COVID-19 Vaccinations Coming to 108 Publix Pharmacies in Georgia

 Publix will distribute COVID-19 vaccinations at 108 Publix pharmacies across the state of Georgia thanks to a collaboration with the State of Georgia and Governor Brian Kemp. Vaccinations are provided by appointment only and are for first responders, health care workers, individuals ages 65 and older and their caregivers, and residents and staff of long-term care facilities. Eligible individuals can make appointments beginning Friday, Jan. 15, using the online reservation system at publix.com/covidvaccine, with vaccinations starting Saturday, Jan. 16.

“At Publix, we know how important it is to be there, especially in times of need,” said Publix CEO Todd Jones. “We are grateful for the opportunity to provide this critical service to the Georgia community.”

Vaccinations are provided to eligible individuals, by appointment only, while supplies last, and at no cost to the individual. Customers with health insurance will need to bring their insurance card to their scheduled appointment. Medicare members should bring their red, white and blue Medicare Part B card. Customers without health insurance will need to provide their driver’s license or Social Security number.

Publix Pharmacy will administer the vaccine at the following locations:

COUNTY	CITY	STORE	ADDRESS
Barrow	Winder	#480, Winder Corners Shopping Center	17 Monroe Highway, Suite A
Bibb	Macon	#1700, Publix at Tobesofkee Crossing	5581 Thomaston Road
Bryan	Richmond Hill	#1154, Publix at Richmond Hill Plantation	12800 Highway 144
Camden	Kingsland	#455, Camden Woods Shopping Center	1601 Georgia Highway 40 E.
Carroll	Carrollton	#608, McIntosh Plaza	1109 S. Park St. Suite 600
Catoosa	Ringgold	#1641, Boynton Ridge Plaza	3775 Battlefield Parkway
Chatham	Pooler	#1364, Pooler Marketplace	467 Pooler Parkway
		#1584, Publix At Blue Moon Crossing	101 Blue Moon Crossing
	Savannah	#521, Island Towne Centre	4717 Highway 80 E., Suite B
		#1186, Largo Plaza	11701 Abercorn St.
Cherokee	Canton	#42, Freehome Village	12424 Cumming Highway
		#624, Riverstone Plaza Shopping Center	1451 Riverstone Parkway
		#1064, Paradise Shoppes of Prominence Point	120 Prominence Point Parkway
		#1248, Laurel Canyon Village	15 Laurel Canyon Village Circle, Suite 118
	Woodstock	#636, The Centre at Woodstock	12165 Highway 92
		#880, Village Shoppes of East Cherokee	6236 Holly Springs Parkway
Clarke	Athens	#1146, Georgetown Square	1860 Barnett Shoals Road
Clayton	Morrow	#461, Publix at Mt. Zion	2035 Mount Zion Road
Cobb	Acworth	#566, Brookstone Village	1727 Mars Hill Road NW
		#1096, Governors Towne Square	6110 Cedarcrest Road NW
	Kennesaw	#146, Wade Green Village	4430 Wade Green Road NW, Suite 100
		#764, Orchard Square Shopping Center	4290 Bells Ferry Road NW
	Marietta	#280, Piedmont Commons Shopping Center	1050 E. Piedmont Road, Suite 130
		#548, Towne Center Prado	50 Barrett Parkway, Suite 1000
		#561, West Cobb Marketplace	2500 Dallas Highway SW, Suite 300
		#672, Sandy Plains Exchange	1860 Sandy Plains Road
	Powder Springs	#670, Publix at Powder Springs	3721 New Macland Road, Suite 300
	Roswell	#86, Publix at Shallowford	4401 Shallowford Road
	Smyrna	#753, Highland Station	4480 S. Cobb Drive SE
Columbia	Evans	#1286, Riverwood Town Center	5119 Washington Road
	Martinez	#534, Fury's Ferry Plaza	403 Furys Ferry Road
Coweta	Newnan	#1143, Stillwood Pavilion at Summer Grove	1111 Lower Fayetteville Road
Dawson	Dawsonville	#1542, Dawson Crossroads	145 Forest Blvd., Suite 100
DeKalb	Atlanta	#691, Briarcliff Village Shopping Center	2162 Henderson Mill Road NE
		#783, Publix at East Lake	2235 Glenwood Ave. SE
	Decatur	#665, Shamrock Plaza	3870 N. Druid Hills Road
		#723, Emory Commons	2155 N. Decatur Road
	Lithonia	#752, Centre at Panola	3045 Panola Road
Douglas	Douglasville	#1139, The Shoppes at Deer Creek	4300 Chapel Hill Road
Fayette	Fayetteville	#579, Fayette Pavilion	108 Pavilion Parkway
		#1087, Summit Point	840 Glynn St. S.
	Peachtree City	#546, Publix at Peachtree East	130 Peachtree East Court, Suite 4
