China - Clover Biopharmaceuticals, Ltd. (Clover; HKEX: 02197), a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world, today announced corporate updates and financial results for the year ended December 31, 2022.
'2022 was a pivotal year for Clover as we successfully transformed into a commercial-stage, vaccines-focused biotech following regulatory clearance for our COVID-19 vaccine in China,' said Joshua Liang, Chief Executive Officer and Executive Director of Clover. 'In 2023, we have expanded our commercial-stage portfolio and now have two premium respiratory vaccines (COVID-19 and seasonal influenza) which are expected to drive meaningful and diversified revenues this year with continued growth thereafter. We plan to leverage our validated R&D capabilities and continue expanding our pipeline, with a focus on building a leading respiratory vaccine franchise and establishing a presence in the pediatric vaccines market, for long-term value creation.'
Key Commercial Highlights & Plans
COVID-19 Vaccine Commercialization: Since receiving emergency use authorization (EUA) for its adjuvanted protein-based COVID-19 vaccine, SCB-2019 (CpG 1018/Alum), in China, Clover has made significant progress in expanding market access, with SCB-2019 now commercially launched in multiple provinces and successfully listed in 24 provinces and municipalities (representing >80% population coverage).
Comprehensive Global Vaccine Development: Clinical trial results released and published in 2022 consistently demonstrated that SCB-2019 elicited broad cross-neutralization across variants. Notably, in January 2022, Clover published the final efficacy results from its global Phase 2/3 study of SCB-2019 in The Lancet. Clover also announced positive data from its Phase 3 study evaluating SCB-2019 as a heterologous COVID-19 booster vaccine. Results demonstrated broad and superior cross-neutralization of all Omicron subvariants tested, including recent major subvariants such as BQ.1.1 and XBB.1.5, in participants who received SCB-2019 as a heterologous fourth dose after three doses of inactivated vaccine compared to a fourth dose of inactivated vaccine.
EUA and Expanding Market Access in China: In December 2022, SCB-2019 was included for EUA in China and subsequently recommended as a prioritized vaccine in China's national immunization plan for a second booster dose (fourth vaccination dose) campaign targeting older adults, immunocompromised individuals and individuals with comorbidities. Since the initial launch in February 2023, Clover has commercialized its vaccine in multiple provinces and has successfully listed in 24 total provinces and municipalities (representing >80% population coverage). This broad nationwide market access positions Clover to be a major player in upcoming vaccination campaigns in 2023. With the Chinese population's recent increasing awareness of the potential disease severity and impact of COVID-19, Clover believes that a robust annual booster market for COVID-19 vaccines in a private market setting could emerge-similar to the growing seasonal influenza vaccination market-favoring premium products such as Clover's adjuvanted protein-based COVID-19 vaccines and introducing attractive product pricing dynamics.
Ex-China Opportunities: Clover is prioritizing global (ex-China) regulatory submissions directly in select countries, primarily in Asia Pacific and Latin America, based on the potential to generate significant near-term revenue and impact via bilateral supply agreements. Clover expects SCB-2019 to receive an EUA in at least one additional country and to complete multiple EUA submissions during H1 2023, potentially driving revenue via bilateral agreements starting in 2023. In addition, Clover expects to establish at least one bilateral supply agreement in H1 2023, which could begin to drive commercial value in 2023.
Manufacturing Milestones: In September 2022, Clover's contract development manufacturing organization (CDMO) facility received a European Union Good Manufacturing Practice (EU GMP) certificate for the production of SCB-2019. Subsequently, Clover's in-house manufacturing facility in Changxing, Zhejiang province was inspected and achieved commercial GMP status in China. With two commercial-ready, GMP-certified facilities, Clover can flexibly meet demand as it continues rolling out the vaccine. Stockpiled inventory of key raw materials to date enables Clover to potentially produce and release over 100 million doses of SCB-2019 in 2023.
Quadrivalent Seasonal Influenza Vaccine Upcoming Commercialization: In February 2023, Clover announced that it entered into an exclusive agreement with Adimmune Corporation (Adimmune) to distribute AdimFlu-S (QIS) in mainland China, where it is the only imported seasonal quadrivalent influenza vaccine approved for use in individuals aged three years and older. With this deal, Clover became the only Chinese company with commercial-stage quadrivalent seasonal influenza and recommended COVID-19 vaccines and established a presence in a rapidly growing market.
Market Opportunity: The market for influenza vaccine in China grew by about 35% annually1 before the pandemic and is expected to continue growing in the post-pandemic era with increasing vaccine awareness and favorable government policies. Moreover, demand in China continues to shift from trivalent to seasonal quadrivalent influenza vaccine options, which accounted for a majority of doses (70%) in 2022.2
Commercialization Plans: Adimmune has already started production of AdimFlu-S (QIS) and is on track to support a commercial launch in mainland China in H2 2023. Sales are expected to be accretive to Clover's earnings starting in 2023 and contribute meaningful growth in 2024 and beyond. Further, the deal enables Clover to leverage its existing and growing commercial presence in China to commercialize both COVID-19 and influenza vaccines.
Additional Opportunities: The agreement with Adimmune also grants Clover rights to commercialize AdimFlu-S (QIS) in Bangladesh, Brazil and the Philippines, contingent upon regulatory approvals, and to potentially collaborate with Adimmune on the development of additional vaccine candidates including next-generation influenza vaccines.
About Clover Biopharmaceuticals
Clover Biopharmaceuticals is a global commercial-stage biotechnology company committed to unleashing the power of innovative vaccines to save lives and improve health around the world. With integrated research and development, manufacturing and commercial capabilities as well as strong partnerships with organizations globally, Clover has a diverse pipeline of candidates that have the potential to meaningfully reduce the burden of vaccine-preventable diseases-and to make more diseases preventable.
Clover Forward-looking Statements
This press release contains certain forward-looking statements and information relating to us and our subsidiaries that are based on the beliefs of our management as well as assumptions made by and information currently available to our management. When used, the words 'aim,' 'anticipate,' 'believe,' 'could,' 'estimate,' 'expect,' 'going forward,' 'intend,' 'may,' 'might,' 'ought to,' 'plan,' 'potential,' 'predict,' 'project,' 'seek,' 'should,' 'will,' 'would' and the negative of these words and other similar expressions, as they relate to us or our management, are intended to identify forward-looking statements.
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Contact:
Albert Liao
Email: media@cloverbiopharma.com
CLOVER BIOPHARMACEUTICALS, LTD. 