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GlaxoSmithKline PLC (GSK)

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Bouleversee
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Re: GlaxoSmithKline PLC (GSK)

#385766

Postby Bouleversee » February 11th, 2021, 4:47 pm

I hope that won't lead to a shortage of antibiotics here. The fewer drugs we import post Brexit, the better, IMHO.

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Re: GlaxoSmithKline PLC (GSK)

#385786

Postby simoan » February 11th, 2021, 5:22 pm


Barnard Castle? Maybe they should get Dominic Cummings to go and have a look :)

All the best, Si

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Re: GlaxoSmithKline PLC (GSK)

#387488

Postby idpickering » February 17th, 2021, 3:34 pm

GSK and Vir Biotechnology expand coronavirus collaboration to advance new therapeutics for influenza and other respiratory viruses .

· Companies applying their combined expertise in immunology and infectious diseases to accelerate the development of promising monoclonal antibody candidates for influenza

· Functional genomics collaboration expanded to include respiratory viruses, Vir's unique technology, and access to GSK's small molecule compounds

· Additional exploration of up to three other antibodies for pathogens beyond influenza and coronaviruses

· GSK is increasing its equity investment by $120 million and making an upfront payment of $225 million


https://www.investegate.co.uk/glaxosmit ... 00014548P/

Nice to see this. GSK are a mainstay in my HYP, and I topped up my holdings this morning.

Ian.

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Re: GlaxoSmithKline PLC (GSK)

#388324

Postby idpickering » February 21st, 2021, 6:54 am

This from our previous haunt, TMF, might interest some here;

GlaxoSmithKline: the GSK share price is down 12% in a month. Should I sell my shares?

What should investors do when core shareholdings fall out of favour? Should they cut their losses by selling up and moving on? Or should they stick with key stocks by holding on for future recovery? At the moment, this is my dilemma with my largest shareholding, my shares in £62.3bn pharma giant GlaxoSmithKline (LSE: GSK). The GSK share price seems to be in freefall, so is should I give up and invest elsewhere?


https://www.fool.co.uk/investing/2021/0 ... my-shares/

For what it's worth the author and I think alike. I mentioned in my last post about GSK over on HYP Practical Board that GSK are;

Imho, they’re a steal right now.
viewtopic.php?p=388246#p388246

Either way, I wouldn't go over the top investing in GSK, or any other share come to think of it. ;)

Ian.

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Re: GlaxoSmithKline PLC (GSK)

#388682

Postby daveh » February 22nd, 2021, 11:48 am

GSK and Sanofi announce new Phase II trial on their Covid vaccine:

https://www.investegate.co.uk/glaxosmit ... 40018837P/

Sanofi and GSK initiate new Phase 2 study of their adjuvanted recombinant protein-based COVID-19 vaccine candidate


· New Phase 2 study assesses potential for refined antigen formulation to achieve optimal immune response, including in older adults

· If results are positive, Phase 3 study to start in Q2 2021, with vaccine expected to be available in Q4 2021

· In parallel, development work on new SARS-CoV-2 variants underway

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Re: GlaxoSmithKline PLC (GSK)

#389935

Postby idpickering » February 25th, 2021, 12:22 pm

GSK announces results evaluating its investigational monoclonal antibody, otilimab, for the treatment of hospitalised adult patients with COVID-19



GlaxoSmithKline plc (LSE/NYSE: GSK) today announced results from the phase 2 proof of concept OSCAR (Otilimab in Severe COVID-19 Related Disease) study with otilimab, an investigational anti-granulocyte macrophage colony-stimulating factor (anti-GM-CSF) monoclonal antibody.

The primary endpoint of the OSCAR study was the proportion of COVID-19 patients who were alive and free of respiratory failure 28 days after treatment with a single dose of otilimab in addition to standard of care (including anti-viral treatments and corticosteroids), compared to patients being treated with standard of care alone. Data from patients of all ages showed a treatment difference of 5.3% (95% CI= -0.8%, 11.4%) but this did not reach statistical significance. However, a pre-planned efficacy analysis by age in patients 70 years and older (N=180, 806 in total study) showed that 65.1% of patients were alive and free of respiratory failure 28 days after treatment with otilimab plus standard of care, compared to 45.9% of patients who received the standard of care alone (delta of 19.1%, 95% CI=5.2%, 33.1%) (nominal p-value=0.009). In addition, in a mortality analysis up to day 60, a treatment difference of 14.4% favouring otilimab was seen with rates of 40.4% on standard of care vs. 26% on otilimab plus standard of care (95% CI= 0.9%, 27.9%) (nominal p-value=0.040) in patients 70 years and older.

