One of the best medical stocks you haven't heard about

 Dr. Reddy's Laboratories (NYSE:RDY) may be one of the best medical stocks you haven't heard of. The pharmaceutical company concentrates on generic and biosimilar medicines for cardiovascular disease, pain management, oncology, gastrointestinal ailments, dermatology, anti-infection treatments, and pediatrics. Though it is the third-largest pharmaceutical company in India, most of its sales (39%) are in North America.

The company's stock is down slightly this year (1.42%), but up more than 35% over the past 12 months, and trends are working in the company's favor. India is the world's largest exporter of generic medicines, responsible for 20% of the world's generic exports, according to Indian Chemical News. There's plenty of growth potential within the country as well, with India expected to surpass China as the most populous nation in the world by 2027.

Dr. Reddy's showed positive gains in the most important financial data, according to its annual report. Revenue for 2020 was listed as $23.7 billion, up 13% over 2019. Gross profit was $1.27 billion, again up 13% year over year. EBITDA was up to $626.8 million, a rise of 36% over 2019. Pharmaceutical companies that specialize in generics have lower margins than other pharmaceutical companies, but Dr. Reddy's has improved its margins over the past two years.

That growth continued in the first quarter with reported revenue of $585 million, up 15% year over year, and gross profit of $328 million, up 25% over the same period in 2020. EBITDA for the quarter was $154 million, up from $150 million in 2020.

Its sales actually declined in India, but that was more than offset with increased sales in Europe, the United States, and emerging markets. Last year was a strong year with 101 generic filings pending for approval with the U.S. Food and Drug Administration (FDA) as of June 2020.

The company also improved its profit margin to 56% in the first quarter, up 4.3% year over year and 4.5% sequentially.

Dr. Reddy's also raised its annual dividend 25% last year to $0.3334 a share. While the yield is only 0.47%, the company has consistently given out a dividend every year since 1996.

TEVA GROSS PROFIT MARGIN DATA BY YCHARTS

Some of the company's biggest generic brands include Omez, an antiulcer and heartburn medication, pain reliever Nise, and Stamlo, a calcium channel blocker.

The company's most recent launch in the U.S. is for albendazole, the generic version of the antiworm medication, Albenza, sold by GlaxoSmithKline. According to a study by MarketsandResearch.biz, the albendazole market should grow with an 8% compound annual growth rate through 2025, reaching $188.4 million.

It also came to terms last September on an agreement with Bristol-Myers Squibb that, starting in 2022, allows Dr. Reddy's to produce a limited supply of the generic form of Revlimid, a multiple myeloma drug that had $12.1 billion in sales last year.

Dr. Reddy's has also focused more on biosimilars. It produced the first approved biosimilar, filgrastim, a protein that helps in the production of white blood cells, in India. It also had the world's first biosimilars for MAb (Rituximab), used as a therapy for certain cancers and autoimmune diseases, and for darbepoetin alfa, a protein that helps fight anemia by helping create red blood cells.

India has been dealing with a mounting COVID-19 threat, with more than 20 million cases of the virus, second only to the United States, and more than 222,000 deaths from COVID-19, third behind the U.S. and Brazil. Dr. Reddy's is in the process of becoming India's third maker of a COVID-19 vaccine as it was granted emergency use approval in April to distribute the Russian Sputnik V vaccine.

The move to distribute the vaccine is a big step for Dr. Reddy's, which has not been that active in vaccines. It received the first batch last week and said it should have approval to distribute the vaccine in a few weeks.

Dr. Reddy's appears to be on the upswing and a good choice for healthcare investors. Over the past three years, it has increased revenue 21% and its profit margin 20%. Because it is in India, it has lower production and labor costs than other big generic competitors, dwarfing the margins of companies such as Teva Pharmaceuticals and Lannett. If Dr. Reddy's can make greater inroads in its own country as well as it has in the United States, there's massive potential for share price growth.

The company's slip in share price the past three months, to me, makes it a more attractive buy with a forward price-to-earnings (P/E) ratio of 24, which is low compared to the 34 forward P/E ratio of most pharmaceutical companies.

https://www.fool.com/investing/2021/05/11/why-is-no-one-talking-about-dr-reddys-stock/

Australia seeks deal with Moderna for domestic production of mRNA vaccines

 Australia is in talks with Moderna Inc to establish domestic manufacturing of messenger ribonucleic acid (mRNA) vaccines such as the company's COVID-19 vaccine, Prime Minister Scott Morrison said on Thursday.

