SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
PURSUANT
TO SECTION 13 OR 15(d) OF THE
SECURITIES
EXCHANGE ACT OF 1934
January
26, 2011 |
Date of report (Date of earliest event reported) |
SurModics, Inc. |
(Exact Name of Registrant as Specified in its Charter) |
Minnesota |
0-23837 |
41-1356149 |
||
(State of Incorporation)
|
(Commission File Number)
|
(I.R.S. Employer Identification No.) |
9924 West 74th Street Eden Prairie, Minnesota |
55344 |
|
(Address of Principal Executive Offices) | (Zip Code) |
(952) 829-2700 |
(Registrant’s Telephone Number, Including Area Code) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2):
⃞ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
⃞ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
⃞ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
⃞ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 2.02. Results of Operations And Financial Condition.
On January 26, 2011, SurModics, Inc., issued a press release announcing the results for the quarter ended December 31, 2010. A copy of the full text of the press release is furnished as Exhibit 99.1 to this report.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
Exhibit |
Description | ||
99.1 | Press Release dated January 26, 2011. |
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 hereunto duly authorized.
SURMODICS, INC. |
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|
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Date: | January 26, 2011 |
|
/s/ Philip D. Ankeny |
Philip D. Ankeny |
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Sr. Vice President and Chief Financial Officer |
EXHIBIT INDEX
Exhibit | |
Number |
Description |
99.1 |
Press Release dated January 26, 2011 |
Exhibit 99.1
SurModics Reports First Quarter 2011 Results
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--January 26, 2011--SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, today reported financial results for the first quarter ended December 31, 2010.
First Quarter Summary:
**Non-GAAP results exclude restructuring and goodwill impairment charges, expenses for certain non-recurring advisory services related to our 2011 Annual Meeting of Shareholders, and an R&D expense benefit from therapeutic tax credits, and include up-front license fees which are amortized under GAAP.
“SurModics is at an important crossroads, and I am excited to be leading this organization and our talented team at such a critical time,” said Gary Maharaj, SurModics' president and chief executive officer. “By refocusing our efforts within a well-defined core, we have an opportunity to build upon our strengths to create sustainable, long-term growth and shareholder value. During the coming months, I will be working diligently with the management team and the Board to develop our strategic plan, and I look forward to sharing more details as they emerge.”
Revenue for the first quarter of fiscal 2011 was $15.2 million, down 2% sequentially compared with $15.5 million in the fourth quarter of fiscal 2010. Operating loss was $0.7 million, compared with an operating loss of $18.1 million in the fourth quarter. Net loss was $0.4 million, compared with a net loss of $21.7 million in the fourth quarter. Diluted earnings per share was a loss of ($0.02), compared with a loss of ($1.25) in the fourth quarter of fiscal 2010. Results for the first quarter of fiscal 2011 included restructuring charges of $1.2 million related to our reorganization announced in October 2010, and a goodwill impairment charge of $0.8 million triggered by an additional milestone payment in connection with the 2007 acquisition of SurModics Pharmaceuticals. First quarter results also included approximately $0.5 million in expenses for certain non-recurring advisory services, and an R&D expense benefit of $0.8 million from therapeutic tax credits. On a non-GAAP basis, excluding these items, and including up-front license fees which are amortized under GAAP: adjusted revenue was $15.4 million, adjusted operating income was $1.1 million, adjusted net income was $0.8 million, and adjusted diluted earnings per share was $0.05.
SurModics’ cash and investment balance totaled $59.7 million as of December 31, 2010, with no debt. Operating cash flow for the first quarter was $5.3 million, compared with $8.3 million in the first quarter of fiscal 2010.
“Based on the continued strength of our balance sheet and positive operating cash flow, we are well-positioned to pursue growth opportunities for our Company,” commented Phil Ankeny, senior vice president and chief financial officer. “We remain committed to actively utilizing our balance sheet and financial flexibility to find the most effective means of deploying capital to create long-term shareholder value, including potential corporate development transactions, share repurchases, and targeted investments in the business.”
