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- 2026-03-10 07:05:12
- Policy
- ‘Gov’t investment and incentives needed to resolve drug shortages’
- by Jung, Heung-Jun Dec 15, 2025 09:16am
- Experts stressed that resolving shortages of essential medicines requires financial investment and policies like drug price incentives on the government’s part.They also argued that reliance solely on the private sector is insufficient, calling for the establishment of public manufacturing infrastructure and proactive cooperation frameworks in areas where dependence on overseas supply is unavoidable.Park Silvia, Research Fellow, Korea Institute for Health and Social AffairsOn the 12th, Park Silvia, a researcher at the Korea Institute for Health and Social Affairs, emphasized the need for policy support to enhance drug supply stability at the Korean Academy of Social and Administrative Pharmacy academic conference.She explained that since the COVID-19 pandemic, countries like the US and Europe are also preparing countermeasures to address pharmaceutical supply disruptions.The US is increasing domestic manufacturing through executive orders and taking measures to ensure excess capacity within its domestic supply chain. To expand domestic production, it provides financial support incentives and has established an evaluation system that rewards excellent manufacturers.This year, regulatory barriers have been lowered to facilitate the establishment of domestic pharmaceutical manufacturing facilities and to shorten approval timelines.Europe is also pursuing strategic projects to strengthen manufacturing capabilities. It has also strengthened supply planning and reporting obligations for license holders and expanded joint purchasing among member states to bridge gaps in access to essential medicines.Park noted that Korea is also seeing a rising number of reports related to drug supply disruptions and shortages, underscoring the urgency of policy responses.Park stated, “Strengthening the essential medicine manufacturing and supply chain has clear limitations when relying solely on corporate willpower. Financial support such as subsidies, grants, low-interest loans, investments, and tax incentives is necessary for developing manufacturing technology and establishing facilities.”She further proposed, “It is necessary to identify priority medicines for focused support and management, centered on national essential medicines. Priorities must be assigned to derive strategies. Additionally, manufacturers' supply risk management plans must be established and their implementation managed.”Park added, "Preferential drug pricing is needed to maintain domestic manufacturing of essential medicines, including APIs. Essential medicines for which domestic manufacturing and diversification are strategically pursued should receive preferential treatment in public procurement.“Finally, Park stressed the importance of the public role, stating, ”Relying solely on private pharmaceutical companies to supply all essential medicines has limitations. Building a public-centered pharmaceutical manufacturing infrastructure is also necessary. Furthermore, in areas where dependence on the global supply chain is unavoidable, a system that ensure active cooperation and solidarity is needed."
- Policy
- Discussions on RWE utilization in reimb decisions
- by Jung, Heung-Jun Dec 15, 2025 09:16am
- Guidelines for using Real World Evidence (RWE) in both the initial listing and subsequent reassessment of drug reimbursement status are expected to be announced in South Korea next year.The research commissioned by the Health Insurance Review and Assessment Service (HIRA) is nearing completion, and the guidelines will be published after gathering industry feedback.However, to use the guidelines for drug reimbursement, significant challenges remain related to securing the reliability of Real-World Data (RWD) and RWE. Furthermore, pushback is anticipated from pharmaceutical companies that are expressing concerns about the burden of generating RWE.On the afternoon of December 12, HIRA officials, the National Health Insurance Service (NHIS), and pharmaceutical companies engaged in a lively debate on the use of RWE for reimbursement decisions at the Korean Society of Social Pharmacy conference.Ra-Won Kang, Department Head of Drug Performance Assessment Management at HIRA.The HIRA announced its plan to publicize the guidelines soon following the completion of research on the use of RWE.Ra-Won Kang, Department Head of Drug Performance Assessment Management at HIRA, stated that the research on RWE utilization is nearing completion, and the guidelines will be published soon.Kang said, "Many major international organizations utilize RWE. In countries like Canada and the UK, RWE is largely used as a crucial basis for decision-making during both initial listing and post-listing reassessment of evidence."Kang emphasized, "The current challenge is how to ensure the reliability of the collection of RWD for the generation of RWE. Research into international cases shows that countries use guidelines tailored