Q2 sales growth from Sanofi Genzyme, Sanofi Pasteur, Emerging Markets

• Net sales were €8,628 million, up 5.5% on a reported basis, up 3.9%⁽³⁾ at CER and up 5.8% at CER/CS⁽⁴⁾.
• Sanofi Genzyme sales up 21.8% due to strong launch performance of Dupixent^®.
• Vaccines sales increased 24.7% mainly reflecting the recovery and growth of Pentaxim^® in China and low basis for comparison.
• CHC sales up 1.1%, as U.S. growth more than offset lower sales in Europe impacted by non-strategic brand divestments.
• Primary Care GBU sales declined 10.4% at CER/CS mainly as a result of lower Diabetes sales.
• Emerging Markets sales⁽⁵⁾ grew double-digits (up 10.0%) supported by higher Vaccines and Rare Disease sales.

2019 business EPS guidance revised upward 

• Q2 2019 business net income increased 5.3% to €1,641 million and 4.9% at CER.
• Q2 2019 business EPS⁽¹⁾ up 4.8% at CER to €1.31.
• Q2 2019 IFRS EPS was -€0.07 (-115.5%) reflecting a €1.8 billion impairment charge mainly related to Eloctate^®.
• Business EPS⁽¹⁾ in 2019 is now expected to grow approximately 5% at CER⁽⁶⁾ barring unforeseen major adverse events. Applying the average July 2019 exchange rates, the currency impact on 2019 business EPS is estimated to be between 1% and 2%.

Key regulatory milestones achieved in R&D

• Isatuximab accepted for review by the FDA and EMA for approval in relapsed/refractory multiple myeloma.
• Libtayo^® approved for advanced cutaneous squamous cell carcinoma in the EU.
• Dupixent^® recommended by CHMP for atopic dermatitis in adolescents.
• Dupixent^® approved in the U.S. for chronic rhinosinusitis with nasal polyposis.
• FDA accepted for review MenQuadfi^TM, a meningococcal vaccine candidate.

https://www.marketscreener.com/SANOFI-4698/news/Sanofi-delivered-solid-growth-in-Q2-2019-28973612/

FDA, EMA Grant GENFIT’s Elafibranor Orphan Drug Status

GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to the discovery and development of innovative therapeutic and diagnostic solutions in metabolic and liver related diseases, today announced that the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have both granted Orphan Drug Designation to elafibranor, a PPAR alpha/delta agonist, for the treatment of PBC.

PBC is a cholestatic liver disease, wherein bile ducts become damaged leading to scarring of liver tissue or cirrhosis. The causes are still unknown. This disease mainly affects women, and many patients cannot benefit from existing therapies, representing a significant unmet medical need.

Elafibranor, in a Phase 2 placebo-controlled trial in PBC patients with inadequate response to UDCA, clearly showed statistical significance on achieving the primary endpoint of reducing ALP versus placebo. Beneficial effects in patients also included improvements in cholestatic markers (GGT, 5’), lipid markers (total cholesterol, LDL, and triglycerides) and anti-inflammatory markers (IgM, CRP, haptoglobin and fibrinogen). These improvements are consistent with the results from the Phase 2b clinical trial evaluating elafibranor in NASH, and essential when treating a cholestatic disease such as PBC, or when treating NASH which is considered as the liver manifestation of the metabolic syndrome.

https://www.marketscreener.com/GENFIT-16311755/news/GENFIT-FDA-and-EMA-Grant-GENFIT-s-Elafibranor-Orphan-Drug-Designation-for-Primary-Biliary-Cholangit-28973734/

GlaxoSmithKline: ViiV submits cabotegravir to EMA for HIV injection

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer Inc. and Shionogi Limited as shareholders, today announced the submission of a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for the investigational, once-monthly, injectable cabotegravir, which will be used in combination with Janssen’s once-monthly, injectable rilpivirine to treat HIV-1 infection in adults whose viral load is suppressed and who are not resistant to cabotegravir or rilpivirine. The application also includes data for cabotegravir oral tablets, intended for use as oral lead-in therapy prior to the commencement of injectable therapy.

