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Halozyme Announces Janssen Receives FDA Approval Of DARZALEX FASPRO® (Daratumumab And Hyaluronidase-fihj) As Treatment For Newly Diagnosed Patients With Light Chain (AL) Amyloidosis

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Halozyme Therapeutics, Inc. (NASDAQ: HALO) today announced that Janssen Biotech, Inc. (Janssen) has received U.S. Food and Drug Administration (FDA) approval of DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, cyclophosphamide and dexamethasone (D-VCd) for the treatment of adult patients with newly diagnosed light chain (AL) amyloidosis.1 DARZALEX FASPRO® is the first and only FDA-approved treatment for patients with this rare and serious blood disorder associated with the production of an abnormal protein which leads to the deterioration of vital organs, most notably the heart, kidneys and liver.1 This indication is approved under accelerated approval and is based on the combination’s hematologic complete response rate (hemCR) measure. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.  DARZALEX FASPRO® is not indicated and is not recommended for the treatment of patients with light chain (AL) amyloidosis who have NYHA Class IIIB or Class IV cardiac disease or Mayo Stage IIIB outside of controlled clinical trials.

“We are delighted that DARZALEX FASPRO® utilizing our ENHANZE® technology has become the first and only FDA-approved treatment for newly diagnosed patients with AL amyloidosis,” said Dr. Helen Torley, president and chief executive officer. “AL amyloidosis represents an area of high unmet medical need.”

The FDA approval is based on positive results from the Phase 3 ANDROMEDA study, which were recently presented at the American Society of Hematology (ASH) 2020 Annual Meeting. The study evaluated DARZALEX FASPRO® in combination with VCd, compared with VCd alone, a common treatment regimen offered to adult patients with newly diagnosed AL amyloidosis. 5  Patients receiving treatment with DARZALEX FASPRO® experienced a hemCR more than triple that of patients receiving VCd alone (42 percent for D-VCd and 13 percent for VCd; P<0.0001).1

Approximately 4,500 people in the U.S. develop this rare disease each year.4  AL amyloidosis is a life-threatening blood cell disorder that occurs when blood plasma cells in the bone marrow produce amyloid deposits, which build up in vital organs and eventually cause organ deterioration.3  The disease can affect different organs in different people, but the most frequently affected organs are the heart, kidneys, liver, spleen, gastrointestinal tract and nervous system.2,3  About one-third of patients visit five or more doctors before receiving a diagnosis, and 72 percent are diagnosed more than one year after they first experience symptoms.3,4  Patients often have a poor prognosis due to the delay in diagnosis of AL amyloidosis, which frequently presents with non-specific symptoms that can mimic other, more common conditions.6  As many as 30 percent of patients with AL amyloidosis die within the first year after diagnosis.7

