EyePoint Pharmaceuticals Reports Third Quarter 2020 Financial Results and Highlights Recent Corporate Developments
- Total revenues of $15.7 million and net product revenues of $5.8 million -
- Sequential quarterly increase in underlying customer demand of over 120% for DEXYCU® and over 5% for YUTIQ® -
- EYP-1901, a potential six-month sustained delivery intravitreal anti-VEGF treatment targeting wet age-related macular degeneration, remains on track for Q4 IND filing -
- CRG debt facility amended, waiving and modifying net product revenue covenants for 2020 and 2021, respectively -
- Cash as of October 31, 2020 at $30.5 Million -
- Management to host a conference call and webcast today at
“With the continued increase in patient office visits and resumption of operations at many healthcare facilities during the quarter, we were encouraged to see customer demand for both YUTIQ® and DEXYCU® near pre-COVID-19 pandemic levels,” said
Commercial Performance in Third Quarter 2020
- Customer demand for YUTIQ, represented as units purchased by physicians from the Company’s distributors, was approximately 450 units in Q3 2020 as compared to approximately 430 units in Q2 2020.
- Customer demand for DEXYCU, represented as units purchased by ambulatory surgery centers (ASCs) from the Company’s distributors, was approximately 4,700 units in Q3 2020 as compared to approximately 2,100 units in Q2 2020.
- Separate purchasing and marketing agreements for expanded access to DEXYCU across the
U.S.were recently executed with Vantage Outsourcing and another undisclosed healthcare network. The Company is actively negotiating agreements with additional group purchasing organizations and networks.
- In August, the Company and ImprimisRx signed a commercial alliance for the joint promotion of DEXYCU in the
U.S.which more than doubles the size of our team engaging directly with physicians and ASCs. During September, ImprimisRx’s sales specialists and inside sales team completed product training and are positioned to call on their ophthalmologist, hospital and ASC accounts.
- The Company continues to actively monitor the COVID-19 pandemic and associated public health recommendations to ensure the safety of our patients, physicians and employees.
- In October, based in part on the return in customer demand for both products following COVID-19-related closures, the Company secured an amendment to its existing debt facility with
CRG Servicing LLC(CRG) in which CRG waived the covenant associated with the Company’s net product revenue for DEXYCU and YUTIQ for the twelve-month period ending on December 31, 2020. CRG also agreed to a reduction of the calendar year 2021 net product revenue covenant to $45 millionfrom $80 million. There were no other material changes made to the term loan agreement and the Company incurred no incremental charges in connection with the amendment.
- In August, the Company and Ocumension Therapeutics announced an expansion of their exclusive license agreements for YUTIQ and DEXYCU in certain markets in
Asia. Under the expanded agreements, Ocumension made a one-time $9.5 millionpayment to EyePoint for rights to commercialize both products under its own brand names in South Koreaand other jurisdictions across Southeast Asiaand as the full and final payment of all remaining development, regulatory, and commercial sale milestone payments under the original license agreements. Royalties for future product sales remain payable to the Company pursuant to the license agreements.
- In October, the Company completed a GLP toxicology study for EYP-1901, a potential six-month sustained delivery intravitreal anti-VEGF treatment using its bioerodible Durasert® technology for wet AMD. The Company expects to file an IND application with the FDA in the fourth quarter of 2020 with a Phase 1 human clinical trial to commence shortly after IND acceptance by the FDA.
Review of Results for Third Quarter Ended
For the three months ended
Net revenue from licenses, royalties and collaborations for the three months ended
Operating expenses for the three months ended
Review of Nine Months Results Ended
For the nine months ended
Net revenue from royalties and collaborations for the nine months ended
Operating expenses for the nine 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 assuming no significant increase in COVID-19-related closures that would materially affect the frequency of ophthalmology office visits or the number of cataract surgical procedures performed 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 wet age-related macular degeneration. 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
||Nine Months Ended|
|Product sales, net||$||5,758||$||1,009||$||14,151||$||8,941|
|License and collaboration agreements||9,535||1,054||11,590||1,125|
|Cost of sales, excluding amortization of acquired intangible
|Research and development||4,090||3,484||12,219||11,237|
|Sales and marketing||5,269||7,778||19,483||22,373|
|General and administrative||5,796||4,365||14,949||13,790|
|Amortization of acquired intangible assets||615||615||1,845||1,845|
|Total operating expenses||17,652||16,569||51,859||50,608|
|Loss from operations||(1,957||)||(14,060||)||(24,553||)||(38,876||)|
|Other income (expense):|
|Interest and other income, net||(4||)||183||58||692|
|Loss on extinguishment of debt||—||—||—||(3,810||)|
|Total other expense, net||(1,844||)||(1,587||)||(5,372||)||(7,507||)|
|Net loss per common share - basic and diluted||$||(0.03||)||$||(0.15||)||$||(0.24||)||$||(0.45||)|
|Weighted average common shares outstanding - basic and diluted||127,945||106,938||122,768||102,900|
CONDENSED CONSOLIDATED BA
|Cash and cash equivalents||$||28,726||$||22,214|
|Accounts and other receivables, net||9,392||11,368|
|Prepaid expenses and other current assets||5,832||5,997|
|Total current assets||47,592||41,717|
|Operating lease right-of-use assets||2,733||3,078|
|Intangible assets, net||25,824||27,669|
|Liabilities and stockholders’ equity|
|Accounts payable and accrued expenses||$||12,030||$||11,024|
|Other current liabilities||597||481|
|Total current liabilities||12,927||11,520|
|Operating lease liabilities - noncurrent portion||2,483||2,898|
|Other long-term liabilities||3,012||3,000|
|Accumulated other comprehensive income||840||840|
|Total stockholders’ equity||7,594||8,330|
|Total liabilities and stockholders’ equity||$||76,791||$||72,971|
Source: EyePoint Pharmaceuticals, Inc.