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Shares of cruise line operators Carnival (NYSE:CCL), Norwegian Cruise Line (NYSE:NCLH), and Royal Carribbean (NYSE:RCL) were all soaring by double-digit rates Monday morning.
Carnival opened 11% higher today and Norwegian and Royal were up 15% each.
So what
A series of positive developments inspired hope among cruise ship investors that the worst may be behind the industry and they could extend their rally for a third consecutive trading day.
A cruise ship in open water.
IMAGE SOURCE: GETTY IMAGES.
Federal Reserve Chairman Jerome Powell, who spooked the markets last week with his gloomy economic assessments, seemed to take a softer stance in a 60 Minutes interview Sunday night, suggesting GDP could plunge 30%, but that he didn't foresee an economic depression.
Combined with better news about new COVID-19 cases slowing and more businesses being allowed to reopen to jump-start the economy again, there was a feeling cruise ships may sail on calmer seas sooner rather than later.
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ACB definitely having a great day this far... Great momentum thus far$$$$$$)
Moderna reports positive early vaccine trial results
Yahoo Finance VideoMay 18, 2020, 8:53 AM CDT
Biotechnology company Moderna announced that its early-stage human trial for a coronavirus vaccine produced COVID-19 antibodies in all trail participants.
Just the beginning folks!!!!
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mRNA-1273 provided full protection against viral replication in the lungs in a mouse challenge model
Anticipated dose for Phase 3 study between 25 µg and 100 µg; expected to start in July
Conference call to be held on Monday, May 18 at 8:30 a.m. ET
Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced positive interim clinical data of mRNA-1273, its vaccine candidate against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
Immunogenicity data are currently available for the 25 µg and 100 µg dose level (ages 18-55) after two doses (day 43) and at the 250 µg level (ages 18-55) after one dose (day 29). Dose dependent increases in immunogenicity were seen across the three dose levels, and between prime and boost within the 25 µg and 100 µg dose levels. All participants ages 18-55 (n=15 per cohort) across all three dose levels seroconverted by day 15 after a single dose. At day 43, two weeks following the second dose, at the 25 µg dose level (n=15), levels of binding antibodies were at the levels seen in convalescent sera (blood samples from people who have recovered from COVID-19) tested in the same assay. At day 43, at the 100 µg dose level (n=10), levels of binding antibodies significantly exceeded the levels seen in convalescent sera. Samples are not yet available for remaining participants.
At this time, neutralizing antibody data are available only for the first four participants in each of the 25 µg and 100 µg dose level cohorts. Consistent with the binding antibody data, mRNA-1273 vaccination elicited neutralizing antibodies in all eight of these participants, as measured by plaque reduction neutralization (PRNT) assays against live SARS-CoV-2. The levels of neutralizing antibodies at day 43 were at or above levels generally seen in convalescent sera.
mRNA-1273 was generally safe and well tolerated, with a safety profile consistent with that seen in prior Moderna infectious disease vaccine clinical studies. The sole incidence of a grade 3 adverse event in the 25 µg and 100 µg dose cohorts was a single participant at 100 µg who experienced grade 3 erythema (redness) around the injection site. To date, the most notable adverse events were seen at the 250 µg dose level, comprising three participants with grade 3 systemic symptoms, only following the second dose. All adverse events have been transient and self-resolving. No grade 4 adverse events or serious adverse events have been reported.
Preclinical results from a viral challenge study in mice conducted in collaboration with NIAID and its academic partners are also available. In this study, vaccination with mRNA-1273 prevented viral replication in the lungs of animals challenged with SARS-CoV-2. Neutralizing titers in Phase 1 clinical trial participants at the 25 µg and 100 µg dose levels were consistent with neutralizing titers that were protective in the mouse challenge model.
Based on the interim Phase 1 data, the Moderna-led Phase 2 study will be amended to study two dose levels, 50 µg and 100 µg, with the aim of selecting a dose for pivotal studies. The NIAID-led Phase 1 study is being amended to include a 50 µg dose level cohort across each of the three age groups. Moderna anticipates the dose for the Phase 3 study to be between 25 µg and 100 µg and expects Phase 3 trial initiation in July, subject to finalization of the clinical trial protocol.
"These interim Phase 1 data, while early, demonstrate that vaccination with mRNA-1273 elicits an immune response of the magnitude caused by natural infection starting with a dose as low as 25 µg," said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. "When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralizing antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials."
"With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA," said Stéphane Bancel, Chief Executive Officer at Moderna. "We are investing to scale up manufacturing so we can maximize the number of doses we can produce to help protect as many people as we can from SARS-CoV-2."
Funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273 and will also support the execution of these studies, as well as the scale-up of mRNA-1273 manufacturing both at the Company’s facilities and that of its strategic collaborator, Lonza Ltd.
Conference Call and Webcast Information
Moderna will host a live conference call and webcast at 8:30 a.m. ET on Monday, May 18, 2020. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 2186342. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. The archived webcast will be available on Moderna’s website approximately two hours after the conference call.
About mRNA-1273
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing.
On May 6, the U.S. Food and Drug Administration (FDA) completed its review of the Company’s Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. On May 12, the FDA granted mRNA-1273 Fast Track designation. Moderna is finalizing the protocol for a Phase 3 study, expected to begin in July 2020. A summary of the company’s work to date on SARS-CoV-2 can be found here.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,400 participants have been enrolled in Moderna’s infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia. Clinical data demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production. Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform.
Moderna currently has nine development candidates in its prophylactic vaccines modality, including:
Vaccines against respiratory infections
Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck)
RSV vaccine for young children (mRNA-1345)
Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653)
Novel coronavirus (SARS-CoV-2) vaccine (mRNA-1273)
Influenza H7N9 (mRNA-1851)
Vaccines against infections transmitted from mother to baby
Cytomegalovirus (CMV) vaccine (mRNA-1647)
Zika vaccine (mRNA-1893 with BARDA)
Vaccines against highly prevalent viral infections
Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readouts for seven prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV and Zika). Moderna’s CMV vaccine is currently in a Phase 2 dose-confirmation study. Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.
LONDON (Reuters) - A keenly-watched COVID-19 vaccine will be priced to allow as wide as possible access to it, if it proves successful, and will be made at huge scale to keep costs down and supply up, said the Oxford University professor co-leading its development.
Adrian Hill, director of Oxford's Jenner Institute, which has teamed up with the drugmaker AstraZeneca (L:AZN) to develop the vaccine, said ensuring wide distribution and low cost have been central to the project from the start.
"This not going to be an expensive vaccine," Hill told Reuters in an interview. "It's going to be a single dose vaccine. It's going to be made for global supply and it's going to be made in many different locations. That was always our plan."
The experimental vaccine, known as ChAdOx1 nCoV-19, is one of the front runners in the global race to provide protection against the new coronavirus causing the COVID-19 pandemic.
Preliminary data from a small trial of the experimental vaccine in six monkeys found that some of the animals given a single shot developed antibodies against the virus within 14 days, and all developed protective antibodies within 28 days.
When the monkeys were exposed to the new coronavirus, the vaccine appeared to prevent damage to the lungs and kept the virus from making copies of itself there, although it was still actively replicating in the nose.
Hill said the data from the animal tests were "encouraging of course" and reinforced his team's high degree of confidence that ongoing human trials of the shot will also show positive results. The first signals on whether and how well it works could come as early as July or August.
Hill's team began early-stage human trials of the vaccine in April, making it one of only a handful to have reached that milestone.
Hill said that as of this week, more than 1,000 people have been dosed in the trial - with around half getting the experimental vaccine and the other half serving as a control group.
Asked about the progress of the human trials, Hill said he and his team "are not going to give a running commentary" but added: "You can conclude that if the trial is still running - as it certainly is - that would mean there have been no major upsets."
