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Operator
Operator
Good day, ladies and gentlemen, and welcome to the fourth-quarter and full-year 2015 Amedica Corporation financial results conference call. At this time, all participants are in a listen-only mode. Later we will conduct a question and answer session, and instructions will follow at that time. (Operator Instructions)
各位女士、各位先生,大家好,歡迎參加 Amedica Corporation 2015 年第四季及全年財務業績電話會議。此刻,所有與會者皆處於僅收聽模式。稍後我們將進行問答環節,屆時將提供相關指示。(接線員指示)
As a reminder, this conference is being recorded. I would now like to introduce your host for today's conference, Mr. Mike Houston, VP of Commercialization. Mike, you may begin.
提醒各位,本次會議將被錄音。現在我想介紹今天會議的主持人:商業化副總裁 Mike Houston 先生。Mike,您可以開始了。
Mike Houston - VP, Commercialization & Communications
Mike Houston - VP, Commercialization & Communications
Thank you, Shanice, and good afternoon. Welcome, everyone, to Amedica Corporation's fourth-quarter and full-year 2015 earnings conference call. On the call with me today are Dr. Sonny Bal, our Chairman and Chief Executive Officer, and Ty Lombardi, Chief Financial Officer.
謝謝你,Shanice,大家下午好。歡迎各位參加 Amedica Corporation 2015 年第四季及全年財報電話會議。今天與我一同出席的有:董事長兼執行長 Sonny Bal 博士,以及財務長 Ty Lombardi。
By now, everyone should have access to the earnings release for the period ended December 31, 2015 that went out this afternoon at approximately 4 PM Eastern time. If you have not received the release, it is available on the Amedica website at www.amedica.com. This call is being webcast, and a replay will be available on the Company's website.
截至目前,各位應已可取得截至 2015 年 12 月 31 日止期間的財報新聞稿,該新聞稿已於今天下午約美東時間 4 點發布。若您尚未收到,亦可至 Amedica 官網 www.amedica.com 取得。本次電話會議將進行網路直播,並將於公司網站提供重播。
I would like to remind you that certain items that may be discussed in today's call are not based entirely on historical facts. These items should be considered forward-looking statements and are subject to many risks, uncertainties, and other factors that are difficult to predict and may affect our businesses and operations. As a result, our actual results may differ materially and adversely from those expressed or implied by our forward-looking statements. A discussion of some of these risks, uncertainties, and other factors are set forth in our SEC filings. We undertake no obligation and do not intend to update any forward-looking statements as a result of new information or future events or circumstances arising after the date on which it was made.
我想提醒各位,今天電話會議中可能討論的某些事項並非完全基於歷史事實。這些事項應被視為前瞻性陳述,並受多項風險、不確定性及其他難以預測且可能影響我們業務與營運的因素所影響。因此,我們的實際結果可能與前瞻性陳述所明示或暗示者存在重大且不利的差異。部分相關風險、不確定性及其他因素之討論已載於我們向 SEC 提交的文件中。對於因新資訊或未來事件或情況(於陳述作成日後發生)而導致的任何前瞻性陳述更新,我們不承擔任何義務,亦無意進行更新。
With that, I would now like to turn the call over to Dr. Sonny Bal. Dr. Bal?
接下來,我想把電話會議交給 Sonny Bal 博士。Bal 博士?
Sonny Bal - Chairman, CEO and President
Sonny Bal - Chairman, CEO and President
Thanks, Mike, and good afternoon to everyone. I will begin by providing an update of recent highlights, and afterwards Ty will give us details on the financial results for the quarter. And, before we open up for questions, I will review our outlook and strategy for this year in 2016.
謝謝你,Mike,也向各位致上下午好。我將先提供近期重點更新,之後 Ty 會為我們說明本季的財務結果細節。在開放提問之前,我也會回顧我們在 2016 年的展望與策略。
During the last half of 2015 -- last year -- and especially during the fourth quarter, we were very busy and very active with our business. We signed an international private label agreement with WinnTi Medical, a fast-growing orthopedic country company in China. This agreement has led to increased interest in our Company, and we anticipate revenues in the future. Ty can discuss this in greater detail during his remarks, but I am pleased with the recent amendments to the previous K outstanding, Series A, and C Warrants. The exercise price for those warrants became fixed in mid-December, reducing the uncertainty of our capital structure and fixing the number of common shares outstanding, something we have worked very hard to accomplish since June of 2014.
在 2015 年下半年——也就是去年——尤其是在第四季期間,我們在業務上非常忙碌且相當積極。我們與中國一家快速成長的骨科公司 WinnTi Medical 簽署了國際自有品牌(private label)協議。該協議提升了外界對本公司的興趣,我們也預期未來將帶來營收。Ty 會在他的發言中更詳細說明,但我對近期針對先前未償還的 K、A 系列與 C 系列認股權證所做的修訂感到滿意。這些認股權證的行使價格於 12 月中旬固定下來,降低了我們資本結構的不確定性,並固定了流通在外普通股的股數——這是我們自 2014 年 6 月以來一直非常努力要達成的目標。
The Company also cleaned up its cap and operational structure while lowering operational cash burn by $5.5 million as compared to the prior year period. A lot of the hard work we set out to do in the early parts of 2015 has already begun to pay dividends this year. In addition to fixing our cap table and reducing cash burn, something that will stay [AK] focused in this year, we continue to place an emphasis on generating awareness, enthusiasm, and excitement for our silicon nitride.
公司也在降低營運現金消耗的同時,整理並精簡了資本與營運架構;相較於前一年度同期,營運現金消耗降低了 550 萬美元。我們在 2015 年初所投入的大量努力,今年已開始帶來成果。除了修正我們的資本結構表(cap table)並降低現金消耗——這也是我們今年將持續[AK]聚焦的重點——我們也持續強調提升市場對我們氮化矽的認知、熱情與期待。
Our R&D team met its impressive goal of submitting 12 peer-reviewed, scientific professional papers for publication during the last 12 months, with nine major presentations at scientific and orthopedic forums, top notch over the past four quarters. These efforts have significantly increased interest in our business development efforts and help underscore a strategy of becoming a differentiated unique biomaterials company.
我們的研發團隊在過去 12 個月達成了令人印象深刻的目標:提交 12 篇經同儕審查的科學專業論文以供發表,並在科學與骨科論壇進行 9 場重要發表,在過去四個季度的表現堪稱一流。這些努力顯著提升了外界對我們業務開發工作的興趣,也有助於凸顯我們成為具差異化、獨特生物材料公司的策略。
In fact, we plan to publish another 15 basic science manuscripts for peer review during the balance of this year and at least that many clinical reports, which will further contribute to a deeper understanding of our material and differentiate our unique silicon nitride composition from all other biomaterials that are used in medicine today. This is truly a phenomenal feat for any company regardless of size, and I am very proud of our efforts to continue validating our existing body of science among our peers.
