BIO-TECHNE RELEASES THIRD QUARTER FISCAL 2021 RESULTS

On May 6, 2021 Bio-Techne Corporation (NASDAQ:TECH) reported its financial results for the third quarter ended March 31, 2021 (Press release, Bio-Techne, MAY 6, 2021, View Source [SID1234579393]).

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Third Quarter FY2021 Snapshot

Third quarter organic revenue increased by 22% (25% reported) to $243.6 million and 17% (19% reported) in the first nine months of fiscal 2021 to $672.0 million.
GAAP EPS was $1.12 versus $0.92 one year ago. Delivered adjusted earnings per share (EPS) of $1.79 versus $1.39 one year ago.
Adjusted Operating Margin increased to 40.1% in the third quarter of fiscal 2021 compared to 36.4% in the third quarter of fiscal 2020.
Excellent commercial execution in both operating segments with Protein Sciences achieving record organic growth of 24% and Diagnostics and Genomics delivering 17% organic growth.
Enhanced Bio-Techne’s Diagnostics and Genomics segment through the acquisition of Asuragen, Inc., which closed April 6th, 2021, adding a portfolio of best-in-class molecular diagnostic and research products and its experienced leadership team.
The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States (GAAP). Adjusted 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.

"Congratulations to the entire global Bio-Techne team for delivering another consecutive record quarter," Said Chuck Kummeth, President and CEO of Bio-Techne. "Our 22% organic growth reflects strong execution across geographies and segments, while our financial discipline delivered an impressive adjusted operating margin of 40.1%. This strength speaks to increasing demand for our portfolio of life science tools and diagnostic solutions, delivering productivity enhancing solutions that are ideal for the current environment and positioning the Company for continued leadership in our platforms as we exit the pandemic."

Kummeth added, "Our end-markets continued to improve during Q3, with biopharma remaining strong and academic labs continuing the reopening process. Our ProteinSimple brand of proteomic analytical tools and ACD brand of tissue biopsy products were standouts in the quarter, with these platforms growing approximately +50% and +40% year-over-year, respectively. The continued rapid adoption of these solutions, combined with our quality reagents and emerging Exosome Dx and Cell and Gene Therapy opportunities, gives us much excitement about what the future still brings for Bio-Techne and all of its stakeholders."

Third Quarter Fiscal 2021

Revenue

Net sales for the third quarter increased 25% to $243.6 million. Organic growth was 22% compared to the prior year, with foreign currency exchange having a favorable impact of 3% and acquisitions contributing an immaterial amount to revenue growth.

GAAP Earnings Results

GAAP EPS increased to $1.12 per diluted share, versus $0.92 in the same quarter last year. GAAP operating income for the third quarter of fiscal 2021 increased 43.6% to $68.6 million, compared to $47.8 million in the third quarter of fiscal 2020. GAAP operating margin was 28.2%, compared to 24.5% in the third quarter of fiscal 2020. GAAP operating margin compared to prior year was positively impacted by volume leverage and cost management.

Non-GAAP Earnings Results

Adjusted EPS increased to $1.79 per diluted share, versus $1.39 in the same quarter last year, an increase of 29%. Adjusted EPS increased due to revenue growth and operating margin expansion. Adjusted operating income for the third quarter of fiscal 2021 increased 37% compared to the third quarter of fiscal 2020. Adjusted operating margin was 40.1%, compared to 36.4 % in the third quarter of fiscal 2020. Adjusted operating margin compared to the prior year was favorably impacted by volume leverage and cost management.

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 third quarter fiscal 2021 net sales were $185.6 million, an increase of 28% from $145.5 million for the third quarter of fiscal 2020. Organic growth for the segment was 24%, with foreign currency exchange having a favorable impact of 4% on revenue growth and acquisitions contributing an immaterial amount to revenue growth. Protein Sciences segment’s operating margin was 47.6% in the third quarter of fiscal 2021 compared to 44.7% in the third quarter of fiscal 2020. The segment’s operating margin compared to the prior year was positively impacted by volume leverage and cost management.

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 third quarter fiscal 2021 net sales were $58.1 million, an increase of 18% from $49.4 million for the third quarter of fiscal 2020. Organic growth for the segment was 17% with foreign currency exchange having a 1% favorable impact on revenue. The Diagnostics and Genomics segment’s operating margin was 17.9% in the third quarter of fiscal 2021 compared to 14.3% in the third quarter of fiscal 2020. The segment’s operating margin was favorably impacted by volume leverage and cost management.

