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Thursday, October 31, 2019

Juul stands accused of shipping a million contaminated vape pods

A former Juul executive is accusing the controversial company of shipping a million contaminated e-cigarette pods earlier this year and not issuing a recall, according to BuzzFeed News. The executive, Juul’s former senior vice president of global finance Siddharth Breja, has filed a lawsuit against the e-cigarette maker. Breja claims the company retaliated against him for raising concerns about the contaminated shipment and that he was fired just a week after doing so.
The lawsuit says Breja learned in an executive meeting on March 12th, 2019 that approximately 250,000 Juul mint refill kits (equivalent to one million pods) with contaminated e-liquid were shipped to retailers and sold to consumers. It goes on to say that Breja protested Juul’s refusal to issue a product recall or to at least issue a public safety notice, but former chief finance officer Tim Danaher “questioned his financial acumen” since doing so would cost the company billions of dollars.
In addition, the former exec says he protested the sale of year-old pods in February and urged Juul to add an expiration date on its packaging. Former chief executive Kevin Burns, who’s since been replaced by former Altria executive K.C. Crosthwaite, allegedly replied: “Half our customers are drunk and vaping like mo-fos, who the fuck is going to notice the quality of our pods?”
Breja’s lawyer Harmeet Dhillon told BuzzFeed News in a statement:
“Mr. Breja became aware of very concerning actions at the company, and he performed his duty to shareholders and to the board by reporting these issues internally. In exchange for doing that, he was inappropriately terminated. This is very concerning, particularly since some of the issues he raised concerned matters of public safety.”
Juul provided us with the following in response to our request for a statement:
Mr. Breja’s claims are baseless. He was terminated in March 2019 because he failed to demonstrate the leadership qualities needed in his role. The allegations concerning safety issues with Juul products are equally meritless, and we already investigated the underlying manufacturing issue and determined the product met all applicable specifications. The company will vigorously defend this lawsuit.
Juul has been under intense scrutiny over the past year for marketing campaigns critics believe were created to make the brand more attractive to teens. The company has been in the crosshairs of authorities like the FTC and the FDA, which accused it of undermining efforts to prevent teen vaping. In addition, the vaping industry has been under the microscope as a whole after the CDC revealed hundreds of cases of severe lung illnesses potentially linked to vaping.

Acute Kidney Injury Often Seen With Checkpoint Inhibitor Use

Patients receiving checkpoint inhibitor therapy often have acute kidney injury (AKI), according to a study published online Oct. 31 in the Clinical Journal of the American Society of Nephrology.
Harish Seethapathy, M.B.B.S., from Massachusetts General Hospital in Boston, and colleagues examined the frequency, severity, etiology, and predictors of AKI among patients receiving checkpoint inhibitor therapy from May 2011 to December 2016. Data were included for 1,016 patients (average age, 63 years).
The researchers found that overall, 17 percent of patients receiving checkpoint inhibitor therapy experienced AKI, defined by an increase in creatinine at least 1.5 times baseline within 12 months; 8 and 3 percent experienced sustained AKI (lasting at least three days) and had potential checkpoint inhibitor-related AKI, respectively. On average, the first episode of sustained AKI occurred 106 days after the initiation of checkpoint inhibitor therapy. Two percent of patients experienced stage 3 sustained AKI and four patients needed dialysis. An association was observed for proton pump inhibitor use at baseline with sustained AKI.
“Nephrologists must be aware of the high frequency of sustained AKI after checkpoint inhibitor therapy and the chances that such events are checkpoint inhibitor-related,” the authors write. “Accurately diagnosing these events, including the use of kidney biopsy when needed, will help ensure appropriate management of patients with AKI after checkpoint inhibitor administration.”
Several authors disclosed financial ties to the pharmaceutical industry.

Agile Therapeutics Rallies After FDA Panel Backs Contraceptive Patch

Agile Therapeutics Inc NASDAQAGRX shares were galloping higher Thursday in a notable turnaround following the precipitous drop they experienced earlier in the week.
What changed?
Agile may finally get the go-ahead for its lead asset Twirla after two unsuccessful attempts.
FDA’s Bone, Reproductive and Urologic Drugs Advisory Committee, which discussed the NDA for Twirla, voted 14-1 Wednesday that the benefits of Twirla outweigh the risks to support approval. One committee member abstained from voting.

Twirla, or AG200-15, is Agile’s investigational, once-weekly combined hormone contraceptive patch containing a type of estrogen and a type of progestin as active ingredients. It is meant to be applied once a week for three weeks, followed by a week without a patch.
The announcement took the Street by surprise, which was bracing for a negative outcome after a briefing document released ahead of the Adcom verdict relayed concerns of FDA staffers regarding Twirla’s efficacy when balanced against its safety.
The panel members were not in agreement with the company’s proposal of including a limitation based on patient weight and BMI in the product label, according to the briefing document.
“We are very pleased that BRUDAC voted in favor of Twirla. We look forward to continuing our dialogue with the FDA about the important data presented today and working toward a potential approval of Twirla,” Agile CEO Al Altomari said in a statement.
“This vote represents a key step toward providing an important new contraceptive option for women.”
The FDA has assigned a PDUFA date of Nov. 16 for Twirla.
The Twirla NDA faced rejection twice before, once in 2013 and the second time in December 2017.

