Press Release
Ocular Therapeutix™ Reports First Quarter 2021 Financial Results and Business Update
DEXTENZA® Achieved Quarterly Record of 16,634 Billable Units Sold to End Customers, Representing Quarterly Sequential Growth of 15%.
“Our progress in the first quarter of 2021 was significant,” said
Recent Business Updates
Presented Pre-Clinical and Clinical Data at the 2021
Data are also being presented on the Company’s products targeting ocular surface disease including pre-clinical pharmacokinetic data on OTX-CSI for the chronic treatment of dry eye disease and OTX-DED for the short-term treatment of signs and symptoms of dry eye disease. Additionally, we are presenting a post-hoc analysis of data on DEXTENZA® (dexamethasone ophthalmic insert) for the treatment of allergic conjunctivitis. The use of DEXTENZA in allergic conjunctivitis is currently under
The Company is also reporting that April in-market, billable units are estimated to have exceeded 8,000 units, setting a new monthly record.
Dosed First Patient in Phase 2 Clinical Trial Evaluating OTX-DED (dexamethasone intracanalicular insert). The Phase 2 clinical trial is a
Key Program Updates
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OTX-TKI (axitinib intravitreal implant) for the potential treatment of wet AMD and other retinal diseases.
-
The Company filed an exploratory IND (eIND) in
November 2020 to initiate a Phase 1 clinical trial of OTX-TKI inthe United States . A plannedU.S. -based Phase 1 clinical trial is anticipated to start in mid-2021.
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The Company filed an exploratory IND (eIND) in
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OTX-TIC (travoprost intracameral implant) for the treatment of patients with primary open-angle glaucoma or ocular hypertension.
- The Company completed enrollment of all four cohorts of its Phase 1 clinical trial.
-
The Company plans to initiate a randomized, double-masked, active-controlled Phase 2 clinical trial in the fourth quarter of 2021 in
the United States with a total of approximately 105 subjects to evaluate two different formulations of OTX-TIC versus a control arm receiving Durysta™.
-
OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease.
-
The Company has completed enrollment of a
U.S. -based Phase 2, randomized, double-masked, multi-center clinical trial to evaluate the safety, efficacy, durability, and tolerability of two different formulations of OTX-CSI versus hydrogel vehicle insert. - Top-line data from the Phase 2 clinical trial are expected in the fourth quarter of 2021.
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The Company has completed enrollment of a
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OTX-DED (dexamethasone intracanalicular insert) for the short-term treatment of the signs and symptoms of dry eye disease.
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The Company dosed the first subject in a
U.S. -based, prospective, randomized, double-masked, vehicle-controlled, multi-center Phase 2 clinical trial in approximately 150 subjects with dry eye disease. - Data from the Phase 2 clinical trial is expected in the first half of 2022.
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The Company dosed the first subject in a
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DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg for the treatment of ocular itching associated with allergic conjunctivitis.
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The FDA has set a target action PDUFA date of
October 18, 2021 .
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The FDA has set a target action PDUFA date of
-
ReSure® Sealant is designed to prevent wound leaks in corneal incisions following cataract surgery.
- The Company has received notification from FDA confirming that the Company has fulfilled all post-approval study requirements for ReSure® Sealant, with a requirement to update the ReSure label reflecting the study results.
