Edesa Biotech Inc (EDSA) 2015 Q4 法說會逐字稿

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  • Operator

    Operator

  • Good day, ladies and gentlemen. Thank you for standing by. Welcome to the Stellar Biotechnologies year-end 2015 corporate update conference call and webcast. This conference is being recorded today, Tuesday, December 15, 2015. (Operator Instructions).

    女士們先生們,美好的一天。謝謝你的支持。歡迎收看 Stellar Biotechnologies 2015 年底企業更新電話會議和網絡廣播。今天,即 2015 年 12 月 15 日,星期二,錄製了這次會議。(操作員說明)。

  • I would now like to turn the conference over to Mark McPartland, Vice President of Corporate Development at Stellar Biotechnologies. Please go ahead, sir.

    我現在想將會議轉交給 Stellar Biotechnologies 公司發展副總裁 Mark McPartland。請繼續,先生。

  • Mark McPartland - VP Corporate Development & Communications

    Mark McPartland - VP Corporate Development & Communications

  • Thank you, Operator, and good day, everyone. We would like to thank you for joining us today for Stellar Biotechnologies' year-end 2015 corporate update conference call and webcast and our first call as a NASDAQ-listed company.

    謝謝接線員,祝大家有美好的一天。感謝您今天加入我們,參加 Stellar Biotechnologies 的 2015 年底公司更新電話會議和網絡廣播,以及我們作為納斯達克上市公司的首次電話會議。

  • Joining me on the call today from Stellar Biotechnologies' senior management team are Mr. Frank Oakes, our CEO and President; Ms. Kathi Niffenegger, our Chief Financial Officer; and Dr. Catherine Brisson, our Chief Operating Officer. Mr. Oakes will provide update on Stellar operations, review our recent achievements, growth opportunities, and Ms. Niffenegger will review our consolidated financial results. After the formal presentation, we will be available for answer your questions from the dial-in callers and, as the operator has already indicated, from the webcast participants as well.

    今天和我一起參加 Stellar Biotechnologies 高級管理團隊的電話會議的是我們的首席執行官兼總裁 Frank Oakes 先生;我們的首席財務官 Kathi Niffenegger 女士;和我們的首席運營官 Catherine Brisson 博士。 Oakes 先生將提供 Stellar 運營的最新信息,審查我們最近的成就、增長機會,Niffenegger 女士將審查我們的綜合財務業績。在正式演示之後,我們將可以回答撥入呼叫者的問題,正如接線員已經指出的那樣,我們也可以回答網絡廣播參與者的問題。

  • I would also like to note that in addition to our press release issued yesterday afternoon, our 10-K annual report for the period ending September 30, 2015, was also filed and is available through the US SEC filing system on EDGAR and the Canadian SEDAR filing system. All documents are also available under the investors section of our website at stellarbiotech.com.

    我還想指出,除了我們昨天下午發布的新聞稿外,我們還提交了截至 2015 年 9 月 30 日的 10-K 年度報告,可通過美國證券交易委員會的 EDGAR 備案系統和加拿大 SEDAR 獲得歸檔系統。所有文件也可在我們網站 stellarbiotech.com 的投資者部分下獲得。

  • Now before I begin, I would like to remind our listeners that today's conference call may include forward-looking statement based on current expectations. Such statements, other than purely historical factual information, including statements relating to revenues or profits or the Company's future plans and objectives or expected sales, cash flows, and capital expenditures, constitute forward-looking statements.

    在開始之前,我想提醒我們的聽眾,今天的電話會議可能包含基於當前預期的前瞻性陳述。這些陳述,除了純粹的歷史事實信息,包括與收入或利潤或公司未來計劃和目標或預期銷售、現金流量和資本支出有關的陳述,構成前瞻性陳述。

  • Forward-looking statements are based on numerous assumptions and subject to all the risks and uncertainties inherent in, among other things, the Company's availability of funds and resources to pursue research and development projects; the successful and timely completion of preclinical or clinical studies by third parties in which the Company's products are utilized; the degree of market acceptance for the Company's products or the Company's degree of market -- or the products in which the Company's products are components; the Company's ability to protect its intellectual property; the volatility of the Company's common share price; the effect of competition; the effect of technological changes; and general changes in economic or business conditions.

    前瞻性陳述基於眾多假設,並受到所有固有風險和不確定性的影響,其中包括公司進行研發項目的資金和資源的可用性;使用公司產品的第三方成功及時地完成臨床前或臨床研究;公司產品的市場接受程度或公司的市場程度——或公司產品構成的產品;公司保護其知識產權的能力;公司普通股價格的波動;競爭的影響;技術變革的影響;經濟或商業狀況的一般變化。

  • There can be no assurance that such forward-looking statements will provide to be accurate as actual results of future events could differ materially from those anticipated in such statements. Accordingly, listeners should not place undue reliance on such statements, except in accordance with applicable securities laws. The Company expressly disclaims any obligation to update any forward-looking statements or forward-looking statements that are incorporated by reference herein.

    無法保證此類前瞻性陳述的準確性,因為未來事件的實際結果可能與此類陳述中的預期結果存在重大差異。因此,聽眾不應過分依賴此類陳述,除非符合適用的證券法。公司明確表示不承擔任何更新任何前瞻性陳述或通過引用併入本文的前瞻性陳述的義務。

  • This conference call does not constitute an offer to sell or a solicitation of an offer to buy any of the Company's securities set out herein in the United States or to -- or for the benefit or account of a US person or person in the United States. Neither the TSX Venture Exchange nor its regulation service provider, as that term is defined in the policies of the TSX Venture Exchange, accepts responsibility for the accuracy and adequacy of this conference.