Almost 4.5 million people have been reported to be infected by the novel coronavirus globally and more than 301,000 have died, according to a Reuters tally.
Health and disease experts say a vaccine that protects people from the new coronavirus could help end the pandemic, but finding one that works and manufacturing enough doses is a huge challenge.
The ChAdOx vaccine, a type known as a recombinant viral vector vaccine, uses a weakened version of the common-cold virus spiked with proteins from the novel coronavirus to generate a response from the body's immune system.
Other vaccines in human trials include those by Moderna Inc (O:MRNA), Pfizer Inc (N:PFE) and BioNTech SE (NASDAQ:BNTX) <22UAy.F> and China's CanSino Biologics Inc (HK:6185).
Hill told Reuters the ChAdOx1 project has at least seven manufacturing sites around the world. Those include India's Serum Institute as well as sites in Europe and China.
Hill has said that up to a million doses of the shot are already being manufactured and will be available by September, even before trials fully prove whether it works.
"The ambition is shared to get a low-priced, very, very extensively available vaccine as soon as possible," Hill said. "And one of the reasons that we chose Astrazeneca was because they shared that ambition and they were convincing.
Agree there with you my friend
That would be great. Going to need some higher volume to get there. I’ve seen it before so anything is possible. Best of trades my friend
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Bank of America analysts Andrew Didora and Geoffrey d’Halluin maintained:
A Neutral rating on Carnival Corp (NYSE: CCL) but raised their price target from $10 to $13;
A Neutral rating on Norwegian Cruise Line Holdings Ltd (NYSE: NCLH) with a $13 target; and
An Underperform rating on Royal Caribbean Cruises Ltd (NYSE: RCL) with a $20 target.
Carnival: 9 Months
Carnival recently suggested it requires $1 billion in liquidity per month to cover operating expenditures, customer refunds, debt obligations and other necessities. At this rate, with debt and equity offerings completed in April, Didora's suspect that Carnival can sustain itself through the end of 2020.
“We believe CCL could be able to reduce its monthly cash burn predominantly given potential delays in ship investments and potential debt maturities holidays, which could extend its liquidity into 2021,” they wrote in a note.
Norwegian: 18 Months
Norwegian Cruise Line is paying between $70 million and $110 million each month for debt obligations, opex and capex. The analysts also anticipate about $67 million per month in refund payouts for the rest of the year.
The company recently raised $2.4 billion in capital, which bolstered its liquidity position to about $3.8 billion, according to Bank of America estimates. This “is enough to get through at least 4Q21 in a worst case of no future cash sales,” they wrote.
Royal Caribbean: 11 Months
According to Didora's estimates, Royal Caribbean has about $3.45 billion in liquidity but is burning about $330 million in cash per month. At that rate, the company can last through the first quarter of 2021 with suspended operations.
“For RCL to extend its liquidity into late 2021 to further de-risk its liquidity profile, we estimate it would need to raise an incremental $1.5-2.0B in capital,” the analysts wrote.
Price Action
At time of publication, Royal Caribbean traded down 1.4% around $34.66, Carnival down marginally around $12.20, and Norwegian down 2.1% around $10.53.
Related Links:
Here's How Much Investing 0 In Carnival Stock Back In 2010 Would Be Worth Today
Cruise Line Analyst Jumps Ship On Norwegian Cruise, Royal Caribbean Amid Coronavirus Cancellations
Latest Ratings for CCL
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One day after large asset managers like BlackRock, State Street and Invesco unveiled a proposal to more precisely label exchange-traded funds, some industry participants pushed back, calling the idea welcome in general, but misguided in practice.
The proposal from the self-named “industry coalition” asked three major exchanges — CBOE, Nasdaq and NYSE — to more clearly identify and categorize the different types of products that are all usually painted, in broad strokes, as “ETFs.”
As previously reported, that broad category includes funds that track assets as diverse as plain-vanilla stocks and commodities which can not only lose all their value, but also go negative. As markets have gyrated over the past months, rocked not only by the fallout of the coronavirus pandemic but also negative oil futures contracts, many unsuspecting retail investors have been swept along.
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Earlier coverage:Are ETFs safe... for retail investors?
The industry proposal “has everything to do with what we’ve seen in markets in recent months,” said Ben Johnson, director of global ETFs at research provider Morningstar.
The discussion isn’t new — the same players had brought a similar proposal to the SEC in the past — but the well-publicized troubles in funds like the United States Oil Fund LP USO, +4.38% “breathed fresh life into it,” Johnson said, and industry titans like BlackRock, owner of the iShares suite of products, are worried that investors will “fail to distinguish between various categories and exposures.”
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(BlackRock, State Street, and Vanguard are often referred to as the industry’s “Giant Three;” Vanguard’s name did not appear on the press release but a company spokesperson confirmed to MarketWatch that the asset manager did support the proposal.)
Johnson thinks the spirit of the proposal is sound, but the specifics are wanting. On Thursday he released a response suggesting what he considers a “more appropriate and intuitive” labeling system, which notably splits out leveraged and inverse funds from those that track options — products that he believes behave very differently, but would share a grouping under the industry proposal.
But for some industry participants, any kind of top-down policing is uncomfortable. Bruce Bond, founder and CEO of Innovator ETFs, helped build the ETF ecosphere decades ago. But more recently, as the founder of a smaller firm that applies the ETF structure to an unconventional asset class, he is now, to his surprise, “the little guy.”
“This is just really big companies coming together to try to squeeze out competition and build wider moats,” Bond said in an interview. “It’s un-American.”
Innovator’s “Defined Outcome” suite of funds UMAR, +0.37% , profiled by MarketWatch last year, have been wildly popular, winning industry accolades and proving their worth during a period of market turbulence in the spring. Under the proposal released Wednesday, they would fall into the category of “Exchange-traded instrument,” a broad catch-all for any fund that doesn’t meet any of the more precisely defined categories.
Bond doesn’t think the labeling would hurt the Defined Outcome funds’ ability to attract assets, per se — an opinion shared by Morningstar’s Johnson — but does worry it could be used by brokerages to deny access to their platforms.
It is unclear what next steps will be. “This is a cheeky move,” Johnson told MarketWatch. “They didn’t like what they heard from the SEC so they’re going to go and ask someone else. But the regulators are the appropriate venue for these conversations.”
Aurora Cannabis shares showed some life on Friday, flying nearly 70% the day after the company’s March quarter results beat expectations.
Aurora said fiscal third-quarter revenue hit 75.5 million Canadian dollars (US$53.8 million), which topped analysts’ consensus estimate at C$66.7 million. The company reported an adjusted earnings before interest, taxes, depreciation, and amortization loss of C$45.9 million, but said it expects that figure, known as adjusted Ebitda, to be positive by the September quarter.
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Biotech company Moderna MRNA, -0.95% has completed the phase 1 trial of its COVID-19 vaccine. A phase 2 study is expected to start this quarter and will follow 600 participants for 12 months. Significantly, Moderna announced a 10-year manufacturing deal with Swiss company Lonza Group LONN, +0.42% on Friday. The deal will enable up to 1 billion doses of the vaccine — if successful — a year. Manufacturing facilities will be set up in Switzerland and the first batch of the vaccine could be produced by July. It could be ready for market in early 2021.
Waitr Holdings Inc. (Nasdaq: WTRH) ("Waitr" or the "Company"), a leader in on-demand food ordering and delivery, today announced the Company is now accepting donations on its website and in their app to be used for hunger relief. These donations will be given to charities such as Feeding America who are supporting the many people in the US that are struggling to find their next meal.
"We are in the business of delivering food to people and we felt that another way we can support our communities is getting them the food they need in these challenging times," said Carl Grimstad, CEO of Waitr. "We want the donations to be used in the markets that we serve and/or where the donations originated, so we look to work with partners that can accommodate that mission, such as Feeding America."
