Announcement • May 29
SK Bioscience Board Approves Financing Plan To Accelerate Global Phase 3 Development Of GBP410 Pneumococcal Vaccine Candidate SK bioscience's board approval follows the Financial Services Commission's May 28 announcement selecting the company as a beneficiary of the KRW 300,000 million (approximately USD 230 million) Korea Growth Fund financing program. SK bioscience became the first Korean novel drug and vaccine developer selected for the Korea Growth Fund, with the financing expected to support late-stage pneumococcal vaccine development. SK bioscience plans to accelerate global Phase 3 development of GBP410, co-developed with Sanofi, while contributing to the strengthening of Korea's vaccine sovereignty. SK bioscience announced that its Board of Directors approved agenda items at a regular board meeting, including a financing plan backed by the Korea Growth Fund. Under the approved plan, the company will secure KRW 300,000 million (approximately USD 230 million) in long-term, low-interest financing through the Korea Growth Fund program. The funds will be utilized for R&D, commercialization preparation, and manufacturing capability enhancement for 'GBP410,' SK bioscience's and Sanofi's 21-valent pneumococcal conjugate vaccine candidate currently undergoing global Phase 3 clinical trials. GBP410 is an innovative pneumococcal vaccine candidate jointly developed with Sanofi, designed to provide broad serotype coverage compared to currently marketed vaccines. Global Phase 3 clinical trials are progressing smoothly, and the company is accelerating commercialization preparation and manufacturing readiness with the goal of announcing top-line results in the second half of next year. In addition to GBP410, SK bioscience is expanding its infectious disease-focused pipeline, including universal COVID-19 vaccines, microneedle patch influenza vaccines, RSV preventive antibody therapeutics, and mRNA vaccine platforms. Earlier this year, the company relocated its headquarters and research center to Songdo, Incheon, integrating R&D, process development (PD), business development (BD), and marketing functions to further enhance its global competitiveness. SK bioscience continues to contribute to Korea's national infectious disease prevention system by supplying self-developed influenza and varicella vaccines through the National Immunization Program (NIP). The company's shingles vaccine, the first developed in Korea, is also being widely utilized in local government vaccination support programs nationwide. In addition, SK bioscience is advancing development of a cell culture-based avian influenza (H5N1) vaccine as part of a government-led initiative, further reinforcing its role in safeguarding public health security. Reported Earnings • Mar 18
Full year 2025 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2025 results: ₩733 loss per share (further deteriorated from ₩698 loss in FY 2024). Revenue: ₩651.4b (up 144% from FY 2024). Net loss: ₩57.4b (loss widened 6.6% from FY 2024). Revenue exceeded analyst estimates by 1.3%. Earnings per share (EPS) missed analyst estimates by 55%. Revenue is forecast to grow 9.0% p.a. on average during the next 2 years, compared to a 22% growth forecast for the Biotechs industry in South Korea. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 94 percentage points per year, which is a significant difference in performance. Announcement • Feb 24
SK bioscience Co.,Ltd., Annual General Meeting, Mar 23, 2026 SK bioscience Co.,Ltd., Annual General Meeting, Mar 23, 2026, at 09:01 Tokyo Standard Time. Location: conference room, 38, yeongudanji-ro, yeonsu-gu, incheon South Korea Announcement • Jan 29
SK Bioscience Initiates International Phase 1/2 Clinical Trial of Universal Vaccine Candidate Targeting Sarbecovirus Family SK bioscience announced the initiation of a global Phase 1/2 clinical trial in Australia for GBP511, a vaccine candidate targeting the sarbecovirus subgenus. Sarbecoviruses are a higher-level coronavirus group that include SARS-CoV-2, encompassing not only currently circulating variants but also potential future novel coronaviruses related SARS-like coronaviruses found in animals that could potentially spill over to humans. SK bioscience aims to develop a universal vaccine capable of inducing broad immune responses across the entire virus family and is establishing a platform applicable to multiple related viruses and variants. Based on Phase 1 results, the optimal dose and regimen will be selected, after which Phase 2 will assess immunogenicity and safety in adult and elderly populations, again comparing the investigational vaccine with Comirnaty, a comparator vaccine. In addition, the study will evaluate cross-reactive immune responses across the sarbecovirus family, including SARS-CoV- 2, to assess the vaccine's potential as a universal coronavirus vaccine. GBP511 incorporates the core technology of SKYCovione, which in 2022 became the only domestically developed COVID-19 vaccine in Korea to achieve commercialization. Building on SKYCovione's computer-designed antigen platform, GBP511 combines SK bioscience's recombinant protein technology with self-assembling nanoparticle design technology developed by the Institute for Protein Design (IPD) at the University of Washington School of Medicine. SKYCovione has previously demonstrated robust immunogenicity and a favorable safety profile through global clinical trials. SKYCovione demonstrated the induction of robust protective neutralizing antibody levels and a favorable safety profile through Global clinical trials, which was the basis of the vaccine's approval by several regulatory authorities. Globally, while multiple companies and research institutions have initiated efforts to develop universal coronavirus vaccines, most programs remain at an early research stage. SK bioscience's entry into global Phase 1/2 clinical development is the first such vaccine to enter clinical trials, demonstrating a comparatively rapid pace of development. The Coalition for Epidemic Preparedness Innovations (CEPI) has designated the SARS-coronavirus family as a " prototype pathogen," noting the high likelihood that future pandemics may repeatedly arise from the same viral family. CEPI has consistently emphasized the limitations of variant- or pathogen-specific approaches and highlighted the need for universal coronavirus vaccines capable of providing broad protection regardless of the outbreak of novel viruses. According to global market research firm Coherent Market Insights, the global COVID-19 vaccine market is estimated at approximately USD 50.6 billion (KRW 70 trillion) in 2025 and is projected to grow at a compound annual growth rate of 7.4% from 2025 to 2032, reaching approximately USD 83.4 billion (KRW 117 trillion) by 2032. Next-generation technologies, such as universal vaccines, are expected to generate new sources of market demand. Dr Richard Hatchett, CEO of CEPI said, "COVID 19 exposed the devastating price of confronting a deadly new virus without a vaccine. Broadly protective coronavirus vaccines have the power to change that story. While we cannot predict when or where the next coronavirus threat will emerge, can prepare. The progression of SK bioscience's broadly protective coronavirus vaccine into Phase 1/2 trials marks a major step forward, showcasing South Korea's leadership in cutting-edge vaccine innovation and bringing closer to a safer future for all". Announcement • Jan 23
SK bioscience Co.,Ltd. to Report Q4, 2025 Results on Feb 03, 2026 SK bioscience Co.,Ltd. announced that they will report Q4, 2025 results on Feb 03, 2026 New Risk • Nov 19
New major risk - Revenue and earnings growth Earnings are forecast to decline by an average of 29% per year for the foreseeable future. This is considered a major risk. Ultimately, shareholders want to see a good return on their investment and that generally comes from sharing in the company's profits. If profits are expected to decline, then in most cases the share price will decline over time as well. In addition, if the company pays dividends it will also likely need to reduce or cut them, striking a dual blow to total shareholder returns. This is currently the only risk that has been identified for the company. Price Target Changed • Nov 19
Price target increased by 9.0% to ₩41,000 Up from ₩37,600, the current price target is an average from 5 analysts. New target price is 21% below last closing price of ₩51,800. Stock is up 4.3% over the past year. The company is forecast to post a net loss per share of ₩472 next year compared to a net loss per share of ₩698 last year. Major Estimate Revision • Nov 06
Consensus EPS estimates fall by 134%, revenue upgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from ₩627.5m to ₩649.5m. Forecast EPS reduced from -₩383 to -₩895 per share. Biotechs industry in South Korea expected to see average net income growth of 31% next year. Consensus price target up from ₩37,600 to ₩38,600. Share price rose 9.8% to ₩55,900 over the past week. Announcement • Oct 16
