On February 6, 2020 Coherus BioSciences, Inc. ("Coherus" or "the Company", Nasdaq: CHRS), reported that its fourth quarter and full year 2019 financial results will be released after market close on Thursday, February 27, 2020 (Press release, Coherus Biosciences, FEB 6, 2020, View Source/news-releases/news-release-details/coherus-biosciences-report-fourth-quarter-and-full-year" target="_blank" title="View Source/news-releases/news-release-details/coherus-biosciences-report-fourth-quarter-and-full-year" rel="nofollow">View Source [SID1234553936]). Starting at 4:30 p.m. ET, Coherus’ management team will host a conference call to discuss financial results and provide a general business update.

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After releasing fourth quarter and full year 2019 financial results, the Company will post them on the Coherus website at View Source." target="_blank" title="View Source." rel="nofollow">View Source

Conference Call Information

When: Thursday, February 27, 2020 starting at 4:30 p.m. ET
Dial-in: (844) 452-6826 (toll free) or (765) 507-2587 (International)
Conference ID: 9658203
Webcast: View Source
Please join the conference call at least 10 minutes early to register. The webcast will be archived on the Coherus website.

On February 6, 2020 Cardinal Health (NYSE: CAH) reported financial results for the second quarter of fiscal 2020 ended December 31, 2019 (Press release, Cardinal Health, FEB 6, 2020, View Source [SID1234553935]). Second quarter revenue was $39.7 billion, an increase of 5% from the second quarter of last year.

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Second quarter GAAP operating earnings decreased 34% to $334 million, which included a $96 million charge in connection to the recently announced voluntary surgical gown-related recalls. Non-GAAP operating earnings increased 1% to $646 million. GAAP diluted earnings per share (EPS) decreased 19% to $0.75, while non-GAAP diluted EPS increased 18% to $1.52. Non-GAAP diluted EPS benefited from a lower effective tax rate and a lower share count.

"With the first half of the year behind us, we are raising our fiscal year 2020 guidance," said Mike Kaufmann, CEO of Cardinal Health. "This increase was driven by improved performance across our Pharmaceutical segment, particularly within our generics program. As we look forward, we remain focused on executing our strategic growth initiatives."

Second quarter revenue for the Pharmaceutical segment increased 6% to $35.7 billion, due to sales growth from Pharmaceutical Distribution and Specialty Solutions customers.

Pharmaceutical segment profit increased 4% to $462 million in the second quarter, reflecting positive performance in the company’s generics program and Specialty Solutions business. This was partially offset by the adverse impact of Pharmaceutical Distribution customer contract renewals.

Medical segment

1 Medical segment profit does not include the $96 million charge incurred for inventory write-offs and certain remediation and supply disruption costs associated with the recently announced voluntary surgical gown-related recalls.
Second quarter revenue for the Medical segment was flat at $4.0 billion. Growth in Cardinal Health at Home was offset by a decline in products and distribution.

Medical segment profit increased 4% to $195 million in the second quarter. This increase reflects benefits from cost savings initiatives, partially offset by a decline in products and distribution.

Tax rate
During the second quarters of fiscal 2020 and 2019, GAAP effective tax rates were 21.0% and 31.0%, respectively. Non-GAAP effective tax rates were 24.8% and 28.5%, respectively. The GAAP effective tax rate benefitted from jurisdictional mix and discrete items recognized in the second quarter of 2020, largely driven by changes as a result of tax reform. The Non-GAAP effective tax rate benefitted from jurisdictional mix.

Fiscal year 2020 Outlook
The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

The company raises its fiscal year 2020 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. to the range of $5.20 to $5.40 from the range of $4.85 to $5.10.

Recent highlights

For the 12th consecutive year in a row, Cardinal Health was honored as one of the "Best Places to Work for LGBTQ Equality" by the Human Rights Campaign (HRC) Foundation, achieving 100% on the HRC’s 2020 Corporate Equality Index (CEI).

Cardinal Health was recognized by the Women’s Forum of New York for having at least 40% of board seats held by women.

Webcast
Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss second quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until February 5, 2021.

Upcoming webcasted investor events

Barclays Global Healthcare Conference on March 10 at 8:30 a.m. Eastern in Miami Beach, Fla.

On February 6, 2020 ALK Positive (a patient-led group of 1,900+ lung cancer patients and caregivers in 50+ countries) and GO2 Foundation for Lung Cancer (a global lung cancer advocacy and education organization) are reported awarding a two-year, $500,000 Research Collaboration Grant to two renowned lung cancer researchers dedicated to overcoming treatment resistance (Press release, Bonnie J Addario Lung Cancer Foundation, FEB 6, 2020, View Source [SID1234553934]).

