EYPT EyePoint Pharmaceuticals Inc.
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
Yutiq
Non-infectious uveitis
|
sNDA Filing
sNDA Filing
|
sNDA filing planned.
|
|
YUTIQ
Non-infectious uveitis
|
Approved
Approved
|
FDA approval announced October 15, 2018.
|
|
Iluvien
Diabetic macular edema
|
Approved
Approved
|
CRL Nov 2011. Second CRL Oct 17 2013. Approved Sept 26 2014
|
Latest News
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WATERTOWN, Mass., May 26, 2020 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that Nancy Lurker, President and Chief Executive Officer, is scheduled to present at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020 at 8:30 AM ET.
A live webcast and subsequent archived replay of the presentation may be accessed via the Investors section of the Company's website at www.eyepoint.com. The replay will be available for 90 days after the event.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals, Inc. (www.eyepointpharma.com) is a pharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders. The Company currently has two commercial products: DEXYCU®, the first approved intraocular product for the treatment of postoperative inflammation, and YUTIQ®, a three-year treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The Company's pipeline leverages its proprietary bioerodible Durasert® technology for extended intravitreal drug delivery including EYP-1901, a VEGF inhibitor, targeting wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts with offices in Basking Ridge, New Jersey. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter and LinkedIn.
Contacts
Investors:
Argot Partners
Sam Martin or Joe Rayne
212-600-1902
[email protected]Media:
Thomas Gibson
201-476-0322
[email protected]
-
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WATERTOWN, Mass., May 18, 2020 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced the presentation of positive retrospective case study data supporting DEXYCU® (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following ocular surgery. The data were presented in three electronic posters and one oral paper session at the American Society of Cataract and Refractive Surgery (ASCRS) 2020 Virtual Annual Meeting on May 16-17, 2020.
The ongoing retrospective study is designed to provide large-scale, real-world data from surgeons based on their early experiences with DEXYCU. The study is expected to enroll up to 600 patients at approximately 40 study sites. Each time point of data in the real-world study reflects patient chart data and frequency of measurement by participating physicians.
"Preliminary results from the retrospective case review of real-world use of DEXYCU have re-confirmed the strong, early-acting anti-inflammatory activity of DEXYCU seen in clinical studies," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "We are pleased with the ambulatory surgical center adoption seen to date and the positive reception around DEXYCU's advantages compared to the burdensome steroid eye drop regimen. We are also encouraged by trends showing the re-opening of centers in areas where COVID-19 pandemic restrictions have been lifted, and we believe that DEXYCU may reduce the frequency of in-person physician follow-up visits and limit physician and caregiver contact with the patient's face and eyes. The retrospective case study data provide additional validation of our belief that DEXYCU can improve patient compliance for this growing ocular unmet need."
DEXYCU administration technique was also featured during the ASCRS Scientific Film session in a video by Michael A. Saidel, M.D., Corneal Specialist and Comprehensive Ophthalmologist, North Bay Eye Associates, entitled, "Evolution of an Administration Technique for Dexamethasone Intraocular Suspension 9%."
Summaries of the ASCRS presentations are as follows:
Paper Session Title: Retrospective Case Study Data on Dexamethasone Intraocular Suspension 9% for Inflammation Control after Cataract Surgery
Presenter: Robert J. Weinstock, M.D., Director of Cataract and Refractive Surgery, The Eye Institute of West Florida and the Weinstock Laser Eye Center
Session Title: Cataract Surgery – MedicationsInterim results presented were from 31 patients administered DEXYCU from Dr. Weinstock's practice. The proportion of patients with complete anterior chamber cell clearing (cell score=0), a measurement of inflammation, was 45.2%, 90.0%, 90.0% and 100.0% at postoperative day 1, 8, 14 and 30, respectively. The proportion of patients with no anterior chamber flares (flare score=0), another measurement of inflammation, was 87.1%, 100.0%, 100.0% and 100.0% at postoperative day 1, 8, 14 and 30, respectively. Mean intraocular pressure at postoperative day 1 was 17.4 mmHg, with levels decreasing through to postoperative day 30.
