-YUTIQ™ and DEXYCU™ commercially
launched in 1Q2019-
EyePoint Pharmaceuticals, Inc. (NASDAQ: EYPT), a specialty
biopharmaceutical company committed to developing and
commercializing innovative ophthalmic products, today reported
financial results for the three and six-month fiscal period ended
December 31, 2018 and highlighted recent corporate
developments.
“We begin 2019 with the achievement of two major
milestones in the Company’s history with the launches of our
innovative ophthalmology products – YUTIQ™ and DEXYCU™ –
that have the potential to alter the treatment landscape for ocular
diseases,” said Nancy Lurker, President and Chief Executive Officer
of EyePoint Pharmaceuticals. “EyePoint has transitioned into a
full-fledged and integrated commercial organization and we are
focused on ensuring that our two product launches are successful on
behalf of patients and families suffering from ocular conditions
that may be treated with our products.”
Recent Highlights
- Commercial launches are underway
for YUTIQ (fluocinolone acetonide intravitreal implant) 0.18 mg for
the treatment of chronic non-infectious uveitis affecting the
posterior segment of the eye (launched February 4, 2019) and DEXYCU
(dexamethasone intraocular suspension) 9% for the treatment of
post-operative inflammation following cataract surgery (launched
March 12, 2019). Company initiatives related to these product
launches include:
- Recruitment and training of the Company’s field sales
organization recently concluded, and the Company now has in place a
44-person sales force (10 for YUTIQ and 34 for DEXYCU) via our
Contract Sales Organization partnership with sales leadership,
field reimbursement managers and MSLs all hired, trained and
deployed internally. Each territory-based sales representative is
solely focused on one EyePoint product and targets high-volume
surgery centers for DEXYCU, or practicing physicians in the case of
YUTIQ.
- Physician product training is underway with an initial focus on
high volume and leading ophthalmologists and their staff.
- EyePoint Assist(SM) was launched simultaneously with
product availability to ensure access to YUTIQ for eligible
patients in need of financial assistance.
- Reimbursement for DEXYCU has been secured by Centers for
Medicare and Medicaid Services (CMS) through a specific and
permanent issuance of a J-code (J1095) and the Company retains
transitional pass-through status for DEXYCU from CMS for three
years from January 1, 2019. YUTIQ is also reimbursed using a
J-Code.
- A signed agreement with Ocumension Therapeutics for development
and commercial rights to Durasert™ three-year uveitis in the
territories of China, Hong Kong, Macau and Taiwan, which resulted
in a $1.75 million upfront licensing fee and up to $10.0 million of
other potential future milestones and sales-based royalties upon
regulatory approval.
- In February 2019, EyePoint secured
a $60 million debt facility with CR Group L.P., of which gross
proceeds from an initial $35 million draw were used to retire a
previous $20 million secured term loan with SWK Funding LLC (SWK)
and add approximately $11.4 million to cash and cash equivalents.
This refinancing provides additional working capital to support the
commercial launches of YUTIQ and DEXYCU.
- David Guyer, M.D., was appointed to
the Company’s Board of Directors in January 2019 and serves on the
Company’s Science Committee. Dr. Guyer currently serves as
Executive Chairman of Ophthotech Corporation, a publicly-traded
biopharmaceutical company specializing in gene therapy treatments
for ocular diseases, which he co-founded.
- Ron Honig, Esq., was appointed
Senior Vice President, General Counsel and Company Secretary in
November 2018 to oversee the Company’s legal activities, including
the legal aspects of licensing, compliance, strategic transactions,
and business development. Mr. Honig brings to EyePoint more than 25
years of legal experience in the medical device, biotechnology,
contract manufacturing and legal services industries.
Three and Six-Month Financial Results
for the Fiscal Period Ended December 31, 2018
Following the change of the Company’s fiscal
year-end from June 30 to December 31, the reported financial
results include the three and six-month periods ended December 31,
2018. EyePoint believes the change of its fiscal year aligns its
financial reporting periods to that of its peer group in the
industry and facilitates the assessment of its financial
performance. The Company will file audited financial statements on
Form 10-K for the six-month transition period ended December
31, 2018.
For the three months ended December 31,
2018, revenues totaled $2.4 million compared to $933,000
for the three months ended December 31, 2017. The revenues increase
was primarily attributable to the recognition of $1.7 million from
the upfront license fee received from Ocumension Therapeutics.
Operating expenses for the three months
ended December 31, 2018 increased to $13.4
million from $6.7 million for the prior year
quarter, due primarily to ongoing investments in sales and
marketing infrastructure and program costs, professional services,
stock-based compensation and amortization of the DEXYCU intangible
asset. Non-operating expense, net, for the three months
ended December 31, 2018 totaled $589,000 and
consisted of interest expense on the SWK term loan, net of interest
income from cash equivalent investments. Net loss for the three
months ended December 31, 2018 was $11.6 million,
or $0.12 per share, compared to a net loss of $5.8
million, or $0.13 per share, for the prior year
quarter.
