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Operator
Operator
Good morning, and welcome to the Verrica Pharmaceuticals second quarter 2024 earnings conference call. After the speaker's remarks, there will be a question-and-answer session. (Operator Instructions) Please note today's call will be recorded. (Operator Instructions) It is now my pleasure to turn the call over to today's host, Kevin Gardner, Managing Director with LifeSci Partners. Please go ahead.
早安,歡迎參加 Verrica Pharmaceuticals 2024 年第二季財報電話會議。演講者發言後,將進行問答環節。(操作員說明)請注意,今天的通話將會被錄音。(操作員說明) 現在我很高興將電話轉給今天的主持人,LifeSci Partners 董事總經理 Kevin Gardner。請繼續。
Kevin Gardner - Managing Director
Kevin Gardner - Managing Director
Thank you, operator. Hello, everyone, and welcome to Verrica Pharmaceuticals second quarter 2024 corporate update and earnings conference call. With me on the line this morning are Ted White, President and Chief Executive Officer of Verrica; Joe Bonaccorso, Chief Commercial Officer; Terry Kohler, Chief Financial Officer; Dr. Gary Goldenberg, Verrica's Chief Medical Officer; and Chris Hayes, Verrica's Chief Legal Officer.
謝謝你,接線生。大家好,歡迎參加 Verrica Pharmaceuticals 2024 年第二季公司更新與收益電話會議。今天早上與我通話的是 Verrica 總裁兼執行長 Ted White;喬·博納科索,首席商務官;特里‧科勒,財務長; Verrica 首席醫療官 Gary Goldenberg 博士;和 Verrica 首席法務官 Chris Hayes。
As a reminder, during today's call, management will make forward-looking statements. These statements may include expectations related to the commercialization of YCANTH, VP-102 for the treatment of molluscum contagiosum, in the United States, regulatory developments, the development and potential benefits of Verrica's product candidates, our expected cash runway as well as overall business strategy and planned operations.
提醒一下,在今天的電話會議中,管理階層將做出前瞻性聲明。這些陳述可能包括與用於治療傳染性軟疣的 YCANTH VP-102 在美國商業化相關的預期、監管發展、Verrica 產品候選者的開發和潛在收益、我們預期的現金跑道以及總體業務戰略和計劃的操作。
These forward-looking statements are based on the company's current expectations and involve inherent risks and uncertainties. And based on those risks and uncertainties, Verrica's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements. Please see Verrica's SEC filings for important risk factors.
這些前瞻性陳述是基於公司目前的預期,涉及固有風險和不確定性。基於這些風險和不確定性,Verrica 的實際結果和事件發生的時間可能與此類前瞻性聲明中的預期有重大差異。請參閱 Verrica 向 SEC 提交的文件,以了解重要的風險因素。
Verrica cautions you not to place undue reliance on forward-looking statements and undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events or changes in expectations.
Verrica 提醒您不要過度依賴前瞻性陳述,並且不承擔因新資訊、未來事件或預期變更而更新任何前瞻性陳述的責任或義務。
In addition, during today's call, we will discuss certain non-GAAP financial measures. These non-GAAP financial measures are in addition to and not a substitute for or superior to measures of financial performance prepared in accordance with GAAP.
此外,在今天的電話會議中,我們將討論某些非公認會計準則財務指標。這些非公認會計原則財務指標是根據公認會計原則制定的財務績效指標的補充,而不是替代或優於這些指標。
There are a number of limitations related to the use of these non-GAAP financial measures versus their closest GAAP equivalents. Our earnings release that we issued today includes GAAP to non-GAAP reconciliations for these measures and is also available on the Investor Relations section of our website.
與最接近的 GAAP 同等指標相比,使用這些非 GAAP 財務指標有許多限制。我們今天發布的收益報告包括這些措施的 GAAP 與非 GAAP 調節表,也可在我們網站的投資者關係部分取得。
I'll now turn the call over to Verrica's President and CEO, Ted White. Ted?
我現在將把電話轉給 Verrica 的總裁兼執行長 Ted White。泰德?
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
Thank you, Kevin, and good morning, everyone, and thank you for joining us for our second quarter 2024 earnings call. I'm pleased to report that we continue to make progress across our business, including with the commercial launch of YCANTH and the exciting data being generated from our development stage pipeline.
謝謝凱文,大家早上好,謝謝您參加我們的 2024 年第二季財報電話會議。我很高興地向大家報告,我們的業務繼續取得進展,包括 YCANTH 的商業發布以及我們的開發階段管道產生的令人興奮的數據。
Starting with YCANTH. For the second quarter, we recorded product revenue net of $4.9 million, which reflects growth in demand for YCANTH as well as the expansion of our distribution footprint with the addition of Cencora as a specialty distribution partner and the related impact of a onetime stock in order.
從 YCANTH 開始。第二季度,我們的產品淨收入為 490 萬美元,這反映了對 YCANTH 需求的增長,以及隨著 Cencora 作為專業分銷合作夥伴的加入而擴大了我們的分銷足跡,以及一次性庫存的相關影響。
Cencora allows us to provide additional customer support through their GPO IPN, which is intended to target dermatologists and drive further buy-and-bill account growth through IPN's membership. We've also added Vizient as a GPO for hospitals, and we believe we will see a positive impact on YCANTH's pull-through demand in the second half of the year.
Cencora 使我們能夠透過其 GPO IPN 提供額外的客戶支援,該服務旨在針對皮膚科醫生,並透過 IPN 會員資格推動購買和帳單帳戶的進一步成長。我們還添加了 Vizient 作為醫院的 GPO,我們相信下半年我們將看到對 YCANTH 拉動需求的正面影響。
We believe that we've addressed many big operational hurdles. And in the back half of the year, we must focus on capturing market share and driving adoption. We continue to focus on simplifying the process for physicians to treat patients. On April 1, YCANTH received a permanent J-Code from CMS. And on July 1, CMS published the Part B schedule listing YCANTH reimbursement at an average selling price plus 6%.
我們相信我們已經解決了許多重大的營運障礙。在今年下半年,我們必須專注於佔領市場份額和推動採用。我們持續致力於簡化醫師治療患者的流程。4 月 1 日,YCANTH 收到 CMS 頒發的永久 J 代碼。7 月 1 日,CMS 發布了 B 部分時間表,列出了 YCANTH 報銷價格,平均售價加 6%。
This created visibility for commercial insurers to further establish their own allowables, which represents the maximum amount a plan will pay for covered health care service. I'm pleased to report that as of today, insurance companies covering approximately 98% of commercial lives with YCANTH coverage have formally published their allowables, which is now visible to physicians electronically at the time of diagnosis.
這為商業保險公司進一步確定自己的允許限額創造了可見性,這代表了計劃為承保醫療保健服務支付的最高金額。我很高興地向您報告,截至今天,YCANTH 承保覆蓋約 98% 商業生活的保險公司已正式公佈其允許限額,醫生在診斷時可以透過電子方式查看這些限額。
We believe that this should drive confidence in payer coverage and additional same-day treatment for established buy-and-bill accounts. In addition to driving growth in buy and build, we continue to promote YCANTH's value proposition for specialty pharmacy customers as we look to maximize adoption across both channels. In a moment, Joe will talk more about our commercial strategy and specific efforts to build additional momentum in the commercialization of YCANTH.
我們認為,這應該會增強人們對付款人承保範圍以及已建立的購買和帳單帳戶的額外當日處理的信心。除了推動購買和建造的成長外,我們還繼續向專業藥房客戶推廣 YCANTH 的價值主張,因為我們希望最大限度地提高兩個管道的採用率。稍後,Joe 將更多地談論我們的商業策略以及為 YCANTH 商業化創造更多動力的具體努力。
We continue to make progress in removing products containing compounded cantharidin in the US. In July, we announced a litigation settlement with Dormer Laboratories that will discontinue the sale by Dormer of compounded cantharidin products in the United States.
