On February 23, 2021 bluebird bio, Inc. (NASDAQ:BLUE) reported financial results and business highlights for the fourth quarter and full year ended December 31, 2020 and shared recent operational progress (Press release, bluebird bio, FEB 23, 2021, View Source [SID1234575464]).

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"For over ten years, bluebird bio has been pioneering gene therapies for patients with rare diseases and cancer, and our work continues with the analysis of the recent safety events identified in our HGB-206 study in patients with sickle cell disease. We have seen the transformative benefit of these therapies and are conducting a scientific and medical investigation to best inform our path forward on behalf of the patients we hope to serve with LentiGlobin," said Nick Leschly, chief bluebird. "While this work is ongoing, we remain focused on the upcoming PDUFA action due date for ide-cel for multiple myeloma next month, the potential EU approval of eli-cel for CALD mid-year and the planned US filings for β-thalassemia and CALD later in the year. Through these challenges, we are keeping patients at the center and were very excited to reach a major milestone of the first commercial infusion of ZYNTEGLO in Germany earlier this month."

RECENT HIGHLIGHTS

COMPANY

CLINICAL HOLD OF PHASE 1/2 AND PHASE 3 STUDIES OF LENTIGLOBIN GENE THERAPY FOR SICKLE CELL DISEASE AND TEMPORARY SUSPENSION OF MARKETING OF ZYNTEGLO IN EUROPE – On February 16, 2021, bluebird bio announced that due to a Suspected Unexpected Serious Adverse Reaction (SUSAR) of acute myeloid leukemia and a SUSAR of myelodysplastic syndrome in our HGB-206 clinical study, the FDA has placed our clinical studies of LentiGlobin for SCD on clinical hold. We are investigating these events and plan to continue to work closely with the FDA in their review of these events. In addition, we are also engaged with the EMA in discussions regarding our proposed development plans for LentiGlobin for SCD in Europe. In light of these SUSARs, we have temporarily suspended marketing of ZYNTEGLO in Europe. Additionally, the EMA has paused the renewal procedure for ZYNTEGLO’s conditional marketing authorization while the EMA’s pharmacovigilance risk assessment committee reviews the risk-benefit assessment for ZYNTEGLO and determines whether any additional pharmacovigilance measures are necessary.
INTENT TO SEPARATE – On January 11, 2021, bluebird bio announced its intent to separate its severe genetic disease and oncology businesses into two independent, publicly traded companies (bluebird bio and "Oncology Newco"). The separation is expected to be completed by year-end 2021 and it is anticipated that the spin out of Oncology Newco is to be tax-free to shareholders, subject to receipt of a favorable Internal Revenue Service (IRS) ruling.
Following the separation, bluebird bio intends to focus on delivery of its Core 3 therapies in β-thalassemia, cerebral adrenoleukodystrophy and sickle cell disease, expand access and reimbursement for our commercial product, ZYNTEGLO, in Europe and continue to explore innovative tools and technologies to ultimately bring these transformative medicines to more patients.
Following the separation, Oncology Newco plans to support commercial success of ide-cel and continued development of bb21217, deliver on the oncology pipeline of cellular therapies with a focus on non-Hodgkin’s lymphoma, acute myeloid leukemia, next-generation multiple myeloma and solid tumors and advance next generation product cycling engine with an overarching goal of 1-2 investigational new drugs (INDs) in each of the years 2021 and 2022.
At the time of separation, bluebird bio plans to capitalize each business with sufficient capital to achieve value creating milestones and intends to provide additional financial details closer to the date of separation.
TRANSFUSION DEPENDENT β-THALASSEMIA