Title: Real-World Efficacy of Dexamethasone Intraocular Suspension 9%: Data from a Retrospective Case Study
Presenter: Cynthia Matossian, M.D., Founder and Chief Executive Officer, Matossian Eye AssociatesInterim results presented were from 271 patients administered DEXYCU with average age of 72. The proportion of eyes with complete anterior chamber cell clearing (cell score=0), a measurement of inflammation, was 51.2%, 60.9%, 86.2% and 90.5% at postoperative day 1, 8, 14 and 30, respectively. The proportion of patients with no anterior chamber flares (flare score=0), another measurement of inflammation, was 85.9%, 97.1%, 99.1% and 99.1% at postoperative day 1, 8, 14 and 30, respectively. Mean intraocular pressure at postoperative day 1 was 18.4 mmHg, with levels decreasing through to postoperative day 30.
Poster Title: Analysis of Performance and Best Practices with Dexamethasone Intraocular Suspension 9%: Data from a Retrospective Case Study
Presenter: Cynthia Matossian, M.D., Founder and Chief Executive Officer, Matossian Eye AssociatesInterim results presented were from 25 patients administered DEXYCU from Dr. Matossian's practice. The proportion of eyes with complete anterior chamber cell clearing (cell score=0), a measurement of inflammation, was 71.4%, 64.7%, 66.7% and 100.0% at postoperative day 1, 8, 14 and 30, respectively. The proportion of patients with no anterior chamber flares (flare score=0), another measurement of inflammation, was 97.1%, 100.0%, 100.0% and 100.0% at postoperative day 1, 8, 14 and 30, respectively. Mean intraocular pressure at postoperative day 1 was 19.4 mmHg, with levels decreasing through to postoperative day 30. DEXYCU was well tolerated.
Poster Title: Surgeon and Patient Satisfaction with Sustained-Release Dexamethasone Intraocular Suspension 9% for Post-Cataract Inflammation Control
Presenter: Cathleen McCabe, M.D., Cataract and LASIK Surgeon, The Eye AssociatesSurgeons participating in the retrospective study were asked a series of questions related to their experience using DEXYCU. In 91.3% of cases, surgeons were "very satisfied" or "satisfied" with their use of DEXYCU on a per-patient basis. In 93.6% of cases, surgeons were
"very satisfied" or "satisfied" with the ease of use of DEXYCU on a per-patient basis. 79.0% of surgeons believed the efficacy of DEXYCU was superior to topical steroids. In 90.6% of cases, patients were "very satisfied" or "satisfied" with their use of DEXYCU according to surgeon reports.About DEXYCU®
DEXYCU® (dexamethasone intraocular suspension) 9% is indicated for the treatment of postoperative inflammation and was approved by the FDA on February 9, 2018. A link to the full product label is available at: https://dexycu.com/wp-content/uploads/2019/01/DEXYCU-PI-20181220.pdf.About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals, Inc. (www.eyepointpharma.com) is a pharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders. The Company currently has two commercial products: DEXYCU®, the first approved intraocular product for the treatment of postoperative inflammation, and YUTIQ®, a three-year treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The Company's pipeline leverages its proprietary bioerodible Durasert® technology for extended intravitreal drug delivery including EYP-1901, a VEGF inhibitor, targeting wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts with offices in Basking Ridge, New Jersey. 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 extent to which our business could be adversely impacted by the effects of the COVID-19 coronavirus pandemic, as well as the timing and clinical development of our product candidates, including EYP-1901; and 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. 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 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 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; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema, or DME; Alimera's ability to obtain additional marketing approvals and the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; Alimera's ability to commercialize ILUVIEN for non-infectious uveitis affecting the posterior segment of the eye in the territories in which Alimera is licensed to do so; our ability to market and sell products; the success of current and future license agreements, including our agreement with Equinox Science; termination or breach of current license agreements, including our agreement with 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; 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.
