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| BUF > SEC Filings for BUF > Form 10-Q on 14-Aug-2008 | All Recent SEC Filings |
14-Aug-2008
Quarterly Report
Three months ended June 30 Six Months ended June 30
% %
2008 2007 Change Change 2008 2007 Change Change
(In millions, except per share amount)
Revenue 4.2 4.3 (0.1 ) -4 % 15.9 7.2 8.7 121 %
Gross profit (0.5 ) 1.0 (1.5 ) -148 % 3.5 1.7 1.8 104 %
Operating expenses 5.8 4.4 1.4 32 % 12.4 8.6 3.8 44 %
Operating loss (6.3 ) (3.4 ) (2.9 ) 85 % (8.9 ) (6.9 ) (2.0 ) 29 %
Non-operating
income/ expense (5.4 ) 0.0 (5.4 ) NA (6.0 ) 0.1 (6.1 ) NA
Net loss (11.7 ) (3.4 ) (8.3 ) 245 % (14.9 ) (6.8 ) (8.1 ) 119 %
Net loss per share (0.24 ) (0.07 ) (0.17 ) (0.30 ) (0.14 ) (0.16 )
Gross profit as %
of revenue -12 % 24 % -36 % points 22 % 24 % -2 % points
Operating expense
as % of revenue 141 % 103 % 38 % points 78 % 119 % -41 % points
Operating loss a %
of revenue -153 % -80 % -73 % points -56 % -96 % 40 % points
Net loss as % of
revenue -282 % -79 % -203 % points -93 % -94 % 1 % points
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Revenue:
Revenue for the second quarter, 2008 declined by $0.1 million, a 4% decline
versus second quarter, 2007. Revenue for the six months ended June 30, 2008 grew
$8.7 million or 121% over revenue for the comparable period in 2007.
The following table contains geographic revenue for the second quarter and the six months ended 2008 and 2007:
(Millions) Three months ended
Region June 30, 2008 June 30, 2007 % Change
United States $ 1.4 $ 1.0 37 %
Europe 0.5 0.4 47 %
Western Hemisphere 1.1 2.6 -59 %
Pacific Rim 1.2 0.3 260 %
Total $ 4.2 $ 4.3 -4 %
(Millions) Six months ended
Region June 30, 2008 June 30, 2007 % Change
United States $ 8.4 $ 1.6 420 %
Europe 2.0 0.5 290 %
Western Hemisphere 2.4 4.3 -44 %
Pacific Rim 3.1 0.8 295 %
Total $ 15.9 $ 7.2 121 %
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Revenue increased in the second quarter, 2008 versus the same period in
2007 in all geographies except Western Hemisphere, where strong Western
Hemisphere revenue second quarter, 2007 created a challenging year-on-year
comparison for the region. For the six-month period ended June 30, 2008, growth
was strong in all regions except Western Hemisphere, driven by very significant
growth that occurred during the first quarter, 2008. In particular, U.S. revenue
grew significantly versus 2007, where approval to sell sevoflurane did not occur
until May, 2007. U.S. revenue accounted for 53% of total six-month revenue in
2008, versus 22% of total revenue in the comparable period last year.
The following table summarizes the Company's revenue by product line for
the second quarter and the first six months of 2008 versus 2007:
(Millions) Three months ended,
Product Line June 30, 2008 June 30, 2007 % Change
Sevoflurane $ 2.7 $ 3.2 -13 %
Other Inhalants 1.4 1.0 29 %
Total Anesthesia and Analgesia 4.1 4.2 -3 %
Image Guidance 0.1 0.1 - 28 %
Total $ 4.2 $ 4.3 -4 %
(Millions) Six months ended,
Product Line June 30, 2008 June 30, 2007 % Change
Sevoflurane $ 11.7 $ 4.8 145 %
Other Inhalants 3.9 2.3 68 %
Total Anesthesia and Analgesia 15.6 7.1 120 %
Image Guidance 0.3 0.1 165 %
Total $ 15.9 $ 7.2 121 %
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The 4% decline in second quarter, 2008 revenue versus the same period in 2007 was driven by the shortfall in the sevoflurane product line, due to product availability in the second quarter, 2008 (as discussed in the gross profit section of this MD&A). The decline in sevoflurane was partially offset by growth in other inhalants during the second quarter. The 121% increase in revenue for the six months ended June 30 was driven by growth across all product lines. Sevoflurane growth for the six-month period ended June 30, 2008 was a result of strong performance of this product line in the first quarter. The $6.9 million sevoflurane increase accounted for 79% of the revenue growth for the first six months, 2008.
