NeurAxis Reports Second Quarter 2024 Financial Results
Rhea-AI Summary
NeurAxis Inc (NYSE American: NRXS) reported Q2 2024 financial results. Key highlights include:
- Expanded covered lives to 22.5 million, up from 4.5 million in May 2023
- Submitted FDA applications for RED device and IB-Stim label expansion
- Q2 revenue of $611.5K, down 5.3% YoY
- Gross profit of $538K, down 6.9% YoY
- Operating loss increased 97.5% to $2.2M
- Net loss increased 30.5% to $2.9M
- Cash on hand: $1.8M
The company expects to double covered lives to 50 million in H2 2024, potentially accelerating growth in late 2024 and 2025. FDA clearance for RED device is anticipated in Q4 2024.
Positive
- Expanded covered lives from 4.5 million to 22.5 million in one year
- Expecting to double covered lives to 50 million in H2 2024
- Submitted FDA applications for RED device and IB-Stim label expansion
- Secured additional $3.0 million funding in May 2024
- Gross margin of 88.0% in Q2 2024
Negative
- Q2 2024 revenue decreased 5.3% year-over-year to $611.5K
- Gross profit declined 6.9% year-over-year to $538K
- Operating loss increased 97.5% to $2.2 million
- Net loss increased 30.5% to $2.9 million
- Short-term debt of $4.8 million as of June 30, 2024
News Market Reaction
On the day this news was published, NRXS gained 9.12%, reflecting a notable positive market reaction.
Data tracked by StockTitan Argus on the day of publication.
Conference call will be held today, Friday, August 9 at 9:00 am ET
Carmel, Ind., Aug. 09, 2024 (GLOBE NEWSWIRE) -- NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American: NRXS), a medical technology company commercializing neuromodulation therapies for chronic and debilitating conditions in children and adults, today announced results for the second quarter period ended June 30, 2024.
Recent Operational Highlights
- Expanded total covered lives to approximately 22.5 million covered lives compared to 4.5 million covered lives as of May 1, 2023. Recent medical policy coverages include:
- BCBS licensee in Florida covering over 6 million lives.
- BCBS licensee in North Dakota covering over 310,000 people.
- BCBS plan in the mid-Atlantic region, providing coverage for approximately 7 million covered lives.
- Medical Policy with a BCBS licensee covering approximately 1 million covered lives
- BCBS plan in the mid-Atlantic with approximately 3.5 million covered lives.
- One of the nation’s largest not for profit health plans, serving over 12 million members, has committed to provide formal coverage beginning October 1st, 2024. Once this policy is in the public domain, the covered lives will be over 35 million.
- Submitted to the FDA its innovative rectal expulsion device (RED) product, which was licensed from the University of Michigan. RED’s innovative design simplifies anorectal function testing and can be used without interrupting clinical workflow. FDA clearance is expected in the fourth quarter of 2024.
- Announced a submission to the FDA for the expansion of IB-Stim label to allow for a larger patient population beyond the current 11-18 years of age to 8-21 years.
- The Company remains committed to clinical research in the pediatric space, with 16 peer-reviewed publications. All studies were carried out in US children’s hospitals using NeurAxis’ PENFS technology. This level of evidence puts NeurAxis in a great position to continue expanding payor coverage and increasing adoption of the technology.
- Announced the results of the largest multicenter, prospective registry in pediatric DGBIs. It evaluated outcomes of pediatric patients (8-18 years) following a 4-week course of IB-Stim in a real‐world clinical setting. Seven large tertiary care centers enrolled patients with pain-associated DGBIs. Patients were asked to fill out validated pediatric questionnaires, including the abdominal pain index (API). Data was collected weekly during therapy and then every 3 months up to 1 year. Compared to baseline scores, there were significant improvements in abdominal pain (API) after 4 weeks of IB-Stim treatment at every time point, including 6 months (p<0.001) and 12 months (p<0.001).
