GlaxoSmithKline PLC (GSK)

[idpickering]

GSK reaches agreement to acquire late-stage biopharmaceutical company BELLUS Health.

· Acquisition further strengthens specialty medicines and respiratory pipeline with camlipixant, a highly selective P2X3 antagonist and potential best-in-class treatment for refractory chronic cough

· Currently in phase III clinical development with anticipated regulatory approval and launch in 2026

· Accretive to adjusted EPS from 2027 with significant sales potential through 2031

GSK plc (LSE/NYSE: GSK) and BELLUS Health Inc. (TSX/NASDAQ: BLU) today announced that they have entered into an agreement under which GSK will acquire BELLUS, a Canada-based, late-stage biopharmaceutical company working to better the lives of patients suffering from refractory chronic cough (RCC) for US$14.75 per share of common stock in cash representing an approximate total equity value of US$2.0 billion (£1.6 billion). The acquisition provides GSK access to camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in phase III development for the first-line treatment of adult patients with RCC.

It is estimated that 28 million patients suffer from chronic cough, with 10 million patients globally and 6 million in the United States (US) and European Union (EU) suffering from RCC for over a year.[1] RCC is defined as a persistent cough for more than eight weeks that does not respond to treatment for an underlying condition or is otherwise unexplained.[2] RCC significantly impacts quality of life, with patients suffering from depression (53%), urinary incontinence (~50%), pain, rib fractures, social withdrawal, and loss of sleep. [3] ,[4] There are no approved medicines for RCC in the US and EU.

https://www.investegate.co.uk/gsk-plc-- ... 00015633W/

This sounds like a good move to me. I intend topping up my GSK holdings soon, not just because of this announcement.

Ian.

[Dod101]

No word that I can find on the cost of this transaction but presumably it is fairly modest. No effect on earnings until 2027 so I cannot see anything to get excited about. It is a long term punt.

Dod

[idpickering]

EMA validates Jemperli filing for new indication.

GSK plc (LSE/NYSE: GSK) today announced that the European Medicines Agency (EMA) validated the Company's Type II Variation for a potential new indication for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with a type of gynaecological cancer known as mismatch repair deficient (dMMR) / microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. As a result, the EMA's Committee for Medicinal Products for Human Use will begin the formal review process to make a recommendation to the European Commission regarding marketing authorisation for the potential new indication.

https://www.investegate.co.uk/gsk-plc-- ... 00052822X/

Ian.

[idpickering]

First quarter 2023.

GSK momentum continues with strong start to 2023
Q1 2023 performance highlights:
• Sales performance reflected lower COVID-19 solutions sales versus Q1 2022. Excluding COVID-19 solutions,
sales grew +10% CER with strong performance across Vaccines, Specialty and General Medicines
• Key growth drivers included Shingrix for shingles, meningitis vaccines, oral two-drug regimen and long-acting
HIV medicines, Benlysta in immunology, Nucala and Trelegy in respiratory, which combined contributed more
than 40% of sales
• Total operating profit and total EPS performance reflected the comparison to Q1 2022 which included the oneoff income benefit of the Gilead settlement and higher Xevudy sales
• Adjusted operating profit was stable at CER, predominately reflecting a 5% adverse impact following expected
lower COVID-19 solutions sales and 4% from legal provisions primarily relating to royalties
• Adjusted EPS increased +7% CER due to lower non-controlling interests, a lower effective tax rate, and strong
sales growth excluding lower COVID-19 solutions (which impacted performance by 7%)
• Cash generated from operations £0.3 billion; free cash outflow (£0.7) billion lower than Q1 2022 primarily due to
Gilead settlement income received in Q1 2022 and timing of profit share payments
• Full-year 2023 guidance affirmed. Dividend of 14p declared for Q1 2023. 56.5p expected for the full-year 2023

And later;

Quarterly dividends

The Board has declared a first interim dividend for Q1 2023 of 14p per share (Q1 2022: 17.50p
(1) per share
retrospectively adjusted for the Share Consolidation).
Dividends remain an essential component of total shareholder return and GSK recognises the importance of
dividends to shareholders. On 23 June 2021, at the 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 expects to declare a dividend of 56.5p per share for 2023.
Payment of dividends
The equivalent interim dividend receivable by ADR holders will be calculated based on the exchange rate on 11
July 2023. An annual fee of $0.03 per ADS (or $0.0075 per ADS per quarter) is charged by the Depositary. The exdividend date will be 18 May 2023, with a record date of 19 May 2023 and a payment date of 13 July 2023.

