Presbia PLC
Presbia PLC (Form: 8-K, Received: 09/08/2017 16:32:34)

 

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

 

 

Date of Report (Date of earliest event reported): September 8, 2017

 

PRESBIA PLC

(Exact Name of Registrant as Specified in Charter)

 

 

 

 

 

 

Ireland

(State or Other Jurisdiction

of Incorporation)

001-36824

(Commission

File Number)

98-1162329

(IRS Employer

Identification No.)

 

 

120/121 Baggot Street Lower

Dublin 2 Ireland

(Address of Principal Executive Offices)(Zip Code)

 

+353 (1) 659 9446

Registrant's Telephone Number

 

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:

 

☐ 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))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (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.


It e m 7.01 R e g u l at i on   F D   D i s c l osu r e .

 

Presbia PLC (the “Company”) intends, from time to time, to present and/or distribute to the investment community and utilize at various industry and investor conferences a slide presentation.  The slide presentation is attached hereto as Exhibit 99.1.

 

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, except as expressly set forth by reference in such a filing.

It e m 9.01.   F i n a n c i al St a t e m e nts   a n d   Exh i b i ts.

(d)  E xh i b i t s

 

N u m b e r

 

E xh i b it

 

 

 

99 . 1

 

Inv e s t or  P r e s e n t a t i on ( f urn i s h e d   h e r e w i t h)

 

 

 

 

 



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.

 

 

 

 

 

PRESBIA PLC

 

 

 

 

 

 

 

By: /s/ Todd Cooper

 

 

 

Name: Todd Cooper

 

 

 

Title:Chief Executive Officer

 

Dated:    September 8, 2017

 

 

SLIDE 1

September 2017 CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use.

SLIDE 2

Disclosure To the extent statements contained in this presentation are not descriptions of historical facts regarding Presbia PLC and its subsidiaries (collectively “Presbia,” “we,” “us,” or “our”), they are forward-looking statements reflecting management’s current beliefs and expectations. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels of activity, performance, or achievements to be materially different from those anticipated by such statements. You can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential,” “intends,” or “continue,” or the negative of these terms or other comparable terminology. Forward-looking statements contained in this presentation include, but are not limited to, statements regarding: (i) the initiation, timing, progress and results of our clinical trials, our regulatory submissions and our research and development programs; (ii) our ability to advance our products into, and successfully complete, clinical trials; (iii) our ability to obtain pre-market approvals; (iv) the commercialization of our products; (v) the implementation of our business model, strategic plans for our business, products and technology; (vi) the scope of protection we are able to establish and maintain for intellectual property rights covering our products and technology; (vii) estimates of our expenses, future revenues, growth of operations, capital requirements and our needs for additional financing; (viii) the timing or likelihood of regulatory filings and approvals; (ix) our financial performance; (x) developments relating to our competitors and our industry; and (xi) statements regarding our markets, including the estimated size and anticipated growth in those markets. Various factors may cause differences between our expectations and actual results, including those risks discussed under “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 29, 2017 and those risks discussed under “Risk Factors” in other reports we may file with the Securities and Exchange Commission. Except as required by law, we assume no obligation to update these forward-looking statements publicly or to update the reasons actual results could differ materially from those anticipated in the forward-looking statements, even if new information becomes available in the future.

SLIDE 3

Presbia Restores Near Vision Presbia has developed a solution for presbyopia, an age related condition affecting people from approximately 40 years of age, to help restore near vision Safe, effective and minimally invasive surgical procedure Currently marketed in certain markets outside the United States Marketed to people with presbyopia who need reading glasses or contact lenses

SLIDE 4

Large, Underserved and Growing Commercial/Market Opportunity 1.9 Billion Presbyopes Source: 2016 Market Scope Refractive Surgery Report (millions)

SLIDE 5

The Presbia Flexivue MicrolensTM The Presbia Flexivue Microlens™ is a best in class treatment option for presbyopia A powered corneal inlay is implanted in the non-dominant eye, with minimal impact to binocular distance vision Presbia has unique competitive advantages A refractive lens like reading glasses Designed to be removable The only option that is adjustable as you age (replace to a higher power) Can easily be done before or after LASIK or cataract surgery

SLIDE 6

True “Microlens” with 3.2 mm diameter and edge thickness of 0.015 mm Hydrophilic acrylic material similar to that used in IOLs for > 20 years Invisible to the naked eye once implanted Can be done concurrently or pre/post LASIK or cataract surgery Offered in a wide range of powers ranging from +1.5 diopter to +3.5 diopter, in 0.25 diopter increments The Presbia Procedure 10-Minute Procedure Utilizing Existing Femtosecond Laser Femtosecond Laser 1 Creates a pocket in patient’s cornea 3 2 Lens Insert Surgeon uses inserter to implant lens in patient’s cornea Self-Sealing Pocket Pocket self-seals, holding lens in place at center of visual axis

