Quanterix Corporation to Release Second Quarter 2021 Financial Results on Aug. 5, 2021

On July 28, 2021 Quanterix Corporation (NASDAQ: QTRX), a company digitizing biomarker analysis to advance the science of precision health, reported that it will release its financial results for second quarter 2021 after the close of trading on Aug. 5, 2021 (Press release, Quanterix, JUL 28, 2021, View Source [SID1234585310]). Company management will host a conference call at 4:30pm ET to discuss Quanterix’ financial results and provide a business update. The call will be hosted by Kevin Hrusovsky, Chairman and Chief Executive Officer, Quanterix.

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Individuals interested in listening to the conference call may do so by dialing 833-686-9351 for domestic callers, or 612-979-9890 for international callers. Please reference the following conference ID: 2299526. A live webcast will also be available at: View Source The webcast will be available on the Company’s website, View Source, for one year following completion of the call.

To access the live webcast of Quanterix’ presentations, please visit the News & Events page within the Investors section of the Quanterix website at www.quanterix.com.

Thermo Fisher Scientific Reports Second Quarter 2021 Results

On July 28, 2021 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, reported its financial results for the second quarter ended July 3, 2021 (Press release, Thermo Fisher Scientific, JUL 28, 2021, View Source [SID1234585327]).

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Second Quarter 2021 Highlights

Second quarter revenue increased 34% to $9.27 billion.
Second quarter GAAP diluted earnings per share (EPS) increased 59% to $4.61.
Second quarter adjusted EPS increased 44% to $5.60.
Launched a range of new products including the Thermo Scientific Orbitrap IQ-X Tribrid Mass Spectrometer to advance complex small molecule research, and the Thermo Scientific Helios 5EXL Wafer DualBeam scanning electron microscope to support the development of increasingly smaller and more complex semiconductors. To advance cell analysis research, the Invitrogen Bigfoot Spectral Sorter and the Invitrogen Attune CytPix Flow Cytometer were also launched in the quarter.
Announced collaborations with leading academic medical centers including the Mayo Clinic to accelerate the development and adoption of more precise and personalized diagnostics for blood-based cancers; a new clinical and commercial cGMP cell therapy manufacturing facility at University of California, San Francisco, to advance innovation in cell and gene therapy; and at the University of California, Davis, a research collaboration to support the rapid scale-up of large cohort studies and clinical research in metabolomics.
Continued to expand both our capacity and capabilities to better serve our customers. In the quarter, we brought additional capacity online to support vaccine and therapy production globally and expanded the production of laboratory plastics in North America and Europe. Shortly after the quarter closed, we opened a new plasmid DNA facility in Carlsbad, California to meet rapidly growing demand for plasmid DNA-based therapies and mRNA-based vaccines.
Building on our environmental sustainability initiatives, we committed to reach net-zero carbon emissions by 2050.
Adjusted EPS, adjusted operating income, adjusted operating margin and free cash flow are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of Non-GAAP Financial Measures."

"Our team delivered an incredibly strong second quarter, building on our excellent start to the year. The strength of our base business reflects our proven growth strategy, and we continue to enable the societal response to the pandemic, which allowed us to deliver exceptional performance in revenue, earnings and free cash flow for the quarter," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "We extended our leading innovation track record, and our ongoing investments in talent, capabilities and infrastructure are positioning our company for an even brighter future."

Casper added, "We’re in a great position at the halfway point of the year and on track to deliver an outstanding 2021."

Second Quarter 2021

Revenue for the quarter grew 34% to $9.27 billion in 2021, versus $6.92 billion in 2020. Organic revenue growth was 28%; acquisitions increased revenue by 2% and currency translation increased revenue by 5%1. Organic revenue growth from the base business was 27%. COVID-19 response revenue was $1.9 billion.

GAAP Earnings Results

GAAP diluted EPS in the second quarter of 2021 increased 59% to $4.61, versus $2.90 in the same quarter last year. GAAP operating income for the second quarter of 2021 was $2.16 billion, compared with $1.39 billion in the year-ago quarter. GAAP operating margin was 23.3%, compared with 20.1% in the second quarter of 2020.

