LakeShore Biopharma Co Ltd (LSB) 2024 Q3 法說會逐字稿

Ladies and gentlemen, thank you for standing by and welcome to YS Biopharma's earnings call for the first nine months of fiscal year 2024.

女士們先生們，感謝你們的支持並歡迎參加 YS Biopharma 2024 財年前 9 個月的財報電話會議。

(Operator Instructions) Please note that this event is being recorded.

（操作員說明）請注意，該事件正在被記錄。

Now I'd like to hand the conference over to your speaker host today, Ms. Alyssa Li, the company's Investor Relations, Director.

現在我想將會議交給今天的演講主持人，公司投資者關係總監李靜女士。

Please go ahead, madam.

請繼續，女士。

Thank you very much.

非常感謝。

Hello everyone and thank you for joining us today.

大家好，感謝您今天加入我們。

Welcome to YS Biopharma's first nine months of physical year 2024 earnings conference call.

歡迎參加 YS Biopharma 2024 年實體年度前九個月的財報電話會議。

Today, you will hear from our President and CEO, Dr. David Shao, who will provide an overview of our operations during the past quarter.

今天，您將聽到我們的總裁兼執行長邵大衛博士的講話，他將概述我們上一季的營運情況。

Our CMO, Dr. Zenaida Mojares, will then share more details on our product pipeline.

我們的首席行銷長 Zenaida Mojares 博士隨後將分享有關我們產品線的更多詳細資訊。

Our CFO, Ms. Brenda Wu, will then provide a closer look into our financials.

然後，我們的財務長 Brenda Wu 女士將仔細研究我們的財務狀況。

After the management team has given their prepared remarks, we will open up the call for questions.

在管理團隊發表準備好的演講後，我們將開始提問。

You can refer to our first nine months of physical year 2024 financial results on our IR website at investor.ysbiopharm.com. You can also access a replay of this call on our IR website, when it becomes available a few hours after its conclusion.

您可以在我們的投資者關係網站 Investor.ysbiopharm.com 上參考我們 2024 年實體年度前 9 個月的財務表現。您也可以在我們的 IR 網站上查看本次電話會議的重播，該網站在會議結束幾小時後即可播放。

Before we continue, I would like to refer you to our safe harbor statement in our earnings press release, which also applies to this call as we will be making forward-looking statements.

在我們繼續之前，我想請您參閱我們的收益新聞稿中的安全港聲明，該聲明也適用於本次電話會議，因為我們將做出前瞻性聲明。

Please also note that all numbers stated in the following prepared remarks by management are in RMB terms.

另請注意，以下管理層準備的評論中列出的所有數字均以人民幣計價。

With that, I'm now pleased to turn the call over to Dr. David Shao, our President and CEO.

現在，我很高興將電話轉給我們的總裁兼執行長邵大衛博士。

Hello everyone and thank you for joining us today for our first nine months of physical year 2024 earnings conference call.

大家好，感謝您今天參加我們 2024 年前 9 個月的收益電話會議。

During the first nine months of physical year 2024, our top line continue to experience the lingering impact of inventory issues from previously supply chain disruption at our YSJA rabies vaccine manufacturing facility.

在 2024 年的前 9 個月，我們的營收繼續受到 YSJA 狂犬病疫苗生產工廠先前供應鏈中斷造成的庫存問題的持續影響。

Thanks to operational enhancement, including improved supply of raw material and refined inventory management strategy.

得益於營運改進，包括改善原材料供應和完善庫存管理策略。

Our vaccine production has returned to normal, and our inventory situation is improving as one of the top rabies vaccine producers in China, higher production circled and the healthier inventory level of finished product.

我們的疫苗生產已恢復正常，作為中國最大的狂犬病疫苗生產商之一，我們的庫存狀況正在改善，產量更高，成品庫存水準更健康。

We have maintained our leadership position in the marketplace.

我們一直保持著市場的領導地位。

Following the decline of our product sales in the first nine months ended December 31, 2023, we have returned to a growth trajectory, and we estimate double-digit year-over-year growth in product sales during the three-month period ended March 31, 2024.

繼截至2023 年12 月31 日的前9 個月我們的產品銷售額下降之後，我們已回到成長軌道，我們預計截至3 月31 日的三個月期間產品銷售額將實現兩位數的同比成長，2024 年。

Based on the current information at the end, we expect the product sales in physical year 2025.

根據年底的現有信息，我們預計 2025 年的產品銷售量。

Starting April 1, 2024, we'd like to increase by double-digit year over year.

