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Merck announces second-quarter 2022 financial results

  • Merck Delivers Robust Sales Growth and Important Clinical Advancements in Second Quarter
  • Second-Quarter 2022 Worldwide Sales Were $14.6 Billion, an Increase of 28% From Second Quarter 2021; LAGEVRIO Sales Were $1.2 Billion, Growth Excluding LAGEVRIO Was 18%; Growth Excluding LAGEVRIO and the Impact From Foreign Exchange Was 20%; Sales Growth Favorably Impacted by COVID-19 Recovery
    • KEYTRUDA Sales Grew 26% to $5.3 Billion; Excluding the Impact From Foreign Exchange, Sales Grew 30%
    • GARDASIL/GARDASIL 9 Sales Grew 36% to $1.7 Billion; Excluding the Impact From Foreign Exchange, Sales Grew 40%
  • Second-Quarter 2022 GAAP EPS From Continuing Operations Was $1.55; Second-Quarter 2022 Non-GAAP EPS Was $1.87
  • Advanced and Expanded Pipeline:
    • The U.S. Food and Drug Administration (FDA) Approved Merck’s VAXNEUVANCE for the Prevention of Invasive Pneumococcal Disease in Infants and Children
    • The U.S. Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices Unanimously Voted to Provisionally Recommend Use of Merck’s VAXNEUVANCE as an Option for Pneumococcal Vaccination in Infants and Children
    • Merck Announced Positive Results From a Phase 1/2 Study for V116, Merck’s Investigational Pneumococcal 21-Valent Conjugate Vaccine for Adults, and Enrolled the First Patient Into the Phase 3 STRIDE-3 Trial Evaluating V116 in Vaccine-Naïve Adults
    • The European Commission (EC) Approved Four Indications for KEYTRUDA
  • 2022 Continuing Operations Financial Outlook:
    • Company Raises and Narrows Expected Full-Year 2022 Worldwide Sales Range To Be Between $57.5 Billion and $58.5 Billion, Reflecting Full-Year Growth of 18% to 20%, Including Negative Impact From Foreign Exchange of Approximately 3%
    • Company Expects Full-Year 2022 GAAP EPS To Be Between $5.89 and $5.99; Company Narrows Expected Full-Year 2022 Non-GAAP EPS Range To Be Between $7.25 and $7.35, Including Negative Impact From Foreign Exchange of Approximately 3%

 

RAHWAY, N.J. — (BUSINESS WIRE) — $MRK #MRK–Merck (NYSE: MRK), known as MSD outside the United States and Canada, recently announced financial results for the second quarter of 2022.


“I continue to be immensely proud of how the Merck team is performing in all facets of our business — scientifically, commercially and operationally,” said Robert M. Davis, chief executive officer and president. “Our strategy is working and our future is bright. I am very confident that we are well-positioned to achieve our near- and long-term goals, anchored by our commitment to deliver innovative medicines and vaccines to patients and value to all of our stakeholders, including shareholders.”

 

Financial Summary

Financial information presented in this release reflects Merck’s results on a continuing operations basis, which excludes Organon & Co. that was spun-off on June 2, 2021.

 

$ in millions, except EPS amounts

Second Quarter

2022

2021

Change

Change

Ex-

Exchange

Sales

$14,593

$11,402

28%

31%

GAAP net income1

3,944

1,213

N/M**

N/M

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

4,743

1,559

N/M

N/M

GAAP EPS

1.55

0.48

N/M

N/M

Non-GAAP EPS that excludes certain items2*

1.87

0.61

N/M

N/M

*Refer to table on page 10

**Not meaningful

 

Generally accepted accounting principles (GAAP) earnings per share (EPS) assuming dilution was $1.55 for the second quarter of 2022. Non-GAAP EPS of $1.87 for the second quarter of 2022 excludes acquisition- and divestiture-related costs, restructuring costs, as well as income and losses from investments in equity securities. In 2022, the company changed the treatment of certain items for purposes of its non-GAAP reporting. Results for 2021 have been recast to conform to the new presentation, which reduced previously reported second-quarter 2021 non-GAAP EPS of $1.31, resulting in revised non-GAAP EPS of $0.61. For more information, refer to the Form 8-K filed by the company on April 21, 2022.

 

Year-to-date results can be found in the attached tables.

 

Vaccines Program Highlights

  • The FDA approved an expanded indication for VAXNEUVANCE (Pneumococcal 15-valent Conjugate Vaccine) to include infants and children. VAXNEUVANCE is now indicated to help prevent invasive pneumococcal disease caused by the serotypes in the vaccine in individuals six weeks and older.
  • The CDC Advisory Committee on Immunization Practices unanimously voted to provisionally recommend use of VAXNEUVANCE as an option to the currently available 13-valent pneumococcal conjugate vaccine (PCV13) for children under 19 years according to currently recommended PCV13 dosing and schedules. These provisional recommendations will be reviewed by the director of the CDC and the Department of Health and Human Services, and final recommendations will become official when published in the CDC’s Morbidity and Mortality Weekly Report.
  • Merck presented positive results from the Phase 1/2 study for V116, Merck’s investigational Pneumococcal 21-Valent Conjugate Vaccine designed to target serotypes that account for 85% of all invasive pneumococcal diseases in U.S. adults 65 years and older as of 20193, and enrolled the first patient into the Phase 3 STRIDE-3 trial evaluating V116 in vaccine-naïve adults. V116 contains eight serotypes not included in any currently licensed pneumococcal vaccine.

 

Oncology Program Highlights

  • Merck announced the following regulatory milestones for KEYTRUDA (pembrolizumab):
    • The FDA accepted an application seeking approval for KEYTRUDA as adjuvant therapy for stage IB (>4 centimeters), II or IIIA non-small cell lung cancer (NSCLC) following complete surgical resection based on data from the Phase 3 KEYNOTE-091 trial. The FDA has set a Prescription Drug User Fee Act date of January 29, 2023, however further data may be provided during the review process that may delay this date.
    • The EC approved four indications for KEYTRUDA:
      • Approved as monotherapy for the adjuvant treatment of adult and adolescent patients (>12 years of age) with stage IIB or IIC melanoma and who have undergone complete resection, based on results from the KEYNOTE-716 trial. The EC also approved expanding the indication for KEYTRUDA in advanced and stage III melanoma to include adolescent patients 12 years and older.
      • Approved in combination with chemotherapy as neoadjuvant treatment, and then continued as adjuvant monotherapy after surgery, for adults with locally advanced or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence, based on results from the KEYNOTE-522 trial.
      • Approved as monotherapy for the treatment of certain adult patients with microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) tumors for five types of cancer: unresectable or metastatic colorectal, gastric, small intestine or biliary cancer, as well as advanced or recurrent MSI-H/dMMR endometrial cancer, based on results from the KEYNOTE-164 and KEYNOTE-158 trials.
      • Approved in combination with chemotherapy, with or without bevacizumab, for patients with persistent, recurrent or metastatic cervical cancer whose tumors express PD-L1 (Combined Positive Score ≥ 1), based on results from the KEYNOTE 826 trial.
  • The European Medicines Agency Committee for Medicinal Products for Human Use adopted a positive opinion for Lynparza (olaparib), an oral poly (ADP-ribose) polymerase (PARP) inhibitor being co-developed and co-commercialized with AstraZeneca, as adjuvant treatment for patients with germline BRCA-mutated, human epidermal growth factor 2-negative high-risk early breast cancer who have been treated with neoadjuvant or adjuvant chemotherapy, based on results from the Phase 3 OlympiA trial.
  • At the 2022 American Society of Clinical Oncology Annual Meeting, Merck presented new data in more than 25 types of cancer and held an investor event to highlight key data and provide updates from its late-stage development programs and diverse early-stage pipeline.

