The post 2024 desembarca con varias infecciones respiratorias appeared first on Investor News.

“Silicon Valley has seen the rise of companies whose inventions have changed the world and, through intellectual prowess, hard work, and sheer determination, this region continues to innovate,” said U.S. Attorney Stephanie M. Hinds. “Capital investment is critical to that innovation. When fraud is perpetrated on those providing the necessary capital, it staunches investment and can cripple an industry. For almost a decade, Elizabeth Holmes fabricated and spread elaborate falsehoods to draw in a legion of capital investors, both big and small, and her deceit caused the loss of hundreds of millions of dollars. Her sentence reflects the audacity of her massive fraud and the staggering damage she caused.”

“Frauds such as the one perpetrated by Holmes can erode investor confidence which impacts our capital markets. Today’s sentence should serve as a warning that deceiving investors will not be tolerated. The FBI is committed to investigating corporate fraud and working with our partners to help keep our capital markets working effectively,” said FBI Special Agent in Charge Robert K. Tripp. “The FBI and our partners worked tirelessly on this multi-year case and are proud justice has been served as a result.”

“Today’s announcement should serve as a reminder that fraud related to medical products will not be tolerated,” said FDA Assistant Commissioner for Criminal Investigations Catherine A. Hermsen. “The FDA will continue to work with our law enforcement partners to bring to justice those who place profits above public health.”

“Postal Inspectors worked closely with our partners at the U.S. Attorney’s Office, the FDA Office of Criminal Investigations, and the FBI to bring this case to court,” said USPIS San Francisco Division Acting Inspector in Charge Kevin Rho. “USPIS remains committed to protecting consumers and investors from fraud.”

Holmes, 38, of Woodside, Calif., founded Theranos in 2003 and held the positions of Chairperson and Chief Executive Officer. Theranos, now defunct, was a blood testing company based in Palo Alto and Newark, Calif. Evidence at her jury trial showed that for more than a decade, Holmes claimed that Theranos had developed a revolutionary blood analyzer, variously referred to as the Theranos Sample Processing Unit (TSPU), Edison, and minilab. She asserted that the Theranos proprietary blood analyzer device could run any blood test that was run by conventional labs, all from a blood sample drawn via a fingerstick rather than the traditional draw from a vein. She asserted the Theranos analyzer produced results that were better, cheaper, and more accurate than existing methods and at a speed faster than ever before possible.

Trial evidence demonstrated that Holmes knew the analyzer was not producing accurate and reliable results. Holmes understood that at best it could only perform a few basic tests and was slower than existing devices. She knew that it could not successfully compete with the established conventional machines. Evidence showed that Holmes repeatedly had to resort to using conventional machines to obtain the blood test results that the Theranos analyzer was supposed to perform, though she led investors and the public to believe that Theranos was conducting most or all of its tests using its own analyzer.

Evidence showed that Holmes, despite being aware of the Theranos analyzer’s failure to perform, was able to induce dozens of investors, many of whom were prominent public figures, to invest hundreds of millions of dollars in Theranos. She used direct communications, marketing materials, statements to the media, financial statements, models, and other information to reach potential investors and induce investments. Holmes consistently provided glowing but false representations to investors and potential investors about the analyzer’s progress and capabilities. She falsely represented to investors that multiple major pharmaceutical companies had comprehensively evaluated Theranos and had validated its technology, and she provided investors with reports bearing logos from pharmaceutical companies, falsely suggesting the pharmaceutical companies endorsed Theranos. Holmes misrepresented to investors that Theranos had a profitable, revenue-generating business relationship with the U.S. Department of Defense and that the Theranos technology had been deployed to the battlefield to treat wounded soldiers. In truth, Holmes knew the technology was never deployed in the battlefield and that Theranos had acquired little revenue from military contracts for trial-runs of the analyzer. Holmes also falsely represented to investors that Theranos would dramatically increase its number of Wellness Centers within stores operated by its partner Walgreens from a few dozen to 900, despite knowing that the relationship with Walgreens was stagnating.

Trial evidence demonstrated that Holmes also misrepresented the dire financial status of Theranos to investors and its prospects for future earnings. In examples at trial, Holmes represented to one investor in 2010 that the projected revenue for Theranos in 2011 was $223 million, when she knew that Theranos’ revenue was dropping precipitously, from $2.8 million in 2009 to less than $600,000 in 2011. Holmes misrepresented to other investors that Theranos, which had zero revenue in 2012 and 2013, was projected to generate over $100 million in revenue in 2014 and to reach nearly $1 billion in 2015. She knew when she made these representations that Theranos would at best generate only modest revenue in 2014 and 2015.

In its memorandum filed for the sentencing hearing, the government pointed to evidence that Holmes’ fraud was immensely successful. Projecting altruistic motives, Holmes raised hundreds of millions of dollars by duping investors of all experience levels to invest in Theranos. She fooled investors new to the healthcare and bio-tech sector as well those with deep sophistication and experience in that arena. By the end of 2014, her stock in Theranos was valued at more than $4 billion. She enjoyed a lavish life while carrying out her fraudulent scheme, living in a $15 million mansion and traveling in a Theranos-paid private jet. She gained a national profile, adorning the cover of Fortune, Forbes, Inc., Glamour, and T: The New York Times Style Magazine. Holmes dined at the White House, joined the Board of Fellows of Harvard Medical School, and was named by Time as one of the 100 Most Influential People in the World. But as the government describes, her scheme not only deprived investors of vast sums of money, it also placed numerous others at risk of great physical harm. Wanting to paint Theranos as a legitimate enterprise, Holmes offered Theranos blood tests to the public, and Theranos’ flawed technology was used on patients with serious medical conditions. As a result, Theranos sent out inaccurate results to patients being screened for cancer, to women monitoring their pregnancies, and to one victim who was led to believe she had the precursor virus to AIDS, among many other examples. Theranos itself eventually concluded a patient impact existed for every test run on patients and voided all tests with its analyzer. The government points out that Holmes was undeterred and again choose deceit over candor by downplaying the extent of the patient impact to investor-victims and continuing forward with her elaborate fraud.

