pSivida LTD SEC Form 8-K Filed May 5, 2021: Current report pursuant to Section 13 or 15(d) Last Updated May 6, 2021 at 1:00 AM DT

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Sequence Document Type File Name Description
1 SEC Form 8-K
2 SEC Form EX-99.1
3 Image g2wylfc1qsf5000001.jpg GRAPHIC
4 XBRL TAXONOMY EXTENSION SCHEMA
5 XBRL TAXONOMY EXTENSION LABEL LINKBASE
6 XBRL TAXONOMY EXTENSION PRESENTATION LINKBASE
7 XML Data eypt-8k_20210505_htm.xml IDEA: XBRL DOCUMENT
8 XML Data R1.htm IDEA: XBRL DOCUMENT
9 Spreadsheet Financial_Report.xlsx IDEA: XBRL DOCUMENT
10 XML Data Show.js IDEA: XBRL DOCUMENT
11 XML Data report.css IDEA: XBRL DOCUMENT
12 XML Data FilingSummary.xml IDEA: XBRL DOCUMENT
14 JSON Data MetaLinks.json IDEA: XBRL DOCUMENT
15 Compressed Data 0001564590-21-023625-xbrl.zip IDEA: XBRL DOCUMENT

8-K

eypt-8k_20210505.htm
false 0001314102 0001314102 2021-05-05 2021-05-05

 

 

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): May 5, 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.  

 

 


 

 

Item 2.02. Results of Operations and Financial Condition.

 

On May 5, 2021, EyePoint Pharmaceuticals, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2021 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 March 31, 2021

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: May 5, 2021

 

By:

 

/s/ George O. Elston

 

 

Name:

 

George O. Elston

 

 

Title

 

Chief Financial Officer and Head of Corporate Development

 

 

EX-99.1

eypt-ex991_6.htm

Exhibit 99.1

 

EyePoint Pharmaceuticals Reports First Quarter 2021 Financial Results and Highlights Recent Corporate Developments

- EYP-1901 DAVIO study for the potential treatment of wet AMD dosed first patient in January; study remains on track for initial data in Q4 2021;

-Completed $115.1 million follow-on financing in February 2021;

-Net product revenues of $6.8 million versus $4.7 million in Q1 2020, a 45% increase;

-Asia partner Ocumension Therapeutics new drug application (NDA) accepted for review by the National Medical Products Administration (NMPA) for OT-401 (YUTIQâ)

 - Management to host a conference call and webcast today at 8:30 AM ET –

 

WATERTOWN, Mass., May 5, 2021 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical company committed to developing and commercializing therapeutics to help improve the lives of patients with serious eye disorders, today announced financial results for the first quarter ended March 31, 2021 and highlighted recent corporate developments.

“This quarter was a productive one for EyePoint, as we continued to execute on our plan to advance our exciting pipeline of ocular products that have the potential to disrupt current treatment paradigms,” said Nancy Lurker, Chief Executive Officer of EyePoint Pharmaceuticals. “We are very pleased to have initiated the Phase 1 DAVIO clinical trial in patients with wet-age macular degeneration (wet AMD) in January and this trial remains on track for interim data in the fourth quarter of this year.”  Ms. Lurker continued, “We were also very pleased to complete a $115.1 million follow-on financing during the first quarter positioning us to advance and expand our pipeline efficiently and purposefully, including plans to expand EYP-1901 into clinical trials in diabetic retinopathy (DR) and retinal vein occlusion (RVO). “On the commercial front, we had a solid first quarter, which historically is weak due to co-pay and coinsurance annual resets, beating 4Q2020 and 45% above 1Q2020 net product revenues. We also are very pleased with our DEXYCU® co-promotion partnership with ImprimisRx and the product demand it is now generating.

 

Corporate Update

 

In February 2021, the Company completed an upsized underwritten public offering with gross proceeds of $115.1 million.

