IntriCon Corporation (IIN) 2021 Q3 法說會逐字稿

Good day, and thank you for standing by, and welcome to the IntriCon Corporation Third Quarter 2021 Earnings Conference Call. (Operator Instructions) Please be advised that today's conference is being recorded. (Operator Instructions) I would now like to turn the call over to your speaker, Leigh Salvo. Please go ahead.

美好的一天，感謝您的耐心等待，歡迎參加 IntriCon 公司 2021 年第三季財報電話會議。 （操作員指示）請注意，今天的會議正在錄製中。 （接線員指示）我現在想將電話轉給您的講者 Leigh Salvo。請繼續。

Thank you, operator. Before we begin, I would like to preface our remarks with the customary Safe Harbor Statement. Today's conference call contains certain forward-looking statements. These statements are based on the current estimates and assumptions of IntriCon's management and are subject to uncertainty and changes in circumstances. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Actual results may vary materially from the expectations contained in today's call. For a list and description of the risks and uncertainties associated with our business, please refer to the Risk Factors section of our most recent annual and quarterly reports on Form 10-K and Form 10-Q, respectively, with the SEC. With that, I would now like to turn the call over to IntriCon's CEO, Scott Longval, for a review of the company's third quarter performance.

謝謝你，接線生。在我們開始之前，我想以慣例的安全港聲明作為我們發言的序言。今天的電話會議包含某些前瞻性陳述。這些陳述是基於 IntriCon 管理層目前的估計和假設，並可能受到環境不確定性和變化的影響。鑑於這些不確定性，您不應過度依賴這些前瞻性陳述。實際結果可能與今天電話會議中的預期有重大差異。有關與我們業務相關的風險和不確定性的清單和描述，請參閱我們分別向 SEC 提交的表格 10-K 和表格 10-Q 的最新年度報告和季度報告的風險因素部分。至此，我現在想將電話轉給 IntriCon 的執行長 Scott Longval，以審查該公司第三季的業績。

Thank you, Leigh. Good afternoon. We appreciate everyone joining us today. On the call with me is Annalee Lutgen, the company's current Treasurer and Director of Finance, who has stepped into the role of interim Chief Financial Officer effective October 29, 2021. The I worked along the side of analyte for nearly 12 years and have the utmost confidence in her ability to guide our finance department as we conduct a search for a permanent CFO.

謝謝你，利。午安.我們感謝今天加入我們的所有人。與我一起通話的是公司現任財務主管兼財務總監 Annalee Lutgen，她已於 2021 年 10 月 29 日起擔任臨時首席財務官。財務長時指導財務部門的能力充滿信心。

Turning to our third quarter results. IntriCon delivered a near record revenue quarter with total revenues increasing approximately 14% year-over-year. We also saw meaningful progress towards several very exciting catalysts on the horizon that we are tracking for accelerated growth across multiple market opportunities. While we continue to experience the impact of pandemic-related labor shortages and supply chain constraints on our manufacturing business, we have continued to be successful in navigating these challenges to identify and implement options in order to meet the increasing demands of our customers and plans for accelerated growth in the coming year.

轉向我們第三季的業績。 IntriCon 季度營收接近創紀錄，總營收年增約 14%。我們也看到了一些非常令人興奮的催化劑取得了有意義的進展，我們正在追蹤這些催化劑，以實現多個市場機會的加速成長。雖然我們繼續經歷與疫情相關的勞動力短缺和供應鏈限制對我們的製造業務的影響，但我們繼續成功地應對這些挑戰，確定和實施選項，以滿足客戶日益增長的需求和計劃來年加速增長。

As a reminder, our components and assemblies are integrated into advanced micro technology in a number of device platforms for global customers in the diabetes, surgical navigation, interventional catheter and hearing health markets. I'd like to take the next few minutes to cover the recent highlights and updates of our business in each of those markets. And then I'll turn the call over to Annalee to cover our financials in more detail.

需要提醒的是，我們的組件和組件已整合到許多設備平台中的先進微技術中，為糖尿病、手術導航、介入性導管和聽力健康市場的全球客戶提供服務。我想用接下來幾分鐘的時間來介紹我們在每個市場的業務的最新亮點和更新。然後我會將電話轉給 Annalee，更詳細地介紹我們的財務狀況。

Starting with the diabetes market, sales to Medtronic Diabetes Group represented 58% of our total revenue in the third quarter, with 24% growth over the third quarter of 2020 and 18% sequentially, primarily attributable to the continued launch success of the Medtronic MiniMed 780G in certain international markets and the Medtronic MiniMed 770G in the U.S. These launches have contributed to our strong results over the past several quarters, and we have the same expectation for the forthcoming Medtronic product launches, including contribution from the approval and launch of Medtronic's Guardian 4 Sensor.

