Revenue | 3. Revenue Product Revenue Reserves and Allowances From January 1, 2023 through May 17, 2023 (the date the Company entered into the product rights agreement with Alimera), the Company’s product revenues were primarily from sales of YUTIQ in the U.S. For the three months ended September 30, 2023, the Company’s product revenues were primarily from the Company’s existing commercial supply agreements with Alimera. For the three and nine months ended September 30, 2022, the Company’s product revenues were made up of $ 7.3 million and $ 19.3 million from the sales of YUTIQ, and $ 2.4 million and $ 10.7 million from the sales of DEXYCU, respectively. The following table summarizes activity in each of the product revenue allowance and reserve categories for the nine months ended September 30, 2023 and 2022 (in thousands): Chargebacks, Government and Fees Rebates Returns Total Beginning balance at January 1, 2023 $ 859 $ 158 $ 871 $ 1,888 Provision related to sales in the current year 1,561 — — 1,561 Adjustments related to prior period sales 40 ( 55 ) ( 154 ) ( 169 ) Deductions applied and payments made ( 2,279 ) ( 103 ) ( 156 ) ( 2,538 ) Ending balance at September 30, 2023 $ 181 $ — $ 561 $ 742 Chargebacks, Government and Fees Rebates Returns Total Beginning balance at January 1, 2022 $ 1,153 $ 1,821 $ 379 $ 3,353 Provision related to sales in the current year 8,913 5,424 464 14,801 Adjustments related to prior period sales — — — — Deductions applied and payments made ( 8,092 ) ( 5,293 ) ( 259 ) ( 13,644 ) Ending balance at September 30, 2022 $ 1,974 $ 1,952 $ 584 $ 4,510 Returns are recorded as a reduction of accounts receivable on the condensed consolidated balance sheets. Chargebacks, discounts and fees and rebates are recorded as a component of accrued expenses on the condensed consolidated balance sheets (See Note 6). License and Collaboration Agreements and Royalty Income Alimera Product Rights Agreement and Commercial Supply Agreement On May 17, 2023 (the Closing Date), the Company entered into a product rights agreement (PRA) with Alimera Sciences, Inc. (Alimera). Under the PRA, the Company granted to Alimera an exclusive and sublicensable right and license (the License) under the Company’s and its affiliates’ interest in certain of the Company’s and its affiliates’ intellectual property to develop, manufacture, sell, commercialize and otherwise exploit certain products, including YUTIQ, for the treatment and prevention of uveitis in the entire world except Europe, the Middle East and Africa (the EMEA). The License also excludes any rights to YUTIQ for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye the Company granted to Ocumension Therapeutics (Ocumension) under the license agreements and a Memorandum of Understanding for YUTIQ (the Ocumension Agreement), pursuant to which rights have been exclusively licensed to Ocumension in China and certain other countries and regions in Asia. Additionally, pursuant to the PRA, the Company transferred and assigned to Alimera certain assets (the Transferred Assets) and certain contracts with third parties related to YUTIQ, including the new drug application #210331 for YUTIQ (collectively, the Asset Transfer). The Transferred Assets consist primarily of agreements and internally developed intangible assets which have zero carrying value. Pursuant to the PRA, Alimera paid the Company a $ 75.0 million Upfront Payment. Alimera will also make four quarterly payments of $ 1.875 million to the Company totaling $ 7.5 million during 2024. Alimera will also pay royalties to the Company from 2025 to 2028 at a percentage of low-to-mid double digits of Alimera’s related U.S. annual net sales of certain products (including YUTIQ) in excess of certain thresholds, beginning at $ 70.0 million in 2025, and increasing annually thereafter. Upon Alimera’s payment of the Upfront Payment and the 2024 quarterly payments, the licenses and rights granted to Alimera will automatically become perpetual and irrevocable. On the Closing Date, the Company and Alimera also entered into a commercial supply agreement (CSA), pursuant to which, during the term of the PRA, the Company agreed to manufacture and exclusively supply to Alimera agreed-upon quantities of YUTIQ necessary for Alimera to commercialize YUTIQ in the United States at certain cost plus amounts, subject to adjustments set forth in the CSA (the Supply Transaction and together with the License and the Asset Transfer, the Transaction). The initial term of the CSA is two years following the Closing Date, subject to certain changes set forth in the CSA. The CSA shall thereafter automatically renew for successive one ( 1 ) year terms; provided, that the term of the CSA automatically terminates upon the successful completion of the transfer of manufacturing for YUTIQ to Alimera or its designee in accordance with the CSA. In addition, the Company entered into a transition services agreement (TSA) under which the Company agreed to provide agreed upon transition services to Alimera, on a cost-plus