United Kingdom Pharmaceuticals 27 Feb 24 – INDUSTRY SNAPSHOTS
Bloomberg.com - New Gonorrhea Pill Is as Good as Injected Antibiotic, GSK Says -
A new antibiotic pill for gonorrhea was as good as current treatments in a late-stage trial for an infection that has resurfaced around the globe, the drugmaker
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BioSpectrum Asia - Mediven and
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Pharmaceutical Technology -
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https://www.pharmaceutical-technology.com/news/nice-recommends-pfizer-ritlecitinib/
Other Stories
Pharmaceutical Technology -
Bloomberg.com - GSK Says HIV Shot Is Better than Daily Pills for Some Patients -
The Guardian -
Bloomberg.com -
Reuters - GSK completes acquisition of Aiolos Bio for up to
Media Releases
Development of a Practical Nomogram for Personalized Anemia Management in Patients Treated with Ataxia Telangiectasia and Rad3-related Inhibitor Camonsertib - By
Industry Overview
The pharmaceutical industry in the
Leading Company Overview
Bristol-Myers Squibb
Eli
Roche Products
Associate: Danny Cliffson Crispin Benos
News and Commentary
Bloomberg.com - New Gonorrhea Pill Is as Good as Injected Antibiotic, GSK Says -
A new antibiotic pill for gonorrhea was as good as current treatments in a late-stage trial for an infection that has resurfaced around the globe, the drugmaker
For the complete story, see:
BioSpectrum Asia - Mediven and
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Pharmaceutical Technology -
For the complete story, see:
https://www.pharmaceutical-technology.com/news/nice-recommends-pfizer-ritlecitinib/
Pharmaceutical Technology -
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Bloomberg.com - GSK Says HIV Shot Is Better than Daily Pills for Some Patients -
For the complete story, see:
The Guardian -
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Bloomberg.com -
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Reuters - GSK completes acquisition of Aiolos Bio for up to
GSK (GSK.L), opens new tab said on Thursday it had completed the acquisition of Aiolos Bio, a clinical-stage biopharmaceutical company focused on respiratory and inflammatory conditions.
For the complete story, see:
Media Releases
EAGLE-1 trial met its primary efficacy endpoint of non-inferiority comparing gepotidacin with intramuscular ceftriaxone plus oral azithromycin combination therapy
Neisseria gonorrhoeae, the bacteria causing gonorrhoea, is recognised by the
Gepotidacin, a late-stage antibiotic in GSK's industry-leading infectious diseases portfolio, is also in development for uncomplicated urinary tract infections (uUTI)
Gonorrhoea is a sexually transmitted infection caused by bacteria called Neisseria gonorrhoeae. It has been estimated that there are 82 million new cases globally each year.i In
The safety and tolerability profile of gepotidacin in the EAGLE-1 phase III trial was consistent with results seen in gepotidacin phase I and II trials.
Detailed results from the EAGLE-1 trial will be presented at an upcoming scientific meeting and shared with global health authorities.
GSK is also developing gepotidacin for the potential treatment of uncomplicated urinary tract infections (uUTI). Positive phase III data from the EAGLE-2 and EAGLE-3 trials were presented at the
The development of gepotidacin has been funded in whole or in part with federal funds from the
Data Safety Monitoring Board (DSMB) for ACTG study recommends study be modified to stop randomisation and to give participants receiving daily oral therapy the option to transition to long-acting injectable therapy
Full data set to be presented at an upcoming scientific conference
"The interim data indicating the superiority of long-acting therapy compared to daily oral therapy in individuals
The LATITUDE (Long-Acting Therapy to Improve Treatment Success in Daily Life) study is ongoing across 31 sites in the
Last week, the DSMB performed a planned interim review. They considered the totality of all the study endpoints together and concluded that the evidence indicated superior efficacy of long-acting ART over daily oral standard of care. The DSMB recommended that all eligible participants should be offered long-acting injectable cabotegravir + rilpivirine.
