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BenzingaEditorial

The COVID-19 Vaccine Front Updates

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While the pandemic that’s raging for the second time this year, the pharmaceutical giants are giving the world hope of ending the COVID-19 nightmare. On Monday, Moderna Inc (NASDAQ: MRNA) said it will apply for U.S. and European emergency authorization of its vaccine candidate as late-stage study results showed its vaccine was 94.1% effective without any serious safety concerns.

Moderna is one week behind Pfizer, but its candidate comes with a significant advantage

With a 100% success rate in preventing severe cases, the efficiency is consistent across age, race, ethnicity and gender demographics. There were no new side effects since the interim analysis on November 16th. The most common side effects were fatigue, injection site redness and pain, headache and body aches, which increased after the second dose but were short-lived. Considering such a potent vaccine, these flu-like symptoms are expected.

The filing that came a week after Pfizer Inc (NYSE:PFE) and its German partner BioNTech’s (NASDAQ:BNTX), sets Moderna’s candidate to be the second vaccine likely to receive U.S. emergency use authorization this year. Both candidates use a new technology called synthetic messenger RNA (mRNA) and showed effectiveness of approximately 95%.

Both the Moderna and Pfizer vaccines proved more effective than anticipated and far superior to the 50% benchmark set by the U.S. Food and Drug Administration. But, Moderna’s distribution is expected to be easier to store than Pfizer’s. It does require a freezer, but not the ultra-cold temperature needed by Pfizer’s vaccine.

Just like other vaccine developers, Moderna will  begin a new trial aimed at adolescents before the end of the year, followed by another trial in even younger volunteers at the beginning of next year. It expects the adolescent version of the vaccine to be available by September next year.

Pfizer’s vaccine comes with challenges

The excitement over Pfizer (NYSE:PFE) and BioNTech’s (NASDAQ:BNTX) vaccine developments has been hampered by some harsh realities. While a marvelous scientific discovery this new technology is, this particular vaccine has significant obstacles to overcome if it wants to contribute in putting an end to the global pandemic. Besides the regulatory approval, distributing and administering this vaccine across the globe may not be the walk in the park the markets seem to assume.

The overall trial counts over 40,000 participants, but the impressive efficacy is based on 170 individuals so we need to wait and see will this rate hold as numbers increase.

The duration of effectiveness is also unknown. Usually, vaccines are not approved unless they offer protection for at least one year. But, these are everything but normal times so this factor won’t hamper the regulatory process. Yet, there are production, distribution and administration issues to consider.

It’s much easier to make a small batch of mRNA for a clinical trial than it is to make millions and billions of doses that are to be distributed worldwide.

In May, Pfizer got valor glass containers by Corning (NYSE:GLW) to prevent contamination and enable a smooth high volume production. But Messenger RNA is very unstable, and these will be the very first mRNA vaccines that are approved for human use. The vaccine requires to be stores at cold temperatures due to this instability. Moreover, Pfizer’s vaccine must be kept at a temperature colder than in Alaska. Moreover,  the negative 94 degrees Fahrenheit that the vaccine requires has not even been recorded in the US.

Given the complex requirements, the company has chosen to distribute its own vaccine rather than rely on the government. To ship the vaccine from its Wisconsin or Michigan manufacturing sites, Pfizer developed a special suitcase. This so-called ‘pizza-box’ allows temperature and location to be tracked at all times. But the necessary temperature can be kept with the help of dry ice only for 10 days. Moreover, the suitcase can only be opened twice per day for less than three minutes at a time.

These freezers are not cheap, nor easy to find. They cost about $20,000. Thankfully, Walgreens (NASDAQ:WBA) and CVS (NYSE:CVS) stated they are up to the task.

