GSK to disclose discontinued operations from Q2 2022

On July 5, 2022 GSK plc (LSE/NYSE: GSK) reported that it will as a consequence of its proposed demerger of the Consumer Healthcare business on 18 July 2022 disclose its Q2 2022 results on 27 July 2022 in accordance with the requirements of IFRS 5 – ‘Non-current Assets Held for Sale and Discontinued Operations’ (Press release, GlaxoSmithKline, JUL 5, 2022, View Source [SID1234616491]). GSK has now satisfied the formal criteria for treating Consumer Healthcare as a ‘Discontinued operation’ effective from 30 June 2022, accordingly it will no longer present the Consumer Healthcare business within ‘Continuing operations’ and will also disclose the assets and liabilities of the Consumer Healthcare business as assets and liabilities held for sale/distribution. The GSK Group (‘Group’) will continue to consolidate the business for reporting purposes until the demerger of the Consumer Healthcare business has completed. Details of the demerger are included in the published Prospectus and Circular for the proposed demerger of the Consumer Healthcare business to form Haleon plc (‘Haleon’).

Requirements of IFRS 5 – ‘Non-current Assets Held for Sale and Discontinued Operations’

GSK has satisfied the requirements under IFRS 5 to treat the Consumer Healthcare business as a ‘disposal group’ effective from 30 June 2022, as it is expected that the carrying amount of the disposal group will be recovered principally through disposal and a distribution, it is available for distribution in its present condition (subject only to the steps to be completed that are usual and customary for the demerger of a business) and it is considered highly probable (the expected date of the demerger being 18 July 2022).

As a consequence of meeting these formal criteria, the Consumer Healthcare business will no longer be presented as ‘Continuing operations’, which will result in the following changes to the presentation of the Q2 2022 results on 27 July 2022:

● Turnover, cost of sales, SG&A expenses, research and development expenses, royalty income, other income and expenses, operating profit, profit before taxation, profit after taxation from continuing operations and Adjusted[1] results of the Group will be presented on the basis of the ‘Continuing operations’ of the Group, with the component of the post-tax Group results attributable to ‘Discontinued operations’ presented as a single line item in the Income Statement. The Total post-tax results of the Group will include ‘Continuing’ and ‘Discontinued operations’.

● The earnings per share of the Group will be presented separately between the earnings per share attributable to ‘Continuing operations’ and earnings per share attributable to ‘Discontinued operations’. Adjusted earnings per share will only be presented for ‘Continuing operations’. Earnings per share for Q2 2022 and for prior periods will be adjusted to reflect the impact of the GSK share consolidation expected to take place following the demerger but prior to the Q2 results announcement on 27 July 2022. The earnings per share figures presented below are based on the current pre-consolidation GSK share capital structure.

● Comparative income statement information will be re-presented on a consistent basis;

● GSK will no longer present a Consumer Healthcare segment and those items previously reported within the Consumer Healthcare segment that do not form part of the ‘Discontinued operations’ of the Group will be shown as part of ‘Continuing operations’ and reported within either the Commercial Operations segment or Corporate and unallocated costs, as appropriate;

● Disclosure of the Total turnover, expenses, pre-tax profit and tax expense of the ‘Discontinued operations’ will be reported as an additional disclosure on a Total basis only;

●The respective totals of the net cash inflow from operations, the net cash inflow from operating activities, the net cash flow from investing activities and the net cash flow from financing activities will be shown split between ‘Continuing operations’ and ‘Discontinued operations’. Free cash flow[2] will be presented only for ‘Continuing operations’;

● The assets and liabilities of the Consumer Healthcare ‘disposal group’ will be presented on the face of the Group balance sheet as assets held for sale/distribution and liabilities held for sale/ distribution respectively as current assets and liabilities. Analysis of the main categories of assets and liabilities reported as assets and liabilities held for sale/distribution will be presented as a note to the financial statements.

Impact of the application of the requirements of IFRS 5

The application of the requirements of IFRS 5 has no impact on the total post-tax results of the Group in the presentation of the restated historical information. However, as a result of the reclassification of the assets and liabilities of the Consumer Healthcare business (the ‘disposal group’) to assets and liabilities held for sale/ distribution with effect from 30 June 2022, they are held at the lower of carrying amount and fair value less costs to distribute and from that point onwards, depreciation and amortisation ceases on those tangible and intangible assets reclassified as part of the assets held for sale/distribution.

The application of IFRS 5 also has no impact on the total reported cash flows of the Group, although under the requirements of IFRS 5, the total for each category of the reported cash flows of the Group (net cash inflow from operations, cash flow from operating activities, cash flow from investing activities and cash flow from financing activities) should be presented split between ‘Continuing’ and ‘Discontinued operations’.

As a result of the presentational changes, cash generated from operations for the full year 2021 was £7,249 million for ‘Continuing operations’ (Q1 2021: £406 million; Q1 2022: £2,353 million) and cash generated from operations was £1,994 million for ‘Discontinued operations’ (Q1 2021: £80 million; Q1 2022: £402 million).