New gene therapy for epilepsy shows long-term suppression of seizures

Teams of researchers from Charité — Universitätsmedizin Berlin and the Medical University of Innsbruck have developed a new therapeutic concept for the treatment of temporal lobe epilepsy. It represents a gene therapy capable of suppressing seizures at their site of origin on demand. Having been shown to be effective in an animal model, the new method will now be optimized for clinical use. Results from this research have been published in EMBO Molecular Medicine.
Epilepsy affects approximately 5 million people in Europe. The disorder is characterized by the recurrent and synchronized firing of groups of nerve cells. The propagation of these electrical discharges interrupts normal brain function and produces an epileptic seizure. The most common form of epilepsy is known as temporal lobe epilepsy (TLE), which is characterized by seizures originating in the temporal lobes. Long-term consequences of TLE can include memory problems as well as impaired learning and emotional control. Additionally, TLE patients’ quality of life is severely affected by restrictions on their ability to work, drive a car or do sports. This is further compounded by the fact that the drugs used to treat TLE patients are often unable to adequately control the disorder yet are still associated with severe side effects. For this particular group of patients, surgical removal of the temporal lobe frequently remains the only treatment alternative. However, this treatment is associated with adverse cognitive outcomes and does not guarantee that patients will remain free from seizures. Working alongside Prof. Dr. Christoph Schwarzer (Medical University of Innsbruck’s Department of Pharmacology), Prof. Dr. Regine Heilbronn (Director of the Institute of Virology on Charité’s Campus Benjamin Franklin) developed a new therapeutic concept for drug-resistant TLE.
The new treatment method is based on targeted gene therapy. This technique involves the selective delivery of a specific gene to nerve cells within the area of the brain from which the epileptic seizures originate. The gene provides the cells with the information needed to synthesize dynorphins. These are naturally produced peptides which modulate neural activity. Once the gene has been delivered into the nerve cells, it remains there permanently. The cells then start to produce and store dynorphins. Explaining the new technique’s mechanism of action, Prof. Schwarzer says: “High-frequency stimulation of the nerve cells, such as that seen at the beginning of a seizure, results in the release of stored dynorphins. Dynorphin dampens signal transduction and, as a result, the epileptic seizure doesn’t spread.” The neurobiologist and epilepsy expert goes on to add: “As the cells will only release this substance when needed, this type of gene therapy is referred to as ‘release-on-demand’.”
Using an animal model, the researchers were able to show that this gene therapy is capable of suppressing epileptic seizures for several months. Reduction of seizures also meant relief from their adverse effects on memory and learning. Moreover, no side effects have been observed so far. This is most probably due to the site-specific release of dynorphin and its short duration of action. Thanks to the substance’s on-demand delivery, there was also no evidence of drug tolerance. The researchers then went on to test their new treatment concept using tissue samples obtained from epilepsy patients. They did so with great success, as dynorphin was shown to significantly reduce the severity and frequency of synchronized nerve cell activity in human epileptic tissue.
“The results from our study are encouraging, prompting us to hope that this new therapeutic concept could also be successful in humans,” says Prof. Heilbronn. “As a transport vehicle for delivering the dynorphin gene, we are using a virus known as ‘adeno-associated virus’. This has been approved for use in humans and is considered to be safe.” Prof. Heilbronn and Prof. Schwarz hope to make this new gene therapy available for clinical use as rapidly as possible. “We are currently working on the viral vector which ferries the gene to its destination, in order to optimize it for use in humans,” explains Prof. Heilbronn. “Our aim is to have this gene therapy ready for its first ever use in a clinical trial in just a few years.” If the treatment is shown to be effective, this one-off treatment would offer a real alternative to patients on whom TLE drugs fail.

Story Source:
Materials provided by Charité – Universitätsmedizin BerlinNote: Content may be edited for style and length.