事實上,我們計畫在今年剩餘期間再發表 15 篇基礎科學稿件供同儕審查,並至少發表同等數量的臨床報告;這將進一步加深對我們材料的理解,並使我們獨特的氮化矽配方與目前醫療領域使用的所有其他生物材料更具差異化。不論公司規模大小,這對任何公司而言都是極為卓越的成就;我也為我們持續在同儕間驗證既有科學成果所做的努力感到非常自豪。
A particular strength of silicon nitride is our ability to engineer the material by manipulating its surface microchemistry, something we have learned to do, thereby altering its properties. We have run our materials through a battery of tests, and I am very excited to announce that we expect to unveil the next generation of silicon nitride in the fourth quarter of this year.
氮化矽的一項特別優勢在於,我們能透過操控其表面微化學(surface microchemistry)來工程化設計材料——這是我們已學會做到的——從而改變其特性。我們已對材料進行一系列測試,我很興奮地宣布:我們預期將在今年第四季揭示下一代氮化矽。
According to the initial testing we have done, this new version should have faster and more intense bone-in growth than existing compositions. And what is even better, we can upgrade our existing inventory of silicon nitride fusion devices to this new standard by applying minimal additional manufacturing processes.
根據我們已完成的初步測試,這個新版本的骨內生長速度應更快、程度也更強於現有配方。更棒的是,我們只需增加極少的製造流程,就能將現有庫存的氮化矽融合器械(fusion devices)升級至這項新標準。
This material upgrade is captured in a number of our recent publications that have been printed and will further distinguish, strengthen, differentiate, validate silicon nitride as a truly cross-platform foundation for medical implants and beyond.
這項材料升級已反映在我們近期多篇已刊印的出版物中,並將進一步凸顯、強化、差異化並驗證氮化矽,作為真正可跨平台應用於醫療植入物乃至更廣領域的基礎材料。
I can't put enough emphasis on the focus we have on the development and commercialization of silicon nitride for medical applications. That is what we are as a company.
我再怎麼強調我們對氮化矽在醫療應用上的開發與商業化之專注都不為過。這就是我們這家公司所代表的核心。
Amedica's silicon nitride addresses a number of relevant serious limitations in modern hip, spine and knee replacement surgery, dental, extremities, and sports medicine and others. Each of these is a large market, and the addressable portion for Amedica the opportunity is huge -- in the billions. While we currently have clearance for spinal fusion products made with our silicon nitride technology, we are busy developing wear and corrosion resistant hip and knee implants, very much applicable today given the demands of the industry and the challenges. In addition, dental implants in collaboration with key strategic partners.
Amedica 的氮化矽可解決現代髖、脊椎與膝關節置換手術、牙科、四肢、運動醫學等領域中的多項重要且嚴重的限制。上述每一項都是龐大市場,而對 Amedica 而言可觸及的機會極其可觀——以十億美元計。雖然我們目前已取得以氮化矽技術製成之脊椎融合產品的許可(clearance),我們也正積極開發耐磨與耐腐蝕的髖與膝植入物;鑑於產業需求與挑戰,這些產品在當前極具適用性。此外,我們也正與關鍵策略夥伴合作開發牙科植入物。
We're the only company with the skill and know-how and art to manufacture and refine silicon nitride for medical implants and we have now implanted over 25,000 implants with an A-tier solid successful track record. It is out there. That knowledge and experience and legacy are the key strengths that enables us to offer new and transformative products in medicine.
我們是唯一具備技術、訣竅與工藝,能夠為醫療植入物製造並精煉氮化矽的公司;目前我們已植入超過 25,000 件植入物,並擁有 A 級、穩健且成功的實績紀錄。它已在市場上被驗證。這些知識、經驗與傳承,是使我們能在醫療領域提供嶄新且具變革性產品的關鍵優勢。
Our goal is to become a leading, differentiated, different biomaterial company focused on our unique silicon nitride technology to develop, manufacture and commercialize a broad range of medical devices. A key component of the strategy is to educate surgeons and others in the medical community about our material and its benefits.
我們的目標是成為領先且具差異化的生物材料公司,聚焦於我們獨特的氮化矽技術,以開發、製造並商業化多元的醫療器材產品。此策略的一個關鍵組成,是教育外科醫師及醫療社群中的其他人士,了解我們材料及其效益。
Truth be told, we are doing these things that should have been done years ago. This is not an overnight effort, but is evident in our aggressive publication and professional meeting schedule in our enthusiasm to get before our peers and be challenged and our sales and marketing efforts through a variety of channels, including industry conferences and key meetings, media outlets through our sales and marketing.
坦白說,我們正在做一些本應在多年前就該完成的事情。這不是一蹴可幾的努力,但從我們積極的出版與專業會議行程、我們熱切地站到同儕面前接受檢驗與挑戰,以及我們透過多元管道(包括產業研討會與重要會議、媒體平台等)所進行的銷售與行銷投入,都可清楚看出這一點。
Throughout the balance of this year, we will continue to establish and cultivate OEM and private label partnerships with multiple spine, orthopedic, and dental companies.
在今年剩餘期間,我們將持續建立並培育與多家脊椎、骨科及牙科公司的 OEM 與自有品牌(private label)合作夥伴關係。
Now, nonmedical, i.e. industrial silicon nitride manufacturers have also taken notice for our material and our unique manufacturing acumen.
目前,非醫療領域,也就是工業用氮化矽製造商,也已注意到我們的材料以及我們獨特的製造專長。
Our material formulation compares very favorably for industrial use as well across a variety of platforms. As you might know, silicon nitride is used very commonly in a variety of applications from electronics to total machinery to aerospace and many, many other industries where an extremely tolerant and strong material is needed.
我們的材料配方在各種平台的工業用途上同樣具有非常突出的競爭力。如各位所知,氮化矽在多種應用中非常常見,從電子產品到整體機械再到航太,以及許多、許多其他需要極高耐受性與強度材料的產業。
Regardless of the application, we believe in the superiority of our technology. We have proven it. We have the scientific data to support these claims. Through OEM and private label partnerships, we can enhance existing implants by offering a more robust material platform that has validated benefits and the clinical data behind it. These opportunities all offer incremental revenue while providing our partners with a better material as manifested by improved bone-in growth, antimicrobial properties, better diagnostic imaging, and better resistance to fracture, wear, and corrosion, all issues that face the medical market today.
無論應用為何,我們都相信我們技術的優越性。我們已經證明了。我們有科學數據支持這些主張。透過 OEM 與自有品牌合作,我們可以提供更強健的材料平台來強化既有植入物,且該平台具備已驗證的效益與其背後的臨床數據。這些機會在為我們帶來增量營收的同時,也為合作夥伴提供更佳材料,具體表現在骨整合生長改善、抗菌特性、更佳的診斷影像,以及更好的抗斷裂、耐磨與抗腐蝕能力——這些都是當今醫療市場面臨的議題。
As Ty will outline later, we are in an improved financial position and making headway toward the short-term and long-term goals. We have positioned for continued success in 2016, and I believe we are in a great growth trajectory. As we have shown in Brazil and in recent private label announcements, we are looking at additional opportunities both in the US and abroad, and we are capitalizing on them. Feedback from our recent participation in the annual Brazil's Fine Congress was very positive as we generated additional interest and awareness with our science and clinical presentation. We anticipate further positive revenue impacts through the balance of this year and next as we continue to cultivate these relationships that we have built across the country.
