September 17, 2021

Virgin Pulse Delivers Vaccination Management Solutions to Help Organizations Address and Adhere to New COVID-19 Mandates

Digital Vaccination Card

Employees can easily and securely enter their vaccination information and upload photo of vaccination card. Also allows employees to digitally carry their digital vaccination card at work or elsewhere.

PROVIDENCE. R.I., Sept. 17, 2021 (GLOBE NEWSWIRE) — In response to the Biden Administration’s recent COVID-19 Action Plan rules and international vaccine regulations and mandates, Virgin Pulse, the leading global provider of tech-enabled health, wellbeing and safety solutions, today announced that it has released new Vaccination Management and Mandate Compliance solutions to help organizations around the world meet evolving mandates and timelines and ensure the ongoing health and wellbeing of their workforce. Available October 4 as part of Virgin Pulse’s VP Passport™ workplace suite, these new capabilities provide real-time reporting, vaccination and testing status, symptom monitoring and next steps guidance so organizations can effectively navigate the ever-changing path of the COVID-19 pandemic.

Real-Time Visibility Dashboards

Employee-specific real-time vaccination information allows employers to make informed data-driven decisions: displays COVID-19 vaccination status, enables filtering by status, supports report exporting and so much more.

“Over the past 17 years, thousands of organizations around the world have trusted Virgin Pulse to protect and ensure the health, wellbeing and safety of their workforces today and in the future,” said Chris Michalak, CEO of Virgin Pulse. “This is a responsibility we are proud to embrace and one that requires us to deliver on our clients’ current requirements while anticipating their future needs which, as we have seen over the past 18 months, are not always linear or predictable. We launched VP Passport in less than 30 days to support organizations in ensuring a safe return to the workplace for their employees. Today, we have the opportunity to direct our expertise and innovation to help organizations clear yet another hurdle as they navigate the challenges of this pandemic.”

Given the fluid nature of these mandates, employers need a solution that meets today’s requirements and is future-proofed for the resurgence of COVID-19 cases. VP Passport equips employers with real-time visibility to vaccination and testing trends and access to intelligence necessary to make informed decisions about the health and safety of their workers in response to their current population health situation.

With VP Passport, employees can now answer a short survey related to vaccination and recent COVID-19 viral tests. These are securely stored within the Virgin Pulse platform where an uploaded digital copy of their vaccination record card is easily accessible for display. Upon request, an employee can display a badge reflecting their vaccination and/or testing status.

To help organizations adhere to the latest vaccination requirements and timelines and alleviate the increased organizational burden these mandates introduce, Virgin Pulse’s Vaccination Management and Mandate Compliance solutions provide:

Real-Time Visibility
A comprehensive dashboard with employee vaccination and testing status enables employers to manage risk and adhere to mandates at scale – whether they have 100 or 100,000 employees. A real-time view with a broad set of filters streamlines staying on top of complex and ever-changing policies. Employers can leverage the data to inform their path to compliance.
Digital Vaccination Card
Employees can self-report and securely store and digitally carry their vaccination card in their Virgin Pulse app for easy verification of vaccination status – at work or elsewhere. Employers can view the vaccination card in their dashboard for digital verification.
At-Home Testing Kits
Employers can make at home testing kits available for their population through Virgin Pulse to address those that need to test prior to coming to the workplace.
Next-Step Communication
Based on employee vaccination or testing status, employers can configure their specific guidance and next steps into the application to ensure effective communication and awareness of policies.

Customizable Vaccination Status Badge

A fully configurable badge that streamlines return to workplace by reflecting vaccination and/or testing status as well as helpful next steps guidance.

Availability
Virgin Pulse’s new vaccination management capabilities are delivered through Virgin Pulse’s VP Passport solution, which is available stand alone or integrated into Virgin Pulse’s Homebase for Health^® platform. Current VP Passport clients will have access to these new features on October 4. For global clients, VP Passport is customizable to meet location and population specific mandates. For more information about VP Passport, visit https://community.virginpulse.com/virgin-pulse-vaccination-management-and-compliance-solution-for-employers

About Virgin Pulse
Virgin Pulse is the global leader and premier provider of digital health, wellbeing and safety solutions focused on helping users make the best decisions about their health at all stages of their health and wellbeing journey and reducing healthcare costs and. Featuring the industry’s only true Homebase for Health^® that unifies and simplifies the health journey, Virgin Pulse fuses high-tech, high-touch, predictive analytics, AI and data to support clients and members across the entire health, wellbeing and benefits lifecycle—from screening and risk assessment to activation, behavior change and the adoption of sustainable, healthy habits to benefits navigation, condition management, gaps in care closure and digital therapeutics guidance. Today, 14 million+ users in more than 190 countries rely on Virgin Pulse’s digital and live solutions to change their lives—and businesses—for good. To learn more, visit VirginPulse.com and follow us on Twitter or LinkedIn.

