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
June 24, 2008
Date of report (Date of earliest event reported)
SurModics, Inc.
(Exact Name of Registrant as Specified in its Charter)
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Minnesota
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0-23837
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41-1356149 |
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(State of Incorporation)
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(Commission File Number)
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(I.R.S. Employer |
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Identification No.) |
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9924 West 74th Street |
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Eden Prairie, Minnesota
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55344 |
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(Address of Principal Executive Offices)
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(Zip Code) |
(952) 829-2700
(Registrants 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):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item 8.01. Other Events.
On June 25, 2008, SurModics, Inc. (the Company) announced in a press release the initiation
by Merck & Co., Inc. of a Phase IIb clinical trial to evaluate the safety and efficacy of the
Companys I-vation TA product in patients with diabetic macular edema. The initiation of this
Phase IIb trial triggers a milestone payment of $9 million from Merck to SurModics under the
License and Research Collaboration Agreement between the companies announced in June 2007.
The Company expects to receive the $9 million milestone payment in its fiscal quarter ending
September 30, 2008, and will recognize as revenue a portion of the milestone payment in the
Companys fiscal quarter ending June 30, 2008, with the remainder being amortized over the
remaining economic life of the I-vation sustained drug delivery system, which the Company estimates
to be 15 years.
A copy of the press release is attached hereto as Exhibit 99 and is incorporated herein by
reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
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99 |
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Press Release Dated June 25, 2008. |
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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Date: June 30, 2008 |
/s/ Philip D. Ankeny
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Philip D. Ankeny |
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Senior Vice President and Chief Financial Officer
(duly authorized officer and principal financial
officer) |
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exv99
EXHIBIT 99
NEWS RELEASE
SurModics Announces Initiation by Merck & Co., Inc. of
Phase IIb Clinical Trial for I-vation TA
EDEN PRAIRIE, Minnesota June 25, 2008 SurModics, Inc. (Nasdaq: SRDX), a leading provider of
surface modification and drug delivery technologies to the healthcare industry, announced today the
initiation by Merck & Co., Inc. of a Phase IIb clinical trial to evaluate the safety and efficacy
of SurModics I-vation TA in patients with diabetic macular edema. The initiation of this Phase
IIb trial triggers a milestone payment of $9 million from Merck to SurModics under the companies
License and Research Collaboration Agreement announced in June 2007.
Todays announcement marks an important milestone and is the culmination of many months of hard
work by the teams at Merck and SurModics in preparation for this next phase of clinical studies,
said Bruce Barclay, president and CEO of SurModics. The unmet clinical need relating to retinal
diseases is significant. We believe the I-vation platform offers the potential for sustained
release drug delivery to the back of the eye, implantation through a minimally invasive procedure
and removal once the drug has been fully released.
The I-vation Intravitreal Implant utilizes a system with the potential to deliver drug on a
sustained release basis for up to two years, however, the implant being utilized in this study is
designed to elute the drug for approximately 12 months. Currently, the majority of treatments being
developed for retinal disease require repeat injections into the eye every one to three months.
Replacing multiple injections with a single implant providing long-term, controlled drug release
could represent a significant advance in therapeutic treatment due to potentially improved patient
compliance and the potential for reduced risk of side effects versus intravitreal injections.
About SurModics, Inc.
SurModics, Inc. is a leading provider of surface modification and drug delivery technologies to the
healthcare industry. SurModics partners with the worlds foremost medical device,
SurModics Announces Initiation by Merck & Co., Inc. of Phase IIb Clinical Trial for I-vation TA
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pharmaceutical and life science companies to develop and commercialize innovative products that
result in improved patient outcomes. Core offerings include: drug delivery technologies (coatings,
microparticles, 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. Collaborative efforts include a sustained
drug delivery system in human trials for treatment of retinal disease and the drug delivery polymer
matrix on the first-to-market drug-eluting coronary stent. SurModics is headquartered in Eden
Prairie, Minnesota and its Brookwood 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, 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 the following: (1)
realizing the full potential benefits of the companys agreement with Merck & Co., Inc. requires
the development of new products and applications of technology; (2) costs or difficulties relating
to the integration of the businesses of Brookwood Pharmaceuticals and BioFX Laboratories with
SurModics business may be greater than expected and may adversely affect the companys results of
operations and financial condition; (3) developments in the regulatory environment, as well as
market and economic conditions, and our reliance on third parties, may adversely affect our
business operations and profitability, and the companys ability to achieve our fiscal 2008
corporate goals and to realize the potential of our pipeline; and (4) other 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, 2007, 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.
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SurModics Announces Initiation by Merck & Co., Inc. of Phase IIb Clinical Trial for I-vation TA
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Contact
Phil Ankeny, Sr. VP and Chief Financial Officer
(952) 829-2700