On January 12, 2020 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company expects to report revenue between $294 million and $296 million for the fourth quarter ended Dec. 31, 2019 (Press release, Exact Sciences, JAN 12, 2020, View Source [SID1234553038]).

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"Building off a transformative 2019, Exact Sciences is uniquely positioned to change the way cancer is diagnosed and treated," said Kevin Conroy, chairman and CEO of Exact Sciences. "Following our combination with Genomic Health, we have the leading scientific minds, an experienced commercial team with deep relationships, and the global footprint necessary to support the growth of current and future cancer diagnostics. We’ve never been more excited about the future of Exact Sciences."

Preliminary, Unaudited Fourth-Quarter 2019 Financial Results

For the three-month period ended December 31, 2019, as compared to the same period of 2018 (where applicable):

Expected total revenue between $294 million and $296 million
Expected Screening revenue between $229 million and $230 million, an increase of 61 percent
Expected Precision Oncology revenue between $65 million and $66 million for the period Nov. 8, 2019 through Dec. 31, 2019, following the close of the Genomic Health acquisition
Expected Precision Oncology proforma revenue for the full fourth quarter between $118 million and $119 million, an increase of 13 percent, assuming Genomic Health were a standalone entity
Cologuard test volume was 477,000, an increase of 63 percent
Oncotype DX test volume was 41,000, an increase of 14 percent
Preliminary, Unaudited 2019 Financial Results

For the twelve-month period ended December 31, 2019, as compared to the same period of 2018 (where applicable):

Expected total revenue between $874.5 million and $876.5 million, including Precision Oncology revenue between $65 million and $66 million for the period Nov. 8, 2019 through Dec. 31, 2019, following the close of the Genomic Health acquisition
Expected Screening revenue between $809.5 million and $810.5 million, an increase of 78 percent
Expected Precision Oncology proforma revenue between $455 million and $456 million, an increase of 16 percent, assuming Genomic Health were a standalone entity
Cologuard test volume was 1.68 million, an increase of 80 percent
Oncotype DX test volume was 156,000, an increase of 14 percent
For the fourth quarter and 2019, Screening includes revenue from Cologuard and Biomatrica products. Precision Oncology includes global Oncotype DX product revenue. Proforma revenue figures for Precision Oncology for the three and twelve-month periods ended Dec. 31, 2019 include results prior to the acquisition of Genomic Health by Exact Sciences which closed on Nov. 8, 2019.

Exact Sciences has not completed preparation of its financial statements for the fourth quarter or full year of 2019. The revenue ranges presented in this news release for the fourth quarter of 2019 and for the year ended Dec. 31, 2019 are preliminary and unaudited and are thus inherently uncertain and subject to change as we complete our financial results for the fourth quarter of 2019. We are in the process of completing our customary year-end close and review procedures as of and for the year ended Dec. 31, 2019, and there can be no assurance that our final results for this period will not differ from these estimates. During the course of the preparation of our consolidated financial statements and related notes as of and for the year ended Dec. 31, 2019, we or our independent registered public accountants may identify items that could cause our final reported results to be materially different from the preliminary financial estimates presented herein.

Exact Sciences plans to report 2019 financial results and provide guidance during its February 2020 earnings call.

About Cologuard
Cologuard was approved by the FDA in August 2014, and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2018) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults 45 years of age and older who are at average risk for colorectal cancer by detecting certain DNA markers and blood in the stool. Do not use Cologuard if you have had precancer, have inflammatory bowel disease and certain hereditary syndromes, or have a personal or family history of colorectal cancer. Cologuard is not a replacement for colonoscopy in high risk patients. Cologuard performance in adults ages 45-49 is estimated based on a large clinical study of patients 50 and older. Cologuard performance in repeat testing has not been evaluated.

The Cologuard test result should be interpreted with caution. A positive test result does not confirm the presence of cancer. Patients with a positive test result should be referred for diagnostic colonoscopy. A negative test result does not confirm the absence of cancer. Patients with a negative test result should discuss with their doctor when they need to be tested again.

Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

On January 12, 2020 Neurocrine Biosciences, Inc. (NASDAQ: NBIX) reported an update on its business performance, including preliminary net product sales results for 2019, and key commercial and clinical development milestones for 2020 (Press release, Neurocrine Biosciences, JAN 12, 2020, View Source [SID1234553040]). Kevin Gorman, Chief Executive Officer of Neurocrine Biosciences, will discuss these updates as part of a webcast presentation at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, Jan. 13 at 11:30 a.m. Pacific Time (2:30 p.m. Eastern Time).

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Preliminary Fourth Quarter and Full-Year 2019 INGREZZA (valbenazine) Net Product Sales and Financial Results (Unaudited)

Based on preliminary unaudited financial information, the Company expects INGREZZA net product sales for the three months and full-year ended December 31, 2019 to be approximately $238 million and $753 million, respectively, compared to $130 million and $410 million for the same periods in 2018. Preliminary analysis of INGREZZA net product sales and TRx for the fourth quarter 2019 compared to third quarter 2019 suggests:

– Continued strength in new patient additions
– End of fourth quarter days-on-hand channel inventory increased relative to the third quarter due to timing of quarter-end purchases resulting in an approximate $11 million benefit to net product sales. Given the increase to year-end channel inventory, the Company anticipates this may lead to a reduction to channel inventory in the first quarter of 2020.
– INGREZZA net product sales per prescription of $5,650 for the fourth quarter of 2019

Preliminary unaudited cash and marketable securities balance as of December 31, 2019 is $970 million.

"Our results reflect our team’s dedication to educating healthcare providers and patients about tardive dyskinesia as seen in the growing number of patients receiving treatment with INGREZZA. We still have a lot of work to do as a majority of people suffering from tardive dyskinesia remain undiagnosed and untreated," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "In 2020, we aim to have three FDA-approved medicines in four indications and will remain focused on helping more tardive dyskinesia patients with INGREZZA, preparing for the anticipated approval of opicapone in the U.S., and advancing our growing pipeline, including three pivotal clinical trial programs. We are well positioned as we evolve towards becoming a leading global neuroscience-focused biopharmaceutical company."

2020 INGREZZA Net Product Sales Outlook

During the first quarter of 2020, the Company expects INGREZZA net product sales to be impacted as a result of payer-related seasonal dynamics, gross-to-net discount increases from payer and Medicare Part D rebates, and potential reduction in channel inventory. The Company does not intend to provide formal INGREZZA net product sales guidance for 2020 as the tardive dyskinesia market continues to evolve.

2020 Expected Milestones and Key Activities

INGREZZA (valbenazine) for Tardive Dyskinesia

– "Talk About TD" disease state awareness campaign
– Continued execution of post-marketing clinical studies, including RE-KINECT, the largest real-world study in patients with possible tardive dyskinesia
– Presentations at key scientific annual meetings, including American Academy of Neurology (AAN), American Psychiatric Association (APA), International Parkinson and Movement Disorder Society (MDS)
– Regulatory submissions for approval by Mitsubishi Tanabe in ASEAN territory

Valbenazine for Chorea in Huntington Disease

– Advance the current Phase III study recruitment and initiate open label portion of study during 1H 2020

Elagolix in Collaboration with AbbVie

– Prescription Drug User Fee Act (PDUFA) date in Q2 2020 of elagolix for uterine fibroids
– Continued launch of ORILISSA (elagolix) to treat moderate to severe pain associated with endometriosis by AbbVie

Opicapone for Parkinson’s Disease

– PDUFA date of April 26, 2020
– Preparation for commercial launch
– Presentations at key scientific annual meetings, including AAN, MDS

Crinecerfont (NBI-74788) for Congenital Adrenal Hyperplasia (CAH)

– Phase IIa data (adults) oral presentation in March at ENDO 2020
– Global registrational study initiation (adults) in mid-2020
– Advancement of pediatric plan including Phase IIa study

NBIb-1817 (VY-AADC) for Parkinson’s Disease

– Present 3yr follow up data from study PD-1101 at appropriate medical conference
– Implement amended protocol for RESTORE-1 registration trial by mid-year based upon feedback from the U.S. Food and Drug Administration (FDA)
– Initiate RESTORE-II registration trial in 2H 2020

