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Monday, July 29, 2019

It’s official. Mylan and Pfizer’s Upjohn to combine

Mylan N.V. (NASDAQ:MYL) and Pfizer’s (NYSE:PFE) Upjohn unit will merge in an all-stock reverse Morris Trust transaction.
A reverse Morris Trust is a tax-free deal involving a spinout of a subsidiary that is merged with another company. Upjohn will issue $12B of debt at or prior to separation. Proceeds will go to Pfizer.
PFE shareholders will own 57% of the combined company while MYL shareholders will own 43%. On a pro forma basis, 2020 revenues should be $19B – 20B with non-GAAP EBITDA of $7.5B – 8.0B and cash flow of more than $4B. Phased synergies should be ~$1B by 2023. Debt/non-GAAP EBITDA should be 2.5x by the end of 2021. At closing, it will have ~$24.5B of debt outstanding.
Upjohn’s product portfolio includes Lipitor (atorvastatin calcium), Celebrex (celecoxib) and Viagra (sildenafil).
The new organization, to be renamed and rebranded when the transaction closes, will be led by Mylan Chairman Robert Coury as Executive Chairman. Upjohn chief Michael Goettler will be CEO and Mylan President Rajiv Malik will be serve as President. Current Mylan CEO Heather Bresch will retire.
Post-spinout, Pfizer expects to generate ~$40B in revenues in 2020 with a mid-30% pre-tax earnings yield and cash flow ops of $11B – 12B.
Pfizer shareholders will receive a stock dividend of 0.12 shares per common share owned provided that the equity distribution is structured as a spinout.
The companies will host a conference call this morning at 8:30 am ET to discuss the tie-up.
MYL is up 16% premarket on robust volume. PFE is down 2% on modest volume.

Exact Sciences to merge with Genomic Health in $2.8B deal

Exact Sciences (NASDAQ:EXAS) and Genomic Health (NASDAQ:GHDX) have agreed to merge in a cash-and-stock transaction valued at $2.8B ($72/GHDX common share). The deal should close by year-end.
GHDX shareholders will receive $27.50 in cash plus $44.50 in EXAS common stock for each share owned.
On a pro forma basis, the combined company should generate ~$1.6B in revenues in 2020. Synergies should be ~$25M by the third year after the close.
The companies are currently hosting a conference call discussing the deal.
GHDX is up 2% premarket while EXAS is down 5%, both on modest volume.

Exact Sciences Q2 revenue up 94%; Cologuard volume up 93%

Exact Sciences (EXASQ2 results: Revenues: $199.9M (+94.3%).
Net Loss: ($38.4M) (-5.5%); Loss Per Share: ($0.30) (unch).
Cologuard test volume: 415K (+93%); average revenue/test: $483; average cost/test: $123.
2019 guidance: Revenue: $800M – 810M from $725M – 740M.
Shares are down 7% premarket.

Mylan up 23% premarket on potential Pfizer deal

The WSJ reports that Pfizer (NYSE:PFE) is in talks with Mylan N.V. (NASDAQ:MYL) to combine its off-patent drugs business with the latter.
The deal, which could be announced as early as today, would result in Mylan owning ~40% of the merged organization and Pfizer owning ~60%. Pfizer would also receive ~$12B in proceeds from the new sale of debt.
Pfizer’s Michael Goettler will head the new company while Mylan Chairman Robert Coury will be Executive Chairman. Current Mylan CEO Heather Bresch will depart.
The companies are hoping that the combination will reignite growth. Generics have been under pressure for some time. The deal may stoke buying in other industry players.
Mylan is up 23% premarket on modest volume while Pfizer is down a fraction.
Selected tickers: Teva Pharmaceutical Industries (NYSE:TEVA) (+9%), Perrigo (NYSE:PRGO) (+1%), Mallinckrodt (NYSE:MNK) (+4%),

