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GlaxoSmithKline PLC (GSK)

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idpickering
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Re: GlaxoSmithKline PLC (GSK)

#539695

Postby idpickering » October 21st, 2022, 7:08 am

GSK regulatory submission accepted by Japanese regulator for respiratory syncytial virus older adult vaccine candidate.

GSK plc (LSE/NYSE: GSK) today announced that a new drug application for its respiratory syncytial virus (RSV) older adult vaccine candidate has been accepted for review by the Japanese Ministry of Health, Labour and Welfare (MHLW). The proposed indication is for adults aged 60 years and above to prevent lower respiratory tract diseases (LRTD) caused by RSV.

The filing is based on positive data from a prespecified interim analysis of the pivotal AReSVi-006 (Adult Respiratory Syncytial Virus) phase III trial which showed high overall vaccine efficacy against RSV-LRTD in adults aged 60 years and above, with a favourable safety profile. Consistent high vaccine efficacy was observed against LRTD in severe disease, adults aged 70-79 years, adults with underlying comorbidities and across RSV A and B strains.


https://www.investegate.co.uk/gsk-plc-- ... 00016400D/

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Re: GlaxoSmithKline PLC (GSK)

#541726

Postby idpickering » October 27th, 2022, 8:01 am

GSK reports outcome from US FDA Advisory Committee meeting on daprodustat for anaemia of CKD.

https://www.investegate.co.uk/gsk-plc-- ... 05012668E/

GSK provides update on ContRAst phase III programme for otilimab in the treatment of moderate to severe
rheumatoid arthritis.

https://www.investegate.co.uk/gsk-plc-- ... 00012582E/

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idpickering
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Re: GlaxoSmithKline PLC (GSK)

#541933

Postby idpickering » October 28th, 2022, 7:06 am

European Medicines Agency validates ViiV Healthcare's marketing authorisation application for cabotegravir long-acting injectable for HIV Prevention.

https://www.investegate.co.uk/gsk-plc-- ... 00034236E/.

Ian.

idpickering
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Re: GlaxoSmithKline PLC (GSK)

#541934

Postby idpickering » October 28th, 2022, 7:08 am

EMA accepts GSK RSV older adult vaccine for review.

https://www.investegate.co.uk/gsk-plc-- ... 00034237E/

Ian.

idpickering
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Re: GlaxoSmithKline PLC (GSK)

#543050

Postby idpickering » November 2nd, 2022, 7:09 am

Third quarter results 2022.

Highlights
Strong commercial execution drives continued sales growth across Specialty Medicines, Vaccines and
General Medicines
• Specialty Medicines £2.7 billion +36% AER, +24% CER; HIV +19% AER, +7% CER; Oncology +28% AER,
+19% CER; Immuno-inflammation and other specialty +29% AER +17% CER; COVID-19 solutions
(Xevudy) sales £0.4 billion
• Vaccines £2.5 billion +14% AER, +5% CER; Shingrix £760 million +51% AER, +36% CER
• General Medicines £2.6 billion +7% AER, +1% CER

Prioritised investment in growth with cost discipline
• Total continuing operating margin 15.2%. Total EPS 255.9p >100% AER, >100% CER primarily reflecting
the gain from discontinued operations arising on the demerger of the Consumer Healthcare business. Total
continuing EPS 18.8p -14% AER, -35% CER
• Adjusted operating margin 33.3%. Adjusted operating profit growth +18% AER, +4% CER. This included a
contribution to growth from COVID-19 solutions of approximately +1% AER, +2% CER
• Adjusted EPS 46.9p +25% AER, +11% CER. This included a contribution to growth from COVID-19
solutions of approximately +1% AER, +3% CER
• Q3 2022 continuing cash generated from operations £1.9 billion. Free cash flow £0.7 billion
Continued strengthening of late-stage R&D pipeline with regulatory approvals, positive data read-outs
and further complementary business development
• US FDA approval for Boostrix maternal and Menveo single-vial presentation. Momelotinib for treatment of
myelofibrosis submitted to US FDA
• Positive phase III data for RSV older adults candidate vaccine presented at ID Week 2022. Priority Review
granted in the US and regulatory submission acceptance in EU and Japan
• Completed Affinivax acquisition on 15 August 2022. Announced exclusive licence agreement with Spero
Therapeutics for late-stage antibiotic tebipenem
• Phase III data readouts expected in Q4 2022: Jemperli in 1L endometrial cancer, Blenrep in 3L multiple
myeloma and gepotidacin for treatment of uncomplicated urinary tract infection
Growing revenues and improving margin support confidence in outlooks
• 2022 Guidance raised: expect to deliver growth in sales of between 8% to 10% CER and growth in 2022
adjusted operating profit of between 15% to 17% CER
• 2022 guidance excludes any contribution from COVID-19 solutions
• Dividend of 13.75p/share declared for Q3 2022. No change to expected dividend from GSK of 61.25p/share
for FY 2022
Emma Walmsley, Chief Executive Officer, GSK:
“GSK has delivered another quarter of excellent performance, with strong growth in Specialty Medicines,
record sales for our shingles vaccine, Shingrix, and further improvements in adjusted operating profit. We
are again raising our full-year guidance and expect good momentum in 2023, further strengthening our
confidence in our performance outlooks, driven by Shingrix global expansion and expected new launches
including our new RSV vaccine. We are also making good progress to strengthen our early-stage pipeline and
will continue to invest in targeted business development to build optionality and support growth in the second
half of the decade.”

