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  • Aspen confirms non-binding term sheet on manufacture and sale of an Aspen- branded COVID-19 vaccine throughout Africa
    on 30.11.2021

    Durban, South Africa - JSE Limited listed Aspen Pharmacare Holdings Limited (APN), a global multinational specialty pharmaceutical company, is pleased to confirm that one of its wholly-owned South African subsidiaries, Aspen SA Operations (Pty) Limited (“Aspen SA”), has confirmed a non-binding term sheet with Janssen Pharmaceuticals, Inc., and Janssen Pharmaceutica NV, two of the Janssen Pharmaceutical Companies of Johnson & Johnson (“Johnson & Johnson”), that will form the basis for negotiation of a definitive agreement on the manufacture and sale of an Aspen-branded COVID-19 vaccine throughout Africa. That agreement would expand the existing technical transfer and manufacturing agreements between the parties to grant Aspen SA the rights to: manufacture finished SARS-CoV-2 COVID-19 vaccine product from COVID-19 drug substance supplied by Johnson & Johnson; andsell the finished form vaccine, to be launched and branded as Aspenovax, to public sector markets in Africa through transactions with designated multilateral organisations and with national governments of member states of the African Union. In addition, Johnson & Johnson would grant Aspen a license to the enabling intellectual property for this purpose. The term of the grant of rights and supply of COVID-19 drug substance, subject to the signing of the definitive agreement, would be until 31 December 2026. The non-binding term sheet contemplates a good faith undertaking between the parties to discuss the expansion of the agreement to include any new versions of the drug substance, such as those developed for new variants or as a different formulation for administration as a booster, and the applicable terms thereof. Stephen Saad, Aspen Group Chief Executive said, “The COVID-19 pandemic has highlighted the inequitable access to vaccines globally. This is evident no more so than in Africa which has historically had no option but to import 99% of its vaccine requirements. Those regions with manufacturing capacity and capabilities have enjoyed ready access to COVID-vaccines, those without have not. Africa remains vaccine constrained, preventing an effective response to the need to protect Africans against the virus. We are most grateful to Johnson & Johnson for their confidence in collaborating with Aspen to address these challenges.” “Through our contract manufacturing partnership with Johnson & Johnson, Aspen has been able to manufacture over 100 million doses of the Janssen COVID-vaccine to date, almost all of which have been supplied to Africa, and today, we are pleased to share the progress being made that would enable Aspen the rights to manufacture and sell Aspen’s own brand of the vaccine in Africa. This has the potential to represent a bold step forward in sustainably capacitating Africa with the ability to manufacture Aspenovax and release it exclusively for supply to African customers. A COVID-19 vaccine made in Africa for Africa.” Stephen Saad added, “As with the solution found over a decade ago resulting in voluntary licenses for antiretrovirals used in treating HIV/AIDS, we hope that this potential license agreement and related technical transfers might serve as a blue-print to assist in capacitating Africa and other developing markets and in so doing ensure that we can truly live and give substance to our global commitment that we are not safe until we are all safe.” President Cyril Ramaphosa, African Union COVID champion said,  “The effectiveness of our response as the African continent to the COVID-19 pandemic has been severely hampered by the grossly unequal distribution of COVID vaccines across the world. Today’s landmark announcement between Africa’s Aspen Pharmacare and Johnson & Johnson is the culmination of months of hard work with, among others, the African Union, Africa Centres for Disease Control and Prevention and the African Vaccine Acquisition Trust, in developing production capacity on the continent. This announcement has the potential to make an important contribution to addressing vaccine inequality and building Africa's capacity to meet its own vaccine needs now and into the future.“ Strive Masiyiwa, African Union special envoy on COVID and Head of the AVAT Trust, said “The biggest and boldest step that Africa took through the Africa Vaccine Acquisition Trust and African Union, was signing a contract with Johnson & Johnson for 400 million doses for the continent, the majority to be produced by Aspen. Today’s announcement is an important milestone. It gets us one step closer to securing Africa’s future vaccine production and ensures that the gross vaccine inequality we witnessed in the early  part of the pandemic is not repeated.” “We welcome this agreement. It is a major development which will help reduce the inequities Africa is facing in accessing COVID-19 vaccines. This cooperation and technology transfer arrangement is an important step forward towards increasing Africa’s manufacturing capacity and the push to ramp up access to vaccines and other key medical interventions,“ said Dr Matshidiso Moeti, World Health Organization Regional Director for Africa.

