International
AstraZeneca 2020: Driven by Covid-19
AstraZeneca 2020: Driven by Covid-19
AstraZeneca has been advancing its scientific research, particularly in the area of oncology, in a bid to raise a whole new crop of blockbusters, but the quest for a vaccine against SARS-CoV-2 has made the company shift into a high-speed tangent.
AstraZeneca PLC
1 Francis Crick Avenue
Cambridge Biomedical Campus
Cambridge CB2 0AA UK
Telephone: +44 (0)20 3749 5000
Website: astrazeneca.com
FINANCIAL PERFORMANCE
(All figures are in millions of dollars, except EPS)
2019
Revenue $24,384
Net income $1,227
Diluted EPS $1.03
R&D expense $6,059
1H 2020
Revenue $12,629
Net income $1,488
Diluted EPS $1.17
R&D expense $2,777
BEST-SELLING Rx PRODUCTS
(All sales are in millions of dollars)
2019
Tagrisso $3,189
Symbicort $2,495
Brilinta $1,581
Farxiga $1,543
Nexium $1,483
Imfinzi $1,469
Pulmicort $1,466
Crestor $1,278
Lynparza $1,198
Faslodex $892
Zoladex $813
Toprol-XL/Seloken $760
Fasenra $704
Bydureon $549
Onglyza $527
1H 2020
Tagrisso $2,016
Symbicort $1,442
Imfinzi $954
Lynparza $951
Farxiga $850
Brilinta $845
Nexium $731
Crestor $583
Zoladex $484
Pulmicort $477
Outcomes Creativity Index Score: 11
Manny Awards – N/A
Cannes Lions – N/A
LIA: Health & Wellness – N/A
Clio Health – 1
One Show: HW&P – N/A
MM&M Awards – 1
Global Awards – 5
Creative Floor Awards – 4
“In the first full year of our return to Product Sales growth, we made good progress in line with our strategy. We anticipate 2020 to be another year of progress,” declared AstraZeneca’s chairman, Leif Johansen, in the beginning of 2020.
CEO Pascal Soriot also expressed optimism about AstraZeneca’s future. “We are now maximizing and exploring the full potential of our leading medicines, rapidly advancing the next wave of science and positioning the company for continued success,” he stated.
And then in February and March came COVID-19. As the pandemic forced country after country to shut down, AstraZeneca, like many other major companies in the pharma industry, had to contend with having a remote workforce and pressure to produce a vaccine against the disease. As results for the first quarter came out, however, Soriot remained positive.
“I could not be prouder of how the AstraZeneca team has responded to the challenges of COVID-19,” he says. “We moved quickly to maintain continuity of care, contribute to society, and use our scientific expertise to fight the pandemic. We hope our efforts to protect organs from damage, mitigate the cytokine storm and the associated hyperinflammatory state, and target the virus prove to be successful.”
The race – and a stumble – for a vaccine
In April, AstraZeneca announced that it had entered a collaboration with Oxford University to produce the university’s recombinant adenovirus vaccine aimed at preventing COVID-19 infection from SARS-CoV-2.
AstraZeneca is responsible for the worldwide manufacturing and distribution of the vaccine, ChAdOx1 nCoV-19, now known as AZD1222. The vaccine uses a viral vector based on a weakened version of the common cold (adenovirus) containing the genetic material of SARS-CoV-2 spike protein. After vaccination, the surface spike protein is produced, which primes the immune system to attack COVID-19 if it later infects the body. By May, the vaccine was in a Phase II/III UK trial in about 10,000 adult volunteers.
In June, AstraZeneca reached an agreement with Europe’s Inclusive Vaccines Alliance (IVA), spearheaded by Germany, France, Italy and the Netherlands, to supply up to 400 million doses of the University of Oxford’s COVID-19 vaccine, with deliveries starting by the end of 2020. “This agreement will ensure that hundreds of millions of Europeans have access to Oxford University’s vaccine following approval,” Soriot stated. “With our European supply chain due to begin production soon, we hope to make the vaccine available widely and rapidly.”
The company had already reached agreements with the United Kingdom, the United States, the Coalition for Epidemic Preparedness Innovations, and Gavi the Vaccine Alliance for 700 million doses, and it agreed to a license with the Serum Institute of India for the supply of an additional 1 billion doses, principally for low- and middle-income countries. AstraZeneca executives say total manufacturing capacity currently stands at 2 billion doses.
As of the end of August, the vaccine was in U.S. Phase III trials, across adults of all age groups. The trial, D8110C00001, is funded by the Biomedical Advanced Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health and Human Services (HHS) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health, and led by AstraZeneca. The NIAID-supported COVID-19 Prevention Network (CoVPN) is participating in the trial.
U.S. trial centers are recruiting up to 30,000 adults aged 18 years and older from diverse racial, ethnic and geographic groups who are healthy or have stable underlying medical conditions, including those living with HIV, and who are at increased risk of infection from the SARS-CoV-2 virus. Centers outside the United States are included based on predicted transmission rates of the virus and executives states that sites in Peru and Chile are planned to initiate recruitment shortly.
Participants are being randomized to receive two doses of either AZD1222 or a saline control, four weeks apart, with twice as many participants receiving the potential vaccine than the saline control. The trial is assessing efficacy and safety of the vaccine in all participants, and local and systemic reactions and immune responses will be assessed in 3,000 participants.
AstraZeneca stated that clinical development of AZD1222 is progressing globally with late-stage clinical trials under way in the UK, Brazil, South Africa, India and Japan with trials planned to start in Russia. These trials, together with the U.S. Phase III program, will enroll up to 50,000 participants globally. Results from the late-stage trials are expected in 2020.
The company ran into some trouble in the progress of the vaccine in September. On September 9, AstraZeneca issued a statement that said, “a standard review process has been triggered, leading to the voluntary pause of vaccination across all trials to allow an independent committee to review the safety data of a single event of an unexplained illness that occurred in the UK Phase III trial.”
Company executives called it “a routine action, which has to happen whenever there is a potentially unexplained illness in one of the trials, while it is investigated, ensuring we maintain the integrity of the trials.”
