NVS Novartis AG

83.1
+0.05  (+0%)
Previous Close 83.05
Open 83.19
52 Week Low 77.04
52 Week High 98.52
Market Cap $185,873,013,975
Shares 2,236,739,037
Float 2,236,739,037
Enterprise Value $215,733,688,032
Volume 1,397,814
Av. Daily Volume 1,844,921
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Upcoming Catalysts

Drug Stage Catalyst Date
177Lu-PSMA-617
Metastatic castration-resistant prostate cancer (mCRPC)
NDA Filing
NDA Filing
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Canakinumab (ACZ885) - CANOPY-1
Non-small cell lung cancer (NSCLC)
Phase 3
Phase 3
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Ligelizumab (QGE031) - Pearl 1
Chronic spontaneous urticaria
Phase 3
Phase 3
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ZOLGENSMA (AVXS-101) - SPRINT
Pre-symptomatic patients with spinal muscular atrophy (SMA) Types 1, 2 and 3
Phase 3
Phase 3
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ECF843
Dry Eye Disease
Phase 2
Phase 2
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Remibrutinib (LOU064)
Chronic spontaneous urticaria (CSU)
Phase 2
Phase 2
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BEOVU (Brolucizumab) - KINGFISHER
Diabetic macular edema (DME)
Phase 3
Phase 3
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COSENTYX (secukinumab) - SUNRISE
Hidradenitis Suppurativa (HS)
Phase 3
Phase 3
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Inclisiran
Hypercholesterolemia
PDUFA
PDUFA
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COSENTYX (secukinumab) - SURPASS
Ankylosing spondylitis (AS)
Phase 3
Phase 3
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ENTRESTO (Sacubitril/valsartan) - Panorama
Heart failure
Phase 3
Phase 3
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ENTRESTO (Sacubitril/valsartan) - PERSPECTIVE
Heart failure
Phase 3
Phase 3
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Kisqali (NATALEE)
Adjuvant breast cancer
Phase 3
Phase 3
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Iptacopan (LNP023) - APPLAUSE-IgAN
IgA nephropathy (IgAN)
Phase 3
Phase 3
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Sabatolimab (MBG453)
Myelodysplastic syndromes (MDS)
Phase 2
Phase 2
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Drug Pipeline

Drug Stage Notes
KISQALI (ribociclib) - MONALEESA-2
Breast cancer
Phase 3
Phase 3
Phase 3 median OS reported as over five years (63.9 months), a survival benefit of over 12 months vs. placebo. Phase 3 primary endpoint met, September 19, 2021.
Iptacopan (LNP023)
C3 glomerulopathy (C3G)
Phase 3
Phase 3
Phase 3 trial has been initiated - mid-2021.
KYMRIAH (tisagenlecleucel) - BELINDA
Diffuse large B-cell lymphoma (DLBCL) - 2nd line
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - August 23, 2021.
Zolgensma Intravenous OAV101 (AVXS-101)
Spinal muscular atrophy (SMA) Type 2
Phase 3
Phase 3
Phase 3 trial to be initiated. Partial clinical hold lifted August 3, 2021.
ENTRESTO (Sacubitril/valsartan) - PARADISE-MI
Post-acute myocardial infarction
Phase 3
Phase 3
Phase 3 data be presented at ACC meeting May 2021.
KENGREAL (cangrelor)
Reduction of thrombotic cardiovascular events including stent thrombosis in patients with coronary artery disease undergoing percutaneous coronary intervention (PCI)
Approved
Approved
CRL April 30 2014. Approved June 22 2015
VABOMERE (meropenem and vaborbactam)
Complicated urinary tract infections (cUTI)
Approved
Approved
Approved August 29, 2017.
ORBACTIV (Oritavancin)
ABSSSI
Approved
Approved
Approved August 6 2014 under priority review.
PROMACTA (eltrombopag)
Severe aplastic anemia (SAA)
Approved
Approved
sNDA approval announced November 16, 2018.
HUMIRA (adalimumab)
Rheumatoid Arthritis
Approved
Approved
FDA approval announced October 31, 2018.
ARZERRA (ofatumumab)
Relapsing multiple sclerosis
Approved
Approved
FDA approval announced August 20, 2020.
EGATEN (triclabendazole)
Fascioliasis
Approved
Approved
FDA Approval announced February 13, 2019.
MAYZENT (siponimod)
Secondary progressive multiple sclerosis
Approved
Approved
FDA approval announced March 26, 2019.
BEOVU (brolucizumab)
Wet age-related macular degeneration (AMD)
Approved
Approved
FDA Approval announced October 8, 2019.
ADAKVEO (crizanlizumab)
Sickle cell disease
Approved
Approved
FDA Approval announced November 15, 2019.
GILENYA (Fingolimod)
Multiple Sclerosis (MS)
Approved
Approved
Approval announced May 11, 2018.
KYMRIAH (tisagenlecleucel)
Cancer - Diffuse Large B-Cell Lymphoma (DLBCL)
Approved
Approved
Approval announced May 1, 2018.
TAFINLAR (dabrafenib) + MEKINIST (trametinib)
Melanoma with BRAF V600E or V600K mutations
Approved
Approved
Approval announced April 30, 2018.
LUTATHERA (lutetium Lu 177)
Inoperable progressive midgut NETs
Approved
Approved
Approved January 26, 2018. Acquired from Advanced Accelerator Applications (NASDAQ: AAAP).
KISQALI (ribociclib)
HR+/HER2- advanced breast cancer
Approved
Approved
Priority review granted November 1, 2016. Approval announced March 13, 2017.
RYDAPT (midostaurin)
Acute myeloid leukemia (AML)
Approved
Approved
Priority review granted November 14, 2016. Approval announced April 28, 2017.
ZYKADIA (ceritinib)
First-line use in patients with ALK+ metastatic NSCLC
Approved
Approved
Priority review granted February 22, 2017. Approval announced May 26, 2017.
KYMRIAH (tisagenlecleucel)
Relapsed/Refractory B-Cell Acute lymphoblastic leukemia
Approved
Approved
Approval announced early - August 30, 2017.
TAFINLAR (dabrafenib) + MEKINIST (trametinib)
Non-small cell lung cancer (NSCLC) with BRAF V600E mutation
Approved
Approved
FDA Approval announced June 22, 2017.
ZOLGENSMA (AVXS-101)
Spinal muscular atrophy (SMA) Type 1
Approved
Approved
FDA Approval announced May 24, 2019.
TABRECTA (capmatinib)
Non-small cell lung cancer
Approved
Approved
FDA Approval announced May 6, 2020.
Alpelisib + FASLODEX (fulvestrant)
HR + Metastatic breast cancer (MBC)
Approved
Approved
FDA Approval announced May 24, 2019.
AIMOVIG (Erenumab)
Migraine
Approved
Approved
Approval announced May 17, 2018.
COSENTYX (secukinumab)
Psoriatic arthritis
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - October 31, 2019.
COSENTYX (secukinumab)
Psoriasis
Approved
Approved
FDA approval announced February 8, 2018.
COSENTYX (secukinumab) - PREVENT
Non-radiographic axial spondyloarthritis
Approved
Approved
FDA Approval announced June 16, 2020.
Canakinumab (ACZ885) - CANOPY-2
Non-small cell lung cancer (NSCLC) - 2nd/3rd line
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - March 9, 2021.
Asciminib (ABL001)
Chronic myeloid leukemia
Phase 3
Phase 3
Phase 3 trial met primary endpoint.
PDR001
Metastatic melanoma
Phase 3
Phase 3
Phase 3 trial completed.
CNP520
Alzheimer’s Disease
Phase 2/3
Phase 2/3
Phase 2/3 trial discontinued due to lack of efficacy.
IONSYS
Acute postoperative pain
Approved
Approved
Approved April 30, 2015.
QAW039 (fevipiprant) - LUSTER-1
Asthma
Phase 3
Phase 3
Phase 3 trial did not meet primary endpoint - December 16, 2019.
Biosimilar pegfilgrastim
Pegfilgrastim biosimilar
Approved
Approved
FDA Approval announced November 5, 2019.
QAW039 (fevipiprant) - ZEAL
Asthma
Phase 3
Phase 3
Phase 3 data did not meet primary endpoint - noted October 22, 2019.
ACZ885 (canakinumab)
CV risk reduction
CRL
CRL
CRL announced October 18, 2018.
Biosimilar rituximab
Various blood cancers, rheumatoid arthritis.
CRL
CRL
CRL issued May 2, 2018.
RELAX-AHF-2 (RLX030)
Acute heart failure
Phase 3
Phase 3
Phase 3 data released March 22, 2017 - primary endpoints not met.