  • Aspen welcomes Kenyan President Uhuru Kenyatta to its Gqeberha manufacturing site
    on 24.11.2021

    Aspen Chairman Kuseni Dlamini (far left) welcoming Kenyan President His Excellency President Uhuru Kenyatta (centre) together with Aspen’s Stavros Nicolaou, Senior Executive Strategic Trade (far right) Gqeberha, South Africa - Aspen, a global multinational specialty pharmaceutical company, earlier today welcomed Kenyan President, His Excellency President Uhuru Kenyatta, to its world class flagship manufacturing site in Gqeberha. President Kenyatta’s visit to Aspen forms part of a broader collaboration and deepening of ties between South Africa and Kenya to lessen Africa’s dependence on pharmaceutical importers and to strengthen the continent’s capacity to address its own public health needs. During his visit President Kenyatta witnessed Aspen’s technical capacity to manufacture and distribute human vaccines for a global market in accordance with international standards and discussed areas of possible cooperation between Aspen and Kenya. Stephen Saad, Aspen Group Chief Executive said, “The COVID-19 pandemic has demonstrated dependence on non-African suppliers to meet African healthcare needs. Aspen is providing a local solution to this need and is committed to working together with Kenyan authorities and their counterparts in strengthening pharmaceutical and health security on the continent. The answer to equitable access to vaccines and other critical lifesaving medicines is to capacitate Af­­rica to serve its own people. Aspen has been able to assist in achieving this goal through the manufacturing capabilities that exist at our sterile manufacturing facility in Gqeberha. It is, for the sake of health security and sustainability, critical that African countries collaborate locally and with the international community to ensure security of demand, underwritten through long-term committed offtakes, and the facilitation of technology licenses and transfers.” Presidents Cyril Ramaphosa and Uhuru Kenyatta met in Pretoria on 23 November 2021 at which time they discussed the latest developments around the global response to the COVID-19 pandemic, including the important matter of vaccine manufacturing and distribution. They reaffirmed their call for the fair and equitable distribution of vaccines.

  • Minister Ebrahim Patel opens Aspen’s world class general anaesthetic manufacturing line
    on 25.10.2021

    Stephen Saad, Aspen Group Chief Executive (left) and Honorable Minister of Trade, Industry and Competition, Mr Ebrahim Patel at the unveiling of Aspen's general anaesthetics manufacturing line in Gqeberha, South Africa Gqeberha, South Africa - Aspen, a global multinational specialty pharmaceutical company, earlier today hosted the Honorable Minister of Trade, Industry and Competition, Mr Ebrahim Patel who officially opened Aspen’s world class general anaesthetics production line at its Gqeberha-based flagship manufacturing site. This manufacturing capability will convert Aspen’s Gqeberha facility into one of the largest manufacturing hubs for general anaesthetic products in the world. The unveiling of the general anaesthetics line follows shortly on the heels of the visit by President Cyril Ramaphosa in March 2021 at the start of the production of the Johnson & Johnson COVID-19 vaccine. Officiating at the opening of Aspen’s general anaesthetics facility, Honorouable Minister Ebrahim Patel said, “This facility consolidates the Eastern Cape as the most significant advanced pharmaceutical hub on the African continent and it will create local jobs. The start of operations is timely as anaesthetics are a class of drug that, among other uses, supports the treatment of COVID-19 patients on ventilators in intensive care units.  South Africa has to date imported the general anaesthetics needed in our healthcare system and the new production line will provide an important medical product for the local market, assuring security of supply, and the bulk of it will be exported across the world, contributing to global patient support.” Stephen Saad, Aspen Group Chief Executive said, “The opening of our general anaesthetics manufacturing line is a significant milestone for Aspen as it will serve as a crucial anaesthetics hub for this critical medication. This is one of the world’s largest general anaesthetics production lines and it positively positions Aspen’s integrated supply, marketing, and sale of anaesthetics globally. Our investment of more than R3.0 billion in this facility is the single largest investment in the pharmaceutical industry in the country and aligns with our commitment to supporting the industrialisation of South Africa.” Sterile Focus Brands, comprising anaesthetic and thrombosis products, is one of Aspen’s key business segments and contributes 28% of revenue. The general anaesthetics production line extends Aspen’s sterile footprint and complements the Group’s strategic vision of delivering quality, affordable medicines using high-technology pharmaceutical equipment, contributing to improved health outcomes for patients.

