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Monday, February 4, 2019

Amazon’s PillPack secures more state licenses, could be eyeing national rollout

Amazon’s PillPack has secured approval in recent months from nine additional state pharmaceutical boards (and is seeking more) to expand its distribution capabilities, leading to more speculation about the retail giant’s intentions.
The newly acquired licenses, in data compiled by Jefferies analysts, give its Arizona facility the ability to ship prescription drugs into more states. The Arizona facility is one of five PillPack distribution centers, its furthest west, giving it quicker access to states there.
Even though the online pharmacy is gaining licenses faster than Jefferies analysts expected, expanding its distribution capabilities at its current facilities will not be enough to meet the demands of a major consumer rollout without acquiring or building more mail order pharmacies, the investment bank’s analysts note.
Although Amazon has not made its intentions clear about its future strategy, some analysts believe a national rollout is almost certain. The licenses were the “cornerstone” of the deal and a first step to any expansion.
“The logical next step for Amazon is to utilize these licenses through a national consumer rollout,” Joshua Mark, an associate analyst at CB Insights, told Healthcare Dive.  ​
“Amazon already had the cash, the talent and the distribution network in place to build its own version of PillPack. What it acquired in the transaction was the time PillPack spent attaining the licenses necessary to build a national business,” he said.
Like Jefferies, a Leerink analyst says PillPack still needs to bulk up its distribution before any larger expansion.
“I think they will need to further scale up and build out full capabilities before a national rollout is possible,” Ana Gupte, an analyst with Leerink told Healthcare Dive.
For context, Express Scripts mail order pharmacies total more than 1 million square feet, and at their peak were serving more than 100 million people across the country.
By comparison, PillPack serves “tens of thousands of customers,” PillPack CEO TJ Parker told Wired last year.
Besides its facilities in Arizona and Brooklyn, the three other distribution centers in New Hampshire, Austin, Texas, and Miami have the ability to ship to nearly every state, according to Jefferies data.
Even amid the uncertainty, the retail giant’s moves into the healthcare sector have spooked the industry. Some suggested that they helped spur some of last year’s blockbuster mergers between CVS-Aetna and Cigna-Express Scripts.
As the nation’s largest insurers and PBMs become merged, Anthem recently said it was speeding up the launch of its own PBM IngenioRx. The nation’s second largest insurer will begin transitioning patients away from the Express Scripts PBM platform to its own starting March 2.
David Friend, managing director at BDO Consulting, said Amazon’s move with PillPack represents a threat to both traditional pharmacies and PBMs.
Ultimately, “they’re going to cut out the pharmacy business and the PBMs,” Friend, told Healthcare Dive. “If they cut the prices enough, consumers are going to say, ‘why should I have to go through more complexity and pay more?'”
Friend envisions a model similar to how some consumers buy eyeglasses. He speculated patients could eventually purchase their drugs through Amazon and send in the claim to their insurance to get reimbursed.
Reached for comment, PillPack noted its goal remains to help patients treat chronic conditions. “That hasn’t changed with the Amazon acquisition in the second half of 2018,” the spokesperson said.

