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Knightscope recently lands $1.25 million contract

Rutgers University expands emergency communication capabilities with K1 Towers and phones

 

MOUNTAIN VIEW, Calif. — (BUSINESS WIRE) — $KSCP #SecurityRobot—Knightscope, Inc. [Nasdaq: KSCP] “(Knightscope” or the “Company),” a leading developer of autonomous security robots and blue light emergency communication systems, announced Tuesday that it received a $1.25 million contract for its K1 Blue Light Towers and K1 E-Phones. Rutgers, The State University of New Jersey “(Rutgers),” signed purchase orders for 145 devices in total.


Rutgers stands among America’s highest-ranked, most diverse public research universities and is the oldest, largest, and top-ranked public university in the New York/New Jersey metropolitan area. It has been using Knightscope’s emergency communication devices since 2022 and has been slowly expanding its footprint of the familiar blue light towers throughout the year. This latest purchase of 138 Towers and 7 E-Phones will be used to blanket 4 campuses with reliable emergency communications for students, faculty and visitors.

 

To learn more about Knightscope’s Autonomous Security Robots and Blue Light Emergency Communication Systems, book a discovery call or demonstration now at www.knightscope.com/discover.

 

About Knightscope

Knightscope is an advanced public safety technology company that builds fully autonomous security robots and blue light emergency communications systems that help protect the places people live, work, study and visit. Knightscope’s long-term ambition is to make the United States of America the safest country in the world. Learn more about us at www.knightscope.com. Follow Knightscope on Facebook, Twitter, LinkedIn and Instagram.

 

Forward-Looking Statements

This press release may contain “forward-looking statements” about Knightscope’s future expectations, plans, outlook, projections and prospects. Such forward-looking statements can be identified by the use of words such as “should,” “may,” “intends,” “anticipates,” “believes,” “estimates,” “projects,” “forecasts,” “expects,” “plans,” “proposes” and similar expressions. Forward-looking statements contained in this press release include, but are not limited to, statements about the Company’s path to profitability, the Company’s targeted annualized revenue run rate, the Company’s plans for top-line growth, the Company’s ability to deliver on its backlog of new orders, the benefits of the Company’s planned streamlining of its operations and rightsizing of its combined workforce and the Company’s ability to achieve improved margins. Although Knightscope believes that the expectations reflected in these forward-looking statements are based on reasonable assumptions, there are a number of risks and uncertainties that could cause actual results to differ materially from such forward-looking statements. These risks and uncertainties include, among other things, the risk that the restructuring costs and charges may be greater than anticipated; the risk that the Company’s restructuring efforts may adversely affect the Company’s internal programs and the Company’s ability to recruit and retain skilled and motivated personnel, and may be distracting to employees and management; the risk that the Company’s restructuring efforts may negatively impact the Company’s business operations and reputation with or ability to serve customers; the risk that the Company’s restructuring efforts may not generate their intended benefits to the extent or as quickly as anticipated. Readers are urged to carefully review and consider any cautionary statements and other disclosures, including the statements made under the heading “Risk Factors” in Knightscope’s Annual Report on Form 10-K for the year ended December 31, 2022. Forward-looking statements speak only as of the date of the document in which they are contained, and Knightscope does not undertake any duty to update any forward-looking statements, except as may be required by law.

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Healthcare Science

Legend Biotech to demonstrate progress in advancing potential treatment options for patients with multiple myeloma at ASCO and EHA Annual Meetings

  • Eight presentations at ASCO and EHA 2023 Annual Meetings showcase continued leadership in CAR-T cell therapy research for patients with multiple myeloma across various clinical settings
  • First analysis from the CARTITUDE-4 Phase 3 study in relapsed and lenalidomide-refractory multiple myeloma patients with one to three earlier lines of therapy to be presented as an oral presentation at ASCO and in a plenary session at EHA
  • Data from the final analysis of the CARTITUDE-1 study

 

SOMERSET, N.J. — (BUSINESS WIRE) — $LEGN–Legend Biotech Corporation (“Legend Biotech” or the “Company”) (NASDAQ: LEGN), a global biotechnology company developing, manufacturing and commercializing novel therapies to treat life-threatening diseases, today announced that new and updated data from the CARTITUDE Clinical Development Program evaluating ciltacabtagene autoleucel (cilta-cel) will be presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association’s (EHA) 2023 Hybrid Congress. Five-year follow-up data from Legend-2 (NCT03090659), an investigator-initiated trial that has been assessing a similar CAR construct since 2015, will also be presented at the meetings.

 

From the CARTITUDE Clinical Development Program, the first analysis of the Phase 3 CARTITUDE-4 study was accepted as a late breaking abstract at ASCO and will be presented as an oral presentation at both ASCO and in a plenary session at EHA. CARTITUDE-4 (NCT04181827) is the first international, randomized, open-label Phase 3 study investigating the treatment of adult patients with relapsed and lenalidomide-refractory multiple myeloma who have received cilta-cel vs standard-of-care regimens, including pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd), following one to three prior lines of therapy.

 

“We are pleased that the latest data from the CARTITUDE-4 study will be officially presented at the meetings. We are continuing to investigate cilta-cel in earlier lines of treatment and the readout from this study is crucial to how we move forward,” said Ying Huang, Ph.D., Chief Executive Officer of Legend Biotech. “We also eagerly anticipate the presentation of the five-year follow-up data from Legend-2 at ASCO. This was the study that showed — in front of the international community back in 2017 —promising results in heavily pretreated patients with multiple myeloma. Since then, we have taken significant steps toward advancing the treatment landscape for myeloma patients in the CARTITUDE Development Program and are exploring the potential of other agents in our pipeline for this and other indications.”

Additional data at this year’s meetings will include longer-term results from the final protocol-specified analysis of the CARTITUDE-1 study (NCT03548207), which will be shared as a poster presentation at ASCO and an oral presentation at EHA. CARTITUDE-1 is a Phase 1b/2 study evaluating cilta-cel for the treatment of heavily pretreated patients with relapsed or refractory multiple myeloma. The study’s 18-month follow-up data supported the U.S. Food and Drug Administration (FDA) approval of CARVYKTI® (ciltacabtagene autoleucel; cilta-cel) in February 2022.

 

Data from the 5-year follow-up analysis of LEGEND-2 will be presented as a poster at ASCO and EHA. This first-in-human, Phase 1 study evaluates LCAR-B38M CAR-T cells in patients with relapsed and refractory multiple myeloma. It is the longest follow-up for any BCMA-targeted CAR-T cell therapy study to be presented at the meetings.

 

A select list of abstracts from the meetings can be found below.

 

ASCO Presentations (June 2-6, 2023)

Abstract Number

Title

Information

Abstract #106

Oral Presentation

First Phase 3 results from CARTITUDE-4: Cilta-cel versus standard of care (PVd or DPd) in lenalidomide-refractory multiple myeloma

Session Title: Clinical Science Symposium – Moving Cellular Therapy into Earlier Lines of Treatment in Hematologic Malignancies: Latest Efficacy Data and The Need to Improve Access

Date/Time: June 5, 2023, 9:45 am – 11:15 am CDT

Location: Hall D1 & On Demand

Abstract #8009

Poster Discussion

CARTITUDE-1 final results: Phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma

Session Title: Hematologic Malignancies – Plasma Cell Dyscrasia

Date/Time: June 5, 2023, 8:00 am – 11:00 am CDT (poster), 3:00 pm – 4:30 pm (discussion)

Location: Hall A & On Demand

Abstract #8010

Poster Discussion

Long-term remission and survival in patients with relapsed or refractory multiple myeloma after treatment of LCAR-B38M CAR-T – at least 5-year follow-up in LEGEND-2

Session Title: Hematologic Malignancies – Plasma Cell Dyscrasia

Date/Time: June 5, 2023, 8:00 am – 11:00 am CDT (poster), 3:00 pm – 4:30 pm (discussion)

Location: Hall A & On Demand

EHA Presentations (June 8-11, 2023)

Abstract Number

Title

Information

Abstract #P904

Poster Presentation

LocoMMotion: A prospective, observational, multinational study of real-life current standards of care in patients with relapsed/refractory multiple myeloma – final analysis at 2-year follow-up

Friday June 9, 2023

18:00 – 19:00 CEST

Abstract #S100

Plenary Session

Encore: First Phase 3 results from CARTITUDE-4: cilta-cel versus standard of care (PVd or DPd) in lenalidomide-refractory multiple myeloma

