-Substantial progress made in the Company’s
accelerated transformation into a commercial entity
EyePoint Pharmaceuticals, Inc. (NASDAQ:EYPT), a specialty
biopharmaceutical company committed to developing and
commercializing innovative ophthalmic products, today reported
operating and financial results for its fiscal 2018 fourth quarter
and full year ended June 30, 2018, and highlighted recent progress
made to support its transformation into a commercial company.
“During EyePoint’s fiscal fourth quarter, we
made significant clinical, corporate and financial achievements
that have contributed to the Company’s rapid advancement towards
commercialization,” said Nancy Lurker, President and Chief
Executive Officer of EyePoint Pharmaceuticals. “In preparation for
the launch of DEXYCU and, if approved, YUTIQ, we added several key
members to our management team, including David Price as Chief
Financial Officer and Jack Weet as Senior Vice President Regulatory
Affairs & Quality, each of whom has substantial experience in
the launch and commercialization of pharmaceutical products.”
Ms. Lurker continued, “Our clinical and research
teams continue to add to the body of evidence supporting YUTIQ for
the treatment of non-infectious posterior segment uveitis with
multiple presentations at the 36th Annual Scientific Meeting of
the American Society of Retina Specialists, and we look
forward to the FDA’s Prescription Drug User Fee Act (PDUFA) date of
November 5, 2018 for this program. In support of our
commercialization strategy, we also successfully strengthened our
balance sheet with support from Essex Woodlands (EW) Healthcare
Partners and Rosalind Advisors, Inc. (Rosalind Advisors), which
have provided additional capital to support our commercialization
plans and growth strategy for the future.”
Recent Highlights
Key Commercial Preparations
- As EyePoint accelerates its transformation from a
clinical-stage company into a commercial company ahead of future
ophthalmic product launches, the Company has strengthened its
infrastructure to support its growth across multiple functions,
including finance, sales and marketing and regulatory, including
the following personnel additions in newly created
positions:
- David Price, Chief Financial Officer, brings more than 25 years
of financial experience in the healthcare, investment banking and
accounting sectors; and
- John (Jack) Weet, Ph.D., SVP, Regulatory Affairs & Quality,
brings over 40 years of experience in regulatory affairs to
EyePoint. He has extensive expertise in the oversight
of FDA relations and negotiations across multiple
therapeutic areas, including ocular disease.
- The Company has continued to execute on its four-pillar
commercialization plan, which is to execute on a robust medical
education road map, train and hire a top tier sales team, gain
payor access and launch with a compelling marketing strategy.
Notably, EyePoint has consummated an agreement with a premier
contract sales organization to ensure a fully trained and highly
seasoned field organization at launch. The Company has also
established and begun executing its medical education, product
marketing and market access plans ahead of product launch.
Strengthened Balance Sheet
- In June 2018, EW Healthcare Partners, an established
healthcare-focused investment firm, Rosalind Advisors and another
accredited investor contributed an aggregate of $25.5 million of
growth capital to EyePoint following stockholder approval of the
financing. The closing of this financing, coupled with the closing,
in March 2018, of the initial tranche of $9.5 million of equity
financing led by EW Healthcare Partners, resulted in total gross
proceeds to the Company of $35.0 million. Under the terms of the
second tranche securities purchase agreement, funds affiliated with
EW Healthcare Partners and the other second tranche investors
received warrants to purchase an additional 20,184,224
shares of the Company's common stock, which, if exercised in
full, would provide the Company with additional gross proceeds of
up to approximately $28.9 million to further strengthen its balance
sheet. The warrants are cash-exercise only and are
exercisable until the close of business on September 28,
2018.
