Thermogenesis Holdings Inc (THMO) 2007 Q2 法說會逐字稿

At this time I would like to turn the conference over to Phil Coelho, Chairman and CEO. Mr. Coelho?

現在我想把會議交給董事長兼首席執行官菲爾·科埃略 (Phil Coelho)。科埃略先生？

Thank you, and thanks to all of you who are joining us on the phone or via Webcast. I would like to welcome everyone to ThermoGenesis' second quarter fiscal year 2007 results. I am joined today by Dr. William Osgood, ThermoGenesis' General Manager of Operations, and Matt Plavan, our Chief Financial Officer.

謝謝你們，也感謝所有通過電話或網絡廣播加入我們的人。我謹歡迎大家了解 ThermoGenesis 2007 財年第二季度的業績。今天與我一起出席的還有 ThermoGenesis 運營總經理 William Osgood 博士和我們的首席財務官 Matt Plavan。

On today's call I will discuss our second-quarter performance, as well as recent developments in our Cell Therapy and Surgical Wound Care businesses. Bill will then provide a brief overview of his plans to reorganize and streamline operations and his priority project since joining ThermoGenesis at the first of January. Matt will then follow with details and analysis of the financial results for second quarter fiscal 2007. After the discussion we will take your questions.

在今天的電話會議上，我將討論我們第二季度的業績，以及我們細胞治療和外科傷口護理業務的最新發展。然後，Bill 將簡要概述自 1 月 1 日加入 ThermoGenesis 以來他的重組和簡化運營計劃以及優先項目。接下來，Matt 將詳細介紹 2007 財年第二季度的財務業績並進行分析。討論結束後，我們將回答您的問題。

ThermoGenesis is growing rapidly, attempting to double revenues over the previous fiscal year. However, this last quarter was negatively impacted by transitional operational changes, and that we were significantly scaling up the AXP disposable bag set production and continuing our consolidation of BioArchive distribution under GE Healthcare's channel.

ThermoGenesis 正在快速增長，試圖將上一財年的收入翻一番。然而，上個季度受到了運營轉型變革的負面影響，我們大幅擴大了 AXP 一次性袋子套件的生產規模，並繼續在 GE Healthcare 的渠道下整合 BioArchive 分銷。

As we meet today we believe these issues are largely behind us. We missed our internal revenue projections for last quarter, but I'm happy to state that we believe we are back on track with our AXP production ramp up. And we are targeting the 5 million revenue mark this quarter, and believe we are on an upward revenue trajectory thereafter.

當我們今天開會時，我們相信這些問題基本上已經過去了。我們沒有達到上季度的內部收入預測，但我很高興地說，我們相信我們的 AXP 產量已回到正軌。我們本季度的目標是實現 500 萬美元的收入大關，並相信此後我們的收入將呈上升趨勢。

However, the ground we lost with revenues last quarter has affected the timing of our revenue ramp-up, and requires a re-calibration of our existing guidance for fiscal 2007 of 20 to 25 million in revenues. As you have probably seen per our earnings release from earlier today, our revised guidance for fiscal 2007 is 18 to 22 million in total revenues.

然而，我們上個季度收入的下降影響了我們收入增長的時間，並需要重新調整我們現有的 2007 財年收入 20 至 2500 萬的指導。正如您可能已經從我們今天早些時候發布的收益報告中看到的那樣，我們修訂後的 2007 財年總收入指引為 18 至 2200 萬美元。

The transitional issues we faced in the second quarter and Bill Osgood's immediate positive impact have strongly reinforced to the Company the importance of continuing to seek out and hire talented senior executives to aid in our maturation to a much larger and more complex business. I certainly wish we had Bill's expertise on board nine months ago when we began the search to fill his position. Had we been able to do so, I believe the scale-up manufacturing problems for the AXP disposables we have experienced would have been avoided.

我們在第二季度面臨的過渡問題和比爾·奧斯古德的直接積極影響強烈強調了公司​​繼續尋找和聘用有才華的高級管理人員以幫助我們成熟為規模更大、更複雜的業務的重要性。我當然希望九個月前我們開始尋找比爾的專業知識來填補他的職位。如果我們能夠做到這一點，我相信我們所經歷的 AXP 一次性用品的擴大生產問題就可以避免。

Bill joined ThermoGenesis on January 1st from his position as Senior Vice President of Sorin cardiopulmonary business. In his position at Sorin, Bill's responsibilities included manufacturing devices and disposables for heart and lung bypass surgeries. These are FDA Class 2 and Class 3 products, which require the most rigorous quality standards in the medical industry. We intend to achieve these same elevated quality standards for our products. As the AutoXpress provides the highest cell recovery performance in the industry, we are committed to providing our customers the disposable bag set of the highest quality in the industry as well.

Bill 於 1 月 1 日加入 ThermoGenesis，此前擔任 Sorin 心肺業務高級副總裁。在 Sorin 任職期間，Bill 的職責包括製造用於心臟和肺繞道手術的設備和一次性用品。這些是 FDA 2 類和 3 類產品，需要醫療行業最嚴格的質量標準。我們打算讓我們的產品達到同樣高的質量標準。由於 AutoXpress 提供業內最高的細胞回收性能，我們也致力於為客戶提供業內最高質量的一次性袋子套件。

Until mid-November, we were on track to report record revenues for the quarter. We had implemented rigorous quality testing of our AXP disposables, and supply was in excess of 1000 bag sets per week. It is pushing this production rate much higher where we ran into trouble. Our contract manufacturer formed a longer production line with twice the assemblers and new bonding and testing equipment in order to accelerate production to 2000 and then 3000 bag sets per week for the last six weeks of the quarter. At this higher rate, quality issues emerged. GE Healthcare had requested that 28,000 bag sets be shipped by the end of the fiscal second quarter. However, given the unforeseen quality issues, we were only able to fulfill 8400 of those orders. Validation and quality assurance testing consumed another 6500 bag sets. Thus our revenues, cost of sales and margins were severely impacted.

直到 11 月中旬，我們都有望報告該季度創紀錄的收入。我們對 AXP 一次性用品進行了嚴格的質量測試，每週供應超過 1000 套袋子。它使我們遇到麻煩的生產率大大提高。我們的合同製造商組建了一條更長的生產線，配備了兩倍的組裝工以及新的粘合和測試設備，以便在本季度最後六週將產量加快到每週 2000 套，然後是 3000 套。在如此高的速度下，質量問題出現了。 GE 醫療集團要求在第二財季末之前發貨 28,000 套袋子。然而，由於不可預見的質量問題，我們只能完成其中的 8400 個訂單。驗證和質量保證測試又消耗了 6500 套袋子。因此，我們的收入、銷售成本和利潤受到嚴重影響。

As a result of these capacity constraints, deliveries of the available AXP bag sets were channeled to satisfy our existing AutoXpress customers, with new customer order fulfillment to follow later. We ended the quarter with a sizable order backlog totaling over 36,000 bag sets, which, at approximately $70 each, equates to 2.5 million in revenue.