Saturday June 10, 2023

14:45-15:00 CEST

Abstract #S202

Oral Presentation

Encore: CARTITUDE-1 final results: Phase 1b/2 study of ciltacabtagene autoleucel in heavily pretreated patients with relapsed/refractory multiple myeloma

Sunday, June 11, 2023

12:00 –12:15 CEST

Abstract #P874

Poster Presentation

Encore: Long-term remission and survival in patients with relapsed or refractory multiple myeloma after treatment of LCAR-B38M CAR-T – at least 5-year follow-up in LEGEND-2

Friday June 9, 2023

18:00 – 19:00 CEST

Abstract #P922

Poster Presentation

Adjusted comparisons of ciltacabtagene autoleucel with therapies from real-world clinical practice: two-year follow-up analysis from CARTITUDE-1 and the prospective LocoMMotion study

Friday, June 9, 2023

18:00 – 19:00 CEST

 

ABOUT CARVYKTI® (CILTACABTAGENE AUTOLEUCEL; CILTA-CEL)

Ciltacabtagene autoleucel is a BCMA-directed, genetically modified autologous T-cell immunotherapy, which involves reprogramming a patient’s own T-cells with a transgene encoding a chimeric antigen receptor (CAR) that identifies and eliminates cells that express BCMA. BCMA is primarily expressed on the surface of malignant multiple myeloma B-lineage cells, as well as late-stage B-cells and plasma cells. The cilta-cel CAR protein features two BCMA-targeting single domain antibodies designed to confer high avidity against human BCMA. Upon binding to BCMA-expressing cells, the CAR promotes T-cell activation, expansion, and elimination of target cells.1

 

In December 2017, Legend Biotech entered into an exclusive worldwide license and collaboration agreement with Janssen Biotech, Inc. (Janssen) to develop and commercialize cilta-cel.

In February 2022, cilta-cel was approved by the U.S. Food and Drug Administration (FDA) under the brand name CARVYKTI® for the treatment of adults with relapsed or refractory multiple myeloma.2 In May 2022, the European Commission (EC) granted conditional marketing authorization of CARVYKTI® for the treatment of adults with relapsed and refractory multiple myeloma.3 In September 2022, Japan’s Ministry of Health, Labour and Welfare (MHLW) approved CARVYKTI®.4 Cilta-cel was granted Breakthrough Therapy Designation in the U.S. in December 2019 and in China in August 2020. In addition, cilta-cel received a PRIority MEdicines (PRIME) designation from the European Commission in April 2019. Cilta-cel also received Orphan Drug Designation from the U.S. FDA in February 2019, from the European Commission in February 2020, and from the Pharmaceuticals and Medicinal Devices Agency (PMDA) in Japan in June 2020. In March 2022, the European Medicines Agency’s Committee for Orphan Medicinal Products recommended by consensus that the orphan designation for cilta-cel be maintained on the basis of clinical data demonstrating improved and sustained complete response rates following treatment.5

 

ABOUT CARTITUDE-1

CARTITUDE-1 (NCT03548207) is a Phase 1b/2, open-label, single arm, multi-center trial evaluating cilta-cel for the treatment of adult patients with relapsed or refractory multiple myeloma, who previously received at least three prior lines of therapy including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD) and an anti-CD38 monoclonal antibody. Of the 97 patients enrolled in the trial, 99 percent were refractory to the last line of treatment and 88 percent were triple-class refractory, meaning their cancer did not respond, or no longer responds, to an IMiD, a PI and an anti-CD38 monoclonal antibody.

 

ABOUT CARTITUDE-4

CARTITUDE-4 (NCT04181827) is the first international, randomized, open-label Phase 3 study evaluating the efficacy and safety of cilta-cel versus pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd) in adult patients with relapsed and lenalidomide-refractory multiple myeloma who received one to three prior lines of therapy.

 

ABOUT LEGEND-2

LEGEND-2 (NCT03090659) is a single arm, open-label, multi-center, Phase 1/2 study, to determine the safety and efficacy of LCAR-B38M CAR-T cells in treating patients diagnosed with refractory/relapsed multiple myeloma.

 

ABOUT LOCOMMOTION

LocoMMotion (NCT04035226) is a prospective, multinational, observational study of real-life current standards of care in patients with relapsed and/or refractory multiple myeloma who received at least 3 prior lines of therapy including a PI, IMiD and CD38 monoclonal antibody treatment.

ABOUT MULTIPLE MYELOMA

Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excessive proliferation of plasma cells.6 In 2023, it is estimated that more than 35,000 people will be diagnosed with multiple myeloma, and more than 12,000 people will die from the disease in the U.S.7 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms that can include bone problems, low blood counts, calcium elevation, kidney problems or infections.8 Although treatment may result in remission, unfortunately, patients will most likely relapse.9 Patients who relapse after treatment with standard therapies, including protease inhibitors, immunomodulatory agents, and an anti-CD38 monoclonal antibody, have poor prognoses and few treatment options available.10,11

 

CARVYKTI® INDICATIONS AND USAGE

CARVYKTI® (ciltacabtagene autoleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma, after four or more prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.

 

CARVYKTI® IMPORTANT SAFETY INFORMATION

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, HLH/MAS, and PROLONGED and RECURRENT CYTOPENIA

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients following treatment with CARVYKTI®. Do not administer CARVYKTI® to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab or tocilizumab and corticosteroids.

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS), which may be fatal or life-threatening, occurred following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with CARVYKTI®. Provide supportive care and/or corticosteroids as needed.

Parkinsonism and Guillain-Barré syndrome and their associated complications resulting in fatal or life-threatening reactions have occurred following treatment with CARVYKTI®.

Hemophagocytic Lymphohistiocytosis/Macrophage Activation Syndrome (HLH/MAS), including fatal and life-threatening reactions, occurred in patients following treatment with CARVYKTI®. HLH/MAS can occur with CRS or neurologic toxicities.

Prolonged and/or recurrent cytopenias with bleeding and infection and requirement for stem cell transplantation for hematopoietic recovery occurred following treatment with CARVYKTI®.

CARVYKTI® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI® REMS Program.

 

WARNINGS AND PRECAUTIONS

Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with CARVYKTI® in 95% (92/97) of patients receiving ciltacabtagene autoleucel. Grade 3 or higher CRS (2019 ASTCT grade) occurred in 5% (5/97) of patients, with Grade 5 CRS reported in 1 patient. The median time to onset of CRS was 7 days (range: 112 days). The most common manifestations of CRS included pyrexia (100%), hypotension (43%), increased aspartate aminotransferase (AST) (22%), chills (15%), increased alanine aminotransferase (ALT) (14%) and sinus tachycardia (11%). Grade 3 or higher events associated with CRS included increased AST and ALT, hyperbilirubinemia, hypotension, pyrexia, hypoxia, respiratory failure, acute kidney injury, disseminated intravascular coagulation and hemorrhage, HLH/MAS, angina pectoris, supraventricular and ventricular tachycardia, malaise, myalgias, increased Creactive protein, ferritin, blood alkaline phosphatase and gamma-glutamyl transferase.

 

Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia and hypotension. CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap. HLH/MAS is a potentially life-threatening condition. In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS. One patient with CRS and suspected HLH/MAS developed a fatal retroperitoneal hemorrhage in the setting of thrombocytopenia, coagulopathy and anticoagulation.

 

Sixty-nine of 97 (71%) patients received tocilizumab and/or a corticosteroid for CRS after infusion of ciltacabtagene autoleucel. Forty-four (45%) patients received only tocilizumab, of whom 33 (34%) received a single dose and 11 (11%) received more than one dose; 24 patients (25%) received tocilizumab and a corticosteroid, and one patient (1%) received only corticosteroids. Ensure that a minimum of two doses of tocilizumab are available prior to infusion of CARVYKTI®.

Monitor patients at least daily for 10 days following CARVYKTI® infusion at a REMS-certified healthcare facility for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 4 weeks after infusion. At the first sign of CRS, immediately institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids.

 

Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time.