SK Bioscience Files for First-In-Human Trial of Universal Coronavirus Vaccine (Pan-Sarbecovirus Vaccine) GBP511 Phase 1/2 Study in Australia SK bioscience announced that it has submitted a Phase 1/2 clinical trial application in Australia for GBP511, a universal coronavirus vaccine (pan-sarbecovirus vaccine) candidate. Sarbecoviruses, a subgenus of coronaviruses, include SARS-CoV-2 (COVID-19), the original SARS virus, and related variants. GBP511 is designed to provide broad protection across the sarbecovirus family, moving beyond the strain-specific approach of existing COVID-19 vaccines. The trial will enroll approximately 500 healthy adults aged 18 and older in Australia, and will evaluate safety and cross-reactive immunogenicity, with topline results expected by 2028. The GBP511 program was initiated in 2021 with support from the Coalition for Epidemic Preparedness Innovations (CEPI), which provided funding of approximately USD 65 million to advance preclinical research, early-stage clinical trials, and manufacturing process development. GBP511 builds on SK bioscience's recombinant protein platform, which was previously validated through the approval of SKYCovione™?--the world's first computer-generated vaccine and Korea's first domestically developed COVID-19 vaccine--in 2022. The candidate also incorporates the self-assembling nanoparticle design technology from the UW Medicine's Institute for Protein Design (IPD). SKYCovione demonstrated favorable safety and immunogenicity in global studies, laying the foundation for broader coronavirus vaccine development. Announcement • Sep 03
SK bioscience Submits IND for Phase 3 Trial of 2-Dose Varicella Vaccine Reflecting Global Standard Shift SK bioscience announced that it has submitted an IND (Investigational New Drug application) to the Ministry of Food and Drug Safety for a global Phase 3 clinical trial of SKYVaricella to add the 2-dose (two-shot) indication, aligning with evolving international standards that increasingly recommend two doses to provide stronger, longer-lasting protection against varicella. The trial will evaluate the immunogenicity and safety of two doses in roughly 800 children aged 12 months to 12 years, with completion targeted by 2027. Varicella vaccines have effectively reduced disease and complications with a single dose, which has been the standard in many countries. However, breakthrough infections may occur over time and international standards are shifting toward a 2-dose schedule to provide stronger, longer- lasting immunity and reduce community transmission. WHO's SAGE (Strategic Advisory Group of Experts on Immunization) officially recommended a 2-dose varicella vaccine in March 2025, boosting demand in global procurement markets including PAHO. The United States implemented a 2-dose schedule in 2006, cutting varicella incidence by over 85%, and countries such as Germany and Japan have since incorporated 2-dose regimens into their national immunization programs. Since its launch in Korea in 2018, SKYVaricella obtained WHO PQ certification in 2019, becoming the second vaccine worldwide to achieve this, entering the international procurement market. It has been administered to over 5 million people globally, with supply expanded through Korea's National Immunization Program, private healthcare providers, and international tenders such as PAHO. Recently, the company signed an additional supply agreement with PAHO for 2025-2027 and plans to accelerate its entry into the global varicella vaccine market through the development of SKYVaricella 2-dose regimen. Reported Earnings • Aug 15
Second quarter 2025 earnings released: ₩210 loss per share (vs ₩148 loss in 2Q 2024) Second quarter 2025 results: ₩210 loss per share (further deteriorated from ₩148 loss in 2Q 2024). Revenue: ₩161.9b (up ₩135.1b from 2Q 2024). Net loss: ₩16.5b (loss widened 44% from 2Q 2024). Revenue is forecast to grow 15% p.a. on average during the next 3 years, compared to a 26% growth forecast for the Biotechs industry in South Korea. Price Target Changed • Aug 05
Price target increased by 9.4% to ₩38,000 Up from ₩34,750, the current price target is an average from 5 analysts. New target price is 18% below last closing price of ₩46,200. Stock is down 14% over the past year. The company is forecast to post a net loss per share of ₩519 next year compared to a net loss per share of ₩698 last year. Announcement • Jul 24
SK bioscience Co.,Ltd. to Report Q2, 2025 Results on Jul 31, 2025 SK bioscience Co.,Ltd. announced that they will report Q2, 2025 results on Jul 31, 2025 Announcement • Jul 17
SK Bioscience Submits IND for Phase 1/2 Clinical Trial of Adjuvanted Influenza Vaccine Candidate SK bioscience announced that the company has submitted an Investigational New Drug (IND) application to the Ministry of Food and Drug Safety (MFDS) for a Phase 1/2 clinical trials of a new influenza vaccine candidate, 'NBP607B'. The candidate incorporates an adjuvant into its existing cell-based influenza vaccine, 'SKYCellflu' to enhance protective efficacy. SK bioscience previously utilized adjuvants in its COVID-19 vaccine, 'SKYCovione', and now seeks to expand this technology to influenza vaccines as part of its broader platform strategy. NBP607B contains an adjuvant developed by the Vaccine Formulation Institute (VFI), a Swiss-based non-profit vaccine research organization. Comprising multiple immune-boosting components, the adjuvant is expected to reduce strong immune responses and antibody production in elderly individuals. SK bioscience has proactively conducted non-clinical studies since 2023 and reported promising results. The Phase 1/2 clinical trial is scheduled to begin during the upcoming Northern Hemisphere flu season, enrolling approximately 320 older adults in Korea and abroad. The study will evaluate the vaccine's immunogenicity and safety compared to an approved high-immunogenicity flu vaccine, with interim results expected by 2027. This marks the first attempt by a Korean company to submit an IND to develop a high-immunogenicity influenza vaccine using an adjuvant. If successful, the company plans to leverage the platform for other vaccines and establish a competitive edge in the global high-value vaccine market. The development aligns with global health authorities' increasing recommendations for enhanced flu vaccines in high-risk groups. Price Target Changed • May 29
Price target decreased by 16% to ₩34,750 Down from ₩41,400, the current price target is an average from 4 analysts. New target price is 19% below last closing price of ₩43,150. Stock is down 18% over the past year. The company is forecast to post a net loss per share of ₩488 next year compared to a net loss per share of ₩698 last year. Major Estimate Revision • May 23
Consensus EPS estimates fall by 57% The consensus outlook for earnings per share (EPS) in fiscal year 2025 has deteriorated. 2025 revenue forecast decreased from ₩650.7m to ₩609.7m. Losses expected to increase from ₩454 per share to ₩711. Biotechs industry in South Korea expected to see average net income growth of 34% next year. Consensus price target down from ₩41,400 to ₩39,800. Share price rose 6.1% to ₩42,550 over the past week. Announcement • May 21
SK Bioscience Wins Patent Lawsuit Against Pfizer over Pneumococcal Vaccine SK bioscience announced that it the Supreme Court of Korea has ruled in its favor in a patent infringement lawsuit filed by large global pharmaceutical giant Pfizer over its 13-valent pneumococcal conjugate vaccine (PCV13). In 2020, Pfizer claimed that SK bioscience's export of PCV13 individual conjugate bulk substances and research-use finished products to Russia infringed on the composition patent of its vaccine, Prevnar 13. However, the Supreme Court ruled that the individual conjugates comprising PCV13 do not fall within the scope of Pfizer's patent claims, thereby upholding the lower court's ruling in favor of SK bioscience. The Court also confirmed that the production and supply of PCV13 finished products for research purposes did not constitute patent infringement. SK bioscience successfully developed Korea's first 13-valent pneumococCal conjugate vaccine, SKYPneumo, in 2016. However, due to the ongoing patent dispute with Pfizer, the company has been prohibited from manufacturing and selling the vaccine in Korea until 2027, when the related patents set to expire. Following the ruling, SK bioscience now plans to initiate new business in pneumococcal conjugate vaccines by exporting individual components of PCV13 to countries with high vaccine demand, such as those in Southeast Asia and Latin America. Technology transfers through local partnerships are also being pursued in parallel. Looking ahead, SK bioscience aims to expand its presence in the global pneumococcal vaccine market. From 2027, the company will be able to manufacture and sell SKYPneumo domestically. In addition, the company is developing a 21-valent pneumococcal conjunctionate vaccine with global pharmaceutical company Sanofi, which entered Phase 3 global clinical in late 2024. Simultaneously, the two companies are also working on a next-generation pneumococcal vaccine that is expected to offer broader protection than current options. The global pneumococcal vaccine market continues to grow. According to Global Market Insights, the market is projected to grow at a compound annual rate of approximately 5.6% to reach USD 15.1 billion (approximately KRW 21.55 trillion) by 2034. This growth is driven by expanded vaccination programs and support from governments and international organizations like WHO and Gavi. SK bioscience's strong track record in public vaccine supply and cooperation with global health organizations positions it well for future expansion. Meanwhile, SK bioscience recently secured a definitive legal victory in a patent invalidation suit against Moderna, successfully challenging the biotech giant's Korean patent related to messenger RNA (mRNA) vaccine technology. The contested patent covers 'modified nucleosides, nucleotides, and nucleic acids and their uses.' This case, which invalidated the only registered mRNA manufacturing patent in Korea, regarded as a major step in reducing patent-related risks and removing barriers to innovation for domestic companies engaged in mRNA research and development. Price Target Changed • Apr 10