NBI-921352 (XEN901) for Epilepsy

– File Investigational New Drug (IND) application with the FDA in mid-2020 in order to start a Phase II trial in SCN8A developmental and epileptic encephalopathy patients in 2H 2020

ACT-709478 for Epilepsy

– Upon IND application acceptance by the FDA, expected in mid-2020, the Company will have 30 days to exercise the option to license ACT-709478
– A Phase II study in a rare pediatric epilepsy is planned in 2H 2020

About INGREZZA (valbenazine) Capsules
INGREZZA, a selective vesicular monoamine transporter 2 (VMAT2) inhibitor, is the first FDA-approved product indicated for the treatment of adults with tardive dyskinesia, a condition associated with uncontrollable, abnormal and repetitive movements of the face, torso, and/or other body parts.

INGREZZA is thought to work by reducing the amount of dopamine released in a region of the brain that controls movement and motor function, helping to regulate nerve signaling in adults with tardive dyskinesia. VMAT2 is a protein in the brain that packages neurotransmitters, such as dopamine, for transport and release in presynaptic neurons. INGREZZA, developed in Neurocrine’s laboratories, is novel in that it selectively inhibits VMAT2 with no appreciable binding affinity for VMAT1, dopaminergic (including D2), serotonergic, adrenergic, histaminergic, or muscarinic receptors. Additionally, INGREZZA can be taken for the treatment of tardive dyskinesia as one capsule, once-daily, together with psychiatric medications such as antipsychotics or antidepressants.

Important Safety Information

Contraindications
INGREZZA is contraindicated in patients with a history of hypersensitivity to valbenazine or any components of INGREZZA. Rash, urticaria, and reactions consistent with angioedema (e.g., swelling of the face, lips, and mouth) have been reported.

Warnings & Precautions
Somnolence
INGREZZA can cause somnolence. Patients should not perform activities requiring mental alertness such as operating a motor vehicle or operating hazardous machinery until they know how they will be affected by INGREZZA.

QT Prolongation
INGREZZA may prolong the QT interval, although the degree of QT prolongation is not clinically significant at concentrations expected with recommended dosing. INGREZZA should be avoided in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. For patients at increased risk of a prolonged QT interval, assess the QT interval before increasing the dosage.

Parkinsonism
INGREZZA may cause Parkinsonism in patients with tardive dyskinesia. Parkinsonism has also been observed with other VMAT2 inhibitors. Reduce the dose or discontinue INGREZZA treatment in patients who develop clinically significant parkinson-like signs or symptoms.

Adverse Reactions
The most common adverse reaction (≥5% and twice the rate of placebo) is somnolence. Other adverse reactions (≥2% and >placebo) include: anticholinergic effects, balance disorders/falls, headache, akathisia, vomiting, nausea, and arthralgia.

On January 12, 2020 Luminex Corporation (Nasdaq: LMNX) reported 2019 highlights and 2020 guidance (Press release, Luminex, JAN 12, 2020, View Source [SID1234553041]).

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All amounts in this release are in conformity with U.S. generally accepted accounting principles ("GAAP").

Preliminary results, contained herein, are based on management’s initial analysis of operations for the quarter and year ended December 31, 2019 and are subject to further internal review and audit by the company’s external auditors.

Current Highlights

Total fourth quarter revenue of $90.4 million, an 11% increase over Q4 2018.
Total full year revenue of $334.6 million, up 6%; and up 19% without consideration of LabCorp revenue and including the effect of the Flow Cytometry acquisition.
Sample-to-answer full year revenue of $75.7 million, up more than 20% vs. 2018, including contracting 200 additional systems.
Licensed Technologies Group full year revenue was relatively unchanged from 2018, as expected; however, end user sales of our technology increased by 12% year over year.
Flow Cytometry full year revenue of $45 million, up 11% vs. 2018.
Anticipate being profitable in the fourth quarter of 2019.
Continued $0.09 per share dividend in the fourth quarter of 2019.
2020 Guidance

The company expects 2020 consolidated revenue to be between $352 and $362 million, up approximately 7% to the mid-point relative to 2019, which includes approximately 2 to 3 percent headwind attributable to the departure of certain remaining sales to LabCorp.

