Eyenovia Inc (EYEN) 2024 Q2 法說會逐字稿

內容摘要

Eyenovia 召開了 2024 年第二季財報電話會議,討論了開發新眼部護理產品的進展、與其他公司的合作以及財務業績。他們強調了 FDA 對氯倍他索的批准以及即將推出的 MydCombi。

該公司致力於將先進的 Gen 2 Optejet 設備推向市場,並積極致力於產品發布的物流工作。 Eyenovia 報告在第二季度出現淨虧損,但正在評估融資方案,並專注於許可協議以獲得潛在收入。

他們對未來的銷售成長持樂觀態度,並正在積極探索乾眼領域的新合作。

完整原文

使用警語:中文譯文來源為 Google 翻譯,僅供參考,實際內容請以英文原文為主

  • Operator

    Operator

  • Greetings.

    問候。

  • Welcome to Eyenovia's second quarter 2024 earnings call.

    歡迎參加 Eyenovia 的 2024 年第二季財報電話會議。

  • (Operator Instructions) Please note, this conference is being recorded.

    (操作員說明)請注意,本次會議正在錄製中。

  • I would now like to turn the conference over to Eric Ribner, Investor Relations.

    我現在想將會議交給投資者關係部 Eric Ribner。

  • Thank you.

    謝謝。

  • You may begin.

    你可以開始了。

  • Eric Ribner - IR Contact Officer

    Eric Ribner - IR Contact Officer

  • Good afternoon, and welcome to Eyenovia's second quarter 2024 earnings conference call and audio webcast.

    下午好,歡迎參加 Eyenovia 2024 年第二季財報電話會議和音訊網路廣播。

  • With me today are Eyenovia's Chief Executive Officer, Michael Rowe; Chief Financial Officer, John Gandolfo; and Chief Operating Officer, Bren Kern.

    今天與我在一起的有 Eyenovia 執行長 Michael Rowe;財務長約翰‧甘道夫;和首席營運長布倫·科恩。

  • This afternoon, we issued a press release announcing financial results for the three months ended June 30, 2024.

    今天下午,我們發布新聞稿,公佈截至 2024 年 6 月 30 日止三個月的財務業績。

  • We encourage everyone to read today's press release as well as Eyenovia's quarterly report on Form 10-Q for the quarter ended June 30, 2024, which was just filed with the SEC.

    我們鼓勵大家閱讀今天的新聞稿以及 Eyenovia 剛剛向 SEC 提交的截至 2024 年 6 月 30 日的季度 10-Q 表格季度報告。

  • The company's press release and annual report are also available on our website at www.eyenovia.com.

    該公司的新聞稿和年度報告也可在我們的網站 www.eyenovia.com 上取得。

  • In addition, this conference call is being webcast on the company's website and will be archived and available for replay for future reference.

    此外,本次電話會議正在公司網站上進行網路直播,並將存檔並可供重播以供日後參考。

  • Please note that on today's call, we will be discussing products, product concepts, and candidates, some of which have yet to receive FDA approval.

    請注意,在今天的電話會議上,我們將討論產品、產品概念和候選產品,其中一些尚未獲得 FDA 批准。

  • Please also note that certain information discussed on the call today is covered under the Safe Harbor provisions of the Private Securities Litigation Reform Act.

    另請注意,今天電話會議中討論的某些資訊受《私人證券訴訟改革法》的安全港條款管轄。

  • We caution listeners that during the call, Eyenovia's management will be making forward-looking statements.

    我們提醒聽眾,在電話會議期間,Eyenovia 的管理層將做出前瞻性聲明。

  • Actual results could differ materially from those stated or implied by these forward-looking statements due to risks and uncertainties associated with the company's business.

    由於與公司業務相關的風險和不確定性,實際結果可能與這些前瞻性陳述中明示或暗示的結果有重大差異。

  • These forward-looking statements are subject to a number of risks, which are described in more detail in our quarterly Form 10-Q, as well as our Annual Reports on Form 10-K.

    這些前瞻性陳述面臨許多風險,這些風險在我們的季度 10-Q 表格以及 10-K 表格年度報告中進行了更詳細的描述。

  • This conference call contains time-sensitive information that is accurate only as of the date of this live broadcast, August 12, 2024.

    本次電話會議包含時間敏感訊息,僅截至本次直播之日(2024 年 8 月 12 日)準確。

  • Eyenovia undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this conference call, except as may be required by the applicable Securities Law.

    Eyenovia 不承擔修改或更新任何前瞻性聲明以反映本次電話會議之後發生的事件或情況的義務,除非適用的證券法有要求。

  • With that said, I'd like to turn the call over to Michael Rowe, Eyenovia's Chief Executive Officer.

    話雖如此,我想將電話轉給 Eyenovia 執行長 Michael Rowe。

  • Michael?

    麥可?

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Thank you, Eric, and welcome to our second quarter 2024 financial results conference call.

    謝謝艾瑞克,歡迎參加我們的 2024 年第二季財務業績電話會議。

  • During the second quarter, we advanced several initiatives that we discussed previously that are designed to strengthen the inherent value of Eyenovia.

    在第二季度,我們推進了先前討論過的幾項舉措,旨在增強 Eyenovia 的內在價值。

  • These include our novel Optejet dispensing technology which we recently bought into three dry eye collaboration agreements of significant midterm potential value; two FDA-approved products, MydCombi and clobetasol and MicroPine.

    其中包括我們新穎的 Optejet 點膠技術,我們最近購買了三項具有重大中期潛在價值的乾眼合作協議;兩種 FDA 核准的產品:MydCombi 和氯倍他索以及 MicroPine。

  • MicroPine is the only drug device combination therapy in late Phase III development for use in pediatric progressive myopia and is rapidly approaching a pivotal data readout.

    MicroPine 是唯一處於 III 期開發後期的藥物設備聯合療法,用於治療兒童進行性近視,並且正在迅速接近關鍵數據讀數。

  • At Eyenovia, our vision is to enhance yours by making topical ophthalmic therapies easier to use and easier to live with.

    在 Eyenovia,我們的願景是透過讓局部眼科療法更易於使用且更容易接受來增強您的治療效果。

  • By addressing a broad range of patients and eye care practitioner needs with novel technologies and products that are designed to be user-friendly, we believe we are building a strong foundation for accelerating value creation in 2025 and beyond.

    透過採用使用者友善的新技術和產品來滿足廣泛的患者和眼保健從業者的需求,我們相信我們正在為 2025 年及以後加速價值創造奠定堅實的基礎。

  • I would like to begin this afternoon with an update on MicroPine.

    我想從今天下午開始介紹 MicroPine 的最新情況。

  • Our drug device combination of low-dose atropine administered with our proprietary Optejet dispenser.

    我們的低劑量阿托品藥物裝置組合透過我們專有的 Optejet 分配器進行給藥。

  • This regimen is being developed as a potential treatment for progressive myopia in children.

    該方案正在開發中,作為治療兒童進行性近視的潛在方法。

  • Recall that MicroPine is currently being evaluated in the ongoing late Phase III CHAPERONE study.

    回想一下,MicroPine 目前正在正在進行的 III 期 CHAPERONE 研究後期進行評估。

  • Pediatric progressive myopia is increasingly recognized as an epidemic in both the United States and China.

    在美國和中國,兒童漸進性近視越來越被認為是一種流行病。

  • Pediatric myopia is a condition in which the eye abnormally elongates, putting children at risk of losing functional vision and can potentially result in severe retinal complications.

    兒童近視是一種眼睛異常伸長的疾病,使兒童面臨喪失功能性視力的風險,並可能導致嚴重的視網膜併發症。

  • In the US alone, of the nearly 20 million children with myopia, approximately $5 million are considered at risk of losing functional vision due to this disease.

    光是在美國,就有近 2,000 萬近視兒童,其中約 500 萬美元被認為面臨因這種疾病而喪失功能性視力的風險。

  • Additionally, the rights to MicroPine have been licensed to Arctic Vision, our partner in China, who is conducting a clinical trial for submission to the Chinese authority.

    此外,MicroPine 的權利已授權給我們在中國的合作夥伴 Arctic Vision,該公司正在進行臨床試驗以提交給中國當局。

  • While glasses and contact lenses are the current standard of care for children diagnosed with myopia, they only slow disease progression, but do not cure the disease.

    雖然眼鏡和隱形眼鏡是目前診斷近視兒童的標準治療方法,但它們只能減緩疾病的進展,而無法治癒疾病。

  • Current treatments are often not well tolerated or appropriate for the youngest, most vulnerable patients who frequently struggle with discomfort and [civ] issues.

    目前的治療方法往往無法很好地耐受或不適合最年輕、最脆弱的患者,他們經常與不適和[公民]問題作鬥爭。

  • Atropine has been shown in prior studies such as LAMP and ATOM, the slow myopia progression by as much as 60%.

    先前的LAMP和ATOM等研究顯示阿托品可以減緩近視加深60%之多。

  • And now a proprietary atrophy formulation administered with the Optejet may offer benefits far beyond what could be obtained with a traditional eye drop.

    現在,使用 Optejet 施用的專有萎縮製劑所提供的益處可能遠遠超出傳統眼藥水所能達到的效果。

  • With the Optejet technology, children in the CHAPERONE study as young as six years old are dosing themselves nightly with minimal parental supervision.

    借助 Optejet 技術,CHAPERONE 研究中年僅 6 歲的兒童可以在父母最少的監督下每晚自行服藥。

  • They can self-administer the dose, because the Optejet doesn't require any help head-tilting or manipulation of an eye dropper bottle, making aiming with the built-in mirror and medication administration achievable.

    他們可以自行給藥,因為 Optejet 不需要任何幫助傾斜頭部或操作滴管瓶,從而可以使用內置鏡子進行瞄準和給藥。

  • The children can see exactly where they are spraying medication and become familiar and comfortable with the dosing process quickly, which can reduce dosing anxiety and minimizes the myriad of struggles parent face when dosing children with conventional eye drops.

    孩子們可以準確地看到他們正在噴灑藥物的位置,並快速熟悉和適應給藥過程,這可以減少給藥焦慮,並最大限度地減少父母在給兒童使用傳統滴眼劑時面臨的無數困難。

  • The side effects of atropine dosed with the Optejet have been notably mild and transient in the CHAPERONE study.

