Abbvie Inc (ABBV)

[retired early]

Wow a $13 mil buy @ end of day. :)

[DewDiligence]

FDA approves Rinvoq for second-line ulcerative colitis:

https://finance.yahoo.com/news/rinvoq-upadacitinib-receives-fda-approval-212900389.html

The 45mg dose is approved for (8-week) UC induction therapy, and the 15mg dose is approved for UC maintenance, with 30mg allowed for those with severe disease.

Rinvoq is also FDA-approved for RA and psoriatic arthritis (15mg dose) and for atopic dermatitis (15mg and 30mg), all in the second-line setting.

[retired early]

Recent investor. Looks like a safer long term than most of my purchases. :) I usually do penny's.

[DewDiligence]

ABBV reports positive Qulipta phase-3 in prevention of chronic migraine:

https://finance.yahoo.com/news/abbvie-announces-positive-phase-3-131500532.html

The current Qulipta label is for prevention of episodic migraine, a less severe form of the condition.

[DewDiligence]

Alvotech settles Humira-US-patent litigation with ABBV:

https://finance.yahoo.com/news/abbvie-resolves-humira-adalimumab-u-213200516.html

Alvotech (which is trading as OACB until the SPAC merger closes) can launch its Humira biosimilar on 7/1/23 if it has received FDA approval by then.

ABBV has now settled its US patent litigation with all Humira-biosimilar companies, as far as I know.

[DewDiligence]

Skyrizi PDUFA date for Crohn’s disease extended three months due to additional data submitted by ABBV during the BLA review:

https://finance.yahoo.com/news/abbvie-provides-regarding-skyrizi-risankizumab-211500107.html

[DewDiligence]

Rinvoq succeeds in second Phase-3 in Crohn’s:

https://www.prnewswire.com/news-releases/second-phase-3-induction-study-confirms-upadacitinib-rinvoq-improved-clinical-and-endoscopic-outcomes-in-patients-with-crohns-disease-301489240.html

[lilLu]

ATH!
ABBV!

[lilLu]

Looking Great!
ABBV

[DewDiligence]

ABBV pipeline:

https://investors.abbvie.com/static-files/886648b5-06d7-4c66-aaa3-7c01a0fd4cbe

[DewDiligence]

ABBV 4Q21 results:

https://news.abbvie.com/news/press-releases/abbvie-reports-full-year-and-fourth-quarter-2021-financial-results.htm

[oxnous]

ABBV chart

[DewDiligence]

FDA approves Rinvoq for second-line atopic dermatitis:

https://finance.yahoo.com/news/u-fda-approves-rinvoq-upadacitinib-181000896.html

The approval includes both dose strengths (15mg and 30mg qD).

[DewDiligence]

ABBV JPM slide set:

https://investors.abbvie.com/static-files/6eaf137c-4bee-4a5d-8047-33b9f299382d

[DewDiligence]

FDA approves Rinvoq for second-line psoriatic arthritis:

https://finance.yahoo.com/news/rinvoq-upadacitinib-receives-u-fda-231800396.html

The second-line restriction (following TNF-a treatment in the first line) is a consequence of the label changes for JAK inhibitors generally in inflammatory diseases (#msg-167001417).

Summary of Rinvoq indications in US and EU:

RINVOQ 15 mg is approved by the U.S. Food and Drug Administration (FDA) for adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to one or more TNF blockers and adults with active psoriatic arthritis who have had an inadequate response or intolerance to one or more TNF blockers. RINVOQ 15 mg is also approved by the European Commission for adults with moderate to severe active rheumatoid arthritis, adults with active psoriatic arthritis and adults with active ankylosing spondylitis. RINVOQ is approved by the European Commission for adults (15 mg and 30 mg) and adolescents (15 mg) with moderate to severe atopic dermatitis. Phase 3 trials of RINVOQ in rheumatoid arthritis, atopic dermatitis, psoriatic arthritis, axial spondyloarthritis, Crohn's disease, ulcerative colitis, giant cell arteritis and Takayasu arteritis are ongoing.

