Author: Michelle Dryden

Categories
Regulations & Security

Keith Raniere, leader of Nxivm sex cult, faces life sentence

Keith Raniere, once idolized by his followers as a genius, was convicted Tuesday, after prosecutors presented evidence that he had a harem of sexual “slaves” kept in line with blackmail.

It was Sept. 18, 2005, a victim said, in her statement. She was 15, and he was 46. He insisted, she said, that they both recognize the date as their anniversary.

The relationship lasted 12 years, Camila said, with Raniere repeatedly summoning her, sexually abusing her and taking nude pictures of her. She said she attempted suicide once.

“He wanted me to believe that my only value came from how he felt about me,” said Camila, who was the first victim speak at Raniere’s sentencing hearing. “It has taken a long time to process the trauma he caused.”

Raniere had promised a path to happiness, seducing successful and wealthy people including those who felt they lacked a higher purpose in life. His company offered self-empowerment workshops that were taken by Hollywood celebrities and business leaders.

But underneath the surface, Mr. Raniere was a puppet master controlling a cultlike criminal enterprise, prosecutors revealed at his trial last year. Some women in Nxivm were forced to have sex with Mr. Raniere, and even branded with his initials in a secret ceremony.

Now, Raniere, 60, is being sentenced in federal court in Brooklyn for his participation in sex trafficking and other crimes.

His conviction last year capped a stunning downfall for a man who was once idolized by his followers, but has since been exposed as a fraudster who exploited Nxivm’s adherents for money, sex and power.

Former Nxivm members said Raniere and his inner circle preyed on insecure people who hoped that immersing themselves in expensive self-help classes would unlock the key to fulfillment. Even highly educated people became trapped inside Mr. Raniere’s system, which he sold as the only way to overcome their fears, shaming anyone who tried to quit.

How the case against Keith Raniere unfolded.

At Mr. Raniere’s trial, prosecutors lifted the veil on a sordid side to Nxivm (pronounced NEX-ee-um). A primary focus was a secretive women-only group inside the organization. During a videotaped initiation ceremony, the women laid naked on a table, saying, “Master, please brand me,” as a cauterizing pen seared their skin without anesthesia.

Some of those women testified that they thought they were joining a women’s empowerment group, only to discover that they were directed to have sex with Mr. Raniere.

Camila said on Tuesday that Mr. Raniere had “damaged me in so many ways,” and that she had to have an abortion “at his direction.”

The women, referred to as “slaves,” needed permission to eat and were regularly required to hand over collateral like sexually explicit videos, which they constantly feared would be released. Prosecutors called it extortion.

A jury convicted Mr. Raniere last summer after a six-week trial. Prosecutors charged him with racketeering, applying a statute that had been used to dismantle the Mafia families in New York. Besides sex trafficking, the jury found him guilty of crimes that included child pornography, forced labor, identity theft and obstruction of justice.

Prosecutors have said in court papers that Mr. Raniere deserves a life sentence, a punishment that is typically reserved for cases involving deaths or murders.

 

— New York Times: Top Stories

Categories
Healthcare

Merck announces third-quarter 2020 financial results

  • Third-Quarter 2020 Worldwide Sales Were $12.6 Billion, an Increase of 1%; Excluding the Impact from Foreign Exchange, Sales Grew 2%
    • KEYTRUDA Sales Grew 21% to $3.7 Billion
    • Animal Health Sales Grew 9% to $1.2 Billion; Excluding the Impact from Foreign Exchange, Sales Grew 12%
  • Third-Quarter 2020 GAAP EPS Was $1.16; Third-Quarter Non-GAAP EPS Was $1.74
  • Advanced and Expanded Broad Pipeline
    • Announced Additional Positive Phase 3 Results for Investigational Pneumococcal Conjugate Vaccine (V114) in Adults
    • Presented Phase 3 Data for Investigational Gefapixant in Development for Chronic Cough; Early Data for MK-4830 in Oncology and MK-8507 for HIV
    • Expanded Pipeline with Seagen Collaborations in Oncology
  • Company Advances Research Programs and Clinical Trials for COVID-19-Related Vaccine and Orally Available Antiviral Research Candidates
  • Company Narrows and Raises 2020 Full-Year Revenue Range to be Between $47.6 Billion and $48.6 Billion, Including a Negative Impact from Foreign Exchange of Approximately 1.5%
  • Company Narrows and Lowers 2020 Full-Year GAAP EPS Range to be Between $4.55 and $4.65; Narrows and Raises 2020 Full-Year Non-GAAP EPS Range to be Between $5.91 and $6.01, Including a Negative Impact from Foreign Exchange of Approximately 2.5%

KENILWORTH, N.J.–(BUSINESS WIRE)–$MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced financial results for the third quarter of 2020.


“We continue to execute on our strategic priorities and remain confident we will achieve solid full-year revenue growth despite the impact of the ongoing COVID-19 pandemic. Demand for our products remains robust, and production, supply and distribution of our medicines, vaccines and animal health products are moving forward with minimal disruption,” said Kenneth C. Frazier, chairman and chief executive officer, Merck. “I am confident in our ability to advance our promising pipeline and clinical trials despite the challenging environment, and I believe that our leadership and track record of solid commercial execution will continue to drive long-term growth.”