About Waitr Holdings Inc.
Founded in 2013 and based in Lafayette, Louisiana, Waitr is a leader in on-demand food ordering and delivery. Waitr, and its sister brand Bite Squad, connects local restaurants and grocery stores to hungry diners in underserved U.S. markets. Together they are a convenient way to discover, order and receive great food from local restaurants, grocery stores and national chains. As of March 31, 2020, Waitr and Bite Squad operated in small and medium sized markets in the United States in over 600 cities.
Aurora Cannabis Inc.'s fiscal third-quarter numbers showed "encouraging signs, for a change," according to Cantor Fitzgerald analyst Pablo Zuanic, who reiterated his overweight rating and C$22 ($16) stock price target in a Friday note. The Canadian company posted sales that were 13% above FactSet consensus, with recreational weed up 24% from the prior quarter, "and began to show cost and cashflow improvements that give credence to the notion of positive EBITDA by the Sep quarter and positive cash flow by late FY21," said the note. The company also said that a new $250 million equity facility was a "backstop" and won't be needed if targets are met. Aurora, with 1.2 times net debt to current sales, is not in the same league as Canopy Growth Corp. CGC, +2.21% WEED, +1.99% or Cronos Inc. CRON, +2.06% CRON, +1.31%, which have bigger backstops thanks to investments from Constellation Brands Inc. STZ, +1.70% in Canopy's case, and Altria Inc. MO, -0.27% in Cronos' case, said Zuanic. "That is why, we believe, ACB trades at a third of those stocks on EV/current sales, despite having similar or better growth prospects. It is in the "levered league." That said, this is not a company going bust, and we see value," the analyst wrote. Jefferies analyst Owen Bennett said the numbers offered reasons to be optimistic, but said that sales were never the issue for Aurora, but rather its cost structure. "To this, although a headline EBITDA miss today, we think consensus will warm to Aurora's chances of hitting their +ve adj. EBITDA target, especially given commentary around further levers to pull," Bennett wrote in a note. "As before, all eyes remain on 1Q as the big catalyst." Bennett rates the stock as hold with a C$1.00 price target. Aurora's U.S.-listed shares were up 23% premarket but are down 74% in the year to date, while the ETFMG Alternative Harvest ETF MJ, +1.27% has fallen 35% and the S&P 500 SPX, +1.15% has fallen 12%.
Waitr Holdings Inc. (Nasdaq: WTRH) ("Waitr" or the "Company"), a leader in on-demand food ordering and delivery, today announced the Company is now accepting donations on its website and in their app to be used for hunger relief. These donations will be given to charities such as Feeding America who are supporting the many people in the US that are struggling to find their next meal.
"We are in the business of delivering food to people and we felt that another way we can support our communities is getting them the food they need in these challenging times," said Carl Grimstad, CEO of Waitr. "We want the donations to be used in the markets that we serve and/or where the donations originated, so we look to work with partners that can accommodate that mission, such as Feeding America."
About Waitr Holdings Inc.
Founded in 2013 and based in Lafayette, Louisiana, Waitr is a leader in on-demand food ordering and delivery. Waitr, and its sister brand Bite Squad, connects local restaurants and grocery stores to hungry diners in underserved U.S. markets. Together they are a convenient way to discover, order and receive great food from local restaurants, grocery stores and national chains. As of March 31, 2020, Waitr and Bite Squad operated in small and medium sized markets in the United States in over 600 cities.
RIDGEFIELD, Conn., May 14, 2020 (GLOBE NEWSWIRE) -- The Chefs’ Warehouse, Inc. (CHEF) (the “Company”), a premier distributor of specialty food products in the United States and Canada, announced today the closing of its previously announced underwritten public offering of 5,769,231 shares of its common stock (the “Offering”). Jefferies LLC (“Jefferies”) and BMO Capital Markets Corp. acted as the underwriters for the Offering (collectively, the “Underwriters”), pursuant to an underwriting agreement entered into between the Company and Jefferies, as representative of the underwriters named therein, dated May 11, 2020. The Company sold a total of 5,769,231 shares, at a price of $13.00 per share to the Underwriters, to be reoffered by the Underwriters at variable prices. In addition, the Company has granted the Underwriters an option, exercisable for up to 30 days, to purchase up to 865,384 additional shares of common stock. The Offering was completed on May 14, 2020, and total proceeds from the Offering received by the Company are approximately $75 million, before deducting offering expenses payable by the Company.
In addition to adding liquidity to the balance sheet, the Company intends to use the proceeds from the Offering for general corporate purposes, which may include, among other things, working capital, repayment of outstanding debt and opportunistic investment in sales and distribution infrastructure.
The Offering was made pursuant to the Company’s effective registration statement on Form S-3ASR (Registration Statement No. 333-237646), filed with the U.S. Securities and Exchange Commission (the “SEC”) on April 10, 2020. The Offering was described in the Company’s prospectus dated April 10, 2020, as supplemented by a preliminary prospectus supplement and a final prospectus supplement, each dated May 11, 2020. The preliminary prospectus supplement, the final prospectus supplement and the accompanying prospectus relating to this offering have been filed with the SEC and are available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this Offering may also be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at 877-547-6340 or by email at Prospectus_Department@Jefferies.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any shares nor shall there be any offer, solicitation or sale of such shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.
About The Chefs’ Warehouse
The Chefs’ Warehouse, Inc. is a premier distributor of specialty food products in the United States and Canada focused on serving the specific needs of chefs who own and/or operate some of the nation's leading menu-driven independent restaurants, fine dining establishments, country clubs, hotels, caterers, culinary schools, bakeries, patisseries, chocolatiers, cruise lines, casinos and specialty food stores. The Chefs’ Warehouse, Inc. carries and distributes more than 55,000 products to more than 34,000 customer locations throughout the United States and Canada.
Forward-Looking Statements
Statements in this press release regarding the Company’s business that are not historical facts are “forward-looking statements” that involve risks and uncertainties and are based on current expectations and management estimates; actual results may differ materially. The risks and uncertainties which could impact these statements include, but are not limited to, the Company’s sensitivity to general economic conditions, including disposable income levels and changes in consumer discretionary spending; the Company’s ability to expand its operations in its existing markets and to penetrate new markets through acquisitions; the Company may not achieve the benefits expected from its acquisitions, which could adversely impact its business and operating results; the Company may have difficulty managing and facilitating its future growth; conditions beyond the Company’s control could materially affect the cost and/or availability of its specialty food products or center-of-the-plate products and/or interrupt its distribution network; the Company’s increased distribution of center-of-the-plate products, like meat, poultry and seafood, involves increased exposure to price volatility experienced by those products; the Company’s business is a low-margin business and its profit margins may be sensitive to inflationary and deflationary pressures; because the Company’s foodservice distribution operations are concentrated in certain culinary markets, the Company is susceptible to economic and other developments, including adverse weather conditions, in these areas; fuel cost volatility may have a material adverse effect on the Company’s business, financial condition or results of operations; the Company’s ability to raise capital in the future may be limited; the Company may be unable to obtain debt or other financing, including financing necessary to execute on its acquisition strategy, on favorable terms or at all; interest charged on the Company’s outstanding debt may be adversely affected by changes in the method of determining London Interbank Offered Rate (LIBOR), or the replacement of LIBOR with an alternative rate; the Company’s business operations and future development could be significantly disrupted if it loses key members of its management team; significant public health epidemics or pandemics, including COVID-19, may adversely affect the Company’s business, results of operations and financial condition; and the fact that the Company’s management will have broad discretion in the use of the proceeds from any sale of the shares.
