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8-K - FORM 8-K - SYNOVIS LIFE TECHNOLOGIES INC | c61603e8vk.htm |
Exhibit 99.1
FROM:
|
FOR: | |
Padilla Speer Beardsley Inc.
|
Synovis Life Technologies, Inc. | |
1101 West River Parkway
|
2575 University Ave. West | |
Minneapolis, Minnesota 55415
|
St. Paul, Minnesota 55114 | |
CONTACTS:
|
CONTACTS: | |
Nancy A. Johnson / Marian Briggs
|
Richard Kramp, President and CEO | |
(612) 455-1745 / (612) 455-1742
|
Brett Reynolds, CFO | |
(651) 796-7300 |
FOR IMMEDIATE RELEASE
SYNOVIS LIFE TECHNOLOGIES REPORTS 21 PERCENT YEAR-OVER-YEAR
REVENUE GROWTH FOR FISCAL 2010 FOURTH QUARTER
Veritas® and Microsurgery Revenue Each Up 32 Percent Over Year-Ago Quarter;
Earnings per Share of $0.13 in Fourth Quarter
Earnings per Share of $0.13 in Fourth Quarter
ST. PAUL, Minn., Dec. 1, 2010 Synovis Life Technologies, Inc. (Nasdaq: SYNO), today reported
its financial results for the fourth quarter and fiscal year ended October 31, 2010.
For the 2010 fiscal fourth quarter, net revenue rose to $18.1 million, a 21 percent increase
over $15.0 million in the year-ago period. Net income for the fiscal 2010 fourth quarter was $1.5
million, or $0.13 per diluted share, compared to adjusted net income (non-GAAP) of $0.6 million, or
$0.05 per diluted share, in the fiscal 2009 fourth quarter. Adjusted fiscal 2009 fourth quarter net
income (non-GAAP) excludes the gain on the sale of auction rate securities and the related impact
on income taxes. Net income on a GAAP basis for the fiscal 2009 fourth quarter was $3.8 million, or
$0.33 per diluted share.
For fiscal 2010, net revenue rose to $68.6 million, up 18 percent from $58.2 million in fiscal
2009. Net income for fiscal 2010 was $4.9 million, or $0.43 per diluted share, compared to adjusted
net income (non-GAAP) of $6.6 million, or $0.56 per diluted share, in fiscal 2009. Adjusted fiscal
2009 net income (non-GAAP) excludes certain special charges. Net income on a GAAP basis for fiscal
2009 was $2.7 million, or $0.23 per diluted share. Non-cash stock-based compensation expense was
$1.5 million in fiscal 2010 ($0.09 per diluted share after-tax), versus $0.9 million ($0.07 per
diluted share after-tax) in fiscal 2009.
We are pleased with our overall revenue results. Our growth of 21 percent in the fourth
quarter and 18 percent for the year is especially significant in light of the economic climate and
the aggressive reaction by healthcare providers to evolving healthcare reform legislation, said
Richard Kramp, Synovis Life Technologies president and chief executive officer. Synovis
double-digit revenue growth speaks favorably of our people, our products and our markets. We have
robust plans in place to continue on a strong growth
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Synovis Life Technologies
Dec. 1, 2010
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Dec. 1, 2010
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trajectory in 2011 and beyond fueled by our high potential products, particularly
Veritas®, the Microsurgical line and our Orthopedic and Wound offerings.
Kramp continued, New management strengthened our Surgical sales and marketing leadership team
during the fourth quarter. We are fortunate Jodi Brendel joined Synovis as our vice president of
sales and marketing early in the quarter. She has brought on a new leader for our U.S. marketing
efforts and a director of international sales and marketing, as well as creating and filling a
director of contracts and pricing position. This experienced leadership team has worked swiftly to
identify high-priority growth drivers for the Surgical business and is focusing on several
opportunities to drive revenue in the short and long term. Our Surgical, Microsurgical, and
Orthopedic and Wound groups are launching their growth plans at their respective national sales
meetings this quarter. I am optimistic about the opportunities before us and the enthusiasm of our
sales professionals.
