Press Release
Ocular Therapeutix™ Reports Second Quarter 2020 Financial Results and Business Update
Newly Published Physician Fee Schedules for 0356T for the
May Financing Yields
DEXTENZA Net Product Revenue in Second Quarter of
“Despite the challenges caused by the global pandemic, it has been a very productive quarter for Ocular Therapeutix,” said
Recent Highlights
Announced published physician fee schedules for the administration of intracanalicular inserts. In July, the Company announced that
Announced new product candidate (OTX-DED) to treat episodic dry eye disease. There are approximately 8.6 million patients diagnosed with episodic dry eye disease in
Amended collaboration with Regeneron for the development of a suprachoroidal injection formulation of the FDA-approved VEGF trap aflibercept. In May, the Company amended its existing collaboration with Regeneron to develop an extended-delivery, suprachoroidal injection formulation of the FDA-approved VEGF trap aflibercept. Under the new amendment, Regeneron has agreed to compensate
Completed common stock financing. In May, the Company raised
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
- In the 200 µg cohort, certain patients who had required frequent anti-VEGF dosing prior to enrollment were shown to not need rescue therapy for as long as 10 months after being treated with OTX-TKI.
- In the 400 µg cohort, two subjects have demonstrated reduction of intraretinal and/or subretinal fluid with durability out to at least 4.5 and 7.5 months, respectively.
- The Company is enrolling a third cohort of patients where half the subjects will be dosed at 600 µg (cohort 3a = 6 patients) and half the subjects will receive a 400 µg dose and an anti-VEGF induction injection (cohort 3b = 6 patients).
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The Company plans to provide a Phase 1 update in the fall and is on track to submit an exploratory IND to the FDA for the
U.S. by the end of 2020.
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 IOP in patients with primary open angle glaucoma or ocular hypertension.
- Data from the first two fully enrolled cohorts (cohort 1 = 5 patients, cohort 2 = 4 patients) have indicated a clinically meaningful reduction in mean IOP values in patients receiving OTX-TIC out to six months with durability demonstrated in one patient out to 21 months.
- The third patient cohort (faster-degrading implant, equivalent dose to cohort 1) is now fully enrolled and the fourth patient cohort (smaller implant, lower dose) is enrolling.
- The Company plans to initiate a Phase 2 clinical trial for OTX-TIC in the first half of 2021.
OTX-CSI (cyclosporine intracanalicular insert)
OTX-CSI is a long-acting cyclosporine intracanalicular insert for the treatment of chronic dry eye disease. The Company has recently initiated a Phase 1, open-label, single-center clinical trial in
- The five patient cohort for the Phase 1 trial has been enrolled.
- The safety committee has met and is supportive of moving forward with a double masked, randomized, placebo-controlled, multi-center Phase 2 trial.
- The Company anticipates initiating a 105 patient Phase 2 clinical trial by year end.
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.
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U.S. Commercial Launch of DEXTENZA. The Company reported net product revenue of DEXTENZA in the second quarter endedJune 30, 2020 of$1.4 million , after a temporary shutdown in elective surgeries resulting from the COVID-19 pandemic. Despite the ongoing market challenges amid the pandemic, the Company reported its strongest month to date of DEXTENZA in-market sales in June, as Ambulatory Surgery Centers (ASCs) and hospital outpatient departments (HOPDs) purchased 2,294 billable inserts, breaking the million dollar threshold for in-market sales in a calendar month for the first time, a threshold that the Company cleared again in July. DEXTENZA has shown a steady and robust rebound with the sales of billable inserts in-market of 64, 790 and 2,294 in April, May and June, respectively, reflecting the reopening of some ASCs and HOPDs. The Company believes the market views its hands-free alternative to drops as compelling and expects to see this momentum carry over into the third quarter.
- DEXTENZA in Allergic Conjunctivitis. The Company remains on track to meet with the FDA and plans to submit an sNDA by the end of 2020.
- DEXTENZA for use in other ocular surface indications. There remains significant interest and excitement in evaluating DEXTENZA in many areas of unmet need with over 70 Investigator Initiated Trial (IIT) requests submitted and 14 IIT studies that are actively enrolling, including two that have completed enrollment.
Second Quarter Ended
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Gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was
$1.6 million for the three months endedJune 30, 2020 . Net product revenue of DEXTENZA and ReSure® Sealant in the second quarter was$1.4 million and$0.2 million , respectively.
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Research and development expenses for the second quarter were
$8.0 million versus$9.4 million for the comparable period in 2019 and primarily reflect a decrease in personnel and unallocated costs due the organizational restructuring announced inNovember 2019 .
-
Selling and Marketing expenses for the second quarter were
$6.2 million as compared to$7.2 million for the same quarter in 2019, stemming primarily from a decrease in travel, consulting, marketing and conference expenses as a result of the COVID-related slowdown in the commercialization of DEXTENZA.
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General and Administrative expenses were
$5.1 million in the second quarter of both 2020 and 2019, with a modest increase in facilities expenses being offset by decreased professional fees in Q2 2020.
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The Company reported a net loss of
$(36.6) million , or a loss of$(0.64) per share on a basic and diluted basis. This compares to a net loss of$(24.5) million , or a loss of$(0.57) per share on a basic and diluted basis, for the same period in 2019. The net loss for the second quarter included$2.5 million in non-cash charges for stock-based compensation and depreciation compared to$2.3 million for the same quarter in 2019. The net loss for the quarter includes a non-cash charge of$17.0 million related to the change in the fair value of the derivative liability associated with the Company’s convertible notes, resulting primarily from the significant increase in the share price of the Company’s common stock as compared to the prior quarter.