 

Neurologic toxicities, which may be severe, life-threatening or fatal, occurred following treatment with CARVYKTI®. Neurologic toxicities included ICANS, neurologic toxicity with signs and symptoms of parkinsonism, Guillain-Barré Syndrome, immune mediated myelitis, peripheral neuropathies, and cranial nerve palsies. Counsel patients on the signs and symptoms of these neurologic toxicities, and on the delayed nature of onset of some of these toxicities. Instruct patients to seek immediate medical attention for further assessment and management if signs or symptoms of any of these neurologic toxicities occur at any time.

 

Overall, one or more subtypes of neurologic toxicity described below occurred following ciltacabtagene autoleucel in 26% (25/97) of patients, of which 11% (11/97) of patients experienced Grade 3 or higher events. These subtypes of neurologic toxicities were also observed in two ongoing studies.

 

Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS): Patients may experience fatal or life-threatening ICANS following treatment with CARVYKTI®, including before CRS onset, concurrently with CRS, after CRS resolution, or in the absence of CRS. ICANS occurred in 23% (22/97) of patients receiving ciltacabtagene autoleucel including Grade 3 or 4 events in 3% (3/97) and Grade 5 (fatal) events in 2% (2/97). The median time to onset of ICANS was 8 days (range 1-28 days). All 22 patients with ICANS had CRS. The most frequent (≥5%) manifestation of ICANS included encephalopathy (23%), aphasia (8%) and headache (6%).

 

Monitor patients at least daily for 10 days following CARVYKTI® infusion at the REMS-certified healthcare facility for signs and symptoms of ICANS. Rule out other causes of ICANS symptoms. Monitor patients for signs or symptoms of ICANS for at least 4 weeks after infusion and treat promptly. Neurologic toxicity should be managed with supportive care and/or corticosteroids as needed.

 

Parkinsonism: Of the 25 patients in the CARTITUDE-1 study experiencing any neurotoxicity, five male patients had neurologic toxicity with several signs and symptoms of parkinsonism, distinct from immune effector cell-associated neurotoxicity syndrome (ICANS). Neurologic toxicity with parkinsonism has been reported in other ongoing trials of ciltacabtagene autoleucel. Patients had parkinsonian and non-parkinsonian symptoms that included tremor, bradykinesia, involuntary movements, stereotypy, loss of spontaneous movements, masked facies, apathy, flat affect, fatigue, rigidity, psychomotor retardation, micrographia, dysgraphia, apraxia, lethargy, confusion, somnolence, loss of consciousness, delayed reflexes, hyperreflexia, memory loss, difficulty swallowing, bowel incontinence, falls, stooped posture, shuffling gait, muscle weakness and wasting, motor dysfunction, motor and sensory loss, akinetic mutism, and frontal lobe release signs. The median onset of parkinsonism in the 5 patients in CARTITUDE-1 was 43 days (range 15-108) from infusion of ciltacabtagene autoleucel.

 

Monitor patients for signs and symptoms of parkinsonism that may be delayed in onset and managed with supportive care measures. There is limited efficacy information with medications used for the treatment of Parkinson’s disease, for the improvement or resolution of parkinsonism symptoms following CARVYKTI® treatment.

 

Guillain-Barré Syndrome: A fatal outcome following Guillain-Barré Syndrome (GBS) has occurred in another ongoing study of ciltacabtagene autoleucel despite treatment with intravenous immunoglobulins. Symptoms reported include those consistent with Miller-Fisher variant of GBS, encephalopathy, motor weakness, speech disturbances and polyradiculoneuritis.

 

Monitor for GBS. Evaluate patients presenting with peripheral neuropathy for GBS. Consider treatment of GBS with supportive care measures and in conjunction with immunoglobulins and plasma exchange, depending on severity of GBS.

 

Immune Mediated Myelitis: Grade 3 myelitis has occurred 25 days following treatment in another ongoing study. Symptoms reported included hypoesthesia of the lower extremities and the lower abdomen with impaired sphincter control. Symptoms improved with the use of corticosteroids and intravenous immune globulin. Myelitis was ongoing at the time of death from other cause.

 

Peripheral Neuropathy: Six patients in CARTITUDE-1 developed peripheral neuropathy. These neuropathies presented as sensory, motor or sensorimotor neuropathies. Median time of onset of symptoms was 62 days (range 4-136 days), median duration of peripheral neuropathies was 256 days (range 2-465 days) including those with ongoing neuropathy. Patients who experienced peripheral neuropathy also experienced cranial nerve palsies or GBS in other ongoing trials of ciltacabtagene autoleucel. Monitor patients for signs and symptoms of peripheral neuropathies.

 

Cranial Nerve Palsies: Three patients (3.1%) experienced cranial nerve palsies in CARTITUDE-1. All three patients had 7th cranial nerve palsy; one patient had 5th cranial nerve palsy as well. Median time to onset was 26 days (range 21-101 days) following infusion of ciltacabtagene autoleucel. Occurrence of 3rd and 6th cranial nerve palsy, bilateral 7th cranial nerve palsy, worsening of cranial nerve palsy after improvement, and occurrence of peripheral neuropathy in patients with cranial nerve palsy have also been reported in ongoing trials of ciltacabtagene autoleucel. Monitor patients for signs and symptoms of cranial nerve palsies. Consider management with systemic corticosteroids, depending on the severity and progression of signs and symptoms.

Hemophagocytic Lymphohistiocytosis (HLH)/Macrophage Activation Syndrome (MAS): Fatal HLH occurred in one patient (1%), 99 days after ciltacabtagene autoleucel. The HLH event was preceded by prolonged CRS lasting 97 days. The manifestations of HLH/MAS include hypotension, hypoxia with diffuse alveolar damage, coagulopathy, cytopenia, and multi-organ dysfunction, including renal dysfunction.

 

One patient with grade 4 HLH/MAS developed fatal intracerebral and gastrointestinal hemorrhage in the setting of coagulopathy and thrombocytopenia 12 days after treatment in another ongoing study. Patients who develop HLH/MAS have an increased risk of severe bleeding. Monitor hematological parameters in patients with HLH/MAS and transfuse per institutional guidelines.

 

HLH is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of HLH/MAS should be administered per institutional standards.

 

CARVYKTI® REMS: Because of the risk of CRS and neurologic toxicities, CARVYKTI® is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the CARVYKTI® REMS.

 

Further information is available at https://www.carvyktirems.com/ or 1-844-672-0067.

 

Prolonged and Recurrent Cytopenias: Patients may exhibit prolonged and recurrent cytopenias following lymphodepleting chemotherapy and CARVYKTI® infusion. One patient underwent autologous stem cell therapy for hematopoietic reconstitution due to prolonged thrombocytopenia.

 

In CARTITUDE-1, 30% (29/97) of patients experienced prolonged Grade 3 or 4 neutropenia and 41% (40/97) of patients experienced prolonged Grade 3 or 4 thrombocytopenia that had not resolved by Day 30 following ciltacabtagene autoleucel infusion.

 

Recurrent Grade 3 or 4 neutropenia, thrombocytopenia, lymphopenia and anemia were seen in 63% (61/97), 18% (17/97), 60% (58/97), and 37% (36/97) after recovery from initial Grade 3 or 4 cytopenia following infusion. After Day 60 following ciltacabtagene autoleucel infusion, 31%, 12% and 6% of patients had a recurrence of Grade 3 or higher lymphopenia, neutropenia and thrombocytopenia, respectively, after initial recovery of their Grade 3 or 4 cytopenia. Eighty-seven percent (84/97) of patients had one, two, or three or more recurrences of Grade 3 or 4 cytopenias after initial recovery of Grade 3 or 4 cytopenia.

Contacts

PRESS CONTACT:
Tina Carter, Corporate Communications Lead, Legend Biotech

tina.carter@legendbiotech.com
(908) 331-5025

INVESTOR CONTACTS:
Joanne Choi, Senior Manager, Investor Relations, Legend Biotech

joanne.choi@legendbiotech.com

Crystal Chen, Manager, Investor Relations, Legend Biotech

crystal.chen@legendbiotech.cn

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B Generous, creator of the world’s first philanthropic credit product, recognized for innovation in PayTech Awards 2023

Fintech-for-good company offering a groundbreaking Donate Now, Pay Later™ platform named a finalist in “PayTech for Good” award honors

 

PARSIPPANY, N.J. — (BUSINESS WIRE) — #AI—Provenir, a global leader in data and AI-powered risk decisioning software, today congratulated its customer B Generous for being recognized as a finalist in the “PayTech for Good” category of the PayTech Awards 2023.