Starting with the diabetes market, sales to Medtronic Diabetes Group represented 58% of our total revenue in the third quarter, with 24% growth over the third quarter of 2020 and 18% sequentially, primarily attributable to the continued launch success of the Medtronic MiniMed 780G in certain international markets and the Medtronic MiniMed 770G in the U.S. These launches have contributed to our strong results over the past several quarters, and we have the same expectation for the forthcoming Medtronic product launches, including contribution from the approval and launch of Medtronic's Guardian 4感應器.

We are especially encouraged by Medtronic's recent announcement that the 1-year real-world clinical data on over 3,000 pediatric and adolescent patients achieved time and range results that well surpassed clinical consensus guidelines for the glycemic control using its MiniMed 780G system with the Guardian Sensor 3. Not only does this open up potential additional market opportunity for the system that further validates its benefits for patients of all ages. We are proud to be their partner of choice in delivering advanced products like this to the global market.

美敦力(Medtronic) 最近宣布，超過3,000 名兒科和青少年患者的1 年真實世界臨床數據所取得的時間和範圍結果遠遠超出了使用其MiniMed 780G 系統和Guardian Sensor 3 進行血糖控制的臨床共識指南，這令我們感到特別鼓舞。我們很榮幸成為他們向全球市場提供此類先進產品的首選合作夥伴。

Turning to our Surgical Navigation and interventional catheter business. We further expanded our business with existing customers as well as progress on several new opportunities that we're confident will provide additional future growth. More specifically, Surgical Navigation, which includes our medical coil product line, continue to build off the strength in the second quarter as we ramped up production capacity to meet customer demand ahead of a planned commercial launch.

轉向我們的手術導航和介入導管業務。我們進一步擴大了與現有客戶的業務，並在一些新機會上取得了進展，我們相信這些新機會將帶來額外的未來成長。更具體地說，包括我們的醫療線圈產品線在內的外科導航在第二季度繼續增強實力，因為我們在計劃的商業發布之前提高了產能以滿足客戶需求。

Medical coil revenue in the third quarter was $2 million, up 31% year-over-year and 18% sequentially from the second quarter of 2021. Interventional catheters developed and manufactured through our Emerald Medical Services business experienced a lighter third quarter following a strong first half due in part to the COVID-related flare-up in Japan around the time of the Olympics, which partially limited operations. This portion of our business also experienced some supply chain-related constraints, but we are actively pursuing alternatives that will best enable us to continue to meet customer demand and time lines.

第三季的醫療線圈營收為200 萬美元，年增31%，較2021 年第二季較上季成長18%。第三季表現較淡一半是由於奧運期間日本爆發的新冠肺炎疫情，部分限制了營運。我們的這部分業務也經歷了一些與供應鏈相關的限制，但我們正在積極尋求替代方案，使我們能夠繼續滿足客戶的需求和時間表。

Revenue from EMS in the third quarter totaled $3.4 million, a 22% year-over-year improvement and an 18% decline over Q2 2021. We expect the continued international adoption of interventional catheters manufactured by EMS and further expansion opportunity with products pending an FDA submission will lead to meaningful upside in 2022. In summary, we believe there is a significant potential for growth in these markets where our collaborative enterprise capabilities of complex catheters and micro coils are well suited to drive innovation and differentiation.

第三季EMS 的營收總計340 萬美元，年增22%，較2021 年第二季下降18%。機會提交申請將在 2022 年帶來有意義的上漲。

Turning to Hearing Health. In the third quarter, revenues declined approximately 14% to the prior year. largely due to timing of orders as year-to-date revenues in this market were up 21%. Supply chain impacts also contributed to the decline year-over-year but we expect to recoup this revenue over the next few quarters. Last month, the FDA published the highly anticipated proposal to establish a new regulatory category for over-the-counter hearing aids. IntriCon has been a major supporter to open this market as we believe it offers much needed broader public access to hearing aids at a significantly lower cost for the estimated 30 million Americans suffering from age-related hearing loss.

