EyePoint, Inc. (EYPT) FY 2024 MD&A
This page reproduces the company's own Item 7 MD&A text from the linked SEC filing. It is filer text, not grepcent analysis, scoring, or investment advice.
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following discussion and analysis of financial condition and results of operations should be read in conjunction with our audited Consolidated Financial Statements and related Notes beginning on page F-1 of this Annual Report on Form 10-K. This discussion contains forward-looking statements, based on current expectations and related to future events and our future financial performance, that involve risks and uncertainties. Our actual results may differ significantly from those anticipated or implied in these forward-looking statements as a result of many important factors, including, but not limited to, those set forth under Item 1A, “Risk Factors,” and elsewhere in this report.
The following Management’s Discussion and Analysis (MD&A) provides a narrative of our results of operations for the year ended December 31, 2024, and the comparable period ended December 31, 2023, respectively, and our financial position as of December 31, 2024 and 2023, respectively. The MD&A should be read together with our consolidated financial statements and related notes included in this Annual Report on Form 10-K.
Overview
We are a company committed to developing and commercializing innovative therapeutics to help improve the lives of patients with serious retinal diseases. Our pipeline leverages our proprietary bioerodible Durasert E™ technology for sustained intraocular drug delivery. The Company’s lead product candidate, DURAVYU™, is an investigational sustained delivery treatment for anti-vascular endothelial growth factor (anti-VEGF) mediated retinal diseases combining vorolanib, a selective and patent-protected tyrosine kinase inhibitor with bioerodible Durasert E™. DURAVYU™ is presently in Phase 3 clinical trials as a sustained delivery treatment for wet age-related macular degeneration (wet AMD), the leading cause of vision loss among people 50 years of age and older in the United States, and in Phase 2 clinical trial for diabetic macular edema (DME).
Fiscal 2024 Overview
The fiscal year ended December 31, 2024, was highlighted by the following events:
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In March 2024, we announced the appointment of Ramiro Ribeiro, M.D., Ph.D. as Chief Medical Officer. Dr. Ribeiro is a trained retinal specialist and joins EyePoint from Apellis Pharmaceuticals, where he served as Vice President, Head of Clinical Development.
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On April 23, 2024, an end of Phase 2 meeting was held with the Food and Drug Administration (FDA) to discuss our proposed phase 3 (pivotal) clinical program for wet AMD indication.
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On June 26, 2024, we hosted an R&D Day in New York City, featuring presentations from EyePoint’s management team as well as key opinion leader (KOL) guest speakers.
R&D day highlights included:
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Phase 3 plans for DURAVYU™ in wet AMD, including key design elements of the Phase 3 LUGANO and LUCIA pivotal trials
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Positive twelve-month safety and efficacy data from the Phase 2 DAVIO 2 clinical trial evaluating DURAVYU™ for the treatment of wet AMD
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The VERONA trial, a Phase 2 trial of DURAVYU™ in DME patients has completed enrollment with 27 patients
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In July 2024, Marcia Sellos-Moura, formerly SVP, Program Leadership, assumed a new position as SVP, Head of Development and Program Management, continuing to report to Dr. Jay S. Duker, President and CEO of the Company. In her expanded role, Dr. Sellos-Moura will manage both the R&D and Product Development teams in addition to Program Management.
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On September 3, 2024, we announced the appointment of esteemed industry leader Fred Hassan to our Board of Directors.
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On October 31, 2024, we completed an underwritten public offering with gross proceeds of $161.0 million. We sold 14,636,363 shares of our common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock. The shares of common stock were sold at a public offering price of $11.00 per share.
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In October 2024, we announced the grand opening of our Northbridge, MA manufacturing facility. The 40,000 square foot Good Manufacturing Process (cGMP) compliant commercial manufacturing facility was built to meet U.S. FDA and
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European Medicines Agency (EMA) and will support global manufacturing across our portfolio, including lead pipeline asset, DURAVYU™ upon potential regulatory approval.
R&D Highlights
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In February 2024, we announced results from new subgroup analyses from the Phase 2 DAVIO 2 clinical trial of DURAVYU™. The presented analyses of the data reveal: in the sub-group of patients who were supplement-free up to 6 months, the DURAVYU™ groups demonstrated numerical superiority in change in BCVA along with strong anatomic control compared to the aflibercept control group. This result confirms that the positive topline data from the Phase 2 DAVIO 2 trial were driven by DURAVYU™ and not by study eyes requiring supplemental injection; visual and anatomical outcomes were not meaningfully influenced by differences in patient baseline BCVA, duration of wet AMD diagnosis, or historical treatment burden; and DURAVYU™ outcomes are consistent and durable in a range of wet AMD patient types.
