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GKOS – Glaukos Announces Market-Leading Clinical Milestone of 200 Peer-Reviewed Publications on iStent® Technologies

SAN CLEMENTE, Calif.–()–Glaukos Corporation (NYSE: GKOS), an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases, announced today an unprecedented clinical data milestone of 200 peer-reviewed publications highlighting the efficacy and safety of iStent® technologies around the world. This achievement represents the largest, most diverse and longest-term body of clinical data for any MIGS procedure. Several points of note in this market-leading body of clinical evidence include:

  • Over 20,000 eyes have been analyzed in a wide range of studies over nearly 20 years.
  • 183 publications detail independently conducted, investigator-initiated studies.
  • 11 studies are prospective, randomized, controlled trials (RCTs).
  • More than 50 of the publications highlight studies in a standalone glaucoma patient population, with 20 meta-analyses and 14 cost-effectiveness studies demonstrating payor and practice efficiency.
  • 15 publications analyze 4- to 8-year outcomes data, establishing the largest and longest-term follow up of any MIGS procedure.
  • Independent research from more than 20 countries has been published, demonstrating efficacy and safety in highly diverse patient populations with varying degrees of glaucoma (ocular hypertension through advanced/refractory disease).
  • First and only MIGS procedure to demonstrate improved patient quality of life from a pivotal trial.

In addition, the official publication of the World Glaucoma Association, the Journal of Glaucoma, selected a study on iStent and iStent inject® as its July 2021 Paper of the Month. In this systematic review and meta-analysis authored by Dr. Paul Healey, a total of 13 studies were analyzed to evaluate the independent effect of iStent and iStent inject without cataract surgery, including four randomized controlled trials and nine non-randomized (single-arm) studies providing data on 778 eyes. In eyes implanted with iStent devices, a weighted mean intraocular pressure (IOP) reduction of 31.1% was observed at 6-12 months. In studies reporting longer-term outcomes, the weighted mean IOP reduction was 30.4% and 32.9% at 36-48 months and 60 months, respectively. The pooled weighted mean IOP reduction from baseline across all studies at 6-12 months and 36-60 months post-stent implantation was 7.0 mmHg and 6.6 mmHg, respectively. Medication burden was reduced by approximately 1.0 medication at 6-18 months, and by 1.2 medications at 36-60 months.

“Since the inception of Glaukos Corporation, our goal has been to transform the treatment of chronic, debilitating eye diseases through development of novel, sustainable therapies,” said Thomas Burns, Glaukos president and chief executive officer. “Scientific evidence and clinical rigor have been at the heart of our organization, with the earliest publication on iStent for the treatment of glaucoma dating back to 2002, two years prior to the initiation of the original iStent pivotal trial. Nearly 20 years later, we apply this same rigor and integrity to our business as we remain focused on generating strong clinical evidence, demonstrated by this trailblazing accomplishment of 200 peer-reviewed publications. I am grateful for our customers and employees around the world who have poured countless hours into this market-leading achievement to support our iStent technologies for the benefit of patients worldwide.”

“As one of the early adopters and investigators in the original iStent pivotal trial, I have experienced first-hand how iStent, as the first MIGS device, has fundamentally revolutionized the way we treat glaucoma today,” said Thomas W. Samuelson, MD, surgeon at Minnesota Eye Consultants, and Adjunct Professor at the University of Minnesota. “Glaukos has been focused on generating high-quality clinical evidence to support the uptake of MIGS procedures since day 1 and has continued to do so over the last 20 years. I am looking forward to Glaukos’s continued innovation and exciting new product launches ahead.”

“Each evolution, from iStent to iStent inject and now to iStent inject W, has been a transition to making the procedure more predictable and effective,” said Ike Ahmed, MD, Research Director at the Kensington Eye Institute and Director of the Glaucoma and Advanced Anterior Segment Surgery Fellowship Program at the University of Toronto. “In my practice, iStent and iStent inject clinical outcomes have stood the test of time as I routinely see patients over 10 years post-iStent surgery whose glaucoma is still well-managed. The high safety and versatility of iStent technologies make this our most commonly used MIGS procedure in mild-moderate open-angle glaucoma.”

Glaukos remains dedicated to innovation and bringing customers around the world best-in-class technologies to serve their patients, continuing to invest upwards of 30% of revenue back into R&D, including new product development. A significant number of clinical studies for both current and future products are ongoing, with additional studies commencing in the near future.

About Glaukos

Glaukos (www.glaukos.com) is an ophthalmic medical technology and pharmaceutical company focused on novel therapies for the treatment of glaucoma, corneal disorders and retinal diseases. The company pioneered Micro-Invasive Glaucoma Surgery, or MIGS, to revolutionize the traditional glaucoma treatment and management paradigm. Glaukos launched the iStent, its first MIGS device, in the United States in 2012, its next-generation iStent inject device in the United States in 2018, and most recently, the iStent inject W device in 2020. In corneal health, Glaukos’ proprietary suite of single-use, bio-activated pharmaceuticals are designed to strengthen, stabilize and reshape the cornea through a process called corneal collagen cross-linking to treat corneal ectatic disorders and correct refractive conditions. Glaukos is leveraging its platform technology to build a comprehensive and proprietary portfolio of micro-scale surgical and pharmaceutical therapies in glaucoma, corneal health and retinal disease.

Forward-Looking Statements

All statements other than statements of historical facts included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future are forward-looking statements. Although we believe that we have a reasonable basis for forward-looking statements contained herein, we caution you that they are based on current expectations about future events affecting us and are subject to risks, uncertainties and factors relating to our operations and business environment, all of which are difficult to predict and many of which are beyond our control, that may cause our actual results to differ materially from those expressed or implied by forward-looking statements in this press release. These potential risks and uncertainties include, without limitation, the timing and extent to which obtain regulatory approval for investigational products, our ability to successfully commercialize such products, the ability to obtain and maintain adequate financial coverage and reimbursement for our products, and the continued efficacy and safety profile of our products as might be suggested in these publications. These and other risks, uncertainties and factors related to Glaukos and our business are described in detail under the caption “Risk Factors” and elsewhere in our Quarterly Report on Form 10-Q for the quarter ended June 30, 2021, which was filed with the Securities and Exchange Commission (SEC) on August 5, 2021, and our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the SEC on March 1, 2021. Our filings with the Securities and Exchange Commission are available in the Investor Section of our website at www.glaukos.com or at www.sec.gov. In addition, information about the risks and benefits of our products is available on our website at www.glaukos.com. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on the forward-looking statements in this press release, which speak only as of the date hereof. We do not undertake any obligation to update, amend or clarify these forward-looking statements whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.

KAR – KAR to Accelerate Dealer-to-Dealer Growth, Profitability Through Acquisition of CARWAVE

CARMEL, Ind., Aug. 23, 2021 /PRNewswire/ — KAR Auction Services, Inc., d/b/a/ KAR Global (NYSE: KAR) has signed a definitive agreement to acquire CARWAVE Holdings LLC (“CARWAVE”) subject to certain regulatory approvals and other customary closing conditions. CARWAVE is an online dealer-to-dealer marketplace featuring certified mechanical inspections, buyer guarantees and a 24/7, direct offer trading format with semi-weekly live auctions. Upon closing, the acquisition will build on KAR’s consistent growth in the dealer-to-dealer segment, enhance KAR’s position in the highly fragmented wholesale used vehicle market, and accelerate the company’s overall transformation to a digital marketplace company. 

“This acquisition will advance our clear growth strategy in the dealer-to-dealer segment and accelerate the positive momentum we’ve sustained over the past several quarters,” said Peter Kelly, CEO of KAR Global. “CARWAVE has a strong, active dealer network in California — the country’s largest wholesale automotive market, as well as a growing presence in Arizona and Texas. The acquisition will enhance our continued growth in all of these areas while providing each company’s unique customers with greater choice through an expanded buyer and seller base. CARWAVE’s asset-light, technology-forward business model, with approximately 100,000 vehicles sold over the past 12 months, will enable us to continue driving innovation, achieve immediate profitability across our dealer-to-dealer offerings and enhance our position in the highly competitive dealer-to-dealer space.”