There are many factors that can influence a person's ability to take medicine every day, including access to health care or health insurance, affordability, unstable housing, stigma and fear of having their HIV status disclosed. Lack of consistent adherence is a common reason why some people living with HIV have difficulty maintaining undetectable viral loads.
LATITUDE is sponsored and funded by the
Application based on results from the TROPION-Lung01 Phase III trial
If approved,
The BLA is based on results from the pivotal TROPION-Lung01 Phase III trial in which datopotamab deruxtecan demonstrated a statistically significant improvement for the dual primary endpoint of progression-free survival (PFS) compared to docetaxel, the current standard of care, in patients with locally advanced or metastatic NSCLC treated with at least one prior line of therapy. For the dual primary endpoint of overall survival (OS), interim results numerically favoured datopotamab deruxtecan over docetaxel in the overall population; however, results did not reach statistical significance at the time of data cut-off. In patients with nonsquamous NSCLC, datopotamab deruxtecan showed a clinically meaningful PFS benefit and a numerically favourable OS trend. The trial is ongoing and OS will be assessed at final analysis.
Datopotamab deruxtecan is a specifically engineered TROP2-directed DXd antibody drug conjugate (ADC) being jointly developed by
Results from TROPION-Lung01 were presented during a Presidential Symposium at the 2023
The safety profile of datopotamab deruxtecan was consistent with that observed in other ongoing trials with no new safety concerns identified.
A parallel BLA for datopotamab deruxtecan based on results from the pivotal TROPION-Breast01 Phase III trial is pending acceptance in the US for the treatment of adult patients with metastatic hormone receptor (HR)-positive, HER2-negative (IHC 0, IHC 1+ or IHC 2+/ISH-) breast cancer. Additional regulatory submissions for datopotamab deruxtecan in lung and breast cancer are underway globally.
Development of a Practical Nomogram for Personalized Anemia Management in Patients Treated with Ataxia Telangiectasia and Rad3-related Inhibitor Camonsertib
Abstract
Purpose:
Camonsertib is a highly selective and potent inhibitor of ataxia telangiectasia and Rad3-related (ATR) kinase. Dose-dependent anemia is a class-related on-target adverse event often requiring dose modifications. Individual patient risk factors for the development of significant anemia complicate the selection of a "one-size-fits-all" ATR inhibitor (ATRi) dose and schedule, possibly leading to suboptimal therapeutic doses in patients at low risk of anemia. We evaluated whether early predictors of anemia could be identified to ultimately inform a personalized dose-modification approach.
Patients and Methods:
On the basis of preclinical observations and a mechanistic understanding of ATRi-related anemia, we identified several potential factors to explore in a multivariable linear regression modeling tool for predicting hemoglobin level ahead of day 22 (cycle 2) of treatment.
Results:
In patients treated with camonsertib monotherapy (NCT04497116), we observed that hemoglobin decline is consistently preceded by reticulocytopenia, and dose- and exposure-dependent decreases in monocytes. We developed a nomogram incorporating baseline and day 8 hemoglobin and reticulocyte values that predicted the day 22 hemoglobin values of patients with clinically valuable concordance (within 7.5% of observations) 80% of the time in a cross-validation performance test of data from 60 patients.
Conclusions:
The prediction of future hemoglobin decrease, after a week of treatment, may enable a personalized, early dose modification to prevent development of clinically significant anemia and resulting unscheduled dose holds or transfusions.