SLIDE 7

Competitive Landscape AcuFocus - KAMRA Non-powered “disc” implanted in the non-dominant eye Utilizes the “pinhole effect” to focus light to enhance near vision The disc is visible to naked eye in light colored eyes Difficult for patient in low light environments Obstructs the view of the retina in diagnostic exams and cataract surgery Requires capital outlay from physician for “centration” equipment Revision Optics - Raindrop Hydrogel placed under a LASIK-like flap in the non dominant eye Changes the curvature of the cornea by adding volume under the flap Non-powered Challenging to remove Corneal inlays are an exciting surgical treatment for presbyopia There are two primary competitors in the corneal inlay space

SLIDE 8

The Physician Appeal LASIK Cataract Presbyopia No established surgical market for the 40–60 year old patient pool 20s 30s 40s 50s 60s 70s 80s ? ? ? Presbia provides ophthalmologist with an exciting new option to treat patients with presbyopia Incremental revenue driver No capital expenditure required Short 10-minute procedure, short learning curve Private pay

SLIDE 9

Commercial Opportunity - LASIK as a Market Benchmark * Market Scope, 2014 Corneal inlay has the potential to impact the Presbyopia market similar to LASIK’s impact on vision correction in younger patients Presbia Flexivue Microlens™ requires a less invasive procedure About 1.6x more people suffer from presbyopia than the conditions that LASIK treats (myopia, astigmatism, and hyperopia) Rapid commercial acceptance of cash pay medical procedure to eliminate glasses Serves early adult demographic, which is now approaching the age at which near vision deteriorates Grew 1230% in the first 5 years of US commercialization – to over 1.2 million procedures annually Steady state is about 2.8 million* procedures per year in North America, Europe and Asia Internal survey of 143 LASIK patients indicate 75% would use a surgical solution to eliminate reading glasses Positive takeaways from LASIK market: 75

SLIDE 10

Focused Commercial Strategy Build global KOL acceptance carrying momentum into US commercial launch Registered to commercialize in 42 different countries Clinics implanting in South Korea, Germany, Ireland, UK, Netherlands, Australia/NZ, and Canada Gain FDA approval and begin marketing in the United States Adjust marketing strategy to differentiate Presbia Flexivue Microlens™ from corneal inlay competitors

SLIDE 11

Compelling Results Subjects can perform almost all near vision tasks without glasses For example, an improvement from reading a subhead in the newspaper (12pt font) to reading the content label (4pt font) on a medicine bottle

SLIDE 12

Improvement in Uncorrected Near Visual Acuity in Operated Eyes ~20/80 ~20/25 +5 line improvement in Uncorrected Near Visual Acuity in treated eyes compared to preoperative visual acuity

SLIDE 13

No change in Binocular Uncorrected Distance Visual Acuity 20/16 to 20/25 ≥ 96% of Subjects with Uncorrected Distance Visual Acuity Preoperatively and at Month 18 between 20/16 and 20/25

SLIDE 14

US Registration Timeline Complete 24 Month follow up for ALL subjects Complete 24 Month follow up for 300 subjects US PMA Submit PMA Anticipate Approval Complete documents for PMA Module 4 (study report, labeling) Q4 2017 Q1 2018 Q2 2018 Q3/4 2018

SLIDE 15

Business Highlights 118 million presbyopes in the U.S.; 1.9 billion presbyopes worldwide (2016)* Large, Underserved Presbyopia Opportunity Best-in-Class Microlens Technology Strong Leadership and Compelling Business Model Refractive corneal inlay restores reading vision—on average 5 lines of improvement which is the highest reported UNVA change‡ Wide range of lens size refractive powers to offer patients a customized therapy—competitors offer single size Compatible with additional diagnostic and surgical procedures (e.g. cataract surgery)—competitors are not§ Senior ophthalmic and global medical device experience; major KOLs worldwide supporting Presbia Compelling surgery center economics: 100% private pay, ~10 minute procedure time, leverage large installed base of femtosecond lasers Irish domicile FDA Pathway Developed Ophthalmic Surgery Market Over 4,000 global ophthalmic surgery centers with no effective treatment of presbyopia† We believe ophthalmic surgeons are highly motivated to develop this market to replace lost LASIK volumes and utilize installed base of expensive femtosecond lasers CE-marked, 1000+ lenses implanted globally Ongoing U.S. pivotal trial targeting FDA approval Q3 2018 *Source: Market Scope 2016 †Source: Market Scope 2013 ‡FDA Submission data §OUS Data non-concurrent

SLIDE 16

CAUTION - Investigational Device. Limited by Federal (or United States) law to investigational use.