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Monday, September 2, 2019

HealthEquity Q2 2020 Earnings Preview

HealthEquity (NASDAQ:HQY) is scheduled to announce Q2 earnings results on Tuesday, September 3rd, after market close.
The consensus EPS Estimate is $0.35 (+2.9% Y/Y) and the consensus Revenue Estimate is $85.28M (+20.0% Y/Y).
Over the last 2 years, HQY has beaten EPS estimates 88% of the time and has beaten revenue estimates 100% of the time.
Over the last 3 months, EPS estimates have seen 2 upward revisions and 4 downward. Revenue estimates have seen 6 upward revisions and 0 downward.

Lilly’s generic insulin not widely used yet

While Eli Lilly’s generic insulin has been approved since March, a significant portion of prescription claims are still for its brand-name counterpart, Humalog, according to an analysis from drug price tracker GoodRx.
Generic insulin lispro’s list price is more than 65 percent cheaper than Humalog at $265 for a pack of five pens. Still, GoodRx found only 8 percent of prescription fills are for generic insulin lispro, while the majority are still for Humalog.
“This low fill count is likely a result of shortages of the medication in certain areas and spotty insurance coverage,” according to GoodRx.
Comparatively, drugmaker Sanofi recently lowered the price of its insulin drug Admelog by 46 percent. It is now more affordable than even generic Humalog.
Read more here.

ESC: Most cardio events avoidable with small blood pressure, cholesterol cuts

The majority of heart attacks, strokes, and deaths from heart disease can be prevented with modest and sustained decreases in blood pressure and cholesterol. The late breaking results are presented in a Hot Line Session today at ESC Congress 2019 together with the World Congress of Cardiology(1) and published in the Journal of the American Medical Association.(2)
Principal investigator Professor Brian Ference of the University of Cambridge, UK said: “Healthy eating and physical activity are effective ways to improve cardiovascular health. The best diet or exercise programme differs for each person. It is the one that produces the greatest reductions in both blood pressure and cholesterol for that person AND to which he or she can adhere because the benefits of the reductions accrue overtime.”
The study found that long-term exposure to the combination of both lower low-density lipoprotein cholesterol (LDL-C) and lower systolic blood pressure (SBP) was linked with independent and additive reductions in the lifetime risk of cardiovascular disease.
The relationship was dose-dependent, meaning that any combination of lower LDL-C and lower SBP was associated with a corresponding reduction in lifetime risk.
The study shows that even small declines in LDL-C and SBP can substantially diminish the likelihood of ever having a heart attack or stroke. For example, the combination of 0.3 mmol/L (14 mg/dL) lower LDL-C and 5 mmHg lower SBP was associated with a 50% lower lifetime risk of cardiovascular disease.
Prof Ference said: “These small modifications in LDL-C and SBP are the kind of changes that can be achieved by eating healthily such as the DASH diet3 or similar diets.”
Larger reductions in LDL-C and SBP with more aggressive lifestyle changes or other therapies to achieve the combination of 1 mmol/L (38.67 mg/dL) lower LDL-C and 10 mmHg lower SBP can reduce lifetime risk of cardiovascular disease by 80% and reduce lifetime risk of cardiovascular death by more than two-thirds (68%).
The study included 438,952 participants of the UK Biobank who experienced a total of 24,980 major coronary events (defined as the first occurrence of non-fatal heart attack, ischaemic stroke, or coronary death).  The average age was 65.2 years (range: 40.4 to 80.0) and 54% were female.
The researchers used genetic variants linked with lower LDL-C and SBP as instruments to randomly divide participants into groups with lifetime exposure to lower LDL-C, lower SBP, or both as compared to a reference group using a 2×2 factorial design. They then compared the differences in plasma LDL-C, SBP and cardiovascular event rates between the groups to estimate associations with lifetime risk of cardiovascular disease.
Prof Ference said: “It is important to encourage patients and populations to invest in their future health.  Maintaining even small reductions in both LDL-C and SBP for prolonged periods of time can pay very big health dividends by dramatically reducing the lifetime risk of cardiovascular disease.”