    在 CHAPERONE 研究中,使用 Optejet 服用阿托品的副作用非常輕微且短暫。

  • These results are consistent with what we have come to expect with our advanced drug device dosing system.

    這些結果與我們對先進藥物裝置劑量系統的預期一致。

  • Throughout the trial, we have been measuring the performance of the Optejet with embedded firmware that allows study doctors to better understand how and when the device has been used.

    在整個試驗過程中,我們一直在測量具有嵌入式韌體的 Optejet 的性能,使研究醫生能夠更好地了解該設備的使用方式和時間。

  • Each time the dosing button is pressed to administer medication, the device records the event and stores the information.

    每次按下給藥按鈕進行給藥時,設備都會記錄該事件並儲存資訊。

  • This information can be accessed and reviewed by the clinic staff during visits from the study.

    臨床工作人員可以在研究訪問期間訪問和審查這些資訊。

  • For the commercial product, we anticipate MicroPine will be equipped with our Optecare system, which can notify patients and their parents when to administer their spray dose as well as communicate important compliance and adherence information to the treating physician.

    對於商業產品,我們預計 MicroPine 將配備我們的 Optecare 系統,該系統可以通知患者及其父母何時施用噴霧劑量,並向治療醫生傳達重要的依從性和依從性訊息。

  • Our engineers are working today on plans to validate the system for FDA approval.

    我們的工程師今天正在製定計劃以驗證該系統以獲得 FDA 批准。

  • We are continuing to advance the Phase III CHAPERONE study and are planning for an efficacy analysis in the fourth quarter of this year, once a statistically sufficient number of patients have reached the study efficacy end points.

    我們正在繼續推進 III 期 CHAPERONE 研究,並計劃在今年第四季一旦統計上足夠數量的患者達到研究療效終點後進行療效分析。

  • If the results are positive, this would significantly derisk the program and potentially enable an NDA submission as soon as late 2025 or early 2026.

    如果結果是正面的,這將極大地降低該計劃的風險,並有可能最早在 2025 年末或 2026 年初提交 NDA。

  • Recall that the FDA has agreed that a properly conducted single Phase III study could be sufficient for an NDA filing and approval.

    回想一下,FDA 已經同意,正確進行的單一 III 期研究足以提交 NDA 並獲得批准。

  • As we have mentioned before, we believe this program would then present a very attractive opportunity for commercialization either by us or a larger partner.

    正如我們之前提到的,我們相信該計劃將為我們或更大的合作夥伴提供非常有吸引力的商業化機會。

  • Turning now to dry eye.

    現在轉向乾眼症。

  • Since our last quarterly update, we have executed three collaboration agreements that leverage our Optejet dispenser for dry eye.

    自從上一季更新以來,我們已經執行了三項合作協議,利用我們的 Optejet 乾眼分配器。

  • Symptoms of dry eye can significantly interfere with daily life, leaving many patients unsatisfied with currently available therapies.

    乾眼症狀會嚴重干擾日常生活,使許多患者對目前可用的治療方法不滿意。

  • According to a recent survey, while 48% of patients reported carefully following their treatment plans, only 13% experienced lasting relief.

    根據最近的一項調查,雖然 48% 的患者表示認真遵循了治療計劃,但只有 13% 的患者獲得了持久的緩解。

  • Nearly 16 million Americans suffer from dry eye with treatment expenditures totaling over $3 billion in the US and $5 billion globally.

    近 1,600 萬美國人患有乾眼症,美國的治療費用總計超過 30 億美元,全球治療費用總計超過 50 億美元。

  • Beginning with Formosa, we recently announced that we signed an agreement to develop a formulation of clobetasol in the Optejet as a potential treatment for acute dry eye.

    從 Formosa 開始,我們最近宣布簽署了一項協議,開發 Optejet 中的氯倍他索配方,作為急性乾眼症的潛在治療方法。

  • This development program, which would require two 15-day clinical trials, would be free of any upfront fees from Eyenovia or development milestones to Formosa until the product is FDA approved.

    該開發計劃需要兩次為期 15 天的臨床試驗,在產品獲得 FDA 批准之前,Eyenovia 或 Formosa 的開發里程碑將免收任何前期費用。

  • This is an ideal extension of our existing relationship with Formosa and demonstrates how we can extend the use of an eye drop formulation through incorporation of the Optejet.

    這是我們與 Formosa 現有關係的理想延伸,並展示了我們如何透過納入 Optejet 來擴展滴眼劑配方的使用。

  • We also recently signed a collaboration agreement with Senju Pharmaceutical to develop a new adjunctive treatment for chronic dry eye disease.

    我們最近也與千住製藥簽署了一項合作協議,開發一種治療慢性乾眼症的新輔助治療方法。

  • For the terms of that agreement, we will jointly work to develop Senju's epithelial wound healing candidate, [SJP-0035], for use with our Optejet dispenser.

    根據該協議的條款,我們將共同開發 Senju 的上皮傷口癒合候選藥物 [SJP-0035],與我們的 Optejet 分配器一起使用。

  • This potential drug device combination is unique because it would be designed for use alongside other dry eye medications.

    這種潛在的藥物裝置組合是獨特的,因為它被設計為與其他乾眼藥物一起使用。

  • In other words, it complements existing products rather than competing with them.

    換句話說,它是現有產品的補充,而不是與它們競爭。

  • We are working towards a meeting with the FDA later this year, followed by completion of a Phase IIb study in 2025.

    我們正努力在今年稍後與 FDA 舉行會議,然後在 2025 年完成 IIb 期研究。

  • If successful, the companies will expand this collaboration to initiate two Phase III studies by 2026.

    如果成功,兩家公司將擴大合作範圍,到 2026 年啟動兩項 III 期研究。

  • SJP-0035 has been shown to be well tolerated at prior Phase I and Phase II studies as a standard eye drop tested at multiple doses in over 250 subjects.

    在先前的 I 期和 II 期研究中,SJP-0035 作為標準滴眼劑在超過 250 名受試者中進行了多次劑量測試,結果顯示具有良好的耐受性。

  • And continuing on with the topic of dry eye, in late February, we entered into a collaboration agreement with SGN Nanopharma, an innovation-led clinical-stage nano pharmaceutical company focused on creating impactful, best-in-class nanotherapeutics targeting large unmet medical needs.

    繼續討論乾眼症這個主題,2 月下旬,我們與SGN Nanopharma 簽訂了合作協議,SGN Nanopharma 是一家以創新為主導的臨床階段奈米製藥公司,專注於開發有影響力的一流奈米療法,以滿足大量未滿足的醫療需求。

  • SGN's proprietary myocellular nanoparticle platform allows for the distribution of an active pharmaceutical ingredient into three or more phases, thereby improving its bioavailability, biodistribution, and pharmacokinetics.

    SGN 專有的肌肉細胞奈米顆粒平台可以將活性藥物成分分佈到三個或更多相中,從而提高其生物利用度、生物分佈和藥物動力學。

  • Per the terms of the agreement, Eyenovia has been conducting feasibility and process manufacturing testing with SGN's Phase III-ready ophthalmic cyclosporine formulation, SGN-101, in combination with our Gen 2 Optejet device as a potential treatment for chronic dry eye.

    根據協議條款,Eyenovia 一直在使用 SGN 的 III 期眼用環孢素製劑 SGN-101 與我們的 Gen 2 Optejet 設備結合作為慢性乾眼的潛在治療方法進行可行性和製程製造測試。

  • A combination of a faster working cyclosporine than the Optejet could be a powerful new treatment option for this large and underserved market.

    對於這個龐大且服務不足的市場,結合比 Optejet 起效更快的環孢菌素可能是一種強大的新治療選擇。

  • With the SGN collaboration, we may have this Phase III-ready asset next year in chronic dry eye.

    透過與 SGN 的合作,我們可能會在明年擁有這項針對慢性乾眼症的 III 期資產。

  • With these three agreements, we can potentially cover the entire dry eye market, which is a $3 billion annual addressable market in the United States with a multimillion patient population and significant unmet needs.

    透過這三項協議,我們有可能涵蓋整個乾眼市場,這是美國每年價值 30 億美元的潛在市場,擁有數百萬患者人口和大量未滿足的需求。

  • We anticipate achieving this through an acute product for flare-ups with Formosa, an adjunctive chronic medication with Senju, and a chronic medication with SGN.

    我們預計透過 Formosa 的急性發作產品、Senju 的輔助慢性藥物和 SGN 的慢性藥物來實現這一目標。

  • Now, I'd like to discuss Clobetasol.

    現在,我想討論一下氯倍他索。

  • The FDA approved Clobetasol on March 4, and shortly after the new drug application or NDA for this product was transferred to us from Formosa.

    FDA 於 3 月 4 日批准了氯倍他索,不久之後該產品的新藥申請或 NDA 從福爾摩沙轉移給我們。

  • Clobetasol is the first new ophthalmic steroid approved in the US in over 15 years.

    氯倍他索是 15 年來第一個在美國獲得批准的新型眼科類固醇。

  • Clobetasol addresses many unmet needs in ophthalmic steroids with its highly differentiated clinical and pharmacologic profile.

    氯倍他索以其高度差異化的臨床和藥理學特徵滿足了眼科類固醇中許多未滿足的需求。

  • It offers twice daily dosing.

    它每天給藥兩次。

  • And from a safety perspective, fewer than 1% of patients experience sudden eye pressure increases, which may be more common with other steroids.

    從安全角度來看,只有不到 1% 的患者會出現眼壓突然升高的情況,而這在使用其他類固醇時可能更為常見。

  • Intraocular inflammation and eye pressure spikes are the primary safety concerns for eye surgeons as they can lead to serious clinical consequences, complications and non-reimbursable costs for providers.

    眼內發炎和眼壓高峰是眼外科醫生面臨的主要安全問題,因為它們可能會給醫療服務提供者帶來嚴重的臨床後果、併發症和不可報銷的費用。

  • We believe that Clobetasol has the potential to become the leading option in the postsurgical space.

    我們相信氯倍他索有潛力成為術後領域的領先選擇。

  • This unique steroid is the first product developed using Formosa's proprietary APNT nanoparticle formulation platform.

    這種獨特的類固醇是第一個使用台塑專有的 APNT 奈米顆粒配方平台開發的產品。

  • Patients do not have to shape the product prior to use, and that is just one of the unique elements of our approved label.