Financial Summary

$ in millions, except EPS amounts

Third Quarter

2020

2019

Change

Change Ex-

Exchange

Sales

$12,551

$12,397

1%

2%

GAAP net income1

2,941

1,901

55%

59%

Non-GAAP net income that excludes certain items1,2*

4,427

3,873

14%

17%

GAAP EPS

1.16

0.74

57%

62%

Non-GAAP EPS that excludes certain items2*

1.74

1.51

16%

18%

*Refer to table on page 11.

GAAP (generally accepted accounting principles) earnings per share assuming dilution (EPS) was $1.16 for the third quarter of 2020. Non-GAAP EPS of $1.74 for the third quarter of 2020 excludes acquisition- and divestiture-related costs, restructuring costs, pretax charges of $1.1 billion related to certain license and collaboration agreements, and certain other items. Year-to-date results can be found in the attached tables.

COVID-19 Research Highlights

Building on the company’s experience with antivirals and vaccines, Merck advanced its multiple scientific programs in an effort to help combat SARS-CoV-2, specifically,

  • Molnupiravir (formerly known as MK-4482) — an orally available antiviral candidate in development for the treatment of COVID-19 in collaboration with Ridgeback Bio with the initiation of two large pivotal Phase 2/3 trials: a trial anticipated to enroll approximately 1,450 non-hospitalized adult COVID-19 patients (outpatient) and another planned to enroll approximately 1,300 hospitalized adult COVID-19 patients;
  • V591 — a SARS-CoV-2 vaccine candidate that uses a measles virus vector platform has entered Phase 1 development; and
  • V590 — a SARS-CoV-2 vaccine candidate in development in collaboration with the International AIDS Vaccine Initiative (IAVI) that uses a recombinant vesicular stomatitis virus (rVSV) platform, the same platform used for Merck’s approved Ebola Zaire virus vaccine, will enter Phase 1 development shortly.

Oncology Pipeline Highlights

Merck continued to advance the development programs for KEYTRUDA (pembrolizumab), the company’s anti-PD-1 therapy; Lynparza (olaparib), a PARP inhibitor being co-developed and co-commercialized with AstraZeneca; and Lenvima (lenvatinib mesylate), an orally available tyrosine kinase inhibitor being co-developed and co-commercialized with Eisai Co., Ltd. (Eisai), in addition to other notable developments as follows:

  • Merck announced the following regulatory milestones for KEYTRUDA:
    • Approval in the United States by the Food and Drug Administration (FDA) of an expanded indication as monotherapy for the treatment of adult patients with relapsed or refractory classical Hodgkin lymphoma (cHL) based on the Phase 3 KEYNOTE-204 trial and an updated pediatric indication for the treatment of pediatric patients with refractory cHL or cHL that has relapsed after two or more lines of therapy, both of which were previously approved under the FDA’s accelerated approval process; and
    • Two approvals in Japan: (1) as monotherapy for the treatment of patients whose tumors are PD-L1-positive and have radically unresectable, advanced or recurrent esophageal squamous cell carcinoma (ESCC) who have progressed after chemotherapy based on the KEYNOTE-181 trial; and (2) use at an additional recommended dosage of 400 mg every six weeks (Q6W) administered as an intravenous infusion over 30 minutes across all adult indications, including KEYTRUDA monotherapy and combination therapy.
  • Merck presented results from the pivotal Phase 3 KEYNOTE-590 trial for the first-line treatment of patients with locally advanced or metastatic esophageal and gastroesophageal junction (GEJ) cancer at the European Society for Medical Oncology (ESMO) Virtual Congress 2020. In the study, KEYTRUDA in combination with platinum-based chemotherapy (cisplatin plus 5-fluorouracil [5-FU]) significantly improved overall survival (OS) and progression-free survival (PFS) versus chemotherapy regardless of histology or PD-L1 expression status.
  • Merck presented five-year survival results from the pivotal Phase 3 KEYNOTE-024 trial at the ESMO Virtual Congress 2020, which demonstrated a sustained, long-term survival benefit and durable responses with KEYTRUDA versus chemotherapy as a first-line treatment in patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1 (tumor proportion score [TPS] ≥50%) with no EGFR or ALK genomic tumor aberrations. Results from KEYNOTE-024 represent the longest follow-up survival data for an immunotherapy in a randomized Phase 3 study for the first-line treatment of metastatic NSCLC.
  • Merck presented long-term findings from the EORTC1325/KEYNOTE-054 trial evaluating KEYTRUDA as adjuvant therapy in resected, high-risk stage III melanoma at the ESMO Virtual Congress 2020.
  • Merck presented three-year survival data from the KEYNOTE-021 (Cohort G) study that evaluated KEYTRUDA in combination with chemotherapy in patients with advanced nonsquamous NSCLC regardless of PD‑L1 expression with no EGFR or ALK genomic tumor aberrations at the IASLC 2020 North America Conference on Lung Cancer (NACLC). Updated follow-up data from a Phase 1/2 study of quavonlimab (MK-1308), a novel investigational anti-CTLA-4 antibody, in combination with KEYTRUDA in patients with advanced NSCLC also was presented; a Phase 3 study of quavonlimab coformulated with KEYTRUDA in first-line advanced NSCLC is planned.
  • Merck and AstraZeneca announced the adoption of two positive opinions by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for Lynparza:
    • As a first-line maintenance treatment with bevacizumab for homologous recombination deficient (HRD)-positive advanced ovarian cancer who are in complete or partial response following completion of first-line platinum-based chemotherapy in combination with bevacizumab based on the Phase 3 PAOLA-1 trial, and
    • As monotherapy for the treatment of BRCA1/2 metastatic castration-resistant prostate cancer (mCRPC) patients who have progressed following a prior therapy that included a new hormonal agent based on the Phase 3 PROfound trial. Final results from this study were recently presented at the ESMO Virtual Congress 2020.
  • Merck and AstraZeneca presented positive five-year follow-up data from the Phase 3 SOLO-1 trial, which demonstrated a long-term PFS benefit of Lynparza versus placebo as a first-line maintenance treatment in patients with newly diagnosed, advanced BRCA-mutated (BRCAm) ovarian cancer who were in complete or partial response to platinum-based chemotherapy.
  • Merck and Eisai presented first-time data from two studies evaluating KEYTRUDA plus Lenvima at the ESMO Virtual Congress 2020: data from the Phase 2 LEAP-004 study for the second-line treatment of patients with unresectable or advanced melanoma who progressed on anti-PD-1/PD-L1 therapy and from the Phase 2 LEAP-005 study in previously-treated patients with six tumor types, including biliary tract cancer, colorectal cancer, gastric cancer, glioblastoma multiforme, ovarian cancer and triple-negative breast cancer.
  • Merck also presented new data for three investigational medicines from its oncology pipeline at the ESMO Virtual Congress 2020:
    • New Phase 1 data for the company’s anti-TIGIT therapy vibostolimab (MK-7684) as monotherapy and in combination with KEYTRUDA in patients with metastatic NSCLC,
    • First-time Phase 1 results for the novel anti-immunoglobulin-like transcript 4 (ILT4) therapy MK-4830 in patients with advanced solid tumors, and
    • New Phase 2 data evaluating the hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor MK-6482 in von Hippel-Lindau (VHL) patients with non-renal cell carcinoma (RCC) tumors and updated data in VHL patients with clear cell RCC.

