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AFIB Acutus Medical

Acutus Medical 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 based in Carlsbad, California.

AFIB stock data

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Data from SEC filings
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Calendar

12 Aug 21
24 Oct 21
31 Dec 21
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Jun 21 Mar 21 Dec 20 Sep 20
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Annual (USD)
Dec 20
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Financial data from company earnings reports.

Cash burn rate (estimated) Burn method: Change in cash Burn method: Operating income/loss Burn method: FCF (opex + capex)
Last Q Avg 4Q Last Q Avg 4Q Last Q Avg 4Q
Cash on hand (at last report) 7.28M 7.28M 7.28M 7.28M 7.28M 7.28M
Cash burn (monthly) 501.33K 1.43M 9.58M 9.35M (positive/no burn) 1.87M
Cash used (since last report) 1.92M 5.47M 36.61M 35.74M n/a 7.17M
Cash remaining 5.36M 1.81M -29.33M -28.46M n/a 108.13K
Runway (months of cash) 10.7 1.3 -3.1 -3.0 n/a 0.1

Beta Read what these cash burn values mean

Date Owner Security Transaction Code Indirect 10b5-1 $Price #Shares $Value #Remaining
10 Aug 21 Niamh Louise Pellegrini Common Stock Grant Acquire A No No 0 4,172 0 4,172
10 Aug 21 Niamh Louise Pellegrini Stock Options Common Stock Grant Acquire A No No 14.38 15,191 218.45K 15,191
5 Aug 21 Steven McQuillan Common Stock Payment of exercise Dispose F No No 15.52 305 4.73K 14,577
5 Aug 21 Burgess Vincent J Common Stock Payment of exercise Dispose F No No 15.52 1,922 29.83K 65,365
19 Jul 21 Flynn James E Common Stock Buy Acquire P Yes No 14 680,592 9.53M 3,438,589
19 Jul 21 Flynn James E Common Stock Buy Acquire P Yes No 14 390,836 5.47M 1,974,638

Data for the last complete 13F reporting period. To see the most recent changes to ownership, click the ownership history button above.

13F holders
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Total holders 0 0
Opened positions 0 0
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Total value 0 0
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Total puts 0 0
Total calls 0 0
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Financial report summary