Net cash inflow from continuing operating activities for the full year 2021 was £6,277 million (Q1 2021: £316 million; Q1 2022: £2,207 million) and net operating cash flows attributable to discontinued activities was £1,675 million (Q1 2021: £15 million; Q1 2022: £335 million).

Net increase/(decrease) in cash and bank overdrafts from ‘Continuing operations’ for the full year 2021 was £(2,505) million (Q1 2021: £(900) million; Q1 2022: £283 million) and net increase/(decrease) in cash and bank overdrafts attributable to ‘Discontinued operations’ was £1,091 million (Q1 2021: £(193) million; Q1 2022: £6,639 million).

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Impact on the Group’s reportable segments

The Group presents its segmental results based on the Adjusted results of the Group from ‘Continuing operations’ and will therefore exclude the Consumer Healthcare business from Q2 2022. As a result, the Group will no longer report a Consumer Healthcare segment. The Group will continue to report the results of the Commercial Operations segment and the Research and Development segment.

As a result of reporting the results of the continuing operations of GSK and no longer reporting the Consumer Healthcare segment, the results of the Commercial Operations segment and those costs shown under Corporate and unallocated costs for prior periods have been revised. This reflects the following principal changes:

● Certain revenues and costs reported within the Consumer Healthcare segment will be split between the ‘Continuing operations’ and ‘Discontinued operations’ of the Group income statement, primarily reflecting contract manufacturing that will continue to be performed by GSK on behalf of the Haleon group after the demerger. The value of the sales and related costs that will be included in the ‘Continuing operations’ of the Group will be reported as part of the Commercial Operations segment;

● The Consumer Healthcare segment included some markets that were not within the perimeter of the Consumer Healthcare joint venture with Pfizer and will not be part of the Consumer Healthcare business to be demerged. These will be reported as part of the Commercial Operations segment.

● Corporate costs that were allocated to the Consumer Healthcare segment and will continue to be incurred by GSK after the demerger. These costs will be reported within the Corporate and unallocated costs as ‘Continuing operations’. Corporate costs incurred by GSK in prior periods on behalf of Consumer Healthcare that have been transferred to Haleon group companies ahead of the demerger will be reported as part of ‘Discontinued operations’.

The impact of these ‘Continuing operations’ sales and costs previously reported in the Consumer Healthcare segment and that do not form part of the ‘Discontinued operations’ do not materially change the reported performance of the Commercial Operations segment.

The tables below set out the revised format for reporting the income statement under the requirements of IFRS 5 that will be applied from the Q2 2022 results, as applied to the Q1 2021, Q2 2021, Q3 2021, Q4 2021 and full year 2021 and the Q1 2022 results.

Lyra Therapeutics Announces Appointment of Richard Nieman, MD, as Chief Medical Officer

On July 5, 2022 Lyra Therapeutics, Inc. (Nasdaq: LYRA), a clinical-stage therapeutics company leveraging its proprietary XTreo platform to enable precise, sustained and local delivery of medications to the ear, nose and throat (ENT) passages and other diseased tissues, reported that Richard Nieman, MD, has been appointed Chief Medical Officer, effective July 11, 2022 (Press release, Lyra Therapeutics, JUL 5, 2022, View Source [SID1234616488]). Dr. Nieman brings more than 25 years of experience in drug development and medical affairs, with a proven track record in developing medicines through commercialization and beyond.

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"We’re pleased to welcome Dr. Nieman as our Chief Medical Officer," said Maria Palasis, PhD, CEO of Lyra Therapeutics. "Dr. Nieman joins the Lyra team at a critical time with our lead candidate LYR-210 in pivotal Phase 3 trials. Having successfully developed and launched numerous innovative medicines for patients and their families during the course of his career, his experience building and leading medical organizations will be invaluable as we work to bring new treatments to patients with chronic rhinosinusitis (CRS)."

"I’m thrilled to be taking on this role during such an exciting time in Lyra’s growth and evolution with late-stage clinical programs," said Dr. Nieman. "There is a significant need for effective treatments for patients suffering with CRS, and I look forward to working with the Lyra team to build on the compelling data to date and contributing my abilities and experience as the company drives towards commercialization."

Dr. Nieman, a respiratory physician (pulmonologist) with deep pharmaceutical medicine experience, has had prior leadership roles as SVP & Worldwide Medical Head of Immunology at Bristol Myers Squibb (BMS), Head of R&D China at BMS, Global Medical Officer & Head of Medical at Teva, and Head of Asia Pacific Medical at Bayer. At Teva, he led the company’s medical and heath economic and outcome research (HEOR) function of 550 professionals and was a member of the Specialty Executive Team. In addition to his U.S. experience and credentials, Richard has also spent significant time working in China, throughout Asia and in Europe. He has been involved in bringing numerous important medicines to the market in the U.S. and Europe, including Cinquair in asthma, Copaxone 40 mg 3x/week in multiple sclerosis, Austedo in movement disorders, Ajovy in migraine and Xarelto in thrombosis and stroke prevention. Richard is a Fellow of the UK Royal College of Physicians, a Visiting Senior Lecturer at the School of Cancer and Pharmaceutical Sciences, Kings College, London, and was a Visiting Professor at Fudan University School of Public Health in Shanghai, China. He has published extensively and trained and practiced medicine in the UK. Dr. Nieman assumes the role of Chief Medical Officer previously held by Dr. Robert Kern, who will continue to work closely with the Company in the role of Chief Clinical Advisor.