For the six-month transition period
ended December 31, 2018, revenues totaled $2.9 million
compared to $1.3 million for the prior year six-month
period. The revenues increase was primarily attributable to the
aforementioned Ocumension upfront license fee and higher royalty
income under existing collaboration agreements, partially offset by
the absence in the six-month transition period ended December 31,
2018 of revenues from feasibility study agreements. Operating
expenses for the six-month transition period ended December
31, 2018 increased to $27.5 million from $13.1
million for the prior year six-months period, due primarily to
expansion of the Company’s leadership team, investments in sales
and marketing infrastructure and program costs, professional
services, stock-based compensation and amortization of the DEXYCU
intangible asset. Non-operating expense, net, in the six-month
transition period ended December 31,
2018 totaled $20.2 million and consisted primarily
of an $18.9 million non-cash change in fair value of derivative
liability, as well as interest expense on the SWK term loan. Net
loss for the six-month transition period ended December 31, 2018
was $44.7 million, or $0.53 per share, compared to a
net loss of $11.8 million, or $0.28 per share, for the
prior year six-month period.
Cash and cash equivalents at December 31,
2018 totaled $45.3 million compared to $38.8
million at June 30, 2018.
Financial Outlook
Management believes amounts available from the
CRG credit facility, together with the Company’s current cash and
cash equivalent position and proceeds from commercial sales of
YUTIQ and DEXYCU and existing collaboration agreements, are
sufficient to fund operations and debt service obligations through
the remainder of 2019.
Conference Call Information
EyePoint will host a conference call
today, Thursday, March 14, 2019, at 8:30 AM ET to discuss
the three and six-month reporting period ended December 31, 2018
and recent clinical and operational developments. 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 1499363. A live webcast will be
available on the Investor Relations section of the corporate
website at http://www.eyepointpharma.com. A replay of the
webcast will also be available on the corporate website.
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. With the approval by the
FDA on October 12, 2018 of the YUTIQ™ three-year treatment of
chronic non-infectious uveitis affecting the posterior segment of
the eye (NIPU), the Company has developed the majority of the
FDA-approved sustained-release treatments for eye diseases. The
most common adverse reactions reported for YUTIQ were cataract
development and increases in intraocular pressure. 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. The most
common adverse reactions reported by 5-15% of patients were
intraocular pressure increased, corneal edema and iritis. DEXYCU
employs the Verisome® extended-release drug delivery technology,
which encompasses a broad number of related, but distinct drug
delivery systems with the potential 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. and Vitrasert® (ganciclovir
implant), for cytomegalovirus retinitis was licensed and sold by
Bausch and Lomb until being discontinued in 2013. The Company's
development programs are focused on using its core Durasert™ and
the Verisome platform technologies to deliver drugs to treat
posterior segment uveitis (shorter duration treatment), 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, plan or believe may occur in the future, including
but not limited to statements about our commercialization of YUTIQ
and DEXYCU, potential for our products to alter the treatment
landscape for ocular diseases; the expected use of proceeds from
our refinancing transactions and our belief that the amounts
available from the CRG credit facility together with our current
cash and cash equivalent position and proceeds from sales of YUTIQ
and DEXYCU and existing collaboration agreements are sufficient to
fund our operations and debt service obligations through the
remainder of 2019, 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; our ability to successfully produce commercial
supply of YUTIQ and DEXYCU and successfully commercialize YUTIQ and
DEXYCU in the U.S.; our ability to successfully build a commercial
infrastructure and enter into and maintain commercial agreements
for the launch of YUTIQ and DEXYCU; the development of our
next-generation YUTIQ short-acting treatment for uveitis; potential
off-label sales of ILUVIEN for NIPU; consequences of fluocinolone
acetonide side effects; successful commercialization of, and
receipt of revenues from, ILUVIEN for diabetic macular edema
(“DME”); 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; potential declines in
Retisert royalties; our ability to market and sell products; the
success of current and future license agreements; termination or
breach of current license agreements; 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; 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.
