electroCore（ECOR）2026年第3四半期決算説明会：過去最高の売上高、ガイダンスのリセット

主なポイント

• electroCoreが発表した2026年第3四半期の売上高は過去最高の970万ドルとなり、前年同期比で約12%増加した。これは主に退役軍人省（VA）チャネルを通じた線維筋痛症向けQuellおよび処方用gammaCoreの販売が牽引した。
• 売上総利益率は88.5%に達し（前年同期は86.0%）、調整後EBITDA赤字は67%縮小して過去最少の70万ドルとなった。
• 同社は2026年通期の売上高ガイダンスを3,900万〜4,200万ドルに修正した。営業組織の再編展開が計画より遅れていることを理由として挙げている。
• 経営陣は2027年の暫定売上高成長率ガイダンスを30%〜40%と提示し、CIPN関連の売上高はこの見通しに対する上振れ要因になり得ると述べた。
• electroCoreは10月27日、化学療法誘発性末梢神経障害（CIPN）を適応症とするQuellについて、510(k)申請を提出した。経営陣は、FDA（米食品医薬品局）からの回答の最短時期は2027年第1四半期後半になる可能性が高いとしている。
• 経営陣は、売上高の成長、業務効率化、および利用可能な資金調達手段を前提として、2027年末までに初となる四半期ベースでの調整後EBITDA黒字化を引き続き目標としている。

主な財務実績

事業および営業実績

VAチャネルは引き続き主な成長牽引役となった。6月以降に追加配置された営業担当者は、第3四半期中にVA向け売上高として月平均約21万ドルを創出したが、これは追加前における同担当地域の月額16万ドルと比較して増加している。経営陣によると、このグループの売上は10月には30万ドルに向かって推移しているという。

新たな営業担当者が生産性を発揮するまでの期間も短縮された。新規顧客アカウントの獲得にかかる期間は従来の6〜7カ月に対し、約2カ月に短縮された。就任3カ月目までに、新規患者の治療開始数は1アカウント当たり3.4人に達し、従来のオンボーディングモデルでの0.3人から大幅に増加した。

electroCoreは第3四半期に、これまで同社製品を使用していなかったVA施設7件を新規開拓した。スタッフが配置されている施設のうちgammaCoreを取り扱っていない施設の割合は、6月から9月の間に34%から28%へと低下した。すべてのVA製品における新規患者の注文数は前年同期比21%増加した。

売上高の集中度も緩和した。第3四半期におけるVA売上高の上位30アカウントの比率は、第2四半期の73%から71%に低下し、単一の施設でVA純売上高の10%超を占めるものはなかった。

線維筋痛症向けQuellは10月に過去最高の月間実績を記録し、electroCoreは2026年中にQuellの処方を受けたVA患者数が1,000人を突破した。経営陣によると、VA施設の70%超は依然として同製品を処方していないという。

リフィル（追加処方）売上高は前期比で10%増加し、過去最高を記録した。9月までの年初来の全国リフィル率は42%だったが、経営陣は患者への指導、治療継続率（コンプライアンス）の向上、および処方医の信頼獲得を通じて70%超を目標としている。

消費者直接取引（D2C）事業では、electroCoreが収益性の低い顧客獲得への支出を抑制したため、Truvagaの売上高は前年同期比で減少した。Truvagaのブランド検索キーワードに入札する競合他社が60%増加し、クリック単価は約42%上昇した。こうした逆風にもかかわらず、広告費用対効果（ROAS）は前年同期比で8%改善した。

業績ガイダンス

経営陣は、30%超の増収としていた従来の見通しを取り下げ、2026年通期の売上高ガイダンスを3,900万〜4,200万ドルに修正した。同社はこの修正について、営業組織の再編が現場全体に浸透するまでに想定以上の時間を要し、期待されていた成長加速の一部が2027年にずれ込んだためとしている。

2027年について、経営陣は前年比30%〜40%という暫定的な売上高成長率ガイダンスを示した。この見通しは主に、VA顧客アカウントのカバレッジ拡大、営業担当区域の細分化、販売責任の明確化、および営業担当者の生産性向上に基づいている。

経営陣は、2027年の暫定的な成長見通しを達成するためにCIPN関連の売上は必須ではなく、FDAの承認が得られれば上乗せ分になると述べた。既存適応症のカバレッジ拡大によるQuellの成長は、同社の業績予想に織り込まれている。

その成長率、80%台後半の売上総利益率、および合理化されたコスト基盤に基づき、electroCoreは2027年末までに初となる四半期単位の調整後EBITDA黒字化を達成できると考えている。この目標は引き続き、計画の実行、営業レバレッジ、および資金調達リソースに左右される。また、同社は株式の希薄化を伴う新規の資金調達を行わずにこのマイルストーンを達成できると考えている。

リスクと注視すべき点

• 修正された2026年の業績見通しを達成するには第4四半期の業績拡大が必要であるが、営業体制の再編には当初の計画より長い時間を要している。
• 現金、現金同等物および有価証券は、第3四半期中に在庫投資や患者宅配送イニシアチブなどを背景に、1,000万ドルから750万ドルへと減少した。
• electroCoreは既存のタームローンの借り換えと元本返済期限の延長に向けた選択肢を検討しているが、経営陣によると合意には達していないという。
• CIPN向けの510(k)申請に関するFDAの審査時期は依然として不透明である。同局の目標審査期間は90日間だが、追加情報の要請によって審査期間のカウントが一時停止する場合がある。
• 同社は現在、CIPNの申請を支援するための追加臨床試験を計画していない。経営陣は、NeuroMetrixの旧一般用医薬品（OTC）製品に関連する未解決のフォーム483（査察指摘事項書）が申請手続きを遅らせることはないと予想しているが、最終的な判断は依然としてFDAの裁量に委ねられている。
• 一般用（OTC）Quell製品の計画は、フォーム483の問題や、収益性の高い売上の創出を重視する経営陣の方針によって遅延している。