Gross Profit:
Gross profit grew 104% for the six months ended June 30, 2008. A strong
first quarter performance, made possible by the start-up of the new independent
sevoflurane production line in December, 2007 was the primary growth driver for
gross profit in the six-month period ended June 30, 2008. However, in the second
quarter, sevoflurane production, and therefore revenue, was significantly
constrained by several factors. Early in the second quarter, 2008, there was a
planned shutdown for cleanout of process equipment at our Bethlehem, PA
facility. Also early in the quarter, due to the inability to obtain raw
materials because of funding constraints, production was limited. In early June,
when raw materials became available, an equipment breakdown in a sevoflurane
reactor caused equipment damage and loss of production capacity, primarily in
the sevoflurane production area. The low production capacity utilization drove
unfavorable manufacturing variances in the second quarter and was a contributing
factor in the gross profit decline of 148% and decline in the gross profit rate
of 3600 basis points versus the prior year. By the end of second quarter, the
facility returned to normal operations.
Gross profit for the second quarter was also unfavorably impacted by
inventory write downs at the Orchard Park, New York facility, primarily for
consumable inventory nearing its expiration date and write downs for Image
Guidance devices that now are considered obsolete.
Operating Expenses:
Operating expenses for the quarter ended June 30, 2008 increased by
$1.4 million, or 32%, versus second quarter, 2007. $1.0 million of the increase
is due to establishing a non-cash reserve for the accounts receivable due from
the Company's U.S. distributor, as discussed in Note 2 to the financial
statements. Finance and administration costs increased $1.0 million, while sales
and marketing costs and research and development costs decreased by $0.1 million
and $0.5 million respectively. Finance and administration cost growth of
$1.0 million, which was a 92% increase, was driven by higher stock option
expense, bad debt expense on international receivables and increased salary
expense and severance costs versus the prior year. The sales and marketing
decrease represented a 7% decline versus the prior year, primarily due to lower
sales commission expenses. The research and development cost decline of
$0.5 million, or 34%, was made possible by several actions. The completion of
several projects, reductions in spending in non-core areas and transfer of
resources to address other priorities within the company drove decreased
spending. Partially offsetting the research and development cost reductions was
$0.1 million increased investment in the conscious sedation project.
For the first six months of 2008, operating expenses increased
$3.8 million, or 44%, versus the comparable period of 2007. The $3.8 million
increase was comprised of the $1.0 million increase due to establishing a
non-cash reserve for potentially uncollectible receivable due from the Company's
U.S. distributor as previously discussed, $1.7 million sales and marketing and
$1.5 million finance and administration increases, less a $0.4 million decrease
in research and development spending. The sales and marketing expense growth of
$1.7 million or 42% was driven by a $1.5 million expenditure for the World
Congress of Anesthesia meeting, a once every four year event, and additional
$0.2 million freight expense due to increased volume and air shipment of
product. The $1.5 million finance and administration expense growth, which was
an increase of 67%, was driven by higher incentive compensation versus the same
period last year, as well as the other factors previously disclosed in the
quarter discussion. Research and development cost reductions of 17% versus the
prior year, or $0.4 million all occurred in the second quarter as discussed
above, with the first quarter, 2008 costs being roughly comparable to the same
period, 2007.