About Halozyme

Halozyme is a biopharmaceutical company bringing disruptive solutions to significantly improve patient experiences and outcomes for emerging and established therapies. Halozyme advises and supports its biopharmaceutical partners in key aspects of new drug development with the goal of improving patients’ lives while helping its partners achieve global commercial success. As the innovators of the ENHANZE® technology, which can reduce hours-long treatments to a matter of minutes, Halozyme’s commercially-validated solution has positively impacted more than 400,000 patient lives via five commercialized products across more than 100 global markets. Halozyme and its world-class partners are currently advancing multiple therapeutic programs intended to deliver innovative therapies, with the potential to improve the lives of patients around the globe. Halozyme’s proprietary enzyme rHuPH20 forms the basis of the ENHANZE® technology and is used to facilitate the delivery of injected drugs and fluids, potentially reducing the treatment burden of other drugs to patients. Halozyme has licensed its ENHANZE® technology to leading pharmaceutical and biotechnology companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion, argenx and Horizon Therapeutics. Halozyme derives revenues from these collaborations in the form of milestones and royalties as the Company’s partners make progress developing and commercializing their products being developed with ENHANZE®. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements including, without limitation, statements concerning the possible activity, benefits and attributes of ENHANZE®, the possible method of action of ENHANZE®, its potential application to aid in the dispersion and absorption of other injected therapeutic drugs, and statements concerning certain other potential benefits of ENHANZE® including facilitating more rapid delivery of injectable medications through subcutaneous delivery and potentially lowering the treatment burden for patients. These forward-looking statements also include statements regarding the product development efforts of Halozyme’s ENHANZE® partner. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are typically, but not always, identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including uncertainties concerning whether collaborative products are ultimately developed or commercialized, unexpected expenditures and costs, unexpected results or delays in development and regulatory review including any potential delays caused by the current COVID-19 global pandemic, unexpected regulatory approval requirements, unexpected adverse events or patient outcomes from being treated with the newly-approved ENHANZE® co-formulated treatment referred to in this press release, and competitive conditions. These and other factors that may result in differences are discussed in greater detail in Halozyme’s most recent Annual and Quarterly Reports filed with the Securities and Exchange Commission. Except as required by law, Halozyme undertakes no duty to update forward-looking statements to reflect events after the date of this release.

1 DARZALEX FASPRO® Prescribing Information. Horsham, PA: Janssen Biotech, Inc.
2 Mayo Clinic. Amyloidosis overview: symptoms and causes. https://www.mayoclinic.org/diseases-conditions/amyloidosis/symptoms-causes/syc-20353178. Accessed January 2021.
3 Lousada I, Comenzo RL, Landau H, et al. Light chain amyloidosis: patient experience survey from the Amyloidosis Research Consortium. Advances in Therapy. 2015;32(10):920-928.
4 McCausland KL, et al. Patient. 2018;11(2):207-216.
5 Kastritis E, et al. Subcutaneous Daratumumab + Cyclophosphamide, Bortezomib, and Dexamethasone (CyBorD) in Patients with Newly Diagnosed Light Chain (AL) Amyloidosis: Primary Results from the Phase 3 ANDROMEDA Study. Available at: https://library.ehaweb.org/eha/2020/eha25th/303396/efstathios.kastritis.subcutaneous.daratumumab.2B.cycl%20ophosphamide.bortezomib.html?f=listing%3D0%2Abrowseby%3D8%2Asortby%3D1%2Amedia%3D3%2Ace_i. Accessed January 2021. 
Mayo Clinic. Amyloidosis diagnosis and treatment. https://mayocl.in/3jK50G4. Accessed January 2021.
7 Merlini G, et al. Light chain amyloidosis: the heart of the problem. Haematologica. 2013;98(10):1492-1495.

Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com

SOURCE Halozyme Therapeutics, Inc.

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BenzingaEditorial

Retailers Are Hoping for a Better 2021

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This week, three major retailers provided a glimpse of hope that the world is returning to normalcy- or at the very least, consumer behavior is. Although The Gap, Inc. (NYSE: GPS) came short on sales estimates, Kohl’s Corporation (NYSE: KSS) and Nordstrom Inc (NYSE: JWN) topped estimates, although they have other issues to deal with.

Kohl’s posted better-than-expected earnings, but activist investors aren’t pleased

Kohl topped Wall Street’s estimates and pointed to stronger growth in 2021. Net income amounted to $343 million but sales dropped to $5.88 billion from $6.54 billion a year earlier despite online sales jumping 22% from a year earlier as they accounted for 42% of total sales.

In 2020, the company added more than 2 million new customers in 2020 thanks to its Amazon (NASDAQ: AMZN) returns service, a third of which are millennials. But the group of activists looking to seize control published a letter to shareholders saying the board seems to be content performing just slightly better than the worst companies in retail. Facing pressure from activist investors whose attempt to seize control was rejected at the end of last month, the company will reinstate its dividend and buy back shares.  The retailer has a market cap of $8.99 billion, which is bigger than Nordstrom’s and Macy’s.