Other Pipeline Highlights

  • Merck announced that two Phase 3 adult studies [the pivotal PNEU-AGE trial (V114-019) as well as the PNEU-TRUE trial (V114-020)] and separately two other Phase 3 adult studies [the PNEU-PATH (V114-016) and PNEU-DAY (V114-017) trials], evaluating the safety, tolerability and immunogenicity of V114, the company’s investigational 15-valent pneumococcal conjugate vaccine, each met their primary immunogenicity objectives. These findings, and additional Phase 3 data from the clinical program, will form the basis of global regulatory licensure applications beginning with the FDA before the end of the year.
  • Merck presented results from two pivotal Phase 3 trials (COUGH-1 and COUGH-2) evaluating gefapixant, an investigational, orally administered selective P2X3 receptor antagonist, in which gefapixant 45 mg twice daily demonstrated a statistically significant reduction in 24-hour cough frequency compared to placebo at Week 12 and 24 in adult patients with refractory or unexplained chronic cough. The gefapixant 15 mg twice daily treatment arms did not meet the primary efficacy endpoint in either Phase 3 study. The results were presented at the Virtual European Respiratory Society (ERS) International Congress 2020.
  • Merck presented Week 96 data from the Phase 2b trial that showed islatravir, the company’s investigational oral nucleoside reverse transcriptase translocation inhibitor (NRTTI), in combination with doravirine (PIFELTRO), maintained viral suppression in treatment-naïve adults with HIV-1 infection. Also presented at the virtual 2020 International Congress on Drug Therapy in HIV Infection (HIV Glasgow 2020 Virtual) were results from Phase 1/1b studies for MK-8507, the company’s investigational once-weekly, oral non-nucleoside reverse transcriptase inhibitor (NNRTI), that support further investigation for once-weekly oral administration as part of combination antiretroviral therapy.
  • The FDA has granted V181, the company’s investigational dengue vaccine in Phase 1 development, Fast Track designation.

Business Developments

  • Merck and Seagen Inc. (formerly known as Seattle Genetics, Inc.) announced two strategic oncology collaborations, in which Merck will make $810 million of upfront payments in the aggregate as well as acquire a $1 billion equity stake in Seagen common stock:
    • Companies to co-develop and co-commercialize Seagen’s ladiratuzumab vedotin, an investigational antibody-drug conjugate targeting LIV-1, globally; and
    • Companies enter into exclusive license and co-development agreement to accelerate global reach of Tukysa (tucatinib), a small molecule tyrosine kinase inhibitor for the treatment of HER-2 positive cancers. Merck was granted an exclusive license to commercialize Tukysa in Asia, the Middle East and Latin America and other regions outside of the U.S., Canada and Europe.
  • Merck and Hanmi Pharmaceutical announced that the companies have entered into an exclusive licensing agreement for the development, manufacture and commercialization of efinopegdutide (formerly HM12525A), Hanmi’s investigational once-weekly glucagon-like peptide-1 (GLP-1)/glucagon receptor dual agonist, for the treatment of nonalcoholic steatohepatitis (NASH);
  • Merck announced the completion of its acquisition of IdentiGEN, a leader in DNA-based animal traceability solutions for livestock and aquaculture; and
  • Merck announced the completion of its acquisition of the worldwide rights to VECOXAN (diclazuril), an oral suspension for the prevention of coccidiosis in calves and lambs.