Fourth Quarter and Fiscal 2010 Highlights
| Revenue from Veritas rose to $3.7 million in the fourth quarter, a 32 percent increase over the comparable period last year. For the full fiscal year, revenue from Veritas rose to $14.4 million, a 64 percent increase over fiscal 2009. Veritas comprised 21 percent of overall net revenue in fiscal 2010, up from 15 percent in fiscal 2009. Synovis launched Veritas less than four years ago in the breast reconstruction and hernia repair markets, and the product is steadily gaining acceptance. | ||
| Revenue from Microsurgical products totaled $3.1 million in the fourth quarter, a 32 percent increase over the same period last year and a quarterly record. Sales of the Flow Coupler®, which received FDA marketing clearance in the fiscal second quarter, contributed to Microsurgicals sales. For the full year, Microsurgical revenue totaled $11.0 million, a 27 percent increase over fiscal 2009. | ||
| Peri-Strips Dry® (PSD) revenue totaled $5.2 million in the fourth quarter, a 9 percent increase from the year-ago period and also a quarterly record. For the full year, PSD revenue totaled $19.4 million, consistent with fiscal 2009. Peri-Strips has been facing competitive pressure in the marketplace, but PSD revenue has increased sequentially since the fiscal 2010 first quarter. | ||
| Orthopedic and Wound product revenue totaled $685,000 for the fiscal fourth quarter, up 16 percent sequentially from the third quarter. For the year, fiscal 2010 revenue from Orthopedic and Wound products totaled $1.9 million. Orthopedic and Wound was established in July 2009 with the acquisition of substantially all of the assets of Pegasus Biologics, Inc. and its products were re-launched in early January 2010 following approval to manufacture and sell by the California Department of Public Health and the training of the initial members of our sales team. The primary products are the OrthADAPT® Bioimplant for orthopedic applications and Unite® Biomatrix for the treatment of chronic wounds. |
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Dec. 1, 2010
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Dec. 1, 2010
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| SG&A expenses totaled $9.6 million in the fourth quarter, up $0.4 million from the year-ago quarter, primarily due to higher sales and marketing costs. | ||
| Research and development (R&D) expenses totaled $1.3 million in the fourth quarter, up $0.2 million from the year-ago period. R&D investment in Orthopedic and Wound was higher than in previous quarters, due to the development and testing of the PROcuff orthopedic product. Synovis expects to launch this arthroscopically delivered device for reinforcement of rotator cuff repairs in the first half of 2011. | ||
| Operating income for the fourth quarter totaled $2.2 million, up 249 percent over operating income of $0.6 million in the year-ago period on higher revenue. |
Balance Sheet and Cash Flow
| Cash and investments totaled $61.9 million as of October 31, 2010, or $5.51 per share, compared to $61.0 million sequentially at the end of the third quarter of fiscal 2010 and $60.7 million at the end of fiscal 2009. | ||
| Operating activities provided cash of approximately $3.5 million in the fourth quarter of fiscal 2010 and $7.1 million in fiscal 2010. In fiscal 2009, operating activities provided cash of approximately $2.8 million in the fourth quarter and $9.8 million for the full fiscal year. | ||
| The company used $2.5 million in cash during the fiscal 2010 fourth quarter to repurchase 172,000 shares of its common stock, at an average price of $14.78. For the full fiscal year, the company used $5.1 million in cash to repurchase 386,000 shares at an average price of $13.22. |
Looking Ahead
Management believes revenue from historical operations (Surgical and Microsurgical products)
will grow approximately 15 percent in fiscal 2011 with gross margins slightly above fiscal 2010
levels, driven by product mix. Operating expenses for historical operations in fiscal 2011 are
expected to grow at a rate higher than revenue as a result of expanded sales and marketing
programs, key investments in R&D and increased post-market clinical studies. Synovis anticipates
that operating margins for historical operations in fiscal 2011 will be in the mid- to high-teens,
with lower operating margins expected early in the year and higher operating margins expected in
the second half of the year.
Management believes that fiscal 2011 revenue from Orthopedic and Wound will more than double
from fiscal 2010, with growth in each successive quarter. Gross margins slightly higher than 50
percent are currently anticipated as the acquired inventory with a stepped-up basis continues to be
sold. The fiscal 2011 operating loss from this unit is expected to range from $5 million to $5.5
million, depending on revenue growth.
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Dec. 1, 2010
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Dec. 1, 2010
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Conference Call and Webcast
Synovis Life Technologies will host a live webcast of its fiscal fourth-quarter conference
call today, Dec. 1, at 10 a.m. CT to discuss the companys results. To participate in the
conference call, please dial (888) 713-4217 and enter pass code 41404167. Please dial in at least
10 minutes prior to the call.
To access the live webcast, go to the investor information section of the companys website,
www.synovislife.com, and click on the webcast icon. A webcast replay will be available beginning at
noon CT, Wednesday, Dec. 1.
If you prefer to listen to an audio replay of the conference call, dial (888) 286-8010 and
enter access number 90191528. The audio replay will be available beginning at 2 p.m. CT on
Wednesday, Dec. 1, through 6 p.m. CT on Wednesday, Dec. 8.