CEO Commentary

"2019 was a transition year for Luminex as we adjusted to the departure of certain sales to LabCorp and the integration of the Flow Cytometry acquisition," said Nachum "Homi" Shamir, President & CEO. "I am very pleased with the significant progress we are making. Luminex is now a more diversified company, with opportunities for strong organic growth, profitability, and cash flow, and exciting new platforms being launched across each of our major product lines. We are well positioned to achieve our mid-term target of $500 million of annual revenue in the next 4 to 5 years."

Luminex Presentation / Webcast at 38th Annual J.P. Morgan Healthcare Conference on January 14, 2020

Luminex President and CEO, Homi Shamir, will present at the 38th Annual J.P. Morgan Healthcare Conference to be held at The Westin St. Francis hotel in San Francisco, CA on Tuesday, January 14 at 12:00 p.m. Pacific Time. A live webcast of the Luminex presentation may be accessed at the company’s website at investor.luminexcorp.com. The presentation will be archived for six months on the website using the ‘replay’ link.

Fourth Quarter and Full Year 2019 Earnings Release on February 10, 2020

The company plans to report results for the fourth quarter and full year ended December 31, 2019 and provide details around the 2020 revenue guidance after the market close on Monday, February 10, 2020. Management will hold a conference call to discuss the operating highlights and financial results on that date, at 5:00 p.m. Eastern Time.

On January 12, 2020 Agios Pharmaceuticals, Inc. (NASDAQ: AGIO) reported its "Agios 2025" six-year strategic vision focused on creating and commercializing differentiated medicines to treat hematologic malignancies, solid tumors and rare genetic diseases (Press release, Agios Pharmaceuticals, JAN 12, 2020, View Source [SID1234553024]). Under this plan, by the end of 2025, the company expects to have four marketed products across at least eight indications, at least six molecules in clinical development and be cash-flow positive. Agios will present at the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 13 at 7:30 a.m. PT (10:30 a.m. ET), and a live webcast will be available at investor.agios.com.

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"We are entering an exciting new chapter for Agios as we advance our first rare genetic disease program across three opportunities in PK deficiency, thalassemia and sickle cell disease and continue our work to expand the benefit of IDH inhibitors to solid tumors as well as to additional indications in hematologic malignancies," said Jackie Fouse, Ph.D., chief executive officer of Agios. "We will realize our 2025 vision by continuing to leverage our unmatched expertise in cellular metabolism, early translational research and our passionately patient-focused team, the same attributes that enabled us to discover, develop and market two targeted oncology medications in just 10 years. With both near- and long-term value drivers, Agios enters 2020 with strong momentum that will continue as we work toward achieving our 2025 strategic vision."

"AGIOS 2025" STRATEGIC VISION

The "Agios 2025" strategic vision delineates the company’s view for growth over the next six years with established and expanding franchises focused on treating hematologic malignancies, solid tumors and rare genetic diseases. As part of this vision, Agios expects to achieve the following milestones by the end of 2025:

4 marketed medicines discovered and developed at Agios
Approvals in 8+ indications spanning hematologic malignancies, solid tumors and rare genetic diseases
6+ molecules in the clinic generated by the company’s internal research discovery engine
Cash-flow positive within the six-year timeframe
ANTICIPATED 2020 KEY MILESTONES

Agios announced today that it expects to achieve the following key milestones in 2020:

Hematologic Malignancies

Deliver full-year U.S. revenue for TIBSOVO of $105-115 million
Receive European Medicines Agency CHMP opinion for TIBSOVO in relapsed or refractory acute myeloid leukemia (AML) with an IDH1 mutation by year-end
Complete enrollment of Phase 3 AGILE trial of TIBSOVO in combination with azacitidine in adult patients with previously untreated IDH1 mutant AML by year-end
Complete enrollment of the relapsed or refractory myelodysplastic syndrome arm of the TIBSOVO Phase 1 study of IDH1 mutant advanced hematologic malignancies by year-end
Solid Tumors

File supplemental new drug application (sNDA) for TIBSOVO in previously treated IDH1 mutant cholangiocarcinoma by year-end
Rare Genetic Diseases