由於這些產能限制，可用 AXP 包套件的交付被用於滿足我們現有的 AutoXpress 客戶的需求，並隨後履行新客戶的訂單。本季度結束時，我們的積壓訂單數量可觀，總計超過 36,000 套包袋，每套約 70 美元，相當於 250 萬美元的收入。

I am happy to report that capacity constraints have begun to ease, and we currently expect AXP disposable shipments this quarter to rise substantially over last quarter. In addition, costs related to validation and quality assurance are expected to be lower in the ongoing third quarter, equating to higher gross margins for the AXP revenue growth in the second quarter -- revenue growth.

我很高興地報告，產能限制已經開始緩解，我們目前預計本季度 AXP 一次性出貨量將比上季度大幅增長。此外，與驗證和質量保證相關的成本預計將在第三季度降低，相當於第二季度 AXP 收入增長（收入增長）的毛利率更高。

Revenue growth in the second quarter was also negatively impacted by a delay in orders for our BioArchive automated core blood storage systems. Specifically, four BioArchives created and prepared to ship to GE in the last week of December were held up due to a delayed purchase order as GE took older sales from previous international distributors. This transition from known distributors in the past to GE in the future has not been without its difficulties. All four BioArchives have now been shipped, and we expect solid BioArchive sales for the rest of this fiscal year.

第二季度的收入增長也受到 BioArchive 自動化核心血存儲系統訂單延遲的負面影響。具體來說，12 月最後一周創建並準備運送到 GE 的四個 BioArchives 由於採購訂單延遲而被擱置，因為 GE 從以前的國際分銷商那裡拿走了較舊的銷售。從過去的知名分銷商到未來的 GE 的轉變並非沒有困難。所有四個 BioArchive 現已發貨，我們預計本財年剩餘時間 BioArchive 的銷售將保持穩定。

In summary, the quality and capacity issues are being addressed. With Bill on board, we have begun to upgrade our operations management team, and we are confident we are heading in the right direction.

總之，質量和能力問題正在得到解決。比爾加入後，我們已經開始升級我們的運營管理團隊，我們相信我們正朝著正確的方向前進。

In regards to Surgical Wound Care, earlier this week we issued a press release stating that we have filed our response to the FDA questions on our PMA application for the CryoSeal Fibrin Sealant system as an adjunct to hemostasis and liver resection surgeries. The response took longer than we expected, which delays our timetable to launch CryoSeal in the U.S. and the South American and Asian countries that require the FDA approval.

關於手術傷口護理，本週早些時候，我們發布了一份新聞稿，聲明我們已就 CryoSeal 纖維蛋白密封劑系統作為止血和肝切除手術的輔助手段的 PMA 申請向 FDA 提出的問題做出回應。我們的反應時間比我們預期的要長，這推遲了我們在美國以及需要 FDA 批准的南美洲和亞洲國家推出 CryoSeal 的時間表。

CryoSeal and TPD platform products are sufficiently innovative that they can change the way surgeries and other procedures are done. Our revenues for these products continue to grow, and we remain excited and confident about their potential, as there is a clear need and well-established market for them.

CryoSeal 和 TPD 平台產品具有足夠的創新性，可以改變手術和其他程序的完成方式。我們這些產品的收入持續增長，我們對它們的潛力仍然感到興奮和充滿信心，因為它們有明確的需求和成熟的市場。

Equally important, we are now clear that fibrinogen and fibrin glues will play an increasingly important role in cell therapy, and autologous fibrin glues appear to have exceptional clinical advantages over pooled plasma conventional fibrin glues. This is a new and potentially very large market for us, as it brings together our Cell Therapy and Surgical Wound Care product technology.

同樣重要的是，我們現在清楚纖維蛋白原和纖維蛋白膠將​​在細胞治療中發揮越來越重要的作用，並且自體纖維蛋白膠似乎比混合血漿傳統纖維蛋白膠具有特殊的臨床優勢。這對我們來說是一個潛在非常大的新市場，因為它匯集了我們的細胞治療和外科傷口護理產品技術。

Examples of just two such applications are - when stem sells are suspended into one of the components of fibrin glue, and then injected into an infarcted area of the heart, the improved cell retention and survival reduces infarct expansion and induces new blood vessel formation. Further, autologous fibrin glue enhances the survival, for instance, of chondrocytes, which are cells used to repair damaged cartilage, while pooled plasma fibrin glues cause the chondrocytes to undergo apoptosis, which is premature death. We believe ThermoGenesis is the only company which has technology to harvest the stem sells from cord blood, peripheral blood or bone marrow, and make autologous fibrin glue from the leftover plasma. We are proceeding to merge the technologies in a new R&D project, as we believe this may become a significant product area in personalized medicine.

此類應用的兩個例子是：當乾細胞懸浮在纖維蛋白膠的一種成分中，然後注射到心臟的梗塞區域時，改善的細胞保留和存活會減少梗塞擴張並誘導新血管形成。此外，自體纖維蛋白膠可以增強軟骨細胞等細胞的存活率，軟骨細胞是用於修復受損軟骨的細胞，而匯集的血漿纖維蛋白膠會導致軟骨細胞凋亡，即過早死亡。我們相信 ThermoGenesis 是唯一一家擁有從臍帶血、外周血或骨髓中獲取乾細胞並從剩餘血漿中製造自體纖維蛋白膠的技術的公司。我們正在著手將這些技術合併到一個新的研發項目中，因為我們相信這可能成為個性化醫療的一個重要產品領域。

We are, however, frustrated with our current rate of revenue growth in this business, and are addressing this issue as part of our reorganization to sharpen our execution. Specifically, we are evaluating if the CryoSeal and TPD products are targeting all of the right markets, if we are using the right channels, and if we have the right partners to realize the tremendous potential and value that we see. By next quarter I expect to be able to update you on our evaluation.

然而，我們對該業務目前的收入增長率感到沮喪，並且正在解決這個問題，作為我們重組的一部分，以提高我們的執行力。具體來說，我們正在評估 CryoSeal 和 TPD 產品是否針對所有正確的市場，我們是否使用正確的渠道，以及我們是否擁有正確的合作夥伴來實現我們所看到的巨大潛力和價值。到下個季度，我希望能夠向您通報我們的評估最新情況。

In regards to Cell Therapy, I would also like to direct your attention to another recent announcement in regards to our Cell Therapy products. Following a written request from the FDA, we completed our transition from FDA master file to a 510-K application for the AutoXpress system for cord blood processing.

關於細胞療法，我還想提請您注意最近關於我們的細胞療法產品的另一項公告。根據 FDA 的書面請求，我們完成了從 FDA 主文件到用於臍帶血處理的 AutoXpress 系統的 510-K 申請的過渡。

FDA action to begin regulating the devices and disposables that manufacture the cord blood stem sell populations is the clearest indication yet that they will soon be issuing biological licenses to cord blood banks. We are very enthusiastic about this FDA progress in the regulation of this remarkable cell therapy.

