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| IFLO > SEC Filings for IFLO > Form 10-K/A on 22-Oct-2008 | All Recent SEC Filings |
22-Oct-2008
Annual Report
The Company's current strategic focus for future growth is on the rapidly
growing Regional Anesthesia market, with particular emphasis on the Company's
pain relief products marketed under its ON-Q® brand. The Company intends to
continue its sales and marketing efforts to further penetrate the United States
post-surgical pain relief market with its ON-Q products.
The Company is also seeking to expand its strategic focus to include general
surgical site care management in addition to its leadership position in Regional
Anesthesia for post-surgical pain management. To that end, on December 13, 2007,
the Company announced that it entered into a binding letter of intent to acquire
AcryMed Incorporated ("AcryMed"), a privately held Oregon-based developer of
innovative infection control and wound healing products. The agreement
contemplated the merger of a new subsidiary of the Company into AcryMed, with
AcryMed being the surviving corporation as a wholly owned subsidiary of the
Company. AcryMed shareholders will receive approximately $25.0 million in cash
from the Company in the merger. The Company completed the acquisition of AcryMed
on February 15, 2008.
Discontinued Operations of InfuSystem
On September 29, 2006, the Company signed a definitive agreement to sell
InfuSystem to HAPC for $140 million in the form of cash and a secured note,
subject to certain purchase price adjustments based on the level of working
capital. On September 18, 2007, the Company amended the definitive agreement
resulting in a new purchase price of $100 million (subject to working capital
adjustments in the definitive agreement) plus a contingent payment right to the
Company of up to a maximum of $12 million (the "Earn-Out"). The Earn-Out
provides that HAPC will make an additional cash payment (the "Additional
Payment") to the Company of up to $12 million based on the compound annual
growth rate ("CAGR") of HAPC's net consolidated revenues over the three year
period ending December 31, 2010. If HAPC's net consolidated revenues for the
fiscal year ending December 31, 2010 ("FY 2010") are less than 2.744 times
InfuSystem's 2007 net revenues, excluding InfuSystem's revenues related to the
Company's ON-Q® product line (the "40% CAGR Target"), no Additional Payment will
be due. If HAPC's net consolidated revenues for FY 2010 equal or exceed 3.375
times InfuSystem's 2007 net revenues, excluding InfuSystem's revenues related to
the Company's ON-Q product line (the "50% CAGR Target"), the Company will
receive the full $12 million Additional Payment. If HAPC's net consolidated
revenues for FY 2010 are between the 40% and 50% CAGR Targets, the Company will
receive an Additional Payment equal to $3 million plus a pro rata portion of the
remaining $9 million.
On October 19, 2007, the Company purchased approximately 2.8 million shares of
common stock of HAPC at $5.97 per share through private transactions with third
parties totaling approximately $17 million. With the shares purchased as of that
date, the Company owned approximately 15% of the issued and outstanding HAPC
common stock and disclosed its intentions to vote such shares in favor of the
acquisition. As of November 13, 2007, the latest date reported by HAPC, the
2.8 million shares held by the Company constitute approximately 16.5% of the
issued and outstanding common stock of HAPC.
On October 22, 2007, because HAPC was unable to obtain the approval of its
stockholders of the acquisition by such date, a termination fee of $3.0 million
pursuant to the definitive agreement, as amended, became unconditionally due and
owing to the Company, regardless of whether or not the transaction was
subsequently consummated.
