Group 1 - The core point of the news is the performance of the Zhongyin Innovation Medical Mixed A fund, which has shown significant growth in its net value and returns over various time frames [1] - As of April 21, 2025, the latest net value of Zhongyin Innovation Medical Mixed A is 1.6127 yuan, reflecting a growth of 2.27% [1] - The fund's one-month return is 14.21%, ranking 9th out of 4672 similar funds; the three-month return is 36.72%, ranking 18th out of 4599; and the year-to-date return is 34.02%, ranking 36th out of 4590 [1] Group 2 - The top ten stock holdings of Zhongyin Innovation Medical Mixed A account for a total of 70.60%, with significant positions in companies such as Heng Rui Pharmaceutical (9.81%), Innovent Biologics (8.55%), and others [1] - The fund was established on November 13, 2019, and as of December 31, 2024, it has a total scale of 2.02 billion yuan [1] - The fund manager, Zheng Ning, has a background in asset management and has held various positions in the industry since 2022 [2]

Core Viewpoint - The recent performance of the Zhongyin Innovation Medical Mixed A fund shows a decline in net value but strong returns over various time frames, indicating potential resilience in the healthcare investment sector [1]. Fund Performance Summary - The latest net value of Zhongyin Innovation Medical Mixed A is 1.5786 yuan, down by 2.81% - The fund's one-month return is 13.30%, ranking 7 out of 4623 in its category - The three-month return stands at 38.74%, ranking 14 out of 4566 - Year-to-date return is 31.19%, ranking 24 out of 4559 [1]. Holdings Summary - The top ten stock holdings of Zhongyin Innovation Medical Mixed A account for a total of 70.60%, with the following key positions: - Heng Rui Pharmaceutical: 9.81% - Xinda Bio: 8.55% - Huaneng Pharmaceutical: 8.41% - Kangfang Biotech: 8.35% - Kangnuo Ya-B: 8.32% - Kelun Botai: 7.87% - BeiGene-U: 6.24% - Rongchang Bio: 5.96% - Hansoh Pharmaceutical: 3.98% - Xin Nuo Wei: 3.11% [1]. Fund Manager Background - Zheng Ning, the fund manager, has a master's degree and extensive experience in the investment sector, having previously worked at Taikang Asset Management and Zhonggeng Fund Management - Zheng joined Zhongyin Fund Management in 2022 and has managed multiple funds since then, including the Zhongyin Innovation Medical Mixed Fund [2].

Company Overview - Akebia Therapeutics, Inc. (AKBA) is currently positioned as an intriguing investment choice within the Medical - Drugs sector due to solid earnings estimate revision activity [1][3] - The company has seen a positive shift in earnings estimates, indicating a more bullish outlook from analysts regarding its short and long-term prospects [3] Industry Context - The Medical - Drugs industry has a Zacks Industry Rank of 83 out of more than 250 industries, suggesting it is well-positioned compared to other segments [2] - A rising trend in the industry can positively impact securities across the board, benefiting companies like Akebia Therapeutics [2] Earnings Estimates - Over the past month, current quarter estimates for Akebia have improved from a loss of 6 cents per share to a loss of 3 cents per share [4] - Current year estimates have also seen an increase, moving from a loss of 14 cents per share to a loss of 13 cents per share [4] - The company holds a Zacks Rank 3 (Hold), which is considered a favorable signal for potential investors [4] Investment Consideration - Given the strong industry performance and positive estimate revisions, Akebia Therapeutics is recommended as a decent pick for investors looking for opportunities in a robust industry segment [5]

Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [3]. Upcoming Event - Akebia will present data at the National Kidney Foundation Spring Clinical Meetings 2025 (NKF SCM25) in Boston, MA from April 10-13, 2025 [1]. - The company will have posters displayed during the Exhibit Hall hours at NKF SCM25 [1]. Research Presentation - On April 10, 2025, Dr. Wolfgang Winkelmayer will present a poster titled "Vadadustat for Treatment of Anemia in Older vs Younger Patients With Dialysis-Dependent-CKD" during the Oral Poster Presentation: Research 3 session [2]. - Akebia will also have a booth (1121) at the NKF SCM25 for attendees to visit [2].