FDA 開始監管生產臍帶血幹細胞的設備和一次性用品的行動是迄今為止最明確的跡象，表明他們將很快向臍帶血庫頒發生物許可證。我們對 FDA 在監管這種非凡的細胞療法方面取得的進展感到非常興奮。

In addition, I would also like to make you aware that we currently have a meeting scheduled with the FDA in early March to discuss the appropriate premarket notification regulatory strategy for the BioArchive system that has no direct substantially equivalent counterpart, but falls within the new FDA guidance in regards to the regulation of cord blood processing and storage devices and disposables. We are now moving on a plan -- by the way, we expect the result of that is to be a regulatory strategy that will provide us some considerable barrier to entry for the services that the BioArchive provides to that industry.

此外，我還想讓您知道，我們目前計劃於 3 月初與 FDA 舉行會議，討論 BioArchive 系統適當的上市前通知監管策略，該系統沒有直接的實質上等效的對應策略，但屬於 FDA 關於臍帶血處理和存儲設備及一次性用品監管的新指南。我們現在正在實施一項計劃——順便說一句，我們預計該計劃的結果將是一項監管戰略，該戰略將為我們進入 BioArchive 向該行業提供的服務提供一些相當大的壁壘。

In addition, we are now planning -- rather, we are now moving on a plan to comprehensively commercialize the AXP technology platform by preparing over the next eight weeks performance data for the AXP with bone marrow and peripheral blood to support additional 510-K applications. After review of a number of existing clinical trials in the U.S. and Europe that utilize bone marrow-derived cells to treat myocardial infarction and peripheral artery disease, and discussions with the clinicians who are running those trials, General Electric Healthcare and ThermoGenesis have jointly initiated a program to accelerate the insertion of the AXP into these and other clinical trials.

此外，我們現在正在計劃——更確切地說，我們現在正在實施一項計劃，通過在未來八週內準備 AXP 的骨髓和外周血性能數據來全面商業化 AXP 技術平台，以支持其他 510-K 應用。在審查了美國和歐洲現有的利用骨髓來源細胞治療心肌梗塞和外周動脈疾病的多項臨床試驗，並與進行這些試驗的臨床醫生進行討論後，通用電氣醫療保健公司和 ThermoGenesis 聯合啟動了一項計劃，以加速將 AXP 插入這些臨床試驗和其他臨床試驗。

This program has four action areas. One, obtain AXP 510-K and CE Mark clearances for all stem sell sources. Two, prepare a uniform template of the technical file that simplifies the task of satisfying hospitals' investigational review board, or IRB, and the FDA investigation of new drug reviews for the trial. In other words, if we prepare the document package ahead of time, it really speeds up the insertion of the product into the trial and makes it very easy as a clinician to accomplish that. Finally -- rather, next, complete our analysis of the 3600 cell therapy clinical trials now enrolling patients to identify those which appear most to benefit from the first-generation AXP performance. And then finally, employ AXP product support specialists to train the clinical groups in AXP production of the stem sell populations they're utilizing clinically.

該計劃有四個行動領域。第一，為所有莖銷售來源獲得 AXP 510-K 和 CE 標誌許可。第二，準備一個統一的技術文件模板，簡化滿足醫院研究審查委員會（IRB）和 FDA 對新藥試驗審查調查的任務。換句話說，如果我們提前準備好文件包，確實可以加快產品插入試驗的速度，並使臨床醫生很容易完成這一任務。最後，更確切地說，接下來，完成我們對目前正在招募患者的 3600 名細胞療法臨床試驗的分析，以確定那些似乎最能從第一代 AXP 性能中受益的患者。最後，聘請 AXP 產品支持專家對臨床小組進行 AXP 生產培訓，以生產他們臨床上使用的干細胞。

I would now like to introduce you to Bill Osgood, who will speak briefly about operations.

現在我想向您介紹比爾·奧斯古德（Bill Osgood），他將簡要介紹運營情況。

Thank you, Phil. First, let me say I'm even more excited about the Company and its future prospects since joining ThermoGenesis early in January, and very impressed with the talent and commitment, the people in the Company, and with my operations team. Being new to the Company, my first goals were to increase the output of the AXP production -- AXP disposables, and to assess and reshape and strengthen the operations organization.

謝謝你，菲爾。首先，我要說的是，自一月初加入 ThermoGenesis 以來，我對公司及其未來前景感到更加興奮，並對公司的人才和承諾、員工以及我的運營團隊印象深刻。作為公司的新人，我的首要目標是增加 AXP 生產（AXP 一次性用品）的產量，並評估、重塑和加強運營組織。

We've made significant progress on both fronts. AXP production is up and running. Even though we are confident in the quality that is being produced, we have a number of initiatives under way to continue improving our quality. At the same time, we [are] systematically removing bottlenecks to increase output. And in parallel, we're working to bring on a second -- on a line -- bring online a second source by the summer.

我們在這兩方面都取得了重大進展。 AXP 生產已啟動並運行。儘管我們對所生產的質量充滿信心，但我們仍在採取許多舉措來繼續提高我們的質量。與此同時，我們正在系統地消除瓶頸以增加產出。與此同時，我們正在努力在夏季之前上線第二個來源。

Our organizational goal is to build a fundamentally sound operations capability that drives rapid development in commercialization projects without distractions. A stronger, more effective operations group will emerge this quarter.

我們的組織目標是建立基本健全的運營能力，以心無旁騖的方式推動商業化項目的快速發展。本季度將出現一個更強大、更有效的運營團隊。

I would now like to turn the call over to Matt to provide our financial highlights.

我現在想將電話轉給馬特，以提供我們的財務亮點。

Thanks, Bill. I'll begin with our fiscal second-quarter results as compared to the same period of the prior year, and then present a few six-month comparative results as well.

謝謝，比爾。我將從我們第二財季的業績與上年同期相比開始，然後介紹一些六個月的比較結果。

Beginning with revenues, revenues for the three months ended December 31, 2006 were 3.7 million compared to 3.1 million for the three months ended December 31, 2005, an increase of 589,000, or 19%. Cell Therapy revenues were 2.6 million for the three months ended December 31, 2006, compared to 2.4 million for the corresponding fiscal 2006 period, an increase of 200,000, or 8%. The increase in revenues is primarily due to the sale of AXP devices and disposables.

從收入開始，截至2006年12月31日止三個月的收入為370萬美元，而截至2005年12月31日止三個月的收入為310萬美元，增加了589,000美元，即19%。截至2006年12月31日止三個月，細胞治療收入為260萬美元，而2006財年同期為240萬美元，增長了20萬美元，即8%。收入的增長主要歸功於 AXP 設備和一次性用品的銷售。

The AXP product line revenues were 643,000 of the Cell Therapy revenues for the quarter ended December 31, 2006, as compared to zero for the corresponding period of the prior year. Sales of Cell Therapy spare parts were 209,000 for the second quarter of fiscal 2007, an increase of $153,000, or 273%. Included in the Cell Therapy revenue, as noted, was 950,000 generated from the sales of BioArchive disposables for the quarter ended December 31, 2006, an increase of 65,000, or 7%, over the same period a year ago.