Nordstrom sales drop despite digital surge

Fourth-quarter sales and earnings topped analysts’ estimates owed to stronger online demand and growth at its Nordstrom Rack business. The department store chain warned that it is still working through impacts from delayed holiday shipments by selling excess inventories during the first quarter, hoping to be back to normal inventory levels by the second quarter. Its quarterly net revenues of $3.64 billion dropped $893 million from fiscal 2019’s quarter, despite digital sales increasing 24% compared to the same period and contributing 54% to total sales. The digital surge wasn’t enough to move the needle and net income shrank to $33 million compared to $193 million a year earlier. Although consumer behavior remains uncertain, the retailer is calling for fiscal 2021 sales to grow more than 25%. The retailer has a market cap of $5.93 billion, which is less than Kohl’s but greater than Macy’s.

Gap misses sales but forecasts return to sales growth in 2021

Ongoing store closures overseas in Europe, parts of Asia and Canada weighed on Gap’s fourth-quarter results, with sales coming up short of estimates. The apparel retailer swung to a profit, thanks to its efforts to sell more merchandise at full price and closing underperforming stores.

For the quarter ended January 30th, Gap reported net income of $234 million, or 61 cents per share, compared with a loss of $184 million, or 49 cents per share, a year earlier. Net sales fell about 5% to $4.42 billion from $4.67 billion a year earlier. The company showed continued strength at its Old Navy and Athleta brands which cover basics and workout gear. But its namesake Gap brand and Banana Republic brands saw another quarter of sales declines. Overall online sales were up 49%, representing 46% of net sales during the quarter.

For fiscal 2021, Gap is calling for net sales to be up a mid- to high-teens percentage, as the company is hoping return to a more normalized, pre-pandemic level of net sales in the second half of the year which depends on customers soon returning to its stores and spending more money on apparel as they resume social activities.

Many retailers are facing shipping headwinds

Backlogged ports in the U.S. and heightened shipping costs continue to hit all kinds of businesses, from those selling apparel and shoes, to appliances and at-home fitness equipment. Moreover, as shoppers do return to stores, the persisting problem could make it even more difficult for retailers to plan their inventories and keep their shelves stocked with goods. COVID-19 will be put to an end by vaccines but the uncertainty that the pandemic created will be more difficult to mend as its long-term impact on consumer behavior is still unknown.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: press@iamnewswire.com Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact: contributors@iamnewswire.com

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BenzingaEditorial

Zoom Is Doing Great But Can It Continue Being a Necessity?

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On Monday, Zoom Video Communications (NASDAQ: ZM) shares rose 11% in extended trading after the company reported fiscal fourth-quarter earnings, beating top and bottom-line expectations and issuing strong guidance.

As COVID-19 made physical contact impossible one year ago, video conferencing became a necessary work tool.  Microsoft Corporation (NASDAQ: MSFT) benefited from the trend thanks to its Microsoft Teams and Google Meet enabled Alphabet Inc. (NASDAQ: GOOG) to take a piece of the pie, but Zoom’s share price has almost quadrupled last year, resulting in a market value of more than $100 billion.

Q4

The video-calling software maker reported its revenue grew 369% YoY in the quarter that ended on January 31st, after growing 367% in the third quarter and losing fewer customers than executives had expected. Revenues soared to $883 million, up from $188 million the year before. Based on formal accounting rules, Zoom’s net income rose from $15 million to $260 million, or 87 cents a share. Gross margin expanded from previous quarter’s 66.7% to 69.7%.

The company also posted gains among small customers as it had 467,100 customers with more than 10 employees at the end of the fiscal fourth quarter, nearly five times as many as it had before the pandemic hitor up 470% on an annualized basis, compared with 354% growth in the previous quarter. It ended the quarter with $4.24 billion in cash, cash equivalents and marketable securities, significantly up from previous quarter’s $1.87 billion. The video conferencing start-up turned in a surprisingly strong performance in the latest quarter during which Covid-19 vaccines were intensively administered and predicted faster than expected growth in the coming year. The news sent Zoom’s shares up nearly 10 per cent in after-market trading on Monday, valuing it at $131billion. They are still more than 20 per cent below their highest level reached back in October, before investors started thinking about the impact of pandemic restrictions.