Price target decreased by 9.3% to ₩44,000 Down from ₩48,500, the current price target is an average from 5 analysts. New target price is 13% above last closing price of ₩38,850. Stock is down 35% over the past year. The company is forecast to post a net loss per share of ₩454 next year compared to a net loss per share of ₩698 last year. Reported Earnings • Mar 21
Full year 2024 earnings: Revenues exceed analysts expectations while EPS lags behind Full year 2024 results: ₩698 loss per share (down from ₩291 profit in FY 2023). Revenue: ₩267.5b (down 28% from FY 2023). Net loss: ₩53.9b (down 341% from profit in FY 2023). Revenue exceeded analyst estimates by 28%. Earnings per share (EPS) missed analyst estimates by 47%. Revenue is forecast to grow 5.3% p.a. on average during the next 3 years, compared to a 35% growth forecast for the Biotechs industry in South Korea. Over the last 3 years on average, the company's share price growth rate has exceeded its earnings growth rate by 115 percentage points per year, which is a significant difference in performance. Announcement • Feb 27
SK bioscience Co.,Ltd., Annual General Meeting, Mar 26, 2025 SK bioscience Co.,Ltd., Annual General Meeting, Mar 26, 2025, at 09:00 Tokyo Standard Time. Location: g.rium hall, 310, pangyo-ro, bundang-gu, gyeonggi-do, seongnam South Korea Announcement • Feb 26
SK Bioscience Initiates Global Clinical Trials of mRNA Japanese Encephalitis Vaccine Candidate SK bioscience announced the commencement of global Phase 1/2 clinical trials for its mRNA-based Japanese encephalitis vaccine candidate, GBP560. SK bioscience's development of vaccine for Japanese encephalitis could not only help to protect against Japanese Encephalitis but also pave the way to the development of an mRNA technology that could be potentially adapted in a matter of weeks to develop a vaccine against a novel as- yet-identified infectious disease 'Disease X'. This rapid response approach would support the '100 Day Mission', a global initiative spearheaded by the Coalition for Epidemic Preparedness Innovations (CEPI) and embraced by the G7, G20 and pharmaceutical companies to accelerate the development of new vaccines against pandemic threats to just over three months following the identification of a Disease X. This project is based on an R&D agreement with CEPI, which committed USD 40 million initial funding, in 2022 to support preclinical and early clinical trials of Japanese encephalitis as well as Lassa fever virus vaccines. A further USD 100 million in funding could be made available later to support late-stage trials/licensure to further validate the mRNA platform and have it ready for use in outbreak situations. SK bioscience's leadership in next pandemic preparedness was recognized as a key R&D partner of CEPI in the '100 Day Mission Implementation Report 2024' recently published by the influential International Pandemic Preparedness Secretariat (IPPS), a global body set up to monitor global readiness for widespread disease outbreaks. Through this project, SK bioscience aims to establish a mRNA vaccine technology capable of addressing not only pandemic threats but also various infectious diseases. By expanding its vaccine pipeline, the company seeks to enhance its competitiveness in the global vaccine industry. The mRNA vaccine technology, which was first commercialized in the COVID-19 vaccines during the pandemic, is available for rapid mass production compared to traditional technologies by utilizing genetic sequences. This capability makes mRNA technology well-suited for pandemic response. Furthermore, the mRNA vaccine technology shows significant potential to be applied to the development of therapeutic drugs, signaling rapid market expansion. According to global market research firm 'Nova One Advisor', the global mRNA therapeutics market is projected to surpass around USD 58.90 billion in 2033, registering a CAGR of 17.06% by 2033. The company aims to secure interim results by 2026. Previously, in preclinical studies, the vaccine candidate demonstrated superior safety and immunogenicity through repeated-dose toxicity studies, safety pharmacology tests, and preclinical protective immunity studies. CEPI and SK bioscience are committed to enabling global equitable access to the vaccines they develop. Under the terms of the funding agreement, SK bioscience has committed to achieving equitable access to the outputs of this project including prioritization of supply for low-income and middle-income countries, production of vaccine volumes required to meet public health needs, and affordable pricing, in line with CEPI's Equitable Access Policy. Major Estimate Revision • Feb 06
Consensus revenue estimates increase by 11%, EPS downgraded The consensus outlook for fiscal year 2025 has been updated. 2025 revenue forecast increased from ₩393.9m to ₩438.6m. EPS estimate fell from -₩373 to -₩519 per share. Biotechs industry in South Korea expected to see average net income growth of 37% next year. Consensus price target broadly unchanged at ₩48,500. Share price was steady at ₩49,500 over the past week. Announcement • Dec 12
SK bioscience Receives Approval for Global Clinical Trials of mRNA Japanese Encephalitis Vaccine Candidate SK bioscience announced that it has received approval from the Human Research Ethics Committee (HREC) in Australia for the clinical trial protocols of a Phase 1/2 trials for its mRNA-based Japanese encephalitis vaccine candidate, GBP560. The company is establishing its mRNA vaccine platform through the development of vaccines against Japanese encephalitis virus as well as Lassa fever virus. The Japanese Encephalitis Virus (viral family: Flaviviruses) and Lassa fever vaccines (viral family: Arenaaviruses) will serve as prototype vaccines that could potentially be adapted in a matter of weeks for use against a future Disease X that might emerge from those same viral families. This approach is key to the 100 Days Mission, a global goal to accelerate the development of vaccines against pandemic threats to just over three months. This joint project is based on an agreement with the Coalition for Epidemic Preparedness Innovations (CEPI), which committed up to USD 40 million initial funding (approximately KRW 57.4 billion) in funding in 2022 to support preclinical and early clinical trials. A further USD 100 million in funding could be made available at a later date to support late-stage trials/licensure to further validate the mRNA platform and have it ready for use in outbreak situations. The partnership builds upon SK bioscience's expertise in cutting-edge vaccine platforms such as cell culture, bacterial culture, and recombinant technology. By expanding the company's capabilities to include the mRNA platform, the collaboration aims to be ready to rapidly respond to Disease X and contribute to equitable access to vaccines, including through a contractual commitment to, if successful, prioritize supply for low-and middle-income countries, produce vaccine volumes required to meet public health needs, and ensure affordable pricing. The mRNA vaccine platform technology, which was first commercialized in the COVID-19 vaccines during the pandemic, is available for rapid mass production compared to traditional platforms by utilizing genetic sequences. This capability makes mRNA technology well-suited for pandemic response. Furthermore, the mRNA vaccine platform shows significant potential to be applied to the development of therapeutic drugs, signaling rapid market expansion. According to global market research firm 'Nova One Advisor', the global mRNA therapeutics market is projected to surpass around USD 58.90 billion (approximately KRW 84.5 trillion) by 2033, registering a CAGR of 17.06% by 2033. The company will evaluate the immunogenicity and safety of GBP560 in 402 healthy adult participants in Australia. In stage 1, the participants will receive two shots of low, medium, high-dose vaccine, or a control vaccine administered 28 days apart. Based on the stage 1 results, the optimal dosage and regimen will be determined for further assessment of the immunogenicity and safety compared to the control group in stage 2. During the Phase 1/2 trials, SK bioscience plans to confirm neutralizing antibody titers and immune responses, along with collecting data on major adverse events, safety indicators, and the rate of adverse reactions. The company aims to secure interim results by 2026. Previously, the company conducted preclinical studies beginning in December 2023, where the vaccine candidate demonstrated superior safety and immunogenicity through repeated-dose toxicity studies, safety pharmacology tests, animal efficacy trials, and protective immunity tests. Major Estimate Revision • Oct 26
