0001157523-20-000872.txt : 20200608 0001157523-20-000872.hdr.sgml : 20200608 20200608084512 ACCESSION NUMBER: 0001157523-20-000872 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20200608 ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200608 DATE AS OF CHANGE: 20200608 FILER: COMPANY DATA: COMPANY CONFORMED NAME: SURMODICS INC CENTRAL INDEX KEY: 0000924717 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 411356149 STATE OF INCORPORATION: MN FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-23837 FILM NUMBER: 20948194 BUSINESS ADDRESS: STREET 1: 9924 W 74TH ST CITY: EDEN PRAIRIE STATE: MN ZIP: 55344 BUSINESS PHONE: 9525007000 MAIL ADDRESS: STREET 1: 9924 WEST 74TH ST CITY: EDEN PRAIRIE STATE: MN ZIP: 55344 FORMER COMPANY: FORMER CONFORMED NAME: BSI CORP DATE OF NAME CHANGE: 19970506 8-K 1 a52231228.htm SURMODICS, INC. 8-K



UNITED STATES
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 8, 2020
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) 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))
 

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Class
Trading Symbol(s)
Name of Each Exchange on Which Registered
Common Stock, $0.05 par value
SRDX
Nasdaq Global Select Market

 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
 
Emerging growth company
☐
   
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
☐
 


Item 8.01.     Other Events.
 
On June 8, 2020, Surmodics, Inc. (the “Company”) issued a press release announcing that it has received CE Mark Certification in the European Union for its SurVeil™ drug-coated balloon. In the press release, the Company also disclosed the milestone payment that that it will receive related to obtaining the CE Mark. A copy of a press release announcing the foregoing is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
 
Item 9.01.     Financial Statements and Exhibits.
 
(d) Exhibits.
 
Exhibit No.
 
 Description of Exhibit
 
 
 
99.1
 
 Press release dated June 8, 2020

 
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.
 
 
 
 
 
 
 
 
 
Date:  June 8, 2020
 
 /s/ Gordon S. Weber
 
 
 
 Gordon S. Weber
 
 
 
Senior Vice President of Legal, General Counsel
and Secretary


Exhibit Index

Exhibit No.
 
 Description of Exhibit
 
 
 
99.1
 
 Press release dated June 8, 2020

EX-99.1 2 a52231228ex99_1.htm EXHIBIT 99.1
Exhibit 99.1

Surmodics Receives CE Mark for its SurVeil™ Drug Coated Balloon

Next generation device adds new technology to how physicians approach treatment of PAD

EDEN PRAIRIE, Minn.--(BUSINESS WIRE)--June 8, 2020--Surmodics, Inc. (NASDAQ:SRDX), a leading provider of medical device and in vitro diagnostic technologies to the health care industry, today announced it has received CE Mark Certification in the European Union for its SurVeil™ drug-coated balloon (DCB).

“I am excited about the potential of the SurVeil DCB to improve the treatment of PAD,” said Professor Marianne Brodmann MD, PhD, interventional cardiologist at Medical University Graz (Austria) and a Principal Investigator in TRANSCEND, Surmodics’ pivotal clinical trial for the SurVeil DCB. “Drug-coated balloons have been widely utilized in Europe as a frontline treatment for PAD."

The SurVeil DCB, a next-generation device that utilizes best-in-class technology in the treatment of peripheral artery disease (PAD), includes a proprietary drug-excipient formulation for a durable balloon coating and is manufactured using an innovative process to improve coating uniformity. Pre-clinical data have shown a more evenly distributed and durable drug effect, and lower incidence of downstream drug particles compared to the control drug-coated balloon.1

“This CE Mark is a critical milestone and an exciting step forward for Surmodics as we continue to demonstrate industry leadership in the development of pioneering vascular medical devices,” said Gary Maharaj, President and Chief Executive Officer of Surmodics. “The design of the SurVeil DCB reflects our dedication to providing innovative solutions that bring real clinical value – benefitting both clinicians and the patients that they treat. Congratulations go out to the entire Surmodics team on this well-deserved achievement.”

In February 2018, Surmodics entered into an agreement with Abbott (NYSE: ABT) that provided Abbott with exclusive worldwide commercialization rights for the SurVeil DCB. Pursuant to the terms of the agreement, Surmodics received a $25 million upfront payment and a $10 million milestone payment for the completion of patient enrollment in the TRANSCEND clinical trial. As a result of CE Mark attainment, Surmodics will receive an additional $10.8 million milestone payment. The company will recognize approximately $6.5 million as revenue in its fiscal third quarter and could earn up to an additional $45 million for future product development milestones. Surmodics is not forecasting material revenue from the sale of its SurVeil DCB product over the remainder of its fiscal year ending September 30, 2020.

Under the agreement, Surmodics will be responsible for the manufacture and supply of clinical and commercial quantities of the product and will realize revenue based on initial product sales to Abbott as well as a share of profits resulting from third-party sales. The SurVeil DCB is not available for sale and is for investigational use only in the United States.

About PAD

PAD is a serious and often underdiagnosed circulatory condition caused by a build-up of arterial plaque, most commonly in the legs. Drug-coated balloons are recognized as an important treatment option in treating PAD, which affects an estimated 200 million people worldwide.2 Between 12 to 20 percent of Americans over 60 years old have PAD.3 PAD increases risk of coronary artery disease, heart attack and stroke, and can impair the ability to walk. If left untreated, PAD can lead to gangrene and limb amputation.4

About Surmodics, Inc.

Surmodics is the global leader in surface modification technologies for intravascular medical devices and a leading provider of chemical components for in vitro diagnostic (IVD) immunoassay tests and microarrays. Surmodics is pursuing highly differentiated medical devices that are designed to address unmet clinical needs and engineered to the most demanding requirements. This key growth strategy leverages the combination of the Company’s expertise in proprietary surface technologies, along with enhanced device design, development and manufacturing capabilities. The Company mission remains to improve the detection and treatment of disease. Surmodics is headquartered in Eden Prairie, Minnesota. For more information, visit www.surmodics.com. The content of Surmodics’ website is not part of this press release or part of any filings that 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 regarding milestone payments and revenues related to product sales, 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 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, 2019, and updated in our subsequent reports filed with the SEC. These reports are available in the Investors section of our website at https://surmodics.gcs-web.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.

  1. Surmodics data on file.
  2. Fowkes FGR, et al. Lancet 2013, 382(9901):1329-1340.
  3. Centers for Disease Control and Prevention. Peripheral Arterial Disease (PAD) Fact Sheet. n.d. Web.
  4. National Institutes of Health. What is Peripheral Artery Disease? n.d. Web.

 

Contacts

Surmodics, Inc.
Tim Arens, 952-500-7000
ir@surmodics.com