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| SYNO > SEC Filings for SYNO > Form 10-Q on 9-Sep-2009 | All Recent SEC Filings |
9-Sep-2009
Quarterly Report
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS - CONTINUED
Results of Operations
Comparison of the Three Months Ended July 31, 2009 with the Three Months Ended
July 31, 2008 (in thousands except per share data)
The following table summarizes our consolidated condensed operating results for
the third quarter of fiscal 2009 and fiscal 2008:
For the quarter ended For the quarter ended
July 31, 2009 July 31, 2008 Change
$ % $ % $ %
Net revenue $ 15,032 100.0 % $ 13,366 100.0 % $ 1,666 12.5 %
Cost of revenue 4,257 28.3 4,171 31.2 86 2.1
Gross margin 10,775 71.7 9,195 68.8 1,580 17.2
Selling, general and
administrative 7,384 49.1 6,070 45.4 1,314 21.6
Research and
development 945 6.3 847 6.4 98 11.6
Other 4,100 27.3 0 0.0 4,100 n/m
Operating expenses 12,429 82.7 6,917 51.8 5,512 79.7
Operating
(loss) income $ (1,654 ) (11.0 %) $ 2,278 17.0 % $ (3,932 ) n/m
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We generated net revenue of $15,032 in the third quarter of fiscal 2009, an increase of $1,666 or 12% from $13,366 in the year-ago quarter. The following table summarizes net revenue by product group and geography:
For the quarter ended
July 31,
2009 % 2008 %
Biomaterial patch products $ 6,395 43 % $ 4,987 37 %
Peri-Strips® 4,833 32 % 4,783 36 %
Devices for microsurgery 2,414 16 % 2,191 16 %
Surgical tools and other 1,390 9 % 1,405 11 %
Orthopedic and woundcare 0 0 % 0 0 %
Total $ 15,032 100 % $ 13,366 100 %
Domestic $ 12,705 84 % $ 11,345 85 %
International 2,327 16 % 2,021 15 %
Total $ 15,032 100 % $ 13,366 100 %
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The increase in net revenue in the third quarter of fiscal 2009 compared to the
prior-year quarter was due to the following:
- Incremental worldwide units sold and product mix changes increased revenue
approximately $1,190; and
- Higher average net selling prices, primarily due to various worldwide hospital list price increases for certain of our products, increased revenue by approximately $475.
We believe that expansion of our direct sales force is a key long-term strategy to increase revenues. During the first half of fiscal 2009, we expanded our direct sales force from 43 to 49 sales representatives in the U.S. In the second half of fiscal 2009, we expect to hire 16 additional sales representatives (excluding sales representatives expected to be hired for Ortho & Wound), giving us a total of 65 sales representatives in the U.S. In the third quarter of fiscal 2009, we hired 11 of the 16 additional sales representatives. We expect to hire the remaining 5 additional sales
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS - CONTINUED
representatives in the fourth quarter, giving us a total of 65 sales
representatives by the end of fiscal 2009. The additional sales representatives
were added with the expectation to grow revenues long-term; however, our sales
expansion strategies have shifted sales management time and focus in the third
quarter from short-term sales growth activities towards our longer-term strategy
of hiring qualified, experienced sales personnel.
In addition to the impacts of our direct sales force expansion, the increase in
worldwide units sales was primarily attributable to increased market acceptance
of Veritas® Collagen Matrix ("Veritas") into the domestic hernia and general
surgery markets and Peri-Strips in the European market.
We cannot fully assess the impact that the current economic downturn may have
had on our results of operations. We believe, however, that the volume of
certain surgical procedures in which our products are used, particularly those
which may be considered elective, have been impacted by the current economic
downturn. In addition, we believe the financial condition of certain of our
hospital customers have been negatively impacted by the economic downturn. The
impact of these items, as well as other factors, may be impacting our results of
operations.
Revenue from biomaterial patch products increased $1,408 or 28% to $6,395 in the
third quarter of fiscal 2009. An 82% increase in Veritas revenue in the current
quarter was driven by sales into the domestic hernia, reconstructive and general
surgery markets. Veritas is a remodelable tissue platform used in surgery to
repair and replace soft tissue. Other drivers of the revenue increase included a
9% increase in unit volumes of Tissue-Guard sold worldwide in the current
quarter and list price increases of our Tissue-Guard and Veritas products in
most worldwide geographies in the first three quarters of fiscal 2009. Our
Tissue-Guard family of products is a permanent tissue platform used to repair
and replace damaged tissue in an array of surgical procedures, including
cardiac, vascular, thoracic, and neurological procedures.
