0000950170-23-036770.txt : 20230802 0000950170-23-036770.hdr.sgml : 20230802 20230802070542 ACCESSION NUMBER: 0000950170-23-036770 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20230802 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20230802 DATE AS OF CHANGE: 20230802 FILER: COMPANY DATA: COMPANY CONFORMED NAME: EyePoint Pharmaceuticals, Inc. CENTRAL INDEX KEY: 0001314102 STANDARD INDUSTRIAL CLASSIFICATION: LABORATORY ANALYTICAL INSTRUMENTS [3826] IRS NUMBER: 262774444 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-51122 FILM NUMBER: 231133699 BUSINESS ADDRESS: STREET 1: 480 PLEASANT STREET STREET 2: SUITE B300 CITY: WATERTOWN STATE: MA ZIP: 02472 BUSINESS PHONE: 617-926-5000 MAIL ADDRESS: STREET 1: 480 PLEASANT STREET STREET 2: SUITE B300 CITY: WATERTOWN STATE: MA ZIP: 02472 FORMER COMPANY: FORMER CONFORMED NAME: pSivida Corp. DATE OF NAME CHANGE: 20080619 FORMER COMPANY: FORMER CONFORMED NAME: pSivida LTD DATE OF NAME CHANGE: 20050111 8-K 1 eypt-20230802.htm 8-K 8-K
0001314102false00013141022023-08-022023-08-02

 

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): August 02, 2023

 

 

EyePoint Pharmaceuticals, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware

000-51122

26-2774444

(State or Other Jurisdiction
of Incorporation)

(Commission File Number)

(IRS Employer
Identification No.)

 

 

 

 

 

480 Pleasant Street

 

Watertown, Massachusetts

 

02472

(Address of Principal Executive Offices)

 

(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: (617) 926-5000

 

 

(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:

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, par value $0.001

 

EYPT

 

The Nasdaq Global 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 2.02 Results of Operations and Financial Condition.

On August 2, 2023, EyePoint Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended June 30, 2023 and certain other information. A copy of the press release is furnished as Exhibit 99.1 hereto.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

 

Exhibit No.

 

Description

99.1

 

Press Release of EyePoint Pharmaceuticals, Inc., dated August 2, 2023

104

 

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

 

 


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:

August 2, 2023

By:

/s/ George O. Elston

 

 

 

George O. Elston
Chief Financial Officer

 


EX-99.1 2 eypt-ex99_1.htm EX-99.1 EX-99.1

img96707757_0.jpg 

Exhibit 99.1

EyePoint Pharmaceuticals Reports Second Quarter 2023 Financial Results and Highlights Recent Corporate Developments

–Phase 2 DAVIO 2 clinical trial evaluating EYP-1901 in wet age-related macular degeneration remains on track to report topline data in December 2023 –

–Phase 2 PAVIA clinical trial evaluating EYP-1901 in non-proliferative diabetic retinopathy remains on track with topline data anticipated in 2Q 2024 –

-
Jay S. Duker, M.D. promoted to President and Chief Executive Officer –

–YUTIQ® franchise sold for $82.5 million cash plus future royalties; all outstanding bank debt retired and cash runway extended into 2025 –

 

Management to host a conference call and webcast today at 8:30 a.m. ET –

 

WATERTOWN, Mass., August 2, 2023 (GLOBE NEWSWIRE) – EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed to developing and commercializing therapeutics to improve the lives of patients with serious eye disorders, today announced financial results for the second quarter ended June 30, 2023 and highlighted recent corporate developments.

“We remain on track for our important Phase 2 wet AMD trial readout of DAVIO 2 in December 2023. In addition, our second fully enrolled Phase 2 trial for EYP-1901, in non-proliferative diabetic retinopathy (NPDR), is on track to read out topline data in the second quarter of 2024,” said Jay Duker, M.D., President and Chief Executive Officer of EyePoint Pharmaceuticals. “Both studies were oversubscribed, indicating the keen interest in sustained delivery treatment options for these serious retinal eye diseases. Last month, we announced interim masked safety data from DAVIO 2 that revealed no reported drug-related ocular or systemic serious adverse events, bolstering our confidence in this differentiated maintenance therapy.”

Dr. Duker continued, “With the sale of the YUTIQ franchise in May, we completed EyePoint's transition into a focused clinical-stage biopharmaceutical company, with EYP-1901 as our lead pipeline program. The sale of YUTIQ® in May was a value-creating transaction that enabled EyePoint to retire all outstanding bank debt, reduce our projected SG&A spending and extend our cash runway into 2025, as we prepare for the potential Phase 3 pivotal trials for EYP-1901. It’s an exciting time to be a part of the EyePoint story as we are well-positioned to execute on key milestones and make a meaningful difference for patients suffering from serious eye diseases. We look forward to providing updates in the quarters to come.”

