BIO-TECHNE RELEASES THIRD QUARTER FISCAL 2022 RESULTS

On May 4, 2022 Bio-Techne Corporation (NASDAQ: TECH) reported its financial results for the third quarter ended March 31, 2022 (Press release, Bio-Techne, MAY 4, 2022, View Source [SID1234613546]).

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Third Quarter FY2022 Highlights

Third quarter organic revenue increased by 17% (19% reported) to $290.4 million and 18% (22% reported) in the first nine months of fiscal 2022 to $817.4 million.
GAAP EPS was $1.48 versus $1.12 one year ago. Delivered record adjusted earnings per share (EPS) of $2.14 versus $1.80 one year ago.
Excellent commercial execution in both operating segments with Protein Sciences delivering organic growth of 16% (15% reported) and Diagnostics and Genomics achieving 19% (34% reported) organic growth.
Announced exclusive agreement with Thermo Fisher Scientific to complete development and commercialize the ExoTRU kidney transplant rejection test.
Adjusted operating income for the third quarter increased 17% (32% reported) when compared to the prior year to $114.6 million, resulting in an adjusted operating margin of 39.6%.
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 momentum in our core markets, especially proteomics, continues to drive double digit growth for the company," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "The Bio-Techne team delivered outstanding results of 17% organic growth, for the second quarter in a row, and an impressive adjusted operating margin of 39.6%, 130 basis points over our prior quarter. Diagnostics also had a good quarter, with 50% ExoDx Prostate test volume growth, passing pre-pandemic testing levels. Diagnostics capped the quarter by closing a very strategic deal with Thermo Fisher Scientific on our ExoTRU Kidney transplant rejection test."

Kummeth added, "Both segments of our company delivered to and exceeded our expectations. Cell and Gene Therapy, a strategic focus for our Protein Sciences Segment, had another stellar quarter of growth with our new GMP protein factory adding two more of the highest quality and lot-to-lot consistent GMP proteins at scale. It has been nice to see so many of our reagent and instrument platforms being purchased, evaluated, and spec’d into Cell and Gene Therapy workflows. I am excited for the future as we continue to develop innovative tools to push science forward and create value for our stakeholders."

Third Quarter Fiscal 2022

Revenue

Net sales for the third quarter increased 19% to $290.4 million. Organic growth was 17% compared to the prior year, with acquisitions contributing 3% to revenue growth and foreign currency exchange having an unfavorable impact of 1%.

GAAP Earnings Results

GAAP EPS was $1.48 per diluted share, versus $1.12 in the same quarter last year. GAAP EPS was favorably impacted by sales growth and changes in fair value of contingent consideration for acquisitions. GAAP operating income for the third quarter of fiscal 2022 increased 31.8% to $90.4 million, compared to $68.6 million in the third quarter of fiscal 2021. GAAP operating margin was 31.1%, compared to 28.2% in the third quarter of fiscal 2021. GAAP operating margin compared to prior year was positively impacted by volume leverage and changes in fair value of contingent consideration for acquisitions.

Non-GAAP Earnings Results

Adjusted EPS increased to $2.14 per diluted share, versus $1.80 in the same quarter last year, an increase of 19%. Adjusted EPS increased primarily due to revenue growth. Adjusted operating income for the third quarter of fiscal 2022 increased 17% compared to the third quarter of fiscal 2021. Adjusted operating margin was 39.6%, compared to 40.4% in the third quarter of fiscal 2021. Adjusted operating margin compared to the prior year was unfavorably impacted by foreign currency exchange and acquisitions.

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 2022 net sales were $213.2 million, an increase of 15% from $185.6 million for the third quarter of fiscal 2021. Organic growth for the segment was 16%, with foreign currency exchange having an unfavorable impact of 1%. Protein Sciences segment’s operating margin was 45.4% in the third quarter of fiscal 2022 compared to 47.9% in the third quarter of fiscal 2021. The segment’s operating margin compared to the prior year was negatively impacted by foreign currency exchange and strategic investments.

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 2022 net sales were $77.7 million, an increase of 34% from $58.1 million for the third quarter of fiscal 2021. Organic growth for the segment was 19%, with acquisitions contributing 15% to revenue growth and foreign currency exchange having an immaterial impact. The Diagnostics and Genomics segment’s operating margin was 25.0% in the third quarter of fiscal 2022 compared to 17.9% in the third quarter of fiscal 2021. The segment’s operating margin was favorably impacted by volume leverage and product mix.

Conference Call

Bio-Techne will host an earnings conference call today, May 4, 2022 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 13728915. 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 13728915. The replay will be available from 11:00 a.m. CDT on Wednesday, May 4, 2022 until 11:00 p.m. CDT on Saturday, June 4, 2022.

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 $0.7 million and $1.6 million for the quarter and nine months ended March 31, 2022, respectively.

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, goodwill and long-lived asset impairments, 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, goodwill and long-lived asset impairment charges, 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.

ADC Therapeutics to Present at the BofA Securities 2022 Healthcare Conference

On May 4, 2022 ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, reported that its executives will be participating in a fireside chat at the BofA Securities 2022 Healthcare Conference on Tuesday, May 10, 2022, at 1:40 pm ET (Press release, ADC Therapeutics, MAY 4, 2022, View Source [SID1234613565]).

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A live webcast of the presentation will be available via the Events & Presentations page in the Investors section of ADC Therapeutics’ website, ir.adctherapeutics.com. A replay of the webcast will be available for approximately 30 days.

