On April 27, 2022 GlaxoSmithKline reported that strong Q1 2022 sales of £9.8 billion, +32% AER, +32% CER; Total EPS 35.9p +67% AER, +66% CER and Adjusted EPS 32.8p +43% AER, +43% CER (Press release, GlaxoSmithKline, APR 27, 2022, View Source [SID1234613015])

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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
Continued R&D delivery and strengthening of pipeline
US FDA regulatory approvals: Cabenuva treatment of virologically supressed adolescents living with HIV; Triumeq dispersible single tablet regimen for treatment of children with HIV
US FDA regulatory submission acceptance of daprodustat for anaemia of chronic kidney disease (PDUFA action date 1 February 2023)
Benlysta approved in China for adults with active lupus nephritis
EU regulatory submission acceptance for Sanofi-GSK COVID-19 vaccine (Vidprevtyn) and Canadian regulatory approval for Medicago-GSK COVID-19 vaccine (Covifenz)
Proposed acquisition of Sierra Oncology Inc. strengthens late-stage specialty pipeline. Momelotinib has potential to address significant unmet medical need of myelofibrosis patients with anaemia
Multiple pipeline catalysts in next nine months, including phase III data read outs for the RSV Older Adults and meningitis (MenABCWY) vaccine candidates, Blenrep, Jemperli and otilimab, and phase IIb data for bepirovirsen
Cost discipline supports delivery of improved operating margin and Adjusted EPS of 32.8p
Total Group operating margin 28.6%. Total EPS 35.9p +67% AER, +66% CER
Adjusted Group operating margin 26.7%. Adjusted EPS 32.8p +43% AER, +43% CER. This included a contribution to growth from COVID-19 solutions of approximately +15% AER, +15% CER for Q1 2022
Q1 2022 cash generated from operations £2.8 billion. Q1 2022 free cash flow £1.7 billion
On track to demerge and list Haleon, a new global leader in consumer healthcare, in July 2022
New growth outlooks set out in Q1 2022, for annual organic revenue growth of 4-6% and sustainable moderate expansion of adjusted operating margin over medium term at CER
Reconfirming 2022 guidance
GSK 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
2022 guidance excludes any contribution from COVID-19 solutions
Dividend of 14p declared for Q1 2022

Emma Walmsley, Chief Executive Officer, GSK said:
"We have delivered strong first quarter results in this landmark year for GSK, as we separate Consumer Healthcare and start a new period of sustained growth. Our results reflect further good momentum across specialty medicines and vaccines, including the return to strong sales growth for Shingrix and continuing pipeline progress. We also continue to see very good momentum in Consumer Healthcare, demonstrating strong potential of this business ahead of its proposed demerger in July, to become Haleon."

On April 27, 2022 Alligator Bioscience AB reported that Interim report January–March 2022 (Press release, Alligator Bioscience, APR 27, 2022, View Source [SID1234613014])

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SIGNIFICANT EVENTS JANUARY-MARCH

Pipeline:

In March, the Company successfully completed the Phase Ib part of the clinical study OPTIMIZE-1, and Phase II is now enrolling patients at the recommended dose of 900 µg/kg.
In January, Alligator initiated a sponsored research collaboration with Dr. Beatty of University of Pennsylvania to support OPTIMIZE-1, and at the same time we welcomed Dr. Beatty as advisor to Alligator.
Company:

Sumeet Ambarkhane was appointed as new Chief Medical Officer to strengthen Alligator’s efforts to further advance the development of our novel immuno-oncology pipeline in the coming year.
The Nomination Committee proposed that the Annual General Meeting 2022 re-elects the current board members, and that Staffan Encrantz and Denise Goode are elected as new board members.
SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD

On April 1, Alligator announced the completion of the 600 mg dose cohort for ATOR-1017, where data indicates no significant safety concerns, with stable disease as the best tumor response. Patient enrollment and treatment for the highest planned dose cohort, 900 mg, has commenced.
FINANCIAL SUMMARY

January–March 2022

Net sales, SEK 5.4 million (0.6)
Operating profit/loss, SEK -43.0 million (-32.5)
Profit/loss for the period, SEK -43.1 million (-32.7)
Earnings per share before and after dilution, SEK -0.20 (-0.42)*
Cash flow for the period, SEK -43.8 million (40.4)
Cash and cash equivalents, SEK 234.4 million (278.1)
*) Previous periods have been adjusted, see Note 8, page 20 in the attached report.

