MENLO PARK, Calif., March 17, 2025 (GLOBE NEWSWIRE) -- PacBio (NASDAQ:PACB), a leading provider of high-quality, highly accurate sequencing platforms, today announced a newly published study in Nature Communications unveiling a powerful new method for analyzing some of the most complex regions of the human genome. Led by researchers from PacBio, GeneDx, and a global consortium of genomics experts, the study utilizes Paraphase, an informatics tool that, when paired with HiFi long-read sequencing, allows for ...

Product Development and Technology - In 2024, the company launched the Vega benchtop sequencer, delivering up to 60 gigabases of long reads per run, making accurate long-read sequencing more accessible[17]. - The SPRQ chemistry for the Revio system reduces DNA input requirements by 75% to just 500 ng, allowing for new sample types and improving sequencing performance by approximately 33%[17]. - Each Revio instrument is expected to sequence up to 2,500 human whole genomes per year at a cost of just under $500 per genome[17]. - The company commenced commercial shipments for the PureTarget repeat expansion panel, analyzing 20 genes associated with serious neurological disorders[17]. - The HiFi long-read sequencing technology has been recognized for its contributions to biological understanding and was named "method of the year" for 2022 by Nature Methods[15]. - The Revio platform enables sub-$500 HiFi genome sequencing, improving methylation detection capabilities and achieving a 75% reduction in DNA input requirements for human whole genome sequencing[51]. - The company is developing Kinnex kits for high-throughput RNA applications, which significantly increase molecular yield and reduce sequencing needs[40]. - HiFi long-read sequencing technology typically achieves greater than 99% read accuracy, often exceeding 99.9% accuracy, supporting a variety of applications across human health and microbiology[35]. - The Onso system for SBB short-read sequencing aims to improve accuracy in detecting rare variants, particularly in complex heterogeneous samples[42]. - The company’s products are utilized across various applications, including human genetics, oncology, and infectious disease, addressing a broad set of scientific and clinical needs[23]. Market and Financial Performance - The market for human genomics is significant, with an estimated 400 million people affected by up to 8,000 distinct rare diseases, 80% of which are believed to be genetic[24]. - As of December 31, 2024, the company's product backlog was approximately $31.2 million, up from $18.7 million as of December 31, 2023, indicating strong demand for its products[51]. - The company recorded $184.5 million in impairment charges during the year ended December 31, 2024[97]. - As of December 31, 2024, the company had approximately $200.0 million in 1.50% Convertible Senior Notes due 2029 and $441.0 million in 1.375% Convertible Senior Notes due 2030[106]. - The company expects to continue incurring substantial losses and negative cash flow for the foreseeable future, with no expectation of profitability in 2025[98]. - The company initiated expense reduction plans in Q2 2024 to align its organizational structure with strategic initiatives, aiming to reduce annualized run-rate operating expenses by year-end[104]. - The company faces risks related to the successful marketing and commercialization of its products, which may be adversely affected by current market conditions[91]. - The company relies on a limited number of customers for a significant portion of its revenues, which may be impacted by funding reductions from the U.S. federal government[88]. - The company may need to raise additional funds through public or private debt or equity financing to support commercialization efforts and product development[107]. - The company may experience limitations on utilizing net operating losses (NOLs) due to ownership changes, which could affect its ability to offset future taxable income[165]. Regulatory and Compliance Challenges - The FDA classifies medical devices into three classes, with Class I and II devices requiring pre-market notification for clearance, while Class III devices typically require pre-market approval (PMA)[65][66]. - The 510(k) clearance process for medical devices generally takes between four to twelve months, but can be longer depending on circumstances[65]. - Regulatory approval processes for medical devices can be expensive and time-consuming, potentially delaying product commercialization[67][71]. - Changes in healthcare regulatory policies could increase costs and impact the commercialization and reimbursement of the company's products[72]. - The company’s products are currently labeled as research use only (RUO), but future regulatory changes could subject them to medical device regulations, impacting commercialization efforts[188]. - The FDA's recent final rule phases out enforcement discretion for laboratory-developed tests (LDTs), which could significantly affect the company's operations and regulatory compliance[191]. - The evolving regulatory landscape may require the company to adapt its business practices, potentially leading to increased costs and operational challenges[186]. - The company faces potential regulatory changes that could impact product sales and require