FY2021

For the year characterized by lockdowns across the globe, sales quadrupled to $2.65 billion with Zoom’s app being downloaded nearly half a billion times or twice as many times as Google’s video chat app, as reported by Apptopia.

FY2022

Despite predictions that its service will play a less central role in the lives of many workers and students in 2021, Zoom expects revenues for its next fiscal year to grow by 43 per cent to $3.76 billion to $3.78 billion, compared to Wall Street projections of about $3.5 billion. It also predicted pro forma earnings per share of $3.59 to $3.65, higher than the $2.96 a share analysts had pencilled in. Still, churn rates remain higher than they were before the pandemic and the trend is expected to persist as people begin to travel.

For the undergoing Q1, adjusted EPS are expected to be between 95 cents and 97 cents with revenue in the range between $900 million and $905 million in revenue. The outlook is significantly brighter than 72 cents and $829.2 million that Refinitiv gathered analysts penciled in.

“Zoom fatigue”

A possible major bump in the road was recently identified by a study from the Silicon Valley Itself that was published on February 23rd in the journal of Technology, Mind and Behavior. Researchers from Stanford University found that all those hours of video calls take more of a toll on our brain and body than regular office work. Seemingly never-ending video calls leave us utterly drained, even though our most strenuous physical activity during the workday involved smiling at the camera. Although it concerns all video chat platforms, researchers named it “Zoom fatigue.” Researchers say Zoom fatigue has four main culprits: excessive and intense eye contact, constantly watching video of yourself at a frequency and duration that hasn’t been seen in the history of people, the limited mobility of being stuck at your desk, and more energy spent identifying social cues that is much easier to do in person. The “non-verbal overload” is a result that we are gifting even strangers with the behavior that is ordinarily reserved for close relationships. Although some issues can be easily resolved such as by removing our selfie from the user interface and going for an audio call, others might require a lot more effort.

Zoom’s prospects

Oddly enough, the founder of a company whose success is inextricably linked to the pandemic-fueled rise of remote work and home offices, Eric Yuan, himself admitted that everybody’s desperate to return to the office. But then again, the company knows too well it has to show no fear about the world going back to its pre-pandemic days if it wants to protect its equity value. The video call software company’s 2020 growth story will probably never be repeated and a post-pandemic slowdown is inevitable but Zoom’s betting on a new normalcy that combines in-person meetings with video calls.

Zoom has plans for an independent future. Like Salesforce.com,inc (NYSE: CRM), it is trying to take on Microsoft Teams with a suite of office collaboration products. The pandemic awarded Zoom with the sort of brand recognition that no money can’t buy. But Microsoft has $132 billion in its war chest and is busy improving Teams, so there’s no way it will relinquish its domination over workplace software willingly.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: press@iamnewswire.com Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact: contributors@iamnewswire.com

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FbMagazine

The Chinese EV Appetite Is To Benefit Both Domestic and Foreign Players

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On Monday, Nio (NYSE: NIO), known as the Tesla (NASDAQ: TSLA) of China delivered its fourth quarter earnings. Although the results were good, they were weaker than expected and for a stock that’s been as strong, the quarter had to be robust. But NIO The stock took a tumble after earnings, as the automaker warned that the global chip shortage will slow production. While revenue scorched higher by 133%, it slightly missed consensus expectations, as did the bottom-line results, with the company reporting a wider loss than analysts had expected.