Journal Reference:
  1. Alexandra S Agostinho, Mario Mietzsch, Luca Zangrandi, Iwona Kmiec, Anna Mutti, Larissa Kraus, Pawel Fidzinski, Ulf C Schneider, Martin Holtkamp, Regine Heilbronn, Christoph Schwarzer. Dynorphin‐based “release on demand” gene therapy for drug‐resistant temporal lobe epilepsyEMBO Molecular Medicine, 2019; 11 (10) DOI: 10.15252/emmm.201809963

Medicare For All Would More Than Double Your Taxes, Bankrupt The Nation

Democratic candidates for president continue to evade questions on how they will pay for their massive, $32 trillion single-payer health care scheme. But on Monday, the Committee for a Responsible Federal Budget (CRFB) released a 10-page paper providing a preliminary analysis of possible ways to fund the left’s socialized medicine experiment.
Worth noting about the organization that published this document: It maintains a decidedly centrist platform. While perhaps not liberal in its views, it also does not embrace conservative policies. For instance, its president, Maya MacGuineas, recently wrote a blog post opposing the 2017 Tax Cuts and Jobs Act, stating that the bill’s “shortcomings outweigh the benefits,” because it will increase federal deficits and debt.
That centrist position makes CRFB’s analysis of single payer all the more devastating, because one cannot write it off as coming from a right-wing group. And its analysis is devastating, carrying it three main messages, as follows.

Everyone’s Taxes Will Go Up—a Lot

Consider some of the options to pay for single payer CRFB examines, along with how they might affect average families.
A 32 percent payroll tax increase. No, that’s not a typo. Right now, employers and employees pay a combined 15.3 percent payroll tax to fund Social Security and Medicare. (While employers technically pay half of this 15.3 percent, most economists conclude the entire amount ultimately comes out of workers’ paychecks, in the form of lower wages.) This change would more than triple current payroll tax rates.
Real-Life Cost: An individual earning $50,000 in wages would pay $8,000 more per year ($50,000 times 16 percent), and so would that individual’s employer.
A 25 percent income surtax. This change would apply to all income above the standard deduction, currently $12,200 for individuals and $24,400 for families.
Real-Life Cost: An individual with $50,000 in income would pay $9,450 in higher taxes ($50,000 minus $12,200, times 25 percent).
A 42 percent Value Added Tax (VAT). This change would enact on the federal level the type of sales/consumption tax that many European countries use to support their social programs. Some proposals have called for rebates to some or all households, to reflect the fact that sales taxes raise the cost of living, particularly for poorer families. However, using some of the proceeds of the VAT to provide rebates would likely require an even higher tax rate than the 42 percent CRFB estimates in its report.
Real-Life Cost: According to CRFB, “the first-order effect of this VAT would be to increase the prices of most goods and services by 42 percent.”
Mandatory Public Premiums. This proposal would require all Americans to pay a tax in the form of a “premium” to finance single payer. As it stands now, Americans with employer-sponsored insurance pay an average of $6,015 in premiums for family coverage. (Employers pay an additional $14,561 in premium contributions; most economists argue these funds ultimately come from employees, in the form of lower wages—but workers do not explicitly pay these funds out-of-pocket.)
Real-Life Cost: According to CRFB, “premiums would need to average about $7,500 per capita or $20,000 per household” to fund single payer. Exempting individuals currently on federal health programs (e.g., Medicare and Medicaid) would prevent seniors and the poor from getting hit with these costs, but “would increase the premiums [for everyone else] by over 60 percent to more than $12,000 per individual.”
Reduce non-health federal spending by 80 percent. After re-purposing existing federal health spending (e.g., Medicare, Medicaid), paying for single payer would require reducing everything else from the federal budget—defense, transportation, education, and more—by 80 percent.
Real-Life Cost: “An 80 percent cut to Social Security would mean reducing the average new benefit from about $18,000 per year to $3,600 per year.”
The report includes other options, including an increase in federal debt to 205 percent of gross domestic product—nearly double its historic record—and a more-than-doubling of individual and corporate income tax rates. The impact of the last is obvious: Take what you paid to the IRS on April 15, or in your regular paycheck, and double it.
In theory, lawmakers could use a combination of these approaches to fund a single-payer health care system, which might blunt their impact somewhat. But the massive amounts of revenue needed gives one the sense that doing so would amount to little more than rearranging deck chairs on a sinking fiscal ship.

Taxing Only the Rich Won’t Pay for Single Payer

CRFB reinforced their prior work indicating that taxes on “the rich” could at best fund about one-third of the cost of single payer. Their proposals include $2 trillion in revenue from raising tax rates on the affluent, another $2 trillion from phasing out tax incentives for the wealthy, another $2 trillion from doubling corporate income taxes, $3 trillion from wealth taxes, and $1 trillion from taxes on financial transactions and institutions.
Several of the proposals CRFB analyzed would raise tax rates on the wealthiest households above 60 percent. At these rates, economists suggest that individuals would reduce their income and cut back on work, because they do not see the point in generating additional income if government will take 70 (or 80, or 90) cents on every additional dollar earned. While taxing “the rich” might sound publicly appealing, at a certain point it becomes a self-defeating proposition—and several proposals CRFB vetted would meet, or exceed, that point.