Company Overview - Akebia Therapeutics, Inc. is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [5]. Offering Details - Akebia announced a public offering of 25,000,000 shares of common stock at a price of $2.00 per share, aiming to raise gross proceeds of $50.0 million before expenses [1]. - The underwriters have a 30-day option to purchase up to 3,750,000 additional shares at the public offering price [1]. - The offering is expected to close on March 21, 2025, pending customary closing conditions [1]. Underwriters - Leerink Partners and Piper Sandler & Co. are serving as joint bookrunning managers for the offering, with BTIG, LLC as the lead manager and H.C. Wainwright & Co. as co-manager [2]. Regulatory Compliance - The shares are being offered under a shelf registration statement filed with the SEC on September 3, 2024, which was declared effective on September 12, 2024 [2]. - A preliminary prospectus supplement has been filed with the SEC, and a final prospectus will also be filed [3]. Contact Information - For inquiries regarding the offering, contact details for Leerink Partners and Piper Sandler & Co. are provided [3].

Core Viewpoint - Akebia Therapeutics, Inc. has initiated an underwritten public offering of its common stock, with the potential for underwriters to purchase an additional 15% of shares sold in the offering [1][2]. Group 1: Offering Details - The offering is being conducted under a shelf registration statement filed with the SEC on September 3, 2024, and declared effective on September 12, 2024 [2]. - A preliminary prospectus supplement detailing the terms of the offering is expected to be filed with the SEC [3]. - The offering is subject to market conditions, and there is no assurance regarding its completion or the final terms [1][6]. Group 2: Company Overview - Akebia Therapeutics is a biopharmaceutical company focused on improving the lives of individuals affected by kidney disease, founded in 2007 and headquartered in Cambridge, Massachusetts [5].

Financial Data and Key Metrics Changes - Total revenues for Q4 2024 were $46.5 million, down from $56.2 million in Q4 2023, and for the full year 2024, revenues were $160.2 million compared to $194.6 million in 2023 [38] - Net product revenues from Auryxia were $44.4 million in Q4 2024, down from $53.2 million in Q4 2023, and for the full year, they were $152.2 million compared to $170.3 million in 2023 [38] - The net loss for Q4 2024 was $22.8 million, compared to a net income of $0.6 million in Q4 2023, and the full year net loss was $69.4 million compared to $51.9 million in 2023 [41][42] Business Line Data and Key Metrics Changes - The launch of Vafseo is in its early stages, with expected net product revenue of $10 million to $11 million for Q1 2025, which is ahead of analyst estimates [10][21] - Auryxia's sales decline was primarily due to a reduction in volume, partially offset by price increases and effective contracting strategies [38] Market Data and Key Metrics Changes - The demand for Vafseo is strong, with over 500 physicians prescribing it by the end of February, averaging about eight prescriptions each [33][76] - Approximately 15% of prescriptions for Vafseo were written for payers other than Medicare fee-for-service, indicating early success in Medicare Advantage coverage [36][86] Company Strategy and Development Direction - The company aims to make Vafseo the standard-of-care for patients with anemia due to chronic kidney disease, focusing on both dialysis and non-dialysis patient populations [10][17] - The strategy includes securing contracts with dialysis organizations and building prescriber demand, with a focus on small to medium-sized dialysis organizations initially [12][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early traction of Vafseo and the potential for it to become a standard treatment option [10][38] - The company is preparing for a Phase 3 clinical trial (VALOR) for non-dialysis patients, with plans to initiate the study in the second half of 2025 [18][96] Other Important Information - The company raised $18.4 million in net proceeds from sales under its ATM facility and drew down $9.3 million from its BlackRock Credit Agreement, strengthening its financial position [44] - Cash and cash equivalents as of December 31, 2024, were $51.9 million, expected to fund operations for at least two years [43] Q&A Session Summary Question: Does Q1 Vafseo revenue include any stocking or inventory build? - Management confirmed that there will be a little bit of inventory included in the revenue guidance, with inventory expected to stay in the two to four week range [48] Question: What are the dose frequency trends for in-center dialysis patients? - Most patients are currently on a daily dosing protocol, with some smaller centers starting TIW dosing [49] Question: How is protocolization gaining uptake at large-scale dialysis organizations? - Management noted that operationalizing protocols is taking longer than expected, but there is a desire from physicians to write prescriptions [52][53] Question: Can you expand on the recent backlog in Auryxia? - The backlog was for all phosphate binders and Vafseo due to the transition to specialty pharmacies, but it has subsided significantly [61] Question: What is the timing for the VALOR study regulatory interaction? - The focus is on study design, and management is looking to initiate the VALOR study as quickly as possible [66][68] Question: What are the launch metrics planned for disclosure? - Over 500 physicians have prescribed Vafseo, with an average of eight prescriptions per prescriber, indicating good breadth and depth of prescribing [76] Question: What is the current gross to net outlook? - Management did not provide specific gross to net figures but indicated that the average prescriptions are for the starting dose, with discounts expected to grow as volumes increase [90][91]