Australia, which on Wednesday agreed to buy 25 million doses of Moderna's COVID-19 vaccine, has pledged to spend A$1.5 billion ($1.2 billion) to revitalise manufacturing across six sectors, including pharmaceuticals.

The move to put manufacturing at the centre of a long-term recovery plan comes amid a realization that Australia has been too reliant on Asia for the supply of essential goods. Sour relations with top trading partner, China, and the pandemic’s impact on global supply chains have also strengthened that view.

"Onshore manufacturing would ensure a secure, long-term supply of Moderna's mRNA-based vaccines against COVID-19, including variants, and for potential future pandemics," Morrison said in a statement.

MRNA vaccines prompt the body to make a protein that is part of the virus, triggering an immune response.

Minister for Health Greg Hunt said Moderna was one of several companies Australia was in talks with over domestic production.

"Our hope is that we will have at least one, if not more than one, manufacturing operation in Australia," Hunt told reporters in Canberra.

"I am confident that over the future period, we will have mRNA production in Australia.

STAGNANT INOCULATIONS

Hunt also said the deal with Moderna would aid Australia's inoculation programme.

Citing delays in securing supplies, Australia now expects to finish inoculating its near 26 million population by the end of the year.

But this timetable relies on deliveries of vaccines from Pfizer after Australia in April restricted the use of AstraZeneca's vaccine in people below 50 years due to rare blood-clotting cases.

Australia on Thursday reported seven likely cases of blood clots in people who had recently received AstraZeneca's COVID-19 vaccine.

Australia has administered about 2.5 million doses of the AstraZeneca vaccine, with 18 people believed to have developed the condition.

Moderna will supply Australia with 10 million shots designed to protect against the original strain of the coronavirus this year, and 15 million doses of its updated variant booster shot in 2022.

Australia has fared much better than many other developed countries in keeping its COVID-19 numbers relatively low, with just over 29,900 cases and 910 deaths.

https://finance.yahoo.com/news/1-australia-active-talks-moderna-010141798.html

Biden’s Tax Plan to Weigh on Corporate America’s Profitability

 US corporate income to become the highest in the industrialised world under Biden’s tax plan. Will the US become less competitive? Prepare for a chart storm.

One of the promises made by Donald Trump before being elected President in 2016 was that his administration would lower the corporate tax. Shortly after winning the election, it did.

The idea behind Trump’s decision was that corporate America would use the lower rate and repatriate much of the profits held abroad. In part, they did, but not to the extent the administration hoped.

Fast forward more than four years, and the new administration in Washington, led by Biden’s Democrats, plans to reverse the corporate tax cut. It is only one of the many Trump decisions being reversed since Biden took office. That is especially interesting since corporate tax rates declined globally during the past decades.

United States Going Against the Trend

Most developed economies have reduced their headline corporate-income-tax rate in the last couple of decades. For instance, even France dropped it below 30%, while Britain has steadily reduced it all the way to below 20% from 30% at the start of the 2000s.

But for America, the calculation is a bit more complicated than that. On the one hand, Biden’s proposal to raise the corporate tax refers to an increase from the current 21% to 28%. Only Australia, Brazil and India will have a higher rate.

In America, the 28% rate combined with the average state corporate tax rate, would imply an actual 32.4%.

In the end, for corporations, what matters is the bottom line – how much is there to pay at the end of the year? As such, it is a question of semantics, as the burden on corporate America is much higher than just 28%. If we add the marginal tax rate on capital gains and dividends and the state tax rates on capital gains and dividends, the burden rises from 47.3% currently to 65.1%.

Will corporate America become less competitive? Perhaps. If we look at the S&P500 index performance after previous increases in the corporate tax rate, we see for the most part that the market took a hit.

https://vantagepointtrading.com/news/bidens-tax-plan-to-weigh-on-corporate-americas-profitability/

Hunt for Link Between Some Covid-19 Vaccines and Rare Blood Clots

 Scientists world-wide are racing to understand why Covid-19 vaccines from AstraZeneca PLC and Johnson & Johnson are causing rare but potentially deadly blood clots.