Non-GAAP Earnings Results

Adjusted EPS in the second quarter of 2021 increased 44% to $5.60, versus $3.89 in the second quarter of 2020. Adjusted operating income for the second quarter of 2021 grew 44% compared with the year-ago quarter. Adjusted operating margin was 29.0%, compared with 27.0% in the second quarter of 2020.

2021 Guidance Update

Thermo Fisher is raising its 2021 revenue and earnings guidance. The company is raising its revenue guidance by $300 million to $35.90 billion; this would result in 11% revenue growth over 2020. The company is raising its adjusted EPS guidance by $0.10 to $22.07, which would represent 13% growth year over year.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the company’s four business segments, as highlighted below. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

Life Sciences Solutions Segment

Life Sciences Solutions Segment revenue grew 37% to $3.56 billion in the second quarter of 2021, compared with revenue of $2.60 billion in the second quarter of 2020. Segment adjusted operating margin was 48.3%, versus 47.4% in the 2020 quarter.

Analytical Instruments Segment

Analytical Instruments Segment revenue grew 41% to $1.48 billion in the second quarter of 2021, compared with revenue of $1.05 billion in the second quarter of 2020. Segment adjusted operating margin was 18.9%, versus 12.9% in the 2020 quarter.

Specialty Diagnostics Segment

Specialty Diagnostics Segment revenue grew 25% to $1.24 billion in the second quarter of 2021, compared with revenue of $0.99 billion in the second quarter of 2020. Segment adjusted operating margin was 19.9%, versus 21.6% in the 2020 quarter.

Laboratory Products and Services Segment

Laboratory Products and Services Segment revenue grew 29% to $3.58 billion in the second quarter of 2021, compared with revenue of $2.79 billion in the second quarter of 2020. Segment adjusted operating margin was 12.4%, versus 10.1% in the 2020 quarter.

Use of Non-GAAP Financial Measures

In addition to the financial measures prepared in accordance with generally accepted accounting principles (GAAP), we use certain non-GAAP financial measures, including adjusted EPS, adjusted operating income and adjusted operating margin, which exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs; restructuring and other costs/income; and amortization of acquisition-related intangible assets. Adjusted EPS also excludes certain other gains and losses that are either isolated or cannot be expected to occur again with any predictability, tax provisions/benefits related to the previous items, and the impact of significant tax audits or events. We exclude the above items because they are outside of our normal operations and/or, in certain cases, are difficult to forecast accurately for future periods. We also use a non-GAAP measure, free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities. We believe that the use of non-GAAP measures helps investors to gain a better understanding of our core operating results and future prospects, consistent with how management measures and forecasts the company’s performance, especially when comparing such results to previous periods or forecasts.

For example:

We exclude costs and tax effects associated with restructuring activities, such as reducing overhead and consolidating facilities. We believe that the costs related to these restructuring activities are not indicative of our normal operating costs.

We exclude certain acquisition-related costs, including charges for the sale of inventories revalued at the date of acquisition and significant transaction costs. We exclude these costs because we do not believe they are indicative of our normal operating costs.

We exclude the expense and tax effects associated with the amortization of acquisition-related intangible assets because a significant portion of the purchase price for acquisitions may be allocated to intangible assets that have lives of up to 20 years. Based on acquisitions closed through the end of the second quarter of 2021, adjusted EPS will exclude approximately $3.40 of expense for the amortization of acquisition-related intangible assets. Exclusion of the amortization expense allows comparisons of operating results that are consistent over time for both our newly acquired and long-held businesses and with both acquisitive and non-acquisitive peer companies.

We also exclude certain gains/losses and related tax effects, the impact of significant tax audits or events (such as changes in deferred taxes from enacted tax rate changes), which are either isolated or cannot be expected to occur again with any predictability and that we believe are not indicative of our normal operating gains and losses. For example, we exclude gains/losses from items such as the sale of a business or real estate, gains or losses on significant litigation-related matters, gains on curtailments of pension plans and the early retirement of debt.