 

Global Pharmaceuticals Program Highlight

  • Merck, in collaboration with Ridgeback Biotherapeutics, announced data from a pre-specified exploratory analysis for LAGEVRIO (molnupiravir) from the Phase 3 MOVe-OUT study indicating that a lower proportion of participants treated with LAGEVRIO had an acute care visit or COVID-19-related acute care visit versus placebo. Additionally, in a post-hoc subgroup analysis, fewer LAGEVRIO-treated patients who were hospitalized post-randomization in MOVe-OUT required respiratory interventions (including invasive mechanical ventilation) compared to those who received placebo.

 

Second-Quarter Revenue Performance

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

 

 

Second Quarter

$ in millions

2022

2021

Change

Change Ex-

Exchange

Total Sales

$14,593

$11,402

28%

31%

Pharmaceutical

12,756

9,980

28%

33%

KEYTRUDA

5,252

4,176

26%

30%

GARDASIL / GARDASIL 9

1,674

1,234

36%

40%

JANUVIA / JANUMET

1,233

1,261

-2%

3%

LAGEVRIO

1,177

0

–

–

PROQUAD, M-M-R II and

VARIVAX

578

516

12%

14%

BRIDION

Lynparza*

426

275

387

248

10%

11%

15%

17%

Lenvima*

231

181

28%

33%

SIMPONI

ROTATEQ

181

173

202

208

-10%

-17%

1%

-14%

Animal Health

1,467

1,472

0%

5%

Livestock

826

821

1%

6%

Companion Animals

641

651

-2%

3%

Other Revenues**

370

(50)

N/M***

N/M

*Alliance revenue for this product 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. The revenue-hedging activities resulted in negative revenue in the second quarter of 2021.

***Not meaningful

 

Pharmaceutical Revenue

Second-quarter pharmaceutical sales increased 28% to $12.8 billion. Pharmaceutical sales growth in the second quarter was 16% excluding LAGEVRIO sales, and was primarily driven by oncology, vaccines and hospital acute care products. The COVID-19 pandemic unfavorably affected sales in the second quarter of 2021 by approximately $400 million, which favorably impacted the growth rate in the second quarter of 2022.

 

LAGEVRIO sales totaled $1.2 billion for the second quarter, primarily consisting of sales in Japan and the U.K. The initial commitment of LAGEVRIO to the U.S. was fulfilled in the first quarter of 2022.

 

Growth in oncology was largely driven by higher sales of KEYTRUDA, which rose 26% to $5.3 billion in the quarter. Global sales growth of KEYTRUDA reflects continued strong momentum from metastatic indications including certain types of NSCLC, renal cell carcinoma, head and neck squamous cell carcinoma, TNBC and MSI-H cancers, and increased uptake across recent earlier-stage launches including certain types of neoadjuvant/adjuvant TNBC in the U.S.

 

Also contributing to higher sales in oncology was a 28% increase in Lenvima (lenvatinib) alliance revenue driven primarily by higher demand in the U.S., and an 11% increase in Lynparza alliance revenue reflecting continued demand globally, particularly in the U.S. driven by strong uptake in earlier-stage breast cancer.

 

Growth in vaccines was primarily driven by higher combined sales of GARDASIL (Human Papillomavirus Quadrivalent [Types 6, 11, 16 and 18] Vaccine, Recombinant) and GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant) vaccines to prevent certain cancers and other diseases caused by human papillomavirus (HPV). Second-quarter GARDASIL/GARDASIL 9 sales grew 36% to $1.7 billion primarily driven by strong demand outside of the U.S., particularly in China, which also benefited from increased supply.

 

Growth in hospital acute care reflects higher demand globally for BRIDION (sugammadex) injection 100 mg/mL, a medicine for the reversal of neuromuscular blockade induced by rocuronium bromide or vecuronium bromide in adults and pediatric patients aged 2 years and older undergoing surgery. Sales increased 10% to $426 million, primarily due to an increase in its share among neuromuscular blockade reversal agents and an increase in surgical procedures during the second quarter. Growth in hospital acute care also reflects higher sales of ZERBAXA (ceftolozane and tazobactam), a combination cephalosporin antibacterial and beta-lactamase inhibitor for the treatment of adults with certain bacterial infections. Sales of $46 million resulted from the phased resupply initiated in the fourth quarter of 2021 that is being expanded to additional markets during 2022.

 

Pharmaceutical sales growth was partially offset by lower combined sales of ISENTRESS/ISENTRESS HD (raltegravir), an HIV integrase inhibitor used in combination with other antiretroviral agents for the treatment of HIV-1 infection, which declined 24% to $147 million reflecting lower global demand. Pharmaceutical sales growth was also partially offset by lower combined sales of JANUVIA (sitagliptin) and JANUMET (sitagliptin and metformin HCI), which declined 2% to $1.2 billion, primarily reflecting the unfavorable effect of foreign exchange and lower pricing in certain international markets, partially offset by the impact of a prior year unfavorable adjustment to rebate reserves in the U.S. The company lost market exclusivity for JANUVIA and JANUMET in China in July and will lose market exclusivity in the European Union in September.

 

Animal Health Revenue

Animal Health sales totaled $1.5 billion for the second quarter of 2022, flat compared to the second quarter of 2021. Excluding the unfavorable effect from foreign exchange, Animal Health sales grew 5%. Sales were driven primarily by livestock products reflecting higher demand globally for ruminant and poultry products. Sales in companion animal products were primarily driven by the BRAVECTO (fluralaner) parasiticide line of products.

 

Second-Quarter Expense, EPS and Related Information

The tables below present selected expense information.