從 2024 年 4 月 1 日開始，我們希望同比增長兩位數。

This would solidify our leadership position as one of the top rabies vaccine producers in China.

這將鞏固我們作為中國最大的狂犬病疫苗生產商之一的領導地位。

This guidance reflects our current and the preliminary views on the market and operational conditions, which are subject to change.

本指引反映了我們對市場和營運狀況的當前和初步看法，這些看法可能會改變。

Let's begin by going over the details of our results for the first nine months of fiscal year 2024.

讓我們先回顧一下 2024 財年前 9 個月的業績詳情。

Our total revenue for the period was RMB438.1 million, representing a year-over-year decline of 24.6%.

期內總收入為人民幣4.381億元，較去年同期下降24.6%。

Gross profit was RMB351.7 million, representing an 8.3% gross margin.

毛利為人民幣351.7百萬元，毛利率為8.3%。

For the first nine months of fiscal year 2024, we recorded a net loss of RMB260 million.

2024財年的前9個月，我們錄得淨虧損2.6億元。

At the end of the period, we had cash and the cash equivalents of RMB222.6 million compared with RMB370.4 million as of March 31, 2023.

截至期末，我們的現金及現金等價物為人民幣2.226億元，截至2023年3月31日為人民幣3.704億元。

Since we launched product sales of our YSJA rabies vaccine in late 2020, market intake of the vaccine has been consistent and strong.

自 2020 年底我們推出 YSJA 狂犬病疫苗產品銷售以來，該疫苗的市場需求量一直保持強勁。

As of December 31, 2023, we have sold more than 25.6 million doses on YSJA rabies vaccine to approximately 1,746 CDC customers, which represent over 6% of CDC customers in China, since October 2020.

截至2023年12月31日，我們已向約1,746名CDC客戶銷售了超過2,560萬劑YSJA狂犬病疫苗，自2020年10月以來，這些客戶佔中國CDC客戶的6%以上。

Next, I'd like to share some insights into our business initiatives.

接下來，我想分享一些對我們業務計劃的見解。

At the corporate level since late 2023, we have embarked a comprehensive series of initiatives aimed at fortifying our foundation for future growth.

自 2023 年底以來，在公司層面，我們啟動了一系列全面的舉措，旨在夯實未來成長的基礎。

This includes the change to the board of directors and the senior management team, which we announced in recent months as well as streamline organizational reporting lines, the (technical difficulty) making process.

這包括我們最近幾個月宣布的董事會和高階管理團隊的變動，以及簡化組織報告線和（技術難度）制定流程。

Additionally, we have implemented measures to enhance internal controls and governance.

此外，我們也採取了加強內部控制和治理的措施。

Starting in March 2024, we took further steps forward, including prioritizing our pre-clinic and clinical pipeline and optimize human resources across all our subsidiaries in the US, China, and Singapore.

從 2024 年 3 月開始，我們採取了進一步的措施，包括優先考慮我們的臨床前和臨床管道，並優化我們在美國、中國和新加坡的所有子公司的人力資源。

We have also implemented more effective cost controls in our manufacturing, sales and marketing, and the general administration functions.

我們還在製造、銷售和行銷以及一般管理職能中實施了更有效的成本控制。

These initiatives which include the cost controls and improvement of operating efficiency are ongoing and will remain a focus throughout the end of fiscal year 2025.

這些措施（包括成本控制和提高營運效率）正在進行中，並將在 2025 財年末繼續成為焦點。

We are confident that these efforts will serve as pillars for our future growth.

我們相信，這些努力將成為我們未來發展的支柱。

We also took steps to build out our infrastructure, expanding our total numbers of satellite warehouse to '26.

我們也採取措施建造基礎設施，將衛星倉庫總數擴大到 26 個。

These dispersed facilities enhance our production distribution capabilities and helping us take advantage of persistent demand for our YSJA rabies vaccine.

這些分散的設施增強了我們的生產分銷能力，並幫助我們利用對 YSJA 狂犬病疫苗的持續需求。

Thanks in part to our effective implementation of this strategic adjustment.

部分得益於我們這次策略調整的有效執行。

We are pleased to report that our production capacity returned to normal level during the third quarter of fiscal year 2024.

我們很高興地報告，我們的產能在 2024 財年第三季恢復正常。

Our second quarter of physical year 2024 was the last to come under significant pressure from impact of the past production delays.

2024 年第二季是最後一個受到過去生產延誤影響的重大壓力的季度。

While resolving our inventory issues, we took steps to strike a balance with our current strategy with the importance of building up our inventory against the need to fulfill market demand.

