Ocular Therapeutix, Inc. (NASDAQ:OCUL, “Ocular”, the “Company”), a
biopharmaceutical company committed to enhancing people’s vision
and quality of life through the development and commercialization
of innovative therapies for wet age-related macular degeneration
(wet AMD), diabetic retinopathy, and other diseases and conditions
of the eye, today reported financial results for the first quarter
ended March 31, 2024.
“Ocular’s excellent progress in 2024 has put the
Company on track to becoming a leading retinal care company. We
have substantially enriched the organization with the appointment
of recognized leaders in retinal care and clinical development;
have completed a successful financing of $325 million in gross
proceeds from existing and new top-tier healthcare investors; and
have progressed our Phase 3 program for AXPAXLI™ in wet AMD,” said
Pravin U. Dugel, MD, Executive Chairman, President and Chief
Executive Officer of Ocular Therapeutix.
Dr. Dugel added, “The Phase 3 SOL-1 study is
making solid progress and our investment in strengthening the
clinical team has put Ocular in a strong position to drive
enrollment. We look forward to sharing an update on the progress of
the study, along with a review of Ocular’s corporate strategy,
during our Investor Day, planned for Thursday, June 13, 2024.”
Recent Achievements and Upcoming
Milestones:
- Appointed Pravin U. Dugel,
MD, as Executive Chairman, President and Chief Executive
Officer and added several strategic and clinical retinal
experts, advancing Ocular’s efforts to become a leading retina care
company.
- Raised gross proceeds of
$325 million in a private financing from existing and new
top-tier healthcare investors, extending Ocular’s cash runway into
2028.
- Initiated site
activation, screening, and
randomization in the Phase 3 AXPAXLI SOL-1 wet AMD
study in accordance with a Special Protocol Assessment
agreement with the FDA.
- Reported positive topline
data from two studies, the Phase 1 HELIOS study of AXPAXLI
in patients with non-proliferative diabetic retinopathy (NPDR) and
the Phase 2 study of PAXTRAVA™ in patients with glaucoma.
- Announced an Investor Day
on the afternoon of Thursday, June 13, 2024, in New York
City, where senior leadership will review the Company’s
corporate strategy. Participating key opinion leaders and logistics
information for the Investor Day, including details regarding the
webcast, will be provided in advance of the event.
First Quarter Ended March 31,
2024, Financial Results
Total cash and cash equivalents
were $482.9 million as of March 31, 2024. The Company completed a
private placement of common stock and pre-funded warrants in
February 2024 that provided gross proceeds of $325.0 million,
before deducting placement agent fees and offering expenses. Based
on current plans and related estimates of anticipated cash inflows
from DEXTENZA®, the Company believes that its current cash balance
is sufficient to support its planned expenses, obligations, and
capital expenditure requirements into 2028.
Total net revenue
was $14.8 million for the first quarter of 2024, a 10.4%
increase over total net revenue of $13.4 million in the comparable
period in 2023, driven by increased DEXTENZA sales. Total net
revenue includes both gross DEXTENZA product revenue, net of
discounts, rebates, and returns, which the Company refers to as net
product revenue, and collaboration revenue.
Research and development
expenses for the first quarter of 2024 were $20.7 million
versus $14.7 million for the comparable period in 2023, reflecting
an increase in overall clinical expenses associated with product
development programs, specifically the SOL-1 Phase 3 clinical
trial.
Selling and marketing expenses
were $10.2 million in the first quarter of 2024, as compared to
$10.8 million for the comparable quarter of 2023, primarily
reflecting a decrease in professional fees and a reduction in
personnel costs.
General and administrative
expenses were $14.1 million for the first quarter of 2024
versus $9.1 million in the comparable quarter of 2023, higher
primarily due to an increase in personnel-related costs and other
expenses.
Net loss for the first quarter of
2024 was $(64.8) million, or a net loss
of $(0.49) per share on both a basic and diluted basis,
compared to a net loss of $(30.3) million, or a net loss
of $(0.39) per share on both a basic and diluted basis,
for the comparable period in 2023. The net loss in the first
quarter of 2024 included a $(28.0) million non-cash loss on
extinguishment of debt in connection with the conversion of the
Company’s convertible notes, and a $(5.2) million non-cash loss,
net, attributable to the changes in the fair value of the
derivative liabilities associated with the Company’s convertible
notes, through the date of conversion, and the Barings credit
facility, as compared to a $(6.6) million non-cash loss
attributable solely to the change in the fair value of the
derivative liability associated with the Company’s convertible
notes for the comparable quarter in 2023.
