0001564590-20-043353.txt : 20200914 0001564590-20-043353.hdr.sgml : 20200914 20200914090023 ACCESSION NUMBER: 0001564590-20-043353 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 16 CONFORMED PERIOD OF REPORT: 20200914 ITEM INFORMATION: Entry into a Material Definitive Agreement ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20200914 DATE AS OF CHANGE: 20200914 FILER: COMPANY DATA: COMPANY CONFORMED NAME: STAAR SURGICAL CO CENTRAL INDEX KEY: 0000718937 STANDARD INDUSTRIAL CLASSIFICATION: OPHTHALMIC GOODS [3851] IRS NUMBER: 953797439 STATE OF INCORPORATION: DE FISCAL YEAR END: 0103 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-11634 FILM NUMBER: 201172395 BUSINESS ADDRESS: STREET 1: 1911 WALKER AVE CITY: MONROVIA STATE: CA ZIP: 91016 BUSINESS PHONE: 6263037902 MAIL ADDRESS: STREET 1: 1911 WALKER AVE CITY: MONROVIA STATE: CA ZIP: 91016 FORMER COMPANY: FORMER CONFORMED NAME: STAAR SURGICAL COMPANY DATE OF NAME CHANGE: 19920703 8-K 1 staa-8k_20200914.htm 8-K staa-8k_20200914.htm
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): September 14, 2020

 

 

STAAR Surgical Company

(Exact Name of Registrant as Specified in Charter)

 

 

Delaware

0-11634

95-3797439

(State or Other Jurisdiction

of Incorporation)

(Commission File Number)

(IRS Employer

Identification No.)

 

 

 

25651 Atlantic Ocean Drive

Lake Forest, California

 

92630

(Address of Principal Executive Offices)

 

(Zip Code)

Registrant’s Telephone Number, Including Area Code: 626-303-7902

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 (see General Instruction A.2. below):

 

☐

Written communication 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 communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐

Pre-commencement communication 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

STAA

NASDAQ

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1 933 (17 CFR §230.405) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2).

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 1.01 Entry into a Material Definitive Agreement.

 

On September 14, 2020, STAAR Surgical Company (the “Company”) entered into a Lease Agreement (the “Lease”) with Calderari & Schwab (“Lessor”), to expand its footprint of leased real property located at Hauptstrasse 104, 2560 Nidau, Switzerland, including additional portions of a commercial building for a total of approximately 2,396 square meters (the “Premises”). The Lease begins on April 1, 2021 and has an initial term of ten years. The additional leased space is intended to accommodate expanded operations, including increased capacity for production and sales support. The Company has an option to extend the Lease for a period of five years.

The foregoing summary is qualified in its entirety by reference to the Lease, a translated version of which is filed as Exhibit 10.39 to this Current Report on Form 8-K and incorporated herein by this reference.

 

Item 7.01 Regulation FD Disclosure.

 

On September 14, 2020, the Company published a press release announcing that patient enrollment for the primary study analysis cohort of 300 subjects has been achieved in its U.S. FDA clinical trial, “A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens.” A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by this reference.

 

The information furnished herewith pursuant to Item 7.01 of this Current Report, including Exhibit 99.1, shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section. The information in Item 7.01 of this Current Report shall not be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this Current Report, regardless of any general incorporation language in the filing.

 

 

Item 9.01 Financial Statements and Exhibits

 

Exhibit No.

 

Description

10.39

 

99.1

 

 

Lease Agreement by and between the Company and Calderari & Schwab.

 

Press release of the Company dated September 14, 2020.

 

 

 

 

104

 

Cover Page Interactive Data File (embedded within the Inline XBRL document).

 

 

 

 

 

SIGNATURE

 

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.

 

STAAR Surgical Company 

 

September 14, 2020

By:

/s/ Caren Mason

 

 

Caren Mason

 

 

President and Chief Executive Officer

 

 

 

 EX-10.39 2 staa-ex1039_24.htm EX-10.39 staa-ex1039_24.htm

1

Exhibit 10.39

6g.b  .REALESTATE & MANAGEMENT

 

 

 

Lease Agreement

between

 

Calderari & Schwab, Schlossstrasse 8a, 2560 Nidau

Enzo Calderari, Neuenburgstrasse 36, 2505 Biel

Walter Schwab, Kirschbaumweg 8, 2572 Mortars

 

and

 

Staar Surgical AG, Hauptstrasse 104, 2560 Nidau

 

 

 

1.