Downloable here;

https://www.gsk.com/en-gb/investors/quarterly-results/

RNS here; https://www.investegate.co.uk/gsk-plc-- ... 00094488X/

Ian.

[monabri]

I've added a bit from the RNS.

"2023 Guidance

Turnover is expected to increase between 6 to 8 per cent

Adjusted operating profit is expected to increase between 10 to 12 per cent

Adjusted earnings per share is expected to increase between 12 to 15 per cent"

[daveh]

Positive opinion on vaccine from european medicines agency

https://www.investegate.co.uk/gsk-plc-- ... 00026159X/

GSK's respiratory syncytial virus older adult vaccine candidate gains positive European Medicines Agency CHMP opinion



· Positive opinion advances GSK's goal to provide the first vaccine to help protect older adults from respiratory syncytial virus disease

· Opinion is supported by data showing the vaccine candidate's exceptional efficacy in older adults, including those with underlying medical conditions

· Decision on EU marketing authorisation expected by July 2023

[idpickering]

GSK announces intention to sell up to 240m shares in Haleon.

Following the successful demerger and premium listing of Haleon plc ("Haleon") as announced on 18 July 2022, GSK has retained a 12.94%1 stake in Haleon.

GSK today announces that it intends to sell up to 240m ordinary shares in Haleon, equivalent to up to 2.5% of Haleon's issued share capital.

The disposal will be conducted through a placing of ordinary shares in Haleon to institutional investors (the "Offering"). The offer price will be determined by means of an accelerated bookbuild offering process which is to start immediately.

A further announcement will be made following completion of the bookbuild and pricing of the Offering.

https://www.investegate.co.uk/announcement/7523591

Ian (I hold GSK).

[Dod101]

GSK announces intention to sell up to 240m shares in Haleon.

Following the successful demerger and premium listing of Haleon plc ("Haleon") as announced on 18 July 2022, GSK has retained a 12.94%1 stake in Haleon.

GSK today announces that it intends to sell up to 240m ordinary shares in Haleon, equivalent to up to 2.5% of Haleon's issued share capital.

The disposal will be conducted through a placing of ordinary shares in Haleon to institutional investors (the "Offering"). The offer price will be determined by means of an accelerated bookbuild offering process which is to start immediately.

A further announcement will be made following completion of the bookbuild and pricing of the Offering.

https://www.investegate.co.uk/announcement/7523591

Ian (I hold GSK).

This stake and the one held by Pfizer are surely going to overhang the Haleon share price for some time but was I think well trailed at the time of the spin off. Good business for the brokers.

Dod

[monabri]

Sale of up to 240 million HLN shares X £3.4 = £816m

2043 million GSK shares x £0.565 (the 2023 dividend) = £1154m

The sale of the HLN shares should plug a good portion of the GSK annual dividend (assuming that the HLN sp holds up!).


(of course, they may spend it on something else!)

[idpickering]

(of course, they may spend it on something else!)

Thanks for your input.

A higher dividend, or even a special, would be nice. But I doubt any of that is likely?

Ian.

[idpickering]

Statement: Zantac (ranitidine) litigation.

GSK plc (LSE/NYSE: GSK) welcomes the decision of the British Columbia Supreme Court in Dussiaume v. Sandoz Canada Inc. 2023 BCSC 795, dismissing a proposed class action on behalf of a class of ranitidine users in Canada.

Since 2019 there have been 13 peer-reviewed epidemiological studies conducted looking at human data regarding the use of ranitidine. The decision recognises that after more than three years of extensive study, the scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk for any type of cancer.

The Court stated: "Given the uncontroverted evidence that neither ranitidine nor NDMA are reliably associated with increased cancer risk, and the absence of evidence that ranitidine or NDMA cause cancer in humans, the plaintiff has failed to raise a bona fide triable issue regarding injury due to the ingestion and/or purchase of ranitidine."

GSK will continue to vigorously defend proposed class actions by ranitidine users that have been filed in Ontario and Quebec as well as individual actions filed by ranitidine users in Canada.

https://www.investegate.co.uk/announcement/7524196

Ian.

[idpickering]

GSK completes sale of shares in Haleon.

Further to the announcement by GSK on 11 May 2023, GSK has agreed to sell 240m ordinary shares in Haleon plc ("Haleon") at a price of 335 pence per share (the "Placing Shares"), raising gross proceeds of approximately £804m (the "Placing").