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This grant funds research to help break down barriers to successful lung cancer treatment and to identify new treatments. A 2019 partnership between ALK Positive and the GO2 Foundation raised the funds for this grant.

Patients with ALK+ lung cancer benefit from targeted therapy medications but drug resistance ultimately limits this benefit: most patients develop progressive disease within one to three years of treatment.

Dr. Trever Bivona, associate professor of medicine at the University of California – San Francisco, and Dr. Christine Lovly, associate professor of medicine, Vanderbilt University Medical Center, are receiving the grant for their project, "Transforming ALK+ lung cancer into a chronic or curable condition by combating drug resistance." Drs. Bivona and Lovly are recognized lung cancer experts. The study will explore if new combinations of targeted therapies can delay or prevent treatment resistance.

"ALK Positive is grateful to GO2 Foundation for their efforts in coordinating this partnership. The fundraising efforts of the ALK Positive members and their supporters have been extraordinary, and we are hopeful this project will make significant strides in accomplishing our mission to ‘improve the life expectancy and quality of life for all ALK-positive patients worldwide’," said Gina Hollenbeck, the group’s president.

"One of the greatest barriers to surviving lung cancer is treatment resistance. This grant will help overcome this significant obstacle, give patients hope, and help to achieve the goal of making lung cancer a chronically-managed disease," said Bonnie J. Addario, co-founder and board chair of the GO2 Foundation. "Lung cancer is truly leading the way to make research personal. This is an example of how patients, advocates and researchers are putting their heads together to create new, game-changing research."

"I am honored to work alongside the ALK Positive community on this effort to accelerate our understanding of resistance and to find new ways to fight it," said Bivona. "At a time when we are making great strides in the treatment of lung cancer, yet research funding is lacking, we are deeply appreciative of this funding from members of ALK Positive," said Lovly.

On February 6, 2020 Blueprint Medicines Corporation (NASDAQ: BPMC), a precision therapy company focused on genomically defined cancers, rare diseases and cancer immunotherapy, reported that the U.S. Food and Drug Administration (FDA) has extended the Prescription Drug User Fee Act (PDUFA) date for its New Drug Application (NDA) seeking accelerated approval of avapritinib for the treatment of adults with fourth-line gastrointestinal stromal tumor (GIST) (Press release, Blueprint Medicines, FEB 6, 2020, View Source [SID1234553928]). The FDA extended the PDUFA action date by three months from February 14, 2020 to May 14, 2020.

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As previously announced, the FDA has requested top-line data from Blueprint Medicines’ ongoing Phase 3 VOYAGER clinical trial, which is comparing avapritinib to regorafenib in third- or fourth-line GIST, to inform the pending action on the NDA for fourth-line GIST. Blueprint Medicines expects to provide the top-line data to the FDA early in the second quarter of 2020 to enable the FDA to take action by the May 14, 2020 PDUFA date.

In addition, Blueprint Medicines reported that the National Comprehensive Cancer Network has updated its Clinical Practice Guidelines in Oncology (NCCN Guidelines) for Soft Tissue Sarcoma to include avapritinib as a recommended category 2A treatment for unresectable or metastatic GIST with a PDGFRA exon 18 mutation, including PDGFRA D842V mutations, as well as fourth-line GIST. This rating indicates that there is uniform NCCN consensus that the intervention is appropriate. The NCCN Guidelines are the recognized clinical standard for cancer care by U.S. healthcare providers and payers, and are maintained by a committee of expert physicians from leading U.S. cancer centers.

About AYVAKIT (avapritinib)

AYVAKIT (avapritinib) is a kinase inhibitor approved by the FDA for the treatment of adults with unresectable or metastatic GIST harboring a PDGFRA exon 18 mutation, including PDGFRA D842V mutations. AYVAKIT is a selective and potent inhibitor of KIT and PDGFRA mutant kinases. It is the only FDA-approved type 1 inhibitor for GIST that works by directly binding to the active kinase conformation from which mutant KIT and PDGFRA signal. AYVAKIT has demonstrated inhibition of a broad range of KIT and PDGFRA mutations associated with GIST, including potent clinical activity against activation loop mutations that are associated with resistance to currently approved therapies. For more information, visit AYVAKIT.com.

Avapritinib is not approved for the treatment of any other indication, including fourth-line GIST, in the U.S. or any other jurisdiction by the FDA or any other health authority.