The PayTech Awards celebrate and recognize outstanding achievements in the use of technology in the finance and payment industry worldwide. The “PayTech for Good” category recognizes technology providers that actively put the wider community first and demonstrate the values of connection, collaboration, and generosity above and beyond the usual confines of business goals.

 

A B2B2C fintech company and fully licensed U.S. loan broker and loan servicer, B Generous created the world’s first philanthropic credit product, allowing donors to Donate Now, Pay Later (DNPL), financing their donation over time without having to pay anything out-of-pocket at the point of donation. Donors get the full tax deduction and the nonprofit receives the full funds immediately, while the donor gains flexibility to pay over 3, 6 or 9 months with no interest or fees. DNPL fundamentally solves the liquidity problem for nonprofits, without putting pressure on donors’ finances, allowing people to give what they want, not merely what they feel constrained to give.

 

With the opportunity to pay over time, 82 percent of donors double their donation — a number rising to 89 percent among donors giving $1,000 or more. B Generous donors give $460 on average – 3.5x more than the average charitable donation of $128.

 

A key element of B Generous’s offering is near-real time credit decisioning, powered by the Provenir Data and AI-Powered Risk Decisioning Platform, which offers a streamlined single point of access to myriad bureaus and data sources for more accurate credit decisioning.

 

“Provenir congratulates B Generous for being recognized as a distinguished finalist in this year’s PayTech Awards,” said Kathy Stares, Provenir’s Executive Vice President for North America. “We are proud to support B Generous’s innovation in transcending the liquidity problem for nonprofits, while easing the pressure on donors’ finances.”

 

About Provenir

Provenir helps fintechs and financial services providers unlock the secret to smarter credit risk decisioning.

 

The company brings together the power of decisioning, data and AI to drive instant decisions. This unique offering gives organizations the ability to power decisioning innovation across the full customer lifecycle, driving improvements in the customer experience, access to financial services, business agility, and more.

 

Provenir works with disruptive financial services organizations in more than 50 countries and processes more than 3 billion transactions annually.

Contacts

Kelly Poffenberger

Lutz Public Relations and Marketing (for Provenir)

kelly@lutzpr.com
714.553.9071

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Photos of ‘The Legend of Zelda: Tears of the Kingdom’ launch event at the Nintendo NY store are available on Business Wire’s website

NEW YORK — (BUSINESS WIRE) — #nintendoswitch — Hundreds of fans celebrated the midnight release of the highly anticipated game The Legend of Zelda: Tears of the Kingdom for the Nintendo Switch family of systems during an official midnight launch event beginning on Thursday, May 11 at the Nintendo NY store in Rockefeller Plaza.


The Legend of Zelda: Tears of the Kingdom is a direct sequel to The Legend of Zelda: Breath of the Wild, where players decide their own path through the sprawling landscapes of Hyrule and discover new destinations, dangers, sights and puzzles that require wits and resourcefulness to overcome.  

 

PHOTO CAPTIONS

  1. In this photo provided by Nintendo of America, Nintendo of America President Doug Bowser sells the very first copy of The Legend of Zelda: Tears of the Kingdom to an excited fan following the game’s midnight launch at the Nintendo NY store in Rockefeller Plaza. The Legend of Zelda: Tears of the Kingdom for Nintendo Switch is available now and a direct sequel to The Legend of Zelda: Breath of the Wild, where players decide their own path through the sprawling landscapes of Hyrule and discover new destinations, dangers, sights and puzzles that require wits and resourcefulness to overcome.
  2. In this photo provided by Nintendo of America, David C. from New Jersey poses with his official copy of The Legend of Zelda: Tears of the Kingdom following the game’s midnight launch at the Nintendo NY Store in Rockefeller Plaza. The Legend of Zelda: Tears of the Kingdom for Nintendo Switch is available now and a direct sequel to The Legend of Zelda: Breath of the Wild, where players decide their own path through the sprawling landscapes of Hyrule and discover new destinations, dangers, sights and puzzles that require wits and resourcefulness to overcome.
  3. In this photo provided by Nintendo of America, a double-decker bus themed to The Legend of Zelda: Tears of the Kingdom is parked outside of the Nintendo NY store at Rockefeller Plaza to welcome fans to the midnight launch of the game. The Legend of Zelda: Tears of the Kingdom for Nintendo Switch is available now and a direct sequel to The Legend of Zelda: Breath of the Wild, where players decide their own path through the sprawling landscapes of Hyrule and discover new destinations, dangers, sights and puzzles that require wits and resourcefulness to overcome.
  4. In this photo provided by Nintendo of America, an excited family purchases The Legend of Zelda: Tears of the Kingdom during the official midnight launch at the Nintendo NY store in Rockefeller Plaza. The Legend of Zelda: Tears of the Kingdom for Nintendo Switch is available now and a direct sequel to The Legend of Zelda: Breath of the Wild, where players decide their own path through the sprawling landscapes of Hyrule and discover new destinations, dangers, sights and puzzles that require wits and resourcefulness to overcome.
  5. In this photo provided by Nintendo of America, Camille Salazar-Hadaway hosts the Launch Event Livestream & Nintendo Treehouse: Live from the Nintendo NY store for The Legend of Zelda: Tears of the Kingdom for Nintendo Switch. The game is available now and a direct sequel to The Legend of Zelda: Breath of the Wild, where players decide their own path through the sprawling landscapes of Hyrule and discover new destinations, dangers, sights and puzzles that require wits and resourcefulness to overcome.

 

Contacts

Eddie Garcia

Golin

213-335-5536

egarcia@golin.com

Categories
Art & Life Business Economics Lifestyle Regulations & Security

Best’s Review looks closely at insurance expense efficiency

OLDWICK, N.J. — (BUSINESS WIRE) — In a new article, Best’s Review speaks with industry experts about the challenges of reducing the expense ratio.

 

According to Bill Pieroni, president and chief executive officer for ACORD, “What we’ve found and seen over the last several years is that the sustainable value carriers are able to have a lower-than-average loss adjustment expense and a lower-than-average pure loss ratio.”

A new Best’s Special Report notes some improvement, as the industry’s average underwriting expense ratio decreased to 26.3% in 2021 from 28.0% in 2011, and the net general expense ratio declined to 6.5% in 2021 from 7.1% in 2011. Read the full story, “Insurers Find Ways to Decrease the Underwriting Expense Ratio.”

 

Best’s Review is AM Best’s monthly insurance magazine, covering emerging issues and trends and evaluating their impact on the marketplace. The complete content of Best’s Review is available here.

 

AM Best is a global credit rating agency, news publisher and data analytics provider specializing in the insurance industry. Headquartered in the United States, the company does business in over 100 countries with regional offices in London, Amsterdam, Dubai, Hong Kong, Singapore and Mexico City. For more information, visit www.ambest.com.

Copyright © 2023 by A.M. Best Company, Inc. and/or its affiliates. ALL RIGHTS RESERVED.

Contacts

Patricia Vowinkel

Executive Editor, Best’s Review®
+1 908 439 2200, ext. 5540

patricia.vowinkel@ambest.com

Categories
Art & Life Business Culture Economics Lifestyle Science

Siegel Egg Co. names Matt Whitney as new CEO

BETHESDA, Md. & EVANSTON, Ill. — (BUSINESS WIRE) — Siegel Egg Co. “(Siegel” or “the Company)” has named Matt Whitney as Chief Executive Officer.

 

Whitney succeeds Matt Saunders, who will retire with this transition. Siegel is a portfolio company of Rotunda Capital Partners “(Rotunda),” a middle-market private equity firm investing in family and founder-owned value-added distributors.


“I am thrilled to bring Matt onto our team,” Saunders said.

 

“We have been actively searching for the right leader to take the baton from me and drive Siegel to future heights. With Rotunda’s continued backing, Matt’s successful background in the food distribution industry will enable us to deliver significant value to our customers and vendor partners while pursuing a multitude of growth opportunities.”

 

“We are excited to welcome Matt to Siegel,” said Dan Lipson, Managing Partner at Rotunda.

 

“Siegel is a regional leader that is poised for accelerated growth, and Matt’s leadership and experience are exactly what we need to continue building on the Company’s strong history and dedication to customer service.”