Outstanding shares as
of May 3, 2024, were approximately 154.9 million.
About Ocular
Therapeutix, Inc.Ocular
Therapeutix, Inc. is a biopharmaceutical company committed to
enhancing people’s vision and quality of life through the
development and commercialization of innovative therapies for wet
age-related macular degeneration (wet AMD), diabetic retinopathy
(DR), and other diseases and conditions of the
eye. AXPAXLI™ (axitinib intravitreal implant, also known
as OTX-TKI), Ocular’s product candidate for retinal disease, is
based on its ELUTYX™ proprietary bioresorbable hydrogel-based
formulation technology. AXPAXLI is currently in a Phase 3 clinical
trial for wet AMD. The clinical portfolio also
includes PAXTRAVA™ (travoprost intracameral implant, also
known as OTX-TIC), currently in a Phase 2 clinical trial for the
treatment of open-angle glaucoma or ocular hypertension.
Ocular’s expertise in the formulation, development, and
commercialization of innovative therapies of the eye and the ELUTYX
platform supported the development and launch of its first
commercial drug product, DEXTENZA®, an FDA-approved
corticosteroid for the treatment of ocular inflammation and pain
following ophthalmic surgery and ocular itching associated with
allergic conjunctivitis. ELUTYX is also the foundation for two
other clinical-stage assets, 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, as well as several preclinical programs.
Follow us on our website, LinkedIn, or X.
DEXTENZA® is a registered trademark of Ocular
Therapeutix, Inc. AXPAXLI™, PAXTRAVA™, ELUTYX™, and Ocular
Therapeutix™ are trademarks of Ocular Therapeutix, Inc.
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 on
the DEXTENZA website.
Forward-Looking Statements: Any statements in
this press release about future expectations, plans, and prospects
for the Company, including the development and regulatory status of
the Company’s product candidates, including the timing, design, and
enrollment of the Company’s SOL-1 Phase 3 clinical trial of AXPAXLI
(also called OTX-TKI) for the treatment of wet AMD; the Company’s
plans to advance the development of AXPAXLI, PAXTRAVA and its other
product candidates; the potential utility of any of the Company’s
product candidates; the Company’s objective to become a leader in
retinal care; the Company’s cash runway and 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; the ability to retain regulatory
approval of DEXTENZA or any product or product candidate that
receives regulatory approval; the initiation, design, timing,
conduct and outcomes of ongoing and planned clinical trials; the
risk that the FDA will not agree with the Company’s interpretation
of the written agreement under Special Protocol Assessment for the
SOL-1 trial; the risk that even though the FDA has agreed with the
overall design of the SOL-1 trial, the FDA may not agree that the
data generated by the SOL-1 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 or
utilize a different formulation than the earlier trials, or whether
preliminary or interim data from a clinical trial will be
predictive of final data from such trial; availability of data from
clinical trials and expectations for regulatory submissions and
approvals; the Company’s scientific approach and general
development progress; 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; the 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 may 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.