Media Inquiries, please contact: Press@virginpulse.com

A video accompanying this announcement is available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/4de90b55-4493-49fb-b020-68242e2be132

Photos accompanying this announcement are available at

https://www.globenewswire.com/NewsRoom/AttachmentNg/2a895b0c-2c22-4777-9754-c264c219e31b

https://www.globenewswire.com/NewsRoom/AttachmentNg/e144f6e9-6176-459f-81d9-1f0e5b7556e7

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September 17, 2021

Junshi Biosciences and Coherus to Present Positive Progression Free Survival and Overall Survival Results from JUPITER-06, a Phase 3 Clinical Trial Evaluating Toripalimab in Combination with Chemotherapy as First-Line Treatment for Advanced Esophageal Squamous Cell Carcinoma

– Interim results to be presented September 17 at the European Society for Medical Oncology (ESMO) Congress 2021 –

– Data support the use of toripalimab with chemotherapy as first-line therapy for patients with ESCC –

– Coherus and Junshi Biosciences plan to submit a BLA supplement for 1L ESCC in 2022 –

SHANGHAI, China, and REDWOOD CITY, Calif., Sept. 16, 2021 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd. (“Junshi Biosciences”, HKEX: 1877; SSE: 688180) and Coherus BioSciences, Inc. (“Coherus”, Nasdaq: CHRS) today announced positive interim results from the pivotal study “JUPITER-06” (NCT03829969), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with chemotherapy as a first-line therapy for patients with advanced or metastatic esophageal squamous cell carcinoma (ESCC). The study met the co-primary endpoints with statistically significant and clinically meaningful improvements in progression free survival (PFS) and overall survival (OS) for patients treated with the toripalimab and chemotherapy combination compared to chemotherapy alone.

The results will be summarized by Dr. Feng Wang, Professor at Sun Yat-sen University Cancer Center (SYUCC), Guangzhou, in a mini-oral session during the ESMO Congress 2021 on Friday, September 17, 2021 at 12:05 pm Eastern Time. The abstract (# 1373MO) is now available on the ESMO website.

“The findings of this interim analysis provide strong evidence that the addition of toripalimab to chemotherapy as a first-line treatment for advanced or metastatic ESCC patients has superior PFS and OS than chemotherapy alone,” said Dr. Wang. “We look forward to updated analyses of overall survival of the JUPITER-06 study in the future and believe that these results will build a strong argument to support the use of toripalimab in combination with chemotherapy as a new standard first-line treatment in patients with advanced or metastatic ESCC.”

“A strong and consistent efficacy and safety profile is emerging for toripalimab across multiple tumor types as data read out from pivotal clinical trials in melanoma, nasopharyngeal carcinoma, urothelial cancer, lung cancer and now also esophageal squamous cell carcinoma,” said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. “We believe toripalimab could be a potential new treatment choice where patients truly need better options. We will collaborate with Coherus to advance a BLA supplement for ESCC to make toripalimab available as quickly as possible for these patients in the U.S.”

“With JUPITER-06, toripalimab has once again exhibited compelling efficacy in a first-line setting,” said Denny Lanfear, CEO of Coherus. “The significant PFS and similarly robust overall survival data demonstrate that toripalimab in combination with chemotherapy could provide significant clinical benefits to patients with advanced or metastatic esophageal squamous cell carcinoma. We plan to work closely with our partner, Junshi Biosciences, to pursue a BLA supplement for this new indication expeditiously.”

About JUPITER-06
A total of 514 treatment-naive advanced or metastatic patients were randomized (1:1) to receive toripalimab or placebo in combination with paclitaxel plus cisplatin chemotherapy followed by toripalimab or placebo maintenance. The primary endpoints were PFS as assessed by a blinded independent central review (BICR) and overall survival (OS).

At a prespecified interim analysis on March 22, 2021, with median follow-up of 7.4 and 7.3 months in the two arms, there was a significant improvement in OS for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm (HR=0.58 [95% CI: 0.43-0.78], P=0.00037) with median OS of 17.0 vs. 11.0 months;
One-year OS rates were 66.0% vs.43.7% for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm, respectively;
A significant improvement in PFS assessed by BICR was also detected for the toripalimab-chemotherapy arm compared to the placebo-chemotherapy arm (HR=0.58 [95% CI: 0.46-0.74], P<0.00001);
The OS and PFS benefits were observed across key subgroups, including all PD-L1 expression subgroups;
The incidence of Grade ≥3 adverse events (AEs) (73.2% vs 70.0%) and fatal AEs (8.2% vs 8.2%) were similar between the two arms. No new safety signals were observed.

Junshi Biosciences and Coherus are planning in 2022 to submit a biologics license application supplement to the United States Food and Drug Adminstration for toripalimab for first-line treatment, in combination with platinum-based chemotherapy, of advanced or metastatic ESCC. In China, the supplemental New Drug Application of this indication has been accepted by the National Medical Products Administration (NMPA) in July, 2021.

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 is thought to recharge the immune system’s ability to attack and kill tumor cells. More than thirty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally, including in China and the United States. Ongoing or completed pivotal clinical trials are evaluating the efficacy and safety of toripalimab for a broad range of tumor types including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney and skin.

In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI^®). On December 17, 2018, toripalimab was granted a conditional approval from the National Medical Products Administration (NMPA) for the second-line treatment of unresectable or metastatic melanoma. In December 2020, toripalimab was successfully included in the updated National Reimbursement Drug List. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy. In April, NMPA granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. In addition, two supplemental NDAs for toripalimab in combination with chemotherapy for the first-line treatment of patients with advanced, recurrent or metastatic NPC or for the first-line treatment of patients with advanced, or metastatic esophageal squamous cell carcinoma were accepted by the NMPA for review in February and July 2021 respectively.