Federal criminal charges were initially filed against Holmes on June 14, 2018. On July 28, 2020, a federal grand jury returned a superseding indictment charging her with two counts of conspiracy to commit wire fraud, in violation of 18 U.S.C. § 1349, and ten counts of wire fraud, in violation of 18 U.S.C. § 1343. Of the two conspiracy counts, one alleged Holmes conspired to defraud investors and the second alleged Holmes conspired to defraud patients who used Theranos services. Some of the ten counts of wire fraud alleged Holmes committed fraud on individual investors while others alleged Holmes defrauded patients who were induced to purchase Theranos services.

On January 3, 2022, after a nearly four-month trial, a federal jury convicted Holmes of one count of conspiracy to commit fraud on investors and three counts of committing fraud on individual investors which involved wire transfers totaling more than $140 million. The jury acquitted Holmes of the patient-related fraud conspiracy count and on three counts of fraud against individual patients. The jury could not reach a unanimous verdict with respect to three individual investor fraud counts. An additional count of wire fraud relating to a Theranos patient had been dismissed during trial.

In addition to the 135 month prison term, U.S. District Judge Davila sentenced Holmes to three years of supervision following release from prison. The parties were instructed to meet and agree on a future date for a hearing to determine the restitution amount to be paid by Holmes. No fine was assessed. Holmes was ordered to surrender on April 27, 2023, to begin serving her prison sentence.

Assistant U.S. Attorneys Robert S. Leach, Jeff Schenk, John C. Bostic, and Kelly Volkar are prosecuting the case with the assistance of Madeline Wachs, Lakisha Holliman, Sara Slattery, Elise Etter, Susan Kreider, and Leeya Kekona. The prosecution is the result of an investigation by the FBI, USPIS, and the FDA Office of Criminal Investigations.

Press release by DOJ.

Featured image: by Got Credit is marked with CC BY 2.0.

The post Elizabeth Holmes Sentenced To More Than 11 Years For Defrauding Theranos Investors Of Hundreds Of Millions appeared first on Investor News.

Sameday Health operates 55 testing locations nationwide, with 16 locations in L.A. County and five in the City, and has made tens of millions in revenue since the beginning of the pandemic. The settlements require the defendants to pay restitution and civil penalties, and comply with permanent injunctions prohibiting them from participating in the alleged activities that led to the City Attorney’s investigation. L.A. County District Attorney George Gascón joined Feuer in this civil enforcement action.

“It’s beyond outrageous that anyone would falsify COVID tests, as we allege happened here. If you get a negative test, you assume it’s safe to go to work, visit family and friends, or take a vacation. But the victims of this alleged scheme might unknowingly have spread COVID to others or failed to receive timely and appropriate care themselves,” said Feuer. “I just got over COVID myself and know how essential it is to have accurate test results. This landmark resolution will stop this alleged scheme, give restitution to consumers and insurers, and impose severe penalties.”

“We’ve intervened to protect consumers in numerous major COVID-related matters, but this may be the most significant consumer protection case to emerge from the pandemic,” Feuer added.

“My office is dedicated to protecting the people of Los Angeles County from dangerous and costly scams like these and seeking appropriate action against those who take advantage of consumers through fraudulent business practices,” District Attorney Gascón said. “It is not only illegal but also unconscionable to defraud people seeking medical assistance in the midst of a public health crisis. We will continue to work to bring justice to victims of all crimes, including fraud.”

According to the complaint, Sameday Health and Huettenbach allegedly falsely advertised that they could deliver COVID-19 test results to consumers within 24-hours, knowing they could not truthfully make that guarantee. When they could not fulfill their false promises, Sameday Health and Huettenbach allegedly faked, falsified and forged COVID-19 test results for at least 500 customers by manipulating old PDF lab reports and results from previous tests. The complaint alleges that, in some cases, Sameday Health sent these fake results to customers before their tests had been run or even delivered to the lab for testing. The complaint also alleges that Sameday Health sometimes sent fake results to customers whose tests were never processed by a lab—meaning that even though the customer received a “negative” result from Sameday Health, Sameday Health had no way of knowing whether the customer actually tested positive for COVID-19.

The two complaints further allege that Sameday Health and Huettenbach partnered with Toll to engage in insurance fraud by charging insurance companies that were already paying for COVID-19 tests an additional fee for medically unnecessary medical consultations. According to the complaint against Sameday Health, Sameday Health and Huettenbach required customers paying with insurance to consent to and participate in medically unnecessary consultations with doctors in order obtain a COVID-19 test. On the other hand, consumers paying with cash, the complaints allege, were not required or even able to obtain these consultations. Sameday Health allegedly targeted its insured consumers and steered them to Toll for superficial, two to three-minute-long telemedicine visits for which they charged health insurers approximately $450. In exchange for steering these customers to him, Toll allegedly gave Sameday Health a large portion of his profits from the consultations as a kickback. In all, the Sameday Health complaint alleges that Sameday Health made millions of dollars from California-based insurance claims alone.