Presentation About Phase 3 Trial of DCVax®-L for Glioblastoma To Be Made At New York Academy Of Sciences

On May 4, 2022 Northwest Biotherapeutics (OTCQB: NWBO) ("NW Bio"), a biotechnology company developing DCVax personalized immune therapies for solid tumor cancers, reported that a presentation entitled "Autologous Tumor Lysate-Loaded Dendritic Cell Vaccination for Glioblastoma" will be made on May 10, 2022 at 11:10 a.m., by Dr. Linda Liau at the Frontiers of Cancer Immunotherapy Conference (CIMT) (Free CIMT Whitepaper) of the New York Academy of Sciences (Press release, Northwest Biotherapeutics, MAY 4, 2022, View Source [SID1234613592]).

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This presentation can be viewed virtually by registering online at the Academy’s website at View Source

Interim Report Q1 2022

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BERGENBIO ANNOUNCES LAUNCH OF BUSINESS STRATEGY FOCUSED ON NSCLC AND COVID-19

On May 4, 2022 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, reported an update on its business strategy (Press release, BerGenBio, MAY 4, 2022, View Source [SID1234613465]). BerGenBio will now focus on two key indications; 1st line non-small cell lung cancer (NSCLC) and COVID-19, which the Company believes offer the optimal path towards translating BerGenBio’s strong scientific foundation into significant value generation from marketed products to address unmet medical needs.

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The opportunity

BerGenBio has for many years pioneered research into AXL inhibition, with its lead development candidate bemcentinib showing clinical potential in oncology and infectious disease. With over 600 patients dosed (approx. 400 in oncology and approx. 200 in COVID-19), the Company has built a large dataset demonstrating biological and clinical activity while simultaneously defining dosing regimens to identify an appropriate balance of safety and efficacy.

The updated business strategy announced today builds on bemcentinib’s mode of action and data gathered from a broad clinical exploration to progress two distinct opportunities with the potential to significantly improve the lives of patients: NSCLC and COVID-19. Both indications show strong evidence of bemcentinib activity, with the advantage of accumulation in target organs, options for accelerated registration, compelling competitive advantages, and both represent high unmet medical needs.

Martin Olin, Chief Executive Officer of BerGenBio, commented: "BerGenBio has been at the forefront of understanding of AXL biology and, having pioneered this area, we remain confident that selective AXL inhibition holds significant potential as a transformative treatment modality for several serious diseases. A rapidly evolving treatment landscape, with improved standards of care in areas such as oncology requires BerGenBio to be nimble and identify specific opportunities where we can address unmet needs in a competitive manner.

With this in mind we believe that by introducing a laser focus and rightsizing the organization on two key areas where we see our pipeline has the greatest impact, we are efficiently advancing BerGenBio’s potential; building on our strong scientific foundation to deliver new drugs to market resulting in better outcomes for patients and the generation of significant value for our shareholders."

NSCLC

Despite advances in treatment, lung cancer remains the leading cause of cancer-related deaths throughout the world. Approximately 85% of lung cancers are classified as NSCLC. BerGenBio is targeting 1st Line STK11 mutated Non-Squamous NSCLC patients, an extremely large patient population with very limited response to the standard of care treatments. STK11 is an important tumor suppressor gene reported to confer immunotherapy resistance in NSCLC and is present in up to 20% of NSCLC patients.

Pre-clinical and clinical studies have suggested a mechanism by which bemcentinib may restore response to immune checkpoint inhibitor therapy and enable the avoidance of chemoresistance in NSCLC patients harboring STK11 mutations, thus potentially offering a treatment option to those patients who respond poorly to existing therapies. Data from the subset of STK11mutated patients treated in the Company’s BGB008 study in 2nd line NSCLC also provides early indications of efficacy in this biomarker driven patient population.

The FDA has recognized that STK11 is currently a "non-actionable" mutation – one that confers poor outcome and has no specific therapeutic approaches today and have granted BerGenBio a Fast Track Designation for bemcentinib in this setting. To date, bemcentinib is to the Company’s knowledge the only selective AXL inhibitor in development for patients with STK11 mutation. BerGenBio has a strong proprietary position for treatment of this population and believes there may be a potential for an accelerated approval pathway in this patient sub-set.

COVID-19

Despite the success of vaccines, there is still a large number of hospitalized patients that remain in need of improved therapeutic options for COVID-19. Research into bemcentinib’s potential in hospitalized COVID-19 patients began in 2020, in response to the emergence of the pandemic, and based on the Company’s understanding of AXL’s role in mediating aggressive diseases.

Recently, BerGenBio announced results from the Phase II sub-protocol of the platform ACCORD2 study, which met its primary and key secondary endpoints, with demonstrable efficacy in patients on top of current standard-of-care treatments including remdesivir and corticosteroids. Further, bemcentinib has been selected to be studied under the EUSolidAct platform trial through a sub-protocol enrolling 500 patients across European sites. Given the ongoing need for new treatment options for hospitalized COVID-19 patients, the novel mechanism of action of bemcentinib (independent of the spike protein), along with potential to confirm the ACCORD2 data in the EUSolidAct trial, the Company believes that this could warrant Emergency Use Authorizations based on precedents.

The Company believes that the unique mechanism of action and properties of bemcentinib positions it well as a novel treatment modality within severe respiratory infections beyond COVID-19.

With a focused strategy and rightsized organization BerGenBio plans to unlock significant potential value related to the two indications selected and define the path to market.