Any forward-looking statements are made pursuant to the Private Securities Litigation Reform Act of 1995 and, as such, speak only as of the date made. A more detailed description of these and other risk factors is contained in the Company’s most recent annual report on Form 10-K filed with the SEC on February 24, 2020 and other reports filed by the Company with the SEC since that date. The Company is not undertaking to update any information in the foregoing report until the effective date of its future reports required by applicable laws.
One day after large asset managers like BlackRock, State Street and Invesco unveiled a proposal to more precisely label exchange-traded funds, some industry participants pushed back, calling the idea welcome in general, but misguided in practice.
The proposal from the self-named “industry coalition” asked three major exchanges — CBOE, Nasdaq and NYSE — to more clearly identify and categorize the different types of products that are all usually painted, in broad strokes, as “ETFs.”
As previously reported, that broad category includes funds that track assets as diverse as plain-vanilla stocks and commodities which can not only lose all their value, but also go negative. As markets have gyrated over the past months, rocked not only by the fallout of the coronavirus pandemic but also negative oil futures contracts, many unsuspecting retail investors have been swept along.
Advertisement
Earlier coverage:Are ETFs safe... for retail investors?
The industry proposal “has everything to do with what we’ve seen in markets in recent months,” said Ben Johnson, director of global ETFs at research provider Morningstar.
The discussion isn’t new — the same players had brought a similar proposal to the SEC in the past — but the well-publicized troubles in funds like the United States Oil Fund LP USO, +4.12% “breathed fresh life into it,” Johnson said, and industry titans like BlackRock, owner of the iShares suite of products, are worried that investors will “fail to distinguish between various categories and exposures.”
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(BlackRock, State Street, and Vanguard are often referred to as the industry’s “Giant Three;” Vanguard’s name did not appear on the press release but a company spokesperson confirmed to MarketWatch that the asset manager did support the proposal.)
Johnson thinks the spirit of the proposal is sound, but the specifics are wanting. On Thursday he released a response suggesting what he considers a “more appropriate and intuitive” labeling system, which notably splits out leveraged and inverse funds from those that track options — products that he believes behave very differently, but would share a grouping under the industry proposal.
But for some industry participants, any kind of top-down policing is uncomfortable. Bruce Bond, founder and CEO of Innovator ETFs, helped build the ETF ecosphere decades ago. But more recently, as the founder of a smaller firm that applies the ETF structure to an unconventional asset class, he is now, to his surprise, “the little guy.”
“This is just really big companies coming together to try to squeeze out competition and build wider moats,” Bond said in an interview. “It’s un-American.”
Innovator’s “Defined Outcome” suite of funds UMAR, +0.24% , profiled by MarketWatch last year, have been wildly popular, winning industry accolades and proving their worth during a period of market turbulence in the spring. Under the proposal released Wednesday, they would fall into the category of “Exchange-traded instrument,” a broad catch-all for any fund that doesn’t meet any of the more precisely defined categories.
Bond doesn’t think the labeling would hurt the Defined Outcome funds’ ability to attract assets, per se — an opinion shared by Morningstar’s Johnson — but does worry it could be used by brokerages to deny access to their platforms.
It is unclear what next steps will be. “This is a cheeky move,” Johnson told MarketWatch. “They didn’t like what they heard from the SEC so they’re going to go and ask someone else. But the regulators are the appropriate venue for these conversations.”
Norwegian Cruise Line posted its first quarter earnings report on Thursday. Wedbush Securities Leisure & Travel Analyst James Hardiman joins Yahoo Finance’s On The Move to discuss Norwegian Cruise Line’s latest financial results and address the challenges the cruise industry may face post-pandemic.
Video Transcript
JULIE HYMAN: Cruise line operator Norwegian came out with its earnings today. The shares were up about 8/10 of 1%, but they've been bouncing around quite a bit. The company reported a $211 million loss. That works out to $0.99 a share. But also, the company had some, of course, one-time costs-- so 1.10 billion dollars in expense-related adjustments.
The company does say that people are booking cruises. And it's not just people who are rebooking canceled cruises. So that looks like what's responsible for a little bit of a recovery in the shares. Carnival, by the way-- its rival-- announcing that it is going to be doing some layoffs and furloughs, although it did not give specific details on that.
Let's talk Norwegian first and bring in James Hardiman. He is Wedbush Securities Leisure & Travel Analyst. He's joining us from Shaker Heights, Ohio. James, so when you look at the Norwegian numbers, it's really interesting here, too, because Norwegian was in trouble financially just a couple weeks ago and was able to raise capital through a debt sale. Are things really looking substantially better for the likes of Norwegian, or is there still a really hard road to come here?
JAMES HARDIMAN: Well, I think it's both, to answer your question. I mean, a couple of weeks ago, it was a little bit unclear what their runway was in terms of surviving this pandemic, right-- a significant monthly cash burn that they had to deal with. And it limited capital. Now, what they were able to do last week was secure significant financing through not only multiple debt offerings but an equity offering.
And so, by our math, even in the scenario where the industry is completely shut down and there's no revenues coming in the door, we think they can last through the end of 2021, which is a big deal. Now, that's a very different question than when things are, in fact, going to go back to normal. So they can answer the question of whether or not they're going to survive this. But the questions going forward are a lot more difficult. And obviously, the first question is how do they reopen their business.
ADAM SHAPIRO: James, it's Adam-- good to see you. What I was thinking is, it would be easier to take a cruise to Put-in-Bay just outside of Cleveland than it would be to get on one of these big ocean liners. I mean, the regulations that could be coming down the pipe-- we know that nursing homes were centers of COVID outbreak.
The cruise ships-- I mean, before this, it was the different-- the what is it, the norovirus-- that people would get. How do the cruise lines get a business model in place where people feel safe going on them and also going to have to deal with countries that aren't going to let them in perhaps?
JAMES HARDIMAN: Yeah, it's going to be a real challenge. And "stay tuned" is the short answer to that question. You know, the first order of business is getting the CDC to lift their no-sail order, which, as of today, goes through the end of June. So if you talk to any of these cruise companies, they're targeting an early-July resumption of sailings.
That is very different, however, from saying that consumers are going to jump back in. And I think it's safe to say that it's going to take a while before we go back to normal. I think most investors continue to be surprised by how many consumers are suggesting that they would be interested in getting on a cruise, not just long-term but fairly near-term. But I think it's going to be years before we get back to the volumes that we saw, you know, '18, '19 time frame.
- James, what do you think it would take for people to feel more comfortable on cruises again? I mean, you know, as Adam said, the norovirus was already an issue. And we had seen some ships that were stuck out at sea, dealing with those kinds of outbreaks. You know, people can fly somewhere a lot faster, get to a resort a lot faster.
They can drive there. You don't have to worry about dealing with being stuck in small, cramped quarters. And you know, I mean, frankly, people died on these ships of COVID-19. What's going to get people to want to be on one?
JAMES HARDIMAN: Well, long-term, clearly, what I think is required for the industry to go back to normality is a virus or at least a treatment now. I don't think anybody thinks that that's going to happen within the next six to nine months at an absolute minimum. It's that in-between phase which is a head-scratcher.
I think everybody that follows this industry-- I think to some extent, you know, they're going to put in unprecedented safety and sanitation standards onboard these cruise ships, number one. Number two, I think they're likely to set sail at something well south of their typical occupancy of 100%, right, in an effort to practice social distancing onboard.
Those are the two easy answers. Now, the difficult answer, I think, that is ultimately going to need to be communicated to first the CDC and other port authorities but then also to consumers tumors is, what exactly happens if somebody contracted the virus onboard, right? A, how do they prevent other people on board from contracting the virus? And B, how can they assure the people onboard that they're not going to get stuck at sea, which we saw time and time again when the outbreak first began?
Those are two questions that I haven't heard definitively answered thus far. I think to a large degree, it's going to depend on getting port authorities and ultimately these different localities and countries comfortable with the idea that people are going to contract the virus. And you still have to let us into the country. So I think there's probably more work to be done on that front-- making that happen and then communicating that to consumers.