  • Aspen increases revenue from continuing operations by 12% to R37,8 billion
    on 01.09.2021

    Johannesburg - JSE Limited listed Aspen Pharmacare Holdings Limited (APN), a global multinational specialty pharmaceutical company, is pleased to report the following salient financial results for the year ended 30 June 2021: Revenue from continuing operations increased by 12% to R37,8 billion (June 2020: R33,7 billion*);Normalised EBITDA from continuing operations increased by 3% to R9,9 billion (June 2020: R9,6 billion*);Normalised headline earnings per share from continuing operations increased by 10% to 1 309,7 cents (June 2020: 1 194,8 cents*);Headline earnings per share from continuing operations increased by 21% to 1 204,3 cents (June 2020: 998,1 cents*);Earnings per share from continuing operations increased by 42% to 1 051,1 cents (June 2020: 740,5 cents*);Total Headline earnings per share decreased by 15% to 1 119,1 cents (June 2020: 1 322,1 cents);Total Earnings per share increased by 3% to 1 052,9 cents (June 2020: 1 021,8 cents);Net Borrowings declined materially to R16,3 billion (from R35,2 billion at June 2020);The leverage ratio, for banking covenant measurement purposes, of 1.7x is significantly below the threshold of 3.5x;Strong operating cash flow conversion rate of 134% aided by a reduction in working capital for the second consecutive year; andResumption of dividends to shareholders of 262 cents per ordinary share (June 2020: no dividend declared or paid). *The prior year comparatives for continuing operations have been restated to include the discontinued European business within discontinued operations in compliance with IFRS 5. The discontinued European business comprises the European Thrombosis assets divested to Mylan until the date of disposal being 27 November 2020, the costs relating to its disposal, related Thrombosis product discontinuations and other product divestments. COMMENTARY GROUP HIGHLIGHTS (CONTINUING OPERATIONS) The commencement of production of COVID-19 vaccines at our Gqeberha manufacturing site in South Africa has been the stand-out achievement in a successful year for Aspen. Johnson & Johnson and Aspen are in discussions to evaluate the further expansion of capacity at the Gqeberha site to enable increased COVID-19 vaccine production, including a possible license for Africa. For the full twelve months, the Group has also continued providing reliable supply of its medicines and products globally despite the ongoing challenges imposed by COVID-19. Group revenue increased 12% to R37,8 billion, with Commercial Pharmaceuticals up 6% and Manufacturing advancing 36%. Normalised EBITDA was 3% higher at R9,9 billion, as a lower gross profit percentage and reduced other operating income were partially offset by well controlled operating expenses. Normalised headline earnings per share (“NHEPS”) increased 10% to R13,10, benefitting from reduced finance costs. Net borrowings declined materially to R16,3 billion as at 30 June 2021, from R35,2 billion in the prior year. The reduction in net borrowings was driven by the cash consideration from the completion of the divestment of the European Thrombosis business, strong operating cash flows and the benefit of a stronger ZAR relative to the EUR and AUD at year-end. The leverage ratio1[1], as at 30 June 2021, is 1,74 times, well below the 3,5 times banking covenant. The table below compares performance from continuing operations in the prior comparable period at reported exchange rates and then at constant exchange rates (“CER”). The difference between reported and CER revenue growth has narrowed since the first half results as a result of the ZAR strengthening during the second half of the current financial year against the majority of the other currencies in which Aspen trades. Continuing operationsReported FY 2021 R’millionRestated FY 2020 R’million^Change at reported rates %Change at CER# %Revenue37 77633 6591210Normalised EBITDA*9 9459 61231NHEPS** (cents)1309,71 194,8107 #CER removes the currency effect on performance. FY2020 reported results was recalculated at FY 2021 average exchange rates. This provides illustrative comparability with the current year’s reported performance. ^FY 2020 has been restated as a result of the discontinued operations *Normalised EBITDA represents operating profit before depreciation and amortisation adjusted for specific non-trading items as defined in the Group’s accounting policy ** NHEPS is HEPS adjusted for specific non-trading items, being transaction costs and other acquisition and disposal-related gains or losses, restructuring costs, settlement of product related litigation costs, net monetary adjustments and currency devaluations relating to hyperinflationary economies and significant once-off tax provision charges or credits arising from the resolution of prior year tax matters. DISCONTINUED OPERATIONS Discontinued operations for the year ended 30 June 2021 comprise the results of the European Thrombosis business to date of disposal (being 27 November 2020), the costs relating to its disposal, related Thrombosis product discontinuations, other product divestments and the residual costs related to prior period disposals. Discontinued operations in the prior period include the results of the operations classified as discontinued in the current period as well as those discontinued