AstraZeneca PLC (AZN)

[idpickering]

9M and Q3 2023 results.

Financial Performance (9M 2023 Figures Unless Otherwise Stated, Growth Numbers At CER)

‒ Total Revenue $33,787m, up 5% despite a decline of $2,896m from COVID-19 medicines[6]

‒ Excluding COVID-19 medicines, both Total Revenue and Product Sales increased 15%

‒ Total Revenue from Oncology medicines increased 20%, CVRM[7] 19%, R&I[8] 9%, and Rare Disease 12%

‒ Core Product Sales Gross Margin[9] of 82%, up two percentage points, reflecting the decline in sales of lower margin COVID‑19 medicines

‒ Core Operating Margin of 35% increased by three percentage points including the previously-announced gain from an update to the contractual relationships for Beyfortus, totalling $712m and recorded in Core Other operating income

‒ Core EPS increased 17% to $5.80

‒ FY 2023 Total Revenue excluding COVID-19 medicines now expected to increase by a low-teens percentage at CER

‒ FY 2023 Core EPS now expected to increase by a low double-digit to low-teens percentage at CER

https://www.investegate.co.uk/announcem ... ts/7869792

Ian (I hold).

[idpickering]

Imfinzi combination improves PFS in liver cancer.

Positive high-level results from the EMERALD-1 Phase III trial showed AstraZeneca's Imfinzi (durvalumab) in combination with transarterial chemoembolisation (TACE) and bevacizumab demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of progression-free survival (PFS) versus TACE alone in patients with hepatocellular carcinoma (HCC) eligible for embolisation. The trial continues to follow the secondary endpoint of overall survival (OS).

Liver cancer, of which HCC is the most common type, is the third-leading cause of cancer death with an estimated 900,000 people worldwide diagnosed each year.1,2 Approximately 20-30% of patients are eligible for embolisation, a procedure that blocks the blood supply to the tumour and can also deliver chemotherapy or radiation therapy directly to the liver.3-9 Despite being the standard of care in this setting, most patients who receive embolisation experience rapid disease progression or recurrence.10-14

https://www.investegate.co.uk/announcem ... er/7870100

Ian.

[idpickering]

Agreement with Eccogene for clinical stage GLP-1RA.

AstraZeneca and Eccogene have entered into an exclusive licence agreement for ECC5004, an investigational oral once-daily glucagon-like peptide 1 receptor agonist (GLP-1RA) for the treatment of obesity, type-2 diabetes and other cardiometabolic conditions.

Preliminary results from the Phase I trial have shown a differentiating clinical profile for ECC5004, with good tolerability and encouraging glucose and body weight reduction across the dose levels tested compared to placebo.

https://www.investegate.co.uk/announcem ... ra/7870087

Ian.

[idpickering]

Update on PACIFIC-2 Phase III trial for Imfinzi.

The PACIFIC-2 Phase III trial for Imfinzi (durvalumab) concurrently administered with chemoradiotherapy (CRT) did not achieve statistical significance for the primary endpoint of progression-free survival (PFS) versus CRT alone for the treatment of patients with unresectable, Stage III non-small cell lung cancer (NSCLC).

https://www.investegate.co.uk/announcem ... zi/7879134

Ian.

[idpickering]

Truqap approved in US for HR+ breast cancer.

AstraZeneca's Truqap (capivasertib) in combination with Faslodex (fulvestrant) has been approved in the US for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN). Eligible patients will have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy.

https://www.investegate.co.uk/announcem ... r-/7887059

Ian.

[idpickering]

Discontinuation of two CRYSTALIZE evidence trials.

AstraZeneca has decided to discontinue the STABILIZE-CKD and DIALIZE-Outcomes Phase III evidence trials for Lokelma (sodium zirconium cyclosilicate). The decision was made due to substantially increased enrolment timelines and low event rates, respectively, which made it prohibitive to deliver study results within a timeframe to meaningfully advance clinical practice.

https://www.investegate.co.uk/announcem ... ls/7914846

Ian.

[idpickering]

AstraZeneca to acquire Icosavax, including potential first-in-class RSV and hMPV combination vaccine with positive Phase II data.

AstraZeneca has entered into a definitive agreement to acquire Icosavax, Inc. (NASDAQ: ICVX), a US-based clinical-stage biopharmaceutical company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform.

https://www.investegate.co.uk/announcem ... x-/7936021

Ian (I hold).