Given these data suggest a potentially important clinical benefit in a pre-defined sub-group of high-risk patients and the public health need, GSK has decided to amend the OSCAR study to expand this cohort to confirm these potentially significant findings.


https://www.investegate.co.uk/glaxosmit ... 00053602Q/

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Re: GlaxoSmithKline PLC (GSK)

#394479

Postby idpickering » March 11th, 2021, 7:18 am

GSK and Vir share positive VIR-7831 data in COVID

Vir Biotechnology and GSK announce VIR-7831 reduces hospitalisation and risk of death in early treatment of adults with COVID-19

· Independent Data Monitoring Committee recommends stopping Phase 3 COMET-ICE trial early given an 85% reduction in hospitalisation or death.

· Vir and GSK plan to immediately seek Emergency Use Authorization in the US and authorisations in other countries.

· Additional new in vitro studies indicate VIR-7831 maintains activity against major circulating COVID-19 variants.


https://www.investegate.co.uk/glaxosmit ... 00048877R/

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Re: GlaxoSmithKline PLC (GSK)

#395624

Postby idpickering » March 15th, 2021, 7:28 am


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Re: GlaxoSmithKline PLC (GSK)

#400352

Postby idpickering » March 30th, 2021, 3:11 pm

GSK publishes respiratory product sales reporting changes

To reflect the different stages of the product life-cycle of certain respiratory products and to ensure consistency of reporting for the sales of products with similar levels of strategic focus, the reporting of Relvar/Breo Ellipta along with the smaller Incruse Ellipta and Arnuity Ellipta product sales will with effect from the first quarter of 2021 be reported under the "Established Respiratory" section of our "Established Pharmaceuticals" category. Product sales of Trelegy Ellipta, Nucala and Anoro Ellipta will continue to be reported within the "Respiratory" category.

In addition, the reporting of sales of Epzicom/Kivexa and Selzentry will going forward be incorporated into the "Other HIV" line within the "HIV category".

The revised Pharmaceutical turnover tables below set out the revised format for reporting Pharmaceutical product sales that will be used from the first quarter 2021 results, in respect of the 2020 Pharmaceutical product sales.


https://www.investegate.co.uk/glaxosmit ... 30019683T/

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Re: GlaxoSmithKline PLC (GSK)

#404532

Postby OLTB » April 15th, 2021, 3:37 pm

Afternoon all

For those unaware as to why the GSK share price has increased today, it appears that Elliott Management - the activist hedge fund - has built a multi-billion stake in GSK. Further news is here https://www.sharecast.com/news/news-and ... 71418.html and it's also on the FT (but I don't have a subscription so can't post a link I'm afraid).

I'm not too sure what it means ultimately (some are suggesting it might speed up the split of the business), so will see what develops (if anything).

Cheers, OLTB.

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Re: GlaxoSmithKline PLC (GSK)

#404536

Postby idpickering » April 15th, 2021, 3:58 pm

OLTB wrote:Afternoon all

For those unaware as to why the GSK share price has increased today, it appears that Elliott Management - the activist hedge fund - has built a multi-billion stake in GSK. Further news is here https://www.sharecast.com/news/news-and ... 71418.html and it's also on the FT (but I don't have a subscription so can't post a link I'm afraid).

I'm not too sure what it means ultimately (some are suggesting it might speed up the split of the business), so will see what develops (if anything).

Cheers, OLTB.


Thanks for that OLTB. Having topped up my GSK holdings in January and February this year, it's nice to see other investors thinking GSK are worth buying. ;)

Ian.

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Re: GlaxoSmithKline PLC (GSK)

#404537

Postby Dod101 » April 15th, 2021, 4:02 pm

OLTB wrote:Afternoon all

For those unaware as to why the GSK share price has increased today, it appears that Elliott Management - the activist hedge fund - has built a multi-billion stake in GSK. Further news is here https://www.sharecast.com/news/news-and ... 71418.html and it's also on the FT (but I don't have a subscription so can't post a link I'm afraid).

I'm not too sure what it means ultimately (some are suggesting it might speed up the split of the business), so will see what develops (if anything).

Cheers, OLTB.


Thanks GSK can do with all the help it needs so an activist investor will do no harm. I hold.

Dod

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Re: GlaxoSmithKline PLC (GSK)

#404551

Postby simoan » April 15th, 2021, 4:38 pm

OLTB wrote:Afternoon all

For those unaware as to why the GSK share price has increased today, it appears that Elliott Management - the activist hedge fund - has built a multi-billion stake in GSK. Further news is here https://www.sharecast.com/news/news-and ... 71418.html and it's also on the FT (but I don't have a subscription so can't post a link I'm afraid).

I'm not too sure what it means ultimately (some are suggesting it might speed up the split of the business), so will see what develops (if anything).

Cheers, OLTB.