Clinical Highlights
- At the 36th Annual Scientific Meeting of the American
Society of Retina Specialists that took place from July 20-25, 2018
in Vancouver, three presentations highlighted twelve-month efficacy
and safety data supporting YUTIQ for the treatment of
non-infectious posterior segment uveitis. Highlights from each of
the presentations include:
- Confirmatory 1-Year Study Results of an Injectable
Fluocinolone Acetonide Intravitreal Insert (FAi) to Treat
Non-infectious Posterior Segment Uveitis. Efficacy results
from this three-year prospective, Phase 3 study showed a decrease
in recurrence of uveitis in FAi versus sham eyes at twelve months.
Safety results demonstrated that 23.8% and 7.7% of FAi and sham
subjects, respectively, experienced intraocular pressure (IOP)
increases of greater than or equal to 12mm Hg, with one of the FAi
study eyes requiring IOP lowering surgery. The results of this
study support previous findings that the FAi is safe and effective
to both treat and prevent recurrent uveitis.
- Controlling Uveitic Recurrences: Results From a
Phase 3 Study of 0.18 mg Fluocinolone Acetonide Insert in
Non-infectious Posterior Uveitis. Data from the first year
of this three-year study showed a lower inflammation recurrence
rate in FAi randomized eyes than in sham eyes (37.9% vs. 97.6%,
respectively). A total of 63 recurrences were reported in
FAi-treated eyes, versus 105 recurrences in the sham-treated eyes.
This data adds to the growing body of evidence evaluating the role
of FAi in decreasing the rate of inflammation occurrence.
- Injectable Fluocinolone Acetonide Intravitreal Insert
Reduces the Need for Adjunctive Treatment in Non-infectious
Posterior Segment Uveitis. Analysis of the full
intent-to-treat cohort at one year indicated that a single
intravitreal injection of FAi provided effective anti-inflammatory
treatment for one year and significantly reduced the need for
adjunctive therapies. 6.9% of FAi eyes, versus 61.9% of sham eyes,
received at least one intra/peri-ocular steroid injection. Of the 6
FAi eyes that required intra/peri-ocular steroid injection, four
required only a single injection through twelve months while half
of the 26 sham eyes required multiple injections up to a maximum of
five.
Corporate Highlights
- Göran Ando, M.D. was added to EyePoint’s Board of Directors in
June 2018 and was appointed Chairman of the Board on September 7,
2018. Dr. Ando is the former Chairman of the Board of Novo
Nordisk A/S (NYSE:NVO), a global pharmaceutical company, and
brings more than 35 years of successful global drug development and
general management experience to EyePoint.
- EyePoint completed its delisting from the Australian Securities
Exchange (ASX) on May 7, 2018. The Company’s decision to delist
from the ASX was due to, among other things, a lower proportion of
the Company's common stock held by Australian shareholders, low
trading volume on the ASX and the costs of maintaining the
listing.
- EyePoint secured transitional pass-through reimbursement from
the Centers for Medicare & Medicaid Services (CMS) for DEXYCU
and was assigned a C-code. The code, C9034, will
become effective on October 1, 2018. Approximately 40% of patients
who undergo cataract surgery are covered by Medicare Part B. Drugs
that are administered as part of the cataract surgery procedures
can be covered under a CMS administered transitional-pass-through
payment.
Anticipated Milestones
- YUTIQ PDUFA date of November 5, 2018.
YUTIQ has been accepted for filing by the FDA and is currently
under standard review with a PDUFA date of November 5, 2018.
Posterior segment uveitis is a high unmet need area with limited
treatment options and the third leading cause of blindness in
the U.S. If approved, the Company plans to launch YUTIQ
in the U.S. in the first half of 2019.
- Launch DEXYCU and YUTIQ - subject to YUTIQ FDA approval
and successful production of commercial supply of DEXYCU - in the
first half of 2019. The Company anticipates two potential
near-term product launches, including DEXYCU, a dropless,
long-acting therapeutic for the treatment of postoperative
inflammation, which was approved by the FDA, and YUTIQ, a
three-year treatment of non-infectious posterior segment uveitis,
which is currently under standard review with a PDUFA date of
November 5, 2018.
Fiscal Fourth Quarter and Full Year 2018
Results
Revenue for the quarter ended June 30, 2018
totaled $715,000 compared to $701,000 for the prior year quarter.
