ContraVir dives after week of rosy studies, filing errors, withdrawn withdrawals

Shares of ContraVir Pharmaceuticals Inc. plunged Tuesday, to cap off a whipsaw week for investors that included upbeat results of drug studies and SEC filings indicating the withdrawal, and the withdrawal of the withdrawal, of a share offering.

Here’s how it all unfolded.

The biopharmaceutical company, which is focused on the treatment of liver disease arising from non-alcoholic steatohepatitis (NASH), announced before the Tuesday open the pricing of its public offering of securities with expected proceeds of $15.6 million. The securities offered included shares of common stock, warrants to buy common stock, shares of convertible preferred stock and warrants to buy converted shares.

The stock CTRV, -43.98%  plummeted 41% in very active Tuesday afternoon trading, putting it on track for the second-biggest one-day selloff since ContraVir shares started trading in February 2014. The biggest decline was 43.4% on April 25, 2019, after the pricing of a $2.14 million public offering of securities.

Trading volume swelled to about 3.7 million shares, or more than four-times the full-day average. With 590,500 shares outstanding after a 1-for-70 reverse stock split went into effect on June 3, ContraVir’s market capitalization has decreased to roughly $3.5 million from $5.7 million on Monday.

It started last Tuesday (June 11) with a 35.7% surge on volume of 2.7 million shares, after the company said the peer-reviewed journal “PLOS ONE” published its research that found its CRV431 drug reduced hepatitis B virus (HBV) DNA in mice liver.

“CRV431 interferes with the way that HBV hijacks our body’s molecules to amplify virus replication, which is distinct from traditional antiviral drugs such as tenofovir that bind only to HBV proteins,” said Chief Executive Robert Foster in a statement.

FactSet, MarketWatch

The stock then pulled back 16.3% the next day (Wednesday June 12) on volume of 511,000 shares, after the company took advantage of the previous session’s price gain to file a registration statement with the Securities and Exchange Commission for the sale of securities including common and preferred stock, and warrants to buy common and preferred shares. Stocks often decline after proposed stock offerings, as investors express concern their shares will become diluted.

Then on Thursday June 13, a Form RW, or a registration withdrawal request, was filed with the SEC and accepted about a half-hour before the close. That sent the stock soaring 27.2% on about 708,000 shares on Thursday.

But at closer look, the RW referred to the withdrawal of ContraVir’s request to accelerate the acceptance of its registration statement, not an actual withdrawal of the registration statement. Therefore, that request should not have been filed on Form RW.

The company did not respond to a request for comment.

So in reaction, about a half-hour after the June 13 close, a Form RW WD was filed, defined as a withdrawal of a registration withdrawal request, to request the immediate withdrawal of the withdrawal, with respect to the registration statement. “The filing of the Form RW was made in error,” the company stated in the RW WD. That sent the stock down 12.1% on volume of 469,000 shares on Friday June 14.

The stock then jumped 9.2% on 5.1 million shares on Monday (June 17), after ContraVir announced findings from its first study with human precision cut liver slice cultures, in which liver disease was simulated in a “unique” experimental model. “Co-administration of ContraVir’s clinical phase drug candidate, CRV431, was found to be 100% effective at preventing fibrosis induction beyond baseline levels,” ContraVir said.

The company said a phase 1 study previously showed that CRV431 was safe and well tolerated in humans. CRV431 is currently being administered in a multiple ascending dose study.

Then came today’s Tuesday announcement of the pricing of the public share offering, and the stock’s tumble. And this volatile week followed a record low close of a split-adjusted $5.00 on June 5.

The stock has lost 95% of its value over the past 12 months, while the iShares Nasdaq Biotechnology exchange-traded fund IBB, +1.27%  has slipped 2.6% and the S&P 500 index SPX, +1.01%  has gained 5.3%.

https://www.marketwatch.com/story/contravirs-stock-plunges-after-seesaw-week-of-upbeat-drug-studies-mistaken-filings-and-withdrawals-of-withdrawals-2019-06-18?siteid=rss&rss=1

Conquering Negativity

The past three posts in this series have dealt withbuilding self-awareness; facing trading fears and anxieties; and overcoming frustration and anger.  In this post, we will tackle negative thinking patterns and how these can be turned around.