- Announced the results of a retrospective study led by the Cincinnati Children’s Hospital Medical Center comparing and reviewing the records of 101 adolescent patients with DGBIs treated with IB-Stim™ therapy or standard-of-care medications, amitriptyline (tricyclic antidepressant) or cyproheptadine (antihistamine). The comparative analysis noted:
- At follow-up, IB-Stim™ therapy showed improvements in abdominal pain (p=0.001) and functional disability (p=0.048) compared to baseline, while amitriptyline showed improvements in abdominal pain (p=0.034).
- In a comparison of outcomes between groups, IB-Stim™ was more effective than cyproheptadine in improving abdominal pain (p=0.04) and did not differ from amitriptyline (p=0.64). Nausea scores did not differ between groups (p>0.05); and
- Disability scores between groups were only more effective for amitriptyline vs. cyproheptadine (p=0.03). Disability scores did not differ from amitriptyline compared with IB-Stim™ (p=0.21).
- In addition to closing
$6.1 million in committed financing from various investors, including affiliates of Inspire Health Alliance, in the first quarter of 2024, the Company secured an additional$3.0 million of funding in May 2024 with identical terms from a reputable healthcare-focused fund. The remainder of the financing is expected to be paid monthly through 2025.
Management Commentary
Brian Carrico, Chief Executive Officer of NeurAxis, commented, “We are excited about another strong quarter of continued execution, bringing us much closer to having the complete foundation in place to scale revenues. Our commercialization strategy for IB-Stim™, based on strong data publication leading to insurance coverage, is beginning to bear fruit. We now have 22.5 million lives under insurance coverage with many pending decisions, a significant increase from 4.5 million a year ago. While revenues in 2Q24 declined
“Further contributing to our growth acceleration in 2H24 will be the commercialization of RED, our licensed innovative rectal expulsion device, a self-inflating balloon expulsion test that allows for point-of-care testing to effectively identify patients with an evacuation disorder, such as pelvic floor dysfunction. We have made the submission to the FDA and expect the device to receive FDA clearance late in the fourth quarter of 2024” Mr. Carrico continued.
Mr. Carrico concluded, “We remain committed to further commercializing our lead pediatric indication for functional abdominal pain associated with IBS in children. We have recently made an FDA submission to expand our label beyond the current 11-18 year old patient population to the 8-21 year old patient population and four devices. In addition, we are advancing our development pipeline for a number of new indications leveraging our unique neuromodulation therapy, including Functional Dyspepsia, Cyclic Vomiting Syndrome, and more. As a result of recent financings with long-term investors in the healthcare space, our balance sheet is well positioned to execute our business plans for the foreseeable future.”
Second Quarter 2024 Financial Results
Revenues in the second quarter of 2024 were
Gross profit in the second quarter of 2024 was
Operating loss in the second quarter of 2024 was
The net loss in the second quarter of 2024 was
Cash on hand as of June 30, 2024 was
Conference Call Details
Date and Time: Friday, August 9, 2024, at 9:00am ET
Live Webcast Information: Interested parties can access the conference call via a live webcast, which is available in the Investor Relations section of the Company's website at https://ir.neuraxis.com/ or https://edge.media-server.com/mmc/p/bettcvsw. For participants listening through the webcast, questions can be sent in through the portal using the “Ask a Question” link or by emailing questions to NRXS@lythampartners.com.
Call-in Information: Interested parties can also access the live conference call by initially registering at the following link. Upon completion of the registration link, call-in participants will receive the dial-in info and a unique PIN to join the call as well as an email confirmation with the details.
Replay: A webcast replay will be available in the Investor Relations section of the Company's website at https://edge.media-server.com/mmc/p/bettcvsw or https://ir.neuraxis.com/.
About NeurAxis, Inc.
NeurAxis, Inc., is a medical technology company focused on neuromodulation therapies to address chronic and debilitating conditions in children and adults. NeurAxis is dedicated to advancing science and leveraging evidence-based medicine to drive adoption of its IB-Stim™ therapy, which is its proprietary Percutaneous Electrical Nerve Field Stimulation (PENFS) technology, by the medical, scientific, and patient communities. IB-Stim™ is FDA cleared for functional abdominal pain associated with irritable bowel syndrome (IBS) in adolescents 11-18 years old. Additional clinical trials of PENFS in multiple pediatric and adult conditions with large unmet healthcare needs are underway. For more information, please visit http://neuraxis.com.
