The financing will fund commercial readiness for the investigational oral obstructive sleep apnea therapy ahead of an anticipated new drug application.
Key takeaways:
- Apnimed entered a credit facility for up to $150 million with HealthCare Royalty Partners, receiving an initial $50 million at closing.
- The capital will strengthen the company’s balance sheet to support commercial readiness and the planned US launch of AD109, a once-daily oral pill for the treatment of obstructive sleep apnea.
- Apnimed is on track to submit a New Drug Application to the FDA for AD109 later this quarter, supported by positive phase 3 trial results.
Apnimed Inc, a pharmaceutical company developing novel oral therapies for obstructive sleep apnea (OSA), has entered into a senior secured credit facility for up to $150 million with funds managed by HealthCare Royalty Partners.
The capital is expected to support commercial readiness activities and the planned US launch of Apnimed’s lead product candidate, AD109, if approved by the US Food and Drug Administration (FDA).
Under the terms of the agreement, Apnimed will receive $50 million at closing. An additional $50 million tranche will become available upon FDA approval of AD109, and the company may access a third $50 million tranche upon achievement of a pre-specified sales milestone, subject to customary closing conditions.
The financing includes an interest-only period of four years, which is extended to five years if Apnimed achieves a specified net sales milestone. Apnimed also agreed to pay a synthetic royalty equal to a low single-digit percentage of net sales of AD109 and certain other specified revenues.
“HCR is a highly respected healthcare investor with deep experience in credit financing, and their investment represents an important validation of our investigational product, AD109 and its commercial potential,” says Larry Miller, CEO of Apnimed, in a release. “This strategic financing provides significant financial flexibility and supports our continued progress toward the potential US commercialization of AD109, if approved.”
AD109 is designed to be the first pharmacological treatment to improve oxygenation during sleep by directly addressing the neuromuscular root cause of upper airway collapse in people with OSA. It is a first-in-class combination of aroxybutynin, a novel antimuscarinic, and atomoxetine, a selective norepinephrine reuptake inhibitor. The once-daily pill is taken at bedtime and is designed to lower the complexity of intervention for patients.
“With its focused regulatory and commercial strategy for AD109, a novel oral therapy designed to address the root causes of OSA, we believe Apnimed is uniquely positioned to meaningfully impact the treatment landscape for patients living with this serious disease,” says Clarke Futch, chairman and CEOof HealthCare Royalty Partners, in a release. “We look forward to supporting Apnimed’s continued growth and mission to bring this innovative treatment option to patients as expeditiously as possible.”
Apnimed previously reported positive results from the pivotal SynAIRgy and LunAIRo phase 3 trials for AD109. These findings will support the planned submission of a New Drug Application (NDA) to the FDA, which is expected later this quarter.
