Isotopia Molecular Imaging begins clinical supply collaboration with Y-mAbs Therapeutics, Inc.

On November 5, 2020 Isotopia Molecular Imaging reported that it has begun a collaboration with Y-mAbs Therapeutics, Inc., a late-stage clinical biopharmaceutical company, for the supply of the medical radioisotope no-carrier-added Lutetium-177 (n.c.a. 177Lu) to support clinical development for 177Lu-DTPA-omburtamab for the treatment of B7-H3 positive Central Nervous System ("CNS") and Leptomeningeal Metastasis ("LM") from tumors in adult patients (Press release, Isotopia Molecular Imaging, NOV 5, 2020, View Source [SID1234570248]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

Y-mAbs is a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer.

177Lu-DTPA-omburtamab embodies Y-mAbs naked omburtamab antibody radiolabeled with lutetium-177, using DTPA to chelate the lutetium radioisotope to the antibody.

Lutetium-177 is a radiopharmaceutical precursor beta-emitter with a half-life of 6.7 days and a maximum energy of 0.5 MeV, corresponding to a maximum soft-tissue penetration of approximately 1 mm from the binding site. 177Lu is used in Targeted Radionuclide Therapy in the field of Precision Oncology. Radiolabeled to disease-specific targeting molecules, the tumor tissue is precisely destroyed. Isotopia has developed a GMP unique stable consistent and reliable method to produce a highly pure form of Lu-177. n.c.a Lu-177 contains no metastable Lu-177m, therefore there is no need for cost intensive clinical waste management.

Isotopia’s Business Development manager, Keren Moshkoviz stated, "Isotopia, Like Y-mAbs aims to improve quality of life of cancer patients with Targeted Radionuclide Therapies. We are very pleased to establish this alliance making significant contribution to innovative and promising therapies for cancer patients worldwide. Isotopia is focusing on supporting clinical studies also for the next generation of radio isotope Tb161 that will be launched soon. We are confident that our growing development platform will make a big contribution to targeted therapies worldwide."

Cigna Reports Third Quarter 2020 Performance, Raises Revenue Guidance

On November 5, 2020 Cigna Corporation (NYSE: CI) reported solid third quarter 2020 performance led by strong execution by its Evernorth segment (Press release, Cigna , NOV 5, 2020, View Source [SID1234570247]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

"In these dynamic and challenging times, we at Cigna continue to act as champions for our customers, clients, and communities as we deliver on our promises to make health care more affordable, predictable and simple," said David M. Cordani, President and Chief Executive Officer. "We delivered attractive revenue growth and strong earnings, while further improving our capital position, driving strategic flexibility. Additionally, our launch of Evernorth accelerates our strategy, broadens our reach and expands our opportunities for growth, further enhancing the value we deliver to the marketplace each and every day."

Total revenues for third quarter 2020 were $41.0 billion. Adjusted revenues1 were $40.8 billion and reflect strong contributions from each of Cigna’s ongoing businesses.

Shareholders’ net income for third quarter 2020 was $1.4 billion, or $3.78 per share, compared with $1.4 billion, or $3.57 per share, for third quarter 2019.

Cigna’s adjusted income from operations2 for third quarter 2020 was $1.6 billion, or $4.41 per share, compared with $1.7 billion, or $4.54 per share, for third quarter 2019 reflecting strong fundamental performance across our businesses as well as the return of medical utilization to more typical levels and COVID-19 related impacts.

Reconciliations of total revenues to adjusted revenues1 and of shareholders’ net income to adjusted income from operations2 are provided on the following page and on Exhibit 1 of this earnings release.

Cigna’s third quarter results reflect revenue growth driven by strong fundamental performance across our businesses led by our Evernorth segment. Third quarter earnings reflect the return of medical utilization to more typical levels and COVID-19 related impacts, as well as focused execution in our businesses.
Year to date through November 4, 2020, the Company repurchased 16.0 million shares of common stock for approximately $2.9 billion.
The debt to capitalization ratio decreased to 42.8% at September 30, 2020 from 45.2% at December 31, 2019.
The SG&A expense ratio4 was 8.1% for third quarter 2020, a decrease from 9.2% for third quarter 2019, driven by significant revenue growth and continued expense efficiency.
The pharmacy customer base5 at third quarter 2020 grew to 86.6 million, an organic increase of 10.7 million customers year to date, driven by strong new health plan sales.
The total medical customer base5 at third quarter 2020 was 17.0 million, a decrease of 163,000 customers year to date, driven by a decline in National Accounts, partially offset by growth in the Select and International Markets segments and in Medicare Advantage.
HIGHLIGHTS OF SEGMENT RESULTS

See Exhibit 1 for a reconciliation of adjusted income (loss) from operations2 to shareholders’ net income.

