65,690. For the three-month
periods ended January 31, 2009 and January 31, 2008 the Company recognized
10
$30,832 and $18,249 and for the six-month periods ended January 31, 2009 and
January 31, 2008 the Company recognized $126,308 and $38,058 in stock based
compensation costs related to the issuance of stock options to employees. This
cost was calculated in accordance with SFAS No. 123R and is reflected in the
Company's operating expenses.
Note 7. Stockholders Equity
On March 6, 2008, we held a closing on the sale (the "Offering") to accredited
investors of an aggregate of 200,000 shares of the Company's no par value Common
Stock sold at $4.00 per share (the "Common Stock") and warrants to purchase
100,000 shares of Common Stock at a purchase price of $5.50 per share that
expire 30 months from the date of issuance (the "Warrants")(the "Common Stock
and the Warrants are referred to herein as the "Securities").
Pursuant to the Stock Purchase Agreements, if during the period commencing on
March 6, 2008 and ending on March 6, 2009, we issue additional shares (the
"Additional Shares") of Common Stock or Common Stock Equivalents (as defined in
the Stock Purchase Agreement) at a purchase, exercise or conversion price less
than $4.00 per share (subject to certain adjustments for splits,
recapitalizations and reorganizations), then we will issue additional shares of
Common Stock to the investors so that the effective purchase price per share
will be the same per share purchase, exercise or conversion price of the
Additional Shares (subject to certain exceptions set forth in the Stock Purchase
Agreement). Notwithstanding the foregoing, the effective price per share will
not be adjusted below $3.00 per share. As of March 6, 2009 we issued no
additional shares.
The Warrants have customary weighted-average anti-dilution rights with respect
to any subsequent issuance of common stock or common stock equivalents at a
price less than $5.50 per share (subject to adjustment), and otherwise in
connection with forward or reverse stock splits, stock dividends,
recapitalizations, and the like. The anti-dilution provisions are not applicable
to employee stock options and shares issued in connection with certain mergers
and acquisitions. The Company received $800,000 in proceeds from the sale of the
Securities. The Company paid no commissions in connection with the Offering.
Investors in the units have "piggyback" registration rights with respect to the
resale of the shares of Common Stock, as well as the shares issuable upon
exercise of the Warrants.
11
Item 2. Management's Discussion and Analysis of Financial Condition and Result
of Operations
Forward Looking Information
This Quarterly Report on Form 10-Q contains certain forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended (the
"Securities Act") and Section 21E of the Securities Exchange Act of 1934, as
amended (the "Exchange Act"), and the Company, intends that such forward-looking
statements be subject to the safe harbors created thereby. These forward-looking
statements, which can be identified by the use of words such as "may," "will,"
"expect," "anticipate," "estimate," or "continue," or variations thereon or
comparable terminology, include the plans and objectives of management for
future operations, including plans and objectives relating to the products and
future economic performance of the Company. In addition, all statements other
that statements of historical facts that address activities, events, or
developments the Company expects, believes, or anticipates will or may occur in
the future, and other such matters, are forward-looking statements.
The forward-looking statements included herein are based on current expectations
that involve a number of risks and uncertainties. These forward-looking
statements are based on assumptions that the Company will retain key management
personnel, BD will exercise the Exclusive License, the Company will be
successful in the development of the BACcel(TM) system, the Company will have
sufficient capital to complete the development of the BACcel(TM) system, the
Company will be able to protect its intellectual property, the Company's ability
to respond to technological change, that the Company will accurately anticipate
market demand for the Company's products and that there will be no material
adverse change in the Company's operations or business. Assumptions relating to
the foregoing involve judgments with respect to, among other things, future
economic, competitive and market conditions and future business decisions, all
of which are difficult or impossible to predict accurately and many of which are
beyond the control of the Company. Although the Company believes that the
assumptions underlying the forward-looking statements are reasonable, any of the
assumptions could prove inaccurate and, therefore, there can be no assurance
that the results contemplated in forward-looking statements will be realized. We
undertake no obligation to publicly update or revise any forward-looking
statements, whether as a result of new information, future events or otherwise.
The following discussion should be read in conjunction with the Company's
unaudited condensed financial statements and related notes included elsewhere
herein. The Company's future operating results may be affected by various trends
and factors which are beyond the Company's control. These include, among other
factors, general public perception of issues and solutions, and other uncertain
business conditions that may affect the Company's business. The Company cautions
the reader that a number of important factors discussed herein, and in other
reports, filed with the Securities and Exchange Commission including the risks
in the section entitled "Risk Factors" its 10-KSB for the year ended July 31,
2008, could affect the Company's actual results and cause actual results to
differ materially from those discussed in forward-looking statements.