R&D Highlights and Updates

 

Oversubscribed Phase 2 DAVIO 2 clinical trial investigating EYP-1901 as a potential six-month maintenance treatment for wet AMD is fully enrolled and remains on track with topline data anticipated in December 2023.

 


 

 

Completed enrollment in the Phase 2 PAVIA clinical trial evaluating EYP-1901 as a potential nine-month treatment for moderate-to-severe NPDR. The trial enrolled 77 patients, exceeding the 60-patient target due to significant investigator and patient interest. Topline data is anticipated in the second quarter of 2024.
Presented the interim masked safety and baseline patient demographics of the DAVIO 2 clinical trial in wet AMD at the OIS Retina Innovation Summit in July. As of July 1, 2023, a masked safety study found that there were no reported drug related ocular serious adverse events (SAEs) or drug related systemic SAEs in the 160 enrolled patients in the DAVIO 2 trial. An analysis of the reported patient demographics suggests that Phase 2 DAVIO 2 patients have, on average, better starting visual acuity and less central subfield thickness than the Phase 1 DAVIO cohort.
Presented 12-month ocular pharmacokinetic results from a study evaluating EYP-1901’s drug delivery through the Durasert platform at the American Society of Retina Specialists (ASRS) Annual Meeting in July. The Company also presented an encore subgroup analysis of the EYP-1901 final twelve-month Phase 1 DAVIO results, which showed that 67% of the DAVIO patients with no excess fluid at screening did not require a supplemental anti-VEGF injection up to the six-month visit.
Presented an encore presentation of the Phase 1 DAVIO clinical trial twelve-month results at the European Society of Ophthalmology Congress 2023 in Prague. The presentation marked the first time that EyePoint presented EYP-1901 clinical trial results outside of the U.S.

 

Recent Corporate Highlights

Appointed Jay S. Duker, M.D. as President and Chief Executive Officer and member of the Board of Directors as part of a CEO transition in July 2023. Dr. Duker was previously Chief Operating Officer and President. Nancy S. Lurker transitioned to the role of Executive Vice Chair of the Board of Directors from the position of CEO.
Sold YUTIQ® franchise to Alimera Sciences in May 2023 for $82.5 million plus future royalties. The Company received $75 million upfront, retiring all outstanding bank debt, with $7.5 million to be received in equal quarterly installments in 2024. Additionally, commencing in 2025, EyePoint will receive a low to mid double-digit royalty on Alimera’s related U.S. net sales above defined thresholds for the calendar years 2025-2028. Under the terms of the agreement, Alimera received global rights to YUTIQ outside of China, Hong Kong, Taiwan, Macau and Southeast Asia, where YUTIQ is exclusively licensed to Ocumension Therapeutics (“Ocumension”) and EyePoint will continue to receive royalties from Ocumension for its YUTIQ sales.
Appointed Marcia Sellos-Moura, Ph.D. as Senior Vice President, Program Leadership on July 31, 2023. Dr. Sellos-Moura brings over 20 years of biopharmaceutical experience to the Company. In connection with the hiring of Dr. Sellos-Moura, the Compensation Committee of the Company’s Board of Directors granted stock options to purchase an aggregate of 100,000 shares of common stock as an inducement award material to Dr. Sellos-Moura entering into employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4). The stock options have an exercise price equal to the closing price of EyePoint's common stock on July 31, 2023, and will vest as follows: 25% on the first anniversary and monthly through the fourth anniversary of the date of grant, subject to the terms of grant.

 

Review of Results for the Second Quarter Ended June 30, 2023

 


 

 

For the second quarter ended June 30, 2023, total net revenue was $9.1 million compared to $11.6 million for the quarter ended June 30, 2022. Net product revenue for the second quarter was $5.3 million, compared to net product revenues for the second quarter ended June 30, 2022 of $11.3 million. The decline in net product revenue resulted from the sale of the YUTIQ franchise in May 2023 and the discontinuation of DEXYCU sales activities in 2023.

Net revenue from royalties and collaborations for the second quarter ended June 30, 2023 totaled $3.8 million compared to $0.3 million in the corresponding period in 2022. The increase was primarily due to partial recognition of deferred revenue from the sale of the YUTIQ franchise which will be recognized over a 2-year period in connection with the delivery of YUTIQ supply units.

Operating expenses for the second quarter ended June 30, 2023 totaled $31.9 million versus $30.8 million in the prior year period. This increase was primarily driven by R&D spending on the ongoing EYP-1901 clinical trials, partially offset by reduced sales and marketing expense. Non-operating expense, net, totaled $0.2 million and net loss was $22.9 million, or ($0.61) per share, compared to a net loss of $19.4 million, or ($0.52) per share, for the prior year period.

