e8vk
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
Date of Report (Date of earliest event reported): January 25, 2006
SurModics, Inc.
(Exact name of Registrant as Specified in its Charter)
Minnesota
(State or Other Jurisdiction of Incorporation)
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0-23837
(Commission File Number)
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41-1356149
(IRS Employer
Identification No.) |
9924 West 74th Street
Eden Prairie, Minnesota 55344
(Address of Principal Executive Offices and Zip Code)
(952) 829-2700
(Registrants telephone number, including area code)
Not Applicable
(Former Name or Former Address, if Changed Since Last Report)
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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 25, 2006, SurModics, Inc. issued a press release announcing the results for its
fiscal quarter ended December 31, 2005. The 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.
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Financial Statements: None. |
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Pro forma financial information: None |
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Exhibits: 99.1 Press Release dated January 25, 2006. |
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.
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SURMODICS, INC. |
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By
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/s/ Philip D. Ankeny |
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Date: January 25, 2006
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Name:
Title:
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Philip D. Ankeny
Chief Financial Officer |
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
EXHIBIT INDEX
to
FORM 8-K
SURMODICS, INC.
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Date of Report:
January 25, 2006
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Commission File No.:
0-23837 |
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Exhibit No. |
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99.1
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Press Release dated January 25, 2006. |
exv99w1
Exhibit 99.1
SurModics
Reports First Quarter 2006 Results
Sixth Consecutive Quarter of Record Non-GAAP Net Income
EDEN PRAIRIE, Minnesota January 25, 2006 SurModics, Inc. (Nasdaq: SRDX), a leading
provider of surface modification and drug delivery technologies to the healthcare industry, today
reported financial results for the first quarter ended December 31, 2005.
First Quarter Highlights:
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Revenue of $16.5 million, up 17% year-over-year |
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R&D revenue of $1.8 million, up 62% sequentially |
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GAAP results: |
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Operating income of $8.6 million |
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Net income of $6.2 million |
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Diluted EPS of $0.33 |
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Record operating income of $9.7 million |
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Record net income of $6.6 million |
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Record diluted EPS of $0.35 |
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Four new licenses signed, including one with Conor Medsystems for the hydrophilic coating on their next
generation drug eluting stent delivery system |
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Record CYPHER sales of $670 million |
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6th consecutive quarter of record non-GAAP net income |
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7th consecutive quarter with non-Cordis revenue exceeding Cordis revenue |
SurModics is pleased to report strong revenue and record adjusted earnings for the first quarter
of fiscal year 2006, said Bruce Barclay, President and CEO. This marks the sixth consecutive
quarter of record non-GAAP net income for SurModics. Several significant events occurred during the
quarter. We are particularly encouraged by the strong sequential growth in research and development
revenue, which is the highest in four quarters. We believe the sequential growth in R&D revenue
speaks to the relevance our technologies have for our customers. A significant amount of the growth
in R&D revenue resulted from customer supported projects incorporating our site specific drug
delivery technologies for cardiovascular and ophthalmology applications. Our R&D
organization continues to make terrific progress on many high potential projects with our growing
customer base.
One year after closing the InnoRx acquisition, we are delighted with the strong customer interest
in our drug delivery platforms, portfolio of polymer technologies and collaborative development
capabilities, as more companies evaluate their drugs for treating serious diseases of the eye,
continued Barclay. We are pleased to report that SurModics currently has multiple paid feasibility
and development programs in ophthalmology underway, evaluating both our drug delivery platforms and
polymer matrix technologies. At least one of these programs is being sponsored by a major
pharmaceutical company. In addition, early feedback from the clinical trial of our I-vation
Intravitreal Implant has been very positive, and we expect to complete enrollment in the near
term.
Further, our customers continue to generate meaningful results which we believe will
benefit SurModics both now and in the future, commented Barclay. The CYPHER Sirolimus-eluting
Coronary Stent from Cordis Corporation, a Johnson & Johnson company, generated record sales in the
quarter; FoxHollow issued strong 2006 revenue guidance; and we are pleased to report that Novocell
commenced their Phase I/II human clinical trial in December.
Revenue for the first quarter of fiscal 2006 was $16.5 million, an increase of 17% from
$14.1 million in the year earlier period. R&D revenue of $1.8 million represents a sequential
increase of 62% from $1.1 million in the September quarter and a slight decline from the first
quarter of 2005 when InnoRx, which we acquired in January 2005, was an important R&D customer. On a
GAAP basis, operating income was $8.6 million; net income was $6.2 million; and diluted earnings
per share was $0.33. This quarter marks the first period in which SurModics results include
expensing of stock options, as required by SFAS No. 123(R). GAAP results also include a $465,000,
or $0.02 per diluted share, benefit related to the reversal of a tax reserve.
