false
0000718937
0000718937
2020-09-14
2020-09-14
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
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
|
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
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.
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.
|
|
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.
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
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
|
|
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.
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
|
|
Changes to the rental property are only permitted with the explicit written consent of the landlord.
|
|
9.
|
Return of rental property
|
|
The rental property must be returned in clean and clean condition upon completion of the rental.
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.
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
|
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