On May 6, 2020 Danaher Corporation (NYSE: DHR) (the "Company") reported results for the quarter ended April 3, 2020. All results in this release reflect only continuing operations unless otherwise noted (Press release, Danaher, MAY 6, 2020, View Source [SID1234557170]).

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For the first quarter 2020, net earnings were $595.1 million, or $0.81 per diluted common share. Non-GAAP adjusted diluted net earnings per common share were $1.05.

Revenues increased 3.0% year-over-year to $4.3 billion, with non-GAAP core revenue growth of 4.5%.

Starting with the second quarter of 2020, the Company intends to present core revenue growth including Cytiva. For the second quarter 2020 the Company anticipates that non-GAAP core revenue growth including Cytiva will be in the range of approximately flat to down 10%.

Thomas P. Joyce, Jr., President and Chief Executive Officer, stated, "We are pleased with our first quarter performance during such an unprecedented time. We delivered 4.5% core revenue growth driven by positive results in each of our three reporting segments, with particular strength in our Cepheid, Radiometer, Pall, and ChemTreat businesses. We were also excited to close our acquisition of the GE Biopharma business, now called Cytiva, on March 31."

Joyce continued, "We are incredibly proud of our team’s response to the challenges presented by the COVID-19 pandemic. We are providing much-needed diagnostic testing capabilities today and supporting our customers’ pursuit of new treatments and vaccines for the future. Looking ahead, we feel well-positioned to navigate through this uncertain environment. We believe that the combination of our strong portfolio, exceptional team, and disciplined execution driven by the Danaher Business System will continue to differentiate Danaher in 2020 and beyond."

Danaher will discuss its results during its quarterly investor conference call on May 7, 2020 starting at 7:30 a.m. ET. The call and an accompanying slide presentation will be webcast on the "Investors" section of Danaher’s website, www.danaher.com, under the subheading "Events & Presentations." A replay of the webcast will be available in the same section of Danaher’s website shortly after the conclusion of the presentation and will remain available until the next quarterly earnings call.

The conference call can be accessed by dialing 866-503-8675 within the U.S. or by dialing +1 786-815-8792 outside the U.S. a few minutes before the 7:30 a.m. ET start and telling the operator that you are dialing in for Danaher’s earnings conference call (access code 3845297). A replay of the conference call will be available shortly after the conclusion of the call and until May 21, 2020. You can access the replay dial-in information on the "Investors" section of Danaher’s website under the subheading "Events & Presentations." In addition, presentation materials relating to Danaher’s results have been posted to the "Investors" section of Danaher’s website under the subheading "Quarterly Earnings."

On May 6, 2020 Lannett Company, Inc. (NYSE: LCI) reported financial results for its fiscal 2020 third quarter ended March 31, 2020 (Press release, Lannett, MAY 6, 2020, View Source [SID1234557169]).

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"I am incredibly proud of the effort and dedication of all of our employees in response to the COVID-19 public health crisis," said Tim Crew, chief executive officer of Lannett. "We focused on employee safety and our team continues to produce important medications for patients. We also recently brought a number of new drug products to market. Fortunately for Lannett, all of our finished-dose manufacturing is U.S. based. We have long articulated our supply chain has less global fragmentation than that of many of our competitors. As a result, our supply chain for products and key ingredients has to date been only modestly affected by challenges associated with COVID-19.

"For our fiscal 2020 third quarter, net sales were higher than expected due to COVID-19, as patients appear to have purchased extra supply of their medications and some customers increased their purchases of some of our products to address patient demand and avoid shortages.

"We plan to launch several new products in the next several months, and look forward to our scheduled meeting in early June with the FDA to plan next steps for the clinical advancement of our biosimilar insulin glargine partnered product candidate."

For the fiscal 2020 third quarter on a GAAP basis, net sales were $144.4 million compared with $172.8 million for the third quarter of fiscal 2019. Gross profit was $41.7 million, or 29% of net sales, compared with $65.3 million, or 38% of net sales. For the fiscal 2020 third quarter, operating expenses included an asset impairment charge of $14.0 million related to the write-down of the value of a product license agreement. Net loss was $16.6 million, or $0.43 per share, versus net income of $10.6 million, or $0.27 per diluted share, for the third quarter of fiscal 2019.