Worldwide net revenue from Peri-Strips was $4,833 in the third quarter of fiscal
2009, an increase of $50 from $4,783 in the third quarter of fiscal 2008.
Peri-Strips is a bovine pericardium-based staple-line buttress used primarily to
control bleeding and leakage of bodily fluids in various medical procedures,
primarily gastric bypass surgery. Our Peri-Strips product line includes both
linear and circular buttresses, and are produced in a wide assortment of sizes
to fit staplers of the two leading surgical stapler companies.
We believe increased market acceptance of Peri-Strips in the European market has
been offset by the impact of increasing competition within the buttressing
market. We believe Covidien, one of the two primary stapler companies, launched
a buttress product integral with their staplers on a limited basis in early 2009
and fully launched in April 2009. During the third quarter, worldwide revenue
from Peri-Strips products which adhere to Covidien staplers decreased 23% from
the second quarter of fiscal 2009. This was partially offset by revenue for
other Peri-Strips products increasing 10%. We are addressing the Covidien
competitive threat through our expanded direct sales force, the development of
product enhancements and strengthened efforts to convert additional
non-buttressing surgeons.
Revenue from devices for microsurgery was $2,414 in the third quarter of fiscal
2009, an increase of $223 or 10% from $2,191 in the year-ago quarter. This
revenue growth was driven by increased list prices for certain microsurgery
products, most notably the Coupler. The Coupler is a device used to connect
extremely small arteries or veins, without sutures, quickly, easily and with
consistently excellent results.
We did not record any revenue from our newly acquired Ortho & Wound business in
the third quarter of fiscal 2009. We are in the process of obtaining the
California Department of Public Health manufacturing license necessary to
repackage acquired inventory with Synovis labeling, as well as to manufacture
new products. We presently expect to obtain this license late in our fiscal 2009
fourth quarter, and to begin manufacturing and selling Ortho & Wound product at
that time.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS - CONTINUED
Our gross margin increased to 72% in the third quarter of fiscal 2009 from 69%
during the third quarter of fiscal 2008. The margin increase was due primarily
to favorable product sales mix in the current period, improved production and
overhead rate utilization associated with product sold in the current period and
higher average net selling prices. Factors which affect gross margin include
sales mix among geographies and product lines, volume and other production
activities. We expect our overall gross margin to decrease in the future as we
begin to sell our Ortho & Wound products. The gross margin of Ortho & Wound
products will be lower as we sell the acquired inventory, which has a stepped-up
basis, and due to expected unabsorbed manufacturing costs as we initiate Ortho &
Wound manufacturing activity. Accordingly, our gross margins may fluctuate from
period to period based on variations in these factors.
Selling, general and administrative ("SG&A") expense during the third quarter of
fiscal 2009 was $7,384, an increase of $1,314 or 22% from SG&A expense of $6,070
in the third quarter of fiscal 2008. As a percentage of net revenue, SG&A
expense was 49% in the third quarter of fiscal 2009 as compared to 45% in the
prior-year quarter. The current quarter SG&A increase was due to the expansion
of our direct sales force from 43 to 60 sales representatives in the first three
quarters of fiscal 2009, $206 of operating expenses related to our Ortho & Wound
business, increased legal expense as well as general and administrative
investments in personnel and information technology. Additionally, stock-based
compensation expense was $252 (2 cents per share) in the current quarter, up
from $128 (1 cent per share) in the third quarter of fiscal 2008.
In the fourth quarter of fiscal 2009, we expect to incur significant additional
operating expense as compared to the third quarter of fiscal 2009. This is
expected to be driven by a full quarter of expense related to our expanded sales
force, as well as expense related to operations of our acquired Ortho & Wound
business. We will incur a full quarter of Ortho & Wound operating activity as
compared to two weeks of operating activity in the third quarter. We presently
expect Ortho & Wound operating costs in the fourth quarter of fiscal 2009 to be
between $1,200 and $1,500.
Research and development ("R&D") expense totaled $945 during the third quarter
of fiscal 2009 as compared to $847 in the prior-year quarter. Activity in the
current quarter focused on several activities, including research to support
current indications for use of Veritas, exploring potential opportunities for
further expanding the indications for use of Veritas, improving the delivery
system for our Peri-Strips products and advancing the technology of the Coupler,
among others. We do not expect to incur material R&D expense related to our
Ortho & Wound business in the fourth quarter of fiscal 2009. R&D expense
fluctuates from period to period based on the timing and progress of internal
and external project-related activities and the timing of such expense will
continue to be influenced primarily by the number of projects and the related
R&D personnel requirements, development and regulatory approval path, and
expected timing and nature of costs for each project.