FIRST PATIENT TREATED WITH ZYNTEGLO GENE THERAPY – bluebird bio is announcing today that a patient was treated earlier this month with the first commercial infusion of ZYNTEGLO [betibeglogene autotemcel (beti-cel)]. The patient was treated at a Qualified Treatment Center (QTC) in Germany.
TDT DATA AT ASH (Free ASH Whitepaper) – On December 5, 2020, bluebird bio presented new data showing that all patients that achieved transfusion independence continue to remain free from transfusions up to six years in the ongoing long-term follow-up study (LTF-303) of beti-cel gene therapy in patients with TDT at the 62nd American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting. The company also presented updated efficacy and safety results for pediatric patients in the Phase 3 HGB-207 (Northstar-2) and HGB-212 (Northstar-3) studies.
SICKLE CELL DISEASE

FIRST PATIENT TREATED IN CONFIRMATORY HGB-210 STUDY –bluebird bio is announcing today that within the first quarter, the first patient was infused in HGB-210, a Phase 3 confirmatory study of LentiGlobin gene therapy (bb1111) for adults and pediatric subjects ≥2 and ≤50 years of age with sickle cell disease (SCD).
SCD DATA AT ASH (Free ASH Whitepaper) – On December 7, 2020, bluebird bio presented new data showing a complete elimination of severe vaso-occlusive events (VOEs) through 24 months of follow-up in patients who had a history of at least four severe VOEs and at least six months follow-up in Group C of its ongoing Phase 1/2 HGB-206 study of bb1111 for patients with SCD at the 62nd ASH (Free ASH Whitepaper) Annual Meeting.
MAGENTA COLLABORATION – On December 4, 2020, bluebird bio and Magenta Therapeutics announced an exclusive clinical trial collaboration to evaluate the utility of MGTA-145, in combination with plerixafor, for mobilization and collection of stem cells in patients with SCD. The combination approach has the potential to achieve safe, rapid and reliable mobilization of sufficient quantities of high-quality stem cells to ultimately improve outcomes associated with stem cell transplantation. The companies will co-fund the clinical trial and Magenta will retain all rights to its product candidate.
MULTIPLE MYELOMA

CRB-401 DATA AT ASH (Free ASH Whitepaper) – On December 5, 2020, bluebird bio and Bristol-Myers Squibb presented longer-term results showing ongoing deep and durable responses in the original Phase 1 study (CRB-401) of the companies’ investigational B-cell maturation antigen (BCMA) directed chimeric antigen receptor (CAR) T cell therapy, idecabtagene vicleucel (ide-cel), in patients with relapsed and refractory multiple myeloma at the 62nd ASH (Free ASH Whitepaper) Annual Meeting.
BB21217 DATA AT ASH (Free ASH Whitepaper) – On December 5, 2020, bluebird bio and Bristol-Myers Squibb presented updated safety and efficacy results showing promising response rates and durability from the ongoing Phase 1 study (CRB-402) of bb21217, an investigational BCMA-directed CAR T cell therapy in patients with relapsed and refractory multiple myeloma at the 62nd ASH (Free ASH Whitepaper) Annual Meeting. The company announced the study has completed enrollment and follow-up is ongoing as data continue to mature and the durability of response at the recommended phase 2 dose is assessed.
UPCOMING ANTICIPATED MILESTONES

Regulatory Outlook

Multiple Myeloma: The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 27, 2021 for the approval of ide-cel (bb2121) in patients with relapsed and refractory multiple myeloma.
SCD: The company is investigating the recently-reported safety events and plans to continue to work closely with the FDA in their review of these events to provide an update on the Company’s development plan and timeline for submission for regulatory approval.
TDT: The company is on track to complete its rolling BLA submission to the U.S. FDA for beti-cel in mid-2021, contingent upon successful resolution of any U.S. FDA concerns applicable to the program arising out of the recently-reported safety events in the SCD program. This submission is anticipated to include patients with transfusion dependent β-thalassemia across all genotypes (including non-β0/β0 genotypes and β0/β0 genotypes).
CALD: The company is on track to complete its BLA submission to the U.S. FDA for elivaldogene autotemcel (eli-cel) in mid-2021. The company plans to receive European approval for eli-cel in patients with cerebral adrenoleukodystrophy (CALD) in mid-2021.
Clinical Updates and Milestones

