FDA Approves Genentech’s Enspryng for Neuromyelitis Optica Spectrum Disorder

 – First and only FDA-approved subcutaneous treatment option for anti-aquaporin-4 antibody positive NMOSD that can be self-administered by a person with NMOSD or a caregiver every four weeks –

First and only approved therapy for NMOSD designed to target and inhibit interleukin-6 receptor activity, using novel recycling antibody technology –

Approval supported by one of the largest clinical trial programs undertaken for this rare disease –

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Enspryng(satralizumab-mwge) as the first and only subcutaneous treatment for adults living with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD). NMOSD is a rare, lifelong and debilitating autoimmune disorder of the central nervous system, often misdiagnosed as multiple sclerosis, that primarily damages the optic nerve(s) and spinal cord, causing blindness, muscle weakness and paralysis.

“Today’s FDA approval of Enspryng, the first subcutaneous NMOSD treatment using novel recycling antibody technology, builds upon the work we’ve done in multiple sclerosis with Ocrevus to develop first-in-class medicines and further the scientific understanding of neuroimmunological diseases,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “We thank the NMOSD community, including patients and investigators who participated in Enspryng clinical trials.”

Enspryng is a humanized monoclonal antibody and the only approved therapy for NMOSD designed to target and inhibit interleukin-6 (IL-6) receptor activity, believed to play a key role in the inflammation associated with NMOSD. The treatment was designed using novel recycling antibody technology, which, compared to conventional technology, allows for longer duration of antibody circulation and subcutaneous dosing every four weeks.

“For people with NMOSD, relapses can cause devastating, irreversible and disabling neurological effects,” said Professor Jeffrey Bennett, University of Colorado Neurology & Ophthalmology, and investigator for the Enspryng pivotal clinical trials. “Having an approved therapy that can be administered subcutaneously in the home and has demonstrated an impact on the frequency of relapses is an important advancement for patients.”

“We are very optimistic the addition of this new approved treatment option will make a meaningful difference for those living with NMOSD, those who love and support them and the doctors who treat them,” said Victoria Jackson, founder, The Guthy-Jackson Charitable Foundation. “When my daughter was diagnosed with NMOSD in 2008, there were no approved treatment options, and a critical lack of resources and understanding for people living with this disabling disorder. After years of dedicated effort and collaboration, the FDA approval of Enspryng exemplifies how patients, industry, and academia can find solutions together.”

Enspryng can be administered in the home by a person living with NMOSD or a caregiver following training from a healthcare provider. Enspryng treatment is administered every four weeks after an initial loading dose.

Enspryng will be available in the United States in two weeks. Genentech is committed to helping patients access the medicines prescribed by their physician. For people with NMOSD, the Enspryng Access Solutions team is available to answer questions, provide product education, injection training and help families understand insurance coverage and navigate appropriate financial assistance options to start and stay on Enspryng. Patients can call 1-844-NSPRYNG (844-677-7964) to speak to a Patient Navigator or visit http://www.Enspryng.com.

FDA approval is based on results from one of the largest pivotal clinical trial programs undertaken for this rare neurological disorder

This approval is supported by results from two randomized controlled Phase III clinical trials, the SAkuraStar and SAkuraSky studies, in which Enspryng demonstrated robust and sustained efficacy and a favorable safety profile in adults with AQP4 antibody positive NMOSD. Results were sustained for 96 weeks, significantly reducing the risk of relapse compared with placebo as a monotherapy and when used concurrently with baseline immunosuppressant therapy (IST), which has commonly been used to manage NMOSD symptoms associated with relapses.

In the SAkuraStar monotherapy study’s AQP4 antibody positive subgroup, 76.5% of Enspryng-treated patients were relapse-free at 96 weeks, compared to 41.1% with placebo. In the SAkuraSky study, which evaluated Enspryng when used concurrently with baseline IST, 91.1% of Enspryng-treated AQP4 antibody positive subgroup patients were relapse-free at 96 weeks, compared to 56.8% with placebo. The primary endpoint of both SAkuraStar and SAkuraSky was time to first protocol-defined relapse (PDR) adjudicated by an independent review committee in the double-blind period.

The most common adverse reactions with Enspryng (incidence ≥ 15%) were nasopharyngitis, headache, upper respiratory tract infection, gastritis, rash, arthralgia, extremity pain, fatigue and nausea.

About SAkuraStar and SAkuraSky in NMOSD

SAkuraStar is a Phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Enspryng monotherapy administered to patients with NMOSD. The primary endpoint is the time to first protocol-defined relapse (PDR), adjudicated by an independent review committee in the double-blind period. Results from the SAkuraStar study were presented at the 35th Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS), September 11-13, 2019, and were published in the May 1, 2020 edition of The Lancet Neurology.

Ninety-five adult patients were randomized to either of the following two treatment groups in a 2:1 ratio: Enspryng (120 mg) or placebo. Both treatments were administered subcutaneously at week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals. The double-blind treatment period ended at 1.5 years after the enrollment of the last patient. After experiencing a PDR or upon completion of the study, patients in both groups were offered treatment with Enspryng in an open label extension (OLE) period. Patients with aquaporin-4 (AQP4) antibody positive or negative neuromyelitis optica (NMO, as defined by the diagnostic criteria in 2006) and those with AQP4 antibody positive NMOSD were enrolled. The number of AQP4 antibody negative patients was limited to approximately 33% of the total population of the study. Data have shown that AQP4 antibody positive patients may experience a greater likelihood of relapse and poorer long-term outcomes than AQP4 antibody negative patients.

SAkuraSky is a Phase III multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Enspryng added to baseline immunosuppressant therapy in patients with NMOSD. The primary endpoint was the time to first PDR as adjudicated by an independent review committee in the double-blind period. Results from the SAkuraSky study were published in the November 28, 2019 edition of the New England Journal of Medicine (NEJM).

Seventy-six adult patients were randomized to either of the following two treatment groups in a 1:1 ratio: Enspryng (120 mg) or placebo added to baseline therapy (azathioprine, mycophenolate mofetil and/or corticosteroids). Both treatments were administered subcutaneously at week 0, 2, and 4. The subsequent treatment was continued at 4-week intervals. The double-blind treatment period ended when patients experienced a PDR; the study ended when the total number of PDRs reached 26. After experiencing a PDR or upon completion of the study, patients in both groups were offered treatment with Enspryng in an OLE period. Patients with AQP4 antibody positive or negative neuromyelitis optica (NMO, as defined by diagnostic criteria in 2006) and those with AQP4 antibody positive NMOSD were enrolled. AQP4 antibody negative patients represented approximately 30% of the SAkuraSky study population.

About neuromyelitis optica spectrum disorder (NMOSD)

NMOSD is a rare, lifelong and debilitating autoimmune condition of the central nervous system that primarily damages the optic nerve(s) and spinal cord, causing blindness, muscle weakness and paralysis. People with NMOSD experience unpredictable, severe relapses directly causing cumulative, permanent, neurological damage and disability. In some cases, relapse can result in death. NMOSD affects over 10,000 people in Europe, up to 15,000 people in the United States and approximately 200,000 people worldwide. NMOSD can affect individuals of any age, race and gender, but is most common among women in their 30s and 40s, and appears to occur at higher rates in people of African or Asian background. There is some evidence that people of African or Asian descent may also experience a more severe disease course.

NMOSD is commonly associated with pathogenic antibodies (AQP4) that target and damage a specific cell type, called astrocytes, resulting in inflammatory lesions of the optic nerve(s), spinal cord and brain. AQP4 antibodies are detectable in the blood serum of around 70-80% of NMOSD patients.

Although most cases of NMOSD can be confirmed through diagnostic tests, people living with the condition are still frequently misdiagnosed with multiple sclerosis. This is due to overlapping characteristics of the two disorders, including a higher prevalence in women, similar symptoms and the fact that both are relapse-based conditions.

About Enspryng™ (satralizumab-mwge)

Enspryng, which was designed by Chugai, a member of the Roche group, is a humanized monoclonal antibody that targets IL-6 receptor activity. The cytokine IL-6 is believed to be a key driver in NMOSD, triggering the inflammation cascade and leading to damage and disability. Enspryng was designed using novel recycling antibody technology, which compared to conventional technology, allows for longer duration of the antibody and subcutaneous dosing every four weeks.

Positive Phase III results for Enspryng, as both monotherapy and used concurrently with baseline immunosuppressant therapy, suggest that IL-6 inhibition is an effective therapeutic approach for NMOSD. The Phase III clinical development program for Enspryng includes two studies: SAkuraStar and SAkuraSky.

Enspryng is also approved in Canada, Japan and Switzerland. Applications are under review with numerous regulators, including in the European Union and China.

Enspryng has been designated as an orphan drug in the United States, Europe and Japan. In addition, it was granted Breakthrough Therapy Designation for the treatment of NMOSD by the FDA in December 2018.

What is Enspryng?

Enspryng is a prescription medicine used to treat neuromyelitis optica spectrum disorder (NMOSD) in adults who are aquaporin-4 (AQP4) antibody positive.

It is not known if Enspryng is safe and effective in children.