正如 Ty 稍後將說明的,我們的財務狀況已有所改善,並正朝短期與長期目標取得進展。我們已為 2016 年的持續成功做好布局,我相信我們正處於良好的成長軌道上。如同我們在巴西以及近期自有品牌公告中所展現的,我們正在美國及海外尋求更多機會,並正加以把握。我們近期參與巴西年度 Fine Congress 的回饋非常正面;我們透過科學與臨床發表引發了更多興趣並提升了知名度。隨著我們持續培育在全國各地建立的這些關係,我們預期在今年剩餘期間及明年將帶來進一步的正面營收影響。
And now, before I turn over the call to tie to review the financials, I would like to remind the listeners that, while we made considerable headway in 2015, 2016 will be even busier and more productive by any measure for Amedica. We are delighted with our progress in 2015, but we will not rest on our laurels in 2016. Amedica is a unique company with a unique biomaterial and a very promising future.
現在,在我把電話交給 Ty 檢視財務之前,我想提醒各位聽眾:雖然我們在 2015 年取得了相當大的進展,但對 Amedica 而言,2016 年無論以任何衡量標準都將更忙碌且更具生產力。我們對 2015 年的進展感到欣喜,但 2016 年我們不會自滿。Amedica 是一家獨特的公司,擁有獨特的生物材料,且前景非常可期。
And, with that said, let me turn it over to Ty Lombardi who will discuss our financial results. Ty?
那麼,接下來我把時間交給 Ty Lombardi,他將討論我們的財務結果。Ty?
Ty Lombardi - CFO
Ty Lombardi - CFO
Thank you, Dr. Bal, and welcome, everyone, as I discuss in greater detail our fourth-quarter and full-year financial results for 2015.
謝謝您,Bal 醫師,也歡迎各位。我將更詳細地說明我們 2015 年第四季及全年財務結果。
Our total revenue for the full year was $19.5 million, a decrease of 15% from 2014, primarily driven by lower metal sales as a result of the decline in the level of activity for a few key surgeons and our outdated metals system, which we are addressing, and Dr. Bal will discuss later.
我們全年總營收為 1,950 萬美元,較 2014 年下降 15%,主要是因為金屬產品銷售下滑,原因包括少數關鍵外科醫師的活動量降低,以及我們較為老舊的金屬系統;我們正在處理此問題,Bal 醫師稍後也會說明。
Silicon nitride sales decreased by $0.7 million or 6% as compared to the same period in 2014. This decline was primarily attributable to consequences from our restructuring and the loss of a few key surgeons during the early part of the year. This was partially offset by the addition of new surgeons during the second half of the year, re-engaging loss surgeons (technical difficulty) private-label sales.
與 2014 年同期相比,氮化矽銷售額減少 70 萬美元(或 6%)。這一下滑主要歸因於我們重整所帶來的影響,以及年初失去少數關鍵外科醫師。此影響部分被下半年新增外科醫師、重新爭取流失的外科醫師(技術問題)、以及自有品牌銷售所抵銷。
The cost of revenue decreased $1.7 million or 21% as compared to the same period in 2014. The decrease in cost of revenue was primarily a result of reduced sales in 2015 as compared to the same period in 2014. Our gross profit as a percentage of product revenue increased by 3 points to 68% in 2015, up from 65% in the first quarter 2014 as a result of our efforts to reduce costs through production efficiency, lower overhead costs, and a decrease in excess and obsolete inventory in 2015 as compared to 2014.
與 2014 年同期相比,營收成本減少 170 萬美元(或 21%)。營收成本下降主要是因 2015 年銷售額較 2014 年同期減少所致。2015 年我們的毛利率(占產品營收比重)提高 3 個百分點至 68%,高於 2014 年第一季的 65%,這是我們透過提升生產效率、降低間接費用,以及在 2015 年相較 2014 年減少過剩與呆滯存貨以降低成本的成果。
Research and development expenses for the year decreased $0.4 million or 7% as compared to the same period in 2014. This decrease is primarily due to a $2.1 million decrease in stock-based compensation and $2 million decrease in personnel related and other development costs. These increases were offset by an increase in operating expenses that were not allocated to inventory due to lower production levels of our Valeo products in 2015 as compared to the prior year period.
本年度研發費用較 2014 年同期減少 40 萬美元(或 7%)。此下降主要來自以股份為基礎的薪酬減少 210 萬美元,以及人員相關與其他開發成本減少 200 萬美元。上述降幅部分被營業費用增加所抵銷;由於 2015 年 Valeo 產品產量低於前一年度同期,部分未分攤至存貨的營業費用因此上升。
General and administrative expenses decreased $7.2 million or 53% as compared to the same period in 2014. This decrease was primarily due to a $5.7 million decrease in stock-based compensation, a $700,000 decrease in personnel-related costs, and a $600,000 decrease in other operating expenses as we have reduced operating costs in 2015.
一般及行政費用較 2014 年同期減少 720 萬美元(或 53%)。此下降主要是因以股份為基礎的薪酬減少 570 萬美元、人員相關成本減少 70 萬美元,以及其他營業費用減少 60 萬美元,反映我們在 2015 年已降低營運成本。
Sales and marketing expenses decreased $6.3 million or 34% as compared to the same period in 2014. This decrease is primarily due to a $2.2 million decrease in stock-based compensation, a $1.6 million decrease in commissions due to lower sales, and a $2.6 million decrease in personnel-related costs, travel, consulting, and other operating expenses.
銷售與行銷費用較 2014 年同期減少 630 萬美元(或 34%)。此下降主要是因以股份為基礎的薪酬減少 220 萬美元、因銷售降低導致佣金減少 160 萬美元,以及人員相關成本、差旅、顧問費與其他營業費用減少 260 萬美元。
Operating expenses decreased $13.8 million or 35% as compared to the same period in 2014. This decrease was primarily due to the items mentioned previously. Net loss for the full-year 2015 was $23.9 million compared to $32.6 million in the prior year period. This year-over-year improvement is primarily a result of the decrease in non-cash stock compensation expense of approximately $9 million, slower operating expenses and lower operating costs incurred during the year. This was partially offset by a loss recognized on the issuance of warrants and increased interest expense. The majority of the derivative liabilities that were extinguished will be classified to equity by December 31, 2015, either as a result of being exercised or fixing the exercised price and number of securities. Now that the majority of these derivative liabilities are behind us, we have approximately 11.3 million shares of common stock outstanding and approximately (technical difficulty) shares on a fully diluted basis.