to their own circumstances for quality control. HIRA has also developed RWE guidelines research, and once it concludes this year, we plan to publish the guidelines next year after gathering input from stakeholders."Se-Rim Oh, Department Head of Negotiation and Post-Management at the NHIS.The statement conveys the message that RWE utilization is the government’s response to resolving uncertainties about increasing drugs subject to economic evaluation exemptions.Se-Rim Oh, Department Head of Negotiation and Post-Management at the NHIS, explained that the government's interest in utilizing RWE stems from concerns about resolving uncertainties amid the increasing number of drugs subject to economic evaluation exemptions.Oh stated, "Some responsibility lies with pharmaceutical companies. Many drugs have entered the market through the economic evaluation exemption route, even though an economic evaluation could have been conducted. Half of the risk-sharing agreement drugs approved this year and last year entered through this exemption," noting that this increases the uncertainty regarding cost-effectiveness. Oh stated, "RWE should be used if necessary. However, generating data can be expensive and difficult. There are concerns that predictability and acceptability might decrease," and added, "If necessary, establishing a legal basis and creating a government-wide registry would be appropriate." She also proposed that expanding performance-based refund agreements conducted by the NHIS and utilizing periodic performance reassessment data could be viable methods.Industry "RWD data have not been standardized…overseas data should also be allowed"The pharmaceutical industry expressed concern that the RWE guidelines could inadvertently become an additional layer of regulation, similar to clinical trials.Companies have complained about the heavy burden of RWE generation, particularly since RWD standardization has not yet been achieved. They strongly advocated for the recognition of international RWE data.Junghyun Na, Daiichi Sankyo Korea Head, stated, "First, the scope of application must be clearly defined. Also, the data in the field are varied and not standardized. Companies will inevitably face a substantial burden." Na emphasized that infrastructure, such as public platforms, must be built before implementation.Furthermore, companies stressed that if the process by which RWE will be reflected in reimbursement and pricing decisions is not predictable, the investment risk for companies would be significant.Jongryun An, Senior Director at Janssen Korea, explained, "Drugs entering through the economic evaluation exemption are reviewed without consideration for cost-effectiveness, but they typically enter at the lowest possible price. Furthermore, they are subject to total expenditure limits." An argued that measures to control high costs are already in place.An also raised the issue that collecting sufficient domestic data for rare and severe disease treatments in South Korea is challenging due to the small patient pool. An requested, "Please be flexible in accepting global RWE data if it was used in the process of obtaining approval or reimbursement in other countries."Additionally, An argued that the guidelines should be flexible, stating, "Overly detailed or strict guidelines could lead to a situation where no decisions can be made."
- Policy
- Bambec to withdraw from Korean mkt after 31yrs
- by Lee, Tak-Sun Dec 12, 2025 07:54am
- Bambec 10mg (bambuterol hydrochloride), used for asthma, is being withdrawn from the domestic market. This is a strategic withdrawal made by a multinational pharmaceutical company in response to declining competitiveness.Yuhan Corporation reported the discontinuation to the MFDS on December 10, noting that the final supply date was October 31.The company stated, “The discontinuation occurred following AstraZeneca Korea’s decision to cease sales, which led to the termination of the contract manufacturing agreement.”Approved in August 1994, Bambec had been sold in Korea for more than three decades. It is a long-acting β-adrenoceptor agonist (LABA) used for bronchial asthma, chronic bronchitis with bronchospasm, pulmonary emphysema, and other respiratory diseases.In recent years, combination therapies have dominated asthma and COPD treatment, reducing the market need for LABA monotherapy products and weakening their market competitiveness. According to UBIST data, Bambec's outpatient prescription sales reached KRW 1.4 billion in 2024.AstraZeneca sells other respiratory drugs in Korea besides Bambec, including Daxas, Pulmicort, and Symbicort. Compared to other products, Bambec’s sales performance is relatively low, and this relatively small market performance likely contributed to the global headquarters’ strategic decision to discontinue sales.Fortunately, generic versions remain available, so the discontinuation of the original drug is unlikely to create a significant gap. Generic versions with the same ingredients and formulation include Chong Kun Dang’s Asterol, Medica Korea’s Bambi, and Ildong Pharmaceutical's Bambutol.