The Industry
The National Health Service (
https://pubmed.ncbi.nlm.nih.gov/10163432/
Act now to bring £68bn economic boost to the
The
While there are some good individual examples of investment, the overall picture in the
One year on from the launch of the
£68 billion in additional GDP over 30 years, owing to increased R&D investment
£16.3 billion additional annual GDP from increased pharmaceutical exports
Supporting 85,000 additional jobs
Up to 40 per cent decrease in disease burden across the whole
Reduced variation in speed of access to new medicines within three months of licensing for all
The report maps the
Clinical research
Phase I clinical trials - early development of new medicines and treatments - initiated in the
Phase II and III clinical trials - which test the efficacy of new medicines and treatments relative to standard of care - initiated in the
This has impacted on innovation in the sector: The
Pharmaceutical industry spend on research and development
The
Manufacturing
While Government has introduced policies to enhance
And, while other countries have expanded production and exports, since 2015 the
Access and uptake
The
Implementing the Life Science Vision and the gains to be made
The authors say there is no single reason the
The report finds that the ambition of the Life Sciences Vision - to build the world's leading medicines and vaccines hub - is feasible. However, there is some way to go.
Four key areas of the Vision are highlighted: Creating the right business environment; research infrastructure; innovation access and uptake; and healthcare challenges of the future.
If the
Creating the right business environment: By increasing the
To do this the
Tackling future healthcare challenges: by raising its performance in tackling the priority challenges set out in the Vision, the
By emulating countries including
Supporting access and uptake environment: Reducing variation in how quickly medicines are available on the
Building on the
Additionally, improving the
Source: Association of
Business enterprise research and development,
Main points
Expenditure on research and development (R&D) performed by
The software development product group had the largest growth in expenditure on R&D in 2020; with an increase of £314 million (18.3%) to £2.0 billion.
The East of
In 2020, total
In 2020, 75% of business R&D was funded by businesses' own funds (£20.3 billion) followed by overseas funding at 15% (£3.9 billion); businesses' own funds also had the largest growth in the value of funding of R&D in 2020, which increased by £661 million.
In 2020, business R&D consisted of civil R&D of 93% (£25.0 billion) and defence R&D of 7% (£2.0 billion); the split between civil and defence has changed over time with civil R&D accounting for 88% and defence R&D accounting for 12% in 2009.
Source: Association of
Leading Companies
Located less than an hour away from
Thanks to the University,
Uxbridge is a thriving town with all the facilities that you would expect from a
Purchased by
https://www.amgen.co.uk/en-gb/about/amgen-in-the-uk-and-ireland/
Key results include:
Total revenues increased 4% to
Volume growth of 11% included double-digit volume growth from BLINCYTO® (blinatumomab), EVENITY® (romosozumab-aqqg), Repatha® (evolocumab) and Nplate® (romiplostim).
GAAP earnings per share (EPS) decreased 19% from
GAAP operating income decreased from
Non-GAAP EPS increased 6% from
Non-GAAP operating income increased from
The Company generated
Product Sales Performance
Total product sales increased 5% for the third quarter of 2023 versus the third quarter of 2022. Unit volumes grew 11%, partially offset by 3% lower net selling price and 3% unfavorable changes to estimated sales deductions.
General Medicine
Repatha® sales increased 31% year-over-year for the third quarter, driven by 44% volume growth, partially offset by lower net selling price. In the
Prolia® (denosumab) sales increased 14% year-over-year for the third quarter, primarily driven by 7% volume growth and higher net selling price. We are on track to treat over 7 million patients with Prolia in 2023.
EVENITY® sales increased 53% year-over-year to a record
Aimovig® (erenumab-aooe) sales decreased 12% year-over-year for the third quarter, driven by lower net selling price, partially offset by favorable changes to estimated sales deductions.