アナリスト質疑応答の要点

経営陣は、gammaCoreとQuellを合わせた販売目標として、VA施設1アカウント当たり月間約14人の新規患者を設定したが、アカウントの潜在力は施設の規模、専門診療科のカバレッジ、および地域の患者数によって異なる。

CIPNについて、経営陣は米国内の潜在患者数を約60万〜70万人と推計しており、そのうちVA内には約1万5,000〜2万人が含まれる。同社はVAが最も直接的な商業化チャネルになると見込んでいるが、保険償還の確立に時間がかかる可能性がある連邦政府市場外での事業機会についても検討する方針である。

経営陣は、既存の営業担当者がCIPNの事業機会の大部分に対応できると述べた。ただし、発売時期が近づくにつれて、より腫瘍学（オンコロジー）に特化した商業化アプローチが必要になる可能性がある。

FDAは以前、同社に対しDe Novo申請から510(k)経路への変更を指示していた。Quellがすでに先発品（述語機器）として存在し、CIPNプログラムが画期的医療機器指定（ブレークスルー指定）を受けていることから、経営陣はこの方針転換を前向きに受け止めているが、承認が保証されているわけではないことを強調した。

患者の継続率に関して、同社はリフィル（追加処方）の利用率を高めるため、指導、アドヒアランスのモニタリング、および処方医への働きかけに注力している。経営陣は、リフィル率の初期の改善が2026年第4四半期に見られ、2027年初頭にはさらなる進展があると見込んでいる。

決算説明会の全編書き起こし

決算説明会の完全なトランスクリプト

経営陣による説明

Operator

Greetings, and welcome to the electroCore Third Quarter 2026 Earnings Conference Call. [Operator Instructions] As a reminder, this conference is being recorded. Earlier today, electroCore published results for the third quarter ended September 30, 2026, and the press release is available on the company's website.

Before we begin, I would like to remind everyone that members on the call will make forward-looking statements within the meaning of the federal securities laws made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical facts should be deemed to be forward-looking, including, without limitation, any guidance, the company's outlook on fourth quarter and full year performance and its path to profitability. These statements involve material risks and uncertainties that could cause actual results to differ materially from those anticipated. For a list of risk factors, please see the company's filings with the Securities and Exchange Commission, including, but not limited to, the current report on 8-K and Form 10-Q filed today with the SEC. ElectroCore disclaims any obligation to update these statements, except as required by law. This call contains time-sensitive information accurate only as of today, November 4, 2026.

Joining us on today's call from ElectroCore are Dr. Thomas Errico, one of the company's founders, Investor and Independent Chairman of the Board of Directors; Joshua Lev, Co-Chief Executive Officer, President and Chief Financial Officer; and Mike Fox, Co-Chief Executive Officer, President and Chief Operating Officer. It is now my pleasure to turn the call over to Dr. Thomas Errico, electroCore's Founder and Independent Chairman, for opening remarks. Dr. Errico?

Thomas Errico

Thank you, operator. Good afternoon, everyone, and thank you for joining electroCore's Third Quarter 2026 Earnings Call. This quarter was about strengthening the foundation, leadership, commercial execution and regulatory clarity. The results strengthen my conviction and excitement about the company's current trajectory. This was a record quarter for electroCore, our highest net sales and our smallest operating loss in company history. Behind those results, management is building a commercial organization designed to grow profitably at a much larger scale. As with any transformation, the changes have been significant, and we believe the changes we have executed have established a foundation that positions electroCore for accelerated growth and an inflection point in positive adjusted EBITDA in 2027.

For me, one of the most exciting developments is our progress opening new markets. On October 27, we filed our 510(k) premarket notification with the FDA seeking clearance for our Quell wearable neurostimulation device for the treatment of chemotherapy-induced peripheral neuropathy or CIPN. This submission comes on the back of the breakthrough designation from the FDA in January 2022, which covers the reduction of moderate to severe symptoms of chemotherapy-induced peripheral neuropathy that have persisted for at least 6 months after chemotherapy ended. If cleared, Quell could offer a new nondrug option for patients experiencing CIPN, an important step for electroCore and those patients looking for symptom relief.

Combined with continued progress in commercial execution and financial discipline, this new opportunity shows the path forward is stronger today than at any point in the last several years. Josh will take you through the quarter and where we are headed. Mike will walk you through the plans implemented for growth and measures we track in the field, and Josh will then return with the financials. Josh?

Joshua Lev

Thank you, Tom. Good afternoon, everyone. This quarter, we delivered record net sales of $9.7 million, up approximately 12% from a year ago and the lowest operating loss in our history with adjusted EBITDA loss improving by nearly $1.4 million in the quarter, ahead of our expectations. Gross margin expanded to 88.5% and loss from operations narrowed to $1.6 million. GAAP net loss improved by $1.3 million or $0.13 per share from $3.1 million or $0.33 per share in the second quarter and adjusted EBITDA loss improved to a company record $700,000. We grew revenue while spending less to do it. I will take you through the full financials later in the call.

I want to be direct about where we are taking this company. We are not managing for short-term gains. We are building long-term revenue that is durable, repeatable and profitable. Every decision we made this year was made on purpose, knowing it could cost us near-term growth for longer-term success and profitability. Truvaga is the clearest example. Direct-to-consumer Truvaga revenue was down from a year ago, and that is exactly what we intended. The number of competitors bidding on Truvaga's own branded search term is up 60%, and our cost per click is up roughly 42%. We could have kept spending to grow the top line, but it would have been empty calorie revenue, ping the revenue line while pushing us further from profitability. So we chose not to chase it, and our return on advertising spend improved 8% year-over-year. This represents how we think about driving revenue, not just driving the top line, but doing it with profitability in mind.