business model adjustments to maintain compliance with applicable laws[193]. - If the FDA subjects the company's products to additional regulations as in vitro diagnostic devices, marketing and sales could be impeded, adversely affecting business prospects and financial condition[194]. - Obtaining FDA pre-market 510(k) clearance or approval for products labeled as medical devices could be time-consuming and costly, with no guarantee of success[196]. Competition and Market Dynamics - The competitive landscape includes major players like Illumina and Thermo Fisher, necessitating continued innovation to maintain market share[59]. - The company faces significant competition from established players like Illumina and Roche, which may lead to pricing pressures and affect market share[141]. - The company may face challenges in converting backlog orders into revenue, which could impact future financial results[153]. - Lengthy and unpredictable sales cycles make revenue forecasting difficult and may lead to significant fluctuations in operating results[155]. - The company's commercial success may be hindered by the availability of third-party sample preparation and informatics tools, which are essential for product adoption[140]. - The company faces pricing pressures due to industry competition and may struggle to acquire additional customers outside of academic and research settings[128]. Intellectual Property and Legal Risks - The company holds or has exclusive licenses to 448 issued U.S. patents and 69 pending U.S. patent applications, indicating a strong intellectual property portfolio[57]. - The company’s intellectual property rights may face challenges, which could diminish its competitive advantage and lead to costly legal disputes[176]. - The company relies on third-party licenses for important intellectual property, and any changes in these rights could adversely affect its business operations[173]. - The company is involved in ongoing legal proceedings to enforce its intellectual property rights, which have resulted in significant expenses and management resource diversion[179]. - The company faces potential patent infringement claims from third parties, including ongoing litigation with Personal Genomics of Taiwan, Inc. and others, which could lead to substantial legal costs and operational disruptions[181]. - The company has not registered some trademarks in all potential markets, which could adversely affect its business if these registrations are not secured[183]. - The company incorporates open source software in its products, which could lead to legal obligations that may adversely affect its ability to maintain proprietary technology[184]. Operational and Workforce Considerations - The company has 575 full-time employees as of December 31, 2024, with the majority located in California, and no employees are represented by labor unions[78]. - The company emphasizes a total rewards philosophy, offering competitive compensation packages that include base salary, bonuses, and long-term equity awards[80]. - The company is committed to health, safety, and wellness programs for employees, providing access to various health and wellness benefits[81]. - The company recognizes the importance of a diverse workforce and offers training programs on diversity awareness to prevent bias[82]. - The company supports ongoing learning and development through a scaled learning platform and formal annual review processes[83]. - The company relies heavily on its senior management and key personnel for success, facing high competition for talent and potential turnover risks[124]. - Changes in U.S. immigration policies may hinder the company's ability to hire qualified personnel, potentially leading to increased labor costs and turnover rates[125]. Economic and Geopolitical Risks - Political and economic tensions between the U.S. and China could adversely affect the company's operations, as components are sourced from China[156]. - The company faces significant risks due to its reliance on Taiwanese suppliers for consumable chips, which could adversely affect its operations and financial condition if geopolitical tensions escalate[159]. - Ongoing geopolitical tensions, particularly related to the war in Ukraine, may adversely affect the company's operations and financial condition[207]. - Enhanced trade tariffs and restrictions, particularly on imports from China, could raise costs and negatively impact sales and financial results[199]. - The U.S. government has increased export controls on semiconductors and related technologies, potentially restricting the company's ability to export products[201]. - Retaliatory measures from the Chinese government in response to U.S. trade restrictions could further impact the company's ability to operate in that market[202]. Environmental and Compliance Issues - Compliance with environmental, health, and safety laws is essential, as violations could result in substantial fines and operational disruptions[206]. - The company faces potential reductions in demand for its technology due to ethical, legal, privacy, and governmental concerns surrounding genetic information[207]. - Compliance with the Dodd-Frank Act has led to additional expenses and could limit the supply and increase costs of materials used in product manufacturing[208].

