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
third quarter ended September 30, 2023, and provided updates on its
ophthalmology pipeline.
“We made significant progress at Ocular Therapeutix in the third
quarter,” said Antony Mattessich, President and CEO. “In a critical
step forward for our clinical program, we initiated the first
pivotal trial evaluating AXPAXLI for the treatment of wet AMD and
subsequently have received FDA agreement with our overall clinical
plan under a Special Protocol Assessment. We are thrilled to have
agreement with the FDA regarding our trial design and are very
excited to continue moving forward toward our goal of bringing a
potentially transformative new treatment to wet AMD patients coping
with vision loss.”
Business Updates
AXPAXLI (axitinib intravitreal implant)
for the potential treatment of wet age-related macular degeneration
(wet AMD) and other retinal vascular diseases.
- The Company
initiated the first pivotal clinical trial, or the SOL trial,
evaluating AXPAXLI for the treatment of wet AMD. The trial is
designed as a superiority trial and will enroll approximately 300
evaluable wet AMD subjects who are treatment naïve in the study
eye. The trial is designed to be a multi-center, parallel-group
Phase 3 trial that will be run primarily at U.S. sites with
subjects randomized to one injection of aflibercept or one implant
of AXPAXLI followed by as needed supplemental anti-VEGF treatment
based on pre-specified criteria. The Company plans to use a single
implant of AXPAXLI with an optimized drug load of 450 µg of
axitinib per implant. This optimized configuration is expected to
provide for a slightly increased daily release of the drug and is
designed to improve synchronization of axitinib drug depletion with
hydrogel bioresorption. The Company currently plans to assess
the safety and efficacy of AXPAXLI by measuring best corrected
visual acuity (BCVA) and central subfield thickness (CSFT) at 36
weeks. AXPAXLI is also referred to by its laboratory code,
OTX-TKI.
- In October 2023, the
Company received written agreement under a Special Protocol
Assessment (SPA) from the U.S. Food and Drug Administration (FDA)
for the SOL trial, securing alignment with the FDA on both the
protocol design and the statistical analysis plan. The Company
gained agreement on several crucial aspects including: the study
population to be enrolled in our clinical trial, the identification
of a suitable control arm for AXPAXLI, the determination of its
dosing regimen, the definition of baseline, the selection of a
primary endpoint and its corresponding timing, as well as the
establishment of an appropriate sample size to ensure the
statistical robustness of our pivotal trial.
- With the agreement
under the SPA, the Company will begin enrolling patients in the SOL
trial and expects to dose the first subject by year-end.
AXPAXLI (axitinib intravitreal implant)
for the treatment of non-proliferative diabetic retinopathy
(NPDR).
- The Company
completed enrollment of the HELIOS trial, a U.S.-based,
double-masked Phase 1 clinical trial in 22 subjects randomized 2:1
to either a single implant of AXPAXLI containing 600 µg of axitinib
or a sham control.
- The Company plans to present nine-month, top-line clinical data
from the trial in Q2 2024.
OTX-TIC (travoprost intracameral implant) for the
treatment of primary open-angle glaucoma (OAG) or ocular
hypertension (OHT).
- The Company plans to
report top-line data from the single-dose portion of 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 subjects with OAG or OHT compared to DURYSTA®
at the ASCRS meeting in early April 2024.
- The Company has
designed the Phase 2 clinical trial to evaluate whether OTX-TIC can
demonstrate a clinically meaningful decrease in intraocular
pressure while preserving endothelial cell health.
- A repeat-dose sub-study in the Phase 2 clinical trial continues
to enroll a small sub-set of subjects with OAG or OHT to evaluate
the safety of a repeat, sustained release dose of OTX-TIC 26 μg.
These subjects will be followed for at least 6 months after their
enrollment in the sub-study in order to evaluate their endothelial
cell health.
