The graves were discovered, vandalized, hours before Trump made his final stop at Grand Rapids late Monday.
— FOX News
Author: Michelle Dryden
- Q1’21 net revenue of $845.7 million increased 27% as-reported, or 26% in constant currency, compared to Q1’20. On an organic basis, constant currency net revenue in Q1’21 grew 20% compared to Q1’20.
- Q1’21 Adjusted EBITDA of $174.4 million increased 37% as-reported, or 35% in constant currency, compared to Q1’20.
- Q1’21 Biologics segment net revenue of $377.1 million doubled compared to Q1’20.
- Net debt leverage of 2.6x as of September 30; more than $1 billion in cash and cash equivalents on-hand at September 30.
- Increased guidance reflects revenue growth of 16-22% and adjusted EBITDA growth of 17-26%, compared to previous guidance of revenue growth of 12-16% and adjusted EBITDA growth of 12-19%.
SOMERSET, N.J.–(BUSINESS WIRE)–Catalent, Inc. (NYSE: CTLT), the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products, today announced financial results for the first quarter of fiscal 2021, which ended September 30, 2020.
“Catalent’s strong start to fiscal 2021 was driven by robust growth in our Biologics segment, which doubled its revenue year-over-year and represented 44% of Catalent’s total revenue in the first quarter. Ongoing elevated demand across our drug product, drug substance and cell and gene therapy offerings, as well as new demand related to potential COVID-19 vaccines and treatments, were partially offset by headwinds in our Softgel and Oral Technologies and Oral and Specialty Delivery segments,” said John Chimi in nski, Chair and Chief Executive Officer of Catalent, Inc. He added, “We have accelerated our growth-related capital expenditures to meet the near-term needs of customers and patients, and to position Catalent for long-term value creation.”
First Quarter 2021 Consolidated Results
First quarter 2021 net revenue of $845.7 million increased 27% as reported, or 26% in constant currency, from the $664.7 million reported for the first quarter a year ago. Overall organic growth was 20%.
First quarter 2021 net earnings were $82.4 million. Accounting for the net earnings attributable to preferred shareholders on Catalent’s Series A convertible preferred stock, net earnings attributable to common shareholders were $68.8 million, or $0.42 per basic share, compared to a net loss attributable to common shareholders of $8.0 million, or a loss of $0.05 per basic share, in the first quarter a year ago.
First quarter 2021 EBITDA from operations, as referenced in the GAAP to non-GAAP reconciliation provided later in this release, was $161.8 million, an increase of $71.7 million from $90.1 million in the first quarter a year ago. First quarter 2021 Adjusted EBITDA (see the GAAP to non-GAAP reconciliation provided later in this release) was $174.4 million, or 20.6% of net revenue, compared to $127.1 million, or 19.1% of net revenue, in the first quarter a year ago. This represents an increase of 37.2% as reported, and an increase of 35.5% on a constant-currency basis.
First quarter 2021 Adjusted Net Income (see the GAAP to non-GAAP reconciliation) was $78.1 million, or $0.43 per diluted share, compared to Adjusted Net Income of $40.5 million, or $0.26 per diluted share, in the first quarter a year ago.
First Quarter 2021 Segment Review
Biologics
Net revenue from the Biologics segment was $377.1 million for the first quarter of fiscal 2021, an increase of 100% as reported and 98% in constant currency, compared to the first quarter a year ago. Segment EBITDA in the first quarter of fiscal 2021 was $106.5 million, an increase of 197% as reported and 194% in constant currency compared to the first quarter a year ago. Segment EBITDA margin was 28.2% in the first quarter of fiscal 2021 compared to 19.0% in the first quarter of the prior year.
Excluding the effect of acquisitions, net revenue increased 83% and segment EBITDA increased 179% compared to the three months ended September 30, 2019.
The Biologics segment represented 44% of Catalent’s total net revenue in the first quarter of fiscal 2021.
Softgel and Oral Technologies
Net revenue from the Softgel and Oral Technologies segment was $221.1 million for the first quarter of fiscal 2021, a decrease of 16% as reported or 17% in constant currency, compared to the first quarter a year ago. Segment EBITDA was $37.8 million in the first quarter of fiscal 2021, a decrease of 18% as reported, or 20% in constant currency, compared to the first quarter a year ago. Segment EBITDA margin was 17.1% in the first quarter of fiscal 2021 compared to 17.6% in the first quarter of the prior year.
After excluding the impact of the October 2019 divestiture of the segment’s consumer health manufacturing site in Australia, net revenue decreased 12% and segment EBITDA decreased 21% compared to the three months ended September 30, 2019.
The Softgel and Oral Technologies segment represented 26% of Catalent’s total net revenue in the first quarter of fiscal 2021.
Oral and Specialty Delivery
Net revenue from the Oral and Specialty Delivery segment was $158.3 million for the first quarter of fiscal 2021, an increase of 19% as reported and 17% in constant currency, over the first quarter a year ago. Segment EBITDA in the first quarter of fiscal 2021 was $21.4 million, a decrease of 23% as reported, or 26% in constant currency, compared to the first quarter a year ago. Segment EBITDA margin was 13.5% in the first quarter of fiscal 2021 compared to 20.9% in the first quarter of the prior year.
Excluding the effect of acquisitions, net revenue decreased 1% and segment EBITDA decreased 61% compared to the three months ended September 30, 2019.
The Oral and Specialty Delivery segment represented 19% of Catalent’s total net revenue in the first quarter of fiscal 2021.
Clinical Supply Services
Net revenue from the Clinical Supply Services segment was $92.7 million for the first quarter of fiscal 2021, an increase of 10% as reported and 8% in constant currency, compared to the first quarter a year ago. Segment EBITDA in the first quarter of fiscal 2021 was $25.0 million, an increase of 16% as reported, or 13% in constant currency, compared to the first quarter a year ago. Segment EBITDA margin was 27.0% in the first quarter of fiscal 2021 compared to 25.5% in the first quarter of the prior year.
The Clinical Supply Services segment represented 11% of Catalent’s total net revenue in the first quarter of fiscal 2021.
Backlog for the Clinical Supply Services segment, defined as estimated future service revenues from work not yet completed under signed contracts, was $428 million as of September 30, 2020, compared to backlog of $425 million as of June 30, 2020 and $374 million as of September 30, 2019. The segment recorded net new business wins of $99 million during the first quarter of fiscal 2021, an increase of 6.4% compared to the net new business wins recorded in the first quarter of the prior year.
Balance Sheet and Liquidity
As of September 30, 2020, Catalent had $3.1 billion in total debt, and $2.1 billion in total debt net of cash and short-term investments, compared to $2.1 billion in total net debt as of June 30, 2020 . The current debt structure does not include any significant maturity until 2026.
Catalent’s net leverage ratio as of September 30, 2020 was 2.6x, compared to 2.8x at June 30, 2020 and 4.3x at September 30, 2019.