Rental Property

 

In the building at Hauptstrasse 104 in 2560 Nidau, the tenant takes over the following premises for rent over a total area of 2’396 m2:

 

 

In the basement:

-  9001: 1 Garage Box

 

-  9002: Small bearing (29 m2)

 

-  9003: Small bearing (34 m2)

 

-  9004: Small bearing (41 m2)

 

-  9005: Small bearing (11 m2)

 

-  9006: Large bearing (102 m2)

 

-  9007: Large bearing (117 m2)

 

 

On the ground floor:

-  1001: Storage / production (210 m2)

 

-  1002: Warehouse / production (210 m2)

 

-  1003: Office / production (210 m2)

 

 

On the 1st floor:

-  1101: Offices (822 m2)

 

-  1102: Office Space (150 m2)

2

 

On the 2nd floor:

-  1201: Offices (460 m2)

 

 

Parking Garage:

-  7001-7003 / 7010-7016: 10 Parking Spaces

 

 

Parking Deck:

-  7020-7026: 6 Parking Spaces

 

 

Parking Spaces Ground Floor:

-  8012-8018: 7 Double Parking Spaces

 

-  8023-8034: 12 Parking Spaces

 

2.Start of Rental

The rent starts on April 1, 2021.

3.Rental Period

The fixed rental period is 10 years. The contract may be terminated by either party with a notice period of 12 months to the end of each month starting March 31, 2031.

3.1.Option Right

The tenant has the right to extend the rental agreement once for five years under the current terms. If the tenant wishes to make use of this extension option, the landlord must deliver the written declaration by March 31, 2030 at the latest.

4.Rent

The net rent is CHF 33'825.- per month

 

In the basement:

-  9001: 1 Garage Box

at CHF 200.-= CHF2’400.- p.a.

 

-  9002: Small bearing (29 m2)

at CHF 80.-= CHF2’320.- p.a.

 

-  9003: Small bearing (34 m2)

at CHF 80.-= CHF2’720.- p.a.

 

-  9004: Small bearing (41 m2)

at CHF 80.-= CHF3’280.- p.a.

 

-  9005: Small bearing (11 m2)

at CHF 80.-= CHF880.- p.a.

 

-  9006: Large warehouse (102 m2)

at CHF 80.-= CHF8’160.- p.a.

 

-  9007: Large bearing (117 m2)

at CHF 80.-= CHF9’360.- p.a.

 

 

 

On the ground floor:

-  1001: Storage / production (210 m2)

at CHF 170.-= CHF35’700.- p.a.

 

-  1002: Storage / production (210 m2)

at CHF 170.-= CHF35’700.- p.a.

 

-  1003: Office / production (210 m2)

at CHF 170.-= CHF35’700.- p.a.

 

 

 

On the 1st floor:

-  1101: Offices (822 m2)

at CHF 158.-= CHF129’860.- p.a.

 

-  1102: Office Space (150 m2)

at CHF 158.-= CHF23’700.- p.a.

 

 

 

On the 2nd floor:

-  1201: Offices (460 m2)

at CHF 158.-= CHF73’600.- p.a.

 

 

 

Underground Parking:

-  7001-7003/7010-7016:10 Parking Spaces

at CHF 120.-= CHF14’400.- p.a.

3

 

Parking Deck:

-  7020-7026: 6 Parking Spaces

at CHF 100.-= CHF7’200.- p.a.

 

 

 

Parking Spaces Ground Floor:

-  8012-8018: 7 Double Parking Spaces

at CHF 100.-= CHF8’440.- p.a.

 

-  8023-8034: 12 Parking Spaces

at CHF 80.-= CHF11’520.- p.a.

 

4.1.

The annual net rent of CHF 404’940.- will remain unchanged for the first three years. Effective April 1, 2024, the rent can be adjusted once a year on January 1st regardless of the fixed rental period of the contract at the request of a partner based on the national index of consumer prices (LIK).

 

The basis for this is: LIK 2015: As of May 2020: 101.30 points.

 

4.2.

Ancillary Costs

 

The contribution on account for the heating and ancillary costs (heating, electricity consumption of the shared areas, the burner, water fees, waste water and waste water disposal fees), which the landlord charges annually as of April 30, amounts to CHF. 3’000.- monthly. Billing is based on the rented square meter.

 

5.

Use of the rental property

 

 

5.1.

The rented property is rented as storage, office and production locations. The tenant is obliged to submit any changes regarding the purpose to the landlord for approval.

 

 

5.2.

Maintenance

 

The tenant has the property according to Art. 259 OR in good, clean condition. Annual repairs that exceed the amount of Fr 500.-- per year shall be paid by the lessee.

If damage to the rented property occurs, the lessee is required to keep the extent of the damage as minimal as possible, be it through immediate measures at his expense or with immediate notification of the landlord.