And later;

Quarterly dividends
The Board has declared a third dividend for 2022 of 13.75p per share retrospectively adjusted for the Share
Consolidation (Q3 2021: 23.75p restated pence per share).
On 23 June 2021, at the new GSK Investor Update, GSK set out that from 2022 a progressive dividend policy
will be implemented guided by a 40 to 60 percent pay-out ratio through the investment cycle. The dividend
policy, the total expected cash distribution, and the respective dividend pay-out ratios for GSK remain
unchanged.

GSK has previously stated that it expected to declare a 27p per share dividend for the first half of 2022, a
22p per share dividend for the second half of 2022 and a 45p per share dividend for 2023 (before the share
consolidation) but that these targeted dividends per share would increase in step with the Share Consolidation
to maintain the same aggregate dividend pay-out in absolute Pound Sterling terms. Accordingly, using the
consolidation ratio, GSK’s expected dividend for the third quarter of 2022 converts to 13.75p per new ordinary
share. The expected dividend for the last quarter of 2022 is expected to be 13.75p resulting in an expected
total dividend for the second half of 2022 of 27.5p per new ordinary share and the expected dividend for 2023
converts to 56.5p per new ordinary share rounded up.
Payment of dividends

The equivalent interim dividend receivable by ADR holders will be calculated based on the exchange rate on
10 January 2023. 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 17 November 2022, with a record date of 18 November 2022 and a
payment date of 12 January 2023.

https://www.gsk.com/media/9632/q3-2022- ... cement.pdf

RNS here; https://www.investegate.co.uk/gsk-plc-- ... 01019931E/

Ian.

idpickering
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Re: GlaxoSmithKline PLC (GSK)

#543059

Postby idpickering » November 2nd, 2022, 7:29 am

GSK's respiratory syncytial virus older adult vaccine candidate granted Priority Review by US FDA.


US FDA has set a Prescription Drug User Fee Act action date of 3 May 2023

This is the third major regulatory milestone for the vaccine candidate following acceptance of regulatory submissions in Europe and Japan

Vaccine candidate has the potential to be the first available to help protect adults aged 60 years and older from lower respiratory tract disease caused by respiratory syncytial virus


https://www.investegate.co.uk/gsk-plc-- ... 00079919E/

Ian.

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Re: GlaxoSmithKline PLC (GSK)

#543067

Postby TheMotorcycleBoy » November 2nd, 2022, 8:05 am

Just off reuters:

https://www.reuters.com/business/health ... 022-11-02/

Nov 2 (Reuters) - GSK (GSK.L) on Wednesday GSK (GSK.L) on Wednesday smashed analysts' estimates for third-quarter earnings, driven by higher sales of its blockbuster shingles vaccine, Shingrix.

This quarter, Shingrix blew past expectations by generating sales of 760 million pounds ($872.86 million) compared to the GSK-compiled consensus of 685 million pounds.

Although demand for the vaccine suffered as adult immunisations took a hit during the first pandemic years, sales have rebounded as COVID-19 pressures have eased.

The British drugmaker - now solely focused on vaccines and medicines months after executing a rehaul of the business with the spinoff of its consumer health unit - also reported stronger than expected quarterly sales in the quarter ended Sept. 30.

GSK reported third-quarter adjusted profit of 46.9 pence on sales of about 7.83 billion pounds, compared with a company-compiled analyst consensus of 40.1 pence on sales of 7.32 billion pounds.