Important Safety Information

Patients should not take Enspryng if they:

  • are allergic to satralizumab-mwge or any of the ingredients in Enspryng
  • have an active hepatitis B infection
  • have active or untreated inactive (latent) tuberculosis (TB)

Enspryng may cause serious side effects including:

  • Infections. Enspryng can increase risk of serious infections some of which can be life-threatening. Patients should speak with their healthcare provider if they are being treated for an infection and call right away if there are signs of an infection, with or without a fever, such as:

    • chills, feeling tired, muscle aches, cough that will not go away or a sore throat
    • skin redness, swelling, tenderness, pain or sores on the body
    • diarrhea, belly pain, or feeling sick
    • burning when urinating or urinating more often than usual
  • A healthcare provider will check for infection and treat it if needed before starting or continuing to take Enspryng

    • A healthcare provider should test for hepatitis and TB before initiating Enspryng
    • All required vaccinations should be completed before starting Enspryng. People using Enspryng should not be given ‘live’ or ‘live-attenuated’ vaccines. ‘Live’ or ‘live-attenuated’ vaccines should be given at least 4 weeks before a patient starts Enspryng. A healthcare provider may recommend that a patient receive a ‘non-live’ (inactivated) vaccine, such as some of the seasonal flu vaccines. If a patient plans to get a ‘non-live’ (inactivated) vaccine it should be given, whenever possible, at least 2 weeks before starting Enspryng
  • Increased liver enzymes. A healthcare provider should order blood tests to check patient liver enzymes before and while taking Enspryng. A healthcare provider will dictate how often these blood tests are needed. Patients should complete all follow-up blood tests as ordered by a healthcare provider. A healthcare provider may wait to start Enspryng if liver enzymes are increased
  • Low neutrophil count. Enspryng can cause a decrease in neutrophil counts in the blood. Neutrophils are white blood cells that help the body fight off bacterial infections. A healthcare provider should order blood tests to check neutrophil counts while a patient is taking Enspryng.
  • Serious allergic reactions that may be life-threatening have happened with other medicines like Enspryng. Patients should call their healthcare provider right away if they have any of these symptoms of an allergic reaction:

    • shortness of breath or trouble breathing
    • swelling of lips, face, or tongue
    • dizziness or feeling faint
    • moderate or severe stomach (abdominal) pain or vomiting
    • chest pain

Before taking Enspryng, patients should tell their healthcare provider about all of their medical conditions, including if they

  • have or think they have an infection
  • have liver problems
  • have ever had hepatitis B or are a carrier of the hepatitis B virus
  • have had or have been in contact with someone with TB
  • have had a recent vaccination or are scheduled to receive any vaccination
  • are pregnant, think they might be pregnant, or plan to become pregnant. It is not known if Enspryng will harm one’s unborn baby
  • are breastfeeding or plan to breastfeed. It is not known if Enspryng passes into breast milk. Patients should speak with their healthcare provider about the best way to feed one’s baby while on treatment with Enspryng

Patients should tell their healthcare provider about all the medicines they take, including prescription and over-the-counter medicines, vitamins and herbal supplements

The most common side effects of Enspryng include:

  • sore throat, runny nose (nasopharyngitis)
  • headache
  • upper respiratory tract infection
  • rash
  • fatigue
  • nausea
  • extremity pain
  • inflammation of the stomach lining
  • joint pain

For more information about the risks and benefit profiles of Enspryng, patients should ask their healthcare provider.

Patients may report side effects to the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch. Patients may also report side effects to Genentech at 1-888-835-2555.

Please see the full Prescribing Information for additional Important Safety Information.

About Genentech in neuroscience

Neuroscience is a major focus of research and development at Genentech and Roche. Our goal is to pursue groundbreaking science to develop new treatments that help improve the lives of people with chronic and potentially devastating diseases.

Genentech and Roche are investigating more than a dozen medicines for neurological disorders, including multiple sclerosis, neuromyelitis optica spectrum disorder, Alzheimer’s disease, Huntington’s disease, Parkinson’s disease, Duchenne muscular dystrophy and autism spectrum disorder. Together with our partners, we are committed to pushing the boundaries of scientific understanding to solve some of the most difficult challenges in neuroscience today.

About Genentech

Founded more than 40 years ago, Genentech is a leading biotechnology company that discovers, develops, manufactures and commercializes medicines to treat patients with serious and life-threatening medical conditions. The company, a member of the Roche Group, has headquarters in South San Francisco, California. For additional information about the company, please visit http://www.gene.com.

Contacts

Media Contact: Justin Hurdle (650) 467-6800

Advocacy Contact: Jo Dulay (202) 316-6304

Investor Contacts: Lisa Tuomi (650) 467-8737

Karl Mahler 011 41 61 687 8503

PFENEX INVESTOR ALERT by the Former Attorney General of Louisiana: Kahn Swick & Foti, LLC Investigates Adequacy of Price and Process in Proposed Sale of Pfenex Inc. – PFNX

NEW ORLEANS–(BUSINESS WIRE)–Former Attorney General of Louisiana Charles C. Foti, Jr., Esq. and the law firm of Kahn Swick & Foti, LLC (“KSF”) are investigating the proposed sale of Pfenex Inc. (NYSE: PFNX) to Ligand Pharmaceuticals Incorporated (NasdaqGM: LGND). Under the terms of the proposed transaction, shareholders of Pfenex will receive $12.00 in cash, and a one-time contingent value right of $2.00 in the event a predefined regulatory milestone is achieved by December 31, 2021, for each share of Pfenex that they own. KSF is seeking to determine whether this consideration and the process that led to it are adequate, or whether the consideration undervalues the Company.

If you believe that this transaction undervalues the Company and/or if you would like to discuss your legal rights regarding the proposed sale, you may, without obligation or cost to you, e-mail or call KSF Managing Partner Lewis S. Kahn (lewis.kahn@ksfcounsel.com) toll free at any time at 855-768-1857, or visit https://www.ksfcounsel.com/cases/nasdaqgm-lgnd/ to learn more.

Please note that the merger is structured as a tender offer, such that time may be of the essence.

To learn more about KSF, whose partners include the Former Louisiana Attorney General, visit www.ksfcounsel.com.

Contacts

Kahn Swick & Foti, LLC

Lewis S. Kahn, 855-768-1857

KSF Managing Partner

lewis.kahn@ksfcounsel.com

Baxter Obtains U.S. FDA Emergency Use Authorization for Regiocit Replacement Solution Used in CRRT

  • Only authorized citrate-based replacement solution available in the U.S. for use in continuous renal replacement therapy (CRRT) during COVID-19 pandemic
  • Supports need for regional citrate anticoagulation in patients at increased risk of bleeding during CRRT
  • Marks Baxter’s fourth FDA Emergency Use Authorization during COVID-19 pandemic, reinforcing its commitment to addressing the needs of critically ill patients

DEERFIELD, Ill.–(BUSINESS WIRE)–Baxter International Inc. (NYSE:BAX), a global leader in acute care, announced it has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for Regiocit, the company’s replacement solution that contains citrate for regional citrate anticoagulation of the extracorporeal circuit. Under the EUA, Regiocit is authorized to be used as a replacement solution only in adult patients being treated with continuous renal replacement therapy (CRRT) and for whom regional citrate anticoagulation is appropriate during the COVID-19 pandemic.

Acute kidney injury (AKI), a potentially life-threatening condition where the kidneys suddenly stop working and fluid and uremic toxins build up in the body, is one of many complications affecting COVID-19 patients. A recent meta-analysis of 20 studies evaluated more than 13,000 hospitalized COVID-19 patients, 43% of whom were in the intensive care unit or had severe infection, and found that AKI prevalence was 17%, with a range of 0.5% – 80.3%.1 CRRT mimics many of the functions of the natural kidney and is the cornerstone of treatment in patients with severe AKI.2 A citrate-based replacement solution can be used for regional citrate anticoagulation in patients who are at greater risk of bleeding during CRRT, as it eliminates the need to administer a blood thinner, such as Heparin, to prevent clotting in the circuit. Regiocit is the only authorized citrate-based replacement solution available in the U.S. for use in CRRT during the COVID-19 pandemic.

“Demand for CRRT remains elevated as the COVID-19 pandemic continues to progress, and we’re proud to offer Regiocit as an important new option to help healthcare providers in the U.S. optimize care for critically ill patients requiring CRRT and regional citrate anticoagulation, while bringing an additional supply of replacement solutions to the U.S.,” said Reaz Rasul, general manager of Baxter’s Acute Therapies business.

During CRRT, the patient’s blood passes through an extracorporeal filter where fluid and uremic toxins are removed before the cleaned blood is returned to the body. CRRT allows for slow and continuous removal of fluid and toxins, which can be better tolerated than other conventional treatments in patients who are hemodynamically unstable. Replacement fluids are needed during CRRT to flush toxins from the body and replace electrolytes and volume lost during the filtration process. There have been reports of increased filter clotting in COVID-19 patients during CRRT, which may result from cytokine storms that occur in some patients when high levels of inflammatory mediators circulate in the blood as an intense immune reaction to the virus.3 Clotting can disrupt the flow of blood and impact the effectiveness of treatment. An anticoagulant is often infused into the blood circuit to help prevent clotting during CRRT.4

Regiocit contains physiological concentrations of sodium (140 mmol/l), chloride (86 mmol/l) and a low concentration of citrate (18 mmol/L) and can provide the necessary pre-filter volumes required to replace filtration losses during convective therapies. It is used in combination with other standard dialysis and replacement solutions that supplement missing electrolytes such as potassium, magnesium and phosphate.

Regiocit has not been approved by FDA in the U.S. but is currently in use in countries around the world, including in Europe and Asia. A limited initial shipment will be available in the U.S. immediately, with more significant production ramping up throughout the coming weeks and months.

Supporting Acute Dialysis in COVID-19 Patient Care

Baxter continues to provide CRRT machines, fluids and sets to help healthcare facilities address patient needs around the world. Baxter has received EUAs for several of its products used in CRRT, including Oxiris, the HF20 Set and the ST Set. Oxiris is the only filter set available in the U.S. to reduce pro-inflammatory cytokine levels in the blood, including for use in CRRT, for confirmed COVID-19 cases admitted to the ICU with confirmed or imminent respiratory failure who require blood purification. Under its EUA, the HF20 Set is authorized to deliver CRRT to treat patients of low weight (8-20 kg) and low blood volume who cannot tolerate a larger extracorporeal circuit volume in an acute care environment during the COVID-19 pandemic. The ST Set is authorized for use under its EUA to provide CRRT to treat patients in an acute care environment during the COVID-19 pandemic. Both the HF20 Set and ST Set can be used with the PrisMax or Prismaflex control units (monitors). The FDA has not cleared or approved Oxiris, the HF20 Set and the ST Set. Rather, the EUAs authorize the products for use in CRRT during the COVID-19 pandemic. As the pandemic evolves, Baxter remains focused on supporting healthcare providers during these extraordinary circumstances.