CARWAVE was founded in 2009 in California and currently serves a broad network of franchise and independent dealers across Arizona, California, Nevada, Oregon and Texas. The company’s online platform enables dealers to conveniently wholesale trade-ins and aged frontline units directly from their lot and quickly source new inventory from anywhere.  

After the transaction closes, key CARWAVE leadership including co-founders John Lauer and Bill Lauer will remain with the company, and KAR intends to continue operating CARWAVE’s Escondido, California headquarters.

“We started CARWAVE to provide dealers with a low cost, low stress and hassle-free alternative to physical wholesale auctions,” said John Lauer, president of CARWAVE. “KAR has truly embraced these core principles, and their progressive approach continues to lead the digital transformation of our industry. Our two organizations share a passion for innovation, a dedication to customer service and a commitment to making wholesale easy. And we look forward to combining our great networks of trusted dealers and delivering the best, most convenient and profitable wholesale solutions possible.”

The purchase price of the acquisition is $450 million and the transaction is expected to close prior to year-end pending the requisite legal and regulatory approvals. Winston & Strawn LLP is serving as legal advisor to KAR Global. Latham & Watkins LLP is serving as legal advisor to CARWAVE.

About KAR

KAR Auction Services, Inc. d/b/a KAR Global (NYSE: KAR), provides sellers and buyers across the global wholesale used vehicle industry with innovative, technology-driven remarketing solutions. KAR Global’s unique end-to-end platform supports whole car, financing, logistics and other ancillary and related services, including the sale of nearly 3.1 million units valued at over $40 billion through our auctions in 2020. Our integrated physical, online and mobile marketplaces reduce risk, improve transparency and streamline transactions for customers in about 75 countries. Headquartered in Carmel, Indiana, KAR Global has employees across the United States, Canada, Mexico, Uruguay, United Kingdom and Europe. For more information and the latest KAR Global news, go to www.karglobal.com and follow us on Twitter @KARspeaks.

About CARWAVE

Founded in 2009, CARWAVE is the dealership’s eyes and ears when purchasing a wholesale vehicle. The company is displacing the $100 billion traditional brick-and-mortar wholesale automobile auction industry with its innovative, internet-based business model. By using the platform, franchise and independent dealerships can increase profit margins, find high-quality cars easier, and avoid the operational headache of traveling to auction houses each month. For more information, please visit https://www.carwave.com.

Forward-Looking Statement

This press release includes certain statements that may be deemed to be “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and are intended to be covered by the safe harbor provisions thereof. All statements, other than statements of historical facts, included in this press release that address activities, events or developments that we expect, believe or anticipate will or may occur in the future, are forward-looking statements. Forward-looking statements are not guarantees of future performance and we caution you not to place undue reliance on such statements. Forward-looking statements are generally identifiable by the use of the words “may,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” “project,” “continue,” or the negative of these words, or other similar words or terms.

Forward-looking statements contained in this press release are subject to a number of risks and uncertainties, many of which are beyond our control, that may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by forward-looking statements made by us. Factors and risks to our business that could cause actual results to differ from those contained in the forward-looking statements are described in our filings with the Securities and Exchange Commission. These risks and uncertainties include, but are not limited to, potential risks and uncertainties relating to the novel coronavirus (COVID-19).

SOURCE KAR Global

Related Links

https://www.karglobal.com

TGT – Top Toy Ready: Target Announces Most Exclusives Ever and Disney Expansion Ahead of Holiday Season

MINNEAPOLIS, Aug. 23, 2021 /PRNewswire/ — Target Corporation (NYSE: TGT) today announces the return of Bullseye’s Top Toys list this holiday season, along with plans to expand to over 160 Disney store at Target locations across the country. With more exclusives and only-at-Target experiences in stores and online, Target is positioned to inspire children of all ages all season long.

Gift givers will find top brands like LEGO and L.O.L. Surprise! alongside a range of new additions that will spark creativity. This includes Target’s guest-favorite, exclusive 70-piece toy collection with FAO Schwarz, of which 85 percent of items are new this year, popular characters like PAW Patrol and Barbie, and the Zoe Doll by Black-owned business Healthy Roots (which inspires girls to love their curls through hair play). 

Target Adds More Disney Store at Target Locations Nationwide

As Target’s partnership with Disney continues to be a major hit, guests will find Top Toys from popular Disney properties, including Star Wars and Raya and the Last Dragon. By the end of the year, Target will expand to over 160 Disney store at Target locations across the country, providing even more guests with the opportunity to enjoy the unique in-store experience. Plus, Target continues to grow its dedicated online Disney experience for fans seeking toys and games from the hottest properties.

“Target continues to be a top toy destination for all families, and we’re pleased to offer unique experiences and a curated toy assortment that brings joy to parents and children of all ages,” said Nik Nayar, SVP of Hardlines, Target. “We’re seeing more guests shop for toys at Target than ever before, and whether it’s Bullseye’s Top Toys or finding joy with one of the 1,300+ exclusive toys and games, guests are choosing Target for our inspiring, easy and affordable gift-giving experience.”

Target Delivers a Convenient Shopping Experience

Guests will find incredible value and ease when shopping Target’s toy selection this holiday season, with Top Toys starting at $19.99. As always, Target’s complete toy selection, and nearly all holiday gifts, are available for same-day pickup or delivery through Target’s industry-leading fulfillment services; Drive Up, Order Pickup and Same-Day Delivery with Shipt – no membership required. Target RedCard holders can also enjoy five percent off their Top Toys purchases all season long.

Bullseye’s Top Toys of 2021 Include:

Inspire New Stories

  • Healthy Roots Zoe Doll
  • Baby Alive Lulu Achoo Dolls
  • Disney Raya and the Last Dragon Land of Kumandra Set – EXCLUSIVE
  • B. Play Ice Cream Truck – EXCLUSIVE
  • Animal Planet Deep Sea Shark Rescue Submarine Set – EXCLUSIVE
  • Kinetic Sand Sandyland Folding Sandbox – EXCLUSIVE
  • OSMO Little Genius Starter Kit – EXCLUSIVE
  • LEGO Creator Botanical Collection Bird of Paradise – EXCLUSIVE
  • LEGO Friends Heartlake City School
  • Gravitrax Speed Marble Run – EXCLUSIVE
  • Peek-a-Roo
  • Orbeez Soothing Spa

Inspire Imagination

  • L.O.L. Surprise! Family Pack 24K DJ and Neon – EXCLUSIVE
  • L.O.L. Surprise! OMG Movie Magic Studio
  • Na! Na! Na! Surprise 3-in-1 Backpack Bedroom Jennel Jaguar and Sarah Snuggles
  • Barbie Dreamhouse
  • Rainbow High Rockstars Lyric Lucas, Vanessa Nova, Carmen MajorEXCLUSIVE
  • Love, Diana Magical Musical Castle
  • Ryan’s World Lost City Adventure Chest – EXCLUSIVE
  • Jurassic World Legacy Collection – Tyrannosaurus Rex Escape Pack – EXCLUSIVE
  • Star Wars Galactic Snackin’ Grogu
  • Batman All-Terrain Batmobile Remote Control Vehicle
  • Hot Wheels Monster Trucks T-Rex Volcano Arena Track Set
  • Monster Jam Remote Control Freestyle Force Grave Digger
  • Imaginext DC Super Friends Transforming Bat-Tech Batbot
  • Unicorn Purse Pets
  • Got2Glow Fairy Finder Pink Jar
  • Magic Mixies