Deborah Waterhouse, CEO of ViiV Healthcare, said: ‘ViiV Healthcare is proud to be sending a regulatory submission to the EMA for what will be a first-of-its-kind treatment. If approved, this long-acting, injectable regimen of cabotegravir and rilpivirine has the potential to give people living with HIV one month between doses with similar safety and efficacy as today’s standard of care – an oral, 3-drug regimen taken every day. We are excited to be one step closer to delivering this long-acting therapy to patients in Europe.’

The submission is based on the global ATLAS (Antiretroviral Therapy as Long-Acting Suppression) and FLAIR (First Long-Acting Injectable Regimen) pivotal phase III studies that included more than 1,100 patients from 16 countries and demonstrated the combination of cabotegravir and rilpivirine, injected monthly, was as effective as a daily, oral, 3-drug regimen in maintaining viral suppression throughout the 48-week study period. The ATLAS and FLAIR studies are part of ViiV Healthcare’s innovative clinical trial programme for 2-drug regimens (2DRs).

Kimberly Smith, M.D., Head of Global Medical Research and Strategy at ViiV Healthcare, said: ‘This regulatory submission supports ViiV Healthcare’s commitment to developing new and innovative options for people living with HIV to manage their virus. We are proud to be at the forefront of this innovation for patients by potentially changing the frequency of therapy from 365 days per year to just 12.’

This application to the EMA follows the recent submission of a New Drug Application (NDA) for the 2DR of cabotegravir and rilpivirine, as well as cabotegravir oral tablets, to the US Food and Drug Administration (FDA) in April 2019. In June, this submission was granted a Priority Review Designation by the FDA with an expected action date of December 29, 2019. ViiV Healthcare and Janssen also plan to submit additional regulatory applications for cabotegravir and rilpivirine to other regulatory agencies in the coming months.

https://www.marketscreener.com/GLAXOSMITHKLINE-9590199/news/GlaxoSmithKline-ViiV-submits-cabotegravir-to-EMA-for-HIV-injection-28973811/

Siemens Healthineers flags challenges at diagnostics unit

 Siemens Healthineerson Monday flagged problems at its diagnostics business and toned down expectations for its Atellica blood and urine testing machines, adding that the head of the division would leave the company.

The German health technology firm is pinning its hopes on the Atellica machine to turn around its In-Vitro diagnostics business which lags market leader Roche, but lengthy installation times at large and complex laboratories have dragged down profit in the division.

“We are facing challenges in the diagnostics business,” Chief Executive Bernd Montag said.

“We are tackling these issues resolutely and are focusing with our outstanding Atellica Solution Platform vigorously on improving growth and earnings strength,” Healthineers said.

Montag will take on responsibility for the diagnostics business as current head Michael Reitermann will leave the company at the end of September, it said.

Healthineers said it expects to ship about 1,800 Atellica machines this year, down from a previous estimate of 2,200-2,500, while upgrades to the system have led to higher costs in the third quarter.

The company in May said measures to improve the roll-out of its new blood and urine testing machines were bearing fruit, and shipments went up to 450 machines in the third quarter from 410 in the previous three months.

But while orders from Europe and Asia were on track, the U.S. market lagged expectations, Healthineers said, and profits at the unit were pressured by higher costs.

Overall, strong sales of medical imaging equipment helped Healthineers post better-than-expected quarterly revenue and earnings growth.

Net profit surged 20% to 353 million euros (£317.6 million) in April-June, beating analysts’ average expectations of 328 million euros.

The profit margin dropped from 16% to 15.2% but the company maintained its outlook for a 17.5-18.5% profit margin in its 2019 fiscal year, with 4-5% sales growth.

Comparable sales growth was 6% in the third quarter, also beating market expectations.

https://www.marketscreener.com/SIEMENS-HEALTHINEERS-42379342/news/Siemens-Healthineers-flags-challenges-at-diagnostics-unit-28973603/

Sanofi reports Q2 results

Sanofi (NASDAQ:SNY): Q2 Non-GAAP EPS of €1.31; GAAP EPS of -€0.07.

Revenue of €8.63B (+5.5% Y/Y)

Press Release

https://seekingalpha.com/news/3482568-sanofi-reports-q2-results

UnitedHealth’s Optum To Take Over Cal. Health System’s Non-Clinical Operations

UnitedHealth Group’s Optum is taking over a California health system’s information technology and back office functions as part of a new model that will allow the healthcare giant to manage “all non-clinical work” for a local medical provider.

The deal announced mid-month will allow Optum to take on John Muir Health’s key “nonclinical functions” including information technology, revenue cycle management, analytics, purchasing and claims management of a healthcare system that boasts a network of more than 1,000 physiciansand two large hospitals east of San Francisco.

Financial terms of the deal aren’t being disclosed by UnitedHealth nor its Optum health services business. But there will be a cost to Optum and UnitedHealth because about 540 John Muir Health employees, or nearly 10% of the health system’s workforce, will become part of Optum.

The arrangement is a different kind for Optum, which has been buying up doctor practices, outpatient clinics, surgery centers and urgent care facilities across the country.

In an era of rapid healthcare consolidation, health systems like John Muir have limited options, Optum executives reason. They could remain independent, merge or be sold, or work this new kind of arrangement Optum is floating to medical care providers that executives say gives the health system greater scale to potentially reduce costs by handing off administrative functions to the larger Optum and its expertise.

“This relationship with John Muir Health is an innovative new model for independent, community-based health systems across the country that want to maintain their independence while reducing cost pressures,” Optum senior vice president Nick Howell said. “John Muir Health is now in an even stronger position to advance quality care and experiences for patients while Optum brings an extensive set of capabilities including operational technologies, revenue cycle management and analytic solutions.”

Optum said all “C-level employees will remain” with John Muir Health, which retains all “care delivery, corporate, facilities, hospital and clinic operations, nursing, physician, finance, marketing and strategy.”

Insiders at UnitedHealth and Optum see the deal as an emerging trend for the future as medical care providers integrate, particularly as rivals are wheeling and dealing to keep up in an escalating battle in the healthcare industry to put providers of medical care under the same umbrella as health insurance companies.

Pharmacy giant CVS Health last year bought Aetna, the nation’s third-largest health insurer; Cigna last year bought the PBM Express Scripts; insurer Humana has been signing deals with multiple providers in the home care, hospice and drugstore space while big Blue Cross and Blue Shield plans including Anthem and Health Care Service Corp. are investing in primary care doctor practices and outpatient clinics.

“Optum’s expertise and capabilities will help us expand upon the high-quality patient care we provide to the Bay Area community,” John Muir Health president and chief executive Cal Knight said. “We are committed to remaining independent while embracing partnerships that help us grow, and serve more patients.”

https://www.forbes.com/sites/brucejapsen/2019/07/17/unitedhealths-optum-to-run-california-health-systems-non-clinical-operations/#1eb1cd2f7dc9

Key events this week – healthcare

Noteworthy events during the week of July 28 – August 3 for healthcare investors.

MONDAY (7/29): American Heart Association Basic Cardiovascular Sciences Scientific Sessions, Boston (2 days). Cytokinetics (NASDAQ:CYTK): Preclinical data on CK-3773274.

TUESDAY (7/30): Radiation Injury Treatment Network Workshop, Arlington, VA (2 days). Pluristem Therapeutics (NASDAQ:PSTI): Data on PLX-R18 as a countermeasure against acute radiation syndrome.

WEDNESDAY (7/31): Mylan NV (NASDAQ:MYL): Investor Day, NYC.

SATURDAY (8/3): FDA action date for Daiichi Sankyo‘s (OTCPK:DSKYF) pexidartinib for tenosynovial giant cell tumor not amenable for surgical resection.

https://seekingalpha.com/news/3479323-key-events-week-healthcare