For the fiscal 2020 third quarter reported on a Non-GAAP basis, net sales were $144.4 million compared with $172.8 million for the third quarter of fiscal 2019. Adjusted gross profit was $52.3 million, or 36% of net sales, compared with $77.0 million, or 45% of net sales, for the prior-year third quarter. Adjusted interest expense was $12.7 million compared with $17.0 million for the third quarter of fiscal 2019. Adjusted net income was $11.7 million, or $0.27 per diluted share, compared with $26.6 million, or $0.68 per diluted share, for the fiscal 2019 third quarter. Adjusted EBITDA for the fiscal 2020 third quarter was $35.9 million.

Guidance for Fiscal 2020

**A reconciliation of Adjusted amounts to most directly comparable GAAP amounts can be found in the attached financial tables.

Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 4:30 p.m. ET to review its results of operations for its fiscal 2020 third quarter ended March 31, 2020. The conference call will be available to interested parties by dialing 800-447-0521 from the U.S. or Canada, or 847-413-3238 from international locations, passcode 49654451. The call will be broadcast via the Internet at www.lannett.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company’s financial status and performance, regulatory and operational developments, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including Adjusted EBITDA, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). Management uses these measures internally for evaluating its operating performance. The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. The company also believes that including Adjusted EBITDA, as defined in the company’s existing Credit Agreement, is appropriate to provide additional information to investors to demonstrate the company’s ability to comply with financial debt covenants. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP.

Detailed reconciliations of non-GAAP financial measures to the most directly comparable GAAP financial measures are included with this release.

Non-GAAP financial measures exclude, among others, the effects of (1) amortization of purchased intangibles and other purchase accounting entries, (2) restructuring expenses, (3) non-cash interest expense, as well as (4) certain other items considered unusual or non-recurring in nature.

*Adjusted EBITDA excludes the same adjustments discussed above, as well as additional adjustments permitted under the company’s existing Credit Agreement.

On May 6, 2020 Cellular Biomedicine Group Inc. (NASDAQ: CBMG) ("CBMG" or the "Company"), a biopharmaceutical firm engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, reported business highlights and financial results for the first quarter of 2020 (Press release, Cellular Biomedicine Group, MAY 6, 2020, View Source [SID1234557168]).

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"We currently have six clinical assets in development. In Q1, China’s National Medical Products Administration (NMPA) accepted our Investigational New Drug (IND) application for B-cell maturation antigen (BCMA) Chimeric antigen receptor (CAR) T-cell therapy for multiple myeloma (MM). Although early in the study, we are guardedly optimistic about the preliminary data of the 19 infused patients with only one patient being observed to have grade 3 cytokine release syndrome (CRS). We are excited to continue the development of this program and believe that our competitive advantages may be partially attributable to our proprietary manufacturing process with reduced vein-to-vein times. We are also conducting an Investigator-Initiated Trial (IIT) on our anti-CD19/CD20 BiCAR-T in non-Hodgkin’s lymphoma (NHL) in China and are seeing promising early data," said Tony (Bizuo) Liu, the Company’s Chief Executive Officer.

Mr. Liu added, "Together with our new Rockville, Maryland facility coming online in the latter part of the year, which will support the early phases of our U.S. clinical trials, and observation of the promising data in our China study, we are taking small steps to explore feasibility of a U.S. clinical trial for anti-CD19/CD20 BiCAR-T for non-Hodgkin’s lymphoma (NHL) as well as the tumor infiltrating lymphocytes (TIL) clinical trial for Non-Small-Cell Lung Cancer (NSCLC).

"Regarding our regenerative medicine program, with the COVID-19 outbreak tapering off in China, we have resumed patients’ enrollment for our knee osteoarthritis (KOA) Phase II allogenic (off the shelf AlloJoin) stem-cell clinical trial and are in the process of preparing for the Phase II autologous (ReJoin) trial as well.

"We are continuing to execute our vision to build a global platform of cutting-edge process development and incisive translational medicine, delivering innovative cell therapies to patients via personalized bespoke manufacturing processes. These transformative capabilities can bring not only fast vein-to-vein delivery but also safe and effective drugs to patients suffering with cancer and degenerative diseases. And amid the COVID-19 pandemic, we are pleased to have secured facilities to bolster our balance sheet to fund our clinical development."