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As of
August 1, 2020 , the Company had approximately 63.0 million shares outstanding.
-
As of the
June 30, 2020 , the Company had$84.3 million in cash and cash equivalents versus$48.2 million at the end of Q1 2020. The cash balance atJune 30, 2020 reflects the addition of$48.3 million in net proceeds generated from a public offering of stock in May and net proceeds of$1.7 million from the sale of common stock under the Company’s 2019 Sales Agreement under which the Company may offer and sell its common stock having aggregate proceeds of up to$50.0 million from time-to-time. Approximately$1.3 million of common stock remains available to be sold under the 2019 Sales Agreement.
The Company believes that its existing cash and cash equivalents of
Conference Call & Webcast Information
Members of the
About 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. DEXTENZA is inserted in the lacrimal punctum and into the canaliculus by the physician following ophthalmic surgery. A single DEXTENZA releases a 0.4 mg dose of dexamethasone for up to 30 days following insertion. DEXTENZA is preservative free, resorbable and does not require removal.
DEXTENZA is contraindicated in patients with active corneal, conjunctival or canalicular infections. Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Steroids should be used with caution in the presence of glaucoma. Intraocular pressure should be monitored during the course of the treatment. Corticosteroids may suppress the host response to, and increase the hazard for and severity of, secondary bacterial, viral, or fungal infections. The use of steroids after cataract surgery may delay wound healing and increase the incidence of bleb formation.
The most commonly reported ocular adverse reactions that occurred in patients treated with DEXTENZA were anterior chamber inflammation including iritis and iridocyclitis (10%) and elevations in intraocular pressure (6%). The most common non-ocular adverse reaction was headache (1%).
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 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 treatment of episodic dry eye disease, OTX-CSI for the treatment of dry eye disease, OTX-TIC for the treatment of primary open-angle glaucoma and 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 other financial 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 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
Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (Unaudited) |
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Three Months Ended |
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Six 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 |
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$ |
1,569 |
|
$ |
650 |
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$ |
4,178 |
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$ |
1,142 |
Total revenue, net |
|
|
1,569 |
|
|
650 |
|
|
4,178 |
|
|
1,142 |
Costs and operating expenses: |
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Cost of product revenue |
|
|
134 |
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|
552 |
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|
953 |
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|
680 |
Research and development |
|
|
8,021 |
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9,414 |
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14,119 |
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20,731 |
Selling and marketing |
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6,153 |
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7,225 |
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13,283 |
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10,572 |
General and administrative |
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5,145 |
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5,058 |
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10,321 |
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10,416 |
Total costs and operating expenses |
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19,453 |
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22,249 |
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38,676 |
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42,399 |
Loss from operations |
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(17,884) |
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(21,599) |
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(34,498) |
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(41,257) |
Other income (expense): |
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Interest income |
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17 |
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379 |
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|
156 |
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|
708 |
Interest expense |
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(1,694) |
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(1,627) |
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(3,327) |
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(2,645) |
Change in fair value of derivative liability |
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(17,007) |
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(1,606) |
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(20,411) |
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1,617 |
Total other income (expense), net |
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(18,684) |
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(2,854) |
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(23,582) |
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(320) |
Net loss and comprehensive loss |
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$ |
(36,568) |
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$ |
(24,453) |
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$ |
(58,080) |
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$ |
(41,577) |
Net loss per share, basic and diluted |
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$ |
(0.64) |
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$ |
(0.57) |
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$ |
(1.06) |
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$ |
(0.98) |
Weighted average common shares outstanding, basic and diluted |
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57,368,292 |
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42,910,084 |
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54,634,572 |
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42,582,501 |
CONSOLIDATED BALANCE SHEETS (In thousands, except share and per share data) (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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$ |
84,294 |
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$ |
54,437 |
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Accounts receivable, net |
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2,874 |
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2,548 |
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Inventory |
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1,067 |
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954 |
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Prepaid expenses and other current assets |
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2,058 |
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2,231 |
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Total current assets |
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90,293 |
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60,170 |
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Property and equipment, net |
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8,934 |
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10,151 |
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Restricted cash |
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1,764 |
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1,764 |
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Operating lease assets |
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6,269 |
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6,655 |
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Total assets |
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$ |
107,260 |
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$ |
78,740 |
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Liabilities and Stockholders’ Equity (Deficit) |
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Current liabilities: |
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Accounts payable |
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$ |
2,650 |
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$ |
3,268 |
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Accrued expenses and other current liabilities |
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5,769 |
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|
7,635 |
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Operating lease liabilities |
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1,238 |
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1,126 |
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Notes payable, net of discount, current |
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4,146 |
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— |
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Total current liabilities |
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13,803 |
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12,029 |
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Operating lease liabilities, net of current portion |
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8,256 |
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8,905 |
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Derivative liability |
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32,535 |
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12,124 |
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Notes payable, net of discount |
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20,970 |
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25,007 |
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2026 convertible notes, net |
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26,352 |
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24,305 |
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Total liabilities |
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101,916 |
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82,370 |
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Commitments and contingencies |
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Stockholders’ equity (deficit): |
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Preferred stock, |
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— |
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— |
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Common stock, |
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6 |
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5 |
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Additional paid-in capital |
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447,033 |
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379,980 |
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Accumulated deficit |
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(441,695) |
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(383,615) |
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Total stockholders’ equity (deficit) |
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5,344 |
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(3,630) |
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Total liabilities and stockholders’ equity (deficit) |
|
$ |
107,260 |
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$ |
78,740 |
View source version on businesswire.com: https://www.businesswire.com/news/home/20200807005105/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: Ocular Therapeutix™, Inc.