Financial Data and Key Metrics Changes - Total revenues for Q4 2024 were $46.5 million, down from $56.2 million in Q4 2023, and for the full year 2024, revenues were $160.2 million compared to $194.6 million in 2023 [38] - Net product revenues from Auryxia were $44.4 million in Q4 2024, down from $53.2 million in Q4 2023, and for the full year, they were $152.2 million compared to $170.3 million in 2023 [38] - The net loss for Q4 2024 was $22.8 million, compared to a net income of $0.6 million in Q4 2023, and the full year net loss was $69.4 million compared to $51.9 million in 2023 [41][42] Business Line Data and Key Metrics Changes - The launch of Vafseo is in its early stages, with expected net product revenue of $10 million to $11 million for Q1 2025, which is ahead of analyst estimates [10][21] - Auryxia's revenues decreased primarily due to a reduction in volume, partially offset by price increases and execution of contracting strategies [38] Market Data and Key Metrics Changes - The demand for Vafseo is strong, with over 500 physicians prescribing it by the end of February, averaging about eight prescriptions each [33][76] - Approximately 15% of prescriptions in February were written for payers other than Medicare fee-for-service, indicating early Medicare Advantage coverage [36][86] Company Strategy and Development Direction - The company aims to make Vafseo the standard-of-care for patients with anemia due to chronic kidney disease, focusing on both dialysis and non-dialysis patient populations [10][17] - The strategy includes securing contracts with dialysis organizations and building prescriber demand, with a focus on small to medium dialysis organizations initially [12][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the early traction of Vafseo and the potential for it to become a standard treatment option [10][38] - The company is preparing for a Phase 3 clinical trial (VALOR) for non-dialysis patients, with plans to initiate the study in the second half of the year [18][96] Other Important Information - The company raised $18.4 million in net proceeds from sales under its ATM facility and drew down $9.3 million from its BlackRock Credit Agreement, strengthening its financial position [44] - Cash and cash equivalents as of December 31, 2024, were $51.9 million, expected to be sufficient to fund operations for at least two years [43] Q&A Session Summary Question: Does Q1 Vafseo revenue include any stocking or inventory build? - Management confirmed that there will be a little bit of inventory included in the revenue guidance, with inventory expected to stay in the two to four week range [48] Question: What are the dose frequency trends for in-center dialysis patients? - Most patients are currently on a daily dosing protocol, with some smaller centers starting protocols with less frequent dosing [49] Question: How is protocolization gaining uptake at large-scale dialysis organizations? - Management noted that operationalizing protocols takes time, and while some larger organizations have written protocols, implementation is slower than desired [52] Question: Can you expand on the recent backlog in Auryxia? - The backlog was for all phosphate binders and Vafseo due to the transition to specialty pharmacies, which initially lacked capacity [60] Question: What is the timing for the VALOR study regulatory interaction? - The focus is on study design, and management is looking to initiate discussions with the FDA to expedite the process [68][96]

Akebia Therapeutics (AKBA) came out with a quarterly loss of $0.10 per share versus the Zacks Consensus Estimate of a loss of $0.08. This compares to break-even earnings per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -25%. A quarter ago, it was expected that this kidney disease treatment developer would post a loss of $0.05 per share when it actually produced a loss of $0.10, delivering a surprise of -100%.Over the last four ...