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 is
conducting a small study to evaluate the performance of OTX-DED
versus fast-dissolving collagen plugs and no inserts at all with
the intention of identifying a potential placebo control for 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 Q3 2023 was $15.0 million, approximately 26% ahead
of Q3 2022 net product revenue of $11.9 million and in line with Q2
2023 net product revenue of $15.0 million.
- In November 2023,
the Centers for Medicare and Medicaid Services (CMS) released the
final rulemaking for CY 2024 under the Outpatient Prospective
Payment System (OPPS). The final rule confirms:
- DEXTENZA will
continue to be separately reimbursed by Medicare in the ambulatory
surgical center (ASC) setting under the non-opioid pain provision;
and
- CPT 68841, the code
that describes the insertion of DEXTENZA, maintains a Q1 status
indicator. The Company intends to request that CMS reconsider its
decision and provide for a separate facility payment in the 2024
(CY 2025) rule-making cycle.
- The Company believes
that DEXTENZA is currently used in less than 5% of cataract
procedures and that growth may be driven by a continued focus on
sales to ASCs, specifically strategic accounts that own and control
multiple ASCs.
Third Quarter Ended September 30, 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
$15.1 million for the third quarter of 2023, an increase of
approximately 26% over third quarter 2022 net revenues of $12.0
million and in line with second quarter net revenue of $15.2
million. For the third quarter of 2023, DEXTENZA net product
revenue grew to $15.0 million from $11.9 million over the
comparable period in 2022 while collaboration revenue was
approximately $0.1 million for each period.
Research and development expenses for the third quarter of 2023
were $15.0 million versus $13.7 million for the comparable period
in 2022, driven primarily by an increase in expenses associated
with clinical trial programs and personnel-related costs, including
stock-based compensation to support those programs.
Selling and marketing expenses in the third quarter of 2023 were
$9.3 million as compared to $10.2 million for the comparable
quarter of 2022, reflecting primarily a decrease in professional
fees and services.
General and administrative expenses were $8.6 million for the
third quarter of 2023 versus $8.5 million in the comparable quarter
of 2022, primarily due to an increase in personnel-related costs,
including stock-based compensation offset by lower professional
related fees and services.
The Company reported a net loss for the third quarter of 2023 of
$(0.5) million, or a net loss of $(0.01) per share on a basic basis
and ($0.25) per share on a diluted basis, compared to a net loss of
$(24.2) million, or a net loss of $(0.31) per share on both a basic
and diluted basis per share for the comparable period in 2022. Net
loss in the third quarter of 2023 included a $ 6.7 million non-cash
gain attributable to a change in the fair value of the derivative
liabilities associated with the Company’s convertible notes and the
Barings credit facility. The Company also recorded gains and losses
from debt extinguishment, net, of $14.2 million in the third
quarter of 2023. Non-cash charges for stock-based compensation and
depreciation and amortization were $5.4 million in the third
quarter of 2023 versus $4.7 million for the comparable quarter in
2022. As of November 3, 2023, the Company had approximately 79.4
million shares outstanding.
2023 Financial Guidance
- The Company anticipates DEXTENZA net
product revenue guidance for the full year 2023 to come in at the
upper end of the current $55 and $60 million range provided by the
Company. The current range represents 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 September 30, 2023, the Company
had $110.6 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 into 2025 and
comply with the Company’s $20.0 million minimum cash covenant in
connection with the Barings Credit Agreement. 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.
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
ELUTYX™. 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: AXPAXLI
(axitinib intravitreal implant), currently in a pivotal Phase 3
trial for wet AMD and a Phase 1 clinical trial for the treatment of
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-CSI
(cyclosporine intracanalicular insert) for the chronic treatment of
dry eye disease and OTX-DED (dexamethasone intracanalicular insert)
for the short-term treatment of the signs and symptoms 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.
About AXPAXLIAXPAXLI is an investigational
bioresorbable, hydrogel implant incorporating axitinib, a small
molecule, multi-target, tyrosine kinase inhibitor with
anti-angiogenic properties, being evaluated for the treatment of
wet AMD and other retinal diseases. AXPAXLI is also referred to by
its laboratory code, OTX-TKI.