[DewDiligence]

Rinvoq hits_primary/secondary_endpoints_in phase-3 trial_in_second-line Crohn’s disease:

https://finance.yahoo.com/news/upadacitinib-rinvoq-achieved-primary-key-133000723.html

Detailed results will be presented at an unspecified medical conference. A second phase-3 Rinvoq trial in Crohn’s has yet to read out.

[DewDiligence]

JAK inhibitors—including ABBV’s Rinvoq and PFE’s Xeljanz—have new FDA labels that relegate these agents to the second-line setting in RA (and other inflammatory diseases) following unsuccessful treatment with a TNFa agent (such as Humira); today’s label changes are in addition to the safety warnings added to the JAK labels three months ago (#msg-165728499).

ABBV’s PR:
https://finance.yahoo.com/news/abbvie-provides-rinvoq-upadacitinib-treatment-211500945.html

Please see #msg-165728499 for related info.

Note: BMY’s TYK2 inhibitor, Deucravacitinib is not affected by the above changes because the FDA considers TYK2 a different drug class from JAK.

[lilLu]

https://seekingalpha.com/article/4465863-abbvie-abbv-undervalued-dividend-growth-stock
ABBV

[lilLu]

Whatever happened to Michael Jordan drug free commercials?...Stop it...Get some Help!
ABBV

[lilLu]

Also the confusion of what is a real 'chemical imbalance' vs normal adolescence= disconnect in families we see today... adds to the problem.. how are kids turning into hypochondriacs at 12?Whenever you see families let's say at a restaurant, or any public place where they have downtime, kids these days are all over their tablets, smart phones, whatever tech they can get their hands on. Glued to it like life support. Zero positive interaction/influence. The easiest way to handle someone's mood that you don't understand is simply, put em on meds. I have seen this countless times now where parents insist their kid has emotion problems. Now your 12 year old is used to taking emotional numbing medication instead of vitamins, fresh air and sunlight. The gates are now opened to stronger meds with a generation being created that cannot handle daily problems without altering their state of mind...if they have kids, will they break the cycle? Unlikely. Now the problem of opioid addiction grows even more and at an accelerated rate. The only obvious answer is to take pharma's to court?... there should be campaigns for the greater good that emphasize Get Outside And Play Sports! That would do more than a $50B lawsuit which won't disperse any of the winnings to fight the problem that they decided to chase down in the first place.
Jmo.
ABBV

[lilLu]

Exactly. You'd be surprised how many peeps would have just sold those extra pills to an addict at a random bus stop or a disturbed teenager. That adds to the problem much more than these pharma's selling the product after its been 'FDA' approved.
ABBV

[trkyhntr]

Just to be clear, some doctors share the blame. They tend to overprescribe pain killing opioids. As an example, when I had knee replacement surgery I got a prescription fot 60 tablets of Oxycodone. I was understandably wary of taking too much of it. I ended up taking only two of them, and after that, found the pain manageable with acetominophen only. I can see how some might become addicted if they believed such a high number of pills was necessary. I guess different people have wide variance in pain tolerance.

[lilLu]

Never understood how marketing campaigns can be linked to addiction. Only one that gets you addicted is YOU. Everyone trying to pin the blame on others. Let's take McDonald's to court for the rise in obesity then? Pfft
Tentative but the right step.
https://www.fiercepharma.com/pharma/johnson-johnson-abbvie-teva-and-endo-score-industry-s-first-opioid-trial-win
ABBV

[lilLu]

And divi's still going strong! ITS A BUY!
ABBV

[DewDiligence]

FDA approves ABBV’s Vuity—(pilocarpine eye drops)—for presbyopia:

https://finance.yahoo.com/news/u-food-drug-administration-approves-213100317.html

The drug works by narrowing the pupil, which improves near focusing. It takes effect in 15 minutes and continues working for approximately 6 hours. The purpose is to avoid having to use reading glasses. I project modest sales.