About Baxter

Every day, millions of patients and caregivers rely on Baxter’s leading portfolio of critical care, nutrition, renal, hospital and surgical products. For more than 85 years, we’ve been operating at the critical intersection where innovations that save and sustain lives meet the healthcare providers that make it happen. With products, technologies and therapies available in more than 100 countries, Baxter’s employees worldwide are now building upon the company’s rich heritage of medical breakthroughs to advance the next generation of transformative healthcare innovations. To learn more, visit www.baxter.com and follow us on Twitter, LinkedIn and Facebook.

Rx Only. Please see full Instructions for Use.

Important Safety Information for Regiocit

Regiocit is authorized by FDA under an Emergency Use Authorization to be used as a replacement solution only in adult patients being treated with CRRT and for whom regional citrate anticoagulation is appropriate during the COVID-19 pandemic. Regiocit will be administered only by a licensed healthcare provider in a critical care setting and will be available for use only in facilities that Baxter has qualified and provided appropriate training on the use of Regiocit. Regiocit is authorized for use for no longer than the duration of the COVID-19 public health emergency and has neither been cleared or approved by the FDA. Regiocit is intended to be used in continuous venovenous hemofiltration (CVVH) and hemodiafiltration (CVVHDF) modalities.

Contraindications for the use of Regiocit include:

  • Severe liver failure
  • Shock with muscle hypoperfusion
  • Known hypersensitivity to any component of Regiocit

All treatments with Regiocit must be prescribed by a physician. The size, weight, metabolic and fluid balance, cardiac status, and general clinical condition of the patient must be carefully monitored by the prescribing physician before each treatment.

This release includes forward-looking statements concerning Regiocit, including potential benefits associated with its use (in connection with the COVID-19 epidemic or otherwise) and its anticipated availability. The statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those in the forward-looking statements: ability to maintain supply continuity; actions of regulatory bodies and other governmental authorities (including with respect to the granting, potential extension or termination of any new or existing EUA by FDA); contractual requirements, product quality, manufacturing or supply, or patient safety issues; changes in law and regulations; and other risks identified in Baxter’s most recent filing on Form 10-K and other SEC filings, all of which are available on Baxter’s website. Baxter does not undertake to update its forward-looking statements.

Baxter, Regiocit, Oxiris, Prismaflex and PrisMax are registered trademarks of Baxter International Inc.


1 Shelief Y. Robbins-Juarez, BA, Long Qian, MD, Kristen L. King, MPH, Jacob S. Stevens, MD, S. Ali Husain, MD, MPH, Jai Radhakrishnan, MD, Sumit Mohan, MD, MPH. A Systematic Review and Meta-Analysis Of Outcomes for Patients with COVID-19 and Acute Kidney Injury. Kidney Int Rep. Published online June 24, 2020

2 Lins RL, Nephrol Dial Transplant. 2012;27:4252-4255

3 Rabb H. Kidney diseases in the time of COVID-19: major challenges to patient care. J Clin Invest. 2020;130(6):2749-2751.

4 Ashita Tolwani, M.D. Continuous Renal-Replacement Therapy for Acute Kidney Injury. N Engl J Med 2012; 367:2505-2514.

Contacts

Media Contact
Andrea Johnson, (224) 948-5353

media@baxter.com

Investor Contact
Clare Trachtman, (224) 948-3020

Sonoma Pharmaceuticals Reports First Quarter 2021 Financial Results

  • Highest Quarterly Revenues in Company History
  • Revenues of $7.3 Million Grow by 65% Compared to Same Period Last Year Fueled by International Growth
  • Reduction in Operating Expenses of $1.3 Million Compared to Last Year
  • Net Quarterly Income of $1.0 million

WOODSTOCK, Ga.–(BUSINESS WIRE)–Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, eye care, nasal care, oral care and dermatological conditions, today announced financial results for its first fiscal quarter ended June 30, 2020.

“We’ve made significant changes to our business model and company structure, and we’re pleased to see these efforts bear fruit,” said Amy Trombly, CEO of Sonoma Pharmaceuticals. She continued, “we’ve expanded our business model to focus on new and existing U.S and international distribution partnerships expanding our reach around the world. Additionally, we’ve transitioned most of our California manufacturing to our existing factory in Mexico, and we closed our California offices on June 24, 2020. We’re beginning to see the cost savings from those actions. In addition to lowering our overhead, relocating our remaining manufacturing to Mexico allows us to offer both customers and partners competitive pricing and we believe this will fuel future growth.”

Business Highlights

The COVID-19 pandemic continues to influence the Company in positive and negative ways. The pandemic led to increased worldwide demand for virucidal and disinfectant technology, areas where Microcyn™ technology has been shown to be effective. We plan to continue to devote resources towards expanding our product offerings in these areas. We’ve also adapted our partnership strategy to seek new distribution partners worldwide and to expand our existing partnerships with new products and territories. The pandemic also caused our sales in U.S. dermatology to decline in the months of March through May 2020 as many areas issued shelter-in-place orders. These orders limited the ability of our sales representatives to conduct in-person sales. We’ve begun to see U.S. dermatology sales rebound in June and July, however, it is too early to tell if the rebound is backlogged demand from the shelter-in-place period or whether it represents a sustained increase in future demand.

Results for the Quarter Ended June 30, 2020

Revenues from continuing operations for the quarter ended June 30, 2020, of $7.3 million increased by $2.9 million, or 65%, as compared to $4.4 million for the same period last year, largely as the result of increased sales in Latin America, Europe and Rest of World.

During the quarter ended June 30, 2020, Sonoma reported revenues of $7.3 million and cost of revenues of $4.3 million resulting in gross profit of $3.0 million, or 41% of revenue, compared to a gross profit of $2.2 million, or 50% of revenue in the same period last year. The reduction in gross profit as a percent of sales is the result of increased international sales which are typically higher volume and lower margin.

Total operating expenses during the first quarter of fiscal year 2021 were $2.8 million, down $1.3 million, or 31%, as compared to the same period in the prior year. This decrease in operating expenses was primarily due to lower employee costs resulting from a reduction in headcount combined with a refocusing of the business activities resulting in cost-reductions across all divisions.

Net income from continuing operations for the quarter was $39,000, down by $492,000, or 93% when compared to income from continuing operations of $531,000 for the three months ended June 30, 2019. The decrease is primarily due to the one-time gain on sale of assets in 2019, partially offset by higher revenues and lower operating expenses in 2020. Net income from discontinued operations for the quarter was $1.0 million versus $0.2 million in the same period last year.

Net income for the quarter was $1.0 million, up by $0.3 million, or 39%, compared to the same period last year. The increase in net income was due to higher revenues and decreased operating expenses, and the sale of our Micromed business unit. EBITDAS income for the first quarter of fiscal 2021 of $0.4 million, was up by $1.8 million, or 129%, compared to an EBITDAS loss of $1.4 million for the same period last year.

As of June 30, 2020, Sonoma had cash and cash equivalents of $4.6 million.

Sale of Micromed Laboratories Business and Impact on Accounting Treatment

With the sale of the Micromed Laboratories business during the quarter, the components of the financial statements related to this transaction have been classified as a discontinued business for accounting purposes and in accordance with this accounting treatment, the income statement and balance sheet have been retroactively revised to reflect the revenue, expenses and balance sheet items of the continuing businesses for this fiscal year and last fiscal year. All of the income statement categories related to Micromed have been condensed to a one line item on the income statement as “Income from discontinued operations.” Also, the discontinued balance sheets items have been listed separately from the continuing operations. As a result, the comparison of results discussed in this press release relate primarily to the continuing businesses in accordance with generally accepted accounting principles.

About Sonoma Pharmaceuticals, Inc.

Sonoma Pharmaceuticals is a global healthcare leader for developing and producing stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound care, animal health care, eye care, nasal care, oral care and dermatological conditions. The company’s products reduce infections, itch, pain, scarring and harmful inflammatory responses in a safe and effective manner. In-vitro and clinical studies of hypochlorous acid (HOCl) show it to have impressive antipruritic, antimicrobial, antiviral and anti-inflammatory properties. Sonoma’s stabilized HOCl immediately relieves itch and pain, kills pathogens and breaks down biofilm, does not sting or irritate skin and oxygenates the cells in the area treated assisting the body in its natural healing process. The company’s products are sold either directly or via partners in 53 countries worldwide and the company actively seeks new distribution partners. The company’s principal office is in Woodstock, Georgia, with manufacturing operations in Latin America. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.sonomapharma.com. For partnership opportunities, please contact businessdevelopment@sonomapharma.com.

Forward-Looking Statements

Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Sonoma Pharmaceuticals, Inc. and its subsidiaries (the “company”). These forward-looking statements are identified by the use of words such as “continue,” “reduce,” “develop” and “expand,” among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the company’s business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the company’s products will not be as large as expected, the company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to meet the company’s cash needs, fund further development, as well as uncertainties relative to the COVID-19 pandemic and economic development, varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the company’s filings with the Securities and Exchange Commission. The company disclaims any obligation to update these forward-looking statements, except as required by law.

Sonoma Pharmaceuticals™ is a trademark or registered trademark of Sonoma Pharmaceuticals, Inc. All other trademarks and service marks are the property of their respective owners.