Contacts
Investors:
Argot Partners
Sam Martin or Joe Rayne
212-600-1902
[email protected]Media:
Thomas Gibson
201-476-0322
[email protected] -
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- Total revenues of $7.5 million and net product revenues of $4.7 million -
- Cash conservation and reorganization initiatives coupled with recent financings support cash runway into 2021 under current COVID-19 pandemic assumptions -
- GLP toxicology studies initiated for EYP-1901, a six-month sustained release anti-VEGF potential treatment for wet age-related macular degeneration -
- Management to host a conference call and webcast today at 8:30 AM ET -
WATERTOWN, Mass., May 06, 2020 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today reported financial results for the first quarter ended March 31, 2020 and highlighted recent corporate developments.
"We are pleased with product revenue performance in the first quarter, despite the negative impact on customer demand caused by COVID-19 pandemic-related closures of customer facilities beginning in March. We are encouraged that certain regions across the country are now starting to reopen for business, allowing us to begin resupplying physicians and ambulatory surgery centers with our innovative products," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "We believe that both YUTIQ® and DEXYCU® are well-positioned to support physicians and patients in this COVID-19 era, as both products deliver extended duration therapeutic treatment from a single injection, which may reduce the frequency of in-person follow-up visits and contact with the patient's face and eyes."
Ms. Lurker continued, "We remain committed to our mission of delivering innovative ophthalmic products to patients in need and continue to advance our lead development asset EYP-1901 toward clinical trials. EYP-1901 is an anti-VEGF, tyrosine kinase inhibitor (TKI) six-month sustained release potential therapy using our bioerodible Durasert® technology initially targeting wet age-related macular degeneration. Good laboratory practice (GLP) toxicology studies were initiated in March and we remain on schedule to file an Investigational New Drug (IND) application later this year with a Phase 1 clinical trial to follow."
Commercial Performance in First Quarter 2020
- Customer demand trended strong for both products during the quarter prior to the emergence of the COVID-19 pandemic in the U.S. causing demand deterioration beginning in March.
- During the quarter, public health authorities and government agencies including the Centers for Medicare & Medicaid Services (CMS), recommended the postponement of all non-essential elective surgeries, including cataract surgery, for an extended period of time during the COVID-19 pandemic. As a result, ambulatory surgery centers (ASCs) closed or limited operations, decreasing DEXYCU product demand and orders. Our sales organization has maintained contact with customers during the pandemic by providing virtual support and education with regard to DEXYCU.
- Uveitis and retinal specialist office visits continued to be conducted for YUTIQ, though at reduced frequency, as chronic non-infectious uveitis affecting the posterior segment of the eye can lead to blindness if left untreated.
- There have been no disruptions to the supply chains for YUTIQ and DEXYCU and the Company continues to produce finished product for commercial sale.
- In April, the Company announced a reorganization of its commercial operations including cancellation or deferral of planned spending to conserve cash due to the COVID-19 pandemic impact on expected revenue. This reorganization was primarily focused on a reduction in the external contract sales organization for DEXYCU. The Company plans to allocate its remaining DEXYCU commercial resources to high-volume ASCs in key U.S. regions.
- The Company expects product demand to continue at current decreased levels until COVID-19 related restrictions on elective surgeries and office visits are lifted.
R&D Highlights
- In March, the Company initiated GLP toxicology studies for EYP-1901, an anti-VEGF, TKI six-month sustained release product candidate using our bioerodible Durasert technology. EYP-1901 is being developed as a potential treatment for wet age-related macular degeneration, with the potential for future indications in diabetic retinopathy and retinal vein occlusion, all of which are diseases representing attractive market opportunities in need of long-lasting treatments to improve treatment compliance. The Company expects to file an IND with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2020 with a Phase 1 clinical trial to commence shortly thereafter.
Operations Update
- In April, the Company received a $2 million loan through the Small Business Administration's Paycheck Protection Program (PPP) under the Coronavirus Aid, Relief and Economic Security Act of 2020 (the CARES Act). The PPP loan will enable the Company to retain key commercial infrastructure and employees and avoid furloughs as product demand and revenues remain significantly reduced due to ASC and physician office closures necessitated by the COVID-19 pandemic. The Company plans to use the proceeds of the PPP loan to cover payroll costs, rent and utilities in accordance with the CARES Act.