Inspire Dreams and Creativity

  • FAO Schwarz Electric Guitar + Amp – EXCLUSIVE
  • LEGO Harry Potter Hogwarts Wizard’s Chess – EXCLUSIVE
  • LEGO Star Wars The Armorer’s Mandalorian Forge – EXCLUSIVE
  • Bluey & Jean Luc’s Caravan Adventures Playset – EXCLUSIVE
  • Melissa & Doug Let’s Explore Park Ranger Cabin and Boat – EXCLUSIVE
  • Our Generation Cozy Cabin
  • 5 Surprise Toy Mini Brands Toy Store
  • Lalaloopsy Sew Royal Princess Party: Suzette & Mimi La Sweet and Cosy & Teacup Hearts
  • PAW Patrol: The Movie Ultimate City Tower Playset

Inspire Active Play

  • Segway C20 Kids Electric Scooter – EXCLUSIVE
  • Jetson Sync All-Terrain Hoverboard Black – EXCLUSIVE
  • NERF Elite 2.0 Flipshots Flip-32 Blaster

Inspire Fun Family Moments

  • Monopoly: Target Edition – EXCLUSIVE
  • Chuckle & Roar Pop It! XL Tie Dye – EXCLUSIVE
  • Throw Throw Avocado – EXCLUSIVE
  • Crossed Signals
  • Beyblade Burst Surge Speedstorm Slayer Showdown Battle Set – EXCLUSIVE
  • Roblox Action Collection – Ninja Legends Deluxe Playset

Inspire Future Gamers

  • Nintendo Switch OLED
  • Nintendo Switch with Neon Blue and Neon Red Joy-Con
  • PlayStation 5 Console
  • Xbox Series S

About Target

Minneapolis-based Target Corporation (NYSE: TGT) serves guests at more than 1,900 stores and at Target.com, with the purpose of helping all families discover the joy of everyday life. Since 1946, Target has given 5% of its profit to communities, which today equals millions of dollars a week. Additional company information can be found by visiting the corporate website and press center and by following @TargetNews.

SOURCE Target Corporation

Related Links

www.target.com

NGCA – Virgin Orbit, a Responsive Launch and Space Solutions Company, to Become Publicly Traded on Nasdaq Through a Business Combination With NextGen Acquisition Corp. II

LONG BEACH, Calif.–()–Virgin Orbit, the responsive launch and space solutions company, through its parent company Vieco USA, Inc. (“Virgin Orbit” or the “Company”) and NextGen Acquisition Corp. II (“NextGen”) (NASDAQ: NGCA), a special purpose acquisition company, announced today that they have entered into a definitive merger agreement (the “Merger Agreement”) under which Virgin Orbit will become a publicly-traded company.

Upon closing, the transaction is expected to provide the combined company up to $483 million in cash proceeds, including up to $383 million of cash held in the trust account of NextGen (assuming no redemptions) and a $100 million fully committed PIPE; the combined company will retain the Virgin Orbit name and is expected to be listed on Nasdaq under the ticker symbol “VORB.” The transaction values Virgin Orbit at an implied pro forma enterprise value of approximately US$3.2 billion and is expected to close around the end of the year, subject to, among other things, approval by NextGen’s shareholders and the satisfaction or waiver of other customary closing conditions.

Virgin Orbit’s existing shareholder base is comprised of Virgin Group, (“Virgin”), Mubadala Investment Company (“Mubadala”), and management and employees. Existing Virgin Orbit shareholders will roll 100% of their equity into the combined company. Assuming no redemptions by NextGen’s shareholders, existing Virgin Orbit shareholders are expected to retain ownership of approximately 85% of the combined company, NextGen’s public shareholders are expected to own approximately 10% of the combined company, with PIPE investors and the SPAC sponsor expected to own approximately 3% and 2%, respectively, in each case, immediately following closing.

OVERVIEW OF VIRGIN ORBIT

LAUNCH

Virgin Orbit has developed a proprietary air-launch technology, coupled with world-class manufacturing infrastructure and a proven team to transform space access for a diverse and global customer base. Since its founding in 2017, Virgin Orbit has developed the world’s first air-launched, liquid-fueled launch system.

The Company’s most recent successful launch – conducted on June 30, 2021 – precisely delivered satellites for commercial and national security customers from the US and abroad directly into their target orbits. In January 2021, the Company successfully launched satellites for NASA.

Virgin Orbit uses a customized 747 aircraft as a mobile launch site, a flying mission control, and a fully-reusable first stage vehicle. By beginning each mission at approximately 35,000 feet above sea level and already travelling at a high speed, the simple and reliable LauncherOne rocket achieves a significant performance advantage over grounded launch sites while reducing local carbon emissions and acoustic impacts at the launch site when compared to a traditional ground launch.

The mobility of the system also allows Virgin Orbit to bring launch capabilities to dozens of nations that currently have space agencies and satellite industries but no domestic launch capability. The Company has been selected by the United Kingdom and Brazil to bring launch to those nations’ shores, in addition to Virgin Orbit’s announced launch site in Japan and multiple locations in the United States.

Having already successfully delivered satellites into precisely targeted orbit for the US Department of Defense and other national security customers, Virgin Orbit’s proven technology can also be leveraged to serve a diverse portfolio of defense and national security applications. Virgin Orbit’s ability to launch responsively from any location around the world delivers a valuable deterrent in ensuring the resiliency and replaceability of critical satellite infrastructure assets.

SPACE-ENABLED DATA AND ANALYTICS SERVICES

Virgin Orbit is selectively investing with constellation partners to provide end-to-end, value-added services for Earth Observation and the Internet of Things (IoT) applications, using the “Satellites as a Service” model. Virgin Orbit’s IoT offering will focus on connectivity applications for ship management, aircraft, pipeline monitoring, and intelligent agriculture, which has the potential to help improve efficiency across some of the world’s biggest industries.

Virgin Orbit is well positioned to expand through its combination of global reach; collaborative partnerships with customers and unique ability to provide end-to-end secure services through in-country launch with its transportable and mobile launch system. Virgin Orbit will seek to expand its Satellite as a Service activities beyond the previously announced investments in innovative satellite companies such as ArQit, HyperSat, and others. Virgin Orbit is entering into commercial partnerships with BigBear.ai and Redwire to develop and enhance next generation space solutions offerings.

MANAGEMENT COMMENTS

Sir Richard Branson, the Founder of Virgin Orbit, said “The Virgin Orbit team has proven its ability to create new ideas, new approaches, and new capabilities. They are building on the incredible foundation of their rapid transition into successful commercial launch operations to find new ways to solve big problems that uplift our customers’ amazing ideas, again and again. I’m very excited we are taking Virgin Orbit public, with the support of our partners at NextGen and our other wonderful investors. It’s another milestone for empowering all of those working today to build space technology that will positively change the world.”

Dan Hart, the CEO of Virgin Orbit, said “We’ve built Virgin Orbit in order to change the business of satellite launch and to open space for everyone, globally. Whether it’s engaging with world leaders at the G7 Summit or seeing the smiles on the faces of our international community of customers after our most recent launch, our mission gets more exciting with every step we take. Our success in launch has driven the business forward, and now we expect this investment will enable us to build on our R&D efforts and our incredible team. We are driving innovation with world-class design and advanced manufacturing capabilities, our unrivaled mobility of launch, and our exciting space solutions services.”

George Mattson and Greg Summe, the Co-Founders of NextGen, said “We are delighted that our search for a great company, with strong organic growth in a large and growing market, disruptive technology and a world class management team has led to our partnership with Virgin Orbit. The space economy is developing rapidly and Virgin Orbit is well positioned to benefit through its ability to competitively launch at any time, from any place on Earth, to any orbit and inclination. This is a truly unique and differentiating capability. We have worked with Sir Richard and the Virgin Group on various projects, including Virgin Galactic, over the last few years and admire their vision and commitment as they have built Virgin Orbit from an idea to a commercial reality. We look forward to leveraging our industry and financial experience, along with our public company leadership and governance experience to help Virgin Orbit deliver the next chapter of its exciting journey as a public company.”