Fiscal Year 2021 Outlook
Catalent is raising its previously issued guidance to reflect first quarter performance and to account for higher net underlying demand, including increased demand related to COVID-19 treatments and vaccines, partially offset by lower demand attributed to the effects of the pandemic in some offerings.
The revised guidance continues to assume no major change to either the current status of the COVID-19 pandemic generally or its effect on Catalent’s operations and business. Also, as with the earlier guidance, the revised guidance does not assume the receipt by any of our customers of any marketing approval, on an emergency basis or otherwise, for their COVID-19 vaccine candidates (but does include the projected revenue from take-or-pay arrangements in executed contracts). The guidance ranges set forth below are broader than in recent years due to the increased uncertainty introduced by the COVID-19 pandemic. The revised guidance projects:
- Net revenue in the range of $3.58 billion to $3.78 billion, compared to the previous range of $3.45 billion to $3.60 billion;
- Adjusted EBITDA in the range of $880 million to $950 million, compared to the previous range of $840 million to $890 million;
- Adjusted Net Income in the range of $410 million to $470 million, compared to the previous range of $390 million to $435 million; and
- A fully diluted share count in the range of 178 million to 180 million shares on a weighted-average basis, counting the Series A convertible preferred shares as-if converted, unchanged from previous guidance.
Earnings Webcast
The Company’s management will host a webcast to discuss the results at 8:15 a.m. ET today. Catalent invites all interested parties to listen to the webcast, which will be accessible through Catalent’s website at http://investor.catalent.com. A supplemental slide presentation will also be available in the “Investors” section of Catalent’s website prior to the start of the webcast. The webcast replay, along with the supplemental slides, will be available for 90 days in the “Investors” section of Catalent’s website at www.catalent.com.
About Catalent, Inc.
Catalent, Inc. (NYSE: CTLT), an S&P 500® company, is the leading global provider of advanced delivery technologies, development, and manufacturing solutions for drugs, biologics, cell and gene therapies, and consumer health products. With over 85 years serving the industry, Catalent has proven expertise in bringing more customer products to market faster, enhancing product performance and ensuring reliable clinical and commercial product supply. Catalent employs more than 14,000 people, including approximately 2,400 scientists, at more than 40 facilities across four continents and in fiscal 2020 generated over $3 billion in annual revenue. Catalent is headquartered in Somerset, N.J. For more information, please visit www.catalent.com.
Non-GAAP Financial Measures
Use of EBITDA from operations, Adjusted EBITDA, Adjusted Net Income and Segment EBITDA
Management measures operating performance based on consolidated earnings from operations before interest expense, expense/(benefit) for income taxes, and depreciation and amortization, adjusted for the income or loss attributable to non-controlling interests (“EBITDA from operations”). EBITDA from operations is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP, and is subject to important limitations.
Catalent believes that the presentation of EBITDA from operations enhances an investor’s understanding of its financial performance. Catalent believes this measure is a useful financial metric to assess its operating performance across periods by excluding certain items that it believes are not representative of its core business and uses this measure for business planning purposes.
In addition, given the significant investments that Catalent has made in the past in property, plant and equipment, depreciation and amortization expenses represent a meaningful portion of its cost structure. Catalent believes that EBITDA from operations will provide investors with a useful tool for assessing the comparability between periods of its ability to generate cash from operations sufficient to pay taxes, to service debt and to undertake capital expenditures because it eliminates depreciation and amortization expense. Catalent presents EBITDA from operations in order to provide supplemental information that it considers relevant for the readers of its consolidated financial statements, and such information is not meant to replace or supersede U.S. GAAP measures. Catalent’s definition of EBITDA from operations may not be the same as similarly titled measures used by other companies.
Catalent evaluates the performance of its segments based on segment earnings before non-controlling interest, other (income)/expense, impairments, restructuring costs, interest expense, income tax expense/(benefit), and depreciation and amortization (“segment EBITDA”). Moreover, under Catalent’s credit agreement, its ability to engage in certain activities, such as incurring certain additional indebtedness, making certain investments and paying certain dividends, is tied to ratios based on Adjusted EBITDA, which is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP, and is subject to important limitations. Adjusted EBITDA is the covenant compliance measure used in the credit agreement governing debt incurrence and restricted payments. Because not all companies use identical calculations, Catalent’s presentation of Adjusted EBITDA may not be comparable to other similarly titled measures of other companies.
Management also measures operating performance based on Adjusted Net Income/(Loss) and Adjusted Net Income/(Loss) per share. Adjusted Net Income/(Loss) is not defined under U.S. GAAP, is not a measure of operating income, operating performance, or liquidity presented in accordance with U.S. GAAP and is subject to important limitations. Catalent believes that the presentation of Adjusted Net Income/(Loss) and Adjusted Net Income/(Loss) per share enhances an investor’s understanding of its financial performance. Catalent believes these measures are a useful financial metric to assess its operating performance across periods by excluding certain items that it believes are not representative of its core business and Catalent uses these measures for business planning purposes. Catalent defines Adjusted Net Income/(Loss) as net earnings/(loss) adjusted for amortization attributable to purchase accounting and adjustments for other cash and non-cash items included in the table below, partially offset by its estimate of the tax effects of such cash and non-cash items. Catalent believes that Adjusted Net Income/(Loss) and Adjusted Net Income/(Loss) per share provides investors with a useful tool for assessing the comparability between periods of its ability to generate cash from operations available to its stockholders. Catalent’s definition of Adjusted Net Income/(Loss) may not be the same as similarly titled measures used by other companies.
The most directly comparable U.S. GAAP measure to EBITDA from operations is operating earnings/(loss). The most directly comparable U.S. GAAP measure to Adjusted EBITDA and Adjusted Net Income/(Loss) is net earnings/(loss). Included in this release is a reconciliation of operating earnings/(loss) to EBITDA from operations and a reconciliation of net earnings/(loss) to Adjusted EBITDA and Adjusted Net Income.
Catalent does not provide a reconciliation of forward-looking non-GAAP financial measures to their comparable U.S. GAAP financial measures because it could not do so without unreasonable effort due to the unavailability of the information needed to calculate reconciling items and due to the variability, complexity and limited visibility of the adjusting items that would be excluded from the non-GAAP financial measures in future periods. When planning, forecasting, and analyzing future periods, Catalent does so primarily on a non-GAAP basis without preparing a U.S. GAAP analysis as that would require estimates for various cash and non-cash reconciling items that would be difficult to predict with reasonable accuracy. For example, equity compensation expense would be difficult to estimate because it depends on Catalent’s future hiring and retention needs, as well as the future fair market value of its common stock, all of which are difficult to predict and subject to constant change. It is equally difficult to anticipate the need for or magnitude of a presently unforeseen one-time restructuring expense or the values of end-of-period foreign currency exchange rates. As a result, Catalent does not believe that a U.S. GAAP reconciliation would provide meaningful supplemental information about its outlook.