In the settlement, Sameday Health and Huettenbach both agree to be subject to a permanent injunction that prohibits them from engaging in the unlawful business practices alleged in the complaint. The injunction also prohibits Huettenbach personally from accessing any test result or medical record belonging to any of Sameday Health’s customers. In addition to the permanent injunction, Sameday Health and Huettenbach have agreed to pay more than $9.5 million in restitution and nearly $13 million in civil penalties. In addition, the settlement requires Sameday Health to hire, and spend up to $100,000 to retain, an independent monitor to ensure that it does not send customers fake COVID-19 test results. Toll, on the other hand, agrees to be enjoined from engaging in any of the conduct alleged against him in the complaint and to pay $1.15 million in civil penalties and more than $2.8 million in restitution.

In all, these settlements require defendants to pay nearly $26.5 million, including more than $12.4 million in restitution and almost $14 million in civil penalties.

All of the defendants cooperated with the investigation into this matter.

Feuer advises those seeking COVID-19 tests to book one through a trusted healthcare provider or with Health Services of L.A. County. He reminds Angelenos to confirm in advance whether the testing service requires customers to pay for services with insurance or cash—especially those that advertise “free” services.

Feuer also advises those obtaining COVID-19 tests to be vigilant concerning tests with possible fake results. Customers should be on the lookout for COVID-19 testing services claiming that they will deliver results to customers one way (such as through a link to an online portal) but actually deliver the results in a different way (such as by attaching a PDF or simply writing the result in an email) or sending results that include any suspicious or incorrect information (such as incorrect dates or locations). These practices could indicate that the results are not trustworthy. Please report any suspicious COVID-19 testing services on the City Attorney’s online Consumer Complaint portal.

Los Angeles Supervising Deputy City Attorney Christina Tusan and Deputy City Attorneys William Pletcher, Alex Bergjans, Carr Tekosky, Louisa Kirakosian and Sarah Spielberger, all of the City Attorney’s Consumer Protection Unit, and Head Deputy District Attorney Hoon Chun and Deputy District Attorney Seza Mikikian, of the Los Angeles County District Attorney’s Consumer Protection Division, are litigating this matter.

Read the Complaints and settlement documents:

• Complaint in People of the State of California v. Sameday Technologies, Inc. et. al.

• Stipulation and Proposed Judgment in People of the State of California v. Sameday Technologies, Inc. et. al.

• Complaint in People of the State of California v. Jeffrey Toll et. al.

• Stipulation and Proposed Judgment in People of the State of California v. Jeffrey Toll et. al.

Since the beginning of the COVID-19 pandemic in Los Angeles in March 2020, City Attorney Feuer has worked to protect Angelenos and has been a national leader in the prosecution of COVID-19 related scams and price gouging, including:

• Obtaining multiple convictions for criminal price gouging of goods by online retailers and brick and mortar stores, resulting in orders of restitution to victims, criminal fines and the donation of personal protective equipment;

• Issuing cease and desist letters to local stores allegedly engaged in price gouging; and

• Filing numerous civil law enforcement actions against companies and individuals who allegedly marketed and sold unauthorized COVID-19 tests and treatments, obtaining orders stopping the unlawful conduct and obtaining hundreds of thousands of dollars in restitution for victims and substantial civil penalties.

Press release distributed by the LA City Attorney Mike Feuer..

The post Sameday Health settles with LA over fake COVID-19 test results appeared first on Investor News.

The post SEC Charges Biotech Company and CEO With Fraud Concerning COVID-19 Blood Testing Device appeared first on Investor News.

Merck introduced in the present day that it divested its direct holding in Moderna within the first half of the fourth quarter of 2020.

Merck, which had invested $50 million in Moderna in 2015 and a further $125 million in 2018, mentioned it might retain oblique publicity by way of its enterprise fund investments.

The pharmaceutical large mentioned it had “achieved a considerable achieve” on its funding, “notably in 2020 given the substantial appreciation” in Moderna’s inventory worth because it has been among the many leaders in COVID-19 vaccine improvement.

Moderna went public in December 2018 at a valuation of $7.6 billion and is at present valued at roughly $58 billion. The corporate filed earlier this week with the FDA for emergency use authorization of its vaccine.

Merck mentioned that it continues to collaborate with Moderna on the event of customized most cancers vaccines along with a most cancers vaccine that encodes the 4 most typical KRAS gene mutations, which happen in as much as 20% of all cancers.

The post Merck Announces Sale of Direct Equity Investment in Moderna appeared first on Investor News.

The corporate has submitted purposes in search of emergency use authorization in the US and the European Union after full outcomes from a late-stage examine confirmed the vaccine was 94.1% efficient with no severe security issues.

“For 500 million, I’m very comfy we’re gonna get there (2021),” Bancel mentioned on the Nasdaq Investor Convention.

He additionally mentioned the corporate would have the ability to preserve a premium value of $37 for its vaccine doses, though the premium is anticipated to fall to $25 for big-volume provides, such because the one to the U.S. authorities.

The Meals and Drug Administration is about to carry an advisory committee assembly on Dec. 17 to debate the corporate’s request for emergency authorization for its COVID-19 vaccine.