In the United States, the first toripalimab BLA has been submitted to the FDA for the treatment of recurrent or metastatic NPC. The FDA has granted Breakthrough Therapy designation for toripalimab in combination with chemotherapy for the 1st line treatment of recurrent or metastatic NPC and also for toripalimab monotherapy in second or third line treatment of recurrent or metastatic NPC. There are currently no PD-1 blocking antibodies approved for use in NPC in the United States. Additionally, FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and orphan drug designations for NPC, mucosal melanoma and soft tissue sarcoma. Earlier in 2021 Coherus in-licensed rights to develop and commercialize toripalimab in the United States and Canada. Coherus and Junshi Biosciences plan to file additional toripalimab BLAs with the FDA over the next three years for multiple rare cancers and highly prevalent cancers.

About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HKEX: 1877; SSE: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 44 drug candidates, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurological, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company that obtained marketing approval for an anti-PD-1 monoclonal antibody in China. Its first-in-human anti-BTLA antibody for solid tumors was the first in the world to be approved for clinical trials by the FDA and NMPA, and its anti-PCSK9 monoclonal antibody was the first in China to be approved for clinical trials by the NMPA. In early 2020, Junshi Biosciences joined forces with the Institute of Microbiology of Chinese Academy of Science and Eli Lilly to co-develop JS016 (etesevimab), China’s first fully human neutralizing monoclonal antibody against SARS-CoV-2. JS016 administered with bamlanivimab has been granted Emergency Use Authorizations (EUA) in more than 12 countries and regions worldwide. The JS016 program is a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has over 2,500 employees in the United States (San Francisco and Maryland) and China (Shanghai, Suzhou, Beijing and Guangzhou). For more information, please visit: http://junshipharma.com.

About Coherus BioSciences
Coherus is a commercial stage biopharmaceutical company with the mission to increase access to cost-effective medicines that can have a major impact on patients’ lives and to deliver significant savings to the health care system. Coherus’ strategy is to build a leading immuno-oncology franchise funded with cash generated by its commercial biosimilar business. For additional information, please visit www.coherus.com.

Coherus markets UDENYCA® (pegfilgrastim-cbqv) in the United States and through 2023 expects to launch toripalimab, an anti-PD-1 antibody, as well as biosimilars of Lucentis®, Humira®, and Avastin®, if approved.

UDENYCA® is a trademark of Coherus BioSciences, Inc.

Avastin® and Lucentis® are registered trademarks of Genentech, Inc.

Humira® is a registered trademark of AbbVie Inc.

Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, Coherus’ ability to generate cash flow from its UDENYCA® business; Coherus’ and Junshi Biosciences’ ability to co-develop toripalimab, and Coherus’ ability to commercialize toripalimab, or any other drug candidates developed as part of its collaboration with Junshi Biosciences in the licensed territory; Coherus’ ability to expand a late-stage pipeline into the rapidly growing checkpoint inhibitor market; any market size expectation for checkpoint inhibitor therapeutic agents in the United States; the potential for Coherus and Junshi to file a BLA in the United States for toripalimab for ESCC in 2022; the potential for Coherus and Junshi to file additional BLAs in the United States for toripalimab over the next three years for multiple rare cancers and highly prevalent cancers; the potential for toripalimab to gain approval in the United States for nasopharyngeal carcinoma, lung cancer, esophageal squamous cell carcinoma, or any indication; Coherus’ plans to invest the cash generated by its biosimilar commercial business to build a focused immuno-oncology franchise; Coherus’ ability to prepare for projected launches through 2023 of biosimilars of Humira®, Avastin® and Lucentis®, if approved.

Such forward-looking statements involve substantial risks and uncertainties that could cause Coherus’ actual results, performance or achievements to differ significantly from any future results, performance or achievements expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the risks and uncertainties inherent in the clinical drug development process; the risks and uncertainties of the regulatory approval process, including the timing of Coherus’ regulatory filings; the risk that Coherus is unable to complete commercial transactions and other matters that could affect the availability or commercial potential of Coherus’ drug candidates; and the risks and uncertainties of possible patent litigation. All forward-looking statements contained in this press release speak only as of the date on which they were made. Coherus undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Coherus’ business in general, see Coherus’ Annual Report on Form 10-K for the year ended December 31, 2020, filed with the Securities and Exchange Commission on February 25, 2021,its Quarterly Report on Form 10-Q for the three and six months ended June 30, 2021, filed with the Securities and Exchange Commission on August 5, 2021

and its future periodic reports to be filed with the Securities and Exchange Commission. Results for the quarter ended June 30, 2021 are not necessarily indicative of our operating results for any future periods.

Junshi Biosciences Contact Information
IR Team:
Junshi Biosciences
info@junshipharma.com
+ 86 021-2250 0300

Solebury Trout
Bob Ai
bai@soleburytrout.com
+ 1 646-389-6658

PR Team:
Junshi Biosciences
Zhi Li
zhi_li@junshipharma.com
+ 86 021-6105 8800

Coherus Contact Information:
IR Contact:
McDavid Stilwell
Coherus BioSciences, Inc.
mstilwell@coherus.com
+1 (650) 395-0152

Media Contact:
Sheryl Seapy
Real Chemistry
sseapy@realchemistry.com
+1 (949) 903-4750

September 17, 2021

Align Technology Introduces First Professional Whitening System Optimized for Invisalign Aligners and Vivera Retainers Powered by Ultradent’s Opalescence Tooth Whitening Systems

‘Invisalign Professional Whitening System – powered by Opalescence’

New Invisalign Professional Whitening System revolutionizes teeth whitening with an all-in-one solution that enables Invisalign trained doctors to straighten and whiten teeth at the same time.