On October 24, 2007, the shareholders of HAPC approved the acquisition of
InfuSystem. The sale was completed on October 25, 2007 and the Company received
the $100 million purchase price at the closing in a combination of (i) cash
equal to $67.3 million and (ii) a secured promissory note with a principal
amount equal to $32.7 million. In addition to the $67.3 million in cash, the
Company at closing received the $3.0 million termination fee discussed above and
fees totaling approximately $2.6 million at closing in connection with the
secured promissory note, including a facility fee of $1.8 million, a ticking fee
of approximately $0.7 million and an annual administrative fee of $75,000. The
termination fee is recognized as part of the gain from the sale. Pursuant to the
definitive agreement and in connection with the Company's commitment to the
secured promissory note, ticking fees were due and payable to the Company equal
to a rate between 0.50% and 1.00% per annum of the maximum amount of the secured
promissory note, which was $75.0 million. The facility and ticking fees are
recorded as deferred finance income and amortized over the life of the secured
promissory note. The administrative fee is recorded as deferred finance income
and amortized on a monthly basis over the period of one year. The Company also
received
reimbursement of approximately $0.9 million by HAPC of certain divestiture
expenses incurred in the current and prior years by the Company directly
resulting from the sale transaction, including legal, audit and other
professional fees, pursuant to the definitive agreement. The reimbursement of
divestiture expenses is recorded in discontinued operations.
In accordance with Statement of Financial Accounting Standards ("SFAS") No. 144,
Accounting for Impairment or Disposal of Long-Lived Assets ("SFAS 144"), we have
reclassified the results of InfuSystem as discontinued operations, reclassifying
previously reported results to reflect all prior periods on a comparable basis.
Summarized financial information for InfuSystem is as follows:
Year Ended December 31,
2007(1)(2) 2006(2) 2005
(Amounts in thousands)
Operating revenues $ 25,001 $ 31,716 $ 28,525
Operating income $ 7,764 $ 7,007 $ 7,445
Income taxes 2,939 3,963 2,861
Income from discontinued operations $ 4,825 $ 3,044 $ 4,584
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(1) Includes financial results for InfuSystem for the period January 1, 2007 through October 25, 2007, which was the date the sale of InfuSystem was consummated.
(2) InfuSystem recorded approximately $2,090,000 of divestiture expenses during the year ended December 31, 2006. In October 2007, at the closing of the sale of InfuSystem, the Company received reimbursement of approximately $946,000 by HAPC of certain divestiture expenses incurred in 2006 and 2007 by the Company directly resulting from the sale transaction, including legal, audit and other professional fees. Since the reimbursement of $946,000 included payments for services incurred for 2006, divestiture expenses recorded during the year ended December 31, 2007 resulted in a net credit of approximately $245,000.
Consolidated Results of Operations for the Year Ended December 31, 2007 Compared
to the Year Ended December 31, 2006
Revenues
Net product sales from continuing operations increased 24%, or $22.9 million, to
$116.5 million for the year ended December 31, 2007 from $93.6 million for the
year ended December 31, 2006.
Management has chosen to organize the enterprise around differences in products
and services, which is the level at which the Company's management regularly
reviews operating results to make decisions about resource allocation and
segment performance. The Company's products are predominately assembled from
common subassembly components in a single integrated manufacturing facility, and
operating results are reviewed by management on a combined basis including all
products as opposed to several operating segments. The Company believes it is
most meaningful for the purposes of revenue analyses, however, to group the
product lines into two categories representing specific clinical applications
- Regional Anesthesia and IV Infusion Therapy.
Regional Anesthesia product revenues increased 32%, or $21.7 million, to
$89.6 million for the year ended December 31, 2007 from $67.9 million for the
year ended December 31, 2006. This increase was primarily due to increased
clinical usage of the ON-Q PainBuster® Post-Operative Pain Relief System and
C-bloc® Continuous Nerve Block System by surgeons in the United States. Revenue
from the C-bloc Continuous Nerve Block Systems increased 141%, or $9.3 million,
to $15.9 million for the year ended December 31, 2007 compared to the prior
year, primarily due to improved customer awareness of clinical efficacy and
favorable reimbursement from third parties. The average selling price for the
year ended December 31, 2007 was comparable to the prior year. Other Regional
Anesthesia products include the Soaker® Catheter and the SilverSoakertm
Catheter.