About Synovis Life Technologies
Synovis Life Technologies, Inc., a diversified medical device company based in St. Paul,
Minn., develops, manufactures and markets biological and mechanical products used by several
surgical specialties to facilitate the repair and reconstruction of soft tissue damaged or
destroyed by disease or injury. The companys products include implantable biomaterials for soft
tissue repair, devices for microsurgery and surgical tools all designed to reduce risks and/or
facilitate critical surgeries, improve patient outcomes and reduce healthcare costs. For
additional information on Synovis Life Technologies and its products, visit the companys website
at www.synovislife.com.
Forward-looking statements contained in this press release are made pursuant to the safe
harbor provisions of the Private Securities Litigation Reform Act of 1995. The statements can be
identified by words such as should, could, may, will, expect, believe, anticipate,
estimate, continue, or other similar expressions. Certain important factors that could cause
results to differ materially from those anticipated by the forward-looking statements made herein
include the timing of product introductions, the ability of the sales force to grow revenues,
the impact of increased competition in various markets Synovis serves, the ability to
re-establish the Orthopedic and Wound products in the marketplace, outcomes of clinical and
marketing studies as well as regulatory submissions, the number of certain surgical procedures
performed, the ability to identify, acquire and successfully integrate suitable acquisition
candidates, any operational or financial impact from the current global economic downturn, the
impact of recently enacted healthcare reform legislation, as well as other factors found in the
Companys filings with the SEC, such as the Risk Factors section in Item 1A of our Annual
Report on Form 10-K for the fiscal year ended October 31, 2009 and our subsequent Quarterly
Reports on Form 10-Q.
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Dec. 1, 2010
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SYNOVIS LIFE TECHNOLOGIES, INC.
Consolidated Statements of Income (unaudited)
(In thousands, except per share data)
(In thousands, except per share data)
Three Months Ended | Twelve Months Ended | |||||||||||||||
October 31 | October 31 | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Net revenue |
$ | 18,116 | $ | 15,010 | $ | 68,565 | $ | 58,211 | ||||||||
Cost of revenue |
5,026 | 4,138 | 19,025 | 16,444 | ||||||||||||
Gross margin |
13,090 | 10,872 | 49,540 | 41,767 | ||||||||||||
Gross margin percentage |
72 | % | 72 | % | 72 | % | 72 | % | ||||||||
Selling, general and administrative expenses |
9,554 | 9,144 | 37,812 | 29,867 | ||||||||||||
Research and development expenses |
1,296 | 1,086 | 4,393 | 3,798 | ||||||||||||
Other |
| | | 4,100 | ||||||||||||
Operating expenses |
10,850 | 10,230 | 42,205 | 37,765 | ||||||||||||
Operating income |
2,240 | 642 | 7,335 | 4,002 | ||||||||||||
Interest income |
73 | 154 | 284 | 920 | ||||||||||||
Gain (loss) on sale of investments |
| 2,750 | | (1,350 | ) | |||||||||||
Other income (loss) |
73 | 2,904 | 284 | (430 | ) | |||||||||||
Income before provision for (benefit from)
income taxes |
2,313 | 3,546 | 7,619 | 3,572 | ||||||||||||
Provision for (benefit from) income taxes |
833 | (289 | ) | 2,743 | 866 | |||||||||||
Net income |
$ | 1,480 | $ | 3,835 | $ | 4,876 | $ | 2,706 | ||||||||
Basic earnings per share |
$ | 0.13 | $ | 0.33 | $ | 0.43 | $ | 0.23 | ||||||||
Diluted earnings per share |
$ | 0.13 | $ | 0.33 | $ | 0.43 | $ | 0.23 | ||||||||
Weighted average shares
outstanding basic |
11,284 | 11,550 | 11,262 | 11,588 | ||||||||||||
Weighted average shares
outstanding diluted |
11,449 | 11,754 | 11,441 | 11,827 |
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Dec. 1, 2010
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SYNOVIS LIFE TECHNOLOGIES, INC.
