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Thursday, April 11, 2019

(Suboxone原廠恐面對30億美金罰款) 美時 夥伴: 商業價值未變_ Buprenorphine/Naloxone舌下含片(Suboxone學名藥)


美時營收風暴沒被發現的真相!先探投資週刊徐玉君╱先探2034 2019411 【徐玉君╱先探2034期】近期整體生技醫藥產業的亮點,都被基亞與日本策略夥伴Oncolys合作的溶瘤病毒新藥OBP-301(Telomelysin)創下國內授權金額紀錄給填滿,然三月營收最令人咋舌非美時莫屬,其中真相文後說明。至於即將正式上路執行的「特管法」相關股票也將有機會啟動新行情。
生醫族群去年獲利創新高 先從基本面來看,年報、息利、首季營收陸續公告,上櫃生技指數一路緩步攀升再度突破一四○點整數關卡,從去年的財報統計數可知,上櫃生技醫療股(上櫃+興櫃)共計一四三檔,整體營收年增十二.四七%,最關鍵的獲利更創下一四四億元的年增近二倍數字最令人驚艷。從EPS數字來看,整體生醫股共計二八檔逾四元以上,其中有八家獲利超過一個股本以上,這些公司賺得多,配息也不手軟,高殖利率、低PE股成為進可攻退可守的標的族群(詳見附表),不少高獲利股PE還不到二○倍,現金殖利率甚至還逾四%以上,可以留意。而從已公告的三月份營收個股來看,已有八家公司創下歷史新高紀錄,第一季累計營收年成長幅度逾三成以上個股也有十家,包括寶齡富錦(1760)、永日(4102)、旭富(4119)、晶宇(4131)、智擎(4162)、瑞基(4171)、福永生技(4183)、藥華藥(6446)、保瑞(6472)及大江(8436)等,不過近期股價表現平平。
新藥股利多題材不斷 當中的藥華藥,治療真性紅血球增生症新藥Besremi,在二月取得國內首家歐盟新藥藥證後,三月份即開始首批小規模出貨予策略夥伴AOP,隨即創造二六三六萬元營收新高紀錄,即便雙方仍有國際仲裁程序在進行,不過賺錢的事情還是放在第一位,而雙方的供貨行銷仍按照原規劃持續推展,如果銷售力道能隨著歐盟各國申請程序的陸續完成,而呈現持續成長態勢,那麼藥華藥對這顆藥一直以來堅持的信念就應該給予掌聲;接下來就是靜待公司與美國FDA洽談藥證申請的訊息。至於保瑞三月創下歷史次高紀錄,僅次於去年三月收購美國Impax旗下益邦製藥,並取得其原先代工訂單的營收。今年公司動作相當積極,除了爭取國際代工訂單業務外,也尋求合作夥伴,近期旗下宇泰欣藥業與法國布瓦宏Boiron藥廠簽訂台灣區的產品獨家行銷業務,並期待能如同目前經銷的日本藥妝市場第三大藥廠SSP與衛采在台灣的保健及保養品般創下驚人銷售成績,短線漲幅也逾十四%。
美時3月營收大減四成 04:102019/04/11 工商時報 杜蕙蓉 因戒毒藥癮上市營運備受關注的美時(1795)公布,3月自結合併營收5.98億元,月衰退率40.91%。美時表示,美國的商業夥伴艾威群判斷市場仍在初步形塑階段,因該品項屬管制藥物,市場動態與其他專科處方藥明顯有別,依市況判斷,價格符合公司預期。營運天蠶變的美時,因戒毒癮藥開賣,2月營收一舉衝破10億元,以10.12億元改寫歷史新高,法人看好該公司今年營收衝破百億元大關。不過,美時10日公布3月營收5.98億元,儘管月減約四成,但年成長率達18.9%,累計第一季營收22.01億元,年成長47.7%。美時表示,第一季的業績表現主要受惠於非亞太區的國際業務高速成長,除了部分外銷品項授權金認列,最重要的事件為Buprenorphine/Naloxone舌下含片自2月下旬於美國上市,基於穩健保守原則,公司以終端狀況認列營收。美時表示,艾威群判斷該戒毒癮藥品市場仍在初步形塑階段,由於是管制藥物,市場動態與其他專科處方藥明顯有別,依市況判斷,價格符合公司預期;預計該藥品轉換的臨界規模約需六個月的時間。由於艾威群已與美國學名藥市場三大客戶之一建立緊密合作關係,該客戶通常占有美國學名藥市場1/3的份額,因此美時對Buprenorphine/Naloxone舌下含片的商業價值看法未改變
British Pharma Firm Charged for Falsely Claiming Its Opioid-Addiction Drugs Were a Safer Option By MOLLY OLMSTEADAPRIL 10, 201911:19 AM Federal prosecutors on Tuesday charged the British pharmaceutical company Indivior with fraud, making a case that the company had swindled Medicare, Medicaid, and other health care providers by falsely marketing its opioids to medical professionals as less prone to abuse than generic alternatives, according to an indictment. Prosecutors also accused Indivior of using a hotline for helping patients struggling with opioid addiction to instead connect them with doctors who were prescribing Suboxone, a drug it produced, and other opioids "to more patients than allowed by federal law, at high doses, and in suspect circumstances," according to the indictment. Its product Suboxone Film, a dissolvable film placed on the tongue, was marketed as a safer and "less abusable" way to ingest the drug Suboxone, which is meant to help with addiction. An investigation by the U.S. Food and Drug Administration and others concluded that Suboxone Film was no safer than the generic tablet version of the drug. That led prosecutors in the Western District of Virginia to file criminal charges claiming that, starting in 2007, the company knew the film version of the drug was potentially more dangerous and more prone to abuse than the generic version about to hit the market but went ahead with its marketing scheme regardless."[R]ather than marketing its opioid-addiction drug responsibly, Indivior promoted it with a disregard for the truth about its safety and despite known risks of diversion and abuse," Assistant Attorney General Jody Hunt said in a statement. Indivior has maintained its innocence and claimed the government misunderstood the science around the drug. "Key allegations made by the Justice Department are contradicted by the government's own scientific agencies, they are almost exclusively based on years-old events from before Indivior became an independent company in 2014, and they are wrong," the company said in a statement. "The department has apparently decided it would rather pursue self-serving headlines on a matter of national significance than achieve an appropriate resolution, but we will contest this case vigorously and we look forward to the full facts coming out in court." Prosecutors are seeking at least $3 billion in penalties if Indivior is found guilty.

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