我們在清除美國含有複合斑蝥素的產品方面繼續取得進展。7 月,我們宣布與 Dormer Laboratories 達成訴訟和解,和解協議將停止 Dormer 在美國銷售複合斑蝥素產品。
As the largest supplier of non-FDA-approved cantharidin-containing products into the US market, the settlement with Dormer marks a major win for patients who seek access to a safe, effective and FDA-approved therapy for the treatment of molluscum. While we expect this sentiment will have a positive impact on demand for YCANTH, removing compounded cantharidin from the marketplace will take time as compounded products typically have a six-month dating.
作為進入美國市場的未經 FDA 批准的含斑蝥素產品的最大供應商,與 Dormer 的和解標誌著尋求安全、有效且經 FDA 批准的軟疣治療方法的患者的重大勝利。雖然我們預計這種情緒將對 YCANTH 的需求產生積極影響,但將複合斑蝥素從市場上移除需要時間,因為複合產品的保質期通常為六個月。
We, therefore, remain focused on customer conversion, but we recognize it will take some time for Dormer's previously sold inventory to work its way through offices. While our main focus remains developing the market opportunity for YCANTH for the treatment of molluscum, we think that's just the beginning for this unique and innovative product.
因此,我們仍然專注於客戶轉化,但我們認識到,多馬之前銷售的庫存需要一些時間才能在辦公室中發揮作用。雖然我們的主要重點仍然是開發 YCANTH 治療軟體動物的市場機會,但我們認為這只是這個獨特創新產品的開始。
The next major opportunity for YCANTH is for the treatment of common warts. And with the prevalence of approximately 22 million patients in the US alone and no FDA-approved therapies, common warts represents one of the largest unmet needs in all of dermatology.
YCANTH 的下一個主要機會是治療尋常疣。光是在美國就有約 2,200 萬名患者患病,而且尚無 FDA 批准的治療方法,尋常疣是所有皮膚病學中最大的未滿足需求之一。
We continue to make important progress in advancing our common warts program. During the quarter, we amended our existing licensing agreement with Torii Pharmaceutical so that both companies will jointly conduct and split the cost of a global pivotal Phase 3 trial for YCANTH in common warts.
我們在推進尋常疣計劃方面繼續取得重要進展。本季度,我們修改了與 Torii Pharmaceutical 的現有授權協議,以便兩家公司將共同開展 YCANTH 治療尋常疣的全球關鍵 3 期試驗並分攤費用。
Torii will fund Verrica's portion of the cost as an offset to Torii's future payment obligations to Verrica based on regulatory milestones and sales of YCANTH for molluscum contagiosum and common warts in Japan. In addition, Torii will make a milestone payment of $8 million to Verrica upon the first patient dosed in Japan in the Phase 3 trial. Importantly, this amendment should benefit both parties from a cost and time to market standpoint and the new funding structure is expected to have minimal impact on our near-term cash position.
Torii 將為 Verrica 的部分成本提供資金,作為 Torii 根據監管里程碑和 YCANTH 在日本治療傳染性軟疣和尋常疣的銷售情況對 Verrica 未來付款義務的抵消。此外,Torii 將在 3 期試驗中在日本第一位患者接受給藥後向 Verrica 支付 800 萬美元的里程碑付款。重要的是,從成本和上市時間的角度來看,這項修正案應該對雙方都有好處,並且新的融資結構預計對我們的近期現金狀況影響最小。
Initiation of a global Phase 3 study remains subject to feedback from the US FDA and Japan's Pharmaceuticals and Medical Device Agency on the proposed design of the Phase 3 trial. We expect to receive feedback from the FDA and the PMDA in Q4 of this year. And based on our current timeline estimates, we anticipate initiating the Phase 3 trial in the first half of 2025.
全球 3 期研究的啟動仍取決於美國 FDA 和日本藥品和醫療器材機構對 3 期試驗建議設計的回饋。我們預計在今年第四季收到 FDA 和 PMDA 的回饋。根據我們目前的時間表估計,我們預計將於 2025 年上半年啟動第 3 階段試驗。
If YCANTH is successfully developed, approved and commercialized for the treatment of common warts, we anticipate a high degree of call point overlap and marketing synergies with our current molluscum promotion of YCANTH.
如果 YCANTH 成功開發、批准並商業化用於治療尋常疣,我們預計與我們目前的軟疣推廣 YCANTH 會產生高度重疊和行銷協同效應。
Now I'd like to briefly review the exciting data we announced this morning for our lead pipeline candidate VP-315, which is being developed for the treatment of basal cell carcinoma. By the way of background, VP-315 is a potential first-in-class oncolytic peptide that has been engineered to provide more targeted delivery to stimulate the patient's immune system and destroy cancer cells.
現在我想簡要回顧我們今天早上宣布的主要候選藥物 VP-315 的令人興奮的數據,該藥物正在開髮用於治療基底細胞癌。作為背景,VP-315 是一種潛在的一流溶瘤肽,經過精心設計,可提供更有針對性的遞送,以刺激患者的免疫系統並破壞癌細胞。
We are developing VP-315 as a therapy that can serve as a potential non-surgical alternative to surgery, including mohs surgery, or as a neoadjuvant chemotherapeutic for basal cell carcinomas, including advanced basal cell. As the most common type of cancer globally, we expect that the commercial opportunity for basal cell carcinoma is sizable with approximately 3.6 million diagnoses each year in the United States alone.
我們正在開發 VP-315 作為一種療法,可作為手術(包括莫氏手術)的潛在非手術替代方案,或作為基底細胞癌(包括晚期基底細胞癌)的新輔助化療藥物。作為全球最常見的癌症類型,我們預計基底細胞癌的商業機會相當大,光在美國每年就有約 360 萬例診斷。
The Phase 2 study is an open-label proof-of-concept trial designed to assess the safety and tolerability, dose regimen and efficacy of VP-315 in biopsy-confirmed basal cell carcinoma. Preliminary efficacy data based on 90 out of 93 lesions treated show that the treatment with VP-315 resulted in approximately 51% complete histologic clearance rate of basal cell carcinoma.
2 期研究是一項開放標籤概念驗證試驗,旨在評估 VP-315 在活檢證實的基底細胞癌中的安全性和耐受性、劑量方案和療效。基於治療的 93 個病灶中的 90 個的初步療效數據表明,VP-315 治療使基底細胞癌的完全組織學清除率約為 51%。
In addition, of the patients who had residual carcinoma, those residual tumors showed approximately 71% reduction in tumor size. Taken together, this represents approximately 86% overall reduction in tumor size across all lesions treated.
此外,在有殘留癌的患者中,這些殘留腫瘤的腫瘤尺寸縮小了約 71%。總而言之,這意味著所有接受治療的病灶的腫瘤大小總體減少了約 86%。
These results, if confirmed in a pivotal study, make a strong argument for the use of VP-315 as first-line therapy in the treatment of local and advanced basal cell carcinoma, which will either eliminate the need for additional treatment entirely or significantly reduce the size of the excision and the surgical burden associated with other treatment regimens, including mohs surgery.
這些結果如果在關鍵研究中得到證實,將為使用 VP-315 作為治療局部和晚期基底細胞癌的一線療法提供強有力的論據,這將完全消除額外治療的需要或顯著減少切除的大小以及與其他治療方案(包括莫氏手術)相關的手術負擔。
No treatment-related serious adverse events were reported in the Phase 2 study, and most treatment-related adverse events were classified as mild to moderate as expected with injection site pain being the most common adverse event.
第二階段研究中沒有報告與治療相關的嚴重不良事件,大多數與治療相關的不良事件如預期被歸類為輕度至中度,其中註射部位疼痛是最常見的不良事件。
Based on these positive efficacy and safety data from the Phase 2 trial, we believe VP-315 has significant potential to become an important first-line treatment option for basal cell carcinoma for use prior to surgery or instead of oral therapies, which have significant systemic side effects.
基於2 期試驗的這些積極的療效和安全性數據,我們相信VP-315 具有成為基底細胞癌重要一線治療選擇的巨大潛力,可在手術前使用或代替口服療法,後者俱有顯著的全身療效。
We are obviously very pleased with these clinical data, and we intend to hold a KOL event in the near future to discuss in more detail the results from the VP-315 Phase 2 study and provide additional insight into physician use case.