 

In addition to the appointment of Matt, Ken Siegel, who ran the Company for over 30 years and is a significant stakeholder, will re-engage with the Company as a Senior Advisor to the leadership team for this next stage of growth.

 

He said, “Siegel has been in my family for almost 100 years, and I couldn’t be more excited to have Matt join the team as the next leader of the business.”

 

Whitney has been a leader in the food distribution industry for over a decade. He joins Siegel after serving as Chief Growth Officer of UNFI, the largest publicly traded wholesale distributor of specialty food in the United States. Prior to that, he spent almost eight years at Sysco, most recently as Corporate Vice President of Field Transformation and Executive Vice President of the Boston Division. Prior to that, he was a Partner at the Lucas Group and Principal at the Parthenon Group. Whitney holds a BA from Tufts University and an MBA from the Tuck School of Business at Dartmouth College.

 

“I am excited to join an organization as respected as Siegel, with almost 100 years of history and reputation,” Whitney said. “I look forward to working closely with the Siegel team, Ken and Rotunda to engage with our customer and vendor partners to accelerate Siegel’s position as a leader in the industry.”

 

About Siegel Egg Co.

Founded in 1924, Siegel is a one of New England’s leading distributors of egg, dairy and bakery ingredients primarily serving commercial bakeries and food service institutions. The Company operates out of a single facility in Billerica, Mass., to distribute over 2,300 SKUs to customers in New England, Connecticut, New Jersey and New York. For more information, visit www.siegelegg.com.

 

About Rotunda Capital Partners

Rotunda Capital Partners is an operationally oriented private equity firm focused on transforming family-founder owned companies into dynamic, data-driven platforms able to achieve and manage significant growth. Since its founding in 2009, Rotunda has partnered with management teams to build great businesses within three primary sectors: value-added distribution, asset-light logistics and industrial, business and residential services. Rotunda strives to achieve replicable results by implementing its Rotunda Performance System to create strategic alignment, develop lean processes and create robust, data-driven infrastructures. For more information, visit www.rotundacapital.com.

Contacts

Jill Lafferty

Rotunda Capital Partners

(847) 280-1295

jill@rotundacapital.com

Categories
Business Environment International & World Lifestyle News Now! Travel & Leisure

Applegreen Electric announces Holly Angell as US CEO, key appointment to lead the team through rapid growth in the US

GLEN ROCK, N.J. — (BUSINESS WIRE) — Applegreen Electric, a leading Electric Vehicle charging network, today announced the appointment of Holly Angell as CEO of the U.S. division of Applegreen Electric.

 

Holly is an experienced global executive with an impressive 25-year track record in retail and energy sectors, particularly in the North America, Australia, and Southeast Asia. In this role, Holly will lead the U.S. Applegreen Electric team to grow its presence and build on the success thus far in establishing universal fast charging across the Applegreen Electric network and seek out new opportunities across the US as the shift toward electric driving accelerates, transforming the way in which we commute.

 

Prior to joining Applegreen Electric, Holly served as the Senior Vice President of Construction, Engineering, Energy and Facilities at 7-Eleven where she led the development of 7Charge, 7-Elevens’s EV charging network. Holly has held several leadership roles at major global companies such as Dairy Farm Group in Hong Kong and Coles in Australia. Throughout her career, Holly has been an avid advocate for sustainability and technology as a catalyst for exceeding customer expectations.

 

Eugene Moore, Group CEO of Applegreen Electric remarked, “We are deeply committed to our customers in the United States and providing them with access to world-class rapid EV charging. We are extremely grateful to have someone of Holly’s caliber join Applegreen Electric to lead the US team. Holly’s experience and expertise is critical to leading our growing team as we continue to deliver on our mission and explore new opportunities.”

 

Currently, Applegreen Electric operates and hosts EV charging in nine states in the United States across the Applegreen network, providing rapid universal EV charging to customers while also ensuring they have access to high quality facilities and popular QSR brands. Applegreen Electric considers economic, environmental, and social responsibility an integral part of its corporate philosophy and understands the contribution Applegreen Electric can make toward a more sustainable future by being an integral part of the DCFC infrastructure across the U.S.

 

“Leading the Applegreen Electric USA Team is an exciting moment in my career,” said Holly Angell. “I am looking forward to expanding Applegreen’s network of reliable alternative fuelling locations, driving revenue growth across our business, providing superior customer service to valued EV drivers and continuing the development of the EV Team.”

 

About Applegreen Electric

Applegreen Electric hosts and operates universal access Electric Vehicle (EV) charging bays. We seek to support our customers on their transition to EV driving by providing a seamless charging experience alongside popular food and beverage brands and high-quality facilities. Applegreen Electric is deeply committed to reducing carbon emissions through the implementation of EV charging stations.

 

Applegreen Electric is a global EV charging network majority owned by Blackstone with a proven track record in the design and operation of over 600 Fast Charging bays across our geographies. Applegreen Electric was established in 2021 as a subsidiary of Applegreen Limited to focus exclusively on EV charging infrastructure. Established in 1992, Applegreen is one of the largest Plaza operators in Europe and the U.S.

 

Today, Applegreen Electric provides 1,000,000+ fast charging sessions to its customers per year in a rapidly growing transition to more sustainable transport fuels with a range of partners. Further information is available at https://www.applegreenelectric.com/

Contacts

Paula Chirhart

paula.chirhart@blackstone.com
347-463-5453

Categories
Business Healthcare Lifestyle Science

DWK Life Sciences completes acquisition of Assem-Pak | Aluseal

WERTHEIM, Germany — (BUSINESS WIRE) — DWK Life Sciences (“DWK”), a leading global manufacturer and supplier of laboratory glassware, plasticware, and primary packaging solutions, has completed the acquisition of Assem-Pak | Aluseal (“Assem-Pak”), a U.S. company based in Vineland, New Jersey.

 

Assem-Pak, which was founded 23 years ago and currently employs 110 people at their New Jersey facility, specializes in the production of premium rubber stoppers and aluminum seals as well as premium services such as washing, cleaning, assembling, and kitting of primary packaging for the Life Science market.

The acquisition will allow DWK to broaden its range of customizable packaging solutions for the Life Science industry segment, enabling it to support customers at every critical step of their development process. Assem-Pak also strengthens DWK’s value proposition of providing bundled solutions, allowing organizations to consolidate and simplify their complex supply chains.

 

DWK’s recent investments in its plants in Rockwood (U.S.) and Holzminden (Germany) have increased its manufacturing capability for glass vials across the U.S. and Europe. With the addition of Assem-Pak, DWK continues its expansion plan to further strengthen its presence in the Life Science packaging solutions market.

 

“I’m excited that Assem-Pak has joined the DWK family to enhance our vision of being a leading packaging solutions provider. Assem-Pak’s combination of manufacturing expertise and service offerings is a great addition to our already extensive global production and service footprint. This acquisition will allow DWK to capitalize on increasing demand for custom solutions to meet the complex needs of the Life Science industry,” said Armin Reiche, CEO of DWK Life Sciences.

 

Jeff Schempp, CEO of DWK Life Sciences LLC (North America) added: “The combination of Assem-Pak’s manufacturing capabilities in rubber stoppers and aluminum seals combined with DWK’s global market access makes this a perfect fit for both companies. We’re happy to have a great team join the DWK Group to help us achieve our objectives for years to come.”

 

About DWK Life Sciences

DWK Life Sciences is the leading global manufacturer and provider of precision labware as well as primary packaging solutions for Life Science Research, Applied Sciences and Diagnostics, and Pharmaceutical markets.

 

With over 35,000 products, the company’s offering includes the most comprehensive range of premium laboratory glassware together with a complementary portfolio of plastic products. They are manufactured at 12 global sites and marketed under the acclaimed brands DURAN®, WHEATON®, and KIMBLE®.

 

Worldwide, our 1,900 employees are dedicated to developing and delivering superior products and services to meet the highest expectations of customers in laboratories and production environments around the world. To learn more, visit www.DWK.com.

 

DWK Life Sciences is a portfolio company of One Equity Partners.

 

About One Equity Partners

One Equity Partners (“OEP”) is a middle market private equity firm focused on the industrial, healthcare, and technology sectors in North America and Europe. The firm seeks to build market-leading companies by identifying and executing transformative business combinations. OEP is a trusted partner with a differentiated investment process, a broad and senior team, and an established track record generating long-term value for its partners. Since 2001, the firm has completed more than 300 transactions worldwide. OEP, founded in 2001, spun out of JP Morgan in 2015. The firm has offices in New York, Chicago, Frankfurt and Amsterdam. For more information, please visit www.oneequity.com.

