Press Release
Ocular Therapeutix™ Reports Fourth Quarter and Year End 2020 Financial Results and Business Update
“The fourth quarter marked considerable commercial, clinical and regulatory progress for the Company,” said
Recent Business Updates
Presented Interim Data from the Phase 1 Clinical Trial of OTX-TKI (axitinib intravitreal implant) in Patients with Wet Age-Related Macular Degeneration (wet AMD) at Angiogenesis, Exudation, and Degeneration 2021. Interim data from the Phase 1 clinical trial continued to support that the product candidate has been generally well tolerated and observed to have a favorable safety profile, shows preliminary biological activity with a decrease in retinal fluid observed by two months in some subjects in cohorts 2 and 3 and initial durability in several subjects in cohort 2 over six months and in one subject over 13 months. The presentation can be accessed by visiting the Investors section of the Company’s website at investors.ocutx.com.
Presented Interim Data from the Phase 1 Clinical Trial of OTX-TIC (travoprost intracameral implant) in Patients with Primary Open Angle Glaucoma or Ocular Hypertension at the 10th Annual Glaucoma 360
Dosed First Patient in Phase 2 Clinical Trial Evaluating OTX-DED (dexamethasone intracanalicular insert). The Phase 2 clinical trial is a
Notified of target PDUFA date for DEXTENZA allergic conjunctivitis sNDA. On
Promoted
Received
Raised an Additional
Key Program Updates
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OTX-TKI (axitinib intravitreal implant) for the potential treatment of wet age-related macular degeneration (wet AMD) and other retinal diseases.
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The Company filed an exploratory IND (eIND) and received clearance from the FDA to initiate a Phase 1 clinical trial of OTX-TKI in
the United States . A plannedU.S. -based Phase 1 clinical trial is anticipated to start in mid-2021 and to consist of 20 subjects: 15 dosed with 600 µg plus an anti-VEGF induction injection and 5 dosed with aflibercept every eight weeks.
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The Company filed an exploratory IND (eIND) and received clearance from the FDA to initiate a Phase 1 clinical trial of OTX-TKI 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.
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The Company plans to initiate a randomized, double-masked, active-controlled Phase 2 clinical trial in mid-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™.
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OTX-CSI (cyclosporine intracanalicular insert) for the chronic treatment of dry eye disease.
- The Company 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 hydrogel vehicle insert in approximately 140 subjects for the chronic treatment of dry eye disease.
- Enrollment in the Phase 2 study has progressed ahead of schedule and topline data is now expected in the fourth quarter of 2021 versus prior guidance of the first half of 2022.
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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
U.S. -based, 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
Fourth Quarter and Year Ended
Gross product revenue net of discounts, rebates, and returns, which the Company refers to as total net product revenue, was approximately
Research and development expenses for the fourth quarter were
Selling and marketing expenses for the fourth quarter were
Finally, general and administrative expenses were
With respect to financial results for the fourth quarter, the Company reported a net loss of
As of
As of the full year ended
Based on our current plans and related estimates of anticipated cash inflows from DEXTENZA and ReSure 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 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 under transitional pass-through and to maintain the effectiveness of established reimbursement codes for DEXTENZA, the initiation, timing, conduct and outcomes 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 severity and duration of the COVID-19 pandemic including its effect on the Company’s and relevant regulatory authorities’ operations, any additional financing needs 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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Three Months Ended |
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Year 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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$ |
7,349 |
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$ |
2,256 |
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$ |
17,403 |
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$ |
4,227 |
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Total revenue, net |
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7,349 |
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2,256 |
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17,403 |
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4,227 |
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Costs and operating expenses: |
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Cost of product revenue |
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680 |
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839 |
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2,083 |
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2,325 |
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Research and development |
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7,624 |
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10,125 |
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28,694 |
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41,091 |
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Selling and marketing |
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6,811 |
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7,143 |
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26,614 |
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24,491 |
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General and administrative |
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6,578 |
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5,551 |
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22,859 |
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22,122 |
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Total costs and operating expenses |
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21,693 |
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23,657 |
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80,250 |
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90,029 |
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Loss from operations |
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(14,344 |
) |
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(21,401 |
) |
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(62,847 |
) |
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(85,802 |
) |
Other income (expense): |
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Interest income |
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6 |
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213 |
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168 |
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1,229 |
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Interest expense |
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(1,725 |
) |
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(1,805 |
) |
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(6,768 |
) |
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(6,101 |
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Change in fair value of derivative liability |
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(69,549 |
) |
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(3,024 |
) |
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(86,189 |
) |
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4,310 |
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Other income (expense), net |
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— |
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— |
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— |
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(8 |
) |
Total other income (expense), net |
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(71,268 |
) |
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(4,616 |
) |
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(92,789 |
) |
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(570 |
) |
Net loss and comprehensive loss |
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$ |
(85,612 |
) |
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$ |
(26,017 |
) |
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$ |
(155,636 |
) |
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$ |
(86,372 |
) |
Net loss per share, basic |
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$ |
(1.21 |
) |
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$ |
(0.54 |
) |
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$ |
(2.56 |
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$ |
(1.91 |
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Weighted average common shares outstanding, basic |
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70,614,333 |
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48,489,846 |
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60,752,225 |
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45,273,231 |
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Consolidated Balance Sheets |
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(In thousands, except share and per share data) |
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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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$ |
228,057 |
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$ |
54,437 |
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Accounts receivable, net |
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12,252 |
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2,548 |
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Inventory |
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1,201 |
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954 |
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Prepaid expenses and other current assets |
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4,650 |
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2,231 |
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Total current assets |
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246,160 |
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60,170 |
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Property and equipment, net |
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8,095 |
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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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5,844 |
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6,655 |
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Total assets |
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$ |
261,863 |
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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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$ |
2,709 |
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$ |
3,268 |
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Accrued expenses and other current liabilities |
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14,307 |
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7,635 |
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Operating lease liabilities |
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1,358 |
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1,126 |
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Notes payable, net of discount, current |
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8,290 |
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— |
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Total current liabilities |
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26,664 |
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12,029 |
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Other liabilities: |
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Operating lease liabilities, net of current portion |
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7,548 |
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8,905 |
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Derivative liability |
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98,313 |
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12,124 |
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Deferred revenue |
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12,000 |
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— |
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Notes payable, net of discount |
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16,936 |
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25,007 |
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2026 convertible notes, net |
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24,307 |
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24,305 |
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Total liabilities |
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185,768 |
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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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8 |
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5 |
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Additional paid-in capital |
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615,338 |
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379,980 |
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Accumulated deficit |
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(539,251 |
) |
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(383,615 |
) |
Total stockholders’ equity (deficit) |
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76,095 |
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(3,630 |
) |
Total liabilities and stockholders’ equity (deficit) |
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$ |
261,863 |
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$ |
78,740 |
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View source version on businesswire.com: https://www.businesswire.com/news/home/20210311005976/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: