Merus to Participate in Upcoming Investor Conferences

On February 1, 2023 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported that Bill Lundberg, M.D., President, Chief Executive Officer of Merus, will participate in a fireside chat at the following investor conferences (Press release, Merus, FEB 1, 2023, View Source [SID1234626720]).

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Guggenheim Healthcare Talks/Oncology Conference: Wednesday, February 8 at 11:20-11:45 a.m. ET
SVB Securities Global Biopharma Conference: Tuesday, February 14 at 3:40-4:10 p.m. ET
Citi’s 2023 Oncology Leadership Summit: Thursday, February 23 at 10:00-11:00 a.m. ET
The webcasts of the presentations will be contemporaneously available on the Investors page of the Company’s website. Archived presentations will also be available there for a limited time after the event.

Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

On February 1, 2023 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported that the Company granted an aggregate of 113,250 restricted stock units (RSUs) to ten newly-hired employees (Press release, Karyopharm, FEB 1, 2023, View Source [SID1234626719]). These RSU awards were granted as of January 31, 2023 pursuant to the Company’s 2022 Inducement Stock Incentive Plan, as amended, as inducements material to the new employees entering into employment with Karyopharm in accordance with Nasdaq Listing Rule 5635(c)(4).

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Each RSU award will vest over three years, with 33 1/3% percent of the shares underlying the RSU award vesting on each of the three consecutive anniversaries of the applicable employee’s employment commencement date. The vesting of each RSU award is subject to the employee’s continued service as an employee of, or other service provider to, Karyopharm through the applicable vesting dates. In addition, each RSU award will be immediately exercisable in full if, on or prior to the first anniversary of the consummation of a "change in control event," the employee’s employment is terminated for "good reason" by the employee or terminated without "cause" by Karyopharm (as such terms are defined in the applicable RSU agreement).

Veracyte Announces Multiple Decipher Urologic Testing Abstracts to be Presented at the 2023 ASCO Genitourinary (GU) Cancers Symposium

On February 1, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that six abstracts highlighting new data focused on the company’s Decipher urologic cancer testing offerings will be presented at the 2023 ASCO (Free ASCO Whitepaper) Genitourinary (GU) Cancers Symposium, taking place in San Francisco, Calif. and online, February 16-18, 2023 (Press release, Veracyte, FEB 1, 2023, View Source [SID1234626718]).

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Data being presented include new insights derived from Veracyte’s Decipher Genomics Resource for Intelligent Discovery (GRID) database, which suggest potential opportunities to further personalize treatment for men with prostate cancer. Additionally, researchers will present new Decipher Prostate Genomic Classifier clinical utility data from the prospective, phase 3, randomized clinical trial, G-MINOR (Genomics in Michigan ImpactiNg Observation or Radiation).

"Veracyte is committed to helping empower physicians with the insights they need to guide more informed, individualized treatment for patients with urologic cancers," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology. "The data being presented at this year’s ASCO (Free ASCO Whitepaper) GU Cancers Symposium advance our understanding of how our Decipher genomic tests and Decipher GRID database may help physicians further stratify risk and guide treatment decisions for their patients with prostate or bladder cancer."

Veracyte also expects additional data regarding the Decipher Prostate test to be highlighted in the following general session presentation:

Title:

Treatment Combinations for Patients Starting Androgen-Deprivation Therapy: Building on Recent Victories

Presenter:

Gerhardt Attard, M.D., Ph.D., University College London Cancer Institute

Date/Time:

Thursday, February 16, 10:00 a.m. – 11:30 a.m. PST

Location:

Level 3, Ballroom

Below are details of the abstracts that will be presented as posters at the 2023 ASCO (Free ASCO Whitepaper) GU Cancers Symposium in the Moscone Center in Moscone West, Level 1.

Title:

Use of prostate cancer subtyping by gene expression to predict response to radiation and chemohormonal therapies.

Presenter:

Adam Benjamin Weiner, M.D., UCLA

Date/Time:

February 16, 2023; 11:30 a.m. PST

Abstract #:

241

Poster #:

J6

Title:

Determining the impact of genomic classifier testing on patient-reported quality of life after prostatectomy: Results from the G-MINOR randomized trial.

Presenter:

Udit Singhal, M.D., University of Michigan

Date/Time:

February 16, 2023; 11:30 a.m. PST

Abstract #:

345

Poster #:

M3

Title:

Comparative transcriptomic analysis of DNA-damage response and androgen receptor pathway activity between biopsy and radical prostatectomy specimens before and after pre-operative real-time MRI-guided stereotactic body radiotherapy.

