Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical
company focused on the formulation, development, and
commercialization of innovative therapies for diseases and
conditions of the eye, today reported financial results for the
first quarter ended March 31, 2023, and provided updates on its
ophthalmology pipeline.
“The strong start to the year has continued through the end of
the first quarter,” said Antony Mattessich, President and CEO. “We
have been in productive conversations with the FDA and believe we
have a pivotal design for OTX-TKI in diabetic retinopathy and two
potential designs in wet AMD. While we are eager to advance both of
these programs, we look forward to sharing top-line 12-month data
from our U.S.-based Phase 1 trial for OTX-TKI in wet AMD at the
Clinic Trials at the Summit meeting being held in June. We are also
making excellent progress advancing our next late-stage program,
the Phase 2 trial of OTX-TIC for the treatment of glaucoma. This
trial continues to enroll well, and we continue to anticipate
providing top-line data from this trial in the fourth quarter of
2023. Glaucoma represents another large potential ophthalmology
market where we believe our hydrogel technology, which we have
branded as Elutyx™, has the potential to redefine the current
standard of care. On the commercial side, DEXTENZA finished with a
strong quarter. In-market billable unit volumes were approximately
8% ahead of fourth quarter volumes, and we continue to guide
towards a full year 2023 net product revenue of $55 to $60 million.
Overall, I am pleased with our continued progress in building a
mid-tier strategic within ophthalmology.”
Business Updates
Presented Pre-Clinical and Clinical Data at the 2023
Association for Research in Vision and Ophthalmology (ARVO) Annual
Meeting held April 23rd to
27th
- Data presented included clinical and
preclinical updates on OTX-TKI, OTX-TIC, and gene delivery programs
that demonstrate the depth of the ELUTYX technology and its
potential to provide solutions to improve efficacy and reduce the
complexity and burden of the current standard of care for a number
of diseases in both the front and back of the eye.
- Access to the presentations made at
ARVO are available on the Company’s investor website.
OTX-TKI (axitinib intravitreal implant) for the
treatment of wet AMD and other retinal vascular
diseases.
- The Company plans to present top-line 12-month data from its
U.S.-based Phase 1 clinical trial of OTX-TKI for the treatment of
wet AMD at the Clinical Trials at the Summit 2023 meeting being
held June 10th 2023 in Park City, Utah.
- The Company has been in discussions with the FDA for the
clinical development of OTX-TKI in the treatment of wet AMD and has
two potential pivotal designs. Subject to obtaining the necessary
financing, the Company plans to be prepared to initiate the first
pivotal trial for OTX-TKI for the treatment of wet AMD as early as
Q3 2023.
OTX-TKI (axitinib intravitreal implant) for the
treatment of diabetic retinopathy
- The Company is currently enrolling patients in a U.S.-based,
randomized, masked Phase 1 clinical trial in approximately 21
patients randomized 2:1 to either a 600 µg OTX-TKI single implant
containing axitinib or a sham control.
- The Company has been in discussions with the FDA for the
clinical development of OTX-TKI in the treatment of diabetic
retinopathy and has a potential pivotal design. Subject to
receiving favorable top-line data from the ongoing Phase 1 trial
and obtaining the necessary financing to fund the trial, the
Company plans to be prepared to initiate a Phase 3 clinical trial
as early as Q1 2024.
OTX-TIC (travoprost intracameral implant) for the
treatment of primary open-angle glaucoma or ocular
hypertension.
- The Company
continues to enroll its U.S.-based Phase 2 prospective,
multi-center, randomized, controlled clinical trial evaluating the
safety, tolerability, and efficacy of OTX-TIC for the treatment of
patients with primary open-angle glaucoma or ocular hypertension
compared to DURYSTA®. The trial is designed to evaluate whether
OTX-TIC can demonstrate a clinically meaningful decrease in
intraocular pressure while preserving endothelial cell health.
- The Company
continues to enroll patients in the Phase 2 trial and plans to
provide top-line data in Q4 2023.