12
Overview
Our vision is to develop and commercialize an innovative diagnostic system for
use with critically ill patients for rapid identification of bacteria and
specific strains based on the presence of major antibiotic resistance
mechanisms. Our business strategy is to demonstrate the value of our technology
in the broad market for biomedical products with the intent of licensing our
proprietary technology to established market leaders.
We are developing the BACcel(TM) system, a rapid bacterial diagnostic platform,
by integrating our proprietary technologies into an automated system.
Proprietary technologies include OptiChem(R) surface coatings, and various
innovative assay processing methods. We have received patents or we have patent
applications pending for the major technology components, methods, and systems.
The BACcel(TM) system development project began with a number of innovative
analytical biological concepts that had no direct precedent, but which adapted
well-accepted microbiological testing principles for automated analysis. Until
now, these testing principles have only been applied to cultures that contain
hundreds of millions of bacteria descended from single organisms, hand-selected
as cultured colonies grown from a patient specimen.
The BACcel(TM) system is based on simple transformations of standard methods,
using advanced automation technology to achieve substantially better performance
than is possible with current testing methods. We believed that speed and
precision should be possible by analyzing, as individuals, many thousands of
cells extracted directly from the patient specimen. This contrasts with standard
culturing in which the descendants of fewer than ten cells are presumed to
represent the entire infectious bacterial population in a specimen, and with
which many hours of repeated growth are required to perform analyses. Typically,
initial testing requires 2-3 days, which is too late to help guide the physician
to make treatment decisions for critically ill patients who often become
infected with drug-resistant bacteria. As a result, initial therapy typically
proves inadequate in 20% to 40% of such cases, causing high mortality, serious
medical complications, and extended length of stay.
Published studies on ICU patients consistently show that a hospital-acquired
infection doubles the risk of mortality and complications. Infection with a
multi-resistant organism quadruples risks relative to comparable un-infected
patients. The most important reason for elevated risk is inadequate initial
therapy, caused by widespread and complex mechanisms of drug resistance.
We intend the BACcel(TM) system to report bacterial quantitation and
identification within 2 hours of patient specimen processing. We plan to augment
the first reported identification with additional identification of major
antibiotic resistance mechanisms.
13
We believe that resistance mechanism identification will require no more than 4
additional hours for a test battery, with some results becoming available more
quickly than others. We have presented research results to the clinical
community that are consistent with our performance objectives.
The purpose of this strategy is to narrow the drug choices for initial therapy
by identifying major resistance mechanisms that are likely to cause drugs to
fail. If successful, this approach would help the physician to subtract
ineffective drugs from the list of available drugs, leaving those that are most
likely to control the infection as initial therapy.
For example, the first report might state that a significant number of common
"Staph" is present in a patient specimen, likely causing a patient's infection.
The second report might then state that all of the organisms fall into a major
antibiotic resistance group known as "MRSA" (methicillin resistant
Staphylococcus aureus, often referred to as "superbugs" in news reports because
of their multiple drug resistance). This identification eliminates from
consideration the most important drugs otherwise preferred for treating Staph
infections.
The same follow up report would also include the identification of additional
important resistance mechanisms that might similarly rule out the next most
important drugs. In this way, we believe that the BACcel(TM) system will
systematically test for the most significant resistance mechanisms. This would
leave the physician with specific drug choices that are most likely to prove
effective. From these, the physician would then be able to hold in reserve those
drugs considered "salvage" or "last choice" drugs. This approach of reserving
drugs helps to delay the emergence of resistance for the few drugs still
available to treat highly resistant strains.
Present practices cannot provide specific guidance, so the physician now has no
choice but to use drugs that would otherwise be reserved, in order to assure
initial infection control but thereby accelerating the risk of losing their
value.
Popular news media have reported widely about MRSA as a multi-resistant
"superbug." However, organizations such as the CDC (US Centers for Disease
Control and Prevention) and IDSA (Infectious Diseases Society of America) have
also identified other multi-drug resistant organisms as presenting even greater
threats. They include Pseudomonas, Acinetobacter, E. coli, and Klebsiella. In
the hospital ICU, MRSA typically causes no more than about 30% of mortality
attributed to acquired infections. The other organisms just listed account for a
much higher percentage.