Lyra has approved the issuance of an equity-based award pursuant to its 2022 Inducement Award Plan to Dr. Nieman upon the commencement of his employment. The inducement grant was approved by a majority of the Company’s independent directors and was made as a material inducement to Dr. Nieman’s acceptance of employment with Lyra in accordance with Nasdaq Listing Rule 5635(c)(4) as a component of his employment compensation. The inducement grant consists of a non-qualified stock option to purchase an aggregate of 230,000 shares of the Company’s common stock. The inducement grant is subject to the terms and conditions of the award agreement covering the performance stock option grant and the Company’s 2022 Inducement Award Plan.

Brand Institute Partners on Brand Name Development for Treatment of Relapsed or Refractor Peripheral T-Cell Lymphoma Now Approved by Ministry of Health, Labour and Welfare (Japan)

On July 5, 2022 Brand Institute reported its work with Solasia Pharma K.K. ("Solasia") in developing the brand name DARVIAS (Press release, Brand Institute, JUL 5, 2022, View Source [SID1234616487]).

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DARVIAS, an organoarsenic compound with anticancer activity, is a novel mitochondrial-targeted agent being developed for the treatment of various hematologic and solid tumors. DARVIAS provokes cell cycle arrest and apoptosis through disruption of mitochondrial functions and increased production of reactive oxygen species in tumor cells. DARVIAS is expected to exert an anticancer effect by inducing cell cycle arrest and apoptosis.

DARVIAS has been approved for relapsed or refractory Peripheral T-Cell Lymphoma by Japan’s Ministry of Health, Labour and Welfare (MHLW). Japan is the first country in the world where DARVIAS has been approved. DARVIAS has been granted orphan drug designation in the US and EU.

"The entire Brand Institute and Drug Safety Institute team congratulates Solasia on the MHLW approval of the DARVIAS injection," said Brand Institute’s Chairman and C.E.O., James L. Dettore.

Skyhawk Announces Collaboration Agreement with Sanofi for Oncology and Immunology Targets

On July 5, 2022 Skyhawk Therapeutics, Inc. reported the signing of an exclusive worldwide collaboration agreement with Sanofi to discover and develop novel small molecules that modulate RNA splicing for challenging oncology and immunology targets (Press release, Skyhawk Therapeutics, JUL 5, 2022, View Source [SID1234616486]).

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Frank Nestle
Global Head of Research and Chief Scientific Officer, Sanofi
"We look forward to this collaboration with Skyhawk, a pioneer in developing novel small molecules that modulate critical RNA splice sites. Skyhawk’s SkySTAR platform integrating proprietary computational biology tools, kinetic models, and conformational structural models of RNA, offers an exciting opportunity to build drugs that treat disease targets which today have limited or no therapeutic options."

Bill Haney
Chief Executive Officer, Skyhawk Therapeutics
"Sanofi is a global leader in the development and commercialization of innovative therapies, and we look forward to working with their talented team to build novel small molecule therapeutics that modify RNA splicing for the treatment of critical diseases of high unmet need. We are excited to develop drugs for challenging targets with Sanofi and look forward to working together on these potentially first- and best-in-class programs."

Terms of the Agreement
Under the collaboration agreement, Sanofi will pay Skyhawk $54 million upfront. Skyhawk will grant Sanofi exclusive licenses to worldwide intellectual property rights to candidates discovered and developed under the collaboration that are directed to program targets. Following DC status, Sanofi will assume responsibility for further development and commercialization. Skyhawk is also eligible to receive over $2 billion in potential milestone payments, as well as potential royalties on future sales.

Exelixis to Webcast Fireside Chat as Part of the William Blair Biotech Focus Conference

On July 5, 2022 Exelixis, Inc. (Nasdaq: EXEL) reported that company management will participate in a pre-recorded fireside chat at the William Blair Biotech Focus Conference 2022, which will be available to view on-demand beginning Monday, July 11, 2022 (Press release, Exelixis, JUL 5, 2022, View Source [SID1234616484]).

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To access the webcast link, log onto www.exelixis.com and proceed to the News & Events / Event Calendar page under the Investors & Media heading. Please connect to the company’s website at least 15 minutes prior to the presentations to ensure adequate time for any software download that may be required to listen to the webcasts. Replays will also be available at the same location for at least 30 days.