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MNK

Mallinckrodt

$3.60

0.37 (11.46%)

06:52
11/26/19
11/26
06:52
11/26/19
06:52

Mallinckrodt announces findings from retrospective Acthar Gel study

Mallinckrodt announced findings from a large retrospective study of Acthar Gel in the treatment of the respiratory disease symptomatic sarcoidosis that assessed patient characteristics, treatment patterns, concomitant medication use and physicians' assessments of treatment response. The study examined medical records from 302 patients with advanced symptomatic sarcoidosis, the majority of whom had comorbidities and had previously been treated with corticosteroids. The analysis showed that the use of Acthar Gel was associated with improved overall health status in 95% of patients as reported by physicians' assessments, with more than half of patients seeing improvements in two or more symptoms. In addition, there was an association observed between the use of Acthar Gel therapy and reduced overall use of other medications. Results of the study were recently published online in Therapeutic Advances in Respiratory Disease, an online, open-access peer-reviewed journal. The study evaluated patient records from 302 adult patients who were treated with Acthar Gel in the previous 36 months at the time of data collection from September 2017 to November 2017. Patients were required to have completed an individualized course of Acthar Gel therapy or received Acthar Gel for six months at the time of data collection. Records were analyzed from 98 physicians in a range of specialties, including pulmonology, rheumatology, primary care, dermatology, cardiology, ophthalmology, gastroenterology and neurology. Sixty-four percent of patients had chest imaging and biopsy-confirmed stage 3 or 4 sarcoidosis and 30% had been hospitalized for sarcoidosis during the previous year. All patients had evidence of pulmonary involvement; 42% had involvement of one extrapulmonary organ and 34% had involvement in multiple extrapulmonary organs, most commonly the skin, joints, heart and eyes. Patients' symptoms included mild-to-moderate shortness of breath, fatigue, bone and joint pain, wheezing/coughing and abnormal heartbeat prior to treatment with Acthar Gel. Overall, 76% of patients reported one or more comorbidities; 24% had no comorbid conditions. The study examined concurrent medication use before, during and after Acthar Gel therapy. Eighty-six percent of patients had received other treatments in the three months prior to receiving Acthar Gel and concurrent medications used included oral corticosteroids, biologics, immunosuppressants and antimalarial agents. The analysis found that patients had varied and individualized dosing regimens. The mean duration of Acthar Gel treatment was 32.5 weeks, with 61.6% of patients continuing treatment for six months. Use of Acthar Gel was associated with a reduction in the use of other medications. Acthar Gel was also associated with an overall decrease in use of corticosteroids from 61.3% during the three months before Acthar Gel initiation to 12.9% three months after the start of Acthar Gel therapy. The analysis also showed an association between Acthar Gel treatment and a decrease in the mean daily dose of corticosteroids from 18.2 mg to 9.9 mg. According to physicians' assessments of change in patient health status following Acthar Gel therapy, improvements were reported in: overall health status as measured by the question "What is the patient's status as of the end of RCI therapy or the six months point in therapy for ongoing treatment patients?" In addition, physicians reported overall reduced symptoms, improved lung function, reduced inflammation, reduction or discontinuation of corticosteroids and increased quality of life.

  • 07

    Dec

MNK Mallinckrodt
$3.60

0.37 (11.46%)

09/05/19
09/05/19
DOWNGRADE
Target $3

Market Perform
Mallinckrodt cut to Market Perform at BMO Capital on opioid restructuring report
As previously reported, BMO Capital analyst Gary Nachman downgraded Mallinckrodt to Market Perform and slashed his price target to $3 from $19 after yesterday's Bloomberg reports that the company hired restructuring firms to help manage through its opioid litigation. The analyst contends that an already challenging situation has "taken a turn for the worse", stating that he previously believed that the company would be able to navigate through these issues. Nachman adds that with the mounting pressures related to the litigation, the possibility of bankruptcy for Mallinckrodt can no longer be ruled out.
09/05/19
09/05/19
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. BHP Group (BHP) downgraded to Underperform from Neutral at Exane BNP Paribas. 2. Mallinckrodt (MNK) downgraded to Market Perform from Outperform at BMO Capital analyst Gary Nachman citing yesterday's Bloomberg reports that the company hired restructuring firms to help manage through its opioid litigation. 3. Yirendai (YRD) downgraded to Underperform from Neutral at Macquarie with analyst Dexter Hsu saying the company not only reported "disappointing" Q2 results, but also closed the merger with CreditEase on unfavorable terms. 4. Green Dot (GDOT) downgraded to Hold from Buy at Jefferies with analyst John Hecht saying the company's organic revenue growth has been slowing and it is trying to establish share in a new customer target market with well-resourced competitors. 5. Royal Dutch Shell (RDS.A, RDS.B) downgraded to Market Perform from Outperform at Cowen with analyst Jason Gabelman saying the downgrade reflects its peer leading exposure to international gas prices which are forecasted lower through 2020 and as a result could limit its free cash flow growth. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
09/09/19
STFL
09/09/19
NO CHANGE
Target $8
STFL
Hold
Mallinckrodt price target lowered to $8 from $20 at Stifel
Stifel analyst Annabel Samimy lowered her price target for Mallinckrodt shares to $8 from $20 after she reduced her expected growth of Acthar for 2019 and beyond and factored in more concrete potential litigation cash-calls. She models a $300M potential settlement with CMS related to the Acthar AMP-pricing reversion and has included a $900M potential liability for opioid-litigation payments, calling those her "best, reasonable estimates at this point" but acknowledging there still remains considerable uncertainty around both issues. Mallinckrodt's settlement of Track 1 of the Ohio multi-district litigations is "only a small step in the sprawling opioid litigation," but the settlement buys the company much-needed time to address New York state litigation or a global settlement, said Samimy, who keeps a Hold rating on Mallinckrodt shares.
09/10/19
STFL
09/10/19
NO CHANGE
STFL
Mallinckrodt's sale of BioVectra helps alleviate cash pressure, says Stifel
Stifel analyst Annabel Samimy maintained a Hold rating and $8 price target on Mallinckrodt, but noted that Mallinckrodt announced the sale of its CDMO organization, BioVectra, to HIG Capital for a potential $250M, which the analyst believes is "a positive step to manage and bolster cash and maintain capital allocation priorities." Samimy added that, with the departure of Specialty Generics President Matthew Harbaugh, the company's suspension of the spin-off appears indefinite.

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AMRN

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AMRN

Amarin

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RTN

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LYV

Live Nation

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  • 26

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BAESY

BAE Systems

$0.00

(0.00%)

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WST

West Pharmaceutical

$146.32

-0.14 (-0.10%)

17:02
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AMRN

Amarin

$24.12

1.12 (4.87%)

17:02
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Earnings
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  • 28

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