Operating Loss:
Loss from operations was $6.3 million for the second quarter, 2008 versus
$3.4 million in 2007 for the same period, driven largely by the gross profit
shortfall and the non-cash U.S. distributor receivable provision. The loss from
operations for the six-month period ended June 30, 2008 was $8.9 million versus
$6.9 million loss in the comparable period last year.
Non-operating income/expense:
Non-operating expense was $5.4 million for the second quarter, 2008 as
compared to minimal non-operating income or expense in the same period prior
year. The non-operating expense includes $1.1 million interest expense,
$4.6 million loss on early extinguishment of debt, less interest income and
other income of $0.3 million. Interest expense of $1.1 million consists
primarily of interest on two long term debt arrangements in place for portions
of the period. The Laminar Direct Capital L.P. term loan was put in place in
February and was extinguished
on May 9, 2008. Senior secured convertible notes were issued on May 5, 2008.
Interest expense during the second quarter from these two arrangements totaled
$1.0 million. The remaining interest related to two development loans with the
Commonwealth of Pennsylvania. The loss on early extinguishment of debt was due
to the retirement of the Laminar note prior to maturity. Included in this charge
are a 5% redemption fee of $0.8 million, the write-off of the unamortized
balance of warrant expense of $3.2 million and unamortized loan fees of
$0.6 million. Remaining other income of $0.3 million includes primarily income
on the receipt of shares of common stock of RxElite in consideration for
extended payment terms.
Non-operating expense for the six-month period ending June 30, 2008 was
$6.0 million as compared to net non-operating income of $0.1 million in the
comparable 2007 period. Of the increase in expense of $6.1 million, $5.3 million
related to the second quarter, which was discussed in the previous paragraph.
The balance of the increase, which is $0.8 million increase in the first
quarter, 2008 was driven by $0.6 million of additional interest due to the
Laminar debt, the Commonwealth of Pennsylvania development loans and a demand
facility with First Niagara Bank extinguished early in 2008.
Liquidity and Capital:
Cash and cash equivalents were $7.6 million at June 30, 2008, as compared
to cash and cash equivalents at December 31, 2007 of $0.2 million, resulting in
an increase in cash and equivalents of $7.4 million in the six-month period
ended June, 2008. The current ratio, which was 0.9: 1 at December 31, 2007 and
2.0:1 at March 31, 2008, improved to 7.8:1 on June 30, 2008.
The following table contains information on our cash flow for six months
ended June 30, 2008 and 2007:
Six months ended June 30
2008 2007
Net Cash used by Operating Activities (15.7 ) (10.8 )
Net Cash provided (used) by Investing Activities (7.2 ) 0.4
Net cash provided by Financing Activities 30.3 6.9
Net Increase (Decrease) in cash and cash equivalents 7.4 (3.5 )
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Net cash used by operating activities was $15.7 million for the first six
months of 2008 compared to $10.8 million in the first six months of 2007. In
2008, cash was used to fund the $14.9 million loss, offset by non-cash items of
$9.5 million, including the reserve for a potentially uncollectible receivable
from a U.S. distributor discussed in footnote 2 to the financial statements.
Cash was also used to fund working capital of $10.3 million. The net increase in
working capital reflects $8.3 million increase in gross accounts receivable and
$2.7 million decrease in inventory. It includes the conversion of high year end
levels of raw materials into finished goods, and ultimately into accounts
receivable. Accounts payable decreased by $4.9 million, as available cash was
used to pay down amounts owed to vendors, reaching current status with most
major vendors. Changes in other assets and liabilities also resulted in a
$0.2 million increase in cash.
Net cash used by investing activities was $7.2 million in the first six
months of 2008, as compared to net cash provided by investing activities of
$0.4 million in the equivalent period last year. In the first six months of
2008, cash was used primarily to pay vendors and contractors for the expansion
of our Bethlehem, Pennsylvania sevoflurane capacity and construction of a tank
farm at the facility that took place primarily in 2007.
