Shares of Mallinckrodt plc MNK have plunged 70.8% year to date compared with the industry’s decline of 8.9%.
It has been a dismal year for this Dublin, Ireland-based company, which develops, manufactures, markets and distributes branded and generic specialty pharmaceutical and biopharmaceutical products.
While the company beat on earnings in the recently-reported second quarter, it is currently facing multiple challenges.
The company is currently under the scanner for the sale and marketing of opioid drugs, which contributed to the ongoing opioid epidemic in the United States. It is facing multiple lawsuits related to the same.
Earlier, allegations against its lead drug Acthar’s previous owner, Questcor, for conducting illegal sales and marketing activities related to the drug negatively impacted Mallinckrodt’s shares. Per the company, the original action was filed in 2012, prior to its ownership of Acthar Gel, and consisted of two complaints filed by former Questcor employees.
It reached an agreement in principle with the U.S. Department of Justice (DOJ) regarding the Questcor litigation to resolve the previously-disclosed government investigation of the drug's legacy sales and marketing activities. Mallinckrodt expects to pay $15.4 million related to legacy Questcor activities, per the civil False Claims Act settlement.
Earlier, shares of the company had plunged after it filed suit in federal district court against the U.S. Department of Health and Human Services (HHS) and Centers for Medicare and Medicaid Services (CMS) to protect Medicaid patient access to Acthar. The lawsuit was filed against the agency’s decision, which required Mallinckrodt to change the base date average manufacturer price (AMP) used to calculate Medicaid drug rebates for the drug. Per the company, the attempted reversal, which CMS seeks unlawfully to make retroactive, would substantially eliminate Medicaid net sales of Acthar.
In December 2018, the company announced that it intends to spin-off the Specialty Generics business into a new company. However, based on current market conditions and developments, including increasing uncertainties regarding the opioid litigation, the company has shelved this plan for now. Mallinckrodt continues to evaluate a range of options for the separation of the Specialty Generics business.
The aforementioned factors have led to a significant decline in the share price. Nevertheless, there is some hope for Mallinckrodt as other companies like Endo International plc ENDP recently reached a settlement in principle with the County of Cuyahoga, Ohio; the County of Summit, Ohio; and certain related persons in connection with the pending lawsuits related to opioid medications. Bigwigs like Johnson & Johnson JNJ and generic maker Teva Pharmaceuticals TEVA are embroiled in similar lawsuits as well.
Mallinckrodt carries a Zacks Rank #3 (Hold). (Strong Buy) stocks here..
与行业下跌8.9%相比， Mallinkrodt plc MNK 的股价今年迄今下跌了70.8%。
早些时候，对其主要药品 Acthar 的前任所有者 Questcor 的指控对 Mallinkrodt 的股票造成了负面影响，因为该公司进行了与该药品有关的非法销售和营销活动。就该公司而言，最初的诉讼是在2012年提起的，在其对 Acthar Gel 的所有权之前，由前 Questcor 雇员提出的两项申诉组成。
它与美国司法部( DOJ )原则上就 Questcor 诉讼达成协议，以解决此前披露的政府对该药物遗留销售和营销活动的调查。根据《民事虚假索赔法》的解决方案， Mallinkrodt 预计将支付与 Questcor 遗留活动有关的1540万美元。
早些时候，该公司的股票在联邦地区法院对美国卫生和公众服务部（ HHS ）和医疗保险和医疗补助服务中心（ CMS ）提起诉讼，以保护 Medicaid 患者使用 Acthar 的权利后大幅下跌。这起诉讼是针对该机构的决定提起的，该决定要求 Mallinkrodt 改变用于计算 Medicaid 药物回扣的制造商平均基准日价格（ AMP ）。按照该公司的说法， CMS 非法寻求的反向措施，将大大减少 Achar 的 Medicaid 净销售额。
2018年12月，公司公告拟将专科基因业务剥离至新公司。然而，基于目前的市场状况和发展情况，包括阿片类药物类诉讼的不确定性不断增加，公司目前搁置了本预案。Mallinkrodt 继续评估 Specialty Generics 业务分离的一系列选项。
前述因素导致股价大幅下跌。尽管如此， Mallinkrodt 还是有一些希望，因为远藤（Endo） International plc ENDP 等其他公司最近与俄亥俄州的 Cuyahoga 县、俄亥俄州的 Summit 县以及与阿片类药物相关的未决诉讼有关的某些相关人员达成了原则上的和解。强生( Johnson & Johnson JNJ )和仿制药制造商梯瓦制药( Teva Pharmaceuticals TEVA )等公司也卷入了类似的诉讼。
Mallinkrodt 携带 Zacks 排名第3（持有）。这里的股票。。