Organon & Co.

  • Merck continued to make progress on the Organon & Co. (Organon) spinoff, including additional leadership appointments, and expects the transaction to be completed in the second quarter of 2021.

Third-Quarter Financial Impact of COVID-19

In the third quarter, the estimated negative impact of the COVID-19 pandemic to Merck’s pharmaceutical revenue was approximately $475 million, bringing the company’s year-to-date negative impact on revenue to approximately $2.1 billion. Lower back-to-school demand negatively impacted vaccine sales, in particular GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) in the U.S. In addition, access to health care providers remains reduced, although improved from the second quarter. The negative impact to Animal Health sales in the third quarter was immaterial.

Operating expenses were positively impacted in the third quarter by approximately $115 million, primarily driven by lower promotional and selling costs as well as lower research and development (R&D) expenses, net of investments in COVID-19-related antiviral and vaccine research programs.

Third-Quarter Revenue Performance

The following table reflects sales of the company’s top pharmaceutical products, as well as sales of animal health products.

$ in millions

Third Quarter

2020

2019

Change

Change Ex-

Exchange

Total Sales

$12,551

$12,397

1%

2%

Pharmaceutical

11,320

11,095

2%

2%

KEYTRUDA

3,715

3,070

21%

21%

JANUVIA / JANUMET

1,327

1,311

1%

2%

GARDASIL / GARDASIL 9

1,187

1,320

-10%

-10%

PROQUAD, M-M-R II and

VARIVAX

576

623

-8%

-7%

PNEUMOVAX 23

375

237

58%

58%

BRIDION

320

284

13%

13%

ROTATEQ

210

180

16%

17%

SIMPONI

209

203

3%

0%

ISENTRESS / ISENTRESS HD

205

250

-18%

-18%

Lynparza*

196

123

59%

58%

IMPLANON / NEXPLANON

189

199

-5%

-4%

Lenvima*

142

109

30%

29%

Animal Health

1,220

1,122

9%

12%

Livestock

758

726

5%

8%

Companion Animals

462

396

17%

18%

Other Revenues**

11

180

-94%

-33%

*Alliance revenue for these products represents Merck’s share of profits, which are product sales net of cost of sales and commercialization costs.

**Other revenues are comprised primarily of third-party manufacturing sales and miscellaneous corporate revenues, including revenue hedging activities.

Pharmaceutical Revenue

Third-quarter pharmaceutical sales increased by $225 million, or 2%, to $11.3 billion. The increase was driven primarily by growth in oncology and certain hospital acute care products, partially offset by the negative impact of the COVID-19 pandemic and the ongoing impacts of the loss of market exclusivity for several products.

Growth in oncology was largely driven by higher sales of KEYTRUDA, which grew 21% to $3.7 billion in the quarter. In the U.S., sales of KEYTRUDA grew 24% to $2.2 billion. Global sales growth of KEYTRUDA reflects continued strong momentum from the NSCLC indications as well as continued uptake in other indications, including adjuvant melanoma, RCC, bladder, head and neck squamous cell carcinoma (HNSCC) and microsatellite instability-high (MSI-H) cancers as well as uptake following the recent launch of the Q6W dosing regimen in the U.S., partially offset by the negative impacts of the COVID-19 pandemic and pricing in Japan. Also contributing to growth in oncology was higher alliance revenue related to Lynparza and Lenvima reflecting continued uptake in approved indications in the U.S., Europe and China.

Performance in hospital acute care reflects higher demand globally for BRIDION (sugammadex), a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults undergoing surgery and the ongoing launch of PREVYMIS (letermovir), a medicine for prophylaxis (prevention) of cytomegalovirus (CMV) infection and disease in adult CMV-seropositive recipients of an allogeneic hematopoietic stem cell transplant.

In addition, sales of JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCI) increased slightly in the quarter reflecting strong demand from certain international markets, partially offset by continued pricing pressure in the U.S.

Vaccine sales performance reflects higher sales of PNEUMOVAX 23 (pneumococcal vaccine polyvalent), a vaccine to help prevent pneumococcal disease, primarily driven by higher volumes in the U.S., Europe and Japan attributable in part to increased demand for pneumococcal vaccination during the COVID-19 pandemic.

Vaccine sales were negatively affected by declines in sales of GARDASIL [Human Papillomavirus Quadrivalent (Types 6,11,16 and 18) Vaccine, Recombinant]/GARDASIL 9, vaccines to prevent certain cancers and other diseases caused by HPV, largely due to lower demand in the U.S. and Hong Kong, SAR, PRC attributable to the COVID-19 pandemic, partially offset by higher volumes in China and in Europe.