Blueprint Medicines is pursuing a broad clinical development program for avapritinib across multiple lines of GIST treatment, as well as for advanced, smoldering and indolent systemic mastocytosis (SM). The FDA has granted Breakthrough Therapy Designation to avapritinib for two indications: one for the treatment of unresectable or metastatic GIST harboring the PDGFRA D842V mutation and one for the treatment of advanced SM, including the subtypes of aggressive SM, SM with an associated hematologic neoplasm and mast cell leukemia. For more information about avapritinib clinical trials, visit www.clinicaltrials.gov or www.blueprintclinicaltrials.com.

Important Safety Information

Intracranial hemorrhage (e.g., subdural hematoma, intracranial hemorrhage, and cerebral hemorrhage) occurred in 1% of 267 patients (0.7% Grade 3 or 4) with GIST and overall in 3% of 335 patients (1.2% Grade 3 or 4) who received AYVAKIT. Overall, 0.9% of patients receiving AYVAKIT required permanent discontinuation for an intracranial hemorrhage. Withhold AYVAKIT and then resume at a reduced dose upon resolution, or permanently discontinue AYVAKIT based on severity.

In 335 patients receiving AYVAKIT, CNS adverse reactions occurred overall in 58% of patients including cognitive impairment (41%; 3.6% Grade 3 or 4), dizziness (20%; 0.6% Grade 3 or 4), sleep disorders (15%; 0.3% Grade 3 or 4), mood disorders (13%; 1.5% Grade 3 or 4), speech disorders (6%; none Grade 3 or 4), and hallucinations (2.1%; none Grade 3 or 4). Overall, 3.9% of patients required permanent discontinuation of AYVAKIT for a CNS adverse reaction. Depending on severity, withhold AYVAKIT and then resume at the same dose or at a reduced dose upon improvement, or permanently discontinue AYVAKIT.

AYVAKIT can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential and pregnant women of the potential risk to a fetus. Advise females and males of reproductive potential to use an effective method of contraception during

treatment with AYVAKIT and for 6 weeks after the final dose of AYVAKIT. Advise women not to breastfeed during treatment with AYVAKIT and for two weeks after the final dose. Advise females and males of reproductive potential that AYVAKIT may impair fertility.

In 204 patients with unresectable or metastatic GIST, the most common adverse reactions (≥ 20%) were edema, nausea, fatigue/asthenia, cognitive impairment, vomiting, decreased appetite, diarrhea, hair color changes, increased lacrimation, abdominal pain, constipation, rash and dizziness.

Avoid coadministration of AYVAKIT with strong and moderate CYP3A inhibitors. If coadministration with a moderate CYP3A inhibitor cannot be avoided, reduce dose of AYVAKIT. Avoid coadministration of AYVAKIT with strong and moderate CYP3A inducers.

On February 6, 2020 Applied DNA Sciences, Inc. (NASDAQ: APDN) ("Applied DNA" or the "Company"), a leader in Polymerase Chain Reaction (PCR)-based DNA manufacturing for product authenticity, traceability solutions and nucleic acid-based biotherapeutic development and a developer of liquid biopsies reported consolidated financial results for the fiscal first quarter ended December 31, 2019 (Press release, Applied DNA Sciences, FEB 6, 2020, View Source [SID1234553927]).

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"During our fiscal first quarter, we made meaningful progress on our strategic priorities for fiscal 2020 to position the company for long-term growth while raising capital to support our growth strategy. Our revenue performance reflects a difficult comparison to the year-ago period, which included revenue related to a Department of Defense contract since completed, as well as our historical revenue pattern that troughs in the first quarter and builds over the balance of the year," stated Dr. James A. Hayward, president and CEO of Applied DNA.

"In our biotherapeutics business that utilizes our proprietary linear DNA production platform for application in adoptive cell therapies; DNA vaccines, such as cancer vaccines; CRISPR and other nucleic acid-based therapies, we continued to build proof points for a new paradigm in linear DNA production with our patented PCR processes ahead of traditional plasmids production. During the quarter, we signed an agreement with Tyme Technologies for our Vita-AssayTM invasive Circulating Tumor Cell ("iCTC") capture assay and services that enable Tyme to monitor disease progression in its pivotal trial for metastatic pancreatic cancer. In our industrials business that utilizes the same platform to illuminate supply chains in large commercial ecosystems for authenticity and traceability, the launch of Colorcon’s on-dose authentication platform powered by our taggant technology demonstrates execution of our pharmaceutical strategy to partner with Colorcon, who will be marketing the platform to its expansive customer base. Strategic progress has continued in this sector into our fiscal second quarter with our entry into the nutraceuticals market with a multi-year CertainT contract with Nutrition 21."

