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GSK delivers FY 2021 reported sales of £34 billion, stable at AER, +5% CER; Total EPS 87.6p -24% AER, -13% CER and Adjusted EPS of 113.2p -2% AER, +9% CER

On February 9, 2022 GSK reported that FY 2021 sales of £34 billion, stable at AER, +5% CER; Total EPS 87.6p -24% AER, -13% CER and Adjusted EPS of 113.2p -2% AER, +9% CER (Press release, GlaxoSmithKline, FEB 9, 2022, View Source [SID1234607874]).

Pharmaceuticals £17.7 billion +4% AER, +10% CER; New and Specialty medicines £10 billion +20% AER, +26% CER; Respiratory +21% AER, +28% CER; Immuno-inflammation +22% AER, +29% CER; Oncology +31% AER, +37% CER; total HIV -2% AER, +3% CER
Vaccines £6.8 billion -3% AER, +2% CER; Shingrix £1.7 billion -13% AER, -9% CER
COVID-19 solutions sales £1.4 billion; Xevudy £958 million; pandemic adjuvant £447 million
Consumer Healthcare £9.6 billion -4% AER, stable CER (+4% excluding brands divested/under review)
Continued momentum in R&D delivery and strengthening of pipeline
3 major product approvals during 2021; Apretude HIV long-acting medicine for prevention (Dec); Xevudy for COVID-19 (Dec); and Jemperli for endometrial cancer (April)
Strong pipeline of 21 vaccines and 43 medicines, many offering potential best or first-in-class opportunities for patients, and of which 22 are in pivotal trials
Positive Phase III data on daprodustat in anaemia due to chronic kidney disease presented at American Society of Nephrology. On track to file in EU and US in H1 2022
20+ deals executed securing access to 5 novel clinical assets, including with iTeos in immuno-oncology, Alector in immuno-neurology and Vir Biotechnology in flu, plus technologies that expand our capabilities in human genetics and AI
Expect to report milestones in 2022 on up to 7 of the 11 potential new vaccines and medicines identified as key future growth drivers including Older Adults RSV vaccine (H1 2022)
Cost discipline supports delivery of Adjusted EPS of 113.2p
Total Group operating margin 18.2%. Total EPS 87.6p -24% AER, -13% CER
Adjusted Group operating margin 25.8%. Adjusted EPS 113.2p -2% AER, +9% CER. This included a contribution to growth from COVID-19 solutions of approximately +8% AER, +9% CER (+17% AER, +20% CER for Q4 2021)
Full year 2021 net cash flow from operations £8.0 billion. Full year free cash flow £4.4 billion
On track to demerge a new world-leading Consumer Healthcare business mid-2022
Progress to create new Board with appointment of Chair Designate
Capital Markets Day on 28 February to highlight overall strategy, capabilities and operations, including detailed financial information and superior growth ambitions
2022 guidance for new GSK
New GSK, the biopharma business, expected to deliver growth in 2022 sales of between 5% to 7% at CER and growth in 2022 Adjusted operating profit of between 12% to 14% at CER including the anticipated benefit in royalty income from Gilead settlement
This 2022 guidance excludes any contribution from COVID-19 solutions
Dividend of 23p declared for Q4 2021; 80p FY 2021

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Emma Walmsley, Chief Executive Officer, GSK said:
"We have ended the year strongly, with another quarter of excellent performance driven by first-class commercial execution, and we enter 2022 with good momentum. This is going to be a landmark year for GSK, with a step-change in growth expected and multiple R&D catalysts, including milestones on up to 7 key late-stage pipeline assets. 2022 is also the year when we demerge our world-leading Consumer Healthcare business. At our capital markets event later this month, we will set out the future growth ambitions and highly attractive financial profile of this business, and the outstanding opportunity it provides for shareholders."

AI-driven Congruence Therapeutics gets $50M to stabilize misfolded proteins

On February 08, 2022 Congruence Therapeutics reported the company is using computational tools to discover and develop drugs that stabilize problem proteins and it’s now out of stealth with $50 million in funding (Press release, Congruence Therapeutics, FEB 8, 2022, View Source [SID1234648822]).

The Series A round of funding announced Tuesday was led by Amplitude Ventures and Fonds de solidarité FTQ.