According to news reports, the trial participant was a woman in the United Kingdom who experienced neurological symptoms consistent with a rare but serious spinal inflammatory disorder called transverse myelitis. Soriot disclosed the details in a private call with investors, reports said. The woman recovered and was discharged from the hospital a few days after the hold was announced.
By September 12, clinical trials had resumed in the United Kingdom, following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so. As of October 2, the clinical trials had also resumed in Japan, Brazil, South Africa and India while discussions with U.S. authorities continued.
There has been increasing political pressure, particularly in the United States, to get a vaccine out sooner than later. In September, Soriot and the CEOs of BioNTech, GlaxoSmithKline, Johnson & Johnson, Merck & Co., Moderna, Novavax, Pfizer and Sanofi signed a pledge vowing to uphold the integrity of the scientific process as they work towards potential global regulatory filings and approvals of the first COVID-19 vaccines. The CEOs promised that their companies would always make the safety and well-being of vaccinated individuals their top priority; continue to adhere to high scientific and ethical standards regarding the conduct of clinical trials and the rigor of manufacturing processes; only submit for approval or emergency use authorization after demonstrating safety and efficacy through a Phase III clinical study that is designed and conducted to meet requirements of expert regulatory authorities such as FDA; and work to ensure a sufficient supply and range of vaccine options, including those suitable for global access.
“We believe this pledge will help ensure public confidence in the rigorous scientific and regulatory process by which COVID-19 vaccines are evaluated and may ultimately be approved,” the CEOs said.
In addition to a vaccine, AstraZeneca continues to explore treatments for COVID-19 patients. In August, the company initiated a Phase I trial for AZD7442, a combination of two monoclonal antibodies (mAbs) in development for the prevention and treatment of COVID-19. The drug combines two mAbs derived from convalescent patients with SARS-CoV-2 infection. Discovered by Vanderbilt University Medical Center and licensed to AstraZeneca in June 2020, the mAbs were optimized by AstraZeneca with half-life extension and reduced Fc receptor binding. The theory is that the half-life extended mAbs should afford at least six months of protection from COVID-19. In a recent Nature publication, the mAbs were shown preclinically to block the binding of the SARS-CoV-2 virus to host cells and protect against infection in cell and animal models of disease.
Calquence (acalabrutinib), a Bruton’s tyrosine kinase (BTK) inhibitor, showed reduced markers of inflammation and improved clinical outcomes of patients with severe COVID-19 disease, according to results published in Science Immunology during June.
Calquence is a next-generation, selective BTK inhibitor approved in the United States for the treatment of certain hematological malignancies. The drug is in a program called CALAVI, comprising two randomized, open-label, multicenter, global trials evaluating the efficacy and safety of Calquence with best supportive care (BSC) versus BSC alone in patients hospitalized with respiratory complications of COVID-19.
These trials are evaluating the addition of Calquence to current BSC in patients who are hospitalized but not on assisted ventilation. These trials are being conducted around the world: one trial in the United States and one trial outside of the United States, including Europe, Japan and South America. The primary efficacy endpoint measures the number of patients alive and free of respiratory failure following treatment.
Financial results
The company generated total revenue of $24.38 billion in 2019, 10.4 percent more than the previous year. According to management, product sales grew by 12 percent to $23.57 billion, driven by progress in all three of AstraZeneca’s therapy areas: Oncology; Cardiovascular, Renal & Metabolism; and Respiratory.
“Underpinning our return to growth has been our science-led innovation,” Soriot says. With the launches of Breztri Aerosphere for COPD and Enhertu for breast cancer in 2019, and the launch of roxadustat for anemia in 2020, the total number of new medicines launched since 2013 is 12 as of 2020.
2019 net income was reported at $2.92 billion, 14 percent less than in the previous year. Earnings per share were $1.03, 39.4 percent less than in 2018.
For the first half of 2020, revenue totaled $12.63 billion, 12 percent more than in the same period of 2019. Net income was $1.49 billion compared with $670 million during first-half 2019. Earnings per share were $1.17 compared with 56 cents in first-half 2019.
AstraZeneca has five platforms for product sales: Oncology; Emerging Markets; Respiratory; New CVRM (including Brilinta and Diabetes); and Japan. Oncology sales were $8.67 billion in 2019, 44 percent more than in the previous year.
Emerging Markets sales in 2019 were $8.17 billion, 18 percent more than in 2018. Respiratory sales grew 10 percent to $5.39 billion. Sales in New CVRM increased 9 percent to $4.38 billion. Sales in Japan grew 27 percent to $2.55 billion.
In 2019, the company’s top-selling products with sales of more than $500 million were Tagrisso, Symbicort, Brilinta, Farxiga, Nexium, Imfinzi, Pulmicort, Crestor, Lynparza, Faslodex, Zoladex, Toprol-XL/ Seloken, Fasenra, Bydureon, and Onglyza.
The oncology drug Tagrisso rose to become AstraZeneca’s top-selling product in 2019, generating $3.19 billion, compared with $1.86 billion in 2018. In the first half of 2020, sales grew to $2.02 billion, 43% more than in the same period of 2019. As of the first half of 2020, Tagrisso has received regulatory approval in 86 countries, including the United States, China, in the EU, and Japan for the first-line treatment of patients with EGFRm non-small cell lung cancer. To date, reimbursement has been granted in 28 countries in this setting, with further reimbursement decisions anticipated in the second half of the year. Company executives say this follows Tagrisso’s initial approval in 89 countries, including the United States, China, in the EU, and Japan for the treatment of patients with EGFR T790M35-mutated nonsmall cell lung cancer.
Slipping to No. 2 for 2019 was AstraZeneca’s former top seller, the lung drug Symbicort, which had sales of $2.5 billion, 3 percent less than in 2018. In the first half of 2020, sales were $1.44 billion, 23 percent more than in first-half 2019. An authorized generic version of Symbicort was launched in the United States by the company’s collaborator, Prasco, in January 2020. Management says Symbicort continued its global market-volume and value leadership within the inhaled corticosteroid/long-acting beta agonist (LABA) class. Emerging Markets sales increased by 10 percent in the 2020 first half to $290 million, reflecting particularly strong performances in China and the Middle East and Africa. In Europe, sales increased by 1 percent in the half to $356 million. In Japan, sales rose 53 percent to $102 million, supported by the continued effect of AstraZeneca regaining full rights, following termination in 2019 of the Astellas co-promotion agreement; the increase was despite the market entry of a generic medicine.
