DEXTENZA® (dexamethasone ophthalmic insert) 0.4
mg Recorded Quarterly Net Product Revenue of $12.5 Million,
Representing Year-Over-Year Growth of 87%
Guiding DEXTENZA Annual Net Product Revenue for
2022 between $55 to $60 million, Representing Annual Growth of
Approximately 26% to 38%
Expanding Commercial Team to Address the
Commercial Opportunity for DEXTENZA in the Office Setting
Topline Data from the U.S.-based Clinical Trial
for OTX-TKI for the Treatment of Wet AMD Anticipated in the Third
Quarter of 2022
Dosing of Subjects in Phase 2 OTX-TIC Clinical
Trial for the Treatment of Glaucoma Began in February, Triggering a
$2M Milestone Clinical Support Payment from AffaMed
Therapeutics
Conference Call to Discuss First 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 March 31, 2022, and provided updates on its
ophthalmology pipeline.
“We have had a solid start to the year,” said Antony Mattessich,
President and Chief Executive Officer. “Following a slowdown in
cataract surgeries in January due to a spike in COVID-19 infections
as a result of the Omicron variant, we saw a rebound in sales as
the quarter progressed, culminating in approximately 10,500
billable units sold to ASCs and HOPDs in March—a monthly record by
more than 500 units. Overall, net product revenue for DEXTENZA®
reached $12.5M, an 87% increase over same quarter of the prior
year. In the pipeline, we also saw great progress in the quarter as
we completed enrollment of the U.S. Phase 1 clinical trial for
OTX-TKI, our treatment for wet-AMD, and began dosing subjects in
our Phase 2 clinical trial for OTX-TIC, our glaucoma product
candidate. We look forward to announcing data from the OTX-TKI
trial in the third quarter and enrolling the OTX-TIC trial as
quickly as possible. We have a lot to look forward to over the
course of this year from both a commercial and pipeline
perspective.”
Recent Business Updates
The U.S. Commercial Uptake of DEXTENZA.
- Net product revenue of DEXTENZA® for the quarter was $12.5
million, an 87% increase over the first quarter of 2021.
- In-market purchases were nearly 28,000 billable units for the
quarter, with March accounting for approximately 10,500 billable
units, setting a new record for a calendar month.
Expanding Commercial Team and the Addition of Vice President
of Sales to Optimize the Commercial Opportunity in the Office
Setting.
- In March 2022, the Company expanded its commercial group with
the hiring of Steve Meyers as Vice President, Surgical and Office
Sales. In addition to overseeing the growing surgical sales force,
Mr. Meyers will also be responsible for leading a separate sales
team focused on the office setting, starting with four Key Account
Managers (KAMs) and supported by the field reimbursement team.
- Mr. Meyers brings to the Company over 20 years of experience
with a deep background selling buy-and-bill specialty products in
the office setting and leading high-performing sales organizations.
Mr. Meyers was most recently Vice President Sales at Flexion
Therapeutics and has served in other commercial roles at leading
biotechnology and pharmaceuticals companies including Regeneron,
AbbVie, and Procter & Gamble.
Presented Data on Ocular Surface and Retinal Programs at
ASCRS and ARVO; Presenting New Data at ASGCT.
- At the American Society of Cataract and Refractive Surgery
(ASCRS) Annual Meeting held on April 22-24, 2022 in Washington
D.C., the Company presented fifteen posters and papers from eight
investigator-initiated trials and seven papers from
Company-sponsored trials on the use of DEXTENZA and pipeline
products. Two of these presentations highlighted real world use of
DEXTENZA for the first 10,000 plus inserts.
- At the Association for Research in Vision and Ophthalmology
(ARVO) Annual Meeting held on May 1-4, 2022 in Denver, the Company
presented six posters from Company-sponsored pre-clinical and
clinical trials on our pipeline. Two posters highlighted recent
studies of OTX-TKI in non-human primates: a pharmacokinetic and
tolerability study and a six-month GLP toxicology study.
- At the American Society of Gene and Cell Therapy (ASGCT) 25th
Annual Meeting held on May 16-19 in Washington, D.C., the Company
is presenting two posters highlighting pre-clinical studies
demonstrating the potential for sustained-release hydrogel implants
as a therapeutic and safety benefit for ocular adeno-associated
virus (AAV) gene therapy to the eye.
- Company-sponsored papers and posters can be found under the
“Events and Presentations” section on the Ocular Therapeutix
website.
2022 Financial Guidance
- Total net product revenue in 2022 is expected to be in the
range of $55 million to $60 million, representing growth of between
26% to 38% over 2021.
- The growth is anticipated to be almost entirely driven by sales
of DEXTENZA for the treatment of post-surgical inflammation and
pain.