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In May 2024, we announced topline results of our Phase 2 PAVIA clinical trial evaluating DURAVYU™ (vorolanib intravitreal insert), previously known as EYP-1901, in patients with non-proliferative diabetic retinopathy (NPDR). The data demonstrated that DURAVYU™ has a biologic effect in patients with NPDR with a favorable safety and tolerability profile, however the trial did not meet the pre-specified primary endpoint. The Company has no plans to further advance DURAVYU™ in NPDR.
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In May 2024, we completed enrollment in the VERONA trial, a Phase 2 trial of DURAVYU™ in DME patients. The trial enrolled 27 patients with topline data anticipated in the first quarter of 2025.
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In June 2024, we announced alignment on pathway to approval with U.S. Food and Drug Administration (FDA) based on positive End of Phase 2 meeting in April 2024 for two non-inferiority trials, 6-month redosing of DURAVYU™ and sham for masking with a one-year endpoint. Each trial is expected to enroll approximately 400 patients with active wet AMD, including previously treated and treatment naïve patients, randomly assigned to either a 2.7mg dose of DURAVYU™ or an on-label aflibercept control. All patients to receive three monthly loading doses of aflibercept prior to DURAVYU™ with randomization occurring on Day 1. The LUGANO (US) trial remains on track to randomize patients for inclusion in 2024 with LUCIA (US/ex-US) to follow.
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In June 2024, we announced positive twelve-month safety and efficacy data from the Phase 2 DAVIO 2 clinical trial evaluating DURAVYU™ for the treatment of wet AMD.
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In August 2024, we presented on sustained-release vorolanib highlighting selective pan-VEGF receptor inhibition and anti-angiogenic effects in VEGF-mediated ocular diseases at the American Retina Forum (ARF) 2024 National Meeting demonstrating the durable efficacy, reliable safety and reduced injection burden of treatment with DURAVYU™.
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In September 2024, we presented a comparison of tyrosine kinase inhibitors being developed for intravitreal delivery at the Retina Society 57th Annual Meeting, demonstrating the differentiation of DURAVYU™ with immediate bioavailability and controlled release via zero-order kinetics for at least six months.
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In October 2024, we announced positive interim 16-week data for the ongoing open label Phase 2 VERONA clinical trial of DURAVYU™ for DME. DURAVYU™ 2.7mg demonstrated an early, sustained, and clinically meaningful improvement in BCVA and anatomical control as measured by optical coherence tomography (OCT) versus the aflibercept control arm. Notably, both DURAVYU™ doses showed an immediate benefit over aflibercept control in both BCVA and CST demonstrating the differentiated drug release profile of DURAVYU™ with immediate bioavailability. Additionally, a favorable safety and tolerability profile continued for both DURAVYU™ arms.
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In October 2024, we announced first patient dosed in the Phase 3 LUGANO clinical trial of DURAVYU™ in wet AMD. Subsequently, in December 2024, we announced the first patient dosed in the second Phase 3 LUCIA clinical trial of DURAVYU™ in wet AMD. The LUGANO and LUCIA clinical trials are designed for potential global regulatory and commercial success with every six-month re-dosing in both trials. With over 160 trial sites committed and robust DAVIO 2 data the company anticipates rapid enrollment of both trials with topline data anticipated in 2026.
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In October 2024, we presented DAVIO 2 twelve-month data at the American Academy of Ophthalmology (AAO) 2024 Subspecialty Day, at the 24th EURetina Congress in September and the Retina Society 57th Annual Meeting in September.
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In February 2025, we announced positive six-month results for the ongoing Phase 2 VERONA clinical trial evaluating DURAVYU™. The clinical trial met its primary endpoint with extended time to first supplemental injection compared to aflibercept control for both DURAVYU™ doses. The trial also demonstrated clinically meaningful outcomes including continued safety with no DURAVYU™ related ocular or systemic serious adverse events (SAEs) and an early and sustained improvement in vision and anatomical control. DURAVYU™ 2.7mg demonstrated a +7.1 letter BCVA gain and
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76-micron CST reduction at week 24, with a supplement-free rate of 73% versus 50% for eyes treated with aflibercept. These positive Phase 2 VERONA results add to a robust dataset across another key indication demonstrating the best-in-class potential for DURAVYU™ in serious retinal diseases.
