Esperion Therapeutics higher on cholesterol data

Esperion announces JAMA publication of results of Phase 3 study of bempedoic acid

Esperion Therapeutics (ESPR) announce that the results from the 779 patient, 52 week, Phase 3, double-blind, randomized placebo-controlled study of bempedoic acid were published in the Journal of the American Medical Association.

Esperion announces 'positive' top-line results from bempedoic acid study, Stockwinners.com
Esperion announces ‘positive’ results from bempedoic acid study, Stockwinners

Bempedoic acid is being developed as a, convenient, once-daily, oral therapy for the treatment of patients with elevated low-density lipoprotein cholesterol added onto maximally tolerated statin therapy.

Bempedoic acid and the bempedoic acid 180 mg + ezetimibe 10 mg fixed dose combination tablets’ new drug applications are currently under regulatory review by the U.S. Food and Drug Administration, and the marketing authorisation applications are currently under centralized review by the European Medicines Agency.

Bempedoic acid in action, Stockwinners

Study 2 evaluated the long-term safety, tolerability and efficacy, of bempedoic acid 180 mg versus placebo in 779 patients with atherosclerotic cardiovascular disease and/or heterozygous familial hypercholesterolemia inadequately controlled with current lipid-modifying therapies, added-on to maximally tolerated statin therapy, which may mean no statin at all.

The JAMA publication includes results from the primary efficacy endpoint of LDL-C lowering at 12-weeks and key secondary endpoints of safety and tolerability over 52-weeks, including that bempedoic acid: significantly lowered LDL-cholesterol by 17 percent on background maximally tolerated statin therapy at 12 weeks, and the effect was durable through 52-weeks; significantly lowered high-sensitivity C-reactive protein, an important marker of the underlying inflammation associated with cardiovascular disease, by 19 percent, and the effect was durable through 52-weeks; reduced hemoglobin A1c by 0.21% vs. placebo in patients with diabetes at 12 weeks, favorable glycemic control and less worsening of diabetes persisted over the 52-week treatment period.

The study showed overall adverse event rates comparable with placebo at 52 weeks, and the proportion of patients with reported serious adverse events was similar compared with placebo at 52 weeks; and showed adjudicated 3-component major adverse cardiac event rates of 2.7% with BA and 4.7% with placebo.

“The CLEAR Wisdom trial demonstrated that bempedoic acid provided additional LDL-cholesterol lowering in patients on background maximally tolerated statin therapy and had an overall adverse event profile that was comparable to placebo,” said Anne C. Goldberg MD, FACP, FAHA, FNLA, Professor of Medicine, Division of Endocrinology, Metabolism and Lipid Research at Washington University, St. Louis and lead study author.

ESPR +$2.42 to $41.14.

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William Lyon Homes sold for $2.4B

Taylor Morrison to acquire William Lyon Homes for $21.45/share in cash and stock

Taylor Morrison Home (TMHC) and William Lyon Homes (WLH) announced they have entered into a definitive agreement pursuant to which Taylor Morrison will acquire all of the outstanding shares of William Lyon Homes common stock for per share consideration of $2.50 in cash and 0.800 shares of Taylor Morrison common stock, implying a company value for William Lyon Homes of $21.45 per share or $2.4B including assumption of debt.

William Lyon Homes sold for $2.4B in stock, Stockwinners

The transaction consideration mix consists of approximately 90% Taylor Morrison stock and 10% cash.

Based on current trading, Taylor Morrison stockholders will own approximately 77% of the combined company while William Lyon Homes stockholders will own approximately 23%.

The transaction has been unanimously approved by the Boards of Directors of both Taylor Morrison and William Lyon Homes and will be submitted to the stockholders of William Lyon Homes for approval.

Taylor Morrison Home buys William Lyon Homes to expand its footprint, Stockwinners

William Lyon Homes designs, constructs, markets, and sells single-family detached and attached homes in California, Arizona, Nevada, Colorado, Washington, Oregon, and Texas. It sells its homes primarily to entry-level, first-time move-up, and second-time move-up homebuyers. 

Taylor Morrison Home Corporation operates as a public homebuilder in the United States. The company designs, builds, and sells single-family and multi-family attached and detached homes; and develops lifestyle and master-planned communities. It operates under the Taylor Morrison and Darling Homes brand names in Arizona, California, Colorado, Florida, Georgia, Illinois, North Carolina and Texas. 

