8-K: Eyenovia Reacquires Rights to MicroPine, Bolstering Late-Stage Pipeline

Eyenovia has reacquired the rights to MicroPine, a potential treatment for pediatric progressive myopia, from Bausch + Lomb, strengthening its late-stage drug portfolio.

Summary

• Eyenovia has reacquired the rights to MicroPine, a drug candidate for pediatric progressive myopia, from Bausch + Lomb.
• The agreement involves Eyenovia paying Bausch + Lomb $2 million in cash and $3 million in Eyenovia common stock.
• Eyenovia will also pay a low single-digit royalty on net sales of MicroPine in the U.S. and Canada for ten years after the first commercial sale.
• Bausch + Lomb will transfer regulatory files and clinical study materials related to the CHAPERONE trial to Eyenovia over the next 90 days.
• Bausch + Lomb will continue to fund the CHAPERONE trial during this transition period.
• Eyenovia estimates the U.S. market for myopia treatment to be nearly $2 billion annually.
• Eyenovia plans to consult with the FDA to explore pathways for faster availability of MicroPine.
• The company anticipates that more than half of the CHAPERONE trial's planned enrollment will have completed at least three years of therapy by mid-2024.
• Eyenovia expects no material effect on cash flow for the next four years, except for the cost of completing the study.
• The reacquisition is expected to more than double the asset value of the MicroPine program for Eyenovia compared to the original license agreement.

Sentiment

Score: 8

Explanation: The document conveys a positive outlook due to the reacquisition of a key asset, the potential for significant market growth, and the company's strategic focus on commercialization. The financial terms of the deal are also favorable for Eyenovia.

Positives

• Eyenovia now has 100% ownership of MicroPine, a late-stage drug candidate.
• The reacquisition is expected to significantly increase the value of the MicroPine program for Eyenovia.
• MicroPine has the potential to be a leader in the multi-billion dollar myopia market.
• Eyenovia plans to explore strategic partnerships to bring MicroPine to children worldwide.
• The company has a commercial launch planned for MydCombi in February 2024 and an FDA PDUFA target action date for APP13007 of March 4, 2024.
• The Optejet dispensing technology offers advantages over traditional eye drops, including less systemic exposure and better compliance.

Negatives

• Eyenovia will need to pay a low single-digit royalty on net sales of MicroPine to Bausch + Lomb for ten years.
• The company will incur costs to complete the CHAPERONE study.
• There are risks and uncertainties associated with the development and commercialization of MicroPine.

Risks

• The development and commercialization of MicroPine are subject to regulatory approvals and clinical trial risks.
• There are risks associated with the company's ability to successfully manufacture, market, and commercialize its products.
• The company faces competition in the ophthalmic market.
• The company's forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially.

Future Outlook

Eyenovia plans to consult with the FDA to explore pathways for faster availability of MicroPine and will evaluate strategic alternatives to bring MicroPine to children around the world, including through new strategic partnerships. The company also plans to accelerate the ongoing CHAPERONE phase III trial.

Management Comments

• Michael Rowe, chief executive officer of Eyenovia, stated that he is thankful to Bausch and Lomb for their work on MicroPine since 2020.
• Michael Rowe believes that owning 100% of MicroPine adds significant accretive value to Eyenovia's portfolio.
• Michael Rowe stated that the re-acquisition of MicroPine is consistent with the company's broader corporate strategy to expedite commercialization of advanced products using the Optejet.
• Michael Rowe believes Eyenovia is ideally positioned to complete remaining development steps in an expedited and capital efficient manner.

Industry Context

This announcement highlights the growing focus on pediatric progressive myopia and the potential for new treatments. Eyenovia's reacquisition of MicroPine positions them to capitalize on this market opportunity, especially with their proprietary Optejet technology. The market is estimated to be nearly $2 billion annually in the U.S. and is underserved.

Comparison to Industry Standards

• The reacquisition of MicroPine by Eyenovia is a strategic move to control a key asset in the competitive ophthalmic market.
• Companies like Novartis and Alcon are also active in the ophthalmic space, but Eyenovia's focus on microdose delivery with Optejet provides a differentiated approach.
• The estimated $2 billion annual market for myopia treatment in the U.S. is a significant opportunity, and Eyenovia's move to reacquire MicroPine is a direct attempt to capture a larger share of this market.
• The CHAPERONE trial is a pivotal study, and its progress will be closely watched by investors and competitors alike.
• The use of atropine for myopia control is well-established, but Eyenovia's Optejet delivery system aims to improve efficacy and reduce side effects compared to traditional eye drops.

Stakeholder Impact

• Shareholders will likely view the reacquisition of MicroPine positively, as it increases the company's asset value and growth potential.
• Employees may see this as a positive development, as it expands the company's pipeline and commercial opportunities.
• Patients may benefit from the potential availability of a new treatment option for pediatric progressive myopia.
• Suppliers and partners may see increased business opportunities with Eyenovia.

Next Steps

• Eyenovia will work with Bausch + Lomb to transfer regulatory files and clinical study materials over the next 90 days.
• Eyenovia plans to consult with the FDA to explore pathways for faster availability of MicroPine.
• Eyenovia will evaluate strategic alternatives to bring MicroPine to children around the world.
• Eyenovia will accelerate the ongoing CHAPERONE phase III trial.

Key Dates

Keywords

MicroPine, myopia, pediatric progressive myopia, Optejet, Bausch + Lomb, ophthalmic, CHAPERONE trial, FDA, MydCombi, APP13007