Repair work, minor finishing work, or any necessary changes to the rental property and the property by the tenant will be allowed without any claims for damages.

 

5.3.

Sublet

 

The tenant is allowed to re-rent rooms. The landlord must be informed of any sublease.

 

5.4.

Accessibility of the rental property

 

The landlord has the right to enter the rental rooms at any time in advance in order to protect his interests.

 

 

 

4

 

6.

Insurance

 

 

The tenant is required to sufficiently insure all machines, equipment and furniture, the goods and generally all objects that are on the rental premises at his own expense against theft, fire, explosion and water damage, as well as all with the operation in relation to risks, in particular rental liability insurance. The lessee shall bear the consequences of any failure to comply with this obligation and shall fully discharge the lessor.

 

7.

Company signs and labels

 

 

7.1.

Mounting and design

 

The lessee may only affix company signs and labels with the approval of the lessor at the location designated by the lessor, in compliance with the state and local authority specifications. Designated location: Above the sales office.

 

7.2.

Cost

 

The cost of re-labeling or changes is assumed by the tenant. Even in the event of any removal due to a change of tenant, the tenant will bear the costs of the restoration to the original state.

 

8.

Changes to rental property

 

 

8.1.

Grant

 

Changes to the rental property are only permitted with the explicit written consent of the landlord.

 

9.

Return of rental property

 

 

9.1.

Cleaning

 

The rental property must be returned in clean and clean condition upon completion of the rental.

 

9.2.

Damage

 

The tenant is liable for all damages that are not due to normal wear and tear. Such damages shall be repaired by the lessee through the termination of the lease.

 

 

 

 

5

 

9.3.

Recovery Obligation.

 

Upon termination of the contract, the tenant is obliged to restore the original condition of the rented property at his own expense.

 

10.

Special Agreements

 

The tenant expressly acknowledges that the landlords insist on their legally guaranteed retention right in accordance with SchKG 283/OR 257 - 259 and 268.

Deadline for a retention request 30 days after written notification.

The tenant is granted the right to have the present rental agreement recorded in the land register at his own expense for the entire duration - also for the extension when exercising the option.

This Agreement shall be governed by Swiss substantive law to the full extent, without regard to conflict of laws (IPRG). The exclusive place of jurisdiction is Nidau. Any dispute arising out of or in connection with this Agreement (including any matter of validity, binding effect, interpretation, performance or non-performance) shall be settled by the competent courts at the place of jurisdiction.

This Agreement supersedes the lease agreement between the parties in June 2019, because the tenant will have additional space on the first floor, in the first basement as well as additional parking spaces of the property on Hauptstrasse 104 in Nidau, and the fixed rental period of the rental relationship is extended.

 

Tenants:

 

The Landlord:

 

 

 

Staar surgical AG

 

EFG Calderari and Schwab

 

 

 

 

 

Enzo Calderari

 

 

 

 

 

Walter Schwab

 

 

 

Nidau, this day 2020

 

Nidau, this day .2020

 

 EX-99.1 3 staa-ex991_85.htm EX-99.1 staa-ex991_85.htm

Exhibit 99.1

STAAR Surgical Announces Completion of Patient Enrollment in EVO Implantable Lens US Clinical Trial

Pivotal Study Successfully Enrolls 300 Subjects Across 14 U.S. Sites

 

LAKE FOREST, CA, September 14, 2020--- STAAR Surgical Company (NASDAQ: STAA), a leading developer, manufacturer and marketer of implantable lenses and companion delivery systems for the eye, is today announcing that patient enrollment for the primary study analysis cohort of 300 subjects has been achieved in its U.S. FDA clinical trial, “A Multicenter Clinical Evaluation of the EVO/EVO+ Visian® Implantable Collamer® Lens.” Primary study analysis will be conducted when 300 primary eyes complete 6 months of follow-up, which is anticipated early in the second quarter of 2021 with submission of the study results to the FDA shortly thereafter.  

 

“Completion of patient enrollment in the clinical trial is a critical step towards the future availability of our proprietary EVO Visian ICL family of products in the U.S. We are very grateful to our clinical trial sites and study investigators for their dedicated work and commitment to successfully achieving the trial’s enrollment milestone in the midst of a challenging COVID-19 operating environment,” said Caren Mason, President and CEO of STAAR Surgical.