The issuance of shares of Taylor Morrison common stock in the transaction will also be submitted to the stockholders of Taylor Morrison for approval.

The transaction is expected to close late in the first quarter or early in the second quarter of 2020 and the closing is subject to the satisfaction of customary closing conditions.

William H. Lyon, executive chairman and chairman of the board and holder of approximately 42 percent of the voting power of William Lyon Homes common stock, has agreed to vote all of the shares of William Lyon Homes common stock controlled by him in support of the transaction.

“The strategic combination creates the nation’s fifth largest homebuilder based on the last 12 months of closings, and firmly places Taylor Morrison in a Top 5 position in 16 of the combined 23 markets with an estimated 14,200 closings for the pro forma combined company,” the companies stated.

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Cision sold for $10 per share

Cision to be acquired by Platinum Equity affiliate in deal valued at $2.74B

Cision (CISN) announced that it has entered into a definitive agreement to be acquired by an affiliate of Platinum Equity in an all cash transaction valued at approximately $2.74B.

Cision sold for $2.74B, Stockwinners

Under the terms of the agreement, which has been unanimously approved by the members of Cision Ltd.’s board of directors, an affiliate of Platinum Equity will acquire all of the outstanding ordinary shares of Cision Ltd. for $10.00 per share in cash.

The purchase price represents a 34% premium over Cision Ltd.’s 60-day volume-weighted average price ended on October 21, 2019.

A special meeting of Cision Ltd.’s shareholders will be held as soon as practicable following the filing of a definitive proxy statement with the U.S. Securities and Exchange Commission (“SEC”) and subsequent mailing to its shareholders.

Certain affiliates of GTCR, collectively holding approximately 34% of the outstanding shares of Cision Ltd., have entered into a voting agreement committing them to, among other things, vote in favor of adopting the acquisition agreement.

The proposed transaction is expected to close in the first quarter of 2020 and is subject to approval by Cision Ltd.’s shareholders, along with the satisfaction of customary closing conditions and antitrust regulatory approvals, as necessary.

Cision Ltd. provides public relations (PR) software, media distribution, media intelligence, and related professional services to businesses worldwide. The company enables public relations and communications professionals to manage, execute, and measure their strategic PR and communications programs.

Upon completion of the acquisition, Cision Ltd. will become wholly owned by an affiliate of Platinum Equity.

Cision Ltd. may solicit alternative acquisition proposals from third parties during a “go-shop” period from the date of the agreement until November 12, 2019.

There is no guarantee that this process will result in a superior proposal, and the agreement provides Platinum Equity with a customary right to match a superior proposal and termination fee if a superior proposal is accepted.

Cision Ltd. does not intend to disclose developments with respect to the solicitation process unless and until the company determines such disclosure is appropriate.

“This transaction will provide shareholders with immediate and substantial cash value, while also providing us with a partner that shares in our commitment to customers and employees and can add strategic and operational value,” said Kevin Akeroyd, Cision’s CEO.

“Based on our extensive engagement with Platinum over the past several months, we are confident that Platinum’s support will enable Cision to execute on its strategy and next phase of growth.”

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Watch Shares of Adverum Biotechnologies!

Adverum Biotechnologies reports additional data from Phase 1 trial of ADVM-022

Adverum Biotechnologies (ADVM) announced additional clinical data for the first cohort of patients in the ongoing OPTIC phase 1 clinical trial of ADVM-022, the company’s intravitreal injection gene therapy, in treatment-experienced patients with wet age-related macular degeneration.

Adverum Biotechnologies reports additional data from Phase 1 trial of ADVM-022 in patients with wet age-related macular degeneration, Stockwinners

Adverum also announced enrollment plans for the third and fourth cohorts in the ongoing OPTIC trial.

The third cohort has been initiated and patients will be treated with ADVM-022 at a dose of 2 x 10^11 vg/eye, the same dose used in the second cohort.

Subsequently, patients in the fourth cohort will be treated with ADVM-022 at a dose of 6×10^11 vg/eye, the same dose used in the first cohort.

Since inflammation has generally been mild and responsive to steroid eye drops, patients in the third and fourth cohorts will receive prophylactic steroid eye drops instead of prophylactic oral steroids.

Previously, on September 12, 2019, Adverum presented data from the first cohort in the ongoing OPTIC trial at a pre-specified 24-week time point.

Wet and Dry Macular Degeneration, Stockwinners

The additional data for this cohort includes key outcomes with a median follow-up of 34 weeks.