Contacts

Cortney Ecklor, Digital Marketing Manager

cortney.ecklor@dwk.com
phone: 865.399.6047

Categories
Business Economics Lifestyle Regulations & Security

Catalent recommends stockholders reject mini-tender offer from TRC Capital Investment Corporation

SOMERSET, N.J. — (BUSINESS WIRE) — Catalent, Inc. (“Catalent”) (NYSE: CTLT) has been notified of an unsolicited “mini-tender offer” by TRC Capital Investment Corporation (“TRC”) to purchase up to 2,000,000 shares of Catalent’s common stock at a price of $42.95 per share in cash. TRC’s offer price is approximately 4.43% lower than the $44.94 closing price of Catalent’s common stock on April 24, 2023, the last trading day prior to the date of the mini-tender offer (April 25, 2023).

 

Catalent does not endorse TRC’s unsolicited mini-tender offer and recommends that stockholders do not tender their shares in response to this unsolicited mini-tender offer because the offer is at a price below the current market price of Catalent’s common stock and is subject to numerous other conditions.

 

Catalent is not affiliated or associated in any way with TRC, its mini-tender offer or the offer documentation. TRC has made similar mini-tender offers for shares of other companies. Mini-tender offers seek to acquire not more than 5 percent of a company’s shares outstanding, thereby avoiding many disclosure and procedural requirements of the U.S. Securities and Exchange Commission (the “SEC”) that are designed to protect investors. As a result, mini-tender offers do not provide investors with the same level of protection as provided by larger tender offers under United States federal securities laws.

 

The SEC has issued “Tips for Investors” regarding mini-tender offers, cautioning investors that some bidders, in making the offers at below-market prices, are “hoping that they will catch investors off guard if the investors do not compare the offer price to the current market price.” The SEC’s advisory may be found on the SEC website at http://www.sec.gov/investor/pubs/minitend.htm.

 

Catalent urges stockholders to obtain current market quotations for their shares of common stock, to consult their broker or financial advisor, and to exercise caution with respect to TRC’s mini-tender offer.

 

Catalent recommends that stockholders who have not responded to TRC’s mini-tender offer take no action. Catalent stockholders who have already tendered their shares may withdraw their shares by providing the written notice described in TRC’s offering documents prior to the expiration of the mini-tender offer, currently scheduled for 12:01 a.m., New York City time, on May 24, 2023, unless the offer is extended or earlier terminated.

 

Catalent urges brokers, dealers and other market participants to review the SEC’s recommendations to broker-dealers in these circumstances, which can be found on the SEC website at http://www.sec.gov/divisions/marketreg/minitenders/sia072401.htm.

 

Catalent requests that a copy of this news release be included with all distributions of materials relating to TRC’s mini-tender offer.

 

About Catalent

Catalent, Inc. (NYSE: CTLT), an S&P 500® company, is the global leader in enabling pharma, biotech, and consumer health partners to optimize product development, launch, and full life-cycle supply for patients around the world. With broad and deep scale and expertise in development sciences, delivery technologies, and multi-modality manufacturing, Catalent is a preferred industry partner for personalized medicines, consumer health brand extensions, and blockbuster drugs. Catalent helps accelerate over 1,000 partner programs and launch over 150 new products every year. Its flexible manufacturing platforms at over 50 global sites supply around 80 billion doses of nearly 8,000 products annually. Catalent’s expert workforce of approximately 18,000 includes more than 3,000 scientists and technicians. Headquartered in Somerset, New Jersey, the company generated nearly $5 billion in revenue in its 2022 fiscal year. For more information www.catalent.com.

Contacts

Investor Contact:

Paul Surdez, Catalent, Inc.

(732) 537-6325

investors@catalent.com

Media Contact:

Chris Halling

+44 (0)7580 041073

media@catalent.com

Categories
Business Economics Lifestyle Special/Sponsored Content

Amneal reports first quarter 2023 financial results

‒ Q1 2023 Net Revenue of $558 million; GAAP Net Loss of $7 million; Diluted Loss per Share of $0.05 ‒

‒ Adjusted EBITDA (1) of $116 million; Adjusted Diluted EPS (1) of $0.12 ‒

‒ Affirming 2023 Full Year Guidance ‒

 

BRIDGEWATER, N.J. — (BUSINESS WIRE) — Amneal Pharmaceuticals, Inc. (NYSE: AMRX) “(Amneal” or the “Company)” on Friday announced its actual results for the first quarter ended March 31, 2023.

 

“We are very pleased with our strong first quarter results and start to 2023. We are confident in our continued momentum driven by the broad-based strength of our diverse and increasingly complex generics portfolio, uptake of our new biosimilars, expansion of our AvKARE business, and the continued growth and potential of our specialty portfolio. Today we are also happy to announce the successful inspection of our fourth and largest injectables facility, and we are working closely with the U.S. FDA ahead of our June 30th PDUFA date for IPX203 in Parkinson’s. These are key building blocks and good indicators of our continued success as we execute our strategy, drive sustainable long-term growth, reduce debt, and create value for all of our stakeholders,” said Chirag and Chintu Patel, Co-Chief Executive Officers.

 

Net revenue in the first quarter of 2023 was $558 million, an increase of 12% compared to $498 million in the first quarter of 2022. The increase was driven by growth across all three business segments with strong performance across our complex Generics portfolio, growth of Rytary® and Unithroid® in Specialty, and continued expansion of AvKARE’s distribution channel.

 

Net loss attributable to Amneal Pharmaceuticals, Inc. was $7 million in the first quarter of 2023 compared to a net loss of $2 million in the first quarter of 2022. Adjusted EBITDA(1) in the first quarter of 2023 was $116 million, an increase of 16% compared to the first quarter of 2022, reflective of robust revenue performance and favorable operating expenses. Diluted loss per share in the first quarter of 2023 was $0.05 compared to a loss of $0.01 for the first quarter of 2022. Adjusted diluted EPS(1) in both the first quarter of 2023 and 2022 was $0.12.

 

(1) See “Non-GAAP Financial Measures” below.

Affirming Full Year 2023 Guidance

The Company is affirming its previously provided full year 2023 guidance.

Full Year 2023 Guidance

Net revenue

$2.25 billion – $2.35 billion

Adjusted EBITDA (1)

$500 million – $530 million

Adjusted diluted EPS (2)

$0.40 – $0.50

Operating cash flow (3)

$200 million – $230 million

Capital expenditures

$50 million – $60 million

Weighted average diluted shares outstanding (4)

Approximately 307 million

 

(1) Includes 100% of EBITDA from the AvKARE acquisition. See also “Non-GAAP Financial Measures” below.

(2) Accounts for 35% non-controlling interest in AvKARE. See also “Non-GAAP Financial Measures” below.

(3) Represents cash provided by operating activities. Guidance does not contemplate one time and non-recurring items such as legal settlements and other discrete items.

(4) Assumes the weighted average diluted shares outstanding of class A and class B common stock under the if-converted method.

 

Amneal’s 2023 estimates are based on management’s current expectations, including with respect to prescription trends, pricing levels, the timing of future product launches, the costs incurred and benefits realized of restructuring activities, and our long-term strategy. The Company’s financial statements are prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”). The Company cannot provide a reconciliation between non-GAAP projections and the most directly comparable measures in accordance with GAAP without unreasonable efforts because it is unable to predict with reasonable certainty the ultimate outcome of certain significant items required for the reconciliation. The items include, but are not limited to, acquisition-related expenses, restructuring expenses and benefits, asset impairments, legal settlements, and other gains and losses. These items are uncertain, depend on various factors, and could have a material impact on GAAP reported results.

 

Conference Call Information

Amneal will host a conference call and live webcast at 8:30 am Eastern Time on May 5, 2023 to discuss its results. The live webcast and presentation will be accessible through the Investor Relations section of the Company’s website at https://investors.amneal.com. To access the call through a conference line, dial 1 (833) 470-1428 (in the U.S.) or for a list of toll-free international numbers, visit this website: https://www.netroadshow.com/events/global-numbers?confId=49327. The access code for the call is 957420. A replay of the conference call will be posted shortly after the call and will be available for seven days. To access the replay, dial 1 (866) 813-9403 (in the U.S.) or for a list of toll-free international numbers, visit this website: https://www.netroadshow.com/events/global-numbers?confId=49327. The access code for the replay is 704782.