    患者無需在使用前塑造產品形狀,這只是我們批准標籤的獨特元素之一。

  • While that may seem minor, it highlights the key difference between Clobetasol and other ophthalmic steroids.

    雖然這看起來微不足道,但它凸顯了氯倍他索和其他眼用類固醇之間的主要差異。

  • Clobetasol's efficacy and its previously discussed safety profile further set it apart.

    氯倍他索的功效和先前討論的安全性進一步使其與眾不同。

  • In clinical results, nearly 9 out of 10 patients experienced complete relief from postsurgical pain and 60% had total resolution of inflammation within 15 days after ocular surgery with all side effects occurring in less than 2% of cases.

    臨床結果顯示,近十分之九的患者術後疼痛完全緩解,60% 的患者在眼科手術後 15 天內發炎完全消退,只有不到 2% 的病例出現所有副作用。

  • Moreover, twice daily dosing without the need for titration is a clear advantage, especially compared to treatments requiring up to four doses a day.

    此外,每天兩次給藥而無需滴定是一個明顯的優勢,特別是與每天最多需要四次劑量的治療相比。

  • This simplicity is particularly valuable for eye surgery patients who will often use multiple medications during recovery.

    這種簡單性對於眼科手術患者尤其有價值,因為他們在恢復期間經常使用多種藥物。

  • Both eye doctors and patients will appreciate this advancement, which may simplify the treatment regimen.

    眼科醫生和患者都會欣賞這一進步,這可能會簡化治療方案。

  • It is estimated that more than 7 million ocular surgeries are performed annually in the US with topical ocular steroids and steroid combinations currently generating $1.3 billion in sales.

    據估計,美國每年進行超過 700 萬例眼科手術,目前眼部局部類固醇和類固醇組合的銷售額為 13 億美元。

  • This represents a significant market opportunity.

    這代表著一個重要的市場機會。

  • We believe we can capture a mid-single-digit market share over the next three or four years, as previously mentioned.

    正如前面提到的,我們相信我們可以在未來三、四年內獲得中個位數的市場份額。

  • Our 10 sales representatives who we began hiring over the last few months and completed their training just two weeks ago, are today prequalifying eye surgery offices for their interest in Clobetasol.

    我們在過去幾個月開始招募並在兩週前完成培訓的 10 名銷售代表今天正在對眼科手術辦公室進行資格預審,因為他們對氯倍他索感興趣。

  • Each representative or key account manager aims to secure 50 offices in preparation for the product launch in the United States.

    每個代表或大客戶經理的目標是確保 50 個辦事處,為在美國推出產品做準備。

  • This approach will allow us to hit the ground running and build upon early success.

    這種方法將使我們能夠立即行動並在早期成功的基礎上再接再厲。

  • We had previously communicated that we were planning on a commercial launch this summer, which would be supplemented by our co-promotion agreement with NovaBay Pharmaceuticals.

    我們之前曾表示,我們計劃在今年夏天進行商業發布,我們與 NovaBay Pharmaceuticals 的聯合推廣協議將對此進行補充。

  • This is still our intent as we await the product arriving here from Formosa.

    當我們等待從福爾摩沙運來的產品時,這仍然是我們的意圖。

  • In the meantime, we have expanded our promotional arrangement with NovaBay to include additional products already used by our core customers, enabling our sales force to operate efficiently, while they set the stage for what we believe will be a game changer in the ocular steroid treatment.

    同時,我們擴大了與 NovaBay 的促銷安排,包括我們的核心客戶已經使用的其他產品,使我們的銷售人員能夠高效運作,同時為我們相信將改變眼部類固醇治療的遊戲規則奠定了基礎。

  • Now, I'll provide an update on MydCombi.

    現在,我將提供 MydCombi 的最新情況。

  • It is the first and only FDA-approved fixed combination of two well-known pupil dilation drugs, tropicamide and phenylephrine, and the first approved ophthalmic spray using the Optejet platform.

    它是 FDA 批准的第一個也是唯一一個由兩種著名的擴瞳藥物托吡卡胺和去氧腎上腺素組成的固定組合,也是第一個使用 Optejet 平台批准的眼科噴霧劑。

  • Now that the hiring and training of our sales force is complete, and we have satisfied licensing requirements in states covering over two-third of the US population, we are promoting MydCombi in earnest.

    現在我們銷售隊伍的招募和培訓已經完成,我們已經滿足了涵蓋美國三分之二以上人口的各州的許可要求,我們正在認真推廣 MydCombi。

  • As of June 30, we had trained and converted 63 offices.

    截至6月30日,我們已培訓並改造了63個辦公室。

  • This was up from approximately eight offices three months earlier.

    這比三個月前大約八個辦公室有所增加。

  • Many of those customers you'll see in our social media channel sharing their positive experiences for the product.

    您會在我們的社群媒體管道中看到許多客戶分享他們對該產品的正面體驗。

  • We are pleased with this initial trajectory and on track to onboard more than 260 new offices by the end of the third quarter.

    我們對這一初步發展軌跡感到滿意,並預計在第三季末開設 260 多個新辦事處。

  • Additionally, we are partnering with these offices on a waiting room promotional campaign to afford patients about MydCombi.

    此外,我們也與這些辦公室合作進行候診室促銷活動,向患者提供有關 MydCombi 的資訊。

  • We are also gathering market research information from these offices to help them bolster their practice satisfaction scores and better care for their patients.

    我們也從這些辦公室收集市場研究信息,以幫助他們提高實踐滿意度分數並更好地照顧患者。

  • Offices and institutions, including the University of California and premier buying groups like Vision Source, have selected MydCombi for several compelling reasons.

    包括加州大學和 Vision Source 等頂級採購集團在內的辦公室和機構出於幾個令人信服的原因選擇了 MydCombi。

  • Unlike traditional eye drops, MydCombi spray delivers precise amount of medication, making the dilation process cleaner and more efficient.

    與傳統眼藥水不同,MydCombi 噴霧可提供精確劑量的藥物,使擴張過程更清潔、更有效率。

  • Clinical studies have reported virtually no stinging, ensuring the comfortable experience for patients.

    臨床研究顯示幾乎沒有刺痛感,確保了患者的舒適體驗。

  • Its hygienic design eliminates protruding tips, reducing the risk of cross contamination between patients.

    其衛生設計消除了突出的尖端,降低了患者之間交叉污染的風險。

  • Moreover, MydCombi works reliably and quickly setting it apart from other options.

    此外,MydCombi 工作可靠且快速,使其與其他選項區分開來。

  • At this point, I'd like to turn the call over to our Chief Operating Officer, Bren Kern, for our manufacturing update.

    此時,我想將電話轉給我們的營運長 Bren Kern,以了解我們的製造最新情況。

  • Bren?

    布倫?

  • Bren Kern - Chief Operating Officer

    Bren Kern - Chief Operating Officer

  • Thanks, Michael.

    謝謝,麥可。

  • Our engineering, manufacturing, quality, and regulatory teams have been focusing on bringing our advanced Gen 2 Optejet device to the market.

    我們的工程、製造、品質和監管團隊一直致力於將我們先進的 Gen 2 Optejet 設備推向市場。

  • As a reminder, our Gen 2 platform offers the same performance as our first-generation platform but simplifies the user experience by utilizing motor control actuation and a sleeker profile.

    提醒一下,我們的第二代平台提供與第一代平台相同的性能,但透過利用馬達控制驅動和更時尚的外形簡化了用戶體驗。

  • This design has also been assessed for scalability, offering fewer production steps, thus bringing us closer to our cost of goods targets.

    該設計還經過了可擴展性評估,提供更少的生產步驟,使我們更接近我們的商品成本目標。

  • Additionally, the Gen 2 device is being designed for future enhancements, such as our digital monitoring program, OptiCare.

    此外,第二代設備正在設計用於未來的增強功能,例如我們的數位監控程式 OptiCare。

  • Fill and finish operations for the Gen 2 platform are performed at our Redwood City facility.

    第 2 代平台的填充和加工操作在我們的雷德伍德城工廠進行。

  • Recently, the production team completed our fourth media fill with passing results, verifying the aseptic process and readying our systems to produce registration batches of MydCombi.

    最近,生產團隊完成了第四次培養基填充,結果合格,驗證了無菌過程,並準備好我們的系統來生產 MydCombi 的註冊批次。

  • The MydCombi bulk drug is scheduled to ship this week where three manufacturing lots will subsequently be filled into the Gen 2 device and evaluated in a 12-month stability study.

    MydCombi 原料藥計劃於本週發貨,隨後將三個生產批次裝入 Gen 2 設備中,並在為期 12 個月的穩定性研究中進行評估。

  • The units that comprise the study are commonly referred to as registration batches as the results of these studies are used to prove the drug product remains stable within the container over an extended duration.

    組成研究的單位通常稱為註冊批次,因為這些研究的結果用於證明藥品在較長時間內在容器內保持穩定。

  • We anticipate the completion of manufacturing for the registration batches at the end of this year.

    我們預計註冊批次的生產將於今年底完成。

  • The data collected over the subsequent 12 months will then be submitted to the FDA for its review.

    隨後 12 個月收集的數據將提交給 FDA 審查。

  • Similarly, the Gen 2 device also needs to undergo functional testing to obtain FDA approval.

    同樣,Gen 2 裝置也需要經過功能測試才能獲得 FDA 的批准。

  • On July 23, of this year, we received feedback from the FDA regarding our Type C meeting request to discuss the qualification of the Gen 2 platform.

    今年 7 月 23 日,我們收到了 FDA 關於我們討論 Gen 2 平台資格的 C 類會議請求的回饋。

  • Content on the Type C meeting included an extensive overview of the Gen 2 device qualification plans covering each aspect of testing we intend to perform.

    C 型會議的內容包括第二代設備資格計畫的廣泛概述,涵蓋了我們打算執行的測試的各個方面。

  • The feedback from the FDA was largely in agreement with our plans, providing high confidence that when complete, the requirements of the FDA will be fully satisfied.

    FDA 的回饋與我們的計劃基本一致,這讓我們充滿信心,一旦完成,將完全滿足 FDA 的要求。

  • Our engineering team is now detailing the associated protocols and scheduling applicable tests.