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Risks
  • We have a limited history operating as a commercial company; if we fail to effectively train our sales force, increase our sales and marketing capabilities or develop broad brand awareness in a cost-effective manner, our growth will be impeded and our business will suffer.
  • The commercial success of our products will depend upon attaining significant market acceptance of these products among hospitals, physicians, patients and payors.
  • We have significant international operations, and intend to further expand our business internationally, which exposes us to market, regulatory, political, operational, financial and economic risks associated with doing business outside of the United States.
  • We rely on our strategic relationship with Biotronik to enhance our product portfolio and to distribute our products in key international markets.
  • We face significant competition, and if we are unable to compete effectively, we may not be able to achieve or maintain significant market penetration or improve our results of operations.
  • If we are unable to manage the anticipated growth of our business, our future revenue and operating results may be adversely affected.
  • Adoption of our products depends upon appropriate physician training, and inadequate training may lead to negative patient outcomes, affect adoption of our products and adversely affect our business.
  • Defects or failures associated with our products could lead to recalls, safety alerts or litigation, as well as significant costs and negative publicity.
  • Coverage and adequate reimbursement may not be available for the procedures that utilize our products, which could diminish our sales or affect our ability to sell our products profitably.
  • Our operations and financial results have been, and will continue to be, adversely impacted by the COVID-19 pandemic in the United States and the rest of the world.
  • We depend on our senior management team and the loss of one or more key employees or an inability to attract and retain highly skilled employees could harm our business.
  • Our results of operations could be materially harmed if we are unable to accurately forecast customer demand for our products and manage our inventory.
  • The failure of third parties to meet their contractual, regulatory, and other obligations could adversely affect our business.
  • Cost-containment efforts of our customers, purchasing groups and governmental organizations could have a material adverse effect on our sales and profitability.
  • We have significant customer concentration, with a limited number of customers accounting for a significant portion of our 2020 revenue. If we fail to retain these customers, our revenue could decline significantly.
  • If our facility becomes damaged or inoperable, or if we are required to vacate a facility, we may be unable to manufacture our products or we may experience delays in production or an increase in costs, which could adversely affect our results of operations.
  • We have limited experience manufacturing our products in commercial quantities, which could harm our business.
  • Technological change may adversely affect sales of our products and may cause our products to become obsolete.
  • We have limited data and experience regarding the safety and efficacy of our products. Results of earlier trials may not be predictive of future clinical trial results, and planned trials may not establish an adequate safety or efficacy profile for such products and other planned or future products, which would affect market acceptance of these products.
  • If our clinical trials are unsuccessful or significantly delayed, or if we do not complete our clinical trials, our business may be harmed.
  • Clinical trials may be delayed, suspended or terminated for many reasons, which will increase our expenses and delay the time it takes to develop new products or seek new indications.
  • If we experience delays in the commencement or completion of any clinical trial of our products, or if any of our clinical trials are terminated, the commercial prospects of our products may be harmed, and our ability to generate revenue from sales may be delayed or materially diminished.
  • The use, misuse or off-label use of our products may result in injuries that lead to product liability suits, which could be costly to our business.
  • We may acquire other companies or technologies, which could fail to result in a commercial product or net sales, divert our management’s attention, result in additional dilution to our stockholders and otherwise disrupt our operations and harm our operating results.
  • The terms of our 2019 Credit Agreement require us to meet certain operating and financial covenants and place restrictions on our operating and financial flexibility. If we raise additional capital through debt financing, the terms of any new debt could further restrict our ability to operate our business.
  • Taxing authorities may successfully assert that we should have collected or in the future should collect sales and use, gross receipts, value added or similar taxes and may successfully impose additional obligations on us, and any such assessments or obligations could adversely affect our business, financial condition and results of operations.
  • Our ability to utilize our net operating loss carryforwards may be limited.
  • If we experience significant disruptions in our information technology systems, our business may be adversely affected.
  • Security breaches, loss of data and other disruptions could compromise sensitive information related to our business or our customer’s patients or prevent us from accessing critical information and expose us to liability, which could adversely affect our business and our reputation.
  • We are subject to stringent privacy laws, information security policies and contractual obligations governing the use, processing and cross-border transfer of personal information and our data privacy and security policies.
  • Certain of our operating results and financial metrics may be difficult to predict as a result of seasonality.
  • We have a history of net losses, and we expect to continue to incur losses for at least the next several years. If we ever achieve profitability, we may not be able to sustain it.
  • Regulatory compliance is expensive, complex and uncertain, and a failure to comply could lead to enforcement actions against us and other negative consequences for our business.
  • Our operations are subject to pervasive and continuing FDA regulatory requirements.
  • Legislative or regulatory reforms may make it more difficult and costly for us to obtain regulatory clearance or approval of our planned or future products and to manufacture, market and distribute our products after clearance or approval is obtained.
  • If we fail to comply with U.S. federal and state fraud and abuse and other healthcare laws and regulations, including those relating to kickbacks and false claims for reimbursement, we could face substantial penalties and our business operations and financial condition could be adversely affected.