 

SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED BALANCE SHEETS

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2020

 

 

 

(Unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

4,551

 

 

$

3,691

 

Accounts receivable, net

 

 

5,220

 

 

 

4,062

 

Inventories, net

 

 

4,193

 

 

 

2,192

 

Prepaid expenses and other current assets

 

 

2,937

 

 

 

2,256

 

Current portion of deferred consideration, net of discount

 

 

188

 

 

 

182

 

Total current assets

 

 

17,089

 

 

 

12,383

 

Operating lease right-of-use assets

 

 

343

 

 

 

963

 

Property and equipment, net

 

 

372

 

 

 

365

 

Deferred consideration, net of discount, less current portion

 

 

779

 

 

 

786

 

Other assets

 

 

69

 

 

 

64

 

Total assets

 

$

18,652

 

 

$

14,561

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

 

 

Accounts payable

 

$

4,133

 

 

$

2,086

 

Accrued expenses and other current liabilities

 

 

743

 

 

 

1,774

 

Deferred revenue

 

 

150

 

 

 

228

 

Deferred revenue Invekra

 

 

46

 

 

 

45

 

Operating lease liabilities

 

 

135

 

 

 

251

 

Current portion of long-term debt

 

 

265

 

 

 

481

 

Total current liabilities

 

 

5,472

 

 

 

4,865

 

Operating lease liabilities-non-current

 

 

220

 

 

 

746

 

Long-term deferred revenue Invekra

 

 

240

 

 

 

245

 

Long-term debt

 

 

1,310

 

 

 

 

Total liabilities

 

 

7,242

 

 

 

5,856

 

Commitments and Contingencies

 

 

 

 

 

 

 

 

Stockholders’ Equity

 

 

 

 

 

 

 

 

Convertible preferred stock, $0.0001 par value; 714,286 shares authorized at June 30, 2020, and March 31, 2020, respectively, 0 and 1.55 shares issued and outstanding at June 30, 2020, and March 31, 2020, respectively

 

 

 

 

 

 

Common stock, $0.0001 par value; 24,000,000 shares authorized at June 30, 2020, and March 31, 2020, 1,966,958 and 1,777,483 shares issued and outstanding at June 30, 2020, and March 31, 2020, respectively

 

 

2

 

 

 

2

 

Additional paid-in capital

 

 

188,112

 

 

 

186,559

 

Accumulated deficit

 

 

(171,253

)

 

 

(172,246

)

Accumulated other comprehensive loss

 

 

(5,451

)

 

 

(5,610

)

Total stockholders’ equity

 

 

11,410

 

 

 

8,705

 

Total liabilities and stockholders’ equity

 

$

18,652

 

 

$

14,561

 

 

SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF COMPREHENSIVE (LOSS) INCOME

(In thousands, except per share amounts)

 

 

 

Three Months Ended

 

June 30,

 

 

2020

 

 

2019

 

 

 

 

 

 

 

 

Revenues

 

$

7,254

 

 

$

4,385

 

Cost of revenues

 

 

4,291

 

 

 

2,202

 

Gross profit

 

 

2,963

 

 

 

2,183

 

Operating expenses

 

 

 

 

 

 

 

 

Research and development

 

 

476

 

 

 

338

 

Selling, general and administrative

 

 

2,369

 

 

 

3,759

 

Total operating expenses

 

 

2,845

 

 

 

4,097

 

Income (Loss) from operations

 

 

118

 

 

 

(1,914

)

Interest expense

 

 

(2

)

 

 

(10

)

Interest income

 

 

2

 

 

 

42

 

Other (expense) income, net

 

 

(156

)

 

 

(59

)

Gain on sale of assets

 

 

77

 

 

 

2,472

 

Income from continuing operations

 

$

39

 

 

$

531

 

Income from discontinued operations

 

 

954

 

 

 

184

 

Net income

 

$

993

 

 

$

715

 

 

 

 

 

 

 

 

 

 

Net income per share: basic

 

 

 

 

 

 

 

 

Continuing operations

 

$

0.02

 

 

$

0.40

 

Discontinued operations

 

 

0.52

 

 

 

0.14

 

 

 

$

0.54

 

 

$

0.54

 

Net income per share: diluted

 

 

 

 

 

 

 

 

Continuing operations

 

$

0.02

 

 

$

0.40

 

Discontinued operations

 

 

0.52

 

 

 

0.14

 

 

 

$

0.54

 

 

$

0.54

 

Weighted-average number of shares used in per common share calculations: basic

 

 

1,839

 

 

 

1,316

 

Weighted-average number of shares used in per common share calculations: diluted

 

 

1,843

 

 

 

1,336

 

 

 

 

 

 

 

 

 

 

Other comprehensive income

 

 

 

 

 

 

 

 

Net income

 

$

993

 

 

$

715

 

Foreign currency translation adjustments

 

 

159

 

 

 

67

 

Comprehensive income

 

$

1,152

 

 

$

782

 

 

SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES

RECONCILIATION OF GAAP MEASURES TO NON-GAAP MEASURES

(In thousands)

(Unaudited)

 

 

 

Three Months Ended

June 30,

 

 

2020

 

2019

(1) Income (Loss) from operations minus non-cash expenses EBITDAS income (loss):

 

 

 

 

 

 

 

 

GAAP income (loss) from operations as reported

 

$

118

 

 

$

(1,914

)

Non-cash adjustments:

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

63

 

 

 

292

 

Depreciation and amortization

 

 

53

 

 

 

76

 

Non-GAAP income (loss) from operations minus non-cash expenses EBITDAS income (loss)

 

$

234

 

 

$

(1,546

)

 

 

 

 

 

 

 

 

 

(2) Net income minus non-cash expenses:

 

 

 

 

 

 

 

 

GAAP net income as reported

 

$

993

 

 

$

715

 

Non-cash adjustments:

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

63

 

 

 

292

 

Depreciation and amortization

 

 

53

 

 

 

76

 

Non-GAAP net income minus non-cash expenses

 

$

1,109

 

 

$

1,083

 

 

 

 

 

 

 

 

 

 

(3) Operating expenses minus non-cash expenses

 

 

 

 

 

 

 

 

GAAP operating expenses as reported

 

$

2,845

 

 

$

4,097

 

Non-cash adjustments:

 

 

 

 

 

 

 

 

Stock-based compensation

 

 

(84

)

 

 

(275

)

Depreciation and amortization

 

 

(30

)

 

 

(22

)

Non-GAAP operating expenses minus non-cash expenses

 

$

2,731

 

$

3,800

(1)

Loss from operations minus non-cash expenses (EBITDAS) is a non-GAAP financial measure. The Company defines operating loss minus non-cash expenses as GAAP reported operating loss minus operating depreciation and amortization, and operating stock-based compensation. The Company uses this measure for the purpose of modifying the operating loss to reflect direct cash related transactions during the measurement period.

(2)

Net loss minus non-cash expenses is a non-GAAP financial measure. The Company defines net loss minus non-cash expenses as GAAP reported net loss minus depreciation and amortization, stock-based compensation, and non-cash foreign exchange transaction losses. The Company uses this measure for the purpose of modifying the net loss to reflect only those expenses to reflect direct cash transactions during the measurement period.

(3)

Operating expenses minus non-cash expenses is a non-GAAP financial measure. The Company defines operating expenses minus non-cash expenses as GAAP reported operating expenses minus operating depreciation and amortization, and operating stock-based compensation. The Company uses this measure for the purpose of identifying total operating expenses involving cash transactions during the measurement period.

 

SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES

PRODUCT RELATED REVENUE SCHEDULES

(In thousands)

(Unaudited)

The following table shows the Company’s product revenues by geographic region

 

 

 

Three Months Ended

 

 

 

 

 

 

 

June 30,

 

 

2020

 

 

2019

 

 

$ Change

 

 

% Change

 

United States

 

$

1,720,000

 

 

$

2,487,000

 

 

$

(767,000

)

 

 

(31%

)

Latin America

 

 

2,320,000

 

 

 

654,000

 

 

 

1,666,000

 

 

255%

Europe and Rest of the World

 

 

3,214,000

 

 

 

1,244,000

 

 

 

1,970,000

 

 

 

158%

 

Total

 

$

7,254,000

 

 

$

4,385,000

 

 

$

2,869,000

 

 

 

65%

 

 

Contacts

Sonoma Pharmaceuticals, Inc.

ir@sonomapharma.com

AgeX Therapeutics Reports Second Quarter 2020 Financial Results and Provides Business Update

ALAMEDA, Calif.–(BUSINESS WIRE)–AgeX Therapeutics, Inc. (“AgeX”; NYSE American: AGE), a biotechnology company developing therapeutics for human aging and regeneration, reported financial and operating results for the second quarter ended June 30, 2020.

AgeX made strides with respect to its newly established licensing and collaboration model, which aims to embed its technology platforms across the cell therapy industry. AgeX has entered into a research license for the use of its immunotolerance UniverCyteTM technology by Sernova Corp. (“Sernova”), a publicly-listed Canadian regenerative medicine therapeutics company. It also entered a Manufacturing, Marketing, and Distribution Agreement with Pluristyx, Inc. (“Pluristyx”), an advanced therapy tools and services company serving customers in the fields of regenerative medicine and cellular and gene therapies. In addition, AgeX signed a letter of intent with ImStem Biotechnology (“ImStem”), for ImStem to utilize AgeX’s ESI-brand pluripotent stem cells to derive a cell therapy product for potential use in the treatment of COVID-19 and as well acute respiratory distress syndrome (ARDS) from non-COVID-19 causes.

“We are working diligently to position our subsidiary Reverse Bioengineering to optimize the potential of induced tissue regeneration (iTR) technology,” said Michael West, CEO of AgeX. “We believe this technology offers a powerful new modality to treat age-related degenerative diseases by reversing developmental aging in a tissue, thereby unlocking an innate capacity of tissues to regenerate scarlessly.”

AgeX completed its restructuring to streamline its operations to allow efficient usage of capital in the current pandemic environment as well to meet near-term strategic company priorities of deriving value and generating preclinical and ultimately clinical data from our technology platforms through external licensing and collaboration agreements. In the longer-term, AgeX remains committed to in-house product development of AgeX-BAT1 and AgeX-VASC1. AgeX is considering options to bring capital into the company.

“AgeX has made excellent progress in terms of its collaboration and licensing model, closing five deals since the beginning of the year so far,” said Greg Bailey M.D., Chairman of AgeX. “The deals have spanned all three of our technology platforms of UniverCyte for the generation of universal cells, PureStem for the derivation and manufacturing of therapeutic cells, and AgeX ESI pluripotent stem cells to act as a source material for cellular therapies. All these deals show the value industry and academia see in our offerings.”