Combined sales of pediatric vaccines VARIVAX (Varicella Virus Vaccine Live), a vaccine to help prevent chickenpox; PROQUAD (Measles, Mumps, Rubella and Varicella Virus Vaccine Live), a combination vaccine to help protect against measles, mumps, rubella and varicella; and M-M-R II (Measles, Mumps and Rubella Virus Vaccine Live), a vaccine to help prevent measles, mumps and rubella, declined in the third quarter, primarily due to lower demand in the U.S. related to the COVID-19 pandemic.

Pharmaceutical sales in the quarter were negatively affected by the ongoing impacts from the loss of market exclusivity, including for NUVARING (etonogestrel/ethinyl estradiol vaginal ring), NOXAFIL (posaconazole) and EMEND (aprepitant)/EMEND (fosaprepitant dimeglumine) for Injection.

Animal Health Revenue

Animal Health sales totaled $1.2 billion in the third quarter of 2020, an increase of 9% compared with the third quarter of 2019; excluding the unfavorable effect from foreign exchange, Animal Health sales grew 12%. Growth in companion animal products was driven largely by higher demand in companion animal vaccines and higher demand for the BRAVECTO (fluralaner) line of products for parasitic control. Performance in livestock products reflects higher demand globally for ruminant, poultry and swine products.

Third-Quarter Expense, EPS and Related Information

The tables below present selected expense information.

$ in millions

Third-Quarter 2020

GAAP

Acquisition- and

Divestiture-

Related Costs3

Restructuring

Costs

Certain Other

Items

Non-GAAP2

Cost of sales

$3,481

$285

$38

$−

$3,158

Selling, general and administrative

2,450

207

15

−

2,228

Research and development

3,390

16

19

1,082

2,273

Restructuring costs

114

−

114

−

−

Other (income) expense, net

(312)

−

−

(1)

(311)

Third-Quarter 2019

Cost of sales

$3,990

$941

$62

$−

$2,987

Selling, general and administrative

2,589

22

1

−

2,566

Research and development

3,204

6

1

982

2,215

Restructuring costs

232

−

232

−

−

Other (income) expense, net

35

6

–

−

29

GAAP Expense, EPS and Related Information

Gross margin was 72.3% for the third quarter of 2020 compared to 67.8% for the third quarter of 2019. The increase reflects lower acquisition- and divestiture-related costs and the favorable effect of product mix, partially offset by the unfavorable effects of pricing pressure, inventory write-offs, higher amortization of intangible assets related to collaborations and foreign exchange.

Selling, general and administrative expenses were $2.5 billion in the third quarter of 2020, a decrease of 5% compared to the third quarter of 2019. The decrease primarily reflects lower administrative and selling costs, including less travel and meeting expenses, due in part to the COVID-19 pandemic, partially offset by higher acquisition- and divestiture-related costs, primarily reflecting costs related to the company’s planned spinoff of Organon.

Research and development expenses were $3.4 billion in the third quarter of 2020, an increase of 6% compared with the third quarter of 2019. The increase was primarily driven by higher upfront payments related to collaborations and license agreements, higher expenses related to clinical development and increased investment in discovery research and early drug development, partially offset by lower charges for the acquisitions of businesses, as well as lower laboratory, travel and meeting expenses due to the COVID-19 pandemic.

Other (income) expense, net, was $312 million of income in the third quarter of 2020 compared to $35 million of expense in the third quarter of 2019, primarily due to higher income from investments in equity securities, net, which was $360 million in 2020 compared with $16 million in 2019, largely from the recognition of unrealized gains on securities.

The effective income tax rate was 14.1% for the third quarter of 2020 compared to 18.7% in the third quarter of 2019. The effective income tax rate in 2019 reflects the unfavorable impact of a charge for the acquisition of Peloton Therapeutics, Inc. (Peloton) for which no tax benefit was recognized.

GAAP EPS was $1.16 for the third quarter of 2020 compared with $0.74 for the third quarter of 2019.

Non-GAAP Expense, EPS and Related Information

Non-GAAP gross margin was 74.8% for the third quarter of 2020 compared to 75.9% for the third quarter of 2019. The decrease in non-GAAP gross margin reflects the unfavorable effects of pricing pressure, inventory write-offs, higher amortization of intangible assets related to collaborations and foreign exchange, partially offset by the favorable effect of product mix.

Non-GAAP selling, general and administrative expenses were $2.2 billion in the third quarter of 2020, a decrease of 13% compared to the third quarter of 2019. The decrease primarily reflects lower administrative and selling costs, including less travel and meeting expenses, due in part to the COVID-19 pandemic.

Non-GAAP R&D expenses were $2.3 billion in the third quarter of 2020, a 3% increase compared to the third quarter of 2019. The increase was primarily driven by higher expenses related to clinical development and increased investment in discovery research and early drug development, partially offset by lower laboratory, travel and meeting expenses due to the COVID-19 pandemic.