    本次電話會議不構成在美國或為了美國個人或美國個人的利益或帳戶而提出的出售要約或購買本文所列任何公司證券的要約邀請. TSX 風險交易所及其監管服務提供商(如 TSX 風險交易所政策中所定義)均不對本次會議的準確性和充分性承擔責任。

  • Please refer to the documents that we file from time to time in Canada on SEDAR or in the United States on EDGAR, which are also available on our website, for information concerning the factors that could affect the Company.

    請參閱我們不時在加拿大 SEDAR 或美國 EDGAR 上提交的文件,這些文件也可在我們的網站上找到,以了解有關可能影響公司的因素的信息。

  • With that taken care of, I would now like to turn the call over to Frank Oakes, President and CEO of Stellar Biotechnologies, for his opening remarks. Frank, begin your --.

    考慮到這一點,我現在想把電話轉給 Stellar Biotechnologies 總裁兼首席執行官 Frank Oakes,讓他發表開場白。弗蘭克,開始你的——。

  • Frank Oakes - Chairman, President, CEO

    Frank Oakes - Chairman, President, CEO

  • Thank you, Mark, and good day, everyone. Thank you for joining us here today for the Stellar Biotechnologies 2015 year-end corporate update conference call.

    謝謝你,馬克,祝大家有美好的一天。感謝您今天加入我們,參加 Stellar Biotechnologies 2015 年終公司更新電話會議。

  • I want to start with a brief reminder of Stellar's business and our industry position. Stellar is the leader in the sustainable manufacture of Keyhole Limpet Hemocyanin, or KLH. KLH, as many of you know, is an important immune-stimulating molecule used in wide-ranging therapeutic and diagnostic markets. KLH is both an active pharmaceutical ingredient in many new immunotherapies in development, as well as a finished product for measuring immune status. We are positioning Stellar to be the leading company supplying the long-term demand for KLH in the immunotherapy field.

    我想首先簡要介紹一下 Stellar 的業務和我們的行業地位。 Stellar 是 Keyhole Limpet 血藍蛋白 (KLH) 可持續生產的領導者。眾所周知,KLH 是一種重要的免疫刺激分子,廣泛用於治療和診斷市場。 KLH 既是許多正在開發的新免疫療法中的活性藥物成分,也是用於測量免疫狀態的成品。我們將 Stellar 定位為在免疫治療領域提供 KLH 長期需求的領先公司。

  • We began fiscal 2015 with a specific objective of strengthening and expanding our core KLH business. I am pleased to report on the strong progress we made and to recap highlights from what we believe has been a very successful year for Stellar Biotechnologies.

    2015 財年伊始,我們的具體目標是加強和擴大我們的核心 KLH 業務。我很高興地報告我們取得的巨大進展,並回顧我們認為 Stellar Biotechnologies 非常成功的一年的亮點。

  • On November 5, Stellar's common shares began trading on the NASDAQ capital market under the symbol SBOT. NASDAQ uplisting is a testimony not only to our growth and maturation as a public company, but also to the hard work of Stellar's team and our commitment to supporting shareholder value. We believe that the NASDAQ listing offers a number of advantages, including broader visibility to the investment community and the potential for increased shareholder liquidity.

    11 月 5 日,Stellar 的普通股開始在納斯達克資本市場交易,股票代碼為 SBOT。納斯達克上市不僅證明了我們作為一家上市公司的成長和成熟,也證明了 Stellar 團隊的辛勤工作和我們支持股東價值的承諾。我們認為,在納斯達克上市具有諸多優勢,包括投資界更廣泛的知名度以及增加股東流動性的潛力。

  • In addition to NASDAQ listing, Stellar's common shares will continue to trade on the TSX Venture Exchange in Canada.

    除了在納斯達克上市,Stellar 的普通股還將繼續在加拿大 TSX 創業板交易。

  • I am pleased to point out that revenue for fiscal 2015 increased by over 100% from the prior year. This growth was driven primarily by increase in production, sales associated with core customers, greater volume, sales under supply agreements, and the promising advancement of clinical trials conducted by our customers.

    我很高興地指出,2015 財年的收入比上一年增長了 100% 以上。這一增長主要是由產量增加、與核心客戶相關的銷售、更大的銷量、供應協議下的銷售以及我們的客戶進行的臨床試驗的有希望的進展推動的。

  • Our Stellar KLH products are now being used as the key ingredient in multiple clinical-stage immunotherapies targeting metastatic breast cancer, ovarian cancer, Alzheimer's disease, systemic lupus, and Crohn's disease.

    我們的 Stellar KLH 產品現在被用作針對轉移性乳腺癌、卵巢癌、阿爾茨海默病、系統性狼瘡和克羅恩病的多種臨床階段免疫療法的關鍵成分。

  • One of our long-term partners is Neovacs S.A. of France. Stellar KLH is a component of Neovacs' Kinoid product candidates, two of which are now in Phase II clinical trials. In 2015, we expanded our agreement with Neovacs in order to ensure adequate supply of KLH as they progress through their trials and to potential commercialization.

    我們的長期合作夥伴之一是法國的 Neovacs S.A.。 Stellar KLH 是 Neovacs 的 Kinoid 候選產品的一個組成部分,其中兩個產品目前正處於 II 期臨床試驗階段。 2015 年,我們擴大了與 Neovacs 的協議,以確保在 KLH 通過試驗和潛在商業化的過程中有足夠的供應。

  • We expect demand for reliable sources of KLH to continue to grow, both from our existing partners and the broader biotech industry. Stellar intends to be the leader in meeting the demand, and so in preparation, this year we entered into a collaboration to secure an exclusive strategic site in Baja California, Mexico, for the potential development of an additional aquaculture locale and expansion of Stellar KLH production.