Abdulla Shadid, Executive Director, Growth & M&A at Mubadala, said “Virgin Orbit is a game changer for the small satellite launch and space solutions industry and its listing is expected to be yet another milestone in its continuing success story. Our investment in Virgin Orbit since its inception is a reflection of our confidence in the company’s ability to carve out a leading role in this sector. It also complements the broad objectives of the UAE’s national space strategy, as reflected in the recent successful “Hope” satellite mission to Mars.”

TRANSACTION SUMMARY

On August 22, 2021, Virgin Orbit has entered into the Merger Agreement to become publicly traded on Nasdaq through a business combination with NextGen. The transaction values Virgin Orbit at an implied pro forma enterprise value of approximately $3.2 billion. The combined company is expected to receive approximately $483 million of gross proceeds from the combination of approximately $383 million of cash held in NGCA’s trust account (assuming no redemptions) and a fully committed common stock PIPE offering of $100 million at $10.00 per share.

Proceeds from the business combination and PIPE transaction are expected to provide growth capital to further scale rocket manufacturing to meet customer demand and to fund growth in its space solutions business and Virgin Orbit’s ongoing product development initiatives.

The boards of directors of both Virgin Orbit and NextGen have unanimously approved the proposed business combination, which is expected to be around the end of the year subject to, among other things, the approval by NextGen’s shareholders and the satisfaction or waiver of other customary closing conditions.

Additional information about the proposed transaction, including a copy of the merger agreement and investor presentation, will be provided in a Current Report on Form 8-K to be filed by NextGen today with the Securities and Exchange Commission (“SEC”) and available at www.sec.gov.

ADVISORS

Credit Suisse Securities (USA) LLC is serving as lead financial advisor and lead capital markets advisor to Virgin Orbit and co-lead placement agent for the PIPE transaction. Perella Weinberg Partners L.P. and LionTree LLC are also serving as additional financial advisors to Virgin Orbit.

Latham & Watkins LLP is serving as legal advisor to Virgin Orbit.

Goldman Sachs & Co. LLC is serving as exclusive financial advisor to NextGen and as co-lead placement agent for the PIPE transaction. Rothschild & Co is acting as an additional financial advisor to NextGen. Skadden, Arps, Slate, Meagher & Flom LLP is serving as legal advisor to NextGen.

Sullivan & Cromwell LLP is serving as legal advisor to the placement agents.

INVESTOR WEBCAST

Management of Virgin Orbit and NextGen will discuss the business and the proposed business combination today, at 8:30 a.m. ET. To access the webcast please click here.

The investor presentation is being filed by NextGen with the SEC and will be available on each company’s investor relations website and on the SEC’s website at www.sec.gov.

ABOUT VIRGIN ORBIT

Virgin Orbit builds and operates one of the most flexible and responsive satellite launchers ever invented: LauncherOne, a dedicated launch service for commercial and government-built small satellites. LauncherOne rockets are designed and manufactured in Long Beach, California, and are air-launched from a modified 747-400 carrier aircraft, Cosmic Girl, which allows Virgin Orbit to operate from locations all over the world in order to best serve each customer’s needs.

In just a span of four years since its creation in 2017, Virgin Orbit has developed a proprietary air-launch technology, coupled with world-class manufacturing infrastructure and a proven team to transform space access for a diverse and global customer base.

ABOUT NEXTGEN

NextGen Acquisition Corp. II is a blank check company whose business purpose is to effect a merger, share exchange, asset acquisition, share purchase, reorganization or similar business combination with one or more businesses. NextGen is led by George Mattson, a former Partner at Goldman, Sachs & Co., and Gregory Summe, former Chairman and CEO of Perkin Elmer and Vice Chairman of the Carlyle Group. NextGen is listed on Nasdaq under the ticker symbol “NGCA.” For more information, please visit www.nextgenacq.com.

ABOUT VIRGIN GROUP

The Virgin Group is a leading international investment group and one of the world’s most recognized and respected brands. Created in 1970 with the birth of Virgin Records, the Virgin Group has gone on to invest in, incubate, and grow a number of successful businesses in the private and public markets. The Virgin Group has expanded into many sectors since its inception, driven by Sir Richard’s ambition to create the world’s most irresistible brand. These sectors include travel & leisure, financial services, health & wellness, technology & internet-enabled, music & entertainment, media & mobile, space, and renewable energy. The Virgin Group has built significant expertise across these sectors, which it has also successfully applied to investments in non-Virgin branded businesses in which it has seen the opportunity to generate attractive financial returns. https://www.virgin.com.

ABOUT MUBADALA

Mubadala Investment Company manages a global portfolio aimed at generating sustainable financial returns for the Government of Abu Dhabi.

Mubadala’s $243.4 billion (AED 894 billion) portfolio spans six continents with interests in multiple sectors and asset classes. Mubadala leverages deep sectoral expertise and long-standing partnerships to drive sustainable growth and profit, while supporting the continued diversification and global integration of the economy of the United Arab Emirates.

Headquartered in Abu Dhabi, Mubadala has offices in London, Rio de Janeiro, Moscow, New York, San Francisco and Beijing. For more information about Mubadala Investment Company, please visit: www.mubadala.com.

ADDITIONAL INFORMATION AND WHERE TO FIND IT

This press release relates to a proposed transaction between Virgin Orbit and NextGen. This press release does not constitute (i) solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed transaction or (ii) an offer to sell or exchange, or the solicitation of an offer to buy or exchange, any security of NextGen, Virgin Orbit, the combined company or any of their respective affiliates, nor shall there be any sale of any such securities in any state or jurisdiction in which such offer, solicitation, sale or exchange would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of the Securities Act of 1933, as amended.

In connection with the proposed transaction, NextGen intends to file a registration statement on Form S-4 with the SEC, which will include a document that serves as a prospectus and proxy statement of NextGen, referred to as a proxy statement/prospectus. A proxy statement/prospectus will be sent to all NextGen shareholders. NextGen also will file other documents regarding the proposed transaction with the SEC.

This communication does not contain all the information that should be considered concerning the proposed transaction and is not intended to form the basis of any investment decision or any other decision in respect of the proposed transaction. Before making any voting or investment decision, investors and security holders of NextGen are urged to read the registration statement, the proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transaction as they become available because they will contain important information about the proposed transaction.

Investors and security holders will be able to obtain free copies of the registration statement, proxy statement/prospectus and all other relevant documents filed or that will be filed with the SEC by NextGen through the website maintained by the SEC at www.sec.gov. In addition, the documents filed by NextGen with the SEC may be obtained free of charge from NextGen’s website at https://www.nextgenacq.com/nextgen-ii.html or upon written request to 2255 Glades Road, Suite 324A, Boca Raton, Florida 33431.

PARTICIPANTS IN THE SOLICITATION

NextGen, Virgin Orbit, and their respective directors and executive officers may be deemed to be participants in the solicitation of proxies from NextGen’s shareholders in connection with the proposed transaction. A list of the names of the directors and executive officers of NextGen and information regarding their interests in the business combination is set forth in NextGen’s registration statement on Form S-1 (File No. 333-253848) filed with the SEC on March 25, 2021. Additional information regarding the interests of those persons and other persons who may be deemed participants in the proposed transaction may be obtained by reading the proxy statement/prospectus regarding the proposed transaction. You may obtain free copies of these documents as described in the preceding paragraph.

