AstraZeneca PLC (AZN)

[idpickering]

Acquisition of Gracell completed

AstraZeneca today announced the successful completion of the acquisition of 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 AstraZenecaÕs cell therapy ambition.

The acquisition enriches 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. GC012F is a potential new treatment for multiple myeloma, as well as other haematologic malignancies and autoimmune diseases including systemic lupus erythematosus (SLE).

Gracell will operate as a wholly owned subsidiary of AstraZeneca, with operations in China and the US.

https://www.investegate.co.uk/announcem ... ed/8051831

Ian.

[idpickering]

Voydeya recommended for EU approval

Voydeya (danicopan) has been recommended for marketing authorisation in the European Union (EU) as an add-on to ravulizumab or eculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia. Voydeya is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris (ravulizumab) or Soliris (eculizumab) to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant extravascular haemolysis (EVH) while treated with a C5 inhibitor.1,2

https://www.investegate.co.uk/announcem ... al/8054729

Ian (I hold).

[idpickering]

Two datopotamab deruxtecan applications validated in the EU for patients with advanced nonsquamous non-small cell lung cancer or HR-positive, HER2-negative breast cancer

The European Medicines Agency (EMA) has validated two marketing authorisation applications (MAAs) for AstraZeneca and Daiichi Sankyo's datopotamab deruxtecan (Dato-DXd) in two types of cancer. One MAA is for the treatment of adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who require systemic therapy following prior treatment. The other MAA is for the treatment of adult patients with unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have progressed on and are not suitable for endocrine therapy and received at least one additional systemic therapy.

The validations confirm the completion of the applications and commence the scientific review process by the EMA's Committee for Medicinal Products for Human Use. The applications are based on data from the pivotal TROPION-Lung01 and TROPION-Breast01 Phase III trials presented during two Presidential Symposia at the 2023 European Society for Medical Oncology Congress.

https://www.investegate.co.uk/announcem ... bc/8067488

Ian (I hold AZN).

[idpickering]

AstraZeneca to acquire Amolyt Pharma, expanding late-stage rare disease pipeline.

AstraZeneca announced that it has entered into a definitive agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases.

The proposed acquisition will bolster the Alexion, AstraZeneca Rare Disease late-stage pipeline and expand on its bone metabolism franchise with the notable addition of eneboparatide (AZP-3601), a Phase III investigational therapeutic peptide with a novel mechanism of action designed to meet key therapeutic goals for hypoparathyroidism. Additionally, Alexion is looking forward to welcoming talent from Amolyt Pharma.

https://www.investegate.co.uk/announcem ... yt/8086858

Ian.

[idpickering]

AstraZeneca to acquire Fusion to accelerate the development of next-generation radioconjugates to treat cancer.

AstraZeneca has entered into a definitive agreement to acquire Fusion Pharmaceuticals Inc., a clinical-stage biopharmaceutical company developing next-generation radioconjugates (RCs). The acquisition marks a major step forward in AstraZeneca delivering on its ambition to transform cancer treatment and outcomes for patients by replacing traditional regimens like chemotherapy and radiotherapy with more targeted treatments.

https://www.investegate.co.uk/announcem ... on/8094051

Ian (I hold AZN).

[idpickering]

Ultomiris approved in the US for NMOSD.

Ultomiris (ravulizumab-cwvz) has been approved in the United States (US) as the first and only long-acting C5 complement inhibitor for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD).1

The approval by the US Food and Drug Administration (FDA) was based on positive results from the CHAMPION-NMOSD Phase III trial, which were published in the Annals of Neurology.2 In the trial, Ultomiris was compared to an external placebo arm from the pivotal Soliris PREVENT clinical trial.

https://www.investegate.co.uk/announcem ... d-/8103655

Ian (I hold).

[idpickering]

Voydeya approved in US.

Voydeya (danicopan) has been approved in the US as add-on therapy to ravulizumab or eculizumab for the treatment of extravascular haemolysis (EVH) in adults with paroxysmal nocturnal haemoglobinuria (PNH).1 Voydeya is a first-in-class, oral, Factor D inhibitor developed as an add-on to standard-of-care Ultomiris (ravulizumab) or Soliris (eculizumab) to address the needs of the approximately 10-20% of patients with PNH who experience clinically significant EVH while treated with a C5 inhibitor.2,3

https://www.investegate.co.uk/announcem ... us/8114830

Ian (I hold).

[idpickering]

FDA accepts Dato-DXd BLA for breast cancer.

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 unresectable or metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior systemic therapy for unresectable or metastatic disease. The Prescription Drug User Fee Act date, the US Food and Drug Administration (FDA) action date for its regulatory decision, is during the first quarter of 2025.

https://www.investegate.co.uk/announcem ... er/8114499

Ian.

