UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
(Mark One)
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended
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Ocular Therapeutix, Inc.
INDEX
| Page | ||
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3 | |||
Condensed Consolidated Balance Sheets as of September 30, 2023 and December 31, 2022 | 3 | ||
4 | |||
5 | |||
6 | |||
8 | |||
Management’s Discussion and Analysis of Financial Condition and Results of Operations | 20 | ||
41 | |||
41 | |||
43 | |||
43 | |||
44 | |||
44 | |||
46 |
FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this Quarterly Report on Form 10-Q, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “predict,” “project,” “target,” “potential,” “goals,” “will,” “would,” “could,” “should,” “continue” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
The forward-looking statements in this Quarterly Report on Form 10-Q include, among other things, statements about:
● | our ongoing clinical trials, including the pivotal Phase 3 clinical trial of AXPAXLI™, or OTX-TKI, that we initiated for the treatment of wet age-related macular degeneration, or wet AMD; our Phase 1 clinical trials of AXPAXLI for the treatment of wet AMD; our Phase 1 clinical trial of AXPAXLI for the treatment of non-proliferative diabetic retinopathy, or NPDR; our Phase 2 clinical trial of OTX-TIC for the reduction of intraocular pressure in patients with primary open-angle glaucoma or ocular hypertension; our Phase 2 clinical trial of OTX-DED for the short-term treatment of the signs and symptoms of dry eye disease; our clinical trial to evaluate DEXTENZA® in pediatric subjects following cataract surgery; and our planned clinical trials, including our planned second pivotal clinical trial of AXPAXLI for the treatment of wet AMD and our planned pivotal clinical trial of AXPAXLI for the treatment of NPDR; |
● | our commercialization efforts for our product DEXTENZA; |
● | our plans to develop, seek regulatory approval for and commercialize AXPAXLI, OTX-TIC, OTX-DED, OTX-CSI, and our other product candidates based on our proprietary bioresorbable hydrogel technology ELUTYX™; |
● | our ability to manufacture DEXTENZA and our product candidates in compliance with Current Good Manufacturing Practices and in sufficient quantities for our clinical trials and commercial use; |
● | the timing of and our ability to submit applications and obtain and maintain regulatory approvals for DEXTENZA and our product candidates; |
● | our estimates regarding future revenue; expenses; the sufficiency of our cash resources; our ability to fund our operating expenses, debt service obligations and capital expenditure requirements; and our needs for additional financing; |
● | our plans to raise additional capital, including through equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements, royalty agreements and marketing and distribution arrangements; |
● | the potential advantages of DEXTENZA and our product candidates; |
● | the rate and degree of market acceptance and clinical utility of our products; |
● | our ability to secure and maintain reimbursement for our products as well as the associated procedures to insert, implant or inject our products; |
● | our estimates regarding the market opportunity for DEXTENZA and our product candidates; |
● | our license agreement and collaboration with AffaMed Therapeutics Limited under which we are collaborating on the development and commercialization of DEXTENZA and our product candidate OTX-TIC in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations; |
1
● | our capabilities and strategy, and the costs and timing of manufacturing, sales, marketing, distribution and other commercialization efforts with respect to DEXTENZA and any additional products for which we may obtain marketing approval in the future; |
● | our intellectual property position; |
● | our ability to identify additional products, product candidates or technologies with significant commercial potential that are consistent with our commercial objectives; |
● | the impact of government laws and regulations; and |
● | our competitive position. |
We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements we make. We have included important factors in the cautionary statements included in this Quarterly Report on Form 10-Q, in our Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission, or the SEC, on March 6, 2023, in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, filed with the SEC on May 8, 2023, and in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC on August 7, 2023, in each case particularly in the section captioned “Risk Factors”, that could cause actual results or events to differ materially from the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures, licensing agreements or investments we may make.
You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q, and our other periodic reports, completely and with the understanding that our actual future results may be materially different from what we expect. The forward-looking statements included in this Quarterly Report on Form 10-Q are made as of the date of this Quarterly Report on Form 10-Q. We do not assume, and we expressly disclaim, any obligation or undertaking to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
This Quarterly Report on Form 10-Q includes statistical and other industry and market data that we obtained from industry publications and research, surveys and studies conducted by third parties. All of the market data used in this Quarterly Report on Form 10-Q involves a number of assumptions and limitations, and you are cautioned not to give undue weight to such data. While we believe that the information from these industry publications, surveys and studies is reliable, we have not independently verified such data. The industry in which we operate is subject to a high degree of uncertainty and risk due to a variety of important factors, including those described in the section titled “Risk Factors.”