Updated data from ongoing clinical study in patients with SCD by the end of 2021.
Updated data from ongoing clinical studies in patients with TDT in mid-2021.
Updated data from ongoing clinical studies in patients with CALD in mid-2021.
bb21217 clinical data from the ongoing CRB-402 study in patients with multiple myeloma by the end of 2021.
Submission of 1 – 2 investigational new drug (IND) applications by the end of 2021.
FOURTH QUARTER AND FULL YEAR 2020 FINANCIAL RESULTS

Cash Position: Cash, cash equivalents and marketable securities as of December 31, 2020 and December 31, 2019 were $1.27 billion and $1.24 billion, respectively. The increase in cash, cash equivalents and marketable securities is primarily a result of proceeds received from the May 2020 public offering of the Company’s common stock and a one-time upfront payment received in connection with the Company’s amended collaboration with BMS, partially offset by cash used in support of ordinary course operating and commercial-readiness activities.
Revenues: Total revenues were $10.7 million for the three months ended December 31, 2020 compared to $10.0 million for the three months ended December 31, 2019. Total revenues were $250.7 million for the twelve months ended December 31, 2020 compared to $44.7 million for the twelve months ended December 31, 2019. The increase for the three-month period was primarily driven by an increase in royalty and other revenue. The increase for the twelve-month period was primarily driven by the amended BMS collaboration and monetization for ex-U.S. milestones and royalties from ide-cel and bb21217, with the majority of the revenue recognized relating to ide-cel license and manufacturing services.
R&D Expenses: Research and development expenses were $137.1 million for the three months ended December 31, 2020 compared to $161.8 million for the three months ended December 31, 2019. Research and development expenses were $588.0 million for the twelve months ended December 31, 2020 compared to $582.4 million for the twelve months ended December 31, 2019. The decrease for the three-month period was primarily driven by a decrease in manufacturing costs, partially offset by increased costs incurred through the amended BMS collaboration. The increase for the twelve-month period was primarily driven by an overall increase in costs incurred to advance and expand the company’s pipeline, partially offset by a decrease in manufacturing costs.
SG&A Expenses: Selling, general and administrative expenses were $77.0 million for the three months ended December 31, 2020 compared to $76.2 million for the three months ended December 31, 2019. Selling, general and administrative expenses were $286.9 million for the twelve months ended December 31, 2020 compared to $271.4 million for the twelve months ended December 31, 2019. The increase for both periods was largely attributable to increased headcount and costs incurred to support the Company’s ongoing operations and growth of its pipeline, partially offset by a decrease in costs related to commercial readiness activities due to delays during 2020 as a result of the COVID-19 pandemic.
Net Loss: Net loss was $199.9 million for the three months ended December 31, 2020 compared to $223.3 million for the three months ended December 31, 2019. Net loss was $618.7 million for the twelve months ended December 31, 2020 compared to $789.6 million for the twelve months ended December 31, 2019.

On February 23, 2021 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that CEO David Giljohann will present at the 2021 H.C. Wainwright Global Life Sciences Conference, March 9-10, 2021 (Press release, Exicure, FEB 23, 2021, View Source [SID1234575480]).

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The presentation will be available to registered conference attendees for on-demand viewing beginning March 9, 2021 at 7:00AM EST via the virtual conference link, and will be archived for 90 days.

Exicure will be taking 1×1 investor meetings with registered conference attendees.

Replays of the presentation will be available on Exicure’s website for 30 days following the presentation.

On February 23, 2021 Teon Therapeutics, a biopharmaceutical company developing small molecules that inhibit the immunosuppressive and cancer-promoting signaling pathways, reported the completion of a $30M Series A financing (Press release, Teon Therapeutics, FEB 23, 2021, View Source [SID1234575496]). The financing was led by Oceanpine Capital with participation from additional new investors Oriza Ventures, Lifespan Investments, and former Gilead senior executives. All existing investors also participated in the financing round including Northern Light Venture Capital, Kaitai Capital and Oriental Fortune Capital. The funds will be used to advance the company’s lead A2BR-selective antagonist TT-702 into the clinic as well as to build the company’s pipeline.