OTX-DED (dexamethasone intracanalicular insert) for the
short-term treatment of the signs and symptoms of dry eye disease
and OTX-CSI (cyclosporine intracanalicular insert) for the chronic
treatment of dry eye disease
- The Company has
initiated a small study in the second quarter of 2023 to evaluate
the performance of OTX-DED versus fast-dissolving collagen plugs
and no inserts at all in order to identify a proper placebo control
for any future trials of these product candidates.
- The Company plans to
use the results of this study to inform the next steps for both the
OTX-DED and OTX-CSI programs.
DEXTENZA (dexamethasone ophthalmic insert) 0.4mg
approved for the treatment of ocular inflammation and pain
following ophthalmic surgery and ocular itching associated with
allergic conjunctivitis.
- Net product revenue
of DEXTENZA for the first quarter of 2023 was $13.2 million,
slightly ahead of first quarter 2022 net product revenue of $12.5
million and slightly behind fourth quarter net product revenue of
$13.9 million.
- In-market unit
volume—units sold to ambulatory surgery centers (ASCs) and hospital
outpatient departments (HOPDs)—was 34,491 for the first quarter of
2023, an approximate 8% increase in unit volume over the fourth
quarter of 2022.
- The Company is
reiterating its guidance of DEXTENZA net product revenue for the
full year 2023 to be between $55 and $60 million, which would
represent potential growth of approximately 10% to 20% over 2022.
The Company believes that DEXTENZA is currently used in less than
5% of cataract procedures and that growth in 2023 will be driven
by: continued separate reimbursement now available under the
non-opioid pain management drug as a surgical supply provision in
ASCs; a renewed focus on sales to ASCs and specifically strategic
accounts that own and control multiple ASCs; the continuing success
of the revised pricing and discounting strategy that was
implemented in the third quarter of 2022; and the introduction of a
Commercial Assurance Program. The Company believes the momentum
with ASCs will more than offset the impact of the loss of separate
drug reimbursement in the HOPD setting in 2023.
First Quarter Ended March 31, 2023 Financial
Results
Total net revenue, which includes both gross DEXTENZA product
revenue net of discounts, rebates, and returns, which the Company
refers to as net product revenue, and collaboration revenue was
$13.4 million for the first quarter of 2023, slightly ahead of
first quarter 2022 net revenues of $13.2 million and slightly
behind fourth quarter net revenue of $14.1 million. DEXTENZA net
product revenue grew from $12.5 million to $13.2 million over the
comparable period in 2022 while collaboration revenue declined from
$0.7 million to $0.2 million.
Research and development expenses for the first quarter of 2023
were $14.7 million versus $13.1 million for the comparable period
in 2022, driven primarily by an increase in expenses associated
with clinical and preclinical programs.
Selling and marketing expenses in the first quarter of 2023 were
$10.8 million as compared to $9.1 million for the comparable
quarter of 2022, reflecting primarily an increase field force
personnel.
General and administrative expenses were $9.1 million for the
first quarter of 2023 versus $7.6 million in the comparable quarter
of 2022, primarily due to an increase in personnel-related costs,
including stock-based compensation, and professional fees.
The Company reported a net loss for the first quarter of 2023 of
$(30.3) million, or a loss of $(0.39) per share on both a basic
basis and diluted basis, compared to a net loss of $(12.5) million,
or a net loss of $(0.16) per share on a basic basis and a loss of
$(0.22) per share on a diluted basis for the comparable period in
2022. Net loss in the first quarter of 2023 included a $6.6 million
non-cash item attributable to a change in the fair value of the
derivative liability associated with the Company’s convertible
notes, increasing total other expenses as the price of the
Company’s common stock increased during the quarter. Non-cash
charges for stock-based compensation and depreciation and
amortization were $5.1 million in the first quarter of 2023 versus
$4.8 million for the comparable quarter in 2022.
As of May 4, 2023, the Company had approximately 77.5 million
shares outstanding.