Revenues in both periods were derived from feasibility study
agreements and royalty income.
Operating expenses for the quarter ended June
30, 2018 increased to $10.5 million from $6.8 million a year
earlier, due primarily to initial investments in sales and
marketing infrastructure and program costs, amortization of the
DEXYCU intangible asset, professional services and stock-based
compensation. Non-operating expense in the quarter ended June
30, 2018 totaled $24.6 million, which included a $24.0 million
non-cash charge for the change in fair value of derivative
liability primarily associated with the revaluation of the second
tranche transaction immediately prior to the June 25, 2018 closing
date and $720,000 of interest expense and amortization of debt
discount in connection with our March 2018 term loan agreement. Net
loss for the quarter ended June 30, 2018 was $34.4 million, or
$0.62 per share, compared to a net loss of $6.1 million, or $0.16
per share, for the prior year quarter.
Revenue for the year ended June 30, 2018 was
$3.0 million compared to $7.5 million for the year ended June 30,
2017. The prior year period included the recognition of deferred
collaborative research and development revenue totaling $5.6
million resulting from the termination of the Pfizer collaboration
agreement.
Royalty income increased to $1.6 million for the
year ended June 30, 2018 compared to $970,000 for the prior year,
related primarily to the consummation of an amended agreement with
Alimera Sciences, Inc. in July 2017 that converted a profit share
arrangement to a sales-based royalty. Operating expenses for
the year ended June 30, 2018 were $29.2 million compared to $26.1
million for the prior year. For the year ended June 30, 2018, the
Company recorded a non-cash charge to non-operating expense of
$26.3 million resulting from the change in fair value of derivative
liability.
Net loss for the year ended June 30, 2018 was
$53.2 million, or $1.15 per share, compared to a net loss of $18.5
million, or $0.52 per share for the year ended June 30, 2017. There
are currently 74,512,048 shares of common stock outstanding.
Conference Call Information
EyePoint will host a conference call
today, Wednesday, September 12, 2018, at 8:30 AM ET, to
discuss the fourth quarter and fiscal year 2018 financial results,
recent accomplishments, clinical developments and commercial launch
plans. To access the conference call, please dial (877)
312-7507 (local) or (631) 813-4828 (international) at least 10
minutes prior to the start time and refer to conference ID 5782568.
A live webcast will be available on the Investor Relations
section of the corporate website
at http://www.eyepointpharma.com.
A replay of the call will be available
beginning September 12, 2018, at approximately 11:30 AM
ET and ending on September 19, 2018 at 11:30 AM ET. The
replay may be accessed by dialing (855) 859-2056 within
the U.S. and Canada or (404) 537-3406 from
international locations, Conference ID Number: 5782568. A replay of
the webcast will also be available on the corporate website during
that time.
About EyePoint
PharmaceuticalsEyePoint Pharmaceuticals,
Inc. (formerly pSivida Corp.) (www.eyepointpharma.com),
headquartered in Watertown, MA, is a specialty
biopharmaceutical company committed to developing and
commercializing innovative ophthalmic products in indications with
high unmet medical need to help improve the lives of patients with
serious eye disorders. The Company has developed three of only
four FDA-approved sustained-release treatments for
back-of-the-eye diseases. In addition, DEXYCU™ was approved by
the FDA on February 9, 2018. DEXYCU, administered as
a single intraocular dose at the end of ocular surgery for the
treatment of postoperative inflammation, is the first and
only FDA-approved intraocular product with this indication.
DEXYCU employs the Verisome® extended-release drug delivery
technology, which encompasses a broad number of related but
distinct drug delivery systems capable of incorporating an
extensive range of active agents, including small molecules,
proteins and monoclonal antibodies. ILUVIEN® (fluocinolone
acetonide intravitreal implant), a micro-insert for diabetic
macular edema, licensed to Alimera Sciences, Inc., is
currently sold directly in the U.S. and several EU countries.