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"This oversubscribed financing, during these uncertain times, validates the potential of our pipeline and reflects the confidence in our leadership team to deliver value for patients and investors. In collaboration with Cancer Research UK, we will advance our A2BR-selective antagonist TT-702 into the clinic later this year, and we will also strive to extend our unique portfolio." said Lina Yao, MD, Ph.D., Founder and Chief Executive Officer of Teon. "We are grateful for the continued support of our existing investors and are excited to welcome our new investors during this exciting time of growth and innovation for Teon. Their expertise will be invaluable as we execute on our vision to improve the lives of cancer patients across the world."

"The rapid development of Teon’s next generation of immunotherapies has been very impressive." said Dave Chenn, Founder, CEO and Managing Partner at Oceanpine Capital. "Teon’s GPCR-focused portfolio is differentiated from other immuno-oncology approaches as evidenced by targeting both immune and cancer cells. We look forward to working with this experienced team and other investors to advance a unique class of cancer immunotherapies into the clinic."

"We are thrilled for our continued partnership with Teon," said Feng Deng, Founding Managing Partner at Northern Light Venture Capital. "We have strong confidence in Teon’s experienced team and world-class GPCR experts and looking forward to working closely together to rapidly develop and expand its pipeline of novel therapies so that it can benefit as many cancer patients as quickly as possible."

On February 23, 2021 Elicio Therapeutics, a private biotechnology company developing a pipeline of potent immunotherapies based on its proprietary lymph-node targeting Amphiphile technology, reported it has received Investigational New Drug (IND) clearance from the U.S. Food and Drug Administration for ELI-002 (Press release, Elicio Therapeutics, FEB 23, 2021, View Source [SID1234575449]). ELI-002 is an Amphiphile (AMP) KRAS therapeutic vaccine containing AMP mKRAS peptides and a proprietary AMP CpG adjuvant, administered subcutaneously. The company’s novel therapeutic vaccine targets KRAS mutations that drive 99% of all KRAS-driven cancers. Phase I/II clinical trials of ELI-002 will enroll patients with mKRAS+ pancreatic ductal adenocarcinoma (PDAC) and other solid tumors. KRAS mutations are present in 90% of pancreatic cancers, 40% of colorectal cancers, 30% of non-small cell lung, 30% of bile duct, 14% of endometrial, and 14% of ovarian cancers. Elicio is developing ELI-002 to treat and prevent disease recurrence with potential to help one quarter of solid tumor patients.

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"Previous vaccine approaches utilizing synthetic peptides have not effectively targeted the critical immune cells residing in the lymph nodes and have elicited only weak or undetectable immune responses in patients," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. "The Amphiphile technology allows us to simultaneously generate immune response to all the mutations commonly present in KRAS driven cancers by targeting antigenic peptides with a powerful adjuvant directly to the lymph nodes, significantly amplifying the resulting immune responses, and producing highly functional mKRAS-specific T cells capable of destroying mKRAS positive cells like tumor cells."

Elicio’s Phase I/II trial will identify patients with PDAC and other solid tumors who have undergone standard of care surgery and neoadjuvant/adjuvant chemotherapy, that have persistent positive circulating tumor DNA indicating likely recurrence and rapid progression. Patients are studied in a window of opportunity after standard therapy is complete but before their tumors have had a chance to grow to a size where they are normally seen in radiographic scans.

"To date, "drugging" mKRAS directly has only been achieved in recent clinical trials for the G12C allele, using covalent inhibitors. Most human tumors have different mutations, where G12C is not a driver mutation. The ELI-002 therapeutic vaccine covers 99% of all mKRAS tumors creating the opportunity for improved durability of response and eradication of cancer," said Julian Adams Ph.D., chief executive officer of Gamida Cell and Chairman of Elicio Therapeutics’ Board of Directors.