Latest News

  1. EAST HANOVER, N.J., Sept. 19, 2021 /PRNewswire/ -- Novartis today announced results of the final overall survival (OS) analysis of the Phase III MONALEESA-2 study, which evaluated Kisqali® (ribociclib) in combination with letrozole compared to placebo plus letrozole in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer with no prior systemic treatment for advanced disease. These data will be presented as a late-breaker oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021 on September 19 (#LBA17).

    Kisqali in combination with letrozole met its key secondary endpoint of OS, demonstrating a statistically significant…

    EAST HANOVER, N.J., Sept. 19, 2021 /PRNewswire/ -- Novartis today announced results of the final overall survival (OS) analysis of the Phase III MONALEESA-2 study, which evaluated Kisqali® (ribociclib) in combination with letrozole compared to placebo plus letrozole in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer with no prior systemic treatment for advanced disease. These data will be presented as a late-breaker oral presentation at the European Society for Medical Oncology (ESMO) Congress 2021 on September 19 (#LBA17).

    Kisqali in combination with letrozole met its key secondary endpoint of OS, demonstrating a statistically significant and clinically meaningful improvement in survival (median 63.9 vs. 51.4 months; HR=0.76; 95% CI: 0.63-0.93; p=0.004)2. The analysis found that after a median follow-up of over six and a half years, the longest for any CDK4/6 inhibitor trial to date, the improvement in the median OS was over one year2. MONALEESA-2 showed that after five years, patients treated with Kisqali in combination with letrozole had more than a 50% chance of survival (52.3% vs. 43.9%; 95% CI: 46.5-57.7 vs. 38.3-49.4)2.

    "These remarkable ribociclib overall survival data are highly encouraging and represent the longest reported median survival from a randomized trial in HR+/HER2- advanced breast cancer. This extension of life is great news for our patients and the building block for further progress," said Gabriel N. Hortobagyi, MD, FACP, professor of medicine with The University of Texas MD Anderson Cancer Center. "I have spent the last 45 years researching and increasing our scientific understanding of breast cancer, so it is incredibly rewarding to see just how far we've come."

    In MONALEESA-2, a 12-month delay in time to chemotherapy was observed with Kisqali (median 50.6 vs. 38.9 months; HR=0.74; 95% CI: 0.61-0.91) compared to those taking letrozole alone2. With this longer follow-up, no new safety signals were observed; adverse events were consistent with previously reported Phase III trial results for Kisqali.

    "As we reimagine medicine and strive for cures, our MONALEESA program continues to push boundaries by demonstrating that Kisqali is unique in its ability to give people living with advanced breast cancer more time," said Susanne Schaffert, PhD, President, Novartis Oncology. "Our mission is to improve and extend the lives of those with cancer. For people with HR+/HER2- advanced breast cancer, these data are not just numbers and may mean more life milestones — yet, we will not rest as we continue to investigate the full potential that Kisqali can bring to patients." 

    In MONALEESA-2, the primary endpoint progression-free survival (PFS) was met at the initial analysis [median PFS; 95% CI (19.3 months - not reached) vs. 14.7 months (13.0 - 16.5 months); HR=0.556; p=0.00000329]5. These new OS results mark the third statistically significant and clinically meaningful survival benefit achieved by Kisqali in the MONALEESA program. Novartis will submit the data to global health authorities to support label updates.

    "When treatment offers long overall survival—and in this case, the longest ever reported in HR+/HER2- advanced breast cancer—patients have more time to be with family and loved ones and to pursue whatever makes them happy. These data offer new hope for people with advanced or metastatic breast cancer, which remains the leading cause of cancer death in women worldwide," said Shirley A. Mertz, President, Metastatic Breast Cancer Network (MBCN). 

    Visit https://www.hcp.novartis.com/virtual-congress/esmo-2021/ for the latest information from Novartis, including our commitment to the Oncology community, and access to our ESMO2021 Virtual Scientific Program data presentations (for registered participants).

    About Kisqali® (ribociclib)

    Kisqali is the CDK4/6 inhibitor with the largest body of clinical trial evidence demonstrating consistent and superior overall survival benefit compared to endocrine therapy alone. Overall survival results from MONALEESA-7 and MONALEESA-3 were presented at ASCO 2019 and ESMO 2019 respectively, as well as published in the New England Journal of Medicine, with updated exploratory analyses presented at SABCS 2020 and ASCO 2021, demonstrating Kisqali plus endocrine therapy significantly extends life in pre/perimenopausal or postmenopausal women with HR+/HER2- advanced breast cancer3,4,6,7.

    Kisqali is approved by the US Food and Drug Administration (FDA) and by the European Commission (EC) as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor. Kisqali in combination with an aromatase inhibitor is approved for the treatment of pre-, peri- or postmenopausal women as initial endocrine-based therapy, and also indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women by the FDA and by the EC9. Kisqali is approved in over 95 countries1.

    Novartis is continuing to reimagine cancer with additional trials of Kisqali. NATALEE is a large confirmatory clinical trial of Kisqali with endocrine therapy in the adjuvant treatment of HR+/HER2- early breast cancer being conducted in collaboration with Translational Research In Oncology (TRIO)10. Novartis is also collaborating with SOLTI, who is leading the Phase III HARMONIA clinical trial evaluating Kisqali compared to palbociclib in patients with HR+/HER2- advanced breast cancer with aggressive tumor biology, defined as HER2-enriched1.

    Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

    Important Safety Information

    KISQALI can cause severe or life-threatening inflammation of the lungs. Patients should tell their health care provider right away if they experience breathing problems or chest pains. KISQALI can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. KISQALI is not indicated for concomitant use with tamoxifen due to an increased risk of QT prolongation. Patients should tell their health care provider right away if they have a change in their heartbeat (a fast or irregular heartbeat), or if they feel dizzy or faint. KISQALI can cause serious liver problems. Patients should tell their health care provider right away if they get any of the following signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice), dark or brown (tea-colored) urine, feeling very tired, loss of appetite, pain on the upper right side of the stomach area (abdomen), and bleeding or bruising more easily than normal. Low white blood cell counts are very common when taking KISQALI and may result in infections that may be severe. Patients should tell their health care provider right away if they have signs and symptoms of low white blood cell counts or infections such as fever and chills.

    Before taking KISQALI, patients should tell their health care provider if they are pregnant, or plan to become pregnant as KISQALI can harm an unborn baby. Females who are able to become pregnant and who take KISQALI should use effective birth control during treatment and for at least 3 weeks after the last dose of KISQALI. Do not breastfeed during treatment with KISQALI and for at least 3 weeks after the last dose of KISQALI.

    Patients should tell their health care provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements since they may interact with KISQALI. Patients should avoid grapefruit or grapefruit juice while taking KISQALI.

    The most common side effects (incidence ≥20%) include white blood cell count decreases, nausea, infections, tiredness, diarrhea, vomiting, hair loss, headache, constipation, rash, and cough. The most common grade 3/4 side effects (incidence >5%) were low neutrophils, low leukocytes, abnormal liver function tests, and low lymphocytes. Abnormalities were observed in hematology and clinical chemistry laboratory tests.

    Please see full Prescribing Information for KISQALI, available at www.kisqali.com.

    About Novartis in Advanced Breast Cancer

    Novartis tackles breast cancer with superior science, collaboration and a passion for transforming patient care. We've taken a bold approach to our research by including patient populations often neglected in clinical trials, identifying new pathways or mutations that may play a role in disease progression and developing therapies that not only maintain, but also improve, quality of life for patients. Our priority over the past 30 years and today is to deliver treatments proven to improve and extend lives for those diagnosed with advanced breast cancer.

    Disclaimer

    This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

    About Novartis 

    Located in East Hanover, NJ Novartis Pharmaceuticals Corporation – an affiliate of Novartis – is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis employs nearly 15,500 people in the United States. For more information, please visit https://www.novartis.us.

    Novartis and Novartis US is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews and @NovartisUS at https://twitter.com/NovartisUS.

    For Novartis multimedia content, please visit https://www.novartis.com/news/media-library.

    For questions about the site or required registration, please contact media.relations@novartis.com.

