EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a company committed
to developing and commercializing therapeutics to improve the lives
of patients with retinal diseases, today announced financial
results for the third quarter ended September 30,
2023, and highlighted recent corporate developments.
“We continued advancing EYP-1901 through clinical development in
the third quarter, announcing positive masked safety results for
our lead product candidate EYP-1901 in the ongoing DAVIO 2 and
PAVIA Phase 2 clinical trials,” said Jay Duker, M.D., President and
Chief Executive Officer of EyePoint Pharmaceuticals. “We remain
on-track to report topline data for the DAVIO 2 trial in wet AMD in
December 2023 and the PAVIA trial in non-proliferative diabetic
retinopathy in the second quarter of 2024. We also plan to initiate
the Phase 2 VERONA trial of EYP-1901 in diabetic macular edema in
the first quarter of 2024.”
Dr. Duker continued, “It is an exciting time for EyePoint as we
are well-positioned to execute on key near-term milestones and
drive value for shareholders. We remain laser focused on our
mission of making a difference in the lives of patients suffering
from retinal diseases.”
R&D Highlights and Updates
- Accepted to present at the upcoming
American Academy of Ophthalmology (AAO) Annual Meeting in November,
including at AAO’s Eyecelerator pre-meeting tomorrow, November 2,
2023. At Eyecelerator, the Company will be presenting interim
masked safety data through October 1, 2023 from its ongoing DAVIO 2
and PAVIA Phase 2 clinical trials.
- At the AAO Annual Meeting, EyePoint
will be presenting an encore presentation of preclinical data
highlighting the potential neuroprotective effect of vorolanib, the
active drug in EYP-1901, against photoreceptor degeneration in a
validated rodent retinal detachment model.
- Presented subgroup analyses of the
Phase 1 DAVIO trial of EYP-1901 demonstrating reduced treatment
burden in wet AMD at the EURETINA Congress and the Retina Society
Annual Meeting in October.
- Presented a comparison of the
antiangiogenic profile of tyrosine kinase inhibitors vorolanib,
axitinib, and sunitinib at the Retina Society Annual Meeting in
October demonstrating effective inhibition of receptors involved in
pathological angiogenesis with vorolanib not having a physiological
impact on TIE 2 function.
- Announced EYP-2301, razuprotafib (a
TIE-2 agonist) in Durasert E as a potential sustained delivery
treatment for patients with serious retinal diseases.
- Presented interim masked safety and
baseline patient demographics of the DAVIO 2 clinical trial in wet
AMD at the OIS Retina Innovation Summit in July. In addition to
positive safety data, an analysis of the reported patient
demographics suggests that Phase 2 DAVIO 2 patients have, on
average, better starting visual acuity and less central subfield
thickness than the Phase 1 DAVIO cohort.
- Presented 12-month ocular
pharmacokinetic results from a study evaluating EYP-1901’s drug
delivery through the Durasert platform at the American Society of
Retina Specialists (ASRS) Annual Meeting in July. The Company also
presented an encore subgroup analysis of the EYP-1901 final
twelve-month Phase 1 DAVIO results, which showed that 67% of the
DAVIO patients with no excess fluid at screening did not require a
supplemental anti-VEGF injection up to the six-month visit.
- Plans to initiate VERONA, a Phase 2
clinical trial evaluating EYP-1901 in diabetic macular edema (DME)
in the first quarter of 2024 remain on track.
Recent Corporate Highlights
- Announced the
promotion of George Elston to Executive Vice President and the
appointment of Stuart M. Duty to the Company’s Board of Directors
in October 2023.
- Appointed Jay S.
Duker, M.D. as President and Chief Executive Officer and member of
the Board of Directors as part of a CEO transition in July
2023. Dr. Duker was previously Chief Operating Officer
and President. Nancy S. Lurker transitioned to the role
of Executive Vice Chair of the Board of Directors from the position
of CEO.
- Appointed Marcia Sellos-Moura, Ph.D. as Senior Vice President,
Program Leadership on July 31, 2023. Dr. Sellos-Moura brings over
20 years of biopharmaceutical experience to the Company.
Review of Results for the Third Quarter Ended September
30, 2023
For the third quarter ended September 30, 2023, total net
revenue was $15.2 million compared to $10.0 million for the quarter
ended September 30, 2022. Net product revenue for the third quarter
was $0.8 million, compared to net product revenues for the third
quarter ended September 30, 2022 of $9.7 million. The decrease in
net product revenue resulted from sale of the YUTIQ franchise in
May 2023 and the discontinuation of DEXYCU commercialization
activities in 2023.