    我們的工程團隊現在正在詳細說明相關協議並安排適用的測試。

  • We are targeting the completion of our first round of testing in early 2025.

    我們的目標是在 2025 年初完成第一輪測試。

  • This provides ample time to complete the associated reports and FDA submission package on or before receiving the results of the aforementioned stability studies.

    這為在收到上述穩定性研究結果時或之前完成相關報告和 FDA 提交包提供了充足的時間。

  • The work we are doing to qualify the Gen 2 MydCombi platform provides us with a model that we're able to apply to other drug platforms.

    我們正在進行的鑑定 Gen 2 MydCombi 平台的工作為我們提供了一個能夠應用於其他藥物平台的模型。

  • For instance, upon receiving FDA approval for the Gen 2 MydCombi, subsequent device testing will likely be limited to verifying key performance characteristics for the new drug and/or any new features we wish to incorporate.

    例如,在獲得 FDA 對 Gen 2 MydCombi 的批准後,後續的設備測試可能僅限於驗證新藥的關鍵性能特徵和/或我們希望納入的任何新功能。

  • These tests comprise a minority of device testing, offering expediency for future platform qualification.

    這些測試包括少數設備測試,為未來的平台資格認證提供了便利。

  • For example, the Gen 2 platform for MydCombi will incorporate features only necessary for office use.

    例如,MydCombi 的 Gen 2 平台將包含僅在辦公室使用所需的功能。

  • But for MicroPine, we will add additional features such as the OptiCare digital compliance system and child safety and lockout feature enabling a more desirable home use platform.

    但對於 MicroPine,我們將添加其他功能,例如 OptiCare 數位合規系統以及兒童安全和鎖定功能,從而實現更理想的家庭使用平台。

  • The engineering team need only to focus on these new features as the MydCombi design has already provided base platform from which to build upon.

    工程團隊只需關注這些新功能,因為 MydCombi 設計已經提供了可供建置的基礎平台。

  • Additionally, this system enables us to best support potential licensing partners in new treatment applications such as dry eye.

    此外,該系統使我們能夠為乾眼等新治療應用的潛在許可合作夥伴提供最佳支援。

  • As mentioned by Michael, our manufacturing team performed fill and finish activities for SGN's Phase III-ready ophthalmic cyclosporine formulation, SGN-101, at the end of July.

    正如 Michael 所提到的,我們的製造團隊在 7 月底對 SGN 的 III 期眼用環孢素製劑 SGN-101 進行了填充和完成活動。

  • Eyenovia and SGN will now collaborate to discuss on the next steps, which may include a preliminary stability evaluation or additional device-related testing.

    Eyenovia 和 SGN 現在將合作討論後續步驟,其中可能包括初步穩定性評估或額外的設備相關測試。

  • Our model for evaluating new drugs begins with a small spray ability study utilizing our first-generation device to assess delivery volume.

    我們評估新藥的模型始於利用我們的第一代設備評估給藥量的小型噴霧能力研究。

  • This preliminary assessment is short in duration, typically less than a month and provides Eyenovia and any potential partner with confidence about drug delivery performance in the Optejet platform.

    此初步評估持續時間較短,通常不到一個月,讓 Eyenovia 和任何潛在合作夥伴對 Optejet 平台的藥物傳輸性能充滿信心。

  • With this hurdle cleared, we then begin discussing manufacturing the product and conducting appropriate engineering tests.

    清除了這個障礙後,我們就開始討論產品的製造並進行適當的工程測試。

  • In the case of SGN, this included fill and finish operations for cyclosporine in the second-generation platform.

    就 SGN 而言,這包括第二代平台中環孢菌素的填充和加工操作。

  • The collaborative and progressive nature of testing ensures critical aspects associated with introducing a new drug into the Optejet platform are properly developed before engaging in a full platform.

    測試的協作性和漸進性確保了與將新藥引入 Optejet 平台相關的關鍵方面在參與完整平台之前得到正確開發。

  • These types of details are covered in the development agreements we established with each potential licensing partner.

    這些類型的詳細資訊包含在我們與每個潛在許可合作夥伴簽訂的開發協議中。

  • While all of this is going on, we are also still just beginning to commercialize our first Optejet-based product, MydCombi.

    儘管這一切都在進行,但我們也才剛開始將我們的第一個基於 Optejet 的產品 MydCombi 商業化。

  • Production continues to progress as planed and as a reminder, earlier this year, our Redwood City facility was approved by the FDA to conduct final assembly, labeling, and packaging of MydCombi in our Gen 1 platform.

    生產繼續按計劃進行,提醒大家,今年早些時候,我們的紅木城工廠獲得 FDA 批准,可以在我們的 Gen 1 平台上進行 MydCombi 的最終組裝、標籤和包裝。

  • This addition, coupled with the capabilities of our CMO and our Reno facility provides synergies and manufacturing by allowing them to occur in relative close proximity and within the same time zone.

    這項補充,加上我們的 CMO 和里諾工廠的能力,透過允許它們在相對較近的距離和同一時區內進行,提供了協同效應和製造。

  • This provides Eyenovia with greater control and scheduling flexibility, which we are leveraging to our advantage.

    這為 Eyenovia 提供了更大的控制和調度靈活性,我們正在利用這一優勢。

  • Moving to Clobetasol.

    轉向氯倍他索。

  • Our distribution systems have largely been established and as a reminder, our Redwood City facility will serve as the distribution center.

    我們的配送系統已基本建立,提醒您,我們的紅木城工廠將作為配送中心。

  • These preparations should enable the Eyenovia sales team, as well as our co-promotion partner, NovaBay, to immediately begin selling upon receiving Clobetasol products.

    這些準備工作將使 Eyenovia 銷售團隊以及我們的共同推廣合作夥伴 NovaBay 在收到氯倍他索產品後立即開始銷售。

  • My enthusiasm for the activities, plans, most importantly, our future has never been higher.

    我對活動、計劃、最重要的是我們的未來的熱情從未如此高漲。

  • We have an amazing delivery platform, incredible team, and have engaged with potential partners that can leverage the Optejet platform in treatments to benefit those afflicted by debilitating eye disease.

    我們擁有令人驚嘆的交付平台、令人難以置信的團隊,並與潛在的合作夥伴進行了合作,他們可以利用 Optejet 平台進行治療,使那些患有衰弱性眼疾的人受益。

  • I would now like to turn the call over to our Chief Financial Officer, John Gandolfo.

    我現在想將電話轉給我們的財務長約翰甘道夫 (John Gandolfo)。

  • John?

    約翰?

  • John Gandolfo - Chief Financial Officer, Secretary

    John Gandolfo - Chief Financial Officer, Secretary

  • Thank you, Bren.

    謝謝你,布倫。

  • For the second quarter of 2024, we reported net loss of approximately $11.1 million or $0.21 per share on approximately 53.1 million weighted average shares outstanding.

    2024 年第二季度,我們報告約 5,310 萬股加權平均已發行股票的淨虧損約為 1,110 萬美元,即每股 0.21 美元。

  • This includes a $0.05 loss related to the $2.9 million of costs for bringing MicroPine back to Eyenovia and a $0.02 gain included in other income from a change in fair value of equity consideration payable.

    其中包括與將 MicroPine 退還給 Eyenovia 的 290 萬美元成本相關的 0.05 美元損失,以及因應付股權對價公允價值變動而計入其他收入的 0.02 美元收益。

  • This compares to a net loss of $6.2 million or $0.16 per share and approximately 38.1 million weighted average shares outstanding for the second quarter of 2023.

    相比之下,2023 年第二季的淨虧損為 620 萬美元或每股 0.16 美元,加權平均流通股約為 3,810 萬股。

  • Research and development expenses totaled approximately $4.6 million for the second quarter of 2024 and this compared to $2.8 million for the first quarter of 2023, an increase of 64%.

    2024 年第二季的研發費用總計約為 460 萬美元,而 2023 年第一季的研發費用為 280 萬美元,成長了 64%。

  • This increase is largely the result of expensing previously deferred clinical supplies.

    這一增長主要是由於先前推遲的臨床用品費用增加所致。

  • And this was related to the reacquisition of the license rights from Bausch + Lomb.

    而這與重新收購博士倫的許可權有關。

  • In addition, the company had increased internal engineering expenses related to development of the Gen 2 Optejet system.

    此外,該公司還增加了與 Gen 2 Optejet 系統開發相關的內部工程費用。

  • For the second quarter of 2024, G&A expenses were approximately $3.8 million as compared to $3.1 million for the second quarter of 2023, an increase of 19%.

    2024 年第二季的一般管理費用約為 380 萬美元,而 2023 年第二季為 310 萬美元,成長 19%。

  • This increase was comprised of a $374,000 increase in salaries and benefits, primarily related to the hiring of our internal sales force for the start of the company's commercialization efforts as well as $255,000 related to a nonrecurring FDA fee.

    這一增長包括 374,000 美元的工資和福利增長(主要與為公司商業化工作的開始而僱用我們的內部銷售人員有關)以及與一次性 FDA 費用相關的 255,000 美元。

  • Total operating expenses for the second quarter of 2024 were approximately $11.2 million, including the previously mentioned $2.9 million in repatriation costs for bringing MicroPine back to Eyenovia, and this compares to $6 million for the same period of 2023.

    2024 年第二季的總營運費用約為 1,120 萬美元,包括先前提到的將 MicroPine 帶回 Eyenovia 的 290 萬美元遣返費用,而 2023 年同期為 600 萬美元。

  • This represents an increase of approximately 88%.

    這意味著增加了約 88%。

  • Our second quarter 2024 operating expense figure included approximately $3.8 million of noncash expenses.

    我們 2024 年第二季的營運支出數據包括約 380 萬美元的非現金支出。

  • At June 30, 2024, we reported unrestricted cash of approximately $2.3 million, and this excludes approximately $5.8 million of capital that was raised after June 30, 2024.

    截至 2024 年 6 月 30 日,我們報告的非限制現金約為 230 萬美元,這不包括 2024 年 6 月 30 日之後籌集的約 580 萬美元資本。

  • In addition to the current resources that we have available, the company is currently evaluating a wide range of capital raising structures and initiatives in order to fund our ongoing strategy.

    除了我們現有的資源外,該公司目前正在評估各種融資結構和舉措,以便為我們正在進行的策略提供資金。

  • In addition, we will continue to look at ways to improve our operating efficiencies and potentially reduce operating expenses going forward.