JULIE HYMAN: James, maybe I'm just bitter because the one time I took a cruise, I contracted some kind of norovirus, which they're also notorious for. The sanitary changes that you're talking about-- the health changes you're talking about-- could they potentially be permanent for the cruise lines because they have had health issues like norovirus pretty frequently in the past? And if so, that seems like a pretty expensive proposition.
JAMES HARDIMAN: Yeah, I mean, I think they're likely to be permanent. Look, I think so much of what we do in terms of sanitation and just personal hygiene and personal interactions with other human beings is going to change, I think, coming out of this. And that's, you know, separate and distinct from the cruise industry. But given that they were ground zero in a lot of ways as we entered this social distancing phase, you know, I think they're going to be pioneers of how we act coming out of it.
So yeah, I'd be hard-pressed to see them institute certain standards, right, within the next few months and then pull back those standards at some point in the future. And yes, to answer your question, those new protocols are not free. They're going to add to the costs that these guys are going to need to incur.
I think those costs probably pale in comparison to having no revenues for a series of months. And ultimately, the second quarter-- you know, the entire industry is going to go without a single penny of revenue. So I think those costs will be well worth it. But yeah, I do think they'll be meaningful.
JULIE HYMAN: Yeah, if they convince people to get back on their ships. James, thank you so much for your perspective. James Hardiman is Wedbush Securities Leisure & Travel Analyst-- appreciate it.
Chicago, IL – May 14, 2020 – Zacks Equity Research highlights Pluralsight PS as the Bull of the Day and Stanley Black Decker SWK as the Bear of the Day. In addition, Zacks Equity Research provides analysis on Gilead Sciences, Inc. GILD, Regeneron Pharmaceuticals Inc REGN and GlaxoSmithKline plc GSK.
Here is a synopsis of all five stocks:
Bull of the Day:
Pluralsight is a Zacks Rank #1 (Strong Buy) and it is the Bull of the Day today. The stock has that growth divergence that I love to see. That means it has an A for Growth and a D for Value – telling me right away that this stock is what growth investors are looking for. That alone makes me want to take a deeper look at the stock.
Description
Pluralsight Inc. is an enterprise technology learning platform. It offers online training courses for professional developers, IT admins and creative artists. The company serves individuals and businesses, as well as academic and government sectors. Pluralsight Inc. is based in Utah, United States.
Earnings History
PS has a great earnings history with four consecutive beats of the Zacks Consensus Estimate.
The most recent quarter saw the company report a loss of nine cents, but that was five cents better than the consensus at a loss of fourteen cents. That positive earnings surprise works out to be 35%.
Over the last four quarters the average positive earnings surprise is 42.8%, which tells these are all really big beats.
Big beats like that tend to lead to higher earnings estimates, and that is what really drives the Zacks Rank.
Estimate Revisions
Those big beats have been driving estimates higher for Pluralsight. The consensus for this quarter has seen a positive increase of two cents. The same is true for next quarter as well.
Two cents here and two cents there tends to add up and the full year estimate ended moving higher by eight cents. Next year also saw an increase of eight cents.
Valuation
The valuation for PS is pretty high and that is what keeps the value investors away from this stock. Since there are no earnings there is no PE to lean on. Instead we look at price to book and we see a lofty 11x multiple. The topline is seeing impressive growth of 33% and that has allowed the price to sales multiple come in at 7.4x. So there is good reason for growth investors to remain interested in the stock.
Bear of the Day:
Stanley Black Decker is a Zacks Rank #5 (Strong Sell) and it is the Bear of the Day today. The stock recently beat the Zacks Consensus Estimate but estimates are moving lower and that is the main reason the stock fell to the lowest Zacks Rank.
Description
Headquartered in New Britain, CT, Stanley Black & Decker, Inc. manufactures and provides tools (power and hand tools) and related accessories, healthcare solutions, electronic security solutions, engineered fastening systems, and many more items and services.
Earnings History
SWK has a really good earnings history. I see four straight beats of the Zacks Consensus Estimate, which makes you wonder why this is a Zacks Rank #5 (Strong Sell).
The Zacks Rank does take into consideration earnings history, but earnings estimates carry a much bigger weight.
Estimate Revisions
Earnings estimates for SWK have fallen drastically. The current quarter was at $2.44 60 days ago and fell to $2.03 30 days ago. Now the estimate stands at $0.11. That is a big move lower.
Next quarter also fell, but not as much moving from $2.37 down to $1.44.
Full year estimates have also dropped in a big way. This year fell from $8.87 60 days ago to $5.19. Next year is also looking at a big move lower.
Valuation
I see a forward PE of 21x and that is a lot for a stock that is seeing topline contraction. The price to book is more reasonable at 2.2x and the price to sales multiple of 1.2x is also respectable.
Additional content:
Biotechs Leading the Search for Coronavirus Vaccine
On May 12, Gilead Sciences, Inc. entered into an agreement with five generic drugmakers to make antiviral drugs in 127 countries, not including the United States. The agreement will allow these drugmakers to manufacture and distribute remdesivir in low-income countries. The deal is royalty free.
Biotechnology companies and drugmakers across the world are leaving no stone unturned to develop a vaccine for the deadly COVID-19. Also, pharmaceutical giants are speeding up vaccine development for the novel coronavirus. Although the FDA is yet to approve a drug or treatment for COVID-19, company has already started ramping up manufacturing lines to meet global demand if any of the experimental vaccines succeed.
Gilead Ramps Up Remdesivir Manufacturing
Gilead said that the deal with the five generic drug manufacturers — Mylan, Cipla, Ferozsons Laboratories, Hetero Labs and Jubilant Lifesciences — is royalty free. This is so until the World Health Organization says the Covid-19 outbreak is no longer a global health crisis or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent the virus, whichever is earlier.
Earlier this month, the FDA granted emergency use authorization for Gilead’s remdesivir to treat COVID-19. Remdesivir, an intravenous drug, has so far shown promise by helping in shortening the recovery time of some hospitalized Covid-19 patients, new clinical trial data suggests.
Pharma and Biotech Giants Lead the COVID-19 Fight
A number of biotech companies and pharmaceutical giants have joined forces to fight the coronavirus that has infected more than 4 million people globally over the past four months. This has seen many big names collaborating on both development and manufacturing of vaccines and drugs.
On May 12, Moderna said that its experimental COVID-19 vaccine has gained Fast Track designation from the FDA. Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need.
Last month, Sanofi and Glaxo collaborated to expedite the development of a vaccine for the Wuhan virus. Sanofi recently said that if successful, the vaccine would be available in the second half of 2021.
Although a vaccine is yet to be developed, many companies have already started ramping up manufacturing process of the experimental vaccines they are working on. Pfizer is reportedly contemplating shifting more of its medicine production to outside contractors, as it is focusing on large-scale production of its experimental COVID-19 vaccine, provided it proves effective in curing the disease.
Earlier this month, Moderna said that it could start manufacturing its yet-unconfirmed COVID-19 vaccine as early as July after it entered a 10-year deal with Swiss contract drugmaker Lonza to ramp up production of the experimental coronavirus vaccine.
Our Choices
A lot of money is being pumped in by biotech companies and drugmakers in research and development of a vaccine to treat the novel coronavirus. Below are five biotech stocks that are set to rally in the near future.
Regeneron Pharmaceuticals Inc is a biopharmaceutical company focused on the discovery, development and commercialization of treatments targeting serious medical conditions.
The company’s expected earnings growth rate for the current year is 11.6%. The stock has rallied 8.7% in the past 30 days. Regeneron has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
GlaxoSmithKline plc has three core businesses – Pharmaceuticals (respiratory, HIV, immuno-inflammation and oncology), Vaccines (meningitis, shingles and influenza vaccines) and Consumer Healthcare (oral health, wellness, skin health and nutrition products).
