EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a pharmaceutical
company committed to developing and commercializing therapeutics to
improve the lives of patients with serious eye disorders, today
announced financial results for the second quarter ended June
30, 2022 and highlighted recent corporate developments.
“We continue to make significant progress at EyePoint, with the
recent Phase 2 clinical trial initiation for EYP-1901 for the
treatment of wet AMD, demonstrating the team’s continued strong
execution in advancing our innovative pipeline,” said Nancy Lurker,
Chief Executive Officer of EyePoint Pharmaceuticals. “In addition
to this key milestone, we presented 12-month Phase 1 DAVIO safety
and efficacy results at the ASRS 2022 Annual Meeting, further
bolstering our belief that EYP-1901 has the potential to
significantly reduce the treatment burden of this serious eye
disease by providing the majority of patients with a safe and
reliable maintenance therapy option for up to six months without
supplemental anti-VEGF therapy. With these positive results
in-hand, supported by our strong balance sheet, we are
well-positioned to advance EYP-1901 through these important Phase 2
trials.”
Ms. Lurker continued, “On the commercial front, we had our
strongest quarter to-date with $11.3 million in net product
revenue, an increase of 30% from the first quarter of this year
along with continued strong customer demand for both YUTIQ® and
DEXYCU®.”
R&D Highlights and Updates
- The first patient was dosed in the Phase 2 DAVIO 2 clinical
trial of EYP-1901 for the treatment of wet AMD in July 2022. The
twelve-month, randomized, controlled DAVIO 2 trial is expected to
enroll approximately 150 patients previously treated with a
standard-of-care anti-VEGF therapy, and topline data is expected in
the second half of 2023. More information about the study is
available at clinicaltrials.gov (identifier: NCT05381948).
- Final twelve-month data from the Phase 1 DAVIO clinical trial
of EYP-1901 for wet AMD was presented at the ASRS 2022 Annual
Meeting in July 2022. Data presented reinforced a positive safety
and efficacy profile for EYP-1901 and showed no dose limiting
toxicities, no reports of ocular serious adverse events (SAEs) and
no drug-related systemic SAEs. There were no reported events of
vitreous floaters, endophthalmitis, retinal detachment, implant
migration in the anterior chamber, retinal vasculitis, or posterior
segment inflammation. The data also confirmed stable best corrected
visual acuity (BCVA) (-4.12 ETDRS letters), stable central subfield
thickness (CST) on optical coherence tomography (OCT) (-2.76 μm),
and a clinically significant 74% reduction in treatment burden (79%
at six-months). These data also showed that 53% of eyes did not
require any supplemental anti-VEGF injections up to six-months and
35% up to twelve months following a single dose of EYP-1901.
- In a poster presentation at the Association for Research in
Vision and Ophthalmology (ARVO) 2022 Annual Meeting in May 2022,
the Company provided an update on the YUTIQ® CALM registry study.
Data from this Phase IV, multi-center registry study indicated
effective control of non-infectious uveitis, with no significant
changes in visual acuity and without major safety signals. The CALM
study is a joint collaboration between EyePoint and the Cleveland
Clinic and could become a valuable resource in furthering the
understanding of posterior segment uveitis.
Recent Corporate Highlights
- Karen Zaderej, M.B.A. was appointed to the Company’s Board of
Directors in July 2022. Ms. Zaderej brings more than 35 years of
biopharmaceutical and medical device experience to the role, and
currently serves as the President and CEO of AxoGen, a leading
company focused specifically on the science, development and
commercialization of technologies for peripheral nerve regeneration
and repair.
- In July 2022, the Company announced that the CMS indicated its
intention not to provide further pass-through extension to expiring
products, including DEXYCU® in its draft 2023 CMS HOPPS (Hospital
Outpatient Prospective Payment System) rule. If the draft rule
becomes final, DEXYCU will lose pass-through separate reimbursement
status on December 31, 2022 and will instead be bundled into the
general Cataract procedure reimbursement code starting on January
1, 2023. The Company intends to request longer pass-through status
given the ongoing pandemic.
- Anthony (Tony) Adamis, M.D. was elected to the Company’s Board
of Directors in June 2022. Dr. Adamis is a highly accomplished
ophthalmology executive with more than 30 years of research and
development experience in the biopharmaceutical industry. He is
best-known for his co-discovery of the role of vascular endothelial
growth factor (VEGF) in ocular disease, including wet AMD and
NPDR.
- In June 2022, the Company and OcuMension Therapeutics announced
that China’s National Medical Products Administration (NMPA) has
approved YUTIQ® (fluocinolone acetonide intravitreal implant)
0.18mg for the treatment of chronic non-infectious uveitis
affecting the posterior segment of the eye.
- The Company entered into an exclusive license agreement with
Betta Pharmaceuticals Co. Ltd. (Betta) to develop and commercialize
EYP-1901 in China, Hong Kong, Macau and Taiwan (the Territory) in
May 2022. Under the terms of this agreement, EyePoint retains all
ophthalmic rights for EYP-1901 in the entire world outside of the
Territory. Concurrently, EyePoint and Betta affiliate, Equinox
Sciences LLC executed an amendment to their 2020 exclusive license
agreement, expanding EyePoint’s exclusive rights to develop and
commercialize vorolanib, the tyrosine kinase inhibitor used in
EYP-1901, through localized delivery for the treatment of all
ophthalmic diseases in the entire world outside of the
Territory.