Net revenue from royalties and collaborations for the third
quarter ended September 30, 2023 totaled $14.4 million compared to
$0.3 million in the corresponding period in 2022. The increase was
primarily due to partial recognition of deferred revenue from the
sale of the YUTIQ franchise which will be recognized over a 2-year
period in connection with the delivery of YUTIQ supply units.
Operating expenses for the third quarter ended September 30,
2023 totaled $29.6 million versus $28.4 million in the prior year
period. This increase was primarily driven by R&D spending on
the ongoing EYP-1901 clinical trials, partially offset by reduced
sales and marketing expense. Non-operating expense, net, totaled
$1.8 million and net loss was $12.6 million, or ($0.33) per share,
compared to a net loss of $18.4 million, or ($.49) per share, for
the prior year period.
Cash and investments at September 30, 2023 totaled $136.0
million compared to $144.6 million at December 31, 2022.
Financial Outlook
We expect the cash, cash equivalents and investments on
September 30, 2023 will enable us to fund our current and planned
operations into 2025.
Conference Call Information
EyePoint will host a conference call today, at 8:30 a.m.
ET to discuss the results for the third quarter ended
September 30, 2023 and recent corporate developments. To access the
live conference call, please register at
https://register.vevent.com/register/BI3b701846a11841ad855aab9d0b8aff10.
A live audio webcast of the event can be accessed via the Investors
section of the Company website at www.eyepointpharma.com. A webcast
replay will also be available on the corporate website at the
conclusion of the call.
About EyePoint Pharmaceuticals
EyePoint Pharmaceuticals (Nasdaq: EYPT) is a company committed
to developing and commercializing therapeutics to help improve the
lives of patients with serious retinal diseases. The Company's
pipeline leverages its proprietary erodible Durasert E™ technology
for sustained intraocular drug delivery including EYP-1901, an
investigational sustained delivery intravitreal anti-VEGF treatment
currently in Phase 2 clinical trials. The proven Durasert® drug
delivery platform has been safely administered to over 80,000
patient eyes across four U.S. FDA approved products. EyePoint
Pharmaceuticals is headquartered in Watertown, Massachusetts. For
more information visit www.eyepointpharma.com.
EYEPOINT 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 sufficiency of our existing
cash resources into 2025; our plans and any other statements about
future expectations, prospects, estimates and other matters that
are dependent upon future events or developments, including
statements containing the words “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, non-proliferative
diabetic retinopathy and diabetic macular edema; our ability to
realize the anticipated benefits of the 2023 sale of YUTIQ® to
Alimera Sciences including our potential to receive additional
payments from Alimera pursuant to the our agreements with Alimera;
our ability to manufacture YUTIQ in sufficient quantities pursuant
to our commercial supply agreements with Alimera and Ocumension
Therapeutics; 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,
including our agreements with Alimera, Ocumension, Equinox Science
and Betta Pharmaceuticals; termination or breach 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; market acceptance of our
products, including our out-licensed products; product liability;
industry consolidation; compliance with environmental laws; risks
and costs of international business operations; volatility of stock
price; possible dilution; the impact of instability in general
business and economic conditions, including changes in inflation,
interest rates and the labor market; the extent to which COVID-19
impacts our business and the medical community; protection of our
intellectual property and avoiding intellectual property
