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Avid Bioservices - CDMOP STOCK NEWS

Welcome to our dedicated page for Avid Bioservices news (Ticker: CDMOP), a resource for investors and traders seeking the latest updates and insights on Avid Bioservices stock.

Overview of Avid Bioservices

Avid Bioservices (CDMO) is a dedicated contract development and manufacturing organization specializing in the development and CGMP manufacturing of biologics. With over three decades of experience, the company offers a comprehensive suite of services that include process development, clinical and commercial drug substance manufacturing, and a broad range of testing and regulatory compliance services. Key industry terms such as CGMP manufacturing, process development, and biologics production are central to its operations, positioning Avid as an essential partner for biotechnology and pharmaceutical companies.

Core Business Areas

Avid Bioservices provides extensive services tailored to meet the evolving needs of life sciences companies. Its operations are divided into several critical segments:

  • Process Development: Encompassing cell line development, upstream and downstream process optimization, analytical methods development, and comprehensive testing and characterization, this segment focuses on building a robust foundation for biologic production.
  • CGMP Manufacturing: Operating state-of-the-art, fully compliant facilities, the company handles both clinical and commercial-scale production of drug substances. It covers bulk packaging, release and stability testing, and supports regulatory submissions.
  • Comprehensive Support Services: In addition to production, Avid offers support in regulatory strategy, assay development, and data analysis, allowing clients to navigate the complex landscape of biologic development with confidence.

Market Position and Industry Significance

Avid Bioservices has established itself as a reliable partner in the highly specialized field of biologics development. Its longstanding track record of consistent regulatory compliance and commitment to quality has earned it trust among leading pharmaceutical and biotech innovators. The company’s ability to manage end-to-end services — from early-stage development to final commercialization — highlights its expertise and deep industry knowledge, making it a significant player in the global CDMO landscape.

Expertise and Operational Excellence

The company prioritizes technological innovation and process optimization to meet the rigorous demands of its clients. Its investments in state-of-the-art facilities and a skilled team proficient in analytical testing and regulatory affairs underline its commitment to operational excellence. Avid Bioservices continuously adapts its service offerings to address the evolving challenges in biologics manufacturing, ensuring high-quality and efficient treatment production.

Competitive Landscape

Avid competes in a dynamic and challenging marketplace alongside other renowned CDMOs. What sets it apart is its specialized focus on biologics, its comprehensive suite of services, and its dedication to maintaining robust regulatory standards. These factors enable the company to offer customized solutions that are not only technically advanced but also meticulously aligned with industry best practices.

Customer Focus and Value Proposition

The core value proposition of Avid Bioservices lies in its ability to support the sustainable innovation of biopharmaceutical products. By integrating advanced process development with scalable manufacturing solutions, the company helps clients bring complex biologics to market efficiently. Its customer-centric approach, underscored by tailored solutions and a deep understanding of regulatory frameworks, enhances overall client value across the product lifecycle.

Conclusion

With a rich history in biologics production, Avid Bioservices stands out for its unwavering commitment to quality, comprehensive service offerings, and precise, regulatory-compliant manufacturing practices. The company remains a crucial partner for biotechnology and pharmaceutical innovators looking for dependable, full lifecycle development and manufacturing solutions, underpinned by a deep well of industry expertise and operational excellence.

Rhea-AI Summary

Avid Bioservices reported $31.5 million in revenue for Q3 FY2022, a 44% year-over-year increase. The company signed $52 million in net new business orders, ending the quarter with a backlog of $140 million, the highest to date. Their gross margin improved to 29%, and net income rose to $2.2 million or $0.04 per share. Avid is on track to expand its facilities, increasing revenue capacity from $120 million to over $350 million within three years. Revenue guidance for FY2022 is reiterated at $115 million to $117 million.

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Avid Bioservices (NASDAQ:CDMO) will report its Q3 fiscal year 2022 financial results on March 8, 2022, after market close. A conference call will follow at 1:30 PM PT, where senior management will discuss the results and corporate developments. Avid, an S&P SmallCap 600 company, has 28 years of experience in CGMP manufacturing and offers a range of services to the biotechnology and biopharmaceutical industries. These services include process development, clinical and commercial manufacturing, and regulatory support.

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Avid Bioservices (NASDAQ:CDMO) announced the completion of the first phase of its Myford facility expansion in Tustin, California. This includes a new downstream processing suite, which significantly boosts capacity and revenue-generating potential. With construction underway for the second phase, the company estimates combined annual revenue capacity of up to $270 million from the mammalian cell business and anticipates reaching $350 million with the addition of a new viral vector facility. The first customer project in the new suite is set to begin shortly.

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Avid Bioservices reported second quarter revenue of $26.1 million, a 24% increase from the prior year. The company signed $36 million in new business and ended the quarter with a backlog of $120 million, marking a 79% increase year-over-year. Avid is expanding into viral vector development for cell and gene therapy, anticipating significant growth. The gross margin improved to 35% from 30% year-over-year. Net income for the quarter was $3.5 million or $0.06 per share. The company maintains full-year revenue guidance of $115 million to $117 million.