Cash and investments at June 30, 2023 totaled $142.5 million compared to $144.6 million at December 31, 2022.

Financial Outlook
We expect the cash, cash equivalents and investments on June 30, 2023 will enable us to fund our current and planned operations into 2025.

Conference Call Information

EyePoint will host a conference call today, at 8:30 a.m. ET to discuss the results for the second quarter ended June 30, 2023 and recent corporate developments. To access the live conference call, please register at https://register.vevent.com/register/BI1f9c401d832f439690f47dc2454e01d6. A live audio webcast of the event can be accessed via the Investors section of the Company website at www.eyepointpharma.com. A webcast replay will also be available on the corporate website at the conclusion of the call.

About EyePoint Pharmaceuticals

EyePoint Pharmaceuticals (NASDAQ: EYPT) is a company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders. The Company's pipeline leverages its proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery including EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment currently in Phase 2 clinical trials. The proven Durasert® drug delivery platform has been safely administered to thousands of patients' eyes across four U.S. FDA approved products. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts. For more information visit www.eyepointpharma.com.

 

EYEPOINT SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: To the extent any statements made in this press release deal with information that is not historical, these are forward-looking statements under the Private Securities Litigation Reform Act of 1995. Such statements include, but are not limited to, statements regarding the sufficiency of our existing cash resources into 2025; our plans and any other statements about future expectations, prospects, estimates and other matters that are dependent upon future events or developments, including statements

 


 

 

containing the words “will,” “potential,” “could,” “can,” “believe,” “intends,” “continue,” “plans,” “expects,” “anticipates,” “estimates,” “may,” other words of similar meaning or the use of future dates. Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Uncertainties and risks may cause EyePoint’s actual results to be materially different than those expressed in or implied by EyePoint’s forward-looking statements. For EyePoint, this includes uncertainties regarding our ability to realize the anticipated benefits of the 2023 sale of YUTIQ® to Alimera Sciences including our potential to receive additional payments from Alimera pursuant to the our agreements with Alimera; our ability to manufacture YUTIQ in sufficient quantities pursuant to our commercial supply agreements with Alimera and Ocumension Therapeutics; the timing and clinical development of our product candidates, including EYP-1901; the potential for EYP-1901 as a novel sustained delivery treatment for serious eye diseases, including wet age-related macular degeneration, non-proliferative diabetic retinopathy and diabetic macular edema; the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; the success of current and future license agreements, including our agreements with Alimera, Ocumension, Equinox Science and Betta Pharmaceuticals; termination or breach of current and future license agreements; our dependence on contract research organizations, co-promotion partners, and other outside vendors and service providers; effects of competition; market acceptance of our products, including our out-licensed products; product liability; industry consolidation; compliance with environmental laws; risks and costs of international business operations; volatility of stock price; possible dilution; the impact of instability in general business and economic conditions, including changes in inflation, interest rates and the labor market; the extent to which COVID-19 impacts our business and the medical community; protection of our intellectual property and avoiding intellectual property infringement; retention of key personnel; manufacturing risks; the sufficiency of the Company’s cash resources and need for additional financing; 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. EyePoint undertakes no obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Investors:

Christina Tartaglia
Stern IR
Direct: 212-698-8700

christina.tartaglia@sternir.com

 

Media Contact:

Amy Phillips

Green Room Communications

Direct: 412-327-9499

aphillips@greenroompr.com

 

 


 

EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

 

(Unaudited)

 

(In thousands, except per share data)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Three Months Ended
June 30,

 

 

Six Months Ended
June 30,

 

 

 

2023

 

 

2022

 

 

2023

 

 

2022

 

Revenues:

 

 

 

 

 

 

 

 

 

 

 

 

    Product sales, net

 

$

5,273

 

 

$

11,318

 

 

$

12,667

 

 

$

20,328

 

    License and collaboration agreements

 

 

3,597

 

 

 

49

 

 

 

3,631

 

 

 

108

 

    Royalty income

 

 

235

 

 

 

198

 

 

 

490

 

 

 

423

 

       Total revenues

 

 

9,105

 

 

 

11,565

 

 

 

16,788

 

 

 

20,859

 

Operating expenses:

 

 

 

 

 

 

 

 

 

 

 

 

    Cost of sales, excluding amortization of acquired
        intangible assets

 

 

1,792

 

 

 

1,734

 

 

 

2,432

 

 

 

3,511

 

    Research and development

 

 

15,730

 

 

 

12,992

 

 

 

29,348

 

 

 

22,937

 

    Sales and marketing

 