88V8
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Re: GlaxoSmithKline PLC (GSK)

#543102

Postby 88V8 » November 2nd, 2022, 10:04 am

No numbers in the report for Zantac.
Reported £40mio set aside, so not really significant.

As flagged, major cut in the divi. OH made a significant cut in her holding.

The quarter's profit is in the range where BPs and Shell's caused much huffing and puffing. Just as well the media aren't working up a narrative of 'greedy drugs companies'.

V8

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Re: GlaxoSmithKline PLC (GSK)

#543186

Postby monabri » November 2nd, 2022, 2:00 pm

88V8 wrote:No numbers in the report for Zantac.
Reported £40mio set aside, so not really significant.

As flagged, major cut in the divi. OH made a significant cut in her holding.

The quarter's profit is in the range where BPs and Shell's caused much huffing and puffing. Just as well the media aren't working up a narrative of 'greedy drugs companies'.

V8



Give them time!

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Re: GlaxoSmithKline PLC (GSK)

#543198

Postby Dod101 » November 2nd, 2022, 2:35 pm

88V8 wrote:No numbers in the report for Zantac.
Reported £40mio set aside, so not really significant.

As flagged, major cut in the divi. OH made a significant cut in her holding.

The quarter's profit is in the range where BPs and Shell's caused much huffing and puffing. Just as well the media aren't working up a narrative of 'greedy drugs companies'.

V8


RE the dividend it is not surprising that the dividend has been substantially cut because after spinning off Haleon, GSK is now a much smaller company, dedicated to R & D and so needing to plough earnings back into that area, at least for now.

Dod

idpickering
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Re: GlaxoSmithKline PLC (GSK)

#543385

Postby idpickering » November 3rd, 2022, 7:29 am

IDMC recommends gepotidacin early efficacy stop.

EAGLE-2 and EAGLE-3 phase III trials for gepotidacin stopped early for efficacy following pre-planned interim analysis by Independent Data Monitoring Committee

· Gepotidacin could be the first new novel oral antibiotic treatment for uncomplicated urinary tract infections in over 20 years

· GSK plans to submit a New Drug Application for gepotidacin to the US Food and Drug Administration (FDA) in H1 2023


https://www.investegate.co.uk/gsk-plc-- ... 00141968F/

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idpickering
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Re: GlaxoSmithKline PLC (GSK)

#544437

Postby idpickering » November 7th, 2022, 7:03 am

DREAMM-3 phase III trial for Blenrep.

GSK plc (LSE/NYSE: GSK) today announced that DREAMM-3, the phase III open-label, randomised head-to-head superiority trial of Blenrep (belantamab mafodotin) monotherapy versus pomalidomide in combination with low dose dexamethasone (PomDex) in patients with relapsed or refractory multiple myeloma (RRMM), did not meet its primary endpoint of progression-free survival (PFS).


https://www.investegate.co.uk/gsk-plc-- ... 00044552F/

Ian.

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Re: GlaxoSmithKline PLC (GSK)

#545690

Postby idpickering » November 11th, 2022, 7:14 am

GSK provides an update on Zejula (niraparib) US prescribing information.

GSK plc (LSE/NYSE: GSK) today provided an update that at the request of the US Food and Drug Administration (FDA) it will restrict the second-line maintenance indication for Zejula (niraparib) to only the patient population with deleterious or suspected deleterious germline BRCA mutations (gBRCAmut). The US first-line indication of Zejula remains unchanged for the maintenance treatment of adult patients with advanced epithelial ovarian, fallopian tube, or primary peritoneal cancer who have a complete or partial response to platinum-based chemotherapy.


https://www.investegate.co.uk/gsk-plc-- ... 00060664G/

Ian.

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Re: GlaxoSmithKline PLC (GSK)

#546211

Postby TheMotorcycleBoy » November 13th, 2022, 12:04 pm

88V8 wrote:No numbers in the report for Zantac.
Reported £40mio set aside, so not really significant.

As flagged, major cut in the divi. OH made a significant cut in her holding.

The quarter's profit is in the range where BPs and Shell's caused much huffing and puffing. Just as well the media aren't working up a narrative of 'greedy drugs companies'.

V8

No. But surely the US Government are very much so? Medicare costs, etc.

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Re: GlaxoSmithKline PLC (GSK)

#548736

Postby idpickering » November 22nd, 2022, 7:08 am

GSK provides an update on Blenrep (belantamab mafodotin-blmf) US marketing authorisation.

