AstraZeneca PLC (AZN)

[idpickering]

Further to the above, that I thought was good news, AZN are down nearly 4% on opening today. According to commentary on Bloomberg there was insufficient data in the announcement to impress the market?

Ian.

[daveh]

Further to the above, that I thought was good news, AZN are down nearly 4% on opening today. According to commentary on Bloomberg there was insufficient data in the announcement to impress the market?

Ian.

I'm never sure that these single drug results should make much of a difference to a large drug companies price whether they are positive or negative. A string of negative announcements would be bad, as would a lack of announcements as that would suggest problems with the pipeline, but I can't see why this one positive report should have knocked the price so much.

Having read through the RNS is it seems fairly positive with one primary endpoint statistically significant at an interim analysis point and the second primary end point showing a positive trend, but not (yet) statistically significant and work ongoing to go to the pre-planned final analysis.

[idpickering]

I'm never sure that these single drug results should make much of a difference to a large drug companies price whether they are positive or negative. A string of negative announcements would be bad, as would a lack of announcements as that would suggest problems with the pipeline, but I can't see why this one positive report should have knocked the price so much.

Having read through the RNS is it seems fairly positive with one primary endpoint statistically significant at an interim analysis point and the second primary end point showing a positive trend, but not (yet) statistically significant and work ongoing to go to the pre-planned final analysis.

I agree with you, as the question mark in my post above shows, in relation to the above RNS and the subsequent downturn in the AZN sp.

Ian.

[idpickering]

Beyfortus approved in US for infant RSV prevention.

AstraZeneca and Sanofi's Beyfortus (nirsevimab) has been approved in the US for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. Beyfortus will be available in the US ahead of the upcoming 2023-2024 RSV season.

https://www.investegate.co.uk/announcem ... on/7637758

Ian (I hold).

[idpickering]

Heads up. The AZN CEO is being interviewed on Bloomberg TV (UK) at 0710hrs today.

Ian.

[idpickering]

Half-year Report.

Total Revenue $22,295m, up 4% despite a decline of $2,181m from COVID-19 medicines[6]

‒ Excluding COVID-19 medicines, Total Revenue increased 16% and Product Sales increased 15%

‒ Total Revenue from Oncology medicines increased 22%, CVRM[7] 20%, R&I[8] 10%, and Rare Disease 12%

‒ Core Product Sales Gross Margin[9] of 83%, up three percentage points, reflecting the decline in sales of lower margin COVID‑19 medicines, the cost of production in prior periods, and ongoing mix shift to more speciality medicines

‒ In Q2 2023, Core Other operating income and expense included the previously-announced gain resulting from an update to the contractual relationships for Beyfortus (nirsevimab), totalling $712m

‒ Core EPS increased 21% to $4.07. Interim dividend maintained at $0.93 (71.8 pence, 9.64 SEK)

‒ Reiterating guidance for FY 2023 Total Revenue and Core EPS

And later;

The record date for the first interim dividend for 2023, payable on 11 September 2023, will be 11 August 2023. The ex-dividend date will be 10 August 2023.

https://www.investegate.co.uk/announcem ... rt/7660546

Ian.

[idpickering]

Alexion enters gene therapy agreement with Pfizer.

Alexion, AstraZeneca Rare Disease, enters agreement with Pfizer to acquire a portfolio of preclinical rare disease gene therapies

https://www.investegate.co.uk/announcem ... er/7660722

Ian.

[idpickering]

The above results have been well received it seems, with the AZN SP being up 3.3% as I type.

I often think that I should've bought more of their shares over the years, but hey ho!

Ian.

[Bouleversee]

My most valuable holding now that PSN have slipped back so much. 17 analysts tipping them as a strong buy. Hope they are right as I have quite a few duds in my P/F at present.

[idpickering]

My most valuable holding now that PSN have slipped back so much. 17 analysts tipping them as a strong buy. Hope they are right as I have quite a few duds in my P/F at present.

Thanks for your input Lorna, and I hope you're well. Also hoping those analysts are right, and I'm sure we all hold a number of dud shares. I know I do.

All the best,

Ian.

[Dod101]

The above results have been well received it seems, with the AZN SP being up 3.3% as I type.

I often think that I should've bought more of their shares over the years, but hey ho!

Ian.

In recent times the share price has bounced around all over the place so I would not personally place too much on the recent uptick.

Dod

[idpickering]

In recent times the share price has bounced around all over the place so I would not personally place too much on the recent uptick.

Dod

A level-headed reminder Dod, thank you.

Ian.

[Bouleversee]

The above results have been well received it seems, with the AZN SP being up 3.3% as I type.

I often think that I should've bought more of their shares over the years, but hey ho!

Ian.

In recent times the share price has bounced around all over the place so I would not personally place too much on the recent uptick.