The company’s expected earnings growth rate for the next year is 1%. The stock has gained 8.6% over the past 30 days. GlaxoSmithKline carries a Zacks Rank #2.
Gilead is a pioneer in developing drugs for the treatment of human immunodeficiency virus (HIV), liver diseases, hematology and oncology diseases, and inflammation and respiratory diseases.
TheZacks Rank #2company’s expected earnings growth rate for the next year is 1.4%. Its shares have rallied 6% in the past 30 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>
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Norwegian Cruise Line posted its first quarter earnings report on Thursday. Wedbush Securities Leisure & Travel Analyst James Hardiman joins Yahoo Finance’s On The Move to discuss Norwegian Cruise Line’s latest financial results and address the challenges the cruise industry may face post-pandemic.
Video Transcript
JULIE HYMAN: Cruise line operator Norwegian came out with its earnings today. The shares were up about 8/10 of 1%, but they've been bouncing around quite a bit. The company reported a $211 million loss. That works out to $0.99 a share. But also, the company had some, of course, one-time costs-- so 1.10 billion dollars in expense-related adjustments.
The company does say that people are booking cruises. And it's not just people who are rebooking canceled cruises. So that looks like what's responsible for a little bit of a recovery in the shares. Carnival, by the way-- its rival-- announcing that it is going to be doing some layoffs and furloughs, although it did not give specific details on that.
Let's talk Norwegian first and bring in James Hardiman. He is Wedbush Securities Leisure & Travel Analyst. He's joining us from Shaker Heights, Ohio. James, so when you look at the Norwegian numbers, it's really interesting here, too, because Norwegian was in trouble financially just a couple weeks ago and was able to raise capital through a debt sale. Are things really looking substantially better for the likes of Norwegian, or is there still a really hard road to come here?
JAMES HARDIMAN: Well, I think it's both, to answer your question. I mean, a couple of weeks ago, it was a little bit unclear what their runway was in terms of surviving this pandemic, right-- a significant monthly cash burn that they had to deal with. And it limited capital. Now, what they were able to do last week was secure significant financing through not only multiple debt offerings but an equity offering.
And so, by our math, even in the scenario where the industry is completely shut down and there's no revenues coming in the door, we think they can last through the end of 2021, which is a big deal. Now, that's a very different question than when things are, in fact, going to go back to normal. So they can answer the question of whether or not they're going to survive this. But the questions going forward are a lot more difficult. And obviously, the first question is how do they reopen their business.
ADAM SHAPIRO: James, it's Adam-- good to see you. What I was thinking is, it would be easier to take a cruise to Put-in-Bay just outside of Cleveland than it would be to get on one of these big ocean liners. I mean, the regulations that could be coming down the pipe-- we know that nursing homes were centers of COVID outbreak.
The cruise ships-- I mean, before this, it was the different-- the what is it, the norovirus-- that people would get. How do the cruise lines get a business model in place where people feel safe going on them and also going to have to deal with countries that aren't going to let them in perhaps?
JAMES HARDIMAN: Yeah, it's going to be a real challenge. And "stay tuned" is the short answer to that question. You know, the first order of business is getting the CDC to lift their no-sail order, which, as of today, goes through the end of June. So if you talk to any of these cruise companies, they're targeting an early-July resumption of sailings.
That is very different, however, from saying that consumers are going to jump back in. And I think it's safe to say that it's going to take a while before we go back to normal. I think most investors continue to be surprised by how many consumers are suggesting that they would be interested in getting on a cruise, not just long-term but fairly near-term. But I think it's going to be years before we get back to the volumes that we saw, you know, '18, '19 time frame.
- James, what do you think it would take for people to feel more comfortable on cruises again? I mean, you know, as Adam said, the norovirus was already an issue. And we had seen some ships that were stuck out at sea, dealing with those kinds of outbreaks. You know, people can fly somewhere a lot faster, get to a resort a lot faster.
They can drive there. You don't have to worry about dealing with being stuck in small, cramped quarters. And you know, I mean, frankly, people died on these ships of COVID-19. What's going to get people to want to be on one?
JAMES HARDIMAN: Well, long-term, clearly, what I think is required for the industry to go back to normality is a virus or at least a treatment now. I don't think anybody thinks that that's going to happen within the next six to nine months at an absolute minimum. It's that in-between phase which is a head-scratcher.
I think everybody that follows this industry-- I think to some extent, you know, they're going to put in unprecedented safety and sanitation standards onboard these cruise ships, number one. Number two, I think they're likely to set sail at something well south of their typical occupancy of 100%, right, in an effort to practice social distancing onboard.
Those are the two easy answers. Now, the difficult answer, I think, that is ultimately going to need to be communicated to first the CDC and other port authorities but then also to consumers tumors is, what exactly happens if somebody contracted the virus onboard, right? A, how do they prevent other people on board from contracting the virus? And B, how can they assure the people onboard that they're not going to get stuck at sea, which we saw time and time again when the outbreak first began?
Those are two questions that I haven't heard definitively answered thus far. I think to a large degree, it's going to depend on getting port authorities and ultimately these different localities and countries comfortable with the idea that people are going to contract the virus. And you still have to let us into the country. So I think there's probably more work to be done on that front-- making that happen and then communicating that to consumers.
JULIE HYMAN: James, maybe I'm just bitter because the one time I took a cruise, I contracted some kind of norovirus, which they're also notorious for. The sanitary changes that you're talking about-- the health changes you're talking about-- could they potentially be permanent for the cruise lines because they have had health issues like norovirus pretty frequently in the past? And if so, that seems like a pretty expensive proposition.
JAMES HARDIMAN: Yeah, I mean, I think they're likely to be permanent. Look, I think so much of what we do in terms of sanitation and just personal hygiene and personal interactions with other human beings is going to change, I think, coming out of this. And that's, you know, separate and distinct from the cruise industry. But given that they were ground zero in a lot of ways as we entered this social distancing phase, you know, I think they're going to be pioneers of how we act coming out of it.
So yeah, I'd be hard-pressed to see them institute certain standards, right, within the next few months and then pull back those standards at some point in the future. And yes, to answer your question, those new protocols are not free. They're going to add to the costs that these guys are going to need to incur.
I think those costs probably pale in comparison to having no revenues for a series of months. And ultimately, the second quarter-- you know, the entire industry is going to go without a single penny of revenue. So I think those costs will be well worth it. But yeah, I do think they'll be meaningful.
JULIE HYMAN: Yeah, if they convince people to get back on their ships. James, thank you so much for your perspective. James Hardiman is Wedbush Securities Leisure & Travel Analyst-- appreciate it.
GlaxoSmithKline plc has three core businesses – Pharmaceuticals (respiratory, HIV, immuno-inflammation and oncology), Vaccines (meningitis, shingles and influenza vaccines) and Consumer Healthcare (oral health, wellness, skin health and nutrition products).
The company’s expected earnings growth rate for the next year is 1%. The stock has gained 8.6% over the past 30 days. GlaxoSmithKline carries a Zacks Rank #2.
Gilead is a pioneer in developing drugs for the treatment of human immunodeficiency virus (HIV), liver diseases, hematology and oncology diseases, and inflammation and respiratory diseases.
TheZacks Rank #2company’s expected earnings growth rate for the next year is 1.4%. Its shares have rallied 6% in the past 30 days.
The Hottest Tech Mega-Trend of All
Last year, it generated $24 billion in global revenues. By 2020, it's predicted to blast through the roof to $77.6 billion. Famed investor Mark Cuban says it will produce "the world's first trillionaires," but that should still leave plenty of money for regular investors who make the right trades early.
