NeurAxis Reports Strong Third Quarter 2024 Financial Results Driven by a 40% Increase in Revenues
NeurAxis (NYSE: NRXS) reported strong Q3 2024 results with revenues increasing 40% to $667,000 compared to Q3 2023. Operating loss improved by 45% to $1.7 million. The company expanded total covered lives to approximately 35 million from 4.5 million last year. Key developments include receiving a new CPT Category I code for PENFS procedures, FDA clearance expanding IB-Stim's age range to 8-21 years, and securing a $5.0 million capital investment. Unit sales grew 50% in Q3, though gross margin slightly declined due to financial assistance program discounts. The company's cash position was $261,000 as of September 30, 2024.
NeurAxis (NYSE: NRXS) ha riportato forti risultati per il terzo trimestre del 2024, con un aumento dei ricavi del 40%, arrivando a $667.000 rispetto al terzo trimestre del 2023. La perdita operativa è migliorata del 45%, raggiungendo i $1,7 milioni. L'azienda ha ampliato il numero totale di persone coperte a circa 35 milioni, rispetto ai 4,5 milioni dell'anno scorso. Sviluppi chiave includono l'ottenimento di un nuovo codice CPT Categoria I per le procedure PENFS, l'approvazione da parte della FDA che estende la fascia d'età per IB-Stim a 8-21 anni e il conseguimento di un investimento di capitale di $5,0 milioni. Le vendite unità sono aumentate del 50% nel terzo trimestre, anche se il margine lordo è leggermente diminuito a causa degli sconti del programma di assistenza finanziaria. La posizione di cassa dell'azienda era di $261.000 al 30 settembre 2024.
NeurAxis (NYSE: NRXS) informó resultados sólidos para el tercer trimestre de 2024, con ingresos que aumentaron un 40% a $667,000 en comparación con el tercer trimestre de 2023. La pérdida operativa mejoró un 45% hasta $1.7 millones. La compañía amplió el total de vidas cubiertas a aproximadamente 35 millones desde 4.5 millones el año pasado. Los desarrollos clave incluyen la recepción de un nuevo código CPT Categoría I para los procedimientos PENFS, la autorización de la FDA que amplía el rango de edad de IB-Stim a 8-21 años, y la obtención de una inversión de capital de $5.0 millones. Las ventas unitarias crecieron un 50% en el tercer trimestre, aunque el margen bruto disminuyó ligeramente debido a los descuentos del programa de asistencia financiera. La posición de efectivo de la empresa era de $261,000 al 30 de septiembre de 2024.
NeurAxis (NYSE: NRXS)는 2024년 3분기 강력한 실적을 보고했으며, 수익이 40% 증가하여 2023년 3분기 대비 $667,000에 달했습니다. 운영 손실은 45% 개선되어 $1.7 백만에 이르렀습니다. 회사는 지난해 4.5 백만에서 약 35 백만으로 총 보장 인원을 확대했습니다. 주요 개발에는 PENFS 절차를 위한 새로운 CPT 카테고리 I 코드 수신, IB-Stim의 연령 범위를 8-21세로 확장하는 FDA 승인이 포함되며, $5.0 백만의 자본 투자 확보도 포함됩니다. 3분기 동안 유닛 판매는 50% 성장했지만, 재정 지원 프로그램 할인으로 인해 총 이익률은 약간 감소했습니다. 2024년 9월 30일 기준으로 회사의 현금 보유액은 $261,000였습니다.
NeurAxis (NYSE: NRXS) a annoncé de solides résultats pour le troisième trimestre 2024, avec des revenus en hausse de 40 %, atteignant 667 000 $ par rapport au troisième trimestre 2023. La perte d'exploitation s'est améliorée de 45 %, s'élevant à 1,7 million de dollars. L'entreprise a élargi le nombre total de vies couvertes à environ 35 millions, contre 4,5 millions l'année dernière. Les développements clés incluent la réception d'un nouveau code CPT de catégorie I pour les procédures PENFS, l'autorisation de la FDA qui étend la tranche d'âge d'IB-Stim à 8-21 ans, et l'obtention d'un investissement en capital de 5,0 millions de dollars. Les ventes unitaires ont augmenté de 50 % au troisième trimestre, bien que la marge brute ait légèrement diminué en raison des remises du programme d'aide financière. La position de trésorerie de l'entreprise était de 261 000 $ au 30 septembre 2024.