Net cash provided by financing activities was $30.3 million for the six
months ended June 30, 2008, as compared to $6.9 million for the same period last
year. For the six-month period ended June 30, 2008, the net activity was the
issuance of $40.0 million of senior secured notes on May 5, 2008, providing
$36.7 million of new funding after fees associated with the issuance. The
company repaid $6 million owed under a demand note with First Niagara Bank,
which was outstanding at December 31, 2007. Additionally in the first six months
of 2008, the company entered into a $15 million three-year note early in the 1st
quarter with Laminar Direct Capital, L.P., which was subsequently extinguished
on May 9, 2008 after the issuance of the senior secured notes.
Based on our business strategy as approved by our Board of Directors, our operational plan for 2008 will be funded by both internal and external sources of cash. Our primary external source of cash was the $40.0 million private placement of senior secured notes which occurred in May of 2008. Our internal sources of cash will be driven by our planned improvement in operating income, gross profit generated by increased sales and production and efficient working capital management. In the event that the U.S. distributor receivable is not collected, (see Note 2 to the financial statements), we will need to seek other sources of cash flow in either the public or private debt or equity markets.
Forward-Looking Statements
This quarterly report on Form 10-Q includes forward-looking statements
within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange
Act. All statements, other than statements of historical fact, contained in this
quarterly report on Form 10-Q constitute forward-looking statements. In some
cases you can identify forward-looking statements by terms such as "may,"
"intend," "might," "will," "should," "could," "would," "expect," "believe,"
"estimate," "anticipate," "predict," "project," "potential," or the negative of
these terms and similar expressions intended to identify forward-looking
statements.
Forward-looking statements are based on assumptions and estimates and are
subject to risks and uncertainties. Reference is made to the information
appearing under the heading "Risk Factors" in Item 1 of our annual report on
Form 10-KSB/A for the year ended December 31, 2007 filed with the SEC on
April 21, 2008 ("Risk Factors"), which is incorporated herein by reference. We
have identified in the Risk Factors and elsewhere in this Form 10-Q some of the
factors that may cause actual results to differ materially from those expressed
or assumed in any of our forward-looking statements. There may be other factors
not so identified. You should not place undue reliance on our forward-looking
statements. As you read this quarterly report on Form 10-Q you should understand
that these statements are not guarantees of performance or results. Further, any
forward-looking statement speaks only as of the date on which it is made and,
except as required by law, we undertake no obligation to update any
forward-looking statement to reflect events or circumstances after the date on
which it is made or to reflect the occurrence of anticipated or unanticipated
events or circumstances. New factors emerge from time to time that may cause our
business not to develop as we expect and it is not possible for us to predict
all of them. Factors that may cause actual results to differ materially from
those expressed or implied by our forward-looking statements include those
described in the Risk Factors.
Item 3. Quantitative and Qualitative Disclosure about Market Risk.
As a "smaller reporting company" as defined by Item 10 of Regulation S-K,
the Company is not required to provide information required by this Item.
Item 4T. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures.
Management is responsible for establishing and maintaining effective
disclosure controls and procedures. As of June 30, 2008, our Chief Executive
Officer and Chief Financial Officer participated with our management in
evaluating the effectiveness of our disclosure controls and procedures (as
defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of
1934, as amended (the "Exchange Act")). Our disclosure controls and procedures
are designed to ensure that information required to be disclosed in the
Securities and Exchange Commission ("SEC") reports we file or submit under the
Exchange Act is recorded, processed, summarized and reported within the time
period specified by the SEC's rules and forms and that such information is
accumulated and communicated to management, including our Chief Executive
Officer and Chief Financial Officer, to allow timely decisions regarding
required disclosure. In light of the discussion of material weaknesses set forth
below, these officers have concluded that our disclosure controls and procedures
were not effective. To address the material weaknesses described below, we
performed additional analyses and other post-closing procedures to ensure our
consolidated financial statements were prepared in accordance with accounting
principles generally accepted in the United States of America (U.S. GAAP).