Bancel mentioned the corporate has seen renewed demand from many nations in search of further doses after it reported scientific knowledge.

Earlier on Friday, Moderna prolonged its contract with the Israeli well being ministry to produce a further 4 million doses of its COVID-19 vaccine candidate.

The corporate mentioned on Thursday it will provide as much as 125 million doses of the vaccine by the primary quarter of 2021.

Reporting by Mrinalika Roy and Trisha Roy in Bengaluru; Modifying by Anil D’Silva, Aditya Soni.

The post Moderna CEO Bancel Confident of Producing 500 Million COVID-19 Vaccine Doses in 2021 appeared first on Investor News.

US stocks have rocketed 28% this year. This is the second largest annual gain since 1999. And the tenth straight year stocks have climbed higher.

This has a lot of investors worried that stocks could tank soon. But this bull market is far from over. My research shows stocks should continue to rise until at least September 2020.

And falling interest rates could help that happen… especially for healthcare stocks.

Falling Rates Push Healthcare Stocks Higher

In July, the Federal Reserve cut interest rates for the first time in over a decade.

As a general rule, lower rates tend to push stocks higher—largely because it makes it cheaper for businesses to borrow and fuels spending.

Lower rates prop up healthcare stocks in particular. According to Barclays, they outperform the S&P 500 by an average of 7% in the nine months after an initial interest rate cut, like the one we saw in July.

That was almost five months ago. And the SPDR Health Care Sector ETF [ (XLV[ARCA] – $101.86 0.20 (0.20%)   )] has climbed 9% since. That’s nearly double the S&P 500’s 5.4% return, as the next chart shows.

Click to enlarge

I’ve covered three ways to play this trend back in July: Johnson & Johnson [ (JNJ[NYE] – $145.87 0.57 (0.39%)    Trade )], AbbVie Inc. [ (ABBV[NYE] – $88.54 0.02 (0.02%)    Trade )], and Abbott Laboratories [ (ABT[NYE] – $86.86 0.06 (0.07%)    Trade )]. Since then, these stocks have climbed an average of 10.1%:

Click to enlarge

That’s more than double the S&P 500’s return over the same period.

Impressive. But remember, if the pattern holds, we’re only halfway through this trend.

The Longview—We’re Getting Old

There are lots of reasons to like healthcare stocks.

To start, America is graying. The share of Americans age 65 and up will jump from 15% in 2018, and up to 21% by 2030.

This has straightforward implications: as people get older, they need more medical care. And it’s one of the last things people skimp on.

In fact, US healthcare spending will grow 5.5% annually through 2027, according to the Centers for Medicare and Medicaid Services (CMS).

Click to enlarge

Consistent spending means healthcare companies earn stable profits, pretty much no matter what.

This makes healthcare stocks ideal for income investors like us.

My New Top Healthcare Picks

Long-term increases in healthcare spending will push healthcare stock prices higher. Add in the short-term interest rate tailwind I mentioned earlier, and you’ve got good reason to hold healthcare stocks today.

The world’s largest medical device company, Medtronic plc [ (MDT[NYE] – $113.45 0.52 (0.46%)    Trade )], is at the top of my list. The company makes pacemakers, insulin pumps, and surgical tools.

The aging US population will keep these products in high demand for decades. This makes Medtronic’s stock and its 2.0% dividend yield very reliable.

Next on my list is global drug company GlaxoSmithKline PLC [ (GSK[NYE] – $46.99 0.09 (0.19%)    Trade )].

GlaxoSmithKline makes a variety of well-known medications, from the nasal spray Flonase, to the antidepressant Wellbutrin, to the antacid Zantac.

The company also holds key patents for highly profitable respiratory and antiviral therapies. This gives it very stable sales and profits.

Best of all, GlaxoSmithKline pays a reliable 4.2% dividend yield. That’s over twice the dividend yield on the S&P 500.

Finally, we have Merck & Co. Inc. [ (MRK[NYE] – $90.95 0.08 (0.09%)    Trade )], another major global drug company. Merck makes a broad range of products, from HIV therapies to insomnia medications and fertility drugs.

It’s also a leading maker of cancer treatments. We all know many cancers get more common with age. So the graying US population will keep Merck’s cancer therapies in high demand.

The company also pays a safe 2.7% dividend yield, which is great for income investors.

Again, I expect this bull market to keep chugging along into 2020. There’s plenty of upside left.

But you still want to control risk by holding safe and reliable dividend-paying stocks. Medtronic, GlaxoSmithKline and Merck fit the bill.

The post 3 Ways To Play the Healthcare Surge appeared first on Investor News.

7 simple steps to improving your chances of success in biotech investing

Exciting. Scary. Lucrative. Risky.

All of these adjectives apply to investing in biotech stocks. The excitement and the prospects for generating huge profits make biotech stocks appealing to many investors. On the other hand, the fear of big losses that stem from the high risk levels associated with many biotech stocks causes other investors to stay away.

How should you go about investing in biotech stocks? There are 7 key steps to follow that should improve your chances of success:

1. Know which stocks are biotech stocks — and which aren’t.
2. Determine your risk tolerance.
3. Understand the risks specific to biotech stocks.
4. Know what to look for in a biotech stock.
5. Evaluate the top biotech stocks and biotech exchange-traded funds (ETFs).
6. Invest cautiously.
7. Monitor changing dynamics.