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements within the meaning of the federal securities laws with respect to the proposed transaction between NextGen and Virgin Orbit. All statements other than statements of historical facts contained in this communication, including statements regarding Virgin Orbit’s or the combined company’s future financial position, business strategy and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “pro forma”, “may”, “should”, “could”, “might”, “plan”, “possible”, “project”, “strive”, “budget”, “forecast”, “expect”, “intend”, “will”, “estimate”, “anticipate”, “believe”, “predict”, “potential” or “continue”, or the negatives of these terms or variations of them or similar terminology. Forward-looking statements include, without limitation, Virgin Orbit’s or NextGen’s expectations concerning the outlook for their or the combined company’s business, productivity, plans and goals for future operational improvements and capital investments, operational performance, future market conditions or economic performance and developments in the capital and credit markets and expected future financial performance, as well as any information concerning possible or assumed future results of operations of the combined company. Forward-looking statements also include statements regarding the expected benefits of the proposed transaction between Virgin Orbit and NextGen.

Forward-looking statements involve a number of risks, uncertainties and assumptions, and actual results or events may differ materially from those projected or implied in those statements. Important factors that could cause such differences include, but are not limited to: (i) the occurrence of any event, change or other circumstances that could give rise to the termination of definitive agreements with respect to the business combination; (ii) the outcome of any legal proceedings that may be instituted against NextGen, Virgin Orbit, the combined company or others following the announcement of the business combination and any definitive agreements with respect thereto; (iii) the inability to complete the Business Combination due to the failure to obtain approval of the shareholders of NextGen; (iv) the inability of Virgin Orbit to satisfy other conditions to closing; (v) changes to the proposed structure of the business combination that may be required or appropriate as a result of applicable laws or regulations or as a condition to obtaining regulatory approval of the business combination; (vi) the ability to meet stock exchange listing standards following the consummation of the business combination; (vii) the risk that the business combination disrupts current plans and operations of Virgin Orbit as a result of the announcement and consummation of the business combination; (viii) the ability to recognize the anticipated benefits of the business combination, which may be affected by, among other things, competition, the ability of the combined company to grow and manage growth profitably, maintain relationships with customers and suppliers and retain its management and key employees, and the costs related to the business combination; (ix) changes in applicable laws or regulations; (x) the possibility that Virgin Orbit or the combined company may be adversely affected by other economic, business, regulatory, and/or competitive factors; (xi) Virgin Orbit’s estimates of expenses and profitability; (xii) the evolution of the markets in which Virgin Orbit competes; (xii) the ability of Virgin Orbit to implement its strategic initiatives and continue to innovate its existing products; (xiii) the ability of Virgin Orbit to defend its intellectual property; (xiv) the ability of Virgin Orbit to satisfy regulatory requirements; (xv) the impact of the COVID-19 pandemic on Virgin Orbit’s and the combined company’s business; and (xv) other risks and uncertainties set forth in the documents filed or to be filed with the SEC by NextGen.

Virgin Orbit and NextGen caution you against placing undue reliance on forward-looking statements, which reflect current beliefs and are based on information currently available as of the date a forward-looking statement is made. Forward-looking statements set forth herein speak only as of the as of the date they are made. Neither Virgin Orbit nor NextGen undertakes any obligation to revise forward-looking statements to reflect future events, changes in circumstances, or changes in beliefs. In the event that any forward-looking statement is updated, no inference should be made that Virgin Orbit or NextGen will make additional updates with respect to that statement, related matters, or any other forward-looking statements. Any corrections or revisions and other important assumptions and factors that could cause actual results to differ materially from forward-looking statements, including discussions of significant risk factors, may appear, up to the consummation of the proposed transaction, in NextGen’s public filings with the SEC or, upon and following the consummation of the proposed transaction, in Virgin Orbit’s public filings with the SEC, which are or will be (as appropriate) accessible at www.sec.gov, and which you are advised to consult.

BMY – U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb's Application for Orencia (abatacept) for the Prevention of Acute Graft Versus Host Disease (aGvHD)

PRINCETON, N.J.–()–Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Orencia (abatacept) for the prevention of moderate to severe acute graft versus host disease (aGvHD) in patients 6 years of age and older receiving unrelated donor hematopoietic stem cell transplantation (HSCT). The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of December 23, 2021.

“While stem cell transplants are an effective treatment for aggressive leukemias and other hematological malignancies, patients who receive stem cell transplants from unrelated and human leukocyte antigens (HLA)-mismatched donors are at high risk for developing aGvHD,” said study lead investigator Leslie Kean, M.D., PhD, Director of the Pediatric Stem Cell Transplantation Program, Boston Children’s Hospital/Dana-Farber Cancer Institute. “There is a tremendous need to expand the stem cell donor pool by lowering the risk of aGvHD in both adults and children receiving unrelated donor stem cell transplants.”

Stem cell transplants include infusion of donor T-cells, a type of white blood cell that recognizes and destroys foreign invaders in the recipient’s body, including cancer cells. GvHD occurs when the donor T-cells also recognize the patient’s healthy cells as foreign and start attacking healthy tissues and organs. To initiate this attack, T-cells require activation through a signaling process called co-stimulation. Between 30 and 70 percent of transplant recipients develop aGvHD, depending on donor type, transplant technique, and other features. Orencia, a therapy currently approved to treat various arthritic conditions, binds to and inhibits protein targets involved in co-stimulation, thus inhibiting T-cell activation.

“For patients who receive unrelated donor stem cell transplants, in particular for racial and ethnic minority patient populations, there is a heightened risk of developing aGvHD, a potentially life-threatening medical complication for which there are no approved preventive therapies,” said Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb. “We look forward to working with the FDA to bring Orencia to this new patient population and employ pathbreaking science in an effort to address unmet needs of underserved patients.”

The sBLA submitted to the FDA is based on results from the Phase 2 ABA2 trial and a registry trial based on real world evidence. The ABA2 trial assessed the impact of Orencia on the prevention of severe aGvHD, when added to a standard GvHD prophylactic regimen administered to patients with hematologic malignancies receiving a stem cell transplant from an unrelated, HLA-matched or mismatched donor. A mismatch in HLA increases the risk of GvHD. Results from ABA2 showed that treatment with Orencia resulted in a significant reduction in severe aGvHD and associated morbidity without an increase in disease relapse. The findings of the real-world analysis were consistent with those of ABA2.

Bristol Myers Squibb thanks the patients and investigators who participated in this clinical trial.

About ABA2

The ABA2 study was a multicenter, Phase 2 investigator sponsored trial conducted by Dr. Leslie Kean of Boston Children’s Hospital/Dana Farber Cancer Institute. ABA2 had two cohorts: a single arm cohort for patients receiving transplants from mismatched unrelated donors (MMUD) (“7/8” cohort), and a randomized, double blind, placebo-controlled cohort for patients receiving transplants from 8/8 matched unrelated donors (MUD) (“8/8” cohort). All subjects received a calcineurin inhibitor (CNI), with dosing starting on day -2 and continuing through at least Day 100 as tolerated, and methotrexate (MTX) on days one, three, six and 11 (transplant day is Day 0). Orencia-treated subjects received 10 mg/kg Orencia on days -1, 5, 14 and 28.

In the ABA2 clinical trial, addition of Orencia to SOC aGvHD prophylaxis of MTX+CNI resulted in a significantly higher aGvHD-free survival (GFS) rate compared to registry controls in the single-arm 7/8 HLA-matched cohort, and numerically higher severe GFS rate in the double-blind, placebo-controlled 8/8 HLA-matched cohort at 180 days post-transplant.

About Acute Graft Versus Host Disease and Impact on a Diverse Patient Population

Graft versus host disease (GvHD) after a hematopoietic stem cell transplant occurs when transplanted donor T-cells recognize antigenic differences between the donor and the recipient, and attack the recipient’s healthy tissue and organs. Acute graft versus-host disease (aGvHD) impacts between 30 and 70 percent of patients, depending on donor type, transplant technique, and other features, with racial and ethnic minority patient populations more likely to experience challenges following a hematopoietic stem cell transplantation. This may be due to several factors that impact overall outcome, including a lack of donor availability and related care. This activation of T-cells can result in severe immune-mediated tissue damage to the host, with the skin, liver and gastrointestinal tract being the most common targets. aGvHD-mediated damage to these vital organs has been associated with increased morbidity and death.