		#799, Wilshire Pavillion	1200 Highway 74 S., Suite 20
	Tyrone	#892, South Hampton Village	1512 Highway 74 N.
Floyd	Rome	#1403, Charles Hight Square	435 Turner McCall Blvd. NE
Forsyth	Alpharetta	#616, Midway Shopping Center	4900 Atlanta Highway
		#1089, The Village at Flynn Crossing	5180 McGinnis Ferry Road
	Cumming	#49, Lanier Commons	3480 Keith Bridge Road
		#1130, Castleberry - Southard Crossing	5475 Bethelview Road
		#1690, Matt Town Center	5310 Matt Highway
	Suwanee	#565, The Shops at Laurel Springs	3245 Peachtree Parkway, Suite A
		#1091, Shakerag Shopping Center	7780 McGinnis Ferry Road
		#1227, The Village Shoppes at Windermere	3120 Mathis Airport Parkway
Fulton	Alpharetta	#762, Bethany Village	13800 Highway 9 N., Suite E
	Atlanta	#282, The Peach	2900 Peachtree Road NW
		#503, Cascade Crossing Shopping Center	3695 Cascade Road SW
		#599, Ansley Mall	1544 Piedmont Ave. NE
		#664, Lenox Marketplace	3535 Peachtree Road NE
		#718, Chastain Square	4279 Roswell Road NE, Suite 300
		#1044, Cheshire Square	2325 Cheshire Bridge Road NE
		#1056, Publix at Princeton Lakes	3730 Carmia Drive SW, Suite 200
		#1061, The Plaza Midtown	950 W. Peachtree St. NW
		#1119, Howell Mill Village	2020 Howell Mill Road NW, Suite A
		#1647, Madison Yards	905 Memorial Drive SE
		#1718, Sandtown Crossing	5829 Campbellton Road SW, Suite 110
	Fairburn	#1183, Parkway Village	5370 Campbellton Fairburn Road
	Johns Creek	#226, Medlock Corners	5805 State Bridge Road
	Roswell	#626, King Plaza	885 Woodstock Road, Suite 100
	Sandy Springs	#646, Trowbridge Crossing	7525 Roswell Road
		#647, Publix at Perimeter	1100 Hammond Drive, Suite 300
Greene	Greensboro	#853, Lake Oconee Village	6350 Lake Oconee Parkway, Suite 106
Gwinnett	Dacula	#803, Dacula Village	720 Dacula Road
	Duluth	#505, Promenade at Pleasant Hill	1625 Pleasant Hill Road, Suite 200
		#585, Duluth Station	2750 Buford Highway
	Lawrenceville	#612, Sugarloaf Crossing	4850 Sugarloaf Parkway
		#859, Village Shoppes of Sugarloaf	3370 Sugarloaf Parkway
		#863, The Shops at Huntcrest	1030 Old Peachtree Road NW
		#1078, The Village Shoppes at Simonton	930 New Hope Road
	Lilburn	#564, Five Forks Corner Shopping Center	4045 Five Forks Trickum Road SW
	Loganville	#789, Grayson Village	2715 Loganville Highway SW
	Snellville	#508, Presidential Market Center	1905 Scenic Highway N., Suite 4000
		#539, Publix at Centerville	3550 Centerville Highway, Suite 201
	Sugar Hill	#596, Sugar Hill Corners	5885 Cumming Highway
	Suwanee	#615, McGinnis Crossing	1000 Peachtree Industrial Blvd.
Hall	Buford	#706, Golden Park Village	4840 Golden Parkway
	Flowery Branch	#634, Robson Crossing	3446 Winder Highway
		#844, Village Shops of Flowery Branch	5900 Spout Springs Road
		#1279, Friendship Springs Village	7334 Spout Springs Road
	Gainesville	#1110, Village Shoppes of Gainesville	879 Dawsonville Highway
Henry	Locust Grove	#1052, The Shops at Locust Grove	2730 Highway 155
	McDonough	#816, Paradise Pointe at Lake Dow	920 Highway 81 E.
		#1054, The Shops at Westridge	2158 Highway 20 W.
Houston	Byron	#1291, Publix at Gunn Battle	6015 Watson Blvd.
	Kathleen	#1008, Paradise Shoppes of Warner Robins	1114 Georgia Highway 96
	Perry	#1233, Paradise Shoppes of Perry	275 Perry Parkway
Lowndes	Valdosta	#430, Baytree Village	1741 Gornto Road
		#1435, Publix at Perimeter Park	3330 Inner Perimeter Road
Muscogee	Columbus	#474, Bradley Park Square	1639 Bradley Park Drive, Suite 600
		#562, Milgen Plaza	5435 Woodruff Farm Road
		#650, Parkway Centre	7600 Schomburg Road
		#1390, Cross Country Plaza	3201 Macon Road, Suite 201
Newton	Covington	#744, Salem Road Station	13015 Brown Bridge Road
Oconee	Watkinsville	#617, Butler's Crossing	2061 Experiment Station Road
Paulding	Dallas	#1063, Paradise Shoppes of New Hope	51 E. Paulding Drive
		#1217, The Village at New Georgia	7953 Villa Rica Highway
Rockdale	Conyers	#1071, Smyrna Crossing	2880 Georgia Highway 212 SW
Thomas	Thomasville	#1498, Publix at Park Place	13775 U.S. Highway 19 S.
Walton	Loganville	#603, Loganville Town Centre	4325 Atlanta Highway