Sales of IV Infusion Therapy products, which include the Company's intravenous
elastomeric pumps, mechanical infusion devices and disposables, increased 4%, or
$1.1 million, to $26.8 million for the year ended December 31, 2007 from
$25.7 million for the year ended December 31, 2006. The increase primarily
resulted from
increased unit sales of IV Infusion Therapy products to B. Braun Medical Inc., a
domestic distributor, offset in part by a decrease in unit sales to
international distributors, including B. Braun Medical S.A. (France). The
average selling price for the year ended December 31, 2007 was comparable to the
prior year. The Company has a distribution agreement with B. Braun Medical S.A.,
a manufacturer and distributor of pharmaceuticals and infusion products, to
distribute the Company's elastomeric infusion pumps in Western Europe, Eastern
Europe, the Middle East, Asia Pacific, South America and Africa.
Cost of Revenues
Cost of revenues from continuing operations increased 22%, or $5.7 million, to
$32.0 million for the year ended December 31, 2007 from $26.3 million for the
year ended December 31, 2006. The increase was primarily due to higher sales
volume. As a percentage of net product sales, product cost of revenues decreased
for the year ended December 31, 2007 by approximately one percentage point
compared to the prior year. The decrease in cost of revenues is primarily due to
the favorable change in sales mix toward high-margin Regional Anesthesia
products.
Selling and Marketing Expenses
Selling and marketing expenses from continuing operations increased 25%, or
$14.2 million, to $71.9 million for the year ended December 31, 2007 from
$57.7 million for the year ended December 31, 2006. This increase was primarily
attributable to increases in compensation and related expenses ($4.6 million),
commissions ($4.4 million), travel and entertainment expenses ($1.8 million),
consulting ($1.2 million), advertising and promotions expenses ($0.7 million),
employee training expenses ($0.2 million) and marketing samples ($0.1 million).
As reflected above, the increases in selling and marketing expenses for the year
ended December 31, 2007 were primarily due to costs related to the realignment
and expansion of the Company's direct sales force in the United States. In a
transaction that was effective as of January 1, 2002, I-Flow re-acquired from
Ethicon Endo-Surgery, Inc. the contractual rights to distribute ON-Q products on
a direct basis. Since that time, ON-Q revenues have increased rapidly, and the
Company's primary strategy in the Regional Anesthesia market has been to rapidly
increase market awareness of the clinical and economic advantages of ON-Q
technology through a combination of clinical studies, sales force expansion and
marketing programs. The increases in commissions, compensation and related
expenses, travel and entertainment expenses, employee training expenses and
marketing samples were directly related to the increase in revenue, an increase
in the number of quota-carrying sales representatives, and changes in the
Company's direct sales force and sales management. As of December 31, 2007, the
Company employed approximately 320 people in its sales organization in support
of its ON-Q sales effort compared to 280 people at December 31, 2006, an
increase of approximately 14%.
As a percentage of net revenues, selling and marketing expenses decreased by
approximately one percentage point for the year ended December 31, 2007 versus
the prior year because net revenues increased at a rate that outpaced the
increase in selling and marketing expenses described above.
General and Administrative Expenses
General and administrative expenses from continuing operations increased 18%, or
$2.7 million, to $17.7 million for the year ended December 31, 2007 from
$15.0 million for the year ended December 31, 2006. This increase was primarily
attributable to increases in non-cash compensation expense related to the
amortization of deferred compensation ($1.3 million), accounting fees
($0.7 million) and legal fees ($0.5 million).
As a percentage of net revenues, general and administrative expenses decreased
by approximately one percentage point for the year ended December 31, 2007
versus the prior year because net revenues increased at a rate that outpaced the
increase in general and administrative expenses described above.
Product Development Expenses
Product development expenses from continuing operations include research and
development for new products and the cost of obtaining and maintaining
regulatory approvals of products and processes. Product development expenses
increased 9%, or $0.2 million, to $2.7 million for the year ended December 31,
2007 from $2.4 million for
the year ended December 31, 2006. The increase in expense was primarily due to
an increase in the amortization of patents and increase in compensation and
related expenses that resulted from an increase in the number of headcount. The
Company will continue to incur product development expenses as it continues its
efforts to introduce new technology and cost-efficient products into the market,
and these expenses are also expected to increase as a result of the recent
acquisition of AcryMed.
