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., Sept. 10, 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, will present in two upcoming virtual conferences in September.
Cantor Virtual Healthcare Conference
Date: Tuesday, September 15
Time: 4:40 PM Eastern TimeH.C. Wainwright 22nd Annual Global Investment Conference
Date: Wednesday, September 16
Time: 2:00 PM Eastern TimeA live webcast and subsequent archived replay of the presentations 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 intraocular drug delivery including EYP-1901, a potential six-month anti-VEGF therapy initially targeting wet age-related macular degeneration. 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., Aug. 24, 2020 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced that it has entered into a purchase and marketing agreement with Vantage Outsourcing for DEXYCU® (dexamethasone intraocular suspension) 9%. Vantage Outsourcing is a leading cataract surgical service provider to a variety of hospitals, ambulatory surgery centers (ASCs), and physicians. The agreement will enable customers in the Vantage Outsourcing network, which spans over a 25+ state service area, to incorporate DEXYCU into their surgical protocols for treating ocular inflammation associated with cataract surgery.
"We are fortunate to partner with Vantage Outsourcing, as we continue to expand our growing lists of ASCs and integrated healthcare networks in the U.S. that can make DEXYCU available to their cataract surgery patients. Vantage Outsourcing represents a unique opportunity to increase our presence with cataract surgery customers that had previously been beyond our reach, and we believe Vantage Outsourcing is an ideal partner due to our shared commitment to patient care," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "This important partnership aligns with our greater strategic approach of making DEXYCU more widely available to key ASCs and their patients in select U.S. regions."
"We are excited to partner with EyePoint in bringing innovative, high quality products to our surgeons and their patients," said Ann Deters, Chief Executive Officer of Vantage Outsourcing. "Being able to add DEXYCU to our product service line will allow us to greatly improve the patient's postoperative experience due to DEXYCU's long-lasting anti-inflammatory activity and single administration."
About Vantage
Vantage's business is a shared-surgical service for hospitals, surgery centers and ophthalmologists. Vantage's technical staff bringing equipment, surgical supplies, implants, micro-instruments, as well as technical expertise, to the operating room suite. This innovative model allows facilities to increase surgery revenue, avoid capital equipment risks, increase surgical efficiencies, and convert fixed costs to variable costs, as it relates to surgical procedures.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 intraocular drug delivery including EYP-1901, a potential six-month anti-VEGF therapy initially targeting wet age-related macular degeneration. 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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WATERTOWN, Mass., Aug. 20, 2020 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, and Ocumension Therapeutics, a China-based ophthalmic pharmaceutical platform company, today announced the expansion of their exclusive license agreements for the development and commercialization of YUTIQ® and DEXYCU® in certain Asian markets. Under the expanded agreements, Ocumension has made a one-time $9.5 million payment to EyePoint for rights to commercialize both products under their own brand names in South Korea and other jurisdictions across Southeast Asia and as the full and final prepayment of all remaining development, regulatory, and commercial sale milestone payments under the original license agreements.
"Ocumension is an important partner that shares our beliefs in the therapeutic potential of YUTIQ and DEXYCU for ocular diseases that represent growing and significant areas of unmet medical need," said George Elston, Chief Financial Officer and Head of Corporate Development of EyePoint Pharmaceuticals. "We are delighted to expand our partnership with Ocumension to include the broader Asian marketplace. The payment from the expanded license agreements will support our operations and the ongoing clinical development of our pipeline, including our lead candidate, EYP-1901, a potential six-month sustained delivery therapy for wet age-related macular degeneration."
"EyePoint's YUTIQ and DEXYCU are important programs in our portfolio of ocular disease treatments that have the potential to replace current standards of care that lack long-term activity, especially given the impact of COVID-19 on patient desire to visit the doctor," said Ye Liu, Chief Executive Officer of Ocumension. "We look forward to continuing our development efforts for both products in order to bring these innovative treatment options to patients in need across Asia."
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 intraocular drug delivery including EYP-1901, a potential six-month anti-VEGF therapy initially targeting wet age-related macular degeneration. 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.
About Ocumension Therapeutics
Ocumension Therapeutics is a China-based ophthalmic pharmaceutical platform company dedicated to identifying, developing and commercializing first- or best-in-class ophthalmic therapies. The company's vision is to provide a world-class pharmaceutical total solution to address significant unmet ophthalmic medical needs in China. Since the inception, Ocumension Therapeutics has focused on building a platform integrating specialized capabilities in each major functionality involved in an ophthalmic drug's development cycle, from research and development, manufacturing to commercialization. Ocumension Therapeutics believes its platform positions it well to achieve leadership in China ophthalmology, with a first-mover advantage over future competitors.