Consensus revenue estimates increase by 16% The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from ₩218.4m to ₩254.0m. EPS estimate reaffirmed at -₩350 per share. Biotechs industry in South Korea expected to see average net income growth of 53% next year. Consensus price target up from ₩46,800 to ₩48,000. Share price fell 8.4% to ₩52,300 over the past week. New Risk • Oct 22
New minor risk - Shareholder dilution The company's shareholders have been diluted in the past year. Increase in shares outstanding: 2.0% This is considered a minor risk. Shareholder dilution occurs when there is an increase in the number of shares on issue that is not proportionally distributed between all shareholders. Often due to the company raising equity capital or some options being converted into stock. All else being equal, if there are more shares outstanding then each existing share will be entitled to a lower proportion of the company's total earnings, thus reducing earnings per share (EPS). While dilution might not always result in lower EPS (like if the company is using the capital to fund an EPS accretive acquisition) in a lot cases it does, along with lower dividends per share and less voting power at shareholder meetings. Currently, the following risks have been identified for the company: Minor Risks Large one-off items impacting financial results. Shareholders have been diluted in the past year (2.0% increase in shares outstanding). Announcement • Oct 17
SK bioscience Co.,Ltd. to Report Q3, 2024 Results on Oct 24, 2024 SK bioscience Co.,Ltd. announced that they will report Q3, 2024 results on Oct 24, 2024 Announcement • Oct 10
SK bioscience Co.,Ltd. (KOSE:A302440) agreed to acquire an unknown stake in Fina Biosolutions, LLC for $3 million. SK bioscience Co.,Ltd. (KOSE:A302440) agreed to acquire an unknown stake in Fina Biosolutions, LLC for $3 million on October 8, 2024. With this acquisition, SK bioscience Co.,Ltd will become Fina Biosolutions, LLC's first and sole strategic investor. Major Estimate Revision • Sep 03
Consensus EPS estimates upgraded to ₩341 loss, revenue downgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from ₩237.1m to ₩220.4m. 2024 losses expected to reduce from -₩500 to -₩341 per share. Biotechs industry in South Korea expected to see average net income growth of 53% next year. Consensus price target down from ₩57,000 to ₩46,800. Share price fell 4.5% to ₩53,000 over the past week. Major Estimate Revision • Aug 31
Consensus revenue estimates decrease by 12%, EPS upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast fell from ₩237.1m to ₩207.8m. EPS estimate increased from -₩500 to -₩479 per share. Biotechs industry in South Korea expected to see average net income growth of 50% next year. Consensus price target down from ₩57,000 to ₩46,800. Share price was steady at ₩55,500 over the past week. Price Target Changed • Aug 23
Price target decreased by 10% to ₩51,667 Down from ₩57,714, the current price target is an average from 7 analysts. New target price is 8.1% below last closing price of ₩56,200. Stock is down 24% over the past year. The company is forecast to post a net loss per share of ₩500 compared to earnings per share of ₩291 last year. Reported Earnings • Aug 16
Second quarter 2024 earnings released: ₩148 loss per share (vs ₩208 loss in 2Q 2023) Second quarter 2024 results: ₩148 loss per share (improved from ₩208 loss in 2Q 2023). Revenue: ₩26.8b (up 1.1% from 2Q 2023). Net loss: ₩11.4b (loss narrowed 29% from 2Q 2023). Revenue is forecast to grow 2.4% p.a. on average during the next 3 years, compared to a 26% growth forecast for the Biotechs industry in South Korea. Announcement • Jul 29
SK bioscience Co.,Ltd. to Report Q2, 2024 Results on Jul 31, 2024 SK bioscience Co.,Ltd. announced that they will report Q2, 2024 results on Jul 31, 2024 Major Estimate Revision • May 04
Consensus EPS estimates fall by 59% The consensus outlook for fiscal year 2024 has been updated. 2024 expected loss increased from -₩504 to -₩801 per share. Revenue forecast unchanged at ₩246.1m. Biotechs industry in South Korea expected to see average net income growth of 19% next year. Consensus price target of ₩58,000 unchanged from last update. Share price rose 2.4% to ₩58,800 over the past week. Board Change • Apr 01
Insufficient new directors No new directors have joined the board in the last 3 years. The company's board is composed of: No new directors. 5 experienced directors. No highly experienced directors. Executive Director Hoon Kim was the last director to join the board, commencing their role in 2021. The following issues are considered to be risks according to the Simply Wall St Risk Model: Insufficient board refreshment. Reported Earnings • Mar 21
Full year 2023 earnings released: EPS: ₩291 (vs ₩1,596 in FY 2022) Full year 2023 results: EPS: ₩291 (down from ₩1,596 in FY 2022). Revenue: ₩369.5b (down 19% from FY 2022). Net income: ₩22.3b (down 82% from FY 2022). Profit margin: 6.0% (down from 27% in FY 2022). Revenue is expected to decline by 9.3% p.a. on average during the next 2 years, while revenues in the Biotechs industry in South Korea are expected to grow by 18%. Announcement • Mar 04
SK bioscience Co.,Ltd., Annual General Meeting, Mar 25, 2024 SK bioscience Co.,Ltd., Annual General Meeting, Mar 25, 2024, at 09:00 Korea Standard Time. Location: Eco-Lab, B2F, G.rium Hall, 310 Pangyo-ro, Bundang-gu, Seongnam-si Gyeonggi-do South Korea Agenda: To consider the financial statements for the 6th term (2023.01.01~2023.12.31); to consider the changes in some articles of association; to consider the appointment of directors; to consider the appointment of an outside director to serve as a member of the Audit Committee; to consider the amendment to the executive severance policy; and to consider the approval of the ceiling of remuneration for directors. Announcement • Feb 23
SK Bioscience Obtains Prequalification Certification from the World Health Organization SK bioscience announced that the company has obtained prequalification (PQ) certification from the World Health Organization (WHO) for its typhoid conjugate vaccine (TCV), SKYTyphoid (project name NBP618). This the fourth WHO PQ the company has received following its two influenza vaccines and varicella vaccine. The WHO PQ system evaluates the manufacturing process, quality, and clinical trial results of a vaccine according to strict criteria to certify its safety and efficacy. The tested vaccine must comply with stringent procedures, including: ex amination of technical documents, including clinical and quality data, testing of sample quality, inspection of manufacturing facilities to ensure adherence to Good Manufacturing Practices (GMP) and quality control standards. SKYTyphoid was jointly developed with the International Vaccine Institute (IVI) and is supported by the Bill & Melinda Gates Foundation. This vaccine utilizes the 'purified Vi polysaccharide-diphtheria toxoid conjugate' method, which conjugates a polysaccharide of typhoid bacteria, serving as an antigen, to a diphtheria toxin protein (diphtheria toxoid), that acts as a carrier. Utilizing this conjugate technology, the vaccine can be safely administered to infants and children aged 6 months to 2 years. It is anticipated to offer comparable immunogenicity and long-term protection with a single dose, compared to existing oral live or polysaccharide typhoid vaccines. SKYTyphoid has received an export license from the Korean Ministry of Food and Drug Safety in 2022, based on the results of a global clinical study. The Phase III study, which enrolled 2,160 participants ranging from toddlers aged 6 months to individuals aged 45 years in Nepal, demonstrated a positive immunogenicity and safety profile of SKYTyphoid. Compared to the existing polysaccharide-protein conjugate typhoid vaccine with WHO PQ certification, SKYTyphoid showed comparable immunogenicity and safety profile across all age groups. These findings were published in The Lancet Infectious Disease, a sister journal to Lancet. With WHO PQ, SK bioscience plans to target global markets with SKYTyphoid, focusing on public procurement markets, including major typhoid-endemic countries with high demands. According to the WHO, there are between 11 to 20 million typhoid fever cases reported worldwide each year, resulting in approximately 120,000 to 160,000 deaths. Major Estimate Revision • Feb 03
