Illumina, Revvity, QIAGEN, CareDx, Guardant Health, BD and Others Report Strong Q3 2024 Financial Results and Strategic Updates

Recently, Illumina announced its financial report for the third quarter of the fiscal year 2024. The financial results for the entire year of 2024, as well as for the third quarter and the whole year of 2023, include the financial performance of GRAIL (which was spun off on June 24, 2024).

Core revenue for the third quarter of 2024 was $1.1 billion, a 2% decrease compared to the third quarter of 2023 on a constant currency basis;GAAP operating margin was 68.6% and non-GAAP operating margin was 22.6% in the third quarter of 2024.Diluted core GAAP earnings per share were $4.03 and non-GAAP diluted earnings per share were $1.14 in the third quarter of 2024.Core revenue guidance for 2024 has been revised downward to a decrease of approximately 3% compared to fiscal year 2023; core revenue for the fourth quarter of 2024 is expected to be approximately $1.07 billion.Increase the 2024 core non-GAAP operating profit margin guidance to a range of 21% to 21.5%;Increase 2024 Core Non-GAAP Diluted EPS Guidance to a Range of $4.05 to $4.15.

Revvity Recently Announced Third Quarter Financial Results as of September 29, 2024.

Revvity Reports GAAP Earnings Per Share of $0.77, Compared to $0.08 in the Same Period Last Year. GAAP Revenue for the Quarter was $684 Million, Compared to $671 Million in the Same Period Last Year. GAAP Operating Income from Continuing Operations for the Quarter was $98 Million, Compared to $69 Million in the Same Period Last Year. GAAP Operating Margin from Continuing Operations was 14.3% of Revenue, Compared to 10.3% in the Same Period Last Year.

QIAGEN recently announced that the U.S. Food and Drug Administration (FDA) has approved the QIAstat-Dx Meningitis/Encephalitis Panel for clinical use. This is the fourth QIAstat-Dx syndrome test to receive approval from U.S. regulators in 2024.

CareDx, Inc. Announces Third Quarter 2024 Financial Results as of September 30, 2024.

Highlights of Q3 2024 Performance:

·Total revenue of $82.9 million, a year-over-year increase of 23%.

·Testing volume reached 44,600 times, a year-on-year increase of 16%.

·GAAP net loss of $7.4 million, non-GAAP net income of $8.0 million, and adjusted EBITDA of $6.9 million, showing significant improvement compared to the third quarter of 2023.

·Operating cash flow of $12.5 million, cash, cash equivalents, and marketable securities of $241 million, and no debt.

·Increase the annual revenue forecast to $327 million to $331 million, with adjusted EBITDA of $18 million to $22 million.

Net sales in the third quarter of 2024 increased by 5% compared to the third quarter of 2023, reaching $502 million, while performance at constant exchange rates (CER) grew by 6% to $502 million, surpassing the CER expectation of at least $495 million. The adjusted operating margin rose by 3 percentage points to 29.6%, driven by the recent decision to discontinue the use of the NeuMoDx system and broader efficiency improvements, which enhanced profitability and freed up resources for targeted reinvestment. Adjusted diluted earnings per share (EPS) were $0.57, with net earnings per share at $0.58, exceeding the expected net earnings per share of at least $0.55.

Guardant Health, Inc., a leading precision oncology company, released its financial report for the third quarter ended September 30, 2024.

Highlights of Q3 2024 Performance:

·Revenue for the third quarter of 2024 was $191.5 million, an increase of 34% compared to the third quarter of 2023.

·Q3 2024 Report: 53,100 clinical trials (excluding Shield) and 10,500 biopharmaceutical trials, representing increases of 21% and 40%, respectively, compared to Q3 2023.

·The average selling price of Guardant360 exceeds $3,000.

·Raises 2024 Annual Revenue Guidance to New Range of $720 Million to $725 Million, Representing Growth of 28% to 29%.

·Free cash flow in the third quarter of 2024 increased from $80 million in the same period last year to $55 million.

·Revised annual free cash flow guidance to ($265) - ($275) million, representing an increase of $70 - $80 million compared to 2023.

BD, a globally leading medical technology company, recently announced its financial results for the fourth quarter of fiscal year 2024 and the full year ending September 30, 2024.

The company completed its acquisition of Edwards Lifesciences' critical care business, expanding BD's portfolio of intelligent and connected care solutions to include advanced artificial intelligence clinical decision-making tools. The combination of leading monitoring and infusion platforms offers future innovation opportunities for closed-loop monitoring and treatment by integrating company datasets and interoperability capabilities.

Veracyte Releases Third Quarter 2024 Financial Results as of September 30, 2024.

