Tesaro sold for $75 per share

Tesaro to be acquired by GSK for approx. $5.1B

 

Tesaro could be sold soon, Stockwinners
Tesaro sold for $75 per share, Stockwinners

GlaxoSmithKline (GSK) and TESARO (TSRO) announced that the companies have entered into a definitive agreement pursuant to which GSK will acquire TESARO, an oncology-focused company based in Waltham, Massachusetts, for an aggregate cash consideration of approximately $5.1B.

The proposed transaction significantly strengthens GSK’s pharmaceutical business, accelerating the build of GSK’s pipeline and commercial capability in oncology. The acquisition price of $75 per share in cash represents a 110% premium to TESARO’s 30 day Volume Weighted Average Price of $35.67 and an aggregate consideration of approximately $5.1B including the assumption of TESARO’s net debt.

Zejula’s revenues in its current approved indication as second-line maintenance treatment for ovarian cancer were $166 million for the 9 months ended 30 September 2018.

GSK expects the acquisition of TESARO and associated R&D and commercial investments will impact Adjusted EPS for the first two years by mid to high single digit percentages, reducing thereafter with the acquisition expected to start to be accretive to Adjusted EPS by 2022. GSK’s guidance for full-year 2018 Adjusted EPS growth remains unchanged at 8 to 10% at CER.

GSK continues to expect to deliver on its previously published Group Outlooks to 2020, but following the acquisition of TESARO now expects Adjusted EPS growth at CER for the period 2016-2020 to be at the bottom end of the mid to high single digit percentage CAGR range.

GSK confirms no change to its current dividend policy and continues to expect to pay 80p in dividends for 2018. GSK expects to fund the acquisition from cash resources and drawing under a new acquisition facility.

Please click here and read our blog when we predicted this transaction.


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Shire sold for $62 billion

Takeda reaches agreement to acquire Shire for $62B in cash and stock

Shire sold for $62 billion, Stockwinners
Shire sold for $62 billion, Stockwinners

Japan’s Takeda Pharmaceutical (TKPYY) and Shire (SHPG) announced that they have reached agreement on the terms of a recommended offer pursuant to which Takeda will acquire the entire issued and to be issued ordinary share capital of Shire.

Under the terms of the acquisition, each Shire shareholder will be entitled to receive $30.33 in cash for each Shire share and either 0.839 new Takeda shares or 1.678 Takeda ADSs. The transaction has been approved by both companies’ boards of directors, and is expected to close in the first half of calendar year 2019.

Upon the closing of the transaction, Takeda shareholders will own approximately 50% of the combined group. “With leading market positions in prioritized therapeutic areas, an attractive geographic footprint, greater scale and efficiencies, and an even more productive R&D engine, the combined group will be better positioned to deliver highly-innovative medicines and transformative care providing better health and a brighter future for patients around the world,” Takeda said.

Takeda has entered into a bridge facility agreement of $30.85B with, among others, J.P. Morgan Chase Bank, Sumitomo Mitsui Banking and MUFG Bank, part of the proceeds of which will be used to fund the cash consideration payable to Shire shareholders in connection with the acquisition.

It is currently contemplated that, prior to completion, the commitments under the bridge facility agreement will be reduced or refinanced with a combination of long-term debt, hybrid capital and available cash resources.

Shire plc, an Irish biotechnology company, researches, develops, licenses, manufactures, markets, distributes, and sells medicines for rare diseases and other specialized conditions worldwide.

Takeda Pharmaceutical Company Limited engages in the research and development, manufacture, marketing, and sale of pharmaceutical products worldwide. The company operates in three segments: Prescription Drug, Consumer Healthcare, and Other.


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GW Pharmaceuticals could soar on its epilepsy drug

GW Pharma seen nearing historic approval for cannabinoid epilepsy treatment

GW Pharmaceuticals could soar on its epilepsy drug, Stockwinners
GW Pharmaceuticals could soar on its epilepsy drug, Stockwinners

GW Pharmaceuticals’ (GWPH) cannabis-based epilepsy treatment associated with Lennox-Gastaut syndrome and Davret syndrome, #Epidiolex, received what analyst called a favorable review from Food and Drug Administration staff ahead of an advisory committee meeting scheduled later this week.

Both Goldman Sachs and Leerink argued that the documents bode well for Epidiolex approval by its June 27 PDUFA date.

FDA ADCOM DOCUMENTS

The FDA released its advisory committee meeting briefing documents regarding CBD-OS for the treatment of LGS and DS ahead of the advisory panel vote on Thursday.