[idpickering]

Wainua (eplontersen) granted first US FDA approval

AstraZeneca and Ionis' Wainua (eplontersen) has been approved in the US for the treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults, commonly referred to as hATTR-PN or ATTRv-PN.1 Wainua is the only approved medicine for the treatment of ATTRv-PN that can be self-administered via an auto-injector.2-4

The approval by the US Food and Drug Administration (FDA) was based on the positive 35-week interim analysis from the NEURO-TTRansform Phase III trial, which showed patients treated with Wainua demonstrated consistent and sustained benefit on the co-primary endpoints of serum transthyretin (TTR) concentration and neuropathy impairment measured by modified Neuropathy Impairment Score +7 (mNIS+7), and key secondary endpoint of quality of life (QoL) on the Norfolk Quality of Life Questionnaire-Diabetic Neuropathy (Norfolk QoL-DN).2,5 Positive results from the NEURO-TTRansform Phase III trial were published in The Journal of the American Medical Association (JAMA) further demonstrating the benefit of Wainua across the spectrum of ATTRv-PN at 35, 66 and 85 weeks.

https://www.investegate.co.uk/announcem ... al/7958011

Ian.

[idpickering]

AstraZeneca acquires Gracell

AstraZeneca has entered into a definitive agreement to acquire Gracell Biotechnologies Inc. (Gracell, NASDAQ: GRCL), a global clinical-stage biopharmaceutical company developing innovative cell therapies for the treatment of cancer and autoimmune diseases, furthering the AstraZeneca cell therapy ambition.

The proposed acquisition will enrich AstraZenecaÕs growing pipeline of cell therapies with GC012F, a novel, clinical-stage FasTCAR-enabled BCMA and CD19 dual-targeting autologous chimeric antigen receptor T-cell (CAR-T) therapy, a potential new treatment for multiple myeloma, as well as other haematologic malignancies and autoimmune diseases including systemic lupus erythematosus (SLE).

https://www.investegate.co.uk/announcem ... ll/7962620

Ian.

[idpickering]

Final Results

Financial Performance For Full Year 2023 (Growth Numbers At CER)
‒ Total Revenue $45,811m, up 6% despite a decline of $3,736m from COVID-19 medicines[4]
‒ Excluding COVID-19 medicines, Total Revenue increased 15% and Product Sales increased 14%
‒ Double-digit Total Revenue growth from Oncology 21%, CVRM 18%, R&I 10%, and Rare Disease 12%
‒ Core Product Sales Gross Margin[5] of 82%, up two percentage points, reflecting the decline in sales of lower margin COVID‑19 medicines
‒ Core Operating Margin of 32% increased by two percentage points including the previously announced gain from an update to the contractual relationships for Beyfortus, totalling $712m and recorded as Core Other operating income. In the quarter, higher SG&A expense drove lower operating margins, partly due to phasing of expenses and increased investment in launches for Airsupra, Wainua and Truqap
‒ The Core Tax Rate for the year was 17%. In the fourth quarter, the tax rate was negatively impacted by reviews by tax authorities, administrative appeal processes and other adjustments, offset by a routine intragroup reorganisation of IP, leading to a tax rate of 10% in the quarter
‒ Core EPS increased 15% to $7.26
‒ Second interim dividend declared of $1.97 per share, making a total dividend declared for FY 2023 of $2.90 per share
‒ Total Revenue and Core EPS in FY 2024 are each expected to increase by a low double-digit to low teens percentage at CER

https://www.investegate.co.uk/announcem ... ts/8027592

Ian (I hold).

[yorkshirelad1]

Final Results
https://www.investegate.co.uk/announcem ... ts/8027592

FY div held at $2.90, but down in GBP terms (last year 239.2p, this year 227.8p)

2021 210.1p
2022 239.2p +13.9%
2023 227.8p -4.8%

(I hold)

[ADrunkenMarcus]

Held since 1998 and AZN has returned almost 200% of book cost in dividends!

Quite happy with a maintained dividend. Return on capital is back up to its highest since 2012, on these results; debt to EBITDA hit 3.2x in 2021 and is declining rapidly, forecast to 0.6x by 2025. AZN boomed in the 2000s, had a lean decade in the 2010s and, hopefully, will boom again in the 2020s.

Best wishes


Mark.

[77ss]

Held since 1998 and AZN has returned almost 200% of book cost in dividends!

Quite happy with a maintained dividend. Return on capital is back up to its highest since 2012, on these results; debt to EBITDA hit 3.2x in 2021 and is declining rapidly, forecast to 0.6x by 2025. AZN boomed in the 2000s, had a lean decade in the 2010s and, hopefully, will boom again in the 2020s.

