Cogent Biosciences to Present Virtually at Jefferies London Healthcare Conference 2021

On November 2, 2021 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported that Andrew Robbins, Chief Executive Officer and President, will participate in a fireside chat and one-on-one investor meetings during the virtual portion of the Jefferies London Healthcare Conference, taking place November 18-19, 2021 (Press release, Cogent Biosciences, NOV 2, 2021, View Source [SID1234594135]).

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The fireside chat will be available to conference attendees starting at 4:00am ET on Thursday, November 18 and lasting through 2:00pm ET on Friday, November 19. Access to the recording will be available under the "Events" tab on the investor relations section of the Cogent Biosciences website at: View Source

BIO-TECHNE RELEASES FIRST QUARTER FISCAL 2022 RESULTS

On November 2, 2021 Bio-Techne Corporation (NASDAQ:TECH) reported its financial results for the first quarter ended September 30, 2021 (Press release, Bio-Techne, NOV 2, 2021, View Source [SID1234594134]).

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First Quarter FY2022 Snapshot

First quarter organic revenue increased by 21% (26% reported) to $257.7 million.

GAAP EPS was $1.69 versus $0.83 one year ago. Delivered adjusted earnings per share (EPS) of $1.83 versus $1.43 a year ago.

Protein Sciences achieved 26% organic growth, its third consecutive quarter of organic growth above 20%.

Adjusted operating income increased 25% (29% reported) when compared to the prior year.

Excellent commercial execution in all major geographic regions, with North America and Europe organic growth of at least 20%, and China increasing over 50%.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted diluted EPS, adjusted earnings, adjusted gross margin, adjusted operating income, adjusted tax rate, organic growth, and adjusted operating margin are non-GAAP measures that exclude certain items detailed later in this press release under the heading "Use of non-GAAP Adjusted Financial Measures." A reconciliation of GAAP to non-GAAP financial measures is included in this press release.

"The Bio-Techne team executed at a high level during the first quarter and our fiscal 2022 is off to a strong start," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "We experienced broad strength across our portfolio of proteomic research reagents and analytical tools, which led to organic growth of 21% in the quarter, as our diverse offering continued to deliver solutions to enable life sciences discoveries."

Kummeth added, "Additionally, our Cell and Gene Therapy initiatives made significant progress in the quarter, as our portfolio of reagents and workflow solutions increased over 60% in the quarter, including growth of over 165% in our GMP protein business. This momentum is having a broader impact throughout the Company, driving adoption of our media, assays, instrumentation, antibodies and other offerings in our portfolio. I am extremely excited about the potential of these emerging therapies and the role Bio-Techne is playing to advance the industry."

First Quarter Fiscal 2022

Revenue

Net sales for the first quarter increased 26% to $257.7 million. Organic growth was 21% compared to the prior year, with acquisitions contributing 4% and foreign currency exchange having a favorable impact of 1%. Organic revenue growth was mainly driven by strong BioPharma demand, especially for products, services and solutions from the Protein Sciences segment and by overall execution of the Company’s long-term growth strategy.

GAAP Earnings Results

GAAP EPS was $1.69 per diluted share, versus $0.83 in the same quarter last year. GAAP EPS was impacted by a current period non-operating mark-to-market gain in on our ChemoCentryx investment compared to a loss in the prior year period. GAAP operating income for the first quarter of fiscal 2022 increased 28.8% to $63.2 million, compared to $49.1 million in the first quarter of fiscal 2021. GAAP operating margin was 24.5%, compared to 24.0% in the first quarter of fiscal 2021. GAAP operating income and operating margin compared to prior year was positively impacted by volume leverage, which was partially offset by additional investments made in the business to support future growth.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.83 per diluted share, versus $1.43 in the same quarter last year, an increase of 28%, primarily attributable to sales growth. Adjusted operating income for the first quarter of fiscal 2022 increased 24.7% compared to the first quarter of fiscal 2021. Adjusted operating margin was 37.8%, compared to 38.2% in the first quarter of fiscal 2021. Adjusted operating margin compared to the prior year was negatively impacted by acquisitions and additional investments made in the business to support future growth, which was partially offset by favorable volume leverage.