營業費用較 2014 年同期減少 1,380 萬美元(或 35%)。此下降主要來自前述項目。2015 年全年淨損為 2,390 萬美元,較前一年度同期的 3,260 萬美元為低。此年對年改善主要是因非現金的股份薪酬費用約減少 900 萬美元、營業費用增速放緩,以及本年度發生的營運成本較低。上述改善部分被認列發行認股權證的損失及利息費用增加所抵銷。截至 2015 年 12 月 31 日,被消滅的大部分衍生性負債將被分類至權益,原因為其已被行使,或已固定行使價格與證券數量。如今大部分衍生性負債問題已告一段落,我們約有 1,130 萬股流通在外普通股,且在完全稀釋基礎下約有(技術問題)股。
Adjusted EBITDA, which is defined as earnings before deductions for interest, taxes, depreciation, amortization, non-cash stock compensation expense, change in fair value of our derivative liabilities, offering costs, loss on extinguishment of derivative liabilities, and loss on extinguishment of debt for the full year of 2015 was a loss of $9 million compared to a loss of $11.9 million for the full year of 2014.
調整後 EBITDA(定義為扣除利息、稅項、折舊、攤銷、非現金股份薪酬費用、衍生性負債公允價值變動、發行成本、衍生性負債消滅損失,以及債務消滅損失之前的盈餘)在 2015 年全年為虧損 900 萬美元,較 2014 年全年的虧損 1,190 萬美元為佳。
As of December 31, 2015, our cash and cash equivalents totaled $11.5 million. The decline in total cash burn year over year was driven by a decrease in operational cash burn of $5.5 million in 2015 or 38% as compared to the prior year period. Total principal debt obligations were $17.8 million at December 31, 2015, a decrease of $6.7 million or 27% from December 31, 2014.
截至 2015 年 12 月 31 日,我們的現金及約當現金合計為 1,150 萬美元。年度總現金消耗(cash burn)年對年下降,主要是因 2015 年營運現金消耗較前一年度同期減少 550 萬美元(或 38%)。截至 2015 年 12 月 31 日,本金債務總額為 1,780 萬美元,較 2014 年 12 月 31 日減少 670 萬美元(或 27%)。
During 2015, we are very focused on reducing cash burn, and we will maintain that focus during 2016 and expect to further reduce (technical difficulty) cash burn (technical difficulty).
在 2015 年期間,我們非常專注於降低現金消耗(cash burn),而我們將在 2016 年維持這項重點,並預期進一步降低(技術問題)現金消耗(技術問題)。
Furthermore, we are focused on improving our current debt position and unlock additional working capital. As Dr. Bal mentioned earlier in the call, we anticipate operational cash burn will improve by $5.5 million and continues to improve as we remain committed to conserving our cash for opportunities that yield the greatest return. These financial improvements speak to the wonderful job our teams have done in reducing operating expenses and properly managing cash levels to date.
此外,我們也專注於改善目前的債務狀況並釋放更多營運資金。正如 Bal 博士稍早在電話會議中提到的,我們預期營運現金消耗將改善 550 萬美元,並且在我們持續致力於保留現金、用於帶來最高報酬的機會之際,將持續改善。這些財務面的改善,說明了我們的團隊在降低營運費用以及迄今妥善管理現金水位方面所做的出色工作。
Lastly, I wanted to take a moment to review our current cap table and the progress we have made over the past 18 months to get us to where we are at today. As you will likely recall, we amended the terms on our Series A and C Warrants at the end of Q4, which, as Dr. Bal outlined earlier, fixed the exercised prices of those warrants and capped a number of issuable shares. Those amendments have truly minimized the uncertainty of our cap table while also limiting the potential dilutive effect with an exercise of those warrants. To help provide perspective as to why this step is so critical for Amedica, back in June of 2014, an existing debt note held with GE Capital was refinanced with Hercules Capital in the amount of (technical difficulty).
最後,我想花一點時間回顧我們目前的資本結構表(cap table),以及過去 18 個月我們為達到今日狀態所取得的進展。各位可能還記得,我們在第四季末修訂了 A 輪與 C 輪認股權證(Series A and C Warrants)的條款;如 Bal 博士先前所說,該修訂固定了這些認股權證的行使價格,並對可發行股份數設定上限。這些修訂確實將我們資本結構表的不確定性降到最低,同時也限制了行使這些認股權證可能造成的稀釋效果。為了讓各位理解為何這一步對 Amedica 如此關鍵,回到 2014 年 6 月,我們將原先由 GE Capital 持有的一筆既有債務票據,以(技術問題)的金額向 Hercules Capital 進行再融資。
Given the elevated cash burn at the time, Hercules required Amedica to have an additional $6 million in cash on the books. In order to refinance the note, management entered into a convertible note agreement with no floor. From that point on, we have participated in two additional follow-on offerings to complete the last step toward completing our capitalization and fixing (technical difficulty).
鑑於當時現金消耗偏高,Hercules 要求 Amedica 帳上必須額外保有 600 萬美元現金。為了完成該票據的再融資,管理團隊簽訂了一份不設底價(no floor)的可轉換票據協議。自那時起,我們又參與了兩次後續增資發行(follow-on offerings),以完成我們資本結構規劃的最後一步,並固定(技術問題)。
In 2015, we will (technical difficulty) uncertainty associated with our capitalization strategy. To go from $26 million in total debt in July of 2014 to less than $18 million during 2015, we get to a position of certainty in our capitalization (technical difficulty) 2015 as a testament to the hard work each team member has put in to get us to where we are today.
在 2015 年,我們將(技術問題)與我們資本結構策略相關的不確定性。我們在 2014 年 7 月的總負債為 2,600 萬美元,到 2015 年降至低於 1,800 萬美元,使我們在資本結構(技術問題)於 2015 年達到更確定的狀態,這也證明每位團隊成員為了讓我們走到今天所付出的努力。
So given all that we have been able to accomplish in such a short period of time, I am extremely optimistic for what the future holds. And, although we have a good portion of heavy lifting behind us, we remain laser focused on continuing down this positive trajectory to reduce total cash burn and achieve operational cash flow breakeven and maintain the certainty of our capitalization table.
因此,鑑於我們在如此短的時間內所完成的一切,我對未來抱持極度樂觀。而且,儘管我們已完成相當多艱鉅的工作,我們仍將高度聚焦,持續沿著這條正向軌跡前進,以降低整體現金消耗、達成營運現金流損益兩平,並維持我們資本結構表的確定性。
With that, I would like to turn the call back over to you, Dr. Bal.
接下來,我想把電話會議交回給您,Bal 博士。
Sonny Bal - Chairman, CEO and President
Sonny Bal - Chairman, CEO and President
Great. Thanks, Ty. I, too, am optimistic for our future and for good reason, and here are the reasons. There is not a single study -- clinical or otherwise -- not one body of research; not one investigation; not a single scientific query or partner to date that has questioned or failed to show the exceptional advantages of our material and just how much we can do it. That is the unique strength of our Company, validated each time another study or presentation rolls out, just about at a monthly clip for the last one year.