ESC: Bypass surgery, coronary stenting yield comparable 10-year survival

Ten-year survival rates are similar for bypass surgery and coronary stenting with drug-eluting stents in randomised patients with de novo three-vessel and left main coronary artery disease, according to late breaking results from the SYNTAX Extended Survival study presented in a Hot Line Session today at ESC Congress 2019 together with the World Congress of Cardiology (1) and published in The Lancet. (2)
Prespecified subgroup analyses showed that surgery provided a survival benefit in patients with three-vessel disease and more complex coronary artery disease, while no treatment differences were found in patients with left main disease.
Ischaemic heart disease is the top cause of death globally. Percutaneous coronary intervention (PCI) and coronary artery bypass grafting (CABG) are options for patients requiring revascularisation. European guidelines advise discussing these patients in a multidisciplinary Heart Team. (3)
Individual randomised trials comparing PCI with drug-eluting stents and CABG have not shown a survival benefit for either therapy at mid-term follow-up (e.g. up to five years). The SYNTAX trial was the first large-scale multicentre, randomised study in patients with de novo three-vessel and left main coronary artery disease that underwent PCI with drug-eluting stents or CABG. When clinical equipoise between PCI and CABG was presumed by the Heart Team, 1,800 patients were randomly assigned to PCI with paclitaxel-eluting stents (n=903) or CABG (n=897). Survival curves started to diverge after one-year follow-up(4) and continued to diverge up to five years, but without reaching statistical significance. (5)
The SYNTAX Extended Survival (SYNTAXES) study examined 10-year all-cause death rates in patients with de novo three-vessel and left main coronary artery disease randomised to PCI with drug-eluting stents or CABG in the SYNTAX trial. All 85 SYNTAX sites from 18 North American and European countries were contacted to provide survival data, which was obtained from healthcare records and national death registries. Completeness of follow-up was achieved in 94% of patients and was well-balanced between the CABG and PCI arms.
At 10-year follow-up, there was no survival difference between PCI with drug-eluting stents and CABG in the overall cohort of patients. There were 244 deaths after PCI and 211 after CABG (hazard ratio [HR] 1.17; 95% confidence interval [CI] 0.97–1.41; p=0.092).
When analyses were conducted according to prespecified subgroups, CABG provided a 10-year survival benefit over PCI in patients with three-vessel disease (151 deaths after PCI versus 113 after CABG; HR 1.41; 95% CI 1.10–1.80; p=0.006). CABG also provided a survival benefit in patients with increasingly complex coronary artery disease (defined by higher SYNTAX scores) – this was observed in the overall cohort and in those with three-vessel disease. In the subgroup of patients with left main coronary artery disease, no survival differences existed between PCI and CABG (93 patients died after PCI versus 98 after CABG; HR 0.90; 95% CI 0.68–1.20; p=0.47). This resulted in a treatment-by-subgroup interaction according to the presence or absence of left main coronary artery disease (p for interaction=0.019). Furthermore, CABG and PCI resulted in comparable 10-year survival in patients with and without diabetes.
First author Dr Daniel Thuijs of the Erasmus University Medical Centre, Rotterdam, the Netherlands said: “The SYNTAX Extended Survival study presents robust, clinically relevant, and complete 10-year randomised survival data and can aid a multidisciplinary Heart Team discussion in the process of deciding on the optimal treatment strategy for a patient with coronary artery disease requiring revascularisation.”

Biotech week ahead, Sept. 3

The biotech space saw muted activity in the week ended Aug. 30. Among the notable news of the week: Amgen, Inc. AMGN 0.79%‘s $13.4-billion deal to buy the psoriasis drug Otezla from Celgene Corporation CELG 0.32% and Johnson & Johnson JNJ 0.11%‘s $572-million settlement agreement with the state of Oklahoma in an opioid lawsuit.

Plus Therapeutics Inc PSTV 8.74%, which previously went by the name Cytori, was among the top performers in the biotech space, advancing in excess of 200% — with no clear catalyst driving the rally.
The following are key catalysts for biotech investors to watch in the unfolding week.

Conferences

  • European Society of Cardiology, or ESC, Congress 2019: Aug. 30-Sept. 4 in Paris, France.
  • Society for the Study of Inborn Errors of Metabolism, or SSIEM, Annual Symposium 2019: Sept. 3-6 in Amsterdam, Netherlands.
  • International Meeting on Dermatopathology & Skin Care: Sept. 4-5 in Paris.
  • Citi 14th Annual Biotech Conference: Sept. 4-5 in Boston, Massachusetts.
  • 2019 Wells Fargo Healthcare Conference: Sept. 4-5 in Boston.
  • Baird’s 2019 Global Healthcare Conference: Sept. 4-5 in New York City.
  • 4th International Congress on Addictive Behavior and Dual Diagnosis: Sept. 5-6 in Budapest, Hungary.
  • International Association for the Study of Lung Cancer, or IASLC, 2019 World Conference: Sept. 7-10 in Barcelona, Spain.

PDUFA Dates

The FDA is set to rule on Roche Holdings AG Basel ADR RHHBY 0.18%‘s Tecentriq along with chemotherapy as first-line treatment of metastatic non-squamous non-small cell lung cancer in patients who do not have EGFR or ALK genomic tumor aberrations. The PDUFA date is set for Monday, Sept. 2.