Q2 Highlights

  • AgeX entered into a research license with Sernova Corp. in which Sernova will utilize AgeX’s UniverCyteTM gene technology to generate immune-protected universal therapeutic cells for use in combination with Sernova’s Cell PouchTM for the treatment of type I diabetes and hemophilia A. The goal is to eliminate the need for immunosuppressive medications following cellular transplantation. Sernova has been granted a time-limited, non-exclusive research license by AgeX. A commercial license for Sernova to utilize UniverCyte for therapeutic and commercial purposes may be negotiated pending successful study outcomes. UniverCyte uses a proprietary, novel, modified form of HLA-G, a potent immunomodulatory molecule, which protects an unborn child from their mother’s immune system. In almost all human cells, native HLA-G expression is silenced after birth. AgeX’s modified HLA-G shows evidence of being resistant to this silencing, hence potentially allowing for long-term, stable and high expression. Sernova is a Canadian regenerative medicine therapeutics company.
  • AgeX and ImStem Biotechnology, Inc. signed a non-binding letter of intent for ImStem to obtain from AgeX a non-exclusive license to use AgeX’s embryonic stem cell line ESI 053 to derive ImStem’s investigational mesenchymal stem cell (MSC) product IMS001 for development in COVID-19 as well as ARDS due to other causes. AgeX and ImStem are cooperating to finalize financial terms and other provisions of a license agreement. ImStem has previously used AgeX ESI 053 to derive its IMS001 product. Earlier this year, the U.S. Food and Drug Administration (FDA) cleared IMS001 to begin a Phase 1 clinical study in patients with multiple sclerosis. This is believed to be the first MSC product derived from human embryonic stem cells to be accepted for a clinical trial by the FDA. ImStem is a biopharmaceutical company developing human embryonic stem cell-derived mesenchymal stem cells.
  • AgeX entered into a Manufacturing, Marketing and Distribution Agreement with Pluristyx, Inc. under which Pluristyx will perform certain services to manufacture, market and distribute on AgeX’s behalf, research-grade and clinical-grade AgeX ESI brand human pluripotent stem cells for therapeutic applications. This agreement allows industry and academia access to current Good Manufacturing Practice (cGMP)-grade, National Institutes of Health (NIH)-registered AgeX ESI cell lines. AgeX ESI cells are among only a few pluripotent stem cell lines from which derived cell therapy candidates have been granted FDA investigational new drug (IND) clearance to begin human trials. Academic and biopharma organizations will need to obtain separate commercial licenses from AgeX in order to advance their cellular product candidates generated from AgeX ESI cell lines into human clinical trials and commercialization. Pluristyx is an advanced therapy tools and services company serving customers in the fields of regenerative medicine and cellular and gene therapies.

Liquidity and Capital Resources

AgeX is in need of additional capital to finance its operations. On March 30, 2020, AgeX entered into a Secured Convertible Facility Agreement (the “New Loan Agreement”) with Juvenescence Limited pursuant to which AgeX may borrow funds from time to time. As of August 14, 2020, AgeX has borrowed $3.5 million and may draw additional funds from time to time subject to Juvenescence’s discretion, prior to the contractual repayment date on March 30, 2023. AgeX may not draw down more than $1.0 million in any single draw. More information about the New Loan Agreement can be found in AgeX’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q for the periods ended March 31, 2020 and June 30, 2020 filed with the Securities and Exchange Commission on March 30, 2020, May 14, 2020, and August 14, 2020 respectively.

On April 13, 2020, AgeX obtained a loan in the amount of $432,952 from Axos Bank under the Paycheck Protection Program (the “PPP Loan”). The PPP Loan bears interest at a rate of 1% per annum. No payments will be due on the PPP Loan during a six month deferral period commencing on the date of the promissory note. Commencing one month after the expiration of the deferral period, and continuing on the same day of each month thereafter until the maturity date of the PPP Loan, monthly payments of principal and interest will be due, in an amount required to fully amortize the principal amount outstanding on the PPP Loan by the maturity date. The maturity date is April 13, 2022. The principal amount of the PPP Loan is subject to forgiveness under the Paycheck Protection Program (“PPP”) to the extent that PPP Loan proceeds are used to pay expense permitted by the PPP, including payroll, rent, and utilities (collectively, “Qualifying Expenses”), during the time frame permitted by the PPP. AgeX believes that it has used the PPP Loan amount for Qualifying Expenses. However, no assurance is provided that AgeX will obtain forgiveness of the PPP Loan in whole or in part.

Staff Reductions

In May 2020, AgeX laid off 11 research and development personnel and consequently paid approximately $105,000 in accrued payroll and unused paid time off and other benefits and recognized approximately $194,800 in restructuring charges in connection with the reduction in staffing, consisting of contractual severance and other employee termination benefits, substantially all of which have been settled in cash. The staff reductions followed AgeX’s strategic review of its operations, giving consideration to the status of its product development programs, human resources, capital needs and resources, and current conditions in the capital markets resulting from the COVID-19 pandemic.

Going Concern Considerations

As required under Accounting Standards Update 2014-15, Presentation of Financial Statements-Going Concern (ASC 205-40), AgeX evaluates whether conditions and/or events raise substantial doubt about its ability to meet its future financial obligations as they become due within one year after the date its financial statements are issued. Based on AgeX’s most recent projected cash flows, and considering that loans from Juvenescence under the New Loan Agreement will be subject to Juvenescence’s discretion, AgeX believes that its cash and cash equivalents, the remaining $5.5 million available under the New Loan Agreement and reduction in staff in May 2020 would not be sufficient to satisfy its anticipated operating and other funding requirements for the twelve months following the filing of AgeX’s Quarterly Report on Form 10-Q for the three and six months ended June 30, 2020. These factors raise substantial doubt regarding the ability of AgeX to continue as a going concern.

Second Quarter 2020 Operating Results

Revenues: Total revenues for the second quarter of 2020 were $414,000 as compared with $380,000 for the second quarter of 2019. AgeX revenues are primarily generated from subscription and advertising revenues from the GeneCards® online database through its subsidiary LifeMap Sciences, Inc. Revenues in 2020 also included approximately $36,000 of allowable expenses under its research grant from the NIH as compared with $47,000 in the same period in 2019.

Operating expenses: Operating expenses for the three months ended June 30, 2020 were $3.0 million as compared to $3.8 million for the same period in 2019. On an as-adjusted basis, operating expenses for the three months ended June 30, 2020 were $2.5 million as compared to $3.1 million for the same period in 2019.

The reconciliation between GAAP and non-GAAP operating expenses is provided in the financial tables included with this earnings release.

Research and development expenses decreased by $0.3 million to $1.4 million during the three months ended June 30, 2020 from $1.7 million during the same period in 2019. The decrease was primarily attributable to the layoff of 11 research and development personnel in May 2020 and decrease in shared services from Lineage Cell Therapeutics, Inc. (“Lineage”) with the termination of our Shared Facilities and Services Agreement on September 30, 2019.

General and administrative expenses decreased by $0.4 million to $1.7 million during the three months ended June 30, 2020 from $2.1 million during the same period in 2019 despite an increase in head count with the employment of AgeX’s own finance team since October 1, 2019. These increases were offset by a decrease in travel and related expenses with the shelter in place mandates since March 15, 2020 resulting from the COVID-19 pandemic, and the elimination of shared facilities and services fees from Lineage following the termination of the Shared Facilities and Services Agreement on September 30, 2019.

About AgeX Therapeutics

AgeX Therapeutics, Inc. (NYSE American: AGE) is focused on developing and commercializing innovative therapeutics for human aging. Its PureStem® and UniverCyte™ manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeX’s revolutionary longevity platform induced Tissue Regeneration (iTR™) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. AGEX-iTR1547 is an iTR-based formulation in preclinical development. HyStem® is AgeX’s delivery technology to stably engraft PureStem cell therapies in the body. AgeX’s core product pipeline is intended to extend human healthspan. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

For more information, please visit www.agexinc.com or connect with the company on Twitter, LinkedIn, Facebook, and YouTube.

Forward-Looking Statements

Certain statements contained in this release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not historical fact including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates” should also be considered forward-looking statements. Forward-looking statements involve risks and uncertainties. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of AgeX Therapeutics, Inc. and its subsidiaries, particularly those mentioned in the cautionary statements found in more detail in the “Risk Factors” section of AgeX’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commissions (copies of which may be obtained at www.sec.gov). Subsequent events and developments may cause these forward-looking statements to change. In addition, with respect to AgeX’s Manufacturing, Marketing and Distribution Agreement with Pluristyx there is no assurance that (i) Pluristyx will generate significant sales of AgeX ESI hESC lines, or (ii) AgeX will derive significant revenue from sales of ESI hESC lines by Pluristyx. AgeX specifically disclaims any obligation or intention to update or revise these forward-looking statements as a result of changed events or circumstances that occur after the date of this release, except as required by applicable law.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED BALANCE SHEETS

(IN THOUSANDS, EXCEPT PAR VALUE AMOUNTS)

 

 

 

June 30,

2020

 

 

December 31,

2019

 

 

 

(Unaudited)

 

 

 

 

ASSETS

 

 

 

 

 

 

 

 

CURRENT ASSETS

 

 

 

 

 

 

 

 

Cash and cash equivalents

 

$

1,033

 

 

$

2,352

 

Accounts and grants receivable, net

 

 

235

 

 

 

363

 

Prepaid expenses and other current assets

 

 

836

 

 

 

1,339

 

Total current assets

 

 

2,104

 

 

 

4,054

 

 

 

 

 

 

 

 

 

 

Property and equipment, net

 

 

681

 

 

 

1,126

 

Deposits and other long-term assets

 

 

100

 

 

 

111

 

Intangible assets, net

 

 

1,872

 

 

 

2,151

 

TOTAL ASSETS

 

$

4,757

 

 

$

7,442

 

 

 

 

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

 

 

 

 

 

 

 

 

CURRENT LIABILITIES

 

 

 

 

 

 

 

 

Accounts payable and accrued liabilities

 

$

1,771

 

 

$

1,582

 

Loan due to Juvenescence, net of debt issuance cost, current portion

 

 

1,821

 

 

 

 

Related party payables, net

 

 

142

 

 

 

64

 

Deferred revenues

 

 

328

 

 

 

283

 

Right-of-use lease liability

 

 

218

 

 

 

428

 

Paycheck Protection Program Loan

 

 

434

 

 

 

 

Insurance premium liability and other current liabilities

 

 

433

 

 

 

940

 

Total current liabilities

 

 

5,147

 

 

 

3,297

 

 

 

 

 

 

 

 

 