Licensing and Revenue - The company received an upfront payment of $10.0 million under the Medice License Agreement for Vafseo, with potential commercial milestone payments up to $100.0 million and tiered royalties ranging from 10% to 30% of annual net sales in the Medice Territory[100][103]. - The company is eligible to receive up to approximately $225.0 million in aggregate payments from MTPC based on the achievement of certain milestones, along with tiered royalty payments ranging from 13% to 20% on annual net sales of Vafseo in the MTPC Territory[109]. - The Vifor License Agreement included an upfront payment of $25.0 million and a profit-sharing arrangement where the company receives approximately 66% of the profits from Vafseo sales[112]. - The company recorded $5.4 million in license revenue related to royalties earned on net sales of Riona in Japan during the year ended December 31, 2024[125]. - The company is eligible to receive up to an additional $55.0 million upon the achievement of certain annual net sales milestones related to Riona[125]. - The company recorded $9.1 million in royalties due to Panion relating to the sales of Auryxia in the U.S. and JT and Torii net sales of Riona in Japan during the year ended December 31, 2024[129]. - The company is eligible to receive royalty payments based on a mid-single digit percentage of net sales of ferric citrate in licensed territories under the Panion Amended License Agreement[127]. Supply Chain and Manufacturing - The company relies on single-source suppliers for the manufacture of Auryxia, with pricing structured on a per-kilogram basis for the drug substance and tiered pricing for the drug product[97]. - The company has engaged Cardinal Health, Inc. as the exclusive third-party logistics distribution agent for commercial sales of Auryxia and Vafseo[98]. - The company has established CMO relationships for the supply of Auryxia to ensure sufficient material for ongoing commercial sales and clinical trials[97]. - The company entered into a supply agreement with Medice to supply Vafseo drug product for commercial and developmental use in the Medice Territory[106]. - The company controls all clinical and commercial manufacturing of praliciguat, which will be conducted by a third-party manufacturer[133]. Patent and Intellectual Property - The company holds 19 issued patents covering vadadustat, with expected expiration dates between 2027 and 2039[142]. - The company has exclusive rights under a series of patents and patent applications to commercialize Auryxia worldwide, with expected expiration dates between 2026 and 2030[145]. - The company has filed applications for patent term extensions for U.S. Patent Nos. 8,299,298, 8,093,423, 7,767,851, and 8,338,642 covering Auryxia due to FDA regulatory review delays[161]. - The company expects to apply for patent term extensions on issued patents covering future product candidates upon FDA or foreign regulatory approval[164]. - The company’s patent term extensions could be critical in maintaining market exclusivity for its products, potentially extending patent life by up to five years[160]. - Patent term restoration under the Hatch-Waxman Act can extend a patent by up to five years for time lost during development and FDA review[262]. Competition and Market Landscape - Auryxia competes in the hyperphosphatemia market against FDA-approved phosphate binders, including Renagel® and Renvela®, as well as newly approved XPHOZAH®[174]. - In the iron deficiency anemia market, Auryxia faces competition from over-the-counter oral iron and various intravenous iron formulations, including Feraheme® and Injectafer®[175]. - Vafseo competes with several established products, including Epogen® and Aranesp®, as well as new therapies like roxadustat and daprodustat in various markets[167][171]. - The company is aware of the competitive landscape, including potential new anemia therapies in development by other companies[169]. - The company faces significant competition from larger pharmaceutical firms with greater resources and R&D capabilities[165]. - The company is currently facing competition from products that may be less expensive or more effective than Auryxia[177]. - The revenue decline for Auryxia post-LoE may be slower than typical due to its inclusion in the ESRD bundle under Medicare Part B[180]. - The timing and number of generic versions entering the market will significantly impact future Auryxia revenues[180]. Regulatory and Clinical Trial Processes - Regulatory processes for drug approvals require substantial time and financial resources, impacting the development timeline[181]. - The FDA requires a 30-day waiting period after IND submission before clinical trials can commence, allowing for safety reviews[188]. - Clinical trials must comply with GCP requirements, including obtaining informed consent from all participants[201]. - The company must disclose clinical trial information on a public registry, with potential penalties for non-compliance[196]. - The FDA requires sponsors to develop and submit a diversity action plan (DAP) for each Phase 3 clinical trial, aimed at increasing diverse patient enrollment[203]. - The FDA's application fee for NDA