Quest Diagnostics Reports Fourth Quarter And Full Year 2018 Financial Results; Provides Guidance For Full Year 2019

On February 14, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the fourth quarter and full year ended December 31, 2018 (Press release, Quest Diagnostics, FEB 14, 2019, View Source [SID1234533345]).

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"In 2018 we grew revenues, adjusted earnings and cash from operations despite some challenges in the marketplace. Quest is well positioned once again in 2019 to deliver on our commitment to grow revenues and earnings, as our in-network status now extends to approximately 90% of commercially insured lives in the U.S.," said Steve Rusckowski, Chairman, CEO and President. "Our guidance for 2019 reflects significant reimbursement pressure offset by strong volume growth and continued execution of our Invigorate program. I am pleased to report our volumes for the year are off to a good start."

Net revenues and selling, general and administrative expenses for the three and twelve months ended December 31, 2017 have been restated to reflect the impact of new revenue recognition rules that became effective January 1, 2018 and were adopted on a full retrospective basis. Under the new rules, the company reports uncollectible balances associated with patient responsibility as a reduction in net revenues; historically these amounts were classified as bad debt expense within selling, general and administrative expenses.

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, net income attributable to Quest Diagnostics, and diluted EPS, see note 2 of the financial tables attached below.

As discussed in the company’s periodic reports filed with the Securities and Exchange Commission, recording revenues and accounts receivable involves judgment and estimation. The company follows a standard process, which considers historical denial and collection experience and other factors, to estimate contractual allowances and implicit patient price concessions, and regularly updates its estimates, recording adjustments in the current period as changes in estimates. Based on this process, during the fourth quarter the company increased its reserves for revenues and accounts receivable.

Guidance for Full Year 2019

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under the accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP measures as follows: (i) for the purpose of income measures the term "adjusted" refers to operating performance measures that exclude special items such as the effect of changes in tax law on our deferred tax assets (liabilities) and reserves, restructuring and integration charges, excess tax benefit ("ETB") associated with stock-based compensation and other items; and (ii) the term "adjusted diluted EPS excluding amortization expense" represents the company’s diluted EPS before the impact of special items (described above) and amortization expense.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-424-7881 for domestic callers or 203-369-0869 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on February 14, 2019 until midnight Eastern Time on February 28, 2019. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Lilly To Participate in Leerink Partners Global Healthcare Conference

On February 14, 2019 Eli Lilly and Company (NYSE: LLY) reported that it will participate in the Leerink Partners Global Healthcare Conference on Wednesday, February 27, 2019 (Press release, Eli Lilly, FEB 14, 2019, View Source [SID1234533344]). Christi Shaw, president of Lilly Bio-Medicines, will participate in a fireside chat at 1:00 p.m., Eastern Time.

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A live audio webcast will be available on the "Webcasts & Presentations" section of Lilly’s investor website at View Source A replay of the fireside chat will be available for approximately 90 days

Tanabe Research Labs Announce FDA Acceptance of its IND Application for TR1801-ADC (MT-8633), an ADC Targeting cMet Positive Solid Tumors

On February 14, 2019 Tanabe Research Laboratories U.S.A. Inc. (TRL), a subsidiary of Mitsubishi Tanabe Pharmaceutical Corporation, is a California based research, development and clinical stage company specializing in antibody technologies to treat cancer and other diseases with unmet medical needs (Press release, Mitsubishi Tanabe Pharma, FEB 14, 2019, View Source [SID1234533335]). TRL announced today that the U.S. Food and Drug administration (FDA) accepted the company’s first Investigational New Drug (IND) application to initiate a phase I trial for its Antibody Drug Conjugate TR1801-ADC (MT- 8633) in patients with cMet positive solid tumors.

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"We are excited to be able to move TR1801-ADC into the clinic," said Roland Newman, TRL’s Chief Scientific Officer. "TR1801-ADC is an extremely potent ADC that combines a non-agonizing anti-c-Met antibody developed at TRL, with a pyrrolobenzodiazepine dimer (PBD) toxin, and has demonstrated potent dose dependent anti-tumor activity against Met positive tumors in preclinical models."

The PBDs were developed by TRL’s collaborative partner MedImmune, the global biologics research and development arm of AstraZeneca (LSE: AZN), via its proprietary Spirogen technology and licensed to TRL. PBDs are of an order of magnitude more potent than other warheads currently used with other ADCs, and in the case of TR1801-ADC are linked to the antibody via a site-specific conjugation site.

cMet, also referred to as the hepatic growth factor receptor (HGFR), is a validated target expressed on a variety of tumor types including colorectal, NSCLC, gastric, esophageal, pancreatic, bile duct and many other cancers. "Patients will be selected based on c-Met expression levels using a histological screening system (IHC) to determine their eligibility. Patients that have either cMet gene amplification or are non-gene amplified will both be eligible for the trial as long as they meet the IHC expression cutoff requirement," said Gary Woodnutt, TRL’s VP of Development.

"The acceptance of this IND by the FDA is an important milestone for TRL," said CEO and President Naoki Sakurai, "as it validates our research efforts and represents the first ADC product in a rich future pipeline. This achievement is a result of hard work by our dedicated employees and is the first drug in TRL’s mission of creating therapies with a meaningful clinical benefit for patients."