In treatment-experienced patients previously requiring frequent anti-VEGF injections to maintain vision, the data continue to demonstrate that the single ADVM-022 injection in this cohort was sufficient to maintain vision, with zero rescue injections required for any of the six patients.

Aaron Osborne, MBBS, chief medical officer of Adverum, added, “The clinical profile of ADVM-022 demonstrates this gene therapy’s potential to be a significant advance for patients with wet AMD. It is very encouraging that there continues to be zero rescue injections in this cohort of treatment-experienced patients with more than 6 months follow-up on all patients. We are expanding the development of ADVM-022 and are excited to share that enrollment is now open for the third cohort in OPTIC.

We look forward to being able to deliver this novel intravitreal gene therapy candidate as soon as possible to patients with wet AMD and diabetic retinopathy, our second indication for ADVM-022. We are grateful for all of the investigators, patients, and caregivers who continue to participate in the OPTIC trial.”

Adverum plans to begin dosing patients in the third cohort of the OPTIC trial in the fourth quarter of 2019 and plans to begin enrollment in the fourth cohort in the first quarter of 2020.

Adverum plans to present 52-week data from the first cohort of patients in the OPTIC trial as well as 24-week data from the second cohort of patients in the first half of 2020.

Adverum plans to submit an investigational new drug application for the treatment of ADVM-022 in diabetic retinopathy in the first half of 2020.

Piper Jaffray

Commenting on Adverum Biotechnologies update at AAO, Piper Jaffray analyst Tyler Van Buren notes that zero rescue injections have been required and disease activity by OCT and visual acuity has been maintained with 6 ADVM-022 patients now out to a median of 34 weeks.

Importantly, despite the intense criticism over inflammation and visual acuity fluctuations during the initial data disclosure last month, numerous KOLs at the conference were unconcerned and believe that ADVM-022 looks like a potential treatment option so far, he contends.

Overall, the analyst argues that safety continues to be clean in these initial patients and looks forward to the 52-week update in first half of 2020.

Van Buren reiterates an Overweight rating and $14 price target on the shares as ADVM-022 continues to look like a viable gene therapy candidate for wet AMD, which has $1B-plus potential.

ADVM closed at $5.29.

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FDA panel approves Aimmune Therapeutics’ peanut allergy treatment

FDA Panel approves peanut allergy treatment, Stockwinners

A Food and Drug Administration panel voted 8-1 in favor of the benefits of Aimmune Therapeutics’ (AIMT) peanut allergy treatment outweigh the risks. The panel also voted 8-1 in favor of the drug’s safety. The body of independent advisers voted 7-2 in favor of effectiveness.

If approved, Palforzia could come with a Risk Evaluation and Mitigation Strategy, or REMS. A REMS includes special steps a physician must take when prescribing a medication to limit serious side effects.

Side effects are key when it comes to Palforzia. In a key study, 11.6% of patients who received the peanut allergy treatment dropped out due to side effects vs. 2.4% of patients who took a placebo. Further, Palforzia patients needed emergency allergy shots more frequently.

Peanut allergy is expected to be a $3.9B market by 2027, Stockwinners

The advisory committee vote is not binding, but is a recommendation to the full FDA.

Peanut allergies are the leading cause of death from food-induced allergic reactions in the United States but a lack of approved preventive treatments has left patients and caregivers desperate for options.

Palforzia, previously known as AR101, is an oral immunotherapy consisting of fixed doses of powdered peanut that is sprinkled over food daily.

While it does not aim to cure peanut allergy, the treatment’s clinical trials have shown that patients consuming small doses of the substance to which they are allergic become desensitized over time, reducing the likelihood or severity of a reaction to it.

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If approved, Palforzia is expected to have a black box warning, the FDA’s harshest, and strict restrictions requiring the therapy to be administered in a certified facility.

Aimmune expects to win approval for use of Palforzia in patients aged 4 to 17 and said it is considering a list price range of between $3,000 and $20,000 a year.

Analyst Comments

Piper Jaffray analyst Christopher Raymond kept an Overweight rating and $60 price target on Aimmune after an FDA’s Allergenic Products Advisory Committee, or APAC, voted in favor of the company’s AR101 peanut allergy drug on both efficacy and safety.

The analyst said, after the vote, he “increasingly likes the chances for Palforzia approval by late January 2020 (if not sooner).” Raymond noted that the stock is likely to open sharply higher on Monday as there is a 30% short interest in Aimmune, and said he is a buyer on the open as he sees “a lot of room to go.”