在解決庫存問題的同時，我們採取措施在當前策略與滿足市場需求之間建立庫存的重要性之間取得平衡。

This approach has led to improvement in our inventory situation to-date.

迄今為止，這種方法已經改善了我們的庫存狀況。

Ideally, we aim to hold 9 to 12 months worth of finished product inventory at any given time.

理想情況下，我們的目標是在任何給定時間持有 9 至 12 個月的成品庫存。

We are working towards achieving this target sometime during next year.

我們正在努力在明年某個時候實現這一目標。

Second, despite the short-term pressure on our top line, we continue to invest in our relationships with customers throughout China.

其次，儘管我們的營收面臨短期壓力，我們仍持續投資於與全中國客戶的關係。

As of December 31, 2023, our sales network in canvassed, 30 out of 31 province-level CDCs and these 1,746 CDC customers across China represent over 6% of CDC customers in the country.

截至2023年12月31日，我們的銷售網路已涵蓋全國31個省級疾管中心中的30個，這1,746個疾管中心客戶佔全國疾管中心客戶的6%以上。

Our sales and a marketing strategy either based on a long-term perspective through robust sales network we have built up over the past several years.

我們的銷售和行銷策略要么基於我們過去幾年建立的強大銷售網絡的長期視角。

For warehouse we've solid foundation from, which we can drive future success.

對於倉庫，我們擁有堅實的基礎，可以推動未來的成功。

Maintaining a network of loyal customer makes it easier for us to reap the benefits our production capacity improvement, especially as a demand for a variety of rabies vaccine remains robust.

維持忠實的客戶網絡使我們更容易從產能提高中獲益，特別是在對各種狂犬病疫苗的需求仍然強勁的情況下。

Our enhanced production capacity combined with this expanded pricing power is a testament to the utility and the value of our existing sales networks.

我們增強的生產能力與擴大的定價能力相結合，證明了我們現有銷售網絡的效用和價值。

With our CDC customer recognition of the safety and efficacy of YSJA rabies vaccine, we are optimistic that this relationship will remain an integral part of our operational strategy.

隨著我們的 CDC 客戶對 YSJA 狂犬病疫苗的安全性和有效性的認可，我們樂觀地認為這種關係將仍然是我們營運策略不可或缺的一部分。

And finally, we believed on our goal to reconfigure our research and development effort to both reaching us for long-term business success.

最後，我們相信我們的目標是重新配置我們的研發工作，以實現長期的業務成功。

By later 2023, we had to shift our focus away from our PIKA COVID-19 vaccine candidate in light of the evolving global health environment, while our R&D expenditures in the first nine months of fiscal year 2024 were still impacted by the 12-month monitoring period for the PIKA COVID-19 vaccines Phase 3 trial.

到2023 年晚些時候，鑑於全球衛生環境不斷變化，我們不得不將注意力從PIKA COVID-19 候選疫苗上轉移，而我們2024 財年前9 個月的研發支出仍然受到為期12 個月監測的影響PIKA COVID-19 疫苗 3 期試驗期間。

We have delivered our goal on prioritizing development of PIKA rabies vaccine.

我們已經實現了優先開發 PIKA 狂犬病疫苗的目標。

We just recently announced interim results of multi-country multi-center Phase 3 clinical study of PIKA rabies Vaccine.

我們最近剛公佈了PIKA狂犬病疫苗多國多中心3期臨床研究的中期結果。

The interim results of this study indicate that PIKA rabies vaccine has successfully met the primary endpoint of the clinical study, and it has the potential to achieve best-in-class, accelerate the production, and meet the WHO’s goal of one-week rabies vaccine regimen to replace the conventional three or four week long regimens.

這項研究的中期結果表明，PIKA狂犬病疫苗已經成功達到了臨床研究的主要終點，並且有潛力實現同類最佳，加速生產，並實現世界衛生組織的一期目標一周狂犬病疫苗接種方案取代傳統的三或四週長的接種方案。

After the completion of Phase 3 study, the production registration and the eventual commercialization of our PIKA rabies vaccines remain a top priority, and we are pleased with the progress we have made towards this goal to today.

第三階段研究完成後，我們的 PIKA 狂犬病疫苗的生產註冊和最終商業化仍然是首要任務，我們對今天在實現這一目標方面所取得的進展感到高興。

As such, we plan to craft a pricing strategy, which distinguishes the PIKA rabies vaccines from other market competitors.

因此，我們計劃制定定價策略，將 PIKA 狂犬病疫苗與其他市場競爭對手區分開來。

To summarize, while we have spent a fair portion of 2024 overcoming lingering production issues, the temporary stack back with this had primary been overcome as we refine our operations and bolstered our resilience.