Publix is also offering COVID-19 vaccines in 12 Florida counties and continues to communicate with the states in its operating area to provide COVID-19 vaccinations as part of their distribution efforts.

Publix, the largest employee-owned company in the U.S. with more than 225,000 associates, currently operates 1,264 stores in Florida, Georgia, Alabama, Tennessee, South Carolina, North Carolina and Virginia.

https://www.marketscreener.com/news/latest/COVID-19-Vaccinations-Coming-to-108-Publix-Pharmacies-in-Georgia--32199811/

Moderna looks to test Covid-19 booster shots a year after initial vax

 Moderna plans to test a booster shot of its Covid-19 vaccine a year after the initial two-dose immunization, as the duration of protection from the new vaccines is still unclear.

The biotech company plans to start the trial in July, according to a corporate presentation at the JPMorgan Healthcare Conference on Monday. Staff at its clinical trial sites have already started to contact participants in its earlier studies, according to an e-mail shared by one of those people.

“From what we’ve seen so far, I think our expectation is that the vaccination should last you at least a year,” Moderna’s chief medical officer, Dr. Tal Zaks, told investors and analysts at the conference. “To the degree that you need a booster shot, we’ll make a data-based recommendation, and that will require us getting the data.”

The first participants in Moderna’s human clinical trials received their shots in mid-March; a second was given four weeks later. Since the earlier trials tested multiple doses of the vaccine, those on lower doses than the one ultimately authorized — 100 micrograms — would get their booster earlier, while those on 100 micrograms or higher would get their booster at the year mark, according to an e-mail to participants.

The booster being planned now is the same version of the vaccine that’s on the market, but Moderna CEO Stephane Bancel said it may be necessary in the coming years to adjust the vaccine to cover new variants.

“I think this will become a market like flu,” he told CNBC. Moderna has recently started a seasonal flu vaccine program as well.

