Acutus Medical Achieves OEM Qualification Milestone in Sale of Left-Heart Access Portfolio to Medtronic
November 03 2022 - 08:00AM
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Acutus Medical, Inc. (“Acutus” or the “Company”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced that the Company has achieved the first milestone under the asset purchase agreement of its left-heart access portfolio with Medtronic. This triggers a $20 million earnout payment from Medtronic to Acutus and allows Acutus to become an original equipment manufacturer (OEM) for Medtronic. Acutus will continue selling the left-heart access portfolio until commercial distribution is transitioned to Medtronic.
“We are very pleased with the partnership we have built with Medtronic, with both teams working diligently to ensure a smooth transition for all stakeholders. We are excited about the potential to accelerate this innovative product line’s impact on patient care with Medtronic’s global reach, and we look forward to supporting Medtronic’s left-heart access commercial launch.” said David Roman, President & CEO of Acutus Medical. “Achieving this key milestone further advances our strategic priorities to strengthen the Company’s financial position and enables us to intensify focus on our differentiated mapping and therapy platform.”
Left-Heart Access Portfolio Sale
On June 30, 2022, Acutus completed the first closing of its previously announced sale of the Company’s left-heart access portfolio, which includes the AcQCross® septal crossing devices, the AcQGuide® MINI sheath and integrated crossing device, the AcQGuide® FLEX Steerable Introducer with integrated crossing device, and the AcQGuide® VUE steerable sheath to Medtronic.
Under the terms of the agreement, at the first closing, Medtronic paid cash consideration of $50 million to Acutus for, among other things, intellectual property rights to the Company’s left-heart access portfolio and certain equipment used in the manufacturing of these products. Acutus has now completed the first major milestone in this transaction with OEM qualification, which will bring in gross proceeds of $20 million. Acutus remains eligible for additional milestone payments associated with certain regulatory activities as well as four years of revenue-based earnouts.
About Acutus Medical, Inc.
Acutus is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to helping physicians achieve better patient outcomes with a unique array of products and technologies which enable physicians to diagnose each patient’s unique disease and create an optimized, personalized treatment strategy. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is based in Carls
Acutus Medical Reports Second Quarter 2022 Financial Results
August 11 2022 - 04:05PM
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Acutus Medical, Inc. (“Acutus” or the “Company”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today reported results for the second quarter of 2022.
Reported revenue of $4.1 million in the second quarter of 2022, compared to $3.7 million in the first quarter of 2022, and $4.7 million in the same quarter last year.
Global mapping procedures volumes increased 20% from the same quarter last year.
Completed first closing of the left-heart access portfolio sale to Medtronic, Inc. and debt refinancing to fund strategic growth priorities on June 30, 2022.
“Our teams continued to execute our strategy in the second quarter, as we intensify focus on utilization and procedure volume as the key drivers of our business,” said David Roman, President & CEO of Acutus. “We registered another quarter of record procedure volumes with year-over-year growth worldwide. Higher procedure volume was complemented by increased revenue share capture within our accounts, as electrophysiologists increase adoption of the Acutus product portfolio. In addition to positive trends in utilization, we made significant strides to strengthen our financial position, completing the first closing of our left-heart access portfolio sale to Medtronic, refinancing our debt, and implementing further cost reduction initiatives.”
Second Quarter 2022 Financial Results
Revenue was $4.1 million for the second quarter of 2022, compared to $4.7 million in the second quarter last year. This decrease of $0.6 million, or 13%, was primarily attributable to a decrease of $0.5 million in capital revenue and $0.2 million in disposable revenue as stocking orders for AcQMap installs declined with the decrease in new customer accounts. Gross margin was negative 138% for the three months ended June 30, 2022 and negative 59% for the three months ended June 30, 2021. This decrease in gross margin was primarily attributable to excess and obsolescence charges to inventory, recognition of manufacturing variances, and idle capacity on console manufacturing.
Excluding the net gain on the sale of our left-heart access portfolio of $43.6 million, operating expenses on a GAAP basis were $23.0 million for the second quarter of 2022, compared with $24.5 million in the same quarter last year. The decrease of $1.5 million was primarily attributable to a decrease of $2.7 million related to headcount related expenses, offset by a change in fair value of $1.2 million for the contingent consideration related to the acquisition of Rhythm Xience, Inc.
Net income on a GAAP basis was $5.7 million for the second quarter of 2022 and net income per share was $0.16 on a weighted average basic and diluted outstanding share count of 28.3 million, compared to a net loss of $28.7 million and a net loss per share of $1.02 on a weighted average basic and diluted outstanding share count of 28.2 million in the same period of the prior year. Excluding amortization of acquired intangibles, non-cash stock-based compensation expense, goodwill impairment, gain on sale of business, debt refinancing charges, restructuring charges, the employee retention credit benefit and changes in the fair value of contingent consideration, the Company’s non-GAAP net loss for the second quarter of 2022 was $26.2 million, or $0.93 per share, compared to a net loss of $25.0 million, or $0.89 per share in the same period of the prior year.