 

Loan due to Juvenescence, net of debt issuance cost, net of current portion

 

 

1,732

 

 

 

1,528

 

TOTAL LIABILITIES

 

 

6,879

 

 

 

4,825

 

 

 

 

 

 

 

 

 

 

Commitments and contingencies (Note 9)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

STOCKHOLDERS’ EQUITY (DEFICIT)

 

 

 

 

 

 

 

 

Preferred stock, $0.0001 par value, authorized 5,000 shares; none issued and outstanding as of June 30, 2020 and December 31, 2019

 

 

 

 

 

 

Common stock, $0.0001 par value, 100,000 shares authorized; 37,658 and 37,649 shares issued and outstanding as of June 30, 2020 and December 31, 2019, respectively

 

 

4

 

 

 

4

 

Additional paid-in capital

 

 

89,555

 

 

 

88,353

 

Accumulated other comprehensive income

 

 

81

 

 

 

69

 

Accumulated deficit

 

 

(92,084

)

 

 

(86,208

)

AgeX Therapeutics, Inc. stockholders’ equity (deficit)

 

 

(2,444

)

 

 

2,218

 

Noncontrolling interest

 

 

322

 

 

 

399

 

Total stockholders’ equity (deficit)

 

 

(2,122

)

 

 

2,617

 

TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

 

$

4,757

 

 

$

7,442

 

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(IN THOUSANDS, EXCEPT PER SHARE DATA)

(UNAUDITED)

 

 

 

Three Months Ended

June 30,

 

 

Six Months Ended

June 30,

 

 

 

2020

 

 

2019

 

 

2020

 

 

2019

 

REVENUES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Subscription and advertisement revenues

 

$

298

 

 

$

275

 

 

$

636

 

 

$

620

 

Grant revenues

 

 

36

 

 

 

47

 

 

 

122

 

 

 

62

 

Other revenues

 

 

80

 

 

 

58

 

 

 

171

 

 

 

86

 

Total revenues

 

 

414

 

 

 

380

 

 

 

929

 

 

 

768

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Cost of sales

 

 

(36

)

 

 

(53

)

 

 

(70

)

 

 

(116

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Gross profit

 

 

378

 

 

 

327

 

 

 

859

 

 

 

652

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OPERATING EXPENSES:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

 

1,350

 

 

 

1,650

 

 

 

2,953

 

 

 

2,988

 

General and administrative

 

 

1,653

 

 

 

2,119

 

 

 

3,726

 

 

 

4,228

 

Total operating expenses

 

 

3,003

 

 

 

3,769

 

 

 

6,679

 

 

 

7,216

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Loss from operations

 

 

(2,625

)

 

 

(3,442

)

 

 

(5,820

)

 

 

(6,564

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

OTHER INCOME/(EXPENSES):

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Interest income (expense), net

 

 

(87

)

 

 

33

 

 

 

(139

)

 

 

45

 

Other income (expense), net

 

 

(19

)

 

 

257

 

 

 

6

 

 

 

229

 

Total other income (expense), net

 

 

(106

)

 

 

290

 

 

 

(133

)

 

 

274

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS BEFORE INCOME TAXES

 

 

(2,731

)

 

 

(3,152

)

 

 

(5,953

)

 

 

(6,290

)

Income tax provision

 

 

 

 

 

(3

)

 

 

 

 

 

(76

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS

 

 

(2,731

)

 

 

(3,155

)

 

 

(5,953

)

 

 

(6,366

)

Net loss attributable to noncontrolling interest

 

 

42

 

 

 

66

 

 

 

77

 

 

 

144

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS ATTRIBUTABLE TO AGEX

 

$

(2,689

)

 

$

(3,089

)

 

$

(5,876

)

 

$

(6,222

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

NET LOSS PER COMMON SHARE:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BASIC AND DILUTED

 

$

(0.07

)

 

$

(0.08

)

 

$

(0.16

)

 

$

(0.17

)

WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

BASIC AND DILUTED

 

 

37,657

 

 

 

37,630

 

 

 

37,654

 

 

 

36,891

 

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(IN THOUSANDS)

(UNAUDITED)

 

 

 

Six Months Ended

June 30,

 

 

 

2020

 

 

2019

 

CASH FLOWS FROM OPERATING ACTIVITIES:

 

 

 

 

 

 

 

 

Net loss attributable to AgeX

 

$

(5,876

)

 

$

(6,222

)

Net loss attributable to noncontrolling interest

 

 

(77

)

 

 

(144

)

Adjustments to reconcile net loss attributable to AgeX to net cash used in operating activities:

 

 

 

 

 

 

 

 

Gain on sale of equity method investment in Ascendance

 

 

 

 

 

(277

)

Depreciation expense

 

 

247

 

 

 

22

 

Amortization of intangible assets

 

 

279

 

 

 

279

 

Amortization of right-of-use asset

 

 

209

 

 

 

99

 

Amortization of debt issuance cost

 

 

130

 

 

 

 

Stock-based compensation

 

 

519

 

 

 

996

 

Foreign currency remeasurement gain (loss) and other

 

 

44

 

 

 

49

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

 

 

Accounts and grants receivable, net

 

 

103

 

 

 

(77

)

Prepaid expenses and other current assets

 

 

511

 

 

 

359

 

Accounts payable and accrued liabilities

 

 

186

 

 

 

121

 

Related party payables

 

 

78

 

 

 

(71

)

Insurance premium liability

 

 

(473

)

 

 

(448

)

Deferred revenues and other liabilities

 

 

(188

)

 

 

(63

)

Net cash used in operating activities

 

 

(4,308

)

 

 

(5,377

)

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM INVESTING ACTIVITIES:

 

 

 

 

 

 

 

 

Proceeds from the sale of equity method investment in Ascendance

 

 

 

 

 

277

 

Security deposit paid

 

 

 

 

 

(77

)

Purchase of equipment and other

 

 

(8

)

 

 

(109

)

Net cash provided by (used in) investing activities

 

 

(8

)

 

 

91

 

 

 

 

 

 

 

 

 

 

CASH FLOWS FROM FINANCING ACTIVITIES:

 

 

 

 

 

 

 

 

Proceeds from exercise of warrants

 

 

 

 

 

4,500

 

Draw down on loan facility from Juvenescence

 

 

2,700

 

 

 

 

Proceeds from Paycheck Protection Program Loan

 

 

433

 

 

 

 

Payment of debt related costs

 

 

(126

)

 

 

 

Repayment of financing lease liability

 

 

(15

)

 

 

(9

)

Net cash provided by financing activities

 

 

2,992

 

 

 

4,491

 

 

 

 

 

 

 

 

 

 

Effect of exchange rate changes on cash and cash equivalents

 

 

5

 

 

 

1

 

 

 

 

 

 

 

 

 

 

NET DECREASE IN CASH, CASH EQUIVALENTS AND RESTRICTED CASH

 

 

(1,319

)

 

 

(794

)

 

 

 

 

 

 

 

 

 

CASH, CASH EQUIVALENTS AND RESTRICTED CASH:

 

 

 

 

 

 

 

 

At beginning of the period

 

 

2,452

 

 

 

6,707

 

At end of the period

 

$

1,133

 

 

$

5,913

 

Non-GAAP Financial Measures

This press release includes operating expenses prepared in accordance with accounting principles generally accepted in the United States (GAAP) and, includes operating expenses, by entity, prepared in accordance with GAAP. This press release also includes certain historical non-GAAP operating expenses and non-GAAP operating expenses, by entity. In particular, AgeX Therapeutics, Inc. (“AgeX”) has provided both (a) non-GAAP total operating expenses, adjusted to exclude noncash stock-based compensation expense, depreciation and amortization expense, and acquired in-process research and development expense, a nonrecurring item, and (b) non-GAAP operating expenses, by entity, to exclude those same charges by the respective entities for consistency. Non-GAAP financial measures are not meant to be considered in isolation or as a substitute for comparable financial measures prepared in accordance with GAAP. However, AgeX believes the presentation of non-GAAP total operating expenses and non-GAAP operating expenses, by entity, when viewed in conjunction with our GAAP total operating expenses, and GAAP operating expenses by entity, respectively, is helpful in understanding AgeX’s ongoing operating expenses and its programs and those of certain subsidiaries.

Furthermore, management uses these non-GAAP financial measures in the aggregate and on an entity basis to establish budgets and operational goals, to manage AgeX’s business and to evaluate its performance and its programs in clinical development.

AGEX THERAPEUTICS, INC. AND SUBSIDIARIES

Reconciliation of Non-GAAP Financial Measure

Adjusted Operating Expenses

 

Amounts In Thousands and Unaudited

For the Three Months Ended

June 30,

For the Six Months Ended

June 30,

2020

2019

2020

2019

GAAP Operating Expenses – as reported

$ 3,003

3,769

 

$ 6,679

$ 7,216

 

Stock-based compensation expense (1)

(259)

(515)

 

(519)

(996)

 

Depreciation and amortization expense (1)

(263)

(152)

 

(526)

(301)

 

Non-GAAP Operating Expenses, as adjusted

$ 2,481

$ 3,102

 

$ 5,634

$ 5,919

 

 

 

 

 

 

 

 

GAAP Operating Expenses – by entity

 

 

 

 

 

 

AgeX and subsidiaries other than LifeMap Sciences (2)

$ 2,410

$ 3,176

 

$ 5,506

$ 6,036

 

LifeMap Sciences, Inc. and subsidiary (3)

593

593

 

1,173

1,180

 

GAAP Operating Expenses – by entity

$ 3,003

$ 3,769

 

$ 6,679

$ 7,216

 

 

 

 

 

 

 

 

Non-GAAP Operating Expenses – as adjusted, by entity

 

 

 

 

 

 

AgeX and subsidiaries other than LifeMap Sciences

$ 2,001

$ 2,624

 

$ 4,689

$ 4,969

 

LifeMap Sciences, Inc. and subsidiary

480

478

 

945

950

 

Non-GAAP Operating Expenses – as adjusted, by entity

$ 2,481

$ 3,102

 

$ 5,634

$ 5,919

 

 

 

 

 

 

 

 

 

(1)

Noncash charges

(2)

AgeX Therapeutics, Inc. includes ReCyte Therapeutics, Inc., a majority-owned and consolidated subsidiary.