- Policy
- RSA Collateral calculation method under review
- by Jung, Heung-Jun Dec 11, 2025 08:39am
- The National Health Insurance Service (NHIS) is currently reviewing improvements to the collateral calculation method for the refund-type risk-sharing agreement.Setting collateral in risk-sharing contracts is a crucial safeguard to secure claims in case refund obligations are not met. While a formula exists for setting the collateral amount, shortcomings were identified in some newly established RSA types, prompting NHIS to review improvements.According to industry sources on the 9th, this year’s NHIS audit highlighted deficiencies in the collateral calculation method for certain RSA types. The NHIS was advised to establish alternatives that would secure unpaid refund amounts for risk-sharing types lacking a collateral calculation formula.The NHIS's collateral-related operations are governed by the “Detailed Operational Guidelines for Drug Price Negotiations under Risk-Sharing Agreements.” Article 13 of the guidelines stipulates that the NHIS must receive collateral from companies to ensure the fulfillment of contractual obligations.Furthermore, the collateral amount is calculated using a separate formula, and the amount can be adjusted based on the type, the expected reimbursement amount, and the level of uncertainty.The collateral calculation methods are broadly categorized and specified in the guidelines as: ▲Conditional sustained treatment and refund hybrid type ▲Total expenditure cap type ▲Refund type ▲Patient-Unit usage cap type. For example, the Total expenditure cap type sets collateral at expected claim amount × refund rate × 30%.Within the RSA refund type, ▲the outcome-based reimbursement type is a newly added category for which no standardized calculation method is defined in the guidelines.According to the NHIS, the type of guarantee calculation formula identified as inadequate during the audit is the ‘outcome-based reimbursement type’. The NHIS stated it is currently under internal discussion and plans to revise the guidelines if necessary.An NHIS official explained, "The guidelines lack a calculation formula for the outcome-based reimbursement type. Internal discussions are ongoing, and revisions will be made to the guidelines if necessary."The outcome-based refund type is a contract type in which the applicant refunds a certain percentage of the total claim amount to the NHIS if the treatment effect set for each treated patient is not achieved after tracking and observing the treatment effect over a specified period.The outcome-based refund type is applied to some ultra-high-priced drugs, including Kymriah and Zolgensma.
- Policy
- Korea’s pharma industry: 20 years of rebate competition
- by Lee, Jeong-Hwan Dec 10, 2025 08:49am
- An argument has been raised that even if generic drug prices are cut, fostering generic drug companies capable of achieving economies of scale in selected therapeutic areas will increase the likelihood of the domestic pharmaceutical industry's global expansion.The logic is that unless the industry structure, in which many pharmaceutical companies produce and sell a little bit of every ingredient's generic version in a multi-product, small-volume production model, is reformed, the repetitive, destructive rebate competition among pharmaceutical companies will inevitably continue.There was also a suggestion that government policy must follow to prevent generic drug price reductions from leading to supply instability for certain generics.On the 5th, Professor Sung-min Park of Seoul National University's Graduate School of Public Health expressed concern at a National Assembly forum on drug pricing policy reform, stating, “Korea’s generic price competition has been distorted for decades and has instead manifested as rebate competition.”Professor Park's view is that the problem, where a higher market share is gained by higher generic prices, resulting in low drug expenditure savings from generic use, has persisted for 20 years. Consequently, the means of generic competition continues to be rebates to prescribing physicians rather than price reductions.Professor Park pointed out, “As sanctions against illegal rebates intensified, the practice became more covert to evade detection. While the margin rate for general wholesalers is 6%, CSO commission rates range from 40% to 50%, and can even reach 100%. The structure requires sales practices that benefit prescribers to secure generic prescriptions.”He stressed, “Korean generic companies have no real competitive tools besides rebates, being forced into rebate wars. Rebate competitiveness is far easier to achieve than price or quality competitiveness. This leads to an increase in small and micro pharmaceutical companies.”Professor Park proposed that the government should focus on creating a generic industry structure where economies of scale operate as a solution to these problems.Professor Park's solution is to transform the domestic generic industry, currently characterized by domestic-focused, multi-item, small-volume production, into an export-driven industry producing consumer goods like cosmetics and automobiles.Professor Park explained, “In the sheltered environment without genuine price competition, Korea's generic industry has many companies producing a little of this and that for the domestic market. Generic companies may be highly competitive in terms of rebates because they work hard to win sales. However, rebate competition that drives domestic prescription is meaningless in the global market.”Professor Park elaborated, “Even if we build competitiveness by supporting companies through methods like paying 40-50% commissions to CSOs, giving special margins to wholesalers who pay upfront, donating to hospital-related foundations, or setting up booths and paying fees at medical conferences, exporting domestic generics overseas remains a distant prospect. For the generic industry to become an export industry, it must achieve economies of scale that allow for price and quality competitiveness.”He noted, "We should refer to Japan's Ministry of Health, Labour and Welfare's generic pharmaceutical industry policy. MHLW categorizes generic companies into two types: general trading company-type firms with high market share, numerous product lines, and overall improved productivity; and specialized domain-focused companies leading specific areas and concentrating on products where they have strengths to secure productivity. Japan concluded that limiting competition to about 5 companies per active ingredient is optimal for a stable supply.Professor Park added, “While lowering generic drug prices, we must foster generic companies to achieve economies of scale across numerous items or in specific areas of strength, enabling global expansion. We must also be cautious that generic drug price reductions do not lead to supply instability for certain generics. We must not repeat the major disruption caused by the acetaminophen shortage during COVID-19.”