Evernorth6

This segment includes a broad range of coordinated and point solution health services, including pharmacy services, benefits management, care solutions and data and analytics, which are provided to health plans, employers, government organizations, and health care providers.

Third quarter 2020 adjusted revenues1 increased 20% relative to third quarter 2019 driven by the insourcing of U.S. Medical pharmacy volumes and strong organic growth, including growth in retail network and specialty pharmacy services.
Third quarter adjusted income from operations, pre-tax2 increased 3% relative to third quarter 2019, reflecting customer growth, higher adjusted pharmacy scripts volumes, benefits from the effective management of the supply chain, and continued strong performance in specialty pharmacy services, partially offset by increased operating expenses to support growth.
Evernorth fulfilled 381 million adjusted pharmacy scripts9 in third quarter 2020, an increase of 22% over third quarter 2019 driven by the insourcing of U.S. Medical pharmacy volumes and strong organic growth.
U.S. Medical6

This segment includes Cigna’s U.S. Commercial and U.S. Government businesses that provide comprehensive medical and coordinated solutions to clients and customers. U.S. Commercial products and services include medical, pharmacy, behavioral health, dental, vision, health advocacy programs and other products and services for insured and self-insured customers. U.S. Government solutions include Medicare Advantage, Medicare Supplement, and Medicare Part D plans for seniors, Medicaid plans, and individual health insurance plans both on and off the public exchanges.

Third quarter 2020 adjusted revenues1 grew 5% over third quarter 2019, reflecting customer growth in the Select segment and Medicare Advantage, as well as premium increases.
Third quarter 2020 adjusted income from operations, pre-tax² and adjusted margin, pre-tax8 reflect unfavorable prior period development primarily related to second quarter 2020, COVID-19 related impacts, and the return of the health insurance tax. COVID-19 related impacts include the net impact of the return of medical utilization to more typical levels and direct COVID-19 costs as well as the costs of actions we have taken to support customers and providers, decreased specialty contributions, and lower net investment income.
The medical care ratio4 ("MCR") of 82.6% for third quarter 2020 reflects continued effective execution in our U.S. Commercial and U.S. Government segments. The third quarter 2020 MCR increased relative to third quarter 2019 due to unfavorable prior period development primarily related to second quarter 2020 and COVID-19 related impacts, partially offset by the pricing effect of the health insurance tax.
U.S. Medical net medical costs payable10 was $2.97 billion at September 30, 2020, $2.73 billion at September 30, 2019, and $2.59 billion at December 31, 2019. Favorable prior year reserve development on a gross pre-tax basis was $126 million and $159 million through third quarter 2020 and 2019, respectively.
International Markets

This segment includes supplemental health, life and accident insurance products and health care coverage in Cigna’s international markets, as well as health care benefits for globally mobile individuals and employees of multinational organizations.

Third quarter 2020 adjusted revenues1,7 grew 3% over third quarter 2019, reflecting continued business growth.
Third quarter 2020 adjusted income from operations, pre-tax2 and adjusted margin, pre-tax8 reflect continued operational efficiency, lower claim levels driven by the effects of the COVID-19 pandemic, and business growth.
Group Disability and Other Operations

This segment includes Cigna’s Group Disability and Life business which offers group long-term and short-term disability, and group life, accident, voluntary and specialty insurance products and services. Additionally, this segment includes Corporate Owned Life Insurance ("COLI") and the Company’s run-off operations.

Third quarter 2020 adjusted income from operations, pre-tax2 and adjusted margin, pre-tax8 reflect elevated claims in Cigna’s Life business primarily related to the COVID-19 pandemic.
On December 18, 2019, Cigna announced a definitive agreement whereby New York Life will acquire Cigna’s Group Disability and Life business for $6.3 billion. Cigna continues to expect the transaction to close in the fourth quarter of 2020, subject to applicable regulatory approvals and other customary closing conditions.
Corporate

Corporate reflects interest expense, as well as amounts not allocated to operating segments and includes intersegment eliminations.