Montreal-based Congruence uses mathematical modeling, physics, and machine learning to characterize the defects of misfolded proteins. The company’s platform technology, called Revenir, designs small molecules that can rescue these mutated proteins—research that is all done on computers. The biotech contends its approach can discover and design novel small molecule stabilizers faster and at scale compared to traditional drug discovery methods.

Congruence was founded last year by CEO Clarissa Desjardins, who was the founder and former chief executive of Montreal-based Clementia Pharmaceuticals. In 2019, Ipsen acquired Clementia and its lead program, a drug for a rare bone disease. Congruence has not disclosed the therapeutic areas it aims to address, other than to say it is pursuing indications with high unmet medical need. Concurrent with that research, Congruence said it is also building a database housing the biophysical properties of mutated proteins, which can be used to develop stabilizes for diseases caused by proteins that are outside of the company’s focus.

"Our industry faces a watershed moment where the application of novel computational tools, including machine learning, is poised to disrupt traditional drug discovery," Desjardins said in a prepared statement."

Congruence said it will use the new funding to build up its drug hunting team. In addition to the financing, Congruent announced that Kenneth Valenzano has been appointed chief scientific officer. Valenzano was most recently senior vice president of drug discovery at Amicus Therapeutics, a rare disease drug developer whose first commercialized product, Galafold, is a small molecule designed to stabilize a key enzyme as a way of treating Fabry disease, an inherited metabolic disorder. At Amicus, Valenzano was involved in the discovery and development of Galafold and other small molecules.

Other disclosed investors participating in the funding round include Lumira Ventures, Investissement Quebec, OrbiMed Advisors, Driehaus Capital Management.

Oxilio NXP-001 formulation development contract

On February 8, 2022 Nuformix plc (LSE: NFX), a pharmaceutical development company targeting unmet medical needs in fibrosis and oncology via drug repurposing, reported that following the Company’s signing of an exclusive global licensing agreement with Oxilio Ltd ("Oxilio") for NXP001 on 13 September 2021, Oxilio has progressed the product and signed a significant service contract with Quotient Sciences Ltd ("Quotient Sciences") to support the formulation development of NXP001 (Press release, Oxilio, FEB 8, 2022, https://www.londonstockexchange.com/news-article/NFX/oxilio-nxp-001-formulation-development-contract/15319186 [SID1234621609]). NXP001 is a proprietary new form of aprepitant which is currently marketed for cancer chemotherapy induced nausea and vomiting ("CINV").

Under the contract Oxilio will work with Quotient Sciences, a drug development and manufacturing accelerator, to identify and evaluate the cocrystal formulation of aprepitant to deliver optimal bioavailability for the treatment of CINV.

Quotient has prior experience of working with the Nuformix NXP-001 co-crystal and previously developed a capsule and a powder for oral suspension formulation, evaluating its performance in a relative bioavailability study versus EMEND (a branded aprepitant).

Quotient will prepare for Oxilio CMC (chemistry, manufacturing and controls) batches and stability data to support a clinical trial application for the new formulation of NXP001.

The Company looks forward to providing further updates on Oxilio’s progress with NXP001 in due course.

Commenting, Alastair Riddell, Executive Chairman of Nuformix, said: "We are very pleased to see the progress Oxilio is making with NXP001. Under the exclusive licence we signed with Oxilio we received an upfront payment, expect to receive milestone payments when the product completes clinical trials and ultimately royalties on any sales. This arrangement is allowing Oxilio to progress NXP001 without cost to the Company whilst we focus on progressing our two lead assets, NXP002 and NXP004. In relation to NXP002 and NXP004 we continue to make significant progress and I look forward to making further announcements in due course."

Cytovation collaborates with Recurrent Respiratory Papillomatosis Foundation to expand its clinical investigations of CyPep-1 into rare neoplastic disease

On February 8 2022 Cytovation AS, a clinical stage immuneoncology company focused on the development of its first-in-class targeted tumor membrane immunotherapy CyPep-1, reported that it is has entered into collaboration with the Recurrent Respiratory Papillomatosis Foundation (RRPF) to advance the development of CyPep-1 for the treatment of this orphan disease alongside the Company’s cancer development program (Press release, Cytovation, FEB 8, 2022, View Source;utm_medium=rss&utm_campaign=cytovation-collaborates-with-recurrent-respiratory-papillomatosis-foundation-to-expand-its-clinical-investigations-of-cypep-1-into-rare-neoplastic-disease [SID1234607956]).