The first principle and most important practice is to live a positive life outside of your trading.  It is impossible to sustain an optimistic and constructive mindset during trading if what you are reinforcing during your other hours is negative.  If you take a look at the recent Forbes posting, you’ll notice a non-traditional take on the recent Father’s Day holiday.  The idea is to turn the holiday into a positive emotional experience by widening its meaning.  This is something that can be done in many areas of life.  Spending time with friends, relationship partners, family, and colleagues is great, but how can we make this time truly fun, inspiring, and meaningful?  As I point out in the book that I am currently writing (due out during the summer), the key is avoiding routine and seeking experiences that are special.

How can we possibly turn our thoughts and behaviors around if we are stuck in a life of routine?

The cognitive approach to conquering negativity is especially powerful.  That requires building the self-awareness to recognize when you are talking to yourself in ways that are not helpful and constructive.  As I’ve mentioned in my books, a great way to reinforce that self-awareness is to regularly ask yourself, “Would I be talking to someone else I cared about who is in my situation the same way that I’m talking to myself?”  This is helpful, because it reframes our thought patterns as conversations.  Very often, if we view our thoughts as ways that we’re talking to ourselves, we can see that the conversations are negative and serve no constructive function.

Once we can recognize the negative thinking patterns, we want to tune into their destructive consequences.  By reminding ourselves that this kind of thinking robs us of energy, takes away our focus, and causes us to be less productive and creative in generating ideas, we gain the ability to become angry at our own negativity.  This is a very important principle.  We are most likely to change a pattern when we view it as an adversary: as something that stands in the way of our happiness and success.  Reminding ourselves of the consequences of our negative self-talk helps us marshal the energy to engage in a much more helpful processing of our situation.

That sequence–recognize negativity, challenge negativity, replace negativity with more constructive self-talk–can become a positive habit pattern if repeated multiple times per day for many days.  Yes, of course, negative thoughts will pop into your head, but you’ll be able to quickly smack them down if you immediate recognize their consequences and generate more helpful ways to view the situation.  In my own trading, I turn negative thoughts into learning thoughts.  If each of my losses and mistakes can teach me something–something about me, something about markets–then I can actually value my mistakes and stay positive in the face of temporary drawdown.

Negative things always happen in life.  The resilient person doesn’t internalize those setbacks.  Setbacks exist for a reason, and we can turn them into fuel for our personal development and the development of our trading.

http://traderfeed.blogspot.com/2019/06/trading-psychology-techniques-9.html

India’s Pharmaceutical Sector Could Benefit from the Sino-US Trade Conflict

Trade tensions between Washington, D.C. and Beijing continue, but have not yet impacted the pharmaceutical products traded between the two countries. However, if the punitive tariffs continue and pharma is impacted, a third global player could step in to fill the void in both countries.

Data and analytics specialist GlobalData predicts that the ongoing trade issues between the U.S. and China could provide the opportunity for India-based pharma companies to step up. The India industry has a significant presence in the United States but is “still in the stage of exploring the Chinese market,” GlobalData said. The U.S. has been the second biggest supplier to China with 15% of the overall drug formulation imports, whereas India’s contribution was only .1%, GlobalData reported. If the Indian sector can increase its influence in both countries, GlobalData forecasts the Indian pharmaceutical market could increase from nearly $30.8 billion in 2018 to more than $38.3 billion by 2022.

Pointing to the Pharmaceuticals Export Promotion Council of India, the U.S. accounted for more than 30% of total Indian pharma exports. In 2018, those imports were worth about $5.82 billion. That was the highest among all countries, the council said, according to GlobalData.

Prashant Khadayate, a pharma analyst at GlobalData, said the Sino-American tensions can be seen as a “grace period” where both the U.S. and China could be seeking other alternatives. The Indian pharma industry, Khadayate said, “can leverage this opportunity to become the partner of choice through strengthening its position in the U.S. market and re-thinking on a long-term strategy for the China market.” India is the largest manufacturer and supplier of generic drugs globally. Eight out of the top 20 global generic drug companies are located out of India. The country is ranked third by volume and 10th by value in pharmaceutical exports, the report shows. Khadayate said India has a strong position in the U.S., particularly when it comes to importing drug formulations. However, Khadayate noted that India’s imports to China, including drug formulations and bulk drugs are “negligible.”

Khadayate went on to add that the United States is cautious of the fact that any disruption related to the supply of bulk drugs from China due to a trade war would have a drastic impact on the pharmaceutical supply chain in the U.S. China is equally dependent on the U.S. for the drug formulations import, he said.