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Avid Bioservices, Inc. (NASDAQ:CDMO) will report its financial results for Q2 of fiscal year 2022 on December 7, 2021, after market close. A conference call and webcast will take place at 1:30 PM PT (4:30 PM ET) on the same day, where senior management will discuss Q1 results and corporate developments. Avid is a dedicated contract development and manufacturing organization specializing in biologics, with nearly 30 years of experience in the biotechnology sector. The company offers a wide range of services, including CGMP manufacturing and process development.

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Avid Bioservices announced the appointment of Elie G. Hanania, Ph.D., as vice president of process development for viral vector technologies. With over 30 years in cell and gene therapy, Dr. Hanania's expertise is expected to bolster Avid's expansion into this growing market. The company is also constructing a new 53,000 sq. ft. CGMP manufacturing facility, projected to cost $75 million and become operational by early 2023. This strategic move aims to address the demand for high-quality viral vector manufacturing as the cell and gene therapy sector continues to expand.

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Avid Bioservices, Inc. (NASDAQ:CDMO) announced its inclusion in the S&P SmallCap 600 Index, effective October 29, 2021. This milestone reflects the company’s successful growth strategy and the contributions of its team. The S&P SmallCap 600 is designed to measure the performance of small-cap U.S. companies with market caps between $850 million and $3.6 billion. Avid focuses on CGMP manufacturing and development services for biologics, with extensive experience in monoclonal antibodies and recombinant proteins.

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Avid Bioservices, Inc. (NASDAQ:CDMO) is expanding into the cell and gene therapy market by building a 53,000 sq. ft. viral vector development and CGMP manufacturing facility in Costa Mesa, CA. The estimated construction cost ranges from $65 million to $75 million, with completion projected within 18 months. This move is driven by the increasing demand for viral vector production. Avid anticipates this expansion could boost its annual revenue-generating capacity to over $350 million. Drew Brennan has been appointed general manager for this new business segment, enhancing Avid's expertise in the market.

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Avid Bioservices has appointed Matthew Kwietniak as Chief Commercial Officer, effective immediately. Kwietniak brings nearly 30 years of sales experience in the CDMO sector, having previously led drug product sales at Thermo Fisher Scientific and held senior roles at Covance. His appointment aims to enhance Avid's growth trajectory and client relations in the CDMO business, which is crucial as the company undertakes expansion projects to increase capacity. The leadership transition is expected to strengthen Avid’s commercial and clinical client base.

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Avid Bioservices reported first quarter revenue of $30.8 million, marking a 21% year-over-year increase. The company achieved its fifth consecutive quarter of operational profitability and signed $23 million in new business orders, ending with a backlog of $110 million, an 83% increase from last year. Gross margin improved to 37%, up from 34% in the prior year, aided by a $3.3 million fee from unused capacity. Avid confirmed its fiscal 2022 revenue guidance of $115 million to $117 million, reflecting expected growth of 20% to 22%. Current cash reserves stand at $160 million.

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FAQ

What core services does Avid Bioservices provide?

Avid Bioservices offers a comprehensive range of services that include process development, CGMP clinical and commercial manufacturing, analytical testing, and regulatory submissions support for biologics.

How does Avid Bioservices serve the biotech and pharmaceutical industries?

The company provides end-to-end development and manufacturing services, from early-stage process development to full-scale commercial production, ensuring high quality and regulatory compliance.

What distinguishes Avid Bioservices in the competitive CDMO market?

Avid Bioservices stands out due to its extensive experience, specialized focus on biologics, state-of-the-art facilities, and a strong commitment to operational excellence and regulatory adherence.

How does Avid ensure quality and compliance in its manufacturing processes?

By adhering to stringent CGMP standards, investing in advanced technological capabilities, and employing a skilled team focused on process optimization and regulatory requirements, Avid ensures high quality and consistent compliance.

What is the significance of process development in Avid Bioservices' operations?

Process development is crucial as it forms the foundation for effective biologics production, involving activities such as cell line development, upstream and downstream optimization, and analytical testing to ensure scalable and compliant manufacturing.

How does Avid Bioservices support its clients throughout the product lifecycle?

Avid offers a full spectrum of services from initial development through to commercialization, providing technical expertise, customized solutions, and continuous support to meet the evolving needs of its clients.

Who are the typical customers of Avid Bioservices?

The company primarily serves biotechnology and pharmaceutical companies that require specialized contract development and manufacturing services for complex biologics.

How does Avid Bioservices maintain its industry expertise?

With over 30 years in the industry, Avid continuously invests in new technologies, staff training, and process innovation, ensuring that its services remain at the forefront of regulatory standards and manufacturing techniques.
Avid Bioservices

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