Determining the connection would help patients, doctors and health agencies better assess any risks posed by the vaccines and safely calibrate their use. In recent weeks, the U.S., the Canadian province of Ontario and several European countries including Norway and Denmark either paused or completely halted rollouts involving these vaccines.

"Understanding the cause is of highest importance for the next-generation vaccines, because [the novel] coronavirus will stay with us and vaccination will likely become seasonal," said Eric van Gorp, a professor at Erasmus University in the Netherlands who heads a group of scientists studying the condition.

In Germany, one researcher thinks he has found what is triggering the clots. Andreas Greinacher, a blood expert, and his team at the University of Greifswald believe so-called viral vector vaccines -- which use modified harmless cold viruses, known as adenoviruses, to convey genetic material into vaccine recipients to fight the coronavirus -- could cause an autoimmune response that leads to blood clots. According to Prof. Greinacher, that reaction could be tied to stray proteins and a preservative he has found in the AstraZeneca vaccine.

Prof. Greinacher and his team has just begun examining Johnson & Johnson's vaccine but has identified more than 1,000 proteins in AstraZeneca's vaccine derived from human cells, as well as a preservative known as ethylenediaminetetraacetic acid, or EDTA. Their hypothesis is that EDTA, which is common to drugs and other products, helps those proteins stray into the bloodstream, where they bind to a blood component called platelet factor 4, or PF4, forming complexes that activate the production of antibodies.

The inflammation caused by the vaccines, combined with the PF4 complexes, could trick the immune system into believing the body had been infected by bacteria, triggering an archaic defense mechanism that then runs out of control and causes clotting and bleeding.

Prof. Greinacher has compared the activation of the dormant response -- which has been supplanted in the evolution of the human immune system, but still lurks in its foundations -- to "awakening a sleeping dragon."

Prof. John Kelton of McMaster University in Canada, whose outfit runs Canada's reference lab for testing patients with blood-clotting symptoms after vaccination, said the lab replicated some of Prof. Greinacher's research and confirmed his findings.

Yet the cause was unclear. "[Prof. Greinacher's] hypothesis could be right, but it could also be wrong," Prof. Kelton said.

Prof. Greinacher is working to confirm his theory, hoping to get cooperation from vaccine makers. His team has tested AstraZeneca vaccines and has just received doses from Johnson & Johnson. Greifswald University is now negotiating with the drugmakers about greater access to their vaccine-making processes.

"We strongly support raising awareness of the signs and symptoms of this very rare event, and we are currently exploring a potential collaboration with Dr. Greinacher," said a Johnson & Johnson spokesman.

AstraZeneca didn't respond to a request for comment.

The type of clotting observed is known as vaccine-induced immune thrombotic thrombocytopenia, or VITT. Peer-reviewed studies by Prof. Greinacher's group, as well as from teams at the University of Oslo and University College London have independently confirmed its existence.

Most of the science hubs investigating the clotting issue, first identified in March, are experts in a condition called heparin-induced thrombocytopenia or HIT, which has near-identical symptoms and outcomes to VITT. With HIT, the blood-thinning drug heparin causes clots paired with an abnormal decrease in the blood's natural clotting agents.

Some scientists think the adenoviruses themselves could play a role in triggering the condition because they have been linked to blood clotting. Others speculate that people affected could have genetic predispositions, or that their immune systems had previously developed the problematic antibody.

Another theory suggested by Prof. van Gorp is that the brief but strong flulike symptoms many recipients report after taking the shot are also causing inflammation that could trigger or exacerbate autoimmune reactions leading to blood clotting.

One reason vaccine-induced clotting might not have been reported in the past is because shots using viral vector technology haven't been administered at scale. The Russian vaccine Sputnik V and the shot by CanSino Biologics from China use the same technology as AstraZeneca and Johnson & Johnson, but haven't been linked to the condition so far.

The only similar shot widely administered before the pandemic is one against Ebola by Johnson & Johnson, which was given to at least 60,000 people as of last July.

