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
November
3, 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 |
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(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) 500-7000 |
(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 November 3, 2011, SurModics, Inc. (the “Company”) issued a press release announcing the results for the quarter and fiscal year ended September 30, 2011. 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. |
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Exhibit |
Description | |||
99.1 | Press Release dated November 3, 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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Date: | November 3, 2011 |
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/s/ Timothy J. Arens |
Timothy J. Arens |
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Vice President Finance and interim Chief |
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Financial Officer |
EXHIBIT INDEX
Exhibit | |
Number |
Description |
99.1 |
Press Release dated November 3, 2011 |
Exhibit 99.1
SurModics Reports Fourth Quarter and Fiscal Year 2011 Results
Sequential Revenue Growth in Core Businesses
Achieved 2011 Non-GAAP Guidance
EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--November 3, 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 fourth quarter and fiscal year ended September 30, 2011.
Fourth Quarter Summary:
Fiscal Year 2011 Summary:
“We are pleased with our fiscal 2011 performance as we have delivered performance consistent with our most recent non-GAAP guidance,” said Gary Maharaj, SurModics’ President and Chief Executive Officer. “We are already seeing benefits from our efforts to refocus on our core businesses. During the year, our Medical Device business delivered record hydrophilic royalty revenue and our In Vitro Diagnostics business generated record product revenue. Additionally, the recent sale of our Pharmaceuticals business allows us to increase our focus on growing our core business.”
Fourth Quarter Fiscal 2011:
Revenue for the fourth
quarter of fiscal 2011 was $17.2 million, down 5% compared with
$18.0 million in the third quarter, reflecting lower R&D revenue in our
Pharmaceuticals business partially offset by growth in our Medical
Device and In Vitro Diagnostics businesses.
An operating loss of $17.4 million in the fourth quarter compared with operating income of $3.4 million in the third quarter. The fourth quarter net loss was $12.9 million compared with net income of $3.8 million in the third quarter. Diluted earnings per share was a loss of ($0.74), compared with earnings per share of $0.22 in the third quarter of 2011.
Results for the fourth quarter of fiscal 2011 include a $17.9 million non-cash asset impairment charge associated with our Pharmaceuticals business and a $1.0 million restructuring charge associated with the August strategic realignment. On a non-GAAP basis, excluding these charges, adjusted diluted earnings per share was $0.06.
Fiscal 2011:
Fiscal 2011 revenue was $67.8 million,
compared with fiscal 2010 revenue of $69.9 million. Fiscal 2011 and
fiscal 2010 revenue included $6.7 million and $9.8 million,
respectively, of revenue associated with products that Cordis, a J&J
company, has indicated it will no longer manufacture by the end of
calendar year 2011.
The operating loss for fiscal 2011 was $17.5 million compared with an operating loss of $14.1 million in the prior year. The full-year net loss was $12.8 million compared with $21.1 million in fiscal 2010. Diluted net loss per share was ($0.73), compared with diluted net loss per share of ($1.21) last year.
On a non-GAAP basis, for fiscal 2011, excluding restructuring charges, goodwill and asset impairment charges and certain other adjustments, adjusted total revenue was $67.8 million and adjusted operating income was $8.0 million. Assuming a normalized effective tax rate of 38%, adjusted net income was $5.6 million, and adjusted diluted net income per share was $0.32.
SurModics’ cash and investment balance totaled $68.2 million as of September 30, 2011, with no debt. Operating cash flow for the fourth quarter was $4.9 million, compared with $5.3 million in the fourth quarter of fiscal 2010. For fiscal year 2011, operating cash flow was $20.0 million, compared with $22.0 million in fiscal year 2010.
“While we have faced a number of challenges and undergone important changes over the past twelve months, we are proud of our entire team for committing to our new vision, executing successfully against our strategic objectives , and in turn, achieving our financial targets in fiscal 2011,” added Maharaj. “Looking ahead, we are excited about the opportunities provided by our two core businesses as well as our new approach to our R&D portfolio, which remains a critical component for driving growth at SurModics. We believe the newly focused and highly efficient structure of our Company will, over the long term, drive sustainable, double digit organic sales growth and profitable earnings growth.”
Outlook
SurModics’ estimates are based on actual
results for 2011, management’s current belief about business trends, the
impact of the Cordis Cypher decision and general economic uncertainties.