顯然,我們對這些臨床數據非常滿意,我們打算在不久的將來舉辦一次 KOL 活動,更詳細地討論 VP-315 2 期研究的結果,並提供對醫生用例的更多見解。
I'll now turn the call over to Joe to review our commercial progress. Joe?
我現在將把電話轉給喬,以審查我們的商業進展。喬?
Joe Bonaccorso - Chief Commercial Officer
Joe Bonaccorso - Chief Commercial Officer
Thanks very much, Ted. As Ted mentioned earlier, in the second quarter, we saw a pull-through demand for YCANTH growth sequentially quarter over quarter. The increase in demand reflects an increase in units dispensed through a specialty pharmacy and a higher number of units sold to hospitals and buy-and-bill offices, including Walgreens community stores.
非常感謝,泰德。正如 Ted 之前提到的,在第二季度,我們看到 YCANTH 的需求較上季成長。需求的增加反映了透過專業藥房配發的單位數量的增加以及出售給醫院和購買和帳單辦公室(包括沃爾格林社區商店)的單位數量的增加。
Although YCANTH showed growth versus the prior quarter, we remain focused on accelerating growth in the second half of the year. We believe that many of our accomplishments from the second quarter, including our settlement with Dormer Labs, and the receipt of a permanent J-Code from CMS and the establishment of allowables across the commercial coverage will translate into increased demand for YCANTH in the second half of 2024 and beyond.
儘管 YCANTH 與上一季相比有所成長,但我們仍然專注於下半年加速成長。我們相信,我們在第二季度取得的許多成就,包括與 Dormer Labs 的和解、從 CMS 收到永久 J 代碼以及在整個商業覆蓋範圍內建立許可,將轉化為下半年對 YCANTH 的需求增加2024 年及以後。
In the third quarter, we are working aggressively to grow applicator demand by focusing on the expansion of our buy-and-bill accounts, which includes the addition of GPO's Vizient for hospitals and IPN for dermatology practices. The targeted conversion of physician practices that were former users of compounded cantharidin and placing an emphasis on driving adherence through treat to clear messaging and medical education.
在第三季度,我們正積極致力於擴大塗抹器需求,重點關注擴大我們的購買和帳單帳戶,其中包括增加用於醫院的 GPO Vizient 和用於皮膚科實踐的 IPN。有針對性地轉變以前使用複合斑蝥素的醫生的做法,並強調透過治療、明確的資訊和醫學教育來推動依從性。
Our coverage footprint also continues to expand. And in the second quarter, we added a number of new Medicaid states, including Michigan, Louisiana, Alabama and West Virginia. With respect to total lives under coverage as of July 31, we have reached 234 million lives under coverage, which encompasses 139 health care plans, spanning commercial, Medicaid, TriCare and federal employee plans.
我們的覆蓋範圍也在不斷擴大。在第二季度,我們增加了一些新的醫療補助州,包括密西根州、路易斯安那州、阿拉巴馬州和西維吉尼亞州。截至 7 月 31 日,我們承保的總生命數已達 2.34 億人,涵蓋 139 項醫療保健計劃,涵蓋商業、醫療補助、TriCare 和聯邦僱員計劃。
With the permanent J-Code in place and allowables established on most commercial plans, we believe broader acceptance by prescribers will continue as the reimbursement process becomes more efficient. We're also very focused on optimizing coverage under the commercial and state Medicaid plans by working with the payer universe to eliminate prior authorizations and other administrative burdens that may potentially be a barrier to patients being able to receive an approved treatment.
隨著永久 J 代碼的到位以及大多數商業計劃中規定的允許範圍,我們相信隨著報銷流程變得更加高效,處方者將繼續獲得更廣泛的接受。我們也非常注重透過與付款人領域合作來優化商業和州醫療補助計劃的覆蓋範圍,以消除可能成為患者接受批准治療的潛在障礙的事先授權和其他行政負擔。
Finally, on our last call, I discussed the addition of 20 new pediatric reps in the major MSAs across the country. I am very pleased with the productivities of these new professionals to our sales force, which we believe is driving increased awareness and utilization of YCANTH in major pediatric medical practices. Pediatricians are also showing interest in buy-and-bill as they prefer to control the patient journey and have the ability to treat same day.
最後,在我們上次的電話會議上,我討論了在全國主要 MSA 中增加 20 名新兒科代表的問題。我對這些新專業人員對我們銷售團隊的生產力感到非常滿意,我們相信這正在推動 YCANTH 在主要兒科醫療實踐中的認識和利用的提高。兒科醫生也對購買和計費表現出興趣,因為他們更願意控制患者的旅程並有能力在當天進行治療。
I'll now pass it to Terry to review our fourth quarter and year-end financial results. Terry?
我現在將其交給特里審查我們的第四季和年終財務業績。特里?
Terry Kohler - Chief Financial Officer
Terry Kohler - Chief Financial Officer
Thanks, Joe. For the second quarter of 2024, we reported total revenues of $5.2 million, which included YCANTH net revenues of $4.9 million. YCANTH's revenue reflects a combination of ex-factory shipments to FFF related to demand pull-through as well as a one-time impact of an initial stock-in order from our new specialty distributor, Cencora, which represented approximately 54% of YCANTH revenue in the quarter.
謝謝,喬。 2024 年第二季度,我們報告的總收入為 520 萬美元,其中包括 YCANTH 的淨收入 490 萬美元。YCANTH 的收入反映了與需求拉動相關的向 FFF 的出廠出貨量以及我們新的專業經銷商 Cencora 的初始庫存訂單的一次性影響,該訂單約佔 YCANTH 2017 年收入的 54%。
Gross product margins for the second quarter of 2024 were 93%, which continued to benefit from certain components of standard cost of goods sold, including bulk production and the assembly of applicators from our registration batches having been expensed as R&D prior to approval.
2024 年第二季的毛產品利潤率為 93%,這繼續受益於銷售商品標準成本的某些組成部分,包括批量生產和我們註冊批次的塗抹器組裝,這些在批准之前已作為研發費用。
Research and development expenses of $3.3 million in the second quarter of 2024 decreased versus the second quarter of 2023 by $2.4 million, driven primarily by a reduction in clinical trial costs related to VP-315 and CMC costs related to pre-approval YCANTH spend in the prior year period.
2024 年第二季的研發費用為330 萬美元,與2023 年第二季相比減少了240 萬美元,這主要是由於與VP-315 相關的臨床試驗成本以及與預批准YCANTH 相關的CMC 成本減少所致上一年期間。
Selling, general and administrative expenses of $16.5 million in the second quarter of 2024, increased versus the second quarter of 2023 by $10.6 million, driven primarily by commercial activity for YCANTH. GAAP net loss was $17.2 million or $0.37 per share for fiscal second quarter 2024 compared to a GAAP net loss of $11 million or $0.24 per share for the prior year period.
2024 年第二季的銷售、一般和管理費用為 1,650 萬美元,比 2023 年第二季增加了 1,060 萬美元,這主要是由 YCANTH 的商業活動推動的。2024 財年第二季的 GAAP 淨虧損為 1,720 萬美元,即每股 0.37 美元,而去年同期的 GAAP 淨虧損為 1,100 萬美元,即每股 0.24 美元。
On a non-GAAP basis, which excludes stock-based compensation and non-cash interest expense, the second quarter of 2024, net loss was $14.4 million or $0.31 per share compared to a net loss of $9.4 million or $0.21 per share for the second quarter of 2023.
以非公認會計準則(不含股票薪資及非現金利息費用)計算,2024 年第二季淨虧損為1,440 萬美元,即每股0.31 美元,而第二季淨虧損為940 萬美元,即每股0.21 美元2023 年第四季。
And finally, as of June 30, 2024, Verrica had aggregate cash and cash equivalents of $31.9 million. The company expects that its cash and cash equivalents as of June 30, 2024, will be sufficient to fund operations into the first quarter of 2025. I will now turn the call back over to Ted for closing remarks.