Recent Developments
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On January 8, 2025, we announced the appointment of renowned retina specialist and industry pioneer Reginald J. Sanders, M.D., FASRS to the Company’s Board of Directors.
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In February 2023, we entered into a research collaboration with RallyBio Corporation to evaluate sustained delivery of their inhibitor of complement component 5 (C5) using our proprietary Durasert E™ technology for sustained intraocular drug delivery. The Company and Rally Bio terminated their research collaboration in Q1 of 2025.
Summary of Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in accordance with U.S. generally accepted accounting principles, (U.S. GAAP). The preparation of these financial statements requires that we make certain estimates, judgments and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods. We base our estimates on historical experience, anticipated results and trends and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily available from other sources. By their nature, these estimates, judgments and assumptions are subject to an inherent degree of uncertainty, and management evaluates them on an ongoing basis for changes in facts and circumstances. Changes in estimates are recorded in the period in which they become known. Actual results may differ from our estimates under different assumptions or conditions.
While our significant accounting policies are more fully described in Note 2 in the accompanying Notes to the Consolidated Financial Statements contained in this Annual Report on Form 10-K, we believe that the following accounting policies are critical to understanding the judgments and estimates used in the preparation of our financial statements. It is important that the discussion of our operating results that follows be read in conjunction with the critical accounting policies discussed below.
Revenue Recognition
Revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, Revenue from Contracts with Customers (ASC 606), we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of ASC 606, we assess the goods or services promised within each contract, determines those that are performance obligations and assesses whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. Sales, value add, and other taxes collected on behalf of third parties are excluded from revenue.
Product sales, net — Effective January 2023, commercial sales of DEXYCU® were no longer supported by the Company, remaining available only through specialty distributors. Effective May 2023, YUTIQ® has been and continues to be sold under commercial supply agreements with Alimera Sciences, Inc. (Alimera) and Ocumension Therapeutics (Ocumension). On September 16, 2024, ANI Pharmaceuticals, Inc. (ANI) announced the completion of the acquisition of Alimera. The acquisition does not impact the terms of the commercial supply agreements (see Note 3). The current supply agreement between the Company and ANI for the supply of YUTIQ® will not renew and, effective June 1, 2025, the Company will no longer be responsible for manufacturing of YUTIQ® for the U.S. market.
Reserves for variable consideration — Product sales were recorded at the wholesale acquisition costs, net of applicable reserves for variable consideration. Components of variable consideration included trade discounts and allowances, provider chargebacks and discounts, payor rebates, product returns, and other allowances that were offered within contracts between us and our Distributors, payors, and other contracted purchasers relating to our product sales. These reserves were based on the amounts earned, or to be
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claimed on the related sales, and were classified either as reductions of product revenue and accounts receivable or a current liability, depending on how the amount was to be settled. Overall, these reserves reflected our best estimates of the amount of consideration to which it was entitled based on the terms of the respective underlying contracts. The actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from the estimates, we adjust these estimates, which would affect product revenue and earnings in the period such variances become known.
License and collaboration agreement revenue — We analyze each element of our license and collaboration arrangements to determine the appropriate revenue recognition. The terms of the license agreement may include payment to us of non-refundable upfront license fees, milestone payments if specified objectives are achieved, and/or royalties on product sales. We recognize revenue from upfront payments at a point in time, typically upon fulfilling the delivery of the associated intellectual property to the customer. For licenses that are combined with other promises, we determine whether the combined performance obligation is satisfied over time or at a point in time, when (or as) the associated performance obligation in the contract is satisfied.
If the contract contains a single performance obligation, the entire transaction price is allocated to the single performance obligation. Contracts that contain multiple performance obligations require an allocation of the transaction price based on the estimated relative standalone selling prices of the promised products or services underlying each performance obligation. We determine standalone selling prices based on the price at which the performance obligation is sold separately. If the standalone selling price is not observable through past transactions, we estimate the standalone selling price taking into account available information such as market conditions and internally approved pricing guidelines related to the performance obligations.