The drug itself is an old generic, but the formulation is new:

…VUITY is an optimized formulation of pilocarpine, an established eye care therapeutic, delivered with pHast technology. The proprietary pHast technology allows VUITY to rapidly adjust to the physiologic pH of the tear film.

[DewDiligence]

ABBV 3Q21 CC transcript:

https://www.fool.com/earnings/call-transcripts/2021/10/29/abbvie-abbv-q3-2021-earnings-call-transcript/

[DewDiligence]

ABBV 3Q21 results:

https://news.abbvie.com/news/press-releases/abbvie-reports-third-quarter-2021-financial-results.htm

Please see #msg-166561607 for info on Botox, specifically.

[lilLu]

You beat me to it. Still a great buy plus divi's.
ABBV

[fuzzy]

AbbVie Stock Gains After Hiking FY21 Earnings Outlook, Annual Dividend
8:04 am ET October 29, 2021 (Benzinga) Print
AbbVie Inc (NYSE: ABBV) reports Q3 adjusted EPS of $3.33, higher than $2.83 reported a year ago and beating the consensus of $3.22.
Overall sales increased 11.2% Y/Y to $14.34 billion, almost in line with the consensus of $14.32 billion.
The immunology portfolio generated $6.67 billion in sales, +15.3% (14.9% on an operational basis).
Hematologic oncology portfolio sales were $1.87 billion, +8.4% (+8.1%).
Sales from the neuroscience portfolio reached $1.57 billion, +25.5% (+25%).
Aesthetics portfolio sales increased 29.3% (+27.7%) to $1.25 billion.
Adjusted gross margin expanded from 81.7% to 83.2%. The operating margin also improved from 48.8% to 51.1%.
FY21 guidance: AbbVie raises FY21 adjusted EPS guidance from $12.52 - $12.62 to $12.63 - $12.67 (consensus of $12.59).
The Company also increased the dividend by 8.5%, from $1.30 per share to $1.41, payable on February 15, 2022, to shareholders of record as of January 14, 2022.
Price Action: ABBV shares are up 3.03% at $113.00 during the premarket session on the last check Friday.

[lilLu]

Oct 29th. 3rd quarter earnings.
ABBV

[DewDiligence]

FDA approves first interchangeable Humira biosimilar—from B-I:

https://www.prnewswire.com/news-releases/fda-approves-cyltezo-the-first-interchangeable-biosimilar-to-humira-301402331.html

B-I’s Humira biosimilar, called Cyltezo, was approved by the FDA in 2017, but only now was granted the interchangeable designation. B-I can launch Cyltezo in Jul 2023, pursuant to a patent settlement with ABBV.

AMGN will have the first Humira-biosimilar launch in the US market, in Jan 2023 (#msg-134970085), but AMGN’s biosimilar is not substitutable for branded Humira by a pharmacist, as B-I’s is.

Several other companies, including PFE, NVS, and Samsung Bioepis, have FDA-approved (but non-interchangeable) Humira biosimilars, so significant price erosion is coming to the US Humira market in 2023.

[lilLu]

https://seekingalpha.com/article/4459620-abbvie-top-dividend-stock-for-long-term
ABBV

[lilLu]

https://seekingalpha.com/article/4458461-abbvie-appears-ready-to-reverse-and-outperform
ABBV

[DewDiligence]

FDA approves ABBV’s Qulipta—(atogepant)—for migraine prevention:

https://finance.yahoo.com/news/fda-approves-qulipta-atogepant-first-224200797.html

Qulipta will compete with BHVN’s Nurtec ODT, which is approved for both prevention and acute treatment (#msg-164076435, #msg-154072129).

ABBV now has three approved agents in its migraine portfolio: Qulipta; Ubrelvy (approved for acute treatment in 2019 [#msg-154072129]); and Botox. All three came to ABBV by way of Allergan.

[lilLu]

https://www.fool.com/investing/2021/09/27/could-abbvies-new-collaboration-be-a-blