October 22, 2019 / 6:08 AM / 23 days ago

BRIEF-Novartis says Zolgensma delay in Europe, Japan due to manufacturing questions from regulators

Oct 22 (Reuters) - Novartis AG:

* SANDOZ Q3 OPERATING INCOME WAS USD 191 MILLION (-47%, -42% CC) IMPACTED BY CHANGES IN LEGAL SETTLEMENT PROVISIONS, HIGHER NET MANUFACTURING AND SANDOZ TRANSFORMATION RESTRUCTURING EXPENSES AND LOWER DIVESTMENT INCOME

* SAYS SANDOZ US DERMATOLOGY BUSINESS AND US ORAL SOLIDS PORTFOLIO SALE TO AUROBINDO PHARMA USA INC EXPECTED TO BE COMPLETED IN THE COMING MONTHS, PENDING REGULATORY APPROVAL

* SAYS MAYZENT Q3 SALES $4 MILLION

* CEO VAS NARASIMHAN SAYS AUROBINDO SALE COMPLETION STILL EXPECTED FOR 2019

* CEO VAS NARASIMHAN SAYS PRIMARY GOAL IS TO INVEST IN BUSINESS, LOOK FOR BOLT-ON M&A, INCREASING DIVIDEND AFTER COMPLETION OF SHARE BUYBACK

* CEO VAS NARASIMHAN SAYS ROUGHLY 50% OF ZOLGENSMA PATIENTS SWITCHED FROM ANOTHER THERAPY

* CEO VAS NARASIMHAN SAYS CONTINUES TO LOOK FOR EXTERNAL BIOSIMILAR OPPORTUNITIES TO BOOST PORTFOLIO

* CEO VAS NARASIMHAN SAYS PRIMARY REASON FOR ZOLGENSMA DELAY IN EUROPE, JAPAN TO 2020 RELATED TO MANUFACTURING QUESTIONS

* CEO VAS NARASIMHAN SAYS NOTHING IN DOCUMENTS FROM EUROPEAN, JAPANESE REGULATORS THAT RESULTED IN ZOLGENSMA DECISION DELAY FOCUSED ON U.S. DATA MANIPULATION ISSUE

* CEO VAS NARASIMHAN SAYS 99% OF POTENTIAL ZOLGENSMA PATIENTS GETTING THERAPY, PATIENTS ARE GETTING TREATMENT WITHIN 30 DAYS

* CEO VAS NARASIMHAN SAYS HAS NOT SEEN UPTAKE IN INSTALLMENT BASED PAYMENTS FOR ZOLGENSMA

* CEO VAS NARASIMHAN SAYS RISKS FOR UPCOMING QUARTERS INCLUDE EXECUTING ON LAUNCHES, “FEELS GOOD ABOUT WHERE WE ARE” WITH LAUNCHES

* CEO VAS NARASIMHAN SAYS HAS NOT SEEN FACTS OR EVIDENCE ON “RUMORS” OF POSSIBLE U.S. TARIFFS ON SWISS DRUG PRODUCTS

* CEO VAS NARASIMHAN SAYS HAS NOT RECEIVED FURTHER CORRESPONDENCE FROM FDA, U.S. SENATE REGARDING ZOLGENSMA DATA MANIPULATION

* CEO VAS NARASIMHAN SAYS KNEW MAYZENT UPTAKE WOULD BE SLOW, SAYS INLINE WITH EXPECTATIONS Source text for Eikon: Further company coverage: (Reporting by John Miller)

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