 

About Amneal

Amneal Pharmaceuticals, Inc. (NYSE: AMRX), headquartered in Bridgewater, NJ, is a fully integrated global essential medicines company. We make healthy possible through the development, manufacturing, and distribution of a diverse portfolio of approximately 270 generic and specialty pharmaceuticals, primarily within the United States. In its Generics segment, the Company is expanding across a broad range of complex product categories and therapeutic areas, including injectables and biosimilars. In its Specialty segment, Amneal has a growing portfolio of branded pharmaceuticals focused primarily on central nervous system and endocrine disorders, with a pipeline focused on unmet needs. Through its AvKARE segment, the Company is a distributor of pharmaceuticals and other products for the U.S. federal government, retail, and institutional markets. For more information, please visit www.amneal.com.

 

Cautionary Statement on Forward-Looking Statements

Certain statements contained herein, regarding matters that are not historical facts, may be forward-looking statements (as defined in the U.S. Private Securities Litigation Reform Act of 1995). Such forward-looking statements include statements regarding management’s intentions, plans, beliefs, expectations, financial results, or forecasts for the future, including among other things: discussions of future operations, including international expansion; expected or estimated operating results and financial performance; the Company’s growth prospects and opportunities as well as its strategy for growth; product development and launches; the successful commercialization and market acceptance of new products, and other non-historical statements. Words such as “plans,” “expects,” “will,” “anticipates,” “estimates,” and similar words, or the negatives thereof, are intended to identify estimates and forward-looking statements.

 

The reader is cautioned not to rely on these forward-looking statements. These forward-looking statements are based on current expectations of future events, including with respect to future market conditions, company performance and financial results, operational investments, business prospects, new strategies and growth initiatives, the competitive environment, and other events. If the underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of the Company.

 

Such risks and uncertainties include, but are not limited to: our ability to successfully develop, license, acquire and commercialize new products on a timely basis; the competition we face in the pharmaceutical industry from brand and generic drug product companies, and the impact of that competition on our ability to set prices; our ability to obtain exclusive marketing rights for our products; our ability to manage our growth through acquisitions and otherwise; our revenues are derived from the sales of a limited number of products, a substantial portion of which are through a limited number of customers; the continuing trend of consolidation of certain customer groups; our dependence on third-party suppliers and distributors for raw materials for our products and certain finished goods; our substantial amount of indebtedness and our ability to generate sufficient cash to service our indebtedness in the future, and the impact of interest rate fluctuations on such indebtedness; our ability to secure satisfactory terms when negotiating a refinancing or other new indebtedness; our dependence on third-party agreements for a portion of our product offerings; legal, regulatory and legislative efforts by our brand competitors to deter competition from our generic alternatives; risks related to federal regulation of arrangements between manufacturers of branded and generic products; our reliance on certain licenses to proprietary technologies from time to time; the significant amount of resources we expend on research and development; the risk of product liability and other claims against us by consumers and other third parties; risks related to changes in the regulatory environment, including U.S. federal and state laws related to healthcare fraud abuse and health information privacy and security and changes in such laws; changes to Food and Drug Administration product approval requirements; the impact of healthcare reform and changes in coverage and reimbursement levels by governmental authorities and other third-party payers; our potential expansion into additional international markets subjecting us to increased regulatory, economic, social and political uncertainties, including bank failures; our ability to identify, make and integrate acquisitions or investments in complementary businesses and products on advantageous terms; the impact of global economic, political or other catastrophic events; our ability to attract, hire and retain highly skilled personnel; our obligations under a tax receivable agreement may be significant; and the high concentration of ownership of our Class A Common Stock and the fact that we are controlled by the Amneal Group. The forward-looking statements contained herein are also subject generally to other risks and uncertainties that are described from time to time in the Company’s filings with the Securities and Exchange Commission, including under Item 1A, “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and in its subsequent reports on Forms 10-Q and 8-K. Investors are cautioned not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made. Forward-looking statements included herein speak only as of the date hereof and we undertake no obligation to revise or update such statements to reflect the occurrence of events or circumstances after the date hereof.

 

Non-GAAP Financial Measures

This release includes certain non-GAAP financial measures, including EBITDA, adjusted EBITDA, and adjusted diluted EPS, which are intended as supplemental measures of the Company’s performance that are not required by or presented in accordance with GAAP. Adjusted diluted EPS reflects diluted earnings per share based on adjusted net income, which is net loss adjusted to (A) exclude (i) non-cash interest, (ii) GAAP provision for (benefit from) income taxes, (iii) amortization, (iv) stock-based compensation, (v) acquisition, site closure expenses, and idle facility expenses, (vi) restructuring and other charges, (vii) charges (credits) related to legal matters, including interest, net, (viii) asset impairment charges, (ix) regulatory approval milestone, (x) change in fair value of contingent consideration, (xi) other, (xii) net income attributable to non-controlling interests not associated with class B common stock, and (B) include non-GAAP provision for income taxes. Non-GAAP adjusted EPS is calculated assuming the weighted average diluted shares outstanding of class A and class B common stock under the if-converted method.

 

Management uses these non-GAAP measures internally to evaluate and manage the Company’s operations and to better understand its business because they facilitate a comparative assessment of the Company’s operating performance relative to its performance based on results calculated under GAAP. These non-GAAP measures also isolate the effects of some items that vary from period to period without any correlation to core operating performance and eliminate certain charges that management believes do not reflect the Company’s operations and underlying operational performance. The compensation committee of the Company’s board of directors also uses certain of these measures to evaluate management’s performance and set its compensation. The Company believes that these non-GAAP measures also provide useful information to investors regarding certain financial and business trends relating to the Company’s financial condition and operating results facilitates an evaluation of the financial performance of the Company and its operations on a consistent basis. Providing this information therefore allows investors to make independent assessments of the Company’s financial performance, results of operations and trends while viewing the information through the eyes of management.

 

These non-GAAP measures are subject to limitations. The non-GAAP measures presented in this release may not be comparable to similarly titled measures used by other companies because other companies may not calculate one or more in the same manner. Additionally, the non-GAAP performance measures exclude significant expenses and income that are required by GAAP to be recorded in the Company’s financial statements; do not reflect changes in, or cash requirements for, working capital needs; and do not reflect interest expense, or the requirements necessary to service interest or principal payments on debt. Further, our historical adjusted results are not intended to project our adjusted results of operations or financial position for any future period. To compensate for these limitations, management presents and considers these non-GAAP measures in conjunction with the Company’s GAAP results; no non-GAAP measure should be considered in isolation from or as alternatives to any measure determined in accordance with GAAP. Readers should review the reconciliations included below, and should not rely on any single financial measure to evaluate the Company’s business.

 

A reconciliation of each historical non-GAAP measure to the most directly comparable GAAP measure is set forth below.

 

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Operations

(Unaudited; In thousands, except per share amounts)

Three Months Ended March 31,

2023

2022

Net revenue

$

557,540

$

497,633

Cost of goods sold

379,354

323,062

Gross profit

178,186

174,571

Selling, general and administrative

102,096

98,665

Research and development

38,690

52,798

Intellectual property legal development expenses

1,644

764

Acquisition, transaction-related and integration expenses

—

434

Restructuring and other charges

510

731

Change in fair value of contingent consideration

2,457

200

Credit related to legal matters, net

(436)

(2,326)

Other operating income

(1,224)

—

Operating income

34,449

23,305

Other (expense) income:

Interest expense, net

(49,315)

(33,335)

Foreign exchange gain (loss), net

1,901

(2,013)

Other income, net

3,539

2,122

Total other expense, net

(43,875)

(33,226)

Loss before income taxes

(9,426)

(9,921)

Provision for (benefit from) income taxes

668

(3,461)

Net loss

(10,094)

(6,460)

Less: Net loss attributable to non-controlling interests

3,151

4,742

Net loss attributable to Amneal Pharmaceuticals, Inc. before accretion of redeemable

non-controlling interest

(6,943)

(1,718)

Accretion of redeemable non-controlling interest

—

(438)

Net loss attributable to Amneal Pharmaceuticals, Inc.