“The Indian pharma industry can take advantage of this situation as it has proven abilities in both drug formulations and the bulk drugs category,” Khadayate said. “Indian players will need to improve their bulk drugs manufacturing capabilities in order to offer more competitive pricing and to gain a stronghold in the U.S.”

Last year, China loosened some restrictions that could benefit India’s industry. In May 2018, China announced the removal of import duties on 28 medicines, including cancer medicines, which provided an opening in the market to Indian pharmaceutical products, GlobalData said. While those restrictions were loosened, GlobalData noted at the time that the Indian industry “exhibited subdued enthusiasm” due to the challenges that had been involved gaining entry into the Chinese market. Regulatory challenges in terms of lengthy clinical trials and delayed approvals were cited as major barriers, GlobalData said.

While the drug supply has not yet been impacted, the White House has raised red flags over venture capital coming out of China. Washington has been increasingly focused on Chinese investment in the United States, particularly in the areas involving intellectual property and biotech. Earlier this year, Congress almost unanimously passed an updated version of the review powers of the Committee on Foreign Investment in the United States. But the law that sought to protect U.S. business interests has led to the termination of a number of deals with China-based companies. For example, in April, the White House ordered the Chinese majority owner of Massachusetts-based healthcare company PatientsLikeMe to sell his stake. The increased scrutiny of the Trump administration has caused a significant decline in Chinese investment in U.S. companies. Over the past two years, direct investment from China into U.S. companies has declined about 90%.

https://www.biospace.com/article/could-india-s-pharmaceutical-business-benefit-from-the-sino-american-trade-conflict-/

Novo Nordisk Wins Expanded Approval for Victoza in Youth With Type 2 Diabetes

Novo Nordisk’s diabetes drug Victoza (liraglutide) earned approval from the U.S. Food and Drug Administration (FDA) for an expanded indication for use in children ages 10 to 17 years who have type 2 diabetes.

The approval marks the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for children and adolescents with type 2 diabetes, Novo announced late Monday. With the approval of the new indication, Novo Nordisk said Victoza now provides a new treatment option for this age group “beyond metformin and insulin for the first time in 19 years.” Victoza was first approved in the U.S. in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes.

The expanded indication is based on the Phase III ELLIPSE trial, which was the first late-stage trial completed in children and adolescents with type 2 diabetes in more than 10 years. In the ELLIPSE study, the youthful patients were randomized to receive Victoza or placebo in combination with or without basal insulin for a more than 26-week double-blinded period followed by a 26-week open-label extension period. Full results of the ELLIPSE trial were presented in May at the Pediatric Endocrine Society (PES)/Pediatric Academic Societies (PAS)Annual Meeting in Maryland. They were also published in the New England Journal of Medicine. As BioSpace reported at the time, Victoza when added to metformin, with or without concurrent insulin treatment, significantly reduced A1C levels at 26 weeks to a level of 0.64% in comparison to placebo, which reduced AIC to 0.42%. That was the primary endpoint of the Phase III study. The drug also maintained that AIC reduction through 52 weeks to 0.5% at 52 weeks, which was the secondary endpoint.

The safety profile in the pediatric group was similar to that as seen in adults. The most common adverse events were gastrointestinal events. Other issues included headache, nasopharyngitis (common cold), dizziness, gastroenteritis, upper respiratory tract infection, rash, pyrexia (fever) and decreased appetite.

Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk said the company is delighted Victoza’s label expansion. Gaining approval in the pediatric indication in type 2 diabetes is a landmark for the company, he said, restating that it is the first-ever GLP-1 receptor agonist approved for this population.

https://www.biospace.com/article/novo-nordisk-wins-expanded-approval-for-victoza-in-children-10-17-with-type-2-diabetes/

Allergan: Evercore sees split more likely

Allergan (NYSE:AGN) has jumped 3.2%, as Evercore ISI notes the company seems to be headed toward a split of its aesthetics and therapeutics business.

After talking with the company’s general counsel, Evercore’s Umer Raffat reportedly says “I walked away with the sense that Allergan is heading towards a split and may likely lay out timelines … We may get an update in ‘next couple of months.’ ” (h/t Andrew Dunn)

Allergan had announced plans last May to sell its women’s health and infectious disease businesses, before that effort stalled earlier this year.

https://seekingalpha.com/news/3472158-allergan-plus-3_2-percent-evercore-seeing-split-likely

Private Medicare Advantage Could Hit 70% Market Share

Enrollment of seniors in private Medicare Advantage plans could reach 70% of those eligible for federal health benefits for the elderly between 2030 and 2040, a new report shows.