 

$ in millions

Second Quarter 2022

GAAP

Acquisition-

and

Divestiture-

Related

Costs4

Restructuring

Costs

(Income)

Loss from

Investments

in Equity

Securities

Certain

Other

Items

Non-

GAAP2

Cost of sales

$4,216

$451

$67

$-

$-

$3,698

Selling, general and administrative

2,512

65

27

–

–

2,420

Research and development

2,798

12

22

–

–

2,764

Restructuring costs

142

–

142

–

–

–

Other (income) expense, net

438

2

–

234

–

202

Second Quarter 2021

Cost of sales

$3,104

$345

$38

$-

$37

$2,684

Selling, general and administrative

2,281

25

2

–

–

2,254

Research and development

4,321

16

6

–

–

4,299

Restructuring costs

82

–

82

–

–

–

Other (income) expense, net

(103)

117

–

(258)

–

38

 

GAAP Expense, EPS and Related Information

Gross margin was 71.1% for the second quarter of 2022 compared to 72.8% for the second quarter of 2021. The decrease primarily reflects impacts from LAGEVRIO, which has a lower gross margin due to profit sharing with Ridgeback, as well as higher inventory write-offs, higher manufacturing costs and higher acquisition- and divestiture-related costs. The gross margin decline was partially offset by the favorable effects of product mix.

 

Selling, general and administrative (SG&A) expenses were $2.5 billion in the second quarter of 2022, an increase of 10% compared to the second quarter of 2021. The increase primarily reflects higher promotion and administrative costs, including compensation and benefit costs, as well as higher acquisition- and divestiture-related costs, partially offset by the favorable impact of foreign exchange.

 

Research and development (R&D) expenses were $2.8 billion in the second quarter of 2022 compared to $4.3 billion in the second quarter of 2021. The decrease was primarily driven by a $1.7 billion charge in the prior year for the acquisition of Pandion Therapeutics, Inc. (Pandion). The decline was partially offset by higher clinical development spending, higher compensation and benefits, and higher investments in technology in support of the digital enablement of Merck’s research operations.

 

Other (income) expense, net, was $438 million of expense in the second quarter of 2022 compared to $103 million of income in the second quarter of 2021, primarily due to net unrealized losses from investments in equity securities in the second quarter of 2022, compared to net unrealized income from investments in equity securities in the second quarter of 2021. Other (income) expense, net, in the second quarter of 2022 also reflects higher pension settlement costs of approximately $100 million compared to the second quarter of 2021.

 

The effective income tax rate was 12.0% for the second quarter of 2022 compared to 29.3% in the second quarter of 2021. The effective income tax rate in the second quarter of 2021 reflects no tax benefit recognized on the charge for the acquisition of Pandion.

 

GAAP EPS was $1.55 for the second quarter of 2022 compared to $0.48 for the second quarter of 2021.

 

Non-GAAP Expense, EPS and Related Information

Non-GAAP gross margin was 74.7% for the second quarter of 2022 compared to 76.5% for the second quarter of 2021. The decrease in non-GAAP gross margin primarily reflects impacts from LAGEVRIO, which has a lower gross margin due to profit sharing with Ridgeback, as well as higher inventory write-offs and manufacturing costs. The gross margin decline was partially offset by the favorable effects of product mix.

 

Non-GAAP SG&A expenses were $2.4 billion in the second quarter of 2022, an increase of 7% compared to the second quarter of 2021. The increase primarily reflects higher promotion and administrative costs, including compensation and benefit costs, partially offset by the favorable impact of foreign exchange.

 

Non-GAAP R&D expenses were $2.8 billion in the second quarter of 2022 compared to $4.3 billion in the second quarter of 2021. The decrease primarily reflects a $1.7 billion charge in the prior year for the acquisition of Pandion. The decline was partially offset by higher clinical development spending, higher compensation and benefits, and higher investments in technology in support of the digital enablement of Merck’s research operations.

 

Non-GAAP other (income) expense, net, was $202 million of expense in the second quarter of 2022 compared to $38 million of expense in the second quarter of 2021 reflecting higher pension settlement costs of approximately $100 million.

 

The non-GAAP effective income tax rate was 13.8% for the second quarter of 2022 compared to 26.7% in the second quarter of 2021. The non-GAAP effective income tax rate in the second quarter of 2021 reflects no tax benefit recognized on the charge for the acquisition of Pandion.

 

Non-GAAP EPS was $1.87 for the second quarter of 2022 compared to $0.61 for the second quarter of 2021.

 

A reconciliation of GAAP to non-GAAP net income and EPS is provided in the table that follows.

 

 

Second Quarter

$ in millions, except EPS amounts

2022

2021

EPS

GAAP EPS

$1.55

$0.48

Difference

0.32

0.13

Non-GAAP EPS that excludes items listed below2

$1.87

$0.61

Net Income

GAAP net income1

$3,944

$1,213

Difference

799

346

Non-GAAP net income that excludes items listed below1,2

$4,743

$1,559

Decrease (Increase) in Net Income Due to Excluded Items:

Acquisition- and divestiture-related costs4

$530

$503

Restructuring costs

258

128

Loss (income) from investments in equity securities

234

(258)

Charge for the discontinuation of COVID-19 development programs

–

37

Net decrease (increase) in income before taxes

1,022

410

Estimated income tax (benefit) expense

(223)

(64)

Decrease (increase) in net income

$799

$346

 

Financial Outlook

Beginning in 2022, Merck no longer excludes expenses for upfront and milestone payments related to collaborations and licensing agreements, or charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions from its non-GAAP results. Historically, the company excluded these charges to the extent they were considered by the company to be significant to the results of a particular period. These changes were made to align with views expressed by the U.S. Securities and Exchange Commission. Prior periods have been recast to reflect this change. For 2021, non-GAAP results have been recast to include $1.7 billion of incremental R&D expense, resulting in revised full-year 2021 EPS of $5.37.

 

Business development continues to be a priority for Merck, as demonstrated by the company’s recent collaboration with Orion announced in July for the development and commercialization of ODM-208, an investigational steroid synthesis inhibitor for the treatment of metastatic castration-resistant prostate cancer. The GAAP and non-GAAP financial outlooks include the upfront payment of $290 million, which will have an estimated $0.09 negative impact on full-year EPS.

 

As an on-going practice, the financial outlook will not include significant potential business development transactions.

 

Merck continues to experience strong global underlying demand across its key pillars of growth, particularly in oncology and vaccines. As a result, Merck is raising and narrowing its full-year guidance for sales.

 

At mid-July 2022 exchange rates, Merck expects sales growth of 18% to 20% in 2022, with full-year sales estimated to be between $57.5 billion and $58.5 billion, including a negative impact from foreign exchange of approximately 3%, a greater than 1% incremental negative impact from prior sales guidance.

 

Merck’s estimated full-year non-GAAP effective income tax rate is unchanged and expected to be between 13.5% and 14.5%.

 

Merck expects its estimated full-year 2022 GAAP EPS to be between $5.89 and $5.99.