最後,截至 2024 年 6 月 30 日,Verrica 的現金及現金等價物總額為 3,190 萬美元。該公司預計截至 2024 年 6 月 30 日的現金和現金等價物將足以為 2025 年第一季的營運提供資金。我現在將把電話轉回給特德,讓他發表結束語。
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
Thanks, Terry. As we progress through the third quarter, we are laser-focused on the launch of YCANTH and accelerating YCANTH demand in the second half of the year. We achieved important wins across multiple areas of our business. Significant amounts of compounded cantharidin have been removed from the US market, and we will continue to be vigilant on this front.
謝謝,特里。隨著第三季的進展,我們將重點放在 YCANTH 的推出以及下半年 YCANTH 需求的加速成長。我們在多個業務領域取得了重要的勝利。大量複合斑蝥素已從美國市場下架,我們將繼續對此保持警惕。
CMS published favorable YCANTH allowables on July 1, and we continue to focus on expanding our buy and bill accounts and demand with the addition of Cencora, IPN and Vizient as GPOs, targeting physician groups and hospitals.
CMS 於 7 月 1 日發布了優惠的 YCANTH 許可,我們繼續專注於擴大我們的購買和帳單帳戶以及需求,增加了 Cencora、IPN 和 Vizient 作為 GPO,針對醫生團體和醫院。
We also made considerable progress in our pipeline. We expect to continue advancing YCANTH for the treatment of common warts through our amended agreement with Torii and the exciting top line data we released today on our Phase 2 data for VP-315 for the treatment of basal cell carcinoma.
我們在管道方面也取得了相當大的進展。我們期望透過與 Torii 的修訂協議以及我們今天發布的有關 VP-315 治療基底細胞癌的 2 期數據的令人興奮的頂線數據,繼續推進 YCANTH 用於治療尋常疣。
Our company remains very excited about VP-315's unique and differentiated product profile, which has the potential to be a primary and neoadjuvant non-invasive therapy that addresses a significant unmet medical need in dermatology. That concludes our formal remarks, and I'll now turn the call over to the operator for Q&A.
我們公司仍然對 VP-315 獨特且差異化的產品概況感到非常興奮,該產品有潛力成為一種主要和新輔助非侵入性療法,可解決皮膚科中未滿足的重大醫療需求。我們的正式發言到此結束,現在我將把電話轉給接線生進行問答。
Operator
Operator
(Operator Instructions)
(操作員說明)
Stacy Ku, TD Cowen.
史黛西·庫,TD·考恩。
Stacy Ku - Analyst
Stacy Ku - Analyst
All right. We had a few questions. Just first on YCANTH. Can you put some metrics around the progress you've made in removing compounded cantharidin and just a better understanding around the timeline of when things might resolve? Just help set some expectations there.
好的。我們有幾個問題。首先是 YCANTH。您能否針對去除複合斑蝥素方面取得的進展制定一些指標,並更好地了解問題何時可能解決的時間表?只是幫助在那裡設定一些期望。
And a quick follow-up on kind of the stocking you've discussed in a lot of detail. Where do you expect it to normalize versus where it is now? So those are our YCANTH questions.
以及您已經詳細討論過的襪子類型的快速跟進。與現在的情況相比,您預計它會在什麼情況下正常化?這些就是我們 YCANTH 的問題。
And then for VP-315. Obviously, the treatment paradigm for BCC is -- has a lot of surgery. So kind of curious what's the pathway forward that could help build enthusiasm beyond the typical cutting out of the lesion?
然後是 VP-315。顯然,基底細胞癌的治療範例是-進行大量手術。很好奇除了典型的切除病變之外,還有什麼方法可以幫助激發熱情?
What are your early thoughts on study design? And what kind of follow-up do you think will be necessary to confirm long-term complete histological clearance? What do you think clinicians will want to see?
您對研究設計的早期想法是什麼?您認為需要什麼樣的追蹤來確認長期完全的組織學清除?您認為臨床醫師希望看到什麼?
And then one more question, if possible, and I can come back and follow up. Do you see any greater success in certain lesions? Kind of curious about the success you've seen maybe on this phase. Thanks so much.
如果可能的話,還有一個問題,我可以回來跟進。您認為某些病變有更大的成功嗎?對您在這個階段所看到的成功有點好奇。非常感謝。
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
Thank you, Stacy. This is Ted. I'll handle the first part on the compounded cantharidin and then turn it over to Terry and then over to Gary Goldenberg for the VP-315.
謝謝你,史黛西。這是特德。我將處理複合斑蝥素的第一部分,然後將其交給 Terry,然後將 VP-315 交給 Gary Goldenberg。
So on the compounded cantharidin, as you know, we've announced that we've been successful with both Lighters and Dormer Laboratories. Typical compounded cantharidin has a shelf life of around six months. We know that in Dormer Laboratories, specifically, there were over 24,000 vials shipped to the United States. So we expect that, that inventory has to bleed out from offices.
因此,如您所知,在複合斑蝥素方面,我們已經宣布與 Lighters 和 Dormer Laboratories 合作取得了成功。典型的複合斑蝥素的保質期約為六個月。我們知道,具體而言,在 Dormer 實驗室,有超過 24,000 個小瓶被運往美國。因此,我們預計,庫存必須從辦公室流失。
And so when you think about it, the last shipment was made in April of 2024. So with a 6-month shelf life, we expect that to bleed out in the second half of the year. And I'll turn the next part over to Terry.
因此,仔細想想,最後一批貨物是在 2024 年 4 月發出的。因此,由於保質期為 6 個月,我們預計該保質期將在今年下半年耗盡。我將把下一部分交給特里。
Terry Kohler - Chief Financial Officer
Terry Kohler - Chief Financial Officer
Sure. Good morning, Stacy. So your question on inventory and normalization, I think our expectation is that we're going to continue to grow demand aggressively over the back half of the year here. And so I think we expect inventory to normalize in the channel in the back half of the year and be normalized by early 2025.
當然。早安,史黛西。因此,關於庫存和正常化的問題,我認為我們的預期是,我們將在今年下半年繼續大幅成長需求。因此,我認為我們預計通路庫存將在今年下半年恢復正常,並在 2025 年初恢復正常。
Stacy Ku - Analyst
Stacy Ku - Analyst
Okay. Do you expect it to have some kind of expectations or guidance around the percentage of realized revenue? Kind of the inventory? Just to help set expectations.
好的。您是否期望它對已實現收入的百分比有某種預期或指導?庫存種類?只是為了幫助設定期望。
Terry Kohler - Chief Financial Officer
Terry Kohler - Chief Financial Officer
Yeah. We'll certainly -- we know that distributors are going to take into account inventory on hand and future demand expectations as they think about what the appropriate level of ex-factory orders will be in the back half of the year, but we can't give any guidance on revenues at this stage or comment really on the cadence of any future ex-factory orders.
是的。我們當然會——我們知道經銷商在考慮下半年出廠訂單的適當水平時會考慮現有庫存和未來需求預期,但我們可以」我們不會對現階段的收入提供任何指導,也不會對任何未來出廠訂單的節奏進行真正的評論。
Stacy Ku - Analyst
Stacy Ku - Analyst
Okay. Understood.
好的。明白了。
Operator
Operator
Gregory Renza, RBC Capital Markets.
格雷戈里·倫扎(Gregory Renza),加拿大皇家銀行資本市場部。
Terry Kohler - Chief Financial Officer
Terry Kohler - Chief Financial Officer
Just as a pause here, I want to make sure we answer the 315 question as well.
在此暫停一下,我想確保我們也回答了 315 問題。
Gary Goldenberg - Chief Medical Officer
Gary Goldenberg - Chief Medical Officer
Yes. Can you hear me? Stacy, how are you doing? Thanks for the questions. Okay. So regarding the paradigm, we believe that based on our Phase 2 data -- and it's Phase 2, not Phase 3. But based on the Phase 2 data, we believe that this product, the VP-315 has the ability to shift the treatment paradigm.
是的。你聽得到我嗎?史黛西,你好嗎?感謝您的提問。好的。因此,關於範例,我們認為基於我們的第 2 階段資料——這是第 2 階段,而不是第 3 階段。但根據第二階段的數據,我們相信這個產品VP-315有能力改變治療模式。
I think if you look at our favorable safety profile in the Phase 2 study, we're very pleased with that. And as you know, Phase 2 really is a safety study, it's a dose escalation safety study. We did not see any severe adverse events related to the treatment. So that's a very positive development.
