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.

New Novartis data demonstrate only Kisqali® offers more life in the first-line setting for postmenopausal HR+/HER2- advanced breast cancer patients

On May 4, 2022 Novartis reported updated median overall survival (OS) results for Kisqali (ribociclib) in combination with fulvestrant in the first-line subgroup of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (Press release, Novartis, MAY 4, 2022, View Source [SID1234613545]). The analysis of patients treated in first-line with Kisqali plus fulvestrant demonstrated a significant OS benefit of nearly 16 months compared to those treated with fulvestrant alone. This updated exploratory OS analysis from the Phase III MONALEESA-3 study will be presented as a late-breaker mini-oral presentation at the 2022 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Breast Cancer Congress (Abstract #LBA4).

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"MONALEESA-3 results continue to demonstrate the survival benefit of treatment with ribociclib for postmenopausal women with advanced breast cancer," said Dennis J. Slamon, MD, Director of Clinical/Translational Research, University of California, Los Angeles Jonsson Comprehensive Cancer Center. "Whether partnered with fulvestrant or an aromatase inhibitor in the first-line setting, ribociclib offers oncologists a CDK4/6 inhibitor with consistent benefit in providing women with HR+/HER2- advanced breast cancer more quality time, regardless of their disease characteristics."

In this MONALEESA-3 exploratory analysis, patients were further evaluated for a median of 71 months, more than two-and-a-half years of additional follow-up since the final key secondary endpoint OS analysis, which was presented at ESMO (Free ESMO Whitepaper) Congress 2019 and published in the New England Journal of Medicine. The final OS analysis demonstrated a statistically significant OS benefit for Kisqali in combination with fulvestrant and a relative reduction in the risk of death by 28% compared to fulvestrant alone in the full population (HR=0.72; 95% CI: 0.568-0.924; p=0.00455)1,5-6.

This new updated analysis with a median follow-up of five years found that in the first-line setting, Kisqali plus fulvestrant (n=237) achieved 67.6 months median OS as compared to 51.8 months for those treated with fulvestrant alone (n=128) (HR=0.673; 95% CI: 0.504-0.899)1. Patients treated with Kisqali plus fulvestrant compared to those on fulvestrant alone in the first-line setting experienced over one-and-a-half years of additional delay to subsequent use of chemotherapy (49.2 months versus 29.0 months, respectively; HR=0.624; 95% CI: 0.481-0.810)1.

With this extended follow-up, the estimated survival rate at five years was 56.5% (95% CI: 49.5-62.9) for women who received Kisqali in combination with fulvestrant in first-line compared to 42.1% (95% CI: 33.2-50.7) for women who received fulvestrant alone1. Additionally, 16.5% of patients in the Kisqali plus fulvestrant arm (n=39) compared to 8.6% of those in the fulvestrant only arm (n=11) were still ongoing on therapy at this longer follow-up1. No new adverse events were observed.

"It is a tremendous achievement to see such remarkable, consistent overall survival results from the MONALEESA clinical trial program, demonstrating how Novartis is transforming care for people with breast cancer as we continue to work toward cures," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development. "The unique profile of Kisqali continues to be reinforced, with results from MONALEESA-3 pushing the boundaries of how using a Kisqali-combination treatment regimen can extend lives of postmenopausal women living with HR+/HER2- advanced breast cancer without compromising quality of life."

The MONALEESA-3 overall survival data from ESMO (Free ESMO Whitepaper) Congress 2019 are featured in a media release6.

About Kisqali (ribociclib)
Kisqali is the only CDK4/6 inhibitor with proven overall survival benefit across all three Phase III advanced trials1-10, and is recognized by the National Comprehensive Cancer Network (NCCN) guidelines as the only CDK4/6 inhibitor with overall survival benefit in first-line HR+/HER2- advanced breast cancer11. Additionally, Kisqali has the highest rating of any CDK4/6 inhibitor on the ESMO (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale, achieving a score of five out of five for first-line premenopausal patients with HR+/HER2- advanced breast cancer12. Further, Kisqali in combination with either letrozole or fulvestrant has received a score of four out of five for first-line postmenopausal patients with HR+/HER2- advanced breast cancer13.