This Quarterly Report on Form 10-Q contains references to our trademarks and service marks and to those belonging to other entities. Solely for convenience, trademarks and trade names referred to in this Quarterly Report on Form 10-Q and the documents incorporated by reference herein may appear without the ® or ™ symbols, but such references are not intended to indicate, in any way, that we will not assert, to the fullest extent under applicable law, our rights or the rights of the applicable licensor to these trademarks and trade names. We do not intend our use or display of other companies’ trade names, trademarks or service marks to imply a relationship with, or endorsement or sponsorship of us by, any other companies.
2
PART I—FINANCIAL INFORMATION
Item 1. | Financial Statements. |
Ocular Therapeutix, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
September 30, | December 31, | |||||
| 2023 |
| 2022 | |||
Assets |
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Current assets: |
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Cash and cash equivalents | $ | | $ | | ||
Accounts receivable, net |
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Inventory |
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Prepaid expenses and other current assets |
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Total current assets |
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Property and equipment, net |
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Restricted cash |
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Operating lease assets | | | ||||
Total assets | $ | | $ | | ||
Liabilities and Stockholders’ Equity |
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Current liabilities: |
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Accounts payable | $ | | $ | | ||
Accrued expenses and other current liabilities |
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Deferred revenue |
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Operating lease liabilities | | | ||||
Total current liabilities |
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Other liabilities: |
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Operating lease liabilities, net of current portion | | | ||||
Derivative liabilities | | | ||||
Deferred revenue, net of current portion | | | ||||
Notes payable, net |
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Other non-current liabilities | | | ||||
Convertible Notes, net |
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Total liabilities |
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Commitments and contingencies (Note 14) |
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Stockholders’ equity: |
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Preferred stock, $ |
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Common stock, $ |
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Additional paid-in capital |
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Accumulated deficit |
| ( |
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Total stockholders’ equity |
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Total liabilities and stockholders’ equity | $ | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
3
Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Loss
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended | Nine Months Ended | |||||||||||
September 30, | September 30, | |||||||||||
| 2023 |
| 2022 |
| 2023 |
| 2022 | |||||
Revenue: |
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Product revenue, net | $ | | $ | | $ | | $ | | ||||
Collaboration revenue |
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Total revenue, net |
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Costs and operating expenses: |
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Cost of product revenue |
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Research and development |
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Selling and marketing |
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General and administrative |
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Total costs and operating expenses |
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Loss from operations |
| ( |
| ( |
| ( | ( | |||||
Other income (expense): |
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Interest income |
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Interest expense |
| ( |
| ( |
| ( | ( | |||||
Change in fair value of derivative liabilities | | ( | | | ||||||||
Gains and losses on extinguishment of debt, net | | — | | — | ||||||||
Other income (expense), net |
| — |
| |
| ( | ( | |||||
Total other income (expense), net |
| |
| ( |
| | | |||||
Net loss | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Net loss per share, basic | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Weighted average common shares outstanding, basic |
| |
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Net loss per share, diluted | $ | ( | $ | ( | $ | ( | $ | ( | ||||
Weighted average common shares outstanding, diluted |
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The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
4
Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Nine Months Ended | ||||||
September 30, | ||||||
| 2023 |
| 2022 | |||
Cash flows from operating activities: |
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Net loss | $ | ( | $ | ( | ||
Adjustments to reconcile net loss to net cash used in operating activities |
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Stock-based compensation expense |
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Non-cash interest expense |
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Change in fair value of derivative liabilities | ( | ( | ||||
Depreciation and amortization expense |