 

5,288

 

 

 

6,883

 

 

 

11,025

 

 

 

13,576

 

    General and administrative

 

 

9,056

 

 

 

8,557

 

 

 

18,298

 

 

 

17,106

 

    Amortization of acquired intangible assets

 

 

 

 

 

615

 

 

 

 

 

 

1,230

 

       Total operating expenses

 

 

31,866

 

 

 

30,781

 

 

 

61,103

 

 

 

58,360

 

Loss from operations

 

 

(22,761

)

 

 

(19,216

)

 

 

(44,315

)

 

 

(37,501

)

Other income (expense):

 

 

 

 

 

 

 

 

 

 

 

 

    Interest and other income, net

 

 

1,623

 

 

 

362

 

 

 

2,825

 

 

 

423

 

    Interest expense

 

 

(435

)

 

 

(552

)

 

 

(1,247

)

 

 

(1,745

)

    Loss on extinguishment of debt

 

 

(1,347

)

 

 

 

 

 

(1,347

)

 

 

(1,559

)

       Total other Income (expense), net

 

 

(159

)

 

 

(190

)

 

 

231

 

 

 

(2,881

)

Net loss

 

$

(22,920

)

 

$

(19,406

)

 

$

(44,084

)

 

$

(40,382

)

    Net loss per common share – basic and diluted

 

$

(0.61

)

 

$

(0.52

)

 

$

(1.17

)

 

$

(1.08

)

    Weighted average common shares outstanding – basic
        and diluted

 

 

37,576

 

 

 

37,322

 

 

 

37,531

 

 

 

37,288

 

 

 


 

 

EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES

 

CONDENSED CONSOLIDATED BALANCE SHEETS

 

(Unaudited)

 

(In thousands)

 

 

 

 

 

 

 

 

 

 

June 30,

 

 

December 31,

 

 

 

2023

 

 

2022

 

Assets

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

  Cash and cash equivalents

 

$

139,597

 

 

$

95,633

 

  Marketable securities

 

 

2,938

 

 

 

48,928

 

  Accounts and other receivables, net

 

 

10,952

 

 

 

15,503

 

  Prepaid expenses and other current assets

 

 

9,370

 

 

 

9,858

 

  Inventory

 

 

4,261

 

 

 

2,886

 

       Total current assets

 

 

167,118

 

 

 

172,808

 

Operating lease right-of-use assets

 

 

5,514

 

 

 

6,038

 

Other assets

 

 

3,023

 

 

 

1,510

 

       Total assets

 

$

175,655

 

 

$

180,356

 

Liabilities and stockholders' equity

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

  Accounts payable and accrued expenses

 

$

25,863

 

 

$

22,278

 

  Deferred revenue

 

 

42,084

 

 

 

1,205

 

  Short-term borrowings

 

 

 

 

 

10,475

 

  Other current liabilities

 

 

970

 

 

 

579

 

       Total current liabilities

 

 

68,917

 

 

 

34,537

 

Long-term debt

 

 

 

 

 

29,310

 

Deferred revenue – noncurrent

 

 

44,021

 

 

 

13,557

 

Operating lease liabilities – noncurrent

 

 

5,455

 

 

 

5,984

 

Other long-term liabilities

 

 

 

 

 

600

 

       Total liabilities

 

 

118,393

 

 

 

83,988

 

Stockholders' equity:

 

 

 

 

 

 

  Capital

 

 

771,855

 

 

 

766,933

 

  Accumulated deficit

 

 

(715,435

)

 

 

(671,351

)

  Accumulated other comprehensive income

 

 

842

 

 

 

786

 

       Total stockholders' equity

 

 

57,262

 

 

 

96,368

 

       Total liabilities and stockholders' equity

 

$

175,655

 

 

$

180,356

 

 

 


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Document And Entity Information
Aug. 02, 2023
Cover [Abstract]  
Document Type 8-K
Amendment Flag false
Document Period End Date Aug. 02, 2023
Entity Registrant Name EyePoint Pharmaceuticals, Inc.
Entity Central Index Key 0001314102
Entity Emerging Growth Company false
Securities Act File Number 000-51122
Entity Incorporation, State or Country Code DE
Entity Tax Identification Number 26-2774444
Entity Address, Address Line One 480 Pleasant Street
Entity Address, City or Town Watertown
Entity Address, State or Province MA
Entity Address, Postal Zip Code 02472
City Area Code (617)
Local Phone Number 926-5000
Written Communications false
Soliciting Material false
Pre-commencement Tender Offer false
Pre-commencement Issuer Tender Offer false
Title of 12(b) Security Common Stock, par value $0.001
Trading Symbol EYPT
Security Exchange Name NASDAQ
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