Inflammation
TEZSPIRE® (tezepelumab-ekko) generated
TAVNEOS® (avacopan) generated
Otezla® (apremilast) sales decreased 10% year-over-year for the third quarter, driven by lower net selling price, unfavorable changes to estimated sales deductions and lower inventory levels, partially offset by 1% volume growth. In the
We expect future growth for Otezla to be driven by its established efficacy and safety profile, strong payer coverage with limited prior authorization requirements and ease of administration. Otezla remains the only approved oral systemic therapy with a broad indication and is well-positioned to help the 1.5 million
Enbrel® (etanercept) sales decreased 6% year-over-year for the third quarter, primarily driven by an 8% decline from unfavorable changes to estimated sales deductions, resulting from a
AMJEVITA®/AMGEVITA™ (adalimumab) sales increased 30% year-over-year for the third quarter, driven by 53% volume growth, partially offset by lower net selling price. Ex-
For full release see:
https://www.amgen.com/newsroom/press-releases/2023/10/amgen-reports-third-quarter-financial-results
We are a global, science-led biopharmaceutical business and our innovative medicines are used by millions of patients worldwide.
Our purpose and values
Our purpose and values help explain why we exist, what we hope to accomplish, the behaviours we value, how we will achieve our goals, and the promise of our brand to our stakeholders.
https://www.astrazeneca.com/our-company.html
Our business strategy
We have transformed our pipeline and returned to growth and, as a result of continued pipeline delivery and commercial execution, we are now entering a new stage of our journey. This is focused on enhanced innovation and the delivery of life-changing medicines that that contribute value to patients and society.
The fundamentals of our strategy are clear. We focus on innovative science and leadership in our three main therapy areas: Oncology; Cardiovascular, Renal and Metabolism; and Respiratory diseases. Backed by a global presence, with strength in Emerging Markets, particularly
At the same time, the world around us is changing and the burden of disease is increasing. We are responding by increasing our focus on growth through innovation - being more patient-centric, doing more with technology, digital and data, and advancing more cutting-edge science.
All this is reflected in our three strategic priorities.
https://www.astrazeneca.com/our-company/our-strategy.html
Full Year and Q4 2023 results
"As
We expect another year of strong growth in 2024, driven by continued adoption of our medicines across geographies. Our differentiated and growing portfolio of approved medicines, global reach and rich R&D pipeline give us confidence that we will continue to deliver industry-leading growth."
Financial performance for full year 2023 (Growth numbers at CER)
Total Revenue
Excluding COVID-19 medicines, Total Revenue increased 15% and Product Sales increased 14%
Double-digit Total Revenue growth from Oncology 21%, CVRM 18%, R&I 10%, and Rare Disease 12%
Core Product Sales Gross Margin5 of 82%, up two percentage points, reflecting the decline in sales of lower margin COVID-19 medicines
Core Operating Margin of 32% increased by two percentage points including the previously announced gain from an update to the contractual relationships for Beyfortus, totalling
The Core Tax Rate for the year was 17%. In the fourth quarter, the tax rate was negatively impacted by reviews by tax authorities, administrative appeal processes and other adjustments, offset by a routine intragroup reorganisation of IP, leading to a tax rate of 10% in the quarter
Core EPS increased 15% to
Second interim dividend declared of
Total Revenue and Core EPS in FY 2024 are each expected to increase by a low double-digit to low teens percentage at CER
Key milestones achieved since the prior results announcement
Three first approvals for new molecular entities: Truqap (capivasertib), Wainua (eplontersen), Voydeya (danicopan)
US approvals for Truqap plus Faslodex in HR-positive, HER2-negative advanced breast cancer with biomarker alterations (CAPItello-291), and Wainua for ATTRv-PN (NEURO-TTRansform).
Enhertu granted Priority Review in the US for patients with metastatic HER2-positive solid tumours
Guidance
The Company issues its Total Revenue and Core EPS guidance for FY 2024 at CER, based on the average foreign exchange rates through 2023.
Total Revenue is expected to increase by a low double-digit to low teens percentage
Core EPS is expected to increase by a low double-digit to low teens percentage
Collaboration Revenue is expected to increase substantially, driven by success-based milestones and certain anticipated transactions
Other operating income is expected to decrease substantially (FY 2023 included a
The Core Tax rate is expected to be between 18-22%
The Company is unable to provide guidance on a Reported basis because it cannot reliably forecast material elements of the Reported results, including any fair value adjustments arising on acquisition-related liabilities, intangible asset impairment charges and legal settlement provisions. Please refer to the cautionary statements section regarding forward-looking statements at the end of this announcement.
