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Thursday, May 2, 2019

Diffusion Pharma up ahead of capital raise

Thinly traded nano cap Diffusion Pharmaceuticals (DFFN +74.4%) breaks free of a near-term downtrend on a healthy 21x surge in volume.
The company is facing a capital raise, stating in March that it had resources to fund operations only into July.
The expected new capital will fund the advancement of lead candidate trans sodium crocetinate (TSC) for the treatment of stroke and cancer.
A Phase 2 clinical trial, PHAST-TSC, assessing TSC for the treatment of acute stroke in an in-ambulance setting should commence soon. Results should be available in ~two years, subject to sufficient funding.
A Phase 3 study, INTACT, evaluating TSC in patients with inoperable glioblastoma multiforme (GBM) (brain cancer) is ongoing. A Phase 2 trial showed a significant survival benefit in a subset of GBM patients compared to control.

What I Bet You Don’t Know About Health Savings Accounts

Health Savings Account plans are the fastest growing product in the health insurance marketplace. At last count, 25 million Americans were covered by an HSA plan and the account balances totaled $50 billion. That’s on a par with the gross domestic product of the entire state of Alaska. It’s more than the GDP of South Dakota, Montana, Wyoming or Vermont.
Readers of this post probably think they are quite familiar with HSAs. But did you know that:
  • HSAs are the best savings vehicle available under the tax code?
  • You can roll your IRA over into an HSA and, at some point in your life, you are foolish if you don’t?
  • The best retirement savings strategy is to put the maximum into an HSA and never spend a dime of it until you get old?
  • You can invest HSA funds just like you invest IRA funds and (again) you are foolish if you don’t?
I have to admit that I didn’t fully understand these things until I read  HSAs: The Tax-Perfect Retirement Account by William Stuart. Most of what follows is based on Stuart’s analysis.
No other savings vehicle can top an HSA.
Not a 401(k) plan. Not an IRA. Not even a Roth IRA.
For starters, deposits to an HSA escape both income and payroll taxes. That can’t be said of the 401(k) deposit. It escapes the income tax, but not the payroll tax. That’s no small matter. Even without adding in the employer’s share, most Americans are paying more in payroll taxes than they are in income taxes.
As for the IRA, those deposits avoid the income tax. But if they are made from wage income, you don’t get any relief from the payroll tax.
During the retirement years, HSA withdrawals for non-medical purposes will face the income tax. But as I show below, your health expenses are going to be huge – larger than what most people realize. HSA withdrawals can be used to pay premiums for Medicare Part B, Part C and Part D, as well as any out-of-pocket medical expenses.
In all likelihood, your HSA funds will never be taxed at all.
By contrast, any withdrawal from an IRA or a 401(k) will be hit with income taxes, regardless of what you do with the money.
At age 70 ½, the government forces you to begin withdrawing (and paying taxes on) funds in your IRA and your 401(k) accounts. There is no such requirement for HSAs. Further, withdrawals from conventional accounts get included in assessing the tax on Social Security benefits. That does not happen with HSA withdrawals, even if you spend the money on non-medical consumption.
Withdrawals from Roth accounts are not taxed. But deposits are made after paying income and payroll taxes. Those are taxes that the HSA holder can expect to escape completely.
You can turn IRA funds into HSA funds.
In 2019, an individual can deposit up to $3,500 into an HSA account and up to $6,000 into an IRA. For reasons just given, you should choose the HSA deposit first. But suppose you do both. The law allows you a one-time roll-over opportunity, which you will want to delay until the retirement years.
At that point you can take funds that would otherwise be subject to forced withdrawals and income taxation and a possibly higher Social Security benefits tax and roll them into an account that can be part of your estate and that will not be taxed at all as long as withdrawals are for qualified medical purposes.
Your need for medical equity is higher than you think.
Stuart cites a Kaiser Family Foundation estimate that out-of-pocket medical expenses for a typical retiree average 41% of Social Security income today and that figure will rise to 50% by 2030. These expenses add up over time. Stuart cites a Fidelity estimate that a couple at age 65 today will spend $280,000 in medical expenses by the time they die. (These estimates include the Medicare premiums.)
HSAs work best when used as savings accounts rather than spending accounts.
In one example, Stuart compares two people, both age 37 and in the 30% tax bracket. They each forgo $3,000 of consumption – increasing that number by $50 a year for 30 years — in order to put funds into accounts that grow at a rate of 6%. At age 67, the one choosing to save through a 401(k) plan has accumulated $304,200 while the HSA saver has accumulated $329,400.
At that point, Stuart assumes annual medical care costs have reached $10,000 a year and they grow at a conventional rate. But because the 401(k) holder’s account is exhausted more quickly and because he must pay taxes on his withdrawals, he will experience a significant depletion of other wealth.
If both individuals live to 101, the 401(k) saver will have spent $409,000 from other accounts while the HSA saver will have withdrawn only $27,000.
Wise saving means wise investment.
Most HSA owners are not investing at all. They use their accounts as spending accounts. That may explain why the average balance in HSAs is only $2,000, However, the law allows account holders to invest funds the way people invest their IRA balances. About one in ten account holders is doing this. The average balance in their accounts is $14,000.