submission in fiscal year 2025 is approximately $4.3 million, with an annual program fee of about $0.4 million per eligible prescription product[216]. - The FDA aims to review most NDAs within ten months of filing, with priority review products targeted for six months[218]. - The FDA may grant fast track designation for products addressing unmet medical needs in serious or life-threatening conditions[224]. - The FDA's review process includes a preliminary review within 60 days of receipt to determine if the application is sufficiently complete[217]. - The FDA conducts inspections of manufacturing facilities and clinical sites to ensure compliance with cGMP and GCP requirements before NDA approval[219][221]. - The FDA may require a Risk Evaluation and Mitigation Strategy (REMS) as a condition of approval to minimize risks associated with a product[222]. - The FDA's draft guidance in June 2023 aims to modernize clinical trial design and conduct, facilitating the development of medical products[204]. - The FDA's Pediatric Research Equity Act mandates that applications must include data to assess safety and effectiveness in pediatric populations[211]. - The FDA may designate a product as a breakthrough therapy if it shows substantial improvement over existing therapies for serious conditions[228]. - The FDA may designate a product for priority review, reducing the review time from ten months to six months for drugs that treat serious conditions and provide significant safety or effectiveness improvements[229]. - Accelerated approval can be granted based on clinical trials showing effects on surrogate endpoints, allowing quicker access to therapies for serious or life-threatening illnesses[230]. - New legislation allows the FDA to require confirmatory clinical trials to be underway before granting accelerated approval and mandates progress reports every six months[231]. - The FDA prefers randomized controlled trials for accelerated approval to ensure robust efficacy and safety assessments, particularly for oncology therapeutics[232]. - The FDA's review process includes a benefit-risk assessment, considering the severity of the condition and the adequacy of existing therapies[236]. - A Complete Response Letter (CRL) indicates deficiencies in an application, requiring substantial additional testing or information for reconsideration[237]. - An approval letter authorizes commercial marketing but may impose specific conditions, including post-approval trials and risk management mechanisms[238]. - The Ensuring Innovation Act mandates the FDA to publish action packages summarizing decisions on new drug approvals within 30 days[239]. - Post-approval requirements may include additional studies and monitoring to assess drug safety and effectiveness[240]. Data Privacy and Compliance - The California Consumer Privacy Act (CCPA) and the California Privacy Rights Act (CPRA) impose new privacy obligations on companies handling personal data[264]. - At least eighteen states have enacted privacy laws similar to the CCPA and CPRA, impacting data processing obligations[265]. - Companies face increasing lawsuits related to privacy violations, particularly concerning the use of web trackers and pixels[266]. - Non-compliance with privacy and data security laws could result in significant penalties, including fines and reputational harm[269]. Clinical Trials in the EU - The Clinical Trials Regulation (EU) No 536/2014 aims to simplify and streamline the authorization and conduct of clinical trials in the EU, requiring only a single application for trials conducted in multiple Member States[272]. - The maximum timeframe for the evaluation of a Marketing Authorization Application (MAA) under the centralized procedure is 210 days, with accelerated evaluation possible in exceptional public health cases, reducing the timeframe to 150 days[281]. - A marketing authorization is valid for five years and can be renewed based on a reevaluation of the risk-benefit balance, with the possibility of unlimited validity upon renewal[287]. - The EMA's PRIME scheme facilitates the development of product candidates for unmet medical needs, providing benefits such as early regulatory dialogue and accelerated assessment[278]. - Non-clinical studies must comply with GLP principles, ensuring the safety of new chemical or biological substances[271]. - The centralized procedure is compulsory for specific products, including orphan medicinal products and advanced therapy products, ensuring a single marketing authorization valid across all EU member states[280]. - The Pediatric Investigation Plan (PIP) is required for marketing authorization in the EU, covering all subsets of the pediatric population unless waivers are granted[279]. - The MA holder must establish a pharmacovigilance system to monitor the safety of medicinal products, including expedited reporting of serious adverse reactions[288]. - The manufacturing process for medicinal products in the EU is highly regulated, requiring compliance with EU GMP standards[290]. - Non-compliance with EU regulations may result in severe penalties, including delays in trial authorization and marketing approvals, product withdrawals, and criminal penalties[293].