2023 Financial Guidance
- Net product revenue in 2023 is expected
to be in the range of $55 to $60 million, representing anticipated
growth of approximately 10% to 20% over 2022. The growth is
anticipated to be driven by sales of DEXTENZA for the treatment of
post-surgical inflammation and pain in the ASC setting.
- As of March 31, 2023, the Company had
$79.0 million in cash and cash equivalents versus $102.3 million as
of December 31, 2022. Based on current plans and related estimates
of anticipated cash inflows from DEXTENZA and anticipated cash
outflows from operating expenses, the Company believes that its
existing cash and cash equivalents are sufficient to enable the
Company to fund planned operating expenses, debt service
obligations and capital expenditure requirements to the middle of
2024. This cash guidance is subject to a number of assumptions
including the revenues, expenses and reimbursement associated with
DEXTENZA, and the pace of research and clinical development
programs, among other aspects of the business, and excludes
expenses related to the Company’s planned clinical trials for
OTX-TKI for the treatment of wet AMD and for the treatment of
diabetic retinopathy.
Conference Call & Webcast Information
Members of the Ocular Therapeutix management team will host a
live conference call and webcast today at 4:30 pm Eastern Time to
review the Company's financial results and provide a general
business update. A live audio webcast will be available at
www.ocutx.com. Interested parties may also register for the webcast
via this link. Analysts wishing to participate in the question and
answer session should use this link. A replay of the webcast will
be available via the company’s investor website approximately two
hours after the call’s conclusion. Those who plan on participating
are advised to join 15 minutes prior to the start time.
About Ocular Therapeutix, Inc.
Ocular Therapeutix, Inc. is a biopharmaceutical company focused
on the formulation, development, and commercialization of
innovative therapies for diseases and conditions of the eye using
its proprietary bioresorbable hydrogel-based formulation
technology. Ocular Therapeutix’s first commercial drug product,
DEXTENZA®, is an FDA-approved corticosteroid for the treatment of
ocular inflammation and pain following ophthalmic surgery and
ocular itching associated with allergic conjunctivitis. Ocular
Therapeutix’s earlier stage development assets include: OTX-TKI
(axitinib intravitreal implant), currently in Phase 1 clinical
trials for the treatment of wet AMD and diabetic retinopathy;
OTX-TIC (travoprost intracameral implant), currently in a Phase 2
clinical trial for the treatment of primary open-angle glaucoma or
ocular hypertension; and OTX-DED (dexamethasone intracanalicular
insert) for the short-term treatment of the signs and symptoms of
dry eye disease; and OTX-CSI (cyclosporine intracanalicular insert)
for the chronic treatment of dry eye disease, both of which have
completed Phase 2 clinical trials.
About DEXTENZA
DEXTENZA is FDA approved for the treatment of ocular
inflammation and pain following ophthalmic surgery and ocular
itching associated with allergic conjunctivitis. DEXTENZA is a
corticosteroid intracanalicular insert placed in the punctum, a
natural opening in the inner portion of the lower eyelid, and into
the canaliculus and is designed to deliver dexamethasone to the
ocular surface for up to 30 days without preservatives. DEXTENZA
resorbs and exits the nasolacrimal system without the need for
removal.
Please see full Prescribing and Safety Information at
www.DEXTENZA.com.
