GlaxoSmithKline PLC (GSK)

[idpickering]

GSK provides update on phase III RSV maternal vaccine candidate programme

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that it has voluntarily paused enrolment and vaccination in the GRACE phase III trial (NCT04605159), evaluating its potential respiratory syncytial virus (RSV) maternal vaccine candidate, as well as two other trials investigating this candidate in pregnant women (NCT04980391, NCT05229068).

This decision was made following a recommendation from the Independent Data Monitoring Committee based on an observation from a routine safety assessment. Monitoring safety signals is an integral part of the clinical development process for potential new vaccines.

This decision does not impact the ongoing AReSVi 006 phase III trial (NCT04886596) for RSV older adults (60 years and above). This trial remains on track with an anticipated data readout in the first half of 2022.

https://www.investegate.co.uk/glaxosmit ... 00090652C/

[idpickering]

GSK Consumer Healthcare to be called Haleon

GlaxoSmithKline plc (GSK) today announced that the new company, to result from the proposed demerger of Consumer Healthcare from GSK in mid-2022, will be called Haleon.

Haleon (pronounced "Hay-Lee-On") is inspired by the merging of the words 'Hale', which is an old English word that means 'in good health' and Leon, which is associated with the word 'strength'. The new brand identity was developed with input from employees, healthcare practitioners and consumers and will be deployed in more than 100 markets around the world where the business operates.

The creation of Haleon results from a series of successful investments and strategic changes to GSK's consumer health business over the last 8 years, including integrations of the consumer product portfolios from Novartis and Pfizer. It is now a highly valuable and focused global business generating annual sales of approximately £10 billion [1] .

As a standalone company, Haleon will be a new world-leader in consumer healthcare, offering a compelling proposition - to bring deep human understanding together with trusted science - to deliver better everyday health with humanity.

Brian McNamara, Chief Executive Officer Designate, Haleon, said: "Introducing Haleon to the world marks another step in our journey to become a new, standalone company. Our name is grounded in our purpose to deliver better everyday health with humanity and to be a world-leader in consumer healthcare. We are on track to launch Haleon in mid-2022 and our business momentum is strong. We look forward to updating investors and analysts more on this at our capital markets event at the end of February."

Emma Walmsley, Chief Executive Officer, GSK, said: "Haleon brings to life years of hard work by many outstanding people to build this new company purely dedicated to everyday health. Haleon has enormous potential to improve health and wellbeing across the world with strong prospects for growth, and through listing will unlock significant value for GSK shareholders."

Haleon will have a world-class portfolio of category-leading global brands, including Sensodyne, Voltaren, Panadol and Centrum. Its brands are trusted by healthcare professionals, customers and people worldwide to improve the health and wellbeing of individuals and their communities. Demand from the £150 billion consumer healthcare sector is strong, reflecting an increased focus on health and wellness, significant demand from an ageing population and emerging middle-class, and unmet consumer needs. The business is therefore well-positioned to deliver human health impact and to sustainably grow ahead of the market in the years to come.

https://www.investegate.co.uk/glaxosmit ... 00004580C/

[Bouleversee]

Will it be selling anything to stop me from throwing up?

[Dod101]

Will it be selling anything to stop me from throwing up?

If it is to be so brilliant what was to stop GSK from doing it itself?

I suppose it is a better name than hln.

Dod

[moorfield]

Haleon. I wonder how much we've paid the brand consultants for this?

I'm told by an acquitance of mine in the industry that it's common now to use software which spits out random words cross-checked against web domains already in use and rude words etc. - I see www.haleon.com is up and running already!

[77ss]

Haleon. I wonder how much we've paid the brand consultants for this?

I'm told by an acquitance of mine in the industry that it's common now to use software which spits out random words cross-checked against web domains already in use and rude words etc. - I see http://www.haleon.com is up and running already!

Quite so. Has the the management bothered to check with its chemists, I wonder?

Sounds like an inert gas to me. Fart without the smell? Big deal!

[GrahamPlatt]

Haleonitosis is what springs to my mind.

[moorfield]

Haleonitosis is what springs to my mind.

I think prefer the anagram:. AN HOLE and will use that instead.

As in one which my dividends appear to be disappearing down. Or management speak up, depending upon your interpretation.