  • Healthcare reform initiatives and other administrative and legislative proposals may adversely affect our business, financial condition, results of operations and cash flows in our key markets.
  • If we fail to comply with the FDA’s QSR, or FDA or EU requirements that pertain to clinical trials or investigations, the FDA or the competent EU authority could take various enforcement actions, including halting our manufacturing operations, and our business would suffer.
  • Our global operations expose us to numerous and sometimes conflicting legal and regulatory requirements, and violation of these requirements could harm our business.
  • Material modifications to our products may require new 510(k) clearances, CE Marks or other premarket approvals or may require us to recall or cease marketing our products and services until clearances are obtained.
  • Our products may be subject to recalls after receiving FDA or foreign approval or clearance, which could divert managerial and financial resources, harm our reputation and adversely affect our business.
  • If any of our products cause or contribute to a death or a serious injury or malfunction in certain ways, we will be required to report under applicable MDR regulations, which can result in voluntary corrective actions or agency enforcement actions.
  • Failure to comply with anti-bribery, anti-corruption, and anti-money laundering laws, including the FCPA, as well as export control laws, customs laws, sanctions laws and other laws governing our operations could result in civil or criminal penalties, other remedial measures and legal expenses.
  • Compliance with environmental laws and regulations could be expensive, and failure to comply with these laws and regulations could subject us to significant liability.
  • If we are unable to obtain and maintain patent protection or freedom to operate for any products we develop and for our technology, or if the scope of the patent protection obtained is not sufficiently broad, our competitors could develop and commercialize products and technology similar or identical to ours, and our ability to successfully commercialize any products we may develop, and our technology, may be adversely affected.
  • We may become a party to intellectual property litigation or administrative proceedings that could be costly and could interfere with our ability to sell and market our products.
  • Our rights to develop and commercialize our products are subject, in part, to the terms and conditions of licenses granted to us by others.
  • We may not be successful in obtaining necessary rights to any products we may develop through acquisitions and in-licenses.
  • If we are unable to protect the confidentiality of our other proprietary information, our business and competitive position may be harmed.
  • Obtaining and maintaining patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements.
  • We may not be able to protect our intellectual property rights throughout the world.
  • We may be subject to claims challenging the inventorship of our patents and other intellectual property.
  • If our trademarks and trade names are not adequately protected, then we may not be able to build name recognition in our markets and our business may be adversely affected.
  • The market price for our common stock has been volatile, it may decline regardless of our operating performance, and an active trading market may not be sustained in our common stock.
  • We may be subject to securities litigation, which is expensive and could divert management attention.
  • The issuance of additional shares of our common stock in connection with financings, acquisitions, investments, our share incentive plans or otherwise will dilute all other stockholders.
  • We currently do not intend to declare dividends on our common stock in the foreseeable future and, as a result, your only opportunity to achieve a return on your investment is if the price of our common stock appreciates.
  • Provisions in our organizational documents and agreements with third parties could delay or prevent a change of control.
  • In connection with the preparation of our consolidated financial statements as of and for the years ended December 31, 2019 and 2018, the Company and our independent registered public accounting firm identified a material weakness in the Company’s internal control over financial reporting. While the material weakness has been remediated, if we are not able maintain an effective system of internal control over financial reporting in the future, investors may lose confidence in the accuracy and completeness of our financial reports, and the market price of our common stock could be materially and adversely affected.
  • Our amended and restated bylaws provide that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the exclusive forums for substantially all disputes between us and our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers or employees.
  • Our quarterly and annual results may fluctuate significantly and may not fully reflect the underlying performance of our business.
  • Our quarterly operating results fluctuate and may fall short of prior periods, our projections or the expectations of securities analysts or investors, which could materially adversely affect our stock price.
  • Our results may be impacted by changes in foreign currency exchange rates.
  • Economic conditions may adversely affect our business.
  • Litigation and other legal proceedings may adversely affect our business.
  • If securities analysts do not publish research or reports about our business or if they downgrade our stock or our sector, our stock price and trading volume could decline.
  • The requirements of being a public company may strain our resources, divert management’s attention and affect our ability to attract and retain qualified board members.
Management Discussion
  • Revenue was $8.5 million for the year ended December 31, 2020, compared to $2.8 million for the year ended December 31, 2019. This increase of $5.6 million, or 198%, was primarily attributable to a $3.5 million increase in purchase volume of our disposable products used in electrophysiology procedures as a result of a higher installed base, and $2.1 million of AcQMap systems sales.
  • Cost of products sold was $15.9 million for the year ended December 31, 2020, compared to $9.2 million for the year ended December 31, 2019. This increase of $6.6 million, or 72%, was primarily attributable to increased revenue. Gross margin was (88)% for the year ended December 31, 2020 compared to (226)% for the year ended December 31, 2019. This improvement in gross margin was primarily attributable to increased revenue and higher production volumes.
  • Research and development expenses were $33.5 million for the year ended December 31, 2020, compared to $23.0 million for the year ended December 31, 2019. This increase of $10.4 million, or 45%, was primarily attributable to $5.3 million in increased materials and supplies costs related to higher engineering project spending and $4.7 million in increased compensation and related costs from higher headcount.
Content analysis
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Readability
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