截至2006年12月31日的季度，AXP產品線的收入佔細胞治療收入的643,000，而上年同期為零。 2007 財年第二季度細胞治療備件的銷量為 209,000 件，增加了 153,000 美元，即 273%。如前所述，細胞治療收入中包括截至 2006 年 12 月 31 日止季度的 BioArchive 一次性用品銷售收入 950,000 美元，比去年同期增加了 65,000 美元，即 7%。

Offsetting the Cell Therapy revenue increase, as noted, was a decrease in the revenues from the sales of BioArchive devices, as Phil had previously mentioned. Three devices were sold in the quarter ended December 31, 2006, versus six in the comparable period of the prior year. And as noted in the press release, we received those orders in January for four BioArchives that had been projected to be in the door by the end of December.

正如菲爾之前提到的，BioArchive 設備銷售收入的減少抵消了細胞治療收入的增長。截至 2006 年 12 月 31 日的季度共售出三台設備，而去年同期售出六台。正如新聞稿中所指出的，我們在一月份收到了四個 BioArchives 的訂單，這些訂單預計將在 12 月底交付。

Surgical Wound Care revenues were 586,000 for the quarter ended December 31, 2006, compared to 230,000 for the quarter ended December 31, 2005. The increase is primarily due to 250,000 in development milestone payments, and an increase in sales of the CP-3 and [cautelous] disposables.

截至2006年12月31日的季度，外科傷口護理收入為586,000美元，而截至2005年12月31日的季度為230,000美元。這一增長主要是由於開發里程碑付款250,000美元，以及CP-3和[謹慎]一次性用品銷量的增加。

Turning now to gross margin performance, gross margin during the quarter was 21%, as compared to 36% for the corresponding fiscal 2006 period. The decrease in gross margin is due primarily to additional AXP disposable product testing and destruction of [lots] totaling approximately $500,000 -- this is what Bill referred to earlier -- as part of the quality assurance programs in the AXP bag set disposables. As he also elaborated on, we expect these amounts to be significantly reduced in future quarters.

現在談談毛利率表現，本季度的毛利率為 21%，而 2006 財年同期的毛利率為 36%。毛利率下降主要是由於額外的 AXP 一次性產品測試和總計約 500,000 美元的[批次]銷毀（這就是 Bill 之前提到的），作為 AXP 袋裝一次性產品質量保證計劃的一部分。正如他還詳細闡述的那樣，我們預計這些金額將在未來幾個季度大幅減少。

One other contributor to the decrease in gross margin was higher warranty claims associated with our BioArchive and CryoSeal devices, approximating $127,000 of additional cost of sales during the quarter. These items were also significantly offset by increases in revenues from milestone payments and license fees.

毛利率下降的另一個原因是與 BioArchive 和 CryoSeal 設備相關的保修索賠增加，本季度的額外銷售成本約為 127,000 美元。這些項目也被里程碑付款和許可費收入的增加所抵消。

Turning to our selling and general administrative expenses, these expenses were 2.3 million for the quarter, as compared to 1.7 million for the comparable fiscal 2006 period, an increase of 554,000, or 32%. This increase is primarily due to salaries and recruiting expenses for the hiring of sales and marketing personnel for the Surgical Wound Care product line and initiating searches for senior management of Cell Therapy and general operations.

至於我們的銷售和一般管理費用，本季度這些費用為 230 萬美元，而 2006 財年同期為 170 萬美元，增加了 554,000 美元，即 32%。這一增長主要是由於為外科傷口護理產品線僱用銷售和營銷人員以及開始尋找細胞治療和一般運營高級管理人員的工資和招聘費用。

Turning to research and development expenses. And just as a reminder, that includes for our company engineering, regulatory affairs, scientific and clinical affairs costs. These costs for the three months ended December 31, 2006 were 973,000, as compared to 1.2 million for the corresponding fiscal 2006 period, a decrease of 204,000, or 17%. The decrease is primarily due to a reduction in the costs associated with the development of the AXP system, which was launched during the fiscal 2006 period, and a decrease in clinical trial costs related to the completion of the CryoSeal clinical trial.

轉向研發費用。提醒一下，這包括我們公司的工程、監管事務、科學和臨床事務成本。截至 2006 年 12 月 31 日止的三個月，這些費用為 973,000 美元，而 2006 財年同期為 120 萬美元，減少了 204,000 美元，即 17%。減少的主要原因是與 2006 財年期間推出的 AXP 系統開發相關的成本減少，以及與完成 CryoSeal 臨床試驗相關的臨床試驗成本減少。

Just quickly here for -- just turning to a few of our six-month highlights, I just wanted to draw your attention to some meaningful increases in our revenues for the comparative six-month period. Revenues for the six months ended December 31, 2006 were 8 million, as compared to 5.2 million for the six months ended December 31, 2005. That's an increase of 53%, or $2.8 million.

很快就到這裡——只是轉向我們六個月的一些亮點，我只是想提請您注意我們在相對六個月期間收入的一些有意義的增長。截至2006年12月31日的六個月的收入為800萬美元，而截至2005年12月31日的六個月的收入為520萬美元。增長了53%，即280萬美元。

Cell Therapy revenues were 5.8 million for the first six months of 2006, compared to 3.9 million for the corresponding fiscal 2006 period, an increase of 50%, or 1.9 million in revenues. The primary driver were the AXP devices and disposables totaling 1.1 million for that six-month period December 31, 2006, as compared to zero for the corresponding six-month period of the prior year.

2006 年前六個月細胞治療收入為 580 萬美元，而 2006 財年同期為 390 萬美元，增長了 50%，即收入 190 萬美元。主要驅動力是 AXP 設備和一次性用品，截至 2006 年 12 月 31 日的六個月期間總計 110 萬台，而去年同期的六個月期間為零。

Surgical Wound Care revenues were 1.2 million for the six months ended December 31, 2006, as compared to 380,000 for the six-month period ended 2005. That's a 220% increase in revenues. This increase is due primarily to 550,000 in development milestone payments; the sale of four CryoSeal devices during the six-month period ended December 31, 2006, versus one during the six months ended December 31, 2005. In addition, there was an increase in sales of CryoSeal disposables, specifically the TPD and the CP-3.

截至2006年12月31日的六個月期間，外科傷口護理收入為120萬美元，而截至2005年的六個月期間，外科傷口護理收入為38萬美元。收入增長了220%。這一增長主要是由於 550,000 美元的開發里程碑付款；截至2006年12月31日的六個月期間銷售了四台CryoSeal設備，而截至2005年12月31日的六個月期間銷售了一台。此外，CryoSeal一次性用品的銷量有所增加，特別是TPD和CP-3。

Lastly, some highlights of our liquidity and capital resources. At December 31, 2006 the Company had cash and short-term investments of 33.9 million and working capital of 37.5 million. This compares to cash and short-term investments of 39 million and working capital of 42.3 million at June 30, 2006. Importantly, the Company -- as we've mentioned during this call, the Company (indiscernible) the backlog as of December 31, 2006 was $2.6 million, of which 2.5 million was for the AXP bag sets.