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Gains and losses on extinguishment of debt, net |
| ( |
| — | ||
Gain (loss) on disposal of property and equipment |
| ( |
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Changes in operating assets and liabilities: |
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Accounts receivable |
| ( |
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Prepaid expenses and other current assets |
| ( |
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Inventory |
| ( |
| ( | ||
Accounts payable |
| ( |
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Operating lease assets and liabilities | | ( | ||||
Accrued expenses |
| |
| ( | ||
Deferred revenue | | | ||||
Net cash used in operating activities |
| ( |
| ( | ||
Cash flows from investing activities: |
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Purchases of property and equipment |
| ( |
| ( | ||
Net cash used in investing activities |
| ( |
| ( | ||
Cash flows from financing activities: |
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Proceeds from issuance of short-term bridge loan |
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| — | ||
Proceeds from issuance of Barings notes payable | | — | ||||
Proceeds from exercise of stock options |
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Proceeds from issuance of common stock pursuant to employee stock purchase plan |
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Payments of debt refinancing costs | ( | — | ||||
Proceeds from issuance of common stock upon public offering, net of issuance costs |
| |
| — | ||
Repayment of MidCap notes payable | ( | — | ||||
Repayment of short-term bridge loan |
| ( | — | |||
Net cash provided by financing activities |
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Net increase (decrease) in cash, cash equivalents and restricted cash |
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| ( | ||
Cash, cash equivalents and restricted cash at beginning of period |
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Cash, cash equivalents and restricted cash at end of period | $ | | $ | | ||
Supplemental disclosure of cash flow information: |
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Cash paid for interest | $ | | $ | | ||
Supplemental disclosure of non-cash investing and financing activities: |
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Additions to property and equipment included in accounts payable and accrued expenses | $ | | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
5
Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(In thousands, except share data)
(Unaudited)
Additional | Total | |||||||||||||
Common Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Par Value |
| Capital |
| Deficit |
| Equity | |||||
Balances at December 31, 2022 | | $ | | $ | | $ | ( | $ | | |||||
Issuance of common stock upon exercise of stock options |
| |
| — |
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| — |
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Issuance of common stock upon vesting of restricted stock units | | — |
| — |
| — |
| — | ||||||
Stock-based compensation expense |
| — |
| — |
| |
| — |
| | ||||
Net loss |
| — |
| — |
| — |
| ( |
| ( | ||||
Balances at March 31, 2023 |
| | $ | | $ | | $ | ( | $ | | ||||
Issuance of common stock upon exercise of stock options |
| | — | | — |
| | |||||||
Issuance of common stock in connection with employee stock purchase plan |
| | — | | — |
| | |||||||
Issuance of common stock upon vesting of restricted stock units | | — | — | — |
| — | ||||||||
Issuance of common stock upon public offering, net of issuance costs |
| | — | | — |
| | |||||||
Stock-based compensation expense |
| — | — | | — |
| | |||||||
Net loss |
| — | — | — | ( |
| ( | |||||||
Balances at June 30, 2023 |
| | $ | | $ | | $ | ( | $ | | ||||
Issuance of common stock upon exercise of stock options |
| |
| — |
| |
| — |
| | ||||
Issuance of common stock upon public offering, net of issuance costs |
| |
| — |
| |
| — |
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Issuance of common stock upon vesting of restricted stock units | | — | — |
| — |
| — | |||||||
Stock-based compensation expense |
| — |
| — |
| |
| — |
| | ||||
Net loss |
| — |
| — |
| — |
| ( |
| ( | ||||
Balances at September 30, 2023 |
| | $ | | $ | | $ | ( | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
6
Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(In thousands, except share data)
(Unaudited)
Additional | Total | |||||||||||||
Common Stock | Paid-in | Accumulated | Stockholders’ | |||||||||||
| Shares |
| Par Value |
| Capital |
| Deficit |
| Equity | |||||
Balances at December 31, 2021 |
| | $ | | $ | | $ | ( | $ | | ||||
Issuance of common stock upon exercise of stock options |
| |
| — |
| |
| — |
| | ||||
Stock-based compensation expense |
| — |
| — |
| |
| — |
| | ||||
Net loss |
| — |
| — |
| — |
| ( |
| ( | ||||
Balances at March 31, 2022 |
| | $ | | $ | | $ | ( | $ | | ||||
Issuance of common stock upon exercise of stock options |
| |
| — |
| |
| — |
| | ||||
Issuance of common stock in connection with employee stock purchase plan |
| |
| — |
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| — |
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Stock-based compensation expense |
| — |
| — |
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| — |
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Net loss |
| — |
| — |
| — |
| ( |
| ( | ||||
Balances at June 30, 2022 |
| | $ | | $ | | $ | ( | $ | | ||||
Issuance of common stock upon exercise of stock options |
| |
| — |
| |
| — |
| | ||||
Stock-based compensation expense |
| — |
| — |
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| — |
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Net income |
| — |
| — |
| — |
| ( |
| ( | ||||
Balances at September 30, 2022 |
| | $ | | $ | | $ | ( | $ | |
The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.