很好。謝謝你,Ty。我也對我們的未來感到樂觀,而且理由充分,原因如下。迄今為止,沒有任何一項研究——無論臨床或其他——沒有任何一份研究成果;沒有任何一項調查;沒有任何一個科學探詢或合作夥伴,曾質疑或未能顯示我們材料的卓越優勢,以及我們能做到的程度。這就是我們公司的獨特優勢,而且每當又有新的研究或發表推出時都再次獲得驗證;在過去一年幾乎以每月一次的頻率持續發生。
First, I would like to begin with our composite silicon nitride fusion device. As you remember, during the fourth quarter of 2015, we submitted the 24-month clinical study outcomes to the FDA for our 510(k) in the US market. These clinical data outcomes were part of our CASCADE study, a blinded randomized trial that compared cervical fusion between our composite silicon nitride spacer device, manufactured with an integrated core of porous silicon nitride to the existing standard, which is plastic filled with a patient's own bone. Porous silicon nitride proved to be the first synthetic material to demonstrate final fusion outcomes at a statistically equivalent to those achieved with the patient's own bone at 24 months, precisely what the goal of the study was. The 24-month data is very clear in both clinical scores and bone fusion. Our device was no different than the predicate consistent with the regulatory standards for a 510(k), and these data we will publish soon in a peer-reviewed journal.
首先,我想從我們的複合式氮化矽(silicon nitride)融合器械開始。各位記得,在 2015 年第四季,我們已將 24 個月的臨床研究結果提交給 FDA,以支持我們在美國市場的 510(k) 申請。這些臨床數據結果是我們 CASCADE 研究的一部分;該研究為一項盲性隨機試驗,比較頸椎融合在兩種方案間的差異:一是我們的複合式氮化矽墊片器械(其製造採用整合式多孔氮化矽核心),另一是既有標準方案,即以病患自體骨填充的塑膠材料。多孔氮化矽證實是第一種合成材料,在 24 個月時展現出與病患自體骨所達成的最終融合結果在統計上等同,這正是本研究的目標。24 個月數據在臨床評分與骨融合兩方面都非常清楚。依 510(k) 的法規標準,我們的器械與對照(predicate)並無差異;我們也將很快在同儕審查期刊上發表這些數據。
These results are also consistent with our understanding of the molecular and surface chemistry and biological characteristics of silicon nitride as published in engineering journals throughout 2015 and continuing into this year. So they are consistent.
這些結果也與我們對氮化矽之分子與表面化學、以及其生物特性的理解一致;相關內容已於 2015 年在工程期刊上發表,並延續至今年。因此,它們是一致的。
As you can imagine, achieving clearance for this product is important to us and furthers our mission to improve patient health by enhancing clinical outcomes, which is why we invested the necessary time and data gathering and analysis to make sure we had it right before the FDA submission.
各位可以想像,取得此產品的核准/許可對我們非常重要,並推進我們透過提升臨床結果以改善病患健康的使命;這也是為什麼我們投入必要的時間進行資料蒐集與分析,以確保在向 FDA 提交之前一切都正確無誤。
A month ago, we got questions from the FDA that concerned technical details, and we are responding to them with the regulatory and law professionals. We are experienced at 510(k) submissions with the FDA. An exact timeline for a final reply from the FDA is not known because of the intricacies inherent in the process, but I am personally engaged in formulating, editing, writing, and helping with the response to the FDA and very familiar with the application and very confident about the quality of the data and specifically the outcomes of the data.
一個月前,我們收到 FDA 針對技術細節提出的問題,我們正與法規與法律專業人士一同回覆。我們在向 FDA 提交 510(k) 申請方面經驗豐富。由於流程本身的複雜性,FDA 最終回覆的確切時程尚不清楚;但我本人正親自參與擬定、編修、撰寫並協助回覆 FDA,也非常熟悉該申請案,並對資料品質、尤其是數據結果非常有信心。
As our principal investigator, Dr. Arts presented last week, the 24-month follow-up clinical data show very clear equivalence to the predicate standard, both in clinical outcomes and in fusion, exactly what we had hoped. We feel these results will allow us to capture a larger share of the global spinal fusion market because of the ability of this device to reduce surgical complexity, time, cost, duration, and eliminate the need to pack a hollow device with biological bone fillers. Our total addressable market should double to $4 billion as the biologics market comes into play for us upon receiving clearance, given the bioactivity of the material that we have proved in a number of publications and demonstrated by the CASCADE study.
如同我們的主要研究者 Arts 醫師上週所發表的,24 個月追蹤臨床數據非常清楚地顯示,無論在臨床結果或融合方面,都與對照標準具有明確的等同性,正如我們所期望。我們認為,憑藉此器械能降低手術複雜度、時間、成本與療程長度,並免除將生物性骨填充物填入中空器械的需求,這些結果將使我們得以在全球脊椎融合市場取得更大的市占。在取得核准/許可後,隨著生物製劑(biologics)市場對我們開啟,我們的總可服務市場(TAM)應可倍增至 40 億美元;這是基於我們已在多篇發表中證實材料的生物活性,並由 CASCADE 研究所展示。
We are prepared to launch the composite product into the market once we receive clearance from the FDA.
一旦收到 FDA 的核准/許可,我們已準備好將該複合式產品推向市場。
Products like this composite device show the competitive strengths of our R&D and manufacturing teams. We cannot emphasize enough the innovation this composite product has unlocked for the Company, and it is the first step toward an innovative product pipeline. It is not the only step. Our ability to synthesize a biomedical ceramic and porous formulation with full control of the ferocity of the product speaks to the highly differentiated and competitive strength of our science R&D and manufacturing teams. Keep in mind, ceramics have been around in healthcare for the last 40 years, and no one has ever formulated a porous substrate as yet. The applications of a porous bioactive high-strength ceramic go well beyond spine surgery and point toward a very innovative pipeline going forward.
像這樣的複合式器械產品,展現了我們研發與製造團隊的競爭優勢。我們再怎麼強調也不為過:這項複合式產品所解鎖的創新,對公司意義重大,並且是邁向創新產品管線的第一步。但這不是唯一的一步。我們能夠合成生醫陶瓷與多孔配方,並能完全控制產品的(technical difficulty,原文如此)特性,顯示出我們科學研發與製造團隊高度差異化且具競爭力的實力。請記住,陶瓷在醫療照護領域已存在 40 年,但至今仍沒有人能配製出多孔基材。多孔、具生物活性且高強度的陶瓷,其應用遠不僅限於脊椎手術,並指向未來非常具創新性的產品管線。
In addition to this unique composite technology, our R&D efforts have also shown something really wonderful, a stem cell affinity for silicon nitride as confirmed by two independent tests, both done by outside parties. Further studies planned in this year will investigate if our material supports cartilage cell differentiation, which will be very exciting. These efforts validate our basic science and keep opening novel doors to unique products addressing current needs and partnerships, particularly with biologics companies looking for a superior material platform.
除了這項獨特的複合技術之外,我們的研發工作也顯示出另一項非常令人振奮的發現:幹細胞對氮化矽具有親和性,且已由兩項相互獨立的測試所確認,兩者皆由外部單位完成。今年規劃的進一步研究將探討我們的材料是否支持軟骨細胞分化,這將非常令人期待。這些努力驗證了我們的基礎科學,並持續開啟通往獨特產品的新大門,以滿足當前需求與合作機會,特別是與尋求更優異材料平台的生物製劑公司合作。
I cannot identify names, but I am pleased to announce we have several preliminary agreements with spine, orthopedic and dental partners who are keen to test this material for a very specific variety of applications.
