Neogen reports third quarter results

On March 24, 2020 Neogen Corporation (NASDAQ: NEOG) reported that its revenues for the third quarter of its 2020 fiscal year, which ended Feb. 29, were $99,869,000, up 2% from the previous year’s third quarter revenues of $97,700,000 (Press release, Neogen, MAR 24, 2020, View Source [SID1234555798]). The third quarter was the 112th of the past 117 quarters that Neogen reported revenue increases as compared with the previous year — including all consecutive quarters in the past 14 years. Current year-to-date revenues were $309,096,000, also up 2% compared to $304,424,000 for the same period a year ago.

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Third quarter net income was $12,200,000, compared to the prior year’s $13,073,000. Earnings per share in the current quarter were $0.23, compared to $0.25 a year ago. Current year-to-date net income was $43,128,000, or $0.82 per share, compared to $44,361,000, or $0.85 per share, for the same period a year ago.

"Given the dramatic world events of the last few months, I am extremely proud of our Neogen employees who are working tirelessly to supply the worldwide demand for our products. Our mission matters more today than ever; we are strategically important to the world’s ability to contain and recover from the global threat posed by COVID-19, and ensuring the safety, quality and quantity of the global food supply," said John Adent, Neogen’s president and chief executive officer. "While operating results overall were disappointing for the quarter, we were encouraged by continued strong performance in our genomics services and growth in a number of our food safety product lines. Additionally, in the third quarter we made four strategic acquisitions to enhance our global footprint.

"The recent acquisitions of our distributors in Argentina and Uruguay demonstrate our strong belief that the Southern Cone of South America, with its large beef and dairy populations, holds significant growth potential for us," continued Adent. "These acquisitions, along with the other recent purchases of our food safety distributors in Australia and Italy, position us to promote, market and sell Neogen’s comprehensive suite of food safety, animal safety and genomics products around the globe."

"The strength of our balance sheet, with no debt, substantial cash reserves and solid cash generation, leaves us well prepared to weather the current adverse economic conditions that threaten the global economy in 2020 as a result of COVID-19," said Steve Quinlan, Neogen’s chief financial officer. "We are proactively addressing issues associated with the current environment, including strengthening our global supply chain to secure availability of the raw materials we need for production. We are also focused on maintaining adequate staffing for our worldwide manufacturing operations to ensure we are able to continue to serve our global customer base."

Revenues for the company’s Food Safety segment decreased 1% during the third quarter compared to the prior year quarter. Sales of the company’s general sanitation products, including its AccuPoint Advanced product line, increased 5% in the third quarter of the 2020 fiscal year, compared to the prior year. Moving forward, Neogen’s AccuPoint Advanced product line is seen as an important tool in the fight against the spread of disease, as it provides an almost instant indication of the cleanliness of a surface — and the effectiveness of a sanitation program. Sales of Neogen’s rapid diagnostic tests to detect natural toxins increased 4% in the quarter; our food allergen product line also grew 4%. These increases only partially offset a significant decrease in sales of drug residue test kits as Neogen ended its exclusive relationship with its distributor of dairy antibiotic tests in Europe during the quarter, and the loss of forensic kit sales in Brazil, due to a large customer switching to an alternative technology platform.

Neogen’s European operations revenues rose 5%, aided by growth in disinfectants to fight the spread of COVID-19 and African swine fever, higher sales of food allergen tests, and equipment sales. Neogen Latinoamerica’s revenues increased 15%, on strength across their diagnostics product portfolio and a large rodenticide order in Mexico. China’s revenues for the current quarter increased 38%, largely the result of increased sales of Neogen’s disinfectant products to combat the spread of COVID-19 in the country. Revenues from the company’s Brazilian operations decreased 16%, as revenues continue to be adversely impacted by the loss of sales of forensic test kits formerly used to test the nation’s truck drivers; as discussed previously, this business was lost in the first quarter of the current fiscal year.

Neogen’s Animal Safety segment reported a 6% revenue increase for the third quarter, largely on the strength of the domestic genomics business, with additional incremental volume of rodenticides, insecticides, and certain cleaners and disinfectants.

Neogen’s worldwide animal genomics business recorded an increase of 8% in the third quarter of fiscal 2020 compared to the prior year. This broad-based increase included strength in the domestic companion animal market, and genomic testing of beef and dairy cattle, swine and poultry around the world. In January, Neogen launched Igenity + Envigor — the first and only genetic test in the beef industry that measures heterosis in crossbred cattle. In cattle, heterosis is the tendency of a crossbred calf to show traits superior to those of its parents.