Consensus revenue estimates fall by 13% The consensus outlook for revenues in fiscal year 2024 has deteriorated. 2024 revenue forecast decreased from ₩238.6m to ₩206.6m. Forecast losses increased from -₩495 to -₩658 per share. Biotechs industry in South Korea expected to see average net income growth of 27% next year. Consensus price target of ₩56,429 unchanged from last update. Share price was steady at ₩64,700 over the past week. Major Estimate Revision • Jan 24
Consensus EPS estimates fall by 12%, revenue upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from ₩333.5m to ₩338.5m. EPS estimate fell from ₩151 to ₩133 per share. Net income forecast to shrink 156% next year vs 26% growth forecast for Biotechs industry in South Korea . Consensus price target of ₩56,429 unchanged from last update. Share price was steady at ₩63,400 over the past week. Announcement • Jan 19
SK bioscience Co.,Ltd. to Report Q4, 2023 Results on Feb 01, 2024 SK bioscience Co.,Ltd. announced that they will report Q4, 2023 results on Feb 01, 2024 Price Target Changed • Jan 10
Price target decreased by 7.5% to ₩56,714 Down from ₩61,286, the current price target is an average from 7 analysts. New target price is 16% below last closing price of ₩67,800. Stock is down 13% over the past year. The company is forecast to post earnings per share of ₩1,958 for next year compared to ₩4,844 last year. Announcement • Oct 25
SK bioscience Co.,Ltd. to Report Q3, 2023 Results on Oct 26, 2023 SK bioscience Co.,Ltd. announced that they will report Q3, 2023 results on Oct 26, 2023 Major Estimate Revision • Oct 12
Consensus revenue estimates increase by 15% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from ₩172.5m to ₩198.3m. EPS estimate unchanged from -₩278 at last update. Biotechs industry in South Korea expected to see average net income growth of 35% next year. Consensus price target broadly unchanged at ₩62,571. Share price rose 4.1% to ₩68,500 over the past week. Valuation Update With 7 Day Price Move • Aug 04
Investor sentiment improves as stock rises 17% After last week's 17% share price gain to ₩84,500, the stock trades at a forward P/E ratio of 249x. Average forward P/E is 37x in the Biotechs industry in South Korea. Total loss to shareholders of 35% over the past year. Major Estimate Revision • Jul 31
Consensus revenue estimates decrease by 17% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from ₩211.4m to ₩175.5m. EPS estimate unchanged from ₩747 per share at last update. Biotechs industry in South Korea expected to see average net income growth of 24% next year. Consensus price target of ₩62,875 unchanged from last update. Share price fell 2.1% to ₩73,300 over the past week. Announcement • Jul 26
SK bioscience Co.,Ltd. to Report Q2, 2023 Results on Jul 28, 2023 SK bioscience Co.,Ltd. announced that they will report Q2, 2023 results on Jul 28, 2023 Major Estimate Revision • Jul 13
Consensus estimates of losses per share improve by 59% The consensus outlook for earnings per share (EPS) in fiscal year 2023 has improved. 2023 revenue forecast increased from ₩238.8m to ₩244.5m. EPS estimate increased from -₩132 per share to -₩53.71 per share. Biotechs industry in South Korea expected to see average net income growth of 35% next year. Consensus price target up from ₩61,625 to ₩62,875. Share price was steady at ₩75,900 over the past week. Announcement • Jun 30
SK Bioscience and Sanofi Announce Positive Results from Phase II Study of 21-Valent Pneumococcal Conjugate Vaccine Candidate SK bioscience announced positive results from its Phase II clinical trials in infants of its 21-valent pneumococcal conjugate vaccine candidate, 'GBP410' (also known as SP0202), evaluating its safety and immunogenicity. GBP410, jointly developed by SK bioscience and Sanofi, is a pneumococcal conjugate vaccine that combines specific proteins with the polysaccharide capsule of Streptococcus pneumoniae, which causes pneumococcal diseases such as pneumonia and invasive pneumococcal disease. The pneumococcal conjugate vaccine is well known to provide the effective protection against pneumococcal infections among the pneumococcal vaccines developed to date. Given that GBP410 includes 21 serotypes, it is anticipated to offer broader serotype coverage than the existing pneumococcal conjugate vaccines that currently dominate the global market. If successfully commercialized, GBP410 is expected to rapidly increase market share by leveraging Sanofi's marketing expertise as the industry leader in the pediatric vaccine market. The Phase II study, which enrolled 140 toddlers aged 12 to 15 months and 712 infants aged 42 to 89 days, demonstrated comparable immunogenicity of GBP410 compared to the control vaccine, following the primary vaccination at 2, 4, and 6 months of age as well as the booster vaccination for ages of 12 to 15 months. This study was conducted in the United States, Canada, and Honduras and it commenced in May 2020. The data also showed a well-tolerated safety profile, with comparable reactogenicity profile to the control vaccine and no vaccine-related serious adverse events. Furthermore, GBP410 did not interfere with the immunogenicity and safety profile of the co-administered recommended pediatric vaccines, such as tetanus, diphtheria, pertussis, polio, and Haemophilus influenzae type b vaccines. Based on the positive safety and immunogenicity data from the Phase II clinical trial, SK bioscience and Sanofi plan to start Phase III in H1 2024, expecting to secure the final data in 2027. In preparation for the commercialization of GBP410, SK bioscience intends to enter the U.S. and European markets with Sanofi by making significant investments in manufacturing facilities. The company will establish production facilities at L HOUSE, its vaccine manufacturing plant in Andong, Korea, ensuring compliance with the FDA's current Good Manufacturing Practice (cGMP) standards. Price Target Changed • Jun 02
Price target decreased by 8.2% to ₩59,875 Down from ₩65,222, the current price target is an average from 8 analysts. New target price is 27% below last closing price of ₩82,100. Stock is down 36% over the past year. The company is forecast to post earnings per share of ₩1,958 for next year compared to ₩4,844 last year. Major Estimate Revision • May 12
Consensus revenue estimates decrease by 34% The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast fell from ₩333.4m to ₩221.1m. EPS estimate unchanged from -₩39.70 per share at last update. Biotechs industry in South Korea expected to see average net income growth of 45% next year. Consensus price target of ₩63,222 unchanged from last update. Share price fell 6.1% to ₩78,000 over the past week. Valuation Update With 7 Day Price Move • May 04
Investor sentiment improves as stock rises 17% After last week's 17% share price gain to ₩83,100, the stock trades at a forward P/E ratio of 72x. Average forward P/E is 23x in the Biotechs industry in South Korea. Total loss to shareholders of 36% over the past year. Major Estimate Revision • Apr 30
Consensus EPS estimates fall by 12%, revenue upgraded The consensus outlook for fiscal year 2023 has been updated. 2023 revenue forecast increased from ₩306.7m to ₩333.4m. EPS estimate fell from ₩825 to ₩727 per share. Net income forecast to shrink 71% next year vs 43% growth forecast for Biotechs industry in South Korea . Consensus price target down from ₩65,222 to ₩63,667. Share price fell 7.2% to ₩70,400 over the past week. Major Estimate Revision • Feb 10
Consensus revenue estimates fall by 18% The consensus outlook for revenues in fiscal year 2023 has deteriorated. 2023 revenue forecast decreased from ₩471.8m to ₩385.6m. EPS estimate fell from ₩1,649 to ₩1,252 per share. Net income forecast to shrink 62% next year vs 20% growth forecast for Biotechs industry in South Korea . Consensus price target down from ₩86,727 to ₩75,545. Share price fell 7.6% to ₩72,900 over the past week. Price Target Changed • Feb 09
Price target decreased by 13% to ₩75,545 Down from ₩86,727, the current price target is an average from 11 analysts. New target price is approximately in line with last closing price of ₩74,600. Stock is down 54% over the past year. The company is forecast to post earnings per share of ₩1,878 for next year compared to ₩4,844 last year. Announcement • Jan 28