On a non-GAAP basis, operating income grew 12% to a record $9.7 million, from $8.7 million
in the prior-year period. Net income increased 24% to a record $6.6 million, from $5.3 million in
the same period last year. Diluted earnings per share was a record $0.35,
compared with $0.30 in the first quarter of fiscal 2005. Non-GAAP results exclude non-cash compensation charges and the tax benefit further
detailed in Note (4) of the Statements of Income for the quarter ended December 31, 2005. Operating expenses, after excluding non-cash
compensation charges, were the lowest in three quarters. Construction of new coating suites and
manufacturing space at our Eden Prairie, Minnesota headquarters is ahead of schedule and under
budget. We now project the roughly $1 million savings in annual operating expenses from exiting our
Bloomington, Minnesota facility to commence in the third quarter of fiscal 2006.
SurModics pipeline continues to represent significant potential. The company signed four new
licenses in the first quarter, making good progress toward its goal of 15 for fiscal year 2006.
One of these licenses is with Conor Medsystems for use of SurModics hydrophilic coating technology
on their next generation DES delivery system. As of December 31, 2005, SurModics customers had 80
licensed product categories generating royalty revenue, unchanged from the prior-year period; the
total number of licensed product classes not yet launched was 74, compared with 63 in the
prior-year period; and major non-licensed opportunities totaled 67, compared with 68 a year ago.
In total, SurModics now has 141 potential commercial products in development representing each of
the companys four focus markets Cardiovascular, Neurology, Ophthalmology and Orthopedics.
SurModics remains in excellent financial condition, said Phil Ankeny, Chief Financial
Officer and Vice President, Business Development. We are managing our expenses responsibly,
without compromising our investment in R&D. Our balance sheet remains strong, with a cash and
investment balance of $80.5 million and no debt as of December 31, 2005. We continue to have an
active business development pipeline, as we evaluate potentially compelling opportunities to put
our balance sheet to work.
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 companys web site,
www.surmodics.com, and click on the first quarter webcast icon. A replay of the first quarter
conference call will be available by dialing 800-405-2236 and entering conference call ID 11050823.
The audio replay will be available beginning at 6:00 p.m. CT on Wednesday, January 25, until 6:00 p.m. CT on Wednesday, February 1.
About SurModics, Inc.
SurModics, Inc. is a leading provider of surface modification technologies in the areas of
biocompatibility, site-specific drug delivery, biological cell encapsulation, and medical
diagnostics. SurModics partners with the worlds foremost medical device, pharmaceutical and life
science companies to bring innovation together for better patient outcomes. Recent collaborative
efforts include the implementation of SurModics Bravo drug delivery polymer matrix as a key
component of the first-to-market drug-eluting coronary stent and the use of the CELLabration
encapsulation system as an immunoprotective coating for implantable human islet cells. SurModics
is also active in the ophthalmology market with a sustained drug delivery system that is currently
in human trials for treatment of retinal disease. A significant portion of SurModics revenue is
generated by royalties earned from the sale of our customers commercial products. SurModics is
headquartered in Eden Prairie, MN. More information about the company can be found at
www.surmodics.com. The content of SurModics web site is not part of this release or part of any
filings the company makes with the SEC.
Safe Harbor for Forward Looking Statements
Certain statements contained in this press release may be deemed to be forward-looking statements
under federal securities laws, and SurModics intends that such forward looking statements be
subject to the safe harbor created thereby. SurModics does not undertake an obligation to publicly
update or revise any forward-looking statements, whether as a result of new information, future
events or otherwise.
Contact
Phil Ankeny, Chief Financial Officer and Vice President, Business Development
(952) 829-2700
SurModics, Inc.