 

Merck is narrowing its expected full-year 2022 non-GAAP EPS range to be between $7.25 and $7.35, including a negative impact from foreign exchange of approximately 3% at mid-July exchange rates. Operational strength of approximately $0.25 that would have resulted in an increase from the previous guidance range is being offset by the following negative impacts:

 

  • The upfront payment of $290 million to Orion
  • A greater than 1% incremental negative impact from foreign exchange
  • Higher U.S. pension settlement expense

 

The non-GAAP range excludes acquisition- and divestiture-related costs and costs related to restructuring programs as well as income and losses from investments in equity securities.

 

The company continues to expect sales of $5.0 billion to $5.5 billion from LAGEVRIO for full-year 2022. Merck shares profits equally with its partner, Ridgeback, which is reflected in cost of sales.

 

The following table summarizes the company’s full-year 2022 financial guidance.

 

GAAP

Non-GAAP2

Sales

$57.5 to $58.5 billion

$57.5 to $58.5 billion*

Operating expenses

$21.0 to $22.0 billion

$20.5 to $21.5 billion

Effective tax rate

12% to 13%

13.5% to 14.5%

EPS**

$5.89 to $5.99

$7.25 to $7.35

*The company does not have any non-GAAP adjustments to sales.

**EPS guidance for 2022 assumes a share count (assuming dilution) of approximately 2.54 billion shares.

 

A reconciliation of anticipated 2022 GAAP EPS to non-GAAP EPS and the items excluded from non-GAAP EPS are provided in the table below.

 

 

$ in millions, except EPS amounts

Full-Year 2022

GAAP EPS

$5.89 to $5.99

Difference

$1.36

Non-GAAP EPS that excludes items listed below2

$7.25 to $7.35

Acquisition- and divestiture-related costs

Restructuring costs

(Income) loss from investments in equity securities

$2,750

550

1,050

Net decrease (increase) in income before taxes

4,350

Estimated income tax (benefit) expense

(900)

Decrease (increase) in net income

$3,450

Contacts

Media Contacts:

Johanna Herrmann

(617) 216-6029

Melissa Moody

(215) 407-3536

Investor Contacts:

Peter Dannenbaum

(908) 740-1037

Steven Graziano

(908) 740-6582

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Categories
Business Environment Science

Despite climate change worry, new study says most professionals in tea and related industries underprioritize sustainability when stocking tea

First-of-its-kind sustainability report reveals purchasing drivers of professionals in tea and related industries.

SECAUCUS, N.J. – A new report from Firsd Tea, the largest importer of Chinese tea in the U.S., finds most professionals in tea and related industries underprioritize sustainability when stocking tea inventory—even with 80% of this group worried about the effects of climate change on business operations.

 

Firsd Tea Sustainability Perspectives 2022 is the first study to gauge opinions of tea sustainability among associated industry professionals.

 

“This finding is surprising to me. We hear so much from our customers about the importance of sustainability. I look forward to better exploring what is behind this potential disconnect between customer concern for sustainability and business purchasing priorities,” Firsd Tea marketing director, Jason Walker, explains.

Respondents listed flavor (96%), leaf grade (90%) and origin/terroir (88%) as the top three characteristics that contributed to their decisions to stock particular tea types. These considerations are followed by demand (86%), consistency of supply (84%) and price (83%). Sustainability (79%) ranks seventh in the list of factors influencing tea-stocking decisions.

 

Sean Cash, PhD, Bergstrom Foundation professor of global nutrition in the Friedman School of Nutrition Science and Policy at Tufts University, says, “The results of this compelling survey indicate that representatives of the tea industry are keenly aware that their sector is threatened by climate change, and to a greater extent than many other crops. This clearly supports the urgent need for collaborations that will help protect and support the future of tea for years to come.”

 

Dr. Cash is a co-principal investigator with Tea & Climate Change Collaborative, an interdisciplinary and cross-institutional project team that researches the effects of climate change on tea quality and socio-economic responses.

 

“Firsd Tea believes stocking sustainable teas should be a win-win. Choosing sustainable teas doesn’t have to mean sacrificing flavor and quality,” explains Shengyuan Chen, Firsd Tea’s executive director.

 

The study derives its results from a two-month long survey beginning in December 2021 to February 2022 conducted in collaboration with Tea & Coffee Trade Journal, a 120+ year-old publication covering the global tea and coffee industries from origin through the supply chain. Princeton-based Crothers Consulting administered the survey to 95 voluntary respondents conducting business in tea and related sectors (e.g. coffee, wine and cocoa).

 

For the full Firsd Tea Sustainability Perspectives 2022 Report, click here.

 

About Firsd Tea:

Firsd Tea is the U.S. subsidiary of parent company, Zhejiang Tea Group, Ltd. (ZJT), China’s largest tea exporter and the world leader in green tea exports. Founded in 1950, ZJT has been the largest tea producer and exporter in China for 25 consecutive years. The company has remained one of the leading and most technologically advanced manufacturers and innovators in the Chinese tea industry. ZJT boasts strategic collaboration with the Science Department of Zhejiang University as well as the Hangzhou Tea Research Institute of All China Federation of Supply and Marketing Co-operatives. Zhejiang Tea Group’s portfolio of products include EU compliant conventional teas and organic teas (first organic tea producer in China since 1989), decaf teas (one of only two companies in China who have a CO2 decaf facility) and chemical solvent-free tea extractions, including instant teas, tea polyphenols, and EGCG.

Categories
Business Healthcare Lifestyle Local News Science

Zicam®, the #1 cold-shortening brand†, adds daily immune support products to its lineup

The brand’s first-ever immune support daily gummy supplements, Zicam Daily Immune Support* and Zicam Sleep + Immune Support* with Melatonin, are set to be released in July 2022 in select retailers nationwide and online

 

EWING, N.J. — (BUSINESS WIRE) — Zicam®, the #1 cold-shortening brand†, announces the launch of two new immune support gummy supplements – Zicam Daily Immune Support* and Zicam Sleep + Immune Support* with Melatonin – developed to provide immune support year-round, day and night.*


Zicam Daily Immune Support* provides immune support while Zicam Sleep + Immune Support* with Melatonin provides the same immune support plus melatonin to support sleep.*

 

Featuring its signature zinc formulas, the new gummy supplements offer 100% daily value of three immune-supporting ingredients: Zinc, Vitamin C, and Vitamin D per serving, with the addition of 3mg of melatonin per serving in Zicam Sleep + Immune Support* with Melatonin.

 

“For over 20 years, Zicam has led the way in helping consumers shorten their colds, and we’re constantly looking at new and innovative ways to aid consumers who care about their immune health,” said Michael Vercelletto, marketing director of Zicam. “Our expansion into the immune support space, with Zicam Daily Immune Support* and Zicam Sleep + Immune Support* with Melatonin, is focused on giving consumers the boost of support that they can rely on in an easy to take delicious gummy supplement — day and night.”