Use of Constant Currency
As changes in exchange rates are an important factor in understanding period-to-period comparisons, Catalent believes the presentation of results on a constant-currency basis in addition to reported results helps improve investors’ ability to understand its operating results and evaluate its performance in comparison to prior periods. Constant-currency information compares results between periods as if exchange rates had remained constant period over period. Catalent uses results on a constant-currency basis as one measure to evaluate its performance. Catalent calculates constant currency by calculating current-year results using prior-year foreign currency exchange rates. Catalent generally refers to such amounts calculated on a constant-currency basis as excluding the impact of foreign exchange or being on a constant-currency basis. These results should be considered in addition to, not as a substitute for, results reported in accordance with U.S. GAAP. Results on a constant-currency basis, as Catalent presents them, may not be comparable to similarly titled measures used by other companies and are not measures of performance presented in accordance with U.S. GAAP.
Forward-Looking Statements
This release contains both historical and forward-looking statements. All statements other than statements of historical fact, are, or may be deemed to be, forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements generally can be identified by the use of statements that include phrases such as “believe,” “expect,” “anticipate,” “intend,” “estimate,” “plan,” “project,” “foresee,” “likely,” “may,” “will,” “would,” or other words or phrases with similar meanings. Similarly, statements that describe Catalent’s objectives, plans, or goals are, or may be, forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Catalent’s expectations and projections. Some of the factors that could cause actual results to differ include, but are not limited to, the following: the current or future effects of the COVID-19 pandemic on Catalent’s and its clients’ businesses; participation in a highly competitive market and increased competition that may adversely affect Catalent’s business; demand for its offerings, which depends in part on its customers’ research and development and the clinical and market success of their products; product and other liability risks that could adversely affect Catalent’s results of operations, financial condition, liquidity and cash flows; failure to comply with existing and future regulatory requirements; failure to provide quality offerings to customers could have an adverse effect on Catalent’s business and subject it to regulatory actions and costly litigation; problems providing the highly exacting and complex services or support required; global economic, political and regulatory risks to Catalent’s operations; inability to enhance existing or introduce new technology or service offerings in a timely manner; inadequate patents, copyrights, trademarks and other forms of intellectual property protections; fluctuations in the costs, availability, and suitability of the components of the products Catalent manufactures, including active pharmaceutical ingredients, excipients, purchased components and raw materials; changes in market access or healthcare reimbursement in the United States or internationally; fluctuations in the exchange rate of the U.S. dollar against other currencies, including as a result of the U.K.’s exit from the European Union; adverse tax legislative or regulatory initiatives or challenges or adjustments to Catalent’s tax positions; loss of key personnel; risks generally associated with information systems; inability to complete any future acquisitions or other transactions that may complement or expand its business or divest of non-strategic businesses or assets and difficulties in successfully integrating acquired businesses and realizing anticipated benefits of such acquisitions; risks associated with timely and successfully completing, and correctly anticipating the future demand predicted for, capital expansion projects at existing facilities, offerings and customers’ products that may infringe on the intellectual property rights of third parties; environmental, health and safety laws and regulations, which could increase costs and restrict operations; labor and employment laws and regulations or labor difficulties, which could increase costs or result in operational disruptions; additional cash contributions required to fund Catalent’s existing pension plans; substantial leverage that may limit its ability to raise additional capital to fund operations and react to changes in the economy or in the industry; and exposure to interest-rate risk to the extent of its variable-rate debt preventing it from meeting its obligations under its indebtedness. For a more detailed discussion of these and other factors, see the information under the caption “Risk Factors” in Catalent’s Annual Report on Form 10-K for the fiscal year ended June 30, 2020, filed August 31, 2020. All forward-looking statements speak only as of the date of this release or as of the date they are made, and Catalent does not undertake to update any forward-looking statement as a result of new information or future events or developments except to the extent required by law.
More products. Better treatments. Reliably supplied.™
|
Catalent, Inc. and Subsidiaries Consolidated Statements of Operations (Unaudited; dollars and shares in millions, except per share data) |
||||||||||||||||||
|
|
Three Months Ended |
|
FX Impact |
|
Constant Currency Increase/(Decrease) |
|||||||||||||
|
|
2020 |
|
2019 |
|
|
|
Change $ |
|
Change % |
|||||||||
|
Net revenue |
$ |
845.7 |
|
|
$ |
664.7 |
|
|
$ |
9.7 |
|
|
$ |
171.3 |
|
|
26 |
% |
|
Cost of sales |
596.8 |
|
|
487.0 |
|
|
5.8 |
|
|
104.0 |
|
|
21 |
% |
||||
|
Gross margin |
248.9 |
|
|
177.7 |
|
|
3.9 |
|
|
67.3 |
|
|
38 |
% |
||||
|
Selling, general, and administrative expenses |
164.7 |
|
|
142.8 |
|
|
0.9 |
|
|
21.0 |
|
|
15 |
% |
||||
|
Impairment charges and (gain)/loss on sale of assets |
1.8 |
|
|
(0.2) |
|
|
— |
|
|
2.0 |
|
|
(1,000) |
% |
||||
|
Restructuring and other |
0.9 |
|
|
0.7 |
|
|
0.1 |
|
|
0.1 |
|
|
14 |
% |
||||
|
Operating earnings |
81.5 |
|
|
34.4 |
|
|
2.9 |
|
|
44.2 |
|
|
128 |
% |
||||
|
Interest expense, net |
25.3 |
|
|
36.3 |
|
|
0.2 |
|
|
(11.2) |
|
|
(31) |
% |
||||
|
Other (income)/expense, net |
(11.2) |
|
|
4.9 |
|
|
1.5 |
|
|
(17.6) |
|
|
(359) |
% |
||||
|
Earnings/(loss) before income taxes |
67.4 |
|
|
(6.8) |
|
|
1.2 |
|
|
73.0 |
|
|
(1,074) |
% |
||||
|
Income tax expense |
(15.0) |
|
|
(6.9) |
|
|
(0.1) |
|
|
(8.0) |
|
|
116 |
% |
||||
|
Net earnings |
$ |
82.4 |
|
|
$ |
0.1 |
|
|
$ |
1.3 |
|
|
$ |
81.0 |
|
|
81,000 |
% |
|
Less: Net earnings attributable to preferred shareholders |
(13.6) |
|
|
(8.1) |
|
|
— |
|
|
— |
|
|
— |
% |
||||
|
Net earnings/(loss) attributable to common shareholders |
$ |
68.8 |
|
|
$ |
(8.0) |
|
|
$ |
— |
|
|
$ |
— |
|
|
— |
% |
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
Weighted average shares outstanding |
164.1 |
|
|
145.7 |
|
|
|
|
|
|
|
|||||||
|
Weighted average diluted shares outstanding |
166.5 |
|
|
145.7 |
|
|
|
|
|
|
|
|||||||
|
|
|
|
|
|
|
|
|
|
|
|||||||||
|
Earnings/(loss) per share: |
|
|
|
|
|
|
|
|
|
|||||||||
|
Basic |
|
|
|
|
|
|
|
|
|
|||||||||
|
Net earnings/(loss) |
$ |
0.42 |
|
|
$ |
(0.05) |
|
|
|
|
|
|
|
|||||
|
Diluted |
|
|
|
|
|
|
|
|
|
|||||||||
|
Net earnings/(loss) |
$ |
0.41 |
|
|
$ |
(0.05) |
|
|
|
|
|
|
|
|||||
Contacts
Investor Contact:
Catalent, Inc.