    References

    1. Novartis Data on File. Novartis Pharmaceuticals Corp: 2021.
    2. Hortobagyi, et al. Overall survival (OS) results from the phase III MONALEESA (ML)-2 trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Presented at the European Society of Medical Oncology (ESMO) Congress, September 16-21, 2021, (Abstract #LBA17).
    3. Im, S. A. et al. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. N Engl J Med 2019; 381:307-316.
    4. Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im S-A, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382(6):514–24.
    5. Hortobagyi G, Stemmer S, Burris H, et al. Ribociclib as First-Line Therapy for HR-Positive, Advanced Breast Cancer. N Engl J Med. 2016;375:1738-1748.
    6. Slamon D, Neven P, Chia S, et al. Updated overall survival (OS) results from the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2− advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, June 5, 2021, (Abstract #1001).
    7. Tripathy D, Im S-A, Colleoni M, et al, Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2− advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Presented at the San Antonio Breast Cancer Symposium, December 9, 2020. Abstract #PD2-04.
    8. Ferlay, J, et al. Global Cancer Observatory: Cancer Today. International Agency for Research on Cancer. Available at: https://gco.iarc.fr/today/online-analysis-table?v=2020&mode=cancer&mode_population=continents&population=900&populations=900&key=asr&sex=2&cancer=39&type=1&statistic=5&prevalence=0&population_group=0&ages_group%5B%5D=0&ages_group%5B%5D=17&group_cancer=1&include_nmsc=1&include_nmsc_other=1, accessed August 18, 2021.  
    9. Kisqali (ribociclib) Prescribing information. East Hanover, New Jersey, USA: Novartis Pharmaceuticals Corporation; July 2020.
    10. Novartis Pharmaceuticals and Translational Research in Oncology (2018, December 7 - 2026, May 29). A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (NATALEE). Identifier NCT03701334. https://clinicaltrials.gov/ct2/show/NCT03701334 .

    Cision View original content:https://www.prnewswire.com/news-releases/novartis-presents-new-kisqali-data-showing-longest-median-overall-survival-ever-reported-in-hrher2--advanced-breast-cancer-301379811.html

    SOURCE B2/Novartis Pharmaceuticals Corporation

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  2. Moderna COVID-19 Vaccine mRNA-1273: Final blinded analysis of Phase 3 COVE study shows 93% efficacy; Efficacy remains durable through six months after second dose ​

    Moderna booster candidates demonstrate robust antibody responses to COVID-19 variants of concern in Phase 2

    Dosing started in Phase 1 studies for quadrivalent seasonal flu vaccine candidate (mRNA-1010) and IL-2 mRNA program for autoimmune disorders (mRNA-6231)

    Moderna has mRNA candidates in clinical development across five therapeutic areas: infectious disease, cardiovascular, oncology, rare disease and autoimmune disorders

    Q2 total revenue of $4.4 billion, net income of $2.8 billion and diluted earnings per share of $6.46

    Moderna establishes new Charitable Foundation to

    Moderna COVID-19 Vaccine mRNA-1273: Final blinded analysis of Phase 3 COVE study shows 93% efficacy; Efficacy remains durable through six months after second dose ​

    Moderna booster candidates demonstrate robust antibody responses to COVID-19 variants of concern in Phase 2

    Dosing started in Phase 1 studies for quadrivalent seasonal flu vaccine candidate (mRNA-1010) and IL-2 mRNA program for autoimmune disorders (mRNA-6231)

    Moderna has mRNA candidates in clinical development across five therapeutic areas: infectious disease, cardiovascular, oncology, rare disease and autoimmune disorders

    Q2 total revenue of $4.4 billion, net income of $2.8 billion and diluted earnings per share of $6.46

    Moderna establishes new Charitable Foundation to promote public health, healthcare and educational opportunities, particularly in underserved populations

    Moderna, Inc. (NASDAQ:MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, today reported financial results and provided business updates for the second quarter of fiscal year 2021.

    "I am proud of the progress our teams at Moderna have made in the past quarter in advancing our development pipeline while addressing a global pandemic and quickly establishing global manufacturing and commercial organizations," said Stéphane Bancel, Chief Executive Officer of Moderna. "We now have mRNA candidates in clinical trials across five therapeutic areas including infectious diseases, cardiovascular, oncology, rare disease and autoimmune disorders. We are pleased that our COVID-19 vaccine is showing durable efficacy of 93% through six months, but recognize that the Delta variant is a significant new threat so we must remain vigilant."

    Looking forward, Bancel said, "We have begun preparing late stage studies for our flu vaccine and RSV vaccine, which received fast track designation from the FDA a few days ago and are looking forward towards our vision of a single dose annual booster that provides protection against COVID-19, flu and RSV for adults. I look forward to the start of our Phase 3 trial for CMV this year and to clinical proof of concept data in the coming quarters from our therapeutics pipeline. We believe this is just the beginning."

    Updates and recent progress include:

    COVID-19 Vaccine Development

    • Robust antibody responses have been observed from existing Moderna booster candidates against COVID-19 in Phase 2 studies
    • The Conditional Marketing Authorization (CMA) for Spikevax™ (Moderna's COVID-19 Vaccine) in the European Union (EU) and authorization in Japan by the Ministry of Health, Labor and Welfare have been expanded to include adolescents 12 years of age and older
    • Moderna has initiated the rolling submission process for a Biologics License Application (BLA) for our vaccine in the U.S. and expects to complete its submission in August
    • Enrollment has completed for the Phase 1 study of mRNA-1283, Moderna's next-generation COVID-19 vaccine, which is a potential refrigerator-stable vaccine that could facilitate easier distribution and storage

    Infectious Diseases

    • Phase 3 study of cytomegalovirus (CMV) vaccine candidate (mRNA-1647) to begin in 2021
    • Dosing started in Phase 1/2 study of quadrivalent seasonal flu vaccine candidate (mRNA-1010)
    • Started dosing in Phase 2 study of Zika virus vaccine candidate (mRNA-1893)
    • Received Fast Track designation from U.S. Food and Drug Administration (FDA) for respiratory syncytial virus (RSV) vaccine candidate (mRNA-1345) for older adults (60 years of age and above)

       

    Autoimmune Disorders

    • First participant dosed in the Phase 1 study of IL-2 mRNA program for autoimmune disorders (mRNA-6231)

    Oncology

    • Discontinued further development of mRNA-2416, our standalone OX40L candidate; focus shifted to the development of mRNA-2752, which comprises mRNAs for OX40L plus two cytokines, IL23 + IL36γ.

    Moderna currently has 23 mRNA development programs in its portfolio with 15 having entered clinical studies. The Company's updated pipeline can be found at www.modernatx.com/pipeline. Moderna and collaborators have published more than 80 peer reviewed manuscripts.

    Summary of Program Highlights by Modality

    Core Modalities

    Prophylactic Vaccines: Moderna is developing vaccines against viral diseases where there is unmet medical need – including complex vaccines with multiple antigens for common diseases, as well as vaccines against threats to global public health. The Company's global public health portfolio is focused on epidemic and pandemic diseases for which funding has been sought from governments and non-profit organizations.

    COVID-19 Vaccine Development

    • Moderna COVID-19 Vaccine: Moderna has received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine in adults from health agencies in more than 50 countries and an Emergency Use Listing (EUL) from the World Health Organization (WHO), as well as authorization for use of its COVID-19 vaccine in adolescents age 12 and up in the European Union and Japan. On June 1, 2021, the Company initiated the rolling submission process for a Biologics License Application (BLA) for the vaccine in the U.S. and expects to complete its submission in August. Moderna is working with additional health agencies on the authorization and/or approval of its vaccine in additional jurisdictions. BARDA, part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), partially supported the research and development of the Moderna COVID-19 Vaccine with federal funding under Contract no. 75A50120C00034. Moderna retains worldwide rights to develop and commercialize the Moderna COVID-19 Vaccine.



      • Six months durability data: In final analysis of Phase 3 COVE study data, the Moderna COVID-19 Vaccine showed 93% efficacy, with the efficacy remaining durable through six months after administration of the second dose.

