London-based Contura’s Bulkamid is a urethral bulking agent for women with stress urinary incontinence (SUI). It is a next-generation hydrogel injected into the urethral wall in a minimally invasive office or outpatient facility procedure to restore the natural closing pressure of the urethra.
It has been clinically proven to retain its bulking characteristics and maintain efficacy over many years, according to a news release. Bulkamid has held CE Mark approval since 2003 and garnered FDA premarket approval in February 2020 before a limited U.S. rollout in mid-2020.
The acquisition includes a total consideration of $200 million in cash and stock, plus a potential future milestone of $35 million. The upfront consideration is comprised of $141.25 million in cash, plus nearly 1.1 million shares of Axonics stock. The cash is funded with a new $75 million term loan from Silicon Valley Bank, while the $35 million milestone payment is subject to the achievement of $50 million in Builkamid sales over any consecutive 12-month period prior to Dec. 31, 2024.
Additionally, Axonics entered into a manufacturing agreement for the supply of the Bulkamid hydrogel, with rights to a technology transfer after June 30, 2022, that would enable Axonics to insource manufacturing of Bulkamid.
Axonics expects the acquisition to leverage its existing commercial footprint in treating SUI and overactive bladder. The company also anticipates that the clinically differentiated SUI solution will add to its offerings and help to make a difference in an underpenetrated market.
The company anticipates that the acquisition will be revenue growth, gross margin and operating margin accretive in 2021 and beyond.
“This acquisition is highly synergistic, leverages our expansive commercial footprint and gives us the opportunity to expand our SNM business around the world,” Axonics CEO Raymond W. Cohen said in the release. “Axonics will provide urogynecologists and urologists with a complete suite of clinically differentiated incontinence solutions for their patients, thereby enhancing Axonics’ value proposition to new and existing customers. Interestingly, in many cases, the patient seeking treatment presents with mixed incontinence, meaning with both SUI and urge urinary incontinence symptoms.
“Similar to SNM, we see the highly underpenetrated SUI market as poised for significant and durable growth in the years ahead, driven by outstanding clinical results and increased patient awareness.”