For now, the regulatory and political environment remains positive for expansion of Medicare Advantage, which allows private health plans to contract with the federal government to provide medical benefits to seniors. Medicare Advantage plans provide extra benefits and services to seniors, such as disease management and nurse help hotlines, as well as some plans providing vision and dental care.

“Today the status and long-term structure of healthcare reform remain in flux, but MA enrollment is still growing — and with largely bipartisan support,” the report released this week by L.E.K. Consulting on Medicare Advantage penetration shows.

Enrollment in MA plans surpassed 22 million last year, which is 35% of total Medicare beneficiaries. “Looking ahead, we expect enrollment growth to continue in line with our previous forecasts of 7.7% compound annual growth rate (CAGR) to reach 47% penetration, or just over 37 million members in 2025,” L.E.K. executives Andrew Kadar, Andrew Garibaldi and Daniel Parker wrote in their 7-page report.

Health insurers Humana, UnitedHealth Group, Anthem, Cigna and CVS Health’s Aetna health insurance business dominate the Medicare Advantage business while Centene is poised to expand with its proposed acquisition of WellCare Health Plans. Meanwhile, several startups like Bright Health and Oscar Health are looking to expand into Medicare Advantage.

Health insurers see growth thanks in part to changes by the Trump administration in regulations that allow Medicare Advantage plans to cover more supplemental benefits. MA plans are also benefitting from more than 10,000 baby boomers turning 65 every day and becoming eligible for Medicare.

“As seniors increasingly eschew Original Medicare in favor of lower payments, enhanced care management and more cost certainty, with encouragement from both health plans and, albeit indirectly, the government, we expect that growth to continue — to 47% penetration by 2025 and, eventually, up to as high as 70%,” L.E.K said in its report. “Payers will therefore need to take aggressive action to grow market share of their Medicare Advantage offering. That could include expanding into new counties, investing in targeted sales to age-ins, and designing new products to attract new members and keep them healthy.”

A wild card could emerge after the 2020 Presidential elections should supporters of a single-payer version of “Medicare of All” succeed in their efforts and potentially diminish the role of insurers in the Medicare program.

“While we remain bullish on the emerging value proposition of Medicare Advantage as the highest-value product choice for a majority of seniors in the current environment, there are at least two regulatory uncertainties that could meaningfully impact the outlook for Medicare Advantage enrollment and penetration and that we monitor closely; proposals for ‘Medicare for All’ and CMS’ recently announced Primary Cares Initiative,” authors of the L.E.K. report wrote.

With two dozen Democrats running for President in 2020 to challenge Donald Trump in 2020 should Republicans re-nominate him to run for re-election to a second term, the Democratic Party’s candidates are backing everything from a single payer approach to Medicare for All to efforts that allow Americans under the age of 65 to buy into Medicare coverage.

Democratic U.S. Sens. Cory Booker of New Jersey, Kirsten Gillibrand of New York, Kamala Harris of California, Bernie Sanders of Vermont and Elizabeth Warren of Massachusetts were among 17 Senators who introduced the Medicare for All Act of 2017. This legislation, which would expand Medicare more broadly to Americans of all ages, would have no premiums, limited cost-sharing and replaces all private insurance along with Medicaid and the Children’s Health Insurance Program.

“These proposals are still in their early days and could have dramatically different impacts on Medicare Advantage enrollment as we know it today,” the L.E.K. report said. “A single payer proposal such as the version proposed by Sen. Bernie Sanders could bring an end to private health insurers’ involvement in Medicare and thus Medicare Advantage entirely. On the other hand, a ‘Medicare Advantage for All’ approach or enabling early buy-in into Medicare (and Medicare Advantage) could dramatically expand Medicare Advantage enrollment.”

https://www.forbes.com/sites/brucejapsen/2019/06/18/private-medicare-advantage-could-hit-70-market-share/#56f004c020ca

Trump Takes A Big Step Toward Personal And Portable Health Insurance

In an ideal world, most people would own their own health insurance and take it with them as they travel from job to job and in and out of the labor market. Some employers may have better insurance than people can find in the open market. But most employers would prefer to make a cash contribution to help employees pay their own premiums rather than provide insurance directly.

Before there was Obamacare, this is what some employers were actually doing.

They used an account called a Health Reimbursement Arrangement (HRA), providing funds employees could use to buy their own health insurance. These funds were not taxed as income to the employee, just as employer-provided insurance isn’t taxed.