The third best-selling product in 2019 was the heart disease and stroke drug Brilinta. The drug generated $1.58 billion, 20 percent more than the previous year. First-half 2020 sales were $845 million, 15 percent more than the first half of 2019. Patient uptake continued in the treatment of acute coronary syndrome and high-risk post-myocardial infarction (MI). Emerging Markets sales increased by 34 percent to $291 million. U.S. sales, at $351 million, represented an increase of 9 percent, driven primarily by increasing levels of demand in both hospital and retail settings, as well as a lengthening in the average-weighted duration of treatment, reflecting the growing impact of 90-day prescriptions. In Europe, where the drug is marketed as Brilique, sales increased by 2 percent in the half to $173 million, mainly reflecting performances in Germany, France and Italy.
The fourth best-selling drug in 2019 was Farxiga for diabetes, chronic kidney disease, and heart failure. Sales grew by 11 percent to $1.54 billion. For the first half of 2020, sales came in at $848 million, 17 percent more than in the same period last year. Emerging Markets sales increased by 49 percent to $306 million. In China, Farxiga was admitted to the NRDL with effect from the start of 2020. AstraZeneca says this adversely impacted pricing, but this effect was more than offset by the volume benefit derived from the launch within the NRDL listing. U.S. sales declined by 12 percent to $237 million, reflecting the impact of competitive activity on pricing and the mix of channel sales that outweighed an encouraging level of volume growth. Sales in Europe increased by 25 percent, partly reflecting growth in the class and an acceleration of new-to-brand prescriptions. In Japan, sales to collaborator Ono Pharmaceutical Co. Ltd., which records in-market sales, increased by 14 percent to $43 million.
The fifth best-selling drug for AstraZeneca in 2020 was the proton-pump inhibitor Nexium, which slipped almost 13 percent to $1.48 billion. First-half 2020 sales were $731 million, a decline of 5 percent. Emerging Markets sales of Nexium were stable, increasing by 4 percent at $370 million. In Europe, first-half sales increased by 20 percent to $38 million, while sales in the U.S. declined by 30 percent to $89 million and in Japan, where AstraZeneca collaborates with Daiichi Sankyo, they fell by 5 percent to $204 million.
Coming in at No. 6 in 2019 sales was the cancer drug Imfinzi, which grew to $1.47 billion from $633 million in the previous year. Sales in the first half of 2020 amounted to $954 million, a 51 percent improvement compared with first-half 2019. The drug has received regulatory approval in 62 countries, including the United States, China, in the EU, and Japan for the treatment of patients with unresectable, Stage III NSCLC whose disease has not progressed following platinum-based chemoradiation therapy. The number of reimbursements increased to 27 in the 2020 first half. During the period, Imfinzi was also approved for the treatment of ES-SCLC patients in eight countries, including the United States. The medicine is already approved for the second-line treatment of patients with locally advanced or metastatic urothelial carcinoma (bladder cancer) in 17 countries, including the United States.
The seventh best-selling drug was the asthma product Pulmicort, which generated $1.47 billion in sales in 2019, an increase of 14 percent from the previous year. Growth was driven by Emerging Markets, in which China stood out. Sales in the first half of 2020 were $477 million, a decrease of 33 percent. Sales of Pulmicort, of which the majority were in China, were adversely impacted in the half by the effects of COVID-19. Pulmicort sales in Emerging Markets declined by 36 percent to $371 million in the first half and by 78 percent to $58 million in the second quarter.
Crestor, which was AstraZeneca’s top-selling drug for a number of years before patent expirations took effect, declined to No. 8 in sales in 2019 at $1.28 billion, 11 percent less than the previous year. The cholesterol drug’s sales in the first half of 2020 totaled $583 million, 10 percent less than in first-half 2019. Sales in Emerging Markets declined by 9 percent to $369 million. According to AstraZeneca, the performance was adversely impacted by the effect of volume-based procurement in China. U.S. sales declined by 17 percent to $45 million. In Europe, sales declined by 13 percent to $65 million, while in Japan, where AstraZeneca collaborates with Shionogi Co. Ltd., sales decreased 5 percent to $81 million.
The ninth best-selling drug for the company in 2019 was the oncology product Lynparza, at $1.2 billion compared with $647 million in 2018. Lynparza has received regulatory approval in 75 countries for the treatment of ovarian cancer and has been approved in 67 countries for the treatment of metastatic breast cancer. The product also is approved in 38 countries, including the United States, for the treatment of pancreatic cancer. By the end of the first half of 2020, Lynparza received regulatory approval in the United States for the second-line treatment of HRRm prostate cancer.
In the first six months of 2020, total Lynparza revenue amounted to $951 million, representing growth of 64 percent. Company management says $135 million of Lynparza Collaboration Revenue, reflecting regulatory-milestone receipts, was recorded in the half. The strong performance was geographically spread, with launches continuing in Emerging Markets and the Established Rest of World region (RoW).
U.S. sales for Lynparza increased by 55 percent, driven by the launch in the 1st-line BRCAm ovarian cancer setting at the end of 2018. Lynparza continued to be the leading medicine in the poly ADP ribose polymerase (PARP)-inhibitor class, as measured by total prescription volumes in both ovarian and breast cancer. Sales in Europe increased by 51 percent to $198 million, reflecting increasing levels of reimbursement and BRCAm-testing rates, as well as successful recent first-line ovarian cancer launches, including in the UK and Germany.
Japan sales of Lynparza during the 2020 first half amounted to $77 million, representing growth of 32 percent. Emerging Markets sales of $120 million, up by 104 percent, were a result of the regulatory approval of Lynparza as a second-line maintenance treatment of patients with ovarian cancer by the China National Medical Products Administration (NMPA) in 2019. Lynparza was admitted to the China NRDL for the same indication, with effect from January 2020.