2020 OUTLOOK

Cigna’s outlook for full year 2020 adjusted revenues1,3 is approximately $158 billion. Cigna’s outlook for full year 2020 consolidated adjusted income from operations2,3 on a per share basis is in the range of $18.30 to $18.60 per share. Cigna’s outlook excludes potential effects of any future share repurchase3. Also, while Cigna continues to expect to close the sale of Cigna’s Group Disability and Life business in the fourth quarter of 2020, Cigna’s outlook assumes a full year of contributions from the Group Disability and Life business.

The foregoing statements represent the Company’s current estimates of Cigna’s 2020 consolidated adjusted revenues1,3 and adjusted income from operations2,3 on a per share basis as of the date of this release. Actual results may differ materially depending on a number of factors. Investors are urged to read the Cautionary Note Regarding Forward-Looking Statements included in this release. Management does not assume any obligation to update these estimates.

This quarterly earnings release and the Quarterly Financial Supplement are available on Cigna’s website in the Investor Relations section (View Source). Management will be hosting a conference call to review third quarter 2020 results and discuss full year 2020 outlook beginning today at 8:30 a.m. ET. A link to the conference call is available in the Investor Relations section of Cigna’s website located at View Source/events/index.page.

Bio-Techne Releases First Quarter Fiscal 2021 Results

On November 5, 2020 Bio-Techne Corporation (NASDAQ:TECH) reported its financial results for the first quarter ended September 30, 2020 (Press release, Bio-Techne, NOV 5, 2020, View Source [SID1234570246]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

First Quarter FY2021 Snapshot

First quarter organic revenue increased by 10% (11% reported) to $204.2 million.
GAAP EPS was $0.83 versus $0.37 one year ago. Delivered adjusted earnings per share (EPS) of $1.43, an increase of 35% over the prior year.
Diagnostics and Genomics segment delivered 17% organic growth (18% reported), highlighted by growth in RNAscope products.
Adjusted operating margin increased to 38.2% in the first quarter of fiscal 2021 compared to 31.8% in the prior year.
The Company opened its new state-of-the-art GMP (Good Manufacturing Practices) manufacturing facility, which is dedicated to supporting large-scale production of GMP-grade proteins and reagents.
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, 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.

"I am very pleased with our team and the results they produced for the first fiscal quarter of 2021," said Chuck Kummeth, President and Chief Executive Officer of Bio-Techne. "Achieving over 10% organic growth, including strong results from our key growth platforms, shows the strength of our diverse portfolio of tools that researchers are turning to in all aspects of life sciences research."

Kummeth added, "We have laid a foundation of COVID-19 related tools and diagnostics to enable researchers and clinicians in the near-term battle against the virus and provide continued insights over the long-term. This quarter was highlighted by the opening of our GMP manufacturing facility in Minnesota to accelerate the ramp and access to the world’s highest quality GMP proteins and reagents to support the growing cell and gene therapy markets."

COVID-19 Business Update

During the first quarter of fiscal year 2021, we experienced a significant increase in the number of customer sites that were either fully or partially opened when compared to prior periods during the COVID-19 pandemic. The reopening of customer sites and demand for our portfolio of life science tools and diagnostic reagents enabled the Company to return to sales volumes experienced prior to the onset of the pandemic. However, we are unable to forecast if any customer sites may reclose given rising COVID-19 cases occurring in certain regions. We are anticipating a positive long-term outlook for sales growth resulting from expected future funding increases within life-science research in response to the current pandemic.

The Company has responded to the pandemic by leveraging our deep product portfolio and scientific expertise to develop a robust COVID-19 product and service offering that provides critical support for both clinical care and therapeutic development. The Company’s ongoing efforts to utilize and expand upon our portfolio of products and services to enable solutions for this evolving pandemic may partially offset the impacts of any future customer site closures.

Adjusted EPS was favorably impacted in the current quarter when compared to prior periods during the COVID-19 pandemic due to increased sales volumes as described above. We anticipate the short- and long-term impacts of COVID-19 on adjusted EPS to be similar to that of sales growth.

The Company remains in a strong financial position with sufficient available cash as well as access to additional funding, if necessary, through our long-term debt agreement. We did not experience any material changes to our September 30, 2020 Balance Sheet resulting from COVID-19 for items such as additional reserves or asset impairments.