Segment Results

Management uses adjusted operating results to monitor and evaluate performance of the Company’s business segments, as highlighted below.

Protein Sciences Segment

The Company’s Protein Sciences segment is one of the world’s leading suppliers of specialized proteins such as cytokines and growth factors, immunoassays, antibodies and reagents, to the biotechnology and academic research communities. Additionally, the segment provides an array of platforms useful in various areas of protein analysis. Protein Sciences segment’s first quarter fiscal 2022 net sales were $197.2 million, an increase of 28% from $154.4 million for the first quarter of fiscal 2021. Organic growth for the segment was 26%, with foreign currency exchange having a favorable impact of 2% on revenue growth. Protein Sciences segment’s operating margin was 45.7% in the first quarter of fiscal 2022 compared to 45.6% in the first quarter of fiscal 2021. The segment’s operating margin compared to the prior year was positively impacted by volume leverage largely offset by strategic investments to support future growth.

Diagnostics and Genomics Segment

The Company’s Diagnostics and Genomics segment provides blood chemistry and blood gas quality controls, hematology instrument controls, immunoassays and other bulk and custom reagents for the in vitro diagnostic market. The Diagnostics and Genomics segment also develops and provides in situ hybridization products as well as exosome-based diagnostics for various pathologies, including prostate cancer. The Diagnostics and Genomics segment’s first quarter fiscal 2022 net sales were $61.0 million, an increase of 22% from $50.1 million for the first quarter of fiscal 2021. Organic growth for the segment was 6%, with acquisitions contributing 15% to revenue growth and foreign currency exchange having a favorable impact of 1%. The Diagnostics and Genomics segment’s operating margin was 12.2% in the first quarter of fiscal 2022 compared to 17.3% in the first quarter of fiscal 2021. The segment’s operating margin was negatively impacted by acquisitions and additional investments made in the business to support future growth.

Conference Call

Bio-Techne will host an earnings conference call today, November 2, 2021 at 8:00 a.m. CDT. To listen, please dial 1-877-407-9208 or 1-201-493-6784 (for international callers), and reference conference ID 13724007. The earnings call can also be accessed via webcast through the following link View Source

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921or 1-412-317-6671 (for international callers) and referencing Conference ID 13724007.The replay will be available from 11:00 a.m. CDT on Tuesday, November 2, 2021 until 11:00 p.m. CDT on Thursday, December 2, 2021.

Use of non-GAAP Adjusted Financial Measures:

This press release contains financial measures that have not been calculated in accordance with accounting principles generally accepted in the U.S. (GAAP). These non-GAAP measures include:

Organic growth
Adjusted diluted earnings per share
Adjusted earnings
Adjusted tax rate
Adjusted gross margin
Adjusted operating income
Adjusted operating margin
We provide these measures as additional information regarding our operating results. We use these non-GAAP measures internally to evaluate our performance and in making financial and operational decisions, including with respect to incentive compensation. We believe that our presentation of these measures provides investors with greater transparency with respect to our results of operations and that these measures are useful for period-to-period comparison of results.

Our non-GAAP financial measure of organic growth represents revenue growth excluding revenue from acquisitions within the preceding 12 months, the impact of foreign currency, as well as the impact of partially owned consolidated subsidiaries. Excluding these measures provides more useful period-to-period comparison of revenue results as it excludes the impact of foreign currency exchange rates, which can vary significantly from period to period, and revenue from acquisitions that would not be included in the comparable prior period. Revenues from partially owned subsidiaries consolidated in our financial statements are also excluded from our organic revenue calculation, as those revenues are not fully attributable to the Company. Revenue from partially owned subsidiaries was $0.4 million for the quarter ended September 30, 2021.