Administering the Pfizer vaccine is also somewhat of a challenge as the vaccine must be mixed at the administration site with a sterile liquid, usually water, and given within six hours of creating the solution.  Therefore, it is hard to decentralise the administration. At the very least, nursing homes, where nearly a third of COVID deaths have occurred, have been covered by CVS (NYSE: CVS) which pledged to administer the vaccine as soon as it has been approved.

Despite the current situation, the U.S. is fortunate regarding the vaccine whereas Australia, despite being a developed economy, will have to figure out a way how to get this vaccine across the globe to its citizens in less than 10 days.

Astrazeneca caused a lot of head-scratching

Britain’s AstraZeneca (NASDAQ: AZN) and University of Oxford announced an average efficacy rate of 70% for their candidate, with the rate increasing up to 90% for a subgroup of trial participants who got a half dose/full dose treatment. But, some scientists have expressed doubts as it remains puzzling why immunization was more effective in trial participants who received a lower dose.

Outlook

There are issues that the potential candidates are yet overcome to reward shareholders and save lives. But the past few weeks of positive developments brought hope for ending the pandemic that has beaten economies to ground and claimed more than 1.45 million lives across the globe. Good news come at a time when new COVID-19 infections and hospitalizations are at record levels. Independent advisers to the U.S. Food and Drug Administration are scheduled to meet on December 10th to review Pfizer’s data, with Moderna’s following up on December 17th. The world will be eagerly waiting for their recommendations to the FDA. But regardless of the outcome of those reviews, it is certain that it will take a while for 2021 to be the year when life went back to normal.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: press@iamnewswire.com Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact: contributors@iamnewswire.com

BenzingaEditorial

Moderna Misses Expectations But Things Are More Than Fine

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Moderna (NASDAQ: MRNA) saw its stock jump on Thursday despite growing losses, after the Covid-19 vaccine-maker reported more than double the revenue Wall Street predicted. Moderna missed EPS expectations with revenue far surpassing analyst forecasts as the company first began to recognize revenue from sales of its COVID-19 vaccine in December 2020. The loss was simply a result of heavy investment to increase production of its COVID-19 vaccine.

The company has spent the past two months producing and shipping its much-awaited coronavirus vaccine but its fourth-quarter is merely the surface of its vaccine success. In 2021, Moderna plans to manufacture 600-700 million doses of its COVID-19 vaccine but it should be able to expand its capacity to 1.4 billion doses in 2022 due to heavy capital investments, all of which should result in massive profits.

Q4 and FY 2020

For the fourth quarter ended December 31s, quarterly loss of $0.69 per share was below Zacks Consensus Estimate of $0.25 but Moderna brought in $570.75 billion in sales. That crushed the average estimate of analysts surveyed by FactSet for $279.4 million andsurpassing the Zacks Consensus Estimate by 74.76%. Just one year ago, revenues amounted to $14.06 million but until its mRNA-1273 coronavirus vaccine, the company had never brought an approved medicine to the market.

Losses grew to 69 cents per share after a 37-cent per-share loss in the year-ago period, whereas analysts expected a 34-cent loss. Although a big portion of revenue still came from the grant received from the Biomedical Advanced Research and Development Authority to advance its Covid vaccine, for the first time,Moderna had product sales, and they amounted to $199.87 million as the company began recognizing Covid vaccine sales in December. Although losses widened in 2020, Moderna’s sales skyrocket to $803.4 million.

Possible threat

One of the biggest risks ahead for all vaccine makers is the prevalence of new coronavirus variants. To tackle this, Moderna is investigating two upgrades. The first is actually a third dose of vaccine that would increase neutralizing antibody levels to better fend off new strains. The second is a strain-specific upgraded version which has been moved into preclinical and phase 1 trials as of end of January. Moderna is designing it to target the. If successful, the company should be able to quickly adapt it to protect against future strainsalthough it is designed to target the South African variation.

Teenagers

In early December, Moderna began a phase 2/3 trial of its covid vaccine in young adults who are 12 to 17years old. The data will be reported in spring and should result in Emergency Use Authorization just in time for the back-to-school period in September. But as of last month, Moderna didn’t have enough adolescent volunteers.