 

Zicam Daily Immune Support* is available in a Citrus Strawberry flavor and Zicam Sleep + Immune Support* with Melatonin is available in a Blackberry Lavender flavor. The daily supplements can be found online and select retailers nationwide, in July 2022, with an MSRP of $16.49.

 

To learn more about Zicam’s products, visit www.zicam.com.

 

About Zicam®

Zicam® is America’s #1 cold-shortening brand† and offers a range of over-the-counter products to shorten colds when taken at the first sign. Zicam delivers a portfolio of homeopathic zinc-based and nasal non-zinc based cold shortening formulas as well as products ranging across multiple categories including nasal health, congestion/sinus relief, immune support, and allergy relief products. With a variety of forms, Zicam is easy to take on the go – allowing consumers to feel equipped to take on any common cold that might come their way.

 

About Church & Dwight Co., Inc.

With a rich heritage of commitment to people and the planet for over 150 years, Church & Dwight is committed to conducting our operations in a sustainable and environmentally responsible manner using recycled materials in our cartons. We are continually assessing the impacts of our operations on the environment while developing, manufacturing, and marketing a broad range of consumer household, personal care and specialty products with sustainability efforts incorporated into our new product innovation including Arm & Hammer™, Xtra™, Trojan™, Oxiclean™, Waterpik™, Orajel™, Kaboom™, Nair™, Viviscal™, Flawless™, Toppik™, Zicam™, Batiste™, Replens™, RepHresh™ and First Response™.

 

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

† Based on unit sales data, IRI Total US Multi-Outlet, latest 52 weeks-ending 5/29/22.

Contacts

Cristina DiCocco

646.964.4446

cristina@gcomworks.com

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Business Healthcare Science

Rite Aid and Quest Diagnostics expand access to COVID-19 PCR testing nationwide

Testing available at no out-of-pocket cost for qualified insured individuals at Rite Aid drive-thru locations with appointment; at all other Rite Aid locations customers can schedule to pick up at-home specimen collection kits for PCR testing

 

PHILADELPHIA & SECAUCUS, N.J. — (BUSINESS WIRE) — Rite Aid (NYSE: RAD) today announced it is collaborating with Quest Diagnostics (NYSE: DGX) to provide access to quality, COVID-19 molecular testing (polymerase chain reaction or similar nucleic acid amplification test) to help Rite Aid customers detect and prevent the spread of COVID-19.

Quest is the world’s leading provider of diagnostic information services and a national leader in COVID-19 testing. The company has performed more than 69 million COVID-19 molecular tests since March 2020.

 

Through the collaboration, Rite Aid and Bartell Drugs’ more than 2,350 stores, now offer access to Quest PCR testing, either through their drive-thru locations or the addition of at home specimen testing kits from stores without drive-thrus, doubling the access to PCR testing for adults and children over 2 years old. Both options require an appointment be made through the Quest website. Quest Diagnostics will provide results electronically to individuals through the MyQuest online portal and app.

 

Customers can schedule to pick up a COVID-19 PCR testing kit with at-home specimen collection or schedule observed drive-thru collection at https://www.riteaid.com/pharmacy/services/covid-19-testing where they will be directed to request a test through Quest’s consumer-initiated test platform QuestDirect™. Bartell Drugs customers may visit bartelldrugs.com/covid19-testing. Quest’s kits come with a prepaid FedEx envelope for overnight shipping to a Quest laboratory. Currently, the average time for Quest Diagnostics to provide a test result is one to two days. Result turnaround times can fluctuate with demand levels and vary by region and other factors.

 

“As new variants spread throughout our communities, testing remains a critical tool as we continue to support our communities in the fight against COVID-19,” said Karen Staniforth, Chief Pharmacy Officer at Rite Aid. “Identifying COVID-19 infection helps individuals obtain the treatment they need while helping to prevent further spread of the disease. We are proud to collaborate with Quest to make testing easily accessible for our customers by expanding to all of our stores.”

 

“As people continue to navigate the COVID-19 pandemic, individuals and families need access to convenient, affordable and quality diagnostic testing in order to engage in activities more safely and responsibly,” adds Cathy Doherty, Senior Vice President, Regional Businesses, Quest Diagnostics. “PCR and other molecular diagnostic tests are the gold-standard for reliable COVID-19 testing. Our relationship with Rite Aid will extend our delivery of COVID-19 testing to more communities in the United States.”

 

PCR and other nucleic acid amplification tests are molecular diagnostic testing technologies. Unlike at-home antigen tests, they are performed in a laboratory. According to the CDC, NAAT is the gold standard for detection of SARS-CoV-2, and they may be useful in some cases in confirming an antigen test result. Customers should discuss their test results with their doctor.

 

In addition to the molecular tests, Rite Aid locations continue to provide rapid, over-the-counter at-home antigen COVID-19 test kits for customers. For more information on Rite Aid’s COVID-19 test options, visit riteaid.com. Rite Aid also continues to provide COVID-19 vaccines and boosters to eligible customers. Customers can schedule a COVID-19 vaccine by visiting: https://www.riteaid.com/pharmacy/scheduler.

All Rite Aid locations are able to dispense the oral medications, Paxlovid, and Lagevrio (molnupiravir), for treatment of COVID-19.

 

For the latest information on Quest’s COVID-19 testing efforts, visit Quest Diagnostics Newsroom – News Releases.

 

About Rite Aid Corporation

Rite Aid is a full-service pharmacy that improves health outcomes. Rite Aid is defining the modern pharmacy by meeting customer needs with a wide range of vehicles that offer convenience, including retail and delivery pharmacy, as well as services offered through our wholly owned subsidiaries, Elixir, Bartell Drugs and Health Dialog. Elixir, Rite Aid’s pharmacy benefits and services company, consists of accredited mail and specialty pharmacies, prescription discount programs and an industry leading adjudication platform to offer superior member experience and cost savings. Health Dialog provides healthcare coaching and disease management services via live online and phone health services. Regional chain Bartell Drugs has supported the health and wellness needs in the Seattle area for more than 130 years. Rite Aid employs more than 6,300 pharmacists and operates more than 2,350 retail pharmacy locations across 17 states. For more information, visit www.riteaid.com.