7
Ocular Therapeutix, Inc.
Notes to the Condensed Consolidated Financial Statements
(Amounts in thousands, except share and per share data)
(Unaudited)
1. Nature of the Business
Ocular Therapeutix, Inc. (the “Company”) was incorporated on September 12, 2006 under the laws of the State of Delaware. The Company 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 ELUTYX. The Company’s mission is to build an ophthalmology-focused biopharmaceutical company that capitalizes on the gaps that the Company believes increasingly exist in the ophthalmology sector between single-product companies and large, multi-product pharmaceutical companies.
The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations, regulatory approval and compliance, reimbursement, uncertainty of market acceptance of products and the need to obtain additional financing. Recently approved products will require significant sales, marketing and distribution support up to and including upon their launch. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization.
The Company is currently commercializing DEXTENZA (dexamethasone insert) 0.4mg, an intracanalicular insert for the treatment of post-surgical ocular inflammation and pain and for the treatment of ocular itching associated with allergic conjunctivitis, in the United States. The Company’s most advanced product candidate, AXPAXLI, is in Phase 3 clinical development; the Company’s other advanced product candidates are in either Phase 1 or Phase 2 clinical development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval and adequate reimbursement or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapidly changing technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants. The Company may not be able to generate significant revenue from sales of any product for several years, if at all. Accordingly, the Company will need to obtain additional capital to finance its operations.
The Company has incurred losses and negative cash flows from operations since its inception, and the Company expects to continue to generate operating losses and negative cash flows from operations in the foreseeable future. As of September 30, 2023, the Company had an accumulated deficit of $
8
2. Summary of Significant Accounting Policies
Basis of Presentation
The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The significant accounting policies used in preparation of these unaudited condensed consolidated financial statements are consistent with those described in Note 2 - Summary of Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 6, 2023.
Use of Estimates
The preparation of these unaudited condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of these unaudited condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include, but are not limited to, the measurement and recognition of reserves for variable consideration related to product sales, revenue recognition related to a collaboration agreement that contains multiple promises, the fair value of derivatives, stock-based compensation, and realizability of net deferred tax assets. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates.
Unaudited Interim Financial Information
The balance sheet at December 31, 2022 was derived from audited consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of September 30, 2023 and for the three and nine months ended September 30, 2023 and 2022 have been prepared by the Company, pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2023 and results of operations and cash flows for the three and nine months ended September 30, 2023 and 2022 have been made. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.
Recently Issued Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board and adopted by us as of the specified effective date. The Company believes that recently issued accounting pronouncements that are not yet effective will not have a material impact on our consolidated financial statements and disclosures.
3. Licensing Agreements and Deferred Revenue
Incept License Agreement (in-licensing)
On September 13, 2018, the Company entered into a second amended and restated license agreement with Incept, LLC (“Incept”) to use and develop certain intellectual property (the “Incept License”). Under the Incept License, as amended and restated, the Company was granted a worldwide, perpetual, exclusive license to use specific Incept technology to develop and commercialize products that are delivered to or around the human eye for diagnostic, therapeutic or prophylactic purposes relating to ophthalmic diseases or conditions. The Company is obligated to pay low single-digit royalties on net sales of commercial products developed using the licensed technology, commencing with the date of the first commercial sale of such products and until the expiration of the last to expire of the patents covered by the license.
9
The terms and conditions of the Incept License are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023.
Royalties paid under this agreement related to product sales (the “Incept Royalties”) were $
AffaMed License Agreement (out-licensing)
On October 29, 2020, the Company entered into a license agreement (“License Agreement”) with AffaMed Therapeutic Limited (“AffaMed”) for the development and commercialization of the Company’s DEXTENZA product regarding ocular inflammation and pain following cataract surgery and allergic conjunctivitis and for the Company’s OTX-TIC product candidate (collectively the “AffaMed Licensed Products”) regarding open-angle glaucoma or ocular hypertension, in each case in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations. The Company retains development and commercialization rights for the AffaMed Licensed Products in the rest of the world.