Pacific Biosciences of California (PACB) ended the recent trading session at $1.22, demonstrating a +1.67% swing from the preceding day's closing price. The stock's change was less than the S&P 500's daily gain of 2.13%. Meanwhile, the Dow experienced a rise of 1.65%, and the technology-dominated Nasdaq saw an increase of 2.61%.Shares of the maker of genetic analysis technology witnessed a loss of 18.92% over the previous month, trailing the performance of the Medical sector with its loss of 2.78% and the S ...

Core Insights - Pacific Biosciences has faced significant challenges over the past four years, with many promising developments turning out to be setbacks instead [1] Group 1: Company Challenges - The company has experienced multiple external challenges, including failed partnerships and increased competition [1] - Uncertainty in the market has further complicated the company's position [1]

Core Insights - PacBio will present at TD Cowen's 45th Annual Health Care Conference on March 4, 2025, at 3:10 PM ET in Boston, MA [1] - A live webcast of the presentation will be available on the company's investor page, with a replay accessible for at least 30 days post-event [2] Company Overview - PacBio is a leading life science technology company specializing in high-quality, accurate sequencing solutions aimed at resolving genetically complex problems [3] - The company utilizes two core technologies: HiFi long-read sequencing and SBB® short-read sequencing, focusing on accuracy, quality, and completeness [3] - PacBio's products cater to various research applications, including human germline sequencing, plant and animal sciences, infectious disease, microbiology, and oncology [3]

Core Insights - PacBio reported an adjusted loss per share of 20 cents in Q4 2024, an improvement from a loss of 27 cents in the previous year, aligning with Zacks Consensus Estimate [1] - The company's full-year adjusted loss per share was 83 cents, better than the $1.11 loss in 2023 but wider than the expected loss of 81 cents [2] Revenue Performance - PacBio's Q4 revenues were $39.2 million, down 32.8% year over year, but slightly above the Zacks Consensus Estimate by 0.1% [3] - Full-year revenues totaled $154 million, reflecting a 23.2% decrease from 2023 [3] Geographical Analysis - Revenues from the Americas were $20.2 million, down 41% year over year, impacted by academic environment and NIH funding uncertainty [4] - Asia-Pacific revenues were $8.9 million, a 33% decline year over year, with government funding challenges affecting capital expenditures [5] - EMEA region revenues were $10.1 million, down 9% year over year, although record consumables revenues were noted [6] Segmental Analysis - Product revenues were $34.1 million, down 36.9% year over year, with instrument revenues at $15.3 million, down 56.4% due to lower Revio system shipments [7] - Consumables revenues were $18.8 million, down 0.5% year over year, while service and other revenues increased by 17.7% to $5.1 million [8] Margin and Expense Trends - Adjusted gross profit decreased 14.9% year over year to $12.3 million, but adjusted gross margin expanded by 656 basis points to 31.3% [9] - Total operating expenses decreased 23.7% year over year to $69.1 million, with a total adjusted operating loss of $56.8 million [10] Financial Position - PacBio ended 2024 with cash and investments of $389.9 million, down from $631.4 million at the end of 2023 [11] Guidance - For Q1 2025, PacBio expects revenues to be lower than Q4 2024 due to seasonality and reduced Revio system and consumables revenues, with a consensus estimate of $43.6 million [12] - The company anticipates full-year revenues between $155 million and $170 million, below the consensus estimate of $189.5 million [13] Overall Assessment - Despite a narrower loss per share and better-than-expected revenues, concerns remain regarding the year-over-year decline in overall revenues and product sales [14][15] - Management noted ongoing macroeconomic pressures and uncertainties in the academic environment, particularly related to NIH funding [15]

PacBio Q4 2024 Earnings Presentation February 13, 2025 Fourth Quarter 2024 Earnings Call 1 Statement regarding use of non‐GAAP financial measures PacBio reports non‐GAAP results for basic net income and loss per share, net income, net loss, gross margins, gross profit and operating expenses in addition to, and not as a substitute for, or because it believes that such information is superior to, financial measures calculated in accordance with GAAP. PacBio believes that non-GAAP financial information, when t ...