Impairment Loss on Investments
For the year ended December 31, 2007, the Company recognized an
other-than-temporary impairment of $6.1 million on its investment in HAPC common
stock. In October 2007, the Company purchased approximately 2.8 million shares
of common stock of HAPC at $5.97 per share through private transactions with
third parties totaling approximately $17 million in connection with the
then-pending sale of InfuSystem. With the shares purchased as of that date, the
Company owned approximately 15% of the issued and outstanding HAPC common stock
and disclosed its intentions to vote such shares in favor of the acquisition. As
of November 13, 2007, the latest date reported by HAPC, the 2.8 million shares
held by the Company constitute approximately 16.5% of the issued and outstanding
common stock of HAPC. Since the time the shares of HAPC common stock were
purchased by the Company, the share price of HAPC common stock has significantly
decreased from the Company's purchase price of $5.97 per share. As of
December 31, 2007, the Company has determined that the decline in the fair value
of the investment in HAPC common stock was other than temporary based primarily
on the significant decline in the market value and its intent to sell the
investment in the short-term. As such, the Company recorded the impairment loss
and established a new cost basis in the investment as of December 31, 2007 in
accordance with SFAS No. 115, Accounting for Certain Investments in Debt and
Equity Securities ("SFAS 115").
Interest, Net
Interest and other income, net, from continuing operations increased 160%, or
$1.5 million, to $2.4 million for the year ended December 31, 2007 from
$0.9 million for the year ended December 31, 2006. The increase was primarily
due to increased investment income from higher cash and cash equivalents and
short-term investments balances. The Company's cash and cash equivalents and
short-term investments increased by approximately $76.1 million from prior year
due to the cash proceeds received from the sale of InfuSystem in October 2007.
Income Taxes
Income tax benefit from continuing operations decreased to $2.5 million for the
year ended December 31, 2007 from $17.6 million for the year ended December 31,
2006. The decrease for the year ended December 31, 2007 was due to a release of
the valuation allowance for deferred tax assets with an incremental tax benefit
of approximately $16.8 million that was recorded during the year ended
December 31, 2006. The remaining valuation allowance relates to temporary timing
differences that are not currently determined to be more likely than not to be
realized. The income tax benefit was consistent with the guidance in
SFAS No. 109, Accounting for Income Taxes, which addresses financial accounting
for deferred tax assets. The Company regularly reviews its deferred tax assets
for recoverability and establishes a valuation allowance when it is more likely
than not, based on available evidence, that projected future taxable income will
be insufficient to recover the deferred tax assets. In the event the Company is
unable to operate at a profit and unable to generate sufficient future taxable
income, it would be required to increase the valuation allowance against all of
its deferred tax assets.
In the design and improvement of its products, I-Flow incurs research and
development costs that qualify for federal and state tax credits. An increase in
credits occurred during the current year due to an additional analysis regarding
the expenses that qualify for state and federal research and development
credits.
The Company's effective tax rate for the year ended December 31, 2007 was a tax
benefit of 21.8% compared to a tax benefit rate of 253.4% for the year ended
December 31, 2006. The change in the effective tax rate is primarily the result
of the valuation allowance release for the year ended December 31, 2006, which
allowed a majority of the Company's deferred tax assets to be recognized.
Consolidated Results of Operations for the Year Ended December 31, 2006 Compared
to the Year Ended December 31, 2005
Revenue
Net product sales from continuing operations increased 30%, or $21.5 million, to
$93.6 million for the year ended December 31, 2006 from $72.1 million for the
year ended December 31, 2005.