 

About Quest Diagnostics

Quest Diagnostics empowers people to take action to improve health outcomes. Derived from the world’s largest database of clinical lab results, Quest’s diagnostic insights reveal new avenues to identify and treat disease, inspire healthy behaviors, and improve health care management. Quest Diagnostics annually serves one in three adult Americans and half the physicians and hospitals in the United States, and our nearly 50,000 employees understand that, in the right hands and with the right context, our diagnostic insights can inspire actions that transform lives. www.QuestDiagnostics.com

Contacts

MEDIA:
Terri Hickey

717-975-5718

press@riteaid.com

Kim Gorode

mediacontact@questdiagnostics.com

Categories
Business Healthcare Science

Q2 update by PQE Group: Two acquisitions’ announcements with United Pharma Technologies Inc. & Quintian Pharma, and new two offices

FLORENCE, Italy — (BUSINESS WIRE) — #GPTWcertified–The first half of 2022 has closed highly positively for PQE Group, the global women-owned quality consulting company for Lifesciences. The Italian parent Group, after having concluded 2021 with + 20% increase in revenues, confirms its development plan with the announcement of two acquisitions and a new legal entity in Melbourne (Australia) and a new office in Buenos Aires (Argentina).


As stated at the beginning of 2022, most of the global staff development plan has been implemented with almost 400 new hires around the world, 200 of which are located in Italy or the US, followed by the PQE Group Mexican Affiliate.

 

With a strong focus on the United States and Latin America, the company managed by Gilda D’Incerti has started the acquisition process of two firms, announcing the affiliation of United Pharma Technologies Inc., a service company based in New Jersey, and Quintian Pharma, based in Malta.

 

The M&A model of the company embraces the concept of a Federation rather than a classic acquisition, which aims to exchange shares with different entities in local markets all over the world to create close knit alliances, allowing to scale up projects’ staff and capabilities faster and more efficiently.

 

“In our unique and different approach to M&A activities, we aim to engage with entrepreneurs and not just companies, bringing business development ideas to the table and acting as a whole organization by sharing the same vision, mission and network.” – Danilo Neri, Vice President Executive and Board Equity Partner at PQE Group.

 

Quintian Pharma, administered by Claude Vella Bonanno, is committed to providing services and support to the pharmaceutical industry, following all EU directives on new products. PQE Group will join the Board as main shareholder (51%) and support the strategic growth of the consulting agency specialized in applying EU Pharmacovigilance standards to clients in the Middle East.

 

United Pharma Technologies Inc., a service agency based in New Jersey – USA, was founded in 2014 and is currently managed by Vasantha Madasu, who will join PQE Group as a local partner in the US and Mexican affiliates and has been named Chief Talent Officer for the Americas.

 

Contacts

PQE Group – Press Office

+39 3491512075 | pressoffice@pqegroup.com

Categories
Business Science

Johnson & Johnson announces quarterly dividend for third quarter 2022

NEW BRUNSWICK, N.J. — (BUSINESS WIRE) — Johnson & Johnson today announced that its Board of Directors has declared a cash dividend for the third quarter of 2022 of $1.13 per share on the company’s common stock. The dividend is payable on September 6, 2022 to shareholders of record at the close of business on August 23, 2022. The ex-dividend date is August 22, 2022.

About Johnson & Johnson

At Johnson & Johnson, we believe good health is the foundation of vibrant lives, thriving communities and forward progress. That’s why for more than 130 years, we have aimed to keep people well at every age and every stage of life. Today, as the world’s largest and most broadly-based health care company, we are committed to using our reach and size for good. We strive to improve access and affordability, create healthier communities, and put a healthy mind, body and environment within reach of everyone, everywhere. We are blending our heart, science and ingenuity to profoundly change the trajectory of health for humanity.

 

Contacts

Press:
Jake Sargent

jsargen3@ITS.JNJ.com

Investors:
Jessica Moore

jmoore29@its.jnj.com

Sarah Wood

swood15@its.jnj.com

Categories
Business Healthcare Science

Iveric Bio announces post-hoc analysis from GATHER1 clinical trial of Zimura® at American Society of Retina Specialists meeting

PARSIPPANY, N.J. — (BUSINESS WIRE) — IVERIC bio, Inc. (Nasdaq: ISEE) recently announced that in a post-hoc analysis from the GATHER1 clinical trial, Zimura showed a reduction of geographic atrophy lesion growth, compared to sham, across all distances from the foveal center point. The analysis was presented by David R. Lally, MD, Director of Retina Research Institute at New England Retina Consultants, at the American Society of Retina Specialists Annual Meeting in New York, New York.


“The vast majority of patients in GATHER1 had GA lesions within the area that clinicians are most concerned about protecting,” said Dr. Lally. “As a result, the potential benefit of Zimura across a broad cross-section of GA patients was observed.”

 

“The multiple post-hoc analyses from GATHER1 continue to provide consistent results, which give us a great deal of confidence in the robustness of the GATHER1 data and the potential of Zimura as a treatment to help a broad patient population with GA,” stated Dhaval Desai, PharmD, Chief Development Officer of Iveric Bio.

 

The analysis reported that approximately 84% of patients had lesions within 500 microns of the foveal center point at baseline and that approximately 28% of patients had lesions within 100 microns of the foveal center point at baseline. These findings were generally balanced across all treatment arms and their corresponding sham control groups in the trial. The accompanying graphs summarize the results of this post-hoc analysis.

 

The most frequently reported ocular adverse events were related to the injection procedure. There were no drug related adverse events such as inflammation or endophthalmitis reported in GATHER1. No additional safety analysis was performed as part of this post-hoc analysis.

 

The full set of slides of the presentation is available on the Company’s website at https://investors.ivericbio.com/events-and-presentation.

 

About GATHER1 and GATHER2

The Company previously announced that in GATHER1, Zimura (avacincaptad pegol) met its pre-specified primary efficacy endpoint with statistical significance. The most frequently reported ocular adverse events in this trial were related to the injection procedure. The Company expects topline data for GATHER2, a second Phase 3 clinical trial for Zimura for GA, to be available in the third quarter of 2022, approximately one year after the enrollment of the last patient in the trial plus the time needed for database lock and analysis. If 12-month results from GATHER2 are positive, the Company plans to submit applications with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) for marketing approval of Zimura for GA. There are no FDA or EMA approved treatments available for patients with GA.

 

About Zimura

Zimura (avacincaptad pegol) is an investigational drug product and has not been approved for use anywhere globally. Zimura is designed to target and inhibit the cleavage of complement protein C5 and the formation of its downstream fragments, C5a and C5b. By inhibiting the formation of these fragments, Zimura is believed to decrease or slow the chronic inflammation and cell death associated with the retinal aging process by decreasing the formation of membrane attack complex (MAC) and inflammasome activity, thereby potentially avoiding or slowing the degeneration of retinal pigment epithelial cells. This potential mechanism is the rationale for Zimura as a potential therapy for geographic atrophy.

 

About Iveric Bio

Iveric Bio is a science-driven biopharmaceutical company focused on the discovery and development of novel treatments for retinal diseases with significant unmet medical needs. The Company is committed to having a positive impact on patients’ lives by delivering high-quality, safe and effective treatments designed to address debilitating retinal diseases including earlier stages of age-related macular degeneration. For more information on the Company, please visit www.ivericbio.com.