    我們預計對 KLH 可靠來源的需求將繼續增長,無論是來自我們現有的合作夥伴還是更廣泛的生物技術行業。 Stellar 打算成為滿足需求的領導者,因此在準備工作中,我們今年開始合作,以確保在墨西哥下加利福尼亞州的獨家戰略地點,以潛在開發額外的水產養殖場所和擴大 Stellar KLH 生產.

  • We believe that this new collaboration will position Stellar to accelerate production to meet anticipated industry growth. We believe that we are positioning Stellar for a strong future with multiple avenues for future sales, as well as a clinical and commercial presence in the broadening range of therapeutic markets.

    我們相信,這項新的合作將使 Stellar 能夠加速生產以滿足預期的行業增長。我們相信,我們將 Stellar 定位為一個強大的未來,未來銷售的多種途徑,以及在更廣泛的治療市場中的臨床和商業存在。

  • To further strengthen Stellar for the future, we are committed to developing new KLH technologies and expertise. Our development goals are to expand the use of this important molecule and to attract new customers to Stellar KLH. In 2015, our research and development included programs such as the development of functional assays to help companies and our customers identify the best form of our KLH for their unique therapeutic targets; also, enhancements in our aquaculture science and infrastructure and the presentation of data from our ongoing research into potential KLH-based immunotherapies for the treatment of infectious diseases.

    為了在未來進一步加強 Stellar,我們致力於開發新的 KLH 技術和專業知識。我們的發展目標是擴大這種重要分子的用途,並吸引新客戶加入 Stellar KLH。 2015 年,我們的研發包括開發功能性分析等項目,以幫助公司和我們的客戶確定我們 KLH 的最佳形式,以滿足他們獨特的治療目標;此外,我們水產養殖科學和基礎設施的改進以及我們正在進行的基於 KLH 的潛在免疫療法治療傳染病的研究數據的呈現。

  • This has been a successful year of strengthening and expansion for Stellar. Our progress is a reflection of the increased market demand for KLH and, we believe, the growing recognition that Stellar is the leader in sustainable, scalable manufacture of GMP-grade KLH products. I'm particularly proud of our continued growth as a public company, as evidenced by the alliances that we've announced and our uplisting to the NASDAQ capital market.

    今年是 Stellar 成功加強和擴張的一年。我們的進步反映了市場對 KLH 需求的增加,我們相信,人們越來越認識到 Stellar 是可持續、可擴展地製造 GMP 級 KLH 產品的領導者。我對我們作為一家上市公司的持續發展感到特別自豪,我們宣布的聯盟和我們在納斯達克資本市場的上市證明了這一點。

  • I would now like to turn the call over to Kathi Niffenegger, our CFO, who will discuss our financial results in more detail. Kathi?

    我現在想把電話轉給我們的首席財務官 Kathi Niffenegger,他將更詳細地討論我們的財務業績。凱西?

  • Kathi Niffenegger - CFO

    Kathi Niffenegger - CFO

  • Thank you, Frank, and thank you, everyone, for joining us on the call today. I will be discussing our fiscal year-end September 30, 2015, financial information.

    謝謝弗蘭克,也謝謝大家今天加入我們的電話會議。我將討論我們截至 2015 年 9 月 30 日的財政年度財務信息。

  • We generated revenue of $759,000 for the fiscal year ended September 30, 2015, an increase of 104% compared to $372,000 for fiscal 2014. The increase in revenue resulted from an increase in the number of customers and associated increase in sales volume, including sales under supply agreements and custom manufactured products.

    截至 2015 年 9 月 30 日止財政年度,我們的收入為 759,000 美元,與 2014 財政年度的 372,000 美元相比增長 104%。收入的增加源於客戶數量的增加以及相關的銷量增長,其中包括以下銷售額供應協議和定制產品。

  • Our expenses for fiscal 2015 decreased to $5.1 million, as compared to $6.1 million incurred in fiscal 2014. Cost of sales and contract services increased to $581,000 for fiscal 2015, as compared to $469,000 for the prior year, consistent with the increased sales and contract services revenue. We reclassified aquaculture costs to present them separately from cost of sales and contract services since those operating costs are incurred regardless of sales levels.

    我們 2015 財年的支出從 2014 財年的 610 萬美元減少到 510 萬美元。2015 財年的銷售和合同服務成本從上一年的 469,000 美元增加到 581,000 美元,這與銷售和合同服務的增加一致收入。我們對水產養殖成本進行了重新分類,將其與銷售成本和合同服務分開列報,因為這些運營成本的產生與銷售水平無關。

  • We also began recording inventory on our balance sheet for the first time beginning September 2014, and continuing in fiscal 2015. Due to the early stage of our development in fiscal 2014, all manufacturing costs of production were expensed during that year, increasing the cost of sales and contract services relative to revenue.

    我們還從 2014 年 9 月開始首次在資產負債表上記錄庫存,並在 2015 財年繼續進行。由於我們在 2014 財年處於早期發展階段,所有生產製造成本都在當年計入費用,增加了成本與收入相關的銷售和合同服務。

  • There were no grant expenses for fiscal 2015, as compared to $37,000 in the prior year due to the closeout of our NSF Phase II/IIb grants in November 2013.