Align signs multi-year agreement with Ultradent, a leader in tooth whitening for over 30 years, to offer Invisalign trained doctors an exclusive professional whitening system with the leading Opalescence PF whitening formula
New Invisalign Professional Whitening System revolutionizes teeth whitening with an all-in-one solution that enables Invisalign trained doctors to straighten and whiten teeth at the same time

TEMPE, Ariz. and SOUTH JORDAN, Utah, Sept. 16, 2021 (GLOBE NEWSWIRE) — Align Technology, Inc. (“Align”) (Nasdaq: ALGN) a leading global medical device company that designs, manufactures, and sells the Invisalign system of clear aligners, iTero intraoral scanners, and exocad CAD/CAM software for digital orthodontics and restorative dentistry, today announced an exclusive supply and distribution agreement with Ultradent Products Inc., a leading developer and manufacturer of high-tech dental materials, devices, and instruments worldwide.

As part of the multi-year agreement, Align will offer Invisalign trained doctors an exclusive professional whitening system with the leading Opalescence PF whitening formula from Ultradent, optimized for use with Invisalign clear aligners and Vivera retainers. The system will carry the co-branded name of ‘Invisalign Professional Whitening System – powered by Opalescence’ and will offer the same great whitening outcomes and streamlined practice experience dental professionals expect from the Opalescence PF product during active tooth movement with Invisalign aligners, as well as during passive retention using Vivera retainers. The Invisalign Professional Whitening System will be commercially available globally in 2022.

“A brighter, whiter smile is an important part of the Invisalign patient journey. In fact, a survey of North American Invisalign practices (1) shows that half of their patients ask for teeth whitening during or after they complete Invisalign treatment,” said Raj Pudipeddi, Align Technology chief product and marketing officer, and SVP and managing director of the Asia Pacific Region. “We believe that by providing an all-in-one solution that combines a leading teeth-whitening system with the most advanced clear aligner system in the world, we enable Invisalign trained doctors to enhance their patients’ treatment experience with a seamless workflow that also enables practice efficiency and growth. We’re very excited to partner with Ultradent to offer the first professional whitening system optimized for use with Invisalign clear aligners and Vivera retainers. Invisalign system trained doctors can use Opalescence PF for in-office teeth whitening treatment and for doctor supervised at-home whitening.”

“We’re honored to partner with Align to make the top professional teeth whitening products available to more clinicians and patients around the world,” said Ultradent President and CEO Dirk Jeffs. “Providing Align with teeth whitening products, ideal for use with Invisalign aligners and Vivera retainers, is a considerable step toward our mission of improving oral health globally and we look forward to pursuing this mission together.”

“Many of my patients would like whiter teeth as well as a straighter smile,” said Dr. Brian Amy, an orthodontist and Align Faculty member practicing in Oklahoma City. “The new Invisalign Professional Whitening System allows me to provide both simultaneously using the brands I trust.”

“After testing this system in my practice, I can confirm that the Invisalign Professional Whitening System is easy to administer and offers a great patient experience by combining whitening with Invisalign aligners or Vivera retainers,” said Dr. Jennifer Bell, a restorative and cosmetic dentist and Align GP Advisory Board Member practicing in Holly Springs, North Carolina. “The simple ordering mechanism minimizes burden on my practice to store and manage whitening products, while providing the brighter, whiter smiles we have come to expect from the Opalescence PF product.”

Ultradent is an ISO13485 certified facility and will manufacture the products according to those standards.

(1) 2017 online survey of Invisalign doctors, data on file at Align Technology.

About Align Technology, Inc.
Align Technology designs, manufactures and offers the Invisalign system, the most advanced clear aligner system in the world, iTero intraoral scanners and services, and exocad CAD/CAM software. These technology building blocks enable enhanced digital orthodontic and restorative workflows to improve patient outcomes and practice efficiencies for over 200 thousand doctor customers and is key to accessing Align’s 500 million consumer market opportunity worldwide. Align has helped doctors treat approximately 10.9 million patients with the Invisalign system and is driving the evolution in digital dentistry through the Align Digital Platform, our integrated suite of unique, proprietary technologies and services delivered as a seamless, end-to-end solution for patients and consumers, orthodontists and GP dentists, and lab/partners. Visit www.aligntech.com for more information.

For additional information about the Invisalign system or to find an Invisalign doctor in your area, please visit www.invisalign.com. For additional information about iTero digital scanning system, please visit www.itero.com. For additional information about exocad dental CAD/CAM offerings and a list of exocad reseller partners, please visit www.exocad.com.

About Ultradent Products, Inc.
Ultradent Products, Inc., is a leading developer and manufacturer of high-tech dental materials, devices, and instruments worldwide. Ultradent’s vision is to improve oral health globally. Ultradent also works to improve the quality of life and health of individuals through financial and charitable programs. For more information about Ultradent, call 800.552.5512, visit ultradent.com or find us on LinkedIn, Facebook, and Instagram.

Forward-Looking Statements

This news release contains forward-looking statements, including the expectations for and the terms of the agreement between Align and Ultradent the availability and capabilities of the combined Invisalign aligner and Opalescence offering, our beliefs regarding the market for the combined offering and the potential benefits to doctors, their offices and patients, and other similar comments or statements that are forward-looking in nature. Forward-looking statements contained in this news release relating to expectations about future events or results are based upon information available to Align as of the date hereof. Readers are cautioned that these forward-looking statements are only predictions and are subject to risks, uncertainties, and assumptions that are difficult to predict. As a result, actual results may differ materially and adversely from those expressed in any forward-looking statement.