我想如果你看看我們在第二階段研究中良好的安全性,我們對此感到非常滿意。如您所知,第二階段確實是一項安全性研究,是一項劑量遞增的安全性研究。我們沒有看到任何與治療相關的嚴重不良事件。所以這是一個非常積極的發展。
If you look at efficacy data for complete histologic clearance and also for tumor size reduction essentially shrinking the tumor, we believe that VP-315 has the potential to be the treatment of choice between biopsy and diagnosis and potential need for surgery. Right now, in vast majority of patients, you get a diagnosis with a biopsy. Your next step of surgery. We believe that VP-315 has the potential to be that step in between.
如果您查看完全組織學清除以及腫瘤尺寸縮小(本質上縮小腫瘤)的療效數據,我們相信 VP-315 有可能成為活檢和診斷以及潛在手術需求之間的治療選擇。目前,絕大多數患者可以透過活檢得到診斷。您的下一步手術。我們相信 VP-315 有潛力成為介於兩者之間的一步。
In 51% of subjects in our study, it was complete histologic clearance, meaning that there would be no need for a surgical intervention. In those patients who did not have histologic clearance, there was a 71% reduction in lesion size. What does that mean for a patient? It means that if they do have to have surgery later on, the surgery now is much smaller. It's decreased by more than 50%.
在我們的研究中,51% 的受試者獲得了完全的組織學清除,這意味著不需要手術幹預。在那些沒有組織學清除的患者中,病灶大小減少了 71%。這對患者意味著什麼?這意味著如果他們以後確實要做手術,那麼現在的手術就會小得多。減少了50%以上。
So their surgical scar, the operation itself, is now much smaller than it would have been prior to using VP-315. So we really believe that this has potential to shift the treatment paradigm. As far as the follow-up time needed and what dermatologists would like to see, I think it's too early to comment. I think these are the things that we will discuss with the agency in our end of Phase 2 meeting, which we anticipate to have it in the first half of next year.
因此,他們的手術疤痕(手術本身)現在比使用 VP-315 之前小得多。所以我們確實相信這有可能改變治療模式。至於所需的追蹤時間以及皮膚科醫生希望看到的結果,我認為現在評論還為時過早。我認為這些是我們將在第二階段會議結束時與該機構討論的事情,我們預計將在明年上半年舉行。
But I think at this point, we are all very excited about the potential of this molecule to shift to the treatment paradigm for the 3.6 million-plus patients with basal cell carcinoma in the United States alone.
但我認為此時此刻,我們都對這種分子轉變為治療模式的潛力感到非常興奮,光在美國就有超過 360 萬名基底細胞癌患者。
Operator
Operator
Gregory Renza, RBC Capital Markets.
格雷戈里·倫扎(Gregory Renza),加拿大皇家銀行資本市場部。
Gregory Renza - Analyst
Gregory Renza - Analyst
Great. Thanks. Good morning. Ted, congrats on the progress. Thanks for taking my question. Ted, as you and Joe and the team talk about really accelerating and doubling down on execution for YCANTH in the market, just wanted to ask if you could just add additional color on some of those levers that you're pulling? How are you prioritizing the detailing there? I know you provided some comments in your prepared remarks.
偉大的。謝謝。早安.特德,祝賀你取得了進步。感謝您提出我的問題。Ted,當您和 Joe 以及團隊談論真正加速並加倍 YCANTH 在市場上的執行時,我只是想問您是否可以在您正在拉動的一些槓桿上添加額外的顏色?您如何優先考慮那裡的細節?我知道你在準備好的發言中提出了一些評論。
Just curious how important is that same-day treatment and lowering those barriers for prior authorizations? I know you've seen that come down. And as we're about a year or so into launch, just wanted to provide -- if you can just provide some of your commentary on the trajectory from here in light of all the execution detailing that you're doing? Thanks.
只是好奇當日治療和降低事先授權的障礙有多重要?我知道你已經看到了這種情況的發生。由於我們已經推出了大約一年左右的時間,我只是想提供一下——您是否可以根據您正在做的所有執行細節,對從這裡開始的軌跡提供一些評論?謝謝。
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
Sure. Thank you, Greg, for the question. So listen, I would tell you a couple of things. Prior authorizations. We typically see that in our Medicaid, in our managed Medicaid area of business, and we are actively working with those accounts as we speak to negotiate to get those PAs removed.
當然。謝謝格雷格提出的問題。聽著,我要告訴你幾件事。事先授權。我們通常會在我們的醫療補助、我們管理的醫療補助業務領域看到這種情況,我們正在積極與這些帳戶合作,並進行談判以刪除這些 PA。
Difference between a medical benefit and a pharmacy benefit, in a medical benefit policy, you cannot treat the same day until you get the authorization code. So it's not like a pharmacy benefit where you can do an electronic prior authorization, CoverMyMeds, et cetera. Medical benefit is different.
醫療福利和藥品福利之間的區別是,在醫療福利保單中,在獲得授權代碼之前,您不能在同一天接受治療。因此,它不像藥房福利,您可以進行電子預先授權、CoverMyMeds 等。醫療福利不同。
So this is a key area that we're focusing on in order to get these PAs removed. Again, we typically see it in managed Medicaid and state Medicaid and then also the Blue Cross Blue Shields of the world. So that's number one.
因此,這是我們重點關注的關鍵領域,以消除這些 PA。同樣,我們通常會在管理醫療補助和州醫療補助以及世界各地的藍十字藍盾中看到它。所以這是第一。
Number two is we're looking to pull a lever with our co-pay program. Right now, our co-pay program is -- there's a variance between $25 to $75. You'll be hearing shortly that we'll be streamlining that process and making it more simplistic for customers and for the patients. So that's another lever.
第二是我們希望透過我們的共同支付計劃來拉動槓桿。目前,我們的共付額計劃是——有 25 美元到 75 美元之間的差異。您很快就會聽到我們將簡化流程,並使其對客戶和患者來說更加簡單。這是另一個槓桿。
I also think that the other lever we have with IPN with Cencora, they have a strong footprint in dermatology, and now we'll be able to do contracting with them and be able to talk spread that, as you know, our field force cannot talk about with customers.
我還認為,我們與Cencora 的IPN 的另一個槓桿是,他們在皮膚科領域擁有強大的影響力,現在我們將能夠與他們簽訂合同,並能夠談論傳播,正如你所知,我們的現場人員無法做到這一點與客戶談論。
And then, of course, we have Vizient for the institutions. And then finally, looking at payers, why we have strong coverage. We'd like to get even stronger coverage and look to go to a dual benefit where we have a pharmacy benefit as well as a medical benefit. And those are the levers that we're actively working on as we speak.
當然,我們還有針對機構的 Vizient。最後,看看付款人,為什麼我們有強大的覆蓋範圍。我們希望獲得更強大的承保範圍,並尋求雙重福利,即我們擁有藥物福利和醫療福利。這些就是我們正在積極研究的槓桿。
Gregory Renza - Analyst
Gregory Renza - Analyst
That's great. Thank you. And just one more maybe for Terry. Just on the sampling. Can you just give us a state of the contribution there and the expectations? And then maybe I'll just lob in. As you see the demand and maybe some of that predictability, I know you didn't provide refraining from guidance on, of course, some inventory.
那太棒了。謝謝。也許還有一個是給特里的。就在採樣上。您能為我們介紹一下那裡的貢獻和期望嗎?然後也許我會插手。當您看到需求以及可能的一些可預測性時,我知道您當然沒有提供有關某些庫存的指導。
But just largely, did you have a timeline as to when you would feel comfortable just internally on projections to provide larger, longer-term guidance when it comes to YCANTH revenues? Thanks again. And congrats guys on the quarter and the data.