Socialized Medicine Will Permanently Shrink the Economy

The report notes that “most of the [funding] options we present would shrink the economy compared to the current system.” For instance, CRFB quantifies the impact of funding single payer via a payroll tax increase as “the equivalent of a $3,200 reduction in per-person income and would result in a 6.5 percent reduction in hours worked—a 9 million person reduction in full-time equivalent workers in 2030.”
By contrast, deficit financing a single-payer system would minimize its drag on jobs, but “be far more damaging to the economy.” The increase in federal debt “would shrink the size of the economy by roughly 5 percent in 2030—the equivalent of a $4,500 reduction in per person income—and far more in the following years.”
Moreover, these estimates assume a great amount of interest by foreign buyers in continuing to purchase American debt. If the U.S. Treasury cannot find buyers for its bonds, a potential debt crisis could cause the economic damage from single payer to skyrocket.
To say single payer would cause widespread economic disruption would put it mildly. Hopefully, the CRFB report, and others like it, will inspire the American people to reject the progressive left’s march towards socialism.

Teladoc revenues, visits rise on heels of UnitedHealth contract

  • Teladoc Health’s revenue was nearly $138 million in the third quarter of this year, up 24% from the same quarter a year ago. The telehealth vendor expects full-year revenue for 2019 in the $546 million to $550 million range, according to its release Thursday after the market close.
  • Compared with a year ago, paid membership in the U.S. was up nearly 55% to 35 million for the quarter, including 15 million from UnitedHealthcare.
  • Use of the platform also grew 45% to 928,000 visits for the quarter. Teladoc expects visits to total between 3.9 million and 4.1 million for the full year.


Despite the growth, Teladoc reported a net loss for the quarter of $20.3 million, or 28 cents per share, and down from a $23.3 million loss, or 34 cents a share, a year ago. For the year, Teladoc expects the net loss-per-share to be between $1.49 and $1.43.
Analysts were bullish on the company's future. SVB Leerink's Daniel Grosslight wrote the "expected good quarter convinces us that the company has built a well-diversified, best-in-class platform that can stave off threats in an increasingly competitive market."
He pointed to catalysts on the horizon for the company, including updates on its inclusion in the UnitedHealth network, more flexible benefits being allowed in MA plans next year, uptake of the Virtual First platform and deeper penetration in the mental health and chronic care market.
Last week, the company announced the launch of Teladoc Medical Experts. The service pairs consumers with complex physical or mental-health needs with a doctor, who helps them navigate virtual and in-person care and treatment options, based on consumers' preferences and preferred networks. Growing out of Teladoc's acquisitions of Advanced Medical and Best Doctors, the service recently enrolled 100,000 employees from Nationwide Insurance and UPS, Teladoc CEO Jason Gorevic said during a quarterly earnings call with analysts.
During the call, Gorevic also touted the inroads Teladoc has made into Medicare Advantage, saying the company has inked contracts with six insurers. The contracts are a result of a final rule from CMS in April giving Medicare Advantage plans more flexibility to pay for telemedicine benefits for people treated in their homes beginning next year.
Though telehealth services have yet to fully catch on, people who have visited a provider virtually are pleased with their experience, according to a survey released this week by J.D. Power.  The survey of nearly 8,300 consumers also found that 85% of telehealth users were able to completely resolve their medical issue as a result of a virtual visit.
Large employers, however, are showing interest in the potential of telehealth to rein in costs. The National Business Group on Health estimates 51% of large employers plan to implement more virtual care tools for their employees next year.
During the call with investors, Gorevic expressed optimism about the growth prospects for telehealth and Teladoc. "As we continue to realize the benefits from our sustained, data-driven member engagement capabilities combined with the breadth of our clinical services, we are uniquely equipped to take advantage of the growing macro consumer adoption tailwinds," he said.
Teladoc also announced that Peter McClennen, president of North American hospitals and group health, will leave the company at the end of the year.