Factors that might cause such a difference include, but are not limited to:

the impact of the COVID-19 pandemic on the health and safety of our employees, customers, patients, and our suppliers, as well as the physical and economic impacts of the various recommendations, orders, and protocols issued by local and national governmental agencies in light of continual evolution of the pandemic, including any periodic reimplementation of preventative measures in various global locations;
difficulties predicting customer and consumer purchasing behavior and changes in consumer spending habits as a result of, among other things, prevailing economic conditions, levels of employment, salaries and wages, and consumer confidence, particularly in light of the pandemic and as pandemic-related restrictions are eased regionally and globally;
unexpected or rapid changes in the growth or decline of our domestic and/or international markets;
increasing competition from existing and new competitors;
rapidly evolving and groundbreaking advances that fundamentally alter the dental industry or the way new and existing customers market and provide products and services to consumers;
the ability to protect our intellectual property rights;
continued compliance with regulatory requirements;
declines in, or the slowing of the growth of, sales of our intraoral scanners domestically and/or internationally and the impact either would have on the adoption of Invisalign products;
the willingness and ability of our customers to maintain and/or increase product utilization in sufficient numbers;
the possibility that the development and release of new products or enhancements to existing products do not proceed in accordance with the anticipated timeline or may themselves contain bugs or errors requiring remediation and that the market for the sale of these new or enhanced products may not develop as expected;
a tougher consumer demand environment in China generally, especially for manufacturers and service providers whose headquarters or primarily operations are not based in China;
the risks relating to our ability to sustain or increase profitability or revenue growth in future periods (or minimize declines) while controlling expenses;
the impact of excess or constrained capacity at our manufacturing and treat operations facilities and pressure on our internal systems and personnel;
the compromise of customer and/or patient data for any reason;
the timing of case submissions from our doctors within a quarter as well as an increased manufacturing costs per case;
foreign operational, political and other risks relating to our international manufacturing operations; and
the loss of key personnel or work stoppages.

The foregoing and other risks are detailed from time to time in our periodic reports filed with the Securities and Exchange Commission, including, but not limited to, our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2021 and our latest Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, which was filed with the SEC on August 4, 2021. Align undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

Align Technology Madelyn Valente (408) 470-1180 mvalente@aligntech.com		Zeno Group Sarah Johnson (828) 551-4201 sarah.johnson@zenogroup.com

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/1742977a-2b2f-4438-a77a-ac27bbc577de

September 17, 2021

Leaders to Gather at UN Against COVID-19 Backdrop

Afghanistan, climate action and the COVID-19 pandemic will be front and center next week when large numbers of world leaders return to New York for their first in-person meetings at the United Nations in more than a year.

The coronavirus pandemic has slowed in-person diplomacy at the United Nations, and last September it was still considered too unsafe to hold the annual gathering that draws nearly 200 presidents and prime ministers and their large delegations in person, so it was all virtual.

Vaccines have made it safer to hold a scaled-down gathering, although the rampant spread of the delta variant left decisions for many about coming until the last minute. Leaders also have the option to stay home and send a video message, which about 50 of them plan to do. Many of those leaders are from lower income countries where vaccines have been in short supply, highlighting the imbalance in vaccine access.

“What we need is a global vaccination plan, and we need those that have power in the world to put their power at the service of vaccine equity,” U.N. Secretary-General Antonio Guterres told reporters recently.

The World Health Organization has set a global target of vaccinating at least 40% of the population of every country against COVID-19 by the end of this year, and 70% of the world’s population by the middle of next year.

More than 5.7 billion vaccine doses have been administered globally, about 260 million of them through COVAX, a multilateral effort for equitable distribution of COVID-19 vaccines. But lower-income countries are still lagging far behind wealthy ones, particularly in Africa, where only 2% of the world’s vaccine doses have been administered.

U.S. President Joe Biden is convening a virtual summit on Wednesday that will urge commitments from both the public and private sectors to work to end the pandemic by next year.

“We are building a coalition of governments, businesses, international institutions and civil society to expand vaccine production, accelerate access to vaccines and life-saving treatment, and strengthen health systems around the globe,” U.S. Ambassador to the United Nations Linda Thomas-Greenfield told reporters on Friday.

Climate emergency

Guterres has encouraged leaders to build back better from the pandemic, and a large part of that is focused on a greener recovery.

The world is not on track to meet pledges made in the 2015 Paris Climate Agreement to slow global warming to well below 2 degrees Celsius, and as low as 1.5 degrees, above pre-industrial levels.

“We really are out of time,” Guterres said Thursday in a video message marking a grim U.N. climate report. “We must act now to prevent further irreversible damage.”

In November, nations will meet in Glasgow, Scotland, to try to remove some of the obstacles to achieving the Paris goals.

“It has to be a turning point where action on mitigation, adaptation and finance happen,” a senior U.N. official said of the Glasgow conference, known as COP26.

On Monday, Guterres will co-host a private summit with British Prime Minister Boris Johnson and a small group of leaders to try to advance some of the priorities for Glasgow to be a success.

“As the [British] prime minister has said, we need urgent progress on cash, cars, coal and trees,” British Ambassador Barbara Woodward said. “That means raising the $100 billion to fund adaptation and resilience for climate-vulnerable countries. It means getting ambitious plans from countries who have not set out how they will cut emissions, particularly phasing out coal, and revitalizing and protecting nature.”