For the full release, see:
Brinton Healthcare
Brinton has today carved a rich heritage in global healthcare encouraging the true spirit of 'qualitative living' in the Life of billions of people around the world. Not limiting to this, with newer products that we consistently innovate and bring to Life, BRINTON touches every Life and envisions a healthier and happier world!
At Brinton, research and innovation are the cornerstones of its long-term business strategy. Product Development commands center stage in our R&D program, primarily focused on developing a quality portfolio of niche differentiated products that address unmet medical needs.
Path-breaking Innovations in Drug Discoveries & Deliveries
Our prodigious pharmacists are constantly pushing the frontiers of research to find unique solutions to challenging ailments and health conditions for better patient care, viz:
World-class multi-locational research & manufacturing partner facilities
International accreditations such as
Innovative formulations in widespread dosage forms
Consumer healthcare as well as Specialty care serving both acute and chronic customer segments in Clinical and Aesthetic Dermatology, and
Global supply chain network
800+ talented & experienced people-friendly workforce
Global Manufacturing' for 'Global Markets'
Our products are manufactured at World-class multi-locational research and manufacturing partner facilities, that are certified by the most stringent global regulatory authorities like the
'Global Capacity Partnership Pool' (GCPP)
We continually strive for unparalleled operational excellence harnessing integrated Production, Quality, and Regulatory Compliance standards. Our 'Global Capacity Partnership Pool' (GCPP) ensures significant operational synergy in bringing innovations to Life. We are thus in a position to serve different markets with customized products through our well-established global supply chain network.
https://www.brintonhealth.com/brinton_healthcare_uk_ltd.php
Bristol Myers Squibb
We're committed to the
Each day, the 1,200 people we directly employ in the
As global citizens, we work sustainably and responsibly and seek to give back. For example, in 2020, we donated £2 million to
Through the
https://www.bms.com/gb/about-us.html
Bristol Myers Squibb Reports Second Quarter Financial Results for 2023
Reports Second Quarter Revenues of
Posts Second Quarter GAAP Earnings Per Share of
Reports Second Quarter Revenue Growth for In-Line Products and New Product Portfolio of 4%
Progresses Portfolio and Pipeline with Significant Regulatory and Clinical Milestones Achieved
Revises Outlook for Total Revenues to Low Single-Digit Decline, GAAP EPS to
Reaffirms 2020-2025 Financial Targets
Announces
"This was an important quarter for
For full release see:
We are a global leading research-based pharmaceutical company working in the neurology and oncology therapeutic areas and we define our corporate mission as "giving first thought to patients and their families, and to increasing the benefits health care provides".
human health care
Our work at
We call this human health care (hhc).