    由於 2013 年 11 月我們的 NSF II/IIb 期贈款結束,2015 財年沒有贈款支出,而上一年為 37,000 美元。

  • Research and development expense was $1.1 million for fiscal 2015, as compared to $2.5 million for fiscal 2014. The decrease was the result of our planned decreased use of contract research organizations, due to a realignment of our focus from internal research and process development to manufacturing our Stellar KLH products in response to increased customer demand.

    2015 財年的研發費用為 110 萬美元,而 2014 財年為 250 萬美元。減少的原因是我們計劃減少使用合同研究機構,因為我們將重點從內部研究和工藝開發轉移到製造我們的 Stellar KLH 產品可滿足日益增長的客戶需求。

  • General and administrative expenses increased to $3.2 million for fiscal 2015, as compared to $2.9 million in the prior year. The increase in G&A was affected by the net impact of increased corporate expenses, including legal and audit fees related to our transition to reporting as a US domestic issuer, rather than a foreign private issuer; our NASDAQ application and listing process; increased business development activity and increased investor relations activity; and partially offset by a decrease in share-based compensation.

    2015 財年的一般和行政費用增至 320 萬美元,而上一年為 290 萬美元。 G&A 的增加受到公司費用增加的淨影響的影響,包括與我們向美國國內發行人而非外國私人發行人的報告過渡相關的法律和審計費用;我們的納斯達克申請和上市流程;增加業務發展活動和增加投資者關係活動;部分被基於股份的薪酬減少所抵消。

  • Our net loss for fiscal 2015 was $2.8 million, or $0.36 loss per share, as compared to a net loss of $8.4 million, or $1.11 loss per share, for fiscal 2014. The decrease in net loss of approximately $5.6 million from fiscal 2014 to 2015 was primarily due to significant fluctuations in non-cash gain or loss on fair value of warrant liability, increased revenues, and decreased research and development expenses.

    我們 2015 財年的淨虧損為 280 萬美元,或每股虧損 0.36 美元,而 2014 財年的淨虧損為 840 萬美元,或每股虧損 1.11 美元。從 2014 財年到 2015 年,淨虧損減少了約 560 萬美元主要是由於權證負債公允價值的非現金損益大幅波動、收入增加以及研發費用減少。

  • The warrant liability occurs because we have warrants with Canadian dollar exercise prices that are treated as derivative liabilities. Each quarter, we adjust the fair value based on the remaining warrants outstanding with those Canadian dollar exercise prices using a Black-Scholes valuation model. Increases in our share price caused a greater warrant liability and a resulting loss on fair value, while decreases in our share price caused a lower warrant liability and a resulting gain on fair value of warrant liability.

    認股權證負債的發生是因為我們持有以加元行使價處理的認股權證,這些認股權證被視為衍生負債。每個季度,我們都會使用 Black-Scholes 估值模型根據剩餘的未償認股權證和加元行使價調整公允價值。我們的股價上漲導致更大的認股權證負債和由此產生的公允價值損失,而我們的股價下跌導致更低的認股權證負債和由此產生的認股權證負債的公允價值收益。

  • And although the amounts can be significant, changes in fair value of warrant liability have no impact on our cash flow. We will have no warrant liabilities after January 2016, when the remaining warrants with Canadian dollar exercise prices expire.

    儘管金額可能很大,但認股權證負債的公允價值變化對我們的現金流量沒有影響。 2016 年 1 月之後,我們將沒有認股權證負債,屆時剩餘的加元行使價認股權證到期。

  • Our financial position remains strong. Cash, cash equivalents, and short-term investments at September 30, 2015, were $9 million, compared to $13.9 million at August 31, 2014.

    我們的財務狀況依然強勁。 2015 年 9 月 30 日的現金、現金等價物和短期投資為 900 萬美元,而 2014 年 8 月 31 日為 1390 萬美元。

  • Net cash used in operating activities during fiscal 2015 was $4.4 million, compared to $4.3 million for fiscal 2014. We expect our current cash position will continue to fund our operating and development programs, as well as upgrades to our facilities, for at least the next 12 months. However, we may seek additional capital through debt or equity raises, as needed, to accelerate the development of our programs in response to market demand or to exploit new opportunities to expand our business.

    2015 財年用於經營活動的淨現金為 440 萬美元,而 2014 財年為 430 萬美元。我們預計我們目前的現金狀況將繼續為我們的運營和發展計劃以及設施升級提供資金,至少在下一個12個月。但是,我們可能會根據需要通過債務或股權融資尋求額外資金,以加快我們的項目開發以響應市場需求或利用新機會來擴展我們的業務。

  • Stellar had positive shareholders' equity of $8 million and approximately 8 million shares outstanding at September 30, 2015, compared to shareholders' equity of $7.7 million and approximately 7.8 million shares outstanding at August 31, 2014.

    截至 2015 年 9 月 30 日,Stellar 擁有 800 萬美元的正股東權益和約 800 萬股已發行股票,而 2014 年 8 月 31 日的股東權益為 770 萬美元和約 780 萬股已發行股票。

  • As Mark mentioned earlier, we filed our fiscal year-end 2015 Form 10-K, which includes consolidated financial statements and related management discussion and analysis, on Monday, December 14, 2015. All of Stellar Biotechnologies' current and past reports and filings can be found on the Canadian securities administrators website, SEDAR.com, or the US SEC website, SEC.gov/EDGAR. They can also easily be accessed from our website, stellarbiotechnologies.com, as financial and SEC reports under the investors section.

