祺驊復健器材8月擴大交貨；今年EPS估1.8元

2012/07/1811:13精實新聞2012-07-1811:13:29記者蕭燕翔報導進入傳統旺季，加上復健器材開始銷日，健身器材零組件廠商祺驊(1593)下半年營收可望較上半年跳升五成，子公司輔康8月起也將轉虧為盈。法人估計，該公司今年單一營收約落在7-7.2億元，稅後盈餘0.45-0.46億元，以目前股本估算，每股稅後盈餘約1.8元。祺驊第二季單一營收1.47億元，季增2.8%，法人估計，上半年平均毛利率將落在22.5-23%，但上季因業外匯兌評價由負轉正，單季獲利將較上半年明顯好轉，上半年累計稅後盈餘估約1,300萬元，以目前股本估算，每股稅後盈餘超過0.5元。展望下半年，祺驊指出，客戶需求看來仍有傳統旺季效應，特別是北美客戶下單相較積極，以接單看來，上、下半年營收應可維持4比6，亦即下半年營收將較上半年成長五成，而7月營收會優於6月，8月會有更明顯成長。除既有產品外，祺驊今年寄予厚望的產品為復健醫療用品，透過與日商策略夥伴Senoh及子公司輔康醫療共同開發合作，提供給中風病人復建使用。棋驊指出，5月產品已有小量樣品出貨，8月將有千台以上的訂單交貨，帶動集團內整機及零組件出貨較大成長，輔康第三季也將挑戰轉虧為盈。法人預估，祺驊今年單一營收約落在7-7.2億元，稅後盈餘0.45-0.46億元，以目前股本估算，每股稅後盈餘約1.8元。

工研院籌組雷射積層製造產業群聚搶進3D列印市場!!

2012-07-1816:16新聞速報【中廣新聞／龐清廉】連結廠商搶進被喻為製造業下一波革命的3D列印技術，工研院結合國內外設備、材料、應用等產學研三十多家廠商，今天在台南市六甲院區舉行「雷射積層製造產業群聚」大會，宣誓跨進3D列印產業，會中並有世界唯二以雷射積層列印出的小提琴現場演奏，和3D金屬列印的應用展出，國內3D列印市場蓄勢待發。3D列印在全球不景氣市場中逆勢快速成長！3D列印積層製造技術被預測是新一波的製造革命，雷射金屬積層製造技術採用逐層堆積製造方法，由傳統減法式製造改變成加法式3D製造，由塑膠材料進展到金屬材料，也從原型製作進化成實際產品製作。工研院南分院引進國內第一台金屬材料雷射積層製造設備EOSM280，以製程技術和應用，連結相關廠商共同來推動3D列印的應用和發展關鍵技術，未來更朝向針對先進材料的積層製造技術來發展。工研院進一步指出，這套雷射積層設備以金屬為材料，可以解決傳統的金屬複雜曲面無法量產問題，克服模具異形冷卻水路的模流製作問題，甚至應用在客製化醫材，包括牙齒、人工支架、人工骨、人工關節及手術器械等製作。技術團隊並與國內廠商與學校進行多項合作，其中一個合作案例，成功為十多歲的黃金獵犬老狗，裝置3D列印的髖關節，並因此將促成第一家以全e化雷射積層製造醫材的新公司在南部成立，後續在產業看好這項技術應用，會有更多的國內投資在此快速成長的新領域。在工研院籌組「雷射積層製造產業群聚」成立大會現場，展示為第一屆工研院院士製作的院士立體証書，以及有世界唯二以雷射積層列印出的小提琴現場演奏，雖然音質沒有深度，不過用印的樂器表現已經讓人驚豔。2011年3D列印全球產值(產品加服務)達17.14億美金，比前一年成長近30%，預估2019年市場將成長4倍，產業前景可期。工研院今年初完成國內第一個金屬雷射積層實驗室，經過半年來的推展，已協助國內廠商相繼投入模具及醫材積層製造，後續將陸續推動雷射源、精微檢測等雷射相關產業群聚，期待在產官學研齊力推動下，讓雷射應用成為南台灣另一個亮點產業。