The improvement in our P&L is the early proof that this approach works. Net sales are up, operating expenses are down and the company that grows while spending less is a company getting stronger. On guidance, we are revising our full year 2026 revenue outlook to $39 million to $42 million from our prior guidance of greater than 30% year-over-year growth. This is a change in timing, not direction. The sales organization changes we made are taking longer to reach the full field than we planned. So the acceleration we expected in the second half of 2026, we now expect in 2027. We made those changes because they are right for the business. That brings me to why we are confident in 2027. It comes down to 3 themes. First, coverage. More staffed VA accounts means more facilities where a representative is in the building, selling both gammaCore and Quell. Second, accountability. Smaller territories give every account a clear owner and a clear standard for results. Third, early proof that the model works.

Mike will walk you through the leading indicators in the field, including how the representatives we have added since June are producing more revenue from their accounts than those accounts generated before they arrived. In addition, our chemotherapy-induced peripheral neuropathy or CIPN 510(k) is under FDA review. If we receive clearance in 2027, we could grow Quell revenue in 2 ways: by making sure reps are carrying Quell across our entire coverage area and by opening a new indication for chemotherapy-induced peripheral neuropathy, where to our knowledge, there is currently no medical device or pharmaceutical alternative specifically indicated for CIPN. We believe these improvements will help us to deliver accelerated revenue growth in the full year 2027 with preliminary 2020 revenue growth guidance of 30% to 40% year-over-year, and we expect to refine this guidance range and provide additional commentary as appropriate in the future.

Similar to what we discussed last quarter and based on our current model, if we achieve that growth, we currently believe the operating leverage in our model with gross margins in the upper 80s on a streamlined cost base, along with our existing cash on hand and financing resources positions us to achieve our first fiscal quarter of positive adjusted EBITDA by the end of 2027 without entering into a new dilutive equity capital financing transaction. The next 12 months are about execution, and I would like Mike to show you how we are going to do that. Mike?

Michael Fox

Thanks, Josh. Good afternoon, everyone. Josh described how we think about revenue acceleration. My job is to make sure our company and field organization is built to capture revenue and identify new opportunities available to expand. What got us here will not get us where we are going. So over the last several months, we have been developing stronger processes and setting higher expectations that will result in better focus and metrics of how we source, hire, train, coach, lead and measure results. I want to give you tangible metrics to show why we are so confident in the trajectory for 2027 and beyond. We track 5 imperatives every month. building leadership talent and sales efficiency, number of new accounts using our products, new patient orders or as we call NPOs, number of prescribers and finally, our national refill rate.

I want to emphasize metrics that underpin 3 of these imperatives, which in turn support our conviction in accelerating revenue growth. First, leadership talent and sales efficiency. We split the Vice President of Sales role into 2 area vice presidents, 1 East and 1 West, who together oversee our 6 regions. We promoted a proven internal colleague from within our company to lead the East area. Our West area Vice President was recruited from outside the company and joined us in October. He has vast experience in leading medical sales organizations, including within the federal market and expanding market share and revenue growth. We also added 2 new regional sales directors to our team in October with the third soon to follow. That gives the field dedicated leadership, higher accountability and greater opportunity for needed field coaching and expertise. Where we have been able to make these changes, we've proven they work.

In the third quarter, our Southeast and Northeast regions each delivered the highest quarterly revenue in their history. In the Southeast, we transitioned territories to high-performing independent representatives focused on driving both Quell and gammaCore utilization, and the results followed quickly. The Southeast is our blueprint. With new leadership in place, we can roll out that model nationally, faster and more effectively. Our new independent representatives show why. Since June, the representatives we added have averaged approximately $210,000 a month in VA revenue in quarter 3.

That's a 30% increase versus the $160,000 a month those territories produced before, and the group is now trending toward $300,000 a month in October. Their September revenue was 62% higher than in June 2026. The early signals from these new representatives are what encouraged me most. Revenue and new accounts are growing quicker, taking roughly 2 months compared with 6 to 7 months prior. And by the third month, new patient starts have reached 3.4 per account compared to just 0.3 for those onboarded previously. These are early numbers, but they point in the direction we expected. faster starts, faster account growth and deeper account penetration.

Second, VA account penetration and impact. We opened 7 VA accounts in Q3 alone that had never used our products, roughly a 5% increase over the second quarter and the percentage of staff facilities not carrying gammaCore decreased to 28% from 34% between June and September. Our revenue is becoming less concentrated. On the measure we gave you last quarter, our top 15 accounts went from 54% of revenue in the second quarter to 51% in the third quarter. Going forward, we will report on our top 30 accounts, roughly the top quarter of VA base, which went from 73% of VA revenue in the second quarter to 71% in the third quarter. In the third quarter, no single facility accounted for more than 10% of our VA net sales. In October 26, Quell fibromyalgia had its best month on record, and we passed 1,000 VA patients prescribed Quell in 2026 alone. This comes with more than 70% of the VA accounts that are not prescribing Quell at this time. For Quell, that shows the opportunity continues to be significant.

Overall, NPOs for all products from the VA rose 21% in the third quarter year-over-year, which means more veterans receiving treatment, our ultimate measure and focus. Third, patient refills. Refills are one of the strongest signals of patient benefit. Refill revenue grew 10% over the second quarter, the highest refill revenue in company history. Our national refill rate is 42% year-to-date through September, and our goal is to take it above 70%, the lever is patient training and prescriber confidence. We are piloting a new patient training initiative that focuses on higher levels of compliance, equating to better patient outcomes and resulting in greater refill rates. Today, our goal is to take patient training and compliance with therapy to a higher standard, which we believe is essential to reaching a 70% refill rate. The work is underway, and we expect refill rate improvements to begin to be recognized in Q4 with additional improvements to be expected in early 2027.