https://www.eisai.eu/
CONSOLIDATED FINANCIAL REPORT [IFRS] for the Six-Month Period Ended
For full release see:
https://www.eisai.com/ir/library/settlement/pdf/e2024Q2_51.pdf
Eli
Founded by Eli
For more than 85 years, we have remained committed to bringing life-changing, innovative medicines to
https://www.lilly.co.uk/who-we-are/lilly-UK
Revenue in Q2 2023 increased 28% as a result of volume-driven growth from Mounjaro, Verzenio, Jardiance and Taltz, as well as
Pipeline progress included positive results in the Phase 3 TRAILBLAZER-ALZ 2 study and the submissions of donanemab for traditional approval to the FDA and EMA; the completed submission of tirzepatide in chronic weight management to the FDA and positive results in the Phase 3 SURMOUNT-3 and -4 studies; and approval of mirikizumab in the EU and re-submission in the
Business development activity included announcements of agreements to acquire
New Products(i) contributed
Q2 2023 EPS increased 86% to
2023 reported EPS guidance raised
"
Positive Phase 3 TRAILBLAZER-ALZ 2 results, which showed donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer's disease, as well as donanemab's submissions for traditional approval to the
The completed submission of tirzepatide in chronic weight management to the FDA and positive Phase 3 SURMOUNT-3 and -4 results, which showed the highest level of weight loss observed in the SURMOUNT program to date;
The approval of mirikizumab in the
The announcements of agreements to acquire
Bio, which would advance
FDA approval of Jardiance® to lower blood sugar along with diet and exercise in children 10 years and older with type 2 diabetes; and
Allocation of an additional
For full release see:
GSK are one of the largest global healthcare companies researching, developing and supplying innovative medicines, vaccines and healthcare products with our global headquarters in the
Currently, GSK invest around £1bn in research and development (R&D) in the
GSK focus on what matters most to our people, this means managers helping employees to be themselves, feel good and keep growing, in ways that work for them. GSK are recognised in the Stonewall LGBT+ rights group as a top global employer and ranked in the Times Top 50 employers for women in the
https://www.gsk.com/en-gb/locations/united-kingdom/
Strong performance and momentum drive upgraded guidance
Sales and earnings growth delivered by key growth drivers
Q2 2023 sales +4% and +11% ex COVID
Vaccines sales +18%, +15% ex COVID with Shingrix +20%
Specialty Medicines sales -7%, +12% ex COVID with HIV +12%
General Medicines sales +8% with Trelegy +30%
Strong sales growth of products launched since 2017 including in Vaccines and HIV contributing to step change in performance
Total operating profit and Total continuing EPS >100% driven by strong operating performance and favourable movements in contingent consideration liabilities
Adjusted operating profit +11% and Adjusted EPS +16% reflects strong sales ex COVID and higher royalty income offset by increased investment in R&D and new product launches
For full release see:
Pfizer
Over the past 66 years, we have continued to invest in the
We support the
OUR
In 2017, we spent over £209 million supporting research and development carried out in the
https://www.pfizer.co.uk/pfizer-uk
PFIZER REPORTS RECORD FULL-YEAR 2022 RESULTS AND PROVIDES FULL-YEAR 2023 FINANCIAL GUIDANCE
Full-Year 2022 Revenues of
Excluding Contributions from Paxlovid and Comirnaty(1), Revenues Grew 2% Operationally
Strong Fourth-Quarter 2022 Revenues of
Excluding Contributions from Paxlovid and Comirnaty(1), Revenues Grew 5% Operationally
Full-Year 2022 Reported Diluted EPS(2) of
Fourth-Quarter 2022 Reported Diluted EPS(2) of
Includes a
Provides Full-Year 2023 Revenue Guidance(4) of
Guidance of
Full-Year 2023 Revenues Excluding COVID-19 Products Expected to Grow 7% to 9% Operationally Compared to Full-Year 2022
Full-Year 2023 Revenue Guidance for Comirnaty(1) of
Revenues from COVID-19 Products Expected to Grow in 2024 After Reaching a
Company Plans to Make Significant Incremental Investments in 2023 to Support Launch Products and
R&D Projects that are Expected to Drive its Long-Term Growth Ambitions
Continues to Make Progress on
The fourth-quarter 2022 earnings presentation and accompanying prepared remarks from management as well as the quarterly update to
EXECUTIVE COMMENTARY
Dr.
For full release see:
https://s28.q4cdn.com/781576035/files/doc_financials/2022/q4/Q4-2022-PFE-Earnings-Release.pdf
Roche Products
We have been committed to improving lives since the company was founded in 1896 in
At Roche
What we do
For well over a century, we've focused our energy and investment in developing tests and treatments that change lives and give everyone more quality time with the people they love.
