Press Release: Novartis delivers continued strong -3-
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harboring alterations leading to METex14 skipping
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Tafinlar + Granted FDA accelerated approval for the treatment
Mekinist of adult and pediatric patients with unresectable
or metastatic solid tumors with BRAF V600E mutation
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Regulatory updates
Scemblix Received CHMP positive opinion for the treatment of
adult patients with Philadelphia chromosome-positive
CML in chronic phase, previously treated with two
or more tyrosine kinase inhibitors
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Results from ongoing trials and other highlights
Kisqali New CDK4/6i data at ASCO 2022, from the Ph3 MONALEESA-2
study, reinforces Kisqali as the only drug in class
with consistently proven overall survival benefit
in HR+/HER2- advanced or metastatic breast cancer.
Kisqali plus letrozole maintained an OS benefit for
postmenopausal patients with HR+/HER2- metastatic
breast cancer treated in the first-line, including
patients who required dose modification. An OS benefit
was also observed in all subgroups treated with Kisqali
and letrozole
Further follow-up of MONALEESA-3 showed Kisqali plus
fulvestrant achieved a median OS of more than five-and-a-half
years (67.6 months) in the first-line setting for
postmenopausal women living with HR+/HER2- advanced
or metastatic breast cancer. Data presented at ESMO
Breast Cancer Congress 2022
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Kesimpta New data from the Ph3 ASCLEPIOS I/II trials and ALITHIOS
open-label extension show that after four years nearly
8 out of 10 of people with relapsing multiple sclerosis
(RMS) treated continuously with Kesimpta had no evidence
of disease activity (NEDA-3), compared with 5 out
of 10 of those who switched to Kesimpta at a later
date after initial teriflunomide treatment
Zolgensma Nature Medicine publication of Zolgensma data demonstrated
nearly all children with two and three copies of the
SMN2 gene treated presymptomatically achieved age-appropriate
milestones, including sitting, standing and walking.
All children were free of respiratory and nutritional
support, and serious, treatment-related adverse events
Scemblix Scemblix showed superior efficacy with more-than-two-fold
improvement in major molecular response rate vs. Bosulif(R)
(bosutinib) at 96 weeks (37.6% vs. 15.8%). Long-term
safety remains consistent, with discontinuation rates
due to adverse events more than three times lower
in the Scemblix vs. Bosulif(R) arm (7.7% vs. 26.3%).
Data presented at the 2022 ASCO and EHA annual meetings
Tislelizumab First-line tislelizumab plus chemotherapy showed median
overall survival of 17.2 months vs. 10.6 months for
chemotherapy and reduced risk of death by 34% in patients
with advanced esophageal squamous cell carcinoma.
Data presented at ESMO World Congress on Gastrointestinal
Cancer
Tafinlar + Treatment with Taf + Mek resulted in 47% ORR vs. chemotherapy
Mekinist (11%) and reduced risk of progression or death by
69%, showing significant efficacy improvement in patients
aged 1 to 17 years old with BRAF V600 low-grade gliomas
requiring first systemic treatment. Data presented
at ASCO 2022
Kymriah In the final ELIANA analysis, 55% of patients with
relapsed or refractory B-cell acute lymphoblastic
leukemia (ALL) who were treated with Kymriah were
still alive after more than five years. 44% of patients
who experienced remission within three months of infusion
were still in remission at the five-year mark, demonstrating
the long-term benefit and curative potential of one-time
Kymriah infusion. The safety profile remained consistent
with previously reported results, without late adverse
effects in these heavily pretreated patients. Data
presented at EHA 2022
Piqray Biomarker analysis from the Ph3 SOLAR-1 study showed
Piqray plus fulvestrant has clinical benefit regardless
of the presence of ESR1 mutations and genes implicated
in CDK4/6 inhibitor resistance. Data presented at
ASCO 2022
Sabatolimab Submission in MDS is expected to be based on the ongoing
Ph3 trial as, in isolation, the Ph2 STIMULUS-MDS-1
readout is not supportive of an early submission.
Ph2 will be presented later this year
Icenticaftor Ph2b in COPD demonstrated dose response across multiple
efficacy endpoints, study results to be presented
by the end of 2022. Out-licensing planned
Capital structure and net debt
Retaining a good balance between investment in the business, a strong capital structure and attractive shareholder returns remains a priority.
During the first half of 2022, Novartis repurchased a total of 61.7 million shares for USD 5.4 billion on the SIX Swiss Exchange second trading line under the up-to USD 15 billion share buyback announced in December 2021. In addition, 1.2 million shares (for an equity value of USD 0.1 billion) were repurchased from employees. In the same period, 10.8 million shares (for an equity value of USD 0.5 billion) were delivered as a result of options exercised and share deliveries related to participation plans of employees. Novartis aims to offset the dilutive impact from equity based participation plans of employees over the remainder of the year. Consequently, the total number of shares outstanding decreased by 52.1 million versus December 31, 2021. These treasury share transactions resulted in an equity decrease of USD 5.0 billion and a net cash outflow of USD 5.2 billion.
As of June 30, 2022, net debt increased to USD 9.5 billion compared to USD 0.9 billion at December 31, 2021. The increase was mainly due to the USD 7.5 billion annual dividend payment and net cash outflow for treasury share transactions of USD 5.2 billion, partially offset by USD 4.2 billion free cash flow during the first half of 2022.
As of Q2 2022, the long-term credit rating for the company is A1 with Moody's Investors Service and AA- with S&P Global Ratings.
2022 outlook
Barring unforeseen events; growth vs. prior year in cc
Innovative Medicines Sales expected to grow mid single digit
Core operating income expected to grow mid to high
single digit, ahead of sales
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Sandoz Sales expected to grow low single digit (revised upwards
from broadly in line)
Core operating income expected to be broadly in line
with prior year (revised upwards from to decline low
to mid single digit)
Group Sales expected to grow mid single digit
Core operating income expected to grow mid single
digit
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Our guidance assumes that we see a continuing return to normal global healthcare systems, including prescription dynamics, and that no Gilenya and no Sandostatin LAR generics enter in the US.
In June 2022, an appeals court held the Gilenya US dosing regimen patent invalid. Novartis plans to petition the appeals court for further review to uphold validity of the dosing regimen patent. There is no generic competition in the US at this time. In Q2, Gilenya US sales were USD 332 million, US sales have been steadily declining due to competitive pressures.
Foreign exchange impact
If mid-July exchange rates prevail for the remainder of 2022, the foreign exchange impact for the year would be negative 6 to negative 7 percentage points on net sales and negative 7 to negative 8 percentage points on core operating income. The estimated impact of exchange rates on our results is provided monthly on our website.
Key figures(1)
Excluding Roche
income(2) Reported
Q2 Q2
Group 2022 2021 % change Q2 2021 % change
USD m USD m USD cc USD m USD cc
---------------------- ------ ------ ------- ------ ------- ---- ----
Net sales 12 781 12 956 -1 5 12 956 -1 5
---------------------- ------ ------ ------- ------ ------- ---- ----
Operating income 2 228 3 479 -36 -30 3 479 -36 -30
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As a % of sales 17.4 26.9 26.9
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Core operating income 4 270 4 345 -2 5 4 345 -2 5
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(MORE TO FOLLOW) Dow Jones Newswires
July 19, 2022 01:00 ET (05:00 GMT)
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| 08:01 | Novartis Hold | Jefferies & Company Inc. | |
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