Announced Positive Interim Data from the
U.S.-based Phase 1 Clinical Trial of OTX-TKI for the Treatment of
Wet AMD at the American Academy of Ophthalmology (AAO) 2022 Annual
Meeting
Initiation of OTX-TKI Phase 1 Clinical Trial
for the treatment of Diabetic Retinopathy Planned for Q1 of 2023
and Phase 2/3 Clinical Trial for the treatment of Wet AMD Planned
for Q3 of 2023
DEXTENZA® (dexamethasone ophthalmic insert) 0.4
mg Recorded Quarterly Net Product Revenue of $11.9 Million
Revised DEXTENZA Annual Net Product Revenue
Guidance for 2022 to be between $48 to $52 million, Representing
Annual Growth of Approximately 10% to 20%
Conference Call to Discuss Third Quarter
Results to be Held at 4:30 p.m. ET
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
quarter ended September 30, 2022, and provided updates on its
ophthalmology pipeline.
“We presented arguably the most important clinical data in the
Company’s history at this year’s AAO meeting” commented Antony
Mattessich, President and CEO. “In the 7-month data from our
U.S.-based Phase 1 clinical trial of a 600 µg, single implant
OTX-TKI for the treatment of controlled wet AMD, 80% and 73% of
subjects were rescue-free up to 6 and 7 months, respectively. In
addition to our goal of moving OTX-TKI into a Phase 2/3 trial for
the treatment of wet AMD in Q3 of 2023, we also plan to initiate a
Phase 1 trial for the treatment of diabetic retinopathy (DR) in Q1
of 2023. Pending good results, and subject to a follow-up meeting
with the FDA, we believe we could be in position to initiate our
first Phase 3 trial of OTX-TKI for the treatment of DR in Q1 of
2024. On the commercial front, DEXTENZA achieved net revenue of
$11.9 million for the quarter despite the continued staffing
challenges that we have observed at our ASC and HOPD customers that
hindered their ability to operate at full capacity. We believe
these challenges are transient in nature and that recent staffing
of our sales force at targeted levels and bringing new sales
territories online should have a near and long term positive impact
on DEXTENZA sales.”
Business Updates
OTX-TKI (axitinib intravitreal implant) for the potential
treatment of wet AMD, diabetic retinopathy and other retinal
diseases.
- Presented positive interim 7-month data from U.S.-based Phase 1
trial of OTX-TKI for the treatment of Wet AMD at the AAO 2022
Annual Meeting. Data was presented using a data cut-off date of
August 24, 2022.
- Interim data showed a single OTX-TKI implant was generally well
tolerated with no drug-related ocular or systemic serious adverse
events (SAEs). There were no reported adverse events such as
elevated IOP, retinal detachment, retinal vasculitis, or implant
migration into the anterior chamber observed in the OTX-TKI arm.
There was one SAE of acute endophthalmitis in the OTX-TKI arm which
occurred following a mandated aflibercept injection at Month
1.
- Subjects treated with a single OTX-TKI implant demonstrated
stable and sustained best corrected visual acuity (BCVA) (mean
change from baseline of -1.3 letters) and central subfield foveal
thickness (CSFT) (mean change from baseline of +9.2 µm) at 7
months, which was comparable with the aflibercept arm dosed every 8
weeks (mean change from BVCA baseline of -1 letter; mean change
from CSFT baseline of +0.4 µm).
- 80% of subjects in the OTX-TKI arm were rescue-free up to 6
months and 73% of subjects in the OTX-TKI arm were rescue-free up
to 7 months.
- The Company intends to present 10-month data at the upcoming
Angiogenesis, Exudation, and Degeneration 2023 Meeting at 8:10 am
on Saturday, February 11th, 2023 and plans to follow subjects at
least until their respective one-year anniversaries of initial
dosing, in accordance with the clinical trial protocol.
- The Company plans to meet with the FDA in early 2023 to discuss
potential future clinical trial requirements with the goal of
initiating a Phase 2/3 clinical trial for the treatment of wet AMD
in Q3 of 2023.
- The Company intends to initiate a U.S.-based Phase 1 clinical
trial for the treatment of DR in Q1 of 2023.
- The US Phase 1 trial is planned to be conducted under an
existing eIND across approximately 10 sites and is designed to
include approximately 20 patients randomized to either a 600 µg
OTX-TKI single implant containing axitinib or sham control.
- Pending good data results from the Phase 1, and subject to a
follow-up meeting with the FDA, the Company believes it could be
well positioned to initiate its first Phase 3 pivotal trial for the
treatment of DR in Q1 of 2024.
OTX-TIC (travoprost intracameral implant) for the treatment
of patients with primary open-angle glaucoma or ocular
hypertension.
- The Company continues to actively 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.