 

EVO Visian ICLs are intended to treat a wide range of refractive error, including myopia (nearsightedness) which is the need for distance vision correction. Myopia is the most common ocular disorder worldwide and its incidence is increasing rapidly.1 STAAR’s EVO lenses are designed with a central hole, which restores more natural aqueous flow and eliminates the need for preoperative peripheral iridotomies. The objective of the U.S. pivotal study is to evaluate the safety, and to collect supportive data on effectiveness, of the EVO Visian ICLs in study participants who have a diagnosis of myopia or myopia with astigmatism. The study includes the following EVO lenses:

 

 

•

EVO Visian® ICL for Myopia

 

•

EVO Visian® Toric ICL for Myopia with Astigmatism

 

•

EVO+ Visian® ICL for Myopia

 

•

EVO+ Visian® Toric ICL for Myopia with Astigmatism

 

By eliminating the need for preoperative peripheral iridotomies STAAR’s EVO Visian ICL provides a simpler, less time-consuming procedure for patients seeking visual freedom. Eliminating the need for preoperative peripheral iridotomies also increases surgeon efficiency and reduces the number of procedures thereby reducing the overall cost and complexity while improving the patient experience and potential positive outcomes.  

 

More than 750,000 EVO Visian® ICLs have been implanted in patients outside the U.S. Additional details on the U.S. clinical trial are available on ClinicalTrials.gov here.

 

1 Neesurg Mehta, MD and Angie Wen, MD, “Myopia: A Global Epidemic, An Overview of the Problem and Efforts to Address It”, Eye, Nov/Dec 2019.

 

About STAAR Surgical

 

STAAR, which has been dedicated solely to ophthalmic surgery for over 30 years, designs, develops, manufactures and markets implantable lenses for the eye with companion delivery systems. These lenses are intended to provide visual freedom for patients, lessening or eliminating the reliance on glasses or contact lenses. All of these lenses are

 

 

foldable, which permits the surgeon to insert them through a small incision. STAAR’s lens used in refractive surgery is called an Implantable Collamer® Lens or “ICL”, which includes the EVO Visian ICL™ product line. More than 1,000,000 Visian® ICLs have been implanted to date and STAAR markets these lenses in over 75 countries. To learn more about the ICL go to: www.discovericl.com.  Headquartered in Lake Forest, CA, the company operates manufacturing and packaging facilities in Aliso Viejo, CA, Monrovia, CA and Nidau, Switzerland. For more information, please visit the Company’s website at www.staar.com.

Forward-Looking Statements

This news release contains forward-looking statements. These statements include but are not limited to statements regarding the commercial significance of the EVO/EVO+ VISIAN Implantable Collamer Lens for Myopia, EVO/EVO+ and VISIAN Toric Implantable Collamer Lens for Myopia with Astigmatism in the US market, the success and timing of our clinical studies; and our ability to obtain and maintain regulatory market approval. Forward-looking statements are based on our management’s current expectations or beliefs regarding future events or circumstances, and you should not place undue reliance on these statements. Such statements involve known and unknown risks, uncertainties, assumptions and other factors, many of which are out of STAAR’s control and difficult to forecast that may cause actual results to differ materially from those that may be described or implied in the forward-looking statements. STAAR cannot be certain about the regulatory approval or commercial success of the EVO/EVO+ VISIAN Implantable Collamer Lens for Myopia, EVO/EVO+ and VISIAN Toric Implantable Collamer Lens for Myopia with Astigmatism in the US market. For a discussion of certain other risks, uncertainties and other factors affecting the statements contained in this news release, see STAAR’s Quarterly Report on Form 10-Q for the quarter ended April 3, 2020, and Annual Report on Form 10-K for the year ended January 3, 2020 under the caption “Risk Factors,” which are on file with the SEC and available in the “Investor Information” section of STAAR’s website under the heading “SEC Filings”. Except as required by law, STAAR assumes no, and hereby disclaims any, obligation to update any of the foregoing or any other forward-looking statements. STAAR nonetheless reserves the right to make such updates from time to time by press release, periodic report or other method of public disclosure without the need for specific reference to this news release. No such update shall be deemed to indicate that other statements not addressed by such update remain correct or create an obligation to provide any other updates.

 

 

CONTACT:Investors & Media

Brian Moore

Vice President, Investor, Media Relations and Corporate Development

(626) 303-7902, Ext. 3023

bmoore@staar.com

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Document And Entity Information
Sep. 14, 2020
Cover [Abstract]  
Document Type 8-K
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Document Period End Date Sep. 14, 2020
Entity Registrant Name STAAR Surgical Co
Entity Central Index Key 0000718937
Entity Emerging Growth Company false
Entity File Number 0-11634
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 95-3797439
Entity Address, Address Line One 25651 Atlantic Ocean Drive
Entity Address, City or Town Lake Forest
Entity Address, State or Province CA
Entity Address, Postal Zip Code 92630
City Area Code 626
Local Phone Number 303-7902
Written Communications false
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