 


 

 

In April 2021, Asia partner Ocumension Therapeutics announced that the new drug application (NDA) for OT-401 (YUTIQ) has been accepted by the National Medical Products Administration of the People’s Republic of China (NMPA). OT-401 (YUTIQ) is the first ophthalmic drug of the Company whose NDA has been accepted by the NMPA, and is also the first sustained-release micro-insert submitted for NDA in mainland China that has a controlled release rate for up to 36 months. It is also the first time the NMPA has accepted the NDA based on real world study data.

Commercial Performance in First Quarter 2021

 

Net product revenue for YUTIQ and DEXYCU was $3.0 million and $3.8 million, respectively.

 

 

Customer demand of approximately 400 units of YUTIQ and approximately 7,000 units for DEXYCU.

 

 

DEXYCU commercial partner, ImprimisRx®, continues to provide momentum and revenue generation through their experienced cataract surgery field force, materially contributing to Q1 customer demand.

 

R&D Highlights

 

In January, the first patient was dosed in the Phase 1 DAVIO study of EYP-1901 as a potential twice-yearly sustained delivery anti-VEGF treatment for wet AMD and the Company expects to report initial data in the fourth quarter of 2021.  EYP-1901 leverages a bioerodible formulation of the Company’s proprietary Durasert® drug delivery technology platform that has been used in four FDA-approved products, including EyePoint’s YUTIQ for chronic non-infectious uveitis affecting the posterior segment of the eye.

 

Investigator studies of DEXYCU will be presented in two separate poster sessions at the Association for Research in Vision and Ophthalmology (ARVO) Annual meeting on May 5, 2021.

 

Review of Results for the First Quarter ended March 31, 2021

For the first quarter ended March 31, 2021, total net revenue was $7.3 million compared to $7.5 million for the quarter ended March 31, 2020. Net product revenue for the first quarter was $6.8 million, compared to net product revenues for the first quarter ended March 31, 2020 of $4.7 million.

Net revenue from royalties and collaborations for the first quarter ended March 31, 2021 totaled $0.5 million compared to $2.8 million in the corresponding period in 2020.

Operating expenses for the first quarter ended March 31, 2021 totaled $18.3 million versus $18.9 million in the prior year period. This decrease was primarily due to a $2.4 million decrease in sales and marketing expense offset by a $0.8 million increase in G&A


expense, a $0.6 million increase in R&D expense and a $0.4 million increase in cost of sales.  Non-operating expense, net, totaled $1.3 million and net loss was $12.3 million, or ($0.50) per share, compared to a net loss of $13.2 million, or ($1.14) per share, for the prior year period.

Cash and cash equivalents at March 31, 2021 totaled $138.6 million compared to $44.9 million at December 31, 2020.

Financial Outlook
We expect the cash on hand at March 31, 2021 and expected net cash inflows from our product sales will enable us to fund our current and planned operations through the end of 2022.

Conference Call Information
EyePoint will host a conference call today, at 8:30 AM ET to discuss the results for the first quarter of 2021 ended March 31, 2021 and recent operational developments. To access the conference call, please dial (877-303-5828) from the U.S. and Canada or (631)-813-4828 (international) at least 10 minutes prior to the start time and refer to conference ID 1261618. A live webcast will be available on the Investor Relations section of the corporate website at 
http://www.eyepointpharma.com. A replay of the webcast will also be available on the corporate website.

About EYP-1901
EYP-1901 is a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment for wet age-related macular degeneration. EYP-1901 leverages a bioerodible formulation of EyePoint’s proprietary Durasert® sustained release technology with vorolanib, a tyrosine kinase inhibitor. Vorolanib provided clear efficacy signals in two prior human trials in wet AMD as an orally delivered therapy with no significant ocular adverse events. EYP-1901 is currently in a Phase 1 clinical trial initially targeting treatment of wet AMD, with the potential for additional indications in diabetic retinopathy and retinal vein occlusion.