Teens aren’t at the greatest risk from serious COVID-19 complications but they play a role in the transmission of the virus, so their vaccination is another  important element in containing the pandemic.

2021

The company expects $18.4 billion in full-year 2021 sales of its Covid vaccine. The figure is based on already inked advance purchase agreements but additional discussions are ongoing for both 2021 and 2022. That outlook shattered forecasts as analysts expected $11 billion. Furthermore, the company said it plans to make 700 million doses of its vaccine this year, while still working to bring that capacity up to 1 billion. In 2022, Moderna expects be able to produce 1.4 billion doses.

Chief Executive Stephane Bancel called 2020 a historic year for the company as it trailed Pfizer (NYSE: PFE) and BioNTech (NASDAQ: BNTX) by a week in the U.S by gaining emergency use authorization. The vaccine is Moderna’s first commercial product with 32 million doses having been administered in the U.S. to millions of people around the world.

In 2020, Moderna went from knowing mRNA vaccines can be highly efficient it went to cash-flow generating commercial company that is helping save the world form the claws of an invisible enemy. The latest reported quarter ended a milestone year for the biotech company. 2020 was a year in which the world went dark but the pandemic helped Moderna shine as it provided us with a glimpse of light at the end of the tunnel. Since the beginning of 2021, its shares gained 38.6%, greatly exceeding S&P 500’s gain of 4.5%.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: press@iamnewswire.com Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact: contributors@iamnewswire.com

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BenzingaEditorial

Li Did Good But Not Good Enough

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Li Auto Inc (NASDAQ: LI) earnings were good but guidance wasn’t good enough as Chinese electric-vehicle maker reported solid fourth-quarter numbers Thursday. Despite producing a surprise profit, stock reversed and Li wasn’t the only one. Nio Limited (NYSE) who is due to report Monday fell 9.7% and Xpeng Inc (NYSE: XPEV) lost 8.55% Thursday. Tesla (NASDAQ: TSLA) gave up 8.1%. Earlier this week, Texas-based Hyliion (Holdings Corporation (NYSE: HYLN), which makes EV powertrains for commercial fleets, reported a loss of 13 cents a share in the fourth quarter.

Figures

The results were a little confusing, but good as Li reported $636 million in sales as revenue jumped 39%, exceeding $604 million that analysts projected in sales. The company reported a loss from operations but a positive net income. Still, the loss from operations was about $12 million which is smaller than expected. Li Auto earnings came in at 2 cents a share whereas analysts expected a loss of 4 cents on a revenue of $565.5 million. The company also generated positive free cash flow. Investors like it when young companies demonstrate the ability to be self-funding by generating the cash they need to grow from their own operations.

Throughout the quarter, Li delivered 14,464 of its Li One SUV, its only vehicle in production which is technically a hybrid because it has a small gas engine to extend its range. This is 67% more than third quarter’s 8,660 with the total for 2020 being approximately 32,624 deliveries Its rival Nio (NYSE: NIO) sold 17,353 units in Q4 and 43,728 for the year, while Xpeng (NYSE: XPEV) sold 12,964 in Q4 and 27,041 for the year. What enabled Li to deliver a bottom-line profit from an operating loss is the required accounting of securities.

Outlook

Management expects first quarter revenue to come in the range of $450.6 million to $493.5 million. This range would represents a growth between 246% and 279% compared to previous fiscal year’s quarter. Deliveries are expected to be in the range between 10,500 and 11,500 vehicles, up 263%-297% compared to the same quarter last year but less than the fourth quarter which will make reaching analyst projections for 2021 sales projections more challenging. The company reported that January deliveries soared 356% YoY to 5,379 but that is below December 2020’s 6,126.