Statements of Income
Reconciliation of GAAP to Non-GAAP Amounts
(In thousands, except per share data)
(Unaudited)
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Three Months Ended |
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December 31, 2005 |
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Non- |
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GAAP(1) |
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Adjustments |
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GAAP(2) |
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Revenue: |
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Royalties and license fees |
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$ |
12,275 |
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$ |
12,275 |
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Product sales |
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2,347 |
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2,347 |
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Research & development |
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1,843 |
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1,843 |
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Total revenue |
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16,465 |
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16,465 |
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Operating expenses: |
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Product |
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681 |
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(23) |
(3) |
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658 |
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Research & development |
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4,593 |
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(452) |
(3) |
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4,141 |
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Sales & marketing |
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324 |
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(38) |
(3) |
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286 |
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General & administrative |
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2,287 |
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(649) |
(3) |
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1,638 |
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Total operating expenses |
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7,885 |
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(1,162 |
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6,723 |
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Income from operations |
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8,580 |
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1,162 |
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9,742 |
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Investment income |
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728 |
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728 |
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Income before income taxes |
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9,308 |
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1,162 |
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10,470 |
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Income tax provision |
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(3,090 |
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(808) |
(4) |
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(3,898 |
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Net income |
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$ |
6,218 |
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354 |
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$ |
6,572 |
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Basic net income per share |
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$ |
0.34 |
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$ |
0.36 |
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Diluted net income per share |
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$ |
0.33 |
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$ |
0.35 |
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Weighted average shares outstanding |
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Basic |
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18,436 |
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18,436 |
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Diluted |
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18,643 |
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18,935 |
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(1) |
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Reflects operating results in accordance with U.S. generally accepted accounting principles (or GAAP). |
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Non-GAAP figures exclude non-cash compensation charges and
the tax items detailed in Note (4). |
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Reflects non-cash compensation charges. |
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Non-GAAP effective tax rate is 37.2% vs. an assumed GAAP continuing operations effective tax
rate of 38.4%. In addition, non-GAAP results exclude a $465,000 benefit related to the reversal of
a tax accrual resulting from settlement during the quarter of a
states prior year tax returns. |
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SurModics, Inc.
Statements of Income
Reconciliation of GAAP to Non-GAAP Amounts
(In thousands, except per share data)
(Unaudited)
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Three Months Ended |
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December 31, 2004 |
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Non- |
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GAAP(1) |
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Adjustments |
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GAAP(2) |
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Revenue: |
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Royalties and license fees |
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$ |
10,091 |
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$ |
10,091 |
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Product sales |
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2,000 |
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2,000 |
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Research & development |
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1,978 |
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1,978 |
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Total revenue |
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14,069 |
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14,069 |
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Operating expenses: |
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Product |
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620 |
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620 |
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Research & development |
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3,355 |
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3,355 |
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Sales & marketing |
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262 |
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262 |
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General & administrative |
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1,194 |
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(94) |
(3) |
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1,100 |
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Total operating expenses |
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5,431 |
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(94 |
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5,337 |
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Income from operations |
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8,638 |
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94 |
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8,732 |
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Investment income |
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(28 |
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(28 |
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Income before income taxes |
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8,610 |
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8,704 |
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Income tax provision |
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(3,373 |
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(36 |
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(3,409 |
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Net income |
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$ |
5,237 |
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58 |
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$ |
5,295 |
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Basic net income per share |
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$ |
0.30 |
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$ |
0.30 |
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Diluted net income per share |
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$ |
0.29 |
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$ |
0.30 |
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Weighted average shares outstanding |
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Basic |
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17,574 |
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17,574 |
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Diluted |
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17,950 |
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17,950 |
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(1) |
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Reflects operating results in accordance with U.S. generally accepted accounting principles (or GAAP). |
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(2) |
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Non-GAAP figures exclude non-cash compensation charges.
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(3) |
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Reflects non-cash compensation charges. |
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SurModics, Inc.
Condensed Balance Sheets
(In thousands)
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December 31, |
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September 30, |
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2005 |
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2005 |
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Assets |
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(Unaudited) |
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Current assets: |
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Cash & investments |
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$ |
33,638 |
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$ |
24,445 |
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Accounts receivable |
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11,307 |
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10,996 |
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Inventories |
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1,153 |
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1,091 |
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Other current assets |
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1,535 |
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5,072 |
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Total current assets |
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47,633 |
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41,604 |
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Property & equipment, net |
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16,658 |
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14,832 |
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Long-term investments |
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46,898 |
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48,874 |
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Other assets |
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19,434 |
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18,915 |
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Total assets |
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$ |
130,623 |
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$ |
124,225 |
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Liabilities & Stockholders Equity |
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Total current liabilities |
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$ |
3,785 |
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$ |
5,123 |
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Other liabilities |
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3,428 |
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3,521 |
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Total stockholders equity |
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123,410 |
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115,581 |
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Total liabilities & stockholders equity |
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$ |
130,623 |
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$ |
124,225 |
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# # #