Outlook
The Company reiterates its previously
communicated expectations for fiscal year 2011, to generate revenue in a
range of $55 to $63 million and non-GAAP diluted EPS of ($0.15) to
$0.05. Non-GAAP diluted EPS would exclude any non-recurring or
event-specific charges, such as restructuring charges, asset impairment
charges, acquisition-related charges, and the like. In the first quarter
of fiscal 2011, the Company recorded restructuring charges of $1.2
million and a goodwill impairment charge of $0.8 million triggered by an
additional milestone payment in connection with the 2007 acquisition of
SurModics Pharmaceuticals. In addition, the Company is likely to incur
an additional milestone payment obligation related to the acquisition of
SurModics Pharmaceuticals. Based on this assumption, the Company expects
to record an additional goodwill impairment charge of approximately $4.9
million later in fiscal 2011. The negative impact of these charges to
GAAP diluted EPS for fiscal 2011 is estimated to be approximately
($0.38) per share. Accordingly, GAAP diluted EPS for fiscal 2011 is
expected to be in a range of ($0.53) to ($0.33).
Live Webcast
SurModics will host a webcast at 5:00 p.m.
ET (4:00 p.m. CT) today to discuss the quarterly results. To access the
webcast, go to the investor relations portion of the Company’s website
at www.surmodics.com, and click on the webcast icon. A replay of
the first quarter conference call will be available by dialing
800-406-7325 and entering conference call ID 4401538. The audio replay
will be available beginning at 7:00 p.m. CT on Wednesday, January 26,
until 7:00 p.m. CT on Wednesday, February 2.
About SurModics, Inc.
SurModics’ vision is to
extend and improve the lives of patients through technology innovation.
The Company partners with the world’s foremost medical device,
pharmaceutical and life science companies to develop and commercialize
innovative products that result in improved diagnosis and treatment for
patients. Core offerings include: drug delivery technologies (coatings,
microparticles, nanoparticles, and implants); surface modification
coating technologies that impart lubricity, prohealing, and
biocompatibility capabilities; and components for in vitro diagnostic
test kits and specialized surfaces for cell culture and microarrays.
SurModics is headquartered in Eden Prairie, Minnesota and its SurModics
Pharmaceuticals subsidiary is located in Birmingham, Alabama. For more
information about the Company, visit www.surmodics.com. The
content of SurModics’ website is not part of this release or part of any
filings the Company makes with the SEC.
Safe Harbor for Forward-Looking Statements
This press
release contains forward-looking statements. Statements that are not
historical or current facts, including statements about beliefs and
expectations, such as the Company’s ability to successfully consummate a
transaction, including the potential sale, of its pharmaceuticals
business, and our performance in the near- and long-term, including our
positioning for profitable growth, are forward-looking statements.
Forward-looking statements involve inherent risks and uncertainties, and
important factors could cause actual results to differ materially from
those anticipated, including (1) our ability to successfully identify,
negotiate, sign and close a potential strategic transaction related to
our Pharmaceuticals business; (2) the inability to realize the
anticipated benefits of any potential transaction regarding our
Pharmaceuticals business, if consummated, or of our other recent cost
savings initiatives; (3) the potential adverse impact to our business as
a result of our announcement to pursue strategic alternatives for our
Pharmaceuticals business; (4) developments in the regulatory
environment, as well as market and economic conditions, may adversely
affect our business operations and profitability; (5) our reliance on
third parties (including our customers and licensees) and their failure
to successfully develop, obtain regulatory approval for, market and sell
products incorporating our technologies may adversely affect our
business operations, our ability to realize the full potential of our
pipeline, and our ability to achieve our corporate goals; and (6) the
factors identified under "Risk Factors" in Part I, Item 1A of our Annual
Report on Form 10-K for the fiscal year ended September 30, 2010, and
updated in our subsequent reports filed with the SEC. These reports are
available in the Investors section of our website at www.surmodics.com
and at the SEC website at www.sec.gov. Forward-looking statements
speak only as of the date they are made, and we undertake no obligation
to update them in light of new information or future events.