Kisqali has been approved in more than 95 countries worldwide, including by the United States Food and Drug Administration (FDA) and the European Commission, for the treatment of women with HR+/HER2- advanced or metastatic breast cancer in combination either with an aromatase inhibitor or with fulvestrant as initial endocrine-based therapy or following disease progression on endocrine therapy14-15. Kisqali in combination with fulvestrant is approved as initial endocrine-based therapy or following disease progression on endocrine therapy in men by the FDA14.

Novartis is continuing to reimagine cancer with additional trials of Kisqali. NATALEE is a large confirmatory clinical trial of Kisqali with endocrine therapy in the adjuvant treatment of HR+/HER2- early breast cancer being conducted in collaboration with Translational Research In Oncology (TRIO)16. Novartis is collaborating with SOLTI, who is leading HARMONIA to test the hypothesis whether Kisqali changes tumor biology to enable a better response to endocrine-based therapy compared to Ibrance* for patients with advanced HR+/HER2-, HER2-enriched subtype.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

Please see full Prescribing Information for Kisqali, available at www.Kisqali.com.

MEDIGENE PROVIDES Q1 2022 UPDATE

On May 4, 2022 Medigene AG (Medigene, FSE: MDG1, Prime Standard), an immuno-oncology company focusing on the development of T-cell-based cancer therapies, reported an update on the first quarter of 2022 and confirms its financial guidance for the full year (Press release, MediGene, MAY 4, 2022, View Source [SID1234613544]). The full version of the Quarterly Statement Q1 2022 can be downloaded here: View Source

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Prof. Dolores Schendel, Chief Executive Officer (CEO) and Chief Scientific Officer (CSO) at Medigene: "Medigene continues to develop technology to power the activity and safety of T cell receptor-modified T cell (TCR-T) immunotherapies in solid cancers. Our extensive partnership signed with BioNTech SE (BioNTech) in February not only validated our leading position in the field but also provided a sound financial basis at an important phase in the Company’s evolution. Also in February, we reported that our blood cancer program MDG1011 was successfully produced, safe, well tolerated, with signals of both biological and/or clinical activity.

The Company is strategically positioned to increase value through partnerships and internal discovery, seeking novel T cell receptors (TCRs) and developing the necessary vital tools that will make TCR-T therapies safer, more efficacious and cost effective."

Business review since beginning of 2022 and outlook

Validating, comprehensive TCR-T and technology partnership with BioNTech SE (BioNTech)

BioNTech recently acquired Medigene’s PRAME-specific TCR-4 from the MDG10XX program and has an exclusive option to acquire additional existing TCRs in Medigene’s discovery pipeline. Medigene will develop a number of new TCRs under a development partnership agreement with BioNTech lasting initially for three years and has granted BioNTech licenses to its PD1-41BB switch receptor and precision pairing library. These are technologies that could make TCR-T therapies safer and more effictive.

Under the agreement, Medigene received an upfront payment of EUR 26 million and will be reimbursed for research and development costs incurred during the period of the collaboration. Medigene will be eligible for development, regulatory and commercial milestone payments up to a triple-digit million Euro amount per program. In addition, the Company will be eligible for tiered deferred option payments on global net sales for products based on TCRs arising from the collaboration and royalties on products utilizing at least one of the licensed technologies.

MDG1011 – clinically validated TCR-T therapy in blood cancers

In June 2021, the last patient was enrolled in the third dose cohort of the Phase-I part of the Phase I/II trial of MDG1011 in blood cancer. Medigene reported on safety, tolerability and feasibility in December 2021. In February 2022, first efficacy and immune monitoring data were published. MDG1011 was successfully produced for 12 of the 13 heavily pretreated patients (92.3%) and proved to be safe and well tolerated. MDG1011 showed signs of both biological and clinical activity. One patient is currently still under observation, over nine months after treatment. In line with Medigene’s focus on solid cancers, the Company has decided that, contingent on the final results from the Phase I part, the Phase II part of the trial would only be conducted with or by a partner.