最後，我們的流動性和資本資源的一些亮點。截至2006年12月31日，公司擁有現金及短期投資3,390萬元，流動資金3,750萬元。相比之下，截至 2006 年 6 月 30 日，現金和短期投資為 3900 萬美元，營運資金為 4230 萬美元。重要的是，公司——正如我們在這次電話會議中提到的那樣，公司（音頻不清晰）截至 2006 年 12 月 31 日的積壓訂單為 260 萬美元，其中 250 萬美元用於 AXP 包套件。

This wraps up my comments on the financials. I'd like to turn the call back over to Phil now for some closing remarks.

我對財務的評論到此結束。我現在想把電話轉回給菲爾，讓他做一些結束語。

Thanks, Matt. In summary, we believe that our recent progress confirms our intense focus on optimizing the market acceptance of our state-of-the-art Cell Therapy and Surgical Wound Care platform products. The personalized therapeutics manufactured by these products meet unmet medical needs, and in the near-term, our priority is to achieve the goals of our business plan by driving sales.

謝謝，馬特。總之，我們相信我們最近的進展證實了我們對優化最先進的細胞治療和外科傷口護理平台產品的市場接受度的強烈關注。這些產品製造的個性化療法滿足了未滿足的醫療需求，短期內，我們的首要任務是通過推動銷售來實現我們的業務計劃目標。

There has never been a more exciting time to be involved in cell therapy. The recent election has brought the stem cell issue to the floor. While President Bush is expected to veto embryonic stem cell legislation that is currently making its way to the Senate, it will provide an excellent platform to discuss completely noncontroversial adult stem cells, the primary focus of our business.

參與細胞治療從未有過如此激動人心的時刻。最近的選舉將乾細胞問題擺到了檯面上。雖然布什總統預計將否決目前正在參議院審議的胚胎幹細胞立法，但它將提供一個絕佳的平台來討論完全無爭議的成體幹細胞，這是我們業務的主要焦點。

The cord blood industry is set to thrive as the government releases additional funds to establish the national cord blood registry and works to define how the FDA should regulate these life-saving cells. We feel that our automated cell processing technology will be a vital component in the growth of the industry.

隨著政府發放額外資金建立國家臍帶血登記處，並努力確定 FDA 應如何監管這些拯救生命的細胞，臍帶血行業必將蓬勃發展。我們認為，我們的自動化細胞處理技術將成為行業發展的重要組成部分。

At the same time, we are always actively exploring the potential of configuring AutoXpress, BioArchive, CryoSeal and Thrombin products to meet the preferred medical requirements of current and future Cell Therapy and Surgical Wound Care clinical trials.

同時，我們始終積極探索配置 AutoXpress、BioArchive、CryoSeal 和 Thrombin 產品的潛力，以滿足當前和未來細胞治療和外科傷口護理臨床試驗的首選醫療要求。

Thank you for your attention today. The operator will now open the line for questions.

感謝您今天的關注。接線員現在將開通提問線路。

(OPERATOR INSTRUCTIONS). [Richard Deutsch], Ladenburg Thalmann.

（操作員說明）。 [理查德·多伊奇]，拉登堡·塔爾曼。

Bill, welcome aboard. Good to have somebody of your caliber join the team. I've got a question for you. If there happens to be, as many people believe, a major breakthrough in any therapy using stem cells or other types of cell material, what sets the AXP system, cell processing system apart from other potential competitive systems in the marketplace?

比爾，歡迎加入。很高興有像您這樣有能力的人加入我們的團隊。我有個問題要問你。如果像許多人相信的那樣，任何使用乾細胞或其他類型細胞材料的療法碰巧出現重大突破，那麼 AXP 系統、細胞處理系統與市場上其他潛在競爭系統的區別是什麼？

Bill can comment as well. Bill is a little new to this. He's concentrating on production. So, let me take an initial stab of it. At the end of the day, if you're collecting cells, recovery is the single most important element, along with cell viability. To our knowledge and the data that has been compiled by independent stem cell laboratories, the AutoXpress recovers more of these important cells than any other device, and the cell viability is essentially close to 100%. The fact that it does it in a closed system and does it very fast are additional elements of it. But I think that will always be the heart of it. It is those things that are important for clinical use.

比爾也可以發表評論。比爾對此有點陌生。他專注於生產。那麼，讓我初步嘗試一下。歸根結底，如果您要收集細胞，恢復以及細胞活力是最重要的因素。據我們所知以及獨立幹細胞實驗室收集的數據，AutoXpress 比任何其他設備回收了更多的重要細胞，並且細胞活力基本上接近 100%。事實上，它是在一個封閉的系統中完成的，而且速度非常快，這是它的附加要素。但我認為這將永遠是它的核心。這些對於臨床使用很重要。

If you're doing this in the operating theater, then being able to do it in the 30-minute timeframe that we have is important. The 30 minutes is also important to cord blood banking, because it has to do with the efficiency of the labor utilization, and the fact that it provides reports which the FDA can use to audit the performance of the stem cell bank. But those are really the main things, and I think that will hold true in every use of cell therapy for which the collection and the processing of the cells is the primary initial step.

如果您在手術室中執行此操作，那麼能夠在我們規定的 30 分鐘時間內完成就很重要。 30 分鐘對於臍帶血庫也很重要，因為它關係到勞動力利用的效率，而且它提供的報告可供 FDA 用來審核幹細胞庫的績效。但這些確實是主要的事情，我認為這在細胞療法的每一次使用中都適用，細胞的收集和處理是主要的初始步驟。

Are you saying that you don't know of any other system that recovers that high recoverability of cells in a sterile environment?

您是說您不知道有任何其他系統可以在無菌環境中恢復如此高的細胞可恢復性嗎？

We're unaware of it. There is one other automated device on the market made by a Swiss company called Sepax. But those published recoveries are -- there are numerous ones, and it falls about 10 or 15% below our recoveries.

我們對此一無所知。市場上還有另一種自動化設備，由一家名為 Sepax 的瑞士公司製造。但公佈的回收率有很多，而且比我們的回收率低 10% 或 15% 左右。

I've got one other question and I'll step back in the queue. In your press release there was a comment about future agreements in distribution, marketing and developmental deals. Can you just give us a little color as to what you're looking at in terms of those deals?

我還有一個問題，我將退後一步。在你們的新聞稿中，有關於未來分銷、營銷和開發交易協議的評論。您能否向我們介紹一下您對這些交易的看法？

I can speak about them in general. We believe that we'll have additional partners in Surgical Wound Care, and we believe that we may have additional partners in the combination of these fibrin gels and the cells collected by the AutoXpress. There is a convergence going on now between these two technologies that could be noticed if you read the literature that's coming out. We have been aware of the possibility for a while, but there is a profusion of articles coming out now that makes that clear that other people are noticing it as well. Matching up the best selling partner with the particular product that is useful for their area of clinical utilization is a careful adjustment, and we have been working on it for a period of time. And we'll announce them as soon as it's appropriate.