轉向聽力健康。第三季度，營收比去年同期下降約 14%。這主要是由於訂單時機所致，該市場今年迄今的收入成長了 21%。供應鏈影響也導致了同比下降，但我們預計將在未來幾季收回這筆收入。上個月，FDA 發布了備受期待的提案，為非處方助聽器建立一個新的監管類別。 IntriCon 一直是開放這個市場的主要支持者，因為我們相信它為估計有 3000 萬患有與年齡相關的聽力損失的美國人提供了急需的更廣泛的助聽器，並且成本顯著降低。

Under the proposal, Americans 18 years or older with perceived mild-to-moderate hearing loss would have access to less expensive and significantly more accessible hearing aid alternatives where previously they would be required to get a prescription from an audiologist in addition to several visits for fitting, adjustments and maintenance. There is a widespread bipartisan support for the proposal, and we are very optimistic for its approval. A long-standing priority for IntriCon has been identifying, securing partnerships with other participants in the market that can benefit from our hardware, firmware, software and back-end support.

根據該提案，18 歲或以上患有輕度至中度聽力損失的美國人將能夠獲得更便宜且更容易獲得的助聽器替代品，而此前他們除​​了多次就診外還需要從聽力學家處獲得處方。該提案得到了兩黨的廣泛支持，我們對其獲得批准非常樂觀。 IntriCon 的長期優先事項是確定並確保與市場上其他參與者的合作夥伴關係，這些參與者可以從我們的硬體、韌體、軟體和後端支援中受益。

We have never been better positioned to partner with a wide range of participants in this emerging market. As part of our preparation to support the OTC market, earlier this year, we commenced a clinical trial for our proprietary self-fitting software. And in September, received notice that Summative Usability Validation had been completed, which allows a clinical trial of the software to progress. With this milestone, we remain on track to complete ahead of the anticipated FDA final ruling, enabling us to further advance our positioning in the ecosystem of care to support customer experience and success with OTC hearing aids.

我們從未像現在這樣能夠更好地與這個新興市場的眾多參與者合作。作為我們支持非處方藥市場的準備工作的一部分，今年早些時候，我們開始了我們專有的自適配軟體的臨床試驗。 9 月，收到總結性可用性驗證已完成的通知，這使得該軟體的臨床試驗得以進展。憑藉這一里程碑，我們將繼續在預期的 FDA 最終裁決之前完成任務，使我們能夠進一步提升我們在護理生態系統中的定位，以支持客戶體驗和 OTC 助聽器的成功。

Our pilot program with HearX continues to expand and has been met with widespread excitement. As the market moves towards an anticipated OTC option encouragingly, we are seeing increased demand from HearX for our hardware, firmware and software technology. In parallel, we are driving opportunities with additional partners that see the value of our ecosystem of care as they enter the space. We have tremendous confidence in the potential of this new market and we have done a great deal of work to position IntriCon as the joint development and manufacture of choice.

我們的 HeartX 試點計畫不斷擴大，並引起了廣泛的興奮。隨著市場令人鼓舞地轉向預期的 OTC 選項，我們看到 HearX 對我們的硬體、韌體和軟體技術的需求不斷增加。同時，我們正在與更多合作夥伴一起推動機會，這些合作夥伴在進入該領域時看到了我們護理生態系統的價值。我們對這個新市場的潛力充滿信心，並且我們做了大量工作，將 IntriCon 定位為共同開發和製造的首選。

As we enter the final quarter of the year, I believe we are better positioned than ever within the markets we serve. Customer demand remains high across all of our core markets. Our existing partnerships are secure, and we have a significant number of catalysts emerging that I'm confident will drive our growth in 2022 and beyond. In the short term, we do anticipate that the fractured supply chain and labor shortages, which created inefficiencies that impacted our margins in the third quarter, will persist at least through the remainder of the year, and may continue to constrain margin expansion in the short term as we enter 2022.

隨著我們進入今年最後一個季度，我相信我們在所服務的市場中處於比以往更好的位置。我們所有核心市場的客戶需求仍然很高。我們現有的合作關係是安全的，而且我們有大量新興的催化劑，我相信這些催化劑將推動我們在 2022 年及以後的成長。從短期來看，我們確實預計，供應鏈斷裂和勞動力短缺導致效率低下，影響了我們第三季的利潤率，這種情況至少將持續到今年剩餘時間，並可能繼續限制短期內利潤率的擴張。

That said, we are taking steps to minimize these challenges, including dual sourcing, increasing inventory levels and customer price increases. We also believe over time, we will reach greater direct labor efficiencies as newer employees are trained and gain line experience. In summary, I'm confident that these challenges to our supply chain and staffing are transitory. We are taking immediate action to mitigate the impact. And over time, as the macro environment stabilizes, we can achieve even greater operational efficiency, resulting in margin improvement.