Retisert® (fluocinolone acetonide intravitreal implant), for
posterior uveitis, is licensed to and sold by Bausch &
Lomb, Inc. The New Drug Application for EyePoint’s lead
product candidate, YUTIQ™ three-year treatment of non-infectious
posterior segment uveitis, has been accepted for filing by
the FDA and is currently under standard review with a
PDUFA date of November 5, 2018. The Company's pre-clinical
development program is focused on using its core Durasert™ and the
Verisome platform technologies to deliver drugs to treat wet
age-related macular degeneration, glaucoma, and other diseases. To
learn more about the Company, please
visit www.eyepointpharma.com and connect on Twitter,
LinkedIn, Facebook and Google+.
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 or believe may occur in the future are
forward-looking statements. 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 include uncertainties with respect to:
our ability to achieve profitable operations and access to needed
capital; fluctuations in our operating results; the number of
clinical trials, including clinical trials conducted outside the
U.S., and data required for marketing approval for YUTIQ in the
U.S.; our ability to use data in promotion for YUTIQ; our ability
to successfully produce commercial supply of DEXYCU and
commercialize DEXYCU in the U.S.; our ability to successfully build
a commercial infrastructure and enter into and maintain commercial
agreements for the launch of DEXYCU and, if approved, YUTIQ; our
ability to successfully commercialize YUTIQ, if approved, in the
U.S.; potential off-label sales of ILUVIEN® for non-infectious
posterior segment uveitis (“NIPU”); consequences of fluocinolone
acetonide side effects; successful commercialization of, and
receipt of revenues from, ILUVIEN for diabetic macular edema
(“DME”) which depends on the ability of Alimera Sciences, Inc.
(“Alimera”) to continue as a going concern; Alimera’s ability to
obtain additional marketing approvals and the effect of pricing and
reimbursement decisions on sales of ILUVIEN for DME; Alimera’s
ability to obtain marketing approval for ILUVIEN in its licensed
territories for NIPU; the development of our next-generation
Durasert™ short-acting treatment for uveitis; potential declines in
Retisert® royalties; our ability to market and sell products; the
success of current and future license agreements, including our
agreement with Alimera; termination or breach of current license
agreements, including our agreement with Alimera; our dependence on
contract research organizations, contract sales organizations,
vendors and investigators; effects of competition and other
developments affecting sales of products; market acceptance of
products; effects of guidelines, recommendations and studies;
protection of intellectual property and avoiding intellectual
property infringement; retention of key personnel; product
liability; industry consolidation; compliance with environmental
laws; manufacturing risks; risks and costs of international
business operations; effects of the potential exit of the United
Kingdom from the European Union; legislative or regulatory changes;
volatility of stock price; possible dilution; absence of dividends;
and other factors described in our filings with the Securities and
Exchange Commission. You should read and interpret any
forward-looking statements in light of these risks. 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. We do
not undertake any obligation to publicly update or revise our
forward-looking statements even if experience or future changes
makes it clear that any projected results expressed or implied in
such statements will not be realized.