Accordingly, management believes that the financial statements included in this
Quarterly Report on Form 10-Q fairly present, in all material respects, our
financial condition, result of operations and cash flows for the periods
presented.
Management's Report on Internal Control over Financial Reporting
A company's internal control over financial reporting is a process designed
by, or under the supervision of, a public company's principal executive and
principal financial officers, or persons performing similar functions, and
effected by the board of directors, management and other personnel, to provide
reasonable assurance regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in accordance with
generally accepted accounting principles ("GAAP") including those policies and
procedures that: (i) pertain to the maintenance of records that in reasonable
detail accurately and fairly reflect the transactions and dispositions of the
assets of the company, (ii) provide reasonable assurance that transactions are
recorded as necessary to permit preparation of financial statements in
accordance with GAAP, and that receipts and expenditures are being made only in
accordance with authorizations of management and directors of the company, and
(iii) provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the company's assets that could
have a material effect on the financial statements.
Management is responsible for establishing and maintaining adequate
internal control over financial reporting. Our management, with the
participation of our Chief Executive Officer and Chief Financial Officer, has
assessed the effectiveness of our internal control over financial reporting as
of December 31, 2007 (the last annual Management's Assessment of Internal
Control over Financial Reporting). In making this assessment, our management
used the criteria established in Internal Control - Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).
A material weakness is a control deficiency, or combination of control
deficiencies, such that there is a reasonable possibility that a material
misstatement of the annual or interim financial statements will not be prevented
or detected on a timely basis. In connection with management's assessment of our
internal control over financial reporting described above, management has
identified the following material weaknesses in the Company's internal control
over financial reporting as of December 31, 2007:
• We were ineffective in maintaining a sufficient complement of qualified
accounting personnel and controls associated with segregation of duties.
Currently, all aspects of our financial reporting process, are performed
by a single individual with limited segregation of duties and limited
secondary review, including but not limited to access to the underlying
accounting records and systems, the ability to post and record journal
entries and responsibility for the preparation of the financial
statements. This creates certain incompatible duties and a lack of review
over the financial reporting process that would likely fail to detect
errors in spreadsheets, calculations, or assumptions used to compile the
financial statements and related disclosures with the SEC. Specifically,
we determined that because of the latter situation, our controls over the
preparation, review and monitoring of the financial statements were
ineffective to provide reasonable assurance that financial disclosures
agreed to appropriate supporting detail, calculations or other documents.
• Our documentation of accounting policies and procedures is incomplete to the level necessary to ensure accounting for transactions are accounted by the limited accounting staff in accordance with generally accepted accounting principles properly each reporting period.
• We installed a new enterprise wide information system during 2007 that is utilized to plan and execute the business. However the accounting modules and functionality of the new system are not fully implemented or utilized by Company personnel to process transactions which have contributed to weaknesses in internal control over financial reporting.
• We have a complex chemical production process which was not properly reflected in the accounting records captured in our enterprise wide information system at the end of 2007 and at interim reporting dates during 2007. In this regard, audit adjustments were made relating to both the quantity and value of inventory at December 31, 2007. Additional management time has been required to ensure that inventory has been properly accounted for during and at the end of each financial reporting period.
As a result of the material weaknesses described above, our management
concluded that as of December 31, 2007, we did not maintain effective internal
control over financial reporting based on the criteria established in Internal
Control - Integrated Framework issued by the COSO.
The annual report included on Form 10-KSB/A referred to above did not
include an attestation report of the Company's registered public accounting firm
regarding internal control over financial reporting. Management's report was not
subject to attestation by the Company's registered public accounting firm
. . .
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