Go or no go? Agile and Lipocine hope to make it third time lucky

Smaller projects dominate the list, but this doesn’t make them any less important for November’s hopefuls.
After some huge US approvals in recent months, November is shaping up to be quieter. There are no decisions on future blockbusters set for next month, Vantage’s regular PDUFA analysis shows.
However, some of the upcoming verdicts will still be a big deal for the companies involved. This includes Agile Therapeutics and Lipocine, which hope to bounce back from complete response letters for the Twirla contraceptive patch and the testosterone replacement therapy Tlando respectively.
ProjectCompanyPDUFA dateNPV ($m)
TaliciaRedhill BiopharmaNov 241
TlandoLipocineNov 9355
Fetroja/S-649266ShionogiNov 14242
Twirla/AG200-15Agile TherapeuticsNov 16211
CenobamateSK Life ScienceNov 21
ExservanAquestive TherapeuticsNov 306
Source: EvaluatePharma.
Twirla’s chances of getting approved got a boost yesterday, with an FDA advisory committee voting 14-1 that the benefits of the projects outweigh its risks – an unexpected outcome given scathing briefing documents released on Monday. The agency questioned the patch’s efficacy, though Agile put unimpressive results from the pivotal Secure trial down to a high number of obese participants, in whom contraceptives do not work as well.
The FDA questioned Twirla’s efficacy even in non-obese women, however, and also raised doubts about whether the project is a low-dose, and therefore potentially safer contraceptive, as Agile has claimed. Shares in the company recovered today after slumping on the briefing docs, but investors’ wild ride might not be over yet.
Meanwhile, Lipocine will hope that an ambulatory blood pressure study will answer questions raised in the FDA’s May 2018 CRL. The company believes that Tlando, an oral therapy, will have an edge over injectable testosterone products. Another oral contender got the FDA nod earlier this year, Clarus Therapeutics’ Jatenzo, and Lipocine is embroiled in a legal wrangle with Clarus over intellectual property.
A project that should get a smoother ride is Shionogi’s S-649266, or cefiderocol, a novel antibiotic targeting Gram-negative pathogens. The project recently got an adcom thumbs up, with panellists voting 14-2 in favour of approval for patients with complicated urinary tract infections and limited or no alternative treatment options.
The project has also shown promise in pneumonia. Still, as with many antibiotics, especially those saved for drug-resistant infections, succeeding commercially will be trickier.
Meanwhile, Redhill Biopharma’s Talicia, which combines two antibiotics and a proton pump inhibitor, is awaiting a verdict in Helicobacter pylori infection. It has a good shot after a positive result in the Eradicate Hp2 trial, and a recent tie-up with Cosmo Pharmaceuticals should also give Redhill sufficient funds for launch.
However, sales expectations are not huge, with EvaluatePharma consensus predicting $27m in 2024.
As for potential supplementary approvals, Lilly and Boehringer hope to get cardiovascular data on the label of their DPPIV inhibitor Tradjenta. However, the product has only shown noninferiority to placebo in the Carmelina study; with other diabetes drugs like the SGLT2s and GLP1s showing cardioprotective effects, the DPPIV class has been put in the shade.
Other decisions, including a verdict on Pfizer’s Humira biosimilar, continue to be expected sometime in the fourth quarter.
The biggest regulatory event of November is not an approval but rather an advisory committee meeting, for Amarin’s Vascepa. On November 14 panellists will consider the product’s expanded use for the reduction of cardiovascular events in patients with high triglycerides; the FDA had previously been expected to make a call here in September.
EvaluatePharma consensus forecasts 2024 Vascepa sales of $2.2bn, but Leerink analysts believe that, if the drug does get expanded approval, US revenues could exceed $4bn.
ProjectCompanyEvent typeDate
TradjentaBoehringer Ingelheim/LillysNDA for cardiovascular risk reduction in type 2 diabetesNov (estimate)
Fluzone QuadrivalentSanofisBLA for influenza vaccine in pts ≥65 – high doseQ4
PF-06410293PfizerBiosimilar Humira; FDA accepted filing in Jan 2019Q4
XtandiPfizer/Astellas PharmasNDA for metastatic hormone-sensitive prostate cancerQ4
Source: EvaluatePharma.

AbbVie Q3 2019 Earnings Preview

AbbVie (NYSE:ABBV) is scheduled to announce Q3 earnings results on Friday, November 1st, before market open.
The consensus EPS Estimate is $2.30 (+7.5% Y/Y) and the consensus Revenue Estimate is $8.37B (+1.6% Y/Y).
Over the last 2 years, abbv has beaten EPS estimates 88% of the time and has beaten revenue estimates 75% of the time.
Over the last 3 months, EPS estimates have seen 8 upward revisions and 0 downward. Revenue estimates have seen 6 upward revisions and 2 downward.

Earnings before Friday’s open


Ideaya Bio up 2% after hours on advancement of lead candidate

IDEAYA Biosciences (NASDAQ:IDYAannounces that, based on FDA feedback, it will initiate a 60-subject Phase 2 single-arm clinical trial evaluating lead candidate IDE196 as monotherapy for the treatment of metastatic uveal melanoma (MUM) this quarter.
The primary endpoint will be overall response rate (ORR).
If successful, it may support a U.S. marketing application under accelerated review status.
IDE196 is a protein kinase C inhibitor in-licensed from Novartis for GNAQ- or GNA11-mutation-positive solid tumors.

Eidos Therapeutics EPS of $0.18

Eidos Therapeutics (NASDAQ:EIDX): Q3 EPS of $0.18 may not be comparable to consensus of -$0.27.
Revenue of $26.69M beats by $24.61M.

Select Medical EPS beats by $0.02, beats on revenue

Select Medical (NYSE:SEM): Q3 Non-GAAP EPS of $0.23 beats by $0.02; GAAP EPS of $0.24 beats by $0.03.
Revenue of $1.39B (+9.4% Y/Y) beats by $80M.
Shares +4.17%.