Commercial Performance in Second Quarter
2022
- Net product revenue for YUTIQ and DEXYCU was $7.4
million and $3.9 million, respectively.
- Customer demand for YUTIQ was approximately 900 units,
representing approximately 40% growth from Q1 2022.
- Customer demand for DEXYCU was approximately 14,700 units,
consistent with Q1 2022.
Review of Results for the Second Quarter ended June 30,
2022
For the second quarter ended June 30, 2022, total net revenue
was $11.6 million compared to $9.0 million for the quarter ended
June 30, 2021. Net product revenue for the second quarter was $11.3
million, compared to net product revenues for the second quarter
ended June 30, 2021 of $8.7 million.
Net revenue from royalties and collaborations for the second
quarter ended June 30, 2022 totaled $0.3 million compared to $0.3
million in the corresponding period in 2021.
Operating expenses for the second quarter ended June 30, 2022
totaled $30.8 million versus $20.0 million in the prior year
period, primarily driven by an increase in clinical trial costs for
EYP-1901 and an increase in investment across the organization in
personnel and stock-based compensation. Non-operating expense, net,
totaled $0.2 million and net loss was $19.4 million, or ($0.52) per
share, compared to a net loss of $10.0 million, or ($0.35) per
share, for the prior year period.
Cash and investments at June 30, 2022 totaled $171.2 million
compared to $190.8 million at March 31, 2022.
Financial Outlook
We expect the cash, cash equivalents and investments on hand on
June 30, 2022 and expected net cash inflows from our product sales
will enable us to fund our current and planned operations into the
second half of 2024.
Conference Call Information
EyePoint will host a conference call today, at 8:30 a.m.
ET to discuss the results for the second quarter ended June
30, 2022 and recent corporate developments. To access the
conference call, please register at
https://register.vevent.com/register/BI2bbb04b8ff6f4995988cc55bd04b8f78.
A live webcast and replay will be available on the Investor
Relations section of the corporate website
at http://www.eyepointpharma.com.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a pharmaceutical
company committed to developing and commercializing therapeutics to
help improve the lives of patients with serious eye disorders. The
Company's pipeline leverages its proprietary Durasert® technology
for sustained intraocular drug delivery including EYP-1901, an
investigational sustained delivery intravitreal anti-VEGF treatment
initially targeting wet age-related macular degeneration. The
proven Durasert drug delivery platform has been safely administered
to thousands of patients' eyes across four U.S. FDA approved
products, including YUTIQ® for the treatment of chronic
non-infectious uveitis affecting the posterior segment of the eye,
which is currently marketed by the Company. EyePoint
Pharmaceuticals is headquartered in Watertown, Massachusetts.
SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION
ACT OF 1995: To the extent any statements made in this press
release deal with information that is not historical, these are
forward-looking statements under the Private Securities Litigation
Reform Act of 1995. Such statements include, but are not limited
to, statements regarding the use of proceeds for the offering and
other statements identified by words such as “will,” “potential,”
“could,” “can,” “believe,” “intends,” “continue,” “plans,”
“expects,” “anticipates,” “estimates,” “may,” other words of
similar meaning or the use of future dates. Forward-looking
statements by their nature address matters that are, to different
degrees, uncertain. Uncertainties and risks may cause EyePoint’s
actual results to be materially different than those expressed in
or implied by EyePoint’s forward-looking statements. For EyePoint,
this includes uncertainties regarding the timing and clinical
development of our product candidates, including EYP-1901; the
potential for EYP-1901 as a novel sustained delivery treatment for
serious eye diseases, including wet age-related macular
degeneration; the effectiveness and timeliness of clinical trials,
and the usefulness of the data; the timeliness of regulatory
approvals; the success of current and future license agreements;
our dependence on contract research organizations, co-promotion
partners, and other outside vendors and service providers; effects
of competition and other developments affecting sales of our
commercialized products, YUTIQ® and DEXYCU®; market acceptance of
our products; product liability; industry consolidation; compliance
with environmental laws; risks and costs of international business
operations; volatility of stock price; possible dilution; absence
of dividends; the continued impact of the COVID-19 pandemic on
EyePoint's business, the medical community and the global economy
and the impact of general business and economic conditions;
protection of our intellectual property and avoiding intellectual
property infringement; retention of key personnel; manufacturing
risks; 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.
EyePoint undertakes no obligation to update or revise any
forward-looking statement, whether as a result of new information,
future events or otherwise.