Q4

Revenue of $1.02 billion resulted in a per-share loss of 14 cents. Gross margin improved to 17.2% in the quarter, from  negative 8.9% a year ago and previous quarter’s 12.9%. Vehicle margin improved 0 17.2% from negative 6% a year ago and Q3’s 14.5%. Cash and cash equivalents climbed to $6.5 billion at the end of the quarter versus the $3.3 billion in the prior quarter. Nio had already disclosed that Q4 2020 deliveries jumped 111% to 17,353 vehicles. As most businesses in China closed for a week during the Lunar New Year holiday, sales dropped to 5,578 vehicles in February from 7,225 vehicles in January but both months were up by triple digits compared to 2019 figures. In February, the ES6 sales led with 2,216 deliveries, followed by 2,035 for the EC6 and 1,327 for the ES8.

Outlook

Nio sees Q1 deliveries in the range between 20,000 and 20,500 vehicles, up 421%-434% from a year ago and up 15% to 18% from fourth quarter. Revenue is expected in the range between $1.13 billion to $1.16 billion, up about 438% to 451% from a year ago and up 11% to 14% from Q4. CEO William Li revealed production capacity had climbed from 7,500 to 10,000 vehicles a month in February, but also warned a shortage in chips and batteries is imposing a slowdown back to 7,500 a month in the second quarter.

Rivals

The results are impacting Tesla too, which was down about 2.5% on the news. Among other EV stocks, Li Auto (NASDAQ: LI) fell 8.2% Tuesday whereas last week it reported a surprise profit. Xpeng Motors (NYSE: XPEV), which reports on March 8th, dropped 11.3%. Tesla slipped 4.45% on Tuesday. Subsidy cuts and rising competition from tech and legacy auto giants in China are weighing on EV players. Tesla was forced to make its made-in-China Model Y more affordable to compete with Nio’s new EC6 electric crossover. Two versions of the much-cheaper Volkswagen (OTC: VWAGY) ID.4 will start getting delivered in China by the end of March. Meanwhile, Nio in January announced the ET7 electric sedan which will compete with Tesla Model 3 due next year.

But, new entrants are coming and there also many less obvious players which can fuel them up for success. One of them is Worksport Ltd (OTC: WKSP), an innovative manufacturer of tonneau covers for pickups. With its TerraVis™ solar tonneau cover system and TerraVis COR™ mobile energy storage system, it aims to become a Tier 1 OEM manufacturer of solar-panel tonneaus for electric vehicle maker as it already partnered to configure its groundbreaking technology for two upcoming pickups. The Canadian-based company announced on Wednesday that following the success of its oversubscribed Regulation-A public offering, the company has received over $2.3 million from investors who have exercised their warrants.  This additional influx of capital will support Worksport’s strategic North American and Chinese manufacturing investments as well as in the development of its revolutionary Terra Vis system.

Nio’s positioning

Edison Yu with Deutsche Bank highlighted Nio’s “impressive” first-quarter guidance which according to him, outline “a very real path to more than 100,000 deliveries this year. The analysts finds that the outlook reflects growing awareness and appreciation of its aspirational brand and ecosystem, putting the company on track to be a market leader in the China premium segment. Dan Ives at Wedbush finds Nio’s “robust” fourth-quarter results describe a transformational EV opportunity playing out in China with all EV players having “massive tailwinds into 2021 as the golden age of EVs takes hold. All the above companies are well-positioned to lead the way forward in this Chinese market opportunity as analysts expect Chinese EV market is set to go from 4.5% penetration to 10% in the next two years based. The jaw-dropping consumer appetite for EVs can benefit well positioned domestic vendors as well as foreign players.

This article is not a press release and is contributed by a verified independent journalist for IAMNewswire. It should not be construed as investment advice at any time please read the full disclosure. IAM Newswire does not hold any position in the mentioned companies. Press Releases – If you are looking for full Press release distribution contact: press@iamnewswire.com Contributors – IAM Newswire accepts pitches. If you’re interested in becoming an IAM journalist contact: contributors@iamnewswire.com

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