To the best of management's knowledge, based on outside opinions and direct
market research, Accelr8 is the only organization in the world to be developing
a rapid diagnostic solution that includes these organisms and strain types.
To date, we have established the functional requirements of the BACcel(TM)
platform. We have begun testing the specific analyses required in the BACcel(TM)
system and published the results at major scientific and clinical conferences.
We have been guided by leading medical experts in our development strategy and
research prototype design.
14
During the next twelve months, the Company intends to expand its experimental
data to characterize and validate test performance to be used in future versions
of the BACcel(TM) system. In addition, we expect to further define requirements
for a commercial research product in advance of clinical product development.
In parallel to the BACcel(TM) system development, we have developed and
independently licensed OptiChem(R) surface coatings to other companies for use
in microarraying and other molecular detection products. We have granted Schott
Jenaer Glas GmbH, a global leader in high-quality glass manufacturing, a
non-exclusive license to manufacture and market microarraying slides using
OptiChem(R) coatings. We have also licensed NanoString Technologies Inc. to use
OptiChem(R) in their innovative molecular bar-coding systems for
high-sensitivity gene expression analysis.
During the quarter ended January 31, 2008, we placed two development systems in
outside academic research facilities. One system is in the Denver Health Medical
Center. The other is in Barnes-Jewish Hospital, St. Louis. The outside
investigators are using the systems for technical validation of the analytical
methods.
We intend to continue making technical presentations concerning our research
results to the clinical community for the remainder of 2009 and beyond. Research
collaborators at Denver Health and Barnes-Jewish may contribute at these
presentations.
During the quarter ended January 31, 2009, we also continued scale-up and
expansion of our proprietary antibody development. These materials provide
support for BACcel(TM) system development, outside research collaborations, and
additional test development. We have also initiated development of secondary
indicators to augment the antibodies in robust identification methods.
On January 6, 2009, Accelr8 Technology Corporation (the "Company") was notified
by the staff of the NYSE Alternext US LLC (the "Exchange"), formerly known as
the American Stock Exchange, Inc., that the staff has determined, following a
review of publicly available information, that the Company is not in compliance
with Section 1003(a)(iii) of the NYSE Alternext Company Guide (the "Company
Guide") in that it has stockholder equity of less than $6 million and losses
from continued operations and net losses in its five most recent fiscal years.
In order to maintain its listing, the Company submitted a plan on February 6,
2009 (the "Plan") advising the Exchange of action it has taken or will take,
that would bring it into compliance with the continued listing standards.
Subject to the Plan being accepted by the Exchange, the Company would have up to
July 6, 2010 to implement the Plan, during which time period the Company would
be subject to periodic review to determine whether it is making progress
consistent with the Plan.
15
Recently Issued Accounting Pronouncements
In February 2007, the FASB issued FASB SFAS No. 159, The Fair Value Option for
Financial Assets and Financial Liabilities, to expand the use of fair value
measurement by permitting entities to choose to measure many financial
instruments and certain other items at fair value that are not currently
required to be measured at fair value. SFAS 159 is effective beginning the first
fiscal year that begins after November 15, 2007. The Company is evaluating fair
value of all financial assets. It is not anticipated that application will
result in any material changes in such assets.
In December 2007, the FASB issued FAS 160 which changes the accounting and
reporting for minority interests. Minority interests will be recharacterized as
noncontrolling interests and will be reported as a component of equity separate
from the parent's equity, and purchases or sales of equity interests that do not
result in a change in control will be accounted for as equity transactions.
In addition, net income attributable to the noncontrolling interest will be
included in consolidated net income on the face of the income statement and,
upon a loss of control, the interest sold, as well as any interest retained,
will be recorded at fair value with any gain or loss recognized in earnings. FAS
160 is effective for annual periods beginning on or after December 15, 2008. The
Company does not expect the adoption of FAS 160 to have an effect on its
financial statements.
In December 2007, the FASB issued SFAS 141(revised 2007), Business Combinations
("SFAS 141R"). SFAS 141R will significantly change the accounting for business
combinations in a number of areas including the treatment of contingent
consideration, contingencies, acquisition costs, IPR&D and restructuring costs.
In addition, under SFAS 141R, changes in deferred tax asset valuation allowances
and acquired income tax uncertainties in a business combination after the
measurement period will impact income tax expense. SFAS 141R is effective for
fiscal years beginning after December 15, 2008. The Company has not yet
determined the impact, if any, of SFAS 141R on its financial statements.