    正如馬克之前提到的,我們於 2015 年 12 月 14 日星期一提交了 2015 財年末的 10-K 表格,其中包括合併財務報表和相關的管理討論和分析。Stellar Biotechnologies 當前和過去的所有報告和文件都可以可在加拿大證券管理機構網站 SEDAR.com 或美國證券交易委員會網站 SEC.gov/EDGAR 上找到。它們也可以從我們的網站 stellarbiotechnologies.com 輕鬆訪問,作為投資者部分下的財務和 SEC 報告。

  • And please note that as a previous foreign private issuer, prior to fiscal 2014 our past annual reports were filed under Form 20-F and past quarterly financial statements were filed under Form 6-K on EDGAR.

    請注意,作為以前的外國私人發行人,在 2014 財年之前,我們過去的年度報告是根據 20-F 表格提交的,過去的季度財務報表是根據 EDGAR 表格 6-K 提交的。

  • And I will now turn the call back over to Frank for closing remarks. Frank?

    我現在將把電話轉回給 Frank 以作結束語。坦率?

  • Frank Oakes - Chairman, President, CEO

    Frank Oakes - Chairman, President, CEO

  • Thank you, Kathi.

    謝謝你,凱西。

  • I would like to just reiterate key points of our presentation. Growth in revenues continued in 2015, we increased KLH sales, and our business development efforts continued to bring in new customers. Our transition in 2015 to a fully reporting US domestic issuer culminated in the uplist to the NASDAQ capital market, a move that we think was important for our shareholders, both for broader outreach and improved liquidity.

    我想重申一下我們演講的要點。 2015 年收入繼續增長,我們增加了 KLH 銷售額,我們的業務發展努力繼續吸引新客戶。我們在 2015 年轉型為全面報告的美國國內發行人,最終在納斯達克資本市場上市,我們認為此舉對我們的股東來說很重要,既可以擴大業務範圍,也可以提高流動性。

  • Our cash position remains strong and we see an excellent opportunity for Company growth in the year to come. I am very excited by the prospects for Stellar Biotechnologies and want to thank our employees, partners, and shareholders for your part in successful 2015.

    我們的現金狀況依然強勁,我們看到了公司在來年實現增長的絕佳機會。我對 Stellar Biotechnologies 的前景感到非常興奮,並感謝我們的員工、合作夥伴和股東在 2015 年取得的成功。

  • Mark McPartland - VP Corporate Development & Communications

    Mark McPartland - VP Corporate Development & Communications

  • Operator, this concludes our formal comments at this time and we would like to open up the call for questions, if you would start the Q&A portion of the call, please.

    接線員,我們的正式評論到此結束,我們想打開問題電話,如果你願意開始電話的問答部分,請。

  • Operator

    Operator

  • Thank you, Mark. We will now begin the question-and-answer session. (Operator Instructions). Jason McCarthy, Maxim Group.

    謝謝你,馬克。我們現在開始問答環節。 (操作員說明)。馬克西姆集團的傑森麥卡錫。

  • Jason McCarthy - Analyst

    Jason McCarthy - Analyst

  • Congratulations. It sounds like you guys had a very good year, the uplisting to the NASDAQ and sales are growing. Just a couple of questions. Can you give us a sense for 2016, what KLH sales could look like, maybe some guidance on grams that you are thinking for the next year? And could you give us a sense of what the consumption rate is for a company like Neovacs, who are -- they are in a Phase IIb and they are going to initiate several other studies in the coming months. How much KLH do you consume at the Phase II level? And then, maybe what a company like that in lupus consume in a Phase III?

    恭喜。聽起來你們今年過得很不錯,在納斯達克上市,銷售額也在增長。只是幾個問題。您能給我們介紹一下 2016 年的情況嗎?KLH 的銷售情況如何?也許您對明年的克數有一些指導意見?你能否告訴我們像 Neovacs 這樣的公司的消費率是多少,他們正處於 IIb 階段,他們將在未來幾個月啟動其他幾項研究。您在 Phase II 階段消耗了多少 KLH?然後,也許像狼瘡這樣的公司在 III 期消費甚麼?

  • Frank Oakes - Chairman, President, CEO

    Frank Oakes - Chairman, President, CEO

  • First, Jason, thank you. Thanks for the congratulations and thanks for the good questions.

    首先,傑森,謝謝你。感謝您的祝賀,也感謝您提出的好問題。

  • As a public company, we can't speculate on future events, in particular those things that are under the control of our partners, like Neovacs. I think you can look to Neovacs. I know that they have given indications through press releases of the expanding -- their expanding Phase IIb lupus trial, and I do know that they have forecasts of their own for the demands. Those are proprietary, but there are two indicators as to why we are confident in our core KLH business and the potential for fast growth.

    作為一家上市公司,我們不能推測未來的事件,尤其是那些在我們的合作夥伴控制下的事情,比如 Neovacs。我想你可以看看 Neovacs。我知道他們通過新聞稿給出了擴大的跡象——他們擴大的 IIb 期狼瘡試驗,我知道他們對需求有自己的預測。這些是專有的,但有兩個指標可以說明我們為什麼對我們的核心 KLH 業務和快速增長的潛力充滿信心。

  • One is that our sales growth reflects really the increasing demand of KLH as companies advance their clinical trials, companies like our partner Araclon, as well as Neovacs. Also, if you look at the pipeline of companies with KLH-based immunotherapies in clinical trials and then imagine how many more there may be in preclinical stages, you'll see that the reason that we are excited about the prospect for growing demand, and I think for indications of specific requirements of companies like Neovacs, I think you would have to look to their press releases to get public information with regard to what each one of those trials would require.