- Based on current operating plans and related estimates of
anticipated cash inflows from product sales, the Company believes
that existing cash and cash equivalents, totaling $145.4 million as
of March 31, 2022, are sufficient to enable the Company to fund
planned operating expenses, debt service obligations and capital
expenditure requirements through 2023.
Key Pipeline Program Updates
- OTX-TKI (axitinib intravitreal implant) for the potential
treatment of wet AMD and other retinal diseases.
- At the Angiogenesis, Exudation, and Degeneration Meeting held
in February 2022, the Company presented interim data from the
ongoing Australia-based Phase 1 clinical trial of OTX-TKI for the
treatment of wet AMD demonstrating preliminary evidence of
biological activity as observed by a clinically meaningful decrease
in intraretinal and/or subretinal fluid in some subjects, and
durability of six months or more in over 60% of subjects across all
cohorts and over 80% of subjects in cohort 3a (600 μg), the dose
being evaluated in the U.S.-based Phase 1 clinical trial.
- The Company continues to follow subjects in the ongoing
Australia-based Phase 1 clinical trial.
- The U.S.-based Phase 1 clinical trial is now fully enrolled,
and the Company expects to report interim, six-month data in the
third quarter of this year.
- OTX-TIC (travoprost intracameral implant) for the treatment
of patients with primary open-angle glaucoma or ocular
hypertension.
- The Company presented interim Phase 1 data for OTX-TIC at
Glaucoma 360 held in February 2022 highlighting the product
candidate’s ability to cause a clinically meaningful decrease in
intraocular pressure (IOP) for six months or longer with a single
implant in many subjects while preserving corneal health.
- The Company is actively enrolling 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 trial will enroll approximately 105
subjects in three different arms (~35 subjects per arm; randomized
1:1:1) in which the subjects are to receive a single OTX-TIC
implant, containing either a 5 µg or 26 µg dose of travoprost,
compared with an injection of Allergan’s DURYSTA™. The trial is
designed to observe the changes in diurnal IOP from baseline (8 am,
10 am, 4 pm) at 2, 6, and 12 weeks, and follow duration of IOP
response over time.
- With the dosing of the first patient in the Phase 2 trial, the
Company earned a $2.0 million clinical support payment from AffaMed
Therapeutics (AffaMed), under its licensing agreement, to support
costs associated with this clinical trial. The Company expects to
receive the payment in the second quarter.
- OTX-CSI (cyclosporine intracanalicular insert) for the
chronic treatment of dry eye disease.
- The Company has resumed development of OTX-CSI, including
formulation work for the insert to allow improved product
retention. The Company is also developing an appropriate vehicle
comparator that may be used in both the OTX-CSI and OTX-DED
programs. Ocular recently received US Patent No. 11,291,627 which
covers the formulation under development.
- OTX-DED (dexamethasone intracanalicular insert) for the
short-term treatment of the signs and symptoms of dry eye
disease.
- The Company is currently developing an optimized clinical,
regulatory and manufacturing plan. This plan is expected to include
some additional improvements to the product’s formulation and the
development of an improved vehicle comparator.
First Quarter Ended March 31, 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 $13.2
million for the first quarter and represented an 81% increase over
the same period in 2021. Net product revenue of DEXTENZA in the
first quarter of 2022 was $12.5 million versus $6.7 million in the
comparable quarter of 2021, reflecting an 87% increase. Total net
revenue for the first quarter of 2022 also included collaboration
revenue of $0.7 million from our licensing agreement with
AffaMed.
Research and development expenses for the first quarter were
$13.1 million versus $10.9 million for the comparable period in
2021 driven primarily by an increase in unallocated expenses,
predominantly unallocated personnel costs, and increased clinical
trial costs.
Selling and marketing expenses in the quarter were $9.1 million
as compared to $8.1 million for the same quarter in 2021,
reflecting increased personnel costs associated primarily with an
expansion of the commercial field force.
General and administrative expenses were $7.6 million for the
first quarter versus $7.7 million in the comparable quarter of
2021.
The Company reported a net loss of $(12.5) million, or a loss of
$(0.16) per share on a basic basis and a loss of $(0.22) per share
on a diluted basis for the three months ended March 31, 2022. This
compares to a net income of $3.1 million, or income of $0.04 per
share on a basic basis and a loss of $(0.24) per share on a diluted
basis for the same period in 2021. Net loss in the first quarter of
2022 included a $7.0 million non-cash increase in the fair value of
the derivative liability associated with the Company’s convertible
notes, driven by a decrease in the price of its common stock during
the quarter. Non-cash charges for stock-based compensation and
depreciation and amortization were $4.8 million in the first
quarter versus $3.7 million for the same quarter in 2021.