CHANGES IN RESULTS OF OPERATIONS: THREE MONTHS ENDED JANUARY 31, 2009 COMPARED
TO THREE MONTHS ENDED JANUARY 31, 2008.
During the three months ended January 31, 2009, OptiChem(R) revenues were
$14,493 as compared to $39,058 during the three month period ended January 31,
2008, a decrease of $24,565 or 62.8%. The decrease was due to the licensing of
the production of slides to others while retaining a royalty interest only.
Technical development fees during the three-month period ended January 31, 2009
were $300,000 as compared to $0 during the three-month period ended January 31,
2008, an increase of $300,000 or 100%. Technical development fees were received
as a result of the Research and Option Agreement with BD entered into in May
2008.
16
There were option fees of $0 during the three months ended January 31, 2009
compared to $45,455 during the three months ended January 31, 2008. This was the
result of receiving an option payment from Becton Dickinson & Company of
$100,000 which expired by its terms on March 31, 2008. The amount represents the
earned portion of such option contract during the three months ended January 31,
2008.
The license fees of $50,000 during the three months ended January 31, 2009 and
2008 were the result of License Agreements entered into with Schott Jenaer Glas
GmbH for Slide H to produce and sell the Company's technology, on coated
OptiChem(R) slides.
Research and development expenses for the three months ended January 31, 2009
were $194,603 as compared to $252,109 during the three months ended January 31,
2008, a decrease of $57,506 or 22.8%. This decrease was primarily due to
decreased direct supply costs related to the development of the BACcel(TM)
system.
During the three months ended January 31, 2009, general and administrative
expenses were $213,714 as compared to $157,215 during the three months ended
January 31, 2008, an increase of $56,499 or 35.9%. The increase was primarily
due to increases in legal costs (Patent filings), and corporate and shareholder
expenses.
The increase in amortization was negligible for the three months ended January
31, 2009 as compared to the three month period ended January 31, 2008.
Marketing and sales expenses for the three months ended January 31, 2009 were
$5,663 as compared to $2,631 during the three months ended January 31, 2008, an
increase of $3,032. The increase was primarily due to expenses related to
presentations at scientific conferences.
Depreciation for the three months ended January 31, 2009 was $5,686 as compared
to $12,036 during the three months ended January 31, 2008, a decrease of $6,350
or 52.7%. The decreased depreciation was the result of some assets becoming
fully depreciated during the three months ended January 31, 2008, coupled with
no new purchases of on-site lab equipment during the quarter ended January 31,
2009 and sale of used equipment.
Costs of goods sold during the three months ended January 31, 2009 were $0 as
compared to $7,719 during the three months ended January 31, 2008, a decrease of
$7,719 or 100%. The decrease in cost of goods sold was primarily the result of
the licensing OptiChem(R) coating production to others.
As a result of the above factors, loss from operations for the three months
ended January 31, 2009 was $116,926 as compared to a loss of $358,888 during the
three months ended January 31, 2008, a decreased loss of $241,962 or 67.4%.
Interest and dividend income during the three months ended January 31, 2009 was
$5,154 as compared to $12,612 during the three months ended January 31, 2008, a
decrease of $7,458 or 59.1%. Interest income decreased as a result of decreased
interest rates and reduced amounts of cash held by the Company.
17
An unrealized holding loss on investments held in the deferred compensation
trust for the three months ended January 31, 2009 was $42,558 as compared to an
unrealized loss of $44,371 during the three months ended January 31, 2008, a
decrease of $1,813. The change was a result of market fluctuations in the price
of marketable securities held in the deferred compensation trust.
Gain on the sale of equipment was $0 during the three months ended January 31,
2009 as compared to $50,407 during the three months ended January 31, 2008. The
gain on the sale of equipment was the result of the sale of used microarray
printers.
As a result of these factors, net loss for the three months ended January 31,
2009 was $154,330 as compared to $340,240 during the three months ended January
31, 2008, a decreased loss of $185,910 or 54.6%.
CHANGES IN RESULTS OF OPERATIONS: SIX MONTHS ENDED JANUARY 31, 2009 COMPARED TO
SIX MONTHS ENDED JANUARY 31, 2008.
During the six months ended January 31, 2009, OptiChem(R) revenues were $15,145
as compared to $53,642 during the six month period ended January 31, 2008, a
decrease of $38,497 or 71.7%. The decrease was due to the licensing of the
production of slides to others while retaining a royalty interest only.
Technical development fees during the six-month period ended January 31, 2009
were $600,000 as compared to $0 during the six-month period ended January 31,
2008, an increase of $600,000 or 100%. Technical development fees were received
as a result of the Research and Option Agreement with BD entered into in May
2008.