Harris Unveils Part of Plan to Transform Health Care to a Federal System

Democratic presidential candidate Sen. Kamala Harris (D., Calif.) released a plan Monday to reshape the U.S. health-care system by transforming it over 10 years to a federal one that would still allow a limited role for private insurers.
Ms. Harris, who has been criticized by some more progressive members of her party for her lack of clarity on her support for Medicare for All, released the plan a day before the start of the second round of Democratic presidential debates, where health care is expected to be a key topic. In the last debate series in June, Ms. Harris raised her hand when candidates were asked if they would abolish private health insurance, but she said the next day she had misunderstood the question.
Her version of Medicare for All would upend the current system for a government-run health-care program that would cover a robust set of benefits, from long-term care to mental health and hospitalization. But private health plans such as those from Cigna and Aetna Inc. could offer Medicare Advantage — in essence, plans with enhanced benefits.
She also would move people into the program over 10 years instead of the four that Sen. Bernie Sanders (I., Vt.) has outlined in his Medicare for All proposal. Ms. Harris’s plan proposes to raise funding revenue with taxes on higher-income families and Wall Street trades and without raising taxes on the middle class.
“Medicare works. It’s popular,” Ms. Harris wrote in a post scheduled to appear Monday morning on the website Medium. “Seniors transition into it every day, and people keep their doctors and get care at a lower cost. Let’s not lose sight that we have a Medicare system that’s already working.”
Democrats fared well in the 2018 midterm elections by portraying the party as the defender of the Affordable Care Act in the face of GOP attempts to repeal it. Progressive Democrats are pushing for Medicare for All, without an option for private insurance, while centrists argue ripping up the current U.S. health system is overly aggressive and risks alienating voters.
Ms. Harris’s plan would permit Medicare Advantage, which are plans offered by private carriers that contract with Medicare. But it would impose new federal regulations aimed at improving plan quality, cost and access though her campaign didn’t disclose details.
Employers would pay into either Medicare for All or Medicare Advantage during the transition period to get coverage for their employees. Medicare Advantage, which has been growing in the last decade, now accounts for one-third of the 64 million people covered by Medicare, according to the Kaiser Family Foundation. About one fifth of Medicare Advantage enrollees are in an employer- or union-sponsored group plan.
This would be the primary role for private health insurers. Employers would pay into the new federal program, and workers would get their coverage from the expanded Medicare program. Many private insurers currently offer these Medicare Advantage plans. The plans they would offer under Ms. Harris’s health system would be subject to new requirements and conditions. Currently, some employers offer Medicare Advantage to older workers; Medicare is now generally a program for people age 65 and older.
The plan aims to expand health coverage in the U.S., Ms. Harris said. Under Medicare for All, consumers have out-of-pocket payments only for prescription drugs. She didn’t release details of how her transition period would work.

What you can do if your health insurance claim is denied

When your health insurance claim is denied or your health insurer refuses preapproval for care you need, you may think your hands are tied. But there’s actually a lot you can do to try getting that decision reversed.
All health insurance policies have an appeals process. An appeal can be challenging, though. In fact, Ruth A. Carnes, an appeal nurse at Mercy Medical Center in Baltimore, says “for people with no medical background, [appeals] can be very overwhelming.”
Pursuing a health insurance appeal takes effort and time, too. But it’s probably worth it. According to Jennifer Obenchain, case management director at the Patient Advocate Foundation in Hampton, Va., 65% of appeals are successful.
Key to success for a health insurance appeal
The key to success: Stay cool.
“The impact of an impending bill that could destroy someone’s life, lead them to lose their homes or ruin their credit creates overwhelming anxiety that often drives people to act irrationally,” says Susan Null, principal at Systemedic, a medical billing and patient advocacy company in New City, N.Y.

