GlaxoSmithKline PLC (GSK)

[idpickering]

Final Results.

Highlights
Step change in commercial execution drives strong sales growth across Specialty Medicines and Vaccines

Sales of £29.3 billion +19% AER, +13% CER. Sales +15% AER, +10% CER excluding COVID-19 solutions

Specialty Medicines £11.3 billion +37% AER, +29% CER; HIV +20% AER, +12% CER; Oncology +23% AER, +17% CER; Immuno-inflammation and other specialty +29% AER +20% CER; COVID-19 solutions (Xevudy) sales £2.3 billion

Vaccines £7.9 billion +17% AER, +11% CER; Shingrix £3 billion +72% AER, +60% CER

General Medicines £10.1 billion +5% AER, +1% CER

Prioritised investment and cost discipline support strong growth in operating profit and EPS

Total continuing operating margin 21.9%. Total EPS 371.4p > 100% primarily reflecting the gain from discontinued operations arising on the demerger of the Consumer Healthcare business. Total continuing EPS 110.8p +34% AER, +18% CER

Adjusted operating margin 27.8%. Adjusted operating profit growth +26% AER, +14% CER. This included a decline in growth from COVID-19 solutions of approximately 3% AER and CER

Adjusted EPS 139.7p +27% AER, +15% CER. This included a decline in growth from COVID-19 solutions of approximately 4% AER, 3% CER

Full-year 2022 cash generated from operations attributable to continuing operations £7.9 billion. Full-year free cash flow £3.3 billion.

And later;

Quarterly dividends

The Board has declared a fourth dividend for 2022 of 13.75p per share (Q4 2021: 28.75p1 per share retrospectively adjusted) for the Share Consolidation.

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 fourth quarter of 2022 converts to 13.75p per new ordinary share, this results in an expected total dividend for the second half of 2022 of 27.5p per new ordinary share. The expected dividend for 2023 is 56.5p per new ordinary share, in line with the original expectation converted for the Share Consolidation and rounded up.

Payment of dividends

The equivalent interim dividend receivable by ADR holders will be calculated based on the exchange rate on 11 April 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 23 February 2023, with a record date of 24 February 2023 and a payment date of 13 April 2023 .

https://www.investegate.co.uk/gsk-plc-- ... 00074922O/

Ian.

[idpickering]

Benlysta granted Orphan Drug Designation by US FDA for the potential treatment of systemic sclerosis.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Benlysta (belimumab), a B-cell inhibiting monoclonal antibody, for the potential treatment of systemic sclerosis. GSK plans to initiate a phase II/III trial of belimumab for systemic sclerosis associated interstitial lung disease (SSc-ILD) in the first half of 2023.

https://www.investegate.co.uk/gsk-plc-- ... 05014982O/

Ian.

[Dod101]

Thanks Ian. I must say I find these results very difficult to follow with the demerger of most of Haleon and the subsequent share consolidation. I note that as usual there a promise of jam tomorrow, in this case 2026! There seems to be progress but it is taking its time.

Dividend as promised. Be interesting to see what the market makes of it.

Dod

[daveh]

Thanks Ian. I must say I find these results very difficult to follow with the demerger of most of Haleon and the subsequent share consolidation. I note that as usual there a promise of jam tomorrow, in this case 2026! There seems to be progress but it is taking its time.

Dividend as promised. Be interesting to see what the market makes of it.

Dod

Seems the market is unmoved with the share price little changed from yesterday as far as I can see. Glad I wasn't the only one who couldn't follow the financial machinations in the accounts following the Haleon demerger.

[idpickering]

Thanks Ian. I must say I find these results very difficult to follow with the demerger of most of Haleon and the subsequent share consolidation. I note that as usual there a promise of jam tomorrow, in this case 2026! There seems to be progress but it is taking its time.

Dividend as promised. Be interesting to see what the market makes of it.

Dod

Seems the market is unmoved with the share price little changed from yesterday as far as I can see. Glad I wasn't the only one who couldn't follow the financial machinations in the accounts following the Haleon demerger.

You're welcome Dod. FWIW, GSK are down 0.25% as I type.

Ian.

[Dod101]

Thanks Ian. I must say I find these results very difficult to follow with the demerger of most of Haleon and the subsequent share consolidation. I note that as usual there a promise of jam tomorrow, in this case 2026! There seems to be progress but it is taking its time.

Dividend as promised. Be interesting to see what the market makes of it.

Dod

Seems the market is unmoved with the share price little changed from yesterday as far as I can see. Glad I wasn't the only one who couldn't follow the financial machinations in the accounts following the Haleon demerger.

You're welcome Dod. FWIW, GSK are down 0.25% as I type.

Ian.