We recognize sales-based milestone payments as revenue upon the achievement of the cumulative sales amount specified in the contract in accordance with ASC 606-10-55-65. For those milestone payments which are contingent on the occurrence of particular future events, we determine that these need to be considered for inclusion in the calculation of total consideration from the contract as a component of variable consideration using the most-likely amount method. As such, we assess each milestone to determine the probability and substance behind achieving each milestone. Given the inherent uncertainty associated with these future events, we will not recognize revenue from such milestones until there is a high probability of occurrence, which typically occurs near or upon achievement of the event.
When determining the transaction price of a contract, an adjustment is made if payment from a customer occurs either significantly before or significantly after performance, resulting in a significant financing component. Applying the practical expedient in paragraph 606-10-32-18, we do not assess whether a significant financing component exists if the period between when we perform our obligations under the contract and when the customer pays is one year or less. None of our contracts contained a significant financing component as of December 31, 2024.
Reimbursement of costs — We may provide research and development services and incur maintenance costs of licensed patents under collaboration arrangements to assist in advancing the development of licensed products. We act primarily as a principal in these transactions and, accordingly, reimbursement amounts received are classified as a component of revenue to be recognized consistent with the revenue recognition policy summarized above. We record the expenses incurred and reimbursed on a gross basis.
Royalties — We recognize revenue from license arrangements with our commercial partners’ net sales of products. Such revenues are included as royalty income. In accordance with ASC 606-10-55-65, royalties are recognized when the subsequent sale of the commercial partner’s products occurs. Our commercial partners are obligated to report their net product sales and the resulting royalty due to us typically within 60 days from the end of each quarter. Based on historical product sales, royalty receipts and other relevant information, we recognize royalty income each quarter and subsequently determine a true-up when we receive royalty reports and payment from our commercial partners. Historically, these true-up adjustments have been immaterial.
Please refer to Note 3 for further details on the license and collaboration agreements into which we have entered and corresponding amounts of revenue recognized during the current and prior year periods.
Deferred Revenue
Amounts received prior to satisfying the above revenue recognition criteria are recorded as deferred revenue on the accompanying consolidated balance sheets. Amounts not expected to be recognized within one year following the balance sheet date are classified as non-current deferred revenue.
Please refer to Note 3 for further details on the license and collaboration agreements into which we have entered and corresponding amounts of revenue recognized for the years ended December 31, 2024 and 2023.
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Recognition of Expense in Outsourced Clinical Trial Agreements
We record accruals for estimated ongoing research and development costs, including costs with respect to outsourced agreements for clinical trials with contract research organizations (CROs). When recording these prepaid and accrued expenses, we analyze progress of the studies, including the phase or completion of events, invoices received, payments made, contracted costs, communications with third-party vendors, and internal tracking of the work performed to date. Judgments and estimates are made in determining the prepaid and accrued balances at the end of any reporting period. Payments made in advance of services provided are recorded as prepaid research and development costs and recognized as expense in the period the expense is incurred. In determining the prepaid and accrued balances, we make assessments of the services performed based on various factors, including reporting from third-party CROs and internal tracking of work performed during the period, which are subject to management’s judgment. Actual results could differ from our estimates.