AIMT last traded at $24.67.

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Intercept falls on NASH study

Intercept falls after releasing ‘supportive data’ from Phase 3 NASH study

Intercept Pharmaceuticals (ICPT) overnight announced additional “supportive data” from its Phase 3 Regenerate study of obeticholic acid in patients with liver fibrosis due to nonalcoholic steatohepatitis.

stockwinners.com ICPT

Intercept falls after releasing ‘supportive data’ from Phase 3 NASH study, Stockwinners

Nonalcoholic steatohepatitis (NASH) is liver inflammation and damage caused by a buildup of fat in the liver. It is part of a group of conditions called nonalcoholic fatty liver disease. You may be told you have a “fatty liver.”

The new data based on additional analyses show that obeticholic acid “demonstrated robust efficacy across a range of additional histologic and biochemical parameters,” Intercept said in a statement.

The data are being presented today at the International Liver Congress in Vienna, Austria.

The primary efficacy analysis assessed efficacy at 18 months in 931 patients with stage 2 or 3 liver fibrosis due to NASH.

Patients with biopsy proven NASH with fibrosis were randomized 1:1:1 to receive placebo, OCA 10 mg or OCA 25 mg once daily.

A repeat biopsy was conducted after 18 months for histologic endpoint assessment.

Overall, study discontinuations in the primary efficacy analysis population were balanced across treatment groups.

As previously reported, in the primary efficacy analysis, once-daily OCA 25 mg met the primary endpoint of fibrosis improvement with no worsening of NASH in 23.1% of patients compared to 11.9% of placebo patients at the planned 18-month interim analysis, the company said.

In the primary efficacy analysis, a numerically greater proportion of patients in both OCA treatment groups compared to placebo achieved the primary endpoint of NASH resolution with no worsening of liver fibrosis; however, this did not reach statistical significance.

As agreed with the FDA, in order for the primary objective to be met, the study was required to achieve one of the two primary endpoints, it added.

Additional supportive efficacy analyses were conducted using the per protocol population.

Approximately three-fold more patients in the OCA 25 mg group achieved an improvement of fibrosis by greater than or equal to 2 stages compared to placebo, Intercept reported.

ICPT is down 12%, or $14.14, to $106.54.

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Advaxis jumps on its prostate cancer drug data

Advaxis says ADXS-PSA in combination with KEYTRUDA prolonged survival in mCRPC

Advaxis jumps on its prostate cancer drug data, Stockwinners

Advaxis (ADXS) announced updated data from the Phase 1/2 KEYNOTE-046 study in metastatic, castration-resistant prostate cancer.

Castrate-resistant prostate cancer refers to prostate cancer that keeps growing even when the amount of testosterone in the body is reduced to very low levels. Many early-stage prostate cancers need normal levels of testosterone to grow, but castrate-resistant prostate cancers do not. 

Androgens are required for normal growth and function of the prostate. Androgens are also necessary for prostate cancers to grow. Androgens promote the growth of both normal and cancerous prostate cells by binding to and activating the androgen receptor, a protein that is expressed in prostate cells Once activated, the androgen receptor stimulates the expression of specific genes that cause prostate cells to grow .

Early in their development, prostate cancers need relatively high levels of androgens to grow. Such prostate cancers are called castration sensitive, androgen dependent, or androgen sensitive because treatments that decrease androgen levels or block androgen activity can inhibit their growth.

This trial is being conducted in conjunction with Merck (MRK) and is evaluating ADXS-PSA, one of Advaxis’ Listeria monocytogenes-based immunotherapies, alone and in combination with KEYTRUDA, Merck’s anti-PD-1 therapy.

Findings will be highlighted in a poster discussion entitled “Effects of ADXS-PSA with or without Pembrolizumab on Survival and Antigen Spreading in Metastatic, Castration-Resistant Prostate Cancer Patients” at the American Association for Cancer Research Annual Meeting underway in Atlanta.

KEYNOTE-046 is an open-label, multicenter, dose-determining safety and tolerability Phase 1/2 trial of 50 heavily pretreated patients conducted in two parts, with a Phase 2 expansion cohort. The objective of the study is to evaluate ADXS-PSA alone and in combination with KEYTRUDA for primary endpoints that include safety, tolerability and dosing.

Secondary endpoints include anti-tumor activity and progression-free survival, and exploratory endpoints include associations between biomarkers of immunologic response with clinical outcomes.