Pushed down to the No. 10 sales rank for 2019 was the oncology drug Faslodex with sales of $892 million, 13 percent less than in 2018. In the first half of 2020, sales declined 40 percent to $312 million. A bright spot during the half was Emerging Markets, with sales increasing 4 percent to $100 million. U.S. sales, however, declined by 87 percent to $34 million, reflecting the launch in 2019 of multiple generic Faslodex medicines. In Europe, where generic competitor medicines are established, sales increased by 6 percent to $116 million, while in Japan, sales declined by 5 percent to $58 million, driven by a mandated price reduction in the second quarter.
Another “legacy” product, the oncology drug Zoladex, placed at No. 11 in 2019 with $813 million, 8 percent more than in 2018. First-half 2020 sales reached $484 million, representing growth of 22 percent. Emerging Markets sales of Zoladex increased by 22 percent to $288 million, which according to AstraZeneca executives reflects increased use and access in prostate cancer. Sales in Europe rose 5 percent to $68 million. In the Established RoW region, sales declined by 7 percent to $81 million, driven by the effects of increased competition.
The 12th top seller in 2019 was another of AstraZeneca’s legacy products, the heart drug Toprol-XL/Seloken. The product generated $760 million, 7 percent more than in 2018. Sales of the product in first-half 2020 were $395 million, about the same as in first-half 2019.
In April 2019, a Louisiana state court granted AstraZeneca’s motion for summary judgment dismissing a state court civil complaint filed by Louisiana’s attorney general. The complaint accused AstraZeneca of engaging in unlawful monopolization and unfair trade practices in connection with enforcement of its patents for Toprol-XL, causing the state government to pay increased prices for the drug. The court entered judgment in AstraZeneca’s favor. The state appealed the ruling. In July 2020, the Louisiana First Court of Appeals reversed the State Court’s ruling and remanded the case to the State Court.
The 13th best-selling drug for AstraZeneca in 2019 was the eosinophilic asthma product Fasenra. The drug had sales of $704 million compared with $297 million in 2018. In first-half 2020, sales grew 44 percent compared with same-period 2019, to $426 million.
Fasenra has received regulatory approval in 58 countries, including the United States, in the EU, and Japan for treating patients with severe, uncontrolled eosinophilic asthma.
First-half 2020 U.S. sales for Fasenra increased by 31 percent to $272 million, supported by an increase in the self-administration use as a result of COVID-19 restrictions. Fasenra ended the half as the leading novel biologic medicine in the United States, as measured by new-to-brand prescriptions. In Europe, sales of $88 million in the half represented an increase of 96 percent, reflecting a number of successful launches. Sales in Japan increased by 21 percent to $46 million. In the drug’s approved indication and among new patients, Fasenra obtained the leading market share of all novel biologic medicines in the ‘top-five’ European countries and in Japan. In Emerging Markets, sales amounted to $7 million compared with $1 million in first-half 2019.
AstraZeneca’s 14th best seller in 2019 was the diabetes drug Bydureon. Sales slipped about 6 percent to $549 million. Sales in the first half of 2020 were $216 million, 24 percent less than in the first half of last year. Company executives say U.S. sales of $185 million reflected a decline of 21 percent in the half, resulting from competitive pressures and the impact of managed markets. Patients continue to transition from the dual-chamber pen to the BCise device. Bydureon sales in Europe fell by 29 percent to $24 million. Reflecting the recent and potential performance of Bydureon, a $102 million intangible-asset impairment charge was recorded in the half.
No. 15 in 2019 sales was the diabetes drug Onglyza, with $527 million, a decrease of 3 percent. First-half 2020 sales declined 5 percent to $256 million. Sales in Emerging Markets increased by 15 percent to $100 million, driven by the performance in China. U.S. sales declined 12 percent in the half to $105 million, and Europe sales slipped by 21 percent to $29 million. Management says this highlights the broader trend of a shift away from the DPP-4 inhibitor class, and that given the significant future potential of Farxiga, the company will continue to prioritize commercial support over Onglyza.
R&D progress
Soriot says 2019 was another exceptional year for AstraZeneca’s science, with the pipeline producing “overwhelmingly positive” news for patients.
“This included a record number of 63 regulatory events, either submissions or approvals for our medicines in major markets,” he stated. “That performance is backed by a healthy pipeline of high potential medicines, with the number of Phase II and Phase III pipeline progressions indicating our ability to deliver longer-term sustainable growth.”
In 2019, the company had 22 pipeline progressions, and an average of 24 progressions in each of the last four years. For 2019, AstraZeneca spent $6.06 billion on R&D, compared to $5.93 billion during 2018. First-half 2020 R&D costs amounted to $2.78 billion versus $2.62 billion for the first six months of 2019.
“We have a range of clinical trials under way investigating the full potential of our marketed medicines and there are plenty more projects in our pipeline,” Soriot says. “Of course, in pushing the boundaries of science, we sometimes experience setbacks which, in 2019, included disappointing results from the Phase III trial of Imfinzi plus tremelimumab in Stage IV non-small cell lung cancer. Overall, however, we continue to make good progress advancing new and exciting candidate medicines designed to change the practice of medicine and ultimately eliminate cancer as a cause of death.”
The company continues to expand indications for already-approved products, especially Imfinzi. In September, Imfinzi was approved in the EU for the treatment of extensive-stage small cell lung cancer (ES-SCLC) in combination with a choice of chemotherapies, etoposide plus either carboplatin or cisplatin. SCLC is a highly aggressive, fast-growing form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy. Imfinzi was also approved in August in Japan for the same indication. The drug is already approved in the United States to treat ES-SCLC.
Also in August, FDA granted Priority Review to Imfinzi for a less-frequent, fixed-dose regimen for treating the approved indications of non-small cell lung cancer (NSCLC) and bladder cancer. If approved, Imfinzi could be administered intravenously every four weeks at a fixed dose of 1500 mg in unresectable Stage III NSCLC after chemoradiation therapy and previously treated advanced bladder cancer, consistent with the approved dosing in extensive-stage small cell lung cancer.
In July, Tagrisso (osimertinib) was granted Breakthrough Therapy Designation (BTD) by FDA for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent. The FDA granted the BTD based on data from the Phase III ADAURA trial.
In more clinical news from July, detailed results from the ground-breaking Phase III DAPA-CKD trial showed that Farxiga (dapagliflozin) on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular or renal death by 39 percent compared to placebo (p<0.0001) in patients with chronic kidney disease Stages 2-4 and elevated urinary albumin excretion. The results were consistent in patients both with and without type 2 diabetes.