See Zacks' 3 Best Stocks to Play This Trend >>
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Moderna Inc. (NASDAQ: MRNA) Chief Executive Officer Stephane Bancel on Tuesday told CNBC he is hoping for approval of multiple vaccines against the novel coronavirus (COVID-19).
emdesivir is the only drug approved to treat COVID-19 patients after promising early trial results prompted U.S. regulators to grant emergency use authorisation on May 2. To expand its access, Gilead said this week it had signed non-exclusive licensing pacts https://in.reuters.com/article/us-health-coronavirus-gilead-sciences/gilead-ties-up-with-generic-drugmakers-for-covid-19-drug-supply-idINKBN22O2HJ with five generic drugmakers based in India and Pakistan, allowing them make and sell remdesivir for 127 countries.
But health access groups say the pacts mean cheaper forms of the drug may not become available in nations seen as non-profitable to the five drugmakers.
"The licenses divide the global market into two and profitable markets are retained with Gilead and less profitable markets are given to the five generic companies," said K. Gopakumar, senior legal researcher at Third World Network, which sent a letter to the Indian government on Wednesday.
The letter by Third World Network, a Malaysia-based non-profit group, followed a similar appeal by India's Cancer Patients Aid Association last week.
The aid group Doctors Without Borders has also opposed Gilead's patents on remdesivir, saying such licensing pacts are "not acceptable" amid a global health emergency.
Gilead's patents on remdesivir in India allow it to exclusively make and sell the drug in the country until 2035 unless it licenses those rights out.
Gilead's India spokeswoman and India's commerce and health ministries did not immediately respond to emails seeking comment.
India's Cancer Patients Aid Association said it might pursue legal action, noting that cancer patients have compromised immunity and are highly susceptible to the virus.
"It is imperative at a time like this that no monopoly rights be granted, so that more manufacturers can produce the drug to be made available to all the people who need it, at affordable costs," it said.
Except for remdesivir, there are currently no other drugs or vaccines approved to fight coronavirus, which has killed more than 200,000 people globally.
B patient my friend. All is well here..... Hold for the long,,,,, Higher lows are upon us $$$$$$$$$
Nothing but POSITIVE NEWs. Patiently waiting $$$$$$$$$
Mylan Signs Non-Exclusive Licensing to Manufacture and Supply Gilead's Remdesivir In Low- and Mid-Income Countries
Mylan NV (NASDAQ: MYL) announced a non-exclusive licensing agreement with Gilead Sciences, Inc. (NASDAQ: GILD), which provides for the former acquiring the rights to manufacture and distribute the latter's antiviral drug remdesivir in 127 low- and middle-income countries, including India.
Mylan also said it's confident it will be able to develop and make available a bioequivalent version of remdesivir in the coming months.
Separately, Indian pharmaceutical company Cipla announced a non-exclusive licensing agreement with Gilead to manufacture remdesivir.
In after-hours trading, Mylan shares rose 3.57% to $16.81.
Shares of The Chefs' Warehouse (NASDAQ:CHEF) fell sharply in early trading on Tuesday after the company announced a secondary offering of its common stock. It was down 10% early before recovering later in the trading session. As of 2:30 p.m. EDT, shares were only down 4%.
The Chefs' Warehouse stock has recovered some in recent weeks, but shares are still down substantially in 2020.
CHEF Chart
CHEF data by YCharts
So what
The Chefs' Warehouse supplies food to small restaurants and caterers across North America. These food-service companies have been hit hard by the COVID-19 pandemic, as many dining rooms are closed. The company just reported earnings for the first quarter of 2020, and organic net sales fell 6.6% year over year. Most of the decline came in the last two weeks of the quarter.
The Chefs' Warehouse has $190 million in cash and $53 million untapped on its credit line to weather the storm. However, the company decided to raise fresh funds by offering new shares of common stock. The offering calls for an initial sale of $75 million in stock, with an option for an additional $11.25 million. The pricing is variable, making it hard to know exactly how many shares we're talking about. But at the current price of $14 per share, that would be over 6 million new shares if the option was exercised.
Considering there were 31 million shares as of April 1, that would be about a 19% increase in the number of shares outstanding. Loss of shareholder value is why this small-cap stock went down today
[color=red][/color]
Among more than 100 experimental vaccines in development for the treatment of COVID-19, three leading candidates made by Cansino, Moderna (NASDAQ:MRNA), and Pfizer (NYSE:PFE) have advanced into phase 2 clinical studies.
Moderna is advancing to phase 2 clinical trials with its vaccine before data from phase 1 was even published. Moderna is expecting to commence its investigation shortly and plans to start phase 3 clinical trials early this summer. Is there something else going on behind the scenes hinting that the experimental vaccine shows promise?
So what's going on?
Moderna's experimental vaccine mRNA-1273 is currently undergoing phase 1 clinical trials. The vaccine is composed of messenger RiboNucleic Acids -- which are chains of nucleotides containing genetic information for cells to produce the antigens encoded in its helical structure. Once the vaccine is administered to patients, the cells transcribe the genetic information from mRNA and produce the corresponding antigens on its surface. Then the body's immune system is able to recognize the antigens and generate antibodies to produce an immune response.
mRNA-1273 is specifically designed to target the spike protein (S-protein) found in COVID-19, which facilitates the virus's entry into host cells by mediating the attachment receptors between the two types of organisms. If the vaccine is successful, then it would induce the immune system to produce antibodies against the S-protein and completely disrupt COVID-19's replication process inside the human body.
Health care worker administering vaccine to miniature globe.
IMAGE SOURCE: GETTY IMAGES.
The phase 1 clinical trial consists of administering mRNA-1273 to 45 healthy adult volunteers aged 18 to 55 over a period of six weeks. The primary endpoints are to measure the potential vaccine's immunogenicity (its ability to provoke an immune response in the body) and safety. There's been no interim data release on this study, although it did complete enrollment in all three cohorts. In addition, Moderna secured a $483 million contract on April 16 from the Biomedical Advanced Research and Development Authority to fund the investigation of mRNA-1273 into later stages.
On May 7, the Food and Drug Administration cleared mRNA-1273 for phase 2 clinical trials, which will involve approximately 600 patients randomized into treatment and placebo cohorts. The endpoints in the trial are largely the same as phase 1, and if successful, the company expects phase 3 to commence in the fall with a Biologic License Application filing by next year.
In my opinion, the investigation is more likely than not to be successful and justifies the trials progressing concurrently. This is because Moderna developed the vaccine directly with scientists at the National Institute of Allergy and Infectious Diseases (NIAID), who have access to the most up-to-date genetic data involving COVID-19 strains. Furthermore, mRNA-1273 received direct praise from NIAID director Anthony Fauci regarding its potential.
Additionally, Moderna has significant levels of expertise when it comes to vaccine development. Since its IPO in 2018, the company has registered more than ten vaccines in undergoing research and development in its pipeline. In a recent interim data release of its Zika vaccine involving 120 participants in phase 1 trials, the vaccine's seroconversion rate (percentage of patients having observable antibodies against a pathogen in their bloodstream) was found to be between 94% to 100%. There were no serious adverse events associated with this experimental vaccine.
Gilead Sciences Inc.’s (GILD) signed non-exclusive licensing agreements with five generic pharmaceutical manufacturers that will allow them to produce and sell its experimental remdesivir coronavirus drug in 127 countries, including India and Pakistan.
Under the terms of the licensing agreements, the generic drugmakers - Cipla Ltd., Ferozsons Laboratories, Hetero Labs Ltd., Jubilant Lifesciences and Mylan – based in India and Pakistan will be entitled to tap the technological know-how of Gilead’s manufacturing process to enable them to scale up production more quickly.
“We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required regulatory approvals,” Shyam S. Bhartia, Co-Chairman and Managing Director at India’s Jubilant Life Sciences. “We also plan to produce the drug’s Active Pharmaceutical Ingredient (“API”) in-house helping its cost effectiveness and consistent availability.”