Neogen’s gross margin was 45.4% of sales in the third quarter of the current year, compared to 45.7% in the same quarter of the prior fiscal year. The gross margin percentage decrease was primarily the result of a greater proportion of total sales derived from the Animal Safety segment, which has lower gross margins than the overall corporate average. Expressed as a percentage of sales, operating income was 13.1% for the current quarter, compared to 15.0% in the third quarter of the 2019 fiscal year, with the decline attributed to the lower gross margin percentage and operating expense growth which exceeded that of revenue. The effective income tax rate for the third quarter was 14.4%, compared to 21.4% in the prior year quarter; this year’s lower rate primarily resulted from the benefit of stock option exercises.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases and sanitation concerns. Neogen’s Animal Safety Division is a leader in worldwide biosecurity products, animal genomics testing, and the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals and veterinary instruments.

Certain portions of this news release that do not relate to historical financial information constitute forward-looking statements. These forward-looking statements are subject to certain risks and uncertainties. Actual future results and trends may differ materially from historical results or those expected depending on a variety of factors listed in Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Company’s most recently filed Form 10-K.

Medical Marijuana, Inc. Investment Company AXIM® Biotechnologies Completes Acquisition of Oncology Research and Development Company Sapphire Biotech, Inc.

On March 24, 2020 Medical Marijuana, Inc. (OTC: MJNA) (the "Company"), the first-ever publicly traded cannabis company in the United States that launched the world’s first-ever cannabis-derived nutraceutical products, brands and supply chain, reported that its investment company AXIM Biotechnologies, Inc. (OTCQB: AXIM) ("AXIM Biotech" or "AXIM") has completed the acquisition of leading oncology research and development company Sapphire Biotech, Inc. ("Sapphire") (Press release, Medical Marijuana Sciences, MAR 24, 2020, https://www.prnewswire.com/news-releases/medical-marijuana-inc-investment-company-axim-biotechnologies-completes-acquisition-of-oncology-research-and-development-company-sapphire-biotech-inc-301028615.html [SID1234555797]).

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In January of this year, AXIM announced that the Company signed a binding term sheet to acquire Sapphire. As part of the acquisition, AXIM has acquired 100 percent of the capital stock of Sapphire and will operate Sapphire as a wholly-owned subsidiary. Sapphire will continue to be led by Catalina Valencia as Chief Executive Officer. Ms. Valencia has stewarded Sapphire in the development of its unique patent-pending pipeline.

"Sapphire Biotech has already proven itself to have great potential in just the one year since its founding. We look forward to bringing them into our family of companies and helping them further their efforts in the field of oncology," said Medical Marijuana, Inc. CEO Dr. Stuart Titus. "It is very exciting to announce that Sapphire Biotech has both a diagnostic application as well as a promising oncology treatment in their arsenal. This acquisition marks a transformation of AXIM while aligning with the therapeutic cannabinoid analog space."

Sapphire has licensed a leading compound called SBI-183, which inhibits and suppresses invasion in vitro and metastasis in vivo. The company recently announced that it now holds exclusive license rights to SBI-183 and intends to study the compound’s ability to treat cancer. In February, Sapphire signed a Sponsored Research Agreement with a leading cancer research organization to conduct preclinical studies to develop a metastatic cancer inhibitor using the licensed SBI-183 compound.

"Sapphire Biotech’s research team is making impressive progress in the field of oncology, which is one of the main reasons we were attracted to the company," said John W. Huemoeller II, Chief Executive Officer of AXIM Biotech. "At the end of the day, we want to help as many people as we can. Through this acquisition, we expect to be able to bring treatments to market for the millions of people battling cancer even more quickly."

In addition to its upcoming research on cancer-treating compounds, Sapphire is also developing a novel line of diagnostics for early cancer detection, response to treatment and recurrence monitoring. One of Sapphire’s diagnostic tools is currently being evaluated in a clinical trial for its potential to diagnose pancreatic cancer.

AXIM chose to acquire Sapphire because of its focus on cancer therapeutics for inhibiting cancer growth and metastasis, its diagnostics line, and a world-renowned research team. Through this acquisition, AXIM not only gains Sapphire’s already existing patent-pending portfolio of technologies but also now has the ability to develop new in-house proprietary molecules and potential treatments for numerous diseases.