Here’s what you need to know about each of these seven steps for investing in biotech stocks.

1. Know which stocks are biotech stocks — and which aren’t

First, you’ll want to know which stocks actually are biotechs and which aren’t. It’s not as easy as you might think.

Biotech is short for biotechnology, a term that references any technology that incorporates biological organisms. Companies that make genetically modified foods fall into this category, as do drugmakers that develop biologic drugs — large, complicated molecules that are manufactured within a living organism.

But while many big pharmaceutical companies develop biologic drugs now, they aren’t usually viewed as biotechs. That’s primarily because these companies make most of their revenue from sources other than biologic drugs.

Also, some drugmakers are typically classified as biotechs even though they don’t make most of their money from biologic drugs. Why? A lot of people call any small drugmaker a “biotech” regardless of whether the drugs it develops use living organisms. Even when these small companies grow to be large, they’re still called biotechs.

If you’re looking to invest in biotech stocks, there is one quick way to determine which stocks are biotechs and which aren’t. You can check out the industry designation for the company on investing sites. On Fool.com, for example, enter the ticker symbol for a given stock and then click on the “Profile” link. If the industry in the company info section is “Med-Biomed/Genetics,” it’s a biotech stock.

2. Determine your risk tolerance

Perhaps the most important step of all with investing in biotech stocks is to determine your risk tolerance. Some investors are aggressive and can tolerate higher levels of risk. Others are more conservative and seek to minimize their risk levels. There’s a big reason you’ll want to know your risk tolerance: It will help you determine which biotech stocks are good investing candidates for you and which aren’t.

If you already know your risk tolerance, great. If you don’t, you might want to complete a risk-tolerance questionnaire to help you determine your investing style.

3. Understand the risks specific to biotech stocks

All stocks have risks. But biotech stocks have some specific risks that aren’t applicable to stocks in many other industries. These risks include clinical failures, regulatory approval setbacks, commercialization problems, and loss of exclusivity/patent expiration.

The risk of clinical failure. Probably the most critical of these biotech-specific risks is the potential of failures in clinical trials. All biotech companies must thoroughly test their experimental drugs to assess the drugs’ safety and efficacy in treating the targeted condition.

This process starts with preclinical testing. Some preclinical testing is conducted in vitro, which literally means “in the glass.” That’s a reference to lab testing in test tubes, culture dishes, and other ways that don’t involve animals or humans. Other preclinical testing is done in vivo, which means “within the living.” This kind of preclinical testing is performed using laboratory animals.

Biotechs that only have experimental drugs in the preclinical stage are especially risky. Most drugs never advance from preclinical testing into clinical studies.

If a drug looks promising in preclinical testing, though, the biotech can seek regulatory approval from the Food and Drug Administration (FDA) in the U.S. or the European Medicines Agency in Europe to begin a phase 1 clinical study. The primary purposes of phase 1 clinical studies are to evaluate the safety of an experimental drug, including identifying possible side effects, and to determine the ideal dosage range for the drug.

Around 37% of drugs that are evaluated in phase 1 clinical studies fail, according to the Biotechnology Innovation Organization (BIO). The successful drugs advance to phase 2 clinical studies. These studies test the efficacy and appropriate dosage levels of the drugs.

Most drugs — nearly 70%, based on BIO’s analysis of historical data — aren’t successful in phase 2 clinical testing. The ones that are move to phase 3 clinical studies, large clinical trials needed to assemble sufficient statistical data that the drugs are both safe and effective. Almost 42% of drugs fail in phase 3 testing.

Overall, only 11% of experimental drugs that begin clinical studies jump all the hurdles needed to file for regulatory approval.

Regulatory approval setbacks. Biotechs still face the risk that drugs that have been successful in clinical studies won’t win regulatory approval. Nearly 15% of drugs submitted for approval get a thumbs-down from the FDA, according to BIO.

In some cases, the biotech can conduct additional clinical studies to persuade regulatory agencies to approve an experimental drug. However, frequently a regulatory rejection means the end of the road for a drug.

Commercialization problems. You might think that once its drug wins regulatory approval, a biotech has it made. Not necessarily. Companies must persuade insurers and government healthcare programs to pay for a new drug.

In the U.S., this process involves working with all of the major insurers and pharmacy benefit managers, as well as Medicare and Medicaid, to provide coverage for a new drug. In Europe, biotechs must negotiate with each country individually for a new drug to be covered.

Invest in Illusio The worlds first Augmented Reality Platform For Cosmetic Surgery

On top of these negotiations, biotechs must build sales teams to promote new drugs to prescribers. In many cases, companies also market directly to consumers via online, print, and TV advertising. Despite all of these efforts, there are significant risks that a biotech will be unsuccessful in achieving commercial success for a new product.

Loss of exclusivity/patent expiration. While biotechs often compete against other drugmakers, they enjoy protection for a while from potential rivals seeking to market generic or biosimilar versions of their drugs. Biologic drugs receive a 12-year period of exclusivity from biosimilar competition, while non-biologic drugs typically have a five-year exclusivity period.

In addition to the exclusivity periods, biotechs usually secure patents on their drugs. These patents expire 20 years after the filing date.

Once a biotech’s drug loses exclusivity and patent protection, rival companies can legally launch “copycat” versions of the drug. This nearly always causes a sharp decline in sales for the biotech’s drug.