Use of Non-GAAP Financial Information
In addition to
reporting financial results in accordance with generally accepted
accounting principles, or GAAP, SurModics is reporting non-GAAP
financial results including non-GAAP revenue, non-GAAP net income (loss)
and non-GAAP diluted net income (loss) per share. We believe that these
non-GAAP measures provide meaningful insight into our operating
performance excluding certain event-specific charges and as it relates
to our accounting treatment for contracts with significant deferred
revenue, such as our agreement with Genentech, and provide an
alternative perspective of our results of operations. We use non-GAAP
measures, including those set forth in this release, to assess our
operating performance and to determine payout under our executive
compensation programs. We believe that presentation of certain non-GAAP
measures allows investors to review our results of operations from the
same perspective as management and our board of directors. We believe
certain non-GAAP measures facilitate investors' analysis and comparisons
of our current results of operations and provide insight into the
prospects of our future performance. We also believe that certain
non-GAAP measures are useful to investors because they provide
supplemental information that research analysts frequently use. The
method we use to produce non-GAAP results is not in accordance with GAAP
and may differ from the methods used by other companies. Non-GAAP
results should not be regarded as a substitute for corresponding GAAP
measures but instead should be utilized as a supplemental measure of
operating performance in evaluating our business. Non-GAAP measures do
have limitations in that they do not reflect certain items that may have
a material impact upon our reported financial results. As such, these
non-GAAP measures presented should be viewed in conjunction with both
our financial statements prepared in accordance with GAAP and the
reconciliation of the supplemental non-GAAP financial measures to the
comparable GAAP results provided for the specific periods presented,
which are attached to this release.
SurModics, Inc. and Subsidiaries | ||||||||
Condensed Consolidated Statements of Operations | ||||||||
(In thousands, except per share data) |
||||||||
Three Months Ended | ||||||||
December 31, | ||||||||
2010 | 2009 | |||||||
(Unaudited) | ||||||||
Revenue | ||||||||
Royalties and license fees | $7,566 | $9,198 | ||||||
Product sales | 4,792 | 4,548 | ||||||
Research and development | 2,810 | 3,635 | ||||||
Total revenue | 15,168 | 17,381 | ||||||
Operating expenses | ||||||||
Product | 1,825 | 1,957 | ||||||
Customer research and development | 4,731 | 3,323 | ||||||
Other research and development | 2,132 | 4,719 | ||||||
Selling, general and administrative | 5,214 | 4,614 | ||||||
Restructuring charges | 1,236 | ― | ||||||
Goodwill impairment charge | 750 | ― | ||||||
Total operating expenses | 15,888 | 14,613 | ||||||
(Loss) income from operations | (720 | ) | 2,768 | |||||
Investment income | 221 | 297 | ||||||
(Loss) income before income taxes | (499 | ) | 3,065 | |||||
Income tax benefit (provision) | 122 | (1,148 | ) | |||||
Net (loss) income | $(377 | ) | $1,917 | |||||
Basic net (loss) income per share | $(0.02 | ) | $0.11 | |||||
Diluted net (loss) income per share | $(0.02 | ) | $0.11 | |||||
Weighted average shares outstanding | ||||||||
Basic | 17,383 | 17,396 | ||||||
Diluted | 17,383 | 17,440 |
SurModics, Inc. and Subsidiaries | ||||||
Condensed Consolidated Balance Sheets | ||||||
(In thousands) |
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December 31, | September 30, | |||||
2010 | 2010 | |||||
Assets |
(Unaudited) | |||||
Current assets: | ||||||
Cash and short-term | ||||||
investments | $24,458 | $20,496 | ||||
Accounts receivable | 8,764 | 8,987 | ||||
Inventories | 3,111 | 3,047 | ||||
Other current assets | 4,340 | 4,948 | ||||
Total current assets | 40,673 | 37,478 | ||||
Property and equipment, net | 65,043 | 65,395 | ||||
Long-term investments | 35,247 | 36,290 | ||||
Other assets | 31,370 | 31,116 | ||||
Total assets | $172,333 | $170,279 | ||||
