The foregoing summary of the Option Agreement and the Collaboration Agreement does not purport to be complete and is subject to, and qualified in its entirety by, the full text of such agreements. Aldeyra expects to file a copy of the Option Agreement, including the form of Collaboration Agreement attached as an exhibit thereto, subject to any applicable confidential treatment, as an exhibit to its Annual Report on Form 10-K for the year ending December 31, 2023.
The following risk factors are provided to supplement Aldeyra’s risk factor previously disclosed in Aldeyra’s Current Report on Form 8-K, filed with the Securities and Exchange Commission on October 16, 2023, and Aldeyra’s risk factors previously disclosed under the heading “Risk Factors” in Aldeyra’s Annual Report on Form 10-K for the year ended December 31, 2022 and Aldeyra’s Quarterly Reports on Form 10-Q for the quarters ended March 31, 2023 and June 30, 2023.
Risks Related to the Potential Development and Commercialization of Reproxalap
If Aldeyra remains responsible for funding further development and commercialization of reproxalap, it may be unable to raise the additional capital required to further develop and commercialize reproxalap or enter into a collaboration agreement with another pharmaceutical company with equivalent or comparable terms, or at all.
If the Option is not exercised, Aldeyra will be responsible for funding further development and commercialization of reproxalap, and it may be unable to raise the additional capital required to further develop and commercialize reproxalap or enter into a collaboration agreement with another pharmaceutical company with equivalent or comparable terms, or at all. If Aldeyra is unable to raise capital when needed or on attractive terms, it could be forced to delay, reduce or eliminate its research and development programs and its reproxalap commercialization efforts.
If Aldeyra is required to continue the development and commercialization of reproxalap on its own, it may need to build its marketing, sales, distribution, managerial and other non-technical capabilities to commercialize reproxalap or make arrangements with third parties to perform these services. The establishment and development of Aldeyra’s own sales force or the establishment of a contract sales force to market reproxalap would be expensive and time-consuming and could delay any commercial launch. Moreover, Aldeyra cannot be certain that it will be able to successfully develop this capability. Aldeyra would have to compete with other pharmaceutical and biotechnology companies to recruit, hire, train and retain marketing and sales personnel. Aldeyra would also face competition in its search for third parties to assist it with the sales and marketing efforts of reproxalap.
If the Option is exercised and the Collaboration Agreement is executed, then pursuant to the terms of the Collaboration Agreement, Aldeyra would work closely with AbbVie to execute a commercialization plan for reproxalap in the United States, and this commercialization plan may never achieve its desired outcomes.
Pursuant to the terms of the Collaboration Agreement, Aldeyra and AbbVie would work to execute a joint commercialization plan for reproxalap in the United States, and execute upon the commercialization plan with the intention to optimize the commercial potential of reproxalap. If this collaboration is not successful, then Aldeyra’s business, financial condition, and results of operations could be adversely affected.
Forward-Looking Statements
This Current Report on Form 8-K contains forward-looking statements, including statements regarding the likelihood and timing of the FDA’s potential approval of the NDA for reproxalap by the PDUFA target action date, or at any other time; the adequacy of the data included in the NDA submission or the supplemental responses to the FDA; the likelihood and timing of the exercise of the Option or extension of the Exercise Period; and the Company’s ability to successfully commercialize (alone or with others) reproxalap. Any statements about the Company’s expectations, beliefs, plans, predictions, forecasts, objectives, assumptions, or future events or performance are not historical facts and may be forward-looking. These statements are often, but not always, made through the use of words or phrases such as “anticipates,” “believes,” “can,” “could,” “may,” “predicts,” “potential,” “should,” “will,” “estimate,” “plans,” “projects,” “continuing,” “ongoing,” “expects,” “intends,” and similar words or phrases.