總而言之，雖然我們在 2024 年花了相當多的時間來克服揮之不去的生產問題，但隨著我們改進營運並增強彈性，暫時性的問題已基本克服。

Since later 2023, we have embarked on a comprehensive series of initiatives, aimed at fortifying our foundation for future growth.

自 2023 年下半年以來，我們啟動了一系列全面的舉措，旨在夯實未來成長的基礎。

Looking ahead, we will continue to advance our product portfolio towards commercialization, focus on operational efficiency, and leverage our refined inventory strategy and the robust sales network to build a sustainable long-term shareholder value.

展望未來，我們將繼續推動產品組合的商業化，並專注於營運效率，利用精細化的庫存策略和強大的銷售網絡，打造可持續的長期股東價值。

I will now turn the call over to our CMO, Dr. Zenaida Mojares to discuss our product candidates in more details.

我現在將把電話轉給我們的首席行銷長 Zenaida Mojares 博士，以更詳細地討論我們的候選產品。

Zenaida, please go ahead.

澤奈達，請繼續。

Thank you, David.

謝謝你，大衛。

Now, from the clinical development pipeline mentioned earlier, we have gone through internal evaluation on current pipeline products and have made a strategic decision on budgeting and prioritizing the preclinical and clinical pipeline.

現在，從前面提到的臨床開發管線來看，我們已經對現有管線產品進行了內部評估，並對臨床前和臨床管線的預算和優先順序做出了策略決策。

PIKA rabies vaccine and PIKA HBV 002 vaccine remain as the key development product candidates going forward.

PIKA 狂犬病疫苗和 PIKA HBV 002 疫苗仍然是未來重點開發的候選產品。

Here, I would like to spotlight two studies sponsored by YS Biopharma.

在這裡，我想重點介紹由 YS Biopharma 贊助的兩項研究。

First, the YS-002, this is the ongoing Phase 3 clinical trial of our PIKA rabies vaccine; and second, the YS-101, the upcoming Phase 1 trial of YS HBV 002, which is a therapeutic vaccine intended to be used as a treatment for chronic hepatitis B.

首先是YS-002，這是我們正在進行的PIKA狂犬病疫苗的3期臨床試驗；其次是 YS-101，即將進行 YS HBV 002 的 1 期試驗，這是一種治療性疫苗，旨在用於治療慢性B型肝炎。

Now let me begin with YS-002 the PIKA rabies study.

現在讓我從 YS-002 PIKA 狂犬病研究開始。

In this large-scale study, we enrolled subjects across seven sites in the Philippines and Pakistan in September 2023, with a total of 4,500 randomized subjects.

在這項大規模研究中，我們於 2023 年 9 月在菲律賓和巴基斯坦的七個地點招募了受試者，總共 4,500 名隨機受試者。

We compared the safety and immunogenic profiles of PIKA rabies vaccine using a five-dose regimen completed in the span of three clinic visits in only seven days so that our leading market competitor with the traditional five dose schedules completed in five clinic visits is spread throughout a 28-day period.

我們比較了PIKA 狂犬病疫苗的安全性和免疫原性特徵，使用僅7 天內在3 次就診中完成的五劑方案，以便我們領先的市場競爭對手在5 次就診中完成的傳統五劑方案在整個市場中推廣。

Rabies virus proliferation within the muscle and nerve tissue can occur as early as the seventh day from viral inoculation.

狂犬病病毒最早在病毒接種後第七天就會在肌肉和神經組織內增生。

Moreover, patient compliance to rabies vaccination has been shown to drop significantly after seven days as well.

此外，患者對狂犬病疫苗接種的依從性在 7 天後也顯著下降。

We have designed the PIKA rabies vaccine regimen with these factors in mind.

我們在設計 PIKA 狂犬病疫苗方案時考慮了這些因素。

Our interim analysis results show that the PIKA rabies vaccine surpassed expectations as highlighted by the three key findings.

我們的中期分析結果表明，PIKA 狂犬病疫苗超出了預期，正如三個關鍵發現所強調的那樣。

First, early onset of protection, seroconversion rate or the production of protective antibodies against rabies, let's note that to be thrice that of the competitor in as early as seven days.

首先，早期的保護作用、血清轉換率或狂犬病保護性抗體的產生，我們要注意的是，早在 7 天內就達到了競爭對手的三倍。

Second, non-inferior and durable protection against rabies, as evidenced by similar seroconversion rates with the competitor on date 14, 28 and 42.