- The reorganization announced in April is expected to result in annual savings of approximately $7 million and one-time savings of approximately $10 million from other planned expenditure cancellations and deferrals.
Review of First Quarter Results Ended March 31, 2020
For the three months ended March 31, 2020, total net revenue was $7.5 million compared to $2.0 million for the three months ended March 31, 2019. Net product revenue for the three months ended March 31, 2020 was $4.7 million, with $3.6 million for YUTIQ and $1.1 million for DEXYCU, compared to net revenue for three months ended March 31, 2019 of $1.2 million, with $543,000 for YUTIQ and $684,000 for DEXYCU.Net revenue from royalties and collaborations for the three months ended March 31, 2020 totaled $2.8 million compared to $785,000 in the corresponding quarter in 2019.
Operating expenses for the three months ended March 31, 2020 increased to $18.9 million from $16.7 million in the prior year period, due primarily to increased sales and marketing costs and research and development costs. Non-operating expense, net, for the three months ended March 31, 2020 totaled $1.7 million of net interest expense. Net loss for the three months ended March 31, 2020 was $13.2 million, or $.11 per share, compared to a net loss of $19.2 million, or $0.20 per share, for the prior year quarter.
Cash and cash equivalents at March 31, 2020 totaled $26.3 million compared to $22.2 million at December 31, 2019.
Financial Outlook
We expect that the Company's cash and cash equivalents combined with projected cash inflows from anticipated YUTIQ and DEXYCU product sales can fund the Company's operating plan into 2021 under current assumptions for the duration of the COVID-19-related closures across the U.S.The Company continues to assess additional cash conservation measures to support its operation through the COVID-19 pandemic.
Conference Call Information
EyePoint will host a conference call today, Wednesday, May 6, 2020, at 8:30 AM ET to discuss the results for the first quarter ended March 31 and recent operational developments. To access the conference call, please dial (877) 312-7507 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 7972168. 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 EyePoint Pharmaceuticals
EyePoint Pharmaceuticals, Inc. (www.eyepointpharma.com) is a pharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders. The Company currently has two commercial products: DEXYCU®, the first approved intraocular product for the treatment of postoperative inflammation, and YUTIQ®, a three-year treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The Company's pipeline leverages its proprietary bioerodible Durasert® technology for extended intravitreal drug delivery including EYP-1901, a VEGF inhibitor, targeting wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts with offices in Basking Ridge, New Jersey. 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 extent to which our business could be adversely impacted by the effects of the COVID-19 coronavirus pandemic, as well as the timing and clinical development of our product candidates, including EYP-1901; and 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. 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 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 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; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema, or DME; Alimera's ability to obtain additional marketing approvals and the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; Alimera's ability to commercialize ILUVIEN for non-infectious uveitis affecting the posterior segment of the eye in the territories in which Alimera is licensed to do so; our ability to market and sell products; the success of current and future license agreements, including our agreement with Equinox Science; termination or breach of current license agreements, including our agreement with 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; 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.