我無法透露名稱,但我很高興宣布,我們已與脊椎、骨科及牙科合作夥伴達成數項初步協議;他們非常希望針對一系列非常特定的應用來測試這種材料。
Now, keep this in mind. In every instance, we have expressed concern not that the testing conditions are too harsh, but rather that they are not harsh enough. Our material is very competitive, and it has been used in industry in extreme applications where other materials failed. We are keen to put it to the test in every which way. We are open to the most intense testing of our material against any other material in the world by any partner.
現在,請記住這一點。在每一個案例中,我們表達的擔憂並不是測試條件太嚴苛,而是它們不夠嚴苛。我們的材料競爭力非常強,且已在工業領域的極端應用中使用過,在其他材料失效的地方仍能勝任。我們很希望以各種方式對它進行測試。我們願意讓任何合作夥伴以最嚴苛的方式,將我們的材料與世界上任何其他材料進行對比測試。
One such alliance with Celling Biosciences came about as their testing showed silicon nitride has 5 times better cell adhesion rates than PEEK, a finding which we had suspected based on our engineering and molecular studies. A few of the newer concepts and devices we have prototyped and could begin testing soon include an all porous silicon nitride fusion device for use in spine, extremities, trauma, or sports medicine applications, the 3D printing of silicon nitride that I am very excited about, bone integration devices for resurfacing of joints, metal on ceramic brazing for both medical and aerospace applications, and other composite devices to meet the unique needs of skeletal articulations. These are not speculations. These are products and testing going on as we speak.
其中一項與 Celling Biosciences 的合作便是源於其測試結果顯示:氮化矽的細胞黏附率比 PEEK 高出 5 倍;這項發現與我們基於工程與分子研究所推測的一致。我們已完成原型、且可能很快開始測試的一些較新概念與裝置包括:用於脊椎、四肢、創傷或運動醫學應用的全多孔氮化矽融合裝置;我非常期待的氮化矽 3D 列印;用於關節表面重建的骨整合裝置;同時適用於醫療與航太應用的金屬對陶瓷釬焊;以及其他複合式裝置,以滿足骨骼關節活動的獨特需求。這些不是臆測。這些是我們正在進行的產品與測試。
The point is that we have a broad product portfolio and continue to develop and innovate in the medical space and beyond. Unlike a one-hit biopharma style company, our future does not rest with one design device or one formulation, even as we have full confidence in our FDA submission and an anticipated meeting with the FDA soon about a ceramic femoral head as well where we will educate the FDA in terms of its guidance, documents and bring it up to date.
重點是,我們擁有廣泛的產品組合,並持續在醫療領域及其他領域開發與創新。不同於一擊即中的生技製藥型公司,我們的未來不會只依賴單一設計裝置或單一配方;同時,我們對 FDA 送件充滿信心,並預期不久將與 FDA 就陶瓷股骨頭進行會議,屆時我們也會就其指引文件向 FDA 說明並協助其更新相關認知。
We will continue to develop new products and novel applications for our silicon nitride that improved the continuum of patient care. I will look forward to announcing additional details on these exciting product and partnership endeavors in the coming future.
我們將持續為我們的氮化矽開發新產品與新穎應用,以改善病患照護的連續性。我期待在不久的將來,公布這些令人振奮的產品與合作計畫的更多細節。
Now, in addition to the strides we have made with our silicon nitride portfolio, let's go to the metals portfolio. We have made progress with a new pedicle screw fixation system. The metals are important because of the pull-through effect. Our efforts on this front have brought into focus the potential pull-through effects that we talked about with a new screw system on our silicon nitride products. As we have updated the instrument set for our design and consulting surgeons in anticipation of a launch later this year, surgeon feedback has been overwhelmingly positive. The unique attributes of a modular screw design and tension head body is something no other company we know can claim as a competitive advantage, allow for additional surgeon ease of use while potentially reducing operating room time. We remain on track for a limited product release in the fourth quarter of this year and look forward to officially unveiling our updated system at this year's NASS meeting in Boston. We will continue to introduce new and innovative products throughout this year while developing and solidifying a foundation to support sustainable growth. I truly believe we are better positioned to develop innovative products and rendering of our materials that are adaptable to the market's needs.
現在,除了我們在氮化矽產品組合上取得的進展之外,讓我們談談金屬產品組合。我們在一套新的椎弓根螺釘固定系統方面已取得進展。金屬之所以重要,是因為其帶動效應(pull-through effect)。我們在這方面的努力,使我們更聚焦於我們先前談到的:新螺釘系統對我們氮化矽產品可能帶來的帶動效應。隨著我們為設計與顧問外科醫師更新器械組,以配合預計今年稍晚的上市,外科醫師的回饋極為正面。模組化螺釘設計與張力頭本體的獨特特性,是我們所知沒有其他公司能宣稱的競爭優勢;它能讓外科醫師使用更便利,同時可能縮短手術室時間。我們仍按計畫在今年第四季進行有限度的產品上市,並期待在今年於波士頓舉行的 NASS 年會上正式揭露我們更新後的系統。我們將在今年持續推出新的創新產品,同時建立並鞏固支持永續成長的基礎。我真心相信,我們在開發創新產品以及能因應市場需求的材料呈現方式方面,已處於更有利的位置。
As a biomaterials company in collaboration with other companies and getting out there aggressively in front of industry is a creed priority, and we will carry that this year.
作為一家生物材料公司,與其他公司合作並積極走到產業第一線,是我們的核心優先事項,我們今年也會持續推進。
Our silicon nitride biomaterial truly is unique, and we believe it is superior to anything on the market today, based not so much on faith but actual data. The material speaks for itself in testing after testing by us and others. It is truly unique. It opens the doors to superior products and platforms that the market desperately needs.
我們的氮化矽生物材料確實獨一無二;我們相信它優於目前市場上的任何產品,這並非基於信念,而是基於實際數據。無論是我們或他人一次又一次的測試,材料本身都能證明其表現。它確實非常獨特。它為市場迫切需要的更優異產品與平台打開了大門。
On that point, doctors, medical experts, scientists, industry partners, competitors are all in agreement. In tandem with a private label and OEM sales strategy, our sales and marketing staff will focus on increasing productivity and continuing to engage independent sales distributors with strong orthopedic surgeon relationships to drive the growth of our traditional spine sales.
在這一點上,醫師、醫療專家、科學家、產業夥伴以及競爭對手都一致認同。配合自有品牌(private label)與 OEM 銷售策略,我們的銷售與行銷團隊將專注於提升生產力,並持續與擁有強大骨科外科醫師關係的獨立銷售經銷商互動,以推動我們傳統脊椎產品銷售的成長。
We may also establish distribution collaborations in the United States and abroad, win access to large or well-established sales and marketing organizations who may help us gain access to new markets, increase sales in our existing markets, or accelerate market penetration for selected products.
我們也可能在美國及海外建立通路合作,爭取進入大型或成熟的銷售與行銷組織;這些組織可能協助我們進入新市場、提升既有市場的銷售,或加速特定產品的市場滲透。
Our Company has a strong infrastructure in place with top level unique manufacturing, business development and R&D. Markets such as Europe, Latin America, and Asia are receptive to ceramic technologies, have experience with them, particularly in skeletal reconstruction, and we will continue to expand into those markets through existing and yet to be announced private label and OEM partnerships.
本公司已建立完善的基礎架構,具備頂尖且獨特的製造能力、業務開發與研發。歐洲、拉丁美洲與亞洲等市場對陶瓷技術接受度高,也具備相關經驗,尤其是在骨骼重建方面;我們將透過既有以及尚待公布的自有品牌與 OEM 合作夥伴關係,持續擴展至這些市場。
We anticipate announcing at least four additional partner deals this year, which will be achieved with the work of business development sales and marketing teams at conferences, roadshows, and through publication efforts.
我們預期今年至少會宣布另外四項合作夥伴交易;這將透過業務開發、銷售與行銷團隊在各類會議、路演,以及出版發表等工作來達成。
Creating interest and educating peers is a large part of our corporate effort. Our persistence to establish, cultivate, and finalize OEM and private label deals leaves the confidence we have in our ability to grow this hybrid sales strategy. And, speaking for myself personally, I am very passionate about the material in the Company and very fortunate to be a part of it.
引發興趣並教育同業,是我們公司努力的重要部分。我們持續推動建立、培育並完成 OEM 與自有品牌交易的堅持,讓我們對於擴大這種混合式銷售策略的能力充滿信心。就我個人而言,我對公司的材料非常有熱情,也很幸運能成為其中一員。
Thank you. Shanice. Would you now please instruct the callers to join the queue for questions?
謝謝。Shanice。請你現在指示來電者加入提問佇列,好嗎?
Operator
Operator
(Operator Instructions) Jeffrey Cohen, Ladenburg Thalmann.
(接線員指示)Jeffrey Cohen,Ladenburg Thalmann。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
So, a few items that come to mind. So you discussed this additional process for the next generation silicon nitride later this year, and you discussed an additional process with the current implants. Does that mean that current material can be modified, or would this just be referral to new material -- new implants?
所以,我想到幾個事項。你提到今年稍晚針對下一代氮化矽的額外製程,也提到針對目前植入物的額外製程。這是否表示現有材料可以被改質,還是這只是指新的材料——新的植入物?
Sonny Bal - Chairman, CEO and President
Sonny Bal - Chairman, CEO and President
It is a good question, and let me clarify the engineering of the next generation product, which is the nitrogen annealed product. It is surface chemistry manipulation, and I will spare you the hard science details. But what it does is it allows us to precisely engineer the surface to encourage more bone cell end growth and faster healing.
這是個好問題,我來釐清一下下一代產品(也就是氮氣退火產品)的工程設計。這是表面化學的調控,我就不深入艱深的科學細節了。但它的作用是讓我們能精準地工程化表面,以促進更多骨細胞向內生長並加速癒合。
So the good news is, if you have already got a structural part like a spacer in our inventory, we can subject it to a surface treatment -- not a remanufacturer and that confers the additional advantageous properties to the existing inventory. So we are very fortunate in that this innovation can be applied to the existing inventory without having to rebuild all of it.
好消息是,如果你已經有像我們庫存中的墊片這類結構件,我們可以對其進行表面處理——不是重新製造——從而賦予現有庫存額外的優勢特性。因此我們非常幸運,這項創新可以套用到既有庫存,而不必把全部都重新製作。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Does that require its own 510(k) application, or do you expect that you will be able to do that with the existing material later this year?
這是否需要另外提出 510(k) 申請,還是你預期今年稍晚可以用既有材料來做?
Sonny Bal - Chairman, CEO and President
Sonny Bal - Chairman, CEO and President
It does not need a new 510(k).
不需要新的 510(k)。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Okay. Got it. So you mentioned that you expect four more partnership agreements. Is that specific to private label or specific to distribution agreements that you have in place now?
好的。了解。所以你提到你預期還會有四項合作協議。那是特指自有品牌,還是特指你們目前已有的通路協議?
Sonny Bal - Chairman, CEO and President
Sonny Bal - Chairman, CEO and President
It is a blend of the two.
兩者都有。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Got it. Okay. And then, generally speaking, Ty or Sonny, how do you feel about the OPEX going forward? Is that kind of that 2015 range of, call it, $25 million or $26 million seem reasonable for 2016?
了解。好的。接著,一般來說,Ty 或 Sonny,你們對未來的 OPEX 有什麼看法?2016 年大概落在 2015 年那個區間,也就是約 2,500 萬或 2,600 萬美元,這樣合理嗎?
Ty Lombardi - CFO
Ty Lombardi - CFO
From an operating expense?
就營運費用而言?
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Yes.
是的。
Ty Lombardi - CFO
Ty Lombardi - CFO
No, we would anticipate our operating expenses to decrease going into 2016, kind of consistent with our cash burn decreasing that we will have -- anticipate some growth in revenue and then reducing operating expenses to further reduce our operating cash burn.
不,我們預期 2016 年的營運費用會下降,這與我們現金消耗下降的趨勢一致——我們預期營收會有一些成長,同時降低營運費用,以進一步降低我們的營運現金消耗。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Okay. So 10% or 20% lower? I know you don't provide guidance, but is that how we should be thinking about it?
好的。所以是低 10% 或 20%?我知道你們不提供財測,但我們應該這樣理解嗎?
Ty Lombardi - CFO
Ty Lombardi - CFO
Yes, we don't provide that exact guidance, but that would be in the range, yes, that we would expect.
是的,我們不提供那麼精確的指引,但大致會在那個範圍內,沒錯,這是我們的預期。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Okay. Got it. Sonny, could you talk a little bit about this CASCADE study as far as the 510(k)? So you will provide a response as far as some of the technical questions from the agency, and you are confident that you will receive a clearance by the end of 2016?
好的。了解。Sonny,你能談談這個 CASCADE 研究在 510(k) 方面的情況嗎?也就是你們會就主管機關的一些技術性問題提供回覆,而你有信心在 2016 年底前取得核准(clearance)?
Sonny Bal - Chairman, CEO and President
Sonny Bal - Chairman, CEO and President
Yes, that is certainly where we hope so. To repeat what I said, upon review of the entire submission, I believe we definitely have our ducks in a row. The study showed what it is supposed to show, what we hoped it would show. The questions are more about intermediate data points, variability, and explanations for which we have the data as a matter of re-analyzing segments of the data to answer those very specific questions.
是的,那當然是我們所希望的。重申我剛才說的,在審視整份送件資料後,我相信我們確實已把一切準備妥當。研究結果呈現了它應該呈現的內容,也就是我們希望它呈現的內容。這些問題更多是關於中間數據點、變異性,以及需要說明之處;我們都有資料,只要重新分析部分資料區段,就能回答那些非常具體的問題。
In looking at the entire body of questions, there are no serious structural issues with our study. So we are going to answer those questions, get into a meeting with the FDA, answer any residual questions, and take it from there. I am confident.