4. Know what to look for in a biotech stock

The perfect biotech stock to buy would be one that has a broad lineup of approved drugs on the market. Each of these drugs would generate billions of dollars in annual sales. They would have a long way to go before the loss of exclusivity or patent expiration. And they would enjoy virtual monopolies for the conditions they treat.

This perfect biotech stock would also have a deep pipeline with a lot of candidates in phase 3 testing. The company would be super-profitable with fast-growing revenue and a mountain of cash built up to use in rewarding investors through share buybacks and dividends. And the stock would be dirt cheap.

Unfortunately, such a biotech stock doesn’t exist. However, these ideal qualities of a perfect biotech stock represent the things you should look for, and they fall into four main categories: current product lineup, pipeline, financial position, and valuation. The closer a given biotech stock rates on each measure, the better investment choice it should be.

Many small biotechs won’t have any approved drugs yet. For the biotechs that do, companies with multiple drugs with strong and growing sales will be less risky than others. It’s also a good sign when a biotech has best-selling drugs in multiple therapeutic areas. Diversified revenue sources are nice to have with any stock.

Pipelines can be difficult to evaluate. However, a pipeline that has several drugs in late-stage testing is preferred because they have less risk than experimental drugs in earlier-stage development. You can also check out what analysts and other industry observers have to say about early stage clinical results to get a sense of whether there are any yellow flags with what might otherwise seem to be positive results.

Established biotechs will have stronger financial positions than small clinical-stage biotechs. Strong revenue and earnings growth is a big plus. Regardless of the size of the biotech, though, look at the company’s cash position. A small biotech with no approved products could have to issue new shares if it doesn’t have enough cash, which causes dilution in the value of existing shares. (Think of a pizza with eight slices that’s cut into 16 slices. Anyone who had a slice initially has less pizza to eat after the second slicing.)

With larger biotech stocks, you can use traditional metrics such as price-to-earnings and price-to-earnings-to-growth (PEG) ratios to assess valuations. The key here is to compare these valuation metrics for a given biotech stock against its peers to determine whether it’s relatively cheap or relatively expensive.

The valuations of smaller biotech stocks with no approved drugs are tied to what investors think about the biotechs’ pipeline prospects. It’s difficult to know how reasonable the growth prospects are for pipeline candidates that haven’t been approved yet.

One important thing you can look at with small biotechs, though, is any partnerships that they have established with larger drugmakers. A major drugmaker wouldn’t partner with a smaller biotech without performing due diligence on its pipeline candidates. Having a big partner doesn’t mean that a small biotech’s pipeline isn’t risky, but investors can usually have more confidence in a small biotech’s pipeline candidate when a major drugmaker has put significant money on the line betting on the success of the experimental drug.

5. Evaluate the top biotech stocks and ETFs

The 10 biggest biotech stocks claim market caps (the total market value of a company’s outstanding shares) of at least $30 billion, with several having market caps of more than $100 million. These are the exceptions, though. There are hundreds of biotech stocks with much smaller market caps. In addition, several biotech ETFs are available that hold positions in many individual biotech stocks. Your risk tolerance will dictate which of these biotech investment alternatives are the best fits for you.

To give you a sense of how to evaluate biotech stocks and ETFs, we’ll look at a few examples that might appeal to investors with different risk tolerances. Note that there are no options provided for investors with low-risk tolerances. Why? Biotech stocks and ETFs probably wouldn’t be well suited for these investors.

Alexion Pharmaceuticals. Alexion currently has four approved products, all of which target rare diseases. The biotech’s biggest blockbuster, Soliris, recently won FDA approval for treating another condition, neuromyelitis optica spectrum disorder. Sales are climbing for all four of Alexion’s drugs, with tremendous growth for its newest product, Ultomiris, which market researcher EvaluatePharma thinks will be the biggest new drug launch of 2019.

The biotech’s pipeline includes three late-stage programs targeting rare diseases. In addition, Alexion has four early stage clinical programs.

Alexion appears to be in a strong financial position. Its revenue and earnings continue to grow rapidly. The company also has a substantial cash stockpile that it can use to reward shareholders through stock buybacks or to make strategic business development deals to fuel growth.

While many biotech stocks have sky-high valuations, Alexion is one of the most attractively valued biotechs on the market. Its forward price-to-earnings multiple, which uses estimated earnings rather than historical earnings, and PEG ratio are both low compared with most other biotech stocks.

Alexion faces some risks, including key patents for Soliris beginning to expire in 2021 and the possibility that its clinical programs won’t be successful.

Amgen. Amgen currently claims 18 approved products. Seven of these generated sales of more than $1 billion in 2018. At least two more of the biotech’s approved drugs, Kyprolis and Aimovig, appear to be on the way to becoming blockbusters.

The company’s pipeline includes six late-stage programs, including the pursuit of additional approved indications for three already-approved drugs, plus three biosimilars in development. Amgen also has 26 programs in phase 1 and phase 2 testing.

Amgen generates tremendous cash flow and has one of the largest cash stockpiles in the industry. The company also pays a dividend with an attractive yield. This strong financial position is a key reason investors with moderate risk tolerances might like Amgen.

The biotech’s forward P/E ratio is low. However, some investors might be leery of Amgen’s high PEG ratio.

However, several of Amgen’s top drugs face intense competition. This situation is likely to weigh on Amgen’s growth in the coming years. Amgen’s pipeline is also risky, with 23 programs in phase 1 clinical studies.