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 potential benefits of our partnership with Ocumension, 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.
EyePoint Contacts:
Investors:
Argot Partners
Sam Martin or Joe Rayne
212-600-1902
[email protected]Media:
Thomas Gibson
201-476-0322
[email protected]Ocumension Contact:
Qinglei Zuo
+86-21-68362137-7796
[email protected] -
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- Total revenues of $4.1 million and net product revenues of $3.7 million impacted by COVID-19 pandemic -
- U.S. commercial alliance with ImprimisRx to expand reach of DEXYCU® -
- Jay S. Duker, M.D., world-renowned retinal specialist, joins as Chief Strategic Scientific Officer to lead EYP-1901 development efforts and support expansion of pipeline -
- EYP-1901, a potential six-month sustained delivery anti-VEGF therapy initially targeting wet age-related macular degeneration, remains on track for Q4 IND filing -
- Management to host a conference call and webcast today at 8:30 AM ET -
WATERTOWN, Mass., Aug. 05, 2020 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, today announced financial results for the second quarter ended June 30, 2020 and highlighted recent corporate developments.
"We were encouraged by the re-opening of healthcare facilities in select regions of the U.S during the quarter-end as underlying customer demand from our distributors was strong in June for both YUTIQ® and DEXYCU®. We believe the distinct advantages of single-injection, long-lasting activity provides for fewer office visits and less contact with patient eyes and positions both products for expanded use during the COVID-19 pandemic and recovery," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "We are also very excited to announce our new U.S. commercial alliance with ImprimisRx for DEXYCU and believe that this collaboration will significantly enhance the DEXYCU opportunity by reaching new physicians and ambulatory surgery centers, while also pairing DEXYCU with Harrow's complementary ophthalmology drug offerings. In addition to increased physician reach, this agreement keeps our commercial cost structure at our previously announced reduced levels. As we continue to further build our commercial efforts and product education initiatives, we remain very focused on our balance sheet and continue to actively manage our spending burn rate as we look to extend our cash runway into 2021."
Ms. Lurker continued, "Our new Chief Strategic Scientific Officer, Dr. Jay Duker, will lead our development efforts for EYP-1901, a potential six-month sustained delivery anti-VEGF therapy using our bioerodible Durasert® technology. The good laboratory practice (GLP) toxicology study for this program is progressing well and we expect data in the coming months to support filing of an Investigational New Drug (IND) application in the fourth quarter. We are very excited to advance this program to potentially treat wet age-related macular degeneration (wet AMD), a significant market in need of innovative, long-lasting therapies."
Commercial Performance in Second Quarter 2020
- During the quarter, public health authorities and government agencies, including the Centers for Medicare & Medicaid Services (CMS), issued recommendations for the re-opening of health care systems and the resumption of non-essential elective surgeries, including cataract surgery, in areas with low or stable incidence of COVID-19.
- As a result, office visits for uveitis and retinal specialists increased and ambulatory surgery centers (ASCs) resumed operations and scheduling of surgeries in select U.S. regions on a limited basis.
- Customer demand for YUTIQ, represented as units purchased by physicians from the Company's distributors, was 428 units in Q2 as compared to 537 units in Q1. June represented 167 units of that demand.
- Customer demand for DEXYCU, represented as units purchased by ASCs from the Company's distributors, was 2,096 units in Q2 as compared to 3,462 units in Q1. June represented one of the highest customer demand months of 2020 for DEXYCU, with 1,592 units, despite reductions in our commercial organization that were announced on April 1.
- The Company continues to actively monitor the COVID-19 pandemic and associated public health recommendations to ensure the safety of our patients and physicians as regions of the U.S. begin to reopen.
Operations Update
- In August, the Company announced a U.S. commercial alliance with ImprimisRx, the nation's leading ophthalmic-focused outsourcing facility, for DEXYCU, in which it will be marketed as prioritized product. Under the terms of the commercial alliance, ImprimisRx will deploy its sales team to immediately begin promoting DEXYCU to its accounts with an initial focus on accounts currently purchasing Tri-Moxi® for ocular surgery inflammation. EyePoint will be responsible for the marketing, selling, pricing, manufacturing, and contracting for DEXYCU while also seeking additional volume-based agreements with ASCs and integrated health care networks to expand patient access. ImprimisRx will be entitled to receive a commission on the incremental sales that exceed pre-specified baselines.
