AstraZeneca PLC (AZN)

[idpickering]

Enhertu approved in the EU for patients with previously treated HER2-positive advanced gastric cancer.

AstraZeneca and Daiichi Sankyo's Enhertu (trastuzumab deruxtecan) has been approved in the European Union (EU) as monotherapy for the treatment of adult patients with advanced HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

The approval by the European Commission follows the positive opinion of the Committee for Medicinal Products for Human Use in November 2022 and is based on results from the DESTINY-Gastric02 and DESTINY-Gastric01 Phase II trials.

https://www.investegate.co.uk/astrazene ... 15040762K/

I hold.

Ian.

[idpickering]

Enhertu recommended for approval in the EU by CHMP for patients with HER2-low metastatic breast cancer.

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 unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received prior chemotherapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.

https://www.investegate.co.uk/astrazene ... 20030763K/

I hold.

Ian.

[idpickering]

Lynparza in combination with abiraterone approved in the EU as 1st-line treatment for patients with metastatic castration-resistant prostate cancer.

AstraZeneca and MSD's Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone has been approved in the European Union for the treatment of metastatic castration-resistant prostate cancer (mCRPC) in adult men for whom chemotherapy is not clinically indicated.

This approval by the European Commission was based on results from the PROpel Phase III trial and follows the positive recommendation in the EU by the Committee for Medicinal Products for Human Use in November 2022.

In the trial, Lynparzain combination with abiraterone and prednisone or prednisolone, reduced the risk of disease progression or death by 34% versus abiraterone and prednisone or prednisolone (based on a hazard ratio [HR] of 0.66; 95% confidence interval [CI] 0.54-0.81; p<0.0001). Median radiographic progression-free survival (rPFS) was 24.8 months for Lynparza plus abiraterone versus 16.6 months for abiraterone alone. Furthermore, a planned rPFS analysis by blinded independent central review (BICR) showed Lynparza plus abiraterone had a median rPFS of 27.6 months compared to 16.4 months with abiraterone alone, extending median rPFS by almost one year.

https://www.investegate.co.uk/astrazene ... 05003942K/

Ian.

[idpickering]

Imfinzi plus chemotherapy approved in the EU as first immunotherapy regimen for patients with advanced biliary tract cancer.

AstraZeneca's Imfinzi (durvalumab) has been approved in the European Union (EU) for the 1st-line treatment of adult patients with unresectable or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).

The approval by the European Commission was based on the primary results from the TOPAZ-1 Phase III trial published in the New England Journal of Medicine Evidence , and on the updated results presented at the European Society for Medical Oncology Congress 2022 . The approval follows the recommendation by The Committee for Medicinal Products for Human Use of the European Medicines Agency in November 2022.

At the interim analysis , Imfinzi plus chemotherapy reduced the risk of death by 20% versus chemotherapy alone (based on a hazard ratio [HR] of 0.80; 95% confidence interval [CI] 0.66-0.97; p=0.021). Updated results from TOPAZ-1 after an additional 6.5 months of follow-up showed a 24% reduction in the risk of death versus chemotherapy alone (HR 0.76; 95% CI, 0.64-0.91), with more than two times as many patients treated with Imfinzi plus chemotherapy estimated to be alive at two years versus chemotherapy alone (23.6% versus 11.5%). Updated median overall survival (OS) was 12.9 months versus 11.3 with chemotherapy.

https://www.investegate.co.uk/astrazene ... 00053923K/

Ian.

[idpickering]

Calquence approved in Japan for adults with treatment-naïve chronic lymphocytic leukaemia.

AstraZeneca's Calquence (acalabrutinib), a selective Bruton's tyrosine kinase (BTK) inhibitor, has been approved in Japan for the treatment of adult patients with treatment-naïve chronic lymphocytic leukaemia (CLL) (including small lymphocytic lymphoma [SLL]). Calquence was previously approved in Japan for the treatment of adults with relapsed or refractory CLL.

The approval by the Japanese Ministry of Health, Labour and Welfare (MHLW) was based on positive results from two clinical trials, including the ELEVATE-TN Phase III trial in adults with treatment-naïve CLL. This trial showed that Calquence combined with obinutuzumab or as monotherapy demonstrated a significantly improved progression-free survival (PFS) when compared with the chemotherapy-based combination of chlorambucil and obinutuzumab.1,2 Data from the interim analysis of ELEVATE-TN was published in The Lancet in 2020 .2 Additionally, a Phase I trial in treatment-naïve Japanese patients with CLL was also submitted to MHLW supporting the approval, with the trial showing an overall response rate of 88.9% (95% CI: 63.2, 98.8%) for Calquence alone and 100% (95% CI: 66.4, 100%) for Calquence combined with obinutuzumab.

https://www.investegate.co.uk/astrazene ... 05069726K/

One of my best performing holdings which I've had for years, and are my only pharma stock. Sometimes I wish I'd bought more at the time. lol.