The terms and conditions of the License Agreement are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023.
In June 2023, the Company received a milestone payment of $
In March 2022, the Company invoiced AffaMed $
The Company recognized collaboration revenue related to the Phase 2 Clinical Trial of OTX-TIC performance obligation of $
As of September 30, 2023, the aggregate amount of the transaction price allocated to the partially unsatisfied Phase 2 Clinical Trial of OTX-TIC performance obligation was $
Deferred revenue activity for the three and nine months ended September 30, 2023 was as follows:
| Deferred Revenue | ||
Deferred revenue at December 31, 2022 | $ | | |
Additions | | ||
Amounts recognized into revenue | ( | ||
Deferred revenue at September 30, 2023 | $ | |
4. Cash Equivalents and Restricted Cash
As of September 30, 2023 and December 31, 2022, the Company held restricted cash of $
The Company’s unaudited condensed consolidated statements of cash flows include restricted cash with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on such statements. A
10
reconciliation of the cash, cash equivalents, and restricted cash reported within the balance sheets that sum to the total of the same amounts shown in the unaudited condensed consolidated statement of cash flows is as follows:
September 30, | September 30, | |||||
| 2023 |
| 2022 | |||
Cash and cash equivalents | $ | | $ | | ||
Restricted cash | | | ||||
Total cash, cash equivalents and restricted cash | $ | | $ | |
5. Inventory
Inventory consisted of the following:
September 30, | December 31, | ||||||
| 2023 |
| 2022 |
| |||
Raw materials | $ | | $ | | |||
Work-in-process | | | |||||
Finished goods |
| |
| | |||
$ | | $ | |
6. Expenses
Accrued expenses and other current liabilities consisted of the following:
September 30, | December 31, | |||||
| 2023 |
| 2022 | |||
Accrued payroll and related expenses | $ | | $ | | ||
Accrued rebates and programs | | | ||||
Accrued professional fees |
| |
| | ||
Accrued research and development expenses |
| |
| | ||
Accrued interest payable on Convertible Notes |
| |
| | ||
Accrued interest payable on Barings Note | | — | ||||
Accrued other |
| |
| | ||
$ | | $ | |
7. Financial Liabilities
Barings Credit Agreement
On August 2, 2023 (the “Closing Date”), the Company entered into a credit and security agreement (the “Barings Credit Agreement”) with Barings Finance LLC (“Barings”), as administrative agent, and the lenders party thereto, providing for a secured term loan facility for the Company (the “Barings Credit Facility”) in the aggregate principal amount of $
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Closing Date, the Barings Royalty Fee is subject to a reduction to an amount that is equal to (i)
The Company determined that the embedded obligation to pay the Barings Royalty Fee (the “Royalty Fee Obligation”) is required to be separated from the Barings Credit Facility and accounted for as a freestanding derivative instrument subject to derivative accounting. The allocation of proceeds to the Barings Royalty Fee Obligation resulted in a discount on the Barings Credit Facility. The Company is amortizing the discount to interest expense over the term of the Barings Credit Facility using the effective interest method. Accrued or paid Barings Royalty Fees are included in the change in fair value of derivative liabilities on the consolidated statements of operations and comprehensive loss. For the three and nine months ended September 30, 2023, Barings Royalty Fees were $
A summary of the Barings Credit Facility at September 30, 2023 is as follows:
| September 30, | ||
| 2023 | ||
Barings Credit Facility | $ | | |
Less: unamortized discount | ( | ||
Total | $ | |
As of September 30, 2023, the full principal for the Barings Credit Facility of $
Convertible Notes
On March 1, 2019, the Company issued $
Concurrently with entering into the Barings Credit Agreement, on August 2, 2023, the Company and the holders of the Convertible Notes extended the maturity of the Convertible Notes, which would otherwise have matured on March 1, 2026, to a date 91 days following the maturity of the indebtedness under the Barings Credit Facility, unless earlier converted, repurchased or redeemed (the “Amendment”). The Company accounted for the Amendment as an extinguishment of debt in accordance with the guidance in Accounting Standards Codification Topic 470-50 Debt (“ASC 470-50”) and derecognized all liabilities related to the Convertible Notes, including the outstanding principal less unamortized discount, a derivative liability, and accrued interest, with a total carrying value of $
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cash upon conversion. The allocation of a portion of the total fair value of the Convertible Notes to the Conversion Option Derivative Liability results in a discount on the Convertible Notes. Application of ASC 470-50 resulted in a gain on extinguishment of $
The Company presents accrued interest after the Amendment in accrued expenses and other current liabilities on the unaudited condensed consolidated balance sheets because the Convertible Notes are currently convertible, and the interest is payable in cash. The Company is amortizing the discount to interest expense over the term of the Convertible Notes using the effective interest method. The effective annual interest rate for the Convertible Notes was
A summary of the Convertible Notes at September 30, 2023 and December 31, 2022 is as follows:
Convertible Notes |
| September 30, | December 31, | |||
| 2023 |
| 2022 | |||
Convertible Notes | $ | | $ | | ||
Less: unamortized discount and current portion | ( | ( | ||||
Total | $ | | $ | |
MidCap Credit Agreement
The Company entered into a credit and security agreement in 2014 (as amended, the “MidCap Credit Agreement”) establishing a credit facility (the “MidCap Credit Facility”). The terms and conditions of the MidCap Credit Agreement and the MidCap Credit Facility are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023, except with respect to Amendments No. 1 and 2 to the MidCap Credit Agreement as described in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC on August 7, 2023.