      • Addressing Variants of Concern: In a Phase 2 study, vaccination with 50 µg of three different Moderna mRNA booster candidates induced robust antibody responses against the wildtype D614G COVID-19 strain and against important variants of concern including Gamma (P.1); Beta (B.1.351); and Delta (B.1.617.2). The booster candidates included mRNA-1273, investigational mRNA-1273.351, and investigational mRNA-1273.211. Neutralizing antibody levels following the boost approached those observed after primary vaccination with two doses of 100 µg of mRNA-1273. These data have been submitted to a peer-reviewed journal for publication.
    • Further Clinical Studies of mRNA-1273



      • Phase 2/3 "TeenCOVE" study of mRNA-1273 in adolescents: The Phase 2/3 study of mRNA-1273 in adolescents ages 12-17 years completed enrollment in the U.S. An initial analysis of 3,732 participants randomized 2:1 in TeenCOVE Study showed a vaccine efficacy rate of 93% in seronegative participants who received at least one injection in a secondary analysis. The analysis included 15 cases (13 in the placebo group and 2 in the mRNA-1273 group) reported 14 days after first dose and based on the CDC definition of COVID-19, which requires one COVID-19 symptom and paired with a nasopharyngeal (NP) swab or saliva sample positive for SARS-CoV-2 by RT-PCR. The median duration for follow-up in this initial analysis was 53 days following the second dose. mRNA-1273 was generally well tolerated. The majority of adverse events were mild or moderate in severity. The most common solicited local adverse event was injection site pain. The most common solicited systemic adverse events after the second dose of mRNA-1273 were headache, fatigue, myalgia and chills. The Conditional Marketing Authorization (CMA) for Spikevax1 in the European Union (EU) has been expanded to include adolescents 12 years of age and older. In addition, the Japanese Ministry of Health, Labor and Welfare also approved Moderna Inc.'s COVID-19 vaccine for ages 12 to 17. Moderna has filed for an emergency use authorization (EUA) for adolescents with the U.S. Food and Drug administration as well as with additional regulatory agencies around the world.



      • Phase 2 "KidCOVE" study of mRNA-1273 in young children: The Phase 2 study of mRNA-1273 in pediatric population ages 6 months to 11 years is ongoing.



      • Phase 3 "COVE Transplant" study of mRNA-1273: The Phase 3 study of mRNA-1273 in adults with a kidney or liver transplant is ongoing, including the offer of a third vaccine dose to these immunocompromised participants



    • Next-generation vaccine against COVID-19 (mRNA-1283): The Phase 1 study of mRNA-1283 is fully enrolled and ongoing. mRNA-1283 is a next-generation vaccine candidate against COVID-19 that encodes for the portions of the SARS-CoV-2 spike protein critical for neutralization, specifically the Receptor Binding Domain (RBD) and N-terminal Domain (NTD). The encoded mRNA-1283 antigen is shorter than mRNA-1273 and is being developed as a potential refrigerator stable mRNA vaccine that will facilitate easier distribution and administration by healthcare providers.

    Vaccines requiring complex antigens and against highly prevalent infections

    • Cytomegalovirus (CMV) vaccine (mRNA-1647): Positive seven-month data from the Phase 2 study assessing the safety, reactogenicity, and immunogenicity of different dose levels (50 μg, 100 μg and 150 μg) of mRNA-1647 were presented at Moderna's annual Vaccines Day on April 14, 2021. Based on the interim analysis of the Phase 2 study, the 100 μg dose has been chosen for the Phase 3 pivotal study. The Company expects the Phase 3 study to begin in 2021. Moderna owns worldwide commercial rights for mRNA-1647.



    • Epstein-Barr virus (EBV) vaccine (mRNA-1189):mRNA-1189 is a vaccine against EBV containing five mRNAs that encode viral proteins (gp350, gB, gp42, gH and gL) in EBV. Similar to Moderna's CMV vaccine (mRNA-1647), the viral proteins in mRNA-1189 are expressed in their native membrane-bound form for recognition by the immune system. Moderna is planning to begin a Phase 1 study of mRNA-1189 in 2021. There is no approved vaccine for EBV. Moderna owns worldwide commercial rights to mRNA-1189.

    Vaccines against respiratory infections

    • Human metapneumovirus (hMPV) and parainfluenza type 3 (PIV3) vaccine (mRNA-1653): Moderna is enrolling seropositive pediatric participants (12-36 months of age) in the Phase 1 study of hMPV/PIV3 study (mRNA-1653). The first cohort in this study has been fully enrolled. Moderna owns worldwide commercial rights to mRNA-1653.



    • Respiratory syncytial virus (RSV) vaccine (mRNA-1345): mRNA-1345 is a vaccine against RSV encoding for a prefusion F glycoprotein, which elicits a superior neutralizing antibody response compared to the postfusion state. RSV is the leading cause of respiratory illness in young children. Older adults (65+) are at high risk for severe RSV infections. The Phase 1 study of mRNA-1345 to evaluate the tolerability and reactogenicity of mRNA-1345 in younger adults, women of child-bearing age, older adults and seropositive toddlers is ongoing. All four cohorts of younger adults (ages 18-49 years) are fully enrolled. Dosing in the older adult cohort (ages 65-79 years) is ongoing. The Company shared the first interim analysis of the Phase 1 study of mRNA-1345, through 1-month post-vaccination, of the younger adult cohorts at its annual Vaccines Day on April 14, 2021. The Company also intends to evaluate the potential of combinations of mRNA-1345 with its vaccines against other respiratory pathogens in children and separately in older adults. The FDA has granted Fast Track designation for mRNA-1345 in adults older than 60 years of age. There is no approved vaccine for RSV. Moderna owns worldwide commercial rights to mRNA-1345.
    • Seasonal influenza vaccine (mRNA-1010, mRNA-1020, mRNA-1030): Seasonal flu (type A and type B) epidemics occur seasonally and vary in severity each year, causing respiratory illnesses and placing substantial burden on healthcare systems. The World Health Organization (WHO) estimates approximately 3-5 million severe cases of flu each year globally, and 290,000-650,000 flu-related respiratory deaths. In the U.S., the estimated average economic burden of flu is approximately $11 billion per year. Current flu vaccines are only approximately 40-60% effective and their formulation is decided 9 months before the vaccines are intended to be used. The Company plans to explore potential combination vaccines against flu, SARS-CoV-2, RSV and human metapneumovirus (hMPV). The Company's first-generation flu program will evaluate multiple candidates comprising multiple antigen combinations against the four seasonal viruses recommended by the WHO. The sentinel cohorts in the Phase 1/2 study of mRNA-1010 have been dosed.

    Public health vaccines

    • Zika virus vaccine (mRNA-1893): The Phase 2 study of mRNA-1893 is enrolling participants. mRNA-1893 is being developed in collaboration with BARDA. Moderna owns worldwide commercial rights to mRNA-1893.

    • HIV vaccine (mRNA-1644 & mRNA-1574): HIV is the virus responsible for acquired immunodeficiency syndrome (AIDS), a lifelong, progressive illness with no effective cure. Approximately 38 million people worldwide are currently living with HIV with 1.2 million in the U.S. Approximately 2 million new infections of HIV are acquired worldwide every year and approximately 690,000 people die annually due to complications from HIV/AIDS. The primary routes of transmission are sexual intercourse and IV drug use, putting young adults at the highest risk of infection. From 2000 to 2015, a total of $562.6 billion globally was spent on care, treatment and prevention of HIV, representing a significant economic burden. mRNA-1644, a collaboration with the International AIDS Vaccine Initiative (IAVI) and the Bill and Melinda Gates Foundation, is a novel approach to HIV vaccine strategy in humans designed to elicit broadly neutralizing HIV-1 antibodies (bNAbs). A Phase 1 study for mRNA-1644 will use iterative human testing to validate the approach and antigens and multiple novel antigens will be used for germline-targeting and immuno-focusing. A second approach, mRNA-1574, is being evaluated in collaboration with the NIH and includes multiple native-like trimer antigens. The Company expects to begin Phase 1 studies for both mRNA-1644 and mRNA-1574 in 2021.



    • Nipah virus (NiV) Vaccine (mRNA-1215): NiV is a zoonotic virus transmitted to humans from animals, contaminated food, or through direct human-to-human transmission and causes a range of illnesses including fatal encephalitis. Severe respiratory and neurologic complications of NiV have no treatment other than intensive supportive care. The case fatality rate among those infected is estimated at 40-75%. NiV outbreaks cause significant economic burden to impacted regions due to loss of human life and interventions to prevent further spread, such as the slaughter of infected animals. NiV has been identified as the cause of isolated outbreaks in India, Bangladesh, Malaysia, and Singapore since 2000 and is included on the WHO R&D Blueprint list of epidemic threats needing urgent R&D action. mRNA-1215 was co-developed by Moderna and the NIH's Vaccine Research Center (VRC).

       

    Systemic Secreted & Cell Surface Therapeutics: In this modality, mRNA is delivered systemically to create proteins that are either secreted or expressed on the cell surface.

    • Antibody against the chikungunya virus (mRNA-1944): Positive interim data from the Phase 1 study evaluating escalating doses of mRNA-1944 in the 0.6 mg/kg dose with steroid premedication cohort and two doses of 0.3 mg/kg (without steroid premedication) given one week apart cohort were presented at Moderna's annual R&D Day in September and demonstrated dose-dependent increases in levels of antibody against chikungunya. Safety and increased CHKV-IgG production in the two-dose regimen shows the platform's ability for repeat dosing.