Financial Data and Key Metrics Changes - In Q4 2024, the company reported revenue of $39.2 million, a decrease of 33% from $58.4 million in Q4 2023 [43] - For the full year, total revenue was $154 million, reflecting 97 Revio shipments [9] - Non-GAAP net loss for Q4 2024 was $55.3 million, or $0.20 per share, compared to a loss of $72.5 million, or $0.27 per share in Q4 2023 [48] - Cash and investments at the end of Q4 2024 totaled $389.9 million, down from $441 million at the end of Q3 2024 [48] Business Line Data and Key Metrics Changes - Instrument revenue in Q4 2024 was $15.3 million, a 56% decrease from $35.1 million in Q4 2023, primarily due to lower Revio system shipments [43] - Consumable revenue was approximately $18.8 million in Q4 2024, remaining roughly flat year-over-year [44] - Service and other revenue increased to $5.1 million in Q4 2024 from $4.4 million in Q4 2023, driven by an increase in service contract revenue related to Revio [44] Market Data and Key Metrics Changes - Revenue from the Americas decreased by 41% to $20.2 million in Q4 2024, impacted by academic and NIH funding uncertainty [44] - Asia Pacific revenue was approximately $8.9 million, down 33% year-over-year, with government funding headwinds affecting capital expenditures [45] - EMEA revenue decreased by 9% to $10.1 million, although consumables revenue reached record levels due to growing Revio utilization [46] Company Strategy and Development Direction - The company aims to achieve sustained double-digit revenue growth as long-range sequencing expands genomic applications [15] - Key priorities include expanding HiFi sequencing adoption, enhancing Revio's value with Spark Chemistry, and providing turnkey bioinformatics solutions [15][17] - The company anticipates turning cash flow positive by the end of 2027, with a focus on lowering cash burn and maintaining financial flexibility [17][58] Management's Comments on Operating Environment and Future Outlook - Management noted that macroeconomic pressures are expected to persist, extending sales cycles for higher CapEx life science instrumentation [12] - The company expects 2025 revenue to range between $155 million and $170 million, reflecting a 6% year-over-year growth at the midpoint [13][52] - Management highlighted the importance of navigating an uncertain funding environment, particularly in the U.S. academic research community [53] Other Important Information - The company successfully launched the Vega Benchtop platform and Spark Chemistry for Revio in 2024, enhancing its product portfolio [18] - The company reduced annualized non-GAAP operating expenses by over $75 million, aligning spending with strategic priorities [37] - A convertible note exchange reduced debt by $259 million and extended the maturity of 2028 notes by 18 months [38] Q&A Session Summary Question: What specifically have you baked in for NIH disruption in the near term? - Management acknowledged the dynamic funding environment and indicated that significant headwinds were contemplated in their guidance, particularly for the first half of the year [64][65] Question: Why are Revio shipments declining this year? - Management clarified that the decline is primarily driven by funding concerns rather than product fading or cannibalization by Vega [84][86] Question: What is the magnitude of the assumed NIH funding cut? - Management indicated that NIH revenue historically represents about 20% of total revenue, but the exact impact of funding cuts is complex and varies by institution [95] Question: Can you talk about the progress on gross margin? - Management expressed optimism about gross margin improvements, citing resolved yield issues and cost reductions from in-sourcing manufacturing [105][106] Question: How is the company addressing customer concentration risk? - Management noted that while there are large-scale programs with key customers, efforts are being made to diversify the customer base and mitigate risks [120][122]

Core Insights - Pacific Biosciences of California (PACB) reported a revenue of $39.22 million for the quarter ended December 2024, reflecting a decline of 32.8% year-over-year [1] - The earnings per share (EPS) for the quarter was -$0.20, an improvement from -$0.27 in the same quarter last year [1] - The reported revenue slightly exceeded the Zacks Consensus Estimate of $39.2 million by 0.06%, while the EPS met the consensus estimate [1] Revenue Breakdown - Revenue from Product - Instrument was $15.30 million, falling short of the estimated $16.94 million by analysts, representing a year-over-year decline of 56.4% [4] - Revenue from Product was $34.10 million, below the estimated $36.10 million [4] - Revenue from Service and other was $5.13 million, surpassing the average estimate of $4.88 million, showing a year-over-year increase of 17.7% [4] - Revenue from Product - Consumable was $18.80 million, slightly below the estimated $19.17 million, with a year-over-year change of -0.5% [4] Stock Performance - Shares of Pacific Biosciences have decreased by 22.1% over the past month, contrasting with a 3.9% increase in the Zacks S&P 500 composite [3] - The stock currently holds a Zacks Rank 4 (Sell), indicating potential underperformance relative to the broader market in the near term [3]

Financial Results - Pacific Biosciences reported preliminary financial results for the quarter and year ended December 31, 2024, with expectations for revenue estimates to be disclosed in the upcoming finalized report[4] - The company emphasized that the financial statements for the mentioned periods are unaudited and subject to change, indicating potential material differences from the preliminary information[8] Business Update - The press release dated January 14, 2025, serves as a business update and includes preliminary cash, cash equivalents, and investments balance as of December 31, 2024[6]