According to the documents: “In 3 consecutive Phase 3 studies, CBD-OS added to other AED therapy met the primary endpoint of reduction in seizure frequency in patients with LGS and DS. Doses of CBD-OS at 10mg/kg/day and 20mg/kg/day were superior to placebo at reducing drop seizure frequency, and efficacy was maximized during the 12-week maintenance period once the target dose was achieved in LGS patients.

Similar results were also seen in DS patients treated with CBD-OS 20mg/kg/day. […] The safety and tolerability profile of CBD-OS is predictable, and the potential risks are manageable through the proposed label and medication guide. […] Elevated transaminases were observed more frequently in CBD-OS patients than placebo, and increased AST and increased ALT were the most common reasons for discontinuing CBD-OS treatment.

Therefore, routine liver tests prior to CBD-OS use and periodically during treatment are recommended.

In addition, GW will implement a post-marketing enhanced pharmacovigilance program to monitor the safety profile of CBD-OS, with a focus on liver abnormality reports.

Overall, CBD-OS provides a positive benefit-risk for patients with drug-resistant LGS or DS and can satisfy an unmet need by providing an additional treatment option to reduce the number of seizures in LGS and the first indicated treatment option for DS.” CBD-OS, or cannabidiol oral solution, is the first-in-class antiepileptic drug for the adjunctive treatment of seizures associated with LGS and DS in patients 2 years of age and older.

GW Research, which is a part of GW Pharmaceuticals and operates under Greenwich Biosciences in the U.S., holds the Investigational New Drug application for CBD-OS.

DOCUMENTS SUPPORT APPROVAL

Commenting on the briefing documents, Goldman Sachs analyst Salveen Richter told investors that the “brevity of the relatively benign documents” along with the half day panel duration suggest a likely straightforward meeting.

The analyst noted that there is only one question for discussion – “Is the benefit-risk profile of cannabidiol favorable for the treatment of seizures associated with Lennox-Gastaut syndrome and Dravet syndrome in patients 2 years of age and older?” – which could support a broad label in “seizures associated with LGS/DS” and in children/adults.

Thus, Richter believes these documents should bode well for Epidiolex approval by the June 27 date assigned by the FDA.

The analyst recommended owning GW Pharmaceuticals shares into the Epidiolex launch, assuming widespread off-label use per physician feedback and optionality from Epidiolex Phase 2/3 Part A data in infantile spasms in the second quarter of 2018.

He reiterated a Buy rating and $177 price target on the stock.

Meanwhile, his peer at #Leerink told investors in a research note of his own that his review of the meeting materials suggests that the FDA is likely to approve Epidiolex, and the outcome of the advisory panel vote on April 19 should be positive.

Additionally, analyst Geoffrey Porges argued that Epidiolex’ review bodes well for Zogenix’ (ZGNX) ZX0008. The latter’s unprecedented efficacy in reducing seizures will allow it to gain significant market share within its first 12 months of approval, he contended.

PRICE ACTION

Shares of GW gained about 11% yesterday following the release of the documents, though they have given back about 2% in Wednesday’s trading to trade near $131 per share.


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Alkermes lower following FDA action

Alkermes announces FDA Refusal to File letter received for ALKS 5461

Alkermes announces FDA Refusal to File letter received for ALKS 5461. Stockwinners
Alkermes announces FDA Refusal to File letter received for ALKS 5461.

Alkermes (ALKS) announced that it received a Refusal to File letter from the U.S. Food and Drug Administration regarding its New Drug Application for ALKS 5461, a once-daily, oral investigational medicine with a novel mechanism of action for the adjunctive treatment of major depressive disorder in patients with an inadequate response to standard antidepressant therapies.

Upon its preliminary review, the FDA has taken the position that it is unable to complete a substantive review of the regulatory package, based on insufficient evidence of overall effectiveness for the proposed indication, and that additional well-controlled clinical trials are needed prior to the resubmission of the NDA for ALKS 5461.

In addition, FDA has requested the conduct of a bioavailability study to generate additional bridging data between ALKS 5461 and the reference listed drug, buprenorphine.

Alkermes said it strongly disagrees with the FDA’s conclusions and plans to appeal the FDA’s decision.

The company intends to seek immediate guidance, including requesting a Type A meeting with the FDA, to determine appropriate next steps and what additional information may be required to resubmit the NDA.

Alkermes is evaluating the impact of this update on its previously-issued financial guidance for 2018; any update will be provided in its first quarter 2018 financial results disclosures.

Alkermes CEO Richard Pops said: “We strongly believe that the clinical development program, including data from more than 1,500 patients with MDD, provides substantial evidence of ALKS 5461’s consistent antidepressant activity and a favorable benefit-risk profile.”