About ELI-002

ELI-002 is an "AMP KRAS-vaccine" containing Amphiphile mKRAS peptides and a proprietary Amphiphile adjuvant, AMP CpG, administered subcutaneously. Elicio’s ELI-002 targets KRAS mutations, present in approximately 25% of all human solid tumors. The Amphiphile mKRAS peptides and Amphiphile CpG are targeted directly to the lymph node as a result binding to tissue albumin after injection, leading to accumulation of the complex into lymph nodes where the peptides and CpG payloads are delivered directly to key immune cells resulting in unprecedented efficiency. ELI-002 has the potential to become a multi-targeted mKRAS therapeutic vaccine with the ability to treat and prevent disease recurrence for hundreds of thousands of patients with mKRAS-driven cancers, including pancreatic, colorectal, lung, bile duct, endometrial, and ovarian. Elicio has demonstrated in multiple tumor models that improving the targeting of immunogens and cell-therapy amplifiers to lymph nodes, where resident immune cells potently orchestrate immunity, can substantially amplify their ability to induce effective tumor-killing immune responses.

About the Amphiphile Platform

The Elicio Amphiphile platform enables precise targeting and delivery of immunogens and cell-therapy amplifiers directly to the lymphatic system, the "brain center" of the immune response, to significantly amplify and enhance the body’s own system of defenses, defeat solid and hematologic cancers, and prevent their recurrence. Once in the lymph nodes, Amphiphile immunotherapies are taken up by antigen presenting cells (APC’s) to orchestrate signaling to natural or engineered immune cells in order to maximize therapeutic immune responses to disease. This strategy has been used to improve the activity of immunostimulatory agents, antigens, adjuvants, and cell-therapies that generate little to no response when used in the conventional forms. By precisely targeting these immunotherapies to the lymph nodes, Amphiphiles can unlock their full potential to generate and amplify anti-tumor immune responses. This substantially enhanced anti-tumor functionality and long-term protective memory may someday unlock the full potential of the immune response to eliminate cancer.

On February 23, 2021 Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in genetic testing and precision medicine, reported financial results for its quarter ended Dec. 31, 2020 and provided an update on recent business performance (Press release, Myriad Genetics, FEB 23, 2021, View Source [SID1234575465]).

Financial Highlights:
Myriad Genetics delivered total revenue in the quarter of $154.6 million which declined 21% year-over-year but increased 6% sequentially from the fiscal quarter ending Sep. 30, 2020, with improved commercial execution and a more stable pricing environment.

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Total test volumes of 224,000 declined 5% year-over-year but increased 7% sequentially. Average revenue per test declined 1% sequentially, demonstrating an increasingly stable pricing environment for the company’s products and was driven by mix shift increases from non-hereditary cancer product and the reduction of zero pay tests.
During the quarter, revenue was impacted by $5.3 million due to changes associated with an increase in our payer reserve, predominantly associated with hereditary cancer revenue. The Company also had immaterial net positive adjustments to revenues related to prior periods.
GAAP gross margin was 69.5% and non-GAAP gross margin was 70.1%. Adjusted gross margin improved 30 basis points sequentially, impacted positively by test volume growth and negatively by increased revenue mix from prenatal testing.
GAAP total operating expenses were $155.7 million. Total adjusted operating expenses declined $7.9 million year-over-year to $119.6 million in the December 2020 quarter.
GAAP operating loss in the quarter was ($48.2) million; non-GAAP operating loss of ($11.3) million.
GAAP earnings per share (EPS) were ($0.59) and adjusted EPS were ($0.12) which improved by $0.03 sequentially.
Free cash flow in the quarter was ($20.4) million, and cash utilization improved by 66% sequentially. The company ended the quarter with $171.7 million in cash and equivalents and investments. In February, Myriad received a tax refund from the U.S. government providing an additional $89 million in cash.
The company negotiated an amendment to its credit facility providing increased financial flexibility. Under the new amendment certain financial covenants are waived until the June 2022 quarter and there is added flexibility around future deployment of capital. The company ended the December quarter with $224.8 million drawn on the $300 million facility. Near-term plans include using proceeds from business unit divestitures to pay down the existing credit facility balance.
Business Performance and Highlights

