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Monday, April 22, 2019

Intuitive Surgical on Track for Largest Percent Decrease in Nearly Five Years

Intuitive Surgical Inc. (ISRG) is currently at $490.61, down $37.45 or 7.09%
— Would be lowest close since Jan. 8, 2019, when it closed at $482.99
— On pace for largest percent decrease since April 23, 2014, when it fell 11.46%
— Earlier Monday, Canaccord Genuity and Raymond James lowered their price target for Intuitive Surgical, Benzinga reported
— On Thursday, Intuitive Surgical reported first-quarter net profit totaled $306.5 million, or $2.56 a share. Excluding stock-based compensation and other items, profit rose to $2.61 from $2.44 a share a year earlier. Revenue jumped 15% to $973.7 million. Analysts surveyed by FactSet expected $2.28 a share in profit, or $2.70 a share as adjusted, on $975 million in revenue
— Currently down six of the past seven days
— Down 14.02% month-to-date
— Up 2.44% year-to-date
— Traded as low as $490.06; lowest intraday level since Jan. 29, 2019, when it hit $486.64
— Down 7.2% at today’s intraday low; largest intraday percent decrease since Nov. 19, 2018, when it fell as much as 7.43%
— Worst performer in the S&P 500 today
— Worst performer in the Nasdaq 100 today

FDA approves new round styles of Sientra gel breast implants

The FDA posted a Premarket Approval supplement with a decision date of April 17 for Sientra’s OPUS Silicone Gel Breast Implants, granting approval for new round implant styles 10621-XP, 10721-XP, 20621- XP, and 20721-XP.