Option fees during the six months ended January 31, 2009 were $0 as compared to
$45,455 during the six months ended January 31, 2008. The option fee for the six
months ended January 31, 2008 consisted of the earned portion of an option from
Becton Dickinson & Company which expired on March 31, 2008. We now receive
research funding from Becton Dickinson quarterly.
License fees during the six months ended January 31, 2009 were $50,000 as
compared to $100,000 during the six months ended January 31, 2008, a decrease of
$50,000 or 50%. The license fees during the six months ended January 31, 2009
were the result of an extension of the existing License Agreement entered into
with Schott Jenaer Glas GmbH to produce and sell the Company's technology on
coated OptiChem(R) Slide H. The license was extended to cover November 24, 2010
to November 24, 2011.
Research and development expenses for the six months ended January 31, 2009 were
$354,380 as compared to $521,176 during the six months ended January 31, 2008, a
decrease of $166,796 or 32.0%. This decrease was primarily due to decreased
consulting/engineering fees related to the development of the BACcel(TM)
platform.
18
During the six months ended January 31, 2009, general and administrative
expenses were $464,177 as compared to $408,282 during the six month period ended
January 31, 2008, an increase of $55,895 or 13.7%. The increase was primarily
due to increases in legal costs (Patent filings), and corporate and shareholder
expenses.
Marketing and sales expenses for the six months ended January 31, 2009 were
$6,829 as compared to $9,143 during the six months ended January 31, 2008, a
decrease of $2,314 or 25.3%. The decrease was primarily due to timing of
expenses related to presentations at scientific conferences.
Depreciation for the six months ended January 31, 2009 was $11,372 as compared
to $27,111 during the six months ended January 31, 2008, a decrease of $15,739
or 58.1%. The decreased depreciation was the result of some assets becoming
fully depreciated during the year ended July 31, 2008, coupled with no new
purchases of on-site lab equipment during the first six months of the current
year and sale of used equipment.
Cost of goods sold during the six months ended January 31, 2009 were $0 as
compared to $9,032 during the six months ended January 31, 2008, a decrease of
$9,032 or 100%. The decrease in cost of goods sold was primarily the result of
the licensing OptiChem(R) coating production to others.
As a result of the above factors, loss from operations for the six months ended
January 31, 2009 was $294,909 as compared to a loss of $897,384 during the six
months ended January 31, 2008, a decrease of losses of $602,475 or 67.1%.
Investment and dividend income during the six months ended January 31, 2009 was
$14,068 as compared to $36,278 during the six months ended January 31, 2008 a
decrease of $22,210 or 61.2%. Interest income decreased as a result of decreased
interest rates and the amounts of cash held by the Company.
An unrealized holding loss on investments held in the deferred compensation
trust for the six months ended January 31, 2009 was $97,588 as compared to a
loss of $18,019 for the six months ended January 31, 2008, an increased loss of
$79,569. The change was the result of market fluctuations in the price of
marketable securities held in the deferred compensation trust.
Gain on the sale of equipment was $0 during the six months ended January 31,
2009 as compared to $51,761 during the six months ended January 31, 2008. The
gain on the sale of equipment was the result of the sale of used microarray
printers.
As a result of these factors, net loss for the six months ended January 31, 2009
was $378,429 as compared to $827,364 during the six months ended January 31,
2008, a decreased loss of $448,935 or 54.3%.
19
Capital Resources and Liquidity
At January 31, 2009, as compared to July 31, 2008, cash and cash equivalents
decreased by $246,243 from $1,233,100 to $986,857, or approximately 20% and the
Company's working capital decreased $177,624 or 16.1% from $1,103,872 to
$926,248. During the same period, shareholders' equity decreased from $4,412,971
to $4,160,850.
The net cash used in operating activities was $148,573 during the six months
ended January 31, 2009 compared to cash used in operating activities of $460,919
during the six months ended January 31, 2008. The principal elements that gave
rise to the decrease of cash used in operating activities were a decrease in the
net loss of $448,935, a decrease in liabilities and deferred revenue that
consists of: accounts payable of $35,513; deferred revenue of $15,145 and
deferred compensation of $49,388.