The booster study for Moderna’s Covid-19 vaccine will evaluate both safety and how much of an immune response an additional shot one year later generates, Bancel said at the conference.

https://www.cnbc.com/2021/01/14/moderna-looks-to-test-covid-19-booster-shots-a-year-after-initial-vaccination.html

What They Said About Lockdowns Before 2020

 In 2020, beliefs about how to handle a new virus shifted massively.

Prior to the Covid-19 pandemic, mainstream epidemiology and public health entities doubted – or even rejected – the efficacy of lockdowns and mass quarantines because they were considered ineffective.

This all changed in March 2020, when sentiment flipped in support of lockdown measures.

Still, there is a vast body of evidence explaining their original stance and why these mandates do not work. 

1. Fauci said that shutting down the country does not work. (January 24, 2020) 

Early into 2020, Fauci spoke to reporters saying, “That’s something that I don’t think we could possibly do in the United States, I can’t imagine shutting down New York or Los Angeles, but the judgement on the part of the Chinese health authorities is that given the fact that it’s spreading throughout the provinces… it’s their judgement that this is something that in fact is going to help in containing it. Whether or not it does or does not is really open to question because historically when you shut things down it doesn’t have a major effect.”

2. World Health Organization Report discusses NPIs and why quarantine is ineffective. (2019)

In a table, WHO lists their recommendations of NPIs depending on severity level. Quarantine of exposed individuals is categorized as “not recommended in any circumstances.” The report explains that “home quarantine of exposed individuals to reduce transmission is not recommended because there is no obvious rationale for this measure, and there would be considerable difficulties in implementing it.”

3. WHO acknowledges social-distancing did not stop or dramatically reduce transmission during the 1918 influenza pandemic. (2006)

The WHO authors ultimately conclude that NPIs, including quarantining, require better and more focused methods to make them more effective and less “burdensome.” “Ill persons,” the authors assert, “should remain home when they first become symptomatic, but forced isolation and quarantine are ineffective and impractical.” Summarizing reports from the 1918 influenza pandemic the WHO cites Lomé (British-occupied Togo) and Edmonton (Canada) as places where “isolation and quarantine were instituted; public meetings were banned; schools, churches, colleges, theaters, and other public gathering places were closed.” Yet, despite additional measures (Lomé halted traffic, and Edmonton restricted business hours) in both cases “social-distancing measures did not stop or appear to dramatically reduce transmission.” A United States, comprehensive report on the 1918 pandemic also concluded that closures “[were] not demonstrably effective in urban areas but might be effective in smaller towns and rural districts, where group contacts are less numerous.” 

4. A study in the Bulletin of Mathematical Biology regarding the 1918 influenza pandemic in Canada also concluded quarantines do not work. (2003)

The study simulated different levels of travel and found that travel limits could be effective but “that a policy of introducing quarantine at the earliest possible time may not always lead to the greatest reduction in cases of a disease.” The authors conclude that, “quarantine measures limiting intercommunity travel are probably never 100% effective, and simulation results suggest that such a situation may actually make things worse, especially in the absence of strong efforts to keep infectious individuals isolated from the rest of the population.”

5. Popular author and Tulane adjunct professor John M. Barry, a strong opponent of the Great Barrington Declaration, argued that quarantines do not work in the case of the Spanish Flu. (2009)

Over a decade ago, Barry found that historically quarantines have been unsuccessful: “This author supports most proposed NPIs except for quarantine, which historical evidence strongly suggests is ineffective, and possibly school closing, pending analysis of recent events.” And instead promotes commonly touted measures, such as remaining home when unwell (and isolating from family members while doing so), frequently washing hands, and wearing a mask if you are sick. On the latter point he warns against healthy people wearing masks, noting: “Evidence from the SARS outbreak suggests that most health care workers infected themselves while removing protective equipment.”