    • IL-2 (mRNA-6231): mRNA-6231 is an mRNA encoding for a long-acting tolerizing IL-2. This autoimmune development candidate is designed to preferentially activate and expand the regulatory T cell population. The first participant in the Phase 1 study of mRNA-6231 in healthy adult participants (between 18 and 50 years of age) has been dosed. mRNA-6231 uses the same LNP formulation as mRNA-1944. The Phase 1 study of mRNA-6231 will be the first clinical demonstration of subcutaneous administration of this delivery technology. Moderna owns worldwide commercial rights to mRNA-6231.



    • PD-L1 (mRNA-6981): mRNA-6981 is an mRNA encoding for PD-L1. This autoimmune development candidate is designed to augment cell surface expression of PD-L1 on myeloid cells to provide co-inhibitory signals to self-reactive lymphocytes. As an initial step to addressing a range of autoimmune indications, the Company intends to pursue proof-of-concept in a Phase 1 study of mRNA-6981 in type 1 autoimmune hepatitis (AIH), a condition that involves liver inflammation and can lead to cirrhosis and liver failure. mRNA-6981 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-6981.



    • Relaxin (AZD7970): Moderna has regained all rights to the Relaxin development candidate from AstraZeneca. Moderna now owns worldwide commercial rights to this development candidate.



    Exploratory Modalities

    Cancer Vaccines: These programs focus on stimulating a patient's immune system with antigens derived from tumor-specific mutations to enable the immune system to elicit a more effective anti-tumor response.

    • Personalized cancer vaccine (PCV) (mRNA-4157): The randomized Phase 2 study investigating a 1 mg dose of mRNA-4157 in combination with Merck's pembrolizumab (KEYTRUDA®), compared to pembrolizumab alone, for the adjuvant treatment of high-risk resected melanoma is ongoing. Phase 1 in multiple cohorts is ongoing. The upsized head & neck cohort is recruiting additional patients. Moderna shares worldwide commercial rights to mRNA-4157 with Merck.



    • Mutant KRAS vaccine (mRNA-5671 or V941): The Phase 1 open-label, multi-center study to evaluate the safety and tolerability of mRNA-5671 both as a monotherapy and in combination with pembrolizumab, led by Merck, is ongoing. Moderna shares worldwide commercial rights to mRNA-5671 with Merck.



    Intratumoral Immuno-Oncology: These programs aim to drive anti-cancer T cell responses by injecting mRNA therapies directly into tumors.

    • OX40L/IL-23/IL-36γ (Triplet) (mRNA-2752): The Phase 1 trial evaluating mRNA-2752 as a single agent and in combination with durvalumab in patients with advanced solid tumor malignancies and lymphoma is ongoing. Moderna owns worldwide commercial rights to mRNA-2752.



    • IL-12 (MEDI1191): The Phase 1 open-label, multi-center study of intratumoral injections of MEDI1191 alone and in combination with durvalumab in patients with advanced solid tumors, led by AstraZeneca, is ongoing. MEDI1191 is an mRNA encoding for IL-12, a potent immunomodulatory cytokine. Moderna shares worldwide commercial rights to MEDI1191 with AstraZeneca.

    Localized Regenerative Therapeutics: Localized production of proteins has the potential to be used as a regenerative medicine for damaged tissues.

    • VEGF-A (AZD8601): The Phase 2a study of AZD8601 VEGF-A, which is being developed for patients with ischemic heart disease undergoing coronary artery bypass grafting surgery with moderately impaired systolic function, led by AstraZeneca, is ongoing. Moderna has licensed worldwide commercial rights to AZD8601 to AstraZeneca.



    Systemic Intracellular Therapeutics: These programs aim to deliver mRNA into cells within target organs as a therapeutic approach for diseases caused by a missing or defective protein.

    • Propionic acidemia (PA) (mRNA-3927): The Phase 1/2 Paramount study of mRNA-3927 is ongoing. mRNA-3927 uses the same LNP formulation as mRNA-1944. This is the Company's first development candidate in its systemic intracellular therapeutics modality to enter the clinic. Moderna owns worldwide commercial rights to mRNA-3927.



    • Methylmalonic acidemia (MMA) (mRNA-3705): Moderna received rare pediatric designation for its next generation MMA candidate (mRNA-3705). The Company plans to file new IND and CTA applications for mRNA-3705 and will focus development efforts on that candidate going forward. mRNA-3705 uses the same LNP formulation as mRNA-1944. Moderna owns worldwide commercial rights to mRNA-3705.



    • Phenylketonuria (PKU) (mRNA-3283): Individuals with PKU have a deficiency in phenylalanine hydroxylase (PAH) resulting in a reduced or complete inability to metabolize the essential amino acid phenylalanine into tyrosine. mRNA-3283 encodes human PAH to restore the deficient or defective intracellular enzyme activity in patients with PKU. mRNA-3283 is in preclinical development. Moderna owns worldwide commercial rights to mRNA-3283.
    • Glycogen storage disease type 1a (GSD1a) (mRNA-3745): Individuals with GSD1a have a deficiency in glucose-6-phosphatase resulting in pathological blood glucose imbalance. mRNA-3745 is an IV-administered mRNA encoding human G6Pase enzyme, designed to restore the deficient or defective intracellular enzyme activity in patients with GSD1a. mRNA-3745 is in preclinical development. Moderna owns worldwide commercial rights to mRNA-3745.

    Information about each development candidate in Moderna's pipeline can be found at investors.modernatx.com.

    Second Quarter 2021 Financial Results

    • Revenue: Total revenue was $4.4 billion for the three months ended June 30, 2021, compared to $67 million for the same period in 2020. Total revenue was $6.3 billion for the six months ended June 30, 2021, compared to $75 million for the same period in 2020. Total revenue increased in 2021, resulting from commercial sales of the Company's COVID-19 vaccine, and to a lesser extent, grant revenue. Product sales for the three and six months ended June 30, 2021 was $4.2 billion and $5.9 billion, respectively, from sales of 199 million and 302 million doses of the Company's COVID-19 vaccine. The increases in grant revenue of $101 million and $291 million for the three and six months ended June 30, 2021, respectively, were primarily driven by increases in revenue from BARDA related to the Company's COVID-19 vaccine development.
    • Cost of Sales: Cost of sales was $750 million, or 18%, of product sales for the three months ended June 30, 2021, including third-party royalties of $148 million. Cost of sales was $943 million, or 16%, of the Company's product sales, for the six months ended June 30, 2021, including third-party royalties of $232 million. A portion of the inventory costs associated with the Company's product sales for the six months ended June 30, 2021 was expensed as pre-launch inventory costs in 2020. At the end of the first quarter of 2021, the Company's zero-cost COVID-19 vaccine inventory was substantially utilized. If inventory sold for the six months ended June 30, 2021 was valued at cost, the Company's cost of sales for the period would have been $1.1 billion, or 19% of product sales.
    • Research and Development Expenses: Research and development expenses were $421 million for the three months ended June 30, 2021, compared to $152 million for the same period in 2020. Research and development expenses were $822 million for the six months ended June 30, 2021, compared to $267 million for the same period in 2020. The growth in spending in 2021 was mainly due to increases in clinical trial expenses, and to a lesser extent, personnel-related costs, manufacturing expenses, and consulting and outside services, largely driven by increased mRNA-1273 clinical development and headcount.
    • Selling, General and Administrative Expenses: Selling, general and administrative expenses were $121 million for the three months ended June 30, 2021, compared to $37 million for the same period in 2020. Selling, general and administrative expenses were $198 million for the six months ended June 30, 2021, compared to $61 million for the same period in 2020. The growth in spending in 2021 was mainly due to increases in consulting and outside services, personnel-related costs, and marketing expenses, primarily attributable to the Company's COVID-19 vaccine commercialization-related activities and increased headcount.
    • Net Income (Loss):Net income was $2.8 billion for the three months ended June 30, 2021, compared to a net loss of $(117) million for the same period in 2020. Net income was $4.0 billion for the six months ended June 30, 2021, compared to a net loss of $(241) million for the same period in 2020.
    • Cash Position: Cash, cash equivalents and investments as of June 30, 2021 and December 31, 2020 were $12.2 billion and $5.2 billion, respectively.
    • Net Cash Provided By (Used In) Operating Activities: Net cash provided by operating activities was $7.0 billion for the six months ended June 30, 2021, compared to $(130) million used in operating activities for the same period in 2020. Net cash provided by operating activities increased significantly in 2021, mainly due to net income of $4.0 billion and additional customer deposits received during the period for the Company's future COVID-19 vaccine supply.
    • Cash Used for Purchases of Property and Equipment: Cash used for purchases of property and equipment was $65 million for the six months ended June 30, 2021, compared to $25 million for the same period in 2020.