Nanox Announces Agreement With CureMetrix For AI-based Assistive Diagnostic Tool to Support Nanox Cloud Platform

On March 24, 2020 NANO-X IMAGING LTD ("Nanox" or the "Company"), an innovative medical imaging company, reported its collaboration with CureMetrix, a global healthcare technology company that develops AI-driven software for radiology, to integrate the CureMetrix advanced AI diagnostics solution into Nanox’s planned cloud-based software platform, the Nanox.CLOUD (Press release, Nanox, MAR 24, 2020, View Source [SID1234555796]).

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Nanox is working to expand the range of medical imaging services it intends to provide to improve the accessibility and affordability of early-detection services. The Nanox.CLOUD is designed to provide an end-to-end medical imaging service, including services such as image repository, radiologist matching, online and offline diagnostics review and annotation, connectivity to diagnostic assistive AI systems, billing and reporting.

The goal of screening exams for breast cancer detection is to identify breast abnormalities as early as possible since the likelihood of survival increases the earlier the cancer is detected. Some of the reasons that breast cancer is missed at initial screening include the high-level of difficulty and complexity in reading mammographic images, the fact that dense breast tissue can obscure anomalies, and the limited number of certified mammographers globally.

Understanding the challenges facing radiologists who read mammograms, CureMetrix has developed AI-based computer-aided diagnostic (CAD) solutions that assist radiologists in detecting cancer earlier.

Almost 2% of screening mammograms in the United States result in a biopsy, and approximately 70% of these biopsies are found to be benign (Taplin, 2010). Approximately $4 billion is spent annually in the U.S. on mammography false positives, breast cancer overdiagnosis, invasive breast cancer and ductal carcinoma (Ong, 2015). However, mammography remains the only early detection screening method shown in randomized clinical trials to decrease breast cancer mortality.

CureMetrix aims to leverage its proprietary algorithm to help reduce unnecessary biopsies. In a recent study of biopsy benign cases, CureMetrix’s cmAssist software was able to correctly classify 70% of the biopsies as benign. As a result, CureMetrix’s AI CAD could potentially reduce unnecessary biopsies and therefore improve cost efficiencies. In addition, studies have shown that false-positive findings on screening mammography could cause long-term psychosocial harm to patients (Brodersen, 2013). As a result, CureMetrix’s AI CAD could also help alleviate patient anxiety about breast cancer screening.

"The planned integration of advanced AI technologies, such as those of CureMetrix, with our planned imaging platform aims to decrease diagnostic results turnaround time, increase diagnostic accuracy, and help radiologists deal with the rising screening demands and workload," said Ran Poliakine, Founder and CEO of Nanox. "We believe the decision assistive information that the CureMetrix AI provides will potentially help the radiologists who we expect to use our platform to deliver a faster, more accurate diagnosis to medical facilities and patients."

"With our aligned goals of increasing the accessibility and affordability of early-detection medical imaging systems worldwide, the integration of CureMetrix with Nanox technologies aims to increase patient access to mammography services and improve breast cancer survival rates across the globe," said Kevin Harris, President of CureMetrix, "We look forward to working with Nanox on this important project."

Samsung Bioepis Announces FDA Approval of 420 mg Multi-dose Vial of ONTRUZANT® (trastuzumab-dttb)

On March 24, 2020 Samsung Bioepis Co., Ltd. reported that the U.S. Food and Drug Administration (FDA) has approved a 420 mg multi-dose vial of ONTRUZANT (trastuzumab-dttb), a biosimilar referencing HERCEPTIN i (trastuzumab) (Press release, Samsung Bioepis, MAR 24, 2020, View Source [SID1234555795]).

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ONTRUZANT was first approved as a 150 mg single-dose vial by FDA in January 2019 across all eligible indications, namely adjuvant treatment of HER2-overexpressing breast cancer, metastatic breast cancer and metastatic gastric cancer or gastroesophageal junction adenocarcinoma in patients who have not received prior treatment for metastatic disease. Please see Boxed Warnings and Important Safety Information for ONTRUZANT below.

ONTRUZANT will be marketed and distributed in the United States (US) by Merck (known as MSD outside the US and Canada), which announced on February 5, 2020, that it intends to spin-off products from its biosimilars businesses, including ONTRUZANT, into a new, independent, publicly-traded company. Merck will continue to fully support the commercialization of ONTRUZANT until the spinoff, which is intended to take place in the first half of 2021, at which time ONTRUZANT will become a product of the new company.

About ONTRUZANT (trastuzumab-dttb)
ONTRUZANT is indicated for adjuvant treatment of HER2-overexpressing node-positive or node-negative (ER/PR-negative or with one high-risk feature*) breast cancer:

As part of a treatment regimen containing doxorubicin, cyclophosphamide and either paclitaxel or docetaxel
With docetaxel and carboplatin
As a single agent following multi-modality anthracycline-based therapy
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
* High-risk is defined as ER/PR positive with one of the following features: tumor size >2 cm, age <35 years, or tumor grade 2 or 3.