Pharma misses its prescription for growth

Caught under a microscope over drug pricing, pharmaceutical companies are predicting 2019 will bring revenue totals noticeably lower than what Wall Street expected for the year ahead.
In recent days, Pfizer, Johnson & Johnson, AbbVie, Allergan and Amgen have all rolled out sales forecasts that have underwhelmed investors. The lackluster guidance makes for a wobbly start to the year for the sector, and raises some pointed questions for companies lacking clear successors to current top-sellers.
A few weeks ago, the industry was enjoying a J.P. Morgan Healthcare Conference enlivened by dealmaking from Bristol-Myers Squibb and Eli Lilly — on the surface, at least, a sign of C-suites ready to pull the trigger on hoped-for acquisitions.
Fourth quarter earnings, however, have brought a dose of doubt about how the year may unfold. While the reasons for disappointing guidance from companies varies, one common undercurrent is a shifting environment around drug pricing and how that translates into sales.
Pharma’s forecasts disappoint Wall Street
2019 SALES GUIDANCE (AT MIDPOINT)WALL STREET ESTIMATE (BILLIONS)DIFFERENCE (BILLIONS)
J&J$80.8 billion$82.6 billion-$1.8 billion
Bristol-MyersMid-single digit*7%Slight miss
AbbVieFlat*2.5%Miss
Pfizer$53.0 billion$54.3 billion-$1.3 billion
Amgen$22.4 billion$22.9 billion-$0.5 billion
*Bristol-Myers, AbbVie did not detail specific 2019 sales estimates SOURCE: Analyst reports, companies
“This is a significant change to the steady diet of low to mid single digit top line growth and high single to low double digit bottom line growth to which biopharma investors have become accustomed,” wrote Leerink analyst Geoffrey Porges in a Jan. 30 note.
“The common culprits on these calls have been risk of rapid erosion of large brands facing either generic or biosimilar entry, and loss of positive pricing power on other products (particularly growth products),” Porges added.
Even as list prices continue to climb, at least four pharmas have noted they expect net prices after rebates to decline, either in the U.S. specifically or globally. That disparity is mostly due to the increasing amount drugmakers pay to insurers and pharmacy benefit managers via rebates, handed over in exchange for favorable coverage.
Data compiled by Iqvia found net prices for “protected brands” — defined as branded drugs on the market for more than two years — rose by 1.5% in the U.S. last year, below the rate of Consumer Price Inflation. Invoice prices, which track wholesale acquisition costs, increased by 5.7%, Iqvia found.
“Pricing is not going to be a growth driver for us now and, I think, in the future,” said Pfizer CEO Albert Bourla on a quarterly earnings call this week, aligning the company’s expected revenue growth with increasing volume of prescriptions for its medicines.
That’s not to say Pfizer is eschewing price increases. Earlier this month the pharma put in place hikes it had announced late last year, raising the list price of 41 medicines — roughly 10% of its overall product portfolio.
Yet Pfizer expects net prices across its business in 2019 to remain flat in the U.S., and decline by low single digits globally.
J&J executives made a similar point, noting net prices for its products in the U.S. declined between 6% and 8% last year. The company expects net price declines to remain at “elevated levels” this year.
Lower net prices don’t necessarily translate to a lesser hit to patient wallets, a point Health and Human Services Secretary Alex Azar has frequently made in calling for a halt to regular list price increases.
They do, however, expose drugmakers that rely on blockbuster older drugs to drive revenue higher. Nearer to the end of their patent life, such products typically see slower volume gains (or outright declines) and are more dependent on pricing to continue growing.
Amgen, for example, has leaned on its drugs Enbrel (etanercept) and Neulasta (pegfilgrastim), which together accounted for about half of Amgen’s $17.4 billion in U.S. sales last year.
Both face competitive challenges, either from newer branded entrants or, for Neulasta, from biosimilar competition. Lower net selling prices have also weighed on sales of both, even as Amgen has continued to raise list prices.
Earlier this month, for example, Amgen increased the wholesale acquisition cost of Enbrel by 6.2%.
Overall, the biotech expects net selling prices to decline by mid-single digits in 2019 — a trend that will put particular pressure on drugs like Enbrel and Neulasta.
A recent analysis by Leerink found that higher pricing accounted for all of the nearly $2 billion in U.S. revenue growth Amgen realized from the two drugs between 2014 and 2017.
Without those pricing tailwinds, Amgen will have to find revenue gains elsewhere. “Our strategy for growth will be driven by volume, not price,” said Amgen CEO Robert Bradway this week.
The challenge, of course, is having a portfolio of new drugs benefiting from accelerating prescription volumes. But that’s not a given in an industry struggling to develop blockbuster hits.
In part because past top-sellers have had such commercial success, several companies’ prospects for maintaining consistent growth appears to be now more in question.

In hiking prices, drugmakers show some signs of tempering increases

  • The first month of 2019 found drugmakers again increasing list prices on some of their most important medicines. The frequency and degree of those hikes, however, appear somewhat diminished compared to years past, an analysis by the investment bank Raymond James concluded.
  • The average price increase was about 6%, compared to roughly 8% last year and 12% in 2014, the report found. Drugmakers appear more sensitive to political and public criticism in the current environment, analyst Elliot Wilbur wrote in a Monday note to investors.
  • Some pharmas continued to push prices up at rates approaching double digits, a mark much of the industry has adopted as an upper bound for their planned increases. In 2014, by contrast, five companies — including Merck & Co. and Bristol-Myers Squibb — enacted double digit price increases on a weighted sales basis, Raymond James calculated.