What it means is that someone has taken the time to do a sum of parts valuation and decided GSK is way too cheap relative to its peer group. I did one myself and posted it somewhere on TLF (maybe Share Ideas?).

All the best, Si

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Re: GlaxoSmithKline PLC (GSK)

#404576

Postby monabri » April 15th, 2021, 5:52 pm

simoan wrote:
OLTB wrote:Afternoon all

For those unaware as to why the GSK share price has increased today, it appears that Elliott Management - the activist hedge fund - has built a multi-billion stake in GSK. Further news is here https://www.sharecast.com/news/news-and ... 71418.html and it's also on the FT (but I don't have a subscription so can't post a link I'm afraid).

I'm not too sure what it means ultimately (some are suggesting it might speed up the split of the business), so will see what develops (if anything).

Cheers, OLTB.

What it means is that someone has taken the time to do a sum of parts valuation and decided GSK is way too cheap relative to its peer group. I did one myself and posted it somewhere on TLF (maybe Share Ideas?).

All the best, Si


Here....

viewtopic.php?p=384132#p384132

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Re: GlaxoSmithKline PLC (GSK)

#406403

Postby idpickering » April 23rd, 2021, 7:04 am

FDA approves GSK's JEMPERLI (dostarlimab-gxly)

· GARNET study represents the largest dataset of anti-PD-1 monotherapy treatment of women with endometrial cancer

· Study results showed an overall response rate of 42%

· 93% of responders had a duration of response of ≥6 months


GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved JEMPERLI (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company's Biologics License Application. Dostarlimab is indicated for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by an FDA-approved test, that have progressed on or following prior treatment with a platinum-containing regimen. This indication is approved under accelerated approval based on tumour response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).


https://www.investegate.co.uk/glaxosmit ... 00053740W/

idpickering
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Re: GlaxoSmithKline PLC (GSK)

#406504

Postby idpickering » April 23rd, 2021, 3:54 pm

Further to the above, The EU have approved it too.

European Commission approves GSK's JEMPERLI (dostarlimab), the first anti-PD-1 therapy approved for recurrent or advanced endometrial cancer

https://www.investegate.co.uk/glaxosmit ... 00014889W/

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Re: GlaxoSmithKline PLC (GSK)

#407670

Postby daveh » April 28th, 2021, 1:46 pm

1st Qtr results:

https://www.investegate.co.uk/glaxosmit ... 00098807W/
GSK delivers Q1 sales of £7.4 billion -18% AER, -15% CER

Total EPS 21.5p, -32% AER, -25% CER; Adjusted EPS 22.9p -39% AER, -33% CER



2021 guidance reconfirmed



Q1 performance reflects expected year-on-year impact and disruption from COVID-19



On track to create New GSK and New Consumer Healthcare company in 2022

Highlights

Strong growth in new pharmaceutical products offset by stocking and pandemic disruption

· Pharmaceuticals £3.9 billion -12% AER, -8% CER, with growth in new and specialty products (+3% CER) including: Respiratory +24% CER; Immuno-inflammation +26% CER; and Oncology +38% CER partly offsetting decline in Established Products -17% CER. HIV -11% CER impacted by 2020 stocking and tender phasing; HIV two-drug regimen sales +41% CER

· Vaccines £1.2 billion -32% AER, -30% CER (Shingrix -47% CER) reflecting government prioritisation of COVID-19 vaccinations. Continue to expect strong growth from Shingrix in H2

· Consumer Healthcare £2.3 billion -19% AER, -16% CER (-9% excluding divestments/brands under review) reflecting year-on-year "pantry-loading" comparison and weak cold/flu season


Effective cost control supports delivery of adjusted earnings per share of 22.9p

· Total Group operating margin 22.8%. Total EPS 21.5p -32% AER, -25% CER

· Adjusted Group operating margin 25.4%. Adjusted EPS 22.9p -39% AER, -33% CER

· Q1 net cash flow from operations £331 million. Free cash outflow £3 million


Continued R&D delivery and strengthening of Biopharma pipeline

· Launch of Cabenuva, the world's first and only long-acting HIV treatment

· Approvals of Rukobia and Jemperli (dostarlimab) and positive regulatory opinion for Benlysta

· Phase III trial starts for RSV older adults vaccine and GSK '294 for severe asthma

· Positive data for antibody treatment VIR-7831 with EUA filed in US and EU

· Phase III trial start with Medicago for adjuvanted COVID-19 vaccine


On track to create New GSK and standalone Consumer Healthcare company in 2022

· Consumer Healthcare JV commercial integration broadly complete; separation activities advancing

· Pharmaceutical portfolio rationalisation continues with cephalosporin divestment announced

· New GSK Investor Update on 23 June to outline strategy, growth outlooks (2022-2031), capital allocation priorities and timing and approach to separation


Reconfirming full-year 2021 EPS guidance and 2022 outlook

· Continue to expect 2021 Adjusted EPS to decline by a mid to high-single digit percentage in CER

· 2022 outlook unchanged with meaningful improvements expected in revenues and margins

Dividend of 19p declared for Q1 2021. Continue to expect 80p/share for 2021


on the dividend:

Quarterly dividends



The Board has declared a first interim dividend for 2021 of 19 pence per share (Q1 2020: 19 pence per share).