NeurAxis (NYSE: NRXS) hat starke Ergebnisse für das dritte Quartal 2024 gemeldet, mit einem Umsatzanstieg von 40% auf $667,000 im Vergleich zum dritten Quartal 2023. Der operative Verlust verbesserte sich um 45% auf $1,7 Millionen. Das Unternehmen hat die insgesamt abgedeckten Leben auf etwa 35 Millionen erweitert, von 4,5 Millionen im letzten Jahr. Zu den wichtigsten Entwicklungen gehört der Erhalt eines neuen CPT-Kategorie-I-Codes für PENFS-Verfahren, die FDA-Zulassung zur Erweiterung des Altersbereichs für IB-Stim auf 8-21 Jahre und die Sicherstellung einer Kapitalinvestition in Höhe von $5,0 Millionen. Die Verkaufszahlen stiegen im dritten Quartal um 50%, obwohl die Bruttomarge aufgrund von Rabatten im Rahmen des finanziellen Unterstützungsprogramms leicht zurückging. Die Liquidität des Unternehmens betrug am 30. September 2024 $261,000.
- Revenue growth of 40% year-over-year to $667,000
- Operating loss improvement of 45% compared to Q3 2023
- Unit sales increase of 50% in Q3 2024
- Expansion of covered lives from 4.5M to 35M
- Secured $5.0M capital investment
- FDA approval for expanded age range (8-21 years) for IB-Stim
- Operating loss of $1.7M in Q3 2024
- Low cash position of $261,000 as of September 30, 2024
- Slight decline in gross margin due to financial assistance program discounts
- Increased cash burn with $4.3M used in operations for nine months
Insights
NeurAxis delivered impressive
However, cash position is concerning at only
The expansion of IB-Stim's FDA-cleared age range from 11-18 to 8-21 years significantly broadens the addressable market. The increase to 4 devices per patient from 3 devices could boost per-patient revenue by
The pending FDA review of the rectal expulsion device (RED) represents a strategic expansion into anorectal testing, diversifying beyond the core PENFS technology. The simplified workflow design could drive adoption in clinical settings if approved in Q4 2024.
Conference call will be held today, Tuesday, November 12 at 9:00 am ET
CARMEL, Ind., Nov. 12, 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 third quarter period ended September 30, 2024.
3Q24 Financial Highlights
- Revenues increased
40% to$667 thousand in the three months ended September 30, 2024 (the “3Q24”) compared to$477 thousand in the three months ended September 30, 2023 (the “3Q23”). - Operating loss improved by
45% compared to the 3Q2023.
Recent Operational Highlights
- Expanded total covered lives to approximately 35 million compared to 4.5 million as of October 1, 2023. Recent medical policy coverages include:
- BCBS licensee in Florida covering over 6 million lives.
- BCBS plan in the mid-Atlantic region, providing coverage for approximately 7 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, is now providing their members with access to PENFS treatment, when medically necessary.
- Received a new Current Procedural Terminology (CPT) Category I code for Percutaneous Electrical Nerve Field Stimulation (PENFS) procedures effective January 1, 2026.
- Received new FDA clearance for the expansion of IB-Stim label:
- to allow for a larger patient population beyond 11-18 years of age to 8-21 years.
- to increase devices per patient to 4 devices.
- 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. Management is cautiously optimistic for FDA clearance in the fourth quarter of 2024.
- 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.
- Secured a
$5.0 million capital investment from a dedicated life sciences fund that will close mid-November 2024 to replace$3.2 million in committed funding from an existing investor.