Results of Operations
Years Ended December 31, 2024 and 2023 (in thousands except percentages)
| Year ended December 31, | Change | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Amounts | % | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales, net | $ | 3,164 | $ | 14,232 | $ | (11,068 | ) | -78 | % | |||||||
| License and collaboration agreements | 38,496 | 30,797 | 7,699 | 25 | % | |||||||||||
| Royalty income | 1,613 | 989 | 624 | 63 | % | |||||||||||
| Total revenues | 43,273 | 46,018 | (2,745 | ) | -6 | % | ||||||||||
| Operating expenses: | ||||||||||||||||
| Cost of sales | 3,712 | 4,632 | (920 | ) | -20 | % | ||||||||||
| Research and development | 132,926 | 64,662 | 68,264 | 106 | % | |||||||||||
| Sales and marketing | 131 | 11,689 | (11,558 | ) | -99 | % | ||||||||||
| General and administrative | 52,358 | 40,102 | 12,256 | 31 | % | |||||||||||
| Total operating expenses | 189,127 | 121,085 | 68,042 | 56 | % | |||||||||||
| Loss from operations | (145,854 | ) | (75,067 | ) | (70,787 | ) | 94 | % | ||||||||
| Other income (expense): | ||||||||||||||||
| Interest and other income, net | 15,088 | 6,949 | 8,139 | 117 | % | |||||||||||
| Interest expense | (14 | ) | (1,247 | ) | 1,233 | -99 | % | |||||||||
| Gain (loss) on extinguishment of debt | — | (1,347 | ) | 1,347 | -100 | % | ||||||||||
| Total other income, net | 15,074 | 4,355 | 10,719 | 246 | % | |||||||||||
| Net loss before income taxes | $ | (130,780 | ) | $ | (70,712 | ) | $ | (60,068 | ) | 85 | % | |||||
| Provision for income taxes | $ | (90 | ) | $ | (83 | ) | $ | (7 | ) | 8 | % | |||||
| Net loss | $ | (130,870 | ) | $ | (70,795 | ) | $ | (60,075 | ) | 85 | % | |||||
| Net loss per share - basic and diluted | $ | (2.32 | ) | $ | (1.82 | ) | $ | (0.50 | ) | 27 | % | |||||
| Weighted average shares outstanding - basic and diluted | 56,298 | 38,904 | 17,394 | 45 | % |
Product Sales, net
Product sales, net represents the gross sales of YUTIQ®. Product sales, net decreased by $11.1 million, or 78%, to $3.2 million for 2024 compared to $14.2 million for 2023. This decrease was driven by the agreement to license YUTIQ® product rights to ANI in May 2023. During the year ended December 31, 2024, the Company recognized $2.6 million of revenue from sales of product supply to ANI under the commercial supply agreement (CSA).
Customer demand had a direct impact on product orders from our specialty distributors that we recorded as net product sales. Net product revenue represented product purchased by our distributors whereas customer demand represented purchases of product by physician practices and ASCs from our specialty distributors.
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License and collaboration agreement
License and collaboration agreement revenues increased by $7.7 million, to $38.5 million in 2024 compared to $30.8 million for 2023. This increase was driven by a full year of revenue recognized as the combined performance obligations under the ANI license and supply agreement are fulfilled, compared to eight months of recognition in the prior year.
Royalty Income
Royalty income increased by $0.6 million, or 63%, to $1.6 million in 2024 compared to $1.0 million for 2023. The increase was primarily attributable to increased Ocumension Therapeutics royalties from YUTIQ® product sales in China.
Cost of Sales
Cost of sales decreased by $0.9 million to $3.7 million for 2024 from $4.6 million for 2023. This decrease was primarily due to lower commercial product sales year over year.
Research and Development
The following table summarizes our research and development expenses for the years ended December 31, 2024 and 2023:
| December 31, | |||||||
|---|---|---|---|---|---|---|---|
| 2024 | 2023 | ||||||
| Direct research and development expenses by program: | |||||||
| DURAVYU™ | $ | 70,818 | $ | 32,014 | |||
| Other direct research and development | 2,656 | 714 | |||||
| Unallocated expenses: | |||||||
| Personnel (including stock based compensation) | 49,676 | 28,274 | |||||
| Facilities | 1,974 | 175 | |||||
| Other | 7,802 | 3,485 | |||||
| Total research and development expenses | 132,926 | 64,662 |
Research and development expenses increased by $68.3 million, or 106%, to $132.9 million for 2024 from $64.7 million in the prior year. This increase was attributable primarily to (i) $26.6 million in increased clinical trial costs, related to the ongoing Phase 2 DAVIO2, PAVIA, and VERONA clinical trials of DURAVYU™ and initiation of Phase 3 LUGANO and LUCIA trials of DURAVYU™, (ii) $21.4 million of increased personnel related costs across the research and clinical organizations, including a $13.8 million increase of stock-based compensation due mainly to increased share price of grants, (iii) $11.7 million in increased spend related to non clinical trial development of DURAVYU™, and (iv) a $5.0 million milestone payment made in connection with the completion of a Phase 2 clinical trial.
Sales and Marketing
Sales and marketing expenses decreased by $11.6 million, or 99%, to $0.1 million for 2024 from $11.7 million for 2023. This decrease was primarily driven by discontinuation of YUTIQ® commercialization activities due to the agreement that granted the license and rights to YUTIQ® to ANI in May 2023.