Our outlook from continuing operations on a GAAP basis excludes any
revenue associated with Cypher and the Pharmaceuticals business. As a
reminder we will report our fiscal 2012 Pharmaceuticals results as
discontinued operations. For the full year, SurModics expects GAAP
revenue from continuing operations to be in the range of $47 to $51
million and diluted GAAP EPS from continuing operations to be in the
range of $0.45 to $0.53 per share.
Live Webcast
SurModics will host a webcast at 5:00 p.m.
ET (4:00 p.m. CT) today to discuss the quarterly and full year 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 fourth quarter conference call will be
available by dialing 800-406-7325 and entering conference call ID
4485778. The audio replay will be available beginning at 7:00 p.m. CT on
Thursday, November 3, until 7:00 p.m. CT on Thursday, November 10.
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 regarding our ability to return to sustainable, long-term
profitability, 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 timely satisfy the closing
conditions in our asset purchase agreement with Evonik Industries AG
relative to the sale of our Pharmaceuticals business; (2) 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 (3)
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 operating income,
non-GAAP net income and non-GAAP diluted net income per share. We
believe that these non-GAAP measures provide meaningful insight into our
operating performance excluding certain event-specific charges, 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 and
facilitates comparisons of our current results of operations. 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 |
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Condensed Consolidated Statements of Operations |
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(in thousands, except per share data) |
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Three Months Ended September 30, |
Year Ended September 30, |
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2011 | 2010 | 2011 | 2010 | |||||||||||||
(Unaudited) | (Unaudited) | |||||||||||||||
Revenue | ||||||||||||||||
Royalties and license fees | $ | 7,796 | $ | 7,944 | $ | 30,583 | $ | 34,277 | ||||||||
Product sales | 6,516 | 4,598 | 22,965 | 20,184 | ||||||||||||
Research and development | 2,840 | 3,007 | 14,233 | 15,437 | ||||||||||||
Total revenue | 17,152 | 15,549 | 67,781 | 69,898 | ||||||||||||
Operating costs and expenses | ||||||||||||||||
Product costs | 2,502 | 2,605 | 8,315 | 9,425 | ||||||||||||
Customer research and development | 4,271 | 5,399 | 18,412 | 18,147 | ||||||||||||
Other research and development | 3,321 | 4,409 | 12,244 | 17,916 | ||||||||||||
Selling, general and administrative | 5,547 | 4,784 | 20,545 | 18,451 | ||||||||||||
Asset impairment charges | 17,890 | 2,631 | 17,890 | 4,896 | ||||||||||||
Restructuring charges | 1,007 | — | 2,243 | 1,306 | ||||||||||||
Goodwill impairment charge | — | 13,810 | 5,650 | 13,810 | ||||||||||||
Total operating expenses | 34,538 | 33,638 | 85,299 | 83,951 | ||||||||||||
Loss from operations | (17,386 | ) | (18,089 | ) | (17,518 | ) | (14,053 | ) | ||||||||
Other income (loss) | ||||||||||||||||
Investment income | 127 | 217 | 1,026 | 1,337 | ||||||||||||
Impairment loss on investments | — | (5,366 | ) | — | (7,943 | ) | ||||||||||
Other income (loss) | 127 | (5,149 | ) | 1,026 | (6,606 | ) | ||||||||||
Loss before income taxes | (17,259 | ) | (23,238 | ) | (16,492 | ) | (20,659 | ) | ||||||||
Income tax benefit (provision) | 4,322 | 1,575 | 3,714 | (430 | ) | |||||||||||
Net loss | $ | (12,937 | ) | $ | (21,663 | ) | $ | (12,778 | ) | $ | (21,089 | ) | ||||
Basic net loss per share | $ | (0.74 | ) | $ | (1.25 | ) | $ | (0.73 | ) | $ | (1.21 | ) | ||||
Diluted net loss per share | $ | (0.74 | ) | $ | (1.25 | ) | $ | (0.73 | ) | $ | (1.21 | ) | ||||
Weighted average shares outstanding | ||||||||||||||||
Basic | 17,449 | 17,374 | 17,419 | 17,372 | ||||||||||||
Diluted | 17,449 | 17,374 | 17,419 | 17,372 | ||||||||||||
SurModics, Inc. and Subsidiaries |
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Condensed Consolidated Balance Sheets |