In May 2020, Farxiga was approved in the United States to reduce the risk of cardiovascular death and hospitalization for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without type 2 diabetes (T2D). With that approval, the drug became the first sodium glucose co-transporter 2 (SGLT2) inhibitor approved by the FDA indicated to treat patients with HFrEF (LVEF ≤ 40 percent).
Farxiga is being assessed in patients with heart failure (HF) in the DELIVER (HF with preserved ejection fraction, HFpEF) and DETERMINE (HFrEF and HFpEF) trials, as well as in patients without T2D following an acute myocardial infarction (MI) or heart attack in the DAPA-MI trial – a first of its kind, indication-seeking registry-based randomized controlled trial.
In July, Calquence (acalabrutinib) was recommended for marketing authorization in the European Union for the treatment of adult patients with chronic lymphocytic leukemia (CLL), the most common type of leukemia in adults.
One of AstraZeneca’s new pipeline drugs, nirsevimab for the prevention of RSV in preterm infants, had results of a Phase IIb trial published in The New England Journal of Medicine (NEJM). Nirsevimab is an extended half-life RSV mAb developed by AstraZeneca and Sanofi as a passive immunization, with the potential to provide immunity directly to infants and offer immediate RSV protection.
The trial demonstrated for the first time that a single-dose mAb can significantly reduce medically attended RSV LRTI, including bronchiolitis and pneumonia, in infants throughout the full RSV season.
In the Respiratory area, AstraZeneca received good news in July with the U.S. approval of Breztri Aerosphere (budesonide/glycopyrrolate/for the maintenance treatment of patients with chronic obstructive pulmonary disease.
FDA approval was based on positive results from the Phase III ETHOS trial in which Breztri Aerosphere, a triple-combination therapy, showed a statistically significant reduction in the rate of moderate or severe exacerbations compared with dual-combination therapies Bevespi Aerosphere (glycopyrrolate/formoterol fumarate) and PT009 (budesonide/formoterol fumarate). The approval was also supported by efficacy and safety data from the Phase III KRONOS trial.
The company’s Cardiovascular portfolio got a boost in June when Brilinta (ticagrelor) was approved in the United States to reduce the risk of a first heart attack or stroke in high-risk patients with coronary artery disease (CAD), the most common type of heart disease. The FDA approval was based on positive results from the Phase III THEMIS trial. The trial showed a statistically significant reduction in the primary composite endpoint of major adverse cardiovascular (CV) events at 36 months with aspirin plus Brilinta 60 mg versus aspirin alone in patients with CAD and type 2 diabetes (T2D) at high-risk of a first heart attack or stroke. The primary composite endpoint was driven by a reduction in heart attack and stroke.
In July AstraZeneca announced that FDA has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Brilinta (ticagrelor) for the reduction of subsequent stroke in patients who experienced an acute ischemic stroke or transient ischemic attack (TIA).
The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, was scheduled for the fourth quarter of 2020.
The sNDA was based on results from the Phase III THALES trial, which showed aspirin plus Brilinta 90 mg used twice daily for 30 days resulted in a statistically significant and clinically meaningful reduction in the risk of the primary composite endpoint of stroke and death, compared to aspirin alone.
Lynparza (olaparib) in July won approval in the European Union for patients with germline BRCA-mutated (gBRCAm) metastatic pancreatic cancer. The European Commission approval was based on results from the Phase III POLO trial, which were published in the NEJM. Lynparza is approved in the United States and several other countries as a first-line maintenance treatment for patients with gBRCAm metastatic pancreatic cancer based on the POLO trial, with ongoing regulatory reviews in other regions.
In May, Lynparza gained U.S. approval for patients with homologous recombination repair (HRR) gene-mutated metastatic castration-resistant prostate cancer (mCRPC).
In the area of rare diseases, selumetinib was granted orphan drug designation in Japan in July for the treatment of neurofibromatosis type 1 (NF1). Selumetinib is being jointly developed and commercialized with Merck & C0., known as MSD outside the United States and Canada.
A new round of collaborations
AstraZeneca entered into a new global development and commercialization agreement in July for Daiichi Sankyo’s DS-1062, a proprietary trophoblast cell-surface antigen 2 (TROP2)-directed antibody drug conjugate (ADC) and potential new medicine for treating multiple tumor types.
DS-1062 is in development for the treatment of multiple tumors that commonly express the cell-surface glycoprotein TROP2. Among them, TROP2 is overexpressed in the majority of non-small cell lung cancers and breast cancers, tumor types that have long been a strategic focus for AstraZeneca. This collaboration reflects AstraZeneca’s strategy to invest in antibody drug conjugates as a class, the innovative nature of the technology, and the successful existing collaboration with Daiichi Sankyo.
According to Soriot, “We see significant potential in this antibody drug conjugate in lung as well as in breast and other cancers that commonly express TROP2. We are delighted to enter this new collaboration with Daiichi Sankyo and to build on the successful launch of Enhertu to further expand our pipeline and leadership in Oncology. We now have six potential blockbusters in Oncology with more to come in our early and late pipelines.”
Enhertu was granted accelerated approval in December 2019 in the United States for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting. The drug is a HER2-directed antibody drug conjugate (ADC) and is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform.
In June, AstraZeneca announced a collaboration with Accent Therapeutics to discover, develop and commercialize transformative therapeutics targeting RNA-modifying proteins (RMPs) for the treatment of cancer. This collaboration focuses on targeting RMPs, proteins that control many aspects of RNA biology and represents a new approach for addressing the process disruptions that can lead to cancer and can cause resistance to medicines. Management says the collaboration combines AstraZeneca’s industry-leading expertise bringing forward novel oncology medicines with Accent’s expertise as a leader in the biology, target identification, and drug discovery of RMP-targeting therapies.
According to José Baselga, executive VP, Oncology R&D, AstraZeneca, “The promise of RMP inhibition is a compelling area of exploration for AstraZeneca. With this collaboration, we will seek to identify novel targets and unlock the full potential of our medicines. We believe that Accent team’s expertise in RNA-modifying protein biology and drug discovery complements AstraZeneca’s extensive research and development portfolio.”