也就是說，我們正在採取措施盡量減少這些挑戰，包括雙重採購、增加庫存水準和提高客戶價格。我們也相信，隨著時間的推移，隨著新員工接受培訓並獲得生產線經驗，我們將實現更高的直接勞動效率。總之，我相信我們的供應鏈和人員配置面臨的這些挑戰是暫時的。我們正在立即採取行動減輕影響。隨著時間的推移，隨著宏觀環境的穩定，我們可以實現更高的營運效率，從而提高利潤率。

Importantly, continued high-level execution and consistent growth throughout an undoubtedly challenging time, perfectly exemplifies the resilience of our business and the team we have assembled. With that, I'll now turn it over to Annalee. Annalee?

重要的是，在毫無疑問充滿挑戰的時期，持續的高水準執行和持續成長，完美地體現了我們的業務和我們組建的團隊的韌性。有了這個，我現在就把它交給安娜莉。安娜莉？

Thank you, Scott. Now turning to our financial results. Recall in the first quarter, we adopted the use of non-GAAP reporting to provide a clear picture of our growth and transformation. Reconciliations to the most directly comparable GAAP measures are provided in the tables accompanying the press release we issued today. For the third quarter of 2021, as Scott noted, we reported net revenues of $31.1 million, an increase of 13.5% over the prior year period, primarily driven by increases in our diabetes, interventional catheter and surgical navigation markets. GAAP net income for the quarter was $300,000 or $0.04 per diluted share versus net income of $600,000 or $0.07 per diluted share in the prior year period. Non-GAAP adjusted net income was $1.7 million or $0.17 per diluted share in the third quarter of 2021 versus net income of $2.4 million or $0.25 per diluted share in the prior year period.

謝謝你，斯科特。現在轉向我們的財務表現。回想一下第一季度，我們採用了非公認會計準則報告來清楚了解我們的成長和轉型。我們今天發布的新聞稿隨附的表格中提供了與最直接可比較的公認會計準則衡量標準的對帳。正如 Scott 指出的，我們報告的 2021 年第三季淨收入為 3,110 萬美元，比去年同期成長 13.5%，這主要是由我們的糖尿病、介入性導管和手術導航市場的成長所推動的。本季 GAAP 淨利潤為 300,000 美元，或稀釋後每股 0.04 美元，而去年同期淨利潤為 600,000 美元，或稀釋後每股 0.07 美元。 2021 年第三季非 GAAP 調整後淨利為 170 萬美元，即稀釋後每股收益 0.17 美元，而去年同期淨利為 240 萬美元，即稀釋後每股收益 0.25 美元。

Diabetes revenue increased 24% to $18 million compared to $14.5 million in the prior year third quarter. The growth was primarily attributable to the continued launch success of the Medtronic MiniMed 780G in certain international markets and the MiniMed 770G in the United States. Interventional catheter revenue increased 22% to $3.4 million from $2.8 million in the comparable prior year period. The year-over-year increase was driven primarily by the continued expansion of Medtronic's Chocolate Balloon manufactured by EMS.

糖尿病業務收入成長 24%，達到 1,800 萬美元，而去年第三季的營收為 1,450 萬美元。這一成長主要歸功於美敦力 MiniMed 780G 在某些國際市場和 MiniMed 770G 在美國的持續成功推出。介入導管收入從去年同期的 280 萬美元成長 22% 至 340 萬美元。同比增長主要是由 EMS 製造的美敦力巧克力氣球的持續擴張所推動的。

Surgical Navigation revenue was $2 million, an increase of 31% over the prior year period and 18% sequentially from the second quarter of 2021. This increase was driven by added production capacity as the company worked through specific labor challenges faced earlier in the year. In our hearing health business, total revenue in the third quarter was $4.7 million, a 14% decline over the prior year third quarter. The primary driver in this market was supply chain input constraint, which we have mostly addressed in early Q4.