Under the MidCap Credit Facility, the Company had a total borrowing capacity of $
On March 12, 2023, the Company requested, and received, a protective advance of $
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8. Derivative Liability
Barings Credit Agreement
The Barings Credit Agreement (Note 7) contains an embedded Royalty Fee Obligation that meets the criteria to be bifurcated and accounted for separately from the Barings Credit Facility (the "Royalty Fee Derivative Liability"). The Royalty Fee Derivative Liability was recorded at fair value upon the entering into the Barings Credit Facility and is subsequently remeasured to fair value at each reporting period. The Barings Credit Facility was initially valued and is remeasured using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis with the embedded Royalty Fee Obligation and then valuing the Barings Credit Facility without the embedded Royalty Fee Obligation. Royalty payments are estimated using a Monte Carlo simulation. Refer to Note 9 for details regarding the determination of fair value.
Convertible Notes
The Convertible Notes (Note 7) contain the Conversion Option Derivative Liability, an embedded conversion option that meets the criteria to be bifurcated and accounted for separately from the Convertible Notes. The Conversion Option Derivative Liability was recorded at fair value upon the issuance of the Convertible Notes and is subsequently remeasured to fair value at each reporting period. The Convertible Notes were initially valued and are remeasured using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis with the embedded conversion option and then valuing the Convertible Notes without the embedded conversion option. The difference between the entire instrument with the embedded conversion option compared to the instrument without the embedded conversion option is the fair value of the derivative, recorded as the Conversion Option Derivative Liability. Refer to Note 9 for details regarding the determination of fair value.
9. Risks and Fair Value
Concentration of Credit Risk and of Significant Suppliers and Customers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company has its cash and cash equivalents balances at two accredited financial institutions, in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
The Company is dependent on a small number of third-party manufacturers to supply products for research and development activities in its preclinical and clinical programs and for sales of its products. The Company’s development programs as well as revenue from future product sales could be adversely affected by a significant interruption in the supply of any of the components of these products.
For the three and nine months ended September 30, 2023,
For the three and nine months ended September 30, 2022,
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Change in Fair Value of Derivative Liabilities
Other income (expenses) from the change in the fair values of derivative liabilities as presented on the Company’s consolidated statements of operations and comprehensive loss includes the following:
Three Months Ended | Nine Months Ended | |||||||||||
September 30, | September 30, | |||||||||||
| 2023 |
| 2022 |
| 2023 |
| 2022 | |||||
$ | | $ | ( | $ | | $ | | |||||
| ( |
| — |
| ( |
| — | |||||
Barings Royalty Fees (Note 7) |
| ( |
| — |
| ( |
| — | ||||
$ | | $ | ( | $ | | $ | | |||||
Fair Value of Financial Assets and Liabilities
The following tables present information about the Company’s financial assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022 and indicate the level of the fair value hierarchy utilized to determine such fair value:
Fair Value Measurements as of | ||||||||||||
September 30, 2023 Using: | ||||||||||||
| Level 1 |
| Level 2 |
| Level 3 |
| Total | |||||
Assets: |
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Cash equivalents: |
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Money market funds | $ | | $ | — | $ | — | $ | | ||||
Liability: | ||||||||||||
Derivative liabilities | $ | — | $ | — | $ | | $ | |
Fair Value Measurements as of | ||||||||||||
December 31, 2022 Using: | ||||||||||||
| Level 1 |
| Level 2 |
| Level 3 |
| Total | |||||
Assets: |
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Cash equivalents: |
|
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Money market funds | $ | | $ | — | $ | — | $ | | ||||
Liability: |
|
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Derivative liabilities | $ | — | $ | — | $ | | $ | |
At September 30, 2023, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $
The fair value of the Royalty Fee Derivative Liability is estimated using a Monte Carlo simulation. The use of this approach requires the use of Level 3 unobservable inputs. The main inputs when determining the fair value of the Royalty Fee Derivative Liability are the amount and timing of the expected future revenue of the Company, the estimated volatility of these revenues, and the discount rate corresponding to the risk of revenue. The estimated fair value presented is not necessarily indicative of an amount that could be realized in a current market exchange. The use of alternative inputs and estimation methodologies could have a material effect on these estimates of fair value.