Key findings from the combination arm of KEYNOTE-046 include the following: The majority of treatment-related adverse events consisted of transient and reversible Grade 1-2 chills/rigors, fever, hypotension, nausea and fatigue.

The combination of ADXS-PSA and pembrolizumab has been well-tolerated, to date, with no additive toxicity observed. Median overall survival was 21.1 months at data cutoff in this dataset of 37 patients.

Correlative immune analyses showed T-cell responses against PSA in 75% of subjects and antigen spreading in 85% of subjects. Broader immune stimulation, including B-cell activation, was observed in the combination arm than in the ADXS-PSA monotherapy arm.

ADXS closed at $5.91, it last traded at $8.15. MRK closed at $83.17.

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Tribune to buy nineteen stations from Nexstar

Nexstar enters agreements to divest nineteen stations for $1.32B

Nexstar to sell 19 stations, Stockwinners

Nexstar Media Group (NXST) and Tribune Media Company (TRCO) announced that Nexstar has entered into definitive agreements to sell a total of nineteen stations in fifteen markets for an aggregate $1.32B in cash following the acquisition of Tribune Media by Nexstar.

Under the terms of the agreements, TEGNA Inc. (TGNA) will acquire eleven stations in eight markets for $740M and The E.W. Scripps Company (SSP) will acquire eight stations in seven markets for $580M.

Separately, Nexstar remains engaged in active negotiations to divest two stations in Indianapolis, Indiana. On December 3, 2018, Nexstar and Tribune Media entered into a definitive merger agreement whereby Nexstar will acquire all outstanding shares of Tribune Media.

Nexstar agrees to acquire Tribune Media, Stockwinners
Nexstar agrees to sell stations from Tribune, Stockwinners

The planned divestiture of nineteen stations reflects Nexstar’s stated intention to divest certain television stations in order to comply with the FCC local and national television ownership rules and to obtain FCC and Department of Justice approval of the proposed Nexstar / Tribune Media transaction.

Nexstar intends to use the net proceeds from the divestitures to fund the Tribune acquisition and to reduce debt.

Given that the net proceeds from the divestitures exceed those initially estimated at the time the transaction was announced, Nexstar now estimates that net leverage at the closing of the transaction will be reduced to approximately 5.1x.

The planned divestiture of the nineteen stations is subject to FCC approval, other regulatory approvals, the closing of the Nexstar / Tribune Media transaction and other customary closing conditions and is expected to be completed on, or about the time of, the closing of the Nexstar / Tribune Media transaction, which is expected later this year.

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ExxonMobil to increase its Permian Basin output

Exxon Mobil to increase Permian output to 1M barrels per day by 2024

ExxonMobil to increase its Permian Basin output, Stockwinners

ExxonMobil (XOM) said it has revised its Permian Basin growth plans to produce more than 1 million oil-equivalent barrels per day by as early as 2024 – an increase of nearly 80 percent and a significant acceleration of value.

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ExxonMobil expects to make 10% return on its Permian Basin fields at $35 per barrel oil, Stockwinners

The size of the company’s resource base in the Permian is approximately 10 billion oil-equivalent barrels and is likely to grow further as analysis and development activities continue.

ExxonMobil’s investments in the Permian Basin are expected to produce double-digit returns, even at low oil prices.

At a $35 per barrel oil price, for example, Permian production will have an average return of more than 10 percent.

The anticipated increase in production will be supported by further evaluation of ExxonMobil’s Delaware Basin’s increased resource size, infrastructure development plans, and secured capacity to transport oil and gas to ExxonMobil’s Gulf Coast refineries and petrochemical operations through the Wink-to-Webster, Permian Highway and Double E pipelines.

Among the company’s key advantages in the Permian, is its acreage position.

The company has large, contiguous acreage that enables multi-well pads in large development corridors connecting to efficient gathering systems, reducing development costs and accelerating production growth.

ExxonMobil’s scale, financial capacity and technical capabilities enable the company to maximize the value of the resource. ExxonMobil is actively building infrastructure to support volume growth.

Plans include construction at 30 sites to enhance oil and gas processing, water handling and ensure takeaway capacity from the basin. Construction activities include central delivery facilities designed to handle up to 600,000 barrels of oil and 1 billion cubic feet of gas per day and enhanced water-handling capacity through 350 miles of already-constructed pipeline.

