EyePoint Pharmaceuticals Reports Second Quarter 2020 Financial Results and Highlights Recent Corporate Developments
- Total revenues of $4.1 million and net product revenues of $3.7 million impacted by COVID-19 pandemic -
- 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 -
“We were encouraged by the re-opening of healthcare facilities in select regions of the
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
- 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.
- 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. Dukerwill 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. Dukeris 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 Centerand Tufts University School of Medicine.
- In July, data from the first Phase 3 trial of YUTIQ were presented at the
American Society of Retina Specialists VirtualAnnual 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 OphthalmologyAnnual 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 Surgery2020 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
Net revenue from royalties and collaborations for the three months ended
Operating expenses for the three months ended
Review of Six Months Results Ended
For the six months ended
Net revenue from royalties and collaborations for the six months ended
Operating expenses for the six months ended
Non-operating expense, net, for the six months ended
Cash and cash equivalents at
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
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,
About EyePoint Pharmaceuticals
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
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands, except per share data)
|Three Months Ended||Six Months Ended|
|Product sales, net||$||3,706||$||6,705||$||8,393||$||7,932|
|License and collaboration agreements||35||5||2,055||70|
|Cost of sales, excluding amortization of acquired intangible assets||502||706||1,482||1,035|
|Research and development||3,276||3,955||8,129||7,753|
|Sales and marketing||6,089||7,284||14,214||14,595|
|General and administrative||4,792||4,815||9,152||9,425|
|Amortization of acquired intangible assets||615||615||1,230||1,230|
|Total operating expenses||15,274||17,375||34,207||34,038|
|Loss from operations||(11,152||)||(10,165||)||(22,596||)||(24,816||)|
|Other income (expense):|
|Interest and other income, net||8||266||62||509|
|Loss on extinguishment of debt||—||—||—||(3,810||)|
|Total other expense, net||(1,798||)||(1,333||)||(3,528||)||(5,920||)|
|Net loss per common share - basic and diluted||$||(0.10||)||$||(0.11||)||$||(0.22||)||$||(0.30||)|
|Weighted average common shares outstanding - basic and diluted||124,771||106,238||120,151||100,847|
CONDENSED CONSOLIDATED BALANCE SHEETS
|Cash and cash equivalents||$||22,814||$||22,214|
|Accounts and other receivables, net||7,350||11,368|
|Prepaid expenses and other current assets||5,895||5,997|
|Total current assets||39,832||41,717|
|Operating lease right-of-use assets||2,852||3,078|
|Intangible assets, net||26,439||27,669|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||9,013||$||11,024|
|Other current liabilities||573||481|
|Total current liabilities||9,586||11,520|
|Operating lease liabilities - noncurrent portion||2,626||2,898|
|Other long-term liabilities||3,026||3,000|
|Accumulated other comprehensive income||840||840|
|Total stockholders’ equity||4,188||8,330|
|Total liabilities and stockholders’ equity||$||69,685||$||72,971|
Source: EyePoint Pharmaceuticals, Inc.