Clotting occurs between one in 28,000 and one in 100,000, according to European data -- extremely rare amid the hundreds of millions of doses administered so far, yet higher than one in 150,000 previously assumed by some medical authorities, Prof. Greinacher said. Most of the hundreds of people who have been diagnosed recover, but between a fifth and a third have died, and others could suffer permanent consequences.

Data from U.S. and European regulators so far suggest young women are primarily affected by the condition. But several scientists, including Sabine Eichinger, a senior Austrian hematologist who treated one of the first-known patients, have said the correlation could reflect that medical workers and teachers were among the first to get the vaccines in Europe, and the majority of them are younger women.

There is no indication that taking contraception pills or having a history of similar diseases puts vaccine recipients at greater risk, Prof. Eichinger said.

Anton Pottegård, a professor of pharmacoepidemiology at the University of Southern Denmark, co-wrote a study of more than 280,000 people in Denmark and Norway who received the AstraZeneca vaccine. The study, which was published in the British Medical Journal on May 5, found the incidence of rare but severe blood clots among vaccine recipients was 2.5 in 100,000.

Prof. Pottegård added that countries such as Denmark and Norway, which this week discontinued using AstraZeneca's vaccine and donated its doses to other countries, were able to change their inoculation plans because they had alternative shots and low infection rates. Doing the same in countries where the pandemic is raging, such as India or Brazil, could result in more deaths, he warned.

"Covid-19 is much, much, much more dangerous than this extremely rare condition," Prof. Greinacher said.

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Inside-the-Hunt-for-a-Link-Between-Some-Covid-19-Vaccines-and-Rare-Blood-Clots-33247767/

Need for Covid boosters questioned

 

COVID-19 vaccine developers are making ever bolder assertions that the world will need yearly booster shots, or new vaccines to tackle concerning coronavirus variants, but some scientists question when, or whether, such shots will be needed.

    In interviews with Reuters, more than a dozen influential infectious disease and vaccine development experts said there is growing evidence that a first round of global vaccinations may offer enduring protection against the coronavirus and its most worrisome variants discovered to date.        

    Some of these scientists expressed concern that public expectations around COVID-19 boosters are being set by pharmaceutical executives rather than health specialists, although many agreed that preparing for such a need as a precaution was prudent.

They fear a push by wealthy nations for repeat vaccination as early as this year will deepen the divide with poorer countries that are struggling to buy vaccines and may take years to inoculate their citizens even once.

    "We don't see the data yet that would inform a decision about whether or not booster doses are needed," said Kate O'Brien, director of the Department of Immunization, Vaccines and Biologicals at the World Health Organization (WHO).

    O'Brien said the WHO is forming a panel of experts to assess all variant and vaccine efficacy data and recommend changes to vaccination programs as needed.

Pfizer Inc Chief Executive Albert Bourla has said people will "likely" need a booster dose of the company's vaccine every 12 months - similar to an annual flu shot - to maintain high levels of immunity against the original SARS-CoV-2 virus and its variants.

"There is zero, and I mean zero, evidence to suggest that that is the case," countered Dr. Tom Frieden, former director of the U.S. Centers for Disease Control and Prevention.

"It's completely inappropriate to say that we're likely to need an annual booster, because we have no idea what the likelihood of that is," Frieden, who now leads the global public health initiative Resolve to Save Lives, said of Pfizer's assertions on boosters.

Pfizer, responding to the criticism, said it expects a need for boosters while the virus is still circulating widely. That could change once the pandemic is more firmly under control, a company spokeswoman said.

Moderna Inc CEO Stephane Bancel aims to produce a vaccine by the fall that targets a variant first identified in South Africa and expects regular boosters will be needed. 

The United States is preparing to have such doses on hand for Americans, while the European Union, Britain and Israel have ordered new supplies of COVID-19 vaccines to deploy as protective boosters.

Some health experts, including Richard Hatchett, chief executive of the Coalition for Epidemic Preparedness Innovations (CEPI) that has funded many vaccine projects, say vaccine makers are right to plan ahead for boosters given the uncertainty over what will be needed in the long run.

Governments can then decide for themselves whether to buy the products, he said.

"A LITTLE EVIDENCE"

Pfizer and German partner BioNTech SE have so far found that their shot remains more than 91% effective for six months after people received their second dose, compared with nearly 95% demonstrated in their clinical trial. The companies will track how robust the protection remains over time.