The investment plans will also bring great benefits to the local area. ExxonMobil’s expansion in the region will benefit communities in West Texas and southeast New Mexico through billions in property tax revenue, economic development and the creation of high-paying jobs.

ExxonMobil remains one of the most active operators in the Permian Basin and has 48 drilling rigs currently in operation and plans to increase its rig count to approximately 55 by the end of the year.

Increased use of technology, including enhanced subsurface characterization, subsurface modeling and advanced data analytics to support optimization and automation, will help the company reduce costs, improve its development plan and increase resource recovery.

Crude oil is up 5 cents to $56.64 per barrel. XOM last traded at $80.22.

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Kraft Heinz shares tumble 28 percent

Kraft Heinz says SEC probing procurement accounting policies

The company (KHC) said in a filing it received a subpoena in October 2018 from the SEC associated with an investigation into the company’s procurement area, more specifically the company’s accounting policies, procedures, and internal controls related to its procurement function, including, but not limited to, agreements, side agreements, and changes or modifications to its agreements with its vendors.

Kraft Heinz shares tumble 28% on SEC investigation, Dividends cut, Stockwinners

Kraft Heinz confirms quarterly dividend cut to 40c from 62.5c per share

The Board of Directors of The Kraft Heinz Company declared a regular quarterly dividend of 40c per share of common stock payable on March 22 to stockholders of record as of March 8.

This represents a reduction of 22.5c from the company’s previous quarterly dividend of 62.5c.

“We believe this action will help us accelerate our deleveraging plan, provide us strategic advantage through a stronger balance sheet, support commercial investments and set a payout level that can both grow over time and accommodate additional divestitures.

By doing this we can improve our growth and returns over time,” said Kraft Heinz CEO Bernardo Hees.

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Buffett loses $4.4billion on Friday, See Stockwinners

Warren’s Loss

Warren Buffett’s Berkshire Hathaway owned 325,634,818 shares of Kraft Heinz as of Dec. 31, according to the latest 13-F filing with the Securities and Exchange Commission. That represented about 26.7% of the shares outstanding, while the value of the holding was just under 8% of Berkshire’s total equity holdings.

If Berkshire’s stake remained intact, it would be worth about $4.4 billion less than it was the day before. And you thought you had a bad day in the market?!?

Berkshire’s stake in Kraft Heinz has been the same since the third quarter of 2015, according to SEC filings.

Before that, filings showed ownership of just 192,666 shares of Kraft Foods Group Inc. and 578,000 shares of Mondelez.

Since Sept. 30, 2015, the stock has now plummeted 50.9%. That indicates Berkshire’s investment has lost $11.7 billion in principal value since then, including an $11.3 billion loss in 2018 alone.

KHC is down 28% to $34.75.

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Achieve Life Sciences higher on smoking data

Achieve Life Sciences announces final data from cytisinicline study

Achieve Life Sciences (ACHV) announced final data from their Phase I/II multi-dose, pharmacokinetic and pharmacodynamics, or PK/PD, clinical study of cytisinicline in smokers.

The study evaluated the repeat-dose PK and PD effects of 1.5 mg and 3 mg cytisinicline in 26 healthy volunteer smokers when administered over the standard 25-day course of treatment.

Smokers in the study had a mean age of 39 years, smoked on average 17.2 cigarettes a day, and were not required to quit smoking or have a predetermined quit date while on study.

All subjects had a significant and immediate reduction in cigarettes smoked within 2 days of initiating cytisinicline treatment.

By Day 26, subjects had an average 80% reduction in cigarettes smoked, 82% reduction in expired carbon monoxide, and 46% had stopped smoking.

The biochemically verified smoking cessation rates were 39% and 54% in the 1.5 mg and 3.0 mg cytisinicline treated groups, respectively.

The PK results indicated expected increases in plasma concentration between the standard 1.5 mg and higher 3.0 mg doses of cytisinicline with no evidence of drug accumulation.

Cytisinicline at either dose was well tolerated with only transient, mild-to-moderate headache as the most common adverse event, which was not treatment limiting. No adverse events were severe, serious, or led to withdrawal from the study.

Cindy Jacobs, CMO at Achieve commented, “Given the short 25-day treatment period, the abstinence rates observed are impressive, particularly since subjects were not required to commit to quitting and received minimal behavioral support during the study. These results continue to support our belief that cytisinicline could be a well-tolerated and effective potential treatment option for the millions of people who are battling nicotine addiction.”

ACHV closed at $1.81, it last traded at $2.88.