Best wishes


Mark.

I thought it was the other way round? With the 2000s being the 'lean decade' and the boom being in the 2010s.

Like you, I am not bothered about the maintained dividend. In $ terms the dividend has barely budged since 2011 (when I bought - at 5.35%!) but there has been some increase in £ dividends, thanks to the seemingly remorseless decline in sterling.

The improvement in net debt/EBITDA is promising and welcome - Alexion was a big morsel to swallow.

I think (hope?) that yesterday's fall was overdone and have duly topped up this morning.

Crossing my fingers!

[ADrunkenMarcus]

I thought it was the other way round? With the 2000s being the 'lean decade' and the boom being in the 2010s.

AZN was worse on pretty much all metrics in the 2010s. Lower profit, lower margin, collapsing ROCE and stagnant dividend.

Best wishes


Mark

[77ss]

I thought it was the other way round? With the 2000s being the 'lean decade' and the boom being in the 2010s.

AZN was worse on pretty much all metrics in the 2010s. Lower profit, lower margin, collapsing ROCE and stagnant dividend.

Best wishes


Mark

Maybe so. Metrics are one thing. Share price performance is another.

As I see it - and I freely admit that I may be missing something - correction welcomed of course - the relevant SP figures (from Yahoo) are:

2000-01-01 22.16
2010-01-01 29.12
2020-01-01 72.24

[ADrunkenMarcus]

Maybe so. Metrics are one thing. Share price performance is another.

My reference was intended to refer to the business rather than the shares. That’s my ultimate concern and the share price ultimately follows the business.

I’m sure your data is correct.

Best wishes


Mark

[idpickering]

FDA accepts Dato-DXd BLA for nonsquamous NSCLC

AstraZeneca and Daiichi Sankyo's Biologics License Application (BLA) for datopotamab deruxtecan (Dato-DXd) has been accepted in the US for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The Prescription Drug User Fee Act date, the Food and Drug Administration (FDA) action date for its regulatory decision, is during the fourth quarter of 2024.

https://www.investegate.co.uk/announcem ... c-/8043593

Ian (I hold AZN).

[idpickering]

Tagrisso improved PFS in Stage III lung cancer

Positive high-level results from the LAURA Phase III trial showed AstraZeneca's Tagrisso (osimertinib) demonstrated a statistically significant and highly clinically meaningful improvement in progression-free survival (PFS) for patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after chemoradiotherapy (CRT) compared to placebo after CRT.

https://www.investegate.co.uk/announcem ... r-/8043383

Ian.

[idpickering]

Tagrisso plus chemo approved in US for lung cancer

AstraZeneca's Tagrisso (osimertinib) with the addition of chemotherapy has been approved in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC).

The approval following a Priority Review by the Food and Drug Administration (FDA) was based on the results from the FLAURA2 Phase III trial published in The New England Journal of Medicine. Tagrisso with the addition of chemotherapy reduced the risk of disease progression or death by 38% compared to Tagrisso monotherapy which is the 1st-line global standard of care (hazard ratio [HR] 0.62; 95% confidence interval [CI] 0.49-0.79; p<0.0001). Median progression-free survival (PFS) by investigator assessment was 25.5 months for patients treated with Tagrisso plus chemotherapy, an 8.8-month improvement versus Tagrisso monotherapy (16.7 months).

https://www.investegate.co.uk/announcem ... er/8043599

Ian.

[idpickering]

Acquisition of Icosavax Completed

AstraZeneca announced today the successful completion of the acquisition of Icosavax, Inc., a US-based clinical-stage biopharmaceutical company focused on developing differentiated, high-potential vaccines using an innovative, protein virus-like particle (VLP) platform. As a result of the acquisition, Icosavax has become a subsidiary of AstraZeneca, with operations in Seattle, US.

The acquisition will build on AstraZeneca's expertise in respiratory syncytial virus (RSV), strengthening AstraZeneca's Vaccines & Immune Therapies late-stage pipeline with Icosavax's lead investigational vaccine candidate, IVX-A12. IVX-A12 is a potential first-in-class, Phase III-ready, combination protein VLP vaccine which targets both RSV and human metapneumovirus (hMPV), two leading causes of severe respiratory infections and hospitalisations in adults 60 years of age and older and those with chronic conditions such as cardiovascular, renal and respiratory disease.1-3

https://www.investegate.co.uk/announcem ... x-/8045142

Ian.