Geopolitical crises

There will be no shortage of political and humanitarian problems to discuss.

Conflict and famine in Ethiopia and a military coup in Myanmar were already in the international spotlight this year. Millions of Yemenis are near starving. The war in Syria has dragged on for more than a decade, and neighboring Lebanon is plunging into an economic abyss.

Haiti was rocked by an earthquake one month ago just weeks after its president was assassinated. Earlier this month, Guinea’s military staged a coup and jailed the president. And not to be ignored, North Korea has resumed test-firing ballistic missiles.

But in recent weeks, the situation in Afghanistan has seized international attention as the government collapsed, the Taliban swept into power in Kabul, and the United States military departed the country ending its 20-year military presence.

Chaos ensued as thousands of terrified Afghans who had worked for the U.S. military and other NATO countries or worked in other sensitive positions, sought to leave the country to avoid Taliban reprisals. The situation has been seen as a foreign policy disaster for the Biden administration, which as Secretary of State Antony Blinken has said, inherited a withdrawal deadline but no plan from the former Trump administration.

Now the United Nations finds itself in a difficult situation, trying to assist nearly 18 million Afghans who are in dire need of assistance after years of conflict, drought and now COVID-19.

“Afghanistan represents an enormous humanitarian challenge for the United Nations, and it’s going to be U.N. agencies responsible for keeping Afghans alive during a period of hunger and political chaos,” said Richard Gowan, U.N. director for the International Crisis Group.

The concern with which wealthy countries view the situation was evident on Monday, when they pledged more than $1.2 billon to provide humanitarian and regional assistance to try to prevent a new refugee crisis.

Western governments are especially worried that the Taliban will impose repressive restrictions on women and girls, jeopardizing 20 years of hard-won gains.

“We’re going to hear European leaders in particular talk about the need to protect women’s rights and human rights in Afghanistan,” Gowan said. “There’s not very much the General Assembly can do to force the Taliban to protect those.”

G-20 foreign ministers will discuss the situation on Wednesday, and it is likely to be a dominant topic in bilateral meetings.

Diplomats say nations need to coordinate a united approach to how they will deal with the Taliban going forward.

The foreign ministers of the five permanent U.N. Security Council members (Britain, China, France, Russia and the United States) are also planning a meeting, and diplomats say Afghanistan will certainly be on the agenda.

Biden debut

The U.N. secretary-general’s spokesman said Guterres and President Biden will meet in person Monday in New York.

The U.S. president’s speech always draws a full General Assembly. This year, due to the COVID-19 restrictions in place at the U.N., delegations will be allowed to have only their leader plus three other people seated in the hall.

Biden will make his debut address to the assembly Tuesday morning as the annual debate gets under way.

“I think Biden will have a message for the leaders, which is that they shouldn’t let China gain too much power in the U.N. system,” said International Crisis Group’s Gowan. “The Biden administration, just like the Trump administration before it, is concerned that the Chinese are gaining influence rapidly in multilateral institutions, and Biden will want to send the message that the U.S. is still the natural leader here.”

Thomas-Greenfield said the president will deliver his speech in person and then return to Washington where he will continue to participate in U.N. meetings virtually.

“President Biden will speak to our top priorities: ending the COVID-19 pandemic, combatting the climate crisis and defending human rights, democracy and the international rules-based order,” she said Friday. “All three are challenges that stretch across borders. They involve every single country on earth.”

Secretary of State Blinken will be in New York Monday through Thursday to engage with international officials. Special presidential envoy for climate, John Kerry, will also be in New York.

COVID-19 precautions

The Biden administration, New York City officials and the U.N. are eager to keep this gathering healthy.

Inside the General Assembly hall, everyone is expected to be vaccinated, although an honor system is in place and delegates will not have to show proof. If they want to sit down and eat in a U.N. cafeteria, they will have to show their vaccination status, as that is required in all city restaurants now.

The U.N. will also have a reduced number of staff in the building, and the hundreds of foreign and visiting journalists who cover the annual meeting have not been granted access this year.

The city will be providing a mobile COVID-19 testing unit outside U.N. headquarters all week, where delegates can also get vaccinated with the single-dose Johnson and Johnson shot.

Thomas-Greenfield said she would be having a COVID-19 test Monday morning before meeting other officials.

“Stopping the spread of COVID is our top priority, both here next week and everywhere going forward,” she said.

Source: Voice of America

September 17, 2021

US Panel Rejects Plan for Widespread COVID Booster Shots

A U.S. government advisory panel rejected a plan Friday for the widespread use of COVID-19 vaccine booster shots, dealing a setback to President Joe Biden’s administration, which had championed extra shots for nearly all Americans.

By a vote of 16-2, a Food and Drug Administration vaccine advisory panel rejected the widespread use of boosters, citing a lack of data on their safety as well as a lack of evidence concerning their value.

The independent panel did endorse extra vaccine doses for people who are 65 and older or at high risk of severe illness.

Drugmaker Pfizer had requested full approval for boosters for people 16 and older, a proposal backed by the Biden administration.

The White House announced last month that Americans who received either the Pfizer or Moderna vaccines could get a booster shot eight months after their second dose.

Earlier on Friday, the White House said it was ready to roll out the booster shots if health officials approved them.

Pfizer submitted data to the FDA this week that it said shows that the efficacy of its vaccine diminishes by about 6% every two months following the second dose, making a booster at the six-month mark safe and effective at strengthening protection against the virus that causes COVID-19.