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The countries for distribution of the experimental remdesivir coronavirus drug consist of nearly all low-income and middle income countries, as well as several upper-middle- and high-income countries, including South Africa and North Korea, that face significant obstacles to healthcare access.
Shares in Gilead fell 3.5% to $77.95 on Tuesday trimming this year’s rally to about 20%.
Five-star analyst Cory Kasimov at J.P. Morgan maintained his Hold rating on the stock with a $85 price target following a call with the company’s management.
“Although we’re impressed by the company’s intensive work with remdesivir, we believe that GILD received ample market credit for it and remdesivir is unlikely to result in tangible long-term cash flows,” Kasimov wrote in a note to investors. “A short-term $5 billion boost sales has marginal impact on our overall valuation and other opportunities for growth will take time to play out.”
TipRanks data shows that out of the 28 analysts covering Gilead in the past three months, 15 are now sidelined with a Hold rating on the stock, 8 say Buy and 5 say Sell, adding up to a Hold consensus rating. The $79.39 average price target suggests analysts see very limited upside potential in the shares in the coming 12 months. (See Gilead stock analysis on TipRanks)
Last week Gilead said that it was also in talks with drugmakers in Europe for supply pacts for its remdesivir COVID-19 drug candidate. The antiviral drug was this month granted emergency use authorization by the U.S. Food and Drug Administration to treat COVID-19 patients.
According to the licensing agreements, the drugmakers will set their own prices for the generic product they produce, Gilead said. The licenses are royalty-free until the World Health Organization declares the end of the Public Health Emergency of International Concern regarding COVID-19, or until a pharmaceutical product other than remdesivir or a vaccine is approved to treat or prevent the virus, whichever is earlier.
Moderna Inc. (MRNA) announced on Tuesday that its experimental coronavirus vaccine has been granted fast track status by the U.S. Food and Drug Administration (FDA).
The fast track status designation is awarded to speed up the regulatory review of its novel coronavirus vaccine candidate (mRNA-1273).
Last week, the FDA completed its review of Moderna’s Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. The clinical stage biotech company said it is finalizing the protocol for a Phase 3 study, expected to begin in early summer of 2020.
“Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus,” said Tal Zaks, Chief Medical Officer at Moderna. “As we await the full set of clinical data from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2.”
By utilizing messenger RNA (mRNA) science, Moderna hopes to create a new class of transformative medicines for patients. mRNA medicines are designed to direct the body’s cells to produce intracellular, membrane or secreted proteins that can have a therapeutic or preventive benefit and have the potential to address a broad spectrum of diseases.
Moderna shares dropped 2.7% to $65.04 in morning U.S. trading after the stock more than tripled this year.
Five-star analyst Yasmeen Rahimi at Roth Capital raised Moderna’s price target to $68 from $41, while maintaining a Buy rating on the shares, saying that with the near-term start of a Phase 2 study for its COVID-19 vaccine, the company remains the front-runner in getting a vaccine to pivotal trials with potential approval by 2021.
Although analysts have a Strong Buy consensus rating on Moderna stock based on 9 Buys and 2 Holds, its recent rally means that the $54.30 average price target now indicates 17% downside potential from current levels.
Moderna, Inc., (Nasdaq: MRNA) a clinical stage biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines to create a new generation of transformative medicines for patients, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the Company’s mRNA vaccine candidate (mRNA-1273) against the novel coronavirus (SARS-CoV-2).
"Fast Track designation underscores the urgent need for a vaccine against the novel coronavirus," said Tal Zaks, M.D., Ph.D., Chief Medical Officer at Moderna. "As we await the full set of clinical data from the NIAID-led Phase 1 study, we are actively preparing for our Phase 2 and Phase 3 clinical studies to continue learning about the potential of mRNA-1273 to protect against SARS-CoV-2."
Fast Track is designed to facilitate the development and expedite the review of therapies and vaccines for serious conditions and fill an unmet medical need. Programs with Fast Track designation may benefit from early and frequent communication with the FDA, in addition to a rolling submission of the marketing application. The Company previously received Fast Track designation for its investigational Zika vaccine (mRNA-1893) and its methylmalonic acidemia (MMA; mRNA-3704) and propionic acidemia (PA; mRNA-3927) programs.
On May 6, the U.S. Food and Drug Administration (FDA) completed its review of the Company’s Investigational New Drug (IND) application for mRNA-1273 allowing it to proceed to a Phase 2 study, which is expected to begin shortly. Moderna is finalizing the protocol for a Phase 3 study, expected to begin in early summer of 2020. Funding from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), supported the planning for these studies and will also support the late-stage clinical development programs, as well as the scale-up of mRNA-1273 manufacturing both at the Company’s facilities and that of its strategic collaborator, Lonza Ltd.
About the Phase 2 Study
Moderna has received initial feedback from the FDA on the design of the planned Phase 2 study, which will evaluate the safety, reactogenicity and immunogenicity of two vaccinations of mRNA-1273 given 28 days apart. The Company intends to enroll 600 healthy participants across two cohorts of adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300). Each participant will be assigned to receive placebo, a 50 µg or a 250 µg dose at both vaccinations. Participants will be followed through 12 months after the second vaccination.
About mRNA-1273
mRNA-1273 is an mRNA vaccine against SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein, which was selected by Moderna in collaboration with investigators from Vaccine Research Center (VRC) at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the NIH. The first clinical batch, which was funded by CEPI, was completed on February 7, 2020 and underwent analytical testing; it was shipped to NIH on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of mRNA-1273 was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. A summary of the company’s work to date on SARS-CoV-2 can be found here.
About Moderna’s Prophylactic Vaccines Modality
Moderna scientists designed the company’s prophylactic vaccines modality to prevent infectious diseases. More than 1,400 participants have been enrolled in Moderna’s infectious disease vaccine clinical studies under health authorities in the U.S., Europe and Australia. Clinical data demonstrate that Moderna’s proprietary vaccine technology has been generally well-tolerated and can elicit durable immune responses to viral antigens. Based on clinical experience across Phase 1 studies, the company designated prophylactic vaccines a core modality and is working to accelerate the development of its vaccine pipeline.
The potential advantages of an mRNA approach to prophylactic vaccines include the ability to combine multiple mRNAs into a single vaccine, rapid discovery to respond to emerging pandemic threats and manufacturing agility derived from the platform nature of mRNA vaccine design and production. Moderna has built a fully integrated manufacturing plant which enables the promise of the technology platform.
Moderna currently has nine development candidates in its prophylactic vaccines modality, including:
Vaccines against respiratory infections
Respiratory syncytial virus (RSV) vaccine for older adults (mRNA-1777 and mRNA-1172 or V172 with Merck)
RSV vaccine for young children (mRNA-1345)
Human metapneumovirus (hMPV) and parainfluenza virus type 3 (PIV3) vaccine (mRNA-1653)
Novel coronavirus (SARS-CoV-2) vaccine (mRNA-1273)
Influenza H7N9 (mRNA-1851)
Vaccines against infections transmitted from mother to baby
Cytomegalovirus (CMV) vaccine (mRNA-1647)
Zika vaccine (mRNA-1893 with BARDA)
Vaccines against highly prevalent viral infections
Epstein-Barr virus (EBV) vaccine (mRNA-1189)
To date, Moderna has demonstrated positive Phase 1 data readouts for seven prophylactic vaccines (H10N8, H7N9, RSV, chikungunya virus, hMPV/PIV3, CMV and Zika). Moderna’s CMV vaccine is currently in a Phase 2 dose-confirmation study. Moderna’s investigational Zika vaccine (mRNA-1893), currently in a Phase 1 study, was granted FDA Fast Track designation in August 2019.
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