    一是我們的銷售增長確實反映了隨著公司推進臨床試驗,我們的合作夥伴 Araclon 以及 Neovacs 等公司對 KLH 的需求不斷增加。此外,如果您查看在臨床試驗中使用基於 KLH 的免疫療法的公司的管道,然後想像可能還有多少處於臨床前階段,您會發現我們對不斷增長的需求前景感到興奮的原因,並且我認為對於像 Neovacs 這樣的公司的具體要求的指示,我認為你必須查看他們的新聞稿以獲取有關每一項試驗需要什麼的公共信息。

  • Jason McCarthy - Analyst

    Jason McCarthy - Analyst

  • Great. And I just want to shift gears. A week or two ago, you had data or an announcement of a poster presentation of a KLH therapeutic vaccine for C. diff, which I thought was great data. It was really interesting. And I am curious if indications in infectious diseases, these in-house therapeutic vaccines, if you would, is something that Stellar is going to continue to pursue. And can we look forward to more preclinical, then ultimately clinical data in these other indications, aside from being a KLH supplier to other vaccine companies?

    偉大的。我只想換檔。一兩個星期前,你有數據或關於艱難梭菌 KLH 治療性疫苗海報展示的公告,我認為這是很好的數據。這真的很有趣。我很好奇 Stellar 是否會繼續追求傳染病的適應症,這些內部治療性疫苗,如果你願意的話。除了成為其他疫苗公司的 KLH 供應商之外,我們能否期待更多這些其他適應症的臨床前、最終臨床數據?

  • Frank Oakes - Chairman, President, CEO

    Frank Oakes - Chairman, President, CEO

  • Great question, and we think that the data from our investment in developing the C. diff immunotherapy is a positive indicator both of the value of that asset, and we are in discussions that could result in partnering relationships to further advance that asset. It is also a great indication of the strength that Stellar has in its R&D program to identify preclinical assets, incorporate KLH into an immunotherapy using those targets for specific disease indications, and we think that we will continue to work in that to identify potential drug candidates and partners to help advance those drug candidates into clinical development.

    很好的問題,我們認為我們投資開發 C. diff 免疫療法的數據是該資產價值的積極指標,我們正在討論可能導致合作關係以進一步推進該資產。這也很好地表明了 Stellar 在其研發計劃中的實力,以確定臨床前資產,將 KLH 納入免疫療法,使用這些目標針對特定疾病適應症,我們認為我們將繼續努力,以確定潛在的候選藥物和合作夥伴幫助將這些候選藥物推進臨床開發。

  • Jason McCarthy - Analyst

    Jason McCarthy - Analyst

  • Great. Thanks, Frank. Great year, again, looking forward to 2016.

    偉大的。謝謝,弗蘭克。又是偉大的一年,期待2016年。

  • Frank Oakes - Chairman, President, CEO

    Frank Oakes - Chairman, President, CEO

  • As are we, Jason, and thank you for the good questions.

    和我們一樣,傑森,謝謝你提出的好問題。

  • Mark McPartland - VP Corporate Development & Communications

    Mark McPartland - VP Corporate Development & Communications

  • Operator, with that, now I am going to take one of our calls from the -- or one of our questions from the webcast participants. And the question is with regard to our expansion in Mexico. Under your current expansion plans in Mexico, can you give us any more detail why this is relevant? And Frank, would you take that question?

    接線員,有了這個,現在我要接聽我們的一個電話,或者來自網絡廣播參與者的一個問題。問題是關於我們在墨西哥的擴張。根據您目前在墨西哥的擴張計劃,您能否更詳細地告訴我們為什麼這是相關的?弗蘭克,你會回答這個問題嗎?

  • Frank Oakes - Chairman, President, CEO

    Frank Oakes - Chairman, President, CEO

  • Yes, that's a good question. It was, we think, one of the highlights of 2015.

    是的,這是個好問題。我們認為,這是 2015 年的亮點之一。

  • As I hope our investors and stakeholders can appreciate, Stellar has advanced its technology for aquaculture production of the source animal. In Ventura County, California, we have developed a state-of-the-art aquaculture facility, but there is always inherent risk in being single-site dependent.

    正如我希望我們的投資者和利益相關者能夠理解的那樣,Stellar 已經改進了其源動物水產養殖生產技術。在加利福尼亞州的文圖拉縣,我們開發了一個最先進的水產養殖設施,但依賴單一地點始終存在固有風險。

  • So both for long-term growth strategy, as well as site redundancy, we think it was critical to acquire a second facility. We are going to go methodically through a two- to three-year feasibility assessment at that site before we make substantial capital commitments to actually build out commercial-scale production facilities, and we hope that site would be available and could be developed coincident with commercial launch of one or more of our partners' drug products so that we can assure both scalability and site security with two production sites.

    因此,對於長期增長戰略和站點冗餘,我們認為收購第二個設施至關重要。我們將有條不紊地對該地點進行為期兩到三年的可行性評估,然後再投入大量資金以實際建設商業規模的生產設施,我們希望該地點可用並且可以與商業同步開發推出我們合作夥伴的一種或多種藥品,以便我們可以通過兩個生產基地確保可擴展性和場地安全。

  • So we think it's a critical asset. And a third point from a competitive strategy, we think we have spent a lot of time looking for an appropriate second site. We think this is one of the best sites that we have seen along the coast of North America, and we think having control of that site clearly gives us competitive advantage because it's not available to a competitor.

    所以我們認為這是一項重要資產。第三點來自競爭戰略,我們認為我們已經花了很多時間尋找合適的第二個地點。我們認為這是我們在北美沿海看到的最好的網站之一,我們認為控制該網站顯然給我們帶來了競爭優勢,因為競爭對手無法獲得它。

  • So, we think both for offensive and defensive strategy, we think it was an excellent move both for our shareholders, as well as for our customers.