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Tribune Media sold for $6.4 billion

Nexstar to acquire Tribune Media for $46.50 per share

Nexstar agrees to acquire Tribune Media, Stockwinners
Nexstar agrees to acquire Tribune Media, Stockwinners

Nexstar Media Group (NXST) and Tribune Media (TRCO) announced that they have entered into a definitive merger agreement whereby Nexstar will acquire all outstanding shares of Tribune Media for $46.50 per share in a cash transaction that is valued at $6.4B including the assumption of Tribune Media’s outstanding debt.
The transaction reflects a 15.5% premium for Tribune Media shareholders based on its closing price on November 30, 2018, and a 45% premium to Tribune Media’s closing price on July 16, 2018, the day the FCC Chairman issued a public statement regarding his intention to circulate a Hearing Designation Order for Tribune Media’s previously announced transaction with a third party.
Tribune Media shareholders will be entitled to additional cash consideration of approximately 30c per month if the transaction has not closed by August 31, 2019, pro-rated for partial months and less an adjustment for any dividends declared on or after September 1, 2019.
The transaction has been approved by the boards of directors of both companies and is expected to close late in the third quarter of 2019, subject to receipt of required regulatory approvals and satisfaction of other customary closing conditions.
Upon closing, the transaction is expected to be immediately accretive to Nexstar’s operating results inclusive of expected operating synergies of approximately $160M in the first year following the completion of the transaction and planned divestitures.
The proposed transaction will combine two leading local media companies with complementary national coverage and will reach approximately 39% of U.S. television households pro-forma for anticipated divestitures and reflecting the FCC’s UHF discount.
The transaction is not subject to any financing condition and Nexstar has received committed financing for the transaction from BofA Merrill Lynch, Credit Suisse and Deutsche Bank. Completion of the transaction is subject to approval by Tribune’s shareholders, as well as customary closing conditions, including approval by the FCC, and satisfaction of antitrust conditions.

Nexstar intends to divest certain television stations necessary to comply with regulatory ownership limits and may also divest other assets which it deems to be non-core. All after-tax proceeds from such asset sales are expected to be applied to leverage reduction.


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Cinedigm to acquire ComicBlitz 

Cinedigm to acquire ComicBlitz 

 

Cinedigm to acquire ComicBlitz , Stockwinners
Cinedigm to acquire ComicBlitz , Stockwinners

Cinedigm (CIDM) announced an agreement to acquire the digital comic book service ComicBlitz, which will provide access to approximately 10,000 digital comic books, with more than 175,000 pages of content from a growing network of 30 or more publishers.

#ComicBlitz content will be distributed globally as a licensed offering for mobile carriers, OTT providers and other media companies.

It will also be integrated with Cinedigm’s existing and planned OTT services, including the fandom lifestyle network CONtv.

Cinedigm expects that the acquisition will close before the end of the year. Cinedigm plans on rapidly enhancing ComicBlitz’s content and services offering by leveraging Cinedigm’s forthcoming, next-generation technology platform and expects to service global distribution of the ComicBlitz content and platform offerings alongside Cinedigm’s existing footprint of nine OTT channel offerings.

From a business perspective, the transaction is expected to generate revenues through content licensing, subscription and advertising revenues, new distribution platform partnerships and by accelerating global expansion of Cinedigm’s OTT business.

Cinedigm expects the acquisition will be accretive within the first quarter following closing, pending certain license deals currently in negotiation. The deal could be expected to generate more than $5M in incremental annual digital revenues within 18-24 months after closing, if new platform and licensing agreements related to this acquisition are consummated.

This deal will support Cinedigm’s strategy to provide high quality turn-key offerings to third party platforms on a global scale through acquisition and partnerships.

It will also provide a deep portfolio of quality comic book offerings that significantly broadens the company’s content portfolio for highly sought after fandom audiences worldwide.

The worldwide digital comic book and graphic novel market is estimated at over $1B in annual sales. Launched in 2015, ComicBlitz has a distribution footprint of over 133 countries, with key penetration in North America and major territories including the United Kingdom, Australia, India, Mexico, Brazil and Germany.


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Athenahealth sold for $5.7 billion

Athenahealth to be acquired by Veritas Capital for $135 per share in cash

Athenahealth sold for $5.7 billion, Stockwinners
Athenahealth sold for $5.7 billion, Stockwinners

Athenahealth (ATHN), Veritas Capital and Evergreen Coast Capital, announced that they have entered into a definitive agreement under which an affiliate of Veritas and Evergreen will acquire athenahealth for approximately $5.7B in cash.

