Press Release
Ocular Therapeutix™ Reports Third Quarter 2020 Financial Results and Business Update
October Financing Raised
DEXTENZA® Net Product Revenue in Third Quarter of
Reported Topline Phase 1 Results and Recently Initiated Phase 2 Clinical Trial of OTX-CSI for the Chronic Treatment of Dry Eye Disease
Announced License Agreement and Collaboration for DEXTENZA and OTX-TIC in Select Asian Countries
“It has been a productive quarter for
Recent Business Updates
Reported the
Completed common stock financing in late October. The Company raised
Announced License Agreement and Collaboration for DEXTENZA and OTX-TIC in Select Asian Countries. The Company announced a license agreement and a collaboration with AffaMed Therapeutics for the development and commercialization of DEXTENZA® and OTX-TIC in
Key Program Updates
OTX-TKI (axitinib intravitreal implant): OTX-TKI is a bioresorbable, hydrogel implant incorporating axitinib, a small molecule tyrosine kinase inhibitor with anti-angiogenic properties for the potential treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases.
-
The Company is conducting a Phase 1, prospective, multi-center, open-label, dose-escalation clinical trial in
Australia intended to evaluate the safety, durability, tolerability, and biological activity of OTX-TKI for the treatment of wet AMD. -
Two cohorts of our Phase 1 clinical trial have been enrolled, a lower-dose cohort of 200 µg with six subjects and a higher-dose cohort of 400 µg with seven subjects. We are currently enrolling a third cohort of twelve subjects, split between parallel arms of six subjects each. Subjects in the first arm of the third cohort will receive a dose of 600 µg, and subjects in the second arm will receive a 400 µg dose combined with an anti-VEGF induction injection. The Company plans to provide a clinical update at the
American Academy of Ophthalmology meeting next week. -
The Company plans to file an exploratory IND by the end of 2020 to initiate clinical development of OTX-TKI in the
U.S. and to initiate a Phase 2 clinical trial inAustralia by mid-2021.
OTX-TIC (travoprost intracameral implant): OTX-TIC is a long-acting travoprost intracameral implant for the treatment of patients with primary open angle glaucoma or ocular hypertension.
- The Company is conducting a Phase 1, prospective, multi-center, open-label, dose-escalation clinical trial which is intended to evaluate the safety, biological activity, durability and tolerability of OTX-TIC for the reduction of elevated intraocular pressure in patients with primary open angle glaucoma or ocular hypertension.
- The Company has completed the first two cohorts, has fully enrolled the third cohort to assess the impact of a faster degrading implant with the same therapeutic dose as administered in cohort one, and is enrolling a fourth cohort to assess an additional formulation with a smaller implant of OTX-TIC.
- The Company plans to initiate a Phase 2 clinical trial for OTX-TIC in mid-2021.
OTX-CSI (cyclosporine intracanalicular insert): OTX-CSI is a long-acting, preservative-free cyclosporine intracanalicular insert for the chronic treatment of dry eye disease.
-
The Company announced topline results for its Phase 1,
U.S. -based, open label, single-center clinical trial intended to evaluate safety, tolerability, durability, and biological activity onOctober 8, 2020 . All subjects completed the 16-week study period with no drop-outs or reported serious adverse effects. Early signs of biological activity were observed including increased tear production and improvements in the signs of dry eye as measured by corneal fluorescein staining and symptoms of dry eye as measured by eye dryness severity and frequency scores using the visual analog scale. - The Company has initiated a Phase 2, randomized, masked, multi-center trial to evaluate the safety, efficacy, durability, and tolerability of two different formulations of OTX-CSI versus vehicle insert in approximately 105 subjects for the chronic treatment of dry eye disease. The Company expects topline results in the first half of 2022.
OTX-DED (dexamethasone intracanalicular insert): OTX-DED incorporates the FDA-approved corticosteroid dexamethasone as an active pharmaceutical ingredient into a hydrogel, drug-eluting, preservative-free intracanalicular insert. OTX-DED is designed to release dexamethasone over a period of two-to-three weeks for the short-term treatment of the signs and symptoms of dry eye disease.