The main inputs to valuing the Royalty Fee Derivative Liability are as follows:
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As of September 30, 2023 | |||
Revenue volatility | |||
Revenue discount rate |
The main inputs to valuing the Royalty Fee Derivative Liability as of the Closing Date were revenue volatility of
A roll-forward of the Royalty Fee Derivative Liability is as follows:
As of | |||
Balance at August 2, 2023 | $ | | |
Change in fair value | | ||
Balance at September 30, 2023 | $ | |
At September 30, 2023, the Convertible Notes, net of the Conversion Option Derivative Liability, were carried at amortized cost totaling $
The fair value of the Convertible Notes with and without the conversion option is estimated using a binomial lattice approach. The use of this approach requires the use of Level 3 unobservable inputs. The main input when determining the fair value of the Convertible Notes is the bond yield that pertains to the host instrument without the conversion option. The significant assumption used in determining the bond yield is the market yield movements of a comparable instrument issued as of the valuation date, which is assessed and updated each period. The main input when determining the fair value for disclosure purposes is the bond yield which is updated each period to reflect the yield of a comparable instrument issued as of the valuation date. To determine the gain on extinguishment related to the Amendment of the Convertible Notes as of August 2, 2023 (Note 7), the Company has determined the fair value of the Convertible Notes with and without the conversion option immediately before and immediately after the Amendment based on the same approach. The estimated fair value presented is not necessarily indicative of an amount that could be realized in a current market exchange. The use of alternative inputs and estimation methodologies could have a material effect on these estimates of fair value.
The main inputs to valuing the Convertible Notes with the conversion option on a recurring basis are as follows:
As of | |||||||
September 30, | December 31, | ||||||
2023 | 2022 | ||||||
Company's stock price | $ | $ | |||||
Volatility | % | % | |||||
Bond yield | % | % |
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The main inputs to valuing the Convertible Notes with the conversion option immediately before the Amendment on August 2, 2023 were the Company’s stock price of $
A roll-forward of the Conversion Option Derivative Liability, including the impact from accounting for the Convertible Notes Amendment, is as follows:
As of | |||
Balance at December 31, 2022 | $ | | |
Change in fair value | | ||
Balance at June 30, 2023 | | ||
Change in fair value | ( | ||
Balance at August 2, 2023 before the Convertible Notes Amendment | | ||
Change in fair value from Convertible Notes Amendment | | ||
Balance at August 2, 2023 after the Convertible Notes Amendment | | ||
Change in fair value | ( | ||
Balance at September 30, 2023 | $ | |
10. Equity
On August 9, 2021, the Company and Jefferies LLC (“Jefferies”) entered into an Open Market Sale Agreement (the “2021 Sales Agreement”) under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $
11. Stock-Based Awards
For the three and nine months ended September 30, 2023, the Company had
During the three and nine months ended September 30, 2023, the Company granted options to purchase
During the three and nine months ended September 30, 2023, the Company granted
During the three and nine months ended September 30, 2023, a total of
At the Company’s Annual Meeting of Stockholders held on June 14, 2023, the Company’s stockholders approved an amendment of the Company’s 2021 Plan which increased the number of shares of common stock of the Company issuable under the 2021 Plan by
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