    Dr. William Gruber, Pfizer's senior vice president of vaccine clinical research and development, told Reuters earlier this month the prediction for yearly boosters was based on "a little evidence" of a decline in immunity over those six months.

    Pfizer expects the COVID-19 vaccine to be a major revenue contributor for years, and has forecast sales of $26 billion from the shot in 2021. Global spending on COVID-19 vaccines and booster shots could total $157 billion through 2025, according to U.S. health data firm IQVIA Holdings.

    Moderna President Stephen Hoge expects boosters will be needed to keep immunity levels high, due in part to vaccine hesitancy, as an estimated 30% of the U.S. population may not agree to be vaccinated. As long as the virus is circulating widely, people at high risk of severe illness may need to boost their immune protection, Hoge said.

    "All governments are in conversations with (Moderna) and other companies about boosters," he said.

    BROADER IMMUNITY?

    Late last year, scientists were optimistic that highly effective vaccines could quickly curb the global pandemic that has battered economies and killed more than 3.4 million people.

    Those hopes dimmed by February with evidence that mutant versions of the virus might evade protection offered by vaccines. Laboratory studies showed that the South African variant could produce six to eight-fold reductions in antibody levels among people vaccinated with the Pfizer or Moderna vaccines.

Clinical trial data also showed that vaccines from AstraZeneca Plc, Johnson & Johnson and Novavax Inc were less effective at preventing infections in South Africa, where the variant is widespread.

    These studies spurred drug companies to start testing booster doses of their vaccines and to develop shots that target specific variants of the virus.

    However, more recent research suggests that the Moderna and Pfizer/BioNTech vaccines produce high levels of protective antibodies to create a "cushion effect" against the known variants, said Dr. Anthony Fauci, head of the National Institutes of Allergy and Infectious Diseases (NIAID) and a top White House adviser.

    And antibodies - which block the coronavirus from attaching to human cells - do not tell the whole story. Several studies suggest that T cells - a type of white blood cell that can target and destroy already infected cells - may help prevent severe COVID-19 and hospitalization.

    NIAID researchers found that T cells in the blood of people who recovered from the original virus could still fight off infections caused by the concerning variants found in the UK, South Africa and Brazil.

    "It's quite possible" that boosters would not be needed, Fauci told Reuters. "It is conceivable that the variants will not be as much a problem with a really good vaccine as we might have anticipated."

    Nevertheless, health authorities in the United States, Britain and Europe are assuring their populations that a new round of shots will be available if needed, with many nations still desperate for vaccine supplies.

    "It's a huge concern that ... wealthy countries would begin administering booster doses and further constraining supply of people's first dose of vaccine," said Rajeev Venkayya, head of global vaccines for Takeda Pharmaceutical Co.

Dr. Monica Gandhi, an infectious disease doctor at the University of California, San Francisco, said ultimately, decisions on whether boosters will be needed "will best be made by public health experts, rather than CEOs of a company who may benefit financially."

https://www.marketscreener.com/quote/stock/ASTRAZENECA-PLC-4000930/news/Top-scientists-question-the-need-for-COVID-19-booster-shots-33247912/

Obstructive sleep apnea is highly prevalent in COVID19 moderate to severe ARDS survivors

 Abhishek Goyal, Khushboo Saxena, Avishek Kar, Alkesh Khurana, Parneet Kaur Bhagtana, Chinta Siva Koti Rupa Sridevi, Abhijit Pakhare

doi: https://doi.org/10.1101/2021.05.04.21256593

This article is a preprint and has not been peer-reviewed [what does this mean?]. It reports new medical research that has yet to be evaluated and so should not be used to guide clinical practice.

PDF: https://www.medrxiv.org/content/10.1101/2021.05.04.21256593v1.full.pdf

Abstract

Study Objectives Studies have found Obstructive Sleep Apnea (OSA) as a risk factor for increased risk for COVID19 Acute respiratory Distress Syndrome (ARDS); but most of the studies were done in already known patients of OSA. This study was done to find prevalence of OSA in patients with COVID-19 related acute respiratory distress syndrome.