SK bioscience Introduces New Partnership Model to Establish Regional Vaccine Hubs SK bioscience introduced a new global partnership model under the title of 'Preparing for Next Pandemic through Global Partnership' at the Riyadh Global Medical Biotechnology Summit 2023 (RGBMS 2023) in the Kingdom of Saudi Arabia(KSA) as a first and an only Korean biopharmaceutical company participating the session. During the presentation, Mr. Ahn shared the successful development history of the Korea's first COVID-19 vaccine while emphasizing the importance of global cooperation in terms of global health security. Further, he suggested a global cooperation based on the SK bioscience's vaccine R&D and manufacturing capabilities that can be transferred to the Middle East in the future. Mr. Ahn also emphasized the partnership that both stably supplying of necessary vaccines in the region during normal times and quickly switching to an emergency vaccine manufacturing system in the pandemic period can be possible once the facilities and the technologies are transferred to countries where insufficient infrastructure still exists. SK bioscience is promoting the 'Glocalization' business based on its R&D and manufacturing capabilities. Under the glocalization project, SK bioscience plans to contribute to resolving the inequitable access of vaccines in low- and middle- income countries with lack of infrastructure, and further create social and economic values by pioneering new markets for self-developed vaccines. Announcement • Jan 21
SK bioscience Co.,Ltd. to Report Q4, 2022 Results on Feb 08, 2023 SK bioscience Co.,Ltd. announced that they will report Q4, 2022 results on Feb 08, 2023 Announcement • Jan 19
SK Bioscience Co.,Ltd. Receives Expanded Manufacturing and Marketing Approval from the Korean Ministry of Food and Drug Safety for Nuvaxovid Novavax Inc. announced that partner SK bioscience has received expanded manufacturing and marketing approval from the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™ (NVX-CoV2373) for use as a booster for active immunization to prevent COVID-19 in adults aged 18 and older. Prior to the approval, in September 2022, the Korean Centers for Disease Control and Prevention set out recommendations that advised that Nuvaxovid could be used as a booster in adults aged 18 and older. This approval is based on data from Novavax' Phase 2 trial conducted in the U.S. and Australia, from a separate Phase 2 trial conducted in South Africa, and from the United Kingdom-sponsored COV-BOOST trial. As part of the Novavax Phase 2 trials, a single booster dose of Nuvaxovid was administered to adult participants approximately six months after their primary two-dose vaccination series of Nuvaxovid. The third dose produced increased immune responses comparable to or exceeding levels associated with protection in Phase 3 clinical trials. In the COV-BOOST trial, Nuvaxovid induced a significant antibody response when used as a booster dose following prior vaccination with other authorized COVID-19 vaccines. In the Novavax-sponsored trials, following the booster, local and systemic reactions had a median duration of approximately two days. The incidence of Grade 3 or higher events remained relatively low. Safety reporting of reactogenicity events showed an increasing incidence across all three doses of Nuvaxovid, often seen with increased immunogenicity. Medically attended adverse events (AE), potentially immune-mediated medical conditions, and severe AEs occurred infrequently following the booster dose and were balanced between vaccine and placebo groups. Novavax' COVID-19 vaccine is authorized for use as an adult booster in more than 35 countries, and a number of other countries have policy recommendations allowing use of the vaccine as a booster dose. The vaccine is actively under review in other markets and has ongoing trials to further explore its efficacy and safety as a booster. Trade Name in the U.S.: The trade name Nuvaxovid™ has not yet been approved by the U.S. Food and Drug Administration (FDA). Important Safety Information: South Korea Nuvaxovid is contraindicated in persons who have a hypersensitivity to the active substance, or to any of the excipients. Events of anaphylaxis have been reported with administration of COVID-19 vaccines. Appropriate medical treatment and supervision should be available in case of an anaphylactic reaction following the administration of the vaccine. Close observation for at least 15 minutes is recommended and a second dose of the vaccine should not be given to those who have experienced anaphylaxis to the first dose of Nuvaxovid. Anxiety-related reactions, including vasovagal reactions (syncope), hyperventilation, or stress–related reactions may occur in association with vaccination as a psychogenic response to the needle injection. It is important that precautions are in place to avoid injury from fainting. Vaccination should be postponed in individuals suffering from an acute severe febrile illness or acute infection. The presence of a minor infection and/or low-grade fever should not delay vaccination. Nuvaxovid should be given with caution in individuals receiving anticoagulant therapy or those with thrombocytopenia or any coagulation disorder (such as haemophilia) because bleeding or bruising may occur following an intramuscular administration in these individuals. The efficacy of Nuvaxovid may be lower in immunosuppressed individuals. Administration of Nuvaxovid in pregnancy should only be considered when the potential benefits outweigh any potential risks for the mother and foetus. Individuals may not be fully protected until seven days after their second dose. As with all vaccines, vaccination with Nuvaxovid may not protect all vaccine recipients. The most common adverse reactions observed during clinical studies were headache, nausea or vomiting, myalgia, arthralgia, injection site tenderness/pain, fatigue, and malaise. Announcement • Jan 10
SK Bioscience Receives Biologics License Application Approval of the Skyzoster™ from the National Pharmaceutical Regulatory Agency in Malaysia SK bioscience announced that the company has received a biologics license application approval of the 'SKYZoster™' from the National Pharmaceutical Regulatory Agency (NPRA) in Malaysia. This is the second overseas approval of SKYZoster™ after Thailand in May 2020. SKYZoster™ is the world's second developed shingles vaccine. It is a live vaccine that attenuates varicella zoster virus. The vaccine was approved in South Korea from the Ministry of Food and Drug Safety (KMFDS) in September 2017 based on results of clinical trials conducted in domestic and global institutions. SKYZoster™ is shown clinically acceptable immunogenicity and safety at Phase III clinical trial. As evaluating immunogenicity by enrolling 824 healthy adults over the age of 50, the result shows that the antibody titer against the varicella zoster virus increased 2.75 times after inoculating SKYZoster™ compared to before vaccination. Furthermore, the result shows that SKYZoster™ is non-inferior compared to the control vaccine (MSD Zostavax), and the cell-mediated immune response was also shown to be at an equal level, proving SKYZoster™ effectively induces immunogenicity against shingles. In terms of safety, the incidence of adverse reactions that occurred 6 weeks after SKYZoster™ vaccination was similar to that of the control vaccine group, and there were no serious adverse reactions that showed any relationship with the study drug reported during 26 weeks after vaccination. In addition, a post-marketing survey of 651 people for 4 years after the launching of SKYZoster™, the KMFDS' safety evaluation result was recently announced, indicating that no serious adverse reactions occurred after the vaccination. SKYZoster™ is steadily expanding the market position in the South Korean domestic market. SK bioscience plans to submit for SKYZoster™'s Pre-Qualification(PQ) to the WHO next year to further accelerate the vaccine's approval for overseas emerging markets, such as Southeast Asia and developing countries. Board Change • Dec 31
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 1 experienced director. No highly experienced directors. Independent Outside Director Choi Jeong-Wook is the most experienced director on the board, commencing their role in 2020. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. Price Target Changed • Nov 16
Price target decreased to ₩103,400 Down from ₩124,300, the current price target is an average from 10 analysts. New target price is 7.0% above last closing price of ₩96,600. Stock is down 59% over the past year. The company is forecast to post earnings per share of ₩2,176 for next year compared to ₩4,844 last year. Price Target Changed • Nov 02
Price target decreased to ₩114,700 Down from ₩124,300, the current price target is an average from 10 analysts. New target price is 50% above last closing price of ₩76,300. Stock is down 69% over the past year. The company is forecast to post earnings per share of ₩2,103 for next year compared to ₩4,844 last year. Announcement • Oct 22