Announce topline data for ACTIVATE and ACTIVATE-T pivotal trials for mitapivat in adults with pyruvate kinase (PK) deficiency by year-end
Submit updated data from the Phase 2 study of mitapivat in thalassemia for presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress and finalize pivotal development strategy by year-end
Achieve proof of concept for mitapivat in sickle cell disease by mid-2020
Receive investigational new drug (IND) clearance for AG-946, a next generation PKR activator, and initiate first-in-human study in healthy volunteers in the first half of 2020
Research

Achieve at least one new development candidate by year-end
RECENT MILESTONES

The company also provided an update on the following 2019 key milestones:

Completed enrollment of ACTIVATE-T, a single-arm trial evaluating mitapivat in regularly transfused adults with PK deficiency
Expect to complete enrollment in ACTIVATE, a 1:1 randomized, placebo-controlled trial in adult PK deficiency patients who do not receive regular transfusions, in the first quarter of 2020
Initiated the registration-enabling Phase 3 INDIGO study of vorasidenib in patients with Grade 2 non-enhancing glioma with an IDH mutation
2019 Year-End Cash and Guidance
Agios ended 2019 with approximately $718 million of cash, cash equivalents and marketable securities. The company expects that its cash, cash equivalents and marketable securities as of December 31, 2019, together with anticipated product and royalty revenue, interest income and expense reimbursements under our collaboration agreements, but excluding any additional program-specific milestone payments, will enable the company to fund its planned operating expenses and capital expenditure requirements through at least the end of 2021.

Presentation at 38th Annual J.P. Morgan Healthcare Conference
Agios will webcast its corporate presentation and break out session from the 38th Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 13, 2020 at 7:30 a.m. PT (10:30 a.m. ET). A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at agios.com. A replay of the webcast will be archived on the Agios website for at least two weeks following the presentation.

On January 12, 2020 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported President and Chief Executive Officer Pascal Touchon will share details of the company’s mission, scientific platform and development pipeline during a presentation at the 38th Annual J.P. Morgan Healthcare Conference on Thursday, January 16 at 8:30 a.m. PST at the Westin St. Francis Hotel in San Francisco (Press release, Atara Biotherapeutics, JAN 12, 2020, View Source [SID1234553025]).

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"As we enter into this new year, we are proud of our progress building a leading off-the-shelf, allogeneic T-cell immunotherapy company with a robust pipeline," said Pascal Touchon, President and Chief Executive Officer of Atara Biotherapeutics. "Backed by our innovative EBV T-cell platform, next-generation CAR T technologies, state-of-the-art manufacturing capabilities and dedication to developing transformative T-cell immunotherapies for patients, we are confident in our ability to execute on our 2020 plans."

Anticipated key milestones across Atara’s four strategic priorities in 2020 include:

Tab-cel (tabelecleucel)

Submitted clinical trial applications (CTAs) to several European countries in November 2019 to enable opening EU clinical sites in 2020
Begin enrollment in a Phase 2 multi-cohort study including patients with other EBV+ cancers in the second half of 2020
Initiate FDA Biologics License Application (BLA) submission for patients with EBV+ PTLD in the second half of 2020
ATA188

Initiate enrollment of randomized, double-blind, placebo-controlled Phase 1b study in patients with progressive MS in the second or third quarter of 2020
Present six- and twelve-month ATA188 Phase 1a clinical results for cohorts 3 and 4 in the first and second halves of 2020, respectively
ATA2271

Submit next-generation mesothelin-targeted autologous CAR T IND for patients with advanced mesothelioma in the second or third quarter of 2020
EBV CAR T Platform

Academic presentation of an off-the-shelf, allogeneic CD19 CAR T clinical proof-of-principle using a partially HLA matched Epstein-Barr virus T cell academic construct for patients with relapsed/refractory B-cell malignancies at the 2020 Transplantation and Cellular Therapy (TCT) Meetings to be held February 19-23 in Orlando, Fla.
A live audio webcast of the J.P. Morgan Healthcare Conference presentation will be available by visiting the Investors and Media section of the Atara website. An archived replay of the webcast will be available on the Company’s website for 14 days following the live presentation.