[idpickering]

Imfinzi significantly improved overall survival and progression-free survival for patients with limited-stage small cell lung cancer in ADRIATIC Phase III trial

Positive high-level results of the ADRIATIC Phase III trial showed AstraZeneca's Imfinzi (durvalumab) demonstrated a statistically significant and clinically meaningful improvement in the dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in patients with limited-stage small cell lung cancer (LS-SCLC) who had not progressed following concurrent chemoradiotherapy (cCRT) compared to placebo after cCRT.

https://www.investegate.co.uk/announcem ... lc/8122199

Ian.

[idpickering]

Enhertu approved in US for HER2+ solid tumours.

AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options.

This indication is approved under accelerated approval based on objective response rate (ORR) and duration of response (DoR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

https://www.investegate.co.uk/announcem ... rs/8124506

Ian (I hold AZN).

[idpickering]

AstraZeneca increases 2024 dividend by 7%.

AstraZeneca announced today that the Board intends to increase the annualised dividend for 2024 by $0.20 to $3.10 per share, underlining the company's confidence in its performance and cash generation. This takes into account other capital allocation priorities as well as previously announced acquisitions and business development.

Michel Demaré, Chair, AstraZeneca said: "The Board is delighted to announce a 7% increase to the dividend, taking it to $3.10 per share. This uplift is in line with our progressive dividend policy, which remains unchanged, and reflects the continuing strength of AstraZeneca's investment proposition for shareholders."

No changes are planned to the Company's normal dividend payment timetable, which is:

· First interim dividend - announced with half-year results and paid in September.

· Second interim dividend - announced with full-year results and paid in March.

The Board also reaffirms its commitment to AstraZeneca's progressive dividend policy.

https://www.investegate.co.uk/announcem ... 7-/8131804

Ian.

[ADrunkenMarcus]

Thank you, Ian.

It is interesting that they did an RNS just to announce a dividend increase - welcome though it is. Astra's financial metrics are looking healthier and healthier, with forecasts for rising CROIC, ROCE, reduced debt and higher cashflow accompanied by higher dividends.

Best wishes


Mark.

[idpickering]

Thank you, Ian.

It is interesting that they did an RNS just to announce a dividend increase - welcome though it is. Astra's financial metrics are looking healthier and healthier, with forecasts for rising CROIC, ROCE, reduced debt and higher cashflow accompanied by higher dividends.

Best wishes


Mark.

You're welcome, thanks for your input. I must admit that I have been a buyer of AZN a couple of times recently, and have been a AZN shareholder for what seems like eons too.

Ian.

[ADrunkenMarcus]

You're welcome, thanks for your input. I must admit that I have been a buyer of AZN a couple of times recently, and have been a AZN shareholder for what seems like eons too.

Ian.

Long since 1998 in my case…when I was too young to understand or hold in my own name!

Best wishes


Mark

[77ss]

Thank you, Ian.

It is interesting that they did an RNS just to announce a dividend increase - welcome though it is. Astra's financial metrics are looking healthier and healthier, with forecasts for rising CROIC, ROCE, reduced debt and higher cashflow accompanied by higher dividends.

Best wishes


Mark.

Not generally the norm. Perhaps I am being unduly cynical, but their AGM is this afternoon.

Whatever, I am a happy holder.

[Bouleversee]

Proably because 35.6 % of investors voted against the proposed review of the company's executive remuneration, policy which was nevertheless duly passed and will inter alia raise Soriot's annual potential maximum performance share award from 65o% to up to 850% of his salary; he is already the highest FTSE 100 boss and I'm afraid I can't agree that he was massively underpaid. Admittedly, AZN is one of my few decent performers as regards value but as I know from previous holdings which have gone sour, profits can suddenly turn into large losses and I now look for decent dividends which cannot be lost once paid. I haven't yet worked out what % that div. wil be on the prices I paid for my shares or checjked it against the current s.p. I wonder what the doctors prescribing the drugs and the nurses administering them think about this. If this is to stop yet another company being taken over by foreigners, we'll soon have only rubbish on the LSE or no LSE.

[idpickering]

1st Quarter Results.

Financial Performance For Q1 2024 (Growth Numbers At CER)
‒ Total Revenue up 19% to $12,679m, driven by an 18% increase in Product Sales and continued growth in Alliance Revenue from partnered medicines

‒ Double-digit growth in Total Revenue from Oncology at 26%, CVRM at 23%, R&I at 17%, and Rare Disease at 16%.

‒ Core Product Sales Gross Margin[3] of 82%

‒ Core Operating Margin of 34%

‒ Core Tax Rate of 21%

‒ Core EPS increased 13% to $2.06. The increase in Core EPS was lower than Total Revenue growth principally due to a $241m gain in the prior year period on the disposal of Pulmicort Flexhaler US rights

‒ As announced at the Annual General Meeting on 11 April 2024, the total dividend for FY 2024 will increase by $0.20 per share to $3.10 per share

‒ Total Revenue and Core EPS guidance at CER for FY 2024 reiterated

https://www.investegate.co.uk/announcem ... ts/8155667

Ian.