Concluded Dr. Hayward, "Looking ahead, we are placing greater emphasis on positioning our platform for biotherapeutic and diagnostic applications where there is a growing imperative for our capabilities while also nurturing key industrials applications to commercial-scale deployments. Our recently acquired liquid biopsy technology – the iCTC liquid biopsy platform – we believe allows us to detect primary cancer tumors often before they are visible to other diagnostic technologies, when preventive care for impending cancer may still be an option. Our iCTC platform is potentially transformative to cancer care, and our relationship with Tyme establishes a partnering model that is applicable to other companies pursuing therapies for such cancers as breast, pancreatic, ovarian, colorectal, among others, that we are actively pursuing."

Fiscal First Quarter 2020 Financial Results:

·Revenues decreased 28% for the first quarter of fiscal 2020 to $634 thousand, compared with $884 thousand reported in the same period of the prior fiscal year and decreased 62% from $1.7 million for the fourth quarter of fiscal 2019. This decrease in revenue year over year is due to a decrease of $167 thousand in service revenue and a decrease of $84 thousand in product revenues. The decrease in service revenues was primarily attributable to a decrease from a government contract award that ended during fiscal 2019. The decrease in product revenues was primarily related to a decrease of approximately $200 thousand in textiles, related to a cotton customer offset by an increase of $135 thousand in biopharmaceutical revenues.

·Total operating expenses decreased to $3.0 million for the first fiscal quarter of 2020, compared with $3.9 million in the prior fiscal year’s first quarter. This decrease was primarily attributable to an approximate $352 thousand decrease in payroll and a decrease of $93 thousand in consulting fees, which are both due to a realignment of the sales force and reductions in overall headcount. In addition, there was a decrease of $285 thousand in stock-based compensation expense and a reduction of $145 thousand in research and development expenses.

·Net loss for the quarter ended December 31, 2019 was $2.7 million, or $1.12 per share, compared with a net loss of $3.2 million, or $4.25 per share, for the quarter ended December 31, 2018, an improvement of 18%, and a net loss of $1.2 million, or $1.44 per share, for the quarter ended September 30, 2019.

·Excluding non-cash expenses, Adjusted EBITDA was negative $2.4 million and a negative $2.6 million for the quarters ended December 31, 2019 and 2018, respectively. See below for information regarding non-GAAP measures.

Select Recent Operational Highlights:

·On February 5, 2020, Applied DNA entered into an amendment to its existing joint development agreement with Takis S.R.L and Evvivax S.R.L.to include pre-clinical development of a potential linear DNA vaccine against 2019-nCoV, the new coronavirus;

·On January 27, 2020, Applied DNA bolstered its patent portfolio when the U.S. Patent and Trademark Office granted it a U.S. patent that covers methods of tagging man-made cellulosic fibers or materials during production and later authenticating the fiber or materials to confirm provenance and/or authenticity. This newly issued patent extends the Company’s addressable market within textiles to include cotton, synthetic fibers and materials, and, now, man-made cellulosic fibers and materials;

·On January 13, 2020, the Company announced a licensing agreement with LifeSensors, Inc. whereby it will incorporate LifeSensors’ high expression SUMO-fusion technologies into the Company’s linear DNA amplicons designed and produced for therapeutic applications. The Company believes that the incorporation of the SUMO-fusion technologies into Applied DNA’s linear amplicons may further optimize protein expression and deliver yet another strength to linear DNA; and

·On December 23, 2018, Colorcon, Inc., a world leader in the development and supply of film coating systems and excipients for pharmaceuticals, formally launched its On-Dose Authentication capability utilizing the Company’s technology to provide track and trace functionality for supply chain security. Applied DNA’s molecular taggants are integrated into Colorcon’s Opadry film coating system to significantly reduce the risks associated with the global problem of counterfeit and falsified medications entering the supply chain.

Fiscal First Quarter 2020 Conference Call Information

The Company will hold a conference call and webcast to discuss its fiscal first quarter-end 2020 results on Thursday, February 6, 2020 at 4:30 PM ET. To participate on the conference call, please follow the instructions below. While every attempt will be made to answer investors’ questions on the Q&A portion of the call, due to the large number of expected participants, not all questions may be answered.

To Participate:

·Participant Toll Free:1-844-887-9402

·Participant Toll: 1-412-317-6798

·Please ask to be joined to the Applied DNA call

Live webcast: View Source

Replay (available 1 hour following the conclusion of the live call through February 7, 2020):

·Participant Toll Free: 1-877-344-7529

·Participant Toll: 1-412-317-0088

·Participant Passcode: 10138146

·Webcast replay: View Source

For those investors unable to attend the live call, a copy of management’s PowerPoint presentation will be available for review under the ‘Events and Presentations’ section of the company’s Investor Relations web site: View Source