中化生神隆報佳音

【經濟日報╱記者黃文奇／台北報導】2012.07.1903:37am原料藥族群昨（18）日同報佳音，中化生（1762）、台灣神隆第3季營運看好；中化生旗下原料藥「Pravts」近期出貨量將放大；神隆美國藥廠客戶Vivus在也宣布新藥Qsymia獲美國食品藥物管理局（FDA）核准，將推升神隆第3季動能。中化生表示，今年第2季營收獲利創下新高，單月營收也在5月創新高，獲利同步走揚，展望第3季也同樣樂觀看待。中化生昨日股價收47.65元，下跌0.25元；神隆昨日股價則收57元，下跌0.7元。在下半年動能方面，中化生說，除了接獲美國上市製藥廠肌肉鬆弛劑新訂單，第3季將交貨700公斤外，占公司營運大宗的「免疫抑制劑」（MMF）原料出貨也同樣看旺，而旗下降血脂原料藥物Pravts也在第3季動能轉強。法人表示，由於MMF占中化生全年出貨比重五成以上，因此第3季若動能不減，則營收將繼續攀升；對此，中化說，第3季起每月出貨維持和上季相同，約5到6公噸的量。神隆方面，其客戶Vivus也在台灣時間18日宣布，旗下藥物Qsymia（原名Qnexa）獲美國食品藥物管理局核准，並將於今年第4季上市。據彭博社報導，未來Qsymia上市後，預計3年內年將貢獻Vivus12.5億美元（近新台幣375億元）營收。【2012/07/19經濟日報】

Feeling sick? There's an app for that !