Women’s Health
The Myriad Women’s Health business — which serves women who are assessing their risk of cancer, and women who are pregnant or planning a family — recorded revenue of $56.3 million in the quarter, a decline of 33% year-over-year. Elective testing for hereditary cancer has been negatively impacted by the COVID-19 pandemic due to delayed elective office visits. The COVID-19 surge in the December quarter led many women to postpone elective testing. The company’s prenatal business continued to demonstrate improving fundamentals with test volumes increasing 15% year-over-year and 7% sequentially.

Myriad myRisk Hereditary Cancer
myRisk Hereditary Cancer test volumes for the Women’s Health business declined 30% year-over-year but increased 6% relative to the September 2020 quarter.
Myriad Foresight Carrier Screen
Technological enhancements to Myriad’s Foresight carrier screen test in the December quarter increased the detection rate for alpha thalassemia inherited blood conditions from 90% to >99% in high-risk ethnicities such as Hispanic patients where the risk of alpha thalassemia can be 200 times greater than the risk of cystic fibrosis. These changes reduced the risk of a false negative by 10 times and improved the accuracy of the Foresight test for ethnic minority populations.
Myriad Prequel Prenatal Screen
The scientific journal Genetics in Medicine published a study demonstrating that Myriad’s proprietary AMPLIFY technology increases the accuracy of the Prequel prenatal screen for five common microdeletions by an average of 9 times. For these microdeletions the Prequel test demonstrated 97.2% sensitivity and 99.8% specificity.
Oncology
The Myriad Oncology business provides hereditary cancer testing for patients who have cancer, and products such as the EndoPredict breast cancer prognostic test, the Prolaris prostate cancer test, and it’s myChoice CDx and BRACAnalysis CDx products for predicting response to PARP inhibitors. The Oncology business delivered total revenue of $60.4 million, down 6% relative to revenue in the December quarter of last year.

Myriad myRisk Hereditary Cancer
myRisk Hereditary Cancer test volumes for the Oncology business declined 16% year-over-year but increased 5% relative to the September 2020 quarter.
Myriad Prolaris Prostate Cancer
Received a new local coverage determination (LCD) for the Prolaris prostate cancer test from Palmetto GBA and CGS Administrators, LLC, two of the administrative contractors for the Centers for Medicare & Medicaid Services, which took effect December 6th. The new LCD expands benefit entitlements for patients with unfavorable intermediate and high-risk prostate cancer and was partially responsible for the 31% sequential growth in Prolaris revenue.
Received acceptance for a new study publication in The Prostate demonstrating high accuracy for Prolaris in predicting metastases and disease specific mortality in men following radical prostatectomy.
A new study in Genitourinary Cancer demonstrated that the Prolaris test can accurately predict which patients will benefit from multi-modality therapy. Using the newly established threshold, 27% of men with newly diagnosed high-risk disease and 73% with unfavorable intermediate-risk disease could avoid multimodality therapy.
Myriad BRACAnalysis CDx
Saw significant increases in BRACAnalysis CDx test volume in Japan with total revenue from the country increasing 167% year-over-year to $8.8 million.
Myriad myChoice CDx
Announced a strategic collaboration with Illumina, Inc. for Illumina to create a kit-based version of the myChoice companion diagnostic (CDx) test for select international markets.
Received new reimbursement for the myChoice diagnostic system in Japan effective January 1, 2021.
Myriad EndoPredict
Received new public reimbursement for EndoPredict in Germany which will take effect between March and June 2021. Currently almost half of European EndoPredict volumes come from Germany.
Mental Health
Myriad’s Mental Health business — which consists of the GeneSight Psychotropic test that helps physicians understand how genetic alterations impact response to antidepressant and other psychotropic medications — saw revenue of $18.0 million in the quarter compared to $22.5 million in the same period last year. Total revenue for GeneSight was up 51% sequentially and test volumes increased 13% sequentially.