3M To Acquire Private Medtech Company Acelity For $6.7B

3M Co MMM 0.69% shares, which came under significant selling pressure following its disappointing first-quarter results April 25 and downward adjustment of full-year guidance, were seeing incremental weakness Thursday after the company announced a multibillion-dollar M&A deal.

What Happened

3M said it has agreed to acquire Acelity and its KCI subsidiaries worldwide from a private equity consortium — Apax Partners, the controlled affiliates of the Canadian Pension Plan Investment Board and the Public Sector Pension Investment Board — for about $6.7 billion, including the assumption of debt.
Acelity manufactures advanced wound care and specialty surgical applications that are marketed under the KCI brand.
3M expects the deal to be dilutive to its GAAP EPS by 35 cents in the first 12 months following the completion of the transaction, including the transaction costs. On an adjusted basis, the deal is accretive to EPS by 25 cents, 3M said.

Why It’s Important

3M has had a rough start to the year, with the manufacturer of Post-It notes and touchscreen displays reporting subpar first-quarter profits and reducing its full-year profit forecast. All five of its business units reported falling operating profits.
Citing headwinds in China and weak automotive and electronics markets, the firm also announced the elimination of 2,000 members of its workforce.
Against this backdrop, the deal relays optimism. In 2018, Acelity generated revenue of $1.5 billion.
“This acquisition bolsters our Medical Solutions business and supports our growth strategy to offer comprehensive advanced and surgical wound care solutions to improve outcomes and enhance the patient and provider experience,” 3M CEO Mike Roman said in a statement.

What’s Next

3M expects the deal to close in the second half of 2019, subject to customary closing conditions and regulatory approvals.
3M now expects 2019 share repurchases to be in the $1 billion to $1.5 billion range, down from the previous $2 billion to $4 billion.
The company said it expects to finance the deal from cash on hand and proceeds from the issuance of new debt.

CMS’ new tech innovation strategy targets ‘outdated’ regulation

CMS Administrator Seema Verma on Thursday unveiled new steps the agency is taking to bolster Medicare coverage of emerging medical technologies.
During remarks at the Medical Device Manufacturers Association’s annual meeting in Washington, Verma said the agency is removing what she called government barriers to innovation.
“When I came to CMS, I inherited outdated government rules and regulation that stifle innovation and access to innovative treatments,” she said. “Our often arcane and outmoded regulations around coverage, coding and payment can lead to unpredictability for innovators.”
The first CMS update would revamp the application process for codes under the Healthcare Common Procedure Coding System, or HCPCS.
Under the current system, the CMS only allows vendors to apply for new Level II codes once per year. The agency plans to redesign the process as a quarterly system for submissions and decisions related to drugs and a semi-annual system for submissions and decisions related to devices.
The second component clarifies coverage of Current Procedural Terminology, or CPT, temporary codes for emerging technologies, also known as category III codes.
For technologies that don’t fall under an existing Local Coverage Determination, Verma said Medicare contractors are not authorized to automatically forgo covering category III items and services. Instead, these contractors must follow the agency’s new Local Coverage Determination process for each decision they make. That process includes an evidence review of the technology in question.
These changes are part of the agency’s broader strategy to address barriers to innovation in the Medicare program, according to Verma.
“The advent of novel medical technologies requires CMS to remove barriers to ensure safe and effective treatments are readily accessible to beneficiaries without delaying patient care,” she said. “In essence, keeping new technologies and treatments moving from bench to bedside—and into the hands of those who need them most.”
As part of her remarks, Verma voiced opposition to Medicare for All-style proposals, saying “Medicare for All leads to innovation for none.”
The announcement builds on recent policies the CMS has proposed for emerging technologies.
Last week, the CMS proposed a new technology add-on payment for breakthrough medical devices that are significantly better than a device already on the market as part of its update to the hospital inpatient prospective payment system. Such devices already get expedited approval from the Food and Drug Administration.