Contacts
Investors:
Argot Partners
Sam Martin or Joe Rayne
212-600-1902
[email protected]Media:
Thomas Gibson
201-476-0322
[email protected]EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)Three Months Ended March 31, 2020 2019 Revenues: Product sales, net $ 4,687 $ 1,227 License and collaboration agreements 2,020 65 Royalty income 782 720 Total revenues 7,489 2,012 Operating expenses: Cost of sales, excluding amortization of acquired intangible assets 980 330 Research and development 4,853 3,797 Sales and marketing 8,125 7,311 General and administrative 4,360 4,610 Amortization of acquired intangible assets 615 615 Total operating expenses 18,933 16,663 Loss from operations (11,444 ) (14,651 ) Other income (expense): Interest and other income, net 54 243 Interest expense (1,784 ) (1,020 ) Loss on extinguishment of debt — (3,810 ) Total other expense, net (1,730 ) (4,587 ) Net loss $ (13,174 ) $ (19,238 ) Net loss per common share - basic and diluted $ (0.11 ) $ (0.20 ) Weighted average common shares outstanding - basic and diluted 115,530 95,452 EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands)March 31, December 31, 2020 2019 Assets Current assets: Cash and cash equivalents $ 26,299 $ 22,214 Accounts and other receivables, net 14,390 11,368 Prepaid expenses and other current assets 5,647 5,997 Inventory 3,358 2,138 Total current assets 49,694 41,717 Operating lease right-of-use assets 2,967 3,078 Intangible assets, net 27,054 27,669 Other assets 575 507 Total assets $ 80,290 $ 72,971 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued expenses $ 9,717 $ 11,024 Other current liabilities 551 481 Deferred revenue 30 15 Total current liabilities 10,298 11,520 Long-term debt 47,716 47,223 Operating lease liabilities - noncurrent portion 2,764 2,898 Other long-term liabilities 3,038 3,000 Total liabilities 63,816 64,641 Stockholders' equity: Capital 494,094 472,776 Accumulated deficit (478,460 ) (465,286 ) Accumulated other comprehensive income 840 840 Total stockholders' equity 16,474 8,330 Total liabilities and stockholders' equity $ 80,290 $ 72,971 -
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WATERTOWN, Mass., April 29, 2020 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, will report results for its first quarter 2020 on Wednesday, May 6, 2020. Management will host a conference call to review the results at 8:30 AM ET on the same day.
The conference call may be accessed by dialing (877) 312-7507 from the U.S. and Canada or (631) 813-4828 from international locations. The conference ID is 7972168. A live webcast will be available on the Investor Relations section of the corporate website at http://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, Inc. (www.eyepointpharma.com) is a pharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders. The Company currently has two commercial products: DEXYCU®, the first approved intraocular product for the treatment of postoperative inflammation, and YUTIQ®, a three-year treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The Company's pipeline leverages its proprietary bioerodible Durasert® technology for extended intravitreal drug delivery including EYP-1901, a VEGF inhibitor, targeting wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts with offices in Basking Ridge, New Jersey. To learn more about the Company, please visit www.eyepointpharma.com and connect on Twitter and LinkedIn.
Contacts
Investors:
Argot Partners
Sam Martin or Joe Rayne
212-600-1902
[email protected]Media:
Thomas Gibson
201-476-0322
[email protected] -
View Full Article Hide Full Article
- Proactive Efforts to Mitigate Spread and Protect Safety and Well-being of Patients, Treating Physicians, Employees and Our Communities -
- Reorganization of Commercial Operations to Align with Focused Approach -
WATERTOWN, Mass., April 01, 2020 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that the Company has taken proactive measures in response to changing market conditions caused by the novel coronavirus (COVID-19) global pandemic. These measures are intended to ensure the safety of its patients and employees and maintain the sustainability of its business operations and operating capital as this unprecedented situation continues to evolve. These measures also include a reorganization of its commercial operations and the cancellation or deferral of planned spending to conserve cash in response to a significant decline in product demand associated with shut-downs of customer facilities and postponements of elective surgical procedures in response to COVID-19.
"COVID-19 driven closures have significantly impacted our customer base and this commercial reorganization is necessary to focus the Company's resources on continuing to serve patients who are still being treated with YUTIQ® and DEXYCU®. We have prioritized our overall spending to focus on a more targeted commercial footprint, conserve cash and to continue advancing EYP-1901, a six-month potential treatment for wet age-related macular degeneration, toward clinical development," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "Our patients, employees, shareholders and the ocular disease community remain our top priorities as we navigate through the COVID-19 pandemic. We want to recognize and thank those affected by this reorganization for their dedication to EyePoint and our patients, and we will work to make their transitions to other opportunities as smooth as possible."