- Policy
- Revaluations for herbal medicines begin in earnest
- by Lee, Tak-Sun Dec 10, 2025 08:48am
- Some herbal preparations are entering comparative clinical trials for equivalence reevaluations.This comes one year after the Ministry of Food and Drug Safety announced the reevaluation of herbal preparations’ reimbursement last December, indicating how long it took for clinical trial protocols to be approved.According to industry sources on the 9th, the MFDS recently approved two clinical trial protocols submitted by manufacturers of Pelargonium sidoides extract tablets for equivalence reevaluations.The original brand for Pelargonium sidoides is Hanwha Pharma’s Umckamin, used for acute bronchitis.The approved clinical trials are reportedly led by Dasan Pharma and Genuone Sciences.Currently, 30 Pelargonium sidoides tablet products maintain marketing authorization (excluding export-only products). Of these, 28 are subject to the equivalence reevaluation. Dasan Pharma’s trial is said to have the largest number of participating products.The clinical trial is expected to proceed to submit a final report in two years. The MFDS granted an additional six months beyond the initially planned duration. However, depending on trial progression, the submission deadline may be shortened or delayed.Unlike Pelargonium sidoides tablets, the generic versions of the gastritis treatment ‘Stillen Tab and the osteoarthritis reliever ‘Layla Tab, which are also subject to reevaluation, are reportedly still undergoing revisions to their clinical trial protocols.The herbal medicine equivalence reevaluations began upon the MFDS’ announcement in December last year. The MFDS stated that proving bioequivalence through standard BE testing was unsuitable for these formulations, and that comparative clinical trials would be required instead. This marks the first time equivalence reevaluation will be performed through full clinical trials.Comparative clinical trials are considered the most burdensome form of equivalence testing for companies, costing tens of billions of won and requiring more than two years. As a result, about half of the original 212 products subject to reevaluation have already withdrawn their marketing authorization or converted to export-only status.Upon the MFDS review announcement, companies submitted clinical trial protocols by June. A total of seven trials will be conducted (three for Stillen generics, three for Umckamin generics, and one for Layla generics). Poonglim Pharmatech will be conducting 2 trials for 2 Stillen generics; Mother’s Pharm 1 for Stillen generic and 1 for Layla generic; and Dasan Pharma and Genuone Scinces, Korea United Pharm will each lead 1 Umckamin generics trial.However, due to MFDS requests for revisions and companies’ extension requests, approvals for the trials have been repeatedly delayed.Consequently, the first trial plan approval came a full year after the announcement. The Umckamin generic companies whose plans were approved this time must submit their result reports by December 2027 to demonstrate equivalence with the original product.