Myriad GeneSight
Saw a strong increase in new ordering providers with over 2,100 physicians ordering GeneSight for the first time in the quarter. Strong growth in new ordering physicians was a contributor to the 13% sequential growth in test volume despite COVID-19 related headwinds.
Had two important publications on GeneSight. The first was a new publication in Psychiatry Research demonstrated that the GeneSight combinatorial test was superior to single gene testing using the Clinical Pharmacogenetics Implementation Consortium (CPIC) guidelines. In a sub-analysis utilizing the GUIDED study data, only the GeneSight combinatorial approach was able to accurately predict variations in outcomes for patients with depression and statistically significantly predicted remission, response, and symptom improvement. The second was a meta-analysis of 1,556 patients based upon four prospective controlled clinical trials and published in Pharmacogenomics. The meta-analysis demonstrated statistically significant improvements in remission, response and symptom improvement. Myriad is actively in discussions with commercial payers based upon these positive data-sets.
Autoimmune
Myriad’s Autoimmune business — which consists of the Vectra test for measuring disease activity in rheumatoid arthritis — generated revenue of $8.9 million in the quarter compared to $10.3 million in the same period last year.

Vectra
Shared new data at the American College of Rheumatology annual meeting further demonstrating that Vectra testing and three additional biomarkers, combined with traditional risk factors, can predict the risk of cardiovascular events in patients with rheumatoid arthritis. The study, which evaluated over 44,000 patients, found that a one-point increase in the Vectra score was associated with being approximately four times greater risk of having a cardiovascular event.
Announced the decision to pursue strategic alternatives for the Myriad Autoimmune business units as part of the company’s transformation and growth plan.
Other
Other revenue – comprised of Myriad RBM contract research services for the pharmaceutical industry and the myPath Melanoma diagnostic test in dermatology — was $11.0 million in the December quarter versus $14.3 million in the same period in the prior year. The decline in revenue is entirely attributable to the previously announced sale of Myriad’s German clinic which occurred at the beginning of calendar year 2020.

Announced the decision to pursue strategic alternatives for the Myriad RBM and Dermatology business units as part of the company’s transformation and growth plan.
In-Network Provider with Anthem Blue Cross Blue Shield

Further expanding coverage for its genetic tests in the United States, Myriad recently signed a contract with the majority of the affiliated commercial health plans of Anthem Blue Cross Blue Shield, the second largest commercial payer in the country. The contract returns all Myriad products to in-network status, including hereditary cancer testing. While the new agreement is not expected to materially impact revenue in fiscal year 2021, it will aid in providing easier access to testing for patients and providers, and reducing non-payment on tests across all the company’s product lines.
Investor Day

Myriad plans to host an investor day to provide an update on its strategic transformation and growth plan on May 4th. The investor day will be a virtual event hosted on the company’s website.
Financial Guidance
Given the continued unpredictability surrounding the COVID-19 pandemic and the impact it has had on the healthcare environment, customer behavior and the ability to market tests to physicians, the company will not provide financial guidance for the quarter ending March 31, 2021 or fiscal year 2021.

Conference Call and Webcast
A conference call will be held today, Tuesday, Feb. 23, 2021, at 5 p.m. EST to discuss Myriad’s financial results for the December quarter and business developments. The dial-in number for domestic callers is 1-800-584-2088. International callers may dial 1-212-231-2924. All callers will be asked to reference reservation number 21990097. An archived replay of the call will be available for seven days by dialing 1-800-633-8284 and entering the reservation number above. The conference call along with a slide presentation will be available through a live webcast at www.myriad.com.