- The Company remains on track to file a Phase 2-enabling IND by the end of 2020 and, if cleared, initiate a Phase 2 trial in the first quarter of 2021.
DEXTENZA (dexamethasone ophthalmic insert) 0.4 mg: DEXTENZA is an FDA-approved corticosteroid indicated for the treatment of ocular inflammation and pain following ophthalmic surgery.
-
U.S. Commercial Launch of DEXTENZA. The Company reported net product revenue of DEXTENZA in the third quarter endedSeptember 30, 2020 of$5.4 million , a 280% sequential increase over the prior quarter. Revenue reflects a record quarter of DEXTENZA in-market sales as Ambulatory Surgery Centers (ASCs) and Hospital Outpatient Departments (HOPDs) purchased nearly 10,000 billable inserts during the period. The increases observed in the third quarter of 2020 build upon the momentum seen in the prior quarter starting in May and reflect continued increases in surgical volumes as ASCs and HOPDs strive to return to pre-COVID shutdown volumes. - Three Medicare Administrative Contractors (MACs) covering approximately 50% of all Medicare beneficiaries have now published physician fee schedules for the reimbursement of procedure code 0356T for the administration of drug-eluting intracanalicular inserts, including DEXTENZA. In addition, three of the remaining four MACs have retired their non-coverage policies for 0356T.
-
On
November 4, 2020 , the Company announced that theAmerican Medical Association (AMA) CPT Editorial Panel has accepted the addition of a permanent Category I CPT procedure code to replace the currently available Category III CPT code (0356T) for the administration of drug-eluting intracanalicular inserts, including DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg, effectiveJanuary 1, 2022 . - The Company remains on track to submit an sNDA for DEXTENZA for the treatment of ocular itching associated with allergic conjunctivitis by the end of 2020.
Third 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 third quarter were
Selling and Marketing expenses for the third quarter were
General and Administrative expenses were
The Company reported a net loss of
As of
As of
Based on current plans and including related estimates of anticipated cash inflows from DEXTENZA and ReSure Sealant product sales and cash outflows from operating expenses, the Company believes that existing cash and cash equivalents, 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 DEXTENZA; 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 allergic conjunctivitis, OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease, OTX-CSI for the chronic treatment of dry eye disease, 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 OTX-AFS as an extended-delivery formulation of the VEGF trap aflibercept 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 operation of the collaboration with Regeneron Pharmaceuticals, including any potential future payments thereunder; projected net product revenue and unit sales and other financial and operational metrics of DEXTENZA; 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 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 retain regulatory approval of DEXTENZA, ReSure Sealant or any product candidate that receives regulatory approval, the ability to maintain reimbursement codes for DEXTENZA, the initiation, timing and conduct of clinical 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 product candidates, the Company’s ability to generate its projected net product revenue and unit 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 outcome of the Company’s ongoing legal proceedings, the severity and duration of the COVID-19 pandemic including its effect on the Company’s and relevant regulatory authorities’ operations, the need for additional financing or other actions and other factors discussed in the “Risk Factors” section contained in the Company’s quarterly and annual reports on file with the
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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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Nine Months Ended |
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2020 |
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2019 |
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2020 |
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2019 |
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Revenue: |
|
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|
|
|
|
|
|
|
|
|
|
Product revenue, net |
|
$ |
5,876 |
|
$ |
829 |
|
$ |
10,054 |
|
$ |
1,971 |
Total revenue, net |
|
|
5,876 |
|
|
829 |
|
|