The Company remains fully operational as we abide by local COVID-19 safety regulations across the world. To achieve this, certain employees are working remotely and the Company has adopted significant protective measures for our employees on site, including staggered shifts, social distancing and hygiene best practices recommended by the Centers for Disease Control (CDC). In addition, the Company has taken additional steps to monitor and strengthen our supply chain to maintain an uninterrupted supply of our critical products and services.

First Quarter Fiscal 2021

Revenue

Net sales for the first quarter increased 11% to $204.2 million. Organic growth was 10% compared to the prior year, with foreign currency exchange having a favorable impact of 1%.

GAAP Earnings Results

GAAP EPS increased to $0.83 per diluted share, versus $0.37 in the same quarter last year, primarily due to sales growth and operating margin expansion. GAAP operating income for the first quarter of fiscal 2021 increased 47.3% to $49.1 million, compared to $33.3 million in the first quarter of fiscal 2020. GAAP operating margin was 24.0%, compared to 18.2% in the first 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 $1.43 per diluted share, versus $1.06 in the same quarter last year, an increase of 35% resulting from sales growth and operating margin expansion. Adjusted operating income for the first quarter of fiscal 2021 increased 33.8% compared to the first quarter of fiscal 2020. Adjusted operating margin was 38.2%, compared to 31.8% in the first quarter of fiscal 2020. Adjusted operating margin compared to the prior year was positively 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. Since these results are used for this purpose, they are also considered to be prepared in accordance with GAAP.

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 2021 net sales were $154.4 million, an increase of 10% from $141.0 million for the first quarter of fiscal 2020. Organic growth for the segment was 8%, with foreign currency exchange having a favorable impact of 2% on revenue growth. Protein Sciences segment’s operating margin was 45.6% in the first quarter of fiscal 2021 compared to 42.2% in the first 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, diagnostic 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 2021 net sales were $50.1 million, an increase of 18% compared to $42.6 million for the first quarter of fiscal 2020. Organic growth for the segment was 17%, with foreign currency exchange having a favorable impact of 1%. The Diagnostics and Genomics segment’s operating margin was 17.3% in the first quarter of fiscal 2021 compared to 2.1% in the first quarter of fiscal 2020. The segment’s operating margin was positively impacted volume leverage.

Conference Call

Bio-Techne will host an earnings conference call today, November 5, 2020 at 8:00 a.m. CST. To listen, please dial 1-855-327-6837 or 1-631-891-4304 (for international callers), and reference conference ID 10011451. 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 10011451.The replay will be available from 11:00 a.m. CST on Thursday, November 5, 2020 until 11:00 p.m. CST on Saturday, December 5, 2020.

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 net earnings
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.

Protalix BioTherapeutics to Present at the H.C. Wainwright 6th Annual Israel Conference

On November 5, 2020 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that Dror Bashan, the Company’s President and Chief Executive Officer will present at the H.C. Wainwright 6th Annual Israel Conference on Thursday, November 12, 2020 at 7:30 AM, Eastern Standard Time (Press release, Protalix, NOV 5, 2020, View Source [SID1234570245]). The conference will be held virtually on November 12, 2020.

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available at www.protalix.com on the event calendar page, View Source;p=irol-calendar. A replay of the presentation will be archived and available for at least 15 days following the presentation.

CASI Pharmaceuticals To Report Third Quarter 2020 Financial Results And Host Conference Call November 9, 2020

On November 5, 2020 CASI Pharmaceuticals, Inc. (Nasdaq: CASI), a U.S. biopharmaceutical company focused on developing and commercializing innovative therapeutics and pharmaceutical products, reported the Company will host a conference call reviewing third quarter highlights at 4:30 p.m. ET on Monday, November 9th, 2020 (Press release, CASI Pharmaceuticals, NOV 5, 2020, https://www.prnewswire.com/news-releases/casi-pharmaceuticals-to-report-third-quarter-2020-financial-results-and-host-conference-call-november-9-2020-301166988.html [SID1234570244]).

Schedule your 30 min Free 1stOncology Demo!
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

                  Schedule Your 30 min Free Demo!

On the call, CASI’s Chairman & CEO will provide an update on recent business developments and review upcoming milestones. The conference call can be accessed by dialing (833) 647-4459 (U.S.), (800) 870-0181 (China), (400) 682-8629 (China, domestic), (580) 86567 (Hong Kong) to listen to the live conference call. The conference ID number for the live call is 8835514.

This call will be recorded and available for replay by dialing (855) 589-2056 (U.S.) or (404)-537-3406 (international) and enter 8835514 to access the replay.