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(in thousands) |
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September 30, 2011 |
September 30, 2010 |
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(Unaudited) | ||||||
Assets | ||||||
Current assets | ||||||
Cash and short-term investments | $ | 38,443 | $ | 20,496 | ||
Accounts receivable | 7,694 | 8,987 | ||||
Inventories | 4,150 | 3,047 | ||||
Other current assets | 3,477 | 4,948 | ||||
Total current assets | 53,764 | 37,478 | ||||
Property and equipment, net | 47,926 | 65,395 | ||||
Long-term investments | 29,753 | 36,290 | ||||
Intangibles, net | 10,629 | 15,257 | ||||
Goodwill | 8,010 | 8,010 | ||||
Other assets | 12,572 | 7,849 | ||||
Total assets | $ | 162,654 | $ | 170,279 | ||
Liabilities and Stockholders’ Equity | ||||||
Current liabilities | $ | 11,040 | $ | 7,647 | ||
Other liabilities | 6,278 | 8,273 | ||||
Total stockholders’ equity | 145,336 | 154,359 | ||||
Total liabilities and stockholders’ equity | $ | 162,654 | $ | 170,279 | ||
SurModics, Inc. and Subsidiaries |
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Condensed Consolidated Statements of Cash Flows |
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(in thousands) |
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Year Ended September 30, |
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2011 | 2010 | |||||||
(Unaudited) | ||||||||
Operating Activities: | ||||||||
Net loss | $ | (12,778 | ) | $ | (21,089 | ) | ||
Depreciation and amortization | 7,145 | 7,818 | ||||||
Stock-based compensation | 4,252 | 5,875 | ||||||
Goodwill impairment charge | 5,650 | 13,810 | ||||||
Asset impairment charges | 17,890 | 4,896 | ||||||
Impairment loss on investments | — | 7,943 | ||||||
Deferred taxes | (5,892 | ) | 446 | |||||
Net other operating activities | (132 | ) | 328 | |||||
Change in operating assets and liabilities | ||||||||
Accounts receivable | 1,293 | 2,333 | ||||||
Accounts payable and accrued liabilities | 1,949 | 1,135 | ||||||
Income taxes | 1,168 | (4,121 | ) | |||||
Deferred revenue | 37 | 2,632 | ||||||
Net change in other operating assets and liabilities | (627 | ) | 2 | |||||
Net cash provided by operating activities | 19,955 | 22,008 | ||||||
Investing Activities: | ||||||||
Net purchases of property and equipment | (3,459 | ) | (9,679 | ) | ||||
Payments related to prior business acquisitions | (5,650 | ) | (750 | ) | ||||
Net other investing activities | 438 | (9,643 | ) | |||||
Net cash used in investing activities | (8,671 | ) | (20,072 | ) | ||||
Financing Activities: | ||||||||
Issuance of common stock | 574 | 892 | ||||||
Purchase of common stock to fund employee taxes | (40 | ) | (545 | ) | ||||
Repurchase of common stock | — | (2,032 | ) | |||||
Net other financing activities | 8 | (496 | ) | |||||
Net cash provided by (used in) financing activities | 542 | (2,181 | ) | |||||
Net change in cash and cash equivalents | 11,826 | (245 | ) | |||||
Cash and cash equivalents | ||||||||
Beginning of period | 11,391 | 11,636 | ||||||
End of period | $ | 23,217 | $ | 11,391 | ||||
SurModics, Inc. and Subsidiaries |
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Supplemental Non-GAAP Information for the |
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Three Months Ended September 30, 2011 |
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(in thousands, except per share data) |
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(Unaudited) |
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As Reported |
Adjustments |
Adjusted |
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Revenue | |||||||||||
Royalties and license fees | $ | 7,796 |
$ |
(49 |
)3 |
$ | 7,747 | ||||
Product sales | 6,516 | 6,516 | |||||||||
Research and development | 2,840 | 2,840 | |||||||||
Total revenue | $ | 17,152 | $ |
(49 |
) |
$ | 17,103 | ||||
(Loss) income from operations | $ | (17,386 | ) |
$ |
18,848 |
4 |
$ | 1,462 | |||
Net (loss) income | $ | (12,937 | ) |
$ |
13,922 |
5 |
$ | 985 | |||
Diluted net (loss) income per share6 |
$ | (0.74 | ) | $ | 0.06 | ||||||