手術導航收入為 200 萬美元，比上年同期增長 31%，比 2021 年第二季度增長 18%。我們的聽力健康業務第三季總收入為 470 萬美元，比去年第三季下降 14%。這個市場的主要驅動因素是供應鏈投入限制，我們在第四季初主要解決了這個問題。

As orders continue to remain strong, we anticipate hearing health to rebound in the 2021 fourth quarter. Third quarter gross margins were 23.1% compared to 26.3% in the prior year comparable period. The lower margin was due in part to supply chain constraints, higher labor costs and product mix. Operating expenses were flat for the third quarter at $6.7 million for both the current and prior year periods. During the 2021 third quarter, we reduced the EMS earn-out liability by $460,000, which was offset by increased business development and marketing investments. As of September 31, 2021, we had $33.1 million of cash and investments compared to $33.5 million as of December 31, 2020, and with positive operating cash inflow from operations of $3.2 million year-to-date, primarily attributable to higher cash earnings associated with our business growth and ease of COVID-19 restrictions.

隨著訂單持續保持強勁，我們預計聽力健康狀況將在 2021 年第四季反彈。第三季毛利率為 23.1%，去年同期為 26.3%。利潤率較低的部分原因是供應鏈限制、勞動成本和產品結構較高。第三季營運支出與去年同期持平，為 670 萬美元。 2021 年第三季度，我們將 EMS 獲利負債減少了 46 萬美元，但業務開發和行銷投資的增加抵消了這一損失。截至2021 年9 月31 日，我們擁有3,310 萬美元的現金和投資，而截至2020 年12 月31 日為3,350 萬美元，年初至今來自營運的正營運現金流入為320 萬美元，主要歸因於相關現金收益的增加隨著我們業務的成長和 COVID-19 限制的放鬆。

Turning to our outlook for the full year. Given our strong year-to-date performance, we're confident in raising the lower end of our guidance and now anticipate our 2021 revenue to range from $123 million to $125 million, representing year-over-year growth of 20% to 22%.

轉向我們對全年的展望。鑑於我們今年迄今的強勁表現，我們有信心提高指導下限，目前預計 2021 年收入範圍為 1.23 億美元至 1.25 億美元，同比增長 20% 至 22% 。

With that, Scott and I would now like to open the call for questions. Operator?

至此，我和史考特現在開始提問。操作員？

(Operator Instructions)

（操作員說明）

We have a question from the line of Jon Block with Stifel.

我們收到喬恩·布洛克 (Jon Block) 和斯蒂菲爾 (Stifel) 的提問。

This is Tom Stephan on for John. If I can start off with diabetes and as it relates to guidance, results were really strong in the quarter and it seems like you're able to get to your guidance of $124 million at the midpoint, up from I think it was the initial $121 million despite the Medtronic U.S. diabetes pipeline potentially slipping into 2022. So Scott, maybe for you, does that speak favorably to the trend line into 2022 in diabetes, maybe as those approvals could potentially be 1H 2022 events?

我是湯姆·史蒂芬（Tom Stephan）替約翰發言。如果我可以從糖尿病開始，因為它與指導相關，那麼本季度的結果非常強勁，似乎您能夠在中點達到 1.24 億美元的指導，高於我認為最初的 121 美元儘管美敦力（Medtronic）美國糖尿病管道可能會推遲到2022 年。

Yes. We think that, obviously, the momentum that we've gained in the diabetes business coming into the third quarter was strong. We continue to see strengthening from that business. A lot of that is attributed to some of the success that they've had with the 780 internationally. Obviously, we talked a little bit about what they're seeing with the 780 in terms of some of the clinical data compared to the real-world data, which is very positive, both in adults and then more recently, the announcement within adolescents.

是的。我們認為，顯然，進入第三季度我們在糖尿病業務中獲得的勢頭很強勁。我們繼續看到該業務的增強。這在很大程度上要歸功於 780 在國際上的成功。顯然，我們討論了他們在 780 上看到的一些臨床數據與現實世界數據的比較，這對於成人和最近在青少年中的宣布都是非常積極的。

So if we think about that momentum, as they look to gain approval here in the U.S., we think there's some tailwinds. And then regarding the 4 Sensor, we also think brings a lot of customer to lights as we look out into 2022 and beyond, we think there's a lot of good things happening with the diabetes business.