Tools to empower TCR-T therapies

Medigene develops several tools to make TCR-T therapies even safer, more specific and more effective, especially for use in solid cancers. In March 2022, preclinical data on Medigene’s PD1-41BB switch receptor were published in the peer-reviewed scientific publication "T-Cells Expressing a Highly Potent PRAME-Specific T-Cell Receptor in Combination with a Chimeric PD1-41BB Co-Stimulatory Receptor Show a Favorable Preclinical Safety Profile and Strong Anti-Tumor Reactivity" in the scientific journal Cancers.

Development partnerships

Medigene continues its successful collaboration with 2seventy bio, Inc. (formerly: bluebird bio, Inc.) and has initiated operations under the new partnership with BioNTech. Cytovant Sciences HK Limited, a biopharmaceutical company founded by Roivant Sciences, has reported that its development activities would be delayed due to the COVID-19 pandemic, and separately has temporarily suspended Medigene’s activities within the second TCR-T development project since April 2022.

To maximize the Company’s value, Medigene continues to evaluate new partnering opportunities related to its suite of technologies and portfolio of product candidates.

Financial development and financial forecast

As of 31 March 2022, cash and cash equivalents amounted to EUR47.8 m (31 December 2021: EUR22.4 m). In Q1 2022, Medigene generated revenues of EUR23.0 m (Q1 2021: EUR2.1 m) and had research and development expenses of EUR2.0 (Q1 2021: EUR4.0 m). As a result, the earnings before interest, taxes, depreciation, and amortization (EBITDA) amounted to EUR16.8 m (Q1 2021: EUR‑3.1 m).

Currently, Medigene does not expect any material impact on revenues, research and development expenses and EBITDA due to COVID-19 or the Ukraine crisis. Thus, Medigene confirms its financial forecast for 2022 published in the Group Management’s Discussion and Analysis 2021 and continues to expect revenues of EUR23 – 28 m, research and development expenses of EUR11 – 15 m and a positive EBITDA in the amount of EUR3 – 5 m in 2022. Based on its current planning, the Company has sufficient financial resources to fund business operations into Q4 2024.

Conference Call

Medigene will not hold a telephone conference regarding the Quarterly Statement Q1 2022, but we remain available in the usual way for all enquiries.

argenx to Present at BofA Securities 2022 Healthcare Conference

On May 4, 2022 argenx (Euronext & Nasdaq: ARGX), a global immunology company committed to improving the lives of people suffering from severe autoimmune diseases, reported that members of management will participate in a fireside chat at the BofA Securities 2022 Healthcare Conference on Wednesday, May 11, 2022 at 10:40 a.m. P.T. in Las Vegas, NV (Press release, argenx, MAY 4, 2022, View Source [SID1234613543]). A live webcast of the presentation may be accessed on the Investors section of the argenx website at argenx.com/investors. A replay of the webcast will be available on the argenx website for approximately 90 days following the presentation.

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Y-mAbs to Announce First Quarter 2022 Financial and Operating Results on May 9, 2022

On May 4, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) reported that it will report its financial results for the quarter March 31, 2022 on Monday, May 9, 2022, after the close of the U.S. financial markets (Press release, Y-mAbs Therapeutics, MAY 4, 2022, View Source [SID1234613541]). The announcement will be followed by a conference call and webcast with the investment community on Tuesday, May 10, 2022, at 9 a.m. ET. Participating on the call from Y-mAbs will be Thomas Gad, founder, Chairman and Interim CEO; Bo Kruse, Chief Financial Officer; and Sue Smith, Chief Commercial Officer.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

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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