    此外,我們將繼續尋找提高營運效率並可能降低未來營運費用的方法。

  • I'll now provide an update on our existing licensing programs with Arctic Vision which covers all three of our products in China and South Korea: MicroPine, MicroLine, as well as MydCombi and provides us sales royalties in addition to development milestones.

    現在,我將提供有關Arctic Vision 的現有許可計劃的最新信息,該計劃涵蓋我們在中國和韓國的所有三種產品:MicroPine、MicroLine 以及MydCombi,並為我們提供除開發里程碑之外的銷售特許權使用費。

  • MicroPine in particular, is a significant opportunity in China for pediatric myopia.

    尤其是MicroPine,對中國兒童近視來說是一個重大機會。

  • If approved, MicroPine could be potentially a meaningful source of nondilutive funding for our company over the long term.

    如果獲得批准,從長遠來看,MicroPine 可能成為我們公司重要的非稀釋性資金來源。

  • To date, our license agreements have generated approximately $16 million in license fees, and we have the potential to earn an additional $25 million in net license and development milestones from Arctic Vision over the next three to four years.

    迄今為止,我們的授權協議已產生約 1,600 萬美元的授權費,並且我們有潛力在未來三到四年內從 Arctic Vision 獲得額外 2,500 萬美元的淨許可和開發里程碑。

  • Included in this amount is approximately $1.5 million to $2 million expected to be received over the next six to nine months.

    其中包括約 150 萬至 200 萬美元,預計將在未來六至九個月內收到。

  • As I said previously, if our products are approved, upon commercialization, Eyenovia is also eligible to earn significant sales royalties.

    正如我之前所說,如果我們的產品獲得批准,在商業化後,Eyenovia 也有資格獲得可觀的銷售特許權使用費。

  • We are continuing to assess potential pipeline expansion opportunities similar to our Formosa, Senju, and SGN agreements, and we will continue to leverage the Optejet technology to address unmet needs and additional large ophthalmic indications beginning with dry eye.

    我們正在繼續評估潛在的管道擴張機會,類似於我們的 Formosa、Senju 和 SGN 協議,我們將繼續利用 Optejet 技術來解決未滿足的需求和從乾眼開始的其他大型眼科適應症。

  • As Michael indicated earlier, we believe the steps we have taken to date create a solid foundation for which to drive meaningful sales growth in 2025 and beyond.

    正如邁克爾早些時候指出的那樣,我們相信迄今為止所採取的步驟為推動 2025 年及以後的銷售成長奠定了堅實的基礎。

  • In conclusion, we are very pleased with our performance in the second quarter of 2024.

    總之,我們對 2024 年第二季的表現非常滿意。

  • And to summarize our key highlights today, we are preparing for a full analysis of data from our ongoing Phase III CHAPERONE trial of MicroPine in pediatric progressive myopia, which, if positive, would allow us to significantly advance its remaining development timelines.

    總結一下今天的主要亮點,我們正在準備對正在進行的 MicroPine 治療兒童進行性近視的 III 期 CHAPERONE 試驗的數據進行全面分析,如果結果積極,將使我們能夠顯著提前其剩餘的開發時間表。

  • We entered into development and collaborations with Formosa, Senju, and SGN to develop novel therapeutic formulation for the Optejet that would potentially address unmet needs in acute chronic dry eye disease.

    我們與 Formosa、Senju 和 SGN 進行開發和合作,為 Optejet 開發新型治療配方,這可能會解決急性慢性乾眼症未滿足的需求。

  • We entered into a co-promotion agreement with NovaBay Pharmaceuticals, whereby NovaBay will market Clobetasol through its US physician dispensed channel.

    我們與 NovaBay Pharmaceuticals 簽訂了一項聯合推廣協議,根據該協議,NovaBay 將透過其美國醫生配藥管道銷售氯倍他索。

  • And the agreement also gives us access to their prescription Avenova, Antimicrobial Lid & Lash Solution, which complements our commercial products.

    該協議還使我們能夠獲得他們的處方 Avenova、抗菌蓋子和睫毛解決方案,它補充了我們的商業產品。

  • Our commercial launch of MydCombi continues to track well with the product now in use at over 63 ophthalmology offices around the country and tracking to more than 260 by the end of the third quarter.

    我們的 MydCombi 商業推出繼續保持良好勢頭,該產品目前在全國超過 63 家眼科診所使用,到第三季末已超過 260 家。

  • And finally, our license agreement with Arctic Vision is progressing well and remains a promising avenue for significant development and regulatory milestones as well as the potential for sales royalties.

    最後,我們與 Arctic Vision 的授權協議進展順利,並且仍然是實現重大開發和監管里程碑以及銷售特許權使用費潛力的有希望的途徑。

  • That concludes our prepared remarks.

    我們準備好的演講到此結束。

  • We would now like to open the call to questions.

    我們現在要開始提問。

  • Operator?

    操作員?

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Matt Kaplan, Ladenburg Thalmann.

    馬特卡普蘭,拉登堡塔爾曼。

  • Matt Kaplan - Analyst

    Matt Kaplan - Analyst

  • Hey, guys.

    嘿,夥計們。

  • Thanks for taking the questions.

    感謝您提出問題。

  • Just can you give us a little bit more detail in terms of the path to the regulatory filing for MicroPine, assuming a positive outcome of the CHAPERONE analysis expected in the near term in the fourth quarter?

    假設 CHAPERONE 分析預計在第四季度的短期內取得正面結果,您能否為我們提供有關 MicroPine 監管備案路徑的更多細節?

  • And then also kind of in that vein, also talk about the evolving competitive landscape for MicroPine and MicroPine and how it can differentiate and -- when it comes to market?

    然後也以這種方式,談論 MicroPine 和 MicroPine 不斷變化的競爭格局,以及它如何脫穎而出,以及——當談到市場時?

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Thank you, Matt.

    謝謝你,馬特。

  • The regulatory pathway would be after looking at the efficacy data, we would request a meeting with the FDA.

    監管途徑是在查看功效數據後,我們將要求與 FDA 舉行會議。

  • The earliest we would probably get that meeting is the beginning of 2025, 75 days after we ask for it, for the FDA to review the efficacy data.

    我們最早可能會在 2025 年初召開該會議,即我們要求召開 75 天后,以便 FDA 審查療效數據。

  • Assuming that goes well, there's also a commitment for 1 year of additional safety, that would be up in about September, October of 2025.

    假設進展順利,也承諾提供 1 年的額外安全保障,預計到 2025 年 9 月、10 月左右到期。

  • So when that is done, we would be able to submit the full data -- full efficacy and safety information.

    因此,完成後,我們將能夠提交完整的數據——完整的功效和安全性資訊。

  • At the same time, we plan to make registration batches of MicroPine beginning the end of this year.

    同時,我們計劃從今年年底開始批量註冊MicroPine。

  • So that by the end of 2025, we would have the efficacy, the safety, and the stability data ready for that NDA submission.

    因此,到 2025 年底,我們將為 NDA 提交準備好有效性、安全性和穩定性資料。

  • And that's why we're saying the end of 2025, early 2026.

    這就是為什麼我們說 2025 年底、2026 年初。

  • And then would be a 10-month review, which would take you to the middle back half of 2026 for approval.

    然後是為期 10 個月的審核,需要到 2026 年中下半年才能獲得批准。

  • In terms of the competitive landscape, there's only one other product that we are aware of that's in late-stage development for this.

    就競爭格局而言,據我們所知,只有另一種產品處於後期開發階段。

  • And that product is similarly a low-dose atropine, but it's an eye drop.

    該產品同樣是低劑量阿托品,但它是一種滴眼劑。

  • And we think there's a tremendous difference between using an eye drop in pediatrics and being able to use the Optejet.

    我們認為在兒科使用眼藥水和使用 Optejet 之間存在巨大差異。

  • With the Optejet, as I mentioned, the kids are doing this themselves, and they have to do it every night.

    正如我所提到的,使用 Optejet,孩子們可以自己做這件事,而且他們每天晚上都必須這樣做。

  • They brush their teeth, they spray their eyes, and go to bed.

    他們刷牙,噴水,然後上床睡覺。

  • But they have to do it for three years at least to get the full benefit of the product.

    但他們必須至少堅持三年才能充分發揮產品的優勢。

  • So this is something that just as a parent myself, I have difficulty imagining me having to do that every night with my children and knowing how much they would enjoy having eye drops put in their eyes.

    因此,作為一名家長,我很難想像我必須每天晚上和我的孩子們一起做這件事,並且知道他們會多麼喜歡滴眼藥水到眼睛裡。

  • Also, our product, at least from what we're seeing in the mask data, is very well tolerated, which is not a surprise given the Optejet uses a lower volume of medication.

    此外,我們的產品,至少從我們在面罩數據中看到的情況來看,具有良好的耐受性,考慮到 Optejet 使用的藥物量較少,這並不奇怪。

  • And inherent with that lower volume of medication, you're also getting less systemic exposure to the active ingredient, which when you're talking about pediatrics, you have small people using a drug over many years, and you want to minimize that as much as possible.

    由於藥物用量較少,您對活性成分的全身暴露也較少,當您談論兒科時,有小個子的人使用藥物多年,您希望盡可能減少這種情況盡可能。

  • And then lastly, you have all the benefits of the electronic Optecare system, which means that parents and the kids and their doctors can see what's going on because if you don't use the medication, you don't get the benefit.

    最後,您可以享受電子 Optecare 系統的所有好處,這意味著父母、孩子和他們的醫生可以看到發生了什麼,因為如果您不使用藥物,您就無法獲得好處。

  • And we want to make sure that everybody gets that benefit.

    我們希望確保每個人都能受益。

  • And we have seen from the initial compliance data that the kids are using it more often and more regularly than one would expect from an eye drop.

    我們從最初的依從性數據中看到,孩子們使用它的頻率和規律性比人們對眼藥水的預期要高。

  • So I think competitively, we'll be in a very good place because of the marriage between the drug and the Optejet system.

    因此,我認為從競爭角度來看,由於該藥物與 Optejet 系統的結合,我們將處於一個非常有利的位置。

  • Matt Kaplan - Analyst

    Matt Kaplan - Analyst

  • Okay.

    好的。

  • That's really helpful.