HSCT is an effective treatment for aggressive leukemias and other hematological malignancies, often representing the only option for cure. However, some of its benefit, especially in the case of unrelated donor transplantation, is offset by a high rate of transplant-related mortality (TRM) stemming largely from severe aGvHD and infection.

About ORENCIA®

ORENCIA® is an immunomodulator that disrupts the continuous cycle of T-cell activation.

U.S. Indications/Usage and Important Safety Information for ORENCIA® (abatacept)

Indications and Usage

Adult Rheumatoid Arthritis: ORENCIA® (abatacept) is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis (RA).

Polyarticular Juvenile Idiopathic Arthritis: ORENCIA® (abatacept) is indicated for the treatment of patients 2 years of age and older with moderately to severely active polyarticular juvenile idiopathic arthritis (pJIA).

Adult Psoriatic Arthritis: ORENCIA® (abatacept) is indicated for the treatment of adult patients with active psoriatic arthritis (PsA).

Limitations of Use: The concomitant use of ORENCIA with other potent immunosuppressants [e.g., biologic disease-modifying antirheumatic drugs (bDMARDS), Janus kinase (JAK) inhibitors] is not recommended.

Important Safety Information for ORENCIA® (abatacept)

Concomitant Use with TNF Antagonists, Other Biologic RA/PsA Therapy, or JAK Inhibitors: Concurrent therapy with ORENCIA and a TNF antagonist is not recommended. In controlled clinical trials, adult RA patients receiving concomitant intravenous ORENCIA and TNF antagonist therapy experienced more infections (63% vs 43%) and serious infections (4.4% vs 0.8%) compared to patients treated with only TNF antagonists, without an important enhancement of efficacy. Additionally, concomitant use of ORENCIA with other biologic RA/PsA therapy or JAK inhibitors is not recommended.

Hypersensitivity: There were 2 cases (<0.1%; n=2688) of anaphylaxis reactions in clinical trials with adult RA patients treated with intravenous ORENCIA. Other reactions potentially associated with drug hypersensitivity, such as hypotension, urticaria, and dyspnea, each occurred in <0.9% of patients. There was one case of a hypersensitivity reaction with ORENCIA in pJIA clinical trials (0.5%; n=190). In post marketing experience, fatal anaphylaxis following the first infusion of ORENCIA and life-threatening cases of angioedema have been reported. Angioedema has occurred as early as after the first dose of ORENCIA, but also has occurred with subsequent doses. Angioedema reactions have occurred within hours of administration and in some instances had a delayed onset (i.e., days). Appropriate medical support measures for treating hypersensitivity reactions should be available for immediate use. If an anaphylactic or other serious allergic reaction occurs, administration of intravenous or subcutaneous ORENCIA should be stopped immediately and permanently discontinued, with appropriate therapy instituted.

Infections: Serious infections, including sepsis and pneumonia, were reported in 3% and 1.9% of RA patients treated with intravenous ORENCIA and placebo, respectively. Some of these infections have been fatal. Many of the serious infections have occurred in patients on concomitant immunosuppressive therapy which, in addition to their underlying disease, could further predispose them to infection. Caution should be exercised in patients with a history of infection or underlying conditions which may predispose them to infections. Treatment with ORENCIA should be discontinued if a patient develops a serious infection. Patients should be screened for tuberculosis and viral hepatitis in accordance with published guidelines, and if positive, treated according to standard medical practice prior to therapy with ORENCIA.

Immunizations: Prior to initiating ORENCIA in pediatric and adult patients, update vaccinations in accordance with current vaccination guidelines. Live vaccines should not be given concurrently with ORENCIA or within 3 months after discontinuation. ORENCIA may blunt the effectiveness of some immunizations.

Use in Patients with Chronic Obstructive Pulmonary Disease (COPD): In Study V, adult COPD patients treated with ORENCIA for RA developed adverse events more frequently than those treated with placebo (97% vs 88%, respectively). Respiratory disorders occurred more frequently in patients treated with ORENCIA compared to those on placebo (43% vs 24%, respectively), including COPD exacerbation, cough, rhonchi, and dyspnea. A greater percentage of patients treated with ORENCIA developed a serious adverse event compared to those on placebo (27% vs 6%), including COPD exacerbation [3 of 37 patients (8%)] and pneumonia [1 of 37 patients (3%)]. Use of ORENCIA in patients with COPD should be undertaken with caution, and such patients monitored for worsening of their respiratory status.

Immunosuppression: In clinical trials in adult RA patients, a higher rate of infections was seen in ORENCIA-treated patients compared to placebo-treated patients. The impact of treatment with ORENCIA on the development and course of malignancies is not fully understood. There have been reports of malignancies, including skin cancer in patients receiving ORENCIA. Periodic skin examinations are recommended for all ORENCIA-treated patients, particularly those with risk factors for skin cancer.

Blood Glucose Testing: ORENCIA for intravenous administration contains maltose, which may result in falsely elevated blood glucose readings on the day of infusion when using blood glucose monitors with test strips utilizing glucose dehydrogenase pyrroloquinoline quinone (GDH-PQQ). Consider using monitors and advising patients to use monitors that do not react with maltose, such as those based on glucose dehydrogenase nicotine adenine dinucleotide (GDH-NAD), glucose oxidase or glucose hexokinase test methods. ORENCIA for subcutaneous (SC) administration does not contain maltose; therefore, patients do not need to alter their glucose monitoring.

Pregnancy: There are no adequate and well-controlled studies of ORENCIA use in pregnant women and the data with ORENCIA use in pregnant women are insufficient to inform on drug-associated risk. A pregnancy registry has been established to monitor pregnancy outcomes in women exposed to ORENCIA during pregnancy. Healthcare professionals are encouraged to register patients by calling 1-877-311-8972.

Lactation: There is no information regarding the presence of abatacept in human milk, the effects on the breastfed infant, or the effects on milk production. However, abatacept was present in the milk of lactating rats dosed with abatacept.

Most Serious Adverse Reactions: Serious infections (3% ORENCIA vs 1.9% placebo) and malignancies (1.3% ORENCIA vs 1.1% placebo).

Malignancies: The overall frequency of malignancies was similar between adult RA patients treated with ORENCIA or placebo. However, more cases of lung cancer were observed in patients treated with ORENCIA (0.2%) than those on placebo (0%). A higher rate of lymphoma was seen compared to the general population; however, patients with RA, particularly those with highly active disease, are at a higher risk for the development of lymphoma. The potential role of ORENCIA in the development of malignancies in humans is unknown.

Most Frequent Adverse Events (≥10%): Headache, upper respiratory tract infection, nasopharyngitis, and nausea were the most commonly reported adverse events in the adult RA clinical studies. Other events reported in ≥5% of pJIA patients were diarrhea, cough, pyrexia, and abdominal pain. In general, the adverse events in pediatric pJIA and adult PsA patients were similar in frequency and type to those seen in adult RA patients.

Note concerning ORENCIA administration options: ORENCIA may be administered as an intravenous infusion only for patients 6 years of age and older. PJIA patients may self-inject with ORENCIA or the patient’s caregiver may administer ORENCIA if both the healthcare practitioner and the parent/legal guardian determines it is appropriate. The ability of pediatric patients to self-inject with the autoinjector has not been tested.

Please click here for Full Prescribing Information.

About Bristol Myers Squibb

Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information about Bristol Myers Squibb, visit us at BMS.com or follow us on LinkedIn, Twitter, YouTube, Facebook and Instagram.