$

(6,943)

$

(2,156)

Net loss per share attributable to Amneal Pharmaceuticals, Inc.’s class A common stockholders:

Basic and diluted

$

(0.05)

$

(0.01)

Weighted-average common shares outstanding:

Basic and diluted

152,109

149,892

Amneal Pharmaceuticals, Inc.

Condensed Consolidated Balance Sheets

(Unaudited; In thousands)

March 31, 2023

December 31, 2022

Assets

Current assets:

Cash and cash equivalents

$

144,674

$

25,976

Restricted cash

6,395

9,251

Trade accounts receivable, net

545,760

741,791

Inventories

529,042

530,735

Prepaid expenses and other current assets

81,424

103,565

Related party receivables

30

500

Total current assets

1,307,325

1,411,818

Property, plant and equipment, net

462,606

469,815

Goodwill

599,156

598,853

Intangible assets, net

1,055,319

1,096,093

Operating lease right-of-use assets

36,127

38,211

Operating lease right-of-use assets – related party

17,244

17,910

Financing lease right-of-use assets

62,400

63,424

Other assets

86,428

103,217

Total assets

$

3,626,605

$

3,799,341

Liabilities and Stockholders’ Equity

Current liabilities:

Accounts payable and accrued expenses

$

467,421

$

538,199

Current portion of liabilities for legal matters

76,317

107,483

Revolving credit facility

100,000

60,000

Current portion of long-term debt, net

29,965

29,961

Current portion of operating lease liabilities

9,017

8,321

Current portion of operating lease liabilities – related party

2,930

2,869

Current portion of financing lease liabilities

3,309

3,488

Related party payables – short term

14,750

2,479

Total current liabilities

703,709

752,800

Long-term debt, net

2,561,724

2,591,981

Note payable – related party

40,128

39,706

Operating lease liabilities

30,782

32,126

Operating lease liabilities – related party

15,163

15,914

Financing lease liabilities

60,241

60,769

Related party payables – long term

11,207

9,649

Other long-term liabilities

41,456

87,468

Total long-term liabilities

2,760,701

2,837,613

Redeemable non-controlling interests

27,527

24,949

Total stockholders’ equity

134,668

183,979

Total liabilities and stockholders’ equity

$

3,626,605

$

3,799,341

Amneal Pharmaceuticals, Inc.

Consolidated Statements of Cash Flows

(Unaudited; In thousands)

Three Months Ended March 31,

2023

2022

Cash flows from operating activities:

Net loss

$

(10,094)

$

(6,460)

Adjustments to reconcile net loss to net cash provided by operating activities:

Depreciation and amortization

58,150

57,815

Unrealized foreign currency (gain) loss

(1,987)

3,140

Amortization of debt issuance costs and discount

2,058

2,195

Change in fair value of contingent consideration

2,457

200

Stock-based compensation

7,596

8,065

Inventory provision

25,204

3,578

Other operating charges and credits, net

2,047

1,155

Changes in assets and liabilities:

Trade accounts receivable, net

195,970

124,268

Inventories

(22,508)

(25,549)

Prepaid expenses, other current assets and other assets

29,160

(4,423)

Related party receivables

470

4

Accounts payable, accrued expenses and other liabilities

(150,483)

(48,777)

Related party payables

1,672

5,132

Net cash provided by operating activities

139,712

120,343

Cash flows from investing activities:

Purchases of property, plant and equipment

(9,688)

(10,793)

Acquisition of business

—

(84,714)

Acquisition of intangible assets

(338)

—

Deposits for future acquisition of property, plant, and equipment

(1,711)

(1,888)

Net cash used in investing activities

(11,737)

(97,395)

Cash flows from financing activities:

Payments of principal on debt, revolving credit facility, financing leases and other

(72,659)

(9,796)

Borrowings on revolving credit facility

80,000

—

Proceeds from exercise of stock options

—

111

Employee payroll tax withholding on restricted stock unit vesting

(2,022)

(3,001)

Payments of deferred consideration for acquisitions – related party

—

(43,998)

Acquisition of redeemable non-controlling interest

—

(1,722)

Tax distributions to non-controlling interests

(18,219)

(3,164)

Net cash used in financing activities

(12,900)

(61,570)

Effect of foreign exchange rate on cash

767

(1,572)

Net increase (decrease) in cash, cash equivalents, and restricted cash

115,842

(40,194)

Cash, cash equivalents, and restricted cash – beginning of period

35,227

256,739

Cash, cash equivalents, and restricted cash – end of period

$

151,069

$

216,545

Cash and cash equivalents – end of period

$

144,674

$

210,477

Restricted cash – end of period

6,395

6,068

Cash, cash equivalents, and restricted cash – end of period

$

151,069

$

216,545

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited, In thousands)

Reconciliation of Net Loss to EBITDA and Adjusted EBITDA

Three Months Ended March 31,

2023

2022

Net loss

$

(10,094)

$

(6,460)

Adjusted to add:

Interest expense, net

49,315

33,335

Provision for (benefit from) income taxes

668

(3,461)

Depreciation and amortization

58,150

57,815

EBITDA (Non-GAAP)

$

98,039

$

81,229

Adjusted to add (deduct):

Stock-based compensation expense

7,596

8,065

Acquisition, site closure, and idle facility expenses (1)

2,701

5,589

Restructuring and other charges

411

731

Charges (credits) related to legal matters, net (2)

4,064

(2,326)

Asset impairment charges

733

—

Foreign exchange (gain) loss

(1,901)

2,013

Change in fair value of contingent consideration

2,457

200

Regulatory approval milestone

—

5,000

Other

2,080

(641)

Adjusted EBITDA (Non-GAAP)

$

116,180

$

99,860

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited; In thousands, except per share amounts)

Reconciliation of Net Loss to Adjusted Net Income and Calculation of Adjusted Diluted Earnings Per Share

Three Months Ended March 31,

2023

2022

Net loss

$

(10,094)

$

(6,460)

Adjusted to add (deduct):

Non-cash interest

1,841

1,982

GAAP provision for (benefit from) income taxes

668

(3,461)

Amortization

39,611

39,152

Stock-based compensation expense

7,596

8,065

Acquisition, site closure expenses, and idle facility expenses (1)

2,701

5,589

Restructuring and other charges

411

731

Charges (credits) related to legal matters, including interest, net (2)

4,882

(2,326)

Asset impairment charges

733

—

Regulatory approval milestone

—

5,000

Change in fair value of contingent consideration

2,457

200

Other

2,229

(500)

Provision for income taxes (3)

(10,829)

(10,185)

Net income attributable to non-controlling interests not associated with our

class B common stock

(5,395)

(2,199)

Adjusted net income (Non-GAAP)

$

36,811

$

35,588

Weighted average diluted shares outstanding (Non-GAAP) (4)

306,370

304,630

Adjusted diluted earnings per share (Non-GAAP)

$

0.12

$

0.12

Amneal Pharmaceuticals, Inc.

Non-GAAP Reconciliations

(Unaudited; In thousands)

Explanations for Reconciliations of Net Loss to EBITDA and Adjusted EBITDA and

Net Loss to Adjusted Net Income and Calculation of Adjusted Diluted Earnings per Share

(1)

Acquisition, site closure, and idle facility expenses for the three months ended March 31, 2023 primarily included site closure costs associated with the planned cessation of manufacturing at our Hauppauge, NY facility. Acquisition, site closure, and idle facility expenses for the three months ended March 31, 2022 primarily included (i) transaction and integration costs associated with the acquisition of the baclofen franchise from certain entities affiliated with Saol International Limited; (ii) integration costs associated with the acquisition of Puniska Healthcare Pvt. Ltd.; and (iii) site closure costs associated with the planned cessation of manufacturing at our Hauppauge, NY facility.

(2)

For the three months ended March 31, 2023 charges (credits) related to legal matters, net included charges of $4.9 million for legal proceedings. For the three months ended March 31, 2022, we recorded a net credit of $2.3 million for an insurance recovery of $4.0 million, partially offset by charges for legal proceedings.

(3)

The non-GAAP effective tax rates for the three months ended March 31, 2023 and 2022 were 22.7% and 22.3%, respectively.

(4)

Weighted average diluted shares outstanding consisted of class A common stock and class B common stock under the if-converted method.

Contacts

Anthony DiMeo

Head of Investor Relations

anthony.dimeo@amneal.com

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