    這真的很有幫助。

  • Thank you, Michael.

    謝謝你,麥可。

  • And then if I may, a couple of more questions.

    如果可以的話,還有幾個問題。

  • In terms of Clobetasol, when do you think you'll be able to launch that?

    就氯倍他索而言,您認為什麼時候能夠推出?

  • It seems like you've been delayed a little bit this summer.

    看來你今年夏天有點晚了。

  • And when do you think to be able to have that in the market?

    您認為什麼時候能夠將其推向市場?

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • So Bren is actually talking with them to figure out the transportation and other logistics, but we're not going to wait for it to show up on the dock.

    因此,布倫實際上正在與他們討論運輸和其他物流問題,但我們不會等待它出現在碼頭上。

  • We have our sales reps out there today prequalifying those offices.

    今天我們的銷售代表正在對這些辦事處進行資格預審。

  • So far, the reaction has been very positive.

    到目前為止,反應非常積極。

  • They like the clinical profile.

    他們喜歡臨床概況。

  • What they like even more is how easy we're making it for them so that they're not going to get callbacks and changes at the pharmacies and other things because we have priced the product at the same price as a branded co-pay.

    他們更喜歡的是我們為他們提供的服務是多麼簡單,這樣他們就不會在藥房和其他地方收到回電和變更,因為我們的產品定價與品牌自付費用相同。

  • So we've removed that whole problem of people not wanting to pay and switches from the equation.

    因此,我們已經解決了人們不想付費的整個問題,並從等式中切換。

  • And we can do that because we're being extremely efficient with the way that we're distributing through ourselves and through one e-pharmacy partner who's well known in ophthalmology and to the optical offices as well.

    我們之所以能做到這一點,是因為我們透過自己和一位在眼科和眼科診所都很知名的電子藥局合作夥伴進行分銷,效率非常高。

  • So I'm hoping that, that happens within -- by the end of the summer sometime in September.

    所以我希望這會在夏末九月的某個時候發生。

  • But in any case, it's not like we're sitting here doing nothing.

    但無論如何,我們並不是坐在這裡無所事事。

  • We're out there prequalifying these offices, and that's the job of the sales force, to make sure those people are ready so that when it becomes available, they can turn the switch on and start using it immediately.

    我們對這些辦公室進行資格預審,這是銷售人員的工作,以確保這些人員做好準備,以便在可用時,他們可以打開開關並立即開始使用。

  • Matt Kaplan - Analyst

    Matt Kaplan - Analyst

  • Okay.

    好的。

  • That makes sense.

    這是有道理的。

  • And then last question.

    然後是最後一個問題。

  • You've signed, I guess, three dry eye collaborations in the last -- very recently.

    我猜你最近簽了三份乾眼合作協議。

  • Can you talk a little bit about the strategy with these collaborations for dry eye?

    能談談這些針對乾眼症的合作策略嗎?

  • I guess, you have one for flare-ups, one is adjunctive, and one is for chronic therapy?

    我想,你有一種用於突發疾病,一種用於輔助治療,一種用於慢性治療?

  • And how to think about those?

    以及如何思考這些?

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Yes.

    是的。

  • Thank you.

    謝謝。

  • So the first thing is that -- what's nice about this is that the three are not competitive with each other.

    所以第一件事是──這樣做的好處是,這三個人並不互相競爭。

  • You have the SGN product, which is a more rapidly acting cyclosporine.

    您擁有 SGN 產品,它是一種起效更快的環孢菌素。

  • So they say that they work, I believe, in 4 weeks and typically cyclosporine will take 12, so people will get faster relief.

    所以他們說他們會在 4 週內起效,而環孢素通常需要 12 週,所以人們會得到更快的緩解。

  • So this is a way to take their product, which could be a foundation product, the first one you go in with dry eye and put it into the Optejet system to make it easier to use.

    因此,這是一種將他們的產品(可能是基礎產品)、乾眼症患者使用的第一個產品放入 Optejet 系統中以使其更易於使用的方法。

  • And also to differentiate their cyclosporine from other products that are out there.

    也是為了將他們的環孢素與其他產品區分開來。

  • Then you have the Senju product, which works with a completely different mechanism, but may need to be paired with something like a cyclosporine or lifitegrast, so that you get the benefit.

    然後你有千住產品,它的工作原理完全不同,但可能需要與環孢素或利菲格斯特等藥物一起使用,這樣你才能受益。

  • Think of it as almost like the glaucoma model, where half of the patients are on two different glaucoma meds.

    可以將其視為青光眼模型,其中一半患者服用兩種不同的青光眼藥物。

  • This could be in dry eye where half the patients are on two different dry eye products.

    這可能是在乾眼症中​​,一半的患者使用兩種不同的乾眼產品。

  • So it could be an adjunct to almost anything.

    所以它幾乎可以成為任何東西的附屬品。

  • So it's noncompetitive and it's really a unique way of looking at the marketplace.

    所以它是非競爭性的,而且它確實是一種看待市場的獨特方式。

  • And then you have Clobetasol, which would be used for acute dry eye flare-ups, which typically happen four or five times.

    然後是氯倍他索,用於治療急性乾眼症,通常會發生四到五次。

  • People that have dry eye where they get a flare-up and they need something to knock down the inflammation.

    患有乾眼症的人會突然發作,他們需要一些東西來消除發炎。

  • So it's a way of getting that also out in the market and differentiating it from the post-surgical steroid.

    因此,這是一種將其推向市場並將其與術後類固醇區分開來的方法。

  • So we looked at the three as a -- almost like a good way to load up the bases and have a product at each phase.

    因此,我們將這三個視為一個幾乎是加載基礎並在每個階段都有產品的好方法。

  • And hopefully, we'll be able to come to the plate and knock all of those home.

    希望我們能夠上場並把所有這些都打回家。

  • Thank you.

    謝謝。

  • Matt Kaplan - Analyst

    Matt Kaplan - Analyst

  • Thanks, Michael.

    謝謝,麥可。

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Thanks, Matt.

    謝謝,馬特。

  • Operator

    Operator

  • Kemp Dolliver, Brookline Capital Markets.

    Kemp Dolliver,布魯克林資本市場。

  • Kemp Dolliver - Analyst

    Kemp Dolliver - Analyst

  • Great.

    偉大的。

  • Thank you and good evening.

    謝謝你,晚上好。

  • First question is the revenue numbers that you are booking right now.

    第一個問題是您現在預訂的收入數字。

  • And how can we think about them in the context of the -- you're seeding the market for MydCombi and then presumably, as we get later in the year, we should see Clobetasol revenue?

    我們如何在這樣的背景下考慮它們——你們正在為 MydCombi 市場播種,然後,正如我們在今年晚些時候得到的那樣,我們應該會看到氯倍他索的收入?

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Yeah.

    是的。

  • I think that -- so we haven't given guidance yet.

    我認為——所以我們還沒有給出指導。

  • We will give guidance obviously once we launch the product.

    一旦我們推出產品,我們就會給予明確的指導。

  • But I think that ultimately, the goal is to capture a 3% to 5% market share over a 12- to 15-month period for Clobetasol.

    但我認為最終的目標是在 12 至 15 個月內佔領氯倍他索 3% 至 5% 的市佔率。

  • John Gandolfo - Chief Financial Officer, Secretary

    John Gandolfo - Chief Financial Officer, Secretary

  • And Kemp, in terms of timing, you're right, right now is -- we're conditioning the market.

    坎普,就時機而言,你是對的,現在是──我們正在調節市場。

  • For MydCombi and Clobetasol, I think that you'll be seeing numbers in the fourth quarter for that because the reps are out there now, again, with the goal that they're going to hit 200 additional new offices for MydCombi between now and the end of September.

    對於 MydCombi 和氯倍他索,我認為您將在第四季度看到相關數據,因為代表現在已經再次出動,他們的目標是從現在到 2019 年期間為 MydCombi 增加 200 個新辦事處。 。

  • And then they're responsible to getting to 500 Clobetasol offices once the product is here, so that will probably be September, October.

    一旦產品到達,他們就負責到達 500 個氯倍他索辦事處,所以可能是 9 月、10 月。

  • So when you're going to actually see those revenues would be with the fourth quarter, I would presume.

    因此,我認為,當您真正看到這些收入時,將是第四季度。

  • Kemp Dolliver - Analyst

    Kemp Dolliver - Analyst

  • Right.

    正確的。

  • Just to dig into this a little bit more because it's an atypical situation, which you've explained clearly.

    只是為了進一步深入研究這一點,因為這是一種非典型情況,您已經清楚地解釋了這一點。

  • Last quarter, you had minimal revenue but cost of certain goods at the same level.

    上個季度,您的收入很少,但某些商品的成本處於同一水平。

  • This quarter, you had negative gross margin.

    本季度,您的毛利率為負。

  • What accounts for that difference?

    造成這種差異的原因是什麼?

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Yeah.

    是的。

  • So that's actually included in that cost of revenue is the onetime write-down of inventory to net realizable value of about $450,000.

    因此,收入成本中實際上包含了庫存一次性減記至可變現淨值約 450,000 美元。

  • And that's a nonrecurring expense.

    這是一項非經常性費用。

  • So if you take that out, you would have seen the revenue and the cost of revenue basically be equal to each other, as it happened in prior quarters.

    因此,如果你把它去掉,你會發現收入和收入成本基本上是相等的,就像前幾季發生的那樣。

  • But we did take one time charge associated with that, which is included in that $490,000 number.

    但我們確實收取了一筆與此相關的費用,該費用包含在 49 萬美元的數字中。

  • Kemp Dolliver - Analyst

    Kemp Dolliver - Analyst

  • Great.

    偉大的。

  • Thank you.

    謝謝。

  • And moving on to other things that are probably a little more interesting.

    然後繼續討論其他可能更有趣的事情。

  • Looking at the dry eye programs, and admittedly, this may be too early to speak to, but are we looking at the same endpoints in registrational trials?

    看看乾眼症項目,誠然,現在談論可能還為時過早,但我們在註冊試驗中是否看到了相同的終點?

  • Or will there be some variations?

    還是會有一些變化?

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Great question, Kemp.

    好問題,坎普。

  • Actually, they're all different from each other, so it's a perfect question.

    事實上,它們彼此不同,所以這是一個完美的問題。

  • So if we look at Clobetasol, since that's acute dry eye, you're talking about two 15-day trials.