(3)

LifeMap Sciences Inc. includes LifeMap Sciences Ltd., both consolidated subsidiaries of AgeX Therapeutics, Inc.

 

Contacts

Contact for AgeX:

Andrea Park

apark@agexinc.com
(510) 671-8620

McKesson to Distribute Future COVID-19 Vaccines in Support of Operation Warp Speed

The Centers for Disease Control is Exercising an Option of an Existing Contract with McKesson for This Effort

IRVING, Texas–(BUSINESS WIRE)–A global leader in the healthcare industry, McKesson Corporation (NYSE: MCK) will expand its existing partnership with the Centers for Disease Control (CDC) to support the U.S. government’s Operation Warp Speed (OWS) team as a centralized distributor of future COVID-19 vaccines and ancillary supplies needed to administer vaccinations. Vaccines and related supplies will be delivered to point-of-care sites across the country at the U.S. government’s direction.

McKesson is committed to supporting public health in the U.S. and around the world,” said Brian Tyler, CEO of McKesson. “Since the onset of the pandemic, McKesson has leveraged our deep expertise to help maintain the integrity of the healthcare supply chain, source and distribute personal protective equipment to frontline workers and stand up COVID-19 testing at Health Mart pharmacies, many in underserved communities. We are honored that the U.S. government has asked McKesson to play a key role in the effort to distribute COVID-19 vaccines.”

The CDC has an existing contract with McKesson to support distribution as part of the CDC’s Vaccines for Children Program (VFC). This contract was awarded to McKesson in a competitive bidding process initiated in 2016 and includes an option for distribution of vaccines in the event of a pandemic. McKesson will utilize its expertise and capabilities, along with other industry partners, to support the CDC’s efforts to vaccinate everyone in the U.S. who wants to receive a COVID-19 vaccine. CDC and McKesson collaborated similarly in response to the H1N1 pandemic.

Beyond programs with the CDC, McKesson is the largest seasonal flu vaccine distributor in the U.S. and distributes up to 150 million doses of all vaccines annually to public health clinics, hospitals, physician offices, nursing homes, pharmacies and other care facilities.

Cautionary Statements

Except for historical information, statements in this press release may constitute “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, that involve risks and uncertainties that could cause actual results to differ materially from those in those statements. It is not possible to identify all such risks and uncertainties. Forward-looking statements may be identified by their use of terminology such as “will” or their references to future events, such as delivery of vaccines to point-of-care sites and support of CDC efforts. The reader should not place undue reliance on forward-looking statements, such as financial performance forecasts, which speak only as of the date they are first made. Except to the extent required by law, the company undertakes no obligation to publicly update forward-looking statements. We encourage investors to read the important risk factors described in the company’s Form 10-K, Form 10-Q and Form 8-K reports filed with the Securities and Exchange Commission.

These risk factors include, but are not limited to: our contracts with government entities involve future funding and compliance risks; we might be harmed by changes in our relationships or contracts with suppliers; we might be adversely impacted by changes or disruptions in product supply and we have experienced and may experience difficulties in sourcing products due to the effects of the COVID-19 pandemic on supply chains; and we might be adversely impacted by events outside of our control, such as widespread public health issues (including the effects we have experienced from the COVID-19 pandemic), natural disasters, political events and other catastrophic events.

About McKesson Corporation

McKesson Corporation is a global leader in healthcare supply chain management solutions, retail pharmacy, community oncology and specialty care, and healthcare information solutions. McKesson partners with pharmaceutical manufacturers, providers, pharmacies, governments and other organizations in healthcare to help provide the right medicines, medical products and healthcare services to the right patients at the right time, safely and cost-effectively. United by our ICARE shared principles, our employees work every day to innovate and deliver opportunities that make our customers and partners more successful – all for the better health of patients. McKesson has been named a “Most Admired Company” in the healthcare wholesaler category by FORTUNE, a “Best Place to Work” by the Human Rights Campaign Foundation, and a top military-friendly company by Military Friendly. For more information, visit www.mckesson.com.

About Operation Warp Speed

OWS is a partnership among components of the Department of Health and Human Services and the Department of Defense, engaging with private firms and other federal agencies, and coordinating among existing HHS-wide efforts to accelerate the development, manufacturing, and distribution of COVID-19 vaccines, therapeutics, and diagnostics.

Contacts

Holly Weiss, 972-969-9174 (Investors)

Holly.Weiss@McKesson.com
David Matthews, 214-952-0833 (Media)

David.Matthews@McKesson.com

Global Laser Therapy Market Forecasts to 2027 with COVID-19 Impact Analysis by Type, Application, End-user and Geography – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Laser Therapy Market Forecast to 2027 – COVID-19 Impact and Global Analysis by Type; Application; End User, and Geography” report has been added to ResearchAndMarkets.com’s offering.

The global laser therapy market is expected to reach US$ 3,514.02 million by 2027 from US$ 1,665.65 million in 2019; it is estimated to grow at a CAGR of 9.9% during 2020-2027.

Factors such as broad range of medical applications and growing number of product launches drive the growth of the market. However, the high cost of laser therapy and devices is the major factor hindering the market growth.

The wide adoption of this therapy in the medical field is ascribed to limited health risks associated with it compared with those with surgical procedures. Moreover, it is a minimally invasive procedure and has broad applications in oncology, ophthalmology, aesthetics, dental, cardiovascular, and pain management, among others.

In oncology, laser therapy is used along with other treatments such as surgery, chemotherapy, or other radiation therapies. Vaginal cancer, vulvar cancer, basal cell skin cancer, cervical cancer, and penile cancer, among others, can be treated with laser therapy. In addition, technological advancements have enabled the painless sealing of nerves using laser therapy after surgery; its ability to seal the injured sites helps prevent blood loss.

In addition, laser therapy is widely accepted in aesthetic applications such as removal of hair, tattoo, moles, birthmarks, warts, and sunspots. Further, the use of laser therapy in primary veincosmetic treatments, skin resurfacing, and hair removal has significantly increased. According to the American Society of Plastic Surgeons (ASPS) annual report, 218,929 laser treatments for veins, 587,903 laser skin resurfacing, and 1,086,830 laser hair removal procedures were performed in 2017 in the US.

The global laser therapy market is segmented on the basis of type, application, end user, and geography. Global laser therapy market, based on type is segmented into, solid, liquid, gas and diode. In 2019, the diode segment held the largest share of the market, by type. Moreover, the same segment is expected to register the fastest CAGR during the forecast period. The laser diode market is expected to witness lucrative growth owing to its rapid adoption in photodynamic treatments and aesthetic procedures.

Key Topics Covered

1. Introduction

1.1 Scope of the Study

1.2 Report Guidance

1.3 Market Segmentation

1.3.1 Laser Therapy Market – By Type

1.3.2 Laser Therapy Market – By Application

1.3.3 Laser Therapy Market – By End-user

1.3.4 Laser Therapy Market – By Geography

2. Laser Therapy Market – Key Takeaways

3. Research Methodology

3.1 Coverage

3.2 Secondary Research

3.3 Primary Research

4. Laser Therapy Market – Market Landscape

4.1 Overview

4.2 PEST Analysis

4.2.1 North America – PEST Analysis

4.2.2 Europe – PEST Analysis

4.2.3 Asia Pacific- PEST Analysis

4.2.4 Middle East and Africa – PEST Analysis

4.2.5 South & Central America

4.3 Expert Opinion

5. Laser Therapy Market – Key Market Dynamics

5.1 Market Drivers

5.1.1 Broad Medical Applications

5.1.2 Growing Product Launches

5.2 Market Restraints

5.2.1 High Cost of Laser Therapy and Devices

5.3 Market Opportunities

5.3.1 Developments in Laser Technology

5.4 Future Trends

5.4.1 Adoption of LLLT

5.5 Impact Analysis

6. Laser Therapy Market – Global Analysis

6.1 Global Laser Therapy Market Revenue Forecast and Analysis

6.2 Global Laser Therapy Market, By Geography – Forecast and Analysis

6.3 Market Positioning of Key Players

7. Laser Therapy Market Analysis – by Type

7.1 Overview

7.2 Laser Therapy Market, By Type, 2019 & 2027 (%)

7.3 Solid

7.4 Liquid

7.5 Gas

7.6 Diode

8. Laser Therapy Market Analysis – by Application

8.1 Overview

8.2 Laser Therapy Market, By Application, 2019 & 2027 (%)

8.3 Dermatology and Aesthetics

8.4 Dental

8.5 Ophthalmology

8.6 Urology

8.7 Cardiovascular

8.8 Oncology

8.9 Other Applications

9. Laser Therapy Market Analysis – by End-user

9.1 Overview

9.2 Laser Therapy Market, By End-user, 2019 & 2027 (% Share)

9.3 Hospitals

9.4 Specialized Clinics

9.5 Ambulatory Clinics

9.6 Others

10. Laser Therapy Market – Geographic Analysis

10.1 North America: Laser Therapy Market

10.2 Europe: Laser Therapy Market

10.3 Asia Pacific: Laser Therapy Market

10.4 Middle East and Africa: Laser Therapy Market

10.5 South and Central America: Laser Therapy Market

11. Impact of COVID-19 Pandemic on Global Laser Therapy Market

11.1 North America: Impact Assessment of COVID-19 Pandemic

11.2 Europe: Impact Assessment Of COVID-19 Pandemic

11.3 Asia-Pacific: Impact Assessment of COVID-19 Pandemic

11.4 Rest of the World: Impact Assessment of COVID-19 Pandemic

12. Laser Therapy Market – Industry Landscape

12.1 Overview

12.2 Growth Strategies Done by the Companies in the Market, (%)

12.3 Organic Developments

12.4 Inorganic Developments

13. Company Profiles

13.1 Alma Lasers

13.2 Coherent Inc.

13.3 Biolitec Group

13.4 BIOLASE Inc.

13.5 IPG Photonics Corporation

13.6 Boston Scientific Corporation

13.7 BTL

13.8 Meditech International Inc. (BIOFLEX Laser Therapy)

13.9 Baring Private Equity Asia Ltd. (Lumenis)

13.10 Cutera

For more information about this report visit https://www.researchandmarkets.com/r/q4ubu1

Contacts

ResearchAndMarkets.com

Laura Wood, Senior Press Manager

press@researchandmarkets.com

For E.S.T Office Hours Call 1-917-300-0470

For U.S./CAN Toll Free Call 1-800-526-8630

For GMT Office Hours Call +353-1-416-8900

Fuse Medical, Inc. Ranked Among Top 150 Public Companies in Dallas-Fort Worth Metroplex

RICHARDSON, Texas–(BUSINESS WIRE)–Fuse Medical, Inc., (OTCPINK: FZMD), (“Fuse” or the “Company”) an emerging manufacturer and distributor of innovative medical devices for the orthopedic and spine marketplace, announced that it has been ranked number 136 on the 2020 list of Dallas-Fort Worth’s 150 largest public companies, by the Dallas Morning News.