- In July, Jay S. Duker, M.D, was appointed to the newly created role of Chief Strategic Scientific Officer. Dr. Duker will lead the strategic advancement of research and development efforts, beginning with our lead development candidate, EYP-1901, for wet AMD and new pipeline expansion opportunities under evaluation. Dr. Duker is world renowned retinal disease expert and serves as the Director of the New England Eye Center. and Professor and Chair of Ophthalmology at Tufts Medical Center and Tufts University School of Medicine.
R&D Highlights
- In July, data from the first Phase 3 trial of YUTIQ were presented at the American Society of Retina Specialists Virtual Annual Meeting. A post-hoc analysis of imputed recurrences revealed over half were from confounding systemic medication use, which suggest the recurrence rate for YUTIQ is likely lower than the reported 56% at 36-months. The results also demonstrated YUTIQ increased the resolution of macular edema and improved visual acuity at 36-months.
- In June, supportive data from the Phase 2 trial of orally delivered vorolanib, the anti-VEGF molecule in EYP-1901, conducted by Tyrogenex, Inc. for the treatment of wet AMD were published in the British Journal of Ophthalmology. Oral vorolanib demonstrated non-inferiority in visual acuity compared to placebo with best corrected visual acuity (BCVA) stable through 12-months. The three oral vorolanib doses levels studied also demonstrated a decreased intravitreal anti-VEGF injection burden and a longer time to first treatment as compared to placebo. There were several instances in which patients on vorolanib did not require another anti-VEGF injection after screening. The trial was prematurely stopped due to gastrointestinal and hepatobiliary toxicity concerns. The efficacy results provide additional validation of vorolanib for use in EYP-1901 as a potential single dose sustained release treatment for wet AMD.
- In June, a post-hoc analysis of cases of bilateral uveitis in the first Phase 3 trial of YUTIQ were presented virtually at the Association for Research in Vision and Ophthalmology Annual Meeting. Outcomes for the untreated fellow eye were examined as a means of understanding the natural history of the disease and showed a recurrence rate of 86.4% compared to 56.3% for YUTIQ treated eyes at 36-months. At 36-months, fellow eyes also showed a higher rate of the need for the assistance of adjunctive intraocular/periocular injection medication for uveitic inflammation, more macular edema, and a one-line average decrease in BCVA. These supportive results reinforce the long-term, anti-inflammatory activity of YUTIQ for this difficult to treat disease.
- In May, four abstracts highlighting data from the ongoing retrospective study of real-world use of DEXYCU were presented at the American Society of Cataract and Refractive Surgery 2020 Virtual Annual Meeting. The data showed DEXYCU's early-acting anti-inflammatory activity resulted in complete anterior chamber cell clearing (cell score=0), a measurement of inflammation, in 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. DEXYCU also received high marks on the physician survey of product satisfaction, ease of use, efficacy compared to topic steroids and patient satisfaction.
Review of Second Quarter Results Ended June 30, 2020
For the three months ended June 30, 2020, total net revenue was $4.1 million compared to $7.2 million for the three months ended June 30, 2019. Net product revenue for the three months ended June 30, 2020 was $3.7 million, with $2.9 million for YUTIQ and $0.8 million for DEXYCU, compared to net product revenue for three months ended June 30, 2019 of $6.7 million generated by YUTIQ. Net product revenue represents product purchased by EyePoint's distributors whereas customer demand represents purchases of product by physician practices and ambulatory surgery centers from EyePoint's distributors.Net revenue from royalties and collaborations for the three months ended June 30, 2020 totaled $416,000 compared to $505,000 in the corresponding quarter in 2019.
Operating expenses for the three months ended June 30, 2020 decreased to $15.3 million from $17.4 million in the prior year period, due primarily to decreased sales and marketing costs from our previously announced restructuring as well as lower research and development costs. Non-operating expense, net, for the three months ended June 30, 2020 totaled $1.8 million of net interest expense. Net loss for the three months ended June 30, 2020 was $13.0 million, or $0.10 per share, compared to a net loss of $11.5 million, or $0.11 per share, for the prior year quarter.
Review of Six Months Results Ended June 30, 2020
For the six months ended June 30, 2020, total revenue was $11.6 million compared to $9.2 million for the six months ended June 30, 2019. Net product revenue for the six months ended June 30, 2020 was $8.4 million, compared to net product revenue for six months ended June 30, 2019 of $7.9 million.Net revenue from royalties and collaborations for the six months ended June 30, 2020 totaled $3.2 million compared to $1.3 million in the corresponding quarter in 2019.