    因此,如果我們看看氯倍他索,因為它是急性乾眼症,所以您談論的是兩次為期 15 天的試驗。

  • Those -- that would be the shortest one.

    那些——那將是最短的。

  • If you look at SGN cyclosporine because the safety profile of cyclosporine is well understood, you're looking probably at a 16-week trial in chronic dry eye.

    如果您因為環孢素的安全性已廣為人知而選擇 SGN 環孢素,那麼您可能正在關註一項針對慢性乾眼症的為期 16 週的試驗。

  • And again, I'm saying all of this, it has to be verified with the FDA, but this is my understanding.

    我再說一遍,所有這些都必須經過 FDA 的驗證,但這是我的理解。

  • And if you look at Senju's product with ours, that potentially could be the longest one with the actual one year plus a 16-week because they would have to establish or we would have to establish long-term safety.

    如果你看看千住的產品和我們的產品,這可能是最長的產品,實際一年加 16 週,因為他們必須建立或我們必須建立長期安全性。

  • So in summary, again, Clobetasol 15 weeks, SGN probably 15 days.

    總而言之,氯倍他索 15 週,SGN 可能 15 天。

  • SGN, probably 16 weeks.

    SGN,大概16週。

  • And Senju would likely be one year unless that data already exists somewhere and I'm not familiar with it.

    千住可能是一年,除非該數據已經存在於某個地方並且我不熟悉它。

  • Kemp Dolliver - Analyst

    Kemp Dolliver - Analyst

  • That's very helpful.

    這非常有幫助。

  • Thanks.

    謝謝。

  • John Gandolfo - Chief Financial Officer, Secretary

    John Gandolfo - Chief Financial Officer, Secretary

  • Kemp, this is John.

    坎普,這是約翰。

  • Let me just make one more point because you had raised something with the cost of revenues, that was a very good point.

    讓我再強調一點,因為你們已經透過收入成本籌集了一些資金,這是一個非常好的觀點。

  • But the other thing I want to point out is this quarter includes a lot of expenses that are nonrecurring relating to us buying back the rights from Bausch + Lomb.

    但我想指出的另一件事是,本季包括許多與我們從博士倫回購權利相關的非經常性費用。

  • So when you look at it, we reported total operating expenses up $11.2 million.

    因此,當你查看它時,我們報告的總營運費用增加了 1,120 萬美元。

  • But when you strip away the reacquisition of the rights as well as all of the noncash charges and expenses related to the Bausch + Lomb transaction, we expect going forward that our R&D and G&A will be a total of $6 million to $6.1 million going forward.

    但是,當您剔除重新收購權利以及與博士倫交易相關的所有非現金費用和支出時,我們預計未來我們的研發和一般行政費用總計將達到 600 萬至 610 萬美元。

  • And I just want to make everybody who's on the call aware that if you look at it at face value, it looks like we're increasing our expenses dramatically, but that's not the case at all.

    我只是想讓每個參加電話會議的人都知道,如果從表面上看,我們似乎正在大幅增加開支,但事實並非如此。

  • It's really tied to that Bausch + Lomb transaction.

    這確實與博士倫交易有關。

  • Kemp Dolliver - Analyst

    Kemp Dolliver - Analyst

  • Thank for that, John.

    謝謝你,約翰。

  • Next two more questions.

    接下來還有兩個問題。

  • The first one is the timeline for the Gen 2 filing that you outlined in the press release and the discussion.

    第一個是您在新聞稿和討論中概述的第二代備案的時間表。

  • That's unchanged, correct?

    那沒有改變,對嗎?

  • We're probably looking at an approval in 2026?

    我們可能會在 2026 年獲得批准?

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Yeah.

    是的。

  • Bren, you can correct me, we're manufacturing in the fourth quarter correct?

    布倫,你可以糾正我嗎,我們是在第四季生產的,對嗎?

  • Bren Kern - Chief Operating Officer

    Bren Kern - Chief Operating Officer

  • Yes, we are producing registration batches in the fourth quarter of this year to put on that stability program to support the filing with the FDA.

    是的,我們將在今年第四季生產註冊批次,以實施穩定性計劃,以支持向 FDA 提交申請。

  • So your timeline is correct.

    所以你的時間線是正確的。

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Yeah.

    是的。

  • So that would be 12 months from there we can file the NDA -- sNDA.

    從那時起,我們可以在 12 個月後提交 NDA——sNDA。

  • Kemp Dolliver - Analyst

    Kemp Dolliver - Analyst

  • Great.

    偉大的。

  • Thanks.

    謝謝。

  • And the last question pertains to the cash runway.

    最後一個問題與現金跑道有關。

  • Are we still looking at a runway into the end of this year?

    我們還在尋找今年年底的跑道嗎?

  • Or are we -- is that any different now?

    或者我們——現在有什麼不同嗎?

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • No, I think in terms of our expenses that we're still looking at it towards the end of this year.

    不,我認為就我們的支出而言,我們仍在考慮今年年底的情況。

  • We do have access to capital today if we wanted it as well as, as I mentioned in my remarks, we are looking at a lot of different structures, whether it be subordinated debt, convertible debt that might add capital as well.

    如果我們想要的話,我們今天確實可以獲得資本,正如我在演講中提到的,我們正在考慮許多不同的結構,無論是次級債務、也可能增加資本的可轉換債務。

  • But I think that that's still accurate at this point.

    但我認為目前這仍然是準確的。

  • Kemp Dolliver - Analyst

    Kemp Dolliver - Analyst

  • Great.

    偉大的。

  • Thanks so much.

    非常感謝。

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Thank you, Kemp.

    謝謝你,坎普。

  • Operator

    Operator

  • Tim Lugo, William Blair.

    提姆·盧戈,威廉·布萊爾。

  • Lachlan Hanbury-Brown - Analyst

    Lachlan Hanbury-Brown - Analyst

  • Hey, guys, this is Lachlan on for Tim.

    嘿,夥計們,我是拉克蘭為提姆發言。

  • Thanks for taking the questions.

    感謝您提出問題。

  • On the mid company adoption, I was just wondering if you can provide more color on sort of the cadence of that throughout the second quarter because that obviously sounds like it grew decently and is growing perhaps even quicker in Q3.

    關於公司中期的採用,我只是想知道您是否可以提供更多關於整個第二季度的節奏的信息,因為這顯然聽起來它增長得不錯,並且在第三季度增長甚至更快。

  • So maybe it's the cadence through Q2.

    所以也許這是第二季的節奏。

  • And now we should expect that to track into Q3.

    現在我們應該預期這種情況會持續到第三季。

  • And that is Q3 going to be a sort of steady state or will it keep growing from there?

    第三季將是一種穩定狀態還是會繼續成長?

  • And related to that on the centers haven't adopted yet, maybe the ones that you've approached would have and adopted it, can you talk about why they haven't adopted it?

    與此相關的中心尚未採用,也許您接觸過的中心已經採用並採用了它,您能談談為什麼他們沒有採用它嗎?

  • And then one other follow up on the dry eye collaborations.

    然後另一個跟進乾眼合作。

  • As you as you noted, you sort of have three -- covering all three areas of treatment.

    正如您所指出的,您有三項——涵蓋所有三個治療領域。

  • Should we think of that as sort of maybe no more dry eye deals in the near term?

    我們是否應該將其視為短期內可能不再有乾眼症交易?

  • Or are you still open to and perhaps more importantly, apartments still open to you developing or partnering for multiple products in the same space.?

    或者您是否仍然願意,也許更重要的是,公寓仍然向您在同一空間內開發或合作開發多種產品開放。

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Well, let me take the second one first, and thank you, Tim.

    好吧,讓我先講第二個,謝謝你,提姆。

  • The dry eye collaboration as of this moment are nonexclusive.

    截至目前,乾眼症合作並非排他性。

  • So if [something comes along that makes more sense for us as] a company, we would certainly consider that.

    因此,如果出現對我們公司更有意義的事情,我們肯定會考慮這一點。

  • So we haven't shut any doors.

    所以我們沒有關閉任何門。

  • And what I'm hoping that people will see and potential partners will see is that interest in our technology is picking up as a great way to extend the runway for things that might have a short patent life or to be more competitive in this market.

    我希望人們和潛在的合作夥伴看到的是,人們對我們的技術的興趣正在增強,這是一種延長專利壽命較短的產品跑道或在這個市場上更具競爭力的好方法。

  • For your first question on MydCombi, it's funny that you're asking this because I just came back personally from an office that we trained about a week ago because I wanted to see what was going out there.

    對於你關於 MydCombi 的第一個問題,你問這個問題很有趣,因為我剛從大約一周前我們訓練過的辦公室回來,因為我想看看那裡發生了什麼。

  • And I think that the reason our cadence is picking up is that our sales force is in place and they are figuring out how to do this.

    我認為我們節奏加快的原因是我們的銷售人員已經就位,他們正在研究如何做到這一點。

  • The general interest and acceptance of MydCombi is high.

    MydCombi 的普遍興趣和接受度很高。

  • What happens though is that people are used to using eye drops.

    然而,人們習慣了使用眼藥水。

  • They've been around for 150 years.

    它們已經存在了 150 年。

  • So the way it works is you bring MydCombi into the office, you find a champion, a tech, for example, who really likes the product and wants to use it first.

    因此,它的工作方式是,您將 MydCombi 帶到辦公室,您會找到一位冠軍,一位技術人員,例如,他真正喜歡該產品並希望首先使用它。

  • And he or she is the one that introduces it within the practice.

    他或她是將其引入實踐的人。

  • And soon, everybody else gets used to it well and finds all the reasons that it's superior to the way that they're doing things now.

    很快,其他人就很好地習慣了它,並找到了所有理由證明它比他們現在做事的方式更好。

  • The issue is that, that takes time.

    問題是,這需要時間。

  • So the way the sales process works is ourselves, representatives need to get into the office.

    因此,銷售流程的運作方式是我們自己,代表需要進入辦公室。

  • Once they're there, they have to do a quick training of everybody to introduce it because it is completely different from anything they've seen before.

    一旦他們到達那裡,他們必須對每個人進行快速培訓以介紹它,因為它與他們以前見過的任何東西都完全不同。

  • They will stick around for a while to make sure everybody is using it correctly and doesn't have any questions.