Paul Surdez
732-537-6325
The sites are key conduits for communication and information. Here’s how they plan to handle the challenges facing them before, on and after Tuesday.
Facebook, YouTube and Twitter were misused by Russians to inflame American voters with divisive messages before the 2016 presidential election. The companies have spent the past four years trying to ensure that this November isn’t a repeat.
They have spent billions of dollars improving their sites’ security, policies and processes. In recent months, with fears rising that violence may break out after the election, the companies have taken numerous steps to clamp down on falsehoods and highlight accurate and verified information.
We asked Facebook, Twitter and YouTube to walk us through what they were, are and will be doing before, on and after Tuesday.
Before the election
Since 2016, Facebook has poured billions of dollars into beefing up its security operations to fight misinformation and other harmful content. It now has more than 35,000 people working on this, the company said.
One team, led by a former National Security Council operative, has searched for “coordinated inauthentic behavior” by accounts that work in concert to spread false information. That team, which delivers regular reports, will be on high alert on Tuesday. Facebook has also worked with government agencies and other tech companies to spot foreign interference.
To demystify its political advertising, Facebook created an ad library so people can see what political ads are being bought and by whom, as well as how much those entities are spending. The company also introduced more steps for people who buy those ads, including a requirement that they live in the United States. To prevent candidates from spreading bad information, Facebook stopped accepting new political ads on Oct. 20.
At the same time, it has tried highlighting accurate information. In June, it rolled out a voter information hub with data on when, how and where to register to vote, and it is promoting the feature atop News Feeds through Tuesday. It also said it would act swiftly against posts that tried to dissuade people from voting, had limited forwarding of messages on its WhatsApp messaging service and had begun working with Reuters on how to handle verified election results.
Facebook has made changes up till the last minute. Last week, it said it had turned off political and social group recommendations and temporarily removed a feature in Instagram’s hashtag pages to slow the spread of misinformation.
On Tuesday, an operations center with dozens of employees — what Facebook calls a “war room” — will work to identify efforts to destabilize the election. The team, which will work virtually because of the coronavirus pandemic, has already been in action and is operating smoothly, Facebook said.
Facebook’s app will also look different on Tuesday. To prevent candidates from prematurely and inaccurately declaring victory, the company plans to add a notification at the top of News Feeds letting people know that no winner has been chosen until election results are verified by news outlets like Reuters and The Associated Press.
Facebook also plans to deploy, if needed, special tools that it has used in “at-risk countries” like Myanmar, where election-related violence was a possibility. The tools, which Facebook has not described publicly, are designed to slow the spread of inflammatory posts.
After the election
After the polls close, Facebook plans to suspend all political ads from circulating on the social network and its photo-sharing site, Instagram, to reduce misinformation about the election’s outcome. Facebook has told advertisers that they can expect the ban to last for a week, though the timeline isn’t set in stone and the company has publicly been noncommittal about the duration.
“We’ve spent years working to make elections safer and more secure on our platform,” said Kevin McAlister, a Facebook spokesman. “We’ve applied lessons from previous elections, built new teams with experience across different areas and created new products and policies to prepare for various scenarios before, during and after Election Day.”
Before the election
Twitter has also worked to combat misinformation since 2016, in some cases going far further than Facebook. Last year, for instance, it banned political advertising entirely, saying the reach of political messages “should be earned, not bought.”
At the same time, Twitter started labeling tweets by politicians if they spread inaccurate information or glorify violence. In May, it added several fact-checking labels to President Trump’s tweets about Black Lives Matter protests and mail-in voting, and restricted people’s ability to share those posts.
In October, Twitter began experimenting with additional techniques to slow the spread of misinformation. The company added context to trending topics and limited users’ ability to quickly retweet content. The changes are temporary, though Twitter has not said when they will end.
The company also used push notifications and banners in its app to warn people about common misinformation themes, including falsehoods about the reliability of mail-in ballots. And it expanded its partnerships with law enforcement agencies and secretaries of state so they can report misinformation directly to Twitter.
In September, Twitter added an Election Hub that users can use to look for curated information about polling, voting and candidates. The company has said it will remove tweets that call for interference with voters and polling places or intimidate people to dissuade them from voting.
“The whole company has really been mobilized to help us prepare for and respond to the types of threats that potentially come up in an election,” said Yoel Roth, Twitter’s head of site integrity.
Election Day
On Tuesday, Twitter’s strategy is twofold: Root out false claims and networks of bots that spread such information by using both algorithms and human analysts, while another team highlights reliable information in the Explore and Trends sections of its service.
Twitter plans to add labels to tweets from candidates who claim victory before the election is called by authoritative sources. At least two news outlets will need to independently project the results before a candidate can use Twitter to celebrate his or her win, the company said.
People looking for updates on Tuesday will be able find them in the Election Hub, Twitter said.
After the election
Twitter will eventually allow people to retweet again without prompting them to add their own context. But many of the changes for the election — like the ban on political ads and the fact-checking labels — are permanent.
YouTube
Before the election
For Google’s YouTube, it wasn’t the 2016 election that sounded a wake-up call about the toxic content spreading across its website. That moment came in 2017 when a group of men drove a van into pedestrians on London Bridge after being inspired by YouTube videos of inflammatory sermons from an Islamic cleric.
Since then, YouTube has engaged in an often confusing journey to police its site. It has overhauled its policies to target misinformation, while tweaking its algorithms to slow the spread of what it deems borderline content — videos that do not blatantly violate its rules but butt up against them.
It has brought in thousands of human reviewers to examine videos to help improve the performance of its algorithms. It has also created a so-called intelligence desk of former analysts from government intelligence agencies to monitor the actions of foreign state actors and trends on the internet.
Neal Mohan, YouTube’s chief product officer, said that he held several meetings a week with staff to discuss the election, but that there was no last-minute effort to rewrite policies or come up with new approaches.
“Of course, we’re taking the elections incredibly seriously,” he said in an interview. “The foundational work that will play a really major role for all of this began three years ago when we really began the work in earnest in terms of our responsibility as a global platform.”
Before Tuesday, YouTube’s home page will also feature links to information about how and where to vote.
Election Day
On Tuesday, Mr. Mohan plans to check in regularly with his teams to keep an eye on anything unusual, he said. There will be no “war room,” and he expects that most decisions to keep or remove videos will be clear and that the usual processes for making those decisions will be sufficient.
If a more nuanced decision is required around the election, Mr. Mohan said, it will escalate to senior people at YouTube, and the call will be made as a group.