GSK recognises the importance of dividends to shareholders and aims to distribute regular dividend payments that will be determined primarily with reference to the free cash flow generated by the business after funding the investment necessary to support the Group's future growth.



The Board currently intends to maintain the dividend for 2021 at the current level of 80p per share, subject to any material change in the external environment or performance expectations.



At our investor update on 23 June we plan to set out in detail the strategy, growth prospects and financial outlooks for New GSK, including an in-depth review of key marketed and pipeline growth drivers. Alongside these we will provide details of a new distribution policy which reflects the future investment priorities focused on delivering sustainable long-term shareholder value. We anticipate that this new policy will deliver competitive and attractive returns informed by appropriate earnings pay-out ratios through the investment cycle well covered by Free Cash Flow and, importantly, expected growth potential. We expect that aggregate distributions for GSK will be lower than at present. This new policy will be implemented for dividends paid in respect of 2022.



Payment of dividends

The equivalent interim dividend receivable by ADR holders will be calculated based on the exchange rate on 6 July 2021. An annual fee of $0.03 per ADS (or $0.0075 per ADS per quarter) is charged by the Depositary.



The ex-dividend date will be 20 May 2021, with a record date of 21 May 2021 and a payment date of 8 July 2021.

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Re: GlaxoSmithKline PLC (GSK)

#412603

Postby idpickering » May 17th, 2021, 7:06 am

Sanofi/GSK COVID-19 Vaccine Positive Ph2 Results

Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial

· Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups

· High immune response after a single dose in patients with prior infection shows strong booster potential

· Global Phase 3 study expected to start in the coming weeks

The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a Phase 2 study with 722 volunteers. A global pivotal Phase 3 study is expected to start in the coming weeks.

The Phase 2 interim results showed 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) and across all doses, with acceptable tolerability and with no safety concerns. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old). After a single injection, high neutralizing antibody levels were generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.


https://www.investegate.co.uk/glaxosmit ... 00098031Y/

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Re: GlaxoSmithKline PLC (GSK)

#412743

Postby Gengulphus » May 17th, 2021, 2:40 pm

idpickering wrote:Sanofi/GSK COVID-19 Vaccine Positive Ph2 Results

Sanofi and GSK COVID-19 vaccine candidate demonstrates strong immune responses across all adult age groups in Phase 2 trial

· Adjuvanted recombinant COVID-19 vaccine candidate triggered strong neutralizing antibody responses in all adult age groups

· High immune response after a single dose in patients with prior infection shows strong booster potential

· Global Phase 3 study expected to start in the coming weeks

The Sanofi and GSK adjuvanted recombinant COVID-19 vaccine candidate achieved strong rates of neutralizing antibody responses, in line with those measured in people who have recovered from COVID-19, in all adult age groups in a Phase 2 study with 722 volunteers. A global pivotal Phase 3 study is expected to start in the coming weeks.

The Phase 2 interim results showed 95% to 100% seroconversion following a second injection in all age groups (18 to 95 years old) and across all doses, with acceptable tolerability and with no safety concerns. Overall, the vaccine candidate elicited strong neutralizing antibody levels that were comparable to those generated by natural infection, with higher levels observed in younger adults (18 to 59 years old). After a single injection, high neutralizing antibody levels were generated in participants with evidence of prior SARS-CoV-2 infection, suggesting strong potential for development as a booster vaccine.

https://www.investegate.co.uk/glaxosmit ... 00098031Y/

This is obviously good news for the company, and also for the world (the total number of vaccine doses given so far is only about 9% of the number required to give everyone in the world two doses, so there's a lot of vaccinations still to be done). But even assuming that everything goes well from here on, there are still months of phase 3 clinical trials to go, plus the time required for national authorities to approve it, so GSK is probably the best part of a year late to the COVID-19 market. That severely limits how good the news will be for GSK even if all goes well from here on - by the time their vaccine is available for actual use, most of the better-off countries will be approaching full vaccination (*), so I think they'll mainly be supplying vaccines to countries that can only afford lower prices.

So I think it's likely to prove better news for the world than for GSK itself...

Gengulphus

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Re: GlaxoSmithKline PLC (GSK)

#412773

Postby monabri » May 17th, 2021, 4:56 pm

I bet that this vaccine will be widely adopted by our "friends" in France...especially as it is Sanofi. ;)


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