但很大程度上,您是否有一個時間表來說明您何時會在內部對 YCANTH 收入方面的預測感到滿意,以提供更大、更長期的指導?再次感謝。並祝賀大家的季度和數據。
Terry Kohler - Chief Financial Officer
Terry Kohler - Chief Financial Officer
Thanks, Greg. Good morning. So on the guidance front, that's something that we'll consider as we get closer to 2025. It's not something that we'll do in the back half of this year. And then on the sample program, so we continue to sample, but I would tell you the sampling has gone significantly down and will continue to go down, we believe, over the back half of the year. Joe, is that --
謝謝,格雷格。早安.因此,在指導方面,隨著 2025 年的臨近,我們將考慮這一點。這不是我們今年下半年會做的事情。然後是樣本計劃,我們繼續抽樣,但我想告訴你,抽樣數量已經顯著下降,我們相信,今年下半年將繼續下降。喬,是那個嗎--
Joe Bonaccorso - Chief Commercial Officer
Joe Bonaccorso - Chief Commercial Officer
Yeah. I mean we look at the sample program as trade doses because they are a starter dose, right, to help the patient. So we're -- that continues to go down as we're continuing to build our coverage and the same-day treatment for physicians. So to Terry's point, that's going to continue to taper down dramatically in the back half of the year here.
是的。我的意思是,我們將範例程序視為交易劑量,因為它們是起始劑量,對吧,可以幫助患者。因此,隨著我們繼續擴大覆蓋範圍和為醫生提供當日治療,這一數字繼續下降。因此,就特里而言,今年下半年這一數字將繼續大幅減少。
Gregory Renza - Analyst
Gregory Renza - Analyst
Great. Thanks, guys.
偉大的。謝謝,夥計們。
Operator
Operator
Glen Santangelo, Jefferies.
格倫桑坦傑洛,傑弗里斯。
Glen Santangelo - Analyst
Glen Santangelo - Analyst
Yeah. Thanks for taking my questions. Hey, Ted, I mean, you commented multiple times, obviously, about the settlement against Dormer Labs, and that's obviously a major step forward. But can you say sort of confidently at this point, you're not really seeing any incremental compounded cantharidin sort of come in to the market at this point? Do you feel like that window has closed?
是的。感謝您回答我的問題。嘿,特德,我的意思是,顯然,您多次評論了針對多默實驗室的和解協議,這顯然是向前邁出的重要一步。但您現在可以自信地說,目前您還沒有真正看到任何增量複合斑蝥素進入市場嗎?你是否感覺到那扇窗已關閉?
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
Hi, Glenn. Yeah. So I could tell you, incrementally, no, we're not seeing any incremental compounded cantharidin in the market. Are there isolated cases where there's been compounded cantharidin seen? Yes, absolutely. And what I mean by that is that's the Dormer inventory that's bleeding out.
嗨,格倫。是的。所以我可以逐步告訴你,不,我們在市場上沒有看到任何增量複合斑蝥素。是否有出現複合斑蝥素的個別病例?是的,絕對是。我的意思是,多馬的庫存正在耗盡。
Glen Santangelo - Analyst
Glen Santangelo - Analyst
Right. So I think what we're all trying to do is we're all trying to sort of reconcile maybe the $2.3 million in revenues you had this quarter with FFF, with the sort of the comments that you made in the press release that you expect prescription growth quarter over quarter in the back half? Sort of taking into consideration that it may take some time to bleed out the compounded cantharidin sort of in the market.
正確的。因此,我認為我們正在努力做的是,我們都在嘗試將您本季與 FFF 獲得的 230 萬美元收入與您在新聞稿中所發表的評論進行調和。某種程度上考慮到複合斑蝥素可能需要一段時間才能在市場上消失。
So you think we're starting to see that now. I mean we're midway through 3Q. I don't know if there's any sort of commentary you can give us sort of at this point, but maybe you feel like we're at the point where we're going to start to see that inflection in Scripps because the compounded cantharidin is sort of almost worked its way fully through the system. Is that kind of the message you're trying to send?
所以你認為我們現在開始看到這一點。我的意思是我們已經進入第三季中期了。我不知道此時您是否可以給我們任何評論,但也許您覺得我們正處於我們將開始看到斯克里普斯的這種變化的時刻,因為複合斑蝥素是幾乎完全通過了系統。這就是您想要發送的訊息嗎?
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
Absolutely. I mean we expect to see the inflection with the Dormer now bleeding out. We're already seeing, Glen, accounts that were on the Dormer target list. As you know, Dormer -- we know those accounts, and we're already seeing orders from those accounts starting to come in as those accounts bleed out their inventory.
絕對地。我的意思是,我們預計會看到多馬的變形現在正在流血。格倫,我們已經看到多默目標名單上的帳戶。如您所知,多馬——我們知道這些客戶,我們已經看到隨著這些客戶的庫存耗盡,來自這些客戶的訂單開始增加。
Glen Santangelo - Analyst
Glen Santangelo - Analyst
Perfect. And maybe my last question is sort of on Ligand's product. You're obviously aware that there is another company that got approval. I don't know if you could sort of comment on the competitive landscape, if there's anything else sort of you're paying attention to and how that approval might ultimately be impacting the market positively or negatively for you.
完美的。也許我的最後一個問題是關於配體的產品。您顯然知道還有另一家公司獲得了批准。我不知道您是否可以對競爭格局發表評論,是否還有其他您正在關注的事情,以及這種批准最終可能會對市場產生積極或消極的影響。
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
Yeah, no, great question. We're fully aware of ZELSUVMI. And listen, I would tell you, we think it's great that somebody else recognize the opportunity within molluscum. And look, for us, I think it only helps Verrica because it's going to increase the share of voice around molluscum.
是的,不,很好的問題。我們完全了解 ZELSUVMI。聽著,我想告訴你,我們認為其他人認識到軟疣中的機會是很棒的。瞧,對我們來說,我認為這只會對維里卡有幫助,因為它會增加軟體動物周圍的聲音份額。
Our customers know that cantharidin is the gold standard for the treatment of molluscum contagiosum. So that -- again, we only see that as a benefit to us.
我們的客戶知道斑蝥素是治療傳染性軟疣的黃金標準。因此,我們再次認為這對我們有利。
Glen Santangelo - Analyst
Glen Santangelo - Analyst
Okay. Thanks, Ted.
好的。謝謝,泰德。
Operator
Operator
Oren Livnat, H.C. Wainwright.
奧倫·利夫納特,H.C.溫賴特。
Oren Livnat - Analyst
Oren Livnat - Analyst
Let me unmute first. Thank you. Exciting time over there. I have a couple of questions on 315 and YCANTH, if I may. Just firstly, I'm really curious if you saw shrinkage in any tumors that weren't directly treated with 315. Essentially, I'm wondering if you saw a systemic immunological response. And was there any control against matched tumors intrapatient?
讓我先取消靜音。謝謝。那裡的時光令人興奮。如果可以的話,我有幾個關於 315 和 YCANTH 的問題。首先,我真的很好奇您是否看到任何未直接接受 315 治療的腫瘤出現縮小。本質上,我想知道您是否看到了全身免疫反應。是否有針對患者體內匹配腫瘤的控制措施?
And bigger picture, if you think about this product strategically, obviously, this is also medical dermatology, which overlaps with where you're at, but it's clearly a different market than the pediatric focus you have now. Presumably, it could be maximized by a larger company as well when you talk about multi-blockbuster potential. So going forward, do you think about trying to maybe partner this and focus on YCANTH? Or are you keeping all your options open, which I assume will be your answer? And then I have YCANTH follow-ups after that. Thanks.
從更大的角度來看,如果你從戰略上考慮這個產品,顯然,這也是醫學皮膚病學,與你所在的領域重疊,但它顯然是一個與你現在關注的兒科市場不同的市場。想必,當你談論多款重磅炸彈的潛力時,大公司也可以將其最大化。那麼展望未來,您是否考慮嘗試與此合作並專注於 YCANTH?或者你是否保留所有選擇,我認為這將是你的答案?之後我還有 YCANTH 後續行動。謝謝。
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
Sure, Oren. This is Ted. So absolutely, we want to keep all of our options open as it relates to 315, including partnerships. So -- and I'll turn the next part over to Gary to answer the other questions that you had.
