EyePoint Pharmaceuticals Reports Fourth Quarter and Full Year 2019 Financial Results and Highlights Recent Corporate Progress
– Total revenues of
– Net product revenues of
– Q4 2019 customer demand for DEXYCU and YUTIQ Increased 111% and 59%, respectively, compared to Q3 2019 –
– EYP-1901, a six-month sustained release anti-VEGF potential treatment for wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion advancing toward clinical development –
– Management to host a conference call and webcast today at 8:30 AM ET –
“Q4 2019 was a pivotal quarter for EyePoint as we continued our commercial momentum, serving an increasing number of patients who suffer from ocular diseases and need better treatment options,” said
Commercial Performance in Fourth Quarter 2019
DEXYCU (dexamethasone intraocular suspension) 9% for the treatment of post-operative inflammation following ocular surgery
- Customer demand, represented as units purchased by ambulatory surgical centers from the Company’s distributors, was up 111% over Q3 with repeat customers representing 98% of Q4 order volume.
- Since launch, over 14,000 patients have been treated with DEXYCU.
- The Company secured multiple new agreements for expanded access of DEXYCU, including contracts with
The Vision Center Network of America, LLC(VCNA) and EyeSouth Partnerswhich collectively perform approximately 115,000 cataract surgeries per year. The Company is actively negotiating agreements with additional group purchasing organizations and networks.
YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for chronic non-infectious uveitis affecting the posterior segment of the eye
- Customer demand, represented as units purchased by physicians from the Company’s distributors, was up 59% over Q3, driven by underlying growth and the permanent and specific J-Code for YUTIQ in effect as of
October 1, 2019.
- Repeat customers represented 87% of Q4 order volume, and importantly, 42% of the target account list has ordered, including 98% of the treating uveitis specialists, representing solid adoption with continued growth opportunity.
March 2020, the Company announced positive topline 36-month follow-up data from the second Phase 3 trial of YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye. This second double-masked, randomized Phase 3 trial of YUTIQ enrolled 153 patients in 15 clinical centers in India, with 101 eyes treated with YUTIQ and 52 eyes receiving sham injections. At 36-months, the recurrence rate in YUTIQ randomized eyes was significantly lower than in sham treated eyes (46.5% vs. 75.0%, respectively; p=0.001). Visual acuity gains or losses of 3-lines or more were both similar between treatment groups. Safety data showed no unanticipated side effects at each follow-up timepoint at 12, 24 and 36-months. These positive results were consistent with the findings from the first Phase 3 study of YUTIQ and provide further validation of its long-term ability to reduce uveitic flares.
February 2020, the Company signed an exclusive license agreement with Equinox Science, LLC, to develop vorolanib, a TKI targeting vascular endothelial growth factor (VEGF) receptors for the treatment of wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. Vorolanib is being developed as EYP-1901 utilizing Eyepoint’s bioerodible Durasert technology as a potential 6-month intravitreal sustained release treatment option. The Company recently completed a positive Type B pre-Investigational New Drug (IND) meeting with the U.S. Food and Drug Administration(FDA) clarifying the pathway for a Phase 1 clinical trial that is expected to provide data in the second half of 2021. Under the terms of the agreement, EyePoint made an upfront payment of $1 millionand is required to make additional payments upon the achievement of certain developmental and regulatory milestones, as well as the payment of post-commercialization royalties.
- Positive retrospective case study data supporting DEXYCU were highlighted in an oral presentation at the 2020 Caribbean Eye Meeting in an oral session entitled, “Drug Delivery: Real-World Experience With Dexamethasone Intraocular Suspension”. The ongoing retrospective study is designed to provide large-scale, real-world data on early experiences with DEXYCU from surgeons. Interim results presented are from 154 patients administered DEXYCU with each time point of data based on patient chart data and frequency of measurement by participating physicians. The proportion of patients with complete anterior chamber cell clearing (cell score=0) was 47.5%, 50.0%, 84.1% and 87.5% 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 77.7%, 98.5%, 98.8% and 99.1% at postoperative day 1, 8, 14 and 30, respectively. Mean intraocular pressure at postoperative day 1 was 17.6mmHg, with levels decreasing through to postoperative day 30.
February 2020, the Company completed an underwritten public offering of 15,000,000 shares of its common stock at a public offering price of $1.45 per share. The gross proceeds of the offering were $21,750,000, before deducting the underwriting discounts and commissions and other transaction expenses. In addition, underwriters were granted a thirty-day option to purchase up to an additional 2,250,000 shares of common stock at the public offering price, less underwriting discounts and commissions. This offering closed on February 25, 2020.