其次，對狂犬病具有不劣質且持久的保護作用，這可以從第 14、28 和 42 日與競爭對手相似的血清轉換率得到證明。

And finally, assuring safety profiles with the majority of adverse events being mild to moderate local and Hispanic complaints.

最後，確保安全性，大多數不良事件都是輕度至中度的當地和西班牙裔投訴。

And there were no serious adverse events suspected to be related to the tests and vaccines.

且沒有發生疑似與檢測和疫苗有關的嚴重不良事件。

In brief, not only that the PIKA rabies vaccine offers substantial protection using a shortened regimen, it also demonstrates promising superiority in generating an earlier protective response compared to a globally marketed comparator.

簡而言之，PIKA 狂犬病疫苗不僅使用縮短的療程提供了實質保護，而且與全球上市的比較疫苗相比，它還顯示出在更早產生保護反應方面的優勢。

A shortened treatment regimen may improve treatment compliance and completion among patients, where it has been found that a major barrier to treatment completion is the long vaccination schedule used by current rabies vaccines.

縮短的治療方案可以提高患者的治療依從性和完成度，已發現治療完成的主要障礙是目前狂犬病疫苗使用的長疫苗接種時間表。

Now, we turn to the YS-101, which is a chronic hepatitis B vaccine study.

現在，我們轉向 YS-101，這是一項慢性B型肝炎疫苗研究。

We successfully received the approval of the Philippine FDA on February 15 of this year to conduct the Phase 1 study by Q2 of this year.

我們於今年2月15日成功獲得菲律賓FDA批准，並將於今年第二季進行一期研究。

The clinical trial unit where the study will be conducted is managed by one of the most prominent researchers in the Philippines.

進行研究的臨床試驗單位由菲律賓最著名的研究人員之一管理。

This study will evaluate the safety, tolerability, and preliminary efficacy of YS-HBV-002 for the treatment of chronic hepatitis B in adults.

本研究將評估YS-HBV-002治療成人慢性B型肝炎的安全性、耐受性和初步療效。

YS-HBV-002 is the proprietary formulation of YS Biopharma of recombinant hepatitis B surface antigen, recombinant hepatitis B core antigen, and our signature immunomodulating platform.

YS-HBV-002是YS Biopharma的重組乙型肝炎表面抗原、重組乙型肝炎核心抗原和我們的標誌性免疫調節平台的專有配方。

This vaccine is intended to be injected intramuscularly with a 14-dose regimen that can be completed in 40 days.

該疫苗旨在透過 14 劑方案進行肌肉注射，可在 40 天內完成。

We designed this investigation as a double-blind, randomized, placebo-controlled dose escalation study.

我們將這項研究設計為雙盲、隨機、安慰劑對照的劑量遞增研究。

Without getting too technical, this means that we will conclude the study with the knowledge of the appropriate dose to be used further along in the clinical development of the vaccine.

在不涉及太多技術的情況下，這意味著我們將在了解疫苗臨床開發中進一步使用的適當劑量的情況下結束研究。

Chronic hepatitis B is responsible for around 80% of cases of hepatocellular carcinoma in the regions with historically high rates of hepatitis B virus infection.

在歷史上乙型肝炎病毒感染率較高的地區，約 80% 的肝細胞癌病例是由慢性B型肝炎引起的。

At the moment, there is no approved curative treatment for chronic hepatitis B that is tolerated well with only a low frequency of severe adverse events.

目前，尚無經核准的慢性B型肝炎治療方法，其耐受性良好且嚴重不良事件發生率較低。

And we are hopeful in the potential of our vaccine to change that.

我們對疫苗能夠改變這一現狀充滿希望。

Thank you for your attention.

感謝您的關注。

And I now pass the floor to our Chief Financial Officer, Brenda Wu.

現在請我們的財務長布倫達·吳發言。

Thank you, Zenaida.

謝謝你，澤奈達。

I will now provide a close look into our financials.

我現在將仔細研究我們的財務狀況。

Please know that all numbers are in RMB terms, that the reporting period is the first nine months of fiscal 2024 versus the comparable period of fiscal 2023, and all comparison are on a year-over-year basis unless otherwise stated.

請注意，所有數據均以人民幣計價，報告期間為 2024 財年的前 9 個月與 2023 財年的可比期間，除非另有說明，所有比較均以同比為基礎。

For the first nine months of fiscal 2024, our revenue was RMB438.1 million compared to RMB581.2 million in the comparable period of 2023, representing a change of 24.6%.