    因此,我們認為無論是進攻還是防禦戰略,我們認為這對我們的股東和客戶來說都是一個很好的舉措。

  • Mark McPartland - VP Corporate Development & Communications

    Mark McPartland - VP Corporate Development & Communications

  • And then as a follow-up to that, there was an additional. How challenging is the environment in Mexico regarding the government acceptance?

    然後作為後續行動,還有一個。墨西哥的環境在政府接受方面有多具有挑戰性?

  • Frank Oakes - Chairman, President, CEO

    Frank Oakes - Chairman, President, CEO

  • Obviously, working in a foreign jurisdiction, there are always cross-border issues, but at this site in Baja California, our partner, Ostiones Guerrero, has great relationship with the local municipalities and officials, and we have cultivated our own relationships with individuals, such as the Mexican National Secretary of Fisheries and Aquaculture and the regional aquaculture director, to build out very strong political alliances, as well as commercial alliances, to assure that we can grow in an expeditious manner and have all of the support both, as I said, both commercial and political support to develop this site, and I think there is a great deal of enthusiasm amongst the partners and stakeholders in Baja California to see biotechnology assets developed in that region. So, we think the climate is excellent and political relationships are well established.

    顯然,在外國司法管轄區工作,總是存在跨境問題,但在下加利福尼亞州的這個站點,我們的合作夥伴 Ostiones Guerrero 與當地市政當局和官員有著良好的關係,我們與個人建立了自己的關係,例如墨西哥國家漁業和水產養殖部長和區域水產養殖主管,建立非常強大的政治聯盟和商業聯盟,以確保我們能夠迅速發展並獲得雙方的所有支持,因為我說,開發該站點的商業和政治支持,我認為下加利福尼亞州的合作夥伴和利益相關者對看到該地區開發的生物技術資產抱有極大的熱情。因此,我們認為氣候非常好,政治關係也已建立。

  • Mark McPartland - VP Corporate Development & Communications

    Mark McPartland - VP Corporate Development & Communications

  • With that, Operator, we would like to turn the call back to live call-in participants, if you would start to poll for questions again?

    有了這個,接線員,我們想把電話轉回現場的電話參與者,如果你願意再次開始投票提問嗎?

  • Operator

    Operator

  • (Operator Instructions). Brian Marckx, Zacks Investment Research.

    (操作員說明)。 Zacks 投資研究部的 Brian Marckx。

  • Brian Marckx - Analyst

    Brian Marckx - Analyst

  • Good afternoon, guys, and congratulations on all the great progress. The 10-K notes Axon Neurosciences contributed, I believe it was, 16% of revenue for the year. Does that relate to their Phase I study for their Alzheimer's candidate?

    下午好,伙計們,祝賀所有的巨大進步。我相信 Axon Neurosciences 的 10-K 筆記貢獻了當年收入的 16%。這與他們針對阿爾茨海默氏症候選人的第一階段研究有關嗎?

  • Frank Oakes - Chairman, President, CEO

    Frank Oakes - Chairman, President, CEO

  • [Mark], thanks. I am glad to see that people are reading our 10-K in detail. But yes, Axon was a significant contributor to the growth in Stellar's revenue.

    [馬克],謝謝。我很高興看到人們正在詳細閱讀我們的 10-K。但是,是的,Axon 是 Stellar 收入增長的重要貢獻者。

  • And although I can't speak specifically to that relationship, as you can appreciate, many of our commercial relationships are under NDA, but I can point you to Axon's news with regard to what they thought were very promising results from a Phase I clinical trial and the announcement that they intend to pursue their tau protein target for Alzheimer's disease in a Phase II trial that they expect to launch in 2016, and I would think that acquisition of KLH would be more forward thinking toward a Phase II trial, rather than a Phase I trial that has already been completed.

    雖然我不能具體談論這種關係,正如你所理解的,我們的許多商業關係都在 NDA 之下,但我可以向你指出 Axon 的新聞,他們認為 I 期臨床試驗的結果非常有希望以及他們打算在預計於 2016 年啟動的 II 期試驗中追求阿爾茨海默氏病的 tau 蛋白目標的公告,我認為收購 KLH 將更具前瞻性地考慮進行 II 期試驗,而不是已經完成的第一階段試驗。

  • Brian Marckx - Analyst

    Brian Marckx - Analyst

  • Okay, okay, that's great. Thanks, Frank. That's all I had.

    好吧好吧,那太好了。謝謝,弗蘭克。這就是我的全部。

  • Frank Oakes - Chairman, President, CEO

    Frank Oakes - Chairman, President, CEO

  • Okay, great, and we appreciate the comments.

    好的,太好了,我們感謝您的評論。

  • Mark McPartland - VP Corporate Development & Communications

    Mark McPartland - VP Corporate Development & Communications

  • Operator, with that, I'm going to take a couple more questions from our webcast participants and we're coming up on the cut-off time we had originally scheduled for the call. But we will take a couple more questions from the webcast participants and then transition from there.

    接線員,我將再回答網絡廣播參與者的幾個問題,我們將在我們原定電話會議的截止時間前來。但我們將從網絡廣播參與者那裡再回答幾個問題,然後從那裡過渡。

  • So, the next question relates to our margins and looking for some more clarity on our margins. So with that, I am going to pass that to Kathi to address that specific regarding our margins.

    因此,下一個問題與我們的利潤率有關,並希望我們的利潤率更加清晰。因此,我將把它傳遞給 Kathi,以解決有關我們利潤率的具體問題。

  • Kathi Niffenegger - CFO

    Kathi Niffenegger - CFO

  • Okay. Thank you for that question. I appreciate the opportunity to explain it a little bit more, because I am asked that fairly regularly, looking back at our comparative financial statements.