Whether you live in
Our purpose
Each year, we transform millions of lives with our joined-up approach to testing and treatment. But our impact extends far beyond those we treat. Behind every child we test are parents looking for peace of mind; behind every grandparent we treat is a family
While most of our work focuses on the sickest people in the
https://www.roche.co.uk/en/About-Roche-in-the-UK.html
Excluding COVID-19 products, Group sales increase strongly by 8%1 at constant exchange rates (CER)
In line with the expected declining demand for COVID-19 products, Group sales decrease 2% (-8% in Swiss francs)
Pharmaceuticals Division sales grow strongly by 8% due to continued high demand for newer medicines; new eye medicine Vabysmo is the strongest growth driver
Diagnostics Division's base business continues its good growth momentum with an increase of 6%, while total divisional sales are 23% lower due to exceptionally high demand for COVID-19 tests in the first half of 2022
Core earnings per share decrease 5%, driven by lower demand for COVID-19 products and a base effect from a patent settlement in 2022; IFRS net income down 9% due to lower core operating profit and higher interest expenses
Highlights in the second quarter of 2023:
US and EU approvals of Columvi (aggressive form of blood cancer)
US approval of Elevidys for
Positive phase III data for subcutaneous injection of Ocrevus (multiple sclerosis); positive long-term efficacy and safety data for Evrysdi (spinal muscular atrophy) and positive phase II data for fenebrutinib (multiple sclerosis)
Start of phase III study of tiragolumab in combination with Tecentriq and Avastin (liver cancer)
Partnership with
Outlook for 2023 confirmed
For full release see:
https://www.roche.com/media/releases/med-cor-2023-07-27
An industry-leading inhaled airways disease-focused business with uniquely integrated formulation, device and development capabilities. Our vision is to transform patients' lives through enhanced inhaled drug delivery. Our strategy is to maximise the value of our differentiated inhaled formulation, device and development capabilities through partnering complex inhaled generics and the enhanced delivery of existing molecules.
https://www.vectura.com/who-we-are
Delisting of Vectura
Update on Offer
On
On
On
As at
PMI and PMI Bidder have therefore acquired or received valid acceptances of the Offer in respect of 473,336,128 Vectura Shares in aggregate, representing approximately 77.57 per cent. of the Vectura Shares currently in issue.
Delisting, cancellation of trading and re-registration
Accordingly, as the Offer is now unconditional in all respects and PMI and PMI Bidder have acquired or received valid acceptances of the Offer in respect of Vectura Shares carrying more than 75 per cent. of the voting rights of Vectura, PMI Bidder will now procure that Vectura makes applications to cancel the listing of Vectura Shares on the Official List, to cancel trading in Vectura Shares on the
Pursuant to Listing Rule 5.2.11R, Vectura announces that the cancellation notice period has now commenced and cancellation is expected to take effect from
As soon as reasonably practicable after delisting and cancellation of trading occurs, it is intended that Vectura will be re-registered as a private limited company under the relevant provisions of the Companies Act.
Delisting of the Vectura Shares and the re-registration of Vectura as a private limited company will significantly reduce the liquidity and marketability of any Vectura Shares in respect of which the Offer has not been accepted at that time, and the reporting and disclosure requirements will be significantly reduced.
Vectura Shareholders are reminded that if they have not accepted the Offer before Vectura is re-registered as a private limited company, they would become minority shareholders in a majority controlled private limited company and, due to the reduction of liquidity and marketability of Vectura Shares, future opportunities to sell their Vectura Shares will be more limited. In addition, there can be no certainty that Vectura would pay any further dividends or other distributions to these minority shareholders or that, after the Offer has been closed, such minority Vectura Shareholders would have the opportunity to sell their Vectura Shares on terms which are equivalent to or no less advantageous than those under the Offer.
Vectura Shareholders
Compulsory Acquisition
As set out in paragraph 1 of Part 1A of the Offer Document, if PMI and PMI Bidder acquire or receive acceptances under the Offer in respect of both 90 per cent. or more in value of the Vectura Shares to which the Offer relates and not less than 90 per cent. of the voting rights carried by those shares, PMI Bidder intends to exercise its rights in accordance with sections 974 to 991 of the Companies Act to acquire the remaining Vectura Shares on a compulsory basis on the same terms as the Offer.