January 2020, the Company signed an exclusive license agreement with Ocumension Therapeutics for the development and commercialization of DEXYCU for the treatment of post-operative inflammation following ocular surgery in Mainland China, Hong Kong, Macauand Taiwan. Under the terms of the agreement, EyePoint received an upfront payment of $2 millionand is eligible to receive up to an additional $12 millionif certain prespecified development, regulatory and commercial sales milestones are achieved by Ocumension, as well as royalties on future product sales. EyePoint maintains worldwide development and commercialization rights outside of the territories licensed to Ocumension.
November 2019, George O. Elstonwas appointed Chief Financial Officer and Head of Corporate Development. Mr. Elstonbrings more than 25 years of diverse financial and senior leadership experience in the biopharmaceutical sector with both global publicly-traded and privately-held organizations. He most recently served as Chief Financial Officer and Head of Corporate Development at Enzyvant Therapeutics and has also held senior executive roles at 2X Oncology, Inc, Juniper Pharmaceuticals, Inc., KBI Biopharmaand Optherion, Inc.
Review of Results for Fourth Quarter Ended December 31, 2019
For the three months ended
Net revenue from licenses, royalties and collaborations for the three months ended December 31, 2019 totaled $750,000 compared to
Operating expenses for the three months ended December 31, 2019 increased to 17.6 million from $13.4 million in the prior year period, due primarily to investments in sales and marketing infrastructure and program costs, and cost of sales related to product revenue. Non-operating expense, net, for the three months ended December 31, 2019 totaled $1.4 million of net interest expense. Net loss for the three months ended December 31, 2019 was 10.4 million, or $0.10 per share, compared to a net loss of $11.6 million, or $0.12 per share, for the prior year quarter.
Review of Results for Full Year Ended
For the full year ended
Net revenue from licenses, royalties and collaborations for the full year ended December 31, 2019 totaled $3.5 million compared to
Operating expenses for the full year ended December 31, 2019 increased to
Cash and cash equivalents at December 31, 2019 totaled $22.2 million compared to $31.8 million at
We expect that the Company’s cash and cash equivalents combined with the
Fourth Quarter and Full Year 2019 Financial Results Conference Call
About EyePoint Pharmaceuticals
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect, plan or believe may occur in the future, including but not limited to statements about our expectations regarding the timing and clinical development of our product candidates, including EYP-1901; and the potential for EYP-1901 as a vital, novel six-month treatment for serious eye diseases, including wet age-related macular degeneration, diabetic retinopathy and retinal vein occlusion. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements are risks and uncertainties inherent in our business including, without limitation: the effectiveness and timeliness of clinical trials, and the usefulness of the data; the timeliness of regulatory approvals; our ability to achieve profitable operations and access to needed capital; fluctuations in our operating results; our ability to successfully produce sufficient commercial quantities of YUTIQ and DEXYCU and to successfully commercialize YUTIQ and DEXYCU in the
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(In thousands except per share data)
|Three Months Ended||Twelve Months Ended|
|Product sales, net||$||7,883||$||—||$||16,824||$||—|
|License and collaboration agreements||236||1,827||1,361||2,625|
|Cost of sales, excluding amortization of acquired intangible assets||1,324||—||2,687||—|
|Research and development||4,132||4,179||15,368||18,502|
|Sales and marketing||7,399||4,529||29,772||9,658|
|General and administrative||4,149||4,739||17,939||15,430|
|Amortization of acquired intangible assets||615||—||2,460||—|
|Total operating expenses||17,619||13,447||68,226||43,590|
|Loss from operations||(8,986||)||(11,005||)||(47,861||)||(39,019||)|
|Other income (expense):|
|Interest and other income, net||363||239||1,054||420|
|Loss on extinguishment of debt||—||—||(3,810||)||—|
|Change in fair value of derivative liability||—||—||—||(45,164||)|
|Total other expense, net||(1,424||)||(588||)||(8,932||)||(47,106||)|
|Net loss per share- basic and diluted||$||(0.10||)||$||(0.12||)||$||(0.54||)||$||(1.27||)|
|Weighted average common shares outstanding - basic and diluted||106,680||94,944||104,307||67,942|
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands except share amounts)
|Cash and cash equivalents||$||22,214||$||45,261|
|Accounts and other receivables, net||11,720||627|
|Other current assets||8,135||1,713|
|Total current assets||42,069||47,601|
|Operating lease right-of-use assets||3,078||—|
|Intangible assets, net||27,669||30,129|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||11,376||$||6,429|
|Accrued development milestone||—||15,000|
|Operating lease liabilities - current portion||481||—|
|Total current liabilities||11,872||21,459|
|Operating lease liabilities - noncurrent portion||2,898||—|
|Other long-term liabilities||3,000||1,455|
|Accumulated other comprehensive income||840||839|
|Total stockholders’ equity||8,330||37,633|
|Total liabilities and stockholders’ equity||$||73,323||$||78,168|
Source: EyePoint Pharmaceuticals, Inc.