I guess that is just market noise.

Dod

[idpickering]

Daprodustat approved by US FDA for anaemia of CKD.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Jesduvroq (daprodustat), an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the once-a-day treatment of anaemia due to chronic kidney disease (CKD) in adults who have been receiving dialysis for at least four months. Jesduvroq is the first innovative medicine for anaemia treatment in over 30 years and the only HIF-PHI approved in the US, providing a new oral, convenient option for patients in the US with anaemia of CKD on dialysis.

https://www.investegate.co.uk/gsk-plc-- ... 00026652O/

Ian (No holding).

[idpickering]

US FDA grants regular approval for Jemperli for the treatment of patients with recurrent or advanced mismatch repair-deficient endometrial cancer.

GSK plc (LSE/NYSE: GSK) today reports that the US Food and Drug Administration (FDA) granted full approval for Jemperli (dostarlimab-gxly) for the treatment of adult patients with mismatch repair-deficient (dMMR) recurrent or advanced endometrial cancer, as determined by a US FDA-approved test, that has progressed on or following a prior platinum-containing regimen in any setting and are not candidates for curative surgery or radiation.

https://www.investegate.co.uk/gsk-plc-- ... 05015648P/

Ian (I hold).

[idpickering]

BERENBERG RAISES TARGET PRICE ON GSK.

Analysts at Berenberg raised their target price on drugmaker GSK from £15.80 each to £17.30 on Friday, citing "steady progress".
Berenberg noted that GSK had delivered "solid Q4 results" on 1 February and 2023 guidance that came in at the top end of consensus expectations and in line with internal medium-term growth outlook for sales above 5% and operating profit above 10%.

The German bank stated the stock has recorded only "a limited recovery" since the dismissal of the Zantac multi-district court litigation in the US and, although state litigation continues, said it now sees the risk as "much reduced".

"We retain our 'buy' rating on GSK, noting that it offers medium-term growth in line with peers at a significant valuation discount," said the analysts.

"GSK trades on 9.6x 2024 adjusted earnings versus peers on 15.3x. On EV/NPV (including a £3.0bn Zantac liability), GSK trades at a 25% discount to global peers (0.79x versus 1.06x). Our price target of £17.30 is derived from an average of P/E relative and equity NPV valuation methodologies."

I found this item on the GSK page on HL, under Company News.

https://www.hl.co.uk/shares/shares-sear ... -gbp0.3125

Ian (I hold)

[Bouleversee]

<sarcasm>
So that's why the s.p, has dropped over 2% today. Will soon be worth buying.
</sarcasm>

[idpickering]

This was mentioned on Bloomberg just now;

GSK kept quiet about cancer risks of heartburn drug for 40 years.

GSK (NYSE:GSK) American Depository Shares lost ~2% pre-market Wednesday after a new report from Bloomberg Businessweek claimed that the British drugmaker chose to keep quiet on the cancer risks of the recalled heartburn medication Zantac.

Zantac, also known as ranitidine, was pulled from the U.S. market in 2020 amid concerns over the unacceptable levels of potential human carcinogen, N-nitrosodimethylamine (NDMA).

Since then, the makers of Zantac generics, including Sanofi (SNY) (OTCPK:SNYNF), GSK (GSK), Pfizer (PFE), and Boehringer Ingelheim GmbH, have faced thousands of lawsuits for failure to adequately warn health risks of the antacid.

Citing court filings, studies, FDA transcripts, and new drug applications obtained through the Freedom of Information Act requests, Bloomberg said that the FDA considered the cancer risks when greenlighting the medication, but GSK (GSK) withheld key study data.

https://www.msn.com/en-us/health/medica ... r-AA17w9Wt

Ian (I hold, and am topping up my holdings soon).

[idpickering]

Landmark New England Journal of Medicine publication reinforces potential of GSK's respiratory syncytial virus older adult vaccine candidate.

GSK plc (LSE/NYSE: GSK) today announced the publication of positive phase III trial results for its respiratory syncytial virus (RSV) older adult vaccine candidate in the New England Journal of Medicine . The publication summarises the pivotal efficacy data ( previously presented at IDWeek 2022), showing the vaccine candidate met the primary endpoint of vaccine efficacy against RSV-lower respiratory tract disease (LRTD) in adults aged 60 years and above, with a favourable safety profile. In addition, positive vaccine efficacy was observed in participants with comorbidities of interest who are at increased risk of severe outcomes.

https://www.investegate.co.uk/gsk-plc-- ... 00010791Q/

Ian.

[idpickering]

ViiV Healthcare announces positive data demonstrating long-acting injectable Cabenuva (cabotegravir, rilpivirine) is as effective as daily oral Biktarvy (BIC/FTC/TAF) for the treatment of HIV-1.

https://www.investegate.co.uk/gsk-plc-- ... 00098272Q/

Ian.