Our non-GAAP financial measures for adjusted gross margin, adjusted operating margin, and adjusted net earnings, in total and on a per share basis, exclude stock-based compensation, the costs recognized upon the sale of acquired inventory, amortization of acquisition intangibles, acquisition related expenses inclusive of the changes in fair value of contingent consideration, and other non-recurring items including non-recurring costs and gains. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjection assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. The Company excludes amortization of purchased intangible assets, purchase accounting adjustments, including costs recognized upon the sale of acquired inventory and acquisition-related expenses inclusive of the changes in fair value contingent consideration, and other non-recurring items including gains or losses on legal settlements and one-time assessments from this measure because they occur as a result of specific events, and are not reflective of our internal investments, the costs of developing, producing, supporting and selling our products, and the other ongoing costs to support our operating structure. Additionally, these amounts can vary significantly from period to period based on current activity. The Company also excludes revenue and expense attributable to partially owned consolidated subsidiaries in the calculation of our non-GAAP financial measures as the revenues and expenses are not fully attributable to the Company.

The Company’s non-GAAP adjusted operating margin and adjusted net earnings, in total and on a per share basis, also excludes stock-based compensation expense, which is inclusive of the employer portion of payroll taxes on those stock awards, restructuring, impairments of equity method investments, gain and losses from investments, and certain adjustments to income tax expense. Impairments of equity investments are excluded as they are not part of our day-to-day operating decisions. Additionally, gains and losses from other investments that are either isolated or cannot be expected to occur again with any predictability are excluded. Costs related to restructuring activities, including reducing overhead and consolidating facilities, are excluded because we believe they are not indicative of our normal operating costs. The Company independently calculates a non-GAAP adjusted tax rate to be applied to the identified non-GAAP adjustments considering the impact of discrete items on these adjustments and the jurisdictional mix of the adjustments. In addition, the tax impact of other discrete and non-recurring charges which impact our reported GAAP tax rate are adjusted from net earnings. We believe these tax items can significantly affect the period-over-period assessment of operating results and not necessarily reflect costs and/or income associated with historical trends and future results.

Investors are encouraged to review the reconciliations of adjusted financial measures used in this press release to their most directly comparable GAAP financial measures as provided with the financial statements attached to this press release.

Concert Pharmaceuticals to Report Third Quarter 2021 Results on November 9, 2021

On November 2, 2021 Concert Pharmaceuticals, Inc. (NASDAQ: CNCE) reported that it will report its financial results for the third quarter of 2021, on Tuesday, November 9, 2021, before the U.S. financial markets open (Press release, Concert Pharmaceuticals, NOV 2, 2021, View Source [SID1234594130]). The Company will host a conference call and webcast at 8:30 a.m. ET to discuss its third quarter 2021 financial results and provide a business update. Individuals interested in participating in the call should dial (855) 354-1855 (U.S. and Canada) or (484) 365-2865 (International).

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A live webcast of the conference call may be accessed in the Investors section of the Company’s website at www.concertpharma.com. A replay of the webcast will be available on Concert’s website for three months.

Acorda Third Quarter 2021 Update: Webcast Scheduled for November 9, 2021

On November 2, 2021 Acorda Therapeutics, Inc. (NASDAQ: ACOR) reported that it will host a Webcast in conjunction with its third quarter 2021 update and financial results on Tuesday, November 9, at 4:30 p.m. ET (Press release, Acorda Therapeutics, NOV 2, 2021, View Source [SID1234594129]).

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To participate in the Webcast, please use the following pre-registration link:

View Source
Once you have registered, you will receive a confirmation email with Webcast details. You will receive an email 2 hours prior to the start of the call with the link to join. The presentation will be available in the Investors section of www.acorda.com.