AMN Healthcare Services EPS beats by $0.08, beats on revenue

AMN Healthcare Services (NYSE:AMN): Q3 Non-GAAP EPS of $0.81 beats by $0.08; GAAP EPS of $0.49 misses by $0.09.
Revenue of $567.6M (+7.7% Y/Y) beats by $4.91M.

Bio-Rad Q3 sales up 3%, ytd cash flow up 65%

Bio-Rad Laboratories (NYSE:BIOQ3 results:
Revenue: $560.6M (+2.8%); Life Sciences: $215.7M (+4.5%); Clinical Diagnostics: $341.8M (+2.4%).
Net loss: ($258.8M) (-196.1%); non-GAAP net income:$48.6M (+76.1%); loss/share: ($8.68) (-197.6%); non-GAAP EPS: $1.61 (+76.9%).
Cash flow ops (9 mo.): $298.1M (+65.2%).
GAAP results negatively impacted by a decline of $390.6M in the market value of securities held primary related to its investment in Sartorius AG.
2019 guidance: Revenue growth: 4.0 – 4.5%.

bluebird bio EPS misses by $0.19, misses on revenue

bluebird bio (NASDAQ:BLUE): Q3 GAAP EPS of -$3.73 misses by $0.19.
Revenue of $8.91M (-22.7% Y/Y) misses by $3.56M.

CareDx EPS beats by $0.01, beats on revenue

CareDx (NASDAQ:CDNA): Q3 Non-GAAP EPS of $0.02 beats by $0.01; GAAP EPS of -$0.04 beats by $0.11.
Revenue of $33.81M (+59.6% Y/Y) beats by $0.67M.

Amgen to Collaborate With BeiGene To Expand Oncology Presence In China

Amgen to Acquire 20.5% Stake in BeiGene for Approximately $2.7 Billion in Cash
BeiGene to Commercialize XGEVA® (denosumab), KYPROLIS® (carfilzomib) and BLINCYTO® (blinatumomab) in China
Companies to Collaborate on Advancing Amgen’s Innovative Oncology Pipeline in China
Amgen Will Continue to Commercialize its Non-Oncology Product Portfolio in China
Amgen to Host Call for Investors Today at 2 p.m. PT
Amgen (NASDAQ:AMGN) announced today that it has entered into a strategic collaboration with BeiGene that will significantly accelerate Amgen’s plans to expand its oncology presence in China, the world’s second-largest pharmaceutical market. BeiGene is a research-based, oncology-focused biotechnology company with an established and highly experienced team in China, including a 700-person commercial organization and a 600-person clinical development organization.
‘This strategic collaboration with BeiGene will enable Amgen to serve significantly more patients by expanding our presence in the world’s most populous country,’ said Robert A. Bradway, Amgen’s chairman and chief executive officer. ‘Cancer is a leading cause of death in China and will only become a more pressing public health issue as the Chinese population ages. With its extensive commercial and clinical capabilities within China and a commitment to global quality standards, BeiGene is the ideal strategic collaborator as we seek to make a meaningful difference in the lives of millions of cancer patients in China and around the world.’
As part of the collaboration:
  • Amgen will acquire a 20.5% stake in BeiGene for approximately $2.7 billion in cash. This represents a purchase price of $174.85 per BeiGene American Depositary Share on NASDAQ, a 36% premium to BeiGene’s 30-day volume-weighted average share price as of Oct. 30, 2019. Amgen will nominate one person to serve on BeiGene’s Board of Directors.
  • Under the agreement, BeiGene will commercialize XGEVA® (denosumab), KYPROLIS® (carfilzomib) and BLINCYTO® (blinatumomab) in China during which time the parties will equally share profits and losses. Two of these products will revert to Amgen, one after five years and one after seven years. Following the commercialization period, BeiGene will have the right to retain one product and will be entitled to receive royalties on sales in China for an additional five years on the products not retained. XGEVA was launched in China in September of this year; KYPROLIS and BLINCYTO are both in Phase 3 trials in China.
  • Amgen and BeiGene will collaborate to advance 20 medicines from Amgen’s innovative oncology pipeline in China and globally. BeiGene will share global research and development costs and contribute up to $1.25 billion to advance these medicines. Amgen will pay royalties to BeiGene on the sales of these products outside of China, with the exception of AMG 510, Amgen’s first-in-class KRASG12C inhibitor that is being studied as a potential treatment for solid tumors. Amgen anticipates utilizing data from clinical trials conducted in China to advance the development of its oncology portfolio globally.
  • Of the 20 oncology medicines in development, BeiGene will assume commercial rights in China for seven years after launch for those that receive approval in China, including AMG 510. After this time, BeiGene will retain rights to up to six of these products in China, excluding AMG 510, while rights on remaining products revert to Amgen. Amgen and BeiGene will share profits in China equally on these products until the rights revert to Amgen, after which Amgen will pay royalties to BeiGene on sales in China for a period of five years after reversion.
  • Amgen will continue to commercialize its non-oncology product portfolio in China. Earlier this year, Amgen launched its first-ever product in China, Repatha® (evolocumab), an LDL cholesterol-lowering treatment proven to reduce the risk of heart attacks and stroke. Amgen expects to launch a number of other non-oncology medicines in China over the next several years, including Prolia® (denosumab), which reduces the risk of fracture in postmenopausal women with osteoporosis.
  • XGEVA, KYPROLIS and BLINCYTO, as well as the medicines in Amgen’s oncology pipeline, will be manufactured at Amgen’s existing facilities.
Since 2011, Amgen has expanded its geographic presence from approximately 50 to 100 countries, enabling the company to play a growing role in serving the rapidly increasing demand for better healthcare around the world. The pharmaceutical market in China is expected to grow briskly as access to new medicines continues to improve. With approximately four million people diagnosed with cancer annually and 2.3 million deaths from the disease each year, the need for new oncology treatments in China is particularly acute and the oncology market is one of the fastest-growing segments of the overall pharmaceutical market there.
Amgen will purchase its equity stake in BeiGene with available cash and expects to retain its investment grade credit rating.
‘Amgen’s capital allocation priorities remain unchanged,’ said David W. Meline, executive vice president and chief financial officer at Amgen. ‘We will continue to grow our business through internal investment and business development, while providing attractive returns to our shareholders through a growing dividend and continued share repurchases.’
The transaction is expected to close in early 2020 subject to BeiGene shareholder approval, the expiration or termination of waiting periods under all applicable antitrust laws, and satisfaction of other customary closing conditions.
Goldman Sachs & Co. LLC is acting as exclusive financial advisor, and Latham & Watkins LLP is serving as legal advisor to Amgen.
Webcast Details
Amgen will host a webcast call today at 2 p.m. PT. where members of Amgen’s executive management team will discuss the Company’s strategic collaboration with BeiGene.
Live audio webcast of the investor call will be broadcast over the internet simultaneously and will be available to members of the news media, investors and the general public.
The webcast, as with other selected presentations regarding developments in Amgen’s business given at certain investor and medical conferences, can be accessed on Amgen’s website,, under Investors. Information regarding presentation times, webcast availability and webcast links are noted on Amgen’s Investor Relations Events Calendar. The webcast will be archived and available for replay for at least 90 days after the event.