Consolidated Revenues (unaudited)
(In thousands)
(In thousands)
Three Months Ended | Twelve Months Ended | |||||||||||||||
October 31 | October 31 | |||||||||||||||
2010 | 2009 | 2010 | 2009 | |||||||||||||
Veritas |
$ | 3,661 | $ | 2,777 | $ | 14,368 | $ | 8,757 | ||||||||
Peri-Strips |
5,153 | 4,707 | 19,414 | 19,384 | ||||||||||||
Tissue-Guard |
4,221 | 3,920 | 16,550 | 15,806 | ||||||||||||
Microsurgery |
3,123 | 2,368 | 11,020 | 8,668 | ||||||||||||
Orthopedic & Wound |
685 | 65 | 1,878 | 65 | ||||||||||||
Surgical tools and other |
1,273 | 1,173 | 5,335 | 5,531 | ||||||||||||
Total Revenue |
$ | 18,116 | $ | 15,010 | $ | 68,565 | $ | 58,211 | ||||||||
Domestic |
$ | 15,247 | $ | 12,918 | $ | 57,700 | $ | 49,290 | ||||||||
International |
2,869 | 2,092 | 10,865 | 8,921 | ||||||||||||
Total Revenue |
$ | 18,116 | $ | 15,010 | $ | 68,565 | $ | 58,211 | ||||||||
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Dec. 1, 2010
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Dec. 1, 2010
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SYNOVIS LIFE TECHNOLOGIES, INC.
Consolidated Balance Sheets
As of October 31, 2010 (unaudited) and 2009
(In thousands, except share and per share data)
As of October 31, 2010 (unaudited) and 2009
(In thousands, except share and per share data)
October 31, | October 31, | |||||||
2010 | 2009 | |||||||
ASSETS |
||||||||
Current assets: |
||||||||
Cash and cash equivalents |
$ | 12,951 | $ | 15,863 | ||||
Short-term investments |
41,119 | 38,960 | ||||||
Accounts receivable, net |
8,701 | 6,925 | ||||||
Inventories |
9,433 | 7,724 | ||||||
Deferred income tax asset, net |
367 | 367 | ||||||
Other current assets |
1,715 | 1,755 | ||||||
Total current assets |
74,286 | 71,594 | ||||||
Investments, net |
7,854 | 5,926 | ||||||
Property, plant and equipment, net |
3,401 | 3,719 | ||||||
Goodwill |
3,620 | 3,618 | ||||||
Other intangible assets, net |
6,182 | 6,841 | ||||||
Deferred income tax asset, net |
2,139 | 2,022 | ||||||
Total assets |
$ | 97,482 | $ | 93,720 | ||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current liabilities: |
||||||||
Accounts payable |
$ | 1,644 | $ | 1,962 | ||||
Accrued expenses |
6,371 | 5,747 | ||||||
Total current liabilities |
8,015 | 7,709 | ||||||
Total liabilities |
8,015 | 7,709 | ||||||
Shareholders equity: |
||||||||
Preferred stock: authorized 5,000,000 shares of $.01
par value; none issued or outstanding at both dates |
| | ||||||
Common stock: authorized 20,000,000 shares of $.01
par value; issued and outstanding 11,228,654 and
11,398,874 at October 31, 2010 and 2009, respectively |
112 | 114 | ||||||
Additional paid-in capital |
61,780 | 63,132 | ||||||
Accumulated other comprehensive income |
26 | 92 | ||||||
Retained earnings |
27,549 | 22,673 | ||||||
Total shareholders equity |
89,467 | 86,011 | ||||||
Total liabilities and shareholders equity |
$ | 97,482 | $ | 93,720 | ||||
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Dec. 1, 2010
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SYNOVIS LIFE TECHNOLOGIES, INC.