Ian.

[idpickering]

Imfinzi plus Imjudo approved in Japan for advanced liver and non-small cell lung cancers, and Imfinzi approved for unresectable biliary tract and liver cancers.

AstraZeneca's immunotherapies Imfinzi (durvalumab) and Imjudo (tremelimumab) have been approved in Japan for the treatment of three cancer types: advanced liver, biliary tract and lung.

The approvals authorise Imfinzi in combination with Imjudo for the treatment of adult patients with unresectable hepatocellular carcinoma (HCC) and for the treatment of adult patients with unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) in combination with chemotherapy. Imfinzi was also authorised for the treatment of adult patients with unresectable HCC as monotherapy and for the treatment of adult patients with curatively unresectable biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine plus cisplatin).

The concurrent approvals by the Japanese Ministry of Health, Labour, and Welfare are based on positive results from the HIMALAYA and TOPAZ-1 Phase III trials, each published in the New England Journal of Medicine Evidence and the POSEIDON Phase III trial, published in the Journal of Clinical Oncology.

https://www.investegate.co.uk/astrazene ... 00089725K/

Ian.

[idpickering]

AstraZeneca to acquire CinCor Pharma to strengthen cardiorenal pipeline.

AstraZeneca has entered into a definitive agreement to acquire CinCor Pharma, Inc. (CinCor), a US-based clinical-stage biopharmaceutical company, focused on developing novel treatments for resistant and uncontrolled hypertension as well as chronic kidney disease.

https://www.investegate.co.uk/astrazene ... 00020139M/

Ian.

[daveh]

airsupra approved for asthma in US

https://www.investegate.co.uk/astrazene ... 00014249M/

Airsupra (PT027) approved in the US for asthma



First and only rescue medication approved in the US for as-needed use to reduce risk of asthma exacerbations



Airsupra (albuterol/budesonide), formerly known as PT027, has been approved in the US for the as-needed treatment or prevention of bronchoconstriction and to reduce the risk of exacerbations in people with asthma aged 18 years and older.

[idpickering]

Acquisition of Neogene Therapeutics completed.

AstraZeneca has completed the acquisition of Neogene Therapeutics Inc. (Neogene), a global clinical-stage biotechnology company pioneering the discovery, development and manufacturing of next-generation T-cell receptor therapies (TCR-Ts).

https://www.investegate.co.uk/astrazene ... 00057467M/

Ian (I hold).

[idpickering]

Full year and Q4 2022 results.

Financial performance (FY 2022 figures unless otherwise stated , growth numbers and commentary at CER)

‒ Total Revenue increased 25% to $44,351m, with growth coming from all therapy areas, and from the addition of Alexion, which was incorporated into the Group's results from 21 July 2021

‒ Total Revenue in the fourth quarter was impacted by the decline in Vaxzevria. Excluding Vaxzevria, Total Revenue in the quarter increased 17%

‒ Oncology Total Revenue including milestone receipts increased 20%; Oncology Product Sales increased 19%. Total Revenue CVRM[5] increased 19%[6], R&I[7] increased 3%, and Rare Disease increased 10%6

‒ Core Gross Margin of 80%, up six percentage points, reflecting the lower revenue from Vaxzevria and the increased share of Oncology and Rare Disease medicines. Core Gross Margin of 77% in the fourth quarter was impacted by inventory write downs and manufacturing termination fees for Evusheld

‒ Core Total Operating Expense increased 23%, reflecting the addition of Alexion, and continued investment in new launches and the pipeline to deliver sustainable long-term growth

‒ Core Operating Margin of 30%, up four percentage points

‒ Core EPS increased 33% to $6.66. Second interim dividend declared of $1.97 per share, making a total dividend declared for FY 2022 of $2.90 for the year. The Core Tax Rate for the year was 17%, reflecting IP incentive regimes, geographical mix of profits and adjustments to prior year tax liabilities

The record date for the second interim dividend for 2022, payable on 27 March 2023, will be 24 February 2023. The ex-dividend date will be 23 February 2023.

https://www.investegate.co.uk/astrazene ... 00083756P/

Ian.