Investors & MediaOcular Therapeutix,
Inc.Bill SlatteryVice President, Investor
Relationsbslattery@ocutx.com
Ocular
Therapeutix, Inc. |
Consolidated
Balance Sheets |
(in
thousands, except share and per share data) |
|
|
|
|
|
|
|
March
31, |
|
December 31, |
|
2024 |
|
2023 |
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash equivalents |
$ |
482,888 |
|
|
$ |
195,807 |
|
Accounts receivable, net |
|
26,546 |
|
|
|
26,179 |
|
Inventory |
|
2,574 |
|
|
|
2,305 |
|
Restricted cash |
|
150 |
|
|
|
150 |
|
Prepaid expenses and other current assets |
|
7,666 |
|
|
|
7,794 |
|
Total current assets |
|
519,824 |
|
|
|
232,235 |
|
Property and
equipment, net |
|
11,450 |
|
|
|
11,739 |
|
Restricted
cash |
|
1,614 |
|
|
|
1,614 |
|
Operating
lease assets |
|
6,059 |
|
|
|
6,472 |
|
Total assets |
$ |
538,947 |
|
|
$ |
252,060 |
|
Liabilities and Stockholders’ Equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
$ |
6,453 |
|
|
$ |
4,389 |
|
Accrued expenses and other current liabilities |
|
16,040 |
|
|
|
28,666 |
|
Deferred revenue |
|
263 |
|
|
|
255 |
|
Operating lease liabilities |
|
1,542 |
|
|
|
1,586 |
|
Total current liabilities |
|
24,298 |
|
|
|
34,896 |
|
Other
liabilities: |
|
|
|
|
|
Operating lease liabilities, net of current portion |
|
6,407 |
|
|
|
6,878 |
|
Derivative liabilities |
|
19,624 |
|
|
|
29,987 |
|
Deferred revenue, net of current portion |
|
14,068 |
|
|
|
14,135 |
|
Notes payable, net |
|
66,456 |
|
|
|
65,787 |
|
Other non-current liabilities |
|
111 |
|
|
|
108 |
|
Convertible Notes, net |
|
— |
|
|
|
9,138 |
|
Total liabilities |
|
130,964 |
|
|
|
160,929 |
|
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, 2024 and
December 31, 2023, respectively |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value; 200,000,000 shares authorized and
154,704,086 and 114,963,193 shares issued and outstanding at
March 31, 2024 and December 31, 2023,
respectively |
|
15 |
|
|
|
12 |
|
Additional paid-in capital |
|
1,170,394 |
|
|
|
788,697 |
|
Accumulated deficit |
|
(762,426 |
) |
|
|
(697,578 |
) |
Total stockholders’ equity |
|
407,983 |
|
|
|
91,131 |
|
Total liabilities and stockholders’ equity |
$ |
538,947 |
|
|
$ |
252,060 |
|
|
|
|
|
|
|
Ocular
Therapeutix, Inc. |
Consolidated
Statements of Operations and Comprehensive Loss |
(in
thousands, except share and per share data) |
|
|
Three Months
Ended |
|
March 31, |
|
2024 |
|
2023 |
Revenue: |
|
|
|
|
|
Product revenue, net |
$ |
14,715 |
|
|
$ |
13,214 |
|
Collaboration revenue |
|
59 |
|
|
|
160 |
|
Total revenue, net |
|
14,774 |
|
|
|
13,374 |
|
|
|
|
|
|
|
Costs and
operating expenses: |
|
|
|
|
|
Cost of product revenue |
|
1,326 |
|
|
|
1,214 |
|
Research and development |
|
20,735 |
|
|
|
14,747 |
|
Selling and marketing |
|
10,183 |
|
|
|
10,835 |
|
General and administrative |
|
14,147 |
|
|
|
9,127 |
|
Total costs and operating expenses |
|
46,391 |
|
|
|
35,923 |
|
Loss from
operations |
|
(31,617 |
) |
|
|
(22,549 |
) |
Other income
(expense): |
|
|
|
|
|
Interest income |
|
3,922 |
|
|
|
563 |
|
Interest expense |
|
(4,051 |
) |
|
|
(1,768 |
) |
Change in fair value of derivative liabilities |
|
(5,152 |
) |
|
|
(6,563 |
) |
Loss on extinguishment of debt |
|
(27,950 |
) |
|
|
— |
|
Other expense |
|
— |
|
|
|
(1 |
) |
Total other income (expense), net |
|
(33,231 |
) |
|
|
(7,769 |
) |
Net
loss |
$ |
(64,848 |
) |
|
$ |
(30,318 |
) |
Net loss per
share, basic |
$ |
(0.49 |
) |
|
$ |
(0.39 |
) |
Weighted
average common shares outstanding, basic |
|
132,021,945 |
|
|
|
77,386,287 |
|
Net loss per
share, diluted |
$ |
(0.49 |
) |
|
$ |
(0.39 |
) |
Weighted
average common shares outstanding, diluted |
|
132,021,945 |
|
|
|
77,386,287 |
|
|
|
|
|
|
|
Grafico Azioni Ocular Therapeutix (NASDAQ:OCUL)
Storico
Da Ago 2024 a Set 2024
Grafico Azioni Ocular Therapeutix (NASDAQ:OCUL)
Storico
Da Set 2023 a Set 2024