By Dina ElBoghdady The Washington Post That's what it took for MIM Software to get the Food and Drug Administration's clearance for a smartphone application that physicians can use to view MRIs and other medical images. "It was 2008 when we first tried," said Mark Cain, the Ohio firm's chief technology officer. "They didn't know what questions to ask and neither did we. . . . But at some point, they had to be thinking, 'How many more people will be lined up behind these guys?' " His was, in fact, among the first apps cleared by the FDA. And since then, medical applications have flooded onto millions of smartphones, offering consumers the chance to check their heart rate, identify a pill in their medicine cabinet or even scan moles for skin cancer. Soon, if a firm called AliveCor gets its way, they may even be able to get an EKG by pressing iPhone to chest. A defect in apps that essentially turn your phone or tablet into a medical device could prove problematic or even life-threatening: The app may not work as it should. For instance, what if lighting or contrast issues distort an X-ray that's viewed on an iPhone or iPad? That's why federal regulators lurched into action a year ago, offering their thinking on how to police this vast new frontier. Just as they were putting the finishing touches on a plan, lawmakers intervened. The Senate moved to put the plan on hold after tech firms convinced lawmakers that more government oversight would stifle innovation and cost jobs. Last week, Congress gave the FDA the green light to proceed with a push to define exactly which apps require government attention. But lawmakers also ordered the Obama administration to come up with a strategy that balances public interest with innovation in the years to come. The task is daunting, given the warp speed of technology. It's a classic showdown between Washington regulators charged with safeguarding the public's health and a free-wheeling tech industrythat prizes agility and first-to-market bragging rights. "There are two completely different mind-sets," said Merrill Matthews, a resident scholar at the Innovative Policy Institute. "The app people think: Where is there a need and how do I fill it? And the FDA thinks: Where is there a problem and how can I control it?" Mobile apps, with their extraordinary reach, have the power to transform health care. Half of cellphone users in the United States have smartphones such as the iPhone or Android software-based devices, which can deliver care to their hands and potentially do so at a lower cost. Using smartphones and wireless tablets as diagnostic tools or monitoring devices could also cut back on emergency room visits. For software developers, especially cash-strapped start-ups, there's an enormous amount riding on whether the FDA steps up enforcement — and exactly how it plans to do it, industry analysts said. "The FDA approval process adds months, if not years, and potentially millions of dollars to what it takes to bring a solution to the market," said Liz Boehm, a director at ExperiaHealth, a consulting firm. "That development process would put many of these guys out of business." Medical apps exploded onto the scene in 2010 and have grown by about 150 percent each year since, according to MobiHealth News, which tracks Apple's iTunes store, where many apps debut. Consumers can choose about 13,000 of these apps; 5,000 more are marketed to medical professionals. The offerings range from very basic — and free — apps that calculate body mass index to more sophisticated ones that make use of pricey supplemental devices. The pharmaceutical firm Sanofi has an app for diabetics that registers glucose levels with the help of a meter that attaches to iPhones. IHealth offers an app that records blood pressure using a cuff that plugs into an iPhone, and WiThing has one that tracks weight and body-fat percentage using the company's WiFi-enabled scale. A survey by the Pew Internet Project found that 11 percent of adults with cellphones downloaded an app last year to help them manage their health. That same year, the mobile health-apps industry generated an estimated $718 million worldwide, seven times more than the previous year, according to Research2Guidance, a consulting firm. While the FDA currently regulates certain medical software, the agency wants to update its thinking now that smartphones have juiced the apps market. A year ago, the agency proposed policing only a subset of those apps: ones that use supplemental attachments to transform a mobile platform into a medical device (such as AliveCor's EKG app) and others that act as accessories to an already regulated medical device (such as MIM Software's app). Rather than overseeing all medical apps, agency officials said they want to limit regulation to a slice of the market and take a pass on low-risk apps, such as calorie counters, according to Bakul Patel, an FDA policy adviser. "We are taking a proactive step by saying that from the FDA perspective," Patel said. "We're not concerned about all those other apps." Software makers, on the other hand, see an agency that currently regulates next to nothing in the mobile apps space taking a sudden interest in regulating more. The FDA proposal, they say, is vague and leaves many questions unanswered. For instance, given that apps can be updated daily, does a software developer have to seek FDA approval for each update? Among the critics is a group called the Health IT Now Coalition. It represents health-care providers, patient advocates and health insurance companies, including Aetna, which last year bought iTriage — an app that helps consumers evaluate medical symptoms and find the proper care. "The issue here is that they're really using a process for approval of these mobile apps that was basically created when the 5 ¼-inch floppy disk was the latest technology," said Joel White, the group's executive director. Dirk Hobbs, chief executive of Medical Voyce Sciences and Multimedia, said the FDA's plan is ambiguous and he doesn't know whether the apps his firm is developing would be regulated. The apps aim to speed communication among medical professionals in different facilities. "This is just going to slam the brakes on an innovative sector that includes tons of small businesses like mine," said Hobbs, who expressed his concerns to Sen. Michael F. Bennet, D-Colo. Bennet and Sen. Orrin G. Hatch, R-Utah, wrote a provision, inserted in a broader FDA funding bill, that would have delayed the FDA proposal by forcing the agency to first reach agreement with other regulators about how to handle these apps. This week, in a compromise reached by House and Senate lawmakers, Congress allowed the FDA to press ahead. But it also directed the agency to work on a report with other regulators that would lay out an appropriate framework to promote innovation and protect patient safety. Former FDA deputy commissioner Scott Gottlieb, who researches medical trends as a fellow at the American Enterprise Institute, said he's disappointed. If consumers can track their blood-sugar levels using pen and paper, he said, why should the government have to clear an app that does the same thing more reliably? Gottlieb said that software developers should be suspicious because regulators have a tendency to tighten their grip on industries as they develop. "If they perceive a power vacuum," he said, "they'll step in and regulate more and more." Some in the tech industry do not perceive a threat. They say they've been expecting the FDA to regulate some apps and are eager for the agency to reveal which ones. A group called the mHealth Regulatory Coalition — which represents established firms such as Qualcomm as well as start-up software developers — was formed in 2010 to deal with mobile health care regulatory issues. Its leaders argue that uncertainty breeds anxiety and drives away potential investors. "We started telling the FDA that they're going to stifle innovation if they don't start clarifying where the lines will be drawn," said Bradley Thompson, the group's general counsel. Other technology groups — including the West Wireless Health Institute and the Application Developers Alliance — have taken a similar position. In a recent meeting with industry representatives, Jeffrey E. Shuren, head of the FDA's Center for Devices and Radiological Health, assured the group that the final plan would include more details than the draft, some attendees said. The agency may even create a Web site with generic examples of apps that would be exempt, Shuren told them. In the end, the FDA's plan may indeed sink some software makers whose products can't withstand federal scrutiny, said Lisa Suennen, co-founder of Psilos Group, a health-care-focused venture capital firm. "But while regulation puts an extra burden on young companies, those that can get through it will have a huge competitive advantage," Suennen said. "You can't have every Tom, Dick and Harry claiming that their medical app adds value without having to prove it." 