Presenter:

Himanshu Nagar, M.D., Weill Cornell Medicine

Date/Time:

February 16, 2023; 11:30 a.m. PST

Abstract #:

375

Poster #:

N13

Title:

Effect of neoadjuvant stereotactic body radiation therapy (SBRT) on the immune microenvironment of high-risk localized prostate cancer in paired transcriptomic analysis of pretreatment biopsy and irradiated prostatectomy specimens.

Presenter:

Ariel E. Marciscano, M.D., Weill Cornell Medical College

Date/Time:

February 16, 2023; 11:30 a.m. PST

Abstract #:

371

Poster #:

N9

Title:

Distinct gene expression patterns identify patients who relapse after neoadjuvant pembrolizumab and radical cystectomy in the PURE-01 study.

Presenter:

Moritz Reike, M.D., University of British Columbia

Date/Time:

February 17, 2023; 12:30 p.m. PST

Abstract #:

549

Poster #:

M12

Title:

Genomic analysis from BLASST-1 (Bladder Cancer Signal Seeking Trial) of nivolumab, gemcitabine, and cisplatin in patients with MIBC undergoing cystectomy.

Presenter:

Shilpa Gupta, M.D., Cleveland Clinic Taussig Cancer Center

Date/Time:

February 17, 2023; 12:30 p.m. PST

Abstract #:

559

Poster #:

N2

Thermo Fisher Scientific Reports Fourth Quarter and Full Year 2022 Results

On February 1, 2023 Thermo Fisher Scientific Inc. (NYSE: TMO), the world leader in serving science, today reported its financial results for the fourth quarter and full year ended December 31, 2022 (Press release, Thermo Fisher Scientific, FEB 1, 2023, View Source [SID1234626717]).

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Fourth Quarter and Full Year 2022 Highlights

•Fourth quarter revenue grew 7% to $11.45 billion.
•Fourth quarter GAAP diluted earnings per share (EPS) was $4.01.
•Fourth quarter adjusted EPS was $5.40.

•Full year revenue grew 15% to $44.92 billion.
•Full year GAAP diluted EPS was $17.63.
•Full year adjusted EPS was $23.24.

•During the year, we strengthened our industry leadership, advanced our trusted partner status with our customers, delivered excellent financial performance for our shareholders, and invested in our world class team.

•Achieved outstanding and differentiated Core organic revenue growth, growing 14% in both the fourth quarter and for the full year.

•Delivered another outstanding year of high-impact innovation, highlighted by the Applied Biosystems SeqStudio Flex Series genetic analyzer, the Thermo Scientific TRACE 1600 Series Gas Chromatograph, the Phadia 2500+ series of instruments, as well as the Orbitrap Ascend Tribrid mass spectrometer. During the quarter, we launched the Thermo Scientific Glacios 2 Cryo-TEM (transmission electron microscope) to accelerate structure-based drug discovery, the Gibco CTS DynaCellect Magnetic Separation System to advance the manufacturing of cell therapies, and the SeCore CDx HLA Sequencing System, which received marketing authorization by the FDA for use as a companion diagnostic with an immunotherapy to treat patients with a rare eye cancer.

•Continued to strengthen our unique customer value proposition by adding capacity and capabilities globally for pharma services, bioproduction, and clinical research services. During the fourth quarter, this included the opening of a new state-of-the-art bioanalytical lab in Richmond, Virginia, to support our clinical research business and the increasing demand for analytical services to accelerate drug development.

•Advanced our industry-leading scale and depth of capabilities in high-growth and emerging markets. During the fourth quarter, this included opening a new biologics manufacturing facility in Hangzhou, China, to offer integrated clinical and commercial drug substance and drug product capabilities for customers.

•Very active year advancing our environmental, social and governance (ESG) priorities. We made strong progress on our Scope 1 and Scope 2 emissions initiatives, enabling us to increase our 2030 greenhouse gas emissions reduction target and accelerate our transition to 100% renewable energy. Among the highlights from our Foundation for Science, we supported students across the globe through our STEM education programs and colleague-led Community Action Councils. Throughout the year, the company also received a variety of awards and recognition for its industry leadership and inclusive culture including being recognized by Forbes magazine during the quarter as one of the World’s Top Female-Friendly Companies and one of America’s Best Employers for veterans.

•Continued to successfully execute our capital deployment strategy in 2022. The integration of PPD is largely complete and drove strong returns for our shareholders with outstanding execution and business performance throughout the year. For the full year, PPD delivered outstanding Core organic revenue growth and is on track to deliver total synergies of $175 million by year 3. Additionally, we returned $3.5 billion of capital to shareholders through stock buybacks and dividends. Shortly after year end, we completed the acquisition of The Binding Site for $2.7 billion.