GSK plc (LSE/NYSE: GSK) today announced it has initiated the process for withdrawal of the US marketing authorisation for Blenrep (belantamab mafodotin-blmf) following the request of the US Food and Drug Administration (FDA). This request was based on the previously announced outcome of the DREAMM-3 phase III confirmatory trial, which did not meet the requirements of the US FDA Accelerated Approval regulations.Blenrep is a monotherapy treatment for adult patients with relapsed or refractory multiple myeloma (RRMM) who have received at least four prior therapies, including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and an immunomodulatory agent.

As part of the Company's efforts to ensure physicians and patients are supported during this important time, p atients already enrolled in the BlenrepRisk Evaluation and Mitigation Strategy (REMS) programme will have the option to enrol in a compassionate use programme to continue to access treatment. Further information on enrolling patients into the compassionate use programme will be provided directly to REMS-enrolled prescribers. Patients currently being treated with Blenrep should consult their healthcare provider.


https://www.investegate.co.uk/gsk-plc-- ... 00011363H/

Ian.

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Re: GlaxoSmithKline PLC (GSK)

#549727

Postby monabri » November 24th, 2022, 10:07 pm


idpickering
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Re: GlaxoSmithKline PLC (GSK)

#551629

Postby idpickering » December 2nd, 2022, 7:07 am

European Medicines Agency accepts marketing authorisation application for momelotinib for the treatment of myelofibrosis.

GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) validated the marketing authorisation application (MAA) for momelotinib, a potential new oral treatment for myelofibrosis. Momelotinib has a differentiated mechanism of action, with inhibitory ability along three key signalling pathways: Janus kinase (JAK) 1, and JAK2 and activin A receptor type I (ACVR1), which could address the significant medical needs of myelofibrosis patients with anaemia.


https://www.investegate.co.uk/gsk-plc-- ... 00063580I/

Ian.

idpickering
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Re: GlaxoSmithKline PLC (GSK)

#551630

Postby idpickering » December 2nd, 2022, 7:09 am

Jemperli (dostarlimab) RUBY phase III trial met its primary endpoint in a planned interim analysis in patients with primary advanced or recurrent endometrial cancer.

GSK plc (LSE/NYSE: GSK) today announced positive headline results from the planned interim analysis of Part 1 of the RUBY/ENGOT-EN6/GOG3031/NSGO phase III trial investigating Jemperli (dostarlimab) plus standard-of-care chemotherapy (carboplatin-paclitaxel) followed by Jemperli compared to chemotherapy plus placebo followed by placebo in adult patients with primary advanced or recurrent endometrial cancer. The trial met its primary endpoint of investigator-assessed progression-free survival (PFS). It showed a statistically significant and clinically meaningful benefit in the prespecified mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) patient subgroup and in the overall population. A clinically relevant benefit in PFS was also observed in the mismatch repair proficient (MMRp)/microsatellite stable (MSS) patient subgroup.


https://www.investegate.co.uk/gsk-plc-- ... 00053578I/

Ian.

idpickering
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Re: GlaxoSmithKline PLC (GSK)

#552878

Postby idpickering » December 7th, 2022, 7:07 am

Statement: Zantac (ranitidine) litigation.

· MDL Court has dismissed all cases alleging the five remaining cancers in the MDL

· Scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer

· GSK will continue to defend itself vigorously, including against all claims brought at the state level in the U.S.

In response to yesterday's court ruling in the Zantac federal Multi-District Litigation (MDL) in the U.S., GSK plc (LSE/NYSE: GSK) today issued the following statement:

GSK welcomes yesterday's ruling by the MDL Court. Following the 12 epidemiological studies conducted looking at human data regarding the use of ranitidine, the scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer. Yesterday's ruling reflects the state of that science and ensured that unreliable and litigation-driven science did not enter the federal courtroom.

In excluding plaintiffs' epidemiological evidence and expert testimony based on their deficiencies and unreliability, the Court has dismissed all MDL cases alleging the five remaining cancers in the MDL (liver, bladder, pancreatic, esophageal, and stomach). GSK will continue to defend itself vigorously, including against all claims brought at the state level.

Further information regarding the litigation can be found in GSK's 11 August 2022 and 16 August 2022 statements, and in its third quarter results press release issued on 2 November 2022. These are available on http://www.gsk.com .


https://www.investegate.co.uk/gsk-plc-- ... 00028794I/

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Re: GlaxoSmithKline PLC (GSK)

#552886

Postby richfool » December 7th, 2022, 8:37 am

Mmm. GSK up 12.7% first thing. Hoping my UK G&I trusts have significant holdings.


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