YouTube said it would be especially sensitive about videos that aimed to challenge the election’s integrity. YouTube does not allow videos that mislead voters about how to vote or the eligibility of a candidate, or that incite people to interfere with the voting process. The company said it would take down such videos quickly, even if one of the speakers was a presidential candidate.
As the polls close, YouTube will feature a playlist of live election results coverage from what it deems authoritative news sources. While YouTube would not provide a full list of the sources, the company said it expected the coverage to include news videos from the major broadcast networks, as well as CNN and Fox News.
After the election
Starting on Tuesday and continuing as needed, YouTube will display a fact-check information panel above election-related search results and below videos discussing the results, the company said. The information panel will feature a warning that results may not be final and provide a link to real-time results on Google with data from The A.P.
Google has said it will halt election advertising after the polls officially close. The policy, which extends to YouTube, will temporarily block any ads that refer to the 2020 election, its candidates or its outcome. It is not clear how long the ban will last.
— New York Times: Top Stories
— Mike Isaac, Kate Conger and
Did Christmas come early this year?
— FOX News
Christian actor and filmmaker Kirk Cameron said people of faith across the nation are realizing “socialism and communism are knocking on our doors.”
— FOX News
Doesn’t seem like it has.
You remember the legal horror show called Bush v. Gore? The Supreme Court couldn’t possibly replicate that. But don’t underestimate the justices’ capacity for self-inflicted wounds. The sequel’s being scripted and it may be worse.
Twenty years ago, the court stepped in to halt a recount in the disputed 2000 presidential election. Both the Constitution and federal law specifically entrusted Congress to resolve such a deadlock. But the justices recklessly inserted themselves anyway. The fiercely divided ruling cost the court its legitimacy and hurt the country.
Now there are widespread worries that the court will jump in again. “I think this will end up in the Supreme Court,” President Trump said in late September. Having just placed Amy Coney Barrett, the sixth Republican-appointed justice on the court, he is evidently thrilled about that prospect.
Only two justices remain on the court who were there in 2000 — Clarence Thomas and Stephen Breyer. Have they and their fellow justices learned anything from the court’s misadventure?
— New York Times: Top Stories
TOKYO & MUNICH & BASKING RIDGE, N.J.–(BUSINESS WIRE)–Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) and AstraZeneca today announced the initiation of DESTINY-Breast05, a global phase 3, head-to-head trial of ENHERTU® (fam-trastuzumab deruxtecan-nxki) versus ado-trastuzumab emtansine (T-DM1) as adjuvant therapy in patients with HER2 positive early breast cancer with high risk of disease recurrence who have residual invasive disease in the breast or axillary lymph nodes after receiving neo-adjuvant therapy. DESTINY-Breast05 will be conducted in collaboration with the National Surgical Adjuvant Breast and Bowel Project Foundation (NSABP), the German Breast Group (GBG), Arbeitsgemeinschaft Gynäkologische Onkologie (AGO-B) and the SOLTI Breast Cancer Research Group.
Neo-adjuvant treatment is given before surgery to help shrink the tumor and make it easier to remove. Patients with residual invasive disease in the breast or lymph nodes at surgery following neo-adjuvant treatment are at greater risk for disease recurrence or death than patients who achieve a pathological complete response, meaning there is no detectable disease in the tissue removed during surgery.1 Adjuvant treatment, given after surgery, aims to eradicate any remaining cancer cells in the breast or the rest of the body, to help lower the risk of the cancer returning.
“Despite recent improvements and approvals of new medicines, there remain significant clinical needs for patients with HER2 positive early breast cancer with residual invasive disease after completing neo-adjuvant treatment. We recognize the important opportunity that exists post-surgery to slow disease progression with further adjuvant treatment,” said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. “This research builds on the data from DESTINY-Breast01 which showed durability of response in previously treated HER2 positive metastatic breast cancer. DESTINY-Breast05 will evaluate ENHERTU in patients with early HER2 positive breast cancer, versus T-DM1, the current standard of care, which marks the first time we will evaluate the clinical benefit of ENHERTU in early breast cancer, reflecting our commitment to transforming treatment for even more patients with HER2 targetable disease.”
“NSABP and our academic collaborators are committed to designing and conducting trials that have potential for further improving the way breast cancer is treated by evaluating promising new therapies that may provide patients and physicians with additional treatment options,” said Charles E. Geyer, Jr, MD, chair of the NSABP Foundation Breast Cancer Committee and Deputy Director of the Houston Methodist Cancer Center. “We are excited to collaborate with Daiichi Sankyo and AstraZeneca on this important study, with the goal of comparing the safety and clinical benefit of the two currently available HER2 directed antibody drug conjugates in early stage breast cancer.”
ENHERTU is approved in the U.S. with Boxed WARNINGS for Interstitial Lung Disease and Embryo-Fetal Toxicity. For more information, please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.
About DESTINY-Breast05
DESTINY-Breast05 is a phase 3, multicenter, randomized, open-label, active-controlled study of ENHERTU versus T-DM1 in patients with high-risk HER2 positive primary breast cancer who have residual invasive disease in breast or axillary lymph nodes following neo-adjuvant therapy. Patients will be defined as high risk based on inoperable cancer at disease presentation (clinical stages T4, N0-3, M0 or T1-3, N2-3, M0) or operable at presentation (clinical stages T1-3, N0-1, M0) with positive pathological node status (ypN1-3) after neo-adjuvant therapy.
Patients will be randomized in a 1:1 ratio to either the ENHERTU or T-DM1 treatment group. Randomization will be stratified by the following factors:
- Operative status at disease presentation, prior to neo-adjuvant therapy (operable [clinical stages T1-3, N0-1, M0] versus inoperable [clinical stages T4, N0-3, M0 or T1-3, N2-3, M0])
- Tumor hormone receptor status (positive versus negative)
- Post-neo-adjuvant therapy pathologic nodal status (positive [ypN1-3] versus negative [ypN0])
- HER2 targeted neo-adjuvant therapy approach (single versus dual)
The primary efficacy endpoint is invasive disease-free survival (IDFS) based on investigator assessment. Secondary efficacy endpoints include overall survival and disease-free survival based on disease recurrence per investigator assessment. Safety endpoints include serious adverse events, treatment-emergent adverse events and adverse events of special interest. Health economics and outcomes research endpoints as well as pharmacokinetic and biomarker endpoints will also be measured.
DESTINY-Breast05 will enroll up to 1,600 patients at approximately 400 sites in North America, Europe, and Asia. For more information about the study, visit ClinicalTrials.gov.
About HER2 Positive Breast Cancer
In women, breast cancer is the most common cancer and one of the most common causes of cancer mortality worldwide; there were an estimated 2.1 million new cases of female breast cancer diagnosed in 2018.2
HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of many types of tumors including gastric, breast and lung cancers. HER2 overexpression may be associated with a specific HER2 gene alteration known as HER2 amplification and is often associated with aggressive disease and poor prognosis in breast cancer.3
About ENHERTU
ENHERTU is a HER2 directed ADC and is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced program in AstraZeneca’s ADC scientific platform.
ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy (“payload”) to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary DXd ADC technology, ENHERTU is comprised of a HER2 monoclonal antibody attached to a topoisomerase I inhibitor payload by a tetrapeptide-based linker.
ENHERTU (5.4 mg/kg) is approved in the U.S. under Accelerated Approval and Japan for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who received two or more prior anti-HER2 based regimens based on the DESTINY-Breast01 trial. ENHERTU (6.4 mg/kg) is also approved in Japan for the treatment of patients with HER2 positive unresectable advanced or recurrent gastric cancer that has progressed after chemotherapy based on the DESTINY-Gastric01 trial.
About the ENHERTU Clinical Development Program
A comprehensive development program is underway globally with eight registrational trials evaluating the efficacy and safety of ENHERTU monotherapy across multiple HER2 targetable cancers including breast, gastric and lung cancers. Trials in combination with other anticancer treatments, such as immunotherapy, are also underway.
In October 2020, ENHERTU was granted Priority Review from the U.S. Food and Drug Administration (FDA) for the treatment of patients with HER2 positive metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma. In May 2020, ENHERTU received a Breakthrough Therapy Designation (BTD) and Orphan Drug Designation (ODD) for gastric cancer, including GEJ adenocarcinoma.
In May 2020, ENHERTU also received a BTD for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors have a HER2 mutation and with disease progression on or after platinum-based therapy. ENHERTU is not approved in the U.S. in either NSCLC or gastric cancer.
In July 2020, the European Medicines Agency’s Committee for Medicinal Products for Human Use granted accelerated assessment for the treatment of adults with unresectable or metastatic HER2 positive breast cancer who have received two or more prior anti-HER2 based regimens.
About the Collaboration between Daiichi Sankyo and AstraZeneca
Daiichi Sankyo and AstraZeneca entered into a global collaboration to jointly develop and commercialize ENHERTU (a HER2 directed ADC) in March 2019, and DS-1062 (a TROP2 directed ADC) in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights. Daiichi Sankyo is responsible for manufacturing and supply of ENHERTU and DS-1062.
U.S. FDA-Approved Indication for ENHERTU
ENHERTU is a HER2-directed antibody and topoisomerase inhibitor conjugate indicated for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens in the metastatic setting.
This indication is approved under accelerated approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.
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WARNING: INTERSTITIAL LUNG DISEASE and EMBRYO-FETAL TOXICITY
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Contraindications
None.
WARNINGS AND PRECAUTIONS
Interstitial Lung Disease / Pneumonitis
Severe, life-threatening, or fatal interstitial lung disease (ILD), including pneumonitis, can occur in patients treated with ENHERTU. In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU, ILD occurred in 9% of patients. Fatal outcomes due to ILD and/or pneumonitis occurred in 2.6% of patients treated with ENHERTU. Median time to first onset was 4.1 months (range: 1.2 to 8.3).
Advise patients to immediately report cough, dyspnea, fever, and/or any new or worsening respiratory symptoms. Monitor patients for signs and symptoms of ILD. Promptly investigate evidence of ILD. Evaluate patients with suspected ILD by radiographic imaging. Consider consultation with a pulmonologist. For asymptomatic ILD/pneumonitis (Grade 1), interrupt ENHERTU until resolved to Grade 0, then if resolved in ≤28 days from date of onset, maintain dose. If resolved in >28 days from date of onset, reduce dose one level. Consider corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥0.5 mg/kg prednisolone or equivalent). For symptomatic ILD/pneumonitis (Grade 2 or greater), permanently discontinue ENHERTU. Promptly initiate corticosteroid treatment as soon as ILD/pneumonitis is suspected (e.g., ≥1 mg/kg prednisolone or equivalent). Upon improvement, follow by gradual taper (e.g., 4 weeks).
Neutropenia
Severe neutropenia, including febrile neutropenia, can occur in patients treated with ENHERTU. Of the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, a decrease in neutrophil count was reported in 30% of patients and 16% had Grade 3 or 4 events. Median time to first onset was 1.4 months (range: 0.3 to 18.2). Febrile neutropenia was reported in 1.7% of patients.
Monitor complete blood counts prior to initiation of ENHERTU and prior to each dose, and as clinically indicated. Based on the severity of neutropenia, ENHERTU may require dose interruption or reduction. For Grade 3 neutropenia (Absolute Neutrophil Count [ANC] <1.0 to 0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less, then maintain dose. For Grade 4 neutropenia (ANC <0.5 x 109/L) interrupt ENHERTU until resolved to Grade 2 or less. Reduce dose by one level. For febrile neutropenia (ANC <1.0 x 109/L and temperature >38.3ºC or a sustained temperature of ≥38ºC for more than 1 hour), interrupt ENHERTU until resolved. Reduce dose by one level.
Left Ventricular Dysfunction
Patients treated with ENHERTU may be at increased risk of developing left ventricular dysfunction. Left ventricular ejection fraction (LVEF) decrease has been observed with anti-HER2 therapies, including ENHERTU. In the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, two cases (0.9%) of asymptomatic LVEF decrease were reported. Treatment with ENHERTU has not been studied in patients with a history of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment.
Assess LVEF prior to initiation of ENHERTU and at regular intervals during treatment as clinically indicated. Manage LVEF decrease through treatment interruption. Permanently discontinue ENHERTU if LVEF of <40% or absolute decrease from baseline of >20% is confirmed. When LVEF is >45% and absolute decrease from baseline is 10-20%, continue treatment with ENHERTU. When LVEF is 40-45% and absolute decrease from baseline is <10%, continue treatment with ENHERTU and repeat LVEF assessment within 3 weeks. When LVEF is 40-45% and absolute decrease from baseline is 10-20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF has not recovered to within 10% from baseline, permanently discontinue ENHERTU. If LVEF recovers to within 10% from baseline, resume treatment with ENHERTU at the same dose. When LVEF is <40% or absolute decrease from baseline is >20%, interrupt ENHERTU and repeat LVEF assessment within 3 weeks. If LVEF of <40% or absolute decrease from baseline of >20% is confirmed, permanently discontinue ENHERTU. Permanently discontinue ENHERTU in patients with symptomatic congestive heart failure.
Embryo-Fetal Toxicity
ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. Verify the pregnancy status of females of reproductive potential prior to the initiation of ENHERTU. Advise females of reproductive potential to use effective contraception during treatment and for at least 7 months following the last dose of ENHERTU. Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months after the last dose of ENHERTU.
Adverse Reactions
The safety of ENHERTU was evaluated in a pooled analysis of 234 patients with unresectable or metastatic HER2-positive breast cancer who received at least one dose of ENHERTU 5.4 mg/kg in DESTINY-Breast01 and Study DS8201-A-J101. ENHERTU was administered by intravenous infusion once every three weeks. The median duration of treatment was 7 months (range: 0.7 to 31).