當然,奧倫。這是特德。因此,我們絕對希望保留與 315 相關的所有選擇,包括合作關係。所以——我將把下一部分交給加里來回答你們提出的其他問題。
Gary Goldenberg - Chief Medical Officer
Gary Goldenberg - Chief Medical Officer
Thanks, Ted. Oren, hi. Thanks for the question. So regarding the abscopal effect, it was one of the secondary endpoints in our protocol. At this point, we're not ready to comment regarding abscopal effect. The only thing I can say is that we did have a few tumors where we did look for abscopal effect and just stay tuned for those data. The only things that we're able to discuss now are the safety and the preliminary top line results.
謝謝,泰德。奧倫,嗨。謝謝你的提問。因此,關於遠隔效應,它是我們方案中的次要終點之一。目前,我們還沒有準備好對遠隔效應發表評論。我唯一能說的是,我們確實有一些腫瘤,我們確實在尋找遠隔效應,並繼續關注這些數據。我們現在唯一能夠討論的是安全性和初步的頂線結果。
Oren Livnat - Analyst
Oren Livnat - Analyst
And just lastly, on 315. You mentioned in the press release you're excited to continue to explore these properties in tissue and blood samples, I think. Does that indicate potentially trying to quickly broaden the potential indications that you might target learning more on that front? Or is this about needing to better characterize the product, maybe in the mechanism of action in the current BCC program?
最後是 315。我想,您在新聞稿中提到,您很高興繼續探索組織和血液樣本中的這些特性。這是否表明您可能試圖快速擴大潛在跡象,表明您可能會在這方面學習更多內容?或者這是否需要更好地表徵產品,也許是在當前 BCC 計劃的作用機制中?
And then on YCANTH, can you just talk about the forward deployed inventory model a little more, which I don't think you addressed recently. How is that playing out in the field? When you look at orders, are physicians stocking essentially in the office to have some on the table if and when they want to actually pull the trigger and use it? How much of that versus just in time essentially ordering even in office, so they're just -- we can see what they're using. Do you have visibility with FFF on that front, how much of that's getting used?
然後在 YCANTH 上,您能否再多談談前向部署的庫存模型,我認為您最近沒有談到這個問題。現場情況如何?當你查看訂單時,醫生是否基本上在辦公室裡備有一些庫存,以便在他們想要真正扣動扳機並使用它時,在桌子上放一些?其中有多少與即時訂購相比,即使是在辦公室,所以他們只是——我們可以看到他們在使用什麼。您是否了解 FFF 在這方面的情況,其中有多少被使用?
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
Okay. I'll --
好的。患病的--
Gary Goldenberg - Chief Medical Officer
Gary Goldenberg - Chief Medical Officer
I'll take the first question.
我來回答第一個問題。
Yeah. Sorry, Ted, please.
是的。對不起,特德,拜託。
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
No. Go ahead.
不。前進。
Glen Santangelo - Analyst
Glen Santangelo - Analyst
So I just want to address the tissue and the blood samples. So I think we're just looking at the basal cell subjects that we studied in our Phase 2 study at this point. And if you look at VP-315 as an immune modulator as an oncolytic peptide, it works by -- at least the proposed mechanism of action or the one that's been elucidated to this point is that it works by activating a local immune response to tumor-specific antigens. So [like] tumor cells, you reveal those antigens, which are normally protected by the tumor and then you get an immune stimulation.
所以我只想談談組織和血液樣本。所以我認為我們現在只是在研究我們在第二階段研究中研究的基底細胞受試者。如果你將VP-315 視為一種免疫調節劑,就像一種溶瘤肽,它的作用原理是——至少擬議的作用機製或迄今為止已闡明的作用機制是,它通過激活針對腫瘤的局部免疫反應來起作用-特異性抗原。因此,就像腫瘤細胞一樣,你會暴露出那些通常受到腫瘤保護的抗原,然後你就會得到免疫刺激。
We want to study this further. We want to see exactly what kind of immune response we're getting in the tissue and whether or not we are getting one in the blood samples, which would give us a window to understanding of whether or not we're going to see a systemic response to basal cell antigens, which I think would be exciting. But at this point, it's just simply to characterize further the MOA and the immune response we're getting by injecting VP-315 into the tumors.
我們想進一步研究這個問題。我們希望確切地了解我們在組織中得到了什麼樣的免疫反應,以及我們是否在血液樣本中得到了這種免疫反應,這將為我們提供一個了解我們是否會看到系統性免疫反應的窗口。對基底細胞抗原的反應,我認為這會令人興奮。但目前,這只是為了進一步表徵 MOA 和我們將 VP-315 注射到腫瘤中所獲得的免疫反應。
Oren Livnat - Analyst
Oren Livnat - Analyst
Perfect. Thank you. (multiple speakers)
完美的。謝謝。(多個發言者)
Joe Bonaccorso - Chief Commercial Officer
Joe Bonaccorso - Chief Commercial Officer
Yeah. It's Joe. Oren, how are you?
是的。是喬。奧倫,你好嗎?
Oren Livnat - Analyst
Oren Livnat - Analyst
Great. Thanks.
偉大的。謝謝。
Joe Bonaccorso - Chief Commercial Officer
Joe Bonaccorso - Chief Commercial Officer
Good. So regarding your question, the forward deployed inventory is still a part of our core model. That is an opportunity for physicians who would rather consign in the inventory, if you will, forward deploy it in and then get billed as they're treating patients.
好的。所以關於你的問題,前向部署庫存仍然是我們核心模型的一部分。對於那些寧願將庫存委託給醫生的醫生來說,這是一個機會,如果願意的話,可以提前部署,然後在治療患者時收取費用。
We also like to keep our buy-and-bill model agile. We have some physicians that are more interested in volume tier discounts and often voice discounting as well. So we're seeing a blended approach on the buy-and-bill side. And again, we try to keep our program agile enough to reflect the needs of the customer and what that particular customer is interested in.
我們也希望保持購買和計費模式的敏捷性。我們有一些醫生對批量折扣更感興趣,而且通常對語音折扣更感興趣。因此,我們在購買和帳單方面看到了混合方法。再次,我們嘗試保持我們的程序足夠敏捷,以反映客戶的需求以及特定客戶的興趣。
Oren Livnat - Analyst
Oren Livnat - Analyst
All right. Thanks. I'll follow-up after. I appreciate it.
好的。謝謝。後續我會跟進。我很感激。
Joe Bonaccorso - Chief Commercial Officer
Joe Bonaccorso - Chief Commercial Officer
You're welcome.
不客氣。
Operator
Operator
Serge Belanger, Needham.
塞爾吉·貝蘭格,李約瑟。
Serge Belanger - Senior Analyst
Serge Belanger - Senior Analyst
Hey. Good morning. Thanks for taking the questions. A couple on YCANTH to start off with. I guess going forward, should we expect any additional distributor or GPO partnerships? And maybe what the impact is on the overall net pricing as you continue expanding the GPO field here?
嘿。早安.感謝您提出問題。首先是 YCANTH 上的一對夫婦。我想,展望未來,我們是否應該期待更多的經銷商或 GPO 合作夥伴關係?當您繼續擴大 GPO 領域時,也許會對整體淨定價產生什麼影響?
And then on VP-315, I guess for Gary. Obviously, pretty exciting data in basal cell carcinoma. Do you feel this derisks the program for squamous cell carcinoma? And is that one of the other non-melanomas you expect to target going forward? Thanks.
然後是 VP-315,我猜是蓋瑞的。顯然,基底細胞癌的數據非常令人興奮。您認為這會危及鱗狀細胞癌計畫的風險嗎?這是您未來希望瞄準的其他非黑色素瘤之一嗎?謝謝。
Terry Kohler - Chief Financial Officer
Terry Kohler - Chief Financial Officer
Hi, Serge. Good morning it's Terry. I'll answer the first part around the pricing. So with the addition of Cencora, we still believe that our overall net sales as a percentage of gross sales is going to continue to be in that 45% to 50% range over time. We'll continue to evaluate that and monitor as we move forward, but that's still our expectation.