6. Seton Hall’s Center for Global Health Studies Director says travel restrictions did not delay the transmission of SARS. (2009)

Yanzhong Huang acknowledges that “travel restrictions and quarantine measures have limited benefit in stopping the spread of disease […] affecting travel and trade, dissuading the very kind of transparency and openness essential for a global response to disease outbreaks.” These measures ultimately undermine a country’s surveillance capacity because “people who show symptoms might choose to shun public health authorities for fear of quarantine or stigmatization [and squander] limited health resources […] Laurie Garrett of the Council on Foreign Relations [noted] by July signs of fatigue and resource depletion had already set in most of the world.

7. A study from Wake Forest University encounters ‘self-protection fatigue’ in simulated epidemic. (2013)

Study uses a multiplayer online game to simulate the spread of an infectious disease through a population composed of the players. The authors find that “people’s willingness to engage in safe behavior waxes or wanes over time, depending on the severity of an epidemic […] as time goes by; when prevalence is low, a ‘self-protection fatigue’ effect sets in whereby individuals are less willing to engage in safe behavior over time.” They say this is “reminiscent of condom fatigue—the declining use of condom as a preventive measure—in the context of HIV/AIDS prevention.”

8. In Biosecurity and Bioterrorism journal, Johns Hopkins epidemiologists reject quarantines outright. (2006)

In an article titled, “Disease Mitigation Measures in the Control of Pandemic Influenza,” JHU epidemiologists note problems with lockdowns: “As experience shows, there is no basis for recommending quarantine either of groups or individuals. The problems in implementing such measures are formidable, and secondary effects of absenteeism and community disruption as well as possible adverse consequences, such as loss of public trust in government and stigmatization of quarantined people and groups, are likely to be considerable.” Their concluding remark emphasized, “experience has shown that communities faced with epidemics or other adverse events respond best and with the least anxiety when the normal social functioning of the community is least disrupted.”

9. In a top journal, American Journal of Epidemiology, authors explain the conditions when quarantine would be effective, which do not align with the characteristics of Covid-19. (2006)

Specifically, they note that quarantines will only be effective when: (1) isolation is not possible; and (2) asymptomatic spread is significant and timed in a narrow way (none of which is the case for Covid). They conclude that “the number of infections averted through the use of quarantine is expected to be very low provided that isolation is effective.” And if isolation is ineffective? Then it will only be beneficial “when there is significant asymptomatic transmission and if the asymptomatic period is neither very long nor very short.” But, should mass quarantine be used it would “inflict significant social, psychological, and economic costs without resulting in the detection of many infected individuals.”

10. In the Epidemiology Journal, Harvard and Yale professors Marc Lipsitch and Ted Cohen say delaying infection can leave the elderly worse off. (2008)

They explain how delaying the risk of infection can work counterintuitively when the pathogen is more lethal for older populations. They say, “Reducing the risk that each member of a community will be exposed to a pathogen has the attendant effect of increasing the average age at which infections occur. For pathogens that inflict greater morbidity at older ages, interventions that reduce but do not eliminate exposure can paradoxically increase the number of cases of severe disease by shifting the burden of infection toward older individuals.” Based on this analysis, Covid-19, which disproportionately harms the older more than the young, is better handled by allowing the community to be exposed, whether through natural infection or vaccination.

11. A team of Johns Hopkins scholars say quarantines don’t work but are pursued for political reasons. (September 2019)

In the report, they explain how quarantine is more political than related to public health: “During an emergency, it should be expected that implementation of some NPIs, such as travel restrictions and quarantine, might be pursued for social or political purposes by political leaders, rather than pursued because of public health evidence.” Later on, they explain the ineffectiveness of quarantine: “In the context of a high-impact respiratory pathogen, quarantine may be the least likely NPI to be effective in controlling the spread due to high transmissibility.”

In March 2020, Michael Osterholm – now Biden’s Covid-19 advisor – also argued that lockdowns are not a “cure” for the pandemic, listing multiple costs from a lockdown. Yet, Osterholm’s New York Times article in August reveals a contrasting viewpoint, stating that “we gave up on our lockdown efforts to control virus transmission well before the virus was under control” by opening “too quickly.” Osterholm and (Neel) Kashkari promote a mandatory shelter-in-place “for everyone but the truly essential workers.”