    好的。謝謝你提出這個問題。我很高興有機會對此進行更多解釋,因為在回顧我們的比較財務報表時,我經常被問到這個問題。

  • And I mentioned that in 2014 and prior, we certainly had had sales at that point, but we had not had the level and consistency of sales of particular products that, under accounting rules, we would be able to support the assurance of recoverability in the future. So we did not put inventory onto our balance sheet.

    我提到,在 2014 年及之前,我們當時確實有銷售,但我們沒有特定產品銷售的水平和一致性,根據會計規則,我們能夠支持保證可收回性未來。所以我們沒有將庫存計入我們的資產負債表。

  • That means that as we had production, all those costs flowed to cost of sales and contract services, whether or not the products had been sold. And so, it actually would look like a negative margin.

    這意味著當我們進行生產時,所有這些成本都流向了銷售和合同服務成本,無論產品是否已售出。因此,它實際上看起來像是一個負利潤率。

  • I think now in the fiscal 2015 where we are recording inventory on our books, that is a much better assessment of -- you can see the sales and the cost of sales, so that's a better assessment of our margin. Of course, it will vary with the product mix, but you can definitely see that there is positive margin at that point in time and hopefully that explains that for people.

    我認為現在我們在賬簿上記錄庫存的 2015 財年,這是一個更好的評估——你可以看到銷售額和銷售成本,所以這是對我們利潤率的更好評估。當然,它會隨著產品組合的不同而變化,但你肯定可以看到在那個時間點存在正利潤率,希望這能為人們解釋這一點。

  • Mark McPartland - VP Corporate Development & Communications

    Mark McPartland - VP Corporate Development & Communications

  • That's great. Yes, I think that covers that. That is very good.

    那太棒了。是的,我認為這涵蓋了這一點。這是非常好的。

  • So we will take one final question from the webcast participants and this should wrap the call for this time. But the next question is, when will companies that you are working with have positive inflection points and when should we expect such future announcements?

    因此,我們將向網絡廣播參與者提出最後一個問題,這應該結束了這次電話會議。但下一個問題是,與您合作的公司何時會出現積極的拐點?我們應該在何時期待此類未來公告?

  • Frank Oakes - Chairman, President, CEO

    Frank Oakes - Chairman, President, CEO

  • Thank you, Mark. This is Frank and I will take that question. Of course, as I said earlier, we can't speak for other companies, of course, and we can't speculate on future events, but the indicators that we believe are important are these.

    謝謝你,馬克。我是弗蘭克,我來回答這個問題。當然,正如我之前所說,我們當然不能代表其他公司說話,也不能推測未來的事件,但我們認為重要的指標就是這些。

  • First, look at the agreements that we have in place now -- long-term contracts, clinical-stage companies in a variety of serious diseases. These show our ability to convert customer inquiries into partnerships.

    首先,看看我們現在達成的協議——長期合同,各種嚴重疾病的臨床階段公司。這些表明我們有能力將客戶諮詢轉化為合作夥伴關係。

  • Second, our sales are increasing, which points to growing demand for Stellar KLH. And lastly, look at the pipeline of dozens of KLH-based immunotherapies in clinical trials. All of these will need a reliable, scalable source of GMP-grade KLH. We see this as virtually untapped market potential and we are positioning to be the Company that supplies that market through our own manufacturing capabilities, our site expansion, and growing relationships and alliances with customers.

    其次,我們的銷售額在增加,這表明對 Stellar KLH 的需求不斷增長。最後,看看臨床試驗中數十種基於 KLH 的免疫療法的流程。所有這些都需要可靠、可擴展的 GMP 級 KLH 來源。我們認為這是幾乎未開發的市場潛力,我們定位為通過我們自己的製造能力、我們的站點擴展以及與客戶的關係和聯盟不斷發展來供應該市場的公司。

  • So we think all of these things are great indicators of the future potential for Stellar and its KLH products.

    所以我們認為所有這些都是 Stellar 及其 KLH 產品未來潛力的重要指標。

  • Mark McPartland - VP Corporate Development & Communications

    Mark McPartland - VP Corporate Development & Communications

  • Thank you, Frank. With that, Frank, I would like to just turn it back to you for closing comments, and then the operator, you can take us from there.

    謝謝你,弗蘭克。有了這個,弗蘭克,我想把它轉回給你結束評論,然後接線員,你可以從那裡帶我們。

  • Frank Oakes - Chairman, President, CEO

    Frank Oakes - Chairman, President, CEO

  • Okay. Thank you, Operator. Once again, I would like to thank all our shareholders and key stakeholders who have participated in today's conference call. If you have any additional questions, please feel free to contact either Mark McPartland or myself.

    好的。謝謝你,運營商。我要再次感謝參加今天電話會議的所有股東和主要利益相關者。如果您有任何其他問題,請隨時聯繫 Mark McPartland 或我本人。

  • Thank you for your continued support and interest in Stellar Biotechnologies over the last year, and we look forward with great excitement to providing future updates on Stellar's progress. Operator?

    感謝您在過去一年中對 Stellar Biotechnologies 的持續支持和興趣,我們非常興奮地期待著提供有關 Stellar 進展的未來更新。操作員?

  • Operator

    Operator

  • Thank you. Ladies and gentlemen, this concludes the Stellar Biotechnologies corporate update conference call. Thank you for your participation. You may now disconnect.

    謝謝。女士們,先生們,Stellar Biotechnologies 公司更新電話會議到此結束。感謝您的參與。您現在可以斷開連接。