Total cash, cash equivalents, marketable securities and restricted cash was $93.1 million as of June 30, 2022.
Non-GAAP Financial Measures
This press release includes references to non-GAAP net loss and non-GAAP net loss per share, which are non-GAAP financial measures, to provide information that may assist investors in understanding the Company’s financial results and assessing its prospects for future performance. The Company believes these non-GAAP financial measures are important indicators of its operating performance because they exclude items that are primarily non-cash accounting line items unrelated to, and may not be indicative of, the Company’s core operating results. These non-GAAP financial measures, as Acutus calculates them, may not necessarily be comparable to similarly titled measures of other companies and may not be appropriate measures for comparing the performance of other companies relative to the Company. These non-GAAP financial results are not intended to represent and should not be considered to be more meaningful measures than, or alternatives to, measures of operating performance as determined in accordance with GAAP. Non-GAAP net loss is defined as net income (loss) before income taxes, adjusted for stock-based compensation, amortization of acquisition-related intangibles, acquisition related costs, discontinued operations, asset/goodwill impairments, changes in the fair value of contingent consideration, restructuring charges, stock repurchases and other adjustments for non-operating items, such as gain on sale of business, debt financing charges, and employee retention credit benefits. To the extent such non-GAAP financial measures are used in the future, the Company expects to calculate them using a consistent method from period to period. A reconciliation of the most directly comparable GAAP financial measure to the non-GAAP financial measure has been provided under the heading “Reconciliation of GAAP Results to Non-GAAP Results” in the financial statement tables attached to this press release.
Webcast and Conference Call Information
Acutus will host a conference call to discuss the second quarter 2022 financial results after market close on Thursday, August 11, 2022 at 1:30 p.m. Pacific Time / 4:30 p.m. Eastern Time. To access the live call via telephone, please register in advance using the link: https://register.vevent.com/register/BI91a149ee60de483ab484237f5ac7b27c. Upon registering, each participant will receive an email confirmation with dial-in numbers and a unique personal PIN that can be used to join the call. The live webinar of the call may be accessed by visiting the Events section of the Acutus investor relations website at ir.acutusmedical.com. A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.
About Acutus Medical, Inc.
Acutus is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and effectively. Through internal product development, acquisitions and global partnerships, Acutus has established a global sales presence delivering a broad portfolio of highly differentiated electrophysiology products that provide its customers with a complete solution for catheter-based treatment of cardiac arrhythmias. Founded in 2011, Acutus is headquartered in Carlsbad, California.
Caution Regarding Forward-Looking Statements
This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe,” “estimate,” “project,” “expect” or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to continue to manage expenses and cash burn rate at sustainable levels, continued acceptance of its products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase the Company’s systems and the timing of such purchases, competitive factors, changes resulting from healthcare policy in the United States and globally, including changes in government reimbursement of procedures, dependence upon third-party vendors and distributors, timing of regulatory approvals, the impact of the coronavirus (COVID-19) pandemic and Acutus’ response to it, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, Acutus undertakes no obligation to update these statements for revisions or changes after the date of this release, except as required by law.
Investor Contact: Media Contact:
Caroline Corner Levitate
Westwicke ICR M: 260-408-5383
D: 415-202-5678 email@example.com
Acutus Medical, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except per share amounts) June 30, 2022 December 31,
Cash and cash equivalents $ 46,567 $ 24,071
Marketable securities, short-term 42,400 76,702
Restricted cash, short-term 150
Acutus Medical Announces Approval of its AcQMap System and AcQMap 3D Imaging and Mapping Catheter in Japan
July 27 2022 - 06:30AM
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Acutus Medical, Inc. (“Acutus”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced approval of its AcQMap High Resolution Imaging and Mapping System and the AcQMap 3D Imaging and Mapping Catheter in Japan. Japan is the 2nd largest medical device market in the world and the EP Mapping and Ablation market is estimated to exceed $1.4 billion in 2022 with more than 150,000 procedures performed and grow to an estimated $1.8 billion by 20251. Acutus’ International Alliance partner BIOTRONIK has commenced training and early market development activities in collaboration with Acutus Medical in preparation for more significant activities in 2023.
“The AcQMap System and Catheter clearance represents a major advancement in the tools available to EPs in Japan,” said David Roman, President & CEO of Acutus Medical. “This approval uniquely enables electrophysiologists in Japan to employ a fully non-contact system to aid in the personalized diagnosis and treatment of patients suffering from cardiac arrhythmias. We view Japan as one of several key growth drivers to accelerate long-term performance. We look forward to entering Japan with BIOTRONIK given its established and respected position in the market.”