In the third quarter of fiscal 2009, we recorded other operating expenses of
$4,100. First, we expensed acquired in-process R&D costs of $3,500 related to
our acquisition of the assets of Pegasus, as it was determined the related
projects had not achieved technological feasibility. Second, we recorded an
impairment charge of $600 related to identifiable intangible assets related to
our fiscal 2007 acquisition of the 4Closure™ Surgical Fascia Closure System
("4Closure") following an impairment analysis. This analysis was performed as a
result of a delay in the expected third quarter of fiscal 2009 re-launch and
re-brand of the product, combined with actual revenues since acquisition not
meeting projected expectations. No such other operating expenses were recorded
in the third quarter of fiscal 2008.
We recorded an operating loss of $1,654 in the third quarter of fiscal 2009,
compared to operating income of $2,278 in the third quarter of fiscal 2008. The
operating loss in the third quarter of fiscal 2009 was driven by the acquired
in-process R&D expense of $3,500 and identifiable intangible asset impairment of
$600 discussed above.
Interest income was $190 in the third quarter of fiscal 2009 compared with $430
in the third quarter of fiscal 2008, primarily due to lower investment yield in
the current period and lower overall investment balances. We recorded
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS - CONTINUED
an impairment of $4,100 related to an other-than-temporary write-down of our
auction rate securities ("ARS") due to a change in our intent and ability to
hold these investments until a complete recovery of par value.
We recorded a benefit from income taxes in the third quarter of fiscal 2009 of
$690. This benefit is at an effective tax rate of 47% of pretax income excluding
the $4,100 impairment of ARS. The $4,100 impairment represents a capital loss,
and we presently do not believe we will have future capital income to realize
the benefit. As such, we did not record any tax benefit related to the ARS
impairment. In the third quarter of fiscal 2008 we recorded a provision for
income taxes of $948 at an effective rate of 35%.
On a year to date basis, our provision for income taxes reflects our current
expected effective tax rate for fiscal 2009 of 28% on pretax income excluding
the $4,100 capital loss on ARS. Our fiscal 2009 effective tax rate is expected
to be lower than the prior-year due to lower pretax income as well as an
expected lower overall rate for state taxes, primarily due to a change in state
apportionment factors caused by the current expected mix of our product sales by
state. Our current expected fiscal 2009 effective tax rate is lower than the 33%
rate we had recorded through our second quarter of fiscal 2009. Our current
expected pretax fiscal 2009 income used to estimate our effective tax rate
decreased in the third quarter due to costs incurred and expected to be incurred
related to our acquired Ortho & Wound business, as well as the impairment of
identifiable intangible assets in the third quarter of fiscal 2009. Our current
estimate of permanent items is consistent with our estimate made in the second
quarter.
Comparison of the Nine Months Ended July 31, 2009 with the Nine Months Ended
July 31, 2008 (in thousands except per share data)
The following table summarizes our consolidated condensed operating results for
the first nine months of fiscal 2009 and fiscal 2008:
For the nine months ended For the nine months ended
July 31, 2009 July 31, 2008 Change
$ % $ % $ %
Net revenue $ 43,201 100.0 % $ 37,085 100.0 % $ 6,116 16.5 %
Cost of revenue 12,306 28.5 11,866 32.0 440 3.7
Gross margin 30,895 71.5 25,219 68.0 5,676 22.5
Selling, general and
administrative 20,723 47.9 17,925 48.3 2,798 15.6
Research and development 2,712 6.3 2,336 6.3 376 16.1
Other 4,100 9.5 - - 4,100 n/m
Operating expenses 27,535 63.7 20,261 54.6 7,274 35.9
Operating income $ 3,360 7.8 % $ 4,958 13.4 % $ (1,598 ) (32.2 %)
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We generated net revenue of $43,201 in the first three quarters of fiscal 2009, an increase of $6,116 or 16% from $37,085 in the year-ago period. The following table summarizes net revenue by product group and geography:
For the nine months ended
July 31,
2009 % 2008 %
Biomaterial patch products $ 17,865 41 % $ 14,142 39 %
Peri-Strips 14,677 34 % 12,985 35 %
Devices for microsurgery 6,300 15 % 5,737 15 %
Surgical tools and other 4,359 10 % 4,221 11 %
Orthopedic and woundcare 0 0 % 0 0 %
Total $ 43,201 100 % $ 37,085 100 %
Domestic $ 36,372 84 % $ 31,191 84 %
International 6,829 16 % 5,894 16 %
Total $ 43,201 100 % $ 37,085 100 %
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS - CONTINUED
The increase in net revenue in the first three quarters of fiscal 2009 compared
to the prior-year period was due to the following:
- Incremental worldwide units sold (inclusive of new product introductions) and
product mix changes increased revenue approximately $4,770; and
- Higher average net selling prices, primarily due to various worldwide hospital list price increases for certain of our products, increased revenue by approximately $1,345.