pricing arrangement for up to six months following the closing of the Transaction. As part of the TSA, the Company agreed to fulfill Alimera sales orders for YUTIQ in the United States, to the extent requested by Alimera, during the period up to six months following the Closing Date, to the Company’s third-party customers on behalf of Alimera, including by invoicing for YUTIQ and receiving payments for such invoiced YUTIQ for fulfilling Alimera sales orders of YUTIQ and remit such payments to Alimera (See Note 6) (the Sales Services). The Sales Services were completed as of September 30, 2023. The Company classified the cash proceeds of the $ 75.0 million Upfront Payment received from Alimera as deferred revenue at the Closing Date, pursuant to the PRA and the CSA because the License and supply units to be delivered under both agreements comprise a single, combined performance obligation as Alimera will not have the right or ability to manufacture YUTIQ (or have YUTIQ manufactured by a third-party contract manufacturing organization) over the initial two-year term pursuant to the CSA. The combined performance obligation is satisfied over time using the units delivered output method to measure progress based on initial estimated supply units of YUTIQ over the two-year term for purposes of recognizing revenue, such that revenue is recognized based on the value transferred in the form of units of product in the satisfaction of a performance obligation. Through this method, the Company compares the actual units delivered to date with the current estimated total to be delivered in the contractual term to measure the satisfaction of the performance obligation and recognize revenue. The Company will monitor its estimate of total units to be delivered to determine if an adjustment is needed to ensure that revenue is recognized proportionally for units delivered to date relative to the total units expected to be delivered for the combined performance obligation. Such estimates of the total delivery will be reassessed on an ongoing basis. If the Company determines that a change in estimate is necessary, it will adjust revenue using a cumulative catch-up method. During the three and nine months ended September 30, 2023, the Company recognized $ 1.0 million and $ 1.2 million, respectively, of revenue from sales of product supply to Alimera under the CSA and recorded this amount in product sales, net on the condensed consolidated statements of operations and comprehensive loss. The Company recognized $ 13.6 million and $ 16.8 million of license and collaboration revenue related to the PRA and the CSA during the three and nine months ended September 30, 2023, respectively. The Company also recognized approximately $ 394,000 and $ 799,000 of license and collaboration revenue, related to additional transitional services for the three and nine months ended September 30, 2023, respectively. As of September 30, 2023, the Company had $ 38.5 million and $ 19.6 million as current and non-current deferred revenue recognized under the PRA, respectively. SWK Royalty Purchase Agreement Pursuant to a royalty purchase agreement (RPA) with SWK Funding LLC (SWK), the Company sold its right to receive royalty payments on future sales of products subject to a licensing and development agreement, as amended, with Alimera (the Amended Alimera Agreement) for an upfront cash payment of $ 16.5 million. The Company classified the proceeds received from SWK as deferred revenue at inception of the RPA and is recognizing revenue as royalty payments are made from Alimera to SWK. The Company recognized $ 249,000 and $ 737,000 of royalty revenue related to the RPA for the three and nine months ended September 30, 2023, respectively, and $ 240,000 and $ 663,000 of royalty revenue related to the RPA for the three and nine months ended September 30, 2022, respectively. As of September 30, 2023, the Company had $ 1.3 million and $ 12.7 million as current and non-current deferred revenue recognized under the RPA, respectively. As of December 31, 2022, the Company classified $ 1.2 million and $ 13.6 million as current and non-current deferred revenue recognized under the RPA, respectively. Ocumension Therapeutics Pursuant to license agreements and a Memorandum of Understanding signed with the Company, Ocumension has: • An exclusive license for the development and commercialization of its three-year micro insert using the Durasert technology for the treatment of posterior segment uveitis of the eye (YUTIQ in the U.S.) in Mainland China, Hong Kong, Macau and Taiwan at its own cost and expense in return for royalties based on sales with the Company supplying products for clinical trials and commercial sale; • An exclusive license for the development and commercialization in Mainland China, Hong Kong, Macau and Taiwan of DEXYCU for the treatment of post-operative inflammation following ocular surgery at its own cost and expense in return for royalties based on sales with the Company supplying product for clinical trials