Regional Anesthesia product revenues increased 36%, or $18.0 million, to
$67.9 million for the year ended December 31, 2006 from $49.9 million for the
year ended December 31, 2005. This increase was primarily due to increased
clinical usage of the ON-Q PainBuster Post-Operative Pain Relief System and
C-bloc Continuous Nerve Block System by surgeons in the United States and an
increase of 11% in the average selling price during the year ended December 31,
2006 compared to the same period in the prior year. The increase in average
selling price was due to a favorable shift in the product mix towards products
with higher average selling prices, such as the C-bloc Continuous Nerve Block
System. Revenue from the C-bloc Continuous Nerve Block System increased 174%, or
$4.2 million, to $6.6 million for the year ended December 31, 2006 from
$2.4 million in the prior year, primarily due to improved customer awareness of
clinical efficacy and favorable reimbursement from third parties.
Sales of IV Infusion Therapy products, which include the Company's intravenous
elastomeric pumps, mechanical infusion devices and disposables, increased 15%,
or $3.4 million, to $25.7 million for the year ended December 31, 2006 from
$22.3 million for the year ended December 31, 2005. The increase primarily
resulted from increased unit sales of IV Infusion Therapy products to U.S. and
international distributors, including B. Braun Medical Inc. in the United States
and B. Braun Medical S.A. (France) internationally.
Cost of Revenues
Cost of revenues from continuing operations increased 34%, or $6.6 million, to
$26.3 million for the year ended December 31, 2006 from $19.7 million. The
increase was primarily due to higher sales volume. As a percentage of net
product sales, product cost of revenues increased for the year ended
December 31, 2006 by approximately one percentage point compared to the prior
year.
Selling and Marketing Expenses
Selling and marketing expenses from continuing operations increased 16%, or
$7.8 million, to $57.7 million for the year ended December 31, 2006 from
$49.9 million for the year ended December 31, 2005. This increase was primarily
attributable to increases in commissions ($3.5 million), compensation and
related expenses ($3.1 million), travel and entertainment expenses
($1.0 million), marketing samples ($0.5 million) and non-cash compensation
expense related to the amortization of deferred compensation ($0.5 million),
partially offset by a decrease of $1.2 million in advertising and promotions
expense.
As reflected above, the increases in selling and marketing expenses for the year
ended December 31, 2006 were primarily due to costs related to the realignment
and expansion of the Company's direct sales force in the United States. The
increases in commissions, compensation and related expenses, travel and
entertainment expenses and marketing samples were directly related to the
increase in revenue, an increase in the number of quota-carrying sales
representatives, and changes in the Company's direct sales force and sales
management. As of December 31, 2006, the Company employed approximately
280 people in its sales organization in support of its ON-Q sales effort
compared to 250 people at December 31, 2005, an increase of approximately 12%.
The Company recognized stock-based compensation costs related to selling and
marketing expenses of approximately $2.4 million and $1.9 million during the
years ended December 31, 2006 and 2005, respectively. The adoption of
SFAS No. 123-revised 2004, Share-Based Payment ("SFAS 123R"), in fiscal 2006 did
not have a significant impact on stock-based compensation expense for selling
and marketing expenses because the Company was required to recognize such
expenses under the prior accounting guidance for the stock awards issued to the
sales force since they were generally granted with an exercise price below fair
market value.
As a percentage of net revenues, selling and marketing expenses decreased by
approximately 7% for the year ended December 31, 2006 versus the prior year
because net revenues increased at a rate that outpaced the increase in selling
and marketing expenses described above.
General and Administrative Expenses
General and administrative expenses from continuing operations decreased 9%, or
$1.3 million, to $15.0 million for the year ended December 31, 2006 from
$16.3 million for the year ended December 31, 2005. This decrease was primarily
attributable to decreases in non-cash compensation expense related to the
amortization of deferred compensation ($2.8 million) and legal fees
($0.5 million), partially offset by increases in compensation and related
expenses ($1.1 million) and insurance expense ($0.3 million).
The decrease in non-cash compensation expense related to the amortization of
deferred compensation was primarily due to the upward repricing and acceleration
of the out-of-the-money stock options on November 9, 2005, offset in part by the
adoption of SFAS 123R in fiscal 2006. The primary purposes of upward repricing
and acceleration of the out-of-the-money stock options were to comply with new
deferred compensation tax laws, to promote employee motivation, retention and
the perception of option value and to avoid recognizing future compensation
. . .
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