EyePoint
ContactsInvestors: Argot PartnersKimberly
Minarovich(646) 368-8014kimberly@argotpartners.com
Joseph Rayne(617)
340-6075joseph@argotpartners.com
Media: Thomas
Gibson201-476-0322 tom@tomgibsoncommunications.com
FINANCIAL TABLES FOLLOW
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EYEPOINT PHARMACEUTICALS, INC. AND
SUBSIDIARIES |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(Unaudited) |
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(In thousands, except per share
amounts) |
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Three Months Ended |
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Six Months Ended |
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December 31, |
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December 31, |
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2018 |
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2017 |
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2018 |
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2017 |
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Revenues: |
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|
|
|
|
|
Collaborative research and development |
|
$ |
1,827 |
|
|
$ |
461 |
|
|
|
$ |
1,883 |
|
|
$ |
601 |
|
|
|
Royalty
income |
|
|
615 |
|
|
|
472 |
|
|
|
|
1,045 |
|
|
|
717 |
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Total revenues |
|
|
2,442 |
|
|
|
933 |
|
|
|
|
2,928 |
|
|
|
1,318 |
|
|
|
|
|
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|
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|
|
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|
Operating
expenses: |
|
|
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|
|
|
|
|
|
|
|
Research
and development |
|
|
4,179 |
|
|
|
4,269 |
|
|
|
|
10,412 |
|
|
|
8,088 |
|
|
|
Sales and
marketing |
|
|
4,528 |
|
|
|
- |
|
|
|
|
8,174 |
|
|
|
- |
|
|
|
General and
administrative |
|
|
4,740 |
|
|
|
2,472 |
|
|
|
|
8,901 |
|
|
|
5,044 |
|
|
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|
|
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|
Total operating
expenses |
|
|
13,447 |
|
|
|
6,741 |
|
|
|
|
27,487 |
|
|
|
13,132 |
|
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|
|
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|
Loss from
operations |
|
|
(11,005 |
) |
|
|
(5,808 |
) |
|
|
|
(24,559 |
) |
|
|
(11,814 |
) |
|
Interest
and other income |
|
|
238 |
|
|
|
26 |
|
|
|
|
367 |
|
|
|
49 |
|
|
Interest
expense |
|
|
(827 |
) |
|
|
- |
|
|
|
|
(1,642 |
) |
|
|
- |
|
|
Change in
fair value of derivative liability |
|
|
- |
|
|
|
- |
|
|
|
|
(18,886 |
) |
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
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|
Net
loss |
|
$ |
(11,594 |
) |
|
$ |
(5,782 |
) |
|
|
$ |
(44,720 |
) |
|
$ |
(11,765 |
) |
|
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Net loss
per common share: |
|
|
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|
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Basic and
diluted |
|
$ |
(0.12 |
) |
|
$ |
(0.13 |
) |
|
|
$ |
(0.53 |
) |
|
$ |
(0.28 |
) |
|
|
|
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|
|
|
|
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|
Weighted
average common shares outstanding: |
|
|
|
|
|
|
|
|
|
|
Basic and
diluted |
|
|
94,944 |
|
|
|
44,530 |
|
|
|
|
85,057 |
|
|
|
41,980 |
|
|
|
|
|
|
|
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|
|
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|
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|
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|
|
|
|
EYEPOINT PHARMACEUTICALS, INC. AND
SUBSIDIARIES |
|
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
|
(Unaudited) |
|
|
(In thousands) |
|
|
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|
|
|
|
|
|
|
|
|
|
|
December 31, |
|
June 30, |
|
|
|
|
|
|
2018 |
|
2018 |
|
|
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|
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|
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|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and
cash equivalents |
$ |
45,261 |
|
|
$ |
38,776 |
|
|
|
|
Other
current assets |
|
2,340 |
|
|
|
1,133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current assets |
|
47,601 |
|
|
|
39,909 |
|
|
|
Intangible
assets, net |
|
30,129 |
|
|
|
31,358 |
|
|
|
Other
assets |
|
|
438 |
|
|
|
403 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
78,168 |
|
|
$ |
71,670 |
|
|
|
|
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts
payable and accrued expenses |
$ |
6,429 |
|
|
$ |
6,663 |
|
|
|
|
Accrued
development milestone |
|
15,000 |
|
|
|
15,000 |
|
|
|
|
Deferred
revenue |
|
30 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
current liabilities |
|
21,459 |
|
|
|
21,663 |
|
|
|
Long-term
debt |
|
|
17,621 |
|
|
|
17,309 |
|
|
|
Derivative
liability |
|
- |
|
|
|
19,780 |
|
|
|
Other
long-term liabilities |
|
|
1,455 |
|
|
|
1,231 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities |
|
|
40,535 |
|
|
|
59,983 |
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders' equity: |
|
|
|
|
|
|
Capital |
|
|
445,287 |
|
|
|
374,840 |
|
|
|
|
Accumulated
deficit |
|
(408,493 |
) |
|
|
(363,991 |
) |
|
|
|
Accumulated
other comprehensive income |
|
839 |
|
|
|
838 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total
stockholders' equity |
|
37,633 |
|
|
|
11,687 |
|
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and stockholders' equity |
$ |
78,168 |
|
|
$ |
71,670 |
|
|
|
|
|
|
|
|
|
|
|
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