Key Performance Highlights:

·Compared with the third quarter of 2023, total revenue in the third quarter increased by 29% to US$115.9 million, and total volume grew by 20% to reach 39,032 tests.

·Test revenue increased 34% to $109.5 million and test volume grew 24% to 36,792 tests compared to the third quarter of 2023.

·Compared to the third quarter of 2023, Decipher’s revenue increased by 48%, and test volume grew by 36% to reach 21,250.

·Compared to the third quarter of 2023, Afirma's revenue increased by 19%, with a 12% increase in volume, approaching 15,100 tests.

·Net revenue increased to $15.2 million in the third quarter, with adjusted EBITDA of $27.3 million, representing 24% of revenue.

·Operations generated $30 million in cash from the third quarter to the end of the quarter, with cash and cash equivalents totaling $274.1 million.

The Board of Directors of Diasorin S.p.A. reviewed and approved the group's consolidated financial statements as of September 30, 2024.

Income:€876 million, an increase of 4% (at both current and constant exchange rates). Excluding the COVID-19 business, revenue of $900 million in 2024 increased by 7% at both current and constant exchange rates compared to the same period last year, which is consistent with the higher end of the guidance for the fiscal year 2024.

In the third quarter of 2024, the revenue growth rate, excluding COVID-19 business, was +9% (+10% at constant exchange rates). This growth is attributed to the outstanding performance of the three business lines.

Natera, Inc., a global leader in cell-free DNA and genetic testing, recently released its financial report for the third quarter ended September 30, 2024.

Strategy and Performance Highlights:

·Total revenue for the third quarter of 2024 was US$439.8 million, compared to US$268.3 million for the third quarter of 2023, representing a record year-over-year increase of 63.9%, with product revenue growing by 64.4% over the same period.

·The gross margin for the third quarter of 2024 was 61.8%, compared to 45.1% for the third quarter of 2023.

·Approximately 775,800 tests were processed in the third quarter of 2024, compared to approximately 626,000 tests in the third quarter of 2023, representing a 23.9% increase.

·Approximately 137,100 oncology tests were conducted in the third quarter of 2024, compared to about 88,800 in the third quarter of 2023, representing a 54.4% increase.

·Approximately $34.5 million in positive cash flow was achieved in the third quarter of 2024.

·Increase annual guidance, now projecting total revenue for 2024 to be between $1.61 billion and $1.64 billion, with a gross margin of 58% to 61%, and net cash flow of $50 million to $75 million.

·Announcement of the completion of the Signatera study using the CALGB (Alliance)/SWOG 80702 Phase III randomized clinical trial for colorectal cancer.

·The first batch of cancer data from the GALAXY study was published in the journal *Nature Medicine* and simultaneously presented at the 2024 European Society for Medical Oncology (ESMO) Congress.

Mainz Biomed N.V., a molecular genetics diagnostics company specializing in early cancer detection, recently announced a collaboration agreement with Thermo Fisher Scientific Inc. through its subsidiary Life Technologies Corporation ("Thermo Fisher"), a global leader in providing life science solutions and services.

The collaboration agreement will enable Mainz Biomed and Thermo Fisher to co-develop and potentially commercialize Mainz Biomed's next-generation colorectal cancer (CRC) screening product. This partnership will leverage Thermo Fisher’s robust technologies, instruments, and informatics translation systems, empowering Mainz Biomed to develop proprietary assays for its mRNA-based next-generation CRC screening test, which is set to redefine the standard for early cancer detection. Mainz Biomed’s flagship non-invasive test not only targets the early detection of colorectal cancer but also focuses on precancerous lesions, particularly advanced adenomas, achieving significant clinical success in trials across the United States and Europe.

Lucid Diagnostics Inc., a commercial-stage cancer prevention medical diagnostics company and a subsidiary of PAVmed Inc., recently provided a business update and announced its financial results for the three months ended September 30, 2024.

EsoGuard-related revenue was $1.2 million for the three months ended September 30, 2024. Operating expenses were approximately $12.9 million, including $1.2 million of stock-based compensation expense. GAAP net loss attributable to common stockholders was approximately $12.4 million, or $0.25 per share.

This test includes one pan-cancer and five tumor-specific indications, applicable to many FDA-approved therapies. MI Cancer Seek is the first and only test based on both whole-exome sequencing (WES) and whole-transcriptome sequencing (WTS), with FDA-approved CDx indications for molecular profiling of solid tumors. MI Cancer Seek is suitable for adult and pediatric patients aged 1-22.

SEKISUI Diagnostics’ Microbial CDMO Business Announces Completion of £15.7 Million ($20.7 Million) cGMP Capacity Expansion at UK Facility for Clinical-Grade API Production