Forward Looking StatementsAny statements in
this press release about future expectations, plans, and prospects
for the Company, including the commercialization of DEXTENZA; the
development, regulatory status and prospects of the Company’s
product candidates, including the timing and design of the
Company’s pivotal trials of AXPAXLI (also called OTX-TKI) for the
treatment of wet AMD including the SOL trial, of the Company’s
ongoing HELIOS trial evaluating AXPAXLI for the treatment of
non-proliferative diabetic retinopathy, and of the Company’s
ongoing Phase 2 clinical trial evaluating OTX-TIC for the treatment
of primary open-angle glaucoma or ocular hypertension; the
Company’s plans to advance the development of its product
candidates or preclinical programs; the potential utility of any of
the Company’s product candidates; projected net product revenue,
in-market sales and other financial and operational metrics of
DEXTENZA; the Company’s cash runway and 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; 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, design, timing, conduct and outcomes
of clinical trials; the risk that the FDA will not agree with the
Company’s interpretation of the written agreement under the SPA;
the risk that even though the FDA has agreed with the overall
design of the SOL trial, the FDA may not agree that the data
generated by the SOL trial supports potential marketing approval;
uncertainty as to whether the data from earlier clinical trials
will be predictive of the data of later clinical trials,
particularly later clinical trials that have a different design
than the earlier trials; availability of data from clinical trials
and expectations for regulatory submissions and approvals; the
Company’s scientific approach and general development progress; the
availability or commercial potential of the Company’s current and
future products and product candidates; the Company’s ability to
meet supply demands for its current and future products;
uncertainties inherent in estimating the Company’s cash runway,
future expenses and other financial results, including its ability
to fund future operations, including clinical trials; Company’s
existing indebtedness and the ability of the Company’s creditors to
accelerate the maturity of such indebtedness upon the occurrence of
certain events of default; the Company’s ability to enter into
strategic alliances or generate additional funding on a timely
basis, on favorable terms, or at all; 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.comorICR WestwickeChris Brinzey,
339-970-2843Managing Directorchris.brinzey@westwicke.com
MediaICR WestwickeBen Shannon,
443-213-0495ben.shannon@westwicke.com
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Ocular Therapeutix, Inc.Condensed
Consolidated Statements of Operations and Comprehensive
Loss(In thousands, except share and per share
data)(Unaudited) |
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Three Months Ended |
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Nine Months Ended |
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September 30, |
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September 30, |
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2023 |
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2022 |
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2023 |
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2022 |
|
Revenue: |
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Product revenue, net |
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$ |
14,950 |
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$ |
11,913 |
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$ |
43,193 |
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$ |
36,555 |
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Collaboration revenue |
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131 |
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52 |
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|
449 |
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|
|
864 |
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Total revenue, net |
|
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15,081 |
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|
|
11,965 |
|
|
|
43,642 |
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|
37,419 |
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Costs and operating
expenses: |
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Cost of product revenue |
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1,377 |
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|
1,073 |
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|
|
3,895 |
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|
|
3,528 |
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Research and development |
|
|
15,019 |
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|
|
13,719 |
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|
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44,860 |
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|
|
39,919 |
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Selling and marketing |
|
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9,315 |
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10,186 |
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31,304 |
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|
29,390 |
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General and administrative |
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8,584 |
|
|
|
8,531 |
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|
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25,915 |
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|
|
23,875 |
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Total costs and operating expenses |
|
|
34,295 |
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|
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33,509 |
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|
|
105,974 |
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|
96,712 |
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Loss from operations |
|
|
(19,214 |
) |
|
|
(21,544 |
) |
|
|
(62,332 |
) |
|
|
(59,293 |
) |
Other income (expense): |
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Interest income |
|
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1,212 |
|
|
|
285 |
|
|
|
2,524 |
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|
|
375 |
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Interest expense |
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|
(3,426 |
) |
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|
(1,797 |
) |
|
|
(7,187 |
) |
|
|
(5,175 |
) |
Change in fair value of derivative liabilities |
|
|
6,722 |
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|
|
(1,133 |
) |
|
|
1,290 |
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|
|
8,598 |
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Gains and losses on extinguishment of debt, net |
|
|
14,190 |
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|
|
— |
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14,190 |
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— |
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Other income (expense), net |
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|
— |
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|
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1 |
|
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(1 |
) |
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(1 |
) |
Total other income (expense), net |
|