Government
Congress’ failure so far to deliver on promise of tens of billions in new research spending threatens America’s long-term economic competitiveness
A deal that avoided a shutdown also slashed spending for the National Science Foundation, putting it billions below a congressional target intended to…
Federal spending on fundamental scientific research is pivotal to America’s long-term economic competitiveness and growth. But less than two years after agreeing the U.S. needed to invest tens of billions of dollars more in basic research than it had been, Congress is already seriously scaling back its plans.
A package of funding bills recently passed by Congress and signed by President Joe Biden on March 9, 2024, cuts the current fiscal year budget for the National Science Foundation, America’s premier basic science research agency, by over 8% relative to last year. That puts the NSF’s current allocation US$6.6 billion below targets Congress set in 2022.
And the president’s budget blueprint for the next fiscal year, released on March 11, doesn’t look much better. Even assuming his request for the NSF is fully funded, it would still, based on my calculations, leave the agency a total of $15 billion behind the plan Congress laid out to help the U.S. keep up with countries such as China that are rapidly increasing their science budgets.
I am a sociologist who studies how research universities contribute to the public good. I’m also the executive director of the Institute for Research on Innovation and Science, a national university consortium whose members share data that helps us understand, explain and work to amplify those benefits.
Our data shows how underfunding basic research, especially in high-priority areas, poses a real threat to the United States’ role as a leader in critical technology areas, forestalls innovation and makes it harder to recruit the skilled workers that high-tech companies need to succeed.
A promised investment
Less than two years ago, in August 2022, university researchers like me had reason to celebrate.
Congress had just passed the bipartisan CHIPS and Science Act. The science part of the law promised one of the biggest federal investments in the National Science Foundation in its 74-year history.
The CHIPS act authorized US$81 billion for the agency, promised to double its budget by 2027 and directed it to “address societal, national, and geostrategic challenges for the benefit of all Americans” by investing in research.
But there was one very big snag. The money still has to be appropriated by Congress every year. Lawmakers haven’t been good at doing that recently. As lawmakers struggle to keep the lights on, fundamental research is quickly becoming a casualty of political dysfunction.
Research’s critical impact
That’s bad because fundamental research matters in more ways than you might expect.
For instance, the basic discoveries that made the COVID-19 vaccine possible stretch back to the early 1960s. Such research investments contribute to the health, wealth and well-being of society, support jobs and regional economies and are vital to the U.S. economy and national security.
Lagging research investment will hurt U.S. leadership in critical technologies such as artificial intelligence, advanced communications, clean energy and biotechnology. Less support means less new research work gets done, fewer new researchers are trained and important new discoveries are made elsewhere.
But disrupting federal research funding also directly affects people’s jobs, lives and the economy.
Businesses nationwide thrive by selling the goods and services – everything from pipettes and biological specimens to notebooks and plane tickets – that are necessary for research. Those vendors include high-tech startups, manufacturers, contractors and even Main Street businesses like your local hardware store. They employ your neighbors and friends and contribute to the economic health of your hometown and the nation.
Nearly a third of the $10 billion in federal research funds that 26 of the universities in our consortium used in 2022 directly supported U.S. employers, including:
A Detroit welding shop that sells gases many labs use in experiments funded by the National Institutes of Health, National Science Foundation, Department of Defense and Department of Energy.
A Dallas-based construction company that is building an advanced vaccine and drug development facility paid for by the Department of Health and Human Services.
More than a dozen Utah businesses, including surveyors, engineers and construction and trucking companies, working on a Department of Energy project to develop breakthroughs in geothermal energy.
When Congress shortchanges basic research, it also damages businesses like these and people you might not usually associate with academic science and engineering. Construction and manufacturing companies earn more than $2 billion each year from federally funded research done by our consortium’s members.
Jobs and innovation
Disrupting or decreasing research funding also slows the flow of STEM – science, technology, engineering and math – talent from universities to American businesses. Highly trained people are essential to corporate innovation and to U.S. leadership in key fields, such as AI, where companies depend on hiring to secure research expertise.
In 2022, federal research grants paid wages for about 122,500 people at universities that shared data with my institute. More than half of them were students or trainees. Our data shows that they go on to many types of jobs but are particularly important for leading tech companies such as Google, Amazon, Apple, Facebook and Intel.
That same data lets me estimate that over 300,000 people who worked at U.S. universities in 2022 were paid by federal research funds. Threats to federal research investments put academic jobs at risk. They also hurt private sector innovation because even the most successful companies need to hire people with expert research skills. Most people learn those skills by working on university research projects, and most of those projects are federally funded.
High stakes
If Congress doesn’t move to fund fundamental science research to meet CHIPS and Science Act targets – and make up for the $11.6 billion it’s already behind schedule – the long-term consequences for American competitiveness could be serious.
Over time, companies would see fewer skilled job candidates, and academic and corporate researchers would produce fewer discoveries. Fewer high-tech startups would mean slower economic growth. America would become less competitive in the age of AI. This would turn one of the fears that led lawmakers to pass the CHIPS and Science Act into a reality.
Ultimately, it’s up to lawmakers to decide whether to fulfill their promise to invest more in the research that supports jobs across the economy and in American innovation, competitiveness and economic growth. So far, that promise is looking pretty fragile.
This is an updated version of an article originally published on Jan. 16, 2024.
Jason Owen-Smith receives research support from the National Science Foundation, the National Institutes of Health, the Alfred P. Sloan Foundation and Wellcome Leap.
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What’s Driving Industrial Development in the Southwest U.S.
The post-COVID-19 pandemic pipeline, supply imbalances, investment and construction challenges: these are just a few of the topics address by a powerhouse…
The post-COVID-19 pandemic pipeline, supply imbalances, investment and construction challenges: these are just a few of the topics address by a powerhouse panel of executives in industrial real estate this week at NAIOP’s I.CON West in Long Beach, California. Led by Dawn McCombs, principal and Denver lead industrial specialist for Avison Young, the panel tackled some of the biggest issues facing the sector in the Western U.S.
Starting with the pandemic in 2020 and continuing through 2022, McCombs said, the industrial sector experienced a huge surge in demand, resulting in historic vacancies, rent growth and record deliveries. Operating fundamentals began to normalize in 2023 and construction starts declined, certainly impacting vacancy and absorption moving forward.