Operating expenses for the six months ended June 30, 2020 totaled $34.2 million from $34.0 million in the prior year period. This increase was primarily from higher cost of sales due to higher product sales as well as an increased royalty expense stemming from a $2 million upfront payment received during Q1-2020 for the licensing of DEXYCU in China.
Non-operating expense, net, for the six months ended June 30, 2020 totaled $3.5 million. Net loss for the six months ended June 30, 2020 was $26.1 million, or $0.22 per share, compared to a net loss of $30.7 million, or $0.30 per share, for the prior year period.
Cash and cash equivalents at June 30, 2020 totaled $22.8 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 and other expected financing activities 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 and generation measures to support its operations through the COVID-19 pandemic.
Conference Call Information
EyePoint will host a conference call today, Wednesday, August 5, 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 5815799. 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 intraocular drug delivery including EYP-1901, a potential six-month anti-VEGF therapy initially targeting wet age-related macular degeneration. 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 Six Months Ended June 30, June 30, 2020 2019 2020 2019 Revenues: Product sales, net $ 3,706 $ 6,705 $ 8,393 $ 7,932 License and collaboration agreements 35 5 2,055 70 Royalty income 381 500 1,163 1,220 Total revenues 4,122 7,210 11,611 9,222 Operating expenses: Cost of sales, excluding amortization of acquired intangible assets 502 706 1,482 1,035 Research and development 3,276 3,955 8,129 7,753 Sales and marketing 6,089 7,284 14,214 14,595 General and administrative 4,792 4,815 9,152 9,425 Amortization of acquired intangible assets 615 615 1,230 1,230 Total operating expenses 15,274 17,375 34,207 34,038 Loss from operations (11,152 ) (10,165 ) (22,596 ) (24,816 ) Other income (expense): Interest and other income, net 8 266 62 509 Interest expense (1,806 ) (1,599 ) (3,590 ) (2,619 ) Loss on extinguishment of debt — — — (3,810 ) Total other expense, net (1,798 ) (1,333 ) (3,528 ) (5,920 ) Net loss $ (12,950 ) $ (11,498 ) $ (26,124 ) $ (30,736 ) Net loss per common share - basic and diluted $ (0.10 ) $ (0.11 ) $ (0.22 ) $ (0.30 ) Weighted average common shares outstanding - basic and diluted 124,771 106,238 120,151 100,847 EYEPOINT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands)June 30, December 31, 2020 2019 Assets Current assets: Cash and cash equivalents $ 22,814 $ 22,214 Accounts and other receivables, net 7,350 11,368 Prepaid expenses and other current assets 5,895 5,997 Inventory 3,773 2,138 Total current assets 39,832 41,717 Operating lease right-of-use assets 2,852 3,078 Intangible assets, net 26,439 27,669 Other assets 562 507 Total assets $ 69,685 $ 72,971 Liabilities and stockholders' equity Current liabilities: Accounts payable and accrued expenses $ 9,013 $ 11,024 Other current liabilities 573 481 Deferred revenue — 15 Total current liabilities 9,586 11,520 Long-term debt 50,259 47,223 Operating lease liabilities - noncurrent portion 2,626 2,898 Other long-term liabilities 3,026 3,000 Total liabilities 65,497 64,641 Stockholders' equity: Capital 494,758 472,776 Accumulated deficit (491,410 ) (465,286 ) Accumulated other comprehensive income 840 840 Total stockholders' equity 4,188 8,330 Total liabilities and stockholders' equity $ 69,685 $ 72,971 -
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WATERTOWN, Mass. and NASHVILLE, Tenn., Aug. 04, 2020 (GLOBE NEWSWIRE) -- EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a pharmaceutical company committed to developing and commercializing innovative ophthalmic products, and ImprimisRx, the nation's leading ophthalmic-focused outsourcing facility and pharmaceutical compounding business and a wholly-owned subsidiary of Harrow Health, Inc. (NASDAQ:HROW), today announced the signing of a commercial alliance for the joint promotion of DEXYCU® (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following ocular surgery in the U.S.
"EyePoint is excited to collaborate with the ImprimisRx team to expand the commercial reach of DEXYCU to cataract surgeons and patients in need of more effective treatments to manage ocular inflammation following surgery," said Nancy Lurker, President and Chief Executive Officer of EyePoint Pharmaceuticals. "Through this agreement, we are able to access the established and complementary ImprimisRx commercial operations in cataract surgery to include DEXYCU as a prioritized product in its existing portfolio of product offerings. The combination of the EyePoint sales and marketing team with the depth of ImprimisRx in the cataract surgery space, positions DEXYCU for accelerated growth bringing its many benefits to more physicians and patients."