Editas Medicine. Editas Medicine is by far the riskiest of the biotech stocks on our list. The company has no approved products and is a long way from even the possibility of launching a drug commercially.

The attraction for Editas is its pipeline. The biotech plans to begin the first in vivo testing of a CRISPR gene editing therapy in humans in 2019. This phase 1 study will evaluate Editas’ lead candidate, EDIT-101, in treating Leber congenital amaurosis type 10, the leading genetic cause of blindness. Allergan is partnering with Editas on developing EDIT-101. Other than EDIT-101, though, Editas’ pipeline consists only of preclinical programs.

Editas has to rely largely on collaboration revenue from Allergan and its other big partner, Celgene, to fund operations. The biotech could have to raise additional cash through issuing new stock in the future.

For a company with no product revenue, Editas’ market cap is quite high. However, the market cap reflects the tremendous excitement among investors about the potential for the biotech’s gene-editing candidates.

But although CRISPR gene editing could be a game-changer in treating diseases, it remains a technology in its infancy. Editas faces considerable challenges in advancing its pipeline candidates.

Vertex Pharmaceuticals. Vertex Pharmaceuticals has three approved drugs on the market, all of which treat the underlying cause of cystic fibrosis (CF). The biotech essentially enjoys a monopoly in CF right now.

It’s likely that Vertex’s pipeline will fuel more growth. The biotech hopes to win approval for a triple-drug CF combo in 2020. This regimen would dramatically increase Vertex’s target patient population. In addition, the biotech’s pipeline includes an experimental pain drug that’s in phase 2 testing and a couple of early stage programs targeting rare diseases.

Vertex’s financial position continues to look better and better as its revenue and profitability increase. The company has a significant amount of cash built up that it plans to use in adding more programs to its pipeline.

While Amgen has a low forward P/E multiple and a high PEG ratio, it’s the opposite case for Vertex. The biotech’s attractive PEG ratio is a sign of the tremendous growth expected for Vertex, with the anticipated launch next year of its triple-drug combo for treating CF.

There is a risk, though, that Vertex could run into regulatory approval problems. The biotech’s pipeline candidates also face risks of failure in clinical studies.

SPDR S&P Biotech ETF. You might wonder why the SPDR S&P Biotech ETF isn’t more suitable for investors with low risk tolerances. Although the ETF holds positions in over 100 biotech stocks, many of these stocks have high or very high risk levels.

For moderately aggressive investors, though, this ETF could be a smart way to profit from growth in the biotech industry. While some of the biotechs among the fund’s holdings could experience pipeline setbacks or other issues, not all of them will.

The primary downside to buying the SPDR S&P Biotech ETF, other than risk, is that the fund has an annual expense ratio of 0.35%. However, that’s not unreasonable, considering the broad basket of biotech stocks the ETF provides.

6. Invest cautiously

Whichever biotech stock or ETF you buy, invest cautiously. Don’t put too much of your portfolio in biotech stocks, because of the risk and volatility associated with the industry.

If you’re buying the stock of a small clinical-stage biotech, you’ll want to be even more cautious. You might consider investing a small amount initially. If clinical study results increase your confidence in the biotech’s prospects, you could then increase your position in the stock.

7. Monitor changing dynamics

The last step for investing in biotech stocks is to monitor changing dynamics. Bad news doesn’t necessarily mean you should sell your biotech stocks, but it could prompt you to do so. Horrible results from a clinical study, for instance, could completely change your entire investing thesis — especially for a clinical-stage biotech.

Keep your eyes on the competition, too. The emergence of new drugs could threaten even a big biotech’s sales.

There’s also the possibility that the reimbursement environment changes dramatically. For example, major changes to the U.S. healthcare system that limit the ability of biotechs to set drug prices would probably negatively affect stock prices.

Back to those adjectives

Yes, investing in biotech stocks can be scary and risky. However, following these seven steps should increase the odds that your experience in investing in biotech stocks is both exciting and lucrative over the long run.

Now that you’ve got the basics,

The post How to Invest in Biotech Stocks appeared first on Investor News.

A leading drug maker, whose founder and top executives have been convicted of bribing doctors to prescribe a highly addictive painkiller, has become the first opioid manufacturer to declare bankruptcy after being hit with huge fines.

On Monday, Insys Therapeutics filed for Chapter 11 bankruptcy protection while it sells off its assets after reaching a $225m settlement with the justice department last week over fraud charges. One of the company’s subsidiaries pleaded guilty to five counts of mail fraud as part of the settlement.

Insys’s founder, John Kapoor, and four former executives are facing lengthy prison sentences after they were convicted last month of bribing doctors to prescribe the company’s opioid spray, Subsys, to patients who did not need it. Subsys is made of fentanyl, an opioid many times stronger than morphine, and was approved for terminal cancer patients. But the company targeted sales at the much larger and more profitable market of people with non-life-threatening chronic pain.

Kapoor oversaw a marketing strategy in which payments to doctors ostensibly for speeches at educational seminars were effectively bribes to prescribe the drug. Prosecutors said the seminars were no more than social gatherings at restaurants, bars and strip clubs.

In one instance, the company paid nearly $260,000 to two New York doctors who wrote more than $6m worth of Subsys prescriptions in 2014. Sales of Subsys surged into the hundreds of millions of dollars a year as a result of the company’s aggressive marketing.