Contacts

Media:

Pamela Eisele

(267) 305-3558

Patrick Ryan

(201) 452-2409

Investors:

Peter Dannenbaum

(908) 740-1037

Michael DeCarbo

(908) 740-1807

Read full story here

Categories
Business

Aetrex revolutionizes 3D foot scanning with Albert 2 launch

All-in-one, integrated foot scanner ensures the right fit & creates a profit center for retailers

TEANECK, N.J.–(BUSINESS WIRE)–Aetrex Worldwide, Inc. (“Aetrex”), the global market leader in foot scanning technology, orthotics and comfort and wellness footwear, today announced the launch of Albert 2, the next generation of the company’s revolutionary 3D foot scanning technology. The all-in-one omnichannel device is a fully integrated foot scanning system engineered to help customers find the right fitting footwear and orthotics and provide an enhanced customer experience at retail. The intelligent system also captures unmatched data and creates a profit center for retail partners. The Albert 2 is the most advanced foot scanning system offered globally and is available to deliver to retailers nationwide starting February 2021.

“The Albert 2 is an easy-to-use, all-in-one scanner that looks beautiful and modern in stores and does everything a retailer could possibly need from a foot scanning technology,” said Larry Schwartz, CEO, Aetrex. “The system eliminates the need for retailers to use traditional, multi-step processes to drive footwear and orthotic sales. The Albert 2 is the fastest, most integrated and streamlined device we’ve ever made.”


The customer experience with Albert 2 begins by stepping onto the sleek, modern scanner in store. The quick, easy-to-use, two-foot-at-once scanning process takes 20 seconds or less and can capture both static and dynamic pressure, as well as 3D measurements of the foot. The accurate, complete foot data is then used to help customers find the best fitting footwear or orthotics on the first try, based on their unique foot profile. The life-like, 3D animated Albert character guides users through the scanning process, while also responding to voice commands, creating a one-of-a-kind, interactive customer experience. The customer’s unique foot scan data can then be sent via email, allowing users to access to their information after they leave the store.

“What’s really unique about Albert 2 is that it can collect an unbelievable amount of data about customers’ feet, and retailers can use it to overcome many challenges they face today,” said Schwartz. Retailers can use the data to help increase store profitability by finding the right fit the first time and providing better customer service. They can also use the data to build customer relationships and loyalty by creating personalized digital marketing strategies based on foot type. Finding the right fit the first time also translates to a reduction in ecommerce returns.

Unlike other foot scanners on the market today, one of the biggest advantages of Albert 2 is the bundle with Aetrex Orthotics as part of scanning process, offering authentic, personalized fitting solutions for customers. “This integrated business model drives add-on sales for retailers, making Albert 2 a profit center rather than a cost center,” said Schwartz. The Aetrex Premium Orthotics line is recognized as the World’s #1 Foot Orthotic System and is designed for a variety of foot types based on arch type and areas of pressure. With Aetrex designing and producing all of their own hardware, software, and orthotics- all with one team- the process is seamless with a focus on quality.

“When a customer steps onto the scanner, it’s always a guaranteed sale. Albert has one of the highest returns on investment per square foot in our stores. We’ve had Albert in our stores for over two years, and I can’t wait for Albert 2 to deliver in February,” said Parks Robinson, General Manager, Fit2Run.

Aetrex Technology has placed over 10,000 scanners worldwide since the inception of foot scanning technology in 2002. Albert is one of the top profit centers per square foot in retail stores today and has proven to increase total sales by 75 percent. For a complete list of retailers, please visit www.aetrex.com/store-locator.

Albert 2 boasts many unique features, such as:

  • 3D Measurements: Albert 2’s 3D foot scan captures the most accurate foot data with key measurements, such as length, width, girth, in-step and arch height, all down to 1/10 of a millimeter. This data is then converted into a 3D model for an engaging, interactive consumer experience.
  • Pressure: Aetrex’s premium pressure plate technology is designed to capture complete foot data about customers’ unique arch types and pressure points. With the Dynamic Test option, Albert 2 can also provide a pressure gait analysis of customers’ feet, including their center of gravity throughout the gait cycle.
  • FitHQ: This proprietary software ensures the right fit the first time by using artificial intelligence (AI). The program can be synced with retailers’ POS or e-commerce systems to help sales associates recommend the best Aetrex orthotics or best fitting shoes by brand, style and size per customer, based on his or her unique foot scan.
  • Voice-Activated Learning Center: Using chatbot technology, Albert’s Learning Center provides an easy way for store associates to navigate the software, as well as provide customers with information on foot health, conditions and Aetrex Orthotics products by simply asking Albert.

Albert 2 comes to market in a modern, compact retail footprint at a fraction of the price of the competition. Albert 2 is available to retailers with different kiosk packages, starting at $2,495 or $83/month, with units launching in stores in February 2021. To learn more about Aetrex’s Albert 2 Technology, visit www.aetrex.com/technology.