2024財年的前9個月，我們的收入為人民幣4.381億元，而2023年同期的收入為人民幣5.812億元，變化為24.6%。

This was mainly due to COVID-related disruptions affecting our manufacturing operations and production, which negatively impacts batch approvals and doses available for sale.

這主要是由於與新冠病毒相關的中斷影響了我們的製造營運和生產，這對批次批准和可供銷售的劑量產生了負面影響。

This was partially offset by an increase in price of YSJA rabies vaccine approximately RMB3.0 per dose.

這被 YSJA 狂犬病疫苗每劑價格上漲約人民幣 3.0 元所部分抵銷。

As David discussed earlier, starting October 2023, we returned to growth trend, and we estimate double digit year-over-year growth in product sales during the three-month period ended March 31, 2024.

正如 David 之前討論的，從 2023 年 10 月開始，我們恢復了成長趨勢，我們預計截至 2024 年 3 月 31 日的三個月內，產品銷售額將實現兩位數的同比增長。

The gross profit was RMB351.7 million compared to RMB449.0 million in the previous year, while gross margin improved by three percentage to 80.3%.

毛利為人民幣351.7百萬元，而上年度為人民幣449.0百萬元，毛利率提高三個百分點至80.3%。

Now, coming to our operating expense.

現在，我們來談談我們的營運費用。

Selling and marketing expenses was RMB229.2 million compared to RMB224.5 million in the comparable period of 2023.

銷售和行銷費用為人民幣 2.292 億元，而 2023 年同期為 2.245 億元。

The change was primarily driven by the increase in promotional and marketing service fees as we continue to promote our YSJA rabies vaccine and established relationship with CDC.

這項變更主要是由於我們繼續推廣 YSJA 狂犬病疫苗並與 CDC 建立了關係，因此促銷和行銷服務費增加。

General and administrative expense with RMB142.8 million compared to RMB68.6 million in the comparable period of 2023.

一般及行政費用為人民幣 1.428 億元，而 2023 年同期為 6,860 萬元。

This was mainly due to increase in provision for inventory impairment and the provision for trade receivables.

主要是存貨跌價準備和應收帳款撥備增加所致。

Research and development expense was RMB244.7 million compared to RMB221.8 million in the comparable period of 2023.

研發費用為人民幣2.447億元，2023年同期為人民幣2.218億元。

The change was primarily driven by the increase in testing and the clinical trial fees, associated with our PIKA rabies vaccine and hepatitis B vaccines as we continue to advance our product pipeline towards commercialization.

這項變更主要是由於我們繼續推進我們的產品線走向商業化，與我們的 PIKA 狂犬病疫苗和乙型肝炎疫苗相關的測試和臨床試驗費用增加。

Net loss was RMB252.3 million compared to RMB64.2 million in the comparable period of 2023.

淨虧損為人民幣 2.523 億元，而 2023 年同期淨虧損為 6,420 萬元。

Turning to our balance sheet.

轉向我們的資產負債表。

We have RMB222.6 million in cash and the cash equivalent as of December 31, 2023, compared with RMB370.4million as of March 31, 2023.

截至2023年12月31日，我們擁有現金及現金等價物人民幣2.226億元，截至2023年3月31日為人民幣3.704億元。

Finally, I would like to provide some commentary on our financial outlook.

最後，我想對我們的財務前景發表一些評論。

We expect product revenue in fiscal year 2025 starting April 1, 2024, to increase at the double-digit rate compared with fiscal year 2024.

我們預計從 2024 年 4 月 1 日開始的 2025 財年產品收入將比 2024 財年以兩位數的速度成長。

At the same time, we are taking further measures to more prudently manage our expenditures and improve our bottom line at the end of fiscal 2025.

同時，我們正在採取進一步措施，更加審慎地管理支出，提高 2025 財年末的利潤。

This guidance reflects our current and preliminary views on the market and operational conditions which are subject to change.

本指引反映了我們對市場和營運狀況的當前和初步看法，這些看法可能會改變。

As we emerge from our pivots disruption with enhanced operational approach, we've been dedicated to address the persistent and growth demand from rabies vaccine across China and Southeast Asia.

隨著我們透過加強營運方式擺脫支點混亂，我們一直致力於滿足中國和東南亞地區對狂犬病疫苗持續成長的需求。

We will continue to strategically advance our pipeline of promotional product candidates.

我們將繼續策略性地推進我們的促銷產品候選產品線。

And we are excited to take advantage of all the opportunities which lie before us.

我們很高興能夠利用擺在我們面前的所有機會。

With this steady fast focus on trading success, we are confident that we will generate long term success and building sustainable value for our shareholders.