“Development starts dropped by 65% year-over-year across the U.S. last year. In Q4, we were down 25% from pre-COVID norms,” began Megan Creecy-Herman, president, U.S. West Region, Prologis, noting that all of that is setting us up to see an improvement of fundamentals in the market. “U.S. vacancy ended 2023 at about 5%, which is very healthy.”
Vacancies are expected to grow in Q1 and Q2, peaking mid-year at around 7%. Creecy-Herman expects to see an increase in absorption as customers begin to have confidence in the economy, and everyone gets some certainty on what the Fed does with interest rates.
“It’s an interesting dynamic to see such a great increase in rents, which have almost doubled in some markets,” said Reon Roski, CEO, Majestic Realty Co. “It’s healthy to see a slowing down… before [rents] go back up.”
Pre-pandemic, a lot of markets were used to 4-5% vacancy, said Brooke Birtcher Gustafson, fifth-generation president of Birtcher Development. “Everyone was a little tepid about where things are headed with a mediocre outlook for 2024, but much of this is normalizing in the Southwest markets.”
McCombs asked the panel where their companies found themselves in the construction pipeline when the Fed raised rates in 2022.
In Salt Lake City, said Angela Eldredge, chief operations officer at Price Real Estate, there is a typical 12-18-month lead time on construction materials. “As rates started to rise in 2022, lots of permits had already been pulled and construction starts were beginning, so those project deliveries were in fall 2023. [The slowdown] was good for our market because it kept rates high, vacancies lower and helped normalize the market to a healthy pace.”
A supply imbalance can stress any market, and Gustafson joked that the current imbalance reminded her of a favorite quote from the movie Super Troopers: “Desperation is a stinky cologne.” “We’re all still a little crazed where this imbalance has put us, but for the patient investor and owner, there will be a rebalancing and opportunity for the good quality real estate to pass the sniff test,” she said.
At Bircher, Gustafson said that mid-pandemic, there were predictions that one billion square feet of new product would be required to meet tenant demand, e-commerce growth and safety stock. That transition opened a great opportunity for investors to run at the goal. “In California, the entitlement process is lengthy, around 24-36 months to get from the start of an acquisition to the completion of a building,” she said. Fast forward to 2023-2024, a lot of what is being delivered in 2024 is the result of that chase.
“Being an optimistic developer, there is good news. The supply imbalance helped normalize what was an unsustainable surge in rents and land values,” she said. “It allowed corporate heads of real estate to proactively evaluate growth opportunities, opened the door for contrarian investors to land bank as values drop, and provided tenants with options as there is more product. Investment goals and strategies have shifted, and that’s created opportunity for buyers.”
“Developers only know how to run and develop as much as we can,” said Roski. “There are certain times in cycles that we are forced to slow down, which is a good thing. In the last few years, Majestic has delivered 12-14 million square feet, and this year we are developing 6-8 million square feet. It’s all part of the cycle.”
Creecy-Herman noted that compared to the other asset classes and opportunities out there, including office and multifamily, industrial remains much more attractive for investment. “That was absolutely one of the things that underpinned the amount of investment we saw in a relatively short time period,” she said.
Market rent growth across Los Angeles, Inland Empire and Orange County moved up more than 100% in a 24-month period. That created opportunities for landlords to flexible as they’re filling up their buildings. “Normalizing can be uncomfortable especially after that kind of historic high, but at the same time it’s setting us up for strong years ahead,” she said.
Issues that owners and landlords are facing with not as much movement in the market is driving a change in strategy, noted Gustafson. “Comps are all over the place,” she said. “You have to dive deep into every single deal that is done to understand it and how investment strategies are changing.”
Tenants experienced a variety of challenges in the pandemic years, from supply chain to labor shortages on the negative side, to increased demand for products on the positive, McCombs noted.
“Prologis has about 6,700 customers around the world, from small to large, and the universal lesson [from the pandemic] is taking a more conservative posture on inventories,” Creecy-Herman said. “Customers are beefing up inventories, and that conservatism in the supply chain is a lesson learned that’s going to stick with us for a long time.” She noted that the company has plenty of clients who want to take more space but are waiting on more certainty from the broader economy.
“E-commerce grew by 8% last year, and we think that’s going to accelerate to 10% this year. This is still less than 25% of all retail sales, so the acceleration we’re going to see in e-commerce… is going to drive the business forward for a long time,” she said.
Roski noted that customers continually re-evaluate their warehouse locations, expanding during the pandemic and now consolidating but staying within one delivery day of vast consumer bases.
“This is a generational change,” said Creecy-Herman. “Millions of young consumers have one-day delivery as a baseline for their shopping experience. Think of what this means for our business long term to help our customers meet these expectations.”
McCombs asked the panelists what kind of leasing activity they are experiencing as a return to normalcy is expected in 2024.
“During the pandemic, shifts in the ports and supply chain created a build up along the Mexican border,” said Roski, noting border towns’ importance to increased manufacturing in Mexico. A shift of populations out of California and into Arizona, Nevada, Texas and Florida have resulted in an expansion of warehouses in those markets.
Eldridge said that Salt Lake City’s “sweet spot” is 100-200 million square feet, noting that the market is best described as a mid-box distribution hub that is close to California and Midwest markets. “Our location opens up the entire U.S. to our market, and it’s continuing to grow,” she said.
The recent supply chain and West Coast port clogs prompted significant investment in nearshoring and port improvements. “Ports are always changing,” said Roski, listing a looming strike at East Coast ports, challenges with pirates in the Suez Canal, and water issues in the Panama Canal. “Companies used to fix on one port and that’s where they’d bring in their imports, but now see they need to be [bring product] in a couple of places.”
“Laredo, [Texas,] is one of the largest ports in the U.S., and there’s no water. It’s trucks coming across the border. Companies have learned to be nimble and not focused on one area,” she said.
“All of the markets in the southwest are becoming more interconnected and interdependent than they were previously,” Creecy-Herman said. “In Southern California, there are 10 markets within 500 miles with over 25 million consumers who spend, on average, 10% more than typical U.S. consumers.” Combined with the port complex, those fundamentals aren’t changing. Creecy-Herman noted that it’s less of a California exodus than it is a complementary strategy where customers are taking space in other markets as they grow. In the last 10 years, she noted there has been significant maturation of markets such as Las Vegas and Phoenix. As they’ve become more diversified, customers want to have a presence there.