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18,698 |
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|
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(2,644 |
) |
|
|
10,816 |
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|
|
3,797 |
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Net loss |
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$ |
(516 |
) |
|
$ |
(24,188 |
) |
|
$ |
(51,516 |
) |
|
$ |
(55,496 |
) |
Net loss per share, basic |
|
$ |
(0.01 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.66 |
) |
|
$ |
(0.72 |
) |
Weighted average common shares
outstanding, basic |
|
|
79,373,272 |
|
|
|
76,975,839 |
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|
78,276,341 |
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|
|
76,829,434 |
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Net loss per share,
diluted |
|
$ |
(0.25 |
) |
|
$ |
(0.31 |
) |
|
$ |
(0.77 |
) |
|
$ |
(0.73 |
) |
Weighted average common shares
outstanding, diluted |
|
|
85,142,504 |
|
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|
76,975,839 |
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84,045,573 |
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82,598,666 |
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Ocular Therapeutix, Inc. Condensed
Consolidated Balance Sheets (In thousands, except
share and per share data)
(Unaudited) |
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September 30, |
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December 31, |
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2023 |
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2022 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
110,550 |
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$ |
102,300 |
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Accounts receivable, net |
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23,589 |
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21,325 |
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Inventory |
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2,257 |
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1,974 |
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Prepaid expenses and other current assets |
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4,862 |
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4,028 |
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Total current assets |
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141,258 |
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129,627 |
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Property and equipment,
net |
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12,494 |
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9,856 |
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Restricted cash |
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1,764 |
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|
1,764 |
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Operating lease assets |
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6,868 |
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|
8,042 |
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Total assets |
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$ |
162,384 |
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$ |
149,289 |
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Liabilities and
Stockholders’ Equity |
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Current liabilities: |
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Accounts payable |
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$ |
3,984 |
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$ |
5,123 |
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Accrued expenses and other current liabilities |
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|
28,887 |
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|
24,097 |
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Deferred revenue |
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|
317 |
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|
576 |
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Operating lease liabilities |
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|
1,878 |
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|
1,599 |
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Total current liabilities |
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35,066 |
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|
31,395 |
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Other liabilities: |
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Operating lease liabilities, net of current portion |
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7,251 |
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8,678 |
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Derivative liabilities |
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24,022 |
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|
6,351 |
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Deferred revenue, net of current portion |
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14,197 |
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13,387 |
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Notes payable, net |
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65,124 |
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25,257 |
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Other non-current liabilities |
|
|
106 |
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|
|
93 |
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Convertible Notes, net |
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|
8,765 |
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|
28,749 |
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Total liabilities |
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|
154,531 |
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|
113,910 |
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Commitments and
contingencies |
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Stockholders’ equity: |
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Preferred stock, $0.0001 par value; 5,000,000 shares authorized and
no shares issued or outstanding at September 30, 2023 and
December 31, 2022, respectively |
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— |
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— |
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Common stock, $0.0001 par value; 200,000,000 shares authorized and
79,412,114 and 77,201,819 shares issued and outstanding at
September 30, 2023 and December 31, 2022,
respectively |
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|
8 |
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|
8 |
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Additional paid-in capital |
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|
676,203 |
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|
652,213 |
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Accumulated deficit |
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|
(668,358 |
) |
|
|
(616,842 |
) |
Total stockholders’ equity |
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|
7,853 |
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|
35,379 |
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Total liabilities and stockholders’ equity |
|
$ |
162,384 |
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|
$ |
149,289 |
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Ocular Therapeutix (NASDAQ:OCUL)
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