我可以概括地談論它們。我們相信，我們將在外科傷口護理方面擁有更多合作夥伴，並且我們相信，在這些纖維蛋白凝膠和 AutoXpress 收集的細胞的組合方面，我們可能會擁有更多合作夥伴。如果您閱讀即將出版的文獻，您可能會注意到這兩種技術之間正在發生融合。我們已經意識到這種可能性有一段時間了，但現在有大量文章發表，清楚地表明其他人也注意到了這一點。將最暢銷的合作夥伴與對其臨床應用領域有用的特定產品相匹配是一項仔細的調整，我們已經為此努力了一段時間。我們將在適當的時候立即宣布它們。

[Matt McBain], Gruber & McBain.

[馬特·麥克貝恩]，格魯伯和麥克貝恩。

I may have missed it, but I did not hear what the cash position was as of December 31st, what the cash burn was during the quarter, and what if any plans you have to utilize your cash balances going forward.

我可能錯過了，但我沒有聽說截至 12 月 31 日的現金狀況是多少，該季度的現金消耗是多少，以及您未來是否有計劃使用現金餘額。

Cash burn was not discussed so far. During the three months ended December 31, 2006, the cash burn -- actually, for the six months ended, the cash burn was 3.6 million from operations. We continue to expect to grow revenues and diminish that number over time, but -- and the final cash position at the end of December was 33.9 million.

到目前為止還沒有討論現金消耗。在截至 2006 年 12 月 31 日的三個月內，現金消耗——實際上，在截至 2006 年 12 月 31 日的六個月內，運營現金消耗為 360 萬美元。我們繼續預計收入會增加，但隨著時間的推移，這個數字會減少，但是 - 12 月底的最終現金頭寸為 3390 萬美元。

Are there additional questions?

還有其他問題嗎？

Mr. McBain, are you done with your question, sir?

麥克貝恩先生，您的問題問完了嗎？

Yes. Thank you.

是的。謝謝。

There are no further questions at this time. Would you like me to re-prompt?

目前沒有其他問題。您需要我重新提示嗎？

No, if --

不，如果——

We have another couple that now have queued in. Jon Hickman, MDB Capital.

現在還有另外一對夫婦在排隊。喬恩·希克曼 (Jon Hickman)，MDB Capital。

Phil, could you update us on kind of the progress of the public blood banks around the country and the money that's coming out of the government? What do you know about that side of things?

菲爾，您能給我們介紹一下全國各地公共血庫的進展情況以及政府提供的資金嗎？你對事情的這一面了解多少？

They've chosen the partners and are beginning to release funds, or have already starting releasing funds, as far as I understand it, for $12 million to six banks. 75% of that went to Duke (indiscernible) blood center, and M.D. Anderson. Those are our customers. Three smaller banks that are not our customers -- well, I guess they are for the manual bag set, but -- got the remaining $3 million. The HRSA is preparing to choose which banks -- probably those banks, maybe some additional -- will get the next tranche of an additional -- I think it's $12 million.

他們已經選擇了合作夥伴並開始發放資金，或者據我所知已經開始向六家銀行發放 1200 萬美元的資金。其中 75% 流向杜克（無法辨認）血液中心和 M.D. 安德森。這些是我們的客戶。三個不是我們客戶的小銀行——嗯，我猜他們是為了手動包套裝，但是——得到了剩下的 300 萬美元。 HRSA 正準備選擇哪些銀行——可能是那些銀行，也許還有一些銀行——將獲得下一批額外的資金——我認為是 1200 萬美元。

The way the funds are expensed is the bank manufactures the product to the specifications that HRSA has laid down. They develop those, of course, along with the FDA. Then they proffer it up to go into the national network, the registry, basically. HRSA then reimburses them an agreed contract amount. And that's the way it's going to proceed through the remainder of the program. The goal of the legislation is 150,000 units. That will take a number of years to accomplish. But there will be annual increases and appropriations to allow that.

資金的支出方式是銀行按照 HRSA 規定的規格生產產品。當然，他們與 FDA 一起開發這些產品。然後他們將其提供給國家網絡，基本上是登記處。然後 HRSA 向他們償還約定的合同金額。這就是程序其餘部分的進行方式。立法目標是15萬輛。這將需要數年時間才能完成。但為此，每年都會增加撥款和撥款。

Richard Jacinto, Atlas Capital.

理查德·哈辛托，阿特拉斯資本。

What is production in Pennsylvania right now?

賓夕法尼亞州現在的產量是多少？

Currently they're producing about 1500 bag sets a week. We have a number of steps in place to increase that, so I expect it to go up fairly soon.

目前他們每週生產約 1500 套包袋。我們採取了一系列措施來提高這一水平，因此我預計這一數字會很快上升。

How long has it been at that kind of 1500 level?

那種1500的水平已經多久了？

It's been in the 1500 to 2500 range over the last several months, or last couple of months. Since I've been here, we've had to make some changes to ensure the quality and stability of that line, so we brought the output down a bit. But it will start to increase now.

過去幾個月或最近幾個月一直在 1500 到 2500 之間。自從我來到這里以來，我們必須做出一些改變以確保該生產線的質量和穩定性，因此我們稍微降低了產量。但現在它將開始增加。

When do you think you'll start to increase it, and what level do you think you'll be able to get it to?

您認為您什麼時候會開始增加它？您認為您能夠將其提高到什麼水平？

This is a manual line. We can build this, and it's a matter of time to get output up. There's not any major constraints other than getting people trained and certified to be able to -- be able to assemble the bag set. The testing, the final test and leak test fixtures are easy to get. So, it really is a matter -- we're wanting to bring this line up in a paste away so that we ensure the quality and we don't see any disruptions as we grow it.

這是一條手動線。我們可以建造這個，提高產量只是時間問題。除了讓人們接受培訓並獲得認證以能夠組裝袋子套件之外，沒有任何重大限制。測試、最終測試和洩漏測試夾具很容易獲得。所以，這確實是一個問題——我們希望把這個系列放在一起，這樣我們就可以確保質量，並且在我們成長的過程中不會看到任何中斷。

Your next step-up in production, what would you -- how many bags per week would you hope that would be at?

您的下一步生產計劃是什麼？您希望每週生產多少袋？

Right now we're wanting to get to the 2000 rate here pretty quickly, that we feel real comfortable that that's sustained. And then from there we'll ramp it up towards 3000.

現在我們希望很快達到 2000 的速度，我們對這種持續下去感到非常滿意。然後從那裡我們將其增加到 3000。

Okay. Can I go ahead and ask another question?

好的。我可以繼續問另一個問題嗎？

Absolutely.

絕對地。

Thank you. How many -- realizing you've got these, a big mandate with GE to increase the AXP bag in other clinicals, can you just tell us where you stand with the AXP bag in current clinical trials -- how many clinical trials, how many patients, when they would expect to be over?

謝謝。有多少——意識到你已經得到了這些，GE 的一項重大任務是在其他臨床中增加 AXP 袋，你能告訴我們你在當前臨床試驗中 AXP 袋的立場嗎——有多少臨床試驗，有多少患者，他們預計什麼時候結束？

We can't -- we're not fully approved by any IRB/IND combination reviews to be -- to go to patients as of yet. That's a relatively lengthy prospect. We're dealing with clinical trials, and we're providing information and working to refine the outputs of the particular cell populations they're looking for. But none of them have traveled all the way through to the cells that are going into patients. That was the purpose of these recent meetings with General Electric, to develop a team that could accelerate all of that. I spoke about that in my presentation, and there is a lot of demand upon us to be able to put it quickly into clinical trials. But there's a fair amount of work that needs to be accomplished to make it work as easily as we expect it will be.