infringement; retention of key personnel; manufacturing risks; the
sufficiency of the Company’s cash resources and need for additional
financing; 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 BALANCE SHEETS |
(Unaudited) |
(In thousands) |
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
|
2023 |
|
|
|
2022 |
|
Assets |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
133,035 |
|
|
$ |
95,633 |
|
Marketable securities |
|
|
2,977 |
|
|
|
48,928 |
|
Accounts and other receivables, net |
|
|
483 |
|
|
|
15,503 |
|
Prepaid expenses and other current assets |
|
|
9,091 |
|
|
|
9,858 |
|
Inventory |
|
|
4,577 |
|
|
|
2,886 |
|
Total current assets |
|
|
150,163 |
|
|
|
172,808 |
|
Operating lease right-of-use assets |
|
|
5,250 |
|
|
|
6,038 |
|
Other assets |
|
|
4,630 |
|
|
|
1,510 |
|
Total assets |
|
$ |
160,043 |
|
|
$ |
180,356 |
|
Liabilities and stockholders' equity |
|
|
|
|
Current liabilities: |
|
|
|
|
Accounts payable and accrued expenses |
|
$ |
22,997 |
|
|
$ |
22,278 |
|
Deferred revenue |
|
|
39,841 |
|
|
|
1,205 |
|
Short-term borrowings |
|
|
- |
|
|
|
10,475 |
|
Other current liabilities |
|
|
1,058 |
|
|
|
579 |
|
Total current liabilities |
|
|
63,896 |
|
|
|
34,537 |
|
Long-term debt |
|
|
- |
|
|
|
29,310 |
|
Deferred revenue - noncurrent |
|
|
32,341 |
|
|
|
13,557 |
|
Operating lease liabilities - noncurrent |
|
|
5,185 |
|
|
|
5,984 |
|
Other long-term liabilities |
|
|
- |
|
|
|
600 |
|
Total liabilities |
|
|
101,422 |
|
|
|
83,988 |
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
Capital |
|
|
785,827 |
|
|
|
766,933 |
|
Accumulated deficit |
|
|
(728,047 |
) |
|
|
(671,351 |
) |
Accumulated other comprehensive income |
|
|
841 |
|
|
|
786 |
|
Total stockholders' equity |
|
|
58,621 |
|
|
|
96,368 |
|
Total liabilities and stockholders' equity |
|
$ |
160,043 |
|
|
$ |
180,356 |
|
|
|
|
|
|
EYEPOINT PHARMACEUTICALS, INC. AND
SUBSIDIARIES |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(Unaudited) |
(In thousands, except per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember 30, |
|
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
816 |
|
|
$ |
9,720 |
|
|
$ |
13,483 |
|
|
$ |
30,048 |
|
|
License and collaboration agreements |
|
|
14,137 |
|
|
|
52 |
|
|
|
17,768 |
|
|
|
160 |
|
|
Royalty income |
|
|
249 |
|
|
|
240 |
|
|
|
739 |
|
|
|
663 |
|
|
Total revenues |
|
|
15,202 |
|
|
|
10,012 |
|
|
|
31,990 |
|
|
|
30,871 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Cost of sales, excluding amortization of acquired intangible
assets |
|
|
1,202 |
|
|
|
1,405 |
|
|
|
3,634 |
|
|
|
4,916 |
|
|
Research and development |
|
|
17,363 |
|
|
|
11,162 |
|
|
|
46,711 |
|
|
|
34,099 |
|
|
Sales and marketing |
|
|
479 |
|
|
|
6,016 |
|
|
|
11,504 |
|
|
|
19,592 |
|
|
General and administrative |
|
|
10,556 |
|
|
|
9,212 |
|
|
|
28,854 |
|
|
|
26,321 |
|
|
Amortization of acquired intangible assets |
|
|
- |
|
|
|
615 |
|
|
|
- |
|
|
|
1,845 |
|
|
Total operating expenses |
|
|
29,600 |
|
|
|
28,410 |
|
|
|
90,703 |
|
|
|
86,773 |
|
Loss from operations |
|
|
(14,398 |
) |
|
|
(18,398 |
) |
|
|
(58,713 |
) |
|
|
(55,902 |
) |
Other income (expense): |
|
|
|
|
|
|
|
|
|
Interest and other income, net |
|
|
1,786 |
|
|
|
640 |
|
|
|
4,611 |
|
|
|
1,067 |
|
|
Interest expense |
|
|
- |
|
|
|
(662 |
) |
|
|
(1,247 |
) |
|
|
(2,408 |
) |
|
Loss on extinguishment of debt |
|
|
- |
|
|
|
- |
|
|
|
(1,347 |
) |
|
|
(1,559 |
) |
|
Total other expense, net |
|
|
1,786 |
|
|
|
(22 |
) |
|
|
2,017 |
|
|
|
(2,900 |
) |
Net loss |
|
$ |
(12,612 |
) |
|
$ |
(18,420 |
) |
|
$ |
(56,696 |
) |
|
$ |
(58,802 |
) |
|
Net loss per common share - basic and diluted |
|
$ |
(0.33 |
) |
|
$ |
(0.49 |
) |
|
$ |
(1.50 |
) |
|
$ |
(1.58 |
) |
|
Weighted average common shares outstanding - basic and diluted |
|
|
38,341 |
|
|
|
37,338 |
|
|
|
37,804 |
|
|
|
37,305 |
|
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