Under the terms of the agreement, athenahealth shareholders will receive $135 in cash per share.

The per share purchase price represents a premium of approximately 12% over the company’s closing stock price on November 9, 2018, the last trading day prior to today’s announcement, and a premium of approximately 27 percent over the company’s closing stock price on May 17, 2017, the day prior to Elliott Management Corporation’s announcement that it had acquired an approximate 9% interest in the company.

Following the closing, Veritas and Evergreen expect to combine athenahealth with Virence Health, the GE Healthcare Value-based Care assets that Veritas acquired earlier this year.

The combined business is expected to be a leading, privately-held healthcare information technology company with an extensive national provider network of customers and world-class products and solutions to help them thrive in an increasingly complex environment.

Following the close of that transaction, the combined company is expected to operate under the athenahealth brand and be headquartered in Watertown, Massachusetts.

The company will be led by Virence Chairman and Chief Executive Officer Bob Segert and an executive leadership team comprised of executives from both companies.

Following the completion of the transaction, Virence’s Workforce Management business will become a separate Veritas portfolio company under the API Healthcare brand.

Athenahealth investor Elliott Management has expressed support for the transaction.

Elliott Partner Jesse Cohn said, “We are pleased to support this transformative transaction combining athenahealth and Virence, which we believe represents an outstanding, value-maximizing outcome for athenahealth shareholders.”

Upon completion of the transaction, Elliott’s private equity subsidiary, Evergreen Coast Capital, will retain a minority investment stake in the combined company.

The transaction is expected to close in the first quarter of 2019, subject to the approval of the holders of a majority of athenahealth’s outstanding shares and the satisfaction of customary closing conditions and regulatory approvals.

The athenahealth Board of Directors has unanimously approved the merger agreement and intends to recommend that athenahealth shareholders vote in favor of it at a Special Meeting of Stockholders, to be scheduled as soon as practicable.

The transaction is not subject to a financing condition. In light of today’s announcement and the pending transaction, athenahealth will no longer be hosting its previously announced Q3 2018 earnings call.

ATHN closed at $120.35.


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LSC Communications sold for $1.4 billion

Quad/Graphics to acquire LSC Communications in all-stock deal valued at $1.4B

LSC Communications sold for $1.4 billion, Stockwinners
LSC Communications sold for $1.4 billion, Stockwinners

Quad/Graphics (QUAD) and LSC Communications (LKSD) announced that their boards of directors have approved a definitive agreement whereby Quad will acquire LSC Communications in an all-stock transaction valued at approximately $1.4B, including the refinancing of LSC Communications’ debt.

As of September 30, 2018, the combined company would have had annual revenue of approximately $8B.

The deal is expected to close in mid-2019, and be accretive to earnings, excluding non-recurring integration costs.

Net synergies are expected to be approximately $135M, and will be achieved in less than two years and result in substantial additional Free Cash Flow generation.

Under the terms of the agreement, LSC Communications shareholders will receive 0.625 shares of Quad Class A common stock for each LSC Communications share they own, representing approximately 29 percent total economic ownership of the combined company and approximately 11 percent of the vote of the combined company.

Based on the closing share prices of both companies on October 30, 2018, the merger consideration represents a premium of 34 percent to LSC Communications shareholders.

Quad shareholders will continue to own Class A and Class B shares, representing approximately 71 percent total economic ownership of the combined company and approximately 89 percent total voting power of the combined company.

The transaction supports Quad’s long-term strategic vision by preserving the Quadracci Family leadership and voting control in the company. Quad expects the transaction to be accretive to earnings, excluding non-recurring integration costs.

Net synergies are expected to be approximately $135 million, and will be achieved in less than two years, through the elimination of duplicative functions, capacity rationalization, greater operational efficiencies and greater efficiencies in supply chain management that will also benefit our clients.

Joel Quadracci will be Chairman, President and Chief Executive Officer of the combined company.

Quad will expand its board of directors to include two members from LSC Communications’ existing board.

The transaction is expected to close in mid-2019, subject to approval by Quad and LSC Communications shareholders, regulatory approval and other customary closing conditions.

The Quadracci Family Voting Trust, holder of approximately 64 percent of the voting power of Quad’s outstanding common stock, has entered into a voting agreement with LSC Communications pursuant to which it will vote in favor of the issuance of shares in connection with the transaction.


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