The full report is attached as PDF available on the company’s website: View Source

The information was submitted for publication, through the agency of the contact person set out above, at 08:00 a.m. CET on April 27, 2022.

On April 27, 2022 United Therapeutics Corporation (Nasdaq: UTHR) reported that it will report its first quarter 2022 financial results before the market opens on Wednesday, May 4, 2022 (Press release, United Therapeutics, APR 27, 2022, View Source [SID1234613012]).

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United Therapeutics will host a public webcast Wednesday, May 4, 2022, at 9:00 a.m. Eastern Time. The webcast will be accessible via United Therapeutics’ website at View Source A rebroadcast of the webcast will be available for one week and can be accessed at the same location.

On April 27, 2022 ISA reported that its representatives will be participating and presenting at the following business conferences in May 2022 (Press release, ISA Pharmaceuticals, APR 27, 2022, View Source [SID1234613011]). If you would like to meet with our team at any of these events, please contact us through the conference partnering systems or via [email protected].

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LSX World Leaders Congress

Date: 10-11 May 2022, London, UK

Panel Presentation by: Anton Mat, Director Business Development, ISA Pharmaceuticals

Title: Key Multi-Stakeholder Considerations In Early-Stage Commercial Deal-Making

Date & Time: Tuesday, 10 May 2022, 14.30pm BST

Bio€quity Europe

Date: 16-18 May 2022, Milan, Italy

Presentation by: Gerben Moolhuizen, Chief Executive Officer, ISA Pharmaceuticals

Date & Time: Virtual, pre-recorded presentation available any time via the partnering system

UBS Global Healthcare Conference

Date: 23-25 May 2022, New York, US

Presentation by: Gerben Moolhuizen, Chief Executive Officer, ISA Pharmaceuticals

Title: ISA Pharmaceuticals Company Presentation

Date & Time: Monday, 23 May 2022, 07.45am ET

On April 27, 2022 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that its partner Cytovia Therapeutics, LLC ("Cytovia"), a biopharmaceutical company empowering natural killer ("NK") cells to fight cancer through stem cell engineering and multispecific antibodies, entered into a definitive business combination agreement with Isleworth Healthcare Acquisition Corp. (NASDAQ: ISLE) ("Isleworth"), a Special Purpose Acquisition Company ("SPAC") (Press release, Cellectis, APR 27, 2022, View Source [SID1234613010]).

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Concurrent with the business combination agreement, Cellectis received a $20 million convertible note in payment of the upfront collaboration consideration provided for pursuant to the research collaboration and non-exclusive license agreement entered between Cellectis and Cytovia in February 2021. The terms of the note provide for conversion into common stock of the combined company upon completion of the business combination, which is subject to the satisfaction or waiver of customary closing conditions. In connection with this convertible note, Cellectis received a warrant to purchase additional shares of the combined company representing up to 35% of the shares issued upon conversion of the note at a predetermined exercise price, with the number of shares issuable upon exercise and the exercise subject to certain adjustments.

« We are impressed by the progress Cytovia has accomplished in the past months. Cytovia shares Cellectis’ mission to provide life-saving off-the-shelf allogeneic cell therapies to patients, and we are excited to be providing them with best-in-class TALEN gene editing for cell therapy applications. Congratulations to the Cytovia team for this transaction, which is an important milestone as they continue their journey to progress gene-edited NK therapeutics towards a cure for cancer! » said André Choulika, CEO of Cellectis.

Cellectis and Cytovia’s research and development collaboration:

In February 2021, Cellectis and Cytovia entered into a strategic research and development collaboration to develop TALEN gene-edited iPSC NK and CAR-NK cells. In November 2021, Cellectis and Cytovia extended their collaboration to include new CAR target and development in China by Cytovia’s strategic partner, CytoLynx Therapeutics.

Financial terms of the collaboration include the $20 million convertible note as well as up to $805 million of development, regulatory, and sales milestones and single-digit royalty payments on the net sales of all partnered products commercialized by Cytovia.

Cellectis is developing custom TALEN, which Cytovia uses to edit iPSCs. Cytovia is responsible for the differentiation and expansion of the gene-edited iPSC master cell bank into NK cells and is conducting the pre-clinical evaluation, clinical development, and commercialization of the mutually-agreed-upon selected therapeutic candidates. Cellectis has granted Cytovia a worldwide license under the patent rights over which Cellectis has control in this field, including in China, in order for Cytovia to modify NK cells to address multiple gene-targets for therapeutic use in several cancer indications.