EyeGate Pharma up 22% ahead of key data readout

Thinly traded nano cap EyeGate Pharmaceuticals (EYEG +22.4%) is up on almost a 4x surge in volume, albeit on turnover of only 82K shares, on no particular news.
A key looming event is the release of data from a pivotal study evaluating its Ocular Bandage Gel eye drop in patients undergoing photorefractive keratectomy (laser surgery on the eye for vision correction). Randomization was completed a month ago with topline results expected by year-end. If all goes well, it expects to file a U.S. marketing application in H1 2020.
On the working capital front, at the end of June, it had $4.7M in cash and equivalents while operations consumed $3.6M in H1.
On October 18, it filed an S-3 for the resale of 1.2M common shares from current stockholders.

Adamis Pharma up 15% ahead of FDA decision on higher dose naloxone

Adamis Pharmaceuticals (ADMP +14.7%) is up on a 6x surge in volume as investors expect the FDA nod for higher dose naloxone for the treatment of opioid overdose. The agency’s action date is today.

Altria Cuts Value of Juul Stake by $4.5B

Altria Group Inc. wrote down its investment in Juul Labs Inc. by more than a third and now holds it at a price that values the e-cigarette maker at about $24 billion.
The Marlboro maker cited unexpected shifts in the market, including proposed U.S. bans on e-cigarette flavors and regulatory crackdowns abroad, for its decision to cut the value of its investment by $4.5 billion.
“Of course, we’re not pleased to have to take an impairment charge on the Juul investment,” the company’s chief executive, Howard Willard, said on a conference call Thursday. “We did not anticipate this dramatic a change in the e-vapor category,” he said.
Facing an accelerating decline in cigarette sales, the tobacco giant last year agreed to pay $12.8 billion for a 35% stake in Juul, making it one of Silicon Valley’s most valuable startups. Now, blamed for a rise in teenage vaping, Juul is bracing for a planned federal ban on e-cigarette flavors that represent more than 80% of its U.S. sales.
The embattled company plans to cut between 400 and 600 jobs by the end of the year as part of a reorganization aimed at mending damaged relationships with regulators, The Wall Street Journal reported on Monday.
Altria on Thursday also lowered its profit growth forecast for the next three years to a range of 5% to 8%, down from its previous forecast of 7% to 9%.
Altria executives said they now expect lower e-cigarette industry sales volumes and a longer time before Juul reaches a profit margin comparable to combustible cigarettes.
The number of adult e-cigarette users in the U.S. rose to 12.6 million in September, including six million who vaped exclusively, Mr. Willard said.
The Marlboro maker aims to offer a menu of cigarette alternatives, Mr. Willard said, including a tobacco-free nicotine pouch in which Altria recently invested and a heated tobacco device that Altria launched in the U.S. in September through a partnership with Philip Morris International Inc. That device, called IQOS, is currently available in Atlanta and will go on sale in Richmond, Va., next month, Altria said.
The company said it supports Juul’s planned staff cuts and its new leadership. Juul’s CEO, K.C. Crosthwaite, left Altria in September to run the startup.
Hedge fund Darsana Capital Partners recently wrote down its investment in Juul by more than a third, valuing the company at $24 billion. And Fidelity Investments this week disclosed that it had slashed the value of its Juul investment by nearly half to a price that valued the startup at around $20 billion.
“One stock decision in particular hurt by far more than any other: electronic cigarette maker Juul Labs,” Fidelity’s Blue Chip Growth Fund said in its quarterly fund commentary. “Juul’s valuation…fell this period as the company faced myriad regulatory challenges.”