[Breelander]

GSK introduces Haleon to investors

Global leader in consumer health set to be a newly independent company with focused strategy to deliver sustainable above-market growth and attractive returns to shareholders

· Demerger and listing of Haleon expected in July 2022

https://www.investegate.co.uk/glaxosmit ... 00020170D/

[idpickering]

ViiV Healthcare announces label update for its long-acting HIV treatment, Cabenuva (cabotegravir, rilpivirine), to be initiated with or without an oral lead-in period.

ViiV Healthcare, the global specialist HIV company majority owned by GlaxoSmithKline plc ("GSK"), with Pfizer Inc. and Shionogi Limited as shareholders, today announced that the US Food and Drug Administration (FDA) approved a label update for Cabenuva (cabotegravir, rilpivirine) making the oral lead-in with cabotegravir and rilpivirine tablets optional. Oral cabotegravir and rilpivirine can be taken for a month to assess tolerability to the medicines prior to initiating cabotegravir and rilpivirine injections, a regimen co-developed as part of a collaboration with the Janssen Pharmaceutical Companies of Johnson & Johnson, but this oral lead-in is now optional after clinical trial data demonstrated similar safety and efficacy profiles for both initiation methods (with or without the oral lead-in).1, 2

https://www.investegate.co.uk/glaxosmit ... 00049397F/

[idpickering]

GSK agrees to acquire Sierra Oncology for $1.9bn.

· Sierra Oncology's differentiated momelotinib has the potential to address the critical unmet medical needs of myelofibrosis patients with anaemia

· Momelotinib complements GSK's existing expertise in haematology, with Sierra Oncology anticipating US regulatory submission in Q2 this year and EU submission in the second half of 2022

· Sales contribution expected to start in 2023 with significant growth potential thereafter

· Supports development of strong portfolio of new specialty medicines and vaccines

https://www.investegate.co.uk/glaxosmit ... 00122407I/

[idpickering]

US Food and Drug Administration accepts New Drug Application for daprodustat.

· Regulatory submission for the treatment of anaemia of chronic kidney disease based on the ASCEND phase III clinical trial programme, consisting of five trials that all met their primary efficacy and safety endpoints in non-dialysis and dialysis patients

· US FDA regulatory submission acceptance is the third major regulatory milestone for daprodustat following the European Medicines Agency (EMA) regulatory submission acceptance and approval of Duvroq in Japan

GlaxoSmithKline plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for daprodustat, an oral hypoxia-inducible factor prolyl hydroxylase inhibitor (HIF-PHI), for the potential treatment of patients with anaemia of chronic kidney disease (CKD). Daprodustat was developed based upon the unique Nobel Prize-winning science that demonstrated how cells sense and adapt to oxygen availability. The FDA has assigned a Prescription Drug User Fee Act (PDUFA) action date of 1 February 2023.

https://www.investegate.co.uk/glaxosmit ... 00115026I/

[idpickering]

1st Quarter Results

Highlights

Strong sales growth across Biopharma and Consumer Healthcare

Biopharma: £7.1 billion +40% AER, +40% CER;+14% AER, +15% CER excluding COVID-19 solutions

Specialty Medicines £3.1 billion +98% AER, +97% CER; HIV +15% AER, +14% CER; Oncology +15% AER, +15% CER; Immuno-inflammation, respiratory and other +18% AER, +18% CER; COVID-19 solutions (Xevudy) sales £1.3 billion

Vaccines £1.7 billion +36% AER, +36% CER; Shingrix £698 million >100% AER, >100% CER

General Medicines £2.3 billion +2% AER, +3% CER

Consumer Healthcare £2.6 billion +14% AER, +14% CER

Sales growth also benefited from favourable comparison to Q1 2021

And later;

Returns to shareholders

Quarterly dividends

The Board has declared a first interim dividend for 2022 of 14 pence per share (Q1 2021: 19 pence per share).

As set out at the new GSK Investor Update in June 2021, from 2022 GSK will adopt a progressive dividend policy targeting a dividend pay-out ratio equivalent to 40 to 60% over the investment cycle. The dividend policy, the total expected cash distribution, and the respective dividend pay-out ratios for new GSK and new Consumer Healthcare remain unchanged.

GSK expects to declare a 27p per share dividend payable by the current group for the first half. This comprises 22p per share for new GSK and 5p per share representing Consumer Healthcare during the first half whilst part of the group. For the second half of 2022, new GSK continues to expect to declare a 22p per share dividend. As previously communicated, new GSK would expect to declare a dividend of 45p per share for 2023.