- Policy
- First batch of Korean anthrax vaccine Barythrax Inj released
- by Lee, Jeong-Hwan Dec 10, 2025 08:48am
- GC Biopharma announced on the 8th that Barythrax Inj., the world’s first recombinant-protein anthrax vaccine that it had co-developed with the Korea Disease Control and Prevention Agency (KDCA), has been released domestically for the first time.This comes about 8 months after receiving marketing approval as Korea’s 39th homegrown new drug last April, marking the country’s transition from full reliance on imported anthrax vaccines to enabling self-sufficiency.The first batch shipped from the Hwasun plant will be supplied as reserve vaccines for the KDCA.Unlike existing vaccines that directly use non-pathogenic anthrax bacteria, Barythrax expresses and purifies only the Protective Antigen (PA) protein, a key component of anthrax toxin, offering a higher safety profile.Preclinical and clinical studies demonstrated Barythrax’s excellent safety and strong immunogenicity, and the platform allows rapid large-scale manufacturing when needed.Barythrax is produced at GC Biopharma’s vaccine plant in Hwasun, Jeonnam, which has the capacity to manufacture up to 10 million doses annually, sufficient for approximately 2.5 million people based on a four-dose regimen per person.GC Biopharma particularly emphasized that Barythrax is a vaccine developed entirely with domestic technology, making it highly significant in terms of securing national vaccine self-sufficiency.The KDCA expects this shipment to help secure the stable supply of essential national medicines. As a core material in the bioterrorism response system, anthrax vaccines have previously relied on overseas products, raising persistent concerns about supply disruptions.The KDCA's position is that securing a domestic production base strengthens vaccine sovereignty and enables a more systematic response to infectious disease and bioterrorism.KDCA Commissioner Seung-Kwan Lim said, “The first shipment of the domestically produced anthrax vaccine is an achievement made through close cooperation between government agencies and private companies. This case will serve as a turning point to elevate the technological capabilities and production base of Korea’s vaccine industry to the next level.”He added, “We will continue to pursue the domestic production of essential national vaccines and build a more robust vaccine stockpiling system for infectious diseases and bioterrorism preparedness.”GC Biopharma CEO Eun-chul Heo remarked, “We are pleased to be able to ship the first supply of a domestically developed anthrax vaccine that we jointly developed with KDCA. GC Biopharma will continue to strive to strengthen Korea’s disease prevention capabilities and achieve vaccine self-sufficiency.”
- Policy
- Changes to DUR criteria for pack unit drugs
- by Jung, Heung-Jun Dec 10, 2025 08:48am
- The changes to the drug utilization review (DUR) system criteria for pharmaceuticals sold in packs will be applied to duration of use, starting on December 11. The issue concerning confirmation of the actual duration of use due to the characteristics of pack units is expected to be improved.New regulatory standards will apply to 39 drug items involving 18 active ingredient codes, including treatments for allergic rhinitis, hormonal preparations, and COVID-19 therapies.On December 9, the Health Insurance Review and Assessment Service (HIRA) informed medical institutes of changes to the Drug Utilization Review (DUR) criteria. By incorporating the total duration of use, duplicate checking will become more thorough.For example, if a prescription for Climen is written for 1 tablet once daily for a 28-day supply, the pharmacy dispensing claim will now record as dose per administration: 0.0356 (1/28), times per day: 1, and total days of Supply: 28.DUR system checks for duplication only for a single day. However, there have been differences in unit size for cases such as a 21-tablet pack or a 30-tablet pack.From now on, the actual period of use will be displayed next to the total days of supply. For example, if the unit is a 28-tablet pack, the period of use will be recorded as 28. This change will make duplication checks easier for the actual 28-day duration of the pack-unit drug.Regarding the rationale behind the improvement, HIRA stated, "For pack-unit drugs, improvements to the review criteria were necessary to accurately reflect the actual duration of use, as unclear prescribing or packaging unit descriptions resulted in inaccurate monitoring."Furthermore, the change is also aimed at preventing drug misuse and abuse through accurate duplication checks of the same active ingredient.HIRA requested cooperation from healthcare institutions, asking them to "accurately record the total days of supply in accordance with the guidelines to ensure the supply of safe use information for pack-unit drugs."The total days of administration will also be reflected in claims for both treatments and dispensing. For example, if a prescription for Climen is written for 1 tablet once daily for a 28-day supply, the pharmacy dispensing claim will now record as dose per administration: 0.0356 (1/28), times per day: 1, and total days of Supply: 28.