Consolidated Statements of Cash Flows
(In thousands)
(In thousands)
For the fiscal years ended October 31, | 2010 | 2009 | ||||||
CASH FLOWS FROM OPERATING ACTIVITIES: |
||||||||
Net income |
$ | 4,876 | $ | 2,706 | ||||
Adjustments to reconcile net income to net cash
provided by operating activities: |
||||||||
Depreciation and amortization of property, plant and equipment |
1,228 | 1,017 | ||||||
Amortization of intangible assets |
782 | 539 | ||||||
Amortization of investment premium, net |
1,626 | 1,027 | ||||||
Loss on sale or disposal of manufacturing equipment |
192 | 25 | ||||||
Provision for uncollectible accounts |
204 | 149 | ||||||
Stock-based compensation |
1,455 | 937 | ||||||
Tax benefit from stock option exercises |
212 | 48 | ||||||
Acquired in-process research and development expense |
| 3,500 | ||||||
Loss on sale of investments |
| 1,350 | ||||||
Impairment of intangible assets |
| 600 | ||||||
Deferred income taxes |
(117 | ) | (2,206 | ) | ||||
Changes in operating assets and liabilities: |
||||||||
Accounts receivable |
(1,980 | ) | (953 | ) | ||||
Inventories |
(1,709 | ) | 62 | |||||
Other current assets |
40 | 677 | ||||||
Accounts payable |
(318 | ) | 637 | |||||
Accrued expenses |
624 | (321 | ) | |||||
Net cash provided by operating
activities |
7,115 | 9,794 | ||||||
CASH FLOWS FROM INVESTING ACTIVITIES: |
||||||||
Purchase of property, plant and equipment |
(1,102 | ) | (1,156 | ) | ||||
Investments in identifiable intangible assets |
(123 | ) | (105 | ) | ||||
Purchase of assets of Pegasus Biologics, Inc. |
| (12,319 | ) | |||||
Purchases of investments |
(79,397 | ) | (43,226 | ) | ||||
Redemptions of investments |
73,618 | 23,405 | ||||||
Decrease in restricted cash |
| 2,950 | ||||||
Other |
(2 | ) | (335 | ) | ||||
Net cash used in investing activities |
(7,006 | ) | (30,786 | ) | ||||
CASH FLOWS FROM FINANCING ACTIVITIES: |
||||||||
Net proceeds related to stock-based compensation plans |
1,996 | 823 | ||||||
Repurchase of the Companys common stock |
(5,101 | ) | (11,018 | ) | ||||
Excess tax benefit of stock option exercises |
84 | 155 | ||||||
Net cash used in financing activities |
(3,021 | ) | (10,040 | ) | ||||
Net change in cash and cash equivalents |
(2,912 | ) | (31,032 | ) | ||||
Cash and cash equivalents at beginning of year |
15,863 | 46,895 | ||||||
Cash and cash equivalents at end of year |
$ | 12,951 | $ | 15,863 | ||||
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SYNOVIS LIFE TECHNOLOGIES, INC.
Reconciliation of Non-GAAP Measures (unaudited)
(In thousands, except per share data)
Reconciliation of Non-GAAP Measures (unaudited)
(In thousands, except per share data)
The company believes adjusting GAAP basis results to exclude the impact of certain special
charges is helpful in analyzing its operating results. There were no special charges in the three
and twelve month periods ended October 31, 2010. A reconciliation of GAAP basis results as reported
to adjusted results (non-GAAP) for the three months ended October 31, 2009 follows:
Operating | Pre-tax | Net | ||||||||||||||
Income | Income | Income | EPS | |||||||||||||
GAAP Results |
$ | 642 | $ | 3,546 | $ | 3,835 | $ | 0.33 | ||||||||
Adjustments |
||||||||||||||||
Gain on sale of ARS |
| (2,750 | ) | (2,750 | ) | (0.24 | ) | |||||||||
Tax benefit on sale of ARS |
| | (477 | ) | (0.04 | ) | ||||||||||
Total Adjustments |
| (2,750 | ) | (3,227 | ) | (0.28 | ) | |||||||||
Adjusted Results (Non-GAAP) |
$ | 642 | $ | 796 | $ | 608 | $ | 0.05 | ||||||||
A reconciliation of GAAP basis results as reported to adjusted results (non-GAAP) for
the twelve months ended October 31, 2009 follows:
Operating | Pre-tax | Net | ||||||||||||||
Income | Income | Income | EPS | |||||||||||||
GAAP Results |
$ | 4,002 | $ | 3,572 | $ | 2,706 | $ | 0.23 | ||||||||
Adjustments |
||||||||||||||||
Loss on sale of ARS |
| 1,350 | 873 | 0.07 | ||||||||||||
Intangible asset impairment |
600 | 600 | 437 | 0.04 | ||||||||||||
In-process R&D expense |
3,500 | 3,500 | 2,548 | 0.22 | ||||||||||||
Total Adjustments |
4,100 | 5,450 | 3,858 | 0.33 | ||||||||||||
Adjusted Results (Non-GAAP) |
$ | 8,102 | $ | 9,022 | $ | 6,564 | $ | 0.56 | ||||||||
The non-GAAP financial measurements are provided to assist in understanding the impact of
certain items on Synovis actual results of operations. Management believes this will assist
investors in making an evaluation of Synovis performance on a comparable basis by adjusting for
these items. Management understands that there are material limitations on the use of non-GAAP
measures. Non-GAAP measures are not substitutes for GAAP measures for the purpose of analyzing
financial performance. These non-GAAP measures are not in accordance with, or an alternative for,
measures prepared in accordance with generally accepted accounting principles and may be different
from non-GAAP measures used by other companies. In addition, these non-GAAP measures are not based
on any comprehensive set of accounting rules or principles. This non-GAAP information should not be
construed as an
alternative to the reported results, which have been determined in accordance with accounting
principles generally accepted in the United States.
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