Celgene and Juno Therapeutics are wholly owned subsidiaries of Bristol-Myers Squibb Company. In certain countries outside the U.S., due to local laws, Celgene and Juno Therapeutics are referred to as, Celgene, a Bristol Myers Squibb company and Juno Therapeutics, a Bristol Myers Squibb company.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 regarding, among other things, the research, development and commercialization of pharmaceutical products. All statements that are not statements of historical facts are, or may be deemed to be, forward-looking statements. Such forward-looking statements are based on historical performance and current expectations and projections about our future financial results, goals, plans and objectives and involve inherent risks, assumptions and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years, that are difficult to predict, may be beyond our control and could cause our future financial results, goals, plans and objectives to differ materially from those expressed in, or implied by, the statements. These risks, assumptions, uncertainties and other factors include, among others, that Orencia (abatacept) may not receive regulatory approval for the additional indication described in this release in the currently anticipated timeline or at all and, if approved, whether such product candidate for such additional indication described in this release will be commercially successful. No forward-looking statement can be guaranteed. It should also be noted that a Priority Review designation does not change the standards for FDA approval. Forward-looking statements in this press release should be evaluated together with the many risks and uncertainties that affect Bristol Myers Squibb’s business and market, particularly those identified in the cautionary statement and risk factors discussion in Bristol Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2020, as updated by our subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the Securities and Exchange Commission. The forward-looking statements included in this document are made only as of the date of this document and except as otherwise required by applicable law, Bristol Myers Squibb undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, changed circumstances or otherwise.

corporatefinancial-news

TXMD – TherapeuticsMD Announces Issuance of a J-Code for ANNOVERA® to Be Utilized in the Public Health Sector

BOCA RATON, Fla.–()–TherapeuticsMD, Inc. (NASDAQ: TXMD), an innovative, leading women’s healthcare company, today announced that the Centers for Medicare and Medicaid Services (CMS) confirmed its preliminary recommendation to assign a permanent product-specific Healthcare Common Procedure Coding System (HCPCS) J Code for ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system). As a result, CMS established the new HCPCS Level II code J7294 “Segesterone acetate and ethinyl estradiol 0.15mg, 0.013mg per 24 hours; yearly vaginal system, each,” which will allow Title X facilities to be reimbursed for dispensing ANNOVERA. The coding action will be effective October 1st, 2021.

This new J Code will allow dispensing Public Health facilities the opportunity to gain reimbursement for ANNOVERA, including the approximately 4,900 Title X Family Planning clinics. Public Health claims submission and payment are standardized with a J Code, facilitating and streamlining billing and reimbursement. Public Health insured patients represent a growing segment of the ANNOVERA user base.

“Having a permanent J Code will simplify Public Health billing and payment, further enhancing patient access to ANNOVERA in a growing segment of our user base. This code is separate and unique to ANNOVERA as the only yearly patient controlled and procedure free vaginal system in the marketplace,” stated Hugh O’Dowd, President of TherapeuticsMD.

About ANNOVERA

ANNOVERA is the first and only FDA-approved long-lasting, reversible contraceptive for women of reproductive age that is patient-controlled and procedure-free. It is inserted for 21 continuous days and removed for 7 days each cycle for one year (13 cycles). ANNOVERA was developed by the global non-profit research organization, Population Council, and has been licensed to TherapeuticsMD for the U.S. market.

IMPORTANT RISK INFORMATION

  • Do not use ANNOVERA (segesterone acetate and ethinyl estradiol vaginal system) if you smoke cigarettes and are over 35 years old. Smoking increases your risk of serious heart and blood vessel (cardiovascular) side effects from hormonal birth control methods, including death from heart attack, blood clots, or stroke. This risk increases with age and the number of cigarettes you smoke.
  • ANNOVERA does not protect against HIV infection (AIDS) and other sexually transmitted infections (STIs). 

DO NOT USE ANNOVERA IF YOU

  • have or have had a blood clot in your arms, legs, lungs, or eyes.
  • have had a stroke.
  • have reduced blood flow to your brain (cerebrovascular disease).
  • have reduced blood flow or blockage in 1 or more of the arteries that supply blood to your heart (coronary artery disease).
  • have had a heart attack.
  • have heart rhythm or heart valve problems that increase your risk of having blood clots, such as an infection of the inner lining of the heart and heart valves or a type of irregular heartbeat called atrial fibrillation.
  • have a problem with your blood that makes it clot more than normal.
  • have high blood pressure that is not controlled with medicine or have high blood pressure with blood vessel damage.
  • have diabetes and are over 35 years old; have diabetes with high blood pressure or problems with your kidneys, blood vessels, eyes, or nerves; or have had diabetes for longer than 20 years.
  • have headaches with changes in vision, numbness or weakness, have migraine headaches with aura, or are over age 35 years old and have any type of migraine headaches.
  • have liver disease or liver tumors.
  • have or have had breast cancer or any cancer that is sensitive to the female hormones estrogen or progesterone.
  • have unexplained vaginal bleeding.
  • are allergic to segesterone acetate, ethinyl estradiol, or any of the ingredients in ANNOVERA.
  • take any Hepatitis C drug combination medicine containing ombitasvir/paritaprevir/ ritonavir, with or without dasabuvir.

WARNINGS

ANNOVERA can cause serious side effects, including: blood clots; toxic shock syndrome (TSS); liver problems, including liver tumors; high blood pressure; gallbladder problems; changes in the sugar and fat (cholesterol and triglycerides) levels in your blood; headache; irregular or unusual vaginal bleeding and spotting between your menstrual periods; depression; possible cancer in your cervix; swelling of your skin especially around your mouth, eyes, and in your throat (angioedema); dark patches of skin on your forehead, cheeks, upper lip, and chin (chloasma). Call your healthcare provider or get emergency medical care right away if any of these serious side effects occur.

The most common side effects of ANNOVERA include:

  • headache, including migraine
  • nausea/vomiting
  • vaginal yeast infection (candidiasis)
  • lower/upper abdomen pain
  • painful periods
  • vaginal discharge
  • urinary tract infection
  • breast pain/tenderness
  • irregular vaginal bleeding
  • diarrhea
  • genital itching

USE

ANNOVERA is a ring-shaped vaginal system with hormones used by females to prevent pregnancy.

ANNOVERA has not been adequately studied in females with a body mass index >29 kg/m2.

The risk information provided here is not complete. To learn more, review the ANNOVERA Patient Information and talk with your healthcare provider or pharmacist. The FDA-approved product labeling, including Patient Information, can be found at annovera.com/pi.pdf.

You may report side effects to the FDA at www.fda.gov/medwatch or by calling 1-800-FDA-1088.

You may also report side effects to TherapeuticsMD at 1-888-228-0150.

About TherapeuticsMD

TherapeuticsMD, Inc. is an innovative, leading healthcare company, focused on developing and commercializing novel products exclusively for women. Our products are designed to address the unique changes and challenges women experience through the various stages of their lives with a therapeutic focus in family planning, reproductive health, and menopause management. The Company is committed to advancing the health of women and championing awareness of their healthcare issues. To learn more about TherapeuticsMD, please visit www.therapeuticsmd.com or follow us on Twitter: @TherapeuticsMD and on Facebook: TherapeuticsMD.