The fund cited the Food and Drug Administration’s plan to remove from the market all e-cigarettes except those formulated to taste like tobacco, as well as a formal rebuke the agency sent Juul in September for making unauthorized claims that its products were safer than traditional cigarettes.
The Wall Street Journal calculated the valuation of about $20 billion assuming the fund hadn’t bought or sold any Juul shares since the end of July. Bloomberg earlier reported Fidelity’s write-down.
Juul is the subject of several investigations, including a criminal probe by federal prosecutors in California. By May, the company must submit for FDA review any products it wants to remain on the U.S. market beyond that point.
Juul’s sales have fallen since the Centers for Disease Control and Prevention in September warned the public to stop using e-cigarettes as it investigated a mysterious vaping-related lung illness. The agency has since narrowed that warning, advising people not to vape THC, the psychoactive ingredient in cannabis. Juul’s products haven’t been linked to the illness.
Shares of Altria rose 1.2% in morning trading Thursday.

Vyndaqel romps away in US, spurring earnings hike from Pfizer

Pfizer’s new drug for a rare heart disease – Vyndaqel – has shattered analysts’ sales forecasts in its first quarter on the market and looks set to quickly enter blockbuster territory.
Five months since becoming the first drug to be approved by the FDA for wild-type or hereditary transthyretin amyloid cardiomyopathy (ATTR-CM), Vyndaqel (tafamidis) has made $156 million in the third quarter, $77 million from the US.
Vyndaqel has previously been approved in European markets and Japan but not the US for hereditary transthyretin amyloid polyneuropathy (ATTR-PN), and while sales in that indication have been modest to date other approvals in ATTR-CM contributed to the drug’s growth.
The sales surge has come from the current four capsules-per-day formulation of the drug, with a one-pill-a-day version – called Vyndamax – launched in September that could further stimulate sales growth.
Previously, analysts said they were expecting Vyndaqel to top $1 billion in sales in 2024, but it seems that Pfizer’s drug is going to beat that timeframe on the back of rising rates of diagnosis helped by a shift from a biopsy approach to a non-invasive imaging technique called scintigraphy.
Vyndaqel’s gathering momentum – coupled with a 25% increase in sales of Pfizer’s blood cancer therapy Ibrance (ibrutinib) to $1.28 billion – helped Pfizer post better-than-expected third-quarter revenues of $12.7 billion.
Sales were down 5% overall in the quarter as Pfizer weathered the loss of patent protection and the start of generic competition for big-selling pain drug Lyrica (pregabalin), which dragged sales of its Upjohn division – due to be spun off and combined with Mylan – down 26%.

Nevertheless, Pfizer chief executive Albert Bourla said revenues for the full-year will now rise by mid-to-high single digits from an earlier prediction of low-to-mid single digits, with its forecast up by $700 million to $51.2-$52.2 billion.
The raised forecast is down to the performance of Vyndaqel and Ibrance but also other drugs including arthritis drug Xeljanz (tofacitinib), anticoagulant Eliquis (apixaban) and Inlyta (axitinib), which have benefited from approvals in combination with cancer immunotherapies for renal cell carcinoma.
That includes a dual regimen with Pfizer’s PD-1 inhibitor Bavencio (avelumab) approved by the European Commission this week for newly-diagnosed RCC, which came after an FDA approval for the combination earlier this year. Sales of Inlyta almost doubled to $139 million in the third quarter.
On a conference call, Bourla said the reshaped Pfizer that will follow the spin-off of Upjohn and the creation of a consumer health joint venture with GlaxoSmithKline will result in a leaner company that will be able to return annual growth of 6% over the next five years.
The company will not need to consider a big M&D deal, he added, and the business development strategy “will continue to be bolt-on, but we’ll have a focus on R&D” in particular phase 2 assets.