Forward Looking Statements
Any statements in this press release about future expectations,
plans, and prospects for the Company, including the
commercialization of DEXTENZA® or any of the Company’s products or
product candidates; the development and regulatory status of the
Company’s product candidates, such as the Company’s development of,
timing of, and prospects for approvability of OTX-TKI for the
treatment of retinal diseases including wet AMD and diabetic
retinopathy including the timing of planned pivotal clinical
trials, OTX-TIC for the treatment of primary open-angle glaucoma or
ocular hypertension, OTX-DED for the short-term treatment of the
signs and symptoms of dry eye disease, and OTX-CSI for the chronic
treatment of dry eye disease; the Company’s plans to advance the
development of its product candidates or preclinical programs; the
Company’s ability to fund the planned and future development of its
product candidates, whether through strategic alliances or other
fundraising; the potential utility of any of the Company’s product
candidates; the size of potential markets for the Company’s product
candidates; 2023 financial guidance, including estimated net
product revenue; the sufficiency of the Company’s cash resources;
and other statements containing the words "anticipate," "believe,"
"estimate," "expect," "intend", "goal," "may", "might," "plan,"
"predict," "project," "target," "potential," "will," "would,"
"could," "should," "continue," and similar expressions, constitute
forward-looking statements within the meaning of The Private
Securities Litigation Reform Act of 1995. Actual results may differ
materially from those indicated by such forward-looking statements
as a result of various important factors. Such forward-looking
statements involve substantial risks and uncertainties that could
cause the Company’s preclinical and clinical development programs,
future results, performance or achievements to differ significantly
from those expressed or implied by the forward-looking statements.
Such risks and uncertainties include, among others, the timing and
costs involved in commercializing DEXTENZA or any product or
product candidate that receives regulatory approval, including the
conduct of post-approval studies, the ability to retain regulatory
approval of DEXTENZA or any product or product candidate that
receives regulatory approval, the ability to maintain and the
sufficiency of product, procedure and any other reimbursement codes
for DEXTENZA, the initiation, timing, conduct and outcomes of
clinical trials, whether clinical trial data will be indicative of
the results of subsequent clinical trials in the same or other
indications or that interim data will be indicative of the full
data from a clinical trial, uncertainties as to the timing and
availability of data from clinical trials and expectations for
regulatory submissions and approvals, the Company’s ability to
enter into and perform its obligations under collaborations and the
performance of its collaborators under such collaborations, the
Company’s scientific approach and general development progress, the
availability or commercial potential of the Company’s product
candidates, the Company’s ability to meet supply demands, the
Company’s ability to generate its projected net product revenue and
in-market sales on the timeline expected, if at all, the
sufficiency of cash resources, the Company’s existing indebtedness,
the ability of the Company’s creditors to accelerate the maturity
of such indebtedness upon the occurrence of certain events of
default, any additional financing needs, the Company’s ability to
recruit and retain key personnel, and other factors discussed in
the “Risk Factors” section contained in the Company’s quarterly and
annual reports on file with the Securities and Exchange Commission.
In addition, the forward-looking statements included in this press
release represent the Company’s views as of the date of this press
release. The Company anticipates that subsequent events and
developments will cause the Company’s views to change. However,
while the Company may elect to update these forward-looking
statements at some point in the future, the Company specifically
disclaims any obligation to do so, whether as a result of new
information, future events or otherwise, except as required by law.
These forward-looking statements should not be relied upon as
representing the Company’s views as of any date subsequent to the
date of this press release.
InvestorsOcular TherapeutixDonald NotmanChief
Financial Officerdnotman@ocutx.com
or
ICR WestwickeChris Brinzey, 339-970-2843Managing
Directorchris.brinzey@westwicke.com
Ocular
Therapeutix, Inc.