On operations, Level Government Services, which handles VA and Department of Defense sales generation, accounted for approximately 91% of our VA orders in September 2026, up from roughly 57% in June '26, showing a significant movement in the number of orders processed through Level since announcing in August our intent to shift more of our sales through Level. Level is now the primary channel for all of our prescription product sales to the VA and Department of Defense. That aligns us with the best partner for federal distribution and is expected to reduce the related transaction fees associated with these direct sales by 3%. This also frees our internal resources to focus on new and emerging markets. In those new markets, we are building relationships across several commercial and federal channels where our products can benefit patients, and we are reporting them as they convert to revenue.

In Q3, Pfizer engaged in coverage discussions with its outside California market. We have also engaged in the Quell evaluation in California and are encouraged by the results of their internal valuation. For Department of Defense and TRICARE in Q3, much work was done to access key stakeholders and engage in conversations that are mutually beneficial to our active military and their families. We have identified pilot areas for federal workers' compensation, but we will hold on further discussions until additional process steps and validation is complete. We have engaged and initiated contracts for both VA Women's Health and first responders consultants. Both consulting groups have immense expertise in networks and discussions have been initiated with key national opinion leaders who can drive progress and adoption of our devices. We're excited about both opportunities, and we'll report metrics as they develop in Q4 and into 2027.

None of these measures tells the whole story, and we are still engaged in our transformation, but they are the measures we run the business on, and we will keep reporting against them so the investors can continue to track progress. As we extend these strategies across our national sales team, we expect stronger, sustained and more profitable growth. With that, I'll turn it back to Josh to walk through the financials.

Joshua Lev

Thank you, Mike. For the 3 months ended September 30, 2026, electroCore reported net sales of $9.7 million compared to $8.7 million during the same period in 2025, an increase of approximately 12% over the prior year. The increase of $1 million was primarily driven by growth in net sales of Quell fibromyalgia products acquired from NeuroMetrix, Inc. in May 2025 and Prescription gammaCore, which are both sold to the VA. During the remainder of 2026, the company intends to generate its sales in the VA channel through the company's agreement with Lovell.

Gross profit increased by $1.1 million to $8.6 million compared to the third quarter of 2025. Gross margin increased to 88.5% from 86% in the prior year period and 86.5% in the second quarter, primarily due to favorable product mix. Research and development expense was $400,000 in the third quarter of 2026 compared to $700,000 in the third quarter of 2025 and $800,000 in the second quarter of 2026. The decrease was primarily due to the timing of open positions, professional fees and development costs. Selling, general and administrative expense were $9.7 million, essentially unchanged from the prior year period and down from $10.1 million in the second quarter of 2026. Sales and marketing increased by $300,000 from the prior year, primarily driven by selling expense that supported the $1 million increase in net sales. General and administrative expense decreased $200,000, primarily due to lower professional fees.

Total operating expenses in the 3 months ended September 30, 2026, were $10.1 million compared to $10.4 million in the 3 months ended September 30, 2025. GAAP net loss in the third quarter of 2026 was $1.3 million compared to $3.4 million in the third quarter of 2025. GAAP net loss includes a gain in other income of approximately $400,000 related to the settlement of claims for indemnification and a $100,000 benefit from income taxes, which consisted of a favorable adjustment to our United Kingdom tax provision following a change in our transfer pricing policy. Net loss per share for the third quarter of 2026 was $0.13 compared to a net loss of $0.40 in the third quarter of 2025. Adjusted EBITDA net loss in the third quarter of 2026 was $700,000 compared to an adjusted EBITDA net loss of $2 million in the third quarter of 2025, an improvement of approximately $1.4 million or 67% year-over-year. Adjusted EBITDA net loss is a non-GAAP financial measure.

The use of non-GAAP financial measure in today's press release for additional information and a reconciliation to GAAP net loss. Total cash, cash equivalents and marketable securities at September 30, 2026, were approximately $7.5 million compared to approximately $10 million at June 30, 2026. Inventories increased to $4 million from $1.6 million at the year-end as we built supply to support forecasted growth in our prescription business. This action for near-term revenue growth acceleration, along with higher patient engagement through in-home delivery accounted for a significant portion of the cash used in the quarter.

Before we close, let me leave you with 3 points that matter most. This was a record quarter. Net sales of $9.7 million, up approximately 12%, gross margins of 88.5% and our lowest ever loss from operations with adjusted EBITDA loss at its all-time low. Revenue is up and expenses are down. We are building long-term sustained revenue, not chasing short-term gains. We are consciously moving towards revenue that moves us closer to profitability, and that improvement in profitability is occurring ahead of our expectations. We are revising full year 2026 revenue guidance to between $39 million and $42 million as we believe that some of the acceleration we expected in the second half of 2026 will come in 2027. More staffed VA accounts, smaller territories with clear accountability, newly added representatives already producing more from their accounts, all give us visibility and confidence in revenue growth that will accelerate the 30% to 40% increase in 2027 revenue over 2026 revenue with additional uptake in Quell if our CIPN 510(k) is cleared.

Our liquidity and capital position are described in our Form 10-Q. Our plan to reach our first quarter of positive adjusted EBITDA by the end of 2027 is built on a ramp in revenue and continued operating efficiencies. We are also evaluating options to refinance our existing term loan, including extending the timing of principal repayments, which we expect would provide additional support for our cash runway and balance sheet as we execute. We have not entered into any agreements and there can be no assurance that we will. But taken together and similar to what we said last quarter, if we are successful in executing these actions, our current model suggests that along with our existing cash on hand and financing resources, we currently believe that we can be positioned to reach our first quarter of positive adjusted EBITDA by the end of 2027 without the need to enter into a new dilutive equity capital financing transaction. The plan is set, the team is in place and the next 12 months are about execution.