Recurrent Respiratory Papillomatosis (RRP) is a rare neoplastic disease that is characterized by the growth of benign tumors in the respiratory tract caused by the human papilloma virus (HPV). Although they primarily occur in the larynx on and around the vocal cords, these growths may spread downward and affect the trachea, bronchi, and occasionally the lungs. Historic estimates from the RRP Taskforce have indicated an incidence among children of about 4.3 per 100,000 and among adults of about 1.8 per 100,000. Currently there are no approved treatments for RRP.

The collaboration will enable Cytovation to draw upon RRPF’s extensive knowledge and network in preparation for a Phase I/II study to be initiated in 2H 2022.

Kim McClellan, RRPF President, commented: "We are delighted to be combining our expertise with Cytovation’s to help investigate CyPep-1 in RRP. For people with rare diseases like RRP, new clinical studies can help advance our understanding of the condition and potentially address the significant unmet needs faced by patients every day. We believe CyPep-1 has great potential and we’re excited to test its efficacy in this difficult condition."

"The opportunity for CyPep-1 in this rare disease indication highlights its broad potential not just across solid cancer types, but also across neoplastic diseases in general," added Lars Prestegarden, MD, PhD, CEO of Cytovation. "We are very pleased to enter this new collaboration with RRPF, which will extend our clinical development plan with CyPep-1 beyond studies targeting cancers – both as a monotherapy and in combination with checkpoint inhibitors – into non-cancer neoplastic rare diseases. We look forward to working with RRPF and to initiating clinical studies in RRP later in 2022."

CyPep-1 is a proprietary first-in-class targeted tumor membrane immunotherapy engineered to selectively target tumor cells. CyPep-1 eliminates these cells by forming pores in the plasma membrane, releasing antigens to the immune system, promoting an inflammatory microenvironment, and inducing a tumor-specific immune response by in situ vaccination.

Solta Medical Corporation Files Registration Statement for Proposed Initial Public Offering

On February 8, 2022 Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") reported that its wholly owned subsidiary, Solta Medical Corporation ("Solta"), has publicly filed a registration statement on Form S-1 (the "Registration Statement") with the U.S. Securities and Exchange Commission (the "SEC") relating to a proposed initial public offering ("IPO") of Solta’s common shares (Press release, Bausch Health, FEB 8, 2022, View Source [SID1234607944]). The number of shares to be offered and the price range for the proposed offering have not yet been determined. Solta has applied to list its common shares on the Nasdaq Global Select Market under the symbol "SLTA."

Bausch Health has completed all internal procedural steps and is fully prepared to launch both the Solta and Bausch + Lomb Corporation IPOs, subject to receipt of regulatory, stock exchange and other approvals. The Company is actively monitoring market conditions to determine the paths forward.

Goldman Sachs & Co. LLC and Morgan Stanley are acting as joint lead book-running managers for the proposed offering. Citigroup, Guggenheim Securities, Barclays and Evercore ISI are acting as joint book-running managers for the proposed offering.

The proposed offering will be made only by means of a prospectus, which forms a part of the Registration Statement. Copies of the Registration Statement and the preliminary prospectus included therein relating to the proposed offering, when available, may be obtained for free by visiting EDGAR on the SEC’s website at www.sec.gov. Alternatively, copies of the prospectus, when available, may be obtained from Goldman Sachs & Co. LLC, Attn: Prospectus Department, 200 West Street, New York, N.Y. 10282, by telephone at 866-471-2526 or by email at [email protected] or Morgan Stanley & Co. LLC, Attn: Prospectus Department, 180 Varick Street, 2nd Floor, New York, N.Y. 10014.

The Registration Statement relating to the proposed offering has been filed with the SEC but has not yet become effective. These securities may not be sold, nor may offers to buy be accepted, prior to the time the Registration Statement becomes effective.

This news release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Any offers, solicitations or offers to buy, or any sales of securities will be made in accordance with the registration requirements of the Securities Act of 1933, as amended. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering. These securities are not being offered to the public in any Canadian jurisdiction and any sales into Canada, if any, will be made in compliance with available exemptions from the Canadian prospectus requirements and only through securities dealers appropriately registered in the jurisdictions of Canada in which sales would be made.