透過對交易成功的持續快速關注，我們有信心為股東創造長期成功並創造永續價值。

That concludes our prepared remarks for today.

我們今天準備好的演講到此結束。

Operator, we are now ready to take questions.

接線員，我們現在準備好回答問題。

(Operator Instructions) Hunter Diamond, Diamond Equity Research.

（操作員說明）Hunter Diamond，鑽石股票研究。

Hi.

你好。

Firstly, congratulations on the recent results.

首先，恭喜最近的成果。

My first question was can you provide an overview of the timeline for the registration and commercialization of the PIKA rabies vaccine following the positive Phase 3 trial?

我的第一個問題是，您能否概述一下 PIKA 狂犬病疫苗在 3 期試驗取得積極結果後註冊和商業化的時間表？

And then additionally what level of market acceptance you anticipate once the vaccine is commercially available?

另外，一旦疫苗上市，您預期市場接受程度如何？

Hey Hunter, this is David.

嘿亨特，這是大衛。

Let me take your call first, then probably I'll ask Dr. Zenaida Mojares to provide additional detail.

讓我先接您的電話，然後我可能會請 Zenaida Mojares 博士提供更多詳細資訊。

As you know that just a few days ago, we announced the internal readout of Phase 3 trial, which is multi-country multi-center study from Philippine and Pakistan.

大家知道，就在幾天前，我們宣布了3期試驗的內部結果，這是來自菲律賓和巴基斯坦的多國多中心研究。

And right now, we are still working on the final report for this clinical trial.

目前，我們仍在準備這項臨床試驗的最終報告。

Afterward, we will provide more update for market about the product registration progress.

隨後，我們將向市場提供更多有關產品註冊進度的最新消息。

At this moment, actually we started discussing with the potential regulatory organizations at the different countries.

此時此刻，實際上我們開始與不同國家的潛在監管機構進行討論。

So, the information for the -- like a condition -- overall occupation and other related application process already.

因此，整個職業和其他相關申請流程的資訊（就像條件一樣）已經存在。

Right now we haven't given the guidance on the specific commercialization timeline, but a different country could be different.

目前我們還沒有給出具體商業化時間表的指導，但不同的國家可能會有所不同。

That’s the kind of situation.

情況就是這樣。

Probably, Zenaida can provide an update on that part.

也許 Zenaida 可以提供這部分的更新。

Thank you, David.

謝謝你，大衛。

Yes, Hunter, this is Zenaida.

是的，亨特，這是澤奈達。

With regards to the PIKA rabies vaccine, we mentioned about the interim analysis, and we have the high-level preliminary results.

關於PIKA狂犬病疫苗，我們提到了中期分析，我們有高水準的初步結果。

Actually, the final interim report will be released by next week.

實際上，最終的中期報告將於下週發布。

So, our plan as indicated within the study, using the interim analysis data, we are really applying for a conditional approval in some countries where it is feasible.

因此，我們的計劃如研究中所示，利用中期分析數據，我們實際上正在一些可行的國家申請有條件批准。

Aside from that, we also have an orphan drug designation.

除此之外，我們還有孤兒藥資格。

Because of the good results, we would try using the interim data.

由於效果良好，我們會嘗試使用中期數據。

Now, with regards to a timeline.

現在，關於時間表。

So, the study will complete all study basis towards the end of December.

因此，該研究將在 12 月底完成所有研究基礎。

And once you close that study, by quarter one of next year, we would be having our final study reports.

一旦你結束這項研究，到明年第一季，我們就會收到最終的研究報告。

And using those data, we intend to submit using rolling submission strategy because there are still a lot of things to be done in the background.

使用這些數據，我們打算使用滾動提交策略來提交，因為後台還有很多事情要做。

Nevertheless, once all documents are ready, all things that have to be done will continue, and we'll check with the regulators for rolling submission.

不過，一旦所有文件都準備好了，所有要做的事情都會繼續進行，我們會與監管機構核實滾動提交的情況。

And then with that, I think, securing marketing authorization would take around one to two years.

然後，我認為獲得行銷授權將需要大約一到兩年的時間。

It depends on the country.

這取決於國家。

So it would probably be out in the market within maximum of two years time.

因此，它可能會在最多兩年內上市。

Did I answer your question, Hunter?

我回答你的問題了嗎，亨特？

Yes, no, thank you.

是的，不，謝謝。

That was a very clear answer to that question.

這是對這個問題的非常明確的回答。

My second follow-up question, then I'll open the line for other questions, but could you offer an update on the development status of the other drugs in your portfolio and key upcoming milestones for these projects, whatever you can mention on your other assets?