Conference Call

Bio-Techne will host an earnings conference call today, May 6, 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 13718437. 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 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13718437. The replay will be available from 11:00 a.m. CDT on Thursday, May 6, 2021 until 11:00 p.m. CDT on Sunday, June 6, 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 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 as well as the impact of foreign currency. 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.

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 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. 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’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. Stock-based compensation is excluded from non-GAAP adjusted net earnings because of the nature of this charge, specifically the varying available valuation methodologies, subjective assumptions, variety of award types, and unpredictability of amount and timing of employer related tax obligations. 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.

GE Healthcare Acquires Zionexa

On May 6, 2021 Zionexa reported to join GE Healthcare to further develop molecular imaging agents in oncology, all aimed at enabling more precise diagnosis, improved treatment decision-making and ultimately better clinical outcomes for patients (Press release, Zionexa, MAY 6, 2021, View Source [SID1234579390]).​

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Our mission has always been to help physicians personalize treatment to improve patients’ pathway and quality of life. We are delighted to be joining an organization rooted in precision health.

Kevin O’Neill, President and CEO of GE Healthcare Pharmaceutical Diagnostics, said: "Like GE Healthcare, Zionexa’s products are aimed at enabling more precise diagnosis, improved treatment decision-making and ultimately better clinical outcomes for patients. This acquisition further demonstrates our commitment to enabling precision health and providing innovations that support oncologists, nuclear medicine specialists and other physicians throughout a cancer patient’s journey, from initial screening and diagnosis to informing therapy selection and monitoring the effectiveness of treatment."

Olivier Carli, President of Denos, the majority owner of Zionexa, said: "We expect GE Healthcare Pharmaceutical Diagnostics’ acquisition to allow Zionexa to accelerate the development of its promising R&D pipeline as well as its commercial footprint, while providing Zionexa’s team with access to global and complementary expertise

CymaBay Therapeutics to Report First Quarter 2021 Financial Results on Thursday, May 13, 2021

On May 6, 2021 CymaBay Therapeutics, Inc. (NASDAQ: CBAY), a clinical-stage biopharmaceutical company focused on developing therapies for liver and other chronic diseases with high unmet need, reported that it will host a conference call and live audio webcast on Thursday, May 13, 2021 at 4:30 p.m. Eastern Time to discuss financial results for the first quarter ended March 31, 2021 and to provide a business update (Press release, CymaBay Therapeutics, MAY 6, 2021, View Source [SID1234579389]).

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Conference Call Details
To access the live conference call, please dial 877-407-0784 from the U.S. and Canada, or 201-689-8560 internationally, Conference ID# 13718350. To access the live and subsequently archived webcast of the conference call, go to the Investors section of the company’s website at View Source

Synlogic Announces First Quarter 2021 Conference Call & Webcast

On May 6, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported the Company will release its first quarter 2021 financial results before the market opens on Thursday, May 13, 2021 (Press release, Synlogic, MAY 6, 2021, View Source [SID1234579388]). The press release will be followed by a conference call at 8:30 am ET, which will be open to the public via telephone and webcast. During the conference call, the Company will review its financial results and provide a corporate update.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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The conference call dial-in numbers are (844) 815-2882 for domestic callers and (213) 660-0926 for international callers. The conference ID number for the call is 2526209. Participants may access the live webcast via a link on the Synlogic website in the Events Calendar of the Investors and Media section. For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Company’s website.

UroGen Pharma to Report First Quarter 2021 Financial Results on Thursday, May 13, 2021

On May 6, 2021 UroGen Pharma Ltd. (Nasdaq: URGN), a biopharmaceutical company dedicated to building and commercializing novel solutions that treat specialty cancers and urologic diseases, reported that it will report first quarter 2021 financial results on Thursday, May 13, 2021, prior to the open of the market (Press release, UroGen Pharma, MAY 6, 2021, View Source [SID1234579387]). The announcement will be followed by a live audio webcast and conference call at 8:30 AM Eastern Time.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Audio Webcast
The webcast will be made available on the Investors section of the Company’s website at View Source Following the live audio webcast, a replay will be available on the Company’s website for approximately 30 days.