    2021 Updated Financial Framework

    • For Expected Delivery in Fiscal Year (FY) 2021: Advance Purchase Agreements (APAs) signed for anticipated product sales of $20 billion, including sales already recorded in the six months ended June 30, 2021.
    • Dose Capacity for FY 2021: The Company expects dose capacity for its COVID-19 vaccine in FY 2021 to be between 800 million and 1 billion doses.
    • For Expected Delivery in FY 2022: The Company has already signed APAs for product sales of approximately $12 billion and options of approximately $8 billion. Numerous additional negotiations are still ongoing for 2022 APAs.
    • For Expected Delivery in 2023: The Company has also started to sign APAs for 2023 as forward-looking countries prepare for the endemic phase of COVID-19​.
    • Dose Capacity for FY 2022: The Company expects dose capacity for its COVID-19 vaccine in FY 2022 to be between 2 billion to 3 billion doses, subject to dose level.
    • Cost of Sales: Cost of sales as percentage of product sales are expected to be between 18-20% for fiscal year 2021.
    • 2021 Research & Development (R&D) and Selling, General & Administrative (SG&A) Expenses: Continue to expect quarter over quarter cost increases in R&D and SG&A expenses during 2021 as commercial and research and development activities and expenses ramp up.
    • Tax Rate: The Company now expects the effective tax rate for 2021 to be approximately 10% as a result of the forecasted global sales mix and utilization of the accumulated net operating loss carry-forward of $2.3 billion.
    • Capital Expenditures: Continue to expect $450-550 million of capital investments for 2021 including the planned capacity expansion announced in April 2021.
    • Share Repurchase Program: The Board of Directors has authorized a share repurchase program of up to $1 billion over a two-year period to return excess capital to shareholders.
    • Further Investments: The Company plans to continue to invest in its technology platform and in potential new modalities. The Company will also consider attractive strategic opportunities that further enable and complement our platform.

    Management Updates

    • Shannon Thyme Klinger joined the Company as Chief Legal Officer and Corporate Secretary on June 1, 2021. Ms. Klinger joined Moderna from Novartis (NYSE:NVS), where she served as Chief Legal Officer and a member of the Novartis Executive Committee since 2018. Previously, she served as Chief Ethics, Risk & Compliance Officer. During her ten-year tenure at Novartis, she held other roles of increasing responsibility, including as Chief Ethics and Compliance Officer and Global Head of Litigation, General Counsel and Global Head of Legal at Sandoz, a Novartis division.
    • Paul Burton M.D., Ph.D., F.A.C.C, M.R.C.S joined the Company as Chief Medical Officer on July 6, 2021. Dr. Burton joined Moderna after spending sixteen years with Johnson & Johnson. Since March 2020, he served as Chief Global Medical Affairs Officer of Janssen Pharmaceuticals where he was responsible for Janssen's worldwide medical affairs strategy and execution. Previously, he served as Janssen's Vice President and Head, Cardiovascular and Metabolic Medical Affairs.



    • Kate Cronin joined Moderna as Chief Brand Officer on July 12, 2021. Ms. Cronin joined Moderna from Ogilvy Health, part of WPP plc., where she served as Global CEO and led the full spectrum of Ogilvy Health's core capabilities including public relations and influence, brand strategy, advertising, medical education, market access, and patient and consumer engagement. Additionally, Ms. Cronin grew Ogilvy's business in the health and wellness arena, encompassing a broad portfolio including pharmaceuticals, consumer health, insurance, hospitals, health technology and medical devices.

    Corporate Updates

    • Full-Time Employees: As of June 30, 2021, Moderna had approximately 1,800 employees, compared to approximately 930 employees as of June 30, 2020.
    • Moderna Charitable Foundation: Moderna announced it is establishing a new charitable foundation with an initial endowment of $50 million to promote public health, healthcare and educational opportunities, particularly in underserved populations.
    • Moderna International Business Services (MIBS) Center: Moderna announced plans to establish an international business services hub in Warsaw, Poland, as the Company continues to build out a global infrastructure.
    • Science Day: Moderna hosted its fourth annual Science Day on May 27.
    • Job Creation in Massachusetts: Moderna reaffirmed its commitment to job creation in Massachusetts.
    • S&P 500: Moderna was added to the Standard & Poor's (S&P) 500 index on Wednesday, July 21.
    • Company Recognition: Moderna was named number one on Fast Company's 2021 Best Workplaces for Innovators list and number three on the Axios/Harris 2021 Poll of Corporate Reputation Rankings.

    Key 2021 Investor and Analyst Event Dates

    • R&D Day – September 9

    Investor Call and Webcast Information

    Moderna will host a live conference call and webcast at 8:00 a.m. ET on Thursday, August 5, 2021. To access the live conference call, please dial 866-922-5184 (domestic) or 409-937-8950 (international) and refer to conference ID 5749439. A webcast of the call will also be available under "Events and Presentations" in the Investors section of the Moderna website at investors.modernatx.com. The webcast and slides are available directly at: https://investors.modernatx.com/events/event-details/moderna-2q-2021-earnings-call. The archived webcast will be available on Moderna's website approximately two hours after the conference call and will be available for one year following the call.

    About Moderna

    In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across six modalities, a broad intellectual property portfolio in areas including mRNA and lipid nanoparticle formulation, and an integrated manufacturing plant that allows for both clinical and commercial production at scale and at unprecedented speed. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna's capabilities have come together to allow the authorized use of one of the earliest and most-effective vaccines against the COVID-19 pandemic.

    Moderna's mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Today, 23 development programs are underway across these therapeutic areas, with 15 programs having entered the clinic. Moderna has been named a top biopharmaceutical employer by Science for the past six years. To learn more, visit www.modernatx.com.

    MODERNA, INC.

    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

    (Unaudited, in millions, except per share data)

     

     

     

    Three Months Ended June 30,

     

    Six Months Ended June 30,

     

     

    2021

     

    2020

     

    2021

     

    2020

    Revenue:

     

     

     

     

     

     

     

     

    Product sales

     

    $

    4,197

     

     

    $

     

     

    $

    5,930

     

     

    $

     

    Grant revenue

     

    139

     

     

    38

     

     

    333

     

     

    42

     

    Collaboration revenue

     

    18

     

     

    29

     

     

    28

     

     

    33

     

    Total revenue

     

    4,354

     

     

    67

     

     

    6,291

     

     

    75

     

    Operating expenses:

     

     

     

     

     

     

     

     

    Cost of sales

     

    750

     

     

     

     

    943

     

     

     

    Research and development

     

    421

     

     

    152

     

     

    822

     

     

    267

     

    Selling, general and administrative

     

    121

     

     

    37

     

     

    198

     

     

    61

     

    Total operating expenses

     

    1,292

     

     

    189

     

     

    1,963

     

     

    328

     

    Income (loss) from operations

     

    3,062

     

     

    (122)

     

     

    4,328

     

     

    (253)

     

    Interest income

     

    3

     

     

    7

     

     

    7

     

     

    15

     

    Other expense, net

     

    (2)

     

     

    (2)

     

     

    (12)

     

     

    (3)

     

    Income (loss) before income taxes

     

    3,063

     

     

    (117)

     

     

    4,323

     

     

    (241)

     

    Provision for income taxes

     

    283

     

     

     

     

    322

     

     

     

    Net income (loss)

     

    $

    2,780

     

     

    $

    (117)

     

     

    $

    4,001

     

     

    $

    (241)

     

     

     

     

     

     

     

     

     

     

    Earnings (loss) per share:

     

     

     

     

     

     

     

     

    Basic

     

    $

    6.93

     

     

    $

    (0.31)

     

     

    $

    9.98

     

     

    $

    (0.66)

     

    Diluted

     

    $

    6.46

     

     

    $

    (0.31)

     

     

    $

    9.30

     

     

    $

    (0.66)

     

     

     

     

     

     

     

     

     

     

    Weighted average common shares used in calculation of earnings (loss) per share:

     

     

     

     

     

     

     

     

    Basic

     

    402

     

     

    381

     

     

    401

     

     

    367

     

    Diluted

     

    431

     

     

    381

     

     

    430

     

     

    367

     

    MODERNA, INC.