Serious adverse reactions occurred in 20% of patients receiving ENHERTU. Serious adverse reactions in >1% of patients who received ENHERTU were interstitial lung disease, pneumonia, vomiting, nausea, cellulitis, hypokalemia, and intestinal obstruction. Fatalities due to adverse reactions occurred in 4.3% of patients including interstitial lung disease (2.6%), and the following events occurred in one patient each (0.4%): acute hepatic failure/acute kidney injury, general physical health deterioration, pneumonia, and hemorrhagic shock.
ENHERTU was permanently discontinued in 9% of patients, of which ILD accounted for 6%. Dose interruptions due to adverse reactions occurred in 33% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose interruption were neutropenia, anemia, thrombocytopenia, leukopenia, upper respiratory tract infection, fatigue, nausea, and ILD. Dose reductions occurred in 18% of patients treated with ENHERTU. The most frequent adverse reactions (>2%) associated with dose reduction were fatigue, nausea, and neutropenia.
The most common adverse reactions (frequency ≥20%) were nausea (79%), fatigue (59%), vomiting (47%), alopecia (46%), constipation (35%), decreased appetite (32%), anemia (31%), neutropenia (29%), diarrhea (29%), leukopenia (22%), cough (20%), and thrombocytopenia (20%).
Use in Specific Populations
- Pregnancy: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise patients of the potential risks to a fetus. There are clinical considerations if ENHERTU is used in pregnant women, or if a patient becomes pregnant within 7 months following the last dose of ENHERTU.
- Lactation: There are no data regarding the presence of ENHERTU in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with ENHERTU and for 7 months after the last dose.
- Females and Males of Reproductive Potential: Pregnancy testing: Verify pregnancy status of females of reproductive potential prior to initiation of ENHERTU. Contraception: Females: ENHERTU can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 7 months following the last dose. Males: Advise male patients with female partners of reproductive potential to use effective contraception during treatment with ENHERTU and for at least 4 months following the last dose. Infertility: ENHERTU may impair male reproductive function and fertility.
- Pediatric Use: Safety and effectiveness of ENHERTU have not been established in pediatric patients.
- Geriatric Use: Of the 234 patients with HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, 26% were ≥65 years and 5% were ≥75 years. No overall differences in efficacy were observed between patients ≥65 years of age compared to younger patients. There was a higher incidence of Grade 3-4 adverse reactions observed in patients aged ≥65 years (53%) as compared to younger patients (42%).
- Hepatic Impairment: In patients with moderate hepatic impairment, due to potentially increased exposure, closely monitor for increased toxicities related to the topoisomerase inhibitor.
To report SUSPECTED ADVERSE REACTIONS, contact Daiichi Sankyo, Inc. at 1-877-437-7763 or FDA at 1-800-FDA-1088 or fda.gov/medwatch.
Please see accompanying full Prescribing Information, including Boxed WARNINGS, and Medication Guide.
About Daiichi Sankyo Cancer Enterprise
The mission of Daiichi Sankyo Cancer Enterprise is to leverage our world-class, innovative science and push beyond traditional thinking to create meaningful treatments for patients with cancer. We are dedicated to transforming science into value for patients, and this sense of obligation informs everything we do. Anchored by our DXd antibody drug conjugate (ADC) technology, our powerful research engines include biologics, medicinal chemistry, modality and other research laboratories in Japan, and Plexxikon Inc., our small molecule structure-guided R&D center in Berkeley, CA. For more information, please visit: www.DSCancerEnterprise.com.
About Daiichi Sankyo
Daiichi Sankyo Group is dedicated to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally by leveraging our world-class science and technology. With more than 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 15,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. In addition to a strong portfolio of medicines for cardiovascular diseases, under the Group’s 2025 Vision to become a “Global Pharma Innovator with Competitive Advantage in Oncology,” Daiichi Sankyo is primarily focused on providing novel therapies in oncology, as well as other research areas centered around rare diseases and immune disorders. For more information, please visit: www.daiichisankyo.com.
1 Von Minckwitz M, et al. Journal of Clinical Oncology. 2012 30:15, 1796-1804
2 GLOBOCAN 2018 Graph production: IARC. World Health Organization. November 2019.
3 Iqbal N, et al. Mol Biol Int. 2014;852748.
Contacts
Global:
Victoria Amari
Daiichi Sankyo, Inc.
vamari@dsi.com
+1 908 900 3010 (mobile)
US:
Don Murphy
Daiichi Sankyo, Inc.
domurphy@dsi.com
+1 917 817 2649 (mobile)
EU:
Lydia Worms
Daiichi Sankyo Europe GmbH
lydia.worms@daiichi-sankyo.eu
+49 (89) 7808751 (office)
+49 176 11780861 (mobile)
Japan:
Masashi Kawase
Daiichi Sankyo Co., Ltd.
kawase.masashi.a2@daiichisankyo.co.jp
+81 3 6225 1126 (office)
Investor Relations Contact:
DaiichiSankyoIR@daiichisankyo.co.jp
Progressivism will gain momentum in the Democratic Party if Joe Biden loses the election, Fox Nation host Lawrence Jones said on Sunday.
“Being on the campaign trail, I’ve been talking about this for a minute about the progressive side of the Democratic Party. They’re not too happy, especially when they feel like Bernie was robbed. Now, I’m not talking about from a voting standpoint, but, as you guys remember in the second quarter of this, a lot of the party elders, including President Obama, came out and kind of pushed some of the moderates out of the race and said, ‘you know, if you are not careful then we’re going to have Bernie Sanders win this thing,’” Jones told “Fox & Friends.“
Jones said that a lot of progressives “feel robbed from that standpoint.” Jones added that progressives have uprooted establishment-associated Democrats from congressional seats, beyond the victory by Rep. Alexandria Ocasio-Cortez in New York.
“When it comes to the energy on the ground, Dems are in a difficult position because these people have the energy. When you look at Corey Bush who took out [Rep. William Lacy Clay] in Missouri, or you look at what happened to [Rep. Eliot Engel] who was primaried in New York City,” Jones said.
”It’s not just AOC anymore, there are a lot of progressives that are going to be coming to Congress as well as in those state seats as well, so they are in a complicated position.”
Jones reacted to a New York Post article about how progressives will attempt to infiltrate the Democratic Party if 2020 Democratic presidential hopeful Joe Biden loses the election.
“Progressives, socialists and Bernie Bros are gearing up for war should Joe Biden fall short of his quest to unseat President Trump in Tuesday’s election,” The Post reported.
“You would see a complete repudiation of the Democratic establishment as we know it,” said Jabari Brisport, 33, a Democratic Socialist-backed candidate for state Senate expected to easily win a Brooklyn seat next week. “The Democratic establishment is not working for everyday people.”
Jones said that Tea Party members felt left behind after the Republican Party establishment continued to lose elections. He said that progressives will also “feel left behind.”