SK bioscience Announces Executive Appointments SK bioscience announced that Dr. Harry Kleanthous, formerly Senior Program Officer in Global Health at the Bill & Melinda Gates Foundation (BMGF), has joined the company as Executive Vice President of Vaccine R&D Strategy and External Innovation. Dr. Harry Kleanthous, an expert in the vaccine field, has devoted 30 years to the vaccine industry in both biotech & large biopharma, serving as Vice President Research at Acambis, and Head of Research for North America at Sanofi Pasteur, where he developed innovative platforms and developed pipelines targeting medically important infectious diseases. He majored in Microbiology and Biochemistry at Manchester Metro University, U.K., and obtained his Ph.D. in Medical Molecular Microbiology at the University of London. SK bioscience is accelerating its entry into the U.S. with the appointment of Dr. Harry Kleanthous. The Company earlier appointed Dr. Hun Kim, Chief Technical Officer at SK bioscience, as Chief Executive Officer of SK bioscience USA Inc., a new entity that will be established early next year. He will be responsible for leading the Company's business globalization effort, development of innovative platforms and future growth engines, and accelerate sustainable growth through recruitment of additional global talents, starting with the appointment of Dr. Harry Kleanthous. Dr. Kim joined SK Chemicals in 2008 and served as Head of the Bio Office from 2014 and then as Head of VAX Development at corporate HQ from 2016. He was appointed as SK bioscience's first Chief Technical Officer since its establishment in 2018. He closely cooperated with key global partners such as the Bill & Melinda Gates Foundation (BMGF), and the Coalition of Epidemic Preparedness (CEPI), and successfully led numerous R&D projects including Korea's first homegrown COVID-19 vaccine 'SKYCovione'. In support of expanding its globalization efforts, SK bioscience has named Dr. Sally Choe, an expert in drug review, clinical pharmacology, and medical product development, as Head of Global Clinical Development and Regulatory Affairs of the Company. In this role, she will be leading the Company's clinical development and execution of innovative products and regulatory affairs to advance SK bioscience's global competitiveness. Dr. Choe joins SK bioscience from the U.S. Food and Drug Administration (FDA) where she most recently served as the Super Office Director of the Office of Generic Drugs (OGD). Prior to her 12 years of tenure at the FDA, she worked at Parexel Regulatory Consulting firm as Senior Director, and also worked in large biopharma including Bristol Myers Squib (BMS) and Pfizer. She majored in Electrical Engineering at the Virginia Polytechnic Institute and State University, and holds a Master's and Ph.D. in Pharmaceutics from the University of Michigan. Announcement • Oct 20
SK bioscience Co.,Ltd. to Report Q3, 2022 Results on Oct 31, 2022 SK bioscience Co.,Ltd. announced that they will report Q3, 2022 results on Oct 31, 2022 Price Target Changed • Oct 19
Price target decreased to ₩124,300 Down from ₩135,333, the current price target is an average from 10 analysts. New target price is 66% above last closing price of ₩74,900. Stock is down 66% over the past year. The company is forecast to post earnings per share of ₩3,324 for next year compared to ₩4,844 last year. Major Estimate Revision • Oct 15
Consensus EPS estimates fall by 11% The consensus outlook for earnings per share (EPS) in 2022 has deteriorated. 2022 revenue forecast decreased from ₩738.8m to ₩691.3m. EPS estimate also fell from ₩3,722 per share to ₩3,324 per share. Net income forecast to shrink 9.6% next year vs 6.8% growth forecast for Biotechs industry in South Korea . Consensus price target of ₩129,300 unchanged from last update. Share price was steady at ₩71,300 over the past week. Valuation Update With 7 Day Price Move • Oct 11
Investor sentiment deteriorated over the past week After last week's 20% share price decline to ₩68,800, the stock trades at a forward P/E ratio of 16x. Average forward P/E is 20x in the Biotechs industry in South Korea. Total loss to shareholders of 71% over the past year. Simply Wall St's valuation model estimates the intrinsic value at ₩103,453 per share. Buying Opportunity • Sep 23
Now 23% undervalued after recent price drop Over the last 90 days, the stock is down 16%. The fair value is estimated to be ₩111,327, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 112% over the last year. Earnings per share has grown by 109%. Revenue is forecast to grow by 23% in 2 years. Earnings is forecast to grow by 24% in the next 2 years. Valuation Update With 7 Day Price Move • Sep 20
Investor sentiment deteriorated over the past week After last week's 16% share price decline to ₩93,200, the stock trades at a forward P/E ratio of 20x. Average forward P/E is 22x in the Biotechs industry in South Korea. Total loss to shareholders of 66% over the past year. Simply Wall St's valuation model estimates the intrinsic value at ₩110,672 per share. Buying Opportunity • Sep 06
Now 20% undervalued after recent price drop Over the last 90 days, the stock is down 16%. The fair value is estimated to be ₩132,029, however this is not to be taken as a buy recommendation but rather should be used as a guide only. Revenue has grown by 112% over the last year. Earnings per share has grown by 110%. Revenue is forecast to grow by 23% in 2 years. Earnings is forecast to grow by 23% in the next 2 years. Valuation Update With 7 Day Price Move • Aug 23
Investor sentiment deteriorated over the past week After last week's 15% share price decline to ₩109,000, the stock trades at a forward P/E ratio of 24x. Average forward P/E is 26x in the Biotechs industry in South Korea. Total loss to shareholders of 64% over the past year. Simply Wall St's valuation model estimates the intrinsic value at ₩128,885 per share. Announcement • Aug 13
SK bioscience Receives Post Approval Change Application Approval from the Korean Ministry of Food and Drug Safety for Nuvaxovid™ (NVX-CoV2373) COVID-19 Vaccine Novavax Inc. announced that partner, SK bioscience, has received a Post Approval Change Application approval from the Korean Ministry of Food and Drug Safety (KMFDS) for Nuvaxovid™ (NVX-CoV2373) COVID-19 vaccine for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in adolescents aged 12 through 17. The approval was based on data from the ongoing pediatric expansion [1] of the Phase 3 PREVENT-19 trial of 2,247 adolescents aged 12 through 17 years across 73 sites in the U.S., to evaluate the safety, effectiveness (immunogenicity), and efficacy of Nuvaxovid. In the trial, Nuvaxovid achieved its primary effectiveness endpoint and demonstrated 80% clinical efficacy overall at a time when the Delta variant was the predominant circulating SARS-CoV-2 strain in the U.S. Preliminary safety data from the trial showed the vaccine to be generally well-tolerated. Serious and severe adverse events were low in number and balanced between vaccine and placebo groups, and not considered related to the vaccine. Local and systemic reactogenicity was generally lower than or similar to adults, after the first and second dose. The most common adverse reactions observed were injection site tenderness/pain, headache, myalgia, fatigue, and malaise. There was no increase in reactogenicity in younger (12 to Trade Name Use in the U.S. Major Estimate Revision • Jul 30
Consensus EPS estimates fall by 11% The consensus outlook for earnings per share (EPS) in 2022 has deteriorated. 2022 revenue forecast decreased from ₩1.01b to ₩913.4m. EPS estimate also fell from ₩4,714 per share to ₩4,173 per share. Net income forecast to grow 4.0% next year vs 15% growth forecast for Biotechs industry in South Korea. Consensus price target down from ₩150,556 to ₩145,111. Share price fell 5.1% to ₩122,000 over the past week. Major Estimate Revision • Jul 20
Consensus revenue estimates fall by 11% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from ₩1.13b to ₩1.01b. EPS estimate fell from ₩5,206 to ₩4,714 per share. Net income forecast to grow 12% next year vs 19% growth forecast for Biotechs industry in South Korea. Consensus price target down from ₩167,222 to ₩150,556. Share price fell 6.0% to ₩134,000 over the past week. Price Target Changed • Jul 16
Price target decreased to ₩151,667 Down from ₩167,222, the current price target is an average from 9 analysts. New target price is 11% above last closing price of ₩137,000. Stock is down 14% over the past year. The company is forecast to post earnings per share of ₩4,866 for next year compared to ₩4,844 last year. Major Estimate Revision • Jul 15
Consensus revenue estimates fall by 10% The consensus outlook for revenues in 2022 has deteriorated. 2022 revenue forecast decreased from ₩1.17b to ₩1.06b. EPS estimate fell from ₩5,206 to ₩4,956 per share. Net income forecast to grow 18% next year vs 24% growth forecast for Biotechs industry in South Korea. Consensus price target down from ₩167,222 to ₩159,444. Share price fell 2.1% to ₩137,000 over the past week. Valuation Update With 7 Day Price Move • Jul 06
Investor sentiment improved over the past week After last week's 21% share price gain to ₩121,500, the stock trades at a forward P/E ratio of 22x. Average forward P/E is 25x in the Biotechs industry in South Korea. Total loss to shareholders of 23% over the past year. Simply Wall St's valuation model estimates the intrinsic value at ₩154,204 per share. Price Target Changed • Jun 26