Following settlement of the Placing, GSK will hold 955m1 ordinary shares in Haleon, representing approximately 10.3% of the issued share capital of Haleon.

GSK and Pfizer Inc. (which holds a 32% stake in Haleon), have each undertaken not to dispose of any further shares in Haleon for a period of 60 days following settlement of the Placing, subject to certain customary exceptions and waiver by BofA Securities.

(1) Excluding shares in Haleon held by the GSK employee share ownership trust.

https://www.investegate.co.uk/announcement/7523888

Ian,

[monabri]

Good news re Zantac ambulance chase!

[daveh]

https://www.investegate.co.uk/announcement/7524937

good results with 5:1 meningococcal vaccine:

GSK presents pivotal data at ESPID confirming effectiveness of its 5-in-1 meningococcal ABCWY vaccine candidate, with demonstrated coverage against a panel of 110 MenB strains



· Preliminary results from phase III trial show all primary endpoints met, demonstrating statistical non-inferiority compared to Bexsero (meningococcal group B vaccine) and Menveo (meningococcal group A, C, W-135, and Y conjugate vaccine), in individuals 10-25 years old with an acceptable safety profile

· Only investigational 5-in-1 vaccine with demonstrated immunological effectiveness against 110 diverse MenB invasive strains in a clinical trial

· If approved, this vaccine candidate could provide the broadest coverage against the most prevalent meningococcal serogroups and could lead to a simplified immunisation schedule

[idpickering]

GSK receives US FDA file acceptance for Jemperli.

GSK plc (LSE/NYSE: GSK) today announced the US Food and Drug Administration (FDA) accepted the supplemental Biologics License Application (sBLA) for Jemperli (dostarlimab) in combination with chemotherapy for the treatment of adult patients with mismatch repair deficient (dMMR)/microsatellite instability-high (MSI-H) primary advanced or recurrent endometrial cancer. If approved in this patient population, dostarlimab plus chemotherapy could represent the first meaningful frontline treatment advancement in decades for patients with primary advanced or recurrent endometrial cancer.

https://www.investegate.co.uk/announcement/7560572

Ian (I hold).

[idpickering]

EU authorisation of GSK’s RSV vaccine Arexvy.

GSK plc (LSE/NYSE: GSK) today announced that the European Commission has authorised Arexvy (respiratory syncytial virus vaccine, adjuvanted) for active immunisation for the prevention of lower respiratory tract disease (LRTD) caused by respiratory syncytial virus (RSV) in adults 60 years of age and older. This is the first time an RSV vaccine for older adults has been granted European Marketing Authorisation. The first launches are planned ahead of the 2023/2024 RSV season which typically starts in the autumn.

https://www.investegate.co.uk/announcement/7562790

Ian.

[idpickering]

GSK announces extension of FDA review period for momelotinib.

GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has extended the review period of the new drug application (NDA) for momelotinib by three months to provide time to review recently submitted data. The extended action date is 16 September 2023.

GSK is confident in the momelotinib NDA and looks forward to working with the FDA as they finalise their review.

Momelotinib is not currently approved in any market.

https://www.investegate.co.uk/announcem ... b-/7578122

Ian (I hold).

[idpickering]

Season two data for GSK Arexvy RSV OA vaccine.

GSK shares positive data for Arexvy, its respiratory syncytial virus (RSV) older adult vaccine, indicating protection over two RSV seasons

· New results from the ongoing AReSVi-006 phase III trial show vaccine efficacy against RSV-lower respiratory tract disease and severe disease over two full RSV seasons, including in participants with underlying medical conditions

· Safety and reactogenicity data were consistent with initial results from the phase III programme

· The clinical development programme will continue to evaluate longer term follow up and the optimal timing for revaccination

https://www.investegate.co.uk/announcem ... ne/7584694

Ian (I hold).

[idpickering]

GSK’s Arexvy recommended by ACIP

https://www.investegate.co.uk/announcem ... ip/7587490

Ian.

[idpickering]

Statement: Zantac (ranitidine) litigation.

GSK plc (LSE/NYSE: GSK) today confirmed it has reached a confidential settlement with James Goetz, and the case he filed in California state court, set to begin trial on July 24, 2023, will be dismissed. The settlement reflects the Company's desire to avoid distraction related to protracted litigation in this case. GSK does not admit any liability in this settlement and will continue to vigorously defend itself based on the facts and the science in all other Zantac cases.

https://www.investegate.co.uk/announcem ... on/7590157

Ian.