    CONDENSED CONSOLIDATED BALANCE SHEETS AND STATEMENTS OF CASH FLOWS DATA

    (Unaudited, in millions)

     

     

    June 30,

     

    December 31,

     

    2021

     

    2020

    Cash, cash equivalents and investments

    $

    12,197

     

     

    $

    5,247

     

    Total assets

    16,153

     

     

    7,337

     

    Total liabilities

    9,449

     

     

    4,776

     

    Total stockholders' equity

    6,704

     

     

    2,561

     

    Total liabilities and stockholders' equity

    16,153

     

     

    7,337

     

     

    Six Months Ended June 30,

     

    2021

     

    2020

    Net cash provided by (used in) operating activities

    $

    7,034

     

     

    $

    (130)

     

    Cash used for purchases of property and equipment

    (65)

     

     

    (25)

     

    Forward-Looking Statements

    This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including regarding: the Company's development of the Moderna COVID-19 Vaccine (mRNA-1273); its efforts to continue developing vaccines against COVID-19, including efforts to develop vaccines against variant strains of SARS-CoV-2 and for booster doses; the ability of the Moderna COVID-19 Vaccine to provide protection against COVID-19 over time and to trigger an antibody response against variants of concern; the Company's plans to submit for a Biologics License Application for mRNA-1273; the development of additional COVID-19 vaccine candidates that may be refrigerator stable; the conduct and timing of clinical trials for programs in the Company's pipeline, including its vaccine candidates against seasonal flu, CMV, RSV, HIV, Nipah virus and EBV; the potential to combine different vaccines into a single dose; the number of doses of the Moderna COVID-19 Vaccine that the Company anticipates being able to manufacture in 2021 and 2022, and investments to facilitate that manufacturing; anticipated doses to be delivered under advance purchase agreement in 2021 and 2022 and the associated dollar amounts to be received, which should not be construed as expected 2021 or 2022 revenue; the anticipated cost of sales associated with the Moderna COVID-19 Vaccine; the Company's commercial rights to its development candidates; future research and development expenses; future sales, general and administrative expenses, and capital expenditures, as well as other expenses; orders for the Company's Moderna COVID-19 Vaccine; the Company's future tax rate; plans to conduct a share repurchase program; plans to establish a charitable foundation; and plans to establish the Moderna International Business Services Center. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include those other risks and uncertainties described under the heading "Risk Factors" in Moderna's most recent Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date hereof.

    1Spikevax is the trade name authorized by the European Medicines Agency (EMA) for the Moderna COVID-19 vaccine.

     

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  3. CARLSBAD, Calif., Aug. 2, 2021 /PRNewswire/ -- Ionis Pharmaceuticals, Inc. (NASDAQ: IONS) today announced that pelacarsen, formerly known as AKCEA-APO(a)-LRx, and licensed by Novartis (NYSE:NVS) for exclusive worldwide development and commercialization,  continues to advance in the clinic as the potential first-in-class treatment for lipoprotein(a) or Lp(a)-driven cardiovascular disease. The Novartis pivotal Phase 3 cardiovascular outcomes study of pelacarsen, Lp(a) HORIZON (NCT04023552), has reached 50% enrollment with a target goal of 7,680 trial participants.

    Pelacarsen is an investigational antisense medicine that uses Ionis' proprietary Ligand Conjugated Antisense (LICA) technology platform. It is designed to inhibit the production of apolipoprotein(a) in the liver to target elevated Lp(a) levels, an independent genetic risk factor for cardiovascular diseases (CVD), that are determined at birth and cannot be controlled with diet or exercise. High Lp(a) levels are associated with significant risk of cardiovascular disease, including heart attacks and strokes. There are no approved pharmacological therapies to effectively lower Lp(a).

    "We are pleased by Novartis progress in advancing the Lp(a) HORIZON study and enrolling nearly 4,000 study participants around the world. Pelacarsen represents a potential first-in-class treatment to address a significant unmet need with the potential to become the new standard of care for Lp(a)-driven cardiovascular disease," said Sotirios "Sam" Tsimikas, M.D., senior vice president, clinical development and cardiovascular franchise leader at Ionis, who specializes in Lp(a). "Ionis' vision is that pelacarsen emerges as an effective therapy to improve cardiovascular outcomes through normalizing Lp(a) levels, as there are an estimated eight million people globally living with elevated Lp(a) and cardiovascular disease."

    Data from a Phase 2 study published in the New England Journal of Medicine showed pelacarsen provided potent dose-dependent reductions of Lp(a) compared to placebo, with a favorable safety and tolerability profile in patients who had elevated Lp(a) levels and established CVD. These data support the potential of antisense-mediated reduction of Lp(a) with pelacarsen.

    Ionis earned a $25 million milestone payment from Novartis for achieving 50% enrollment in the pivotal Phase 3 study. In 2017, Novartis entered a collaboration agreement with Ionis for pelacarsen. In February 2019, Novartis exercised an option to license the rights to develop and commercialize pelacarsen for targeted cardiovascular therapy for $150 million. Under the terms of the agreement, Novartis is exclusively responsible for worldwide development and commercialization of pelacarsen and Ionis is eligible to receive up to $675 million in regulatory and sales milestones. Ionis is also eligible to receive tiered royalties in the mid-teens to low 20% range on net sales of pelacarsen.

    Additional information about Lp(a) HORIZON may be found at www.ClinicalTrials.gov (NCT04023552). 

    About Lp(a) HORIZON

    Lp(a) HORIZON is a pivotal, global multicenter, double-blind, placebo-controlled pivotal Phase 3 study conducted by Novartis. The trial is designed to support an indication for the reduction of cardiovascular risk in patients with established CVD and elevated Lp(a) with 80 mg of pelacarsen administered monthly via subcutaneous administration. The study has a targeted enrollment of 7,680 participants. The estimated study completion date is in 2024.

    The primary objectives of the trial are to demonstrate superiority compared to placebo in reducing the risk of expanded MACE (major adverse cardiac events such as cardiovascular death, non-fatal myocardial infarction, non-fatal stroke and urgent coronary re-vascularization requiring hospitalization) in the overall study population with established CVD and Lp(a) ≥ 70 mg/dL, and in the population with Lp(a) ≥ 90 mg/dL.

    About pelacarsen

    Pelacarsen, licensed by Novartis for exclusive worldwide development and commercialization, is an investigational antisense medicine designed to reduce apolipoprotein(a) production in the liver to offer a direct approach for reducing circulating lipoprotein(a), or Lp(a), an atherogenic, pro-inflammatory and thrombogenic lipoprotein that induces additional cardiovascular risk independent of LDL-cholesterol, in patients already treated with LDL-C-lowering therapies (such as statins or PCSK9 inhibitors). Elevated Lp(a) is recognized as an independent, genetic cause of coronary artery disease, heart attack, stroke and peripheral arterial disease. Currently, there is no effective drug therapy to specifically and robustly lower elevated levels of Lp(a). Lp(a) levels are determined at birth and, therefore, lifestyle modification, including diet and exercise, does not impact Lp(a) levels. Even patients with LDL-C lowered to target levels (<70 mg/dL) remain at high-risk of cardiovascular events if they have high levels of Lp(a).

    Pelacarsen is being developed for patients who are at significant risk of CVD because of their elevated Lp(a).

    About Lp(a)

    Lp(a) is a lipoprotein particle assembled in the liver that consists of an LDL-C-like particle and apolipoprotein(a). Lp(a) is considered a key driver for cardiovascular disease due to its association with an increased risk of coronary heart disease. There is evidence that elevated Lp(a) levels may contribute directly to coronary artery disease, heart attacks, strokes and peripheral artery disease. Lp(a) levels in the blood can vary greatly between individuals primarily due to genetic variations and do not correlate with LDL-C levels. Because elevated Lp(a) is a genetically determined condition that is not responsive to lifestyle changes, patients are unable to adequately control their Lp(a) levels through improved diet or increased physical activity. Moreover, current therapies are not able to normalize Lp(a) levels in patients who have high Lp(a). Although Lp(a) can be measured by a variety of reliable and readily available simple tests, the lack of drugs to effectively lower Lp(a) has made treating patients with Lp(a)-driven cardiovascular disease difficult.

    About Ionis Pharmaceuticals, Inc.

    For more than 30 years, Ionis has been the leader in RNA-targeted therapy, pioneering new markets and changing standards of care with its novel antisense technology. Ionis currently has three marketed medicines and a premier late-stage pipeline highlighted by industry-leading neurological and cardiometabolic franchises. Our scientific innovation began and continues with the knowledge that sick people depend on us, which fuels our vision of becoming one of the most successful biotechnology companies.

    To learn more about Ionis, visit www.ionispharma.com and follow us on twitter @ionispharma.