The increase in worldwide units sales was primarily attributable to our
expanding direct sales force growing product sales, as well as increased market
acceptance of Veritas into the domestic hernia and general surgery markets and
Peri-Strips in the domestic and European markets.
Revenue from biomaterial patch products increased $3,723 or 26% to $17,865 in
the first three quarters of fiscal 2009 from $14,142 in the year-ago period. An
83% increase in Veritas revenue in the first three quarters of fiscal 2009 was
driven by sales into the domestic hernia, reconstructive and general surgery
markets. Other drivers of the revenue increase included an 8% increase in unit
volumes of Tissue-Guard sold worldwide in the current period and list price
increases of our Tissue-Guard and Veritas products in most worldwide geographies
in the first three quarters of fiscal 2009.
Worldwide net revenue from Peri-Strips was $14,677 in the first three quarters
of fiscal 2009, an increase of 13% from $12,985 in the same period of fiscal
2008. Peri-Strips growth rate exceeded the estimated growth of procedures in
which the product is used, which we believe was attributable to product
performance, our direct sales force communicating the benefits of Peri-Strips,
and the increased international market penetration of PSD Veritas, partially
offset by increased competition.
Revenue from devices for microsurgery was $6,300 in the first three quarters of
fiscal 2009, as compared to $5,737 in the year-ago period. This revenue growth
was driven by Coupler unit sales growth in the current year as well as list
price increases to the Coupler in late fiscal 2008.
Our gross margin increased to 72% in the first three quarters of fiscal 2009
from 68% during the comparative period of fiscal 2008. The margin increase was
due primarily to favorable sales mix (geographic and product) in the current
period, improved production and overhead rate utilization associated with
product sold in the current period and higher average net selling prices.
SG&A expense during the first three quarters of fiscal 2009 was $20,723, an
increase of $2,798 or 16% from SG&A expense of $17,925 in the first three
quarters of fiscal 2008. As a percentage of net revenue, SG&A expense was 48% in
both the first three quarters of fiscal 2009 and 2008. The SG&A increase was due
to the expansion of our direct sales force from 43 to 60 sales representatives
in the first three quarters of fiscal 2009, $206 of operating expenses related
to our Ortho & Wound business, increased legal expense as well as general and
administrative investments in new business development, clinical personnel and
information technology. Additionally, stock-based compensation expense was $687
(4 cents per share) in the first three quarters of fiscal 2009, up from $362 (2
cents per share) in the first three quarters of fiscal 2008.
R&D expense totaled $2,712 during the first three quarters of fiscal 2009, as
compared to $2,336 in the first three quarters of fiscal 2008. R&D activity in
the first three quarters of fiscal 2009 focused on several activities, including
research to support current indications for use of Veritas, exploring potential
opportunities for further expanding the indications for use of Veritas,
improving the delivery system for our Peri-Strips products and advancing the
technology of the Coupler, among others.
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS - CONTINUED
In the first three quarters of fiscal 2009, we recorded other operating expenses
of $4,100. First, we expensed acquired in-process R&D costs of $3,500 related to
our acquisition of the assets of Pegasus, as it was determined the related
projects had not achieved technological feasibility. Second, we recorded an
impairment charge of $600 on identifiable intangible assets related to our
fiscal 2007 acquisition of 4Closure following an impairment analysis. This
analysis was performed as a result of a delay in the expected third quarter of
fiscal 2009 re-launch and re-brand of the product, combined with actual revenues
since acquisition not meeting projected expectations. No such other operating
expenses were recorded in the first three quarters of fiscal 2008.
We recorded operating income of $3,360 in the first three quarters of fiscal
2009, as compared to operating income of $4,958 in the first three quarters of
fiscal 2008. The decrease in operating income in the first three quarters of
fiscal 2009 as compared to the prior-year period was driven by the acquired
in-process R&D expense of $3,500 and the identifiable intangible asset
impairment of $600.
. . .
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