- Policy
- DREC deems 42 drugs appropriate for reimbursement
- by Jung, Heung-Jun Dec 09, 2025 08:28am
- According to the Health Insurance Review and Assessment Service (HIRA), the Drug Reimbursement Evaluation Committee (DREC) deemed reimbursement appropriate for 42 drug items during the 12 meetings held this year.Among them, 30 cases involved new drug listings or expanded reimbursement indications, averaging about 2.5 approvals per month. Another 12 were approved for reimbursement when accepted at or below the evaluated price.Based on the results of the twelve meetings held by HIRA’s DREC on the 7th, Dailypharm examined the status of reimbursement appropriateness approvals by the DREC this year.Although final listing requires successful price negotiations with NHIS and subsequent review by the Health Insurance Policy Deliberation Committee, passing the DREC remains the most critical hurdle toward reimbursement listing in Korea.This year, Janssen Korea and Eli Lilly Korea appeared most frequently among the 42 approved items. Janssen led with four products, followed by Lilly with three, marking strong performance.Janssen Korea secured reimbursement approval for Balversa (erdafitinib), a targeted therapy for urothelial carcinoma. Darzalex (daratumumab) for multiple myeloma and Erleada (apalutamide) for prostate cancer were recognized as appropriate for reimbursement expansions.Additionally, Opsynvi (macitentan/tadalafil) for pulmonary arterial hypertension received conditional approval, making drug price negotiations critical.Lilly Korea received positive evaluations for Jaypirca (pirtobrutinib), a treatment for mantle cell lymphoma, and Mounjaro Prefilled Pen (tirzepatide) as an adjunct therapy for diabetes. Also, Ebglyss Autoinjector Inj (lebrikizumab) was conditionally approved at or below the evaluation price.Other multinational companies, including Novartis Korea, AstraZeneca Korea, GSK, and Sanofi, had 2 items approved each, including conditional approvals.Among domestic companies, Hanmi, Jeil Pharmaceutical, JW Pharmaceutical, HLB Pharma, GC Pharma, Shinpoong Pharm, and Samoh Pharmaceutical all received reimbursement adequacy approvals from DREC.Notably, Handok is the only domestic company with two items approved. Its bile duct cancer treatment, Pemazyre Tab (pemigatinib), received reimbursement adequacy approval, while its thrombocytopenia treatment Doptelet Tab (avatrombopag) received conditional approval. Both drugs were listed after price negotiations with the National Health Insurance Service.
- Policy
- Application submitted for salt change generic to 'Jakavi'
- by Lee, Tak-Sun Dec 09, 2025 08:28am
- Novartis' rare blood cancer treatment 'Jakavi'The first applications for a generic to Novartis's 'Jakavi (ruxolitinib phosphate)', used for rare blood cancers, have been filed in South Korea. Jakavi is facing generic competition ahead of the expiration of its domestic substance patent on January 14, 2027. Currently, Daewoong Pharmaceutical and Chong Kun Dang are actively seeking to circumvent a composition patent.According to the Ministry of Food and Drug Safety (MFDS), applications for different dosage variants of a salt form-changed generic to Jakavi were filed on the 24th and 27th of last month. In response, the MFDS notified the original patent holder, who had registered patents on the drug listing, of the generic applications, in accordance with the Patent-Approval Linkage System.The generic drug has a different salt form from the original Jakavi. While Jakavi is the phosphate salt, the generic drug uses the hemifumarate salt. This change in salt form is interpreted as a strategy to circumvent the patent.Currently, Daewoong Pharmaceutical and Chong Kun Dang are also working to circumvent the composition patent by filing suits for negative confirmation of the scope of right with the Korean Intellectual Property Trial and Appeal Board. If these suits are successful, they will be able to launch their generic drugs immediately after the substance patent expires on January 14, 2027.Another key characteristic of the generic drug applications is that they exclude the Graft-versus-Host Disease (GVHD) indication, which still has a remaining Post-Marketing Surveillance (PMS) period.Jakavi is indicated for the treatment for Myelofibrosis (MF), Polycythemia Vera (PV), and Graft-versus-Host Disease (GVHD). However, the GVHD indication was added in 2022 and has a remaining PMS period until May of next year (2026). During the PMS period, the filing of generic drug applications is generally prohibited.Generics to Jakavi are reportedly under development, besides those form Daewoong and Chong Kun Dang. Jakavi is a global blockbuster product, with worldwide sales reaching KRW 6.6 trillion as of 2024. Its sales in South Korea are rapidly rising after successfully securing reimbursement coverage for MF and subsequently for GVHD in 2023.Given that rare disease drugs often lack alternatives and carry high costs, analysis suggests that companies succeeding in an early launch of a generic drug can secure a stable sales performance.