As of May 6, 2022, the Company had 76.8 million shares
outstanding
As of March 31, 2022, the Company had $145.4 million in cash and
cash equivalents versus $164.2 million at December 31, 2021. Based
on current plans and related estimates of anticipated cash inflows
from DEXTENZA and anticipated cash outflows from operating
expenses, the Company believes that 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. The live webcast can be accessed by visiting the
Investors section of the Company’s website at investors.ocutx.com.
Please connect at least 15 minutes prior to the live webcast to
ensure adequate time for any software download that may be needed
to access the webcast. Alternatively, please call (844) 464-3934
(U.S.) or (765) 507-2620 (International) to listen to the live
conference call. The conference ID number for the live call will be
6054473. An archive of the webcast will be available until August
9, 2022 on the Company’s website.
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 includes 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) recently began a Phase 2
clinical trial to evaluate the reduction of intraocular pressure in
patients with primary open-angle glaucoma or ocular hypertension.
Ocular Therapeutix has also completed Phase 2 clinical trials for
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. 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 commercial launch of, and the
effectiveness of and amounts applicable to reimbursement codes for,
DEXTENZA; the conduct of post-approval studies of and compliance
with related labeling requirements for DEXTENZA and ReSure Sealant;
the Company’s sales and marketing strategy; the development and
regulatory status of the Company’s product candidates, such as the
Company’s development of and prospects for approvability of OTX-CSI
for the chronic treatment of dry eye disease, OTX-DED for the
short-term treatment of the signs and symptoms of dry eye disease,
OTX-TIC for the treatment of primary open-angle glaucoma or ocular
hypertension, and OTX-TKI for the treatment of retinal diseases
including wet AMD; the ongoing development of the Company’s
extended-delivery hydrogel depot technology; the size of potential
markets for our product candidates; the potential utility of any of
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 Company’s participation in
scientific conferences; potential market sizes for indications
targeted by the Company’s product candidates, if approved; 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
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.
Consolidated Statements of
Operations and Comprehensive Loss
(In thousands, except share
and per share data)
(Unaudited)
Three Months Ended
March 31,
2022
2021
Revenue:
Product revenue, net
$
12,498
$
7,342
Collaboration revenue
689
—
Total revenue, net
13,187
7,342
Costs and operating expenses:
Cost of product revenue
1,300
892
Research and development
13,100
10,927
Selling and marketing
9,063
8,086
General and administrative
7,557
7,665
Total costs and operating expenses
31,020
27,570
Loss from operations
(17,833
)
(20,228
)
Other income:
Interest income
18
12
Interest expense
(1,683
)
(1,679
)
Change in fair value of derivative
liability
6,958
25,016
Other income (expense), net
(2
)
—
Total other income, net
5,291
23,349
Net (loss) income attributable to common
stockholders
$
(12,542
)
$
3,121
Net (loss) income per share, basic
$
(0.16
)
$
0.04
Weighted average common shares
outstanding, basic
76,745,663
76,071,017
Net (loss) income per share, diluted
$
(0.22
)
$
(0.24
)
Weighted average common shares
outstanding, diluted
82,514,895
87,245,706
Ocular Therapeutix,
Inc.
Consolidated Balance
Sheet
(In thousands, except share
and per share data)
March 31,
December 31,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
145,417
$
164,164
Accounts receivable, net
23,207
21,135
Inventory
1,358
1,250
Prepaid expenses and other current
assets
4,670
4,751
Total current assets
174,652
191,300
Property and equipment, net
6,614
6,956
Restricted cash
1,764
1,764
Operating lease assets
4,592
4,867
Total assets
$
187,622
$
204,887
Liabilities and Stockholders’
Equity
Current liabilities:
Accounts payable
$
3,420
$
4,592
Accrued expenses and other current
liabilities
17,636
20,121
Deferred revenue
1,208
—
Operating lease liabilities
1,696
1,624
Total current liabilities
23,960
26,337
Other liabilities:
Operating lease liabilities, net of
current portion
5,472
5,924
Derivative liability
13,234
20,192
Deferred revenue, net of current
portion
13,103
13,000
Notes payable, net of discount
25,063
25,000
2026 convertible notes, net
26,995
26,435
Total liabilities
107,827
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
March 31, 2022 and December 31, 2021, respectively
—
—
Common stock, $0.0001 par value;
200,000,000 shares authorized and 76,759,614 and 76,731,940 shares
issued and outstanding at March 31, 2022 and December 31, 2021,
respectively
8
8
Additional paid-in capital
638,133
633,795
Accumulated deficit
(558,346
)
(545,804
)
Total stockholders’ equity
79,795
87,999
Total liabilities and stockholders’
equity
$
187,622
$
204,887
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220509006050/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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