Also in March 2020, these findings from the listed works and many others culminated in an open letter to vice-president Mike Pence signed by 800 medical specialists from numerous universities throughout the country which pointed out: “Mandatory quarantine, regional lockdowns, and travel bans[…] are difficult to implement, can undermine public trust, have large societal costs and, importantly, disproportionately affect the most vulnerable segments in our communities.”

While expert consensus regarding the ineffectiveness of mass quarantine of previous years has recently been challenged, significant present-day evidence continuously demonstrates that mass quarantine is both ineffectual at preventing disease spread as well as harmful to individuals. Learning the wrong lesson – assuming that mass quarantines are both good and effective – sets a dangerous precedent for future pandemics.

By Amelia Janaskie via The American Institute For Economic Research

https://www.zerohedge.com/covid-19/what-they-said-about-lockdowns-2020

Could Lilly’s donanemab readout in Alzheimer’s boost Biogen’s prospects?

 When Eli Lilly reported results for donanemab in Alzheimer’s disease earlier this week it was hailed as a rare win for the amyloid hypothesis, although there’s no shortage of candidates that have failed despite positive mid-stage trial results.

Some analysts have intimated that given the small size of the study at just over 270 patients, rival amyloid drug developers Biogen and Eisai could claim the biggest benefit from the data in positive sentiment ahead of an FDA decision later this year.

Goldman Sachs analyst Terence Flynn said the result was a “positive surprise” after Lilly revealed top-line data from the TRAILBLAZER-ALZ study showing that donanemab slowed cognitive decline by a third in people with early Alzheimer’s and completely resolved the amyloid beta plaques that are a hallmark of the disease.

Flynn also said the data was an “incremental positive” for Biogen, whose Eisai-partnered aducanumab is already filed for approval and awaiting an FDA decision by 7 March, as it lends further weight to the amyloid beta hypothesis of Alzheimer’s.

Biogen is nearest to market with aducanumab but a positive verdict from the US regulator is far from assured. In November, an FDA advisory committee voted ten to one against approval, saying the clinical data backing the drug was inconclusive, but that came on the back of a positive assessment by the FDA’s own reviewer.

Wolfe analyst Tim Anderson said in a research note issued ahead of the donanemab readout that the FDA could be influenced by the donanemab data and – if positive – that would raise the chances of a greenlight for aducanumab.

There’s an alternative view however that donanemab’s data might actually harm aducanumab’s prospects. Analysts at Jefferies told Barron’s this week that the FDA may have been minded to approve Biogen and Eisai’s drug because there were no other late-stage candidates in play, but Lilly’s drug could change that perception.

Donanemab is unlike most other amyloid-targeting drugs – including aducanumab – because it targets a pyroglutamated form of amyloid beta called N3pG that is found only in amyloid plaques and according to some research can stimulate misfolding of proteins.

Lilly’s hypothesis – as yet unproven – is that clearing those plaques has a direct association with cognitive benefits.

Lilly says TRAILBLAZER-ALZ met its primary endpoint, slowing decline on the Integrated Alzheimer’s Disease Rating Scale in the donanemab group by 32% compared to placebo, with trends towards improvement on secondary endpoints that didn’t hit statistical significance.

On safety, around 27% of the treatment arm showed ARIA-E – an inflammatory reactions also seen with other amyloid-targeting antibodies – but there’s little other data available yet.

Lilly started a 500-patient phase 2 trial called TRAILBLAZER-ALZ-2 last June that it suggests could serve as a confirmatory pivotal study and potentially support regulatory filings – dramatically shortening the development timeline for the drug. That’s due to read out in next year or later.

https://pharmaphorum.com/news/could-lillys-alzheimers-drug-readout-boost-biogens-prospects/

Therapy app Talkspace to go public in $1.4B deal with blank check firm

 The booming special purpose acquisition company (SPAC) market shows no signs of slowing down in 2021 with another big digital health deal announced this week.