About TRL:

TRL is an independent subsidiary of MTPC located in San Diego California, whose role is to discover and develop biological drug candidates for therapy. Currently, TRL’s efforts are directed towards antibody-related research to target tumors and other diseases with high unmet needs. TRL has established collaborative relationships with other companies and academic research organizations to develop Antibody Drug Conjugates (ADCs) and to identify therapeutic lead compounds for development. View Source

Forbius Announces a Clinical Trial Collaboration with the Myeloproliferative Neoplasm Research Consortium to Evaluate AVID200, a Novel TGF-beta Inhibitor, in Myelofibrosis

On February 14, 2019 Forbius, a clinical-stage company that develops biologics for the treatment of cancer and fibrosis, reported a collaboration agreement with the Icahn School of Medicine at Mount Sinai and the Myeloproliferative Neoplasm Research Consortium (MPN-RC) (Press release, Forbius, FEB 14, 2019, View Source [SID1234533334]). This collaboration will launch an investigator-initiated trial (IIT) evaluating AVID200, a highly potent and isoform-selective TGF-beta inhibitor, as a potential treatment for myelofibrosis (MF). The Phase 1/2 clinical trial will be sponsored by the MPN-RC with NIH grant support and is expected to start during Q1 2019.

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"We have demonstrated that blocking TGF-beta signaling reverses bone marrow fibrosis and restores hematopoiesis in preclinical models. We believe that selective TGF-beta inhibition by AVID200 could address the underlying cause of bone marrow failure and become the first disease-modifying therapy in MF. Our consortium is eager to commence evaluation of AVID200 in the upcoming clinical study," commented Dr. Ronald Hoffman, founder of the MPN-RC and Director of the Myeloproliferative Disorders Research Program at the Icahn School of Medicine at Mount Sinai.

Forbius is evaluating the immuno-oncology and anti-fibrotic effects of AVID200 in Phase 1 trials, including solid tumors and systemic sclerosis. Additionally, Forbius is expanding the AVID200 clinical development program by supporting IITs through the provision of drug, scientific input, and collaboration on the conduct of translational studies. Additional details pertaining to the prospective IIT in MF will be disclosed in due course.

About the Myeloproliferative Neoplasm Research Consortium (MPN-RC)

The MPN-RC was founded in 2006 and is the only independent, multi-center, international consortium of scientists and clinicians that is dedicated to developing novel therapeutic strategies for MF and other myeloproliferative neoplasms (MPN). The MPN-RC is funded by the NIH to conduct clinical trials based on the most promising preclinical MPN research. The goal of the consortium is to adapt quickly in response to scientific advances and a changing clinical landscape, in order to develop effective therapeutics for MPN patients.

About AVID200

AVID200 is an isoform-selective and highly potent inhibitor of TGF-beta 1 & 3, the two principal pro-fibrotic TGF-beta isoforms. These TGF-beta isoforms are central regulators in the pathogenesis and progression of fibrotic diseases, including MF (Chagraoui et al., 2002). AVID200 was rationally designed to be minimally active against TGF-beta 2, which is a promoter of hematopoiesis and normal cardiac function. This optimal selectivity positions AVID200 to be an effective and well-tolerated therapeutic in MF and other fibrotic diseases.

About Myelofibrosis (MF)

MF is a rare, life-threatening blood cancer characterized by progressive bone marrow fibrosis, which causes ineffective hematopoiesis. Approximately 30,000 people in the US alone are affected by this disease. Currently, there are no approved therapies targeting the underlying bone marrow fibrosis available to MF patients.

CEL-SCI Corporation Reports First Quarter Fiscal 2019 Financial Results

On February 14, 2019 CEL-SCI Corporation (NYSE American: CVM) reported financial results for the quarter ended December 31, 2018 (Press release, Cel-Sci, FEB 14, 2019, View Source [SID1234533333]).

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CEL-SCI’s Phase 3 head and neck cancer study continued to follow all 928 patients who were enrolled. The Company is now awaiting final study results. All that remains to be done in this pivotal Phase 3 study, the largest in the world in head and neck cancer, is to continue to track patient survival until it can be determined if the primary endpoint has been met. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine* treatment regimen plus Standard of Care (SOC) vs. SOC alone, will be determined after a total of 298 events have occurred in the two main comparator arms of the study and have been recorded in the study database. These final results could come soon since the last patients were treated in September 2016.
The U.S. Patent and Trademark Office issued two new patents for CEL-SCI’s LEAPS platform technology. The inventions relate to methods for diagnosing, preventing, and treating disease by generating or modulating immune response through the use of specific peptides.
During the first quarter, CEL-SCI’s LEAPS platform technology continued its development program as a therapeutic vaccine for rheumatoid arthritis under a $1.5 million grant from the U.S. National Institutes of Health (NIH).
Between January 1, 2019 and February 13, 2019, the Company received approximately $2.1 million through the exercise of warrants to purchase shares of the Company’s common stock.
"During the first quarter of fiscal 2019, we continued to follow patients in our Phase 3 head and neck cancer trial, as we await a readout of topline results from this pivotal study, which may result in the first new approved first line therapy for advanced primary (not yet treated) head and neck cancer in over 60 years. Concurrently, we continue to advance our LEAPS platform through studies with the NIH while fortifying our intellectual property around this unique vaccine technology," stated CEL-SCI CEO, Geert Kersten.

CEL-SCI reported a net income of $1.2 million for the quarter ended December 31, 2018 versus a net loss of $6.2 million for the quarter ended December 31, 2017. The net income increase was mainly due to the non-cash derivative gain of approximately $5.6 million for the three months ended December 31, 2018 versus a loss on derivative instruments of approximately $1.0 million for the three months ended December 31, 2017. Net interest expense also decreased by approximately $0.6 million for the three months ended December 31, 2018 compared to the three months ended December 31, 2017. The total operating expense remained constant for the quarter ended December 31, 2018 versus the quarter ended December 31, 2017.