Dod

I think AZN has been more consistent than most, Dod; top of this year's Citywire list of "the top 10 UK shares the world's best investors are buying", one of only 3 companies to be carried over from last year with a total return of 120% for the 5 years to July 23. ( https://citywire.com/funds-insider/news ... fea=362428 ). I'll settle for that, especially as I approve of their business. I was pleased to see that I am a holder (for many years) of the top 7 of that list. Let's hope it does better than last year's list did; that contained only 4 of my holdings, which thankfully didn't include the flops, some of which I had never even heard of.

[idpickering]

Update on US review of Ultomiris for NMOSD.

The US Food and Drug Administration (FDA) has issued a complete response letter (CRL) regarding the supplemental Biologics License Application (sBLA) for long-acting C5 complement inhibitor Ultomiris (ravulizumab-cwvz) for the treatment of adult patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 (AQP4) antibody positive (Ab+).

The CRL did not request additional analysis or reanalysis of the Phase III CHAMPION-NMOSD trial data included in the sBLA submission and did not raise concerns about the efficacy or safety data from the trial.

https://www.investegate.co.uk/announcem ... sd/7737661

Ian (I hold).

[idpickering]

Enhertu recommended in EU for HER2-mutant NSCLC.

AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been recommended for approval in the European Union (EU) as monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

https://www.investegate.co.uk/announcem ... lc/7758843

Ian.

[idpickering]

Alexion completes Pfizer gene therapy agreement.

Alexion, AstraZeneca Rare Disease, has completed a definitive purchase and licence agreement for a portfolio of preclinical rare disease gene therapy programmes and enabling technologies from Pfizer Inc. (Pfizer).

These new resources build on the combined capabilities of Alexion and AstraZeneca in genomic medicine, with the objective to develop new genetic therapies with improved safety and efficacy profiles. Additionally, several of the Pfizer employees associated with the portfolio will join Alexion as employees.

Financial considerations

Alexion has purchased and licenced the assets of Pfizer's early-stage rare disease gene therapy portfolio for a total consideration of up to $1bn, plus tiered royalties on sales.

https://www.investegate.co.uk/announcem ... t-/7765880

Ian (I hold AZN).

[idpickering]

Dato-DXd improved PFS in breast cancer.

Datopotamab deruxtecan demonstrated statistically significant and clinically meaningful progression-free survival benefit in patients with HR-positive, HER2-low or negative breast cancer in TROPION-Breast01 Phase III trial.

Positive high-level results from the TROPION-Breast01 Phase III trial showed datopotamab deruxtecan (Dato-DXd) demonstrated a statistically significant and clinically meaningful improvement for the primary endpoint of progression-free survival (PFS) compared to investigator's choice of chemotherapy in patients with inoperable or metastatic hormone receptor (HR)-positive, HER2-low or negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer previously treated with endocrine-based therapy and at least one systemic therapy.

https://www.investegate.co.uk/announcem ... r-/7770871

Ian.

[idpickering]

AstraZeneca settles Nexium liability litigations.

AstraZeneca has entered into settlement agreements in the product liability litigations related to Nexium and Prilosec. The agreements effectively resolve the product liability claims that are currently pending in the Multidistrict Litigation in the US District Court for the District of New Jersey, as well as in the Delaware Superior Court and the New Jersey Superior Court. The specific terms of the agreements are confidential.

AstraZeneca continues to believe these claims are without merit and admits no wrongdoing in the settlement agreement. These settlements avoid continued costly litigation and allow the Company to move forward with its purpose of delivering life changing medicines to millions of patients around the world.

A single case remains pending in the US District Court for the Middle District of Louisiana. Trial is scheduled in that case for April 15, 2024.

Financial considerations
AstraZeneca will make payment of $425 million, for which a provision has been taken.

https://www.investegate.co.uk/announcem ... ns/7792343

Ian.

[idpickering]

AstraZeneca shares fall as lung cancer drug trial data abstract disappoints.

Shares in AstraZeneca (AZN.L) fell more than 4% on Wednesday after a data abstract on its experimental precision drug's use in lung cancer patients in a late-stage trial disappointed some analysts.

The abstract on the drug, datopotamab deruxtecan, was published ahead of the European Society for Medical Oncology's (ESMO) congress that kicks off in Madrid on Friday.

Jefferies analyst Stephen Barker said in a note the data was "worse-than-expected", citing the drug only improved the time patients with non-small cell lung cancer live without their disease worsening by 0.7 months compared to chemotherapy.

https://www.reuters.com/business/health ... 023-10-18/

Ian.

[idpickering]

AstraZeneca cell & gene therapy deal w/ Cellectis.

AstraZeneca today announced a collaboration and investment agreement with Cellectis, a clinical-stage biotechnology company, to accelerate the development of next generation therapeutics in areas of high unmet need, including oncology, immunology and rare diseases.

Under the terms of the collaboration agreement, AstraZeneca will leverage the Cellectis proprietary gene editing technologies and manufacturing capabilities, to design novel cell and gene therapy products, strengthening AstraZeneca's growing offering in this space. As part of the agreement, 25 genetic targets have been exclusively reserved for AstraZeneca, from which up to 10 candidate products could be explored for development.

https://www.investegate.co.uk/announcem ... is/7851930

Ian (I hold).