About 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's pipeline leverages its proprietary Durasert® technology for sustained intraocular drug delivery including EYP-1901, a potential twice-yearly sustained delivery intravitreal anti-VEGF treatment initially targeting wet age-related macular degeneration. 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. 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: 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 anticipated use of proceeds for the proposed offering and other statements identified by words such as “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 the continued impact of the COVID-19 pandemic on EyePoint’s business, the medical community and the global economy and the impact of general business and economic conditions, our expectations regarding the timing and clinical development of our product candidates, including EYP-1901; and the potential for EYP-1901 as a novel twice-yearly treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion; the effectiveness and timeliness of clinical trials, and the usefulness of the 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; 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, co-promotion partners, and other outside vendors and service providers; 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; 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:

Christina Tartaglia
SternIR
Direct: 212-698-8700
christina.tartaglia@sternir.com

 


 

Media:

 

Green Room Public Relations

Caren Begun

Green Room Communications

Direct: (201) 396-8551 

caren@greenroompr.com   

 


 

EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

(In thousands, except per share data)

 

 

 

Three Months Ended

March 31,

 

 

 

2021

 

 

2020

 

Revenues:

 

 

 

 

 

 

 

 

Product sales, net

 

$

6,802

 

 

$

4,687

 

License and collaboration agreements

 

 

341

 

 

 

2,020

 

Royalty income

 

 

180

 

 

 

782

 

Total revenues

 

 

7,323

 

 

 

7,489

 

Operating expenses:

 

 

 

 

 

 

 

 

Cost of sales, excluding amortization of acquired

   intangible assets

 

 

1,390

 

 

 

980

 

Research and development

 

 

5,479

 

 

 

4,853

 

Sales and marketing

 

 

5,659

 

 

 

8,125

 

General and administrative

 

 

5,115

 

 

 

4,360

 

Amortization of acquired intangible assets

 

 

615

 

 

 

615

 

Total operating expenses

 

 

18,258

 

 

 

18,933

 

Loss from operations

 

 

(10,935

)

 

 

(11,444

)

Other income (expense):

 

 

 

 

 

 

 

 

Interest and other income, net

 

 

1

 

 

 

54

 

Interest expense

 

 

(1,346

)

 

 

(1,784

)

Total other expense, net

 

 

(1,345

)

 

 

(1,730

)

Net loss

 

$

(12,280

)

 

$

(13,174

)

Net loss per common share - basic and diluted

 

$

(0.50

)

 

$

(1.14

)

Weighted average common shares outstanding -

   basic and diluted

 

 

24,735

 

 

 

11,553

 

 


 

EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(Unaudited)

(In thousands)

 

 

 

March 31,

 

 

December 31,

 

 

 

2021

 

 

2020

 

Assets

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

138,579

 

 

$

44,909

 

Accounts and other receivables, net

 

 

12,332

 

 

 

9,453

 

Prepaid expenses and other current assets

 

 

2,856

 

 

 

3,419

 

Inventory

 

 

5,586

 

 

 

5,337

 

Total current assets

 

 

159,353

 

 

 

63,118

 

Operating lease right-of-use assets

 

 

2,484

 

 

 

2,610

 

Intangible assets, net

 

 

24,594

 

 

 

25,209

 

Other assets

 

 

709

 

 

 

780

 

Total assets

 

$

187,140

 

 

$

91,717

 

Liabilities and stockholders’ equity

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable and accrued expenses

 

$

11,770

 

 

$

13,256

 

Deferred Revenue

 

 

973

 

 

 

945

 

Other current liabilities

 

 

698

 

 

 

687

 

Total current liabilities

 

 

13,441

 

 

 

14,888

 

Long-term debt

 

 

38,124

 

 

 

37,977

 

Deferred revenue - noncurrent

 

 

15,349

 

 

 

15,616

 

Operating lease liabilities - noncurrent

 

 

2,172

 

 

 

2,330

 

Other long-term liabilities

 

 

2,347

 

 

 

2,365

 

Total liabilities

 

 

71,433

 

 

 

73,176

 

Stockholders’ equity:

 

 

 

 

 

 

 

 

Capital

 

 

637,826

 

 

 

528,380

 

Accumulated deficit

 

 

(522,960

)

 

 

(510,680

)

Accumulated other comprehensive income

 

 

841

 

 

 

841

 

Total stockholders’ equity

 

 

115,707

 

 

 

18,541

 

Total liabilities and stockholders’ equity

 

$

187,140

 

 

$

91,717

 

 

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