As the automotive industry is undergoing a once-in-a-century shift to smart EVs, the fourth quarter ended a big year for Li that grew significantly due to strong demand for its distinctive product offering and superior user experience. Government’s support for EVs also doesn’t hurt as to encourage adoption, not only are license plates guaranteed but they are also free.

The earnings provided a sigh of relief for investors as Li stock has had a rocky ride lately. As of Wednesday’s close, shares were down about 11% month to date.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: press@iamnewswire.com Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact: contributors@iamnewswire.com

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BenzingaEditorial

Baidu Is Determined To Show It Has More to Offer

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For two decades, the 21-year-old company has been viewed as an online marketing tool that sells ads through its web search results. But now, the internet company is ready to show it has much more to offer. Last week, it reported fourth quarter earnings for 2020 that beat market expectations and revealed its ambitious plans to enter the EV land. Many years of investing in AI has finally started to pay off as Baidu is finally monetizing the technology used with smart devices. Company’s investments in non-core businesses iarealso helping it defend its core search platform from rivals Alibaba (NYSE: BABA), Tencent Holdings (OTC: TCEHY) and privately-ownedByteDance, whose products are just as popular.

The Chinese tech giant has recovered from the worst impact that the pandemic had on its business as advertising rebounded. Moreover, non-marketing revenue which excludes advertising and includes its cloud and autonomous driving business, grew 52% YoY. Baidu is also tapping into capital markets, including a potential second listing in Hong Kong. Baidu beefs up its autonomous and smart transport technology to tainto the EV market as it revealed back in January it would set up a smart electric vehicle (EV) company with Geely.

As the domestic economy recovers, the company want to tap into into the fast-growing electric-vehicle market to diversify revenue sources.

Figures

Full year revenue for 2020 amounted to $16.4 billion which is flat compared to 2019. Adjusted earnings of $3.08 per share versus analyst estimates of $2.79 per share came after revenues of $4.6 billion versus analyst estimates of $4.7 billion, according to FactSet.

The company provided guidance for the undergoing quarter that was ahead of analyst estimates. Revenue is expected to be in the $4.0 billion and $4.4 billion, representing a growth rate of 15% to 26% YoY, but it does not include potential contribution from its acquisition of live streaming app YY Live. The acquisition was announced last November and is expected to close in the first half of the year. The guidance is also based on the assumption that its core revenue will grow between 26% and 39% on a YoY basis.

EVs

Baidu places a lot of emphasis on its Apollo self-driving technology. Last month, the company formed a strategic partnership with the Chinese car company Zhejiang Geely Holding Group to create a standalone electric car company. Baidu is the majority shareholder. Together, they aim to launch a smart EV model inthree years. Robin Li, Baidu’s CEO Li also said a brand name has been chosen but did not release it.

CNBC has confirmed Xia Yiping, co-founder of bike-sharing start-up Mobike, will be the CEO of the new entity. Xia previously worked at Fiat Chrysler (NYSE: FCAU) and Ford before co-founding a company that was part of China’s boom and eventual bust in shared bike start-ups.

Even Xiaomi is following Baidu’s EV footsteps as the Chinese search engine leader has been basking in newfound investor love as the next EV-maker wannabe. Unlike other EV makers, Baidu’s strategy is akin to Google’s (NASDAQ: GOOGL) (NASDAQ: GOOG) Android for smartphones.

Outlook

Baidu ended an unprecedented year on a solid note and showed it is recovering from the consequences of the global health crisis as its business benefited from an improving macroeconomic environment and the digitalization of businesses and lifestyles. Its commitment on innovation through technology is paying off for the Chinese tech giant. Baidu is well positioned as a leading AI company with a strong foundation to seize the enormous market opportunities in cloud services, autonomous driving, smart transportation, along with all kinds of new opportunities that AI will inevitably bring to the table. The online marketing company chose to be in the right place, at the right time.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: press@iamnewswire.com Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact: contributors@iamnewswire.com

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