Research has shown that although immunity levels decrease over time in those vaccinated, the Pfizer vaccine still provides strong protection against severe illness and death, even in delta variant cases.

The FDA panel’s recommendation is not binding; the FDA is not required to follow the panel’s recommendations, but it generally does.

Next week, an independent advisory panel for the Centers for Disease Control and Prevention will weigh in on who should get a booster and when.

Meanwhile, media reports say Biden is expected next week at the U.N. General Assembly to urge countries to pledge resources to vaccinate 70% of the world by next September. According to the World Health Organization, that would require about 11 billion doses. Moreover, the effort could still run into supply bottlenecks. Pfizer points to obstacles offshore in vaccine packing, distribution and cold storage.

However, Pfizer CEO Albert Bourla said in an open letter that the company is “continuing to work around the clock so we can bring the vaccine to the world as quickly, efficiently and equitably as possible.”

In June, the U.S. purchased 500 million doses to be distributed by Covax, the WHO-backed initiative, for low- and middle-income countries. As of August, the U.S. government had donated 110 million doses overseas. The Washington Post reports that the Biden administration is expected to announce next week it has bought another 500 million doses of the Pfizer vaccine to donate.

That has done little to satisfy critics, such as Amnesty International, which says Western countries are “hoarding” vaccines for their own populations.

The WHO says that of the 5.7 billion vaccine doses so far administered globally, 73% have been administered in just 10 countries. High-income countries have administered 61 times as many doses per inhabitant as low-income countries, according to WHO.

Johns Hopkins Coronavirus Resource Center said early Saturday it had recorded more than 227 million global COVID cases and 4.7 million deaths.

In Australia Saturday, police in Melbourne clashed with anti-lockdown protesters and arrested more than 200 people.

American Samoa reported its first COVID case on Friday. The infected person, a resident of the U.S. territory, had returned home from Hawaii on Monday, the first day commercial flights were allowed to resume operation from Honolulu to Pago Pago since March.

The Associated Press reports the infected traveler was “fully vaccinated” and had “tested negative for COVID-19 before boarding the flight back to American Samoa.”

India’s health ministry reported more than 35,000 new COVID-19 cases Saturday and 281 deaths.

Over 660,000 white flags have been installed on the National Mall in Washington to commemorate the people in the U.S. who have died from COVID. “In America. How could this happen” is the name of artist Suzanne Brennan Firstenberg’s installation.

The artist will “ceremoniously add” new flags every day to keep up with the COVID death toll, according to her website. The installation was mounted Friday and will last until October 3. There are benches among the flags, allowing “visitors to sit in quiet reflection.”

Johns Hopkins reports there have been more than 672,000 COVID-related U.S. deaths.

Source: Voice of America

September 17, 2021

Corona Hard Seltzer Announces New, Multi-Year Partnership with the Buffalo Bills

Corona Hard Seltzer becomes a new official hard seltzer sponsor of the Buffalo Bills complete with a new Corona Beach Break fan cam branded stadium experience and Block Party activations in local communities

CHICAGO, Sept. 16, 2021 (GLOBE NEWSWIRE) — As the 2021 NFL season has kicked off, Corona Hard Seltzer is excited to announce a new partnership with the Buffalo Bills. Corona Hard Seltzer is now an official hard seltzer sponsor of the team, providing fans new ways to cheer on their favorite team.

“Corona Hard Seltzer recognizes the passion that our fans have for the Buffalo Bills,” said Dan Misko, Pegula Sports & Entertainment’s Sr. Vice President of Business Development. “We’re proud to welcome Corona Hard Seltzer as an official hard seltzer sponsor of the Bills, and excited to work together to create meaningful experiences for our fans in the years to come.”

Corona Hard Seltzer is now a presenting sponsor of immersive fan experiences at retail locations in the Western New York community, such as fun sweepstakes where fans can win a variety of prizes. Bills fans will have a unique opportunity to come together through mobile “Block Party” caravan events surrounding marquee games, including Nov. 14 (against New York) and Dec. 12 (against Tampa Bay). Each rally will touch different communities, providing lawn signs, official gear and prizes to different season ticket members and fans it passes along the way. Fans at Highmark Stadium will also have a chance to show their pride during the “Beach Break” fan cam segments at Bills games this year.

“Western New York is a hotspot of Corona Hard Seltzer’s explosive growth in the United States,” said Rene Ramos, VP Field, Lifestyle & Experiential Marketing, Constellation Brands. “Corona Hard Seltzer will connect with the Bills Mafia both inside and outside the stadium delivering cultivated experiences to amplify what is already an electric tailgate and gameday experience.”

ABOUT THE CORONA BRAND FAMILY:
The Corona brand family is home to Corona Extra, Corona Light, Corona Familiar, Corona Premier, Corona Refresca, and Corona Hard Seltzer. The entire Corona portfolio is brewed in Mexico by Constellation Brands and imported and marketed exclusively to the U.S. by the company. Corona Extra, the flagship brand of the Corona brand family, is a pilsner-style lager with a golden hue that was first brewed in Mexico in 1925. Corona embodies “La Vida Más Fina” or “The Fine Life” as a modern expression of the brand’s lifestyle. The refreshing flavor and carefree attitude of Corona Extra holds a respected place in U.S. culture as the #1 most loved beer brand.