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Liabilities and Stockholders’ Equity |
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Current liabilities | $9,136 | $7,647 | ||||
Other liabilities | 8,429 | 8,273 | ||||
Total stockholders’ equity | 154,768 | 154,359 | ||||
Total liabilities and stockholders’ equity | $172,333 | $170,279 |
SurModics, Inc. and Subsidiaries | ||||||||
Condensed Consolidated Statements of Cash Flows | ||||||||
(In thousands) |
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Three Months Ended | ||||||||
December 31, | ||||||||
2010 | 2009 | |||||||
(Unaudited) | ||||||||
Operating Activities | ||||||||
Net (loss) income | $(377 | ) | $1,917 | |||||
Depreciation and amortization | 1,792 | 1,745 | ||||||
Stock-based compensation | 974 | 1,535 | ||||||
Goodwill impairment charge | 750 | ― | ||||||
Net other operating activities | (988 | ) | 2,912 | |||||
Change in operating assets and liabilities: | ||||||||
Accounts receivable | 223 | (341 | ) | |||||
Accounts payable and accrued liabilities | 428 | (263 | ) | |||||
Income taxes | 1,056 | (2,501 | ) | |||||
Deferred revenue | 1,406 | 3,370 | ||||||
Net change in other operating assets and liabilities | 11 | (124 | ) | |||||
Net cash provided by operating activities | 5,275 | 8,250 | ||||||
Investing Activities | ||||||||
Net purchases of property and equipment | (1,393 | ) | (3,572 | ) | ||||
Business acquisitions, net of cash acquired | (750 | ) | (750 | ) | ||||
Net other investing activities | (212 | ) | (4,314 | ) | ||||
Net cash used in investing activities | (2,355 | ) | (8,636 | ) | ||||
Financing Activities | ||||||||
Issuance of common stock | ― | 282 | ||||||
Purchase of common stock to fund employee taxes | ― | (365 | ) | |||||
Net other financing activities | (2 | ) | (38 | ) | ||||
Net cash used in financing activities | (2 | ) | (121 | ) | ||||
Net change in cash and cash equivalents | 2,918 | (507 | ) | |||||
Cash and Cash Equivalents | ||||||||
Beginning of period | 11,391 | 11,636 | ||||||
End of period | $14,309 | $11,129 |
SurModics, Inc. and Subsidiaries | ||||||||||||||||||||||||
Supplemental Non-GAAP Information | ||||||||||||||||||||||||
For the Three Months Ended December 31, 2010 | ||||||||||||||||||||||||
(In thousands, except per share data) |
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(Unaudited) |
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Long-term Agreement | ||||||||||||||||||||||||
Adjustments | ||||||||||||||||||||||||
As | Adjusted | |||||||||||||||||||||||
Reported | Revenue | Billed | Other | Non-GAAP | ||||||||||||||||||||
GAAP (1) | Recognized | Activity | Adjustments | (2) | ||||||||||||||||||||
Revenue: | ||||||||||||||||||||||||
Royalties and license fees | $7,566 | $(49 | ) | (3) | $250 | (4) | $7,767 | |||||||||||||||||
Product sales | 4,792 | 4,792 | ||||||||||||||||||||||
Research and development | 2,810 | 2,810 | ||||||||||||||||||||||
Total revenue | $15,168 | $(49 | ) | $250 | $15,369 | |||||||||||||||||||
(Loss) income from operations | $(720 | ) | $(49 | ) | $250 | $ | 1,659 | (5) | $1,140 | |||||||||||||||
$(377 | ) | $(30 | ) | $155 | $844 | |||||||||||||||||||
Net (loss) income | (6) | (6) | $ | 1,096 | (6) | |||||||||||||||||||
Diluted net (loss) income per share (7) | $(0.02 | ) | $0.05 | |||||||||||||||||||||
Balance at | Balance at | |||||||||||||||||||||||
September | Revenue | Billed | December | |||||||||||||||||||||
30, 2010 | Recognized | Activity | 31, 2010 | |||||||||||||||||||||
Deferred revenue (8) | $3,516 | $(49 | ) | $250 | ||||||||||||||||||||
$3,717 | ||||||||||||||||||||||||
(1) Reflects operating results in accordance with U.S. generally accepted accounting principles (GAAP). | ||||||||||||||||||||||||
(2) Adjusted Non-GAAP amounts consider adjustments in the period associated with up-front license fees received under certain of our customer agreements (including our agreement with Genentech) (long-term agreements), and certain other non-recurring or event-specific items recognized in the period in accordance with GAAP. | ||||||||||||||||||||||||