Following separation, the dividend policy for the new Consumer Healthcare company will be the responsibility of its Board of Directors and is expected to be guided by a 30 to 50 per cent pay-out ratio. We expect a second-half dividend from the new Consumer Healthcare company equivalent to a pay-out of around 3p per share, subject to its Board's decisions on the intra-year phasing of dividend payments.

n aggregate, this would represent on the full year 2022 basis the equivalent of a Group dividend of around 52p per share. Dividends payable by Consumer Healthcare will only be receivable by shareholders who remain invested in Consumer Healthcare post-separation and at the appropriate record dates.

Payment of dividends

The equivalent interim dividend receivable by ADR holders will be calculated based on the exchange rate on 29 June 2022. 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 19 May 2022, with a record date of 20 May 2022 and a payment date of 1 July 2022.

https://www.investegate.co.uk/glaxosmit ... 00094453J/

[Dod101]

Hardly earth shattering but the company name is being changed (according to Interactive Investor) to GSK plc.

Dod

[monabri]

Hardly earth shattering but the company name is being changed (according to Interactive Investor) to GSK plc.

Dod

Oh well, at least they didn't spend too much time/money/effort on coming up with a name. I heard that they tried to use the same marketing team as abdrn but they refused the job on the basis of there not being enough letters to hack at

[88V8]

1st Quarter Results.... In aggregate, this would represent on the full year 2022 basis the equivalent of a Group dividend of around 52p per share.

At least they've been explicit about the extent of the divi cut, and indeed this has been well trailed.
Any divi investor who has held onto the shares, especially with the recent relatively high SP, has shot themselves in the foot...

What would Doris have done....

V8

[Dod101]

1st Quarter Results.... In aggregate, this would represent on the full year 2022 basis the equivalent of a Group dividend of around 52p per share.

At least they've been explicit about the extent of the divi cut, and indeed this has been well trailed.
Any divi investor who has held onto the shares, especially with the recent relatively high SP, has shot themselves in the foot...

What would Doris have done....

V8

Neither of the two pharma companies are really income shares any longer, but I am content in that we are getting some growth in the share price. Speculation on what Doris would have done will, by past actions, be banned from discussion on this Board

Dod

[idpickering]

1st Quarter Results.... In aggregate, this would represent on the full year 2022 basis the equivalent of a Group dividend of around 52p per share.

At least they've been explicit about the extent of the divi cut, and indeed this has been well trailed.
Any divi investor who has held onto the shares, especially with the recent relatively high SP, has shot themselves in the foot...

What would Doris have done....

V8

I sold my GSK holdings on 09 Mar 22, as I mentioned at the time on these boards elsewhere. I'm not Doris, and couldn't be doing with any upcoming kerfuffle. I only hold AZN in the sector now, and I'm ok with that.

Ian.

[Darka]

Sold mine this morning for a 30% capital gain (held over many years, most of that gain is recent...). they have not been a great investment for me over the years and I can't be doing with the upcoming mess as they split the company.

Will reinvest in IT's (not sure what yet) for better income and better diversification.

[idpickering]

GSK Cervarix two-dose schedule approved by NMPA
.

· China's National Medical Products Administration (NMPA) has approved a two-dose vaccine schedule for Cervarix in girls aged between 9 to 14 years for the prevention of cervical cancer, cervical intraepithelial neoplasia and adenocarcinoma in situ causally related to oncogenic Human Papillomavirus (HPV) types 16 and 18

· In 2020, there were approximately 110,000 new cases of cervical cancer and 59,000 deaths due to the disease in China1

GSK plc (LSE/NYSE: GSK) announced today that a two-dose schedule for its HPV vaccine Cervarix [Human Papillomavirus bivalent (types 16, 18) Vaccine, Recombinant)] has been approved by China's NMPA for girls aged 9 to 14. With this approval, Cervarix is the first imported two-dose HPV vaccine for this age group in mainland China.

The NMPA authorisation of the two-dose regimen adds China to two-dose approvals in approximately 100 countries, including the European Union, Asia, Africa, and Latin America2-7. The three-dose schedule remains on the label for girls and women aged 15-45 years in China.

https://www.investegate.co.uk/gsk-plc-- ... 00029809M/

Ian.