-- Clover’s two premium respiratory vaccines approved in
-- Clover’s COVID-19 vaccine now listed in 24 provinces and municipalities in
-- AdimFlu-S (QIS) commercial production ongoing and on-track for H2 2023 launch as the only imported quadrivalent seasonal influenza vaccine approved in mainland
-- On track to build a leading respiratory vaccine franchise; currently the only company in
“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
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
Comprehensive Global Vaccine Development : Clinical trial results released and published in 2022 consistently demonstrated that SCB-2019 elicited broad cross-neutralization across variants. Notably, inJanuary 2022 , Clover published the final efficacy results from its global Phase 2/3 study of SCB-2019 inThe 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 : InDecember 2022 , SCB-2019 was included for EUA inChina 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 inFebruary 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 inAsia Pacific andLatin 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 inChina . 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
- 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 inChina 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 inChina 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 andthe Philippines , contingent upon regulatory approvals, and to potentially collaborate with Adimmune on the development of additional vaccine candidates including next-generation influenza vaccines.
Focused on Building a Leading Respiratory Vaccine Franchise: Clover is focused on building a leading respiratory vaccine franchise to address unmet needs in preventing serious respiratory infectious diseases and to capture related significant cross-promotion, co-administration, and long-term lifecycle management opportunities. In pursuing these varied value-creation opportunities, Clover is leveraging its synergistic capabilities in R&D, manufacturing, and commercialization. Prioritized areas include respiratory syncytial virus (RSV), pneumococcus and next-generation seasonal influenza. Additionally, Clover plans to establish a presence in the pediatric vaccine market, with enterovirus A71 (EV71) and DTaP (diphtheria, tetanus, and pertussis) being two prioritized areas of interest for Clover.
- Mid- to Late-Stage Pipeline Expansion: In addition to the Adimmune quadrivalent seasonal influenza deal, Clover further anticipates at least one additional in-licensing deal in 2023 to expand its mid- to late-stage pipeline (Phase 2, Phase 3, Commercial).
- Multivalent SARS-CoV-2 Vaccine Candidate: Clover is conducting research to develop a multivalent SARS-CoV-2 vaccine leveraging the Trimer-Tag technology platform and designed to be broadly protective against currently circulating and potential future strains of the virus. Clinical development is planned to begin in 2023, with Phase 3 immunological bridging to SCB-2019 planned to support potential regulatory approvals.
- Trimer-Tagged Pre-Clinical Assets: Clover continues to leverage the validated Trimer-Tag platform technology to develop innovative protein-based vaccines with ongoing pre-clinical vaccine R&D activities.
Corporate & Financial Updates
- Cash Position: Cash and cash equivalents were
RMB1,856.5 million as ofDecember 31, 2022 , compared toRMB2,835.3 million as ofDecember 31, 2021 , primarily attributable to preparations for the commercialization of SCB-2019 including a strategic procurement and stockpiling campaign for key raw material inventory and continued investment in R&D activities. Clover’s cash position is expected to support and position the company for success beyond 2023. - Operating Expenses:
- R&D expenses were
RMB1,465.3 million for 2022, compared toRMB1,826.3 million for 2021. This decrease was primarily attributable to the decrease in clinical trial expenses for late-stage clinical development of SCB-2019. The decrease was partially offset by the increase in raw materials and consumables usage and CDMO service fees mainly related to technology transfer and process validation which have been substantially completed in 2022. - Administrative expenses were
RMB410.2 million for 2022, compared toRMB345.7 million for 2021. This increase was primarily attributable to the annualization of personnel costs in 2022 for new hires, most of whom onboarded in mid-2021. It was offset by the decrease in third-party recruitment agency costs. - Clover expects both R&D and G&A expenses in 2023 to decrease significantly compared to 2022, as the late-stage clinical development for SCB-2019 (including multiple global Phase 2/3 clinical trials) has been substantially completed, and the company continues to streamline corporate operations.
- R&D expenses were
- Annual Loss Estimates:
- International Financial Reporting Standards (IFRS) net loss was
RMB2,451.9 million for 2022, compared toRMB6,016.3 million for 2021. The decrease was primarily attributable to the non-cash, one-time change ofRMB3,807.6 million in the fair value of convertible redeemable preferred shares as required under the IFRS for 2021. - Non-IFRS adjusted loss was
RMB2,356.9 million for 2022, compared toRMB2,083.5 million for 2021. Adjusted loss for the year represents the loss for the year excluding the effect brought by share-based payment expenses and certain non-cash items and non-recurring events, namely the fair value changes of convertible redeemable preferred shares.
- International Financial Reporting Standards (IFRS) net loss was
- Placement: In
December 2022 , Clover announced that it completed the placement of a total of 128,000,000 new shares, receiving net proceeds ofHK$500.5 million after deducting related fees and expenses. Clover has been using the net proceeds from the placement to expand commercialization capabilities and production capacity and extend working capital needs to strengthen Clover’s financial position and ensure Clover has adequate resources to support commercialization and sustained growth.
About
For more information, please visit Clover's website: www.cloverbiopharma.com and follow the company on LinkedIn and Twitter.
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.
Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. We give no assurance that these expectations and assumptions will prove to have been correct. Because forward-looking statements relate to the future, they are participant to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Our results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees or assurances of future performance. We caution you therefore against placing undue reliance on any of these forward-looking statements. Any forward-looking statement made by us in this document speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. Participant to the requirements of applicable laws, rules and regulations, we undertake no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. All forward-looking statements contained in this document are qualified by reference to this cautionary statement.
Executive Director, Corporate Communications
media@cloverbiopharma.com
Director, Investor Relations
investors@cloverbiopharma.com
1 Compound annual growth rate (CGAR) based on influenza vaccine doses released in mainland
2 Estimate based on batch release data from the
Source:
2023 GlobeNewswire, Inc., source