Historically, about 40% of the industry’s price hikes for the year occur in January, the bank’s report found, making the month an important barometer of pricing for the year ahead.
With fresh data from last month in hand, Raymond James’ Wilbur predicted a new normal of mid-single digit hikes, with the potential for future moves to more closely track inflation levels.
“The days of double-digit price increases are long gone and the new pricing model has increasingly tended toward a series of modestly lower mid-single digit increases,” Wilbur wrote.
Highest average January 2019 price increases, per Raymond James
COMPANYWEIGHTED PRICE INFLATION
Purdue9.5%
Allergan9.3%
Teva8.5%
Almirall7.7%
Novartis7.3%
SOURCE: Raymond James
The analysis tracked roughly 6,500 branded drugs by wholesale acquisition cost broken down by individual product packaging configurations. Measured year over year, the total number of price increases dropped from 2,383 last January to 2,103 last month.
While that figure’s meaning is diluted somewhat by including multiple variations of a single drug, the findings correspond with recent moves by drugmakers to take a more selective approach to pricing.
*Weighting by trailing 12 month sales
Credit: Andrew Dunn / BioPharma Dive, Raymond James data
Weighted price increase figures take into account a drug’s sales over the past 12 months, in effect tying the increases to how much revenue a product has earned.
The bank’s findings come as the Iqvia Institute for Human Data Science recently forecasted a similar future for pharmaceutical pricing over the next few years.
The group recently predicted invoice price growth will range between 4% and 7% in the near term. Invoice prices, which largely track with list prices, are what a hospital or pharmacy pays to drug distributors and can include some discounts, such as for volume.
Pharmas often argue that net prices, accounting for rebates, paint a clearer picture of drug pricing than do list prices — messaging that Health and Human Services Secretary Alex Azar has recently pushed back against.
The Iqvia report will likely give drugmakers more ammunition to make their case, however, forecasting net price growth for protected brands in the next five years to be between 0% and 3%.
Last year was the first time in recent years that net price growth fell below inflation levels as measured by consumer prices, the report found.

Reporting before Tuesday’s open

Notable companies reporting before Feb 5’s open, with earnings consensus, include Becton Dickinson (BDX), consensus $2.62…Centene (CNC), consensus $1.32… WellCare Health Plans (WCG), consensus $1.56… Catalent (CTLT), consensus 37c…

CymaBay reiterated as buy at Cantor

Cantor Fitzgerald restated their buy rating on shares of CymaBay Therapeutics (NASDAQ:CBAY) in a report released on Friday, The Fly reports. Cantor Fitzgerald currently has a $20.00 price target on the biopharmaceutical company’s stock.
“Reiterate our Overweight rating; increasing 12-mo. PT to $20. CymaBay is a liver disease company with lead asset, seladelpar, in Ph3 for primary biliary cholangitis (PBC). Our checks suggest seladelpar’s strong profile in PBC has the potential to grow the market significantly from where it is today. We think the opportunity in PBC alone (~$350M in 2026 unadjusted sales vs. cap of $500M) should justify upside. We see further potential for seladelpar with a 2Q19 Ph2b NASH proof of concept readout, which could be a much larger opportunity (~ $4B+) for Seladelpar if successful. In our 75-page slide deck, we took a close look at PPAR-delta biology & role in NASH. Our Take: PPAR-delta has the potential to be a major target in the NASH space,” the firm’s analyst commented.

Piper Jaffray uncertain of benefits from increased Roche access for Senseonics

Piper Jaffray analyst JP Kim kept his Neutral rating and $2.70 price target on Senseonics (SENS) after the company announced an extension of agreement with Roche (RHHBY). The analyst notes that the management is likely willing to trade off the near term price gains for long term volume gain through this deal, but adds that a reset of consensus estimates for sales that would lead to Senseonics becoming a “beat and raise story” is uncertain.

Piper Jaffray expects impact on Abiomed from FDA letter to be minimal

Piper Jaffray analyst Matt O’Brien kept his Overweight rating and $480 price target on Abmiomed, saying there are nuances to the recent issuance of a “Dear Doctor” letter related to the Impella RP. The analyst notes that 16 of the 23 patients enrolled in the PAS “would not have met the enrollment criteria for the premarket study”, so the survival in patients on protocal would have been higher than the 17% reported at 43% or 57%. O’Brien expects the impact of the letter to be minimal to RP utilization, stating that the opportunity for the program “remains healthy”.
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