因此，如果我們考慮到這種勢頭，當他們希望在美國獲得批准時，我們認為存在一些順風車。關於 4 Sensor，我們也認為，展望 2022 年及以後，我們認為糖尿病業務會發生很多好事。

Great. And then if I can pivot to hearing. Maybe a couple here. Just on the OTC hearing landscape and potential partnerships, how would you describe your discussions today with potential partners, proposed rules were obviously published. Have they accelerated or even entered more final stages?

偉大的。然後我是否可以轉向聽力。也許這裡有一對。就場外交易聽證會的情況和潛在的合作夥伴關係而言，您如何描述今天與潛在合作夥伴的討論，擬議的規則顯然已公佈。他們是否加速甚至進入了更多的最後階段？

Yes. So we've been working, as we've mentioned, with a host of partners for the last several quarters. And those continue -- those discussions continue to evolve. We've talked in detail kind of the pilots that we're doing with HearX. There's other potential partners that we're well down the path of putting business plans together as they look to enter this market probably in conjunction with the final OTC regulations, but those discussions are pretty far down the path. We're very excited about those relationships, we think both of the groups that we're working with today have the ability to effectively scale in this market and meet the consumer at the point of care, which they think will be most advantageous.

是的。正如我們所提到的，過去幾季我們一直在與許多合作夥伴合作。這些討論仍在繼續發展中。我們已經詳細討論了我們正在使用 HearX 進行的試點。還有其他潛在的合作夥伴，我們正在製定商業計劃，因為他們希望與最終的場外交易法規結合進入這個市場，但這些討論還很遙遠。我們對這些關係感到非常興奮，我們認為今天合作的兩個團隊都有能力在這個市場上有效地擴大規模，並在護理點滿足消費者，他們認為這將是最有利的。

So excited to be working with multiple partners. And then I would say since the OTC regulation draft guidance was issued there's just been more and more activity there. And so this is where IntriCon is going to have to be disciplined to ensure that we're being thoughtful in terms of the partners that we want to move forward and spend our time and effort supporting. So those partners, again, had the ability to scale the financial wherewithal to scale, had the expertise in directly engaging consumers. Those are the traits that we're looking for. And based on what we've seen we think, again, this market continues to harbor tremendous opportunity for us.

很高興能與多個合作夥伴合作。然後我想說，自從 OTC 監管指南草案發布以來，那裡的活動越來越多。因此，這就是 IntriCon 必須遵守紀律的地方，以確保我們對我們想要前進的合作夥伴深思熟慮，並花費我們的時間和精力來支持。因此，這些合作夥伴有能力擴大財務規模，並擁有直接吸引消費者的專業知識。這些正是我們所尋找的特質。根據我們所看到的情況，我們再次認為這個市場繼續為我們提供巨大的機會。

Okay. Great. That's great to hear. And if I can squeeze in a follow-up just to that question. What can or will you convey to the Street as far as these OTC partnerships and wins go? I think it would be helpful just to get a sense for what types of updates or disclosures we may be getting as things can now move forward at a greater pace?

好的。偉大的。很高興聽到這個消息。如果我能擠出一個後續問題來回答這個問題。就這些場外交易夥伴關係和勝利而言，您可以或將會向華爾街傳達什麼訊息？我認為，隨著事情現在可以以更快的速度向前發展，了解我們可能會得到哪些類型的更新或披露會很有幫助？

Yes. Thank you. And that's a difficult one for us. As you know, we're working with a lot of partners, and we do it in a confidential manner as they're working to put their business plans together. So a lot of those relationships until we're actually out there with them and they're marking the programs, we probably won't be able to talk too much in terms of specifics. That being said, we'll continue to give kind of general comments in terms of how we think those relationships are progressing and hopefully be able to give insights in greater detail after the launches occur.

是的。謝謝。這對我們來說是一件困難的事。如您所知，我們正在與許多合作夥伴合作，並且在他們努力製定業務計劃時我們以保密的方式進行。因此，在我們真正與他們合作並且他們正在標記程式之前，我們可能無法在具體細節上談論太多這些關係。話雖這麼說，我們將繼續就我們認為這些關係的進展發表一般性評論，並希望能夠在發布後提供更詳細的見解。

And I'm not showing any further questions in the queue. I would like to turn the call back to Scott for any final remarks.

我不會在隊列中顯示任何其他問題。我想把電話轉回給史考特，讓他聽聽最後的評論。

Sorry, Sir, we just got 1 more that jump in the queue. If you don't mind?