ONTRUZANT is indicated:

In combination with paclitaxel for the first line treatment of HER2-overexpressing metastatic breast cancer
As a single agent for treatment of HER2-overexpressing breast cancer in patients who have received one or more chemotherapy regimens for metastatic disease
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.
ONTRUZANT is indicated, in combination with cisplatin and capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease.
Select patients for therapy based on an FDA-approved companion diagnostic for a trastuzumab product.

Select Important Safety Information

Cardiomyopathy

Administration of ONTRUZANT can result in sub-clinical and clinical cardiac failure.
Evaluate left ventricular function in all patients prior to and during treatment with ONTRUZANT. Discontinue ONTRUZANT treatment in patients receiving adjuvant therapy and withhold ONTRUZANT in patients with metastatic disease for clinically significant decrease in left ventricular function
Infusion Reactions; Pulmonary Toxicity

Administration of ONTRUZANT can result in serious and fatal infusion reactions and pulmonary toxicity. Symptoms usually occur during or within 24 hours of administration. Interrupt ONTRUZANT infusion for dyspnea or clinically significant hypotension. Monitor patients until symptoms completely resolve. Discontinue ONTRUZANT for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome
Embryo-Fetal Toxicity

Exposure to ONTRUZANT during pregnancy can result in oligohydramnios and oligohydramnios sequence manifesting as pulmonary hypoplasia, skeletal abnormalities, and neonatal death. Advise patients of these risks and the need for effective contraception
Exacerbation of Chemotherapy-Induced Neutropenia

In randomized, controlled clinical trials, the per-patient incidences of NCI-CTC Grade 3-4 neutropenia and of febrile neutropenia were higher in patients receiving trastuzumab products in combination with myelosuppressive chemotherapy as compared to those who received chemotherapy alone. The incidence of septic death was similar among patients who received trastuzumab and those who did not
Most Common Adverse Reactions

The most common adverse reactions for trastuzumab products in breast cancer were fever, nausea, vomiting, infusion reactions, diarrhea, infections, increased cough, headache, fatigue, dyspnea, rash, neutropenia, anemia, and myalgia
The most common adverse reactions for trastuzumab products in metastatic gastric cancer were neutropenia, diarrhea, fatigue, anemia, stomatitis, weight loss, upper respiratory tract infections, fever, thrombocytopenia, mucosal inflammation, nasopharyngitis, and dysgeusia

Gossamer Bio Announces Fourth Quarter and Full-Year 2019 Financial Results and Provides Business Update

On March 24, 2020 Gossamer Bio, Inc. (Nasdaq:GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the fourth quarter and year ended December 31, 2019 and provided a business update (Press release, Gossamer Bio, MAR 24, 2020, View Source [SID1234555794]).

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"Our hearts are with the patients, families, caregivers and medical professionals suffering and sacrificing in the ongoing Covid-19 viral pandemic. We are monitoring the situation on a daily basis to understand the impact on Gossamer and our programs and are taking the necessary actions now to do what is best for our patients, employees and company," said Sheila Gujrathi, M.D., Co-Founder and Chief Executive Officer of Gossamer Bio.

"2019 was a year of execution for Gossamer Bio, as we continued to advance all four of our clinical-stage product candidates in our target areas of immunology, inflammation and oncology. Notwithstanding the Covid-19 pandemic, we expect to continue our momentum in 2020, with data from all of our candidates expected this year. We are committed to advancing our product candidates and the field of medicine for the betterment of patients and their families, and we look forward to providing updates on these efforts throughout the year."

Clinical-Stage Product Candidate Updates

GB001: Oral DP2 Antagonist for Eosinophilic Asthma and Chronic Rhinosinusitis (CRS)