Thank you for your time and your continued support. We look forward to updating you next quarter. With that, I'd like to open the call for questions. Operator?

Operator

[Operator Instructions] Our first question is from Jeff Cohen with Ladenburg Thalmann.

質疑応答

Destiny Buch

This is Destiny on for Jeff. I have quite a few here, so I'm going to try to condense them a bit. Can we start maybe -- and Mike, this might be for you more so. But how are you thinking about the sales force in terms of maximum revenue contribution, right? So it went from the 160 number to 210. At what level do you think these reps would be kind of at capacity? And maybe I'll start with that because I have a second part to it.

Michael Fox

Thanks for the question. And it's a great question. As you know, accounts are variable in size, number of vets, number of specialties. The word saturation is a very difficult thing to define in the VA because of the markets we're in, specifically with migraine and fibromyalgia, including some of the subspecialties like women's health. The way we're looking at this right now, I don't think we have to worry about the word saturation as much as we're taking care of the patients where they're at. Community care is a large component of federal business, which means the veterans are being treated outside the VA, but have the benefits to get our products through prosthetics. So at this moment, I think we do have some accounts that are large in comparison to other ones. But when we talk to providers in those accounts, there are still a lot of uncared for patients that are spread across the VA space.

So I would say our goal is to have about 14 new patients per month per account total between both products. That would be a good goal. But I don't know about the word saturation. That really would depend on the market of that account, for example, Dallas, versus like Iron Mountain, Wisconsin. They're totally different in space. But we have goals for every account in every territory, especially with the diversification of the number of providers. So hopefully, that gives you somewhat of an answer, even though I know the word saturation is hard to define.

Destiny Buch

No, that's actually very helpful. And you answered my second question. It was going to be patient start target per month. I think did I hear you correctly, it was 14, right?

Michael Fox

Yes. We're looking at -- yes, about 2 patients per week for the migraine product gammaCore and about 1.5 to 2 per week for fibromyalgia, just depending on the account. But that is the expectation we're setting with the sales force. Of course, we'd love them to exceed that, but that's the goals we're setting.

Destiny Buch

And then turning more to the CIPN potential here. How are you thinking about that from a commercial perspective? Is it -- will you be able to leverage the same sales force you have? Or do you think you might need a group that's a little more specialized? What's -- I know it's early, but just generally speaking, what are you thinking about that?

Michael Fox

Specifically with the chemotherapy-induced peripheral neuropathy, 510(k)?

Destiny Buch

Yes.

Michael Fox

That's a great question. And we're under evaluation for that just at this point, just like you said, to deal with peripheral neuropathy in the VA is a very big market. But when you start seeing chemotherapy-induced, we are identifying there are some different targets, especially with oncology and different types of nurse practitioners tied to those therapies. So we're evaluating. I'm confident we'll be able to do a significant number of opportunity accounts with what sales force we have today, but there may be a need for us to have more specialized or a more focused approach with the oncology focus of that product to be determined as we get closer to the launch.

Destiny Buch

And then just lastly for me. For your DTC channel, I'm curious, I was encouraged to see that the ROAs have improved. How should we be thinking about that in terms of revenue contribution and growth, if any? If you could just talk to that a little bit more, that would be super helpful.

Joshua Lev

Destiny, it's Josh. Thanks so much for the question. The short answer is really we're staying consistent with what we had said earlier on in the year, which is that we're not going to chase unprofitable revenue. Our goal is really to change the way that we think about driving revenue so that we get closer and closer to that adjusted EBITDA positive towards the end of 2027. So to that end, we believe that year-over-year, our Truvaga revenue will grow. We've said that we believe that we were going to do that. However, our goal is not to grow it at the same, call it, triple digits that it grew 2025 over 2024. That growth will be slowed down dramatically because the profitability of each revenue dollar that we generate through that growth is going to be up.

So in terms of the way you think about it, what I would say is our expectation is that year-over-year, it will be up somewhat, but the profitability that we're seeing on the back end is really our focus. We're not going to just chase what we said in the script, which are empty calories, right? Empty calorie revenue. We're really going to focus on how do we get those every dollar contribution to have a higher contribution margin than they did in the past.

Operator

Our next question is from RK with H.C. Wainwright.

Swayampakula Ramakanth

My first question is on the guidance itself. You're guiding for $39 million to $42 million. That requires you to do somewhere either from 6% to like almost 30% in terms of sequential growth, which we have not really seen in the last 3 or 4 quarters. So what gives you confidence that the business is at a place where it can give at least the low single digit -- low double-digit growth sequentially?

Joshua Lev

So RK, I'll jump in first, and then I'll let Mike go from there. Mike gave a lot of KPIs in the -- in today's remarks. But really, what it comes down to is really 2 main things. I'd say, number one, the number of VAs or specifically the number of people that we've got calling on the VA we believe are going to be sort of, I'd say, fully staffed beginning in this October. As Mike went through, we've changed the way that we organize our sales organization. We broke up the organization such that now we have 2 area vice presidents. We've got 6 regional sales directors. So I think the first and foremost, the most important thing is during the third quarter, what we established is that we have to continuously find new people, people that are able to be more productive and people that have established networks and relationships within the VA to help sell our products. I think that's the first thing.