Management Commentary
Brian Carrico, Chief Executive Officer of NeurAxis, commented, “We are excited about our strong performance in the 3Q24, as revenues increased
In recent weeks we have achieved very significant milestones in our commercialization efforts of IB-Stim. Two weeks ago, we received a new FDA 510(K) clearance, expanding IB-Stim’s indication from 11-18 year olds to 8-21 year olds, and from 3 devices, not to exceed 4 weeks, to 1 device per week for 4 weeks. In addition, we recently announced that American Medical Association has established a new Current Procedural Terminology (CPT) Category I code for Percutaneous Electrical Nerve Field Stimulation (PENFS) procedures. Obtaining a Category I code for this important technology is important for our initiatives to drive patient access for IB-Stim and future PENFS treatments.”
Our strong momentum has continued, and we are excited to note that 4Q24 is off to a great start. We are continuing our efforts for success in the near and long term. As a result of financings in 2024 with long-term investors in the healthcare space, our balance sheet is well positioned to execute our business plans for the foreseeable future.”
Third Quarter 2024 Financial Results
Revenues in the third quarter of 2024 were
Gross profit in the third quarter of 2024 was
Operating loss in the third quarter of 2024 was
The net loss in the third quarter of 2024 was
While cash on hand as of September 30, 2024 was
Conference Call Details
Date and Time: Tuesday, November 12, 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://edge.media-server.com/mmc/p/op4xi3gu or https://ir.neuraxis.com/. 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/op4xi3gu 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 the 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 8-21 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 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, among other things, 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 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.
For contraindications, precaution, warnings, and IFU, please 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 September 30, | Nine Months Ended September 30, | ||||||||||||||
| 2024 | 2023 | 2024 | 2023 | ||||||||||||
| Net sales | $ | 666,625 | $ | 477,460 | $ | 1,924,760 | $ | 1,928,590 | |||||||
| Cost of goods sold | 97,050 | 67,287 | 256,949 | 231,000 | |||||||||||
| Gross profit | 569,575 | 410,173 | 1,667,811 | 1,697,590 | |||||||||||
| Selling expenses | 95,430 | 64,210 | 226,374 | 250,933 | |||||||||||
| Research and development | 72,422 | 44,950 | 132,304 | 171,536 | |||||||||||
| General and administrative | 2,052,996 | 3,323,352 | 6,999,358 | 6,316,411 | |||||||||||
| Operating loss | (1,651,273 | ) | (3,022,339 | ) | (5,690,225 | ) | (5,041,290 | ) | |||||||
| Other (expense) income: | |||||||||||||||
| Financing charges | - | - | (230,824 | ) | (2,772 | ) | |||||||||
| Interest expense, net | (64,676 | ) | (100,525 | ) | (171,934 | ) | (451,766 | ) | |||||||
| Change in fair value of warrant liability | (6,726 | ) | 592,853 | (8,434 | ) | 791,610 | |||||||||
| Change in fair value of derivative financial instruments | - | 6,394 | - | 198,551 | |||||||||||
| Amortization of debt discount and issuance costs | (40,888 | ) | (1,331,030 | ) | (126,387 | ) | (4,881,622 | ) | |||||||
| Extinguishment of debt liabilities | - | (4,779,069 | ) | - | (3,649,571 | ) | |||||||||
| Other income | 17,072 | 9,931 | 20,032 | 11,483 | |||||||||||
| Other expense | (8,743 | ) | (1,578 | ) | (585,824 | ) | (9,008 | ) | |||||||
| Total other (expense) income, net | (103,961 | ) | (5,603,024 | ) | (1,103,371 | ) | (7,993,095 | ) | |||||||
| Net loss | $ | (1,755,234 | ) | $ | (8,625,363 | ) | $ | (6,793,596 | ) | $ | (13,034,385 | ) | |||
FAQ
What was NeurAxis (NRXS) revenue growth in Q3 2024?
How much did NeurAxis (NRXS) reduce its operating loss in Q3 2024?
How many covered lives does NeurAxis (NRXS) now have for its treatments?
What new FDA clearance did NeurAxis (NRXS) receive for IB-Stim?