Our primary use of capital has been for the research and development of the
BACcel(TM) system. The Company has historically funded its operations generally
through its existing cash balances, cash flow generated from operations and the
sale of equity securities. Notwithstanding our investments in research and
development, there can be no assurance that BD will exercise their Exclusive
License, that the BACcel(TM) system or any of our other products will be
successful, or even if they are successful, will provide sufficient revenues to
continue our current operations. Our working capital requirements are expected
to increase in line with the growth of our business. We have no lines of credit
or other bank or off balance sheet financing arrangements. We believe our
capital requirements will continue to be met with our existing cash balance,
additional issuance of equity or debt securities and/or the exercise of the BD
Exclusive License or a capital infusion from potential partners in the
development of the BACcel(TM) system. If we are unable to realize any revenues
from our products, we will require additional funds from other sources to
continue operations. Further, if capital requirements vary materially from those
currently planned, we may require additional capital sooner than expected.
Management believes that current cash balances plus cash flow from operations
will be sufficient to fund our capital and liquidity needs for the next 12
months.
Thereafter, the Company may have to seek capital resources from other sources to
meet its obligations in the future. There can be no assurance that such capital
will be available in sufficient amounts or on terms acceptable to us, if at all.
Additional issuances of equity or convertible debt securities will result in
dilution to our current common stockholders.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Interest Rate Risk
The Company's interest income is sensitive to fluctuations in the general level
of U.S. interest rates. As such, changes in U.S. interest rates affect the
interest earned on the Company's cash, cash equivalents, and short-term
investments.
20
Item 4. Controls and Procedures
An evaluation was conducted under the supervision and with the participation of
the Company's management, including Thomas V. Geimer, the Company's Chief
Executive Officer ("CEO") and Chief Financial Officer ("CFO"), of the
effectiveness of the design and operation of the Company's disclosure controls
and procedures as of January 31, 2009. Based on that evaluation, Mr. Geimer
concluded that the Company's disclosure controls and procedures were effective
as of such date to ensure that information required to be disclosed in the
reports that it files or submits under the Securities Exchange Act of 1934, as
amended, is recorded, processed, summarized and reported within the time periods
specified in SEC rules and forms. Such officers also confirm that there was no
change in the Company's internal control over financial reporting during the
quarter ended January 31, 2009.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings
Not Applicable.
Item 1A. Risk Factors
There have been no material changes to the Risk Factors discussed in our Annual
Report on Form 10-KSB for the fiscal year ended July 31, 2008 filed with the
Securities and Exchange Commission on October 29, 2008 and investors are
encouraged to review those risk factors in detail before making any investment
in the Company's securities.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
Not Applicable.
Item 3. Defaults upon Senior Securities
Not applicable.
Item 4. Submission of Matters to a Vote of Security Holders
The Annual Meeting of the Company's Shareholders was held on December 18,
2008. The matters considered at the meeting were:
a) The election of Thomas V. Geimer, A. Alexander Arnold III, and Charles E.
Gerretson to the Company's Board of Directors;
b) To ratify the selection of Comiskey & Company, P.C. as the independent
public accountants of the Company for the fiscal year ending July 31, 2009.
21
Each of the nominees was elected to the Board of Directors and Comiskey &
Company, P.C. were ratified as the Company's independent public accountants.
The votes cast at the annual meeting upon the matters considered were as
follows:
For Withhold
--- --------
Election of Directors
Thomas V. Geimer 6,969,558 91,961
A. Alexander Arnold III 7,041,052 20,467
Charles E. Gerretson 7,026,350 35,169
|
A. Alexander Arnold III subsequently resigned as a member of the Board of
Directors and John Kucera was appointed a director to fill the vacancy.
Ratification of Comiskey & Company, P.C. as the independent registered
public accountants firm of the Company for the fiscal year ending July 31, 2009.
For Against Withhold
--- ------- --------
6,968,963 79,908 12,648
|
Item 5. Other Information
None.
Item 6. Exhibits
a) Exhibits:
Exhibit 31.1 Certification of Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
Exhibit 31.2 Certification of Officer Pursuant to Section 302 of the
Sarbanes-Oxley Act of 2002.
Exhibit 32.1 Certification of Officer Pursuant to 18 U.S.C. 1350, as adopted
pursuant to Section 906 of the Sarbanes-Oxley Act 0f 2002.
22
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned thereunto duly authorized.
Dated: March 16, 2009 ACCELR8 TECHNOLOGY CORPORATION
/s/ Thomas V. Geimer
-------------------------------------
Thomas V. Geimer, Secretary,
Chief Executive Officer and
Chief Financial Officer
/s/ Bruce H. McDonald
-------------------------------------
Bruce H. McDonald, Principal
Accounting Officer
|
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