in the prior financial year. SEGMENTAL PERFORMANCE Commercial Pharmaceuticals Commercial Pharmaceuticals, comprising of Aspen’s Regional Brands and Sterile Focus Brands, grew revenue by 6% (+4% CER) to R27,9 billion. Gross profit increased 4% (+3% CER) to R15,6 billion, supported by a resilient performance from Regional Brands, partially diluted by an unfavourable mix in Sterile Focus Brands as well as higher manufacturing and supply chain costs associated with operating during the pandemic. Regional Brands Regional Brands revenue increased 3% (+2% CER) to R17,2 billion. This is a sound performance given the negative impact from the pricing adjustment to the European oncology products and the persistent unfavourable influence of COVID-19 on certain therapies within this portfolio. A strong performance in OTC products underpinned growth in the key territories of Africa Middle East (+2% CER) and Australasia (+6% CER). Sustained positive revenue gains in Latin America supported the growth in the Americas region (+9% CER). The gross profit percentage improved as cost savings outweighed downsides from the pricing reductions in the oncology portfolio. Sterile Focus Brands Revenue from Sterile Focus Brands increased 11% (+9% CER) to R10,7 billion. Demand remained volatile, following the COVID-19-wave trends with products used as interventions for COVID-19 patients picking up as infections in a country increased while products used in elective surgeries fell. Growth was driven by strong sales in China, Russia and Latin America. Gross profit percentages declined due to changes in product mix. Manufacturing Manufacturing revenue increased 36% (+29% CER). Excluding the supplies to the counterparties of recent transactions, Manufacturing revenue was up 12% (+7% CER). The low/no margin nature of the transaction-related finished dose form supply and the higher costs of production under COVID-19 weighed on the gross profit percentage. COVID-19 vaccine sales (circa R400 million) commenced at the end of the third quarter of the financial year. PROSPECTS The commencement of production of the COVID-19 vaccine at our manufacturing site in Gqeberha towards the end of the third quarter of the financial year ended 30 June 2021 was a landmark event in our endeavours to increase access to medicines, particularly for our home continent of Africa. Our strategy to invest in sterile manufacturing facilities has positioned us to play an increasing role in the provision of the COVID-19 vaccine with potential to make a meaningful contribution to addressing the inequality in access to medicines. Aspen is hopeful that the current discussions between Johnson & Johnson and Aspen, including a possible license for Africa, could make a meaningful contribution to improving equitable COVID-vaccine access for the continent. Our reshaped Commercial Pharmaceutical business has delivered solid organic revenue growth, which is anticipated to continue in the year ahead. We will continue to refine our product portfolios to ensure that Aspen’s offering remains relevant to dynamic market conditions. The Manufacturing business has made a number of important advances over the past year and is poised to play a material role in driving top and bottom line growth. Many new opportunities are under assessment. Gearing of the balance sheet has been substantially reduced and we now have significant capacity in terms of our capital allocation model for value adding investments when suitable opportunities are identified. The 2022 financial year promises to be an exciting one for Aspen. Assuming business as usual, CER revenue growth is expected in the higher single digits with an improved EBITDA margin percentage and reduced finance costs allowing CER NHEPS to grow even more strongly. Exchange rate fluctuations may influence reported results. Any forecast information provided in the abovementioned paragraph has not been reviewed or reported on by the Group’s auditors. DIVIDEND TO SHAREHOLDERS Taking into account the earnings and cash flow performance for the year ended 30 June 2021, existing debt service commitments, future proposed investments and funding options, notice is hereby given that the Board has declared a gross dividend, which is paid from income reserves, of 262 cents per ordinary share to shareholders (or 209,6 cents net of a 20% dividend withholding tax, where this maximum rate of tax applies) recorded in the share register of the Company at the close of business on 23 September 2021 (2020: no dividend declared or paid).   [1] Calculated in terms of the relevant Facilities Agreement

  • Stephen Saad discusses the J&J vaccine release with eNCA’s Sally Burdett
    on 27.07.2021

    Aspen confirmed on 26 July 2021 that the first supplies to South Africa of the Johnson & Johnson COVID-19 vaccines, from the new API source located in Europe, were being released to Johnson & Johnson from its flagship Gqeberha-based manufacturing site. These vaccines will be further distributed throughout South Africa in line with the various distribution arrangements between Johnson & Johnson, the National Department of Health and other stakeholders. In addition, vaccines from these batches will be made available through the African Vaccine Acquisition Task Team/African Union platform. https://vimeo.com/579759755

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