到目前為止，我們還不能——我們還沒有得到任何 IRB/IND 聯合審查的完全批准——去接觸患者。這是一個相對漫長的前景。我們正在處理臨床試驗，我們正在提供信息並努力完善他們正在尋找的特定細胞群的輸出。但它們都沒有一路進入進入患者體內的細胞。這就是最近與通用電氣舉行會議的目的，即建立一支能夠加速這一切的團隊。我在演講中談到了這一點，我們迫切需要能夠將其快速投入臨床試驗。但要使其像我們期望的那樣輕鬆工作，還需要完成大量工作。

Where would you guess you'll actually start to be in clinicals and being used on patients?

您認為您實際上會從哪裡開始進入臨床並用於患者？

That's predicting things outside of our control entirely. But I think it's likely that we'll be in patients here before the end of our fiscal year.

這就是預測完全超出我們控制範圍的事情。但我認為我們很可能會在本財年結束之前收治這裡的患者。

If I can jump onto one last topic?

我可以跳到最後一個話題嗎？

Sure.

當然。

And realizing this is out of your control also, but where do things stand with the New York Blood Center and the FDA at this point in time?

意識到這也是你無法控制的，但此時紐約血液中心和 FDA 的情況又如何呢？

There's actually been an interesting development there. The FDA issued a document right around the first of January that allows cord blood banks to basically -- that are qualified and can produce a similar product, to proceed to license. In other words, what they've done is they've made the statement that the clinical data now provided to the FDA -- and that is the New York Blood Center's data, predominantly -- has led to them to conclude that it is safe and efficacious for the diseases currently treated. And those are the leukemias, lymphomas and all those genetic diseases.

實際上那裡有一個有趣的發展。 FDA 於 1 月 1 日左右發布了一份文件，基本上允許合格且可以生產類似產品的臍帶血庫獲得許可。換句話說，他們所做的就是聲明，現在向 FDA 提供的臨床數據（主要是紐約血液中心的數據）使他們得出結論，該藥物對於目前治療的疾病是安全有效的。這些是白血病、淋巴瘤和所有這些遺傳疾病。

As a result of that, each and every new cord blood bank that requires -- that wishes to get, to obtain biological license, does not have to develop all that information on the basis of their own units. That's a rather remarkable statement, indicating the urgency even that the FDA feels to license more than one bank. So, the FDA -- the New York Blood Center is continuing to work with the FDA. There's people working on it all the time. We've been expecting it for some period of time. It hasn't concluded yet.

因此，每個新的臍帶血庫都需要——希望獲得生物許可證，不必在自己的單位的基礎上開發所有這些信息。這是一項相當引人注目的聲明，表明 FDA 認為向多家銀行頒發許可證的緊迫性。因此，FDA——紐約血液中心正在繼續與 FDA 合作。一直有人在努力。我們已經期待它有一段時間了。事情還沒有結束。

But the two elements that lead us to believe it's in the near-term -- although I've said this before -- is the fact that they now have notified us they've given all the manufacturers making medical devices a year in which everyone has to be in compliance. They did that in the first of January. We filed here, as you know, just this week. But that only makes sense in the context of nearing also the biological license for cord blood banks. So I've been repeatedly wrong in predicting exactly when this would occur, but this was certainly evidence that it's in motion and nearing the end of the road.

但讓我們相信這是近期的兩個因素——儘管我之前已經說過——事實上他們現在已經通知我們，他們已經給所有製造醫療設備的製造商一年的時間，要求每個人都必須遵守規定。他們在一月一號就這麼做了。如你所知，我們就在本週在這裡提交了申請。但這只有在臍帶血庫也接近獲得生物許可證的情況下才有意義。因此，我在準確預測這種情況何時發生時一再錯誤，但這確實證明它正在運動並接近路的盡頭。

Tim Quinlisk, Mayo Capital.

蒂姆·昆利斯克，梅奧資本。

I had a quick question regarding the impact of the AXP manufacturing problems on your ability to go to market. I guess what I mean by that, Phil, is my understanding is a lot of the initial capacity has been dedicated to one of the big customers where you signed a multiyear relationship to. Has GE had to pull back on their efforts, in terms of approaching additional customers, until such time you've been able to prove out the production?

我有一個關於 AXP 製造問題對你們進入市場的能力的影響的快速問題。菲爾，我想我的意思是，我的理解是，很多初始產能都專用於與您簽訂了多年合作關係的大客戶之一。在您能夠證明生產之前，GE 是否必須在接觸更多客戶方面放棄他們的努力？

That's correct. They simply can't run anywhere near as wide open an effort as they would like to until the capacity starts approaching the demand.

這是正確的。在容量開始接近需求之前，他們根本無法像他們希望的那樣進行廣泛的開放工作。

Okay. I guess what I'm trying to drive at is you've talked about 1500 a week, which drives you to about 75,000 units on an annual basis. I know there's a lot of loading in terms of inventory for safety reasons, etcetera. But, is that -- sort of the 3000 that you're striving to get to, is that already sort of spoken for, if you will, from the existing customers you have in place?

好的。我想我想要達到的目標是您所說的每週 1500 輛，這將使您每年生產約 75,000 輛。我知道出於安全等原因，庫存量很大。但是，您正在努力爭取的 3000 名客戶是否已經從現有客戶那裡得到了認可（如果您願意的話）？

You see the level of the orders that we have in to handle the quarters we're present. Basically, the consumption rate of the several customers we have here is in the range of 70,000 a year, 75,000 a year. So the $1500 doesn't -- or 1500 units doesn't get us beyond that. It's clearly the ramp-up above and beyond that that starts allowing us to really expand.

您可以看到我們當前季度處理的訂單水平。基本上我們這裡的幾個客戶的消費率都在一年七萬，七萬五千左右。所以 1500 美元並不能——或者說 1500 單位不能讓我們超越這個範圍。顯然，正是超越這一點的提升才開始讓我們真正擴張。

So you're confident once you can get there that those sales to the 3000 units will be there?

那麼，您有信心一旦實現這一目標，就能實現 3000 台的銷量嗎？

The answer is I absolutely am confident.

答案是我絕對有信心。

And most of that is just around traditional cord blood applications?

其中大部分只是圍繞傳統的臍帶血應用？

Yes. Right now it would be inappropriate to filter in any of what we expect in these other clinical trials. So we're -- just looking at cord blood, both public banks and private family banks, we believe, will more than consume that capacity.

是的。目前，過濾掉我們在這些其他臨床試驗中所期望的任何內容都是不合適的。因此，我們只是關注臍帶血，我們相信，無論是公共銀行還是私人家庭銀行，都將消耗更多的容量。

Okay. One final follow-up. The 3000 a week, is that -- I think it was mentioned that you're looking at a second source to increase your capacity. Does that include this, or is just this out of the one out of Pennsylvania?