從整體問題來看,我們的研究沒有任何嚴重的結構性問題。所以我們會回答這些問題,與 FDA 開會,回覆任何剩餘問題,然後再往下推進。我有信心。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Okay. Got it. And on the new metals introduction, I thought it would have been sooner in 2016. You were talking about a limited launch by the end of the year, and what product specifically, a pedicle screw fixation, and what else? Rods? Plates?
好的。了解。至於新金屬產品的導入,我原本以為 2016 年會更早。你提到年底前會做有限度上市(limited launch),具體是哪個產品?椎弓根螺釘固定(pedicle screw fixation)還有什麼?連接棒(rods)?鋼板(plates)?
Mike Houston - VP, Commercialization & Communications
Mike Houston - VP, Commercialization & Communications
Jeff, this is Mike. It is a pedicle screw system with the accompanying instrumentation to go with it. So the focus is on the screw and updating the instrumentation that goes with it.
Jeff,我是 Mike。這是一套椎弓根螺釘系統,並搭配相應的器械(instrumentation)。所以重點在螺釘本身,以及更新與之配套的器械。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
For (inaudible)?
用於(聽不清)?
Mike Houston - VP, Commercialization & Communications
Mike Houston - VP, Commercialization & Communications
Correct. And it would include the rods as well.
沒錯。也會包含連接棒(rods)。
Sonny Bal - Chairman, CEO and President
Sonny Bal - Chairman, CEO and President
It is MIS surgery friendly. It was in desperate need of an upgrade to modern standards. The design and the features of the screw are very competitive as it is. We simply needed a newer model of it.
它對微創手術(MIS)很友善。它非常需要升級到現代標準。就螺釘的設計與功能而言,本身已很有競爭力。我們只是需要它的新版本。
Jeffrey Cohen - Analyst
Jeffrey Cohen - Analyst
Okay. Got it. And one more. Sonny, just generally speaking, are you seeing more chatter or papers or publications about PEEK out there, kind of going into some of the malfunction and cracking that is going on?
好的。了解。再問一個。Sonny,一般來說,你是否看到外界對 PEEK 的討論、論文或出版物變多了,提到一些正在發生的故障與裂紋問題?
Sonny Bal - Chairman, CEO and President
Sonny Bal - Chairman, CEO and President
There was a study recently at NASS talking about delamination. As an orthopedic surgeon, I can tell you that the lure of the fool's gold of sticking coatings on materials has been with us for a long time and continues to be that way because it is a cheap, easy way to get to where we are already. Most materials are not that facile. They are one-dimensional.
最近在 NASS 有一項研究談到分層(delamination)。作為骨科外科醫師,我可以告訴你,把塗層加在材料上的那種「愚人金」誘惑已存在很久,現在仍然如此,因為那是一種便宜、容易的方式,讓你看起來好像達到我們早已達到的水準。大多數材料沒那麼容易處理。它們是單一維度的。
So if you have got something soft that can grow into bone but you need something hard on the other side that can articulate our material, you can engineer it that way. Most materials, you have got to coat or do something with not very happy results, for the most part, and the reason is that the body is harsh. We are asked why the testing conditions are so harsh by our competitors whose products don't measure up to ours. And the reason is, any implant in your body has to last over decades, multimillion cycles, and it is salty, warm fluid. Much like an ocean ship, only worse.
所以如果你有一種較軟、可以長入骨頭的材料,但另一側又需要較硬、能與我們的材料形成關節運動的材料,你可以用工程方式把它設計成那樣。但大多數材料,你必須去塗層或做些處理,而結果多半不太理想;原因在於人體環境很嚴苛。我們的競爭對手常問,為什麼測試條件要這麼嚴苛,因為他們的產品比不上我們。原因是,任何植入人體的植入物都必須維持數十年、承受數百萬次循環,而且環境是含鹽、溫暖的體液。就像海上的船,甚至更糟。
So things, just like on ships, corrode and undergo changes that are not very good. Now, on top of that, if you add a coating, like the PEEK coatings that you are talking about, you have got one more mode of failure, namely shear stresses, which the body subjects to any implant in a structural setting.
所以就像船一樣,東西會腐蝕並發生不太好的變化。此外,如果你再加上一層塗層,例如你提到的 PEEK 塗層,就多了一種失效模式,也就是剪切應力;在結構性應用情境下,人體會讓任何植入物承受這種應力。
So I predict an unhappy ending for most, if not all, of these so-called innovations because we have been there before with hip replacement, bearings, knee replacements, polyethylene innovations, in-growth surfaces, so on and so forth.
因此我預測,這些所謂的創新大多(如果不是全部)都會以不愉快的結局收場,因為我們以前在髖關節置換、軸承、膝關節置換、聚乙烯創新、骨長入表面等等方面都見過類似情況。
Operator
Operator
And this does conclude our question and answer portion. I would now like to turn the conference back over to Dr. Sonny Bal for any further remarks.
以上為問答環節的結束。接下來我想把電話會議交回給 Sonny Bal 醫師,請他做進一步的結語。
Sonny Bal - Chairman, CEO and President
Sonny Bal - Chairman, CEO and President
Thanks, Shanice, and thanks, everyone, who participated on the call and a very special thank you to our loyal and patient shareholders.
謝謝你,Shanice,也謝謝所有參與本次電話會議的各位,並特別感謝我們忠誠且有耐心的股東。
In closing, I would like to restate my optimism and total commitment to the Company for 2016 and beyond. Recent industry trends, coupled with discussions with potential OEM, private partner labels -- private label partners, surgeons, distributors, and the ceramic industry at large -- it is a very big industry, medical and nonmedical -- show that there is an increased demand for silicon nitride, silicon nitride specifically across a broad spectrum of medical and nonmedical industries from your cell phone to aerospace to all kinds of industries. We, Amedica, are uniquely positioned for this incredible opportunity, being the only truly differentiated player in that space with our experience and strength in biomedical engineering. With our improved financial position, best in class material situations, we could not be better positioned to take opportunity out of this enormous market.
最後,我想再次表達我對 2016 年及未來的樂觀態度,以及我對公司的完全承諾。近期的產業趨勢,加上與潛在 OEM、民間合作夥伴品牌——自有品牌合作夥伴、外科醫師、經銷商,以及整體陶瓷產業(這是一個非常大的產業,涵蓋醫療與非醫療)之間的討論——都顯示市場對氮化矽(silicon nitride)的需求正在增加,且特別是氮化矽在廣泛的醫療與非醫療產業中都有需求,從你的手機到航太到各式各樣的產業。我們 Amedica 憑藉在生物醫學工程方面的經驗與實力,作為該領域唯一真正具差異化的參與者,具備獨特的有利位置,能把握這個難得的機會。隨著我們財務狀況改善、材料條件達到同級最佳,我們已處於最佳位置,能在這個龐大市場中把握機會。
I will look forward to providing another update next quarter. Really appreciate for your continued support. Thank you.
我期待在下個季度再提供一次更新。非常感謝各位持續的支持。謝謝。
Operator
Operator
Ladies and gentlemen, thank you for your participation in today's conference. This does conclude the program. You may now disconnect. Everyone, have a great day.
各位女士先生,感謝各位參與今天的電話會議。本次議程到此結束。您現在可以掛線。祝各位有美好的一天。