- The Company has designed the Phase 2 trial to evaluate whether
OTX-TIC can cause a clinically meaningful decrease in intraocular
pressure while preserving endothelial cell health, enabling repeat
dosing.
- The Company plans to provide a topline data release in Q4 of
2023.
Dry Eye Programs moving forward in a measured manner with a
collaborative study of OTX-DED (dexamethasone intracanalicular
insert) for the short-term treatment of the signs and symptoms of
dry eye disease.
- The Company intends to initiate a collaborative clinical trial
in the first half of 2023 to evaluate the performance of OTX-DED
versus fast-dissolving collagen plugs and no inserts at all.
Specifically, the Company plans to conduct this trial to explain
the magnitude of the placebo effect seen in both the OTX-DED and
the OTX-CSI (cyclosporine intracanalicular insert for the chronic
treatment of dry eye disease) Phase 2 trials in which the vehicle
hydrogel placebo insert remained in the canaliculus longer than
anticipated, performing more like an active comparator than a
placebo comparator.
- The Company plans to use the results of the collaborative study
to inform the next steps for both OTX-DED and OTX-CSI.
DEXTENZA (dexamethasone ophthalmic insert) 0.4mg is FDA
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 quarter was $11.9
million, in line with the third quarter of 2021 and down
approximately 2% sequentially quarter-over-quarter.
- In-market purchases were over 26,000 billable units for the
quarter, down approximately 2% quarter-over-quarter as the Company
believes many end customers, primarily ASCs, continued to operate
below capacity due to staffing challenges.
- In light of this performance, the Company is revising its
guidance to $48 to $52 million in net product revenue for
2022.
- The Company presented multiple posters on the real-world
safety, demographic and clinical characteristics of DEXTENZA using
the Academy’s IRIS® Registry at the AAO 2022 Annual Meeting.
- On November 1, 2022, the Centers for Medicare and Medicaid
Services (CMS) issued the calendar year 2023 hospital outpatient
prospective payment system (OPPS) rule, confirming that DEXTENZA,
as anticipated, will be separately payable in ambulatory surgery
centers under the non-opioid supply provision for CY 2023.
Third Quarter Ended September 30, 2022 Financial
Results
Net revenue, which includes both gross product revenue net of
discounts, rebates, and returns, which the Company refers to as
total net product revenue, and collaboration revenue was $12.0
million for the third quarter of 2022 and represented an
approximately 2% decrease over the same period in 2021. DEXTENZA
net product revenue was $11.9 million for the third quarter of
2022, flat to the comparable quarter of 2021 and down approximately
2% on a sequential quarterly basis. Net revenue in the third
quarter of 2022 also included $0.1 million in collaboration revenue
associated with the Company’s work with AffaMed. Net product
revenue in the third quarter of 2021, included $0.3 million
attributable to sales of ReSure Sealant.
Research and development expenses for the third quarter of 2022
were $13.7 million versus $12.7 million for the comparable period
in 2021 driven primarily by an increase in personnel and a higher
level of preclinical development activity.
Selling and marketing expenses in the third quarter of 2022 were
$10.2 million as compared to $9.6 million for the comparable
quarter of 2021, reflecting primarily an increase in field force
personnel.
General and administrative expenses were $8.5 million for the
third quarter of 2022 versus $8.1 million in the comparable quarter
of 2021, primarily due to an increase in personnel related costs,
including stock-based compensation.
The Company reported a net loss for the third quarter of 2022 of
$(24.2) million, or a loss of $(0.31) per share on a basic and
diluted basis, compared to net income of $2.7 million, or net
income of $0.03 per share on a basic basis and a loss of $(0.23)
per share on a diluted basis for the same period in 2021. Net loss
in the third quarter of 2022 included a $1.1 million non-cash item
attributable to an increase in the fair value of the derivative
liability associated with the Company’s convertible notes, as the
price of its common stock increased during the quarter. Non-cash
charges for stock-based compensation and depreciation and
amortization were $4.7 million in the third quarter of 2022 versus
$4.4 million for the same quarter in 2021.
As of November 4, 2022, the Company had 77.0 million shares
outstanding.
2022 Financial Guidance
- Total net product revenue in 2022 is expected to be in the
range of $48 to $52 million, representing growth of between 10% to
20% over 2021. The growth is anticipated to be driven by sales of
DEXTENZA for the treatment of post-surgical inflammation and
pain.
- As of September 30, 2022, the Company had $121.0 million in
cash and cash equivalents versus $134.5 million at June 30, 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 through 2023. This cash guidance is
subject to a number of assumptions including the impacts from the
ongoing COVID-19 pandemic; 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. 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 other retinal diseases;
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. Ocular Therapeutix's
first product, ReSure® Sealant, is an FDA-approved device to
prevent wound leaks in corneal incisions following cataract
surgery.