康聯近期佈局中國市場分析

康聯2012年醫藥代理的突破將有望使營收成長呈現漸入佳境的表現2012/07/1800:00(LeadingEdge提供)F-康聯控股公司(簡稱F-康聯)營運主體是上海國創醫藥有限公司(簡稱上海國創)，公司銷售之B型肝炎藥物「代丁」，在2005年上市後到2010年為止，年複合成長率高達54%，迅速成為整體中國肝藥市場市佔率第三名之肝炎藥物。2012年醫藥代理的突破將有望使營收成長呈現漸入佳境的表現。今年2月9日，康聯與英國葛蘭素史克(GSK)藥廠簽訂合作協議取得「力百汀」的中國獨家銷售權，同日也取得浙江仙琚過敏性鼻炎用藥「糠酸莫米松」的經銷權。3月份更取得B型肝炎用藥拉米夫定「銀丁」的銷售權，預估在三個新力兵加入下，下半年可開始貢獻營收，全年營收可望成長2成左右。由於今年第一季新代理藥品尚未開始貢獻營收，2012第一季營收較去年同期下降7.37%，為台幣3.84億元，營業毛利由去年同期56.11%提高至59.9%，但推銷費用增加2成，營業淨利為1.03億元，稅後淨利1.5元。今年下半年預估新產品加入後，預估營業淨利可達3.85億元，稅後每股淨利為5.4元。投資亮點預估2012年末，肝藥「銀丁」(拉米夫定)在便可開始貢獻營收，由於代丁和銀丁分別為肝炎不同階段治療用藥，二者搭配使用可以達到降低抗藥性的作用。因此我們認為，在銀丁順利加入F-康聯的代理用藥後，除本身可貢獻的銷售外，預估還可順利的再提高及延長代丁的生命週期。子公司上海國創醫藥在6月20日宣佈以約略新台幣3億元的代價，收購黑龍江同澤醫藥51%股權，加速深耕東北地區，並一併購入心腦血管產品之銷售權。我們預估公司在各省的直營據點以外，未來若仿照與同澤醫藥的購併方式，將可有效迅速擴大營銷範圍。由於F-康聯積極調整產品組合，降低肝藥代丁銷貨過於集中的風險，在2011年產品營收比重，代丁由2010年佔比92%下降為82%，骨材銷售則由4%提高至14%。我們認為銷貨集中問題在2013年之後會更加改善。受到第一季財報不理想和上半年新產品出現空窗期的雙重衝擊下，F-康聯跌幅高過同類公司，自前波高點下跌幅度已超過5成，目前領先本益比未達12倍，股價淨值比不到2.3倍，投資價值已經浮現。我們對F-康聯長期營運仍舊保持樂觀，惟近期受到國際金融情勢不樂觀，熱錢風險意識大增和台股證所稅議題和成交量縮影響，我們對公司投資的目標價調整為87~95元，本益比約當16~18倍左右，依7/17收盤價62.4計算，潛在報酬率為39.4%~52.2%，建議投資人可伺機逢低進場。經營項目公司已上市產品涉及抗肝、炎神經系統、抗腫瘤、呼吸系統、脊柱內固定產品及抗生素等治療領域。2005年F-康聯推出抗B肝藥物阿德福韋酯，是，對野生和耐藥變異的B型肝炎病毒都有很強的抗HBV活性。該藥品2005年到2010年複合成長率高達54%，2010年度佔公司營收91.4%，為公司的主要產品。主要用於預防腎移植病人的排斥反應，以及預防心臟、肝臟移植可能出現的急性器官排斥症狀，順友的主要競爭者為羅氏藥廠的，由於順友推出時間晚於，在市佔率表現上尚無法超越對手。因為中國空氣物染嚴重、吸煙人口也居高不下，2006到2010年呼吸系統藥物年複合成長益高達34%之多。F-康聯去年與浙江仙琚製藥公司合作，推出塞托溴銨粉霧劑（彼多益），並在2011年3月上市。屬於抗生素一種，主要針對葡萄球菌、鏈球菌、肺炎雙球菌、腦膜炎球菌及其他細菌感染症做治療。適用於一般如常見的上下呼吸道感染，扁桃腺炎、鼻竇炎、支氣管肺炎等；生殖泌尿道感染如膀胱炎、尿道炎等；蜂窩組織炎、傷口感染等做治療使用。屬手掀式噴霧裝置，治療成人、青少年或幼兒季節性或長發性鼻炎。F-康聯的醫療器械產品主要為脊柱內固定產品，脊柱內固定技術為在脊柱退變、創傷及矯正等諸多疾病的治療。公司代理之產品主要為鈦合金、聚醚醚酮及不銹鋼材料，2010年度及2011年銷售金額佔公司總營收分別為3.49%及14%。計畫中藥物估值分析同類公司比較(資料來源：各公司財報、公開觀測站公司資料，LeadingEdge分析)註1：各公司2012年預估每股盈餘及每股淨值時以目前股本計算。註2：港幣換算台幣以匯率3.89計算營業數據及財務分析

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