 

Forward-looking Statements

Any statements in this press release about Iveric Bio’s future expectations, plans and prospects constitute forward-looking statements for purposes of the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. Forward-looking statements include any statements about the Company’s strategy, future operations and future expectations and plans and prospects for the Company, and any other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “seek,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions. In this press release, the Company’s forward looking statements include statements about its expectations regarding its development and regulatory strategy for Zimura, including the timing of receipt of topline data from the GATHER2 clinical trial and its plans to file for marketing approval for geographic atrophy if the results of GATHER2 are positive, the potential utility of Zimura and the clinical meaningfulness of clinical trial results and data, including from post-hoc analyses of the GATHER1 clinical trial. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s development programs, future results, performance, or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the progress and success of research and development programs and clinical trials, developments from the scientific and medical community and other factors discussed in the “Risk Factors” section contained in the quarterly and annual reports that the Company files with the Securities and Exchange Commission. Any forward-looking statements represent the Company’s views only as of the date of this press release. The Company anticipates that subsequent events and developments may cause its views to change. While the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so except as required by law.

ISEE-G

Contacts

Investors:
Kathy Galante

Senior Vice President, Investor Relations

kathy.galante@ivericbio.com

or

Media:
Jeannie Neufeld

Senior Director, Public Relations & Communications

jeannie.neufeld@ivericbio.com

Categories
Healthcare Local News Science

Orcosa appoints Andrew C. von Eschenbach, M.D. and former commissioner of the FDA, as Senior Advisor

EWING, N.J. — (BUSINESS WIRE) — Orcosa Inc. (“Orcosa” or the “Company”), a clinical-stage life sciences company improving patient outcomes through its next generation drug delivery technology – the Rapid Infusion Technology (RITe™) Platform – today announced the appointment of Dr. Andrew C. von Eschenbach, former Commissioner of the U.S. Food and Drug Administration (“FDA”) as Senior Advisor. In his role, Dr. von Eschenbach will provide strategic counsel on regulatory and public affairs, clinical trial development, and other corporate matters.

“We are honored and privileged to have Dr. von Eschenbach join our team as Senior Advisor,” said Bryan Ridall, President of Orcosa. “His commitment to improving public health, and his uniquely complete understanding of patients’ needs, and the dynamics of biopharmaceutical research and development are an invaluable complement to our leadership team. We are grateful for his support as we continue to execute on our long-term strategy.”

 

Dr. von Eschenbach said, “As a physician and former FDA Commissioner, I was immediately impressed with Orcosa’s innovative drug delivery platform and thoughtful approach to clinical development and collaboration. The company’s RITe platform is already demonstrating how it has incredible potential to improve patient outcomes across a range of therapeutic areas – including most critically, in pain management to help reduce opioid usage. I am excited to be part of the Orcosa team, particularly at such a pivotal time in the company’s growth story.”

 

Dr. von Eschenbach is widely recognized as a leading physician, surgeon, oncologist, and executive, and served as Commissioner of the FDA from 2006 to 2009, after being appointed Acting Commissioner in 2005. In that role, he developed and oversaw the FDA’s Critical Path Initiative which aimed at improving the regulatory pathway for drugs and medical devices. Dr. von Eschenbach joined FDA after serving for four years as Director of the National Cancer Institute at the National Institutes of Health, and currently serves on the Board of Directors of the Reagan-Udall Foundation for the Food and Drug Administration.

 

Dr. von Eschenbach earned a B.S. from St. Joseph’s University and his medical degree from Georgetown University School of Medicine. After completing a residency in urologic surgery at Pennsylvania Hospital in Philadelphia, he was an instructor in urology at the University of Pennsylvania School of Medicine. He completed a Fellowship in Urologic Oncology at the University of Texas M.D. Anderson Cancer Center.

 

About Orcosa Inc.

Orcosa Inc. is a life sciences company modernizing the way medicines are taken and improving patient outcomes through its proprietary therapeutic delivery technology, the Rapid Infusion Technology (RITe™) Platform. Orcosa is the inventor, developer and exclusive owner of the RITe™ Platform, a fast acting, easy-to-take tablet engineered to enhance drug absorption. Orcosa’s lead program, ORAVEXX™, is a non-addictive proprietary cannabidiol composition that utilizes the RITe™ Platform to treat pain and has the potential to provide a safe, alternative treatment option to opioids and NSAIDs. The company is currently supporting clinical trials at leading American research institutions to evaluate the safety and effectiveness of ORAVEXX™ for pain management. For more information on Orcosa, please visit https://www.orcosa.com.

 

Forward-Looking Statements

Certain statements made herein constitute “forward-looking statements”. These forward-looking statements include, but are not limited to, the development of ORAVEXX™ and the RITe™ Platform. These statements are based on the current expectations of Orcosa and are not predictions of actual performance. Such forward-looking statements involve risks, uncertainties and other factors, which may cause the actual results, performance or achievements of Orcosa to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

Contacts

Devin Broda

FGS Global

Devin.Broda@fgsglobal.com
212-687-8080

Investor

IR@orcosa.com

Categories
Business Healthcare Science

Samsara Vision announces first U.S. surgeries of the SING IMT™ (Smaller-Incision New-Generation Implantable Miniature Telescope), for age-related macular degeneration as part of the CONCERTO study

FAR HILLS, N.J. — (BUSINESS WIRE) — #AMD—Samsara Vision, a company focused on bringing vision and freedom back to patients with late-stage, age-related macular degeneration (AMD) through advanced visual prosthetic devices, today announced the completion of the first U.S. surgeries of its SING IMT™ (Smaller-Incision New-Generation Implantable Miniature Telescope), as part of the CONCERTO clinical study, a U.S.-based Food and Drug Administration (FDA) study to evaluate improvements in visual acuity and safety of the device in people living with late-stage AMD. David RP Almeida, MD, MBA, PhD, from Erie Retinal Surgery (PA), and Marc H. Levy, MD, from the Sarasota Retina Institute (FL), performed the first procedures using the SING IMT™ in late June.


“The SING IMT™ procedure represents a potential technological leap forward and the surgery, using the pre-loaded delivery system, allowed for not only a smaller corneal incision, but also a consistent and predictable insertion of the device,” said Dr. Levy.

 

The CONCERTO trial will recruit 100 adults aged 65 and older living with stable (non-active neovascularization), bilateral central scotomas (blind spots) due to late-stage AMD and fovea-involving geographic atrophy or disciform scar to receive a SING IMT™ in one eye. In addition, candidates cannot have had previous cataract surgery in the study eye and must agree to post-operative comprehensive visual rehabilitation and training.