好的。最後的後續行動。每週 3000 個，我想有人提到你正在尋找第二個來源來增加你的能力。這是否包括這個，或者只是賓夕法尼亞州的一個？

This is -- the focus here is on Pennsylvania. And then we'll bring up the other supplier in parallel, which will add more capability.

這是——這裡的焦點是賓夕法尼亞州。然後我們將同時引入其他供應商，這將增加更多的能力。

But -- and just from a technical point of view, the manufacturing of these bags is -- how complex is it versus the traditional manual press bags or other bags? Is this a high-risk proposition that you can actually get to production in high volume?

但是，僅從技術角度來看，這些袋子的製造與傳統的手動壓袋或其他袋子相比有多複雜？這是一個高風險的提議，您實際上可以大批量生產嗎？

My background for many years was -- at COBE and Sorin was in custom tubing sets for perfusion. We were making and producing substantially higher volume, obviously. And they were all custom sets. So, I look at this product -- it's not as easy as it looks, but it is going to be a lot easier to get the volume we want. So, I don't see any real obstacles, other than putting in place all the fundamentally sound ways you build these products, making sure operators are trained properly, making sure we have the right equipment, right applicators, etcetera, and the right quality control. And that's what my focus has been on right now. So, we're building the foundation so that we can ramp out without problems.

我多年來的背景是——在 COBE 和 Sorin 從事用於灌注的定制管組。顯然，我們的產量大大提高了。而且它們都是定制套裝。所以，我看看這個產品——它並不像看起來那麼容易，但獲得我們想要的數量會容易得多。因此，我沒有看到任何真正的障礙，除了採用構建這些產品的所有基本合理方法，確保操作員接受適當的培訓，確保我們擁有正確的設備、正確的塗抹器等以及正確的質量控制。這就是我現在關注的重點。因此，我們正在打下基礎，以便我們能夠毫無問題地逐步發展。

Okay. Great. Phil, just one last question. The relationship you have with GE on an exclusive distribution basis for the AXP bag, does that extend currently beyond just applications for cord?

好的。偉大的。菲爾，最後一個問題。您與 GE 建立了 AXP 包獨家經銷關係，目前這種關係是否超出了繩索應用範圍？

The agreement calls for General Electric to be the distributor for the AXP in all the different areas.

該協議要求通用電氣成為 AXP 在所有不同領域的經銷商。

[Al Kalbani], [SF Capital].

[阿爾·卡爾巴尼]，[SF資本]。

Apologies if this was covered before I jumped on, but any further color you can provide on the announcement earlier this week about the questions or the update that's been provided for the PMA application? Anything you can say about the nature of the questions and timeline here from here?

如果我在開始之前就已經涵蓋了這一點，我深表歉意，但是您可以在本週早些時候發布的關於 PMA 申請的問題或更新的公告中提供更多信息嗎？關於問題的性質和時間表，您有什麼想說的嗎？

These were questions focused on the secondary endpoint. The FDA had no questions about the primary endpoint, which is to say how fast did our product stop the bleeding in the patient population versus the control. That -- the FDA had no questions about that.

這些問題集中在次要終點。 FDA 對主要終點沒有任何疑問，也就是說，與對照組相比，我們的產品在患者群體中止血的速度有多快。 FDA 對此沒有任何疑問。

The secondary endpoint had to do with blood loss, and there were a lot of imputed values in the course of generating that data. Remember, this is an application that if you were standing there, it would come up to your waist from the floor. And so there's an awful lot of data. The FDA had very legitimate questions about some of the data, and we had to go back with Quintiles and basically review it all at the hospital. So, it took longer than we expected, but it has not changed in any way our sense that we will get approved. Of course, the FDA could ask us more questions. But one of the reasons we took so long is we tried very hard to answer all of the questions in great detail -- hopefully, any additional that they may come up with.

次要終點與失血有關，在生成數據的過程中存在很多估算值。請記住，這是一個應用程序，如果您站在那裡，它會從地板上升到您的腰部。所以有大量的數據。 FDA 對某些數據提出了非常合理的問題，我們不得不返回昆泰公司並基本上在醫院審查所有數據。因此，花費的時間比我們預期的要長，但這並沒有以任何方式改變我們將獲得批准的感覺。當然，FDA 可以問我們更多問題。但我們花了這麼長時間的原因之一是我們非常努力地詳細回答所有問題——希望他們能提出任何其他問題。

In terms of time, this is the FDA. Basically what they're required to do is respond within six months. They can do it sooner. They have -- they've looked at this, so it's not like they're unaware of this application. But they set their own timetable, and they can always restart the clock with additional questions.

從時間上來說，這是FDA。基本上他們需要做的是在六個月內做出回應。他們可以更快地做到這一點。他們已經研究過這個，所以他們並不是不知道這個應用程序。但他們設定自己的時間表，並且隨時可以通過其他問題重新開始計時。

When you say restart the clock, that's a six-month timeframe that they have up to?

當你說重新啟動時鐘時，他們最多有六個月的時間範圍？

Yes. Basically you expect these turnaround times not to exceed six months.

是的。基本上，您預計這些周轉時間不會超過六個月。

Matt McBain, Gruber & McBain.

馬特·麥克貝恩、格魯伯和麥克貝恩。

The previous questioners asked [sort of] this question, but I just want to make perfectly clear to myself what you're saying in lowering your guidance from, say, the low end, 20 million, down to 18. All of that (technical difficulty) AXP, and the AXP issue is related to production, not demand. Is that correct?

之前的提問者問了[某種程度上]這個問題，但我只是想完全清楚地向自己解釋一下，您所說的將指導值從低端 2000 萬降低到 18。所有這些（技術難度）AXP 以及 AXP 問題都與生產有關，而不是與需求有關。那是對的嗎？

Yes. That dominates it. We ran into problems we did not expect. I think if Bill had been here, we would have expected them and got around them. We think it's well in hand with Bill here, but we're a little gun shy, so we thought appropriate to drop the guidance. So that's basically what we did. But the demand is right now considerably exceeding our supply. We think when the GE sales force sees the supply matching the demand and going above it, then they will not have trouble finding additional orders.

是的。這主導了它。我們遇到了意想不到的問題。我想如果比爾在這裡，我們就會預料到他們並繞過他們。我們認為比爾對此掌握得很好，但我們有點害羞，所以我們認為放棄指導是適當的。這基本上就是我們所做的。但目前的需求大大超過了我們的供應。我們認為，當通用電氣銷售人員看到供應與需求相匹配並高於需求時，他們在尋找額外訂單時不會遇到困難。

I thank you very much for all your questions. This was a quarter that was disappointing for us and for you, but we remain as confident -- more confident in the value of these products in the marketplace as, I think, does General Electric. So we're moving on, and look to have a much better conference call here in three months. Thank you very much for attending.

我非常感謝你提出的所有問題。這個季度對我們和你們來說都令人失望，但我們仍然充滿信心，對這些產品在市場上的價值更有信心，我認為，就像通用電氣一樣。因此，我們將繼續前進，並希望在三個月內召開一次更好的電話會議。非常感謝您的出席。