So, remain focused on the necessary and appropriate steps in the appeal process instead of letting emotions rule.
You may be upset, but don’t assume this is war.
Dr. Magda Lenartowicz, medical director at SCAN Health Plan, a Medicare Advantage insurance plan in Long Beach, Calif., says health insurers are willing to work with patients. “We can often help track down information and walk them through the process, which eliminates the stress of trying to figure it out on their own.”
Remember: Your goal is to prove the insurer is contractually obligated to pay for the service, not the hardship that’s been created for you. “Appealing to emotion will not win an appeal,” says Null.
Making your argument
Instead, focus on presenting a logical argument.
To increase your chances of winning an appeal, start immediately after receiving the bill or denial. “Too many people start the dispute process years down the road when the bills have already been sent to collection,” says Null.
If your quarrel is due to a billing error on the statement — a common cause for denials — phone your insurer. “Ask what is the quickest way to resolve the issue,” advises Carnes.
Obenchain points out that there may be “missing medical records or mismatched billing codes.” If either is the problem, call your health care provider and ask the office to send the insurer the correct records or billing codes.
If there isn’t an easy fix, scrutinize the denial letter. The Affordable Care Act requires health insurers to provide a written denial with an explanation and clear deadlines. This is your road map for moving forward.
Levels of appeal for a health insurance denial
There are several levels for appeal. The first is what’s known as reconsideration. This generally involves a peer-to-peer phone review between your doctor and a doctor at the insurer. It’s up to you to get this line of appeal started, though.
If this is unsuccessful, the next step is an internal appeal, reviewed by a medical director. If this is denied, the final step in the appeals process is what’s known as an independent external review with a third-party board-certified physician.
Throughout the appeal process, it’s critically important that you remain organized.

“The biggest mistakes that patients seem to have with appeals are the deadlines and staying on top of the requirements,” says Obenchain. So, document every call and keep every piece of paper you receive related to your problem. Write a timeline with what happened, when and who you talked with on each call.
Also, write down the appeal deadlines and tick them off when you meet them.
Writing an appeal letter
If your phone calls haven’t been effective, you’ll need to write a letter explaining why the denial was incorrect.
The Patient Advocate Foundation has sample appeal letters on its site that you can use as templates. The foundation also has booklets describing each step in the appeal process.
In your letter, include documentation from your physician (such as case notes and a letter explaining why treatment is necessary), test results and details on how you know the insurance plan covers this treatment. You could also include information from experts (such as journal articles) for additional weight.
Carnes says your letter should “describe your medical condition briefly and the impact it has had on your life. Be pleasant and brief, not conveying your frustration or becoming threatening.”
She recommends asking your doctor to review your letter and make any revisions necessary, and to also submit his or her own letter.
Send everything by certified mail, return receipt requested.
Null says that if your doctor won’t cooperate, “you have no choice but to use that against them and in your defense.” Point out any errors your doctor made that led to the denial.
Because appeals are technical, you may want to get some help. The Patient Advocate Foundation provides free appeals assistance if you’ve been diagnosed with a chronic, life-threatening or debilitating disease.
Another option is to work with a professional patient advocacy company. It might cost between $125 and $300 for an initial review and then you’ll be billed hourly.

My husband and I hired a patient advocate when my son’s claim was denied. My husband’s employer had switched insurers and the new one denied pre-authorization for a treatment my son had been receiving. The insurance change also meant switching doctors to keep us “in-network.” The new doctor refused to even take the peer-to-peer call from the insurer. Our patient advocacy company received records from the doctor, crafted the appeals letter and ultimately got the treatment approved.
If your appeal fails
If internal and external appeals fail to overturn the insurer’s decision, you’re not necessarily out of options.
Talk with the hospital or your doctor for assistance. As a last resort, you can also consider hiring an attorney. That will be an additional expense, of course. But if the insurance denial means huge costs, a lawyer may be worth the money.

Novartis updates on Phase III PARAGON-HF trial in heart failure

  • PARAGON study narrowly misses statistical significance on the primary endpoint; overall safety profile confirmed
  • Totality of evidence suggests potential clinically important benefit; results will be presented in September at the ESC Congress 2019, the annual meeting of the European Society of Cardiology (ESC) 
  • Novartis plans to engage in conversations with clinical experts and regulators on next steps