There was always legal uncertainty about this practice, however. Many insurance agents were fearful that if they knew the policies they sold were being purchased with employer money, they could be penalized. So, it was common practice for everyone to act on the principle of “don’t ask; don’t tell.”

Then came Obamacare.

In January, businesses will be able to help patients buy their own insurance. Credit: Getty

GETTY

The Obama administration didn’t just dislike the practice of employers helping employees obtain their own insurance. They hated the idea. An Obama regulation stipulated that employers caught giving their employees pre-tax dollars to purchase their own coverage could be fined as much as $100 per day for each employee, or $36,500 a year. This was the highest penalty in all of Obamacare regulations.

Thankfully, the Trump administration is eliminating this penalty and much more. Beginning next January, employers will be able to use HRAs to help employees obtain their own coverage with the administration’s blessing.

This regulatory change is coming at the right time. Readers may be surprised to learn that the extent of private insurance coverage has gone down under Obamacare, despite huge federal subsidies in the individual market and a government mandate requiring most employers to offer coverage.

The biggest losses are among small businesses. Among firms that employ 3-24 workers, the percentage of employees covered by employer health benefits fell from 44% in 2010 to 30% in 2018. Among firms that employ 24-29 workers, the percentage fell from 59% in 2010 to 44% in 2018.

Moreover, 27% of employees of small and medium-sized firms (3 to 199 workers) turn down their employer’s offer of health insurance. This is probably because Obamacare mandates have made all insurance more expensive and less attractive.

Will employees be able to find better coverage in today’s individual market? That may depend on where they live. An acquaintance of mine in New York City has seen her individual market premium jump fivefold in the past four years. She now pays more than $25,000 for a family coverage with a high deductible and increasingly narrow network of providers. Not many employees will envy her experience.

Some states, however, have obtained Obamacare waivers. By using dedicated funds for high-cost enrollees, they are allowing premiums to fall for everyone else.

Employees may also benefit because of another Trump administration change. Employers are allowed to deposit up to $1,800 a year in an “excepted benefit HRA” and these funds can be used to purchase short-term, limited-duration insurance.  This insurance does not have to comply with Obamacare regulations, including their prohibition on basing premiums on the health condition of the applicant. Traditionally, such plans only lasted up to one year and they were purchased by people who were transitioning between jobs or from school to work.

To discourage their use the Obama administration limited these plans to three months’ duration. However, the Trump administration has reversed that regulation and extended the duration to three years. It is also allowing people to buy a second kind of insurance that I call “health status insurance.” This second plan protects people from any extra premium they might be charged in a second three-year period, should their health condition deteriorate during the first three-year period.

By stringing together these two types of insurance, people will be able to purchase insurance that meets family needs, rather than the needs of bureaucrats and regulators – indefinitely, into the future. People will be able to purchase, say, a Blue Cross plan similar in benefits and price to what they could obtain before there was Obamacare.

Note, however, that state governments can sharply curtail these plans and even regulate them out of existence. Several blue states have already done so.

In promoting these reforms President Trump is exercising a very aggressive use of executive authority. He is also providing needed leadership to a party that has lost its way when it comes to health policy.

In the last several years, the only Republican plan to reform Obamacare that included personal and portable insurance and health status insurance was a bill sponsored by House Rules Committee chairman Pete Sessions and Sen. Bill Cassidy. (Fair disclosure: I helped write it.) The other proposals, including ones preferred by the Republican leadership, did little more than help Obamacare work better.

The reforms discussed here were announced by the president at a Rose Garden ceremony. But they were well known (because regulatory changes invite public comments) before the last election. Can you think of a single Republican candidate in last fall’s election who campaigned on these reforms? I can’t. Nor was there even a single congressional hearing designed to showcase the need for the reforms.

Trump has also taken on the special interests. Almost all the major players in health policy – especially the large insurance companies – oppose these changes.   But just as he took on the pharmaceutical companies on drug prices and the hospitals on price transparency, the president doesn’t seem to hesitate when Big Insurance objects.

Executive action can only go so far, however. Obamacare is still law. To fully realize the Trump vision of health reform, Congress needs to act. That means that Republicans and Democrats must ignore all the special interests and support reforms that work for ordinary citizens.

https://www.forbes.com/sites/johngoodman/2019/06/18/donald-trump-takes-a-big-step-toward-personal-and-portable-health-insurance/#7109cdb171c1