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®, ReSure® Sealant, or any of the
Company’s product candidates; the development and regulatory status
of the Company’s product candidates, such as the Company’s
development of and prospects for approvability of OTX-TIC for the
treatment of primary open-angle glaucoma or ocular hypertension,
OTX-TKI for the treatment of retinal diseases including wet AMD and
diabetic retinopathy, 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
ongoing development of the Company’s extended-delivery hydrogel
depot technology; the potential utility of any of the Company’s
product candidates; the size of potential markets for the Company’s
product candidates; the potential benefits and future operations of
Company collaborations, including any potential future costs or
payments thereunder; projected net product revenue, in-market sales
and other financial and operational metrics of DEXTENZA and ReSure
Sealant; the expected impact of the COVID-19 pandemic on the
Company and its operations; 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, ReSure Sealant or any product
candidate that receives regulatory approval, including the conduct
of post-approval studies, the ability to successfully develop and
commercialize products for the ophthalmology office setting, the
ability to retain regulatory approval of DEXTENZA, ReSure Sealant
or any 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 such as the data reported in this release will be indicative
of the results of subsequent clinical trials, 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, the severity and
duration of the COVID-19 pandemic including its effect on the
Company’s revenues and relevant regulatory authorities’ operations,
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.
Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Operations and
Comprehensive Income (Loss) (In thousands, except share and
per share data) (Unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2022
2021
2022
2021
Revenue:
Product revenue, net
$
11,913
$
12,153
$
36,555
$
31,214
Collaboration revenue
52
—
864
—
Total revenue, net
11,965
12,153
37,419
31,214
Costs and operating expenses:
Cost of product revenue
1,073
1,310
3,528
3,298
Research and development
13,719
12,719
39,919
37,505
Selling and marketing
10,186
9,576
29,390
26,054
General and administrative
8,531
8,077
23,875
24,345
Total costs and operating expenses
33,509
31,682
96,712
91,202
Loss from operations
(21,544)
(19,529)
(59,293)
(59,988)
Other income (expense):
Interest income
285
7
375
27
Interest expense
(1,797)
(1,658)
(5,175)
(4,991)
Change in fair value of derivative
liability
(1,133)
23,837
8,598
62,249
Other income (expense), net
1
—
(1)
—
Total other income (expense), net
(2,644)
22,186
3,797
57,285
Net (loss) income
$
(24,188)
$
2,657
$
(55,496)
$
(2,703)
Net (loss) income per share, basic
$
(0.31)
$
0.03
$
(0.72)
$
(0.04)
Weighted average common shares
outstanding, basic
76,975,839
76,552,060
76,829,434
76,317,563
Net (loss) income per share, diluted
$
(0.31)
$
(0.23)
$
(0.73)
$
(0.75)
Weighted average common shares
outstanding, diluted
76,975,839
85,446,886
82,598,666
82,086,795
Ocular Therapeutix, Inc.
Condensed Consolidated Balance Sheets (In thousands,
except share and per share data) (Unaudited)
September 30,
December 31,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
120,950
$
164,164
Accounts receivable, net
19,802
21,135
Inventory
1,545
1,250
Prepaid expenses and other current
assets
3,318
4,751
Total current assets
145,615
191,300
Property and equipment, net
7,196
6,956
Restricted cash
1,764
1,764
Operating lease assets
4,004
4,867
Total assets
$
158,579
$
204,887
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
5,308
$
4,592
Accrued expenses and other current
liabilities
21,614
20,121
Deferred revenue
603
—
Operating lease liabilities
1,744
1,624
Total current liabilities
29,269
26,337
Other liabilities:
Operating lease liabilities, net of
current portion
4,610
5,924
Derivative liability
11,594
20,192
Deferred revenue, net of current
portion
13,533
13,000
Notes payable, net of discount
25,192
25,000
2026 convertible notes, net
28,152
26,435
Total liabilities
112,350
116,888
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.0001 par value;
5,000,000 shares authorized and no shares issued or outstanding at
September 30, 2022 and December 31, 2021, respectively
—
—
Common stock, $0.0001 par value;
200,000,000 shares authorized and 77,010,385 and 76,731,940 shares
issued and outstanding at September 30, 2022 and December 31, 2021,
respectively
8
8
Additional paid-in capital
647,521
633,795
Accumulated deficit
(601,300)
(545,804)
Total stockholders’ equity
46,229
87,999
Total liabilities and stockholders’
equity
$
158,579
$
204,887
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221107005999/en/
Investors Ocular Therapeutix Donald Notman Chief
Financial Officer dnotman@ocutx.com or ICR Westwicke Chris Brinzey,
339-970-2843 Managing Director chris.brinzey@westwicke.com
Media Ocular Therapeutix Scott Corning Senior Vice
President, Commercial scorning@ocutx.com
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