Zymeworks reports Q1 EPS (43c), consensus (67c)

Reports Q1 revenue $11.9M, consensus $0.7M. Revenue includes an $8.0M development milestone payment upon Lilly’s submission of an investigational new drug application, $3.5M of recognized deferred revenue from our licensing and collaboration agreement with BeiGene, as well as $0.4 million in other research support payments. As of March 31, 2019, Zymeworks had $180.3M in cash and cash equivalents and short-term investments.

Glaxo 3-in-1 inhalable drug shows promise in asthma study

British drugmaker GlaxoSmithKline Plc said on Thursday that its three-in-one drug Trelegy met the main goal of a late-stage asthma study, signalling a possible boost to its lung medicines division that has been hit by generic competition.

The company, along with co-developer Innoviva Inc, said the once-daily inhaler improved lung function in patients with uncontrolled asthma, compared to its other medicine Relvar/Breo Ellipta.
However, GSK said Trelegy Ellipta did not meet its secondary goal of showing a reduction in the rate of exacerbations.
“We plan to submit these data for regulatory review after the full dataset is available,” said GSK’s Chief Scientific Officer Hal Barron.
The results come at a time when GSK is hit by generic competition for its blockbuster asthma treatment Advair and it looks to newer respiratory drugs to make up for declines in older medicines.
Trelegy Ellipta is already approved for treatment of chronic obstructive pulmonary disease (COPD), a condition that limits airflow to the lungs.
The drug became the first once-daily triple medicine for COPD when U.S. regulators gave it the green light in late 2017, putting GSK ahead of rivals such as AstraZeneca and Novartis.
More than 30 percent of asthma patients cannot fully restore their lung functions with two-drug inhalable combinations such as GSK’s Breo, creating a market opportunity for a more powerful combination therapy.
Trelegy, delivered through GSK’s inhaler Ellipta, generated 156 million pounds ($203 million) in sales last year, from its use against chronic obstructive pulmonary disease (COPD), or smokers’ lung.
Analysts at HSBC project 1.4 billion pounds in Trelegy revenue by 2023, also helped by future use against asthma, though COPD will likely remain the larger commercial opportunity.

Fresenius makes solid start to year after turbulent 2018

Fresenius reported a rise in first-quarter sales and operating profit on Thursday, helped by growth at its generic infusion drugs and dialysis units, as its troubled German hospital business showed signs of stabilisation.

The German group has flagged 2019 as an investment year as it steps up a drive to improve German hospitals that have suffered from declining admissions and high staff turnover. It also wants to scale up its home dialysis business.
Currency-adjusted quarterly sales rose 5 percent to 8.5 billion euros (£7.3 billion), helped by growth at its Kabi infusion unit and separately listed Fresenius Medical Care. Operating profit rose 2 percent to 1.11 billion euros.
“All four Fresenius business segments have developed in line with our expectations, putting us well on course to meet our targets for the year,” Chief Executive Stephan Sturm said.
Fresenius had a turbulent 2018 as it grappled with operating problems at two of its three major businesses and was tied up with a court battle over its aborted takeover of generic drugmaker Akorn, which it won.
Bankhaus Lampe analysts were encouraged the company had managed to stop the margin erosion at its Helios Germany hospitals business, even though sales fell 6 percent and operating profit declined 16 percent, hurt by a nursing shortage and a less pronounced flu season.
“We see our thesis supported that none of the businesses are facing material structural challenges,” wrote analyst Volker Braun, who rates the stock ‘buy’.
But Jefferies analyst James Vane-Tempest said it was too early to call a stabilisation trend at Helios given the company faces challenges from reforms to the German hospital payments system that kick in next year.
Shares in Fresenius, which have surged 19 percent so far this year, outperforming a 9.6 percent increase in the European health sector index, pared early gains to trade 0.1 percent lower at 0942 GMT.
At Fresenius Medical Care, which has faced a slowdown in North America, its most important market, adjusted sales rose 6 percent to 4.13 billion euros, helped by agreements that materialised earlier than planned.
Operating profit increased by 4 percent in constant currencies to 551 million euros.
Adjusted quarterly sales at Kabi rose 4 percent, while revenue at its smallest division Vamed, which manages projects for hospitals and provides post-acute care in central Europe, jumped 33 percent.
Despite expected earnings dilution from its $2 billion acquisition of home dialysis maker NxStage, Fresenius confirmed its guidance for currency-adjusted sales growth of 3-6 percent this year compared with 6 percent last year, while profit is expected to stay around the same level as 2018.