    他們會停留一段時間,以確保每個人都正確使用它並且沒有任何問題。

  • And then over the next couple of weeks, they check back in to see how everything is.

    然後在接下來的幾週內,他們會回來查看一切。

  • And I've seen this time and time again that you get that one person or two people in there who really like it and all of a sudden, you have a half dozen and then all of the text who like it soon after that.

    我一次又一次地看到,那裡有一個或兩個人真正喜歡它,突然間,你有六個人,然後很快所有的文字都喜歡它。

  • So what we've learned is we have to have patience and we have to do it right.

    所以我們學到的是我們必須有耐心,我們必須做得正確。

  • And then once we do, that's how we get the reorders.

    一旦我們這樣做了,這就是我們獲得重新訂單的方式。

  • The people that we found that you don't go to is you don't go into offices where they are entirely driven by, I just want to get these patients in and out, in and out, in and out like a machine.

    我們發現你不去拜訪的人是你不去他們完全被驅動的辦公室,我只是想讓這些病人像機器一樣進出,進出,進出。

  • And that's not our customer.

    那不是我們的客戶。

  • Our customer is the one that cares about the patient experience and also cares about the other benefits of the product.

    我們的客戶既關心患者體驗,也關心產品的其他好處。

  • For example, when I was in that office, they had a number of elderly patients.

    例如,當我在那個辦公室時,他們有很多老年患者。

  • It was a glaucoma practice, and the elderly patients can't tilt their heads back to have these drops put in their eyes.

    這是一種青光眼治療,老年患者無法將頭部向後傾斜以將這些藥物水滴入眼睛。

  • So it was especially helpful to use MydCombi with them because they could look straight ahead for the dilation process.

    因此,與他們一起使用 MydCombi 特別有幫助,因為他們可以直視前方的擴張過程。

  • And that was something that I did not even consider until I actually saw it.

    在我真正看到它之前,我什至沒有考慮過這一點。

  • So I'm very encouraged by what we've seen.

    所以我對我們所看到的感到非常鼓舞。

  • And I think this is the right way to do this.

    我認為這是正確的做法。

  • It reminds me of the old, try it, you'll like it commercials because I'm confident they'll try it and they'll like it.

    它讓我想起了老話,嘗試一下,你會喜歡它的廣告,因為我相信他們會嘗試並且會喜歡它。

  • Lachlan Hanbury-Brown - Analyst

    Lachlan Hanbury-Brown - Analyst

  • Got it.

    知道了。

  • Thanks.

    謝謝。

  • And on the timing of the Clobetasol launch, are there like actual updates that you've had on that?

    關於氯倍他索的上市時間,您是否有類似的實際更新?

  • Or is that -- are you just delaying that because you previously said maybe August and you sort of haven't heard anything?

    或者是——你只是推遲了,因為你之前說過也許八月,但你還沒有聽到任何消息?

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • No.

    不。

  • Bren and I are talking with them weekly.

    布倫和我每週都會與他們交談。

  • This is all logistics and paperwork that we're combing through [not anything I'm fairly] concerned about.

    這是我們正在梳理的所有後勤和文書工作[不是我相當關心的]。

  • It is something I'm not dancing about because I would have liked it as soon as possible.

    我不會為此跳舞,因為我會盡快喜歡它。

  • But I am convinced that everybody is working as quickly as they can to get the product here.

    但我相信每個人都在盡可能快地工作以將產品帶到這裡。

  • Lachlan Hanbury-Brown - Analyst

    Lachlan Hanbury-Brown - Analyst

  • Okay.

    好的。

  • So does Formosa have the export license then?

    那麼台塑有出口授權嗎?

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • No, they don't yet.

    不,他們還沒有。

  • That's what we're working on.

    這就是我們正在努力的方向。

  • Lachlan Hanbury-Brown - Analyst

    Lachlan Hanbury-Brown - Analyst

  • Okay.

    好的。

  • Thanks.

    謝謝。

  • Operator

    Operator

  • (Operator Instructions)

    (操作員說明)

  • Matthew Caufield, H.C. Wainwright.

    馬修‧考菲爾德,H.C.溫賴特。

  • Matthew Caufield - Analyst

    Matthew Caufield - Analyst

  • Great.

    偉大的。

  • Thank you.

    謝謝。

  • Hi, Michael and team.

    嗨,邁克爾和團隊。

  • So my question was on dry eye and kind of thinking about comparisons to standard of care.

    所以我的問題是關於乾眼症以及與護理標準的比較的思考。

  • How common is it to segment those dry eye patients currently?

    目前乾眼症患者細分有多常見?

  • In other words, is there any risk prescribers would ultimately be more familiar with just the overall dry eye indication itself versus breaking out inflammation patients from those that need faster relief, for example?

    換句話說,與將發炎患者從需要更快緩解的患者中分離出來相比,處方者最終會更熟悉整體乾眼症本身是否有任何風險?

  • My understanding at least is that they're kind of all in one bigger bucket currently.

    至少我的理解是,目前它們都在一個更大的桶子裡。

  • Just wanted to kind of hear your perspective there.

    只是想聽聽您的觀點。

  • Thanks.

    謝謝。

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Thanks, Matthew.

    謝謝,馬修。

  • Great to hear from you.

    很高興收到你的來信。

  • I think if you spoke to a doctor who treats dry eye patients, he or she will honestly tell you that they are among the most difficult patients to treat because they are in a lot of discomfort and not -- there's nothing that works for everybody.

    我認為,如果您與治療乾眼症患者的醫生交談,他或她會誠實地告訴您,他們是最難治療的患者之一,因為他們有很多不適,但沒有什麼對每個人都有效。

  • And in fact, I think I saw some research that even with RESTASIS, fewer than half of the patients actually are satisfied with the release that they get.

    事實上,我想我看到了一些研究,即使使用 RESTASIS,只有不到一半的患者實際上對他們獲得的釋放感到滿意。

  • So what happens now is they might try one drug or they might try the other.

    所以現在發生的情況是他們可能會嘗試一種藥物,也可能會嘗試另一種藥物。

  • And when it doesn't work, they'll switch to another drug.

    當它不起作用時,他們會改用另一種藥物。

  • So what I like about the SGN faster working RESTASIS is that you'll get an answer as to whether this is going to work or not much faster than you would with the existing products out there.

    因此,我喜歡 SGN 更快工作的 RESTASIS 的一點是,您將得到一個答案,即這是否會比現有產品更快地發揮作用。

  • Plus, it's easier to use with the Optejet.

    此外,與 Optejet 一起使用更容易。

  • What I like about the Senju product is that because it works differently, you can add it on to anything.

    我喜歡千住產品的一點是,因為它的工作原理不同,所以你可以將它添加到任何東西上。

  • So instead of switching, you can go to an add-on therapy, okay, the cyclosporine or whatever I'm using is not enough.

    因此,您可以採取附加療法,而不是轉換,好吧,環孢素或我正在使用的任何藥物都不夠。

  • Let's add this additional thing and think if this does the trick.

    讓我們添加這個額外的東西,並思考這是否有效。

  • And the reason it works differently is that it's basically a wound-healing drug instead of an inflammation drug, so it's treating a different aspect of what's causing dry eye.

    它的作用不同的原因是它基本上是一種傷口癒合藥物而不是發炎藥物,因此它可以治療導致乾眼症的不同方面。

  • And then for Clobetasol, I think the prescribers are very familiar with flare ups.

    對於氯倍他​​索,我認為處方者對突發症狀非常熟悉。

  • They usually happen around the seasons and other things.

    它們通常發生在季節和其他事情周圍。

  • And so this will, again, just be a different way of using a steroid, hopefully one that has a very low incidence of intraocular pressure spikes.

    因此,這將再次成為使用類固醇的一種不同方式,希望這種方式眼壓高峰的發生率非常低。

  • If it's only 1% in the bottle when you're using the Optejet, and you're getting even less medication rolling around the eye, maybe it's even better there, so it could offer some clinical benefit there, too.

    如果您使用 Optejet 時瓶中的濃度僅為 1%,並且眼睛周圍滾動的藥物更少,那麼可能效果更好,因此它也可以提供一些臨床益處。

  • Thanks.

    謝謝。

  • Matthew Caufield - Analyst

    Matthew Caufield - Analyst

  • Yeah.

    是的。

  • Very helpful.

    非常有幫助。

  • Thank you.

    謝謝。

  • Operator

    Operator

  • We have reached the end of our question and answer session.

    我們的問答環節已經結束。

  • I would like to turn the conference back over to Michael Rowe for closing comments.

    我想將會議轉回給邁克爾·羅(Michael Rowe)徵求結束意見。

  • Michael Rowe - Chief Executive Officer, Director

    Michael Rowe - Chief Executive Officer, Director

  • Thank you, Sharon, and thanks to everyone on the call today for taking the time to be with us.

    謝謝莎倫,也感謝今天參加電話會議的所有人抽出時間與我們在一起。

  • This is an exciting time to be with Eyenovia.

    與 Eyenovia 共事是一個令人興奮的時刻。

  • Our advanced Gen2 device is getting ready for production while our CHAPERONE study for pediatric progressive myopia is intended to read out later this year.

    我們先進的 Gen2 設備已準備好投入生產,而我們針對兒童漸進性近視的 CHAPERONE 研究計劃將於今年稍後公佈。

  • Upon a positive result, we look forward to moving MicroPine forward with the FDA.

    獲得積極結果後,我們期待與 FDA 合作推動 MicroPine 的發展。

  • We have two FDA-approved products, one being actively promoted and the other one we look to do very, very soon.

    我們有兩種 FDA 批准的產品,一種正在積極推廣,另一種我們希望很快就能推廣。

  • Both are very differentiated and well positioned in the eye care space.

    兩者都非常與眾不同,並且在眼部護理領域處於有利地位。

  • I encourage everyone to keep up to date with our progress on eyenovia.com or through our social media links.

    我鼓勵每個人在 eyenovia.com 或透過我們的社交媒體連結了解我們的最新進展。

  • And this concludes our call, and we look forward to talking with you again in November.

    我們的通話到此結束,我們期待在 11 月再次與您交談。

  • Operator

    Operator

  • Thank you.

    謝謝。

  • You may disconnect your lines at this time, and thank you for your participation.

    此時您可以斷開線路,感謝您的參與。