Online therapy app Talkspace plans to go public through a merger with SPAC Hudson Executive Investment Corp. The combined company will operate as Talkspace and intends to be listed on the Nasdaq under the symbol "TALK."

The deal values Talkspace—which connects users with licensed therapists via video chat or text—at $1.4 billion, including debt. The deal will provide the company with $250 million in cash to be used as growth capital, the companies announced Wednesday.

The transaction is expected to close late in the first quarter or early in the second quarter of 2021.

Once the transaction closes, Talkspace will be the first and only publicly traded virtual behavioral health company.

Private tech companies have been looking to merge with a SPAC or blank check company as a nontraditional route to going public rather than a typical IPO. With the IPO market rattled by COVID-19 and wild volatility, it has become a more attractive way to go public.

There has been an increasing number of technology-focused blank check companies issued in recent months, including SOC Telemed, Hims & Hers, Clover Health, Augmedix and Butterfly Network.

Former Livongo executives who didn't make the jump to Teladoc are backing a new blank check healthcare technology company and are preparing an IPO of up to $500 million.

Co-founded by Roni and Oren Frank in 2012, Talkspace promotes behavioral health as a lifestyle, not as a one-time event. The company provides access to an extensive network of certified, credentialed and professional clinicians through two channels: direct-to-consumer and enterprise.

Talkspace has seen robust user growth, with approximately 46,000 active members and more than 39 million lives covered by employer or healthcare insurance agreements. Like many digital mental health providers, Talkspace has seen accelerated growth during the COVID-19 pandemic as the health crisis drives up stress levels and exacerbates existing mental health issues.

In the U.S. alone, it is estimated that more than 70 million people suffer from some form of mental illness and that less than half of people with a behavioral illness receive care because of cost, lack of access or stigma, according to Talkspace.

"Roni and I started Talkspace nine years ago to establish a next-generation technology company, exclusively focused on behavioral health, with the mission of opening up access to mental healthcare, improving clinical outcomes, and helping those in need live happier and healthier lives," said Oren Frank in a statement.

"Today, this mission is more important than ever before. We are proud of the positive impact Talkspace has made and are excited for the next phase in the company's journey. Hudson Executive's experience and relationships in healthcare, expertise in capital markets, and alignment with our mission will be invaluable as we continue to grow, innovate and improve mental health outcomes," Frank said.

Douglas Braunstein, founder and managing partner of Hudson Executive Capital, said Talkspace is a purpose-built technology company designed to meet the unmet medical needs in behavioral health by improving access, decreasing costs, improving outcomes and creating value for patients, providers and employers.

For 2021, Talkspace's estimated net revenue is $125 million, up approximately 69% from 2020 estimated net revenue.

Roni and Oren Frank will continue to lead Talkspace, along with the company's president, chief operating officer and chief financial officer Mark Hirschhorn. Following the closing, Braunstein will serve as chairman of the company's new board of directors. 

The transaction will be funded with Hudson Executive Investment's $414 million of cash in trust, a $25 million forward purchase from Hudson Executive Capital and an additional $25 million committed by Hudson Executive Capital to backstop redemptions. The transaction is further supported by an oversubscribed $300 million fully committed private investment in public equity at $10 per share anchored by leading investors including the Federated Hermes Kaufmann Funds, Jennison Associates LLC, Woodline Partners LP and Deerfield.

J.P. Morgan Securities LLC acted as lead financial adviser, and Jefferies acted as financial adviser to Talkspace. Latham & Watkins LLP acted as legal counsel to Talkspace.

Citigroup Inc and J.P. Morgan Securities LLC acted as capital markets advisers and placement agents. Citigroup acted as financial adviser, and Milbank LLP acted as legal counsel to Hudson Executive Investment Corp.

https://www.fiercehealthcare.com/tech/talkspace-to-go-public-1-4b-deal-blank-check-firm

Community Health net operating revenue near $12B in 2020, outlines 2021 guidance

 Community Health Systems had an estimated net operating revenue of between $11.7 and $11.8 billion for 2020 thanks in part to relief funding that helped the system weather the COVID-19 financial crisis.