And then the second thing, which is really just a continuation on that thought, is the people that we have onboarded and the newer individuals and resources that we have selling our product are actually proven to be more productive than those people that we had here historically and they're getting up to speed quicker than what we have seen beforehand. So from our point of view, I think we're really enthusiastic about the level of talent that we brought in over the course of the last couple of months. Those individuals have proven an ability to sell products historically, but they really are proving an ability to sell our products as well. And their ability to get up and running quicker and generate sales faster is something that Mike went through in sort of some KPIs before. But Mike, is there anything you want to add to that?

Michael Fox

Yes. Thanks, Josh. RK, yes, there are so many things that give me confidence. But I think just like Josh said, from the personnel side, that adds the biggest weight. Also just know that there are resources internally from a targeting and actionable dashboard and reports to help our representatives identify those patients that need refills. We have more updated and really stronger data that they can take action on to work with the providers to help them understand if patients are doing well with therapy that their therapy needs to be refilled. Our refill rate is a big focus. And some of the numbers that we have put in the forecast is a combination of better strength for getting additional new patients started, but also getting a higher refill rate that aligns with the evidence of this product in our clinical data. So those things combined with everything Josh talked about, that's why we're seeing those forecast numbers where they're at. I hope that answers your question, RK.

Swayampakula Ramakanth

Then just keeping up with the guidance question itself. Going into the next year, are we considering any revenues from the CIPN indication in that growth trajectory that you're guiding for? Or is this all based on what work you have done so far with the sales team and the products and the indications that you currently have in the bag?

Joshua Lev

Yes, I see that as being upside. Ultimately speaking, we filed the 510(k). The soonest that, that 510(k) that we would hear back from the FDA is probably not going to be until, call it, the back half of the first quarter, which means that from a sales point of view, actual sales itself within the, call it, the fiscal 2027 really wouldn't start generating until the back half of the year. So to us, the way we see it is it's gravy as it relates to CIPN revenue. But we do believe that it could, in theory, open up new call points for us, having the ability to start talking about it.

Remember, our product for CIPN for Quell specifically has breakthrough designation already. So given that we filed, given that we have the breakthrough designation that we received for CIPN. We see it as an opportunity to open up for sales of Quell, which is part of the 2027 forecast, but anything CIPN-specific would really be incremental to that.

Swayampakula Ramakanth

And on Quell itself, can you help us understand the sequential performance of Quell in terms of order cadence and any organizational transitions that you're currently doing? And also, Josh, I'm just trying to understand, I believe the Quell and the CIPN initially it was requested for 510(k), then something got changed in between and then again came back to 510(k). So can you kind of walk me through that historical back and forth with the FDA and how confident are we that the 510(k) is the right way to do this?

Joshua Lev

Yes, sure. So I'll answer that question, and then I'll kick it over to Mike to answer just sort of like the cadence of Quell revenue and where we're seeing that and where we see it going. So just in terms of the 510(k) that was filed, you are correct. So originally, when -- prior to us acquiring the company, prior to us acquiring NeuroMetrix, conversations were being held by the former management there and the FDA about possibly putting in the submission. And without getting too much into the details, the advice that was essentially provided was to go down the de novo pathway for CIPN. We, when we acquired the business, didn't necessarily think that to necessarily be accurate. I mean we also -- not only is the product for Quell for fibromyalgia already exists. So the predicate was already there.

We also had the breakthrough designation, which we thought as part and parcel of what the objective of having a breakthrough designation would be, which is to help streamline the ability of having new innovative products come to FDA to get approved, we thought that the 510(k) pathway probably, in our opinion, made a lot more sense. Fast forward a few years, the members of the FDA that were responsible for reviewing what would be the CIPN filing is different. And the new team that was involved took a look when we started having conversations with them. We actually filed the de novo per their request. And the new team that was on board took a look at it and said, we don't believe that this really should go down the de novo pathway based on who we are and what our mandate is, we think that going down a 510(k) pathway is probably more appropriate given where you are and given the breakthrough designation. So what they advised us to do was recall the de novo, which we did and then resubmitted as a 510(k), which we did and we announced late last week.

In terms of does it make us feel more confident or less confident? -- at the end of the day, we're still talking about the FDA. The data itself hasn't changed. I do believe it's a good sign that the FDA review team has taken a look at the product and said, look, we don't think that there is a de novo pathway here. We think that the safety that exists already through the predicate device being Quell is probably sufficient. So that part of it is -- we're choosing to be optimistic, but it's still the FDA, right? Even though there's a breakthrough designation, even though the government and the FDA and this particular political party, although that's an interesting comment to make on November 4, although that's been -- that's changing in its own right. But current administration was really keen to try to push forward a new innovative product. So we're taking it as good news. But at the end of the day, it's still the FDA. They will still go through their progress, and we're still dealing with the government agency on it.

So I guess we always plan for the worst, hope for the best, but we are hopeful that the information that we provided and the team that is reviewing it does see the benefits and the data that shows the potential benefits to the sufferers of CIPN primarily because there are no medical device or pharmaceutical products that are cleared specifically or approved specifically for CIPN. So it would be the first, which would be great. In terms of the cadence of the business, I'll just leave with this tidbit before I hand it over to Mike, which is in the month of October, we surpassed 1,000 Quell patients, users, which is amazing. And I think the month of October was our largest Quell month in company history. So with that good news, I'll let -- I'll hand it over to Mike. I'll let Mike elaborate a little bit.

Michael Fox

Yes, RK, just to help understand when you say cadence, could you give me a little bit more -- what would you like to hear more about is what I'd like to know.

Swayampakula Ramakanth

I was just thinking about how the orders are progressively. How are they doing in terms of the growth of the orders? And where should we think about this product going from currently $1.2 million or so per quarter? How high could it get to, not including the CIPN? Obviously, the CIPN could be another additional market. And I don't know what you're thinking of that market itself, the CIPN?