(3) Reflects amortization of deferred revenue recognized in the period under GAAP associated with long-term agreements. | ||||||||||||||||||||||||
(4) Reflects amounts billed and deferred in the period associated with long-term agreements. | ||||||||||||||||||||||||
(5) Reflects restructuring charges of $1,236, goodwill impairment charge of $750, government grant income associated with qualifying therapeutic discovery projects of $827, and expenses of $500 for certain non-recurring advisory services related to our 2011 Annual Meeting of Shareholders. | ||||||||||||||||||||||||
(6) Reflects the after tax impact of the adjustments. The Company’s adjusted non-GAAP effective tax rate for the period was 38.0%. The goodwill impairment charge of $750 did not generate a tax benefit. | ||||||||||||||||||||||||
(7) Diluted net (loss) income per share is calculated using the diluted weighted average shares outstanding for the period presented. | ||||||||||||||||||||||||
(8) Reflects the activity for the period presented in the deferred revenue balance sheet accounts associated with long-term agreements. |
SurModics, Inc. and Subsidiaries | |||||||||||||||||||||||
Supplemental Non-GAAP Information | |||||||||||||||||||||||
For the Three Months Ended September 30, 2010 | |||||||||||||||||||||||
(In thousands, except per share data) |
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(Unaudited) |
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Long-term Agreement | |||||||||||||||||||||||
Adjustments | |||||||||||||||||||||||
As | |||||||||||||||||||||||
Reported | Revenue | Billed | Other | Adjusted | |||||||||||||||||||
GAAP (1) | Recognized | Activity | Adjustments | Non-GAAP (2) | |||||||||||||||||||
Revenue: | |||||||||||||||||||||||
Royalties and license fees | $7,944 | $(47 | ) | (3) | $-- | (4) | $7,897 | ||||||||||||||||
Product sales | 4,598 | 4,598 | |||||||||||||||||||||
Research and development | 3,007 | 3,007 | |||||||||||||||||||||
Total revenue | $15,549 | $(47 | ) | $-- | $15,502 | ||||||||||||||||||
Loss from operations | $(18,089 | ) | $(47 | ) | $-- | $16,441 | (5) | $(1,695 | ) | ||||||||||||||
$(21,663 | ) | $(29 | ) | $-- | $(905 | ) | |||||||||||||||||
Net loss | (6) | (6) | $20,787 | (6) | |||||||||||||||||||
Diluted net loss per share (7) | $(1.25 | ) | $(0.05 | ) | |||||||||||||||||||
Balance at | Balance at | ||||||||||||||||||||||
June 30, | Revenue | Billed | September 30, | ||||||||||||||||||||
2010 | Recognized | Activity | 2010 | ||||||||||||||||||||
Deferred revenue (8) | $3,563 | $(47 | ) | $-- | |||||||||||||||||||
$3,516 | |||||||||||||||||||||||
(1) Reflects operating results in accordance with U.S. generally accepted accounting principles (GAAP). | |||||||||||||||||||||||
(2) Adjusted Non-GAAP amounts consider adjustments in the period associated with up-front license fees received under certain of our customer agreements (including our agreement with Genentech) (long-term agreements), and certain other non-recurring or event-specific items recognized in the period in accordance with GAAP. | |||||||||||||||||||||||
(3) Reflects amortization of deferred revenue recognized in the period under GAAP associated with long-term agreements. | |||||||||||||||||||||||
(4) Reflects amounts billed and deferred in the period associated with long-term agreements. | |||||||||||||||||||||||
(5) Reflects asset impairment charges of $2,631, and a goodwill impairment charge of $13,810. | |||||||||||||||||||||||
(6) Reflects the after tax impact of the adjustments. The “Other Adjustments” column includes an impairment loss on investments of $5,366. The Company’s adjusted non-GAAP effective tax rate for the period was 38.8%. The goodwill impairment charge of $13,810 and the impairment loss on investments of $5,366 did not generate a tax benefit. | |||||||||||||||||||||||
(7) Diluted net loss per share is calculated using the diluted weighted average shares outstanding for the period presented. | |||||||||||||||||||||||
(8) Reflects the activity for the period presented in the deferred revenue balance sheet accounts associated with long-term agreements. |
CONTACT:
SurModics, Inc.
Phil Ankeny, 952-829-2700
Senior Vice
President and Chief Financial Officer