 

Dr. Almeida added, “The surgery went well. I’m pleased that the SING IMT™ telescopic micro-optical device allows for ease of insertion and centration. It’s wonderful to see the excitement of eligible phakic patients with severe vision loss and – as these patients adapt and learn to use their new vision during visual rehabilitation – I believe we will see a significant interest and demand for this important intervention.”

 

“It’s highly encouraging that our first surgeries went smoothly. We look forward to working with the eye health community across the country during the CONCERTO study. Our goal is to bring our new technology to people blinded by late-stage AMD across the United States,” said Thomas Ruggia, Chief Executive Officer at Samsara Vision. “We intend to work closely with the FDA to determine a timely pathway to bring the SING IMT™ to market in the United States.”

 

SING IMT™

The SING IMT™ is a Galilean-style telescope implant designed to improve visual acuity and quality of life for patients with late-stage AMD. It is implanted during typical, out-patient cataract surgery with a corneal incision range between 6.5 mm to 7.5 mm. Images seen in “straight-ahead” vision are magnified 2.7x and projected onto healthy, undamaged areas of the macula in the back of the eye, reducing the apparent impact of the AMD “blind spot” on central vision.

 

To learn more about the CONCERTO study, visit www.concertostudy.com.

 

Unmet Treatment Needs in Age-Related AMD

Age-related macular degeneration (AMD) is a leading cause of permanent vision loss for people age 50 and older, and the number one cause of blindness in people age 65 years and older. As many as 11 million Americans are affected by some form of macular degeneration and this number will increase to 22 million by 2050. Nearly 2 million Americans have advanced forms of AMD with associated vision loss. While treatments exist to try to slow the progression of AMD, and there are assistive devices that can help people with reduced vision see better with magnification or more light, many patients will progress in their disease. There is no cure for late-stage AMD. The SING IMT™ is approved for late-stage AMD patients who are 55 years of age or older in CE Referenced Countries, but it is not currently FDA approved in the United States.

 

The SING IMT™ is not a cure for late-stage AMD. It will not return vision to the level a patient had before AMD, nor will it completely make up for vision loss. The most common risks of the SING IMT™ surgery include inflammatory deposits or precipitates on the device and increased intraocular pressure. Significant adverse events include corneal edema, vision-impairing corneal edema, corneal transplant, and decrease in visual acuity. There is a risk that having the telescope implantation surgery could worsen your vision rather than improve it. Individual results may vary.

 

About Samsara Vision

Samsara Vision is a privately held specialty medical device company headquartered in the United States and engaged in the research, development, manufacture, and marketing of proprietary implantable ophthalmic devices and technologies that are intended to significantly improve vision and quality of life for individuals with untreatable retinal disorders. We believe that rejuvenating eyesight revives the spirit, allowing people to reconnect to the things in life that they love to see and do. Our approach includes working collaboratively with health care providers, researchers, payers, and advocates to ensure that people living with deteriorating vision have access to our novel technologies and support paths thereby better ensuring a future where they can see anew. Learn more at https://www.samsaravision.com

 

Safe Harbor Statement

This press release contains express or implied forward-looking statements pursuant to U.S. Federal securities laws. Forward-looking statements include those about the potential benefits to be derived from the SING IMT™ and the intent to work closely with the FDA to determine a timely pathway to bring the SING IMT™ to market in the United States and the belief that rejuvenating eyesight revives the spirit, allowing people to reconnect to the things in life that they love to see and do. These forward-looking statements and their implications are based on the current expectations of the management of Samsara only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: claims by other companies and persons regarding ownership over intellectual property; changes in technology and market requirements; Samsara may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Samsara’s products may not be approved by regulatory agencies, Samsara’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Samsara may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Samsara’s process; Samsara’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Samsara’s patents may not be sufficient; Samsara’s products may harm recipients; changes in legislation may adversely impact Samsara; inability to timely develop and introduce new technologies, products and applications; the risk factors and uncertainties described in the Registration Statement on Form S-1, as amended (File No. 333-260742) filed with the U.S. Securities and Exchange Commission; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Samsara to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Samsara undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

 

Contacts

Media Contact:
Jessica Daitch

Jessica L. Daitch Communications LLC

For Samsara Vision

917-816-6712

jessicadaitch@hotmail.com

Categories
Healthcare International & World Local News Science

Dr. Reddy’s Laboratories announces the launch of Fesoterodine Fumarate extended-release tablets in the U.S. market

HYDERABAD, India &PRINCETON, N.J. — (BUSINESS WIRE) — $RDY #DRREDDY–Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) announces the launch of Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets, a therapeutic generic equivalent to Toviaz® (fesoterodine fumarate) Extended-Release Tablets in the U.S. market following the approval by the U.S. Food and Drug Administration (USFDA).

The Toviaz® brand had U.S. sales of approximately $211 million MAT for the most recent twelve months ending in May 2022 according to IQVIA.

 

Dr. Reddy’s Fesoterodine Fumarate Extended-Release Tablets are available in 4 mg and 8 mg Tablets, each in bottle count sizes of 30.

 

Please click here to see the full prescribing information: https://www.drreddys.com/pil/pi_fesoterodine-fumarate-er-oral-tablet-extended-release-24-hour.pdf.

 

Toviaz is a trademark of Pfizer Inc.

RDY-0622-424

 

About Dr. Reddy’s: Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY) is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. For more information, log on to: www.drreddys.com

 

Disclaimer: This press release may include statements of future expectations and other forward-looking statements that are based on the management’s current views and assumptions and involve known or unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements. In addition to statements which are forward-looking by reason of context, the words “may”, “will”, “should”, “expects”, “plans”, “intends”, “anticipates”, “believes”, “estimates”, “predicts”, “potential”, or “continue” and similar expressions identify forward-looking statements. Actual results, performance or events may differ materially from those in such statements due to without limitation, (i) general economic conditions such as performance of financial markets, credit defaults , currency exchange rates, interest rates, persistency levels and frequency / severity of insured loss events, (ii) mortality and morbidity levels and trends, (iii) changing levels of competition and general competitive factors, (iv) changes in laws and regulations and in the policies of central banks and/or governments, (v) the impact of acquisitions or reorganization, including related integration issues, and (vi) the susceptibility of our industry and the markets addressed by our, and our customers’, products and services to economic downturns as a result of natural disasters, epidemics, pandemics or other widespread illness, including coronavirus (or COVID-19), and (vii) other risks and uncertainties identified in our public filings with the Securities and Exchange Commission, including those listed under the “Risk Factors” and “Forward-Looking Statements” sections of our Annual Report on Form 20-F for the year ended March 31, 2022. The company assumes no obligation to update any information contained herein.

Contacts

INVESTOR RELATIONS
AMIT AGARWAL

amita@drreddys.com

MEDIA RELATIONS
USHA IYER

USHAIYER@DRREDDYS.COM