    Ionis' Forward-looking Statement

    This press release includes forward-looking statements regarding Ionis' business and the therapeutic and commercial potential of Ionis' technologies, pelacarsen and other products in development. Any statement describing Ionis' goals, expectations, financial or other projections, intentions or beliefs is a forward-looking statement and should be considered an at-risk statement. Such statements are subject to certain risks and uncertainties, including those related to the impact COVID-19 could have on our business, and including but not limited to those related to our commercial products and the medicines in our pipeline, and particularly those inherent in the process of discovering, developing and commercializing medicines that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such medicines. Ionis' forward-looking statements also involve assumptions that, if they never materialize or prove correct, could cause its results to differ materially from those expressed or implied by such forward-looking statements.

    Although Ionis' forward-looking statements reflect the good faith judgment of its management, these statements are based only on facts and factors currently known by Ionis. As a result, you are cautioned not to rely on these forward-looking statements. These and other risks concerning Ionis' programs are described in additional detail in Ionis' annual report on Form 10-K for the year ended December 31, 2020, and the most recent Form 10-Q quarterly filing, which are on file with the SEC. Copies of these and other documents are available from the Company.

     

    Cision View original content to download multimedia:https://www.prnewswire.com/news-releases/lpa-horizon-achieves-50-enrollment-in-trial-to-assess-the-safety-and-efficacy-of-pelacarsen-in-reducing-recurrent-cardiovascular-events-301346042.html

    SOURCE Ionis Pharmaceuticals, Inc.

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  4. BASEL, SWITZERLAND

    --News Direct--

    BASEL, SWITZERLAND, August 2, 2021 /3BL Media/ - Novartis and children's rights organization Save the Children are launching their first common health project tackling child mortality in Kenya's Kibera and Mathare slums. This is a first step in their collaboration with the objective of providing affordable and effective healthcare to the most deprived children in Kenya. The project will help improve the case management of common childhood diseases like pneumonia through trainings of community health volunteers in Nairobi.

    Dr. Lutz Hegemann, Group Head of Corporate Affairs and Global Health at Novartis says: "Novartis is committed to delivering sustainable healthcare solutions to help transform the lives and health

    BASEL, SWITZERLAND

    --News Direct--

    BASEL, SWITZERLAND, August 2, 2021 /3BL Media/ - Novartis and children's rights organization Save the Children are launching their first common health project tackling child mortality in Kenya's Kibera and Mathare slums. This is a first step in their collaboration with the objective of providing affordable and effective healthcare to the most deprived children in Kenya. The project will help improve the case management of common childhood diseases like pneumonia through trainings of community health volunteers in Nairobi.

    Dr. Lutz Hegemann, Group Head of Corporate Affairs and Global Health at Novartis says: "Novartis is committed to delivering sustainable healthcare solutions to help transform the lives and health of underserved populations. We are excited to join forces with Save the Children to help reduce the number of children under the age of 5 dying from preventable and treatable diseases."

    Adrian Förster, CEO of Save the Children Switzerland says: "This project is the start of a powerful partnership that will improve the living conditions of the most deprived children. We see that high-density urban centres are very challenging for children and their ability to grow up healthy. We are very happy to join our expertise and our capacity with Novartis to improve the access to medical treatment and the health of children in this particular context."

    The planned health project is located in Kenya's urban slums including Kibera and Mathare in Nairobi County and aims to improve access to medical support. Local community and health volunteers are trained to diagnose and treat common diseases in children. Malaria, pneumonia, diarrhea and malnutrition cause the majority of preventable deaths among children under the age of five. Through the project, Novartis and Save the Children aim at tackling under five mortality and improving support for the most deprived children in urban, high-density centres.

    Mathare and Kibera are home to thousands of the urban poor, living in deprived sanitary conditions and inadequate shelter. Inhabitants of these slums lack access to basic water and sanitation, paucity of health care facilities and vulnerability in getting infectious diseases. This holistic program, targeting the main causes of morbidity and mortality amongst children, will go a long way in reducing the incidence of communicable diseases. The project also seeks to improve the social economic conditions of the communities, through timely response, accessing care and economic empowerment through a community savings scheme. Health education, prevention of disease and early treatment are some of the key interventions that will bring change in the community. This program supplements what other organizations are doing to improve the lives of the urban poor.

    Disclaimer

    This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this media update, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this media update will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.

    About Novartis

    Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

    Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews

    For Novartis multimedia content, please visit https://www.novartis.com/news/media-library

    For questions about the site or required registration, please contact media.relations@novartis.com

    # # #

    Novartis Media Relations

    E-mail: media.relations@novartis.com

    Antonio Ligi

    Novartis External Communications

    +41 79 723 3681 (mobile)

    antonio.ligi@novartis.com

    Carolyn Canham

    Novartis Corporate Affairs & Global Health Communications

    +41 79 334 4325 (mobile)

    carolyn.canham@novartis.com

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  5. BASEL, SWITZERLAND

    --News Direct--

    BASEL, SWITZERLAND June 23, 2021 /3BL Media/ -— Novartis and Hewlett Packard Enterprise (HPE) today announced a collaboration that aims to accelerate the use of data and digital technologies within Novartis efforts to reimagine global health and improve access to healthcare and medicines.

    The collaboration will focus on three global health enablers: identifying and integrating complex data sources related to health; advancing the application of artificial intelligence, machine learning and geo-spatial analytics to these data; and expanding access to technology in remote and underserved locations.

    "Novartis is committed to applying its expertise and full organizational capability to address major, unresolved global…

    BASEL, SWITZERLAND

    --News Direct--

    BASEL, SWITZERLAND June 23, 2021 /3BL Media/ -— Novartis and Hewlett Packard Enterprise (HPE) today announced a collaboration that aims to accelerate the use of data and digital technologies within Novartis efforts to reimagine global health and improve access to healthcare and medicines.

    The collaboration will focus on three global health enablers: identifying and integrating complex data sources related to health; advancing the application of artificial intelligence, machine learning and geo-spatial analytics to these data; and expanding access to technology in remote and underserved locations.

    "Novartis is committed to applying its expertise and full organizational capability to address major, unresolved global health challenges. With Hewlett Packard Enterprise, we will seek to leverage data, digital and technology capabilities to maximize this impact," said Lutz Hegemann, Group Head of Corporate Affairs and Global Health at Novartis.

    Data-related insights are essential to improve access to healthcare and medicines, especially in low-resource settings, because they enable decision makers to target interventions to achieve the greatest impact. However, data is often unavailable, outdated, incomplete or not in digital form. Novartis and HPE therefore aim to identify and integrate diverse data sources to enable real-time disease insights to inform targeted response strategies.

    Disease surveillance solution to help remediate the growing threat of dengue fever

    The first use case for the partnership will seek to develop a disease surveillance solution for dengue fever, initially focusing on India. More than 3.9 billion people in over 129 countries are at risk of contracting dengue fever, with an estimated 400 million cases and 40,000 deaths each year. The World Health Organization has identified dengue fever as one of the top ten global health threats.

    Together, Novartis and HPE aspire to help remediate the growing threat of dengue fever by developing publicly available insights to help authorities proactively deploy response strategies targeting at-risk populations. The resulting real-world evidence will complement the drug-discovery efforts of the Novartis Institute for Tropical Diseases, which is dedicated to finding new medicines to treat neglected, infectious diseases including Dengue fever.

    Disclaimer

    This media update contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as "potential," "can," "will," "plan," "may," "could," "would," "expect," "anticipate," "look forward," "believe," "committed," "investigational," "pipeline," "launch," "to accelerate," "advancing," "to target," or similar terms, or by express or implied discussions regarding the activities and efforts described in this media update. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the activities and efforts described in this media update, including the collaboration with HPE, will achieve any of its intended goals, or succeed in the expected time frame or at all. In particular, our expectations regarding the collaboration with HPE could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG's current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this media update as of this date and does not undertake any obligation to update any forward-looking statements contained in this media update as a result of new information, future events or otherwise.

    About Novartis

    Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

     

    Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews

    For Novartis multimedia content, please visit https://www.novartis.com/news/media-library

    For questions about the site or required registration, please contact media.relations@novartis.com

     

    # # #

    Novartis Media Relations

    E-mail: media.relations@novartis.com

     

    Name

    Antonio Ligi

    Novartis External Communications

    +41 79 723 3681 (mobile)

    antonio.ligi@novartis.com

    Name

    Katrina Lucking

    Novartis Global Health Communications

    +41 79 484 7625 (mobile)

    katrina.lucking@novartis.com

     

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