How Washington’s drug-pricing promise could lose its way

Kathy Sego, a choir teacher from Indiana, sat before the Senate Finance Committee in late January and tried to show lawmakers how drastically drug pricing needs to change.
Sego told senators how her diabetic son secretly rationed his insulin after he realized it cost his insured parents $1,700 per month. She described his sharp and sudden weight loss and spiraling health problems. She explained what it was like to take a trip to Hungary and see a $10 price tag for the same vial of insulin that cost them $487 back home.
She detailed how she and her husband each work more than 80 hours per week and stretch out their payments to the point their electricity got cut off so they could buy the medicine.
Her voice cracked as she laid out her son’s insulin-dependent future. “He wonders—can he pay for an apartment?” Sego said, her voice wavering as she began to cry. “Utility bills? His student loans? Will he be able to have a social life? Take a girl on a date? The thing is, it really comes down to this: Hunter needs insulin to live, but should that need for insulin keep him from living?”
Then lawmakers and experts got to work. That meant Sego sat for hours mostly in silence, as analysts seated beside her talked about innovation, competition and inflation caps.
The scene is familiar on Capitol Hill, where the pageantry played out in hearing rooms fades into a cautious dance.
It’s been nearly four months since an energized Democratic majority in the House started 2019 with promises of sweeping reform of drug prices, supported by the ambitious goals of the Trump administration and milder assurances of the GOP-led Senate. Although lawmakers emphasize that it’s still early in the 116th Congress, and reiterate their agreement to do something big, the window to develop their ideas is narrowing.
Leading lawmakers have yet to decide what “something big” would look like. They certainly haven’t cohesively rallied around the boldest Trump administration ideas, such as banning rebates for pharmacy benefit managers and tying high Medicare Part B drug prices to their costs in foreign countries that pay less. And there are plenty of factors in play to shrink Congress’ drug-pricing ambitions down to size.
Last week brought a fresh reminder of the pharmaceutical industry’s massive war chest and targeted lobbying. Early 2019 fundraising receipts for members of Congress show a trail of pharma donations to key committee leaders.
AN EARLY START
Top pharmaceutical company donations
January-March 2019
Pallone for Congress
Rep. Frank Pallone Jr. (D-N.J.)
Chair, House Energy and Commerce Committee
$2,500 AmerisourceBergen
Corp. PAC
$2,000 Pfizer PAC
$1,000 Johnson & Johnson PAC
$1,000 Amgen PAC
Richard Neal for Congress
Rep. Richard Neal (D-Mass.)
Chair, House Ways and Means Committee
$2,500 Genentech PAC
$2,500 Sanofi U.S. Services 
Employees’ PAC
$2,000 Abbott PAC
Source: Federal Election Commission filings
House Energy and Commerce Committee Chair Frank Pallone (D-N.J.), Ways and Means Chair Richard Neal (D-Mass.), and Energy and Commerce Health Subcommittee Chair Anna Eshoo (D-Calif.) collected thousands of dollars from pharma groups and companies.
That isn’t unusual, as the pharmaceutical industry has traditionally put its money toward committees of influence.
But this year, when Democratic leadership has promised regular order to give committee chairs sway over legislation, these chairmanships are as important as ever.
Pallone’s top pharma contributors in the first quarter of 2019 included Pfizer, AmerisourceBergen, Johnson & Johnson and Amgen. Neal’s contributions came from Abbott, Biogen, Genentech, Sanofi and Merck, among others.
Eshoo brought in more than $20,000 from Gilead Sciences, Denmark-based Lundbeck, Jazz Pharmaceuticals, Amgen, AbbVie, the Pharmaceutical Research and Manufacturers of America, and executives of some of those firms.
None of the tallies count money from consulting and lobbying firms that also represent the industry.
The outlier among the House committee heavyweights is Rep. Lloyd Doggett (D-Texas), who chairs the Ways and Means Committee’s health panel. A vocal pharma critic, he has proposed holding drug patents as leverage to lower prices for Medicare. And manufacturers responded accordingly.
Still, Doggett has a biotech donor in the Austin-based company Asuragen, whose executives contributed more than $7,000 to his 2020 campaign.
Major pharma contributions aren’t new for any of these lawmakers—a criticism that followed Eshoo in particular as she assumed the Energy and Commerce Health Subcommittee chairmanship. Her district houses biotech giants and in the last election cycle the industry was her biggest donor, accounting for more than $160,000 of her campaign funds, according to OpenSecrets.org.
Big Pharma's top donors
When Pallone was ranking member on Energy and Commerce, pharma gave nearly $250,000 to his campaign for the 2018 cycle. That compares to roughly $414,000 he raised from other health professional groups.
Neal’s donations were even higher. Last cycle he raised more than $282,000 from the drug industry. That’s in comparison to more than $381,000 from insurers, according to OpenSecrets.
For context, the former GOP chairs of these same committees were top recipients of pharmaceutical money in the 2018 election cycle, according to an analysis from the Center for Responsive Politics, which operates the OpenSecrets website. Rep. Greg Walden (R-Ore.), then leader of Energy and Commerce, ranked first for pharma contributions to House lawmakers last year, while Rep. Kevin Brady (R-Texas), former chair of Ways and Means, came in fourth.
These are the easy-to-track contributions. There’s also so-called dark money, which is funneled through 501(c) organizations and used to advocate policy along ideological arguments.
The Center for Responsive Politics last November found PhRMA disbursed millions of dollars to dark money groups aligned with Republicans.
This boosts issues-focused groups to lobby Republicans in Congress against some of the administration’s ideas, notably the international reference-pricing model for Medicare Part B.
The top 501(c) recipients of PhRMA money included the American Conservative Union, an organization that has been out front in opposition to the reference-pricing proposal.
Last year PhRMA also gave $1.5 million to the American Action Network—a group that in 2016 spent $2.6 million on an issues campaign against a Medicare Part D negotiation policy.
Conservative groups are also arguing against ideas like personal importation—bringing $10 insulin back from Hungary, for instance—which Senate Finance Committee Chair Chuck Grassley, a Republican, has supported.
The other side of the aisle raked in big bucks too: $1.19 million of PhRMA’s contributions went to Center Forward, a group that spent $1.3 million on Democrats for the 2018 midterms. Among the top recipients for Center Forward were the two moderate Democratic House political action committees—the Blue Dogs and the New Democrat Coalition.
Members of these groups are more sensitive than other Democrats to arguments about “price fixing,” and they also have more power in numbers now. The New Democrat Coalition got an enormous boost in the 2018 midterms, as Democrats took the House through swing districts nabbed by moderates.
The other critical influence on how the final drug-pricing legislation will turn out has less to do with money, but is arguably more pressing: the calendar. Grassley said he wants the Senate package wrapped up by June or July, given all that Congress needs to address before the fall—like the debt limit.
So far, House committees have approved uncontroversial measures like , a  and the Creates Act, all of which are expected to go to the House floor. Democrats in particular want to go much bigger, yet House Speaker Nancy Pelosi (D-Calif.) has yet to disclose the “flagship” bill that would allow Medicare to negotiate prices in Part D.
In the vacuum of other Medicare negotiation proposals, progressives in the House have  and plan to take their advocacy for his idea nationwide through Facebook Live town halls. But the idea likely won’t gain traction since it affects the U.S. patent system so drastically, and committee Republicans have made it clear they would never support it.
This leaves other Democrats hanging, and the conversations about hard-line policy have remained vague.
Rep. Kurt Schrader (D-Ore.), a leading member of the Blue Dogs and the New Democrat Coalition, said he thinks people want Congress to do something beyond low-hanging fruit, but he couldn’t pinpoint exactly what that is.
Eshoo was also noncommittal. “I think it’s important to explore all avenues to lower drug prices,” she said, when asked for her view on a policy like arbitration. “I don’t think that lowering drug prices is done by one action.”
For all the industry influence and time constraints, there’s one more pressure point: 2020. Democrats want to defend their House majority and Republicans have a lot of Senate seats up for a challenge, not to mention the presidency.
“Republicans and Democrats have got to deliver for the American people on lower prescription drug prices, period,” Rep. Debbie Dingell (D-Mich.) said. “You hear about the cost of insulin wherever you go, from the children to the seniors. So instead of everybody pitting us against each other, we’ve got to find a way to deliver for the people who elected us, or everyone’s in trouble.”