抱歉，先生，我們剛剛還有 1 個插隊。如果你不介意的話？

Absolutely.

絕對地。

Kyle Bauser with Colliers Securities.

高力證券的凱爾·鮑瑟。

Scott, thanks for slipping me in.

史考特，謝謝你讓我進來。

Absolutely. Absolutely.

絕對地。絕對地。

So just a quick follow-up. So on the self-fitting trial, great to see the update on being able to move forward, and it's going to jive really nicely with the current public comment period regarding the FDA guidelines. I think ends in January at some point. Can you just kind of walk through what some of the next steps are? So do you envision press releasing any sort of data readout? Or would it be more of a situation where you just press release the fact that you've submitted the application to the FDA? Just trying to understand the cadence of milestones for that trial.

所以只是快速跟進。因此，在自我擬合試驗中，很高興看到能夠向前推進的更新，並且它將與目前有關 FDA 指南的公眾評議期非常吻合。我認為在一月份的某個時候結束。能簡單介紹一下接下來的步驟嗎？那麼您是否設想發布任何類型的數據讀數？或者這更像是您只是發布了您已向 FDA 提交申請的事實？只是想了解試驗的里程碑的節奏。

Yes. Thanks, Kyle. So as we've talked about in the past, in order to kind of satisfy our statistical goal, we need roughly 80 patients in the clinical. We have over 116 that are currently signed up. Our goal is to continue to push through the clinical. At the point at which we submit to the FDA, obviously, we'll have some communication. And depending on what the data reads and how much we want to have public at that point, we'll include some of the details. But I would say don't expect too much in terms of that release other than the fact that we have submitted the application to the FDA.

是的。謝謝，凱爾。正如我們過去談到的，為了滿足我們的統計目標，我們需要大約 80 名臨床患者。目前我們有超過 116 個已註冊。我們的目標是繼續推進臨床。顯然，當我們向 FDA 提交文件時，我們會進行一些溝通。根據數據讀取的內容以及我們當時希望公開的程度，我們將包含一些詳細資訊。但我想說的是，除了我們已經向 FDA 提交了申請之外，不要對該版本抱有太多期望。

Got it. Got it. But it sounds like even after the public comment period, it takes a couple more months for the rule to become final. It sounds like that you're on a pretty good pace with the trial ahead of kind of the final ruling. Is that fair?

知道了。知道了。但聽起來即使在公眾意見徵詢期之後，該規則還需要幾個月的時間才能成為最終版本。聽起來您在最終裁決之前的審判進展順利。這樣公平嗎？

Yes. And that's what we've talked about, Kyle, trying to make sure that we timed it correctly, right? So if you look, the draft guidance was released on October 20, we know they had a comment period for 90 days, and we will have our own formal comments to the FDA. There will be a period of time in which the final rule will be written and then that will go into effect 30 days after. So I think we're looking most likely towards the end of the second quarter, maybe the early part of third quarter. But regardless -- if you look at what was included in that draft guidance, there's a lot of benefits to IntriCon, a lot of the topics that we have been focused on over the last several years that we think is key to increase penetration in the U.S. market where encompassed, right?

是的。這就是我們討論過的，凱爾，試圖確保我們的時間安排正確，對吧？所以，如果你看一下，指南草案於 10 月 20 日發布，我們知道他們有 90 天的評論期，我們將向 FDA 提出我們自己的正式評論。最終規則將在一段時間內制定，並在 30 天後生效。所以我認為我們最有可能在第二季末，也許是第三季初。但無論如何，如果你看看該指南草案中包含的內容，你會發現 IntriCon 有很多好處，我們在過去幾年中一直關注的許多主題，我們認為這些主題是提高滲透率的關鍵美國市場包含在哪裡，對嗎？

So having the self-fitting devices, have their own regulatory classifier was critical. Being able to include mild to moderate, and those moderate individuals make up, in my estimation, the largest pool of people at which the OTC will be directed. And that was kind of confirmed with some of the dB output limits that they put out there. So we know we're going to be able to meet those needs of the moderate hearing loss.