General and Administrative
General and administrative expenses increased by $12.3 million, or 31%, to $52.4 million for 2024 from $40.1 million for 2023. This increase was attributable primarily to a (i) $13.6 million increase in personnel and related expenses, including a $11.2 million increase of stock-based compensation due mainly to increased share price of grants. This increase was partially offset by $1.3 million reduction in professional fees in 2024 compared to 2023.
Interest (Expense) Income
Interest income from investments in marketable securities and institutional money market funds increased by $8.1 million, to $15.1 million for 2024 compared to $6.9 million for 2023. This increase was due primarily to an increase in cash invested in
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marketable securities. We anticipate a decrease in interest income in immediate future periods due to lower interest earned on our cash and investment balances due to a general decrease in market interest rates.
Interest expense decreased by $1.2 million, or 99%, to $0.0 million for 2024, compared to $1.2 million for 2023. We incurred lower interest expense due to the repayment of the SVB Loan (as the term is defined below) on May 17, 2023.
Loss on Extinguishment of Debt
Loss on extinguishment of debt in 2023 was for the early repayment of the loan made to the Company by Silicon Valley Bank (SVB) on March 9, 2022 (SVB Loan) resulting in a $1.3 million non-cash write-off of the remaining balance of unamortized debt discount.
Recently Adopted and Recently Issued Accounting Pronouncements
For a full discussion of recently adopted and recently issued accounting pronouncements, see Note 2, "Significant Accounting Policies" to the Consolidated Financial Statements included under Item 15, "Exhibits and Financial Statement Schedules."
Liquidity and Capital Resources
We have had a history of operating losses and an absence of significant recurring cash inflows from revenue, and at December 31, 2024, we had a total accumulated deficit of $873.0 million. Our operations have been financed primarily from public and private offerings of our common stock, issuance of debt and a combination of license fees, milestone payments, royalty income and other fees received from collaboration partners.
Financing Activities
Also during the year ended December 31, 2024, we completed an underwritten public offering with gross proceeds of $161.0 million. The Company sold 14,636,363 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase an additional 1,909,090 shares of common stock. The shares of common stock were sold at a public offering price of $11.00 per share.
During the year ended December 31, 2024, we sold 1,299,506 shares of our common stock under the ATM facility at a weighted average price of $9.36 per share for gross proceeds of approximately $12.2 million. Share issue costs, including sales agent commissions, totaled approximately $0.4 million.
During the year ended December 31, 2023, we sold 15,294,116 shares in the December 2023 underwritten stock offering for gross proceeds of $230.0 million, and we sold 902,769 shares of our Common Stock utilizing our at-the-market facility (ATM) at a weighted average price of $11.05 per share for gross proceeds of approximately $10.0 million.
On May 17, 2023, we utilized a portion of the Upfront Payment from the ANI PRA (see Note 3) and repaid in full all outstanding amounts under the SVB Loan Agreement. The SVB Loan Agreement was then terminated, and all security interests and other liens granted to or held by the Lender were terminated and released.
Future Funding Requirements
At December 31, 2024, we had cash, cash equivalents, and investments in marketable securities of $370.9 million. We expect that our cash and investments in marketable securities will enable us to fund our operations into 2027. Due to the difficulty and uncertainty associated with the design and implementation of clinical trials, we will continue to assess our cash and cash equivalents, investments in marketable securities, and future funding requirements. However, there is no assurance that additional funding will be achieved and that we will succeed in our future operations.
Actual cash requirements could differ from management’s projections due to many factors including additional investments in research and development programs, clinical trial expenses for DURAVYU™ and potentially EYP-2301, competing technological and market developments and the costs of any strategic acquisitions and/or development of complementary business opportunities.
The amount of additional capital we will require will be influenced by many factors, including, but not limited to:
1.
the scope, progress, results, and costs of clinical trials of DURAVYU™, as a sustained delivery intravitreal treatment for wet AMD and DME;
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2.
our expectations regarding the timing and clinical development of our product candidates, including DURAVYU™ and EYP-2301;
3.
the duration, scope, and outcome of the DOJ Subpoena and its impact on our financial condition, results of operations, or cash flows;
4.
whether and to what extent we internally fund, whether and when we initiate, and how we conduct additional pipeline product development programs;
5.
payments we receive under any new collaboration agreements or payments expected from existing agreements;
6.
whether and when we are able to enter into strategic arrangements for our products or product candidates and the nature of those arrangements;
7.
the costs involved in preparing, filing, prosecuting, maintaining, defending, and enforcing any patent claims;
8.
the costs and timing to implement corrective and preventive actions required by the Warning Letter to the satisfaction of the FDA;
9.
changes in our operating plan, resulting in increases or decreases in our need for capital; and
10.
our views on the availability, timing, and desirability of raising capital.