A replay of the audio portion will be available from 7:30 p.m. ET on November 9, 2021 until 11:59 p.m. ET on December 9, 2021. To access the replay, please dial (866) 813 9403 (domestic) or +44 204 525 0658 (international); access code 602929. The archived webcast will be available in the Investor Relations section of the Acorda website at www.acorda.com.

Surface Oncology to Present Preclinical Data for Lead Clinical Programs at the Society for Immunotherapy of Cancer 2021 Annual Meeting

On November 2, 2021 Surface Oncology (Nasdaq: SURF), a clinical-stage immuno-oncology company developing next-generation immunotherapies that target the tumor microenvironment, reported that scientific posters sharing preclinical data will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021 Annual Meeting, to be held virtually and at the Walter E. Washington Convention Center in Washington, D.C. November 10-14, 2021 (Press release, Surface Oncology, NOV 2, 2021, View Source [SID1234594128]).

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The posters include preclinical data from Surface Oncology’s two lead clinical-stage antibody therapies: SRF617 (targeting CD39) and SRF388 (targeting IL-27), both of which are in Phase 1 clinical studies. Surface scientists will be in attendance on-site in Washington D.C. to present the data. Full posters will be placed on Surface Oncology’s website following the presentations. Details are provided below; full posters will be placed on Surface Oncology’s website following the presentations.

Details of Surface’s SITC (Free SITC Whitepaper) presentations:

Presentation Type: Poster Presentation (Abstract: 247)
Title: The fully human antibody SRF617 is a potent inhibitor of ecto-enzyme CD39 in vivo
Session: Poster Hall Session
Lead Author: Stephan Matissek, Ph.D. and Ricard Masia, M.D., Ph.D.
Presentation Date and Time: November 12, 2021 from 7:00 a.m. to 8:30 p.m.

Presentation Type: Poster Presentation (Abstract: 674)
Title: IL-27 signaling drives a type 1 interferon-like gene expression program of immunoregulatory pathways associated with cancer progression
Session: Poster Hall Session
Lead Author: Devapregasan Moodley, M.D.
Presentation Date and Time: November 13, 2021 from 7:00 a.m. to 8:30 p.m.

About SRF617:
SRF617 is a fully human antibody designed to inhibit the enzymatic activity of CD39 in the tumor microenvironment, allowing for a dual mechanism of action to promote anti-tumor immunity via reduction of immunosuppressive adenosine in addition to increasing levels of immunostimulatory ATP. A substantial body of research supports a role for CD39 in allowing cancer to evade immune responses. For example, pancreatic cancer stromal cells within the tumor micro-environment express high levels of CD39 which may inhibit anti-cancer immune responses. In preclinical studies, SRF617 has exhibited strong affinity for and inhibition of CD39, the ability to reduce adenosine and increase ATP levels and anti-tumor activity both as a single agent and in combination with multiple therapeutic agents. SRF617 has been granted Orphan Drug designation for the treatment of advanced pancreatic cancer by the FDA.

About SRF388:
SRF388 is a fully human anti-IL-27 antibody designed to inhibit the activity of this immunosuppressive cytokine. Surface Oncology has identified particular tumor types, including liver, kidney and lung cancer, where IL-27 appears to play an important role in the immunosuppressive tumor microenvironment and may contribute to resistance to treatment with checkpoint inhibitors. SRF388 targets the rate-limiting p28 subunit of IL-27, and preclinical studies have shown that treatment with SRF388 blocks the immuno-suppressive biologic effects of IL-27, resulting in immune cell activation in combination with other cancer therapies including anti-PD-1 therapy, as well as potent anti-tumor effects as a monotherapy. Furthermore, Surface Oncology has identified a potential biomarker associated with IL-27 that may be useful in helping to identify patients most likely to respond to SRF388. In November 2020, Surface announced that SRF388 was granted Orphan Drug designation and Fast Track designation for the treatment of hepatocellular carcinoma from the FDA.