我的第二個後續問題，然後我將打開其他問題的線路，但是您能否提供有關您的產品組合中其他藥物的開發狀態的最新信息以及這些項目即將到來的關鍵里程碑，無論您在其他方面可以提到什麼資產？

Right, yeah.

對，是的。

Right now, we're really looking forward to start our vaccine for chronic hepatitis B treatment.

現在，我們非常期待開始使用疫苗來治療慢性B型肝炎。

The scheduled start is either May or June.

預定的開始時間是五月或六月。

As you know, there are also other HBV vaccines that are in the trial stage, but having HBV vaccine would maybe a better option to really come up with a treatment for this chronic disease because currently, we only have antiviral medications, which have their own side effects, and patients will be taking this for life.

如你所知，還有其他B型肝炎疫苗正處於試驗階段，但接種B肝疫苗可能是真正治療這種慢性疾病的更好選擇，因為目前我們只有抗病毒藥物，而抗病毒藥物有自己的特徵副作用，患者將終生服用。

Whereas if we come up with an HBV vaccine, a single regimen, which will take around 40 days would really help them turn back to the normal condition.

而如果我們研發出B肝疫苗，只需 40 天左右的單一治療方案，就能真正幫助他們恢復正常狀態。

Now, another thing that we are doing, aside from our PIKA rabies vaccine outside of China, this is also being done inside China.

現在，我們正在做的另一件事，除了我們在中國境外的PIKA狂犬病疫苗外，這也在中國境內進行。

So these are the things.

這些就是事情。

And the management team is also trying to brainstorm and discuss of a probability of using our immunomodulating platform, that is our PIKA adjuvant in coming up with an adjuvanted flu vaccine.

管理團隊也正在嘗試集思廣益，討論使用我們的免疫調節平台，也就是我們的 PIKA 佐劑來研發佐劑流感疫苗的可能性。

But that is not yet confirmed.

但這尚未得到證實。

Is that okay?

可以嗎？

Yes.

是的。

Thank you.

謝謝。

That was a great answer to the question.

這是對這個問題的一個很好的答案。

Yes.

是的。

Hunter, I just add one more sentence on this approach with the hepatitis B vaccine.

亨特，我只是對乙型肝炎疫苗的這種方法再補充一句。

We do have a clinical team on ground in Philippines, and we're also very fortunate to have this Phase 1 clinical trial license approved by the Philippines FDA recently to conduct Phase 1 study.

我們在菲律賓確實有一個臨床團隊，我們也很幸運最近獲得了菲律賓 FDA 批准的一期臨床試驗許可證來進行一期研究。

If you look at the details we disclosed on this study, we are able to directly use this clinical candidate among chronic hepatitis B patients at the Phase 1 trial.

如果您查看我們在這項研究中披露的詳細信息，我們可以在 1 期試驗中直接在慢性乙型肝炎患者中使用該臨床候選藥物。

This is not easy to get.

這並不容易得到。

If we apply Phase 1 study in other countries, probably we have to start with healthy volunteers.

如果我們在其他國家進行第一階段研究，可能我們必須從健康的志工開始。

But in Philippines, this time, we are able -- we're fortunate to have a chance to directly to use this medication for chronic hepatitis B patients that do actually, hopefully we can collect more meaningful result from this study very quickly to provide additional evidence for us to move this project forward.

但在菲律賓，這一次，我們能夠——我們很幸運有機會直接將這種藥物用於慢性乙型肝炎患者，希望我們很快就能從這項研究中收集到更有意義的結果，以提供更多資訊我們推進該專案的證據。

Right.

正確的。

Makes perfect sense.

很有道理。

So okay, thank you very much for taking my questions and congratulations again on the results.

好的，非常感謝您回答我的問題，並再次祝賀我們的結果。

Thank you, Hunter.

謝謝你，亨特。

As there are no further questions, I will now turn the call back over to our management for closing remarks.

由於沒有其他問題，我現在將把電話轉回給我們的管理層進行總結發言。

Thank you again for joining us today.

再次感謝您今天加入我們。

If you have any further questions, please feel free to contact us or submit a request through our IR website.

如果您還有任何其他問題，請隨時聯絡我們或透過我們的 IR 網站提交請求。

We look forward to speaking with everyone during our next call.

我們期待在下次通話中與大家交談。

Have a good day.

祝你有美好的一天。

The conference has now concluded.

會議現已結束。

Thank you for attending today's presentation.

感謝您參加今天的演講。

You may now disconnect.

您現在可以斷開連線。