[idpickering]

US FDA Advisory Committee votes to support effectiveness and safety of GSK's respiratory syncytial virus older adult vaccine candidate

· Committee votes unanimously that the data support the effectiveness of the vaccine, and 10-2 that the data support the safety of the vaccine

· FDA decision on US approval expected by 3 May 2023, with the potential for the vaccine to be the first approved for older adults

· Evidence reviewed by the Committee was supported by pivotal data recently published in the New England Journal of Medicine

https://www.investegate.co.uk/gsk-plc-- ... 00025977R/
.
Ian.

[idpickering]

China National Medical Products Administration accepts regulatory submission for Nucala (mepolizumab) in severe eosinophilic asthma.

GSK plc (LSE/NYSE: GSK) today announced that the ChinaNational Medical Products Administration hasaccepted for review a new drug application for Nucala (mepolizumab) as an add-on maintenance treatment for severe eosinophilic asthma (SEA). If approved, Nucala would be the first targeted anti-Interleukin-5 (IL-5) treatment in Chinafor adult and adolescent patients with this condition.

https://www.investegate.co.uk/gsk-plc-- ... 00028237S/

Ian (I hold).

[idpickering]

GSK announces positive pivotal phase III data for 5-in-1 Meningococcal ABCWY vaccine candidate.

· MenABCWY combination vaccine candidate met all 11 primary endpoints of the pivotal phase III clinical trial and was well tolerated with a safety profile consistent with Bexsero and Menveo

· The primary endpoint data demonstrated statistical non-inferiority compared to Bexsero and Menveo in individuals 10-25 years old, with the 5-in-1 vaccine candidate eliciting a clinically meaningful immune response

· If approved, this 5-in-1 vaccine candidate could provide the broadest meningococcal serogroup coverage and could lead to a simplified immunisation schedule

https://www.investegate.co.uk/gsk-plc-- ... 05018287S/

Ian.

[daveh]

Statement re Zantac litigation:

https://www.investegate.co.uk/gsk-plc-- ... 59111677U/

In response to yesterday's Sargon ruling by the California state court in respect of the Goetz case, GSK plc (LSE/NYSE: GSK) today issued the following statement:



GSK respectfully disagrees with this ruling by the California state court. Following the 13 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.



The litigation is still at an early stage and yesterday's decision relates only to the question of whether the plaintiff's experts can testify at trial in the Goetz case. It does not mean that the Court agrees with plaintiff's experts' scientific conclusions or their litigation-driven science. GSK will press additional defences and the plaintiff still needs to prove his case at trial.



This ruling does not affect other state cases or the December 2022 Daubert ruling made in the federal Multi-District Litigation.

[idpickering]

Publication of Notice of Annual General Meeting 2023.

The Company has today published on its website ( http://www.gsk.com/en-gb/investors/shar ... l-meeting/ ) the Notice of Annual General Meeting ('AGM') 2023 (the '2023 AGM Notice'), which will be distributed to shareholders shortly.

The Company's AGM will be held on Wednesday 3 May 2023 at 2.30pm at the Sofitel London Heathrow, Terminal 5, London Heathrow Airport, TW6 2GD and will also be broadcast live for shareholders to join electronically. Full details of how to join the meeting either in person or electronically are contained in the 2023 AGM Notice and AGM Guide.

In compliance with Listing Rule 9.6.1R of the UK Financial Conduct Authority, the 2023 AGM Notice and Proxy Form for the AGM will be submitted to the UK Listing Authority and will, in due course, be available for inspection at https://data.fca.org.uk/#/nsm/nationalstoragemechanism .

https://www.investegate.co.uk/gsk-plc-- ... 00043438U/

Ian (I hold and intend topping up my holdings soon).

[idpickering]

Phase III RUBY clinical trial demonstrates potential of Jemperli (dostarlimab) plus chemotherapy to redefine the treatment of primary advanced or recurrent endometrial cancer versus chemotherapy alone

https://www.investegate.co.uk/gsk-plc-- ... 00073877U/

Ian.

[idpickering]

Gepotidacin positive phase III data.

GSK plc (LSE/NYSE: GSK) presented positive results from the pivotal EAGLE-2 and EAGLE-3 phase III trials for gepotidacin, an investigational, first-in-class oral antibiotic with a novel mechanism of action for uncomplicated urinary tract infections (uUTI) in female adults and adolescents. The data were disclosed today in an oral presentation at the European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Copenhagen, Denmark.

https://www.investegate.co.uk/gsk-plc-- ... 00043395W/

Ian.