[Dod101]

Profits on a consolidated basis are well up but the dividend is still being held. They seem to be covering themselves by telling us shareholders that the profit available is from the Holding Company and its distributable reserves. There is otherwise not much in the report that I can see about its shareholders and their rewards for patience over several years.

In some ways they are not treating their shareholders very well and a dose of realism might be helpful. After all, without their shareholders..........

Dod

[idpickering]

Profits on a consolidated basis are well up but the dividend is still being held. They seem to be covering themselves by telling us shareholders that the profit available is from the Holding Company and its distributable reserves. There is otherwise not much in the report that I can see about its shareholders and their rewards for patience over several years.

In some ways they are not treating their shareholders very well and a dose of realism might be helpful. After all, without their shareholders..........

Dod

Thanks for your input Dod. I couldn't agree more with your comment.

Ian.

[Bubblesofearth]

Shares up 2.5% as I write and have been my best performer since purchase over 10 years ago.

I'm a very happy shareholder

BoE

[idpickering]

Shares up 2.5% as I write and have been my best performer since purchase over 10 years ago.

I'm a very happy shareholder

BoE

Agreed, and likewise. There is a temptation to trim my holdings tbh as they've become very overweight in my HYP. HYP chat is not for hereabouts though.

Ian.

[77ss]

Shares up 2.5% as I write and have been my best performer since purchase over 10 years ago.

I'm a very happy shareholder

BoE

Up 5% now. compensating for the similar drop in BATS - some you win.....

I too have been very happy with AZN. When bought in 2011 the yield was 5.36%. It is now a paltry 2.11%, but I can live with that, given that the share price has almost quadrupled.

[scrumpyjack]

The actual EPS of $2.12 still doesn't cover the dividend of $2.90 so it isn't surprising they are not increasing it.

The excellent results focus on 'Core' EPS which is an Alice in Wonderland figure that leaves out all the bad stuff!

They are making huge progress on drug innovation but so far as real shareholder profit is concerned it is still jam tomorrow.

[Bubblesofearth]

The actual EPS of $2.12 still doesn't cover the dividend of $2.90 so it isn't surprising they are not increasing it.

The excellent results focus on 'Core' EPS which is an Alice in Wonderland figure that leaves out all the bad stuff!

They are making huge progress on drug innovation but so far as real shareholder profit is concerned it is still jam tomorrow.

That makes no sense to me. I've made a very healthy profit in terms of total return as a shareholder over the years.

Do you mean that the current share price assumes significantly higher earnings in the future?

BoE

[77ss]

....so far as real shareholder profit is concerned it is still jam tomorrow.

As ever, it all depends upon ones circumstances, objectives and purchase price.

But, boy, have I reaped a whole load of jam with this share!

If the share price went to zero today, I would still be sitting on an XIRR of over 9%.

Patience is a virtue.

[scrumpyjack]

The actual EPS of $2.12 still doesn't cover the dividend of $2.90 so it isn't surprising they are not increasing it.

The excellent results focus on 'Core' EPS which is an Alice in Wonderland figure that leaves out all the bad stuff!

They are making huge progress on drug innovation but so far as real shareholder profit is concerned it is still jam tomorrow.

That makes no sense to me. I've made a very healthy profit in terms of total return as a shareholder over the years.

Do you mean that the current share price assumes significantly higher earnings in the future?

BoE

Core eps excludes things like legal costs, aborted development costs, write offs etc all of which happen every year and are a normal part of being a pharmaceutical company and are cash costs in the long term. But all pharma companies focus on an adjusted or core figure which excludes them.
If you look at their balance sheet over the years the cash goes down and the borrowings go up. The SP is forward looking and the hope is that at some point the actual cash profits will be similar to the core profit, but that tomorrow never seems to come. I don't have any pharma shares (did have some AZN but sold some and gave the rest to the grandchildren) because, as a retired chartered accountant I have this old fashioned preference for companies that make actual cash profits which more than cover their dividends and do not have large special write offs every year.

[yorkshirelad1]

[snip] but the dividend is still being held. Dod

The results (https://www.astrazeneca.com/media-centre/press-releases/2023/full-year-and-q4-2022-results.html) show a full year dividend held at $2.90. The results also note a full year dividend of 239.2 pence. That's compared to 210.1p last year. I make that +13.9% . Just saying.