and commercial sale; and • Exclusive rights to develop and commercialize YUTIQ and DEXYCU products under its own brand names in South Korea and other jurisdictions across Southeast Asia in Brunei, Burma (Myanmar), Cambodia, Timor-Leste, Indonesia, Laos, Malaysia, the Philippines, Singapore, Thailand and Vietnam, at its own cost and expense in return for royalties based on sales with the Company supplying product for clinical trials and commercial sale. The Chief Executive Officer of Ocumension is a member of the Company's board of directors. During the three and nine months ended September 30, 2023, the Company recognized $ 0 and $ 471,000, respectively, of revenue from sales of product supply to Ocumension under the supply agreement and recorded this amount in product sales, net on the condensed consolidated statements of operations and comprehensive loss. The Company recognized approximately $ 17,000 and $ 65,000 of license and collaboration revenue, respectively, related to additional technical assistance during the three and nine months ended September 30, 2023. During the three and nine months ended September 30, 2022, in addition to $ 20,000 and $ 87,000 of revenue from product sales, respectively, the Company recognized approximately $ 50,000 and $ 158,000 of license and collaboration revenue, respectively, related to additional technical assistance. No royalty income was recorded for the three and nine months ended September 30, 2023 and 2022. Exclusive License Agreement with Betta Pharmaceuticals, Co., Ltd. On May 2, 2022, the Company entered into an exclusive license agreement (the Betta License Agreement) with Betta Pharmaceuticals Co., Ltd. (Betta), an affiliate of Equinox Sciences, LLC (Equinox) (see Note 11). Under the Betta License Agreement, the Company granted to Betta an exclusive, sublicensable, royalty-bearing license under certain of the Company’s intellectual property to develop, use (but not make or have made), sell, offer for sale and import the Company’s product candidate, EYP-1901, an investigational sustained delivery intravitreal anti-VEGF treatment that combines an erodible formulation of the Company’s proprietary sustained-release technology with the compound vorolanib (the Licensed Product), in the field of ophthalmology (the Betta Field) in the greater area of China, including China, the Hong Kong Special Administrative Region, the Macau Special Administrative Region, and Taiwan (the Betta Territory). The Company retained rights under the Company’s intellectual property to, among other things, conduct clinical trials on the Licensed Product in the Betta Field in the Betta Territory. In consideration for the rights granted by the Company, Betta agreed to pay the Company tiered, mid-to-high single-digit royalties based upon annual net sales of Licensed Products in the Betta Territory. The royalties are payable on a Licensed Product-by-Licensed Product and region-by-region basis commencing on the first commercial sale of a Licensed Product in a region and continuing until the later of (i) the date that is twelve (12) years after first commercial sale of such Licensed Product in such region, and (ii) the first day of the month following the month in which a generic product corresponding to such Licensed Product is launched in the relevant region. The royalty rate is subject to reduction under certain circumstances, including when there is no valid claim of a licensed patent that covers a Licensed Product in a particular region. Betta is responsible for all costs relating to development, registration, manufacturing, marketing, advertising, promotional, launch and sales activities in connection with the Licensed Products in the Betta Field in the Betta Territory. Betta is required to use commercially reasonable efforts to develop, seek regulatory approval for, and commercialize at least one Licensed Product in the Betta Field in the Betta Territory. The Betta License Agreement also requires Betta to achieve certain diligence milestones relating to regulatory filings, patient dosing and regulatory approval by certain specified deadlines set forth in the Betta License Agreement, subject to certain exceptions and extensions as set forth in the Betta License Agreement. Betta’s development activities will be conducted pursuant to a development plan subject to periodic updates. In the event that the Company conducts a global registrational clinical trial for a Licensed Product in the Betta Field, Betta will have the right to participate in such clinical trial by including clinical trial sites in the Betta Territory in accordance with the terms of the Betta License Agreement. The Company has also agreed to provide certain technology transfer and other support services to Betta subject to certain conditions and limitations set forth in the Betta License Agreement. The Company recorded no revenue from product sales, license and collaboration revenue, or royalty income for the three and nine months ended September 30, 2023 and 2022 related to this agreement. |