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MarketScreener Homepage  >  Equities  >  Swiss Exchange  >  Novartis AG    NOVN   CH0012005267

NOVARTIS AG

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Novartis CEO promises to speed data integrity disclosures

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09/09/2019 | 09:41am EDT
FILE PHOTO: CEO Vas Narasimhan of Swiss drugmaker Novartis addresses the company's annual news conference in Basel

ZURICH (Reuters) - Novartis Chief Executive Vas Narasimhan, facing an uproar over data manipulation involving $2.1 million gene therapy Zolgensma, pledged on Monday to tell regulators quickly if credible questions emerge in future over data integrity.

Novartis has said it knew of discrepancies in Zolgensma data it had submitted to the U.S. Food and Drug Administration before it won approval for the world's most expensive medicine in May, but delayed informing regulators until June 28 while it completed an internal investigation.

While the FDA has concluded Zolgensma is safe and effective and should remain on the market, the U.S. drug watchdog raised questions about the timing of Novartis's disclosure. U.S. senators have also demanded the Swiss drugmaker explain why it took so long to inform the agency.

Novartis could face possible civil or criminal penalties, the FDA has said. Zolgensma treats spinal muscular atrophy, the leading genetic cause of death in infants.

"We are making a voluntary commitment to notify the FDA within five business days of receipt by our quality (control) organization of any credible allegation related to data integrity impacting any pending application in the Novartis Group," Narasimhan said at an investor event, adding Novartis will take a similar approach in other jurisdictions.

Novartis said it gave "detailed explanations" on Aug. 23 to the FDA about the company's investigation into the data manipulation, and addressed regulators' questions over why the company waited until late June to make disclosures.

The company has said it has "exited" scientists it identified in its data manipulation probe. One of those scientists, Brian Kaspar, through his lawyer, has denied wrongdoing.

During Monday's investor event on corporate governance, Narasimhan said the Basel-based company has countless instances where its employees must use judgment about how to manage potential problems that crop up with its drugs, but that the tumult surrounding Zolgensma prompted it to change its practices.

"What we realized through this situation is, during a filing, it's difficult for us to exercise that judgment without it being later considered maybe not the best judgment," Narasimhan said. "So we're just taking judgment out of that equation" with the new five-day rule.

(Reporting by John Miller; Editing by Michael Shields)

By John Miller

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DEERE & COMPANY -0.43% 220.18 Delayed Quote.28.07%
JUST GROUP PLC -1.63% 43.4 Delayed Quote.-44.15%
NOVARTIS AG -0.36% 80.5 Delayed Quote.-12.09%
SWISS RE LTD -1.81% 68.5 Delayed Quote.-35.82%
WILL GROUP, INC. 3.19% 874 End-of-day quote.-30.19%
WORLD CO., LTD. 0.48% 1475 End-of-day quote.-45.19%
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Financials (USD)
Sales 2020 49 742 M - -
Net income 2020 8 921 M - -
Net Debt 2020 18 443 M - -
P/E ratio 2020 20,1x
Yield 2020 3,91%
Capitalization 177 B 193 B -
EV / Sales 2020 3,94x
EV / Sales 2021 3,60x
Nbr of Employees 110 000
Free-Float 86,9%
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Technical analysis trends NOVARTIS AG
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TrendsNeutralNeutralNeutral
Income Statement Evolution
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Mean consensus OUTPERFORM
Number of Analysts 23
Average target price 107,32 $
Last Close Price 80,50 $
Spread / Highest target 73,6%
Spread / Average Target 33,3%
Spread / Lowest Target 1,18%
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Managers
NameTitle
Vasant Narasimhan Chief Executive Officer
Hans Jörg Reinhardt Independent Non-Executive Chairman
Harry Werner Kirsch Chief Financial Officer
John Tsai Chief Medical Officer
Elizabeth Theophille Chief Technology & Digital Officer
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