Axonics reports Q2 EPS (54c), consensus (65c) » 16:1008/0608/06/20
Reports Q2 revenue $15.2M…
Reports Q2 revenue $15.2M vs. $1.5M last year. Cash used in operating activities in the second quarter 2020 was $13.0 million. As of June 30, 2020, cash and cash equivalents were $288 million.
|Over a week ago|
Proposed CMS rates positive for neuromodulation names, says PiperSandler » 14:1408/0408/04/20
AXNX, INSP, LIVN
The Centers for Medicare…
The Centers for Medicare and Medicaid Services earlier today issued its proposed rule for 2021 for the rate of Medicare facility reimbursement in the hospital outpatient department and ambulatory surgery center settings, Piper Sandler analyst Adam Maeder tells investors in a research note. The analyst views the proposed changes as favorable for the neuromodulation names he follows such as Axonics (AXNX), Inspire Medical (INSP) and LivaNova (LIVN). The 2021 proposed rate of facility reimbursement for a permanent sacral neuromodulation implant s $20,790, up 8% year-over-year, in the hospital outpatient department and $18,305, up 6%, for procedures done in ambulatory surgery centers, says the analyst.
Piper says Axonics positioned for continued share taking despite Medtronic nod » 10:1908/0308/03/20
After Medtronic (MDT)…
After Medtronic (MDT) announced that it received FDA approval for its next-gen InterStim Micro device for the treatment of overactive bladder, fecal incontinence and non-obstructive urinary retention, Piper Sandler analyst Adam Maeder said he believes the FDA nod should help the company narrow the competitive gap some from a technology standpoint, but he still sees Axonics (AXNX) having the better product and being well-positioned for continued, "meaningful, durable" share capture. Maeder, who reiterates an Overweight rating and $45 price target on Axonics shares, would recommend investors buy on any weakness following the Medtronic news.
Axonics data 'strong and consistent' with one-year results, says Piper Sandler » 09:5207/2707/27/20
Piper Sandler analyst…
Piper Sandler analyst Adam Maeder reiterates an Overweight rating on Axonics Modulation Technologies with a $45 price target saying the two-year top-line results from its ARTISAN-SNM U.S. pivotal trial appear "strong and consistent" with the one-year results. At two years, 88% of all implanted patients were therapy responders, which compares to the one-year responder rate of 89%, Maeder tells investors in a research note. It is encouraging to see the durable treatment effect with r-SNM at two years, says the analyst, who views ARTISAN-SNM as the "most compelling" clinical evidence in the sacral neuromodulation category to date. Given that Medtronic (MDT) elected to not run a U.S. pivotal trial to support regulatory approval for InterStim Micro, the ARTISAN-SNM data will likely be a primary selling point and competitive advantage for Axonics in the field, contends Maeder.
Axonics completes clinical results from its ARTISAN-SNM pivotal study » 06:0207/2707/27/20
Axonics Modulation Technologies announced completion of 2-year follow-ups and topline clinical results from its ARTISAN-SNM pivotal study that was conducted to evaluate the safety and efficacy of the Axonics r-SNM System. The 2-year study results demonstrate that patients implanted with the Axonics r-SNM System continue to receive clinically meaningful and statistically significant improvements in urinary urgency incontinence symptoms and quality of life. At 2 years, 88% of all implanted patients were therapy responders, consistent with the 89% therapy responder rate reported at 1-year. 80% of patients achieved greater than75% improvement, with 37% being completely dry. There were no serious adverse or unanticipated device related events. Detailed study results will be presented to interested parties by study investigators via an Axonics-hosted webinar to be announced in the coming weeks.
Axonics reports preliminary Q2 revenue $15.2M, consensus $5.19M » 06:0707/1307/13/20
Sales to customers in the…
Sales to customers in the United States accounted for approximately 96% of total revenue. Raymond Cohen, CEO of Axonics, commented, "Axonics has stayed focused on supporting physicians and their patients during the COVID-19 pandemic, along with building finished goods inventory, signing agreements with national, regional and local hospital systems, and advancing regulatory filings with the FDA. In the second quarter, we continued to make meaningful progress on new customer acquisition, with over 45% of the top 1,000 centers in the United States now having implanted patients with the Axonics r-SNM System. While gross margins will be impacted by lower overhead absorption and other related factors, we are highly encouraged by the trajectory of new order flow in June. Given these factors, we are confident that Axonics is well positioned for growth in the second half of 2020, while recognizing that a sustained recovery in elective procedures is contingent on factors that are outside of our control." Cohen continued, "We continue to invest in innovation and enhancing the patient experience, having announced several recent FDA approvals that will accrue to SNM becoming the preferred therapy for overactive bladder and bowel dysfunction. The overwhelmingly positive feedback from clinicians and patients on their experience with our product in tandem with our commitment to increase patient awareness supports our conviction that the SNM market is poised for significant expansion in the years ahead."
|Over a month ago|
Fly Intel: After-Hours Movers » 18:5507/0107/01/20
VERO, FEIM, NUS, FORM, AXNX, LDOS, CULP, BLFS, PLYA, AKRO, MCD, FIZZ
Check out this evening's…
Axonics gets FDA approval for 3T full-body MRI scans » 16:0107/0107/01/20
Axonics Modulation Technologies announced that it has received FDA approval under a premarket approval supplement for 3T full-body magnetic resonance imaging conditional labeling for the Axonics r-SNM System. In September 2019, the FDA approved the Axonics r-SNM System with full-body conditional labeling for 1.5T MRI scanners. With this "incremental approval for 3T scans, the Axonics device continues to be the only SNM system available in the United States that is MRI compatible for both 1.5T and 3T full-body scans", the company states in its press release.
Axonics' wireless patient remote control approved by FDA » 06:0306/0306/03/20
Axonics announced FDA…
Axonics announced FDA approval of its new wireless patient Remote Control with SmartMRI technology for the Axonics r-SNM System under a premarket approval supplement. The new Remote Control simplifies the process by which patients can receive a full-body MRI. The new patient Remote Control with SmartMRI technology will be included in all new orders of the Axonics r-SNM System in the U.S. beginning this month. The Axonics r-SNM System is approved for 1.5T full-body MRI scans in the United States and both 1.5T and 3.0T full-body MRI scans in Canada and Europe.
Axonics announces publication of results from ARTISAN-SNM study » 06:0505/1905/19/20
Axonics Modulation Technologies announced the publication of the 1-year results from its ARTISAN-SNM study in the peer-reviewed journal Neurourology & Urodynamics. Axonics also plans to launch a multi-center registry study in the U.S to collect additional real-world clinical evidence on the performance, safety and patient experience with the Axonics r-SNM System across all approved indications to advance physician knowledge and patient access to rechargeable sacral neuromodulation therapy. Using a conservative "as treated" analysis method, the 1-year results found that 89% of all implanted patients with the Axonics r-SNM System had successful therapy outcomes, and 93% of treated patients were satisfied with their r-SNM therapy. Currently, 2-year follow-up visits in the ARTISAN study are ongoing.