We also report free cash flow, which is operating cash flow, excluding net capital expenditures to provide a view of the continuing operations’ ability to generate cash for use in acquisitions and other investing and financing activities.

Thermo Fisher Scientific’s management uses these non-GAAP measures, in addition to GAAP financial measures, as the basis for measuring the company’s core operating performance and comparing such performance to that of prior periods and to the performance of our competitors. Such measures are also used by management in their financial and operating decision-making and for compensation purposes.

The non-GAAP financial measures of Thermo Fisher Scientific’s results of operations and cash flows included in this press release are not meant to be considered superior to or a substitute for Thermo Fisher Scientific’s results of operations prepared in accordance with GAAP. Reconciliations of such non-GAAP financial measures to the most directly comparable GAAP financial measures are set forth in the accompanying tables. Thermo Fisher Scientific does not provide GAAP financial measures on a forward-looking basis because we are unable to predict with reasonable certainty and without unreasonable effort items such as the timing and amount of future restructuring actions and acquisition-related charges as well as gains or losses from sales of real estate and businesses, the early retirement of debt and the outcome of legal proceedings. The timing and amount of these items are uncertain and could be material to Thermo Fisher Scientific’s results computed in accordance with GAAP.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, July 28, 2021, at 8:30 a.m. Eastern time. To listen, dial (833) 714-0931 within the U.S. or (778) 560-2662 outside the U.S. The conference ID is 6292118. You may also listen to the call live on our website, www.thermofisher.com, by clicking on "Investors." You will find this press release, including the accompanying reconciliation of non-GAAP financial measures and related information, in that section of our website under "Financial Results." An audio archive of the call will be available under "Webcasts and Presentations" through Friday, August 13, 2021.

Complix Signs Global Drug Discovery and Development Agreement with Jiangsu Nhwa Pharmaceutical Co. to Develop Novel Alphabody Therapeutics for Treatment of CNS Diseases

On July 28, 2021 Complix, a biopharmaceutical company developing a pipeline of transformative Alphabody therapeutics, reported that it has signed a global collaboration and license agreement with Jiangsu Nhwa Pharmaceutical Co., one of China’s leading CNS companies, to develop Cell Penetrating Alphabodies (CPABs) able to cross the blood brain barrier, for the improved treatment of diseases of the central nervous system (CNS) (Press release, Complix, JUL 28, 2021, View Source;utm_medium=rss&utm_campaign=complix-signs-global-drug-discovery-and-development-agreement-with-jiangsu-nhwa-pharmaceutical-co-to-develop-novel-alphabody-therapeutics-for-treatment-of-cns-diseases [SID1234585443]). This agreement is an important corporate milestone for Complix, as it seeks to apply its industry leading CPAB platform in yet another major disease area, beyond oncology, autoimmunity, and viral diseases.

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Jiangsu Nhwa Pharmaceutical Co. (Nhwa) is a leading CNS company in China, which has developed an innovative and differentiated pipeline in the areas of anesthesia, analgesia, psychiatry, and neurology via both its own in-house R&D and global partnerships. Nhwa has more than 4000 employees, with capabilities in research, clinical development, manufacturing, and commercialization of CNS drugs.

Complix and Nhwa will collaborate to develop novel biotherapeutics against two selected CNS targets. Complix will apply its proprietary CPAB technology, that enables biologics to traverse membrane systems and act with high affinity and precision on disease targets that are considered intractable by current drug formats. The novel compounds to be developed under this collaboration, will be designed to cross the blood brain barrier to address important disease targets in the central nervous system.

Under the terms of the agreement, Complix has granted an exclusive license to Nhwa to develop, manufacture and commercialize the CPABs resulting from this collaboration in Greater China. Both companies retain joint development and commercialization rights for these CPABs in the rest of the world.

Complix is entitled to upfront license payments and further milestone payments subject to the progress of clinical development and regulatory approval. Complix is also eligible for royalty payments based on the future commercial sales of the CPABs in China.