PRICE ACTION

ALKS closed at $57.96, it last traded at $47.00.

Shares of Intra-Cellular Therapies (ITCI) are down 9%, or $1.92, to $19.13 in premarket trading. STAT’s Adam Feuerstein tweeted following the Alkermes news, “Anyone confident in $ITCI now? I wouldn’t be.”

Intra-Cellular on March announced that it had a “positive” pre-New Drug Application meeting with the FDA regarding lumateperone for the treatment of schizophrenia.

At the meeting, the company and the FDA agreed on the proposed content and timing of a rolling NDA submission. The company plans to complete its NDA submission by mid-2018.


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Valeant higher amid debt offering, insider buying

Valeant moves higher amid debt offering, insider buying

Insurers are dropping Valeant's top products. See Stockwinners.com Market RadarValeant moves higher amid debt offering, insider buying

Shares of specialty pharmacy company Valeant (VRX) are higher this afternoon amid a relatively weak market backdrop.

DEBT OFFERING

On March 12, Valeant announced a private offering of $1.25B aggregate principal amount of unsecured senior notes due 2026. The proceeds of the newest offering will help fund the repurchase of $1.25B of outstanding debt, including its 6.375% Senior Notes due 2020, 5.375% Senior Notes due 2020 and up to $100M of its 6.750% Senior Notes due 2021.

Wells Fargo analyst David #Maris said earlier this week that less than two weeks after filing a shelf offering, Valeant Pharmaceuticals launched a $1.25B offering of unsecured senior notes due 2026.

Based on discussions with his firm’s high yield debt analyst, Maris estimates the debt likely has a 9%-plus coupon.

Valeant is looking to push out 2020 maturities, which may be reflective of its business outlook for the period between now and maturity, Maris told investors earlier in the week.

INSIDER BUYING

In a regulatory filing after the close of trading Tuesday night, Valeant chairman and CEO Joseph Papa disclosed the purchase of 30,000 common shares of the company at a price of $16.05 per share.

EARNINGS

Late in February, Valeant reported adjusted EBITDA was $875M for Q4, as compared to $1.047B for Q4 of 2016, a decrease of $172M. Revenue for Q4 was $2.16B, just below forecasts for $2.2B.

Unfortunately, Valeant also said it expects sales of $8.1B-$8.3B in 2018, below the $8.37B consensus. Shares of the drug maker dropped precipitously after the recent earnings report.

ANALYSTS ON EARNINGS

Soon after Valeant’s Q4 results, Wells Fargo analyst David Maris said Valeant reported “weak” Q4 results, noting that when adjusted for divestitures, two of the company’s three business units showed revenue declines and the third, B&L/International, had a slowdown from Q3 to “only” 4% growth.

Valeant didn’t give an adjusted EPS figure, but he calculates its Q4 adjusted EPS at 98c, compared to his 99c estimate and consensus of 97c. Maris, who said at the time, he does not see “the stabilization, the turnaround, or the transformation Valeant mentions in its earnings presentation.”

Maris kept an Underperform rating on the stock.

PRICE ACTION

Shares of Valeant are up 5.7% to $16.99.


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Intra-Cellular announces ‘positive’ pre-NDA meeting with FDA

Intra-Cellular announces ‘positive’ pre-NDA meeting with FDA for lumateperone

 

Intra-Cellular to move forward with lumateperone long-term safety study. See Stockwinners.com Market Radar for details
Intra-Cellular announces ‘positive’ pre-NDA meeting with FDA

 

Intra-Cellular Therapies (ITCI) announced that the company had a positive pre-New Drug Application meeting with the U.S. Food and Drug Administration regarding lumateperone for the treatment of schizophrenia.

 

At the meeting, the company and the FDA agreed on the proposed content and timing of a rolling NDA submission.
As previously announced, the company plans to complete its NDA submission by mid-2018.

 

In 2017 the FDA granted Fast Track designation for lumateperone for the treatment of schizophrenia.

 

The company requested Fast Track designation for lumateperone based on clinical evidence that lumateperone has the potential to address unmet medical needs for the treatment of schizophrenia.

 

Lumateperone (developmental code names ITI-007ITI-722) is an investigational atypical antipsychotic which is currently under development by Intra-Cellular Therapies, licensed from Bristol-Myers Squibb, for the treatment of schizophrenia It is also being developed for the treatment of bipolar disorder, depression, and sleep and behavioral disturbance in dementia, autism, and other neuropsychiatric disorders.

 

ITCI closed at $23.46.

 


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