Axonics, Inc. - AXNX STOCK NEWS

Axonics (AXNX) reported strong Q3 2024 financial results with net revenue of $116.2 million, marking a 25% year-over-year growth. Both sacral neuromodulation and Bulkamid® segments showed 25% growth, reaching $92.3 million and $23.8 million respectively. The company's gross margin improved to 77.2% from 74.2% year-over-year. Despite recording an operating loss of $6.3 million, which included $8 million in one-time legal and acquisition-related costs, Adjusted EBITDA increased to $23.6 million from $14.0 million. The company maintained a strong cash position of $367 million as of September 30, 2024.

Axonics, Inc. (Nasdaq: AXNX) has received regulatory approval from the Therapeutic Goods Administration (TGA) to market its Axonics R20® rechargeable sacral neuromodulation (SNM) system in Australia. The system is approved to treat adults with overactive bladder and fecal incontinence. Key features of the R20 neurostimulator include:

• Functional life of at least 20 years in the body
• Recharging required only once every 6 to 10 months for one hour
• Same 5cc form factor as the previous generation (Axonics R15®)
• Enhanced programming capabilities and expanded MRI labeling

Axonics began SNM commercial activities in Australia in March 2023 and received approval for its F15® recharge-free SNM system in May 2024. The company also markets Bulkamid® for female stress urinary incontinence in Australia. Sales of the R20 are expected to commence in November.

Axonics, Inc. (Nasdaq: AXNX) has prevailed in a patent infringement lawsuit brought by Medtronic in the U.S. District Court for the Central District of California. The jury unanimously found that Axonics does not infringe any of the three patents-in-suit. This verdict recognizes the differentiation of Axonics' proprietary tined lead design and temperature sensor technology from Medtronic's intellectual property.

Axonics CEO Raymond W. Cohen stated that the company viewed Medtronic's lawsuit, initiated in late 2019, as an attempt to stifle competition, limit patient and physician choice, and protect Medtronic's monopoly in sacral neuromodulation. Axonics remains focused on its mission to positively impact the lives of adults with bladder and bowel dysfunction.

Axonics (NASDAQ: AXNX) reported strong financial results for Q2 2024, with record revenue of $114.6 million, up 23% year-over-year. The company achieved significant milestones:

- Sacral neuromodulation revenue: $91.2 million (+23%)
- Bulkamid revenue: $23.4 million (+25%)
- Gross margin: 77.8% (up from 75.6%)
- Net income: $6.9 million (vs. $7.3 million loss in Q2 2023)
- Adjusted EBITDA: $23.4 million (vs. $18.4 million in Q2 2023)

CEO Raymond W. Cohen attributed the growth to higher utilization at existing customers, new account onboarding, and improved manufacturing yields. The company remains confident in its market expansion strategy and looks forward to its future as part of Boston Scientific.

Kestra Medical Technologies, a privately held wearable medical device and digital healthcare company, has announced the appointment of Raymond W. Cohen to its board of directors as an independent member. Cohen, with over 40 years of life sciences industry experience, is currently the CEO and board member of Axonics Inc. (Nasdaq: AXNX), which recently agreed to be acquired by Boston Scientific for $3.7 billion.

Brian Webster, President & CEO of Kestra, highlighted Cohen's extensive experience in external defibrillation and commercial growth strategies as valuable assets for the company. Kestra recently closed a $196 million funding round to support commercial expansion and advance its mission of protecting at-risk patients with its wearable cardioverter defibrillator. The funding was co-led by Andera Partners, Ally Bridge Group, Longitude Capital, and Omega Funds, with participation from new and long-term investors.

Axonics announced it received regulatory approval from the Therapeutic Goods Administration (TGA) in Australia for its Axonics F15™ recharge-free sacral neuromodulation (SNM) system, intended to treat adults with overactive bladder. This approval allows Australians to access a device with longer longevity, constant current stimulation, and a user-friendly remote control. The launch in Australia follows Axonics' commencement of SNM commercial activities in March 2023. Additionally, Axonics markets Bulkamid®, a hydrogel product for female stress urinary incontinence, in the region. Axonics aims to continue promoting its innovative incontinence therapies globally.

Axonics, Inc. (Nasdaq: AXNX) reported positive first quarter 2024 financial results with a 29% revenue growth year over year. The company saw increases in revenue for sacral neuromodulation and Bulkamid products, achieving a record gross margin of 75.8%. Operating expenses included acquisition-related costs related to the Boston Scientific merger, leading to a net loss of $19.1 million. Adjusted EBITDA improved to $3.0 million. Cash, cash equivalents, short-term investments, and restricted cash totaled $349 million as of March 31, 2024.

Boston Scientific (NYSE: BSX) reported strong financial results for the first quarter of 2024, with net sales of $3.856 billion, a 13.8% increase on a reported basis. The company achieved GAAP net income of $495 million, compared to $300 million a year ago, and an adjusted EPS of $0.56. Various business segments and regions showed growth, with significant developments in product launches, clinical trials, and regulatory approvals.

Axonics, Inc. (AXNX) stockholders vote to adopt merger agreement with Boston Scientific (BSX). The majority of shares voted in favor of the merger. The closing is expected in the first half of 2024, subject to certain conditions.