Gossamer has made available three poster presentations from its GB001 program for patients with asthma. All three posters, which Gossamer had planned to present at the now cancelled 2020 American Academy of Allergy, Asthma & Immunology (AAAAI) Annual Meeting, can be found in the Posters and Publications section of Gossamer’s website:
"Effect of the DP2 Antagonist GB001 on Asthma Worsening in Patients with Mild-Moderate Asthma" showed that GB001 treatment is associated with longer time to asthma worsening / exacerbation and observed treatment effects were greater in the populations with higher baseline FeNO and / or eosinophils.
"In Vitro and In Vivo Profile of GB001, a Potent and Selective DP2 Antagonist for the Treatment of Moderate-Severe Asthma" demonstrates that, in pre-clinical studies, GB001 is an insurmountable antagonist and compares favorably to other DP2 antagonists in functional residence time and prolonged pharmacodynamic effects, while inhibiting immune cell infiltration and improving airway function.
"Corticosteroid Use Across Asthma Healthcare Providers: A Real-world Experience." The widespread use of OCS revealed by this claims analysis underscores the high level of unmet need for these patients and the need for new therapies.
Enrollment in the ongoing Phase 2b LEDA study in patients with moderate-to-severe eosinophilic asthma has been completed. We are on track to conduct an interim analysis in the second quarter of this year, following study completion by approximately two thirds of patients. Topline results are expected in the second half of this year.
Enrollment in the ongoing Phase 2 TITAN proof-of-concept study in chronic rhinosinusitis, both with and without nasal polyps has been completed. Topline data from the TITAN study are expected in the second half of this year.
We continue to evaluate the possibility of initiating a Phase 2 study in chronic spontaneous urticaria and expect to make this decision in the second half of the year following a review of available data and the competitive landscape.
GB002: Inhaled PDGFR Inhibitor for Pulmonary Arterial Hypertension (PAH)

Enrollment is underway in the Phase 1b study of GB002 in patients with PAH. Gossamer expects to report initial topline results from the study in the second quarter of this year.
Due to the ongoing Covid-19 viral pandemic, the Phase 2 study in patients with PAH will likely commence in the second half of this year. This trial will enroll functional class II and III PAH patients. Patients will remain on their background therapies throughout the study. The primary endpoint for this 24-week study will be change in PVR from baseline. A key secondary endpoint will be change from baseline in 6-minute walk distance at week 24.
GB004: Oral HIF-1α Stabilizer for Inflammatory Bowel Disease

Enrollment is complete in the Phase 1b study of GB004 in patients with active mild-to-moderate ulcerative colitis (UC). The primary goals of the study are to assess safety, tolerability, PK, PD and target engagement in patients with active disease. Gossamer expects to report topline results from this Phase 1b study in the second quarter of this year.
GB1275: Oral CD11b Modulator for Oncology Indications

Enrollment for the KEYNOTE-A36 Phase 1/2 study to evaluate GB1275 as a monotherapy and in combination with either KEYTRUDA (pembrolizumab) or chemotherapy in patients with selected advanced solid tumors is underway, and we expect to report initial Phase 1 data in the second half of this year.
Financial Results for Quarter and Full Year Ended December 31, 2019

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of December 31, 2019, were $401.8 million. In response to the ongoing Covid-19 viral pandemic and anticipated potential challenges to clinical trials globally, Gossamer has planned a series of cost-optimization initiatives. As a result, we currently expect cash, cash equivalents and marketable securities, and access to our debt facility will be sufficient to fund operating and capital expenditures to the middle of 2022.
Research and Development (R&D) Expenses: For the quarter ended December 31, 2019, R&D expenses were $42.6 million, compared to R&D expenses of $25.9 million for the same period in 2018. R&D expenses for the full year ended December 31, 2019, were $143.4 million compared to $55.3 million for the full year ended December 31, 2018. The increases were primarily due to an increase in expenses for GB001, GB002, GB004 and GB1275 and increased headcount.
In-Process Research and Development (IPR&D) Expenses: For the quarter ended December 31, 2019, IPR&D expenses were $1.6 million, compared to $0.0 million for the same period in 2018. IPR&D expenses for the full year ended December 31, 2019, were $3.6 million compared to $49.7 million for the full year ended December 31, 2018.
General and Administrative (G&A) Expenses: For the quarter ended December 31, 2019, G&A expenses were $11.6 million, compared to $13.9 million for the same period in 2018. G&A expenses for the full year ended December 31, 2019, were $39.1 million compared to $44.1 million for the full year ended December 31, 2018. The decreases were primarily attributable to a decrease in stock-based compensation costs, which was partially offset by increases in personnel-related costs, professional and legal fees, costs associated with insurance, and facility and office-related costs.
Net Loss: Net loss for the three months ended December 31, 2019, was $54.7 million, or $0.89 per share, compared to a net loss of $38.8 million, or $4.92 per share, for the same period in 2018. Net loss for the full year ended December 31, 2019, was $180.3 million, or $3.29 per share compared to a net loss of $147.0 million, or $22.59 per share, for the full year ended December 31, 2018.