“We are excited to bring this innovative technology to Japan,” said Dr. Hans-Jürgen Wildau, Segment Head EP & Sensors, BIOTRONIK SE & Co. KG. “These approvals represent another successful milestone in the market readiness work we’ve done with Acutus over the past 24 months. We believe Japanese physicians specifically will appreciate the innovation the Acutus platform brings to the diagnosis of complex arrhythmias especially in mapping non-pulmonary vein triggers which is a significant unmet need in the treatment for atrial fibrillation.”
The AcQMap 3D Imaging and Mapping Catheter are the cornerstones of Acutus’ innovative mapping platform as the world’s only integrated ultrasound-based imaging and non-contact mapping catheter capable of capturing cardiac imaging information and cardiac activation mapping, all without touching the heart. The AcQMap System can uniquely map the electrical conduction of each heartbeat to characterize the most complex arrhythmias across the entire atrial chamber.
The ability to map every beat allows the physician to visualize global chamber activity of irregular rhythms like atrial fibrillation, complex flutters and tachycardias, and clinically relevant, fleeting rhythms such as non-sustained tachycardia which are all burdensome with conventional contact-based systems that rely on probing the heart sequentially over many heartbeats to create diagnostic maps. The unique capability of AcQMap to understand these complex arrythmias helps physicians to personalize a diagnosis and treatment strategy for each individual patient leading to superior outcomes.2,3,4
For more information, visit www.acutusmedical.com/us/.
1 Millennium Research Group: 2021 Electrophysiology Mapping and Ablation Devices | Market Insights | Japan | 2021
2Shi R, et al, An Individualised Ablation Strategy to Treat Persistent Atrial Fibrillation: Core-to-Boundary Approach Guided by Charge-Density Mapping, Heart Rhythm 2021
3Shi R, et al. Novel aggregated multiposition noncontact mapping of atrial tachycardia in humans: From computational modeling to clinical validation. Heart Rhythm. 2022
4Gagyi R, et al. New Possibilities in the Treatment of Brief Episodes of Highly Symptomatic Atrial Tachycardia: The Usefulness of Single-Position Single-Beat Charge Density Mapping. Circulation: Arrhythmia and Electrophysiology 2021
About Acutus Medical
The run-up to $2.16 was simply AMAZING! :)
Acutus Medical Announces CEO Appointment and Preliminary Second Quarter Revenue Results
July 21 2022 - 06:30AM
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Acutus Medical, Inc. (“Acutus” or the “Company”) (Nasdaq: AFIB), an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated, today announced that David Roman has been appointed President and Chief Executive Officer, and member of the Board of Directors, effective immediately. The Company also announced preliminary second quarter revenue results.
“Since being appointed interim CEO, David has hit the ground running with an intense focus on reinvigorating the Company’s strategy, driving operational improvements, and successfully completing the first close of our left-heart access portfolio sale to Medtronic and debt refinancing,” said Scott Huennekens, Chairman of the Acutus Board of Directors. “As the Board considered the needs of the Company, we determined that this focus as well as David’s performance over the past two months made him the right person to lead Acutus moving forward. In addition, David has demonstrated strong and engaging leadership with the senior management team as well as the Board, and we are confident in David’s ability to drive long-term growth and value creation at Acutus.”
Mr. Roman said, “Acutus benefits from a dedicated and passionate team, and as CEO I am excited to continue driving the adoption of our electrophysiology mapping and therapy solutions as well as improving our operational and financial performance. We have a tremendous amount of opportunity ahead of us, and I am confident in our ability to execute on our plans and maintain positive momentum in 2022 and beyond.”
Mr. Roman, who joined the Company as Chief Financial Officer in March 2021, has also been serving as Interim Chief Executive Officer since May 13, 2022. He will continue as Chief Financial Officer until a replacement is determined.
Preliminary Second Quarter Revenue
The Company expects second quarter 2022 revenues of approximately $4.0-$4.1 million compared to $4.7 million in the second quarter of 2021 and $3.7 million in the first quarter of 2022.
“We are pleased with the progress in our business through the second quarter. Our deliberate focus on procedure volumes and utilization is gaining momentum, as we achieved another quarter of record procedure volumes with growth on a both a sequential and year-over-year basis,” said Mr. Roman. “In addition, we are starting to see the benefits of our cost improvement programs with a significant decline in our second quarter 2022 cash burn when compared to the first quarter of 2022. We look forward to providing additional updates on our second quarter 2022 earnings call in August.”
The preliminary unaudited revenue results described in this press release are estimates only and subject to revision until we report our full financial results for the second quarter 2022 during our earnings announcement planned for August.
About Acutus Medical, Inc.
Acutus is an arrhythmia management company focused on improving the way cardiac arrhythmias are diagnosed and treated. Acutus is committed to advancing the field of electrophysiology with a unique array of products and technologies which will enable more physicians to treat more patients more efficiently and
I'm happy with today's close of $1.16 up 7.4% and were steadily going higher each week. Hoping for news soon.
Thank you for that info cash4. I feel we will get there over time while more great news hits.