Medicare spending to shoot up by 2038: trustee report

Total Medicare costs are expected to grow from 3.7% of gross domestic product in 2018 to 5.9% in 2038, according to a new report from the Social Security and Medicare Boards of Trustees released Monday.
The report also projected that Medicare’s hospital insurance trust fund that covers Part A will run out by 2026, which the trustees predicted last year.
Since 2008, national health expenditure growth has been below historical averages, the report said. Medicare costs will increase gradually after 2038 to about 6.5% of GDP.
Reserves in the trust fund that covers Medicare Part A decreased by $2 billion to a total of $200 billion at the end of last year, according to the report. The trustees project that hospital insurance expenditures are expected to be slightly higher than last year’s estimates as payroll taxes decrease.
Things are rosier for the Supplementary Medical Insurance Trust Fund, which has $104 billion in assets at the end of the year and is on solid financial footing.
The trust fund covers both Medicare Part B and Part D. The trustees expect both parts of Medicare will be funded over the next decade and beyond as the fund resets premium income and general revenue income each year.
For Social Security, the trustees project that benefits will be able to be paid out until 2035, a full year later than projected in last year’s report.

FDA approves new dosage form of Amgen’s Corlanor

https://thefly.com/landingPageNews.php?id=2895217

Zymeworks price target raised to $42 from $37 at Wells Fargo

Wells Fargo analyst Jim Birchenough reiterated an Outperform rating on Zymeworks and raised his price target on shares to $42 from $37 following the recent initiation of phase 2 development for HER2 biparatopic antibody therapeutic ZW25 as frontline treatment for metastatic HER2+ gastroesophageal cancers. The analyst said he sees a reasonable likelihood of success due to strong phase 1b data.

Pump the Brakes on the Illumina and Pacific Biosciences Deal

When Illumina (NASDAQ:ILMN) announced it had agreed to acquire Pacific Biosciences(NASDAQ:PACB) in November 2018, the already concentrated world of DNA sequencing was bracing for further consolidation. The $1.2 billion acquisition promised to combine the world’s leading technology platform for reading short fragments of DNA (short-read) with the world’s most proven technology platform for reading long fragments of genetic material (long-read). It would also give the $46 billion sequencing titan near-full control of the global $8 billion market opportunity by 2022.
While Illumina has been built on acquisitions, investors weren’t off base for wondering if gobbling up Pacific Biosciences would make a little too much noise in the halls of trade authorities across the globe. Now they have an answer: The United Kingdom’s Competition and Markets Authority (CMA) has opened an investigation into the transaction.
The inquiry is still in the earliest stages of development and the situation is complicated, but it’s the first sign to investors that the acquisition — originally expected to close in mid-2019 — could come under increased scrutiny from regulators.

What’s at stake in the acquisition?

On paper, the acquisition would allow Illumina to absolutely dominate the global DNA sequencing market. It’s already pretty dominant today. The business reported $3.3 billion in revenue last year and held an estimated 77% global market share the year before. But that’s all courtesy of short-read technology, which chops up strands of DNA into tiny fragments and reads the pieces as they’re reassembled.
Short-read is useful for many sequencing applications, but cannot read an estimated 9% of the human genome, suffers on certain accuracy metrics, and isn’t ideal for various non-human organisms. Researchers are increasingly craving more detailed genomic information provided by long-read technologies, which can peer into regions the genome short-read is blind to. The problem has always been the cost.
Consider that Pacific Biosciences could use its novel long-read technology platform to sequence a human genome for $12,000 (expressed as the cost of the chemical reagents to run its machines) in early 2018. But the company promised technology upgrades would nudge that down to $7,000 in late 2018 and all the way down to $1,000 in early 2019. If successful, the global long-read market could jump to $2.5 billion in 2022 from just $660 million in 2017. Over the really long term, cheap and accurate long-read tech could make short-read close to obsolete.
That road map and growth potential (and ability to stave off competition down the road) was convincing enough for Illumina, which can throw large sums of capital at the cost problem to help long-read technology meet its long-term goals — if trade authorities sign off on the deal, of course.

Will the United Kingdom torpedo the acquisition?

The CMA of the United Kingdom opened an investigation into the Illumina and Pacific Biosciences deal on April 17. Under the Enterprise Act 2002, the body has the authority to review mergers in which “the two merging companies together supply or acquire at least 25% of any particular goods or services supplied in the U.K.” By definition, any acquisition by Illumina would clear that bar, and those of trade authorities in most other countries.
So why is the United Kingdom the only country putting the acquisition under the microscope? Well, the U.K. is home to Oxford Nanopore Technologies, which is developing a novel long-read sequencing platform of its own utilizing nanopore technology. There are numerous advantages to nanopore sequencing on paper, but it has to overcome cost and accuracy concerns before translating that into a market advantage.
That said, the business is quickly and quietly making progress on its promise to enable a sub-$800 human genome. By the way, that’s the straight-up cost, whereas Illumina uses depreciation in its per-genome cost calculation, and Pacific Biosciences only reports consumables expense. In fact, Oxford Nanopore’s latest technology upgrade, now available in an early access program, has achieved the same level of accuracy that prompted Illumina to acquire Pacific Biosciences in the first place: 99.999% consensus accuracy. The quick rise of nanopore sequencing was likely a significant factor in the acquisition — and that’s true for a very different reason.