First Quarter Ended
Gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was
Research and development expenses for the first quarter of 2021 were
Selling and marketing expenses in the first quarter of 2021 were
General and administrative expenses were
The Company reported net income of
As of
As of
Conference Call & Webcast Information
Members of the
About
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 effectiveness of reimbursement codes for, DEXTENZA; the conduct of post-approval studies of and compliance with related labeling requirements for DEXTENZA and ReSure Sealant; the development and regulatory status of the Company’s product candidates, such as the Company’s development of and prospects for approvability of DEXTENZA for additional indications including the PDUFA target action date scheduled for
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Consolidated Statements of Operations and Comprehensive Loss |
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(In thousands, except share and per share data) |
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(unaudited) |
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Three Months Ended |
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2021 |
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2020 |
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Revenue: |
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|
|
|
|
|
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Product revenue, net |
|
$ |
7,342 |
|
|
$ |
2,609 |
|
Total revenue, net |
|
|
7,342 |
|
|
|
2,609 |
|
Costs and operating expenses: |
|
|
|
|
|
|
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Cost of product revenue |
|
|
892 |
|
|
|
819 |
|
Research and development |
|
|
10,927 |
|
|
|
6,098 |
|
Selling and marketing |
|
|
8,086 |
|
|
|
7,130 |
|
General and administrative |
|
|
7,665 |
|
|
|
5,176 |
|
Total costs and operating expenses |
|
|
27,570 |
|
|
|
19,223 |
|
Loss from operations |
|
|
(20,228 |
) |
|
|
(16,614 |
) |
Other income (expense): |
|
|
|
|
|
|
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Interest income |
|
|
12 |
|
|
|
139 |
|
Interest expense |
|
|
(1,679 |
) |
|
|
(1,633 |
) |
Change in fair value of derivative liability |
|
|
25,016 |
|
|
|
(3,404 |
) |
Total other income (expense), net |
|
|
23,349 |
|
|
|
(4,898 |
) |
Net income (loss) attributable to common stockholders |
|
$ |
3,121 |
|
|
$ |
(21,512 |
) |
Net income (loss) per share, basic |
|
$ |
0.04 |
|
|
$ |
(0.41 |
) |
Weighted average common shares outstanding, basic |
|
|
76,071,017 |
|
|
|
51,900,882 |
|
Net income (loss) per share, diluted |
|
$ |
(0.24 |
) |
|
$ |
(0.41 |
) |
Weighted average common shares outstanding, diluted |
|
|
87,245,706 |
|
|
|
51,900,882 |
|
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Consolidated Balance Sheets |
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(In thousands, except share and per share data) |
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(unaudited) |
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2021 |
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2020 |
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Assets |
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Current assets: |
|
|
|
|
|
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Cash and cash equivalents |
|
$ |
209,378 |
|
$ |
228,057 |
|||||||
Accounts receivable, net |
|
|
13,631 |
|
|
12,252 |
|||||||
Inventory |
|
|
1,123 |
|
|
1,201 |
|||||||
Prepaid expenses and other current assets |
|
|
4,000 |
|
|
4,650 |
|||||||
Total current assets |
|
|
228,132 |
|
|
246,160 |
|||||||
Property and equipment, net |
|
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7,527 |
|
|
8,095 |
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Restricted cash |
|
|
1,764 |
|
|
1,764 |
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Operating lease assets |
|
|
5,617 |
|
|
5,844 |
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Total assets |
|
$ |
243,040 |
|
$ |
261,863 |
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Liabilities and Stockholders’ Equity |
|
|
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Current liabilities: |
|
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|
|
|
|
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Accounts payable |
|
$ |
4,152 |
|
$ |
2,709 |
|||||||
Accrued expenses and other current liabilities |
|
|
13,574 |
|
|
14,307 |
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Operating lease liabilities |
|
|
1,421 |
|
|
1,358 |
|||||||
Notes payable, net of discount, current |
|
|
8,290 |
|
|
8,290 |
|||||||
Total current liabilities |
|
|
27,437 |
|
|
26,664 |
|||||||
Other liabilities: |
|
|
|
|
|
|
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Operating lease liabilities, net of current portion |
|
|
7,169 |
|
|
7,548 |
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Derivative liability |
|
|
73,297 |
|
|
98,313 |
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Deferred revenue |
|
|
12,000 |
|
|
12,000 |
|||||||
Notes payable, net of discount |
|
|
14,907 |
|
|
16,936 |
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2026 convertible notes, net |
|
|
24,822 |
|
|
24,307 |
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Total liabilities |
|
|
159,632 |
|
|
185,768 |
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Commitments and contingencies |
|
|
|
|
|
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Stockholders’ equity (deficit): |
|
|
|
|
|
|
|||||||
Preferred stock, |
|
|
— |
|
|
— |
|||||||
Common stock, |
|
|
8 |
|
|
8 |
|||||||
Additional paid-in capital |
|
|
619,530 |
|
|
615,338 |
|||||||
Accumulated deficit |
|
|
(536,130) |
|
|
(539,251) |
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Total stockholders’ equity |
|
|
83,408 |
|
|
76,095 |
|||||||
Total liabilities and stockholders’ equity |
|
$ |
243,040 |
|
$ |
261,863 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20210505005896/en/
Investors
Chief Financial Officer
dnotman@ocutx.com
or
Westwicke, an
Managing Director
chris.brinzey@westwicke.com
Media
Senior Vice President, Commercial
scorning@ocutx.com
Source: