ACIP endorses XBB/monovalent COVID boosters for_all_people >=6 months_of_age_by_13-1_vote:
The previous bilvalent booster shots are no longer recommended.
PFE establishes_mechanism_to monetize HLN stake via off-market sales:
PFE currently has a 32% equity stake in HLN, worth ~$12B at the current market price.
Pavlovid weekly prescriptions have increased fourfold from their 2Q23 nadir, according to PFE’s CCO on today’s MS webcast. Weekly prescriptions are now running at about 60% of the peak 2023 level reached in January.
What is it about life
That makes it
(PFE)/SGEN—Tidvak shows statsig-superior OS/PFS/ORR compared_to_chemo at interim analysis in second-line cervical cancer in phase-3 “innovaTV 301” trial (https://www.clinicaltrials.gov/study/NCT04697628?term=NCT04697628 ):
Details will be presented at a medical conference, but the hazard ratio for OS (the primary endpoint) must have been impressive to trigger a successful halt of the trial at the interim analysis.
Success of the innovaTV 301 phase-3 trial will surely be sufficient to convert the FDA’s 2021 accelerated approval of Tidvak (https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-tisotumab-vedotin-tftv-recurrent-or-metastatic-cervical-cancer ) to a full FDA approval.
PFE expects to close the $43B buyout of SGEN in late 2023 or early 2024.
It has already happened
Only for those
To catch up
FDA approves PFE’s Abrysvo maternal vaccine_to_protect_infants_ from RSV during their first season:
FDA approves PFE’s Elrexfio—(elranatamab)—for rrMM:
This is an accelerated approval for patients who have failed four or more prior therapies, so the addressable market for this indication is pretty small. PFE plainly intends to move Elrexfio in earlier lines of treatment, where the addressable market is larger—and the competition is stiffer.
Elrexfio is a bispecific mAb injected subcutaneously once per week (or every other week after one year). Elrexfio is currently under review by the EMA (#msg-171269528).
Episode 4 of the Breaking Point documentary series
~~~ Features multiple experts explaining the depth of the deception ~~~
Behind the pandemic
For more updates, visit: http://www.brighteon.com/channel/hrreport
imo...depending on one's faith in true internet news.....it is circulating and appears that CEO of Pfizer, Albert Bourla, has been apprehended by the US Military for crimes against humanity.....our efforts at ihub message boards do not go unnoticed.
It's much more than that
Different lots can be designated
To different groups in varying locations
All while keeping tabs on their effectiveness
Experimental drugs need honing
Fitting a particular agenda
While keeping results hidden
And you can bet the @^$#* politicians got the same vax...
Australia Pfizer Senate
~~~ What about the 10 plus pages of adverse effects released in 2021 ~~~
Pfizer dodging every question
~~~ About the safety of the covid-19 Injections ~~~
PFE reports 2Q23 results—reiterates_2023_non-GAAP EPS guidance and 2023_COVID-revenue_guidance—lowers_organic_growth_rate_slightly:
2Q23 revenue was $12.7B, -54% YoY but +5% YoY excluding COVID revenue. 2Q23 non-GAAP EPS was $0.67, down from $2.04 in 2Q22. 2Q23 COVID-related revenue was: $1.49B for Comirnaty (COVID vaccine), -79% QoQ and -83% YoY; and $139M for Paxlovid, -97% QoQ and -98% YoY.
PFE says 2Q23 was a nadir in COVID-related sales due to the gap between the end of government procurement and the start of commercial sales in September. PFE reiterated 2023 guidance of $13.5B for Comirnaty and $8.5B for Paxlovid; this guidance implies 2H23 revenue of $8.9B for Comirnaty and $4.4B for Paxlovid. However, if it becomes clear that COVID-related sales will fall well short of the above figures, PFE is prepared to cut operating costs accordingly.
2023 guidance for non-GAAP EPS remains unchanged at $3.25-3.45. 2023 revenue guidance is now $67-70B (upper bound reduced from $71B three months ago).
Guidance for 2023 organic sales growth excluding COVID products is now 6-8% (down from 7-9% three months ago); the main impetus for the lowered organic-sales guidance is ACIP’s less than enthusiastic support for PFE’s RSV vaccine, Abrysvo—i.e. the fact that ACIP did not unconditionally recommend Abrysvo for older adults, but rather said that patients should “discuss” Abrysvo with their healthcare provider.
The SGEN acquisition is still expected to close in 2023 or early 2024.
2Q23 CC slides:
Prepared CC remarks (synched with slides):
PFE With Covid revenues falling, Pfizer lays out growth plans and possible cost cuts
Max Gelman Senior Editor Endpoint News
August 1, 2023 11:55 AM EDT Pharma
As the Pfizer behemoth continues chugging along post-pandemic, the drugmaker is starting to clarify how its Covid-19 profits will turn into future growth.
For the first time Tuesday morning, Pfizer broke down detailed growth expectations from its slew of acquisitions made over the last year and a half. By 2030, Pfizer set a goal for at least $10 billion in Seagen-related revenue. It expects another $10.5 billion out of its deals for Biohaven, Arena, Global Blood Therapeutics and ReViral.
In total, Pfizer has targeted $25 billion by 2030 from its BD deals, and in Tuesday’s second-quarter earnings update another $5 billion is labeled as the “remaining gap,” making clear there is more to do. Pfizer CEO Albert Bourla didn’t face many questions on this topic, but when asked by Credit Suisse analyst Trung Huynh about whether non-Covid mid-term sales would hit high-single-digit growth ahead of that timeframe, Bourla said he remains confident.
“We’ll continue and we are at 6% right now. All these years we’re right here,” Bourla said. “The non-Covid business, the success of the [upcoming] launches is very important, so we’ll see a lot of things coming ahead of us.”
Pfizer’s Covid-19 vaccines, booster shots and its antiviral drug have been huge sellers, but are in decline. Its Covid-19 vaccine generated $36.8 billion in 2021 sales and $37.8 billion last year, while Paxlovid pulled in $18.9 billion in 2022 revenue — accounting for $93.5 billion in total.
Its deal spending, meanwhile, has added up to $67.2 billion: $43 billion for Seagen, $11.6 billion for Biohaven, $6.7 billion for Arena, $5.4 billion for Global Blood Therapeutics and $525 million for ReViral. That suggests the company may have at least $10 billion or more to spend to make up the last piece of its revenue goal.
But with Covid vaccine sales expected to be down 64% compared with 2022, and Paxlovid revenue expected to decline 58%, both Bourla and CFO Dave Denton cautioned that cost-cutting measures may be coming, depending on revenue this fall.
“If our Covid-19 revenues are less than what we assumed, we are prepared to launch an enterprise-wide cost improvement program aligned with the longer-term revenue projections for our business,” Denton said.
Bourla added that Pfizer is expecting a new wave of Covid-19 cases in the second half of the year. Vaccine and Paxlovid demand are expected to increase in response, after which Pfizer will be able to more accurately predict sales.
“We expect the vaccination and treatment rates from the upcoming respiratory disease season to be a reliable predictor of trends in subsequent years,” Bourla said.
Several analysts asked Bourla and Denton for clarity on where specifically such measures will take place. Though they declined to divulge too many specifics, saying the details would come after the fall, Denton noted the cuts would likely be balanced between SI&A and R&D.
Overall, Pfizer reported $12.7 billion in revenue in the second quarter, down 53% from the same period a year ago. Covid-19 products made up the vast majority of that decline, Pfizer said; non-Covid revenues rose by 5%. The company also narrowed its projected full-year revenue from $67-$71 billion reported in the first quarter, to $67-$70 billion Tuesday.