About Aetrex

Aetrex Worldwide, Inc. is widely recognized as the global leader in foot scanning technology, orthotics, and comfort and wellness footwear. Aetrex has developed state-of-the-art foot scanning devices, including Albert and iStep, designed to accurately measure feet and determine foot type and pressure points. Since 2002, Aetrex has placed over 10,000 scanners worldwide that have performed more than 40 million unique customer foot scans, averaging more than 2.5 million scans a year. The company is renowned for its over-the-counter orthotics – the worlds #1 foot orthotic. With fashion, function and quality at the forefront, Aetrex also designs and manufactures stylish, performance footwear. Based in New Jersey, Aetrex is consistently named one of New Jersey’s Top 100 Privately Held Companies and was also included in NJBIZ’s Top 30 Manufacturing Companies. It has remained privately owned by the Schwartz family for three generations. For additional information, please visit www.aetrex.com.

Contacts

Cori Hays

Matter Communications

971-361-9604

aetrex@matternow.com

Categories
For Edit

Tiffany Trump hitting campaign trail in NC, Michigan, other battleground states

President Trump’s youngest daughter, Tiffany Trump, will be campaigning for her father in four battleground states, North Carolina, Pennsylvania, Michigan and Minnesota, after keeping a low profile during the 2016 campaign.

 

— FOX News

Categories
For Edit

Sarah Silverman says progressives don’t offer a ‘path to redemption’ for victims of cancel culture

Comedian Sarah Silverman feels that victims of cancel culture deserve a “path to redemption” and acknowledged that progressives don’t typically offer forgiveness and the abandoned party might head to the “mother—–g dark side” to find love.

 

–FOX News

Categories
For Edit

A crush of early voters makes for long waits in N.Y.C.

For the first time ever, New Yorkers cast their ballots early for a presidential election, sometimes standing in line for five hours.

 

 

— New York Times: Top Stories

Categories
For Edit

Rapper Silento arrested after going 143 mph on Georgia highway, tells police he’s not ‘a regular person’

Rapper Silento, best known for the hit 2015 track “Watch Me (Whip/Nae Nae),” was arrested Friday and accused of driving 143 mph on Interstate 85 in Georgia.

— FOX News

Categories
Business

U.S.’ second largest county to deploy NICE Inform Intelligence Center for digital transformation of its consolidated 911 operation

NICE Inform Intelligence Center’s advanced capabilities will help Cook County Sheriff’s Police 911 Center save time and improve service levels for member agencies

HOBOKEN, N.J.–(BUSINESS WIRE)–NICE (Nasdaq: NICE) today announced that the Cook County Sheriff’s Police 911 Center, a consolidated 911 center serving Cook County, Illinois, will be deploying the NICE Inform Intelligence Center and other advanced NICE Inform capabilities to digitally transform processes around tracking performance metrics and performing quality assurance reviews. Through this transformation, the County expects to achieve time savings and improve levels of service for member agencies, communities, state’s attorneys, and other stakeholders. Cook County, Illinois, is the second largest county in the United States, with a population of more than 5 million.

As a consolidated center, the Cook County Sheriff’s Police 911 Center takes approximately 150,000 911 calls a year (550,000 in total including non-emergency calls) and provides dispatching services for 13 other public safety agencies. With consolidation now legally mandated in Illinois for any 911 center serving populations under 25,000, the Center has grown dramatically, continuing to add member agencies and more than doubling dispatchers in the past six years. The center’s highly skilled dispatchers also handle calls regarding incidents and maintenance issues on the Metra rail system, the third largest rail system in the United States, used by over 300,000 commuters each day.

Martin Bennett, ENP, Executive Director for the 911 Center and Cook County ETSB, said, “As we’ve grown, our challenges have become amplified. We have more dispatchers, taking more types of calls, supporting more member agencies and more evidentiary requests coming from the court system. With all of these added complexities, we need access to timely data that can tell us what happened and how we can perform better. Today, all of this data resides in different systems, so finding it and piecing it together can consume enormous resources. The NICE Inform Intelligence Center, along with other advanced capabilities of NICE Inform, give us everything we need, all in one solution, to proactively address these challenges.”

Chris Wooten, Executive Vice President, NICE, said, “Because our NICE Inform Intelligence Center sits at the center of today’s emergency communications center ecosystem and integrates to all of the key systems – CAD, 911, radio, and more – 911 centers get a single system of record leveraging all their data, and unprecedented insights they can’t get anywhere else. We are pleased to bring this next-generation public safety 911 incident intelligence solution to Cook County, a long time NICE customer.”

Leveraging NICE Inform Intelligence Center’s incident intelligence dashboards and other advanced NICE Inform capabilities, the Cook County Sheriff’s Police 911 Center will digitally transform processes around:

  • Tracking performance metrics to provide insights into where improvements can be made: The NICE Inform Intelligence Center’s dashboards automatically consolidate data from all systems to provide instant visibility into what’s happening, with dozens of real-time metrics including time to answer, time to enter, time to dispatch, time to on-scene and more. Managers can drill down to the dispatcher level and even view metrics for different incident types or individual member agencies. Member agencies will also have access to their own dashboards to view response metrics and heat maps that show what calls are coming from what locations so they can better understand crime patterns and allocate resources accordingly.
  • Automating quality assurance (QA) reviews and proactively addressing small problems before they become big issues: The Cook County Sheriff’s Police 911 Center will use NICE Inform to replace random quality checks with more consistent, automated, data-driven quality assurance reviews, to keep up with growing call volumes. For example, using data from the CAD and telephony systems, NICE Inform can automatically pull specific types of calls for supervisors to review (based on their priority, excessive time to dispatch, or other criteria).
  • Automating incident reconstruction to cut down on resource drain and save time: FOIA (Freedom of Information) and state’s attorney requests received by the Cook County Sheriff’s Police 911 Center have almost tripled in recent years. Instead of logging into different systems and databases, and spending hours or days pulling data and piecing it together, records custodians will now be able to pull complete incident reconstructions, simply by keying in a CAD incident number.