"We are thrilled to add the first and only FDA-approved intracameral injectable steroid product to our portfolio of surgical formulations, which will help us address unmet medical needs in the ocular surgery market," said John Saharek, President of ImprimisRx. "Based on the conversations we've have had with our customers, there is strong demand and preference for FDA-approved products, which gives me confidence that our customers will embrace the option of using DEXYCU. DEXYCU will be marketed as a top priority program within our commercial organization and our initial focus will be on accounts currently purchasing Tri-Moxi®. Having sold over 250,000 ophthalmic injectable units used during cataract surgery in 2019 to our loyal customer base, the choice to use DEXYCU, an innovative FDA-approved injectable steroid product with a specific and permanent reimbursement J-code, will give hundreds of our surgical customers a new tool to improve the health outcomes of their patients. We look forward to working in collaboration with the EyePoint team to greatly enhance the level of commercial success of DEXYCU and build customer demand in this attractive and growing market."
Under the terms of the commercial alliance, ImprimisRx will deploy its sales specialists and their inside sales team to promote DEXYCU to ophthalmologist, hospital, and ambulatory surgical center (ASC) customers beginning immediately. ImprimisRx will initially focus on accounts currently purchasing Tri-Moxi and will be prioritizing its Tri-Moxi resources to support DEXYCU moving forward. EyePoint will be responsible for the marketing, selling, pricing, manufacturing, and contracting for DEXYCU while also seeking additional volume-based agreements with ASCs and integrated health care networks to expand patient access. ImprimisRx will be entitled to receive a commission on the incremental sales that exceed pre-specified volume targets. EyePoint will retain all commercial rights for DEXYCU outside of the U.S.
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 intraocular drug delivery including EYP-1901, a potential six month VEGF inhibitor initially targeting wet age-related macular degeneration. 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.About Harrow Health
Harrow Health, Inc. (NASDAQ:HROW) owns a portfolio of healthcare businesses, including ImprimisRx, the nation's leading ophthalmology outsourcing facility and pharmaceutical compounding business. The company holds large equity positions in Eton Pharmaceuticals, Surface Pharmaceuticals, and Melt Pharmaceuticals. Harrow also owns Mayfield Pharmaceuticals, Stowe Pharmaceuticals, and Visionology, all companies founded as subsidiaries of Harrow Health. The Company also owns royalty rights in certain drug candidates being developed by Surface, Melt, and Mayfield. Harrow intends to create, invest in and grow paradigm shifting healthcare businesses that put patients first. For more information about Harrow Health, please visit the Investor Relations section of the corporate website by clicking here.About ImprimisRx
ImprimisRx is the nation's leading ophthalmology-focused outsourcing facility and pharmaceutical compounding business, serving thousands of ophthalmologists and optometrists in all 50 states, with 40 proprietary ophthalmic formulations. ImprimisRx is headquartered in San Diego, CA and owns two FDA-inspected production and dispensing facilities in Ledgewood, New Jersey. There have been over three million eyes served by the formulations produced at these facilities. For more information about ImprimisRx, including ordering instructions, please visit our website, www.imprimisrx.com/.EyePoint Forward-Looking Statements
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.Harrow Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include our ability to make commercially available our compounded formulations and technologies in a timely manner or at all; physician interest in prescribing our formulations; risks related to our compounding pharmacy operations; our ability to enter into other strategic alliances, including arrangements with pharmacies, physicians and healthcare organizations for the development and distribution of our formulations; our ability to obtain intellectual property protection for our assets; our ability to accurately estimate our expenses and cash burn, and raise additional funds when necessary; risks related to research and development activities; the projected size of the potential market for our technologies and formulations; unexpected new data, safety and technical issues; regulatory and market developments impacting compounding pharmacies, outsourcing facilities and the pharmaceutical industry; competition; and market conditions. These and additional risks and uncertainties are more fully described in Harrow Health's filings with the Securities and Exchange Commission, including its Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Such documents may be read free of charge on the SEC's web site at www.sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow Health undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.EyePoint Contacts:
Investors:
Argot Partners
Sam Martin or Joe Rayne
212-600-1902
[email protected]Media:
Thomas Gibson
201-476-0322
[email protected]Harrow Contacts:
Investors:
Andrew Boll
[email protected]
615-733-4731Media:
Deb Holliday
Holliday Communications, Inc.
[email protected]
412.877.4519