因此，擁有自安裝設備、擁有自己的監管分類器至關重要。能夠涵蓋輕度至中度，在我看來，這些中度個體構成了 OTC 所針對的最大人群。他們提出的一些 dB 輸出限制也證實了這一點。所以我們知道我們將能夠滿足中度聽力損失的這些需求。

And I think the other thing in that OTC that help kind of build a moat around IntriCon's technology, both the hardware, software and firmware is some of the electroacoustical performance requirements. So it was clear when the FDA put this draft guidance out, they were very thoughtful in terms of the types of devices that they would classify as an OTC hearing aid, and those had to be ones that performed at a very high level. We think that puts us in a very strong position as we've seen over the last several years, there's a number of I'll call them cheap personal sound amplifiers that are out on the market. That's not going to cut the mustard for what the FDA has laid out in terms of their electric acoustical performance requirements. So all that, I think, puts us in a really strong position as we start to think about 2022 and how we're going to be really the support engine for what's going to be a very exciting hearing health care market evolving in the U.S. over the next several years.

我認為 OTC 中有助於圍繞 IntriCon 技術（硬體、軟體和韌體）建立護城河的另一件事是一些電聲性能要求。因此，很明顯，當 FDA 發布這份指南草案時，他們對於將被歸類為 OTC 助聽器的設備類型非常深思熟慮，而且這些設備必須具有非常高的性能水平。我們認為這使我們處於非常有利的地位，正如我們在過去幾年中看到的那樣，市場上有許多我稱之為廉價的個人聲音放大器。這並不能滿足 FDA 所製定的電聲性能要求。因此，我認為，當我們開始思考 2022 年以及我們將如何真正成為美國不斷發展的非常令人興奮的聽力保健市場的支援引擎時，所有這些都使我們處於非常有利的地位。

Got it. No, that's helpful. And then maybe just lastly, regarding the EMS business, I mean, from transaction perspective, is probably one of the best most accretive transactions we've seen in the last 12 to 24 months. I'm just curious, how do you size that market? What's the medium-term growth rate that would make sense? Just trying to understand how much runway we have there.

知道了。不，這很有幫助。也許最後，關於 EMS 業務，我的意思是，從交易的角度來看，這可能是我們在過去 12 到 24 個月中看到的最好的、最具增值性的交易之一。我只是好奇，你如何確定這個市場的規模？合理的中期成長率是多少？只是想了解我們那裡有多少跑道。

Yes. So as we've laid out, we saw some hyper growth coming out of that business over the last several quarters. Slowed a little bit here in the third quarter, and that was really driven by some flare-ups of COVID over in pockets in Asia. And we do have some supply constraints for raw materials for that business in the fourth quarter that we're working through. But longer term, we're very excited about where that business can go not only with current programs that we're working on that are in development with customers that we think can provide meaningful revenue contributions in the back half.

是的。正如我們所闡述的，我們看到該業務在過去幾個季度中出現了一些高速成長。第三季的成長速度略有放緩，其實是由亞洲部分地區的新冠疫情爆發所推動的。我們正在解決的第四季度該業務的原材料供應確實存在一些限制。但從長遠來看，我們對該業務的發展方向感到非常興奮，不僅是我們正在開發的當前項目，我們認為這些項目可以在下半年提供有意義的收入貢獻。

But longer term, we see a convergence of that interventional catheter business with some of the work that we're doing on the medical coil side and the sensor side. so putting sensors in catheters that allow for biometric readings that can provide greater information to the doctors and the nurses. And we think there's a lot of opportunities there where kind of medicine is moving and we're going to be in a good position to take advantage of that.

但從長遠來看，我們看到介入導管業務與我們在醫療線圈側和感測器側所做的一些工作的融合。因此，將感測器放入導管中，可以進行生物識別讀數，從而為醫生和護士提供更多資訊。我們認為，藥物正在發展，那裡有很多機會，我們將處於有利的位置來利用它。

And turning the call back to you, Scott, I don't see any additional questions.

然後將電話轉回給你，斯科特，我沒有看到任何其他問題。

Excellent. Well, I'd just like to thank everybody for spending some time today on giving an update with IntriCon. We're very excited about the business that we built, the opportunities that we have in front of us and look forward to continuing to update the group accordingly. Stay safe, and have a great evening.

出色的。嗯，我想感謝大家今天花一些時間來提供 IntriCon 的最新情況。我們對我們建立的業務和擺在我們面前的機會感到非常興奮，並期待繼續相應地更新團隊。確保安全，祝您有個美好的夜晚。

And with that, ladies and gentlemen, thank you for participating in today's program. You may now disconnect. Have a wonderful day.

女士們、先生們，感謝你們參加今天的節目。您現在可以斷開連線。祝你有美好的一天。