Axonics® Expands into Stress Urinary Incontinence with the Acquisition of Bulkamid®
Combination creates a global leader for incontinence solutions
Acquisition of Bulkamid is expected to be immediately accretive to Axonics
SUI is a large and highly underpenetrated market with a prevalence of an estimated 20 million women in the
Bulkamid is a next generation hydrogel that is injected into the urethral wall in a minimally invasive, office or outpatient facility procedure, to restore the natural closing pressure of the urethra. Bulkamid is clinically proven to retain its bulking characteristics and maintain efficacy for many years, providing women with long lasting relief of their SUI symptoms.
Bulkamid received CE Mark approval in 2003 and is a covered service from a reimbursement standpoint in most European countries. Sales in 2019 from international markets were approximately
Bulkamid is currently sold through a direct salesforce in the
Leverages commercial footprint. The acquisition of Bulkamid leverages Axonics’ existing commercial footprint of over 220 sales and clinical specialists in the
U.S.and Europethat call on urogynecologists and urologists. Axonics can now offer customers best-in-class solutions for patients with various types of overactive bladder and SUI.
- Clinically differentiated SUI solution. Bulkamid is a unique, next-generation bulking agent that we believe addresses the shortcomings of existing particulate-based bulking agents while also offering an alternative to patients who desire to avoid sling surgery and instead opt for a minimally invasive solution. Bulkamid has generated extensive clinical validation and a strong safety profile, with over 70,000 women treated to date.
Large, highly underpenetrated SUI market. An estimated 20 million women suffer from SUI in the
U.S.alone, though the majority of women are unaware of treatment options and have not sought treatment. While Bulkamid is still in the initial phase of commercial development in the U.S., we believe there is significant demand for the product.
- Compelling financial profile. The acquisition of Bulkamid is expected to be revenue growth, gross margin, and operating margin accretive to Axonics in 2021 and beyond.
Total upfront consideration is comprised of
$141,250,000paid in cash and the issuance of 1,096,583 shares of Axonics stock.
The upfront cash consideration is funded with a new
$75 millionterm loan from Silicon Valley Bankand existing cash on the balance sheet.
$35 millionmilestone payment is subject to the achievement of $50 millionof Bulkamid sales in any consecutive 12-month period prior to December 31, 2024.
Axonics entered into a manufacturing agreement for the supply of the Bulkamid hydrogel. Axonics has rights to a technology transfer after
June 30, 2022that would enable Axonics to insource the manufacturing of Bulkamid.
Webcast and Conference Call
Axonics will host a conference call today,
The live teleconference may be accessed by dialing 888-771-4371 (
The live webcast of the conference call may be accessed by visiting the Events & Presentations section of the Axonics investor relations website. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Axonics website for 90 days.
Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “planned,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the