Dedicated to Delivering Our Innovative Ocular Disease Treatments to Patients
EyePoint is committed to providing uninterrupted access to our products during the COVID-19 pandemic for those patients who are in essential need of treatment. Our supply chains for YUTIQ and DEXYCU are robust and have not been interrupted during the pandemic. The Company has ample supply of API and other raw materials for YUTIQ and DEXYCU, and EyePoint continues to produce finished product for commercial sale. Our commercial team is providing ongoing support services for patients and physician offices on an as-needed basis, while respecting the need to maintain social distancing.Focusing of Commercial Operations in Response to COVID-19 Impact on Commercial Markets
The Company will downsize its current workforce, with reductions coming primarily from the external DEXYCU sales force and supporting commercial operations as cataract surgery is considered a non-essential procedure due to the pandemic. The Company plans to allocate its remaining DEXYCU commercial resources to high-volume ambulatory surgery centers (ASCs) in key U.S. regions, subject to the availability of such ASCs to perform elective cataract surgery upon the lifting of restrictions associated with the COVID-19 pandemic. The Company will continue to invest in its YUTIQ commercial operations, as treatments for patients suffering from non-infectious uveitis affecting the posterior segment of the eye continue to be deemed essential during the COVID-19 pandemic, given that irreversible blindness is a potential consequence of delaying treatment.The reorganization is expected to result in annual savings of approximately $7 million from workforce reductions and one-time savings of approximately $10 million from other planned expenditure cancellations and deferrals. Based on these actions, coupled with cash conservation activities, the Company is able to reconfirm its expected cash runway into 2021 under current assumptions for the duration of the COVID-19-related closures across the U.S.
The Company estimates that it will record approximately $0.6 million for severance and other costs related to the workforce reduction in the second quarter of 2020. Further details on the financial implications of the corporate restructuring will be included in the Company's 10-Q for the first quarter of 2020 and other filings to be made with the Securities and Exchange Commission.
Business Continuity Plan to Protect Employees and Advance Development Pipeline
In early March 2020, the Company mandated a work from home policy for all employees who are not deemed essential to our manufacturing operations and suspended all non-essential travel. The Company has maintained a rotating, limited schedule to ensure continued production of YUTIQ and DEXYCU with heightened safety precautions for our employees.Research and development initiatives remain on schedule. In March, the Company initiated a good laboratory practice (GLP) toxicology study for EYP-1901, a six-month sustained release anti-VEGF potential treatment for wet age-related macular degeneration. We expect to file an investigational new drug (IND) application for this program in the fourth quarter of 2020 with a Phase 1 clinical trial to commence shortly thereafter.
The Company continues to assess its policies, business continuity plans and employee support needs during the COVID-19 pandemic.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals, Inc. (www.eyepointpharma.com) is a pharmaceutical company committed to developing and commercializing innovative ophthalmic products in indications with high unmet medical need to help improve the lives of patients with serious eye disorders. The Company currently has two commercial products: DEXYCU®, the first approved intraocular product for the treatment of postoperative inflammation, and YUTIQ®, a three-year treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. The Company's pipeline leverages its proprietary bioerodible Durasert® technology for extended intravitreal drug delivery including EYP-1901, a VEGF inhibitor, targeting wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. EyePoint Pharmaceuticals is headquartered in Watertown, Massachusetts with offices in Basking Ridge, New Jersey. 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 extent to which our business could be adversely impacted by the effects of the COVID-19 coronavirus pandemic, as well as the timing and clinical development of our product candidates, including EYP-1901; and 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. 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 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 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; successful commercialization of, and receipt of revenues from, ILUVIEN for diabetic macular edema, or DME; Alimera's ability to obtain additional marketing approvals and the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; Alimera's ability to commercialize ILUVIEN for non-infectious uveitis affecting the posterior segment of the eye in the territories in which Alimera is licensed to do so; our ability to market and sell products; the success of current and future license agreements, including our agreement with Equinox Science; termination or breach of current license agreements, including our agreement with 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; 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.
Contacts
Investors:
Argot Partners
Sam Martin or Joe Rayne
212-600-1902
[email protected]Media:
Thomas Gibson
201-476-0322
[email protected]