The US attorney in Boston who prosecuted Insys, Andrew Lelling, accused the company of “illegal conduct that prioritised its profits over the health of thousands of patients” and of “fuelling the opioid epidemic”.

Before the agreement with the justice department, Insys was facing large legal bills as it fought hundreds of lawsuits alongside other companies accused of fuelling an epidemic that has claimed more than 400,000 lives over the past two decades. They include Purdue Pharma, the maker of the powerful opioid, OxyContin, which kickstarted the crisis.

The multinational drug giant, Johnson & Johnson, is in the midst of a civil trial in Oklahoma where it has been accused of “a cynical, deceitful multimillion-dollar brainwashing campaign” to drive up sales of its powerful painkillers.

Oklahoma’s attorney general, Mike Hunter, said greed led the company to play a leading role in “the worst manmade health crisis in the history of the country and the state”. Oklahoma is seeking billions of dollars in compensation to help cover the long-term consequences of the opioid epidemic in the state.

A statement by the lead counsels in the combined legal cases of more than 1,800 states, cities and other communities seeking billions of dollars in compensation from 22 opioid manufacturers, distributors and pharmacies, said they would continue to pursue the legal action against Insys to recover the costs of the epidemic on public finances, from increased crime to addiction treatment and care for orphaned children.

“Bankruptcy and restructuring does not necessarily mean that a company is insolvent. Additionally, the goal of the litigation is not to bankrupt these opioid companies, but to abate the current opioid epidemic and seek long-term, sustainable solutions. If any defendant files for bankruptcy, we will work through all legal avenues to see that our clients’ end goal of abating the crisis is met,” they said. “The American public deserves to see the truth behind this epidemic revealed and justice served.”

The post Opioid manufacturer Insys files for bankruptcy after $225m settlement appeared first on Investor News.

This week and next week, some very important upstarts in the cannabis industry will be reporting. The pending release of revenue numbers is highly anticipated as the nascent cannabis industry’s pricing and multiple is largely constructed on square-footage, pending sales, and just sheer speculation. So, this week is a crucial as it gives analysts more hard data, and here are a few you should be watching out for:

1. Charlotte’s Web (CSE:CWEB)(CWBHF) – Today, Thursday afternoon at 4:30pm EST

With a featurette in the New York Times – the company is run by a family of seven brothers – and some lavish parties at Sundance, Charlotte’s Web  already one of the most well-recognized names in CBD. The company is expected to see an increase of $6 million in revenue – going to $23 million from $17 million in the previous quarter. CWEB has been able to build on revenues thanks to their high margin CBD oil that has staked a following with medical patients. As a brand leader, CWBHF’s earning will be a real gauge of the CBD market’s potential.

2. Grow Generation (GRWG) – Monday, April 1st at 4:30pm EST

Grow Generation notched $8.4 million in quarterly sales, according to reports updated on March 15th. This puts GRWG just behind Tilray at $10 million and placing it 12th on the list of top revenue generators. Recently, the big news for GrowGeneration was the acquisition of Reno Hydroponics, which sells to both commercial and home cannabis growers, and will eventually buoy the company’s revenues, just don’t expect that to show up for some time. However, the move is a smart one as tiny operators are opening up all across the flats of Nevada and GrowGeneration now has products to sell them from a trusted name in the area.

3. iAnthus Capital (CSE:IAN)(ITHUF) – Tuesday, April 2nd at 8:30am EST

Last time iAnthus Capital reported in late September of last year, they netted $939k. But, with the business arrangement with MPX Bioceutical  (MPXEF[OTCQX] – $0.    ) ([] – $0.  (%)   )closed, this is a whole new ITHUF. MPX’s subsidiary GreenMart NLV was awarded four conditional retail licenses in Nevada within Clark, Reno, Henderson and in Las Vegas proper. This move will allow MPX to push GreenMart’s successful “Health for Life” brand in front of bustling Vegas cannabis tourists. For its part iAnthus, which is a holding company that operates a variety of brands, has a steady market presence in Massachusetts, Florida, Vermont and New York. The company has signed 16 leases in Florida and has plans to open 30 stores across the state, which should make it a big contributor to revenue for the company. Something to note, iAnthus did just receive their license to sell flower in Florida, which just became legal in the Sunshine State.

4. Green Thumb Industries (GTII)(GTBIF)- Tuesday, April 9th at 5:00pm EST

Green Thumb Industries  is the 6th highest revenue generator in the cannabis market as of the middle of this month with $17.2 million- just behind Charlotte’s Web. The last time Green Thumb reported it caused quite a stir across the markets. GTBIG announced 344% year-over-year increased in revenue and 26% sequential revenue growth.

The company has recently (January of this year) positioned itself into the Connecticut cannabis market with the purchase of Advanced Grow Labs gaining access to the latter’s manufacturing facility and partially-owned dispensary. Green Thumb has worked similar deals across Nevada and Pennsylvania.

5. Delta 9 (NINE)(VRNDF) – Tuesday, April 23rd at 9:00am EST

Delta 9 has offered some insight into their results for last year (unaudited) and they were impressive. The company estimated anywhere from $5.3 to $6.1 million revenues for the last three months of 2018. The full year-end results will be telling about their retails expansion – Delta 9 is planning to hit 60,000 kgs by 2022- but it will not include how their entry into Saskatchewan will improve their bottom line and accelerate growth.

The post 5 Cannabis Companies Reporting Soon that You Should be Watching appeared first on Investor News.