Methodology A hospital based longitudinal study was conducted among COVID 19 Intensive Care Unit (ICU) survivors. All consecutive COVID19 with moderate to severe ARDS were evaluated for OSA by Level I Polysomnography (PSG) after 4-6 weeks of discharge. Prevalence of OSA and PSG variables {Total sleep time, Sleep efficiency, sleep stage percentage, Apnea Hypopnea Index (AHI), T90, nadir oxygen} was estimated.

Results Out of 103 patients discharged from ICU during study period (October 2020 to 15 December 2020), 67 underwent Level I PSG. Mean Age was 52.6±10.9 years and mean Body Mass Index was 27.5 ± 6.2 Kg/m2. Total sleep time was 343.2 ± 86 minutes, sleep efficiency was 75.9±14.2%. OSA (AHI ≥5) was seen in 65/67 patients and 49 patients had moderate to severe OSA (i.e. AHI ≥ 15).

Conclusion Moderate-severe OSA was highly prevalent (73%) in COVID19 moderate to severe ARDS survivors. Role of OSA in pathophysiology of COVID19 ARDS needs further evaluation.

Competing Interest Statement

The authors have declared no competing interest.

Funding Statement

This was a non funded study

https://www.medrxiv.org/content/10.1101/2021.05.04.21256593v1

Neutralizing antibody vaccine for pandemic and pre-emergent coronaviruses

 Kevin O. Saunders1,2,3,4 ✉, Esther Lee1,5, Robert Parks1,5, David R. Martinez6 , Dapeng Li1,5, Haiyan Chen1,5, Robert J. Edwards1,5, Sophie Gobeil1,5, Maggie Barr1,5, Katayoun Mansouri1,5, S. Munir Alam1,5, Laura L. Sutherland1,5, Fangping Cai1,5, Aja M. Sanzone1,5, Madison Berry1,5, Kartik Manne1,5, Kevin W. Bock7 , Mahnaz Minai7 , Bianca M. Nagata7 , Anyway B. Kapingidza1,5, Mihai Azoitei1,5, Longping V. Tse6 , Trevor D. Scobey6 , Rachel L. Spreng1,5, R. Wes Rountree1,5, C. Todd DeMarco1,5, Thomas N. Denny1,5, Christopher W. Woods1,5,8, Elizabeth W. Petzold8 , Juanjie Tang9 , Thomas H. Oguin III1,5, Gregory D. Sempowski1,5, Matthew Gagne10, Daniel C. Douek10, Mark A. Tomai11, Christopher B. Fox12, Robert Seder10, Kevin Wiehe1,5, Drew Weissman13, Norbert Pardi13, Hana Golding9 , Surender Khurana9 , Priyamvada Acharya1,2, Hanne Andersen14, Mark G. Lewis14, Ian N. Moore7 , David C. Montefiori1,2, Ralph S. Baric6 & Barton F. Haynes

DOI: https://doi.org/10.1038/s41586-021-03594-0

Abstract

Betacoronaviruses (betaCoVs) caused the severe acute respiratory syndrome (SARS) and Middle East Respiratory Syndrome (MERS) outbreaks, and the SARS-CoV-2 pandemic1–4 . Vaccines that elicit protective immunity against SARS-CoV-2 and betaCoVs circulating in animals have the potential to prevent future betaCoV pandemics. Here, we show that macaque immunization with a multimeric SARS-CoV-2 receptor binding domain (RBD) nanoparticle adjuvanted with 3M-052/Alum elicited cross-neutralizing antibody (cross-nAb) responses against batCoVs, SARS-CoV-1, SARS-CoV-2, and SARS-CoV-2 variants B.1.1.7, P.1, and B.1.351. Nanoparticle vaccination resulted in a SARS-CoV-2 reciprocal geometric mean neutralization ID50 titer of 47,216, and protection against SARS-CoV-2 in macaque upper and lower respiratory tracts. Importantly, nucleoside-modifed mRNA encoding a stabilized transmembrane spike or monomeric RBD also induced SARS-CoV-1 and batCoV cross-nAbs, albeit at lower titers. These results demonstrate current mRNA vaccines may provide some protection from future zoonotic betaCoV outbreaks, and provide a platform for further development of pan-betaCoV vaccines.

https://www.nature.com/articles/s41586-021-03594-0_reference.pdf