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 restructuring charges of $1,007, asset impairment charges of $17,890 and amortization of deferred revenue recognized in the period under GAAP associated with long-term agreements. | |
5 |
Reflects the after tax impact of the adjustments. The Company’s adjusted non-GAAP effective tax rate for the period was 38.0%. | |
6 |
Diluted net (loss) income per share is calculated using the diluted weighted average shares outstanding for the period presented. | |
SurModics, Inc. and Subsidiaries |
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Supplemental Non-GAAP Information for the |
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Year Ended September 30, 2011 |
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(in thousands, except per share data) |
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(Unaudited) |
|||||||||||
As Reported |
Adjustments |
Adjusted |
|||||||||
Revenue | |||||||||||
Royalties and license fees | $ | 30,583 |
$ |
54 |
3 |
$ | 30,637 | ||||
Product sales | 22,965 | 22,965 | |||||||||
Research and development | 14,233 | 14,233 | |||||||||
Total revenue | $ | 67,781 | $ | 54 | $ | 67,835 | |||||
(Loss) income from operations | $ | (17,518 | ) |
$ |
25,510 |
4 |
$ | 7,992 | |||
Net (loss) income | $ | (12,778 | ) |
$ |
18,369 |
5 |
$ | 5,591 | |||
Diluted net (loss) income per share6 |
$ | (0.73 | ) | $ | 0.32 | ||||||
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 and amounts billed and deferred in the period associated with long-term agreements. | |
4 |
Reflects restructuring charges of $2,243, goodwill impairment charges of $5,650, asset impairment charges of $17,890, government grant income associated with qualifying therapeutic discovery projects of $827, expenses of $500 for certain non-recurring advisory services related to our 2011 Annual Meeting of Shareholders, amortization of deferred revenue recognized in the period under GAAP associated with long-term agreements, and amounts billed and deferred in the period associated with long-term agreements. | |
5 |
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 charges of $5,650 did not generate a tax benefit. | |
6 |
Diluted net (loss) income per share is calculated using the diluted weighted average shares outstanding for the period presented. |
SurModics, Inc. and Subsidiaries |
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Supplemental Segment Information |
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(in thousands) |
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(Unaudited) |
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Three Months Ended September 30, | |||||||||||||||
2011 | 2010 | % Change | |||||||||||||
Revenue | % of Total | % of Total | |||||||||||||
Medical Device | $ | 10,234 | 59.7 | % | $ | 9,827 | 63.2 | % | 4.1 | % | |||||
Pharmaceuticals | 3,251 | 18.9 | 2,847 |
18.3 |
14.2 | ||||||||||
In Vitro Diagnostics | 3,667 | 21.4 | 2,875 |
18.5 |
27.5 |
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Total revenue | $ | 17,152 | 100.0 | % | $ | 15,549 | 100.0 | % | 10.3 | % | |||||
Year Ended September 30, | |||||||||||||||
2011 | 2010 | % Change | |||||||||||||
Revenue | % of Total | % of Total | |||||||||||||
Medical Device | $ | 39,576 | 58.4 | % | $ | 43,211 | 61.8 | % | -8.4 | % | |||||
Pharmaceuticals | 15,055 | 22.2 | 15,493 | 22.2 | -2.8 | ||||||||||
In Vitro Diagnostics | 13,150 | 19.4 | 11,194 | 16.0 | 17.5 | ||||||||||
Total revenue | $ | 67,781 | 100.0 | % | $ | 69,898 | 100.0 | % | -3.0 | % | |||||
Three Months Ended September 30, |
Year Ended September 30, |
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2011 | 2010 | 2011 | 2010 | |||||||||||||
Operating Loss | ||||||||||||||||
Medical Device | $ | 4,962 | $ | 3,725 | $ | 19,847 | $ | 19,524 | ||||||||
Pharmaceuticals | (20,406 | ) | (18,293 | ) | (32,522 | ) | (26,479 | ) | ||||||||
In Vitro Diagnostics | 952 | 732 | 4,275 | 3,304 | ||||||||||||
Corporate | (2,894 | ) | (4,253 | ) | (9,118 | ) | (10,402 | ) | ||||||||
Total operating loss |
$ | (17,386 | ) | $ | (18,089 | ) | $ | (17,518 | ) | $ | (14,053 | ) |
CONTACT:
SurModics, Inc.
Tim Arens, 952-500-7000
Vice President
of Finance and interim Chief Financial Officer