Contacts
Investors:Argot
PartnersKimberly Minarovich(646)
368-8014kimberly@argotpartners.com
Joseph Rayne(617)
340-6075joseph@argotpartners.com
Media:Thomas
Gibson201-476-0322tom@tomgibsoncommunications.com
FINANCIAL TABLES FOLLOW
|
|
EYEPOINT PHARMACEUTICALS, INC. AND
SUBSIDIARIES |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(Unaudited) |
(In thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended |
|
|
Year Ended |
|
June 30, |
|
|
June 30, |
|
|
|
|
|
|
|
|
|
|
2018 |
|
2017 |
|
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
Collaborative research and development |
$ |
218 |
|
|
$ |
461 |
|
|
|
$ |
1,343 |
|
|
$ |
6,569 |
|
Royalty
income |
|
497 |
|
|
|
240 |
|
|
|
|
1,618 |
|
|
|
970 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
revenues |
|
715 |
|
|
|
701 |
|
|
|
|
2,961 |
|
|
|
7,539 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research
and development |
|
4,765 |
|
|
|
4,213 |
|
|
|
|
16,178 |
|
|
|
14,880 |
|
Sales and
marketing |
|
1,512 |
|
|
|
- |
|
|
|
|
1,512 |
|
|
|
- |
|
General
and administrative |
|
4,220 |
|
|
|
2,624 |
|
|
|
|
11,545 |
|
|
|
11,235 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
operating expenses |
|
10,497 |
|
|
|
6,837 |
|
|
|
|
29,235 |
|
|
|
26,115 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
(9,782 |
) |
|
|
(6,136 |
) |
|
|
|
(26,274 |
) |
|
|
(18,576 |
) |
Interest and other
income |
|
27 |
|
|
|
20 |
|
|
|
|
101 |
|
|
|
91 |
|
Interest expense |
|
(720 |
) |
|
|
- |
|
|
|
|
(720 |
) |
|
|
- |
|
Change in fair value of
derivative liability |
|
(23,953 |
) |
|
|
- |
|
|
|
|
(26,278 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(34,428 |
) |
|
$ |
(6,116 |
) |
|
|
$ |
(53,171 |
) |
|
$ |
(18,485 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common
share: |
|
|
|
|
|
|
|
|
Basic and
diluted |
$ |
(0.62 |
) |
|
$ |
(0.16 |
) |
|
|
$ |
(1.15 |
) |
|
$ |
(0.52 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average common
shares outstanding: |
|
|
|
|
|
|
|
|
Basic and
diluted |
|
55,387 |
|
|
|
38,673 |
|
|
|
|
46,226 |
|
|
|
35,344 |
|
|
|
|
|
|
|
|
|
|
|
EYEPOINT PHARMACEUTICALS, INC. AND
SUBSIDIARIES |
CONDENSED CONSOLIDATED BALANCE
SHEETS |
(Unaudited) |
(In thousands) |
|
|
|
|
|
June 30, |
|
June 30, |
|
2018 |
|
2017 |
|
|
|
|
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and
cash equivalents |
$ |
38,776 |
|
|
$ |
16,898 |
|
Other
current assets |
|
1,133 |
|
|
|
842 |
|
|
|
|
|
|
|
|
|
Total current
assets |
|
39,909 |
|
|
|
17,740 |
|
Intangible assets,
net |
|
31,358 |
|
|
|
364 |
|
Other assets |
|
403 |
|
|
|
573 |
|
|
|
|
|
|
|
|
|
Total
assets |
$ |
71,670 |
|
|
$ |
18,677 |
|
|
|
|
|
Liabilities and
stockholders' equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts
payable and accrued expenses |
$ |
6,663 |
|
|
$ |
5,240 |
|
Accrued
development milestone |
|
15,000 |
|
|
|
- |
|
Deferred
revenue |
|
- |
|
|
|
50 |
|
|
|
|
|
|
|
|
|
Total current
liabilities |
|
21,663 |
|
|
|
5,290 |
|
Long-term debt |
|
17,309 |
|
|
|
- |
|
Derivative
liability |
|
19,780 |
|
|
|
- |
|
Other long-term
liabilities |
|
1,231 |
|
|
|
51 |
|
|
|
|
|
|
|
|
|
Total
liabilities |
|
59,983 |
|
|
|
5,341 |
|
|
|
|
|
Stockholders'
equity: |
|
|
|
Capital |
|
374,840 |
|
|
|
323,323 |
|
Accumulated deficit |
|
(363,991 |
) |
|
|
(310,820 |
) |
Accumulated other comprehensive income |
|
838 |
|
|
|
833 |
|
|
|
|
|
|
|
|
|
Total stockholders'
equity |
|
11,687 |
|
|
|
13,336 |
|
|
|
|
|
Total
liabilities and stockholders' equity |
$ |
71,670 |
|
|
$ |
18,677 |
|
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