Clinical Trial Readouts

ESC Congress Presentations
AstraZeneca plc AZN 0.91%: already released Phase 3 data for Farxiga in heart failure as well as already released Phase 3 data for Brilinta in Type 2 diabetes (both scheduled for Sept. 1).
PhaseBio Pharmaceuticals Inc PHAS 2.92%: Phase 1 data for PB2452 as a reversal agent for AstraZeneca’s ticagrelor.
Alnylam Pharmaceuticals, Inc. ALNY 2.06% and The Medicines Company MDCO 2.4%: already released Phase 3 data for inclisiran that is being evaluated in a Phase 3 trial dubbed ORION 10 for atherosclerotic cardiovascular disease (Sept. 2).
SSIEM Annual Symposium Presentations
Aeglea Bio Therapeutics Inc AGLE 1.5%: Phase 1/2, 20-week repeat dose data for pegzilarginase in arginase 1 deficiency (Sept. 3).
Orchard Therapeutics PLC – ADR ORTX 2.99%: Phase 2 data for OTL-200 in metachromatic leukodystrophy (Sept. 4).
Synlogic Inc SYBX 6.69%: Full Phase 2 data for SYNB1619 in phenylketonuria (Sept. 4).
Mid-2019 Readouts
AnaptysBio Inc ANAB 1.65%: Phase 2 data for ANB019 in generalized pustular psoriasis.
Akcea Therapeutics Inc AKCA 0.99% and Ionis Pharmaceuticals Inc IONS 1.39%: Phase 2 pilot study data for AKCEA-ANGPTL3-LRx in rare hyperlipidemias.

Earnings

Tuesday
Zai Lab Ltd ZLAB 1.3%
Thursday
PAVmed Inc PAVM 1.06%

Roche’s Xofluza shows treatment benefit in young kids

Roche (OTCQX:RHHBYannounces positive results from a Phase 3 clinical trial, MINISTONE-2, evaluating a single dose of an oral suspension formulation of Xofluza (baloxavir marboxil) for the treatment of influenza in otherwise healthy children aged one to less than 12 years old. The data were presented at the OPTIONS X congress in Singapore.
The study met the primary endpoint of a statistically significant proportion of participants with adverse events (AEs) or severe AEs up to day 29, demonstrating a safety profile consistent with the tablet formulation. Efficacy was comparable to Tamiflu (oseltamivir phosphate). Specifically, 46.1% of children receiving oral suspension Xofluza experienced at least one treatment-emergent AE versus 53.4% in the oseltamivir arm.
Xofluza reduced viral shedding (the period when the virus is actively reproducing) by more than two days compared to oseltamivir (median of 24.2 hours vs. median of 75.8 hours).
Key secondary endpoints were also met.
The FDA approved the tablet formulation of Xofluza in October 2018 for patients at least 12 years old. It was discovered by Shionogi (OTCPK:SGIOY). Roche owns global rights except Japan and Taiwan.

China expands drug bulk-buy program, puts pressure on pharma firms

China has expanded a pilot drug bulk-buying program to almost the entire country in an attempt to negotiate lower prices from drug manufacturers, heaping fresh pressure on multinational pharmaceutical companies and their domestic rivals.

The program rolled out last year saw 11 Chinese cities, including Beijing and Shanghai, band together behind a tender process to bulk-buy 25 types of drugs. This caused the price of some medicines to plunge over 90%, state news agency Xinhua said.
The scheme will be expanded to 25 provinces and regions, who will form a league to look for suppliers for these drugs that will be stocked at public hospitals as well as some military and private medical institutions, according to documents released on Sunday by the drug procurement branch of the Shanghai Healthcare Security Administration.
The drugs on the list include off-patent blockbusters that are made by Western pharmaceutical giants, but which have generics made by local players, such as Eli Lilly’s cancer treatment drug Pemetrexed, which is sold under the brand name Alimta, and leukaemia therapy Imatinib sold by Novartis as Gleevec.
The tenders for the two drugs in last year’s pilot program were won by Chinese drugmakers’ generic products.
Beijing’s nationwide expansion measure could add strains on multinational drugmakers to consider larger price cuts for their off-patent blockbusters, a move that they have tended to refrain from in order to maintain their premium brand image, analysts said.
The documents also cited that as many as three winners of the tender for each drug could obtain as much as 70% share of the government’s purchase volumes, while the sole winner of a tender could win up to a 50% share of purchase volumes.
Under the new expansion plan, only the provinces of Fujian and Hebei are not involved in the program on mainland China.
“The 11 cities [in the previous pilot program] accounted for a relatively low market share in China,” John Yung, head of Asia healthcare research at Citi, told Reuters. “But as for the 70% market in the entire nation, the pressure is different.”
Novartis and Eli Lilly offered to cut prices for Gleevec and Pemetrexed by about 30% in some provinces earlier this year, according to releases on local governments’ drug procurement websites.