To learn more about the NICE Inform Intelligence Center:

About the Cook County Sheriff’s Police 911 Center

The Cook County Sheriff’s Police 911 Center, located in Des Plaines, Illinois, serves a population of over 200,000 residents throughout Cook County and over 300,000 daily commuters who ride the Metra rail system throughout the six-county area in Illinois and Kenosha County, Wisconsin. It generates approximately 800,000 CAD incidents a year and processes an average of 550,000 calls (emergency and non-emergency) annually. As a consolidated center, it provides dispatching services for the Cook County States Attorney’s Office Investigators, the Berkeley Fire Department, and the following Cook County police departments: Berkeley, Blue Island, Cook County Sheriff’s Office & Police, Cook County Forest Preserve, Harvey, Hometown, Indian Head Park, Lyons, Merrionette Park, Metra, Palos Park, and Phoenix. Several more departments have already signed on to join the consolidated center in 2021. For more information, visit https://cookcounty911.com/.

About NICE

NICE (Nasdaq: NICE) is the world’s leading provider of both cloud and on-premises enterprise software solutions that empower organizations to make smarter decisions based on advanced analytics of structured and unstructured data. NICE helps organizations of all sizes deliver better customer service, ensure compliance, combat fraud and safeguard citizens. Over 25,000 organizations in more than 150 countries, including over 85 of the Fortune 100 companies, are using NICE solutions. www.nice.com.

Trademark Note: NICE and the NICE logo are trademarks or registered trademarks of NICE Ltd. All other marks are trademarks of their respective owners. For a full list of NICE’s marks, please see: www.nice.com/nice-trademarks.

Forward-Looking Statements

This press release contains forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements, including the statements by Mr. Wooten, are based on the current beliefs, expectations and assumptions of the management of NICE Ltd. (the “Company”). In some cases, such forward-looking statements can be identified by terms such as “believe,” “expect,” “seek,” “may,” “will,” “intend,” “should,” “project,” “anticipate,” “plan,” “estimate,” or similar words. Forward-looking statements are subject to a number of risks and uncertainties that could cause the actual results or performance of the Company to differ materially from those described herein, including but not limited to the impact of changes in economic and business conditions, including as a result of the COVID-19 pandemic; competition; successful execution of the Company’s growth strategy; success and growth of the Company’s cloud Software-as-a-Service business; changes in technology and market requirements; decline in demand for the Company’s products; inability to timely develop and introduce new technologies, products and applications; difficulties or delays in absorbing and integrating acquired operations, products, technologies and personnel; loss of market share; an inability to maintain certain marketing and distribution arrangements; the Company’s dependency on third-party cloud computing platform providers, hosting facilities and service partners;, cyber security attacks or other security breaches against the Company; the effect of newly enacted or modified laws, regulation or standards on the Company and our products and various other factors and uncertainties discussed in our filings with the U.S. Securities and Exchange Commission (the “SEC”). For a more detailed description of the risk factors and uncertainties affecting the company, refer to the Company’s reports filed from time to time with the SEC, including the Company’s Annual Report on Form 20-F. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company undertakes no obligation to update or revise them, except as required by law.

Contacts

Corporate Media
Christopher Irwin-Dudek, 201561 4442, ET, chris.irwin-dudek@nice.com

Investors
Marty Cohen, +1 551 256 5354, ET, ir@nice.com
Yisca Erez +972 9 775 3798, CET, ir@nice.com

Categories
For Edit

The Sunday read: ‘My mustache, my self’

One writer’s facial hair experiment during quarantine led him into a deep consideration of his Blackness.

During months of pandemic isolation, Wesley Morris, a critic at large for The New York Times, decided to grow a mustache.

The reviews were mixed and predictable. He heard it described as “porny” and “creepy,” as well as “rugged” and “extra gay.”

It was a comment on a group call, however, that gave him pause. Someone noted that his mustache made him look like a lawyer for the N.A.A.C.P.’s legal defense fund.

“It was said as a winking correction and an earnest clarification — Y’all, this is what it is,” Wesley said. “The call moved on, but I didn’t. That is what it is: one of the sweetest, truest things anybody had said about me in a long time.”

 

— NYT: Top Stories

Categories
For Edit

Biden says in video he has created ‘voter fraud organization’

In a recent video, Democratic Nominee Joe Biden said his team has created “the most extensive and inclusive voter fraud organization in the history of American politics.”

 

— FOX News