First Quarter 2020 and Other Recent Corporate Developments

− Anti-BCMA CAR-T for Relapsed or Refractory Multiple Myeloma

• National Medical Products Administration of China (NMPA) accepted our IND application for Phase I clinical trial;

• 19 patients have been infused under investigator-initiated studies; 17 patients have evaluable data for clinical efficacy with only one grade 3 CRS observed;

− Anti-CD19/CD20 Bi-Specific CAR-T for Non-Hodgkin’s Lymphoma

• 4 patients have been infused under investigator-initiated studies; 3 patients have evaluable data for clinical efficacy;

− On April 30, 2020, we received approval for CNY 30 million line of credit (approximately USD $4.2 million).

First Quarter 2020 Financial Results

− Cash Position: Cash, cash equivalents and restricted cash of March 31, 2020 were $21.6 million, compared to $15.4 million as of December 31, 2019;

− Research & Development Expenses: R&D expenses were $7.8 million for the first quarter of 2020, compared to $6.0 million for the first quarter of 2019;

− General & Administrative Expenses: G&A expenses were $3.4 million for the first quarter of 2020, compared to $3.4 million for the first quarter of 2019;

− Net loss was $11.5 million for the first quarter of 2020, compared to $9.3 million for the first quarter of 2019;

− Executed a bridge loan of $16 million.

On May 6, 2020 Innovent Biologics, Inc. ("Innovent") (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high quality medicines for the treatment of cancer, autoimmune, metabolic and other major diseases, reported with Eli Lilly and Company ("Lilly",NYSE: LLY) the results of a phase 3 study in China. The ORIENT-12 trial of TYVYT (sintilimab injection) in combination with Gemzar (gemcitabine for injection) and platinum chemotherapy in first-line advanced or metastatic squamous non-small cell lung cancer (sqNSCLC) met the predefined primary endpoint of progression-free survival (PFS) (Press release, ImmunoGen, MAY 6, 2020, View Source [SID1234557167]). This is the first randomized, double-blind phase 3 study evaluating the combination of anti-PD-1 antibody with Gemzar and platinum chemotherapy in the world.

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TYVYT in combination with gemcitabine and platinum chemotherapy demonstrated a statistically significant improvement in PFS compared to placebo in combination with gemcitabine and platinum chemotherapy, meeting the pre-defined endpoint. The safety profile of TYVYT in this trial was consistent with previously reported studies, and no new safety signals were identified. Relevant data will be presented at an upcoming medical conference.

Innovent and Lilly will initiate regulatory discussions for registration with the National Medical Products Administration (NMPA) of China in the near future.

"Lung cancer is the leading cause of cancer death (25.2%), of which NSCLC accounts for 80-85 percent, with about 35 percent of those patients having the squamous subtype. In the past 20 years, drug development to treat NSCLC has been mainly focused on nonsquamous NSCLC, while drug development of sqNSCLC has been slower due to its lack of driving mutation and its unique epidemiological, histopathological and molecular characteristics," Professor Caicun Zhou, Head of Department of Oncology, Shanghai Pulmonary Hospital. "The emergence of the anti-PD-1 antibody has brought a new treatment modality for patients with sqNSCLC. We are delighted to see that TYVYT in combination with gemcitabine and platinum chemotherapy has met the predefined primary endpoint in the ORIENT-12 study. Different from the KEYNOTE-407 study in a different chemotherapy regimen, ORIENT-12 has demonstrated for the first time significant PFS benefit with a PD-1 inhibitor in combination with gemcitabine and platinum in first-line sqNSCLC."

"Sintilimab is the only anti-PD-1 monoclonal antibody included in the New Catalogue of the National Reimbursement Drug List (NRDL). It was officially approved by the NMPA in 2018 for the treatment of relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy," said Dr. Hui Zhou, Vice President and Head of Oncology Strategy and Medical Sciences of Innovent. "Currently, we have several phase 3 randomized clinical trials ongoing in lung cancer. With the encouraging result of ORIENT-12 we are hopeful that sintilimab has the potential to benefit more patients with squamous NSCLC. For Innovent, this is the second randomized study of NSCLC that met its primary endpoint; the first was ORIENT-11, a randomized Phase 3 study of 1L non-squamous NSCLC (NCT03607539)."