Mark Vaeck, CEO of Complix, said:
"We are thrilled to announce this exciting collaboration with Nhwa. We are confident that the unique targeting capabilities of our CPABs will allow us to jointly develop novel biotherapeutics that will deliver improved treatment outcomes for patients suffering from severe neurological diseases. We believe that partnering with an innovative company like Nhwa, specialized in the area of CNS diseases, is substantially value creating, as it provides access to significant research and clinical development expertise in the CNS area, as well as a strong commercial platform in China. I am confident that together we can deliver on our ambitions to develop innovative and highly needed solutions for patients with severe neurological conditions".

Jiaquan Sun, CEO of Jiangsu Nhwa added:
"We are pleased to collaborate with Complix to gain access to its highly innovative CPAB platform as we look to further strengthen our position as a market leader in CNS therapies in China. We are looking forward to working with the team at Complix as we tap into their world leading intracellular targeting expertise to generate novel therapeutics that can cross the blood brain barrier to address major unmet medical needs that still exist in the CNS disease area today’’.

Pfizer reports Second-Quarter 2021 results

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Integra LifeSciences Reports Second Quarter 2021 Financial Results

On July 28, 2021 Integra LifeSciences Holdings Corporation (NASDAQ: IART), a leading global medical technology company, reported financial results for the second quarter ending June 30, 2021 (Press release, Integra LifeSciences, JUL 28, 2021, View Source [SID1234585256]).

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"We are pleased with second quarter results that exceeded our forecasts. Our business segments were well-positioned to capitalize on the improving demand driven by the ongoing global market recovery," said Peter Arduini, Integra’s president and chief executive officer. "We saw particularly healthy order activity in products used in neurosurgery, instruments, burn, trauma and surgical reconstruction as markets gradually recovered. Areas such as capital equipment and our international indirect markets are still early in their recovery but are reporting encouraging trends. As a result of our better than expected second quarter financial performance, we are raising our full-year revenue and EPS guidance."

Second Quarter 2021 Consolidated Performance

Total reported revenues of $390.0 million increased 50.8% on a reported basis and 48.7% on an organic basis compared to the prior year. Total reported revenues include $17.7 million from the acquisition of ACell, which was completed on January 20, 2021.

The Company reported GAAP gross margin of 61.2%, compared to 59.2% in the second quarter of 2020. Adjusted gross margin was 68.1% compared to 66.2% in the prior year.

Adjusted EBITDA for the second quarter of 2021 was $101.0 million, or 25.9% of revenue, compared to $52.8 million, or 20.4% of revenue in the prior year. Adjusted EBITDA margins benefited from higher revenue and higher adjusted gross margins, partially offset by higher operating expenses attributable to the gradual return of spending, which was reduced during the same period in the prior year in response to the global pandemic.

The Company reported GAAP net income of $35.1 million, or $0.41 per diluted share, in the second quarter of 2021, compared to a GAAP net loss of $(0.4 million), or $(0.00) per diluted share, in the prior year.

Adjusted net income for the second quarter of 2021 was $67.4 million, or $0.79 per diluted share, compared to $28.4 million, or $0.33 per diluted share, in the prior year.

Second Quarter 2021 Segment Performance

Codman Specialty Surgical (66% of Revenues)

Total revenues were $256.8 million, representing reported growth of 51.3% and organic growth of 49.5% compared to the second quarter of 2020. Broad-based strength in both neurosurgery and instruments were driven by a recovery in demand.
Tissue Technologies (34% of Revenue)

Total revenues were $133.2 million, representing reported growth of 49.8% and organic growth of 47.1% compared to the second quarter of 2020. Growth was led by strength in burn, trauma and surgical reconstruction.
Strategic Initiatives and Key Developments

