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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): January 11, 2021

 

EyePoint Pharmaceuticals, Inc.

(Exact Name of Registrant as Specified in Charter)

 

 

Delaware		000-51122		26-2774444
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

 

480 Pleasant Street

Watertown, MA 02472

(Address of Principal Executive Offices, and Zip Code)

(617) 926-5000

Registrant’s Telephone Number, Including Area Code

(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 Stock, par value $0.001		EYPT		The Nasdaq Stock Market LLC

 

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.  ☐

 

 

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Item 2.02. Results of Operations and Financial Condition.

 

On January 11, 2021, EyePoint Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its preliminary fourth quarter and full-year 2020 revenues, and certain other corporate updates. The amounts included in the press release are preliminary, have not been audited and are subject to change upon completion of the Company’s audited financial statements for the year ended December 31, 2020. Additional information and disclosures would be required for a more complete understanding of the Company’s financial position and results of operations as of December 31, 2020. A copy of the press release is filed as Exhibit 99.1 hereto.

 

The information included under Item 2.02 of this current report on Form 8-K, including Exhibit 99.1, is deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and, therefore, may be incorporated by reference in filings under the Securities Act of 1933, as amended.

 

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.		Description
99.1		Press Release of EyePoint Pharmaceuticals, Inc., dated January 11, 2021
104		Cover Page Interactive Data File (embedded within the inline XBRL document)

 

 

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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.

 

		EyePoint Pharmaceuticals, Inc.
Date: January 11, 2021		By:		/s/ George O. Elston
		Name:		George O. Elston
		Title		Chief Financial Officer and Head of Corporate Development

 

 

Exhibit 99.1

 

 

EyePoint Pharmaceuticals Provides Business Update and Preliminary Fourth Quarter and Full-Year 2020 Net Product Revenues

 

- IND filed in December 2020 for EYP-1901, a potential six-month sustained delivery intravitreal

anti-VEGF treatment targeting wet age-related macular degeneration -

- anticipated Phase 1 clinical trial initiation in Q1 2021 -

 

- Q4 2020 net product revenues are estimated to be $6.2 - $6.6 million versus $7.9 million in 2019 and $20.3 - $20.7 million for the full year 2020 as compared to $16.8 million for the full year 2019 -

- Sequential quarterly increases in customer demand of 30% and 10% for DEXYCU® and YUTIQ®, respectively -

- Approximately $44M of cash and cash equivalents estimated on December 31, 2020 -

 

WATERTOWN, Mass., January 11, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products provided a business update and preliminary fourth quarter and full-year 2020 net product revenues as the company concluded 2020 with the achievement of several positive milestones and is looking forward to an eventful and promising 2021.

“EyePoint had a pivotal year in 2020 as we significantly improved our balance sheet, advanced our pipeline and navigated our commercial business through pandemic closures to be well-poised for a strong 2021,” said Nancy Lurker, President and Chief Executive Officer. “We are particularly excited by the filing of an IND for EYP-1901 in December, as this program has the potential to be a safe and effective twice-yearly sustained treatment for wet AMD.  This disease continues to devastate the eyesight of millions of patients, and although current approved treatments are effective, they require monthly or bi-monthly eye injections resulting in poor compliance and outcomes. The need for a less frequent treatment option is a significant opportunity for EYP-1901.”  

Ms. Lurker continued, “Upon FDA clearance of the IND, we anticipate the Phase 1 trial for EYP-1901 to begin in the first quarter of 2021 and we expect to report topline results in the second half of this year. In parallel with this activity, our commercial programs YUTIQ and DEXYCU, demonstrated sequential growth in Q3 and Q4 of 2020, despite the ongoing impact of the COVID-19 pandemic on these franchises. Both YUTIQ and DEXYCU are well-positioned for 2021, assuming the frequency of

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ophthalmology office visits and the number of cataract surgeries performed in the U.S. do not significantly decrease in the coming months due to the pandemic.”

 

EYP-1901 leverages the Company’s proprietary Durasert® drug delivery technology that is currently used in four FDA-approved products, including YUTIQ.  EYP-1901 uses a bioerodible formulation of Durasert coupled with a clinically validated anti-VEGF molecule, vorolanib. Vorolanib has demonstrated efficacy and ocular safety through Phase 2 trials in wet AMD as an oral therapy.  In addition to the current program to evaluate EYP-1901 as a potential treatment for wet AMD, EYP-1901 is also anticipated to be studied in additional retinal applications, including diabetic retinopathy and retinal vein occlusion.

R&D Update:

 

Fourth Quarter Commercial Performance

Financial Highlights

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The preliminary fourth quarter and full-year 2020 revenue results and cash on hand included in this release were calculated prior to the completion of a review by the Company’s independent registered public accounting firm and are therefore subject to adjustment.

Financial Outlook
Cash and cash equivalents are estimated to be approximately $44 million on December 31, 2020.  Cash on hand, combined with cash inflows from anticipated product sales and continued cash conservation activities are expected to fund the Company’s operating plan into the second half of 2021, assuming no significant increase in COVID-19-related closures that would considerably decrease the frequency of ophthalmology office visits or the number of cataract surgical procedures performed across the U.S.

About EyePoint Pharmaceuticals

EyePoint Pharmaceuticals, Inc. (Nasdaq:EYPT) is a pharmaceutical company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious eye disorders. The Company has two commercial products: YUTIQ®, for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye, and DEXYCU®, for the treatment of postoperative inflammation following ocular surgery. The Company's pipeline leverages its proprietary bioerodible Durasert® technology for extended intraocular drug delivery including EYP-1901, a potential six-month sustained delivery intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter and LinkedIn.

SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, including but not limited to statements about our expectations regarding the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a vital, novel six-month treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion; and preliminary financial information as of December 31, 2020, are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements are risks and uncertainties inherent in our business including, without limitation: the extent to which COVID-19 impacts our business; the effectiveness and timeliness of clinical trials, and the usefulness of the

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data; the timeliness of regulatory approvals; our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; our ability to successfully produce sufficient commercial quantities of YUTIQ and DEXYCU and to successfully commercialize YUTIQ and DEXYCU in the U.S.; our ability to sustain and enhance an effective commercial infrastructure and enter into and maintain commercial agreements for YUTIQ and DEXYCU; the development of our YUTIQ line extension shorter-duration treatment for non-infectious uveitis affecting the posterior segment of the eye; potential off-label sales in the U.S. by Alimera Sciences of ILUVIEN® for non-infectious uveitis affecting the posterior segment of the eye; consequences of fluocinolone acetonide side effects for YUTIQ; consequences of dexamethasone side effects for DEXYCU; our ability to market and sell products; the success of current and future license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; termination or breach of current license agreements, including our agreements with Ocumension Therapeutics and Equinox Science; our dependence on contract research organizations, contract sales organizations, vendors and investigators; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; volatility of stock price; possible dilution; absence of dividends; the potential for our preliminary financial information to change in connection with the finalization of our financial results for the fourth quarter of 2020; and other factors described in our filings with the Securities and Exchange Commission. We cannot guarantee that the results and other expectations expressed, anticipated or implied in any forward-looking statement will be realized. A variety of factors, including these risks, could cause our actual results and other expectations to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.

Investors:

 

Lisa Sher

SternIR

Direct: 212-698-8700

Lisa.sher@sternir.com

 

Media Contact

Tom Gibson

Tom Gibson Communications

Direct: (201) 476-0322

Tom@tomGibsoncommunications.com