Fuse Medical’s 2019 revenue of $22.9 million secured its title as the 136th largest public company in DFW, moving them up one spot from where they ranked last year. The annual list, compiled by Bloomberg for the Dallas Morning News, examines public companies in a seventy-county area in North Texas, and ranks them by their total revenue for the prior fiscal year.

Christopher C. Reeg, Chief Executive Officer, commented, “We are honored to have been named by Dallas Morning News as one of the top 150 public companies in Dallas-Fort Worth for the third year in a row. It is a privilege to work alongside a dedicated and hardworking team of employees, surgeons, advisors, customers and strategic partners, without whom this accomplishment would not be possible. Even through this challenging time with the COVID-19 pandemic, we remain optimistic that Fuse will continue to increase shareholder value by staying focused on our strategic initiatives, and to continuously provide exceptional service and products that will meet and exceed the evolving needs of our customers.”

To view the full list of companies and more information visit: Dallas Morning News: A Searchable Guide to Dallas-Fort Worth’s 150 Largest Public Companies for 2020.

About Fuse Medical, Inc.

Fuse is an emerging manufacturer and distributor of innovative medical devices for the orthopedic and spine marketplace. We provide a comprehensive portfolio of products in the orthopedic total joints, sports medicine, trauma, foot and ankle space, as well as, degenerative and deformity spine, orthobiologics and regenerative medicine products. For more information about the Company, or if you’re interested in becoming a distributor of any Fuse’s products, please contact us at info@fusemedical.com or visit: www.fusemedical.com.

Forward Looking Statements

Certain statements in this press release, constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend,” or similar expressions or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based only on information available to the Company as of the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the Securities and Exchange Commission; the failure of the Company to close the transaction; and integration issues with the consolidated company. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events, or otherwise, except as required by law.

Contacts

Fuse Medical, Inc.
Devon Morgan, Sr. Investor Relations Analyst
Office (469) 862-3030
Facsimile (469) 862-3035
info@Fusemedical.com

Global Tetanus Toxoid Vaccine Market (2020 to 2025) – Growth, Trends, and Forecast – ResearchAndMarkets.com

DUBLIN–(BUSINESS WIRE)–The “Tetanus Toxoid Vaccine Market – Growth, Trends, and Forecast (2020 – 2025)” report has been added to ResearchAndMarkets.com’s offering.

The Tetanus Toxoid Vaccine Market is expected to register a CAGR of 4.8% during the forecast period.

Tetanus also known as lockjaw is a non-communicable serious disease caused by a bacterial toxin that affects the nervous system, leading to painful muscle contractions, particularly jaw and neck muscles. It is caused by Clostridium tetani (C tetani) which is found in human and animal feces, soil and street dust.

The bacteria enter the body through wounds. Some of the symptoms include lockjaws (paralysis of the jaw), muscle stiffness, back pain, difficulties in breathing and spasms. Most of all cases of tetanus occur in people who have never been vaccinated or in adults who haven’t kept up with their 10-year booster shots. The different vaccines that include protection against tetanus are DTaP vaccine, DT vaccine, Tdap vaccine and Td vaccine.

Companies Mentioned

  • Merck & Co. Inc
  • GlaxoSmithKline Plc
  • Sanofi (Sanofi Pasteur, Inc)
  • Pfizer, Inc
  • Bharat Biotech
  • Astellas Pharma Inc
  • Panacea Biotec Ltd
  • BB – NCIPD Ltd
  • PT Bio Farma
  • Biological E Limited

Key Market Trends

Diphtheria, Tetanus, and Pertussis (DTaP) Vaccines Segment is Expected to Hold a Major Market Share in the Tetanus Toxoid Vaccine Market

  • Diphtheria, Tetanus, and Pertussis (DTaP) vaccines segment holds a significant market share in the tetanus toxoid vaccine market and is anticipated to show a similar trend over the forecast period owing to growing government initiatives to eradicate these diseases.
  • DTaP is a vaccine that helps in developing immunity against three deadly diseases caused by diphtheria, tetanus, and whooping cough (pertussis) in children younger than 7 years old.
  • According to the World Health Organization (WHO), in 2017 worldwide 38,000 people died from tetanus. Around half (49%) were younger than five years old. Moreover, 77% of all deaths from tetanus, 29,500 lives lost, occur in South Asia and Sub-Saharan Africa. In addition, South Asia and Sub-Saharan Africa account for 82% of all tetanus cases globally.
  • Low costs of the vaccine, increasing cases of tetanus and increasing availability in low resource economies like Africa are the key driving factors in the Diphtheria, Tetanus, and Pertussis (DTaP) vaccines segment.

North America is Expected to Hold a Significant Share in the Market

North America is expected to hold a major market share in the global tetanus toxoid vaccine market due to increasing cases of tetanus and diphtheria, and higher cost, high coverage, and adoption in this region. According to the Centers for Disease Control and Prevention (CDC), in 2017, a total of 33 tetanus cases and 2 deaths were reported in the United States.

Moreover, from 2009 through 2017, a total of 264 cases and 19 deaths from tetanus were reported. Sixty cases (23%) were in people with 65 years of age or older, 168 cases (64%) in people 20 to 64 years of age, and 36 cases (13%) were in younger than 20 years. All tetanus-related deaths occurred among patients greater than 55 years of age. Furthermore, increasing focus to control the incidence and presence of well-established healthcare infrastructure is also fueling the growth of the overall regional market to a large extent.

Key Topics Covered:

1 INTRODUCTION

1.1 Study Assumptions

1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS

4.1 Market Overview

4.2 Market Drivers

4.2.1 Rising Cases of Tetanus and Diphtheria

4.2.2 Growing Research and Development Activities for New Vaccines

4.2.3 Increasing Government Initiatives Programs for Vaccination

4.3 Market Restraints

4.3.1 Side-Effects Associated with Toxoid Vaccine

4.4 Porter’s Five Force Analysis

5 MARKET SEGMENTATION

5.1 By Vaccine Type

5.1.1 Diphtheria, Tetanus, and Pertussis (DTaP)

5.1.2 Diphtheria and Tetanus (DT)

5.1.3 Tetanus, Diphtheria, And Pertussis (Tdap)

5.1.4 Other Vaccines

5.2 By End User

5.2.1 Hospitals and Clinics

5.2.2 Other End Users

5.3 Geography

5.3.1 North America

5.3.1.1 United States

5.3.1.2 Canada

5.3.1.3 Mexico

5.3.2 Europe

5.3.2.1 Germany

5.3.2.2 United Kingdom

5.3.2.3 France

5.3.2.4 Italy

5.3.2.5 Spain

5.3.2.6 Rest of Europe

5.3.3 Asia-Pacific

5.3.3.1 China

5.3.3.2 Japan

5.3.3.3 India

5.3.3.4 Australia

5.3.3.5 South Korea

5.3.3.6 Rest of Asia-Pacific

5.3.4 Middle-East and Africa

5.3.4.1 GCC

5.3.4.2 South Africa

5.3.4.3 Rest of Middle-East and Africa

5.3.5 South America

5.3.5.1 Brazil

5.3.5.2 Argentina

5.3.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE

6.1 Company Profiles

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

For more information about this report visit https://www.researchandmarkets.com/r/vdv0tv

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Citi Appointed as Depositary Bank for Freeline’s ADR Programme

LONDON–(BUSINESS WIRE)–Citi, acting through Citibank N.A., has been appointed by Freeline Therapeutics Holdings plc (“Freeline”), a clinical-stage gene therapy company, to act as depositary bank for its American Depositary Receipt (“ADR”) programme.

Freeline’s American Depositary Shares (“ADS”) trade on The Nasdaq Global Select Market under the symbol “FRLN”. Each ADS represents one ordinary share of the company.

Commenting on the appointment, Dirk Jones, Global Head of Issuer Services, at Citi said: “We look forward to supporting Freeline’s ADR programme and expanding the company’s investor outreach through the expertise of our Investor Relations Advisory team and the breadth of our global equity distribution network.”

For more information on Citi’s Depositary Receipt Services, visit www.citi.com/dr.

About Freeline

Freeline is a clinical-stage biotechnology company focused on AAV-based gene therapy targeting the liver. Its vision is to create better lives for people suffering from chronic, systemic diseases using the potential of gene therapy as a one-time treatment to provide a potential functional cure. Freeline is headquartered in the UK and has operations in Germany and the US.

About Citi

Citi, the leading global bank, has approximately 200 million customer accounts and does business in more than 160 countries and jurisdictions. Citi provides consumers, corporations, governments and institutions with a broad range of financial products and services, including consumer banking and credit, corporate and investment banking, securities brokerage, transaction services, and wealth management.

Additional information may be found at www.citigroup.com | Twitter: @Citi | YouTube: www.youtube.com/citi | Blog: http://blog.citigroup.com | Facebook: www.facebook.com/citi | LinkedIn: www.linkedin.com/company/citi

Contacts

Citi Media Contacts:
Susan Monahan

+44 (0) 20 7508 0786

susan.monahan@citi.com

Freeline Investor Contacts:
JW Communications

Julia Wilson

+44 (0) 7818 430877

juliawilsonuk@gmail.com