Price target decreased to ₩167,222 Down from ₩186,000, the current price target is an average from 9 analysts. New target price is 63% above last closing price of ₩102,500. Stock is down 33% over the past year. The company is forecast to post earnings per share of ₩5,206 for next year compared to ₩4,844 last year. Price Target Changed • Jun 21
Price target decreased to ₩167,222 Down from ₩189,222, the current price target is an average from 9 analysts. New target price is 66% above last closing price of ₩100,500. Stock is down 34% over the past year. The company is forecast to post earnings per share of ₩5,206 for next year compared to ₩4,844 last year. Major Estimate Revision • Jun 17
Consensus EPS estimates fall by 12% The consensus outlook for earnings per share (EPS) in 2022 has deteriorated. 2022 revenue forecast decreased from ₩1.25b to ₩1.21b. EPS estimate also fell from ₩6,191 per share to ₩5,455 per share. Net income forecast to grow 31% next year vs 24% growth forecast for Biotechs industry in South Korea. Consensus price target down from ₩189,222 to ₩179,444. Share price fell 14% to ₩104,000 over the past week. Valuation Update With 7 Day Price Move • Jun 15
Investor sentiment deteriorated over the past week After last week's 16% share price decline to ₩105,500, the stock trades at a forward P/E ratio of 16x. Average forward P/E is 24x in the Biotechs industry in South Korea. Total loss to shareholders of 35% over the past year. Price Target Changed • May 05
Price target decreased to ₩192,250 Down from ₩216,250, the current price target is an average from 7 analysts. New target price is 48% above last closing price of ₩129,500. Stock is down 19% over the past year. The company is forecast to post earnings per share of ₩5,616 for next year compared to ₩4,844 last year. Major Estimate Revision • May 04
Consensus EPS estimates fall by 17% The consensus outlook for earnings per share (EPS) in 2022 has deteriorated. 2022 revenue forecast decreased from ₩1.38b to ₩1.32b. EPS estimate also fell from ₩6,773 per share to ₩5,616 per share. Net income forecast to grow 21% next year vs 2.5% decline forecast for Biotechs industry in South Korea. Consensus price target down from ₩216,250 to ₩208,750. Share price fell 7.8% to ₩129,500 over the past week. Price Target Changed • Apr 27
Price target decreased to ₩216,250 Down from ₩248,571, the current price target is an average from 8 analysts. New target price is 55% above last closing price of ₩139,500. Stock is down 15% over the past year. The company is forecast to post earnings per share of ₩6,773 for next year compared to ₩4,844 last year. Board Change • Apr 27
Less than half of directors are independent Following the recent departure of a director, there is only 1 independent director on the board. The company's board is composed of: 1 independent director. 6 non-independent directors. Independent Outside Director Kwang-Hyun Jeon was the last independent director to join the board, commencing their role in 2022. The company's minority of independent directors is a risk according to the Simply Wall St Risk Model. Price Target Changed • Apr 07
Price target decreased to ₩225,714 Down from ₩248,571, the current price target is an average from 7 analysts. New target price is 57% above last closing price of ₩143,500. Stock is up 14% over the past year. The company is forecast to post earnings per share of ₩6,764 for next year compared to ₩4,844 last year. Valuation Update With 7 Day Price Move • Jan 27
Investor sentiment deteriorated over the past week After last week's 15% share price decline to ₩161,000, the stock trades at a forward P/E ratio of 26x. Average forward P/E is 23x in the Biotechs industry in South Korea. Announcement • Jan 13
South Korea Ministry of Food and Drug Safety Approves Novavax COVID-19 Vaccine Novavax, Inc. and SK bioscience Co. Limited announced that South Korea's Ministry of Food and Drug Safety (MFDS) has approved a Biologics License Application (BLA) from SK bioscience for Nuvaxovid™ COVID-19 Vaccine (recombinant, adjuvanted) for active immunization in individuals 18 years of age and older for the prevention of COVID-19 caused by SARS-CoV-2. Nuvaxovid™, Novavax' COVID-19 vaccine also known as NVX-CoV2373, is the first protein-based COVID-19 vaccine to be approved for commercial use in South Korea and will be manufactured and marketed in the country by SK bioscience. SK bioscience has an advance purchase agreement with the South Korean government to supply 40 million doses of Novavax' vaccine. The companies also recently announced expanded collaboration and license agreements that are expected to increase manufacturing capacity and provide SK bioscience with additional non-exclusive territories. Novavax' vaccine also recently received conditional marketing authorization (CMA) in the European Union and emergency use listing (EUL) from the World Health Organization (WHO) under the brand name Nuvaxovid. The Novavax/Serum Institute of India Pvt. Ltd. vaccine (brand name, Covovax™) recently received emergency use authorization (EUA) in India, Indonesia and the Philippines, as well as WHO EUL. Together, the WHO EULs for the vaccine from both companies reflect the potential opportunity for authorization in over 170 countries. The vaccine is also currently under review by multiple additional regulatory agencies worldwide and the company expects to receive additional worldwide authorizations in the first half of 2022. This includes the submission of its complete chemistry, manufacturing and controls (CMC) data package to the U.S. Food and Drug Administration (FDA) at the end of 2021. The company expects to submit a request for EUA for the vaccine in the U.S. after one month in accordance with guidance from the FDA regarding submission of all EUA vaccines. Announcement • Sep 01
SK Bioscience and GSK Start Phase 3 Trial of Adjuvanted Covid-19 Vaccine Candidate SK bioscience (SK) and GlaxoSmithKline plc (GSK) announced the initiation of a Phase 3 clinical study of SK's COVID-19 vaccine candidate, GBP510, in combination with GSK's pandemic adjuvant following positive interim Phase 1/2 results. The randomised, active-controlled global trial will enroll around 4,000 participants from a range of countries and will aim to evaluate GBP510's safety and immunogenicity compared to an active comparator - the AstraZeneca/Oxford University COVID-19 vaccine. The study will be one of the first global Phase 3 trials to compare two different COVID-19 vaccine candidates. The advance to Phase 3 study follows positive interim Phase 1/2 data which showed that all participants who received the adjuvanted vaccine candidate developed strong neutralizing antibody responses, demonstrating a 100% seroconversion rate. Neutralizing antibody titres were between five and a maximum of eight times higher compared to sera from people recovered from COVID-19. No safety concerns have been identified to date in this ongoing study. GBP510 is a self-assembled nanoparticle vaccine candidate targeting the receptor binding domain of the SARS-CoV-2 Spike protein, combined with GSK's pandemic adjuvant. The antigen is being developed by SK in collaboration with the Institute for Protein Design (IPD) at the University of Washington with support from BMGF and CEPI as part of the 'Wave 2' vaccine investment project to develop more accessible and affordable COVID-19 vaccines. Results from the Phase 3 study are expected in the first half of 2022 after which, subject to positive results and regulatory approval, the vaccine is expected to be supplied at scale worldwide through the COVAX facility. GSK's response to COVID-19 has been one of the broadest in the industry, with two potential treatments in addition to the company's vaccine candidates in development. GSK is collaborating with several organizations on COVID-19 vaccines by providing access to the company's pandemic adjuvant. As well as working with SK, the company is collaborating with Sanofi and Medicago to develop adjuvanted, protein-based vaccine candidates, and all are now in Phase 3 clinical trials. The use of an adjuvant can be of particular importance in a pandemic since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and contributing to protect more people in need. GSK is also working with mRNA specialist, CureVac, to jointly develop next generation, optimized mRNA vaccines for COVID-19 with the potential to address multiple emerging variants in one vaccine. GSK is also exploring potential therapeutic or treatment options for COVID-19 patients. The company is collaborating with Vir Biotechnology to develop existing and identify new anti-viral antibodies that could be used as therapeutic or preventive options for COVID-19. Sotrovimab, a monoclonal antibody for the early treatment of COVID-19 in adults at high risk of hospitalization, received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) in May 2021. The company is also assessing whether an investigational monoclonal antibody, otilimab, can help severely ill COVID-19 patients aged over 70 who experience an overreaction of their immune system. 