We do not know if additional capital will be available when needed or on terms favorable to us or our stockholders. Collaboration, licensing, or other agreements may not be available on favorable terms, or at all. If we seek to sell our equity securities, we do not know whether and to what extent we will be able to do so, or on what terms. If available, additional equity financing may be dilutive to stockholders, debt financing may involve restrictive covenants or other unfavorable terms and dilute our existing stockholders’ equity, and funding through collaboration, licensing, or other commercial agreements may be on unfavorable terms, including requiring us to relinquish rights to certain of our technologies or products. If adequate financing is not available if and when needed, we may delay, reduce the scope of, or eliminate research or development programs, or other new products, if any, postpone or cancel the pursuit of product candidates, or otherwise significantly curtail our operations to reduce our capital requirements and extend our cash runway.
Our consolidated statements of historical cash flows are summarized as follows (in thousands):
| Year ended December 31, | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2024 | 2023 | Change | ||||||||||
| Cash flows from operating activities: | ||||||||||||
| Net loss | $ | (130,870 | ) | $ | (70,795 | ) | $ | (60,075 | ) | |||
| Changes in operating assets and liabilities | (27,773 | ) | 58,882 | (86,655 | ) | |||||||
| Other adjustments to reconcile net loss to cash flows from operating activities: | 32,417 | 13,788 | 18,629 | |||||||||
| Net cash (used in) provided by operating activities | $ | (126,226 | ) | $ | 1,875 | $ | (128,101 | ) | ||||
| Net cash (used in) provided by investing activities | $ | (219,355 | ) | $ | (3,315 | ) | $ | (216,040 | ) | |||
| Net cash provided by (used in) financing activities | $ | 164,022 | $ | 187,070 | $ | (23,048 | ) |
Operating cash outflows for the year ended December 31, 2024, totaled $126.2 million, primarily due to our net loss of $130.9 million offset by $32.4 million of non-cash expenses, which included $36.7 million of stock-based compensation. This was further offset by changes in working capital of $27.8 million, including $30.6 million of deferred revenue related to the agreement to license YUTIQ® product rights to ANI offset by $2.9 million of other working capital changes.
Operating cash inflows for the year ended December 31, 2023, totaled $1.9 million, primarily due to our net loss of $70.8 million reduced by $13.8 million of non-cash expenses, which included $12.1 million of stock-based compensation, $1.3 million of loss on extinguishment of debt, and $0.7 million for the provision of excess and obsolete inventory. This was further offset by changes in working capital of $58.9 million, including $44.5 million of deferred revenue related to the agreement to license YUTIQ® product rights to ANI, and $14.4 million of other working capital changes.
Net cash used in investing activities for the year ended December 31, 2024, consisted of $215.3 million of net cash purchases of marketable securities and $4.1 million for the purchase of property and equipment.
Net cash used in investing activities for the year ended December 31, 2023, consisted of $3.5 million for the purchase of property and equipment, partially offset by $0.2 million of net cash provided by the sale of marketable securities.
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Net cash provided by financing activities for the year ended December 31, 2024 totaled $164.0 million and consisted of the following:
(i)
$163.3 million of net proceeds from the issuance of 14,636,363 shares of our common stock in follow on offering and issuance of 1,299,506 shares of our common stock sold utilizing our ATM; and
(ii)
$1.5 million of proceeds from exercise of employee stock options and stock issued under our employee stock purchase plan
Net cash provided by financing activities for fiscal 2023 totaled $187.1 million and consisted of the following:
(i)
$215.9 million of net proceeds from the issuance of 15,294,116 shares of our common stock;
(ii)
$40.5 million used to pay off the SVB loan;
(iii)
$1.4 million used to pay debt extinguishment costs related to the SVB loan;
(iv)
$9.6 million of net proceeds from the issuance of 902,769 shares of our common stock sold utilizing our ATM; and
(v)
$3.4 million of proceeds from exercise of employee stock options and stock issued under our employee stock purchase plan
Off-Balance Sheet Arrangements
We do not have any off-balance sheet arrangements that have, or are reasonably likely to have, a current or future effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources that would be material to investors.