Continuation of the Offer and action to be taken
As announced on
Forms of Acceptance not yet returned should be completed and returned in accordance with the instructions set out in the Offer Document and in the Form of Acceptance so as to be received as soon as possible, and in any event not later than
Capitalised terms used but not defined in this announcement have the meaning given to them in the Offer Document.
https://www.vectura.com/wp-content/uploads/2021/09/VecturaIntranet_15189470.pdf
Vectura reports 2020 financial performance ahead of expectations and announces intention to pay special dividend of approximately £115m to shareholders during 2021
Chippenham,
Financial summary
2020
2019 (Restated)
% change
Revenue
£190.6m
£178.3m
6.9%
Gross profit
£101.4m
£95.3m
6.4%
Research and development [1] ('R&D') expenses
(£23.8m)
(£36.6m)
(35.0%)
General and administrative 1 expenses
(£28.7m)
(£27.3m)
5.1%
Adjusted EBITDA [2]
£61.5m
£43.4m
41.7%
Operating profit/(loss) [3]
£132.8m
(£27.0m)
n/m
Basic earnings/(loss) per share 3
20.5p
(3.4p)
n/m
Cash generated from operating activities
£31.5m
£19.3m
63.2%
Free cash flow [4]
£24.1m
£12.5m
92.8%
% change
Cash and cash equivalents
£78.6m
£74.1m
6.1%
Operational highlights
Strong execution of strategy to become an industry-leading inhalation CDMO
New Business Development team now established with presence in East and West Coast US,
18 new CDMO contracts signed during the year, contributing £3.0m to revenues in H2 2020
Progress across co-development pipeline
Approval of VR315 (US), generic Advair® programme partnered with
Approval of Enerzair® Breezhaler® in
Operational transformation continues, with phased transition of R&D operations from
US jury verdict upheld at appeal in patent litigation against GSK; £127.6m received to-date in 2021, with further royalties due for Q1 and Q2 2021
Post period update: Following a review of the Group's capital allocation priorities, the Board has approved, in principle, a special dividend of approximately £115m intended to be paid during 2021
Financial highlights
Total revenue of £190.6m increased by 6.9% versus prior year (2019: £178.3m)
Product supply revenue decreased by 4.4% to £109.9m; flutiform® product supply revenues marginally ahead of guidance at £95.8m
Development services revenues increased by 4.4% to £11.9m (2019: £11.4m), reflecting contribution from new CDMO contracts in H2 2020
Royalty and other marketed revenues increased by 32.6% to £68.8m (2019: £51.9m), driven by milestones and Q4 GSK Ellipta® royalties of £6.5m following successful US litigation outcome
Gross profit increased by 6.4% to £101.4m (2019: £95.3m)
Adjusted EBITDA2 increased by 41.7% to £61.5m (2019: £43.4m), reflecting an increase in Royalty and other marketed revenues and a material decrease in R&D investment
Operating profit of £132.8m (2019: £27.0m loss) driven by the recognition of £121.1m exceptional income for damages and interest associated with the enforcement of a patent covering three US GSK Ellipta® products and improved adjusted EBITDA performance
Strong liquidity maintained with closing cash and cash equivalents of £78.6m (2019: £74.1m), reflecting free cash flow generation of £24.1m and a share buyback of approximately £16.4m during 2020
Commenting on the results,
"The business has performed well during 2020, delivering financial performance ahead of expectations. We are pleased with the progress we have made against our inhalation CDMO strategy, signing 18 deals during 2020, with £3.0m revenue recognised in the second half of the year.
"After the positive outcome of the appeal in the GSK US patent litigation, initial proceeds were received by Vectura in
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https://ir.q4europe.com/Solutions/VecturaIntranet/3832/newsArticle.aspx?storyid=15002670
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