Investors:
Christina TartagliaStern IRDirect:
212-698-8700christina.tartaglia@sternir.com
Media Contact:
Amy PhillipsGreen Room CommunicationsDirect:
412-327-9499aphillips@greenroompr.com
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EYEPOINT PHARMACEUTICALS, INC. AND
SUBSIDIARIES |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(Unaudited) |
(In thousands, except per share data) |
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedJune 30, |
|
Six Months EndedJune 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
Revenues: |
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
11,318 |
|
|
$ |
8,738 |
|
|
$ |
20,328 |
|
|
$ |
15,540 |
|
License and collaboration agreements |
|
|
49 |
|
|
|
94 |
|
|
|
108 |
|
|
|
435 |
|
Royalty income |
|
|
198 |
|
|
|
181 |
|
|
|
423 |
|
|
|
361 |
|
Total revenues |
|
|
11,565 |
|
|
|
9,013 |
|
|
|
20,859 |
|
|
|
16,336 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Cost of sales, excluding amortization of acquired intangible
assets |
|
|
1,734 |
|
|
|
1,929 |
|
|
|
3,511 |
|
|
|
3,319 |
|
Research and development |
|
|
12,992 |
|
|
|
5,605 |
|
|
|
22,937 |
|
|
|
11,084 |
|
Sales and marketing |
|
|
6,883 |
|
|
|
6,659 |
|
|
|
13,576 |
|
|
|
12,318 |
|
General and administrative |
|
|
8,557 |
|
|
|
5,184 |
|
|
|
17,106 |
|
|
|
10,299 |
|
Amortization of acquired intangible assets |
|
|
615 |
|
|
|
615 |
|
|
|
1,230 |
|
|
|
1,230 |
|
Total operating expenses |
|
|
30,781 |
|
|
|
19,992 |
|
|
|
58,360 |
|
|
|
38,250 |
|
Loss from operations |
|
|
(19,216 |
) |
|
|
(10,979 |
) |
|
|
(37,501 |
) |
|
|
(21,914 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
Interest and other income, net |
|
|
362 |
|
|
|
280 |
|
|
|
423 |
|
|
|
281 |
|
Interest expense |
|
|
(552 |
) |
|
|
(1,376 |
) |
|
|
(1,745 |
) |
|
|
(2,722 |
) |
Gain (loss) on extinguishment of debt |
|
|
- |
|
|
|
2,065 |
|
|
|
(1,559 |
) |
|
|
2,065 |
|
Total other expense, net |
|
|
(190 |
) |
|
|
969 |
|
|
|
(2,881 |
) |
|
|
(376 |
) |
Net loss |
|
$ |
(19,406 |
) |
|
$ |
(10,010 |
) |
|
$ |
(40,382 |
) |
|
$ |
(22,290 |
) |
Net loss per common share - basic and diluted |
|
$ |
(0.52 |
) |
|
$ |
(0.35 |
) |
|
$ |
(1.08 |
) |
|
$ |
(0.83 |
) |
Weighted average common shares outstanding - basic and diluted |
|
|
37,322 |
|
|
|
28,744 |
|
|
|
37,288 |
|
|
|
26,750 |
|
EYEPOINT PHARMACEUTICALS, INC. AND
SUBSIDIARIES |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(Unaudited) |
(In thousands) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
|
2022 |
|
|
|
2021 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
82,134 |
|
|
$ |
178,593 |
|
Marketable securities |
|
|
89,033 |
|
|
|
32,965 |
|
Accounts and other receivables, net |
|
|
22,594 |
|
|
|
18,354 |
|
Prepaid expenses and other current assets |
|
|
8,851 |
|
|
|
4,217 |
|
Inventory |
|
|
3,254 |
|
|
|
3,616 |
|
Total current assets |
|
|
205,866 |
|
|
|
237,745 |
|
Operating lease right-of-use assets |
|
|
4,787 |
|
|
|
2,252 |
|
Intangible assets, net |
|
|
21,519 |
|
|
|
22,749 |
|
Other assets |
|
|
1,261 |
|
|
|
626 |
|
Total assets |
|
$ |
233,433 |
|
|
$ |
263,372 |
|
Liabilities and stockholders' equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
21,370 |
|
|
$ |
21,807 |
|
Deferred revenue |
|
|
1,137 |
|
|
|
1,069 |
|
Short-term borrowings |
|
|
10,475 |
|
|
|
- |
|
Other current liabilities |
|
|
408 |
|
|
|
782 |
|
Total current liabilities |
|
|
33,390 |
|
|
|
23,658 |
|
Long-term debt |
|
|
29,181 |
|
|
|
36,562 |
|
Deferred revenue - noncurrent |
|
|
14,070 |
|
|
|
14,560 |
|
Operating lease liabilities - noncurrent |
|
|
4,826 |
|
|
|
1,860 |
|
Other long-term liabilities |
|
|
600 |
|
|
|
2,352 |
|
Total liabilities |
|
|
82,067 |
|
|
|
78,992 |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
Capital |
|
|
760,243 |
|
|
|
752,636 |
|
Accumulated deficit |
|
|
(609,479 |
) |
|
|
(569,097 |
) |
Accumulated other comprehensive income |
|
|
602 |
|
|
|
841 |
|
Total stockholders' equity |
|
|
151,366 |
|
|
|
184,380 |
|
Total liabilities and stockholders' equity |
|
$ |
233,433 |
|
|
$ |
263,372 |
|
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