Forward-Looking Statements
Certain statements in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements which include, but are not limited to, statements regarding FDA clearance in the fourth quarter of 2024, the timing of the receipt of financing proceeds, revenue growth, and wider insurance acceptance of our products are based on management’s current assumptions and expectations of future events and trends, which affect or may affect the Company’s business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. There are a number of important factors that could cause actual results, developments, business decisions or other events to differ materially from those contemplated by the forward-looking statements in this press release. These factors include, but are not limited to,, the conditions in the U.S. and global economy, the trading price and volatility of the Company’s stock, public health issues or other events, the Company’s compliance with applicable laws, the results of the Company’s clinical trials and perceptions thereof, the results of submissions to the FDA, the timing of decisions by insurance companies to provide coverage of our products, the results of the shareholder vote to enable the issuance of the Preferred Stock, and factors described in the Risk Factors section of NeurAxis’s public filings with the Securities and Exchange Commission (SEC). Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date of this press release and, except to the extent required by applicable law, the Company undertakes no obligation to update or revise these statements, whether as a result of any new information, future events and developments or otherwise.
This page discusses research activities with percutaneous electrical nerve field stimulator (PENFS) technology. Please note, the research being described includes information about technology and intended uses of that technology which have not been reviewed or approved/cleared by the U.S. FDA, and is being provided for informational purposes only. NeurAxis does not recommend or suggest the use of its PENFS™ IB-Stim™ device for uses beyond those that are cleared by the U.S. FDA. See https://ibstim.com/important-information/.
Contacts:
Company
NeurAxis, Inc.
info@neuraxis.com
Investor Relations
Lytham Partners
Ben Shamsian
646-829-9701
shamsian@lythampartners.com
| NeurAxis, Inc. Condensed Statements of Operations (Unaudited) | |||||||||||||||
| Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Net sales | $ | 611,500 | $ | 646,021 | $ | 1,258,135 | $ | 1,451,131 | |||||||
| Cost of goods sold | 73,458 | 67,813 | 148,539 | 163,713 | |||||||||||
| Gross profit | 538,042 | 578,208 | 1,109,596 | 1,287,418 | |||||||||||
| Selling expenses | 62,274 | 78,791 | 142,304 | 186,723 | |||||||||||
| Research and development | 54,312 | 109,789 | 59,882 | 126,586 | |||||||||||
| General and administrative | 2,628,288 | 1,507,169 | 4,946,362 | 2,987,923 | |||||||||||
| Operating loss | (2,206,832 | ) | (1,117,541 | ) | (4,038,952 | ) | (2,013,814 | ) | |||||||
| Other (expense) income: | |||||||||||||||
| Financing charges | - | - | (230,824 | ) | (2,772 | ) | |||||||||
| Interest expense | (80,697 | ) | (194,690 | ) | (107,257 | ) | (356,378 | ) | |||||||
| Change in fair value of warrant liability | 7,576 | (36,050 | ) | (1,708 | ) | 198,757 | |||||||||
| Change in fair value of derivative financial instruments | - | 860 | - | 192,157 | |||||||||||
| Amortization of debt discount and issuance costs | (63,817 | ) | (887,937 | ) | (85,500 | ) | (3,550,592 | ) | |||||||
| Extinguishment of debt liabilities | - | - | - | 1,129,498 | |||||||||||
| Other income | 2,961 | 2 | 2,961 | 1,552 | |||||||||||
| Other expense | (576,901 | ) | (258 | ) | (577,081 | ) | (7,430 | ) | |||||||
| Total other (expense) income, net | (710,878 | ) | (1,118,073 | ) | (999,409 | ) | (2,395,208 | ) | |||||||
| Net loss | $ | (2,917,710 | ) | $ | (2,235,614 | ) | $ | (5,038,361 | ) | $ | (4,409,022 | ) | |||
FAQ
What was NeurAxis's (NRXS) revenue for Q2 2024?
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When does NeurAxis (NRXS) expect FDA clearance for its RED device?
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