Michael Fox

Well, let's just talk about Quell fibromyalgia as a stand-alone first because that's what we're able to do now. CIPN in itself is a very exciting opportunity for the patients that we're going to be able to help, but also because of the unmet need. But currently, just to give you a little flavor of numbers, like Josh said, we had a very strong October. Dollar revenue and new patient orders in October were higher than January and February combined this year. So we are seeing growth. Are we at a growth rate that we are happy with? I don't think we're ever happy. But we're satisfied that we're seeing the trends go in the direction it should be going. We have a lot of work to do and a lot of VAs. It aligns with our strategies for other things going on within the company.

But from a cadence standpoint, the uptake of Quell within the federal space has been very positive, but we definitely need to continue to identify other ways that we can access more of these VAs because currently right now, we have too many VAs that have not touched Quell yet, and those are the areas that we're placing more emphasis with new representatives or enhanced coaching so we can have a better diversity of accounts here by the end of the year. But yes, so far, it's in the right direction, RK. I think the nice thing to always remember is -- this product was from a company that was a stand-alone company. And I truly believe with the market of fibromyalgia and what this product can provide, it could be a stand-alone product for a company. We're lucky to have it as a second product or even a first of 2 products, however you want to rank gammaCore Quell. It's a very impressive technology, and I'm excited to see where this thing can go.

Operator

Our next question is from Jeremy Pearlman with Maxim Group.

Jeremy Pearlman

First, I want to talk about a little bit on the guide. So just it seems like in the last earnings release on the call, you had guided towards adjusted EBITDA 27% in the third quarter. And this release, it seems like it's now by the end of '27. And just you're guiding to 30%, 40% revenue growth and lower OpEx. So just maybe what some of the underlying assumptions, why it seems like that profitability has shifted a little bit?

Joshua Lev

Yes. Great question, Jeremy. Thanks for joining. It's really just a function of timing. Some of the revenues that we were hoping to see within the 2026, we see it now coming and accelerating in 2027. So it's a function of basically shifting the time.

Jeremy Pearlman

And then just -- I know you mentioned some of the improvements from the sales reps in this quarter. Just is that -- those improvements, is that what -- is that more reflective of the productivity of the actual sales reps or maybe just also underlying maturation of the existing accounts, a combination of some? Maybe just if you could parse that out a little bit.

Michael Fox

Yes. I can tell you you're exactly right. I'd say yes to all of it. We do have some very strong reps that have been here for a long time, helping to have them grow and expand the number of providers in their existing accounts has been a big focus. Some of them had only been selling gammaCore and now we have them selling both Quell and gammaCore. But we also have replaced some account coverage with new 1099s, new regional sales directors with relationships, better access and better expertise within the VA. So I would say it's a combination of everything. We're assessing every single account and every single person that sells our products on a monthly basis. So there's a lot of different spots to be taken care of, but we're welding everything as tight as we can when we find where the weak spots are and sharpening them when we need to be sharper.

Jeremy Pearlman

And maybe just also a little bit on the same point. There must be some sort of attrition rate from the actual -- the patients are using the gammaCore. What can you do to maybe stem some of that and keep the patients subscribing longer?

Michael Fox

It's a great question. The biggest thing for what we found in medical device, especially within at-home devices where the patients are using it themselves is the consistent opportunity for us to what we say, show them the mirror so they can understand sometimes they forget that they were having 12 to 15 migraines a month, and now they only have 6 to 8 just to verify the quality of life and the benefits they're seeing and some of the secondary effects of our therapies as well that they may not be recognizing. Also just to make sure that the providers continually become advocates and make sure that they understand the value of continuing these products. In the VA, for example, a lot of triptans and migraine medications are used, what they call rescue meds.

There's a lot of physicians that understand the value of reducing medications in these patients, especially that are on things that are outside of label within the antidepressant class or angiolytics and things just to continue to control migraines on top of their triptans. So the less medications they use, the better for everyone. And so as we continue to work on higher compliance rates and higher refill utilization, really the ultimate goal is to help the patients become healthier and happier and a more fulfilled life as we owe our service members for all they've done for us. So that's the plan.

Jeremy Pearlman

And then just last question related to the 510(k) submission. Just what is -- how large is the addressable market should that get approved? How many patients? And are you going to be selling -- is that going to be within the VA? Or is it going to be separate outside of that?

Joshua Lev

So look, the answer is hopefully both, right? That's ideally. Again, as I said earlier, there is no other approved product, whether pharmaceutical or medical device that is on market right now for CIPN specifically. So we think that it's a great opportunity for us to enter into what's known as a blue ocean or a market that doesn't have an opportunity. In terms of the overall opportunity itself, just to give you very high-level numbers, roughly 50% of the people that go through chemotherapy have some form of a neurotoxin and roughly 50% of those people end up with some form of CIPN. So the total addressable market, I think in the United States would be roughly 600,000 to 700,000 within the VA would be roughly 15,000 to 20,000. But they're large markets, but more importantly, they're large markets with no other alternative.

So being able to leverage the science, the technology, the safety profile of what we can offer based off of our bioelectronic technologies. We don't want to commit to not entering a larger market. But right now, as you and all of our investors know, the VA is primarily where we sell. And that is probably going to be, if you will, the lowest hanging fruit as a way for us to start.

Michael Fox

Yes, I was just going to say you said the addressable markets. We're going to address the market. So we're not just going to stop at the federal space. But as you know, outside the VA, it takes a little longer because you start looking at reimbursement coverage and things. But with this type of opportunity, we're definitely going to investigate outside federal space. But that's just want to add to that. We're going to go different directions with that. How that works and where that reimbursement comes, we'll keep you posted.

Operator

Our next question is from Fozia Ahmed with Brookline Capital Markets.