“These people weren’t ideologues, these people just wanted to have smaller government and they like the party had left them behind,” Jones said about the Tea Party.
“Expect that to happen if Joe Biden loses this race because, you know, this is the last shot for that establishment, we gave you your shot the last two elections. The third time, I don’t think they’re going to be given.”
— FOX News
Many Americans have lost the comfortable bliss of not paying attention to politics.
What did we talk about before Donald Trump? What will we talk about after Donald Trump? Will there even be an after? And was there ever really a before?
One summer day five years or a millennium ago, a boorish TV businessman, a B-list personality with a taste for the tabloid, announced one of those publicity-stunt bids for the presidency you usually hear about only in jokey montages at the end of the local news. Then, somehow, there was a catch in the fabric of time. Maybe we’d misused our technology or maybe it was cosmic retribution for our decadence, or maybe just a bad roll of the dice. Whatever it was, that day our collective attention became fixed upon this one man, and there we have remained ever since. We are stuck in eternal orbit around an expanding black hole, irresistibly sucked in.
His pull grows stronger with each turn of a relentless feedback loop: The more we look, the more he turns us off; the more he turns us off, the more we look. By the time of his inauguration, Trump was already one of the most covered, most discussed, most famous living human beings of all time.
That was only the beginning; each day since, he has come to dominate more of our lives. Now you hear from him anywhere, everywhere, at any time. He’s there on every screen and status update, in every conversation, dream, nightmare. As subtext, he lurks within the arts, in sports, in the weather reports, in houses of worship. For some of us, hardly an hour goes by in which we are not forced to think about the person occupying the White House. Even now, on the precipice of an election that may finally offer an exit from this infinite loop, the end of having to think about Trump seems nowhere close.
Sometimes I wonder about the opportunity cost of all this. If you could count up the time and energy we have spent considering this single person, how much global productive capacity would it amount to? What could we have done instead with all that attention? And what do we have to show for it?
I am no Trump fan, so I am tempted to say it’s all been a waste. I’d like to say that the biggest loss we have experienced under Trump is just this — the loss of our attention, a quiet focus that may otherwise have been put to use fixing one of the planet’s many terrible woes. In the closing days of the presidential campaign, Trump’s insatiable appetite for attention, and our inability to resist feeding it, has even become an argument against his re-election. Two-thirds of Americans report feeling “worn out” by the news. If Joe Biden wins, “it just won’t be so exhausting,” Barack Obama said at a rally the other day. “You might be able to have a Thanksgiving dinner without having an argument.”
That would be nice; I am as excited as anyone for a boring president.
Yet when I got to thinking about how Trump has redirected our attention, I realized I was mistaken. All the time we spent focused on him has not been for nothing; there has been an unexpected upside to his omnipresence. Even as Trump’s presidency has been tiring — not to mention profoundly cruel, deadly and embarrassing for our nation — it has also been something else: motivating.
With nearly every tweet, Trump gave us a new 10-car pileup from which we couldn’t look away. But in the process of making us look at him, Trump forced many of us to actually look for the first time. By turning us into a nation of rubbernecks, he has pushed us to reckon with why things are crashing in the first place and to examine the faulty infrastructure of our democracy.
If we’re lucky, this will be his only lasting legacy. For many of us, Trump has shattered the comfortable bliss of not having to pay attention.
Trump got us to recognize a truth long ignored in American politics: that a competent government is important. American greatness and American goodness can never again be taken for granted. His inept reign has proved that the country cannot run on autopilot, and there is no longer any basis for the lazy idea that America will always, in some automatic and reflexive way, “work things out.”
Trump’s gutting of federal agencies, from the Environmental Protection Agency to the State Department to the Centers for Disease Control and Prevention, proved, through their resulting failures and missteps, the importance of governmental capacity and competence. It is now tragically clear what happens if the federal government is left to wither, if expertise and experience is undermined and overruled, and if honesty, decency, integrity and fairness are abandoned by public officials: People die, people lose their jobs, hate and mistrust fester, long-term problems become sudden emergencies, and the country steadily loses unity and moral standing.
It’s difficult to remember now, but before Trump, to a lot of Americans much of what the federal government did could be relegated to an incidental corner of life. Sure, politics was a blood sport on Twitter and cable TV, but for those other than politics junkies, the Obama years were defined by a deep complacency and cynicism toward the democratic process. The midterm elections of 2010 and 2014 and the presidential races of 2012 and 2016 were low-engagement, low-turnout affairs. You might even say that American political life in the past decade has been determined more by the inaction of those who didn’t participate than by the actions of those who did.
Obama frequently called on Americans to rise above political apathy. Yet beyond his own campaigns, his policies rarely generated mass enthusiasm for the political process. His was an administration of incremental progress, averted disaster and quiet competence. Those are salutary goals, but as Trump would say, they’re boring — it’s difficult to prompt much excitement about the recession that didn’t turn into a depression, the health care plan that solved some problems but not others or the pandemic that wasn’t a national catastrophe.
From Day 1, there was nothing quiet or incremental about Trump. He attacked American institutions frontally and clamorously, shocked us into realizing their fragility and compelled us to stand up against his wrecking ball.
The backlash was swift. When Trump attacked the media, people subscribed in droves. Even as he made moves to dismantle Obamacare, the law remained as popular as it had ever been, scuttling the effort to repeal it. When Trump spewed racist ideas from the White House, many Americans recoiled. For the first time, more Americans now favor expanding immigration instead of restricting it, and a majority of Americans say they support Black Lives Matter. The more that Trump has pushed white identity politics, the less popular it has become.
It wasn’t just public opinion that shifted. The backlash prompted political action. In 2018, a wave of candidates across the country, a lot of them women and people of color, ran for office for the first time. Nearly 120 million Americans voted that year, the highest turnout for the midterms in more than 100 years. This year’s vote could shatter all records. Already, the number of people voting early has far surpassed 2016’s early voting turnout; experts say overall turnout could reach the highest rate since the election of 1908.
Then there are the other, less direct ways Trump has shaken us out of complacency. Would the #MeToo movement have had the same impact if we hadn’t elected a president who had been accused repeatedly of sexual assault? Would lawmakers have begun questioning the role that tech companies play in our lives if the man in the White House hadn’t been a geyser of social media-fueled misinformation? Would Democrats be talking about far-reaching reforms for our democracy — eliminating the Electoral College, expanding the Supreme Court, statehood for the District of Columbia and Puerto Rico — if we weren’t shocked by the dreadful chief executive this broken system has given us?
I don’t think so, at least not to the degree we are now. The Trump years have been among the most disastrous in recent American history. But they weren’t for naught. One day, inshallah, we will look back on this time as the beginning of the great American awakening.
— New York Times: Top Stories
— Columnist Farhad Manjoo
“Saturday Night Live” aired its final “Weekend Update” segment before the 2020 Election Day where it debuted host Colin Jost’s new wedding ring and took direct shots at President Donald Trump.
— FOX News