嗨,塞爾日。早上好,我是特里。我將回答有關定價的第一部分。因此,隨著 Cencora 的加入,我們仍然相信,隨著時間的推移,我們的整體淨銷售額佔總銷售額的百分比將繼續保持在 45% 至 50% 的範圍內。我們將繼續評估這一點並在前進過程中進行監控,但這仍然是我們的期望。
Joe Bonaccorso - Chief Commercial Officer
Joe Bonaccorso - Chief Commercial Officer
Yeah. And Serge, for the second part about the possibility of activating our market further with distributors or opportunities. Look, I mean, we have to remain opportunistic as an organization. This is a big market, and we certainly are exploring ways to make sure we can reach the customers that need the product.
是的。Serge,第二部分是關於透過經銷商或機會進一步啟動我們市場的可能性。聽著,我的意思是,作為一個組織,我們必須保持機會主義。這是一個很大的市場,我們當然正在探索各種方法,以確保我們能夠接觸到需要產品的客戶。
It could be through an expansion, perhaps of some degree with some regional pharmacies or we can look into further opportunities that might help in areas such as the Department of Defense and other customer segments that we're spending time in. So really, the message here is we'll look to be opportunistic and be mindful as we're building it out.
這可能是透過擴張,也許是在某種程度上與一些地區藥局的擴張,或者我們可以尋找可能對國防部和我們正在花時間研究的其他客戶群等領域有所幫助的進一步機會。所以,實際上,這裡傳達的訊息是,我們在建造它時會抓住機會並保持警惕。
Gary Goldenberg - Chief Medical Officer
Gary Goldenberg - Chief Medical Officer
Serge, regarding your question on SEC, just a reminder that we do have the global rights to develop VP-315 for basal cell carcinoma, squamous cell carcinoma and non-metastatic melanoma and non-metastatic Merkel cell carcinoma.
Serge,關於你關於 SEC 的問題,只是提醒一下,我們確實擁有針對基底細胞癌、鱗狀細胞癌、非轉移性黑色素瘤和非轉移性默克爾細胞癌開發 VP-315 的全球權利。
I think at this point, we're focused on basal cells since it is the most common malignancy in humans with over 3.6 million cases in the United States. But it doesn't mean that we wouldn't think about another opportunity like squamous cell, which is the second most common skin cancer in humans. It doesn't mean that we wouldn't think about that at some point.
我認為目前我們將重點放在基底細胞,因為它是人類最常見的惡性腫瘤,在美國有超過 360 萬例。但這並不意味著我們不會考慮像鱗狀細胞癌這樣的另一種機會,鱗狀細胞癌是人類第二常見的皮膚癌。這並不意味著我們在某個時候不會考慮這個問題。
But right now, I think our focus remains basal cell moving forward with an end of Phase 2 meeting sometime in the first half of next year, discussing a Phase 3 program with the agency and then hopefully moving forward into the Phase 3 program.
但現在,我認為我們的重點仍然是基底細胞,並在明年上半年的某個時候結束第二階段會議,與該機構討論第三階段計劃,然後希望進入第三階段計劃。
Serge Belanger - Senior Analyst
Serge Belanger - Senior Analyst
Great. Just a follow-up on YCANTH. Can you just talk about the mix of prescribers between derms and peds since you deployed your pediatric sales force? Maybe just comment on if you've seen any off-label use of the product to -- or some of the wart indications.
偉大的。只是 YCANTH 的後續。您能談談自從您部署兒科銷售隊伍以來,皮膚科醫生和醫生之間的處方者組合嗎?如果您發現該產品有任何標籤外用途,或某些疣適應症,請發表評論。
Joe Bonaccorso - Chief Commercial Officer
Joe Bonaccorso - Chief Commercial Officer
Yeah, we can't support off-label use, and our co-pay program doesn't cover for that. So we have no visibility into what's happening in the practice because we can't support it. The second piece of it is the dermatologists, pediatric dermatologists' hospital base, continue to be the major treaters of molluscum. But our pediatric team is making quick inroads here having just deployed in April.
是的,我們不支援標籤外使用,我們的自付額計劃也不涵蓋這一點。因此,我們無法了解實踐中發生的情況,因為我們無法支持它。第二塊是皮膚科醫生,小兒皮膚科醫生的醫院基地,仍然是軟疣的主要治療者。但我們的兒科團隊在四月剛部署,正在迅速取得進展。
What's been fascinating to us is not only the outreach and the interest from the pediatricians, but the willingness to take the product into their office on direct purchase because they'd like to treat patients same day and do it under the supervision of a health care professional.
讓我們著迷的不僅是兒科醫生的外展和興趣,還在於他們願意直接購買產品到他們的辦公室,因為他們希望在同一天治療患者並在醫療保健的監督下進行專業的。
Operator
Operator
Kemp Dolliver, Brookline Capital Markets.
Kemp Dolliver,布魯克林資本市場。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
Great. Thank you. Two brief questions on YCANTH. First, you had previously expected gross margin to start to normalize at a lower level around this time, which hasn't yet occurred. What are you thinking about that now? Has this been pushed out into, say, 2025 or will we start to see it in the second half of the year?
偉大的。謝謝。關於 YCANTH 的兩個簡短問題。首先,您之前預計毛利率將在此時開始在較低水平正常化,但這尚未發生。你現在在想什麼?這是否會被推遲到 2025 年,或者我們會在今年下半年開始看到它?
Terry Kohler - Chief Financial Officer
Terry Kohler - Chief Financial Officer
Good morning, Kemp, this is Terry. Yes, we would expect to see that start to happen in the second half of the year. But just as a reminder, over the long term, we still expect gross margins to be in that low 90s percentage. Obviously, we have -- we're focused on continuing to drive cost down as we move forward. So there's a potential that we could see some of that benefit pull through in 2025. But too early to talk about that at this stage. So I think that low 90s is still a good place for us to be from a gross margin standpoint.
早安,坎普,我是特里。是的,我們預計這種情況會在今年下半年開始發生。但提醒一下,從長遠來看,我們仍然預計毛利率將保持在 90 % 的低水平。顯然,我們專注於在前進的過程中繼續降低成本。因此,我們有可能在 2025 年看到部分效益得以實現。但現階段談論這個還為時過早。因此,我認為從毛利率的角度來看,90 年代低仍然是我們的好地方。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
Great. And the second question is going back to the compounded shipments by Dormer and Lighters. Ted, I think you quoted a number. What was that number again?
偉大的。第二個問題是回到 Dormer 和 Lighters 的複合出貨量。特德,我想你引用了一個數字。那個數字又是多少?
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
Well, what we know is about 24,000 vials that have been shipped to the US from Dormer Laboratories.
據我們所知,大約有 24,000 個小瓶子已從 Dormer Laboratories 運往美國。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
Okay. Great. And no visibility on what Lighters had been doing prior to your agreement with them?
好的。偉大的。在您與 Lighters 達成協議之前,不知道他們在做什麼?
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
No.
不。
Kemp Dolliver - Analyst
Kemp Dolliver - Analyst
Great. Thank you.
偉大的。謝謝。
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
Thank you.
謝謝。
Operator
Operator
Thank you. That concludes our question-and-answer session. I will now turn the call back to Ted White for closing remarks.
謝謝。我們的問答環節到此結束。現在,我將把電話轉回給特德懷特,讓其致閉幕詞。
Ted White - President, Chief Executive Officer, Director
Ted White - President, Chief Executive Officer, Director
Thank you, operator. I'd like to thank all of you for joining us this morning. We're obviously very pleased with the significant accomplishments in the second quarter of 2024, including today's announcement on the positive top line results of 315 for basal cell carcinoma, and we look forward to providing another update on our third quarter earnings call in November. Thank you.
謝謝你,接線生。我要感謝大家今天早上加入我們。顯然,我們對 2024 年第二季度取得的重大成就感到非常滿意,包括今天宣布的 315 治療基底細胞癌的積極頂線結果,我們期待在 11 月的第三季度財報電話會議上提供另一次更新。謝謝。
Operator
Operator
Thank you. This does conclude the Verrica Pharmaceuticals' second qarter 2024 earnings conference call. You may disconnect your line at this time and have a wonderful day.
謝謝。Verrica Pharmaceuticals 的 2024 年第二季財報電話會議到此結束。此時您可以斷開線路並度過美好的一天。