In the last decade, Gustafson said, the consumer base has shifted. Tenants continue to change strategies to adapt, such as hub-and-spoke approaches. From an investment perspective, she said that strategies change weekly in response to market dynamics that are unprecedented.
McCombs said that construction challenges and utility constraints have been compounded by increased demand for water and power.
“Those are big issues from the beginning when we’re deciding on whether to buy the dirt, and another decision during construction,” Roski said. “In some markets, we order transformers more than a year before they are needed. Otherwise, the time comes [to use them] and we can’t get them. It’s a new dynamic of how leases are structured because it’s something that’s out of our control.” She noted that it’s becoming a bigger issue with electrification of cars, trucks and real estate, and the U.S. power grid is not prepared to handle it.
Salt Lake City’s land constraints play a role in site selection, said Eldridge. “Land values of areas near water are skyrocketing.”
The panelists agreed that a favorable outlook is ahead for 2024, and today’s rebalancing will drive a healthy industry in the future as demand and rates return to normalized levels, creating opportunities for investors, developers and tenants.
This post is brought to you by JLL, the social media and conference blog sponsor of NAIOP’s I.CON West 2024. Learn more about JLL at www.us.jll.com or www.jll.ca.
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Analyst reviews Apple stock price target amid challenges
Here’s what could happen to Apple shares next.
They said it was bound to happen.
It was Jan. 11, 2024 when software giant Microsoft (MSFT) briefly passed Apple (AAPL) as the most valuable company in the world.
Microsoft's stock closed 0.5% higher, giving it a market valuation of $2.859 trillion.
It rose as much as 2% during the session and the company was briefly worth $2.903 trillion. Apple closed 0.3% lower, giving the company a market capitalization of $2.886 trillion.
"It was inevitable that Microsoft would overtake Apple since Microsoft is growing faster and has more to benefit from the generative AI revolution," D.A. Davidson analyst Gil Luria said at the time, according to Reuters.
The two tech titans have jostled for top spot over the years and Microsoft was ahead at last check, with a market cap of $3.085 trillion, compared with Apple's value of $2.684 trillion.
Analysts noted that Apple had been dealing with weakening demand, including for the iPhone, the company’s main source of revenue.
Demand in China, a major market, has slumped as the country's economy makes a slow recovery from the pandemic and competition from Huawei.
Sales in China of Apple's iPhone fell by 24% in the first six weeks of 2024 compared with a year earlier, according to research firm Counterpoint, as the company contended with stiff competition from a resurgent Huawei "while getting squeezed in the middle on aggressive pricing from the likes of OPPO, vivo and Xiaomi," said senior Analyst Mengmeng Zhang.
“Although the iPhone 15 is a great device, it has no significant upgrades from the previous version, so consumers feel fine holding on to the older-generation iPhones for now," he said.
Big plans for China
Counterpoint said that the first six weeks of 2023 saw abnormally high numbers with significant unit sales being deferred from December 2022 due to production issues.
Apple is planning to open its eighth store in Shanghai – and its 47th across China – on March 21.
Related: Tech News Now: OpenAI says Musk contract 'never existed', Xiaomi's EV, and more
The company also plans to expand its research centre in Shanghai to support all of its product lines and open a new lab in southern tech hub Shenzhen later this year, according to the South China Morning Post.
Meanwhile, over in Europe, Apple announced changes to comply with the European Union's Digital Markets Act (DMA), which went into effect last week, Reuters reported on March 12.
Beginning this spring, software developers operating in Europe will be able to distribute apps to EU customers directly from their own websites instead of through the App Store.
"To reflect the DMA’s changes, users in the EU can install apps from alternative app marketplaces in iOS 17.4 and later," Apple said on its website, referring to the software platform that runs iPhones and iPads.
"Users will be able to download an alternative marketplace app from the marketplace developer’s website," the company said.
Apple has also said it will appeal a $2 billion EU antitrust fine for thwarting competition from Spotify (SPOT) and other music streaming rivals via restrictions on the App Store.
The company's shares have suffered amid all this upheaval, but some analysts still see good things in Apple's future.
Bank of America Securities confirmed its positive stance on Apple, maintaining a buy rating with a steady price target of $225, according to Investing.com.
The firm's analysis highlighted Apple's pricing strategy evolution since the introduction of the first iPhone in 2007, with initial prices set at $499 for the 4GB model and $599 for the 8GB model.
BofA said that Apple has consistently launched new iPhone models, including the Pro/Pro Max versions, to target the premium market.
Analyst says Apple selloff 'overdone'
Concurrently, prices for previous models are typically reduced by about $100 with each new release.
This strategy, coupled with installment plans from Apple and carriers, has contributed to the iPhone's installed base reaching a record 1.2 billion in 2023, the firm said.
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Apple has effectively shifted its sales mix toward higher-value units despite experiencing slower unit sales, BofA said.
This trend is expected to persist and could help mitigate potential unit sales weaknesses, particularly in China.
BofA also noted Apple's dominance in the high-end market, maintaining a market share of over 90% in the $1,000 and above price band for the past three years.
The firm also cited the anticipation of a multi-year iPhone cycle propelled by next-generation AI technology, robust services growth, and the potential for margin expansion.
On Monday, Evercore ISI analysts said they believed that the sell-off in the iPhone maker’s shares may be “overdone.”
The firm said that investors' growing preference for AI-focused stocks like Nvidia (NVDA) has led to a reallocation of funds away from Apple.
In addition, Evercore said concerns over weakening demand in China, where Apple may be losing market share in the smartphone segment, have affected investor sentiment.
And then ongoing regulatory issues continue to have an impact on investor confidence in the world's second-biggest company.
“We think the sell-off is rather overdone, while we suspect there is strong valuation support at current levels to down 10%, there are three distinct drivers that could unlock upside on the stock from here – a) Cap allocation, b) AI inferencing, and c) Risk-off/defensive shift," the firm said in a research note.
Related: Veteran fund manager picks favorite stocks for 2024
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