"We had another exceptional year, exceeding our goals and delivering for all of our stakeholders in 2022," said Marc N. Casper, chairman, president and chief executive officer of Thermo Fisher Scientific. "Thanks to our incredible global team, we successfully executed our proven growth strategy, effectively navigated the macro-environment, and delivered impressive financial results, as we continued to enable our customers to make the world healthier, cleaner and safer."

Casper added, "We are incredibly well positioned as we enter 2023. Our high-impact innovation and unique customer value proposition continue to drive significant share gain. Our experienced management team, PPI Business System and the benefits of scale, position our company to deliver another outstanding year of value creation for all of our stakeholders and ensure we create an even brighter future."

Fourth Quarter 2022

Revenue for the quarter grew 7% to $11.45 billion in 2022, versus $10.70 billion in 2021. Organic revenue was 3% lower, Core organic revenue growth was 14%, and COVID-19 testing revenue was $0.37 billion.

GAAP Earnings Results

GAAP diluted EPS in the fourth quarter of 2022 was $4.01, versus $4.17 in the same quarter last year. GAAP operating income for the fourth quarter of 2022 was $1.86 billion, compared with $2.54 billion in the year-ago quarter. GAAP operating margin was 16.3%, compared with 23.7% in the fourth quarter of 2021.

Non-GAAP Earnings Results

Adjusted EPS in the fourth quarter of 2022 was $5.40, versus $6.54 in the fourth quarter of 2021. Adjusted operating income for the fourth quarter of 2022 was $2.56 billion, compared with $3.16 billion in the year-ago quarter. Adjusted operating margin was 22.4%, compared with 29.5% in the fourth quarter of 2021.

Full Year 2022

Revenue for the full year grew 15% to $44.92 billion in 2022, versus $39.21 billion in 2021. Organic revenue grew slightly, Core organic revenue growth was 14%, and COVID-19 testing revenue was $3.11 billion.

GAAP Earnings Results

GAAP diluted EPS for the full year was $17.63, versus $19.46 in 2021. GAAP operating income for 2022 was $8.39 billion, compared with $10.03 billion a year-ago. GAAP operating margin was 18.7%, compared with 25.6% in 2021.

Non-GAAP Earnings Results

Adjusted EPS for the full year was $23.24, versus $25.13 in 2021. Adjusted operating income for the full year was $10.99 billion, compared with $12.14 billion a year-ago. Adjusted operating margin was 24.5%, compared with 31.0% in 2021.

Annual Guidance for 2023

Thermo Fisher is initiating revenue and adjusted EPS guidance for the full year 2023. The company expects to achieve 2023 revenue of $45.3 billion and full year Core organic revenue growth of 7%. The company expects to achieve adjusted EPS of $23.70.

Use of Non-GAAP Financial Measures

Adjusted EPS, adjusted net income, adjusted operating income, adjusted operating margin, free cash flow, organic revenue growth and Core organic revenue growth are non-GAAP measures that exclude certain items detailed after the tables that accompany this press release, under the heading "Supplemental Information Regarding Non-GAAP Financial Measures." The reconciliations of GAAP to non-GAAP financial measures are provided in the tables that accompany this press release.

Conference Call

Thermo Fisher Scientific will hold its earnings conference call today, February 1, 2023, at 8:30 a.m. Eastern Time. To listen, dial (844) 200-6205 within the U.S. or (929) 526-1599 outside the U.S. The conference ID is 982319. 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 "Financials." An audio archive of the call will be available under "News & Events" through Friday, February 17, 2023.

Scenic Biotech Enters Cooperative Research and Development Agreement with the National Institutes of Health for Genetic Modifier-Based Treatment Approach for Niemann-Pick Type C Disease

On February 1, 2023 Scenic Biotech, a pioneer in the discovery of genetic modifiers developing therapeutics to treat severe diseases, reported that it has entered into a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH), to support its therapeutic program for the treatment of Niemann-Pick Type C (NPC) disease, which is a severe, progressive and lethal neurological disorder (Press release, Scenic Biotech, FEB 1, 2023, View Source [SID1234626716]). The goal of the collaboration is to obtain clinical insights into genes that can reduce the severity of NPC. Under the terms of the CRADA, NICHD will grant Scenic Biotech access to its extensive clinical dataset and whole genome DNA sequence data derived from NPC patients. Forbes D. Porter, MD, PhD, Senior Investigator at NICHD, will be the principal investigator for this study based on his long-running clinical protocols that track the natural history of rare genetic disorders, including NPC.

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"The CRADA with the NIH will help advance our work toward identifying genetic modifiers for NPC. Our aim is to develop novel therapeutics that act by suppressing or completely blocking the effect of a disease-causing mutated gene. Through the combined efforts with Dr. Porter’s team, we hope to further enable the discovery of a tailor-made, disease-modifying small molecule therapeutic for this devastating disease," commented Sebastian Nijman, CSO and co-founder of Scenic Biotech.