Forward Looking Statements

This press release by TherapeuticsMD, Inc. may contain forward-looking statements. Forward-looking statements may include, but are not limited to, statements relating to TherapeuticsMD’s objectives, plans and strategies as well as statements, other than historical facts, that address activities, events or developments that the company intends, expects, projects, believes or anticipates will or may occur in the future. These statements are often characterized by terminology such as “believes,” “hopes,” “may,” “anticipates,” “should,” “intends,” “plans,” “will,” “expects,” “estimates,” “projects,” “positioned,” “strategy” and similar expressions and are based on assumptions and assessments made in light of management’s experience and perception of historical trends, current conditions, expected future developments and other factors believed to be appropriate. Forward-looking statements in this press release are made as of the date of this press release, and the company undertakes no duty to update or revise any such statements, whether as a result of new information, future events or otherwise. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties, many of which are outside of the company’s control. Important factors that could cause actual results, developments and business decisions to differ materially from forward-looking statements are described in the sections titled “Risk Factors” in the company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as reports on Form 8-K, and include the following: whether Title X family planning clinics will prescribe ANNOVERA and utilize the product-specific J Code; the effects of the COVID-19 pandemic; the company’s ability to maintain or increase sales of its products; the company’s ability to develop and commercialize IMVEXXY®, ANNOVERA®, and BIJUVA® and obtain additional financing necessary therefor; whether the company will be able to comply with the covenants and conditions under its term loan facility; whether the company will be able to successfully divest or obtain an investment in its vitaCare business and the proceeds that may be generated by such divestiture or investment; the potential of adverse side effects or other safety risks that could adversely affect the commercialization of the company’s current or future approved products or preclude the approval of the company’s future drug candidates; whether the FDA will approve the lower dose of BIJUVA; the company’s ability to protect its intellectual property, including with respect to the Paragraph IV notice letters the company received regarding IMVEXXY and BIJUVA; the length, cost and uncertain results of future clinical trials; the company’s reliance on third parties to conduct its manufacturing, research and development and clinical trials; the ability of the company’s licensees to commercialize and distribute the company’s products; the ability of the company’s marketing contractors to market ANNOVERA; the availability of reimbursement from government authorities and health insurance companies for the company’s products; the impact of product liability lawsuits; the influence of extensive and costly government regulation; the volatility of the trading price of the company’s common stock and the concentration of power in its stock ownership.

BGCP – kACE partners with Algorithmica to launch FX Volatility Aggregator

LONDON, Aug. 23, 2021 /PRNewswire/ — kACE, a division of Fenics Software Limited, an entity within the BGC Partners, Inc. (NASDAQ: BGCP) (“BGC Partners,” “BGC” or the “Company”) group of companies, announced today the launch of its kACE Volatility Aggregator (kACE VA) application, a collaboration between kACE and Algorithmica, leveraging both organisations’ vast experience in FX derivatives and advanced analytical solutions to deliver unparalleled volatility aggregation functionality.

The kACE VA application allows users to combine FXO volatilities from multiple sources to create a unique surface that feeds downstream into client applications such as kACE Pro, back and middle office systems and proprietary technologies. Users have full control over blending aggregation and data cleansing algorithms, providing custom weighting and data selection criteria as well as removing outlier and stale data.

Richard Brunt, Managing Director at kACE, said, “We are very pleased with the results of our collaboration with Algorithmica. Clients are demanding more control over their data, and more transparency on the provenance of the data that they use.”  Rich Winter, Senior Managing Director at Fenics Market Data and Information Analytics, added, ‘Clients are moving away from black box composite data feeds to sources that provide high levels of provenance and market accuracy.  The kACE Volatility Aggregator allows clients to select their preferred data suppliers, including from our own Fenics Market Data group, specific counterparty banks and other proprietary sources to create their own golden source. They no longer need to rely on a generic one size fits all data feed”.

Robert Thorén, Partner at Algorithmica, said, “To hit the mark of excellence in providing kACE and ultimately kACE clients with a solution for volatility aggregation is a major milestone for Algorithmica. Working with highly skilled professionals at kACE has been absolutely key to get to a product ready for launch. Achieving this without physical meetings during a pandemic makes the effort even more impressive. We now look forward to rolling out the product and building on the next release with features and requests from kACE clients.”

About kACE
kACE is the product brand for the solutions provided by Fenics Software Limited. The brand was launched in July 2018 following the acquisition of Kalahari Limited by Fenics Software Limited. The product range includes pricing, analytics, distribution and trading tools for a broad range of asset classes.

Fenics Software Limited has over 30 years’ experience providing intuitive pre-trade analysis, risk management, automated client price distribution, post trade processing and innovative pricing solutions for the FX derivatives and financial markets. The extensive range of APIs facilitate connectivity to third parties and bespoke front-end solutions. Through its hosted Gateway service, Fenics Software Limited connects its client community to counterparties, venues, regulators and vendors.

About Algorithmica
Algorithmica focuses on providing efficient tools for real-time quantitative analysis, thus enabling its customers to better price, trade, and risk manage financial transactions. Solutions built for speed and performance are powered by Quantlab®, the award-winning software development platform for quantitative financial analysis. In addition, Algorithmica provides products for enterprise-wide risk management and for market data management including time-series data, static data, and calculated data.

Having head-office and development in Stockholm, Sweden, the customers include a number of well-known financial institutions mainly in the Nordics and London. Algorithmica is led by the Chief Executive Officer and founder Niclas Holm. For more information, please visit http://www.algorithmica.com. You can also follow Algorithmica at https://www.linkedin.com/company/algorithmica-research

About BGC Partners, Inc.
BGC Partners, Inc. (“BGC”) is a leading global brokerage and financial technology company. BGC specializes in the brokerage of a broad range of products, including Fixed Income (Rates and Credit), Foreign Exchange, Equities, Energy and Commodities, Shipping, Insurance, and Futures. BGC also provides a wide variety of services, including trade execution, brokerage, clearing, trade compression, post-trade, information, and other back-office services to a broad range of financial and non-financial institutions. Through brands including Fenics, BGC Trader, Capitalab, Lucera, and Fenics Market Data, BGC offers financial technology solutions, market data, and analytics related to numerous financial instruments and markets. BGC, BGC Trader, GFI, Fenics, Fenics Market Data, Capitalab, Lucera, Corant Global, Corant, and Piiq are trademarks/service marks and/or registered trademarks/service marks of BGC and/or its affiliates.

BGC’s customers include many of the world’s largest banks, broker-dealers, investment banks, trading firms, hedge funds, governments, corporations, and investment firms. BGC’s Class A common stock trades on the NASDAQ Global Select Market under the ticker symbol “BGCP”. BGC is led by Chairman of the Board and Chief Executive Officer Howard W. Lutnick. For more information, please visit http://www.bgcpartners.com. You can also follow BGC at https://twitter.com/bgcpartners, https://www.linkedin.com/company/bgc-partners and/or http://ir.bgcpartners.com/Investors/default.aspx.

Discussion of Forward-Looking Statements about BGC
Statements in this document regarding BGC that are not historical facts are “forward-looking statements” that involve risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements. These include statements about the effects of the COVID-19 pandemic on the Company’s business, results, financial position, liquidity and outlook, which may constitute forward-looking statements and are subject to the risk that the actual impact may differ, possibly materially, from what is currently expected. Except as required by law, BGC undertakes no obligation to update any forward-looking statements. For a discussion of additional risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see BGC’s Securities and Exchange Commission filings, including, but not limited to, the risk factors and Special Note on Forward-Looking Information set forth in these filings and any updates to such risk factors and Special Note on Forward-Looking Information contained in subsequent reports on Form 10-K, Form 10-Q or Form 8-K.

Media contact at BGC Partners, Inc.:
Harjeet Singh
+44 207 894 8829

Investor contact at BGC Partners, inc.:
Jason Chryssicas
+1 212 610 2426

SOURCE Fenics Software Limited

Related Links

https://www.bgcpartners.com/

WPP – WPP acquires agency specialising in artificial intelligence

WPP Group PLC (LSE:WPP), the advertising and marketing conglomerate, has acquired Satalia, a technology company offering market-leading artificial intelligence (AI) solutions for clients.

Satalia, which employs more than 80 people across multiple markets in Europe, will join WPP’s Wunderman Thompson Commerce division and will also act as a hub of AI expertise for all WPP agencies.

Daniel Hulme, the founder and chief executive officer of Satalia, will become chief AI officer of WPP, working closely with WPP’s chief technology officer and WPP agencies to promote AI capabilities across the company.

“Advances in technology are revolutionising how people live, work and shop, how brands go to market, and how products and services are delivered. Clients are looking for end-to-end solutions that harness these technologies to grow their business. I’m delighted to welcome Daniel and the Satalia team to WPP as we continue to strengthen our offer to global brands,” said Mark Read, the chief executive officer of WPP.