A brand that has long been synonymous with the beach, Corona is committing to removing 1 million pounds of plastic from shorelines and its business by the brand’s 100th birthday in 2025 through its “Protect Our Beaches” initiative with Oceanic Global, a nonprofit leader in ocean conservation. Believing there is no such thing as a better tomorrow without our beaches, the brand is on a mission to preserve these special places for generations to come.

ABOUT BUFFALO BILLS
Founded in 1959, the Buffalo Bills are one of the most storied franchises in the National Football League (NFL). The Bills have won two American Football League (AFL) Championships (1964 – 1965) and won an NFL record four straight AFC Championships (1990 – 1993) that included four trips to the Super Bowl. Owned by Terry and Kim Pegula, the Bills are proud to be a member of the Western New York community for more than 55 years. For more information regarding the Bills visit buffalobills.com, call (716) 648-1800, become a fan on Facebook at facebook.com/buffalobills, or follow the Bills on Twitter at twitter.com/buffalobills.

Media Contact:

Kevin Hyde
kevin.hyde@ketchum.com

September 17, 2021

GA-ASI SeaGuardian Flies First Approved Point-to-Point UAS Flight in UK

Flight Demonstrates Safety of UAS Flights in Civil Airspace

MQ-9B SeaGuardian at Lossiemouth

LOSSIEMOUTH, Scotland, Sept. 16, 2021 (GLOBE NEWSWIRE) — The UK’s Civil Aviation Authority (CAA) for the first time approved a point-to-point domestic flight of an unmanned aircraft that utilized the UK’s airways structure when General Atomics Aeronautical Systems, Inc. (GA-ASI) flew its MQ-9B SeaGuardian^® Remotely Piloted Aircraft (RPA) from Lincolnshire, England, to Moray, Scotland, on Sept. 12, 2021. The GA-ASI-owned RPA flew from Royal Air Force (RAF) Waddington to RAF Lossiemouth and the SeaGuardian flight was controlled by NATS, the UK’s civilian Air Navigation Service Provider.

“The Airspace Coordination Notice issued by the CAA for this series of demonstration flights in UK airspace is the largest and most meticulous we have ever produced so that the airspace integration of SeaGuardian is at the highest level of safety,” said Tom Gratton, CAA Airspace Regulator.

“We appreciate the cooperation and collaboration with the CAA and NATS in helping to move the industry forward,” said GA-ASI Vice President of International Strategic Development Robert Schoeffling. “This successful flight paves the way not only for future operations of Protector in UK airspace, but also for other civil and commercial UAS flights.”

Protector RG Mk1 is the RAF’s designation for the RPA they have ordered from GA-ASI that is based on the MQ-9B. The GA-ASI-owned, civil-registered aircraft that made this groundbreaking flight is operating from RAF airfields as part of an ongoing set of demonstrations being conducted by GA-ASI for the RAF.

According to NATS, the flight was controlled through more complex airspace than any previous UAS flights in the UK. “This flight required that we transfer control between multiple civil airspace sectors,” said Mark Watson, Head of Unmanned Aircraft Systems Traffic Management (UTM) Service Integration for NATS. “The procedures for this flight were close to what we do already with conventional crewed aircraft. This helped us validate that our existing methods of control are equally applicable to controlling remotely crewed aircraft – when the aircraft performs like SeaGuardian.”

Among the capabilities on display is GA-ASI’s revolutionary Detect and Avoid (DAA) system, a safety and situational awareness enhancement designed to support Protector’s flight in non-segregated UK airspace, as well as the platform’s capability to integrate into broader European airspace. DAA will enable Protector to operate amongst normal aviation traffic in the UK’s national airspace, unlike any other aircraft in its class. The demonstration flights are also assisting RAF Waddington, the future home of the RAF Protector Force, to prepare and integrate the new aircraft into its daily operations.

The demos continue until the end of September with the completion of Exercise Joint Warrior. The goal of the flight series has been to showcase the many operational capabilities of the MQ-9B, including the platform’s advanced maritime Intelligence, Surveillance and Reconnaissance (ISR), industry-leading endurance, and interoperability with NATO partners.

SeaGuardian is the maritime version of the MQ-9B SkyGuardian^®. The RAF has ordered 16 Protector RG Mk1 RPA systems as part of its Protector program.

About GA-ASI

General Atomics-Aeronautical Systems, Inc. (GA-ASI), an affiliate of General Atomics, is a leading designer and manufacturer of proven, reliable remotely piloted aircraft (RPA) systems, radars, and electro-optic and related mission systems, including the Predator^® RPA series and the Lynx^® Multi-mode Radar. With more than six million flight hours, GA-ASI provides long-endurance, mission-capable aircraft with integrated sensor and data link systems required to deliver persistent flight that enables situational awareness and rapid strike. The company also produces a variety of ground control stations and sensor control/image analysis software, offers pilot training and support services, and develops meta-material antennas. For more information, visit www.ga-asi.com.

Avenger, Lynx, Predator, SeaGuardian and SkyGuardian are registered trademarks of General Atomics Aeronautical Systems, Inc.

GA-ASI Media Relations
General Atomics Aeronautical Systems, Inc.
+1 (858) 524-8101
ASI-MediaRelations@ga-asi.com

SeaGuardian flew from Royal Air Force (RAF) Waddington to RAF Lossiemouth and the SeaGuardian flight was controlled by NATS, the UK’s civilian Air Navigation Service Provider.

This content was issued through the press release distribution service at Newswire.com.

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MQ-9B SeaGuardian at Lossiemouth