Condensed Consolidated Statements of
Operations and Comprehensive Loss(In thousands,
except share and per share data)
(Unaudited)
|
|
|
|
|
|
|
Three Months Ended |
|
March 31, |
|
2023 |
|
2022 |
Revenue: |
|
|
|
|
|
Product revenue, net |
$ |
13,214 |
|
|
$ |
12,498 |
|
Collaboration revenue |
|
160 |
|
|
|
689 |
|
Total revenue, net |
|
13,374 |
|
|
|
13,187 |
|
Costs and operating
expenses: |
|
|
|
|
|
Cost of product revenue |
|
1,214 |
|
|
|
1,300 |
|
Research and development |
|
14,747 |
|
|
|
13,100 |
|
Selling and marketing |
|
10,835 |
|
|
|
9,063 |
|
General and administrative |
|
9,127 |
|
|
|
7,557 |
|
Total costs and operating expenses |
|
35,923 |
|
|
|
31,020 |
|
Loss from operations |
|
(22,549 |
) |
|
|
(17,833 |
) |
Other income (expense): |
|
|
|
|
|
Interest income |
|
563 |
|
|
|
18 |
|
Interest expense |
|
(1,768 |
) |
|
|
(1,683 |
) |
Change in fair value of derivative liability |
|
(6,563 |
) |
|
|
6,958 |
|
Other expense, net |
|
(1 |
) |
|
|
(2 |
) |
Total other (expense) income, net |
|
(7,769 |
) |
|
|
5,291 |
|
Net loss |
$ |
(30,318 |
) |
|
$ |
(12,542 |
) |
Net loss per share, basic |
$ |
(0.39 |
) |
|
$ |
(0.16 |
) |
Weighted average common shares
outstanding, basic |
|
77,386,287 |
|
|
|
76,745,663 |
|
Net loss per share,
diluted |
$ |
(0.39 |
) |
|
$ |
(0.22 |
) |
Weighted average common shares
outstanding, diluted |
|
77,386,287 |
|
|
|
82,514,895 |
|
Ocular
Therapeutix, Inc.
Condensed Consolidated Balance
Sheets (In thousands, except share and per share
data) (Unaudited)
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
2023 |
|
2022 |
Assets |
|
|
|
|
|
Current assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
79,026 |
|
|
$ |
102,300 |
|
Accounts receivable, net |
|
21,124 |
|
|
|
21,325 |
|
Inventory |
|
2,266 |
|
|
|
1,974 |
|
Prepaid expenses and other current assets |
|
4,746 |
|
|
|
4,028 |
|
Total current assets |
|
107,162 |
|
|
|
129,627 |
|
Property and equipment,
net |
|
12,022 |
|
|
|
9,856 |
|
Restricted cash |
|
1,764 |
|
|
|
1,764 |
|
Operating lease assets |
|
7,625 |
|
|
|
8,042 |
|
Total assets |
$ |
128,573 |
|
|
$ |
149,289 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
Accounts payable |
$ |
5,441 |
|
|
$ |
5,123 |
|
Accrued expenses and other current liabilities |
|
21,993 |
|
|
|
24,097 |
|
Deferred revenue |
|
463 |
|
|
|
576 |
|
Operating lease liabilities |
|
1,818 |
|
|
|
1,599 |
|
Total current liabilities |
|
29,715 |
|
|
|
31,395 |
|
Other liabilities: |
|
|
|
|
|
Operating lease liabilities, net of current portion |
|
8,114 |
|
|
|
8,678 |
|
Derivative liability |
|
12,914 |
|
|
|
6,351 |
|
Deferred revenue, net of current portion |
|
13,340 |
|
|
|
13,387 |
|
Notes payable, net of discount |
|
25,321 |
|
|
|
25,257 |
|
Other non-current liabilities |
|
100 |
|
|
|
93 |
|
2026 convertible notes, net |
|
29,358 |
|
|
|
28,749 |
|
Total liabilities |
|
118,862 |
|
|
|
113,910 |
|
Commitments and
contingencies |
|
|
|
|
|
Stockholders’ equity: |
|
|
|
|
|
Preferred stock, $0.0001 par value; 5,000,000 shares authorized and
no shares issued or outstanding at March 31, 2023 and
December 31, 2022, respectively |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 200,000,000 shares authorized and
77,516,638 and 77,201,819 shares issued and outstanding at
March 31, 2023 and December 31, 2022,
respectively |
|
8 |
|
|
|
8 |
|
Additional paid-in capital |
|
656,863 |
|
|
|
652,213 |
|
Accumulated deficit |
|
(647,160 |
) |
|
|
(616,842 |
) |
Total stockholders’ equity |
|
9,711 |
|
|
|
35,379 |
|
Total liabilities and stockholders’ equity |
$ |
128,573 |
|
|
$ |
149,289 |
|
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