The 86-hospital system released its preliminary earnings on Thursday and also gave a financial outlook for 2021.

CHS’ adjusted earnings before interest, taxes, depreciation and amortization (EBITDA) were $1.6 to $1.8 billion. That was slightly above the financial guidance it gave back in February before it was withdrawn in April after the onset of the pandemic.

The pandemic has caused massive financial disruptions for hospital systems as volumes plummeted in March and April when hospitals were forced to cancel elective procedures to preserve capacity to fight the virus.

While volumes rebounded in late spring and summer, some systems are seeing volumes still below pre-pandemic levels and hospitals have faced renewed surges of the virus.

Like other hospital systems, CHS got help from a $175 billion provider relief fund passed by Congress last April.

The system recognized approximately $600 million in relief funds for 2020. However, CHS estimates that the revenues lost from the pandemic “exceed the aforementioned amount of pandemic relief funds recognized,” the earnings said.

But CHS did put out a preliminary earnings guidance for 2021. It anticipates net operating revenue for the year of between $11.7 and $12.5 billion and adjusted EBITDA of $1.6 and $1.8 billion.

“This guidance reflects anticipated continued execution of our previously-stated margin initiatives and does not take into account the potential recognition of additional pandemic relief funds,” CHS said.

It remains unclear if Congress will approve more relief funds. President-elect Biden and the Democratic-controlled Congress have called for more relief.

https://www.fiercehealthcare.com/hospitals/chs-reports-net-operating-revenue-nearly-12b-2020-outlines-2021-guidance

JPM: For Gilead, remdesivir is big story but HIV, cancer products gaining

 Gilead Sciences unveiled a surprise Monday: It enjoyed a bigger-than-expected sales boost from COVID-19 therapy Veklury, better known as remdesivir.

But what changed since October, when Gilead last predicted 2020 sales? Hospitalizations are up fourfold, for one—and Veklury use is way up, too.

“One in two patients hospitalized now is treated with Veklury in the United States,” CEO Dan O’Day said during Gilead’s Monday presentation at the annual J.P. Morgan healthcare conference, noting that Veklury use in hospitalized COVID-19 patients is up from 30% in October to around 50% to 60% today.

The result? Veklury sales of between $2.8 and $2.83 billion for last year, Gilead said Monday. The California company now expects total 2020 sales to check in between $24.3 billion and $24.35 billion, well above the $23 billion to $23.5 billion range it had previously laid out.

“It speaks volumes to the role Veklury is playing in this pandemic,” O’Day said.

But while Gilead is convinced Veklury has plenty more to give when it comes to fighting the pandemic—and Gilead has plenty more of it, with supply “greatly over the demand” around the world, commercial chief Johanna Mercier said—O’Day was eager Monday to lay out a vision for Gilead’s growth that excluded the antiviral.

“Biktarvy, Biktarvy, Biktarvy—that’s very important,” O’Day said of the products that would fuel Gilead’s short-term sales expansion. “Biktarvy is in a tremendous growth mode right now and will continue in this growth mode going into 2021 and beyond,” he added.

That’s not news to anyone who's been following the red-hot HIV med, which holds the title of No. 1 regimen across previously untreated patients and those switching from other treatments, too, Mercier said. But another drug O’Day name-dropped—Trodelvy—is newer on the scene.

The centerpiece of Gilead’s $21 billion Immunomedics buy, the treatment is a “transformational” med for Gilead, to hear O’Day tell it. It’s put up “astonishing” survival numbers in tough-to-treat, late-stage triple-negative breast cancer, and it “clearly has potential in many tumors,” he said.

Gilead certainly hopes so. Its last major cancer buy—2017’s $11.9 billion Kite Pharma acquisition, meant to establish oncology as a major revenue generator after the Big Biotech’s hepatitis C business came crashing down—still hasn’t turned up the kind of revenue numbers industry watchers expected when the deal went through.

https://www.fiercepharma.com/pharma/jpm-gilead-s-veklury-now-used-half-hospitalized-u-s-covid-patients-delivers-big-revenue-bump