10,054 |
|
|
1,971 |
Costs and operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Cost of product revenue |
|
|
450 |
|
|
806 |
|
|
1,403 |
|
|
1,486 |
Research and development |
|
|
6,951 |
|
|
10,235 |
|
|
21,070 |
|
|
30,966 |
Selling and marketing |
|
|
6,520 |
|
|
6,777 |
|
|
19,803 |
|
|
17,349 |
General and administrative |
|
|
5,961 |
|
|
6,155 |
|
|
16,282 |
|
|
16,571 |
Total costs and operating expenses |
|
|
19,882 |
|
|
23,973 |
|
|
58,558 |
|
|
66,372 |
Loss from operations |
|
|
(14,006) |
|
|
(23,144) |
|
|
(48,504) |
|
|
(64,401) |
Other income (expense): |
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|
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Interest income |
|
|
6 |
|
|
308 |
|
|
162 |
|
|
1,016 |
Interest expense |
|
|
(1,715) |
|
|
(1,651) |
|
|
(5,042) |
|
|
(4,296) |
Change in fair value of derivative liability |
|
|
3,771 |
|
|
5,717 |
|
|
(16,640) |
|
|
7,334 |
Other income (expense), net |
|
|
— |
|
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(8) |
|
|
— |
|
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(8) |
Total other income (expense), net |
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2,062 |
|
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4,366 |
|
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(21,520) |
|
|
4,046 |
Net loss and comprehensive loss |
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$ |
(11,944) |
|
$ |
(18,778) |
|
$ |
(70,024) |
|
$ |
(60,355) |
Net loss per share, basic |
|
$ |
(0.19) |
|
$ |
(0.40) |
|
$ |
(1.22) |
|
$ |
(1.37) |
Weighted average common shares outstanding, basic |
|
|
62,992,558 |
|
|
46,944,536 |
|
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57,440,885 |
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44,052,470 |
Net loss per share, diluted |
|
$ |
(0.21) |
|
$ |
(0.45) |
|
$ |
(1.22) |
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$ |
(1.37) |
Weighted average common shares outstanding, diluted |
|
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68,761,790 |
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52,713,768 |
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57,440,885 |
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44,052,470 |
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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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2020 |
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2019 |
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Assets |
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Current assets: |
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Cash and cash equivalents |
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$ |
70,642 |
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$ |
54,437 |
Accounts receivable, net |
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7,779 |
|
|
2,548 |
Inventory |
|
|
1,154 |
|
|
954 |
Prepaid expenses and other current assets |
|
|
2,328 |
|
|
2,231 |
Total current assets |
|
|
81,903 |
|
|
60,170 |
Property and equipment, net |
|
|
8,490 |
|
|
10,151 |
Restricted cash |
|
|
1,764 |
|
|
1,764 |
Operating lease assets |
|
|
6,062 |
|
|
6,655 |
Total assets |
|
$ |
98,219 |
|
$ |
78,740 |
Liabilities and Stockholders’ Equity (Deficit) |
|
|
|
|
|
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Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
3,238 |
|
$ |
3,268 |
Accrued expenses and other current liabilities |
|
|
12,165 |
|
|
7,635 |
Operating lease liabilities |
|
|
1,297 |
|
|
1,126 |
Notes payable, net of discount, current |
|
|
6,206 |
|
|
— |
Total current liabilities |
|
|
22,906 |
|
|
12,029 |
Operating lease liabilities, net of current portion |
|
|
7,909 |
|
|
8,905 |
Derivative liability |
|
|
28,764 |
|
|
12,124 |
Notes payable, net of discount |
|
|
18,964 |
|
|
25,007 |
2026 convertible notes, net |
|
|
23,802 |
|
|
24,305 |
Total liabilities |
|
|
102,345 |
|
|
82,370 |
Commitments and contingencies |
|
|
|
|
|
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Stockholders’ equity (deficit): |
|
|
|
|
|
|
Preferred stock, |
|
|
— |
|
|
— |
Common stock, |
|
|
6 |
|
|
5 |
Additional paid-in capital |
|
|
449,507 |
|
|
379,980 |
Accumulated deficit |
|
|
(453,639) |
|
|
(383,615) |
Total stockholders’ deficit |
|
|
(4,126) |
|
|
(3,630) |
Total liabilities and stockholders’ equity (deficit) |
|
$ |
98,219 |
|
$ |
78,740 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20201105006086/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
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