"The Center for Drug Evaluation, NMPA just recently accepted a new drug application for sintilimab in combination with pemetrexed and platinum chemotherapy as first-line treatment for nonsquamous NSCLC. The promising results we see in the ORIENT-12 study demonstrate sintilimab’s potential in sqNSCLC," said Dr. Li Wang, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs Center. "We would like to express our gratitude to the patients and their families, investigators and clinical trial sites participating in the study, and to our colleagues from Innovent. We look forward to bringing this new treatment option to lung cancer patients in China."

About the ORIENT-12 Trial

ORIENT-12 is a randomized, double-blind, Phase 3 study to evaluate the efficacy and safety of TYVYT (sintilimab injection) or placebo in combination with Gemzar (gemcitabine for injection) and platinum chemotherapy as first-line therapy for locally advanced or metastatic sqNSCLC (ClinicalTrials.gov, NCT03629925). The primary endpoint is progression-free survival (PFS) assessed by Independent Radiographic Review Committee (IRRC) based on RECIST v1.1. The secondary endpoints include overall survival (OS) and safety profile.

A total of 357 subjects have been enrolled in ORIENT-12 trial and randomized in a 1:1 ratio to receive either TYVYT (sintilimab injection) 200mg or placebo in combination with Gemzar (gemcitabine for injection) and platinum chemotherapy every 3 weeks for 4 – 6 cycles, followed by either TYVYT (sintilimab injection) or placebo maintenance therapy. The subjects will receive treatment until radiographic disease progression, unacceptable toxicity or any other conditions that require treatment discontinuation. Conditional crossover is permitted.

About sqNSCLC

Lung cancer is a malignancy with the highest morbidity and mortality in China. NSCLC accounts for about 80 percent to 85 percent of lung cancer. Approximately 70 percent of NSCLC are locally advanced or metastatic at initial diagnosis, resulting in patients having little to no chance of radical resection. Meanwhile, even after radical surgery, patients still have a high chance of recurrence and eventually die from disease progression. About 35 percent of NSCLC in China are squamous subtype. Squamous NSCLC lacks a driver mutation, and response rate of first-line chemotherapy is approximately 30 percent. So far pembrolizumab in combination with carboplatin and paclitaxel is the only regimen with PD-1 antibody approved by FDA and NMPA for first-line sqNSCLC. There remains still a huge unmet medical need.

About TYVYT (Sintilimab Injection)

TYVYT (sintilimab injection), an innovative drug developed with global quality standards jointly developed in China by Innovent and Lilly, has been granted marketing approval by the NMPA for relapsed or refractory classic Hodgkin’s lymphoma after second-line or later systemic chemotherapy, and included in the 2019 Guidelines of Chinese Society of Clinical Oncology for Lymphoid Malignancies. TYVYT (sintilimab injection) is the only PD-1 inhibitor that has been included in the new Catalogue of the National Reimbursement Drug List (NRDL) in November 2019.

TYVYT (sintilimab injection) is a type of immunoglobulin G4 monoclonal antibody, which binds to PD-1 molecules on the surface of T-cells, blocks the PD-1/ PD-Ligand 1 (PD-L1) pathway and reactivates T-cells to kill cancer cells. Innovent is currently conducting more than 20 clinical studies with TYVYT (sintilimab injection) to evaluate its safety and efficacy in a wide variety of cancer indications, including more than 10 registration or pivotal clinical trials.

On May 6, 2020 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that Mark Enyedy, President and CEO, and Anna Berkenblit, Chief Medical Officer, will participate in a fireside chat at the upcoming RBC Capital Markets Global Healthcare Virtual Conference (Press release, ImmunoGen, MAY 6, 2020, View Source [SID1234557166]). The presentation is scheduled for May 19, 2020 at 10:20am ET.

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A webcast of the presentation will be accessible through the Investors and Media section of the Company’s website on www.immunogen.com. Following the live webcast, a replay will be available at the same location.