Fozia Ahmed

My first question is regarding CIPN program. When do you anticipate an additional information request from the FDA? And I know 2 studies were used to support the data for the CIPN. Are there any additional studies which are ongoing or anticipated to support this submission? And additionally, do you see that open 483 form to have any effects on the timing of the application that was submitted for CIPN?

Joshua Lev

So thanks, Fozia, for the questions. Regarding the time line, so typically, the FDA say that for a 510(k) submission, what they do is they look to get back to you within 90 days to give you an answer after 90, what they call review days. And what review days mean is they take the application. They usually take about 2 to 3 weeks to review the application to make sure it's complete. And if it's in its complete form, then it goes to final review. From a final review point of view, the VA meaning the FDA have the ability to go back and forth and ask questions. So every time the FDA asks a question about the data, what will happen is the clock stops. And then when you answer the question, whether the company answers the question, the clock remains.

So the target date usually for the FDA is 90 review days, but that's really just their target. in our -- we think in a best case scenario, again, best case scenario, the first we'll hear from them about it will be the second half of the first quarter. In terms of the data itself, there are no currently -- there are no plans currently in place for us to do additional trials for the application.

Fozia Ahmed

And the effect of the open Form 483, do you think that can delay the time line?

Joshua Lev

No, I don't think so. Good question. The 483 was very much specific to the over-the-counter NeuroMetrixproduct that was sold back in 2017. So we do not believe that, that could delay it. But again, it's the FDA, and it's completely their prerogative to ask as many questions about the safety and efficacy as they so choose.

Operator

Our next question is from Dr. Charles Theophilus, private investor.

Unknown Analyst

Josh and Mike, I want to congratulate you on leading this company in a new direction and bringing in a dynamic sales force, bold, and I think it's going to work out extremely well. I was personally involved with the Quell acquisition for electroCore. And when it was acquired, they had a significant over-the-counter market with Quell, at one point, reaching $15 million a year. Does ElectroCore want to revisit going over the counter with Quell?

Joshua Lev

Dr. Theophilus, first of all, thank you very much for joining. Always your support of the company has really been unmatched. So we really appreciate you and all that you've done. For those of you on the call who may not know, Dr. Theophilus is more than just an investor. He is also a founder of the technology. So we greatly appreciate you and the support you've given to the company. So in terms of your question, we believe that there is a market that could exist for an over-the-counter type of product for Quell. We call it Quell 2.0 or Quell over-the-counter when we talk about it in terms of our filings. We originally had stated that our intent was for us to launch that this year. But given the 483 letter that Fozia had just mentioned earlier, that has been delayed.

So because the over-the-counter, the 483 commentary was really around the way that we think about the over-the-counter product, that product itself has been delayed. We do -- would like, I should say, for us to go ahead and to launch some form of an over-the-counter-based product using Quell. But the timing for that right now is to be determined, pending not just some of the 483 commentary, but also really going back to what we said earlier, which is -- our goal, first and foremost, is to chase profitable revenue. And we need to make sure that the market exists in a way that we can make those sales, but do it in a way that's profitable and brings us closer and closer to that adjusted EBITDA profitability towards the end of next year. And that will be sort of our guiding star.

Operator

Our next question is from Walter Schenker with MAZ Partners.

Walter Schenker

The company recently released a study -- clinical study done in the Air Force showing the benefits in healthy participants both for physical and mental performance. Again, you've published a number of those. Just want to bring us up, and I know Mike has had a lot of other stuff on his plate, but sort of how he looks at the opportunities away from headaches and fibromyalgia into TAC-STIM or other police forces, government, sports, all the other opportunities where enhanced performance is probably a good thing.

Michael Fox

Yes, I couldn't agree more. I think the -- that's one of the main reasons I came to this company is when I saw the research of what has been published on the prescription devices, but then also the work that Dr. Stat and many others have done just on technology specific to vagus nerve stimulation. You hit a big topic there with the Air Force Research Lab. No question that data was extremely exciting to see. Just to let you know that, obviously, that data is transferable to other high-stress types of roles. Air traffic controllers is also another opportunity that have been in discussions. A lot of the first responders that we've been focused on here since the end of Q2 to really start identifying places where this could be a benefit just beyond the active military, but other people that are living in a very high parasympathetic sympathetic response type of role where they have a lot of trauma and they have a lot of stress.

So the answer is yes. It is a lot of transferable information. We just have to get the message to those. And that's one of the consultants that we brought in, in Q3 that is very aligned with a lot of the New Jersey area police SWAT and Port Authority to see if we can continue to work with them on their needs and then also work with some of the other opportunities within the military and those that are in similar stressful situations. So yes, hopefully, that answers your question. But yes, I agree. That's not actually information you want to just leave on the shelf. A lot of other people need to see that.

Operator

We have now concluded the live Q&A portion of the call. I will turn the call over to Joshua for closing remarks.

Joshua Lev

Thank you, operator. We really appreciate it. Before we close, I just -- I want to take a step back from our quarterly results for a minute. We have a platform with real science behind it and a first to market that we have barely begun to penetrate. Where we've made our commercial changes, they're working, and now we have the leadership in place to take them national. We don't just believe the growth is coming. We see what we believe to be the early indicators within the numbers. So for us, the timing has moved, but our conviction has not. And it is now our job to turn those early indicators into sustained results.

So I want to just take the opportunity to thank our shareholders for your patience and your continued support. Of course, to our patients, our providers and our partners, thank you for trusting us with your care. And most importantly, to our team, thank you for showing up every day with the discipline and the ambition that this opportunity demands. We appreciate everyone's participation in today's call, and we look forward to speaking with you again next quarter.

Operator

This concludes today's call. Thank you for your participation.