Advancing key products

Cerelink – next generation intracranial pressure monitor is scheduled for a controlled market release in the third quarter.
Aurora Surgiscope in minimally invasive tumor removal procedures – a targeted phased market launch will begin in the third quarter to generate clinical evidence and gain insights for a broader commercial launch in the second half of 2022.
PriMatrix Dermal Repair Scaffold – during the second quarter, the Company completed a randomized clinical study of PriMatrix for use in the closure of Diabetic Foot Ulcers (DFUs). This multi-center study enrolled over 225 patients and found that PriMatrix demonstrated statistically and clinically significant results, healing more DFUs in 12 weeks versus standard of care, with a median number of one application. The results of this study have been published in the Journal of Wound Care.
The Company announced that Peter Arduini will step down as Chief Executive Officer at the end of 2021 to accept the role of President and Chief Executive Officer of GE Healthcare. The Board of Directors has initiated a formal search and appointed a special committee to direct the search and ensure a seamless transition of responsibilities.
Balance Sheet, Cash Flow and Capital Allocation

The Company generated cash flow from operations of $91.3 million in the quarter. The Company paid down $100 million of debt on its senior credit facility during the second quarter. Net debt at the end of the quarter was $1,166 million and the consolidated total leverage ratio was 2.4x, an improvement of 0.6x from December 31, 2020.

As of quarter end, the Company had total liquidity of approximately $1.7 billion, including approximately $397 million in cash and the remainder available under the revolving credit facility.

2021 Outlook

The Company is providing forward-looking guidance regarding adjusted earnings per diluted share, but is not providing a reconciliation to GAAP earnings per share, because certain GAAP expense items are highly variable and management is unable to predict them with reasonable certainty and without unreasonable effort. Specifically, the financial impact and timing of divestitures, acquisitions, integrations, structural optimization and efforts to comply with the EU Medical Device Regulation are uncertain, depend on various dynamic factors and are not reasonably ascertainable at this time. These expense items could have a material impact on GAAP results. Adjusted earnings per diluted share also excludes the impact of intangible asset amortization associated with prior business acquisitions, which we expect to be approximately $0.71 per diluted share for the full-year 2021.

In addition, the Company will continue to monitor the ongoing uncertainty around the scope and duration of the pandemic and its impact on financial performance. The Company does not expect the ongoing impact of the pandemic to be uniform across all markets and product lines. The Company’s guidance assumes a gradual improvement in surgical procedures with no further setbacks from new surges or new COVID variants.

Full-Year 2021 Outlook

The Company is raising its full-year 2021 revenue guidance by $15 million to a range of $1,540 million to $1,550 million from $1,525 million to $1,535 million. This new guidance range represents a reported growth range of 12% to 13% and an organic growth range of 13% to 14%. The Company is also raising its full-year 2021 adjusted earnings per share guidance to new range of $2.98 to $3.05, from its prior range of $2.86 to $2.93.

The Company has revised its outlook for a revenue contribution from ACell to $70 million to $74 million for the full-year 2021, from its previous range of $83 million to $88 million, due to the impact of an accelerated integration of the sales force during the pandemic. The Company remains confident in the long-term growth expectations for the ACell portfolio. Strong performance in other parts of the CSS and TT businesses more than offset the slower start in ACell and are included in the new total company revenue guidance range.

Third Quarter Outlook

For the third quarter 2021, the Company expects revenues to be in a range of $382 million to $389 million, representing reported growth of approximately 3% to 5% and organic growth of 5% to 7%. Adjusted earnings per diluted share are expected to be in a range of $0.71 to $0.74.

In the future, the Company may record, or expects to record, gains or losses, expenses, or charges as described in the Discussion of Adjusted Financial Measures below, which will be excluded from the calculation of adjusted EBITDA, adjusted earnings per share for historical periods and in adjusted earnings per share guidance.

Conference Call and Presentation Available Online

Integra has scheduled a conference call for 8:30 a.m. ET today, Wednesday, July 28, 2021, to discuss financial results for the second quarter. The conference call will be hosted by Integra’s senior management team and will be open to all listeners. Additional forward-looking information may be discussed in a question and answer session following the prepared remarks.

Integra’s management team will reference a presentation during the conference call. The presentation can be found on investor.integralife.com.

Access to the live call is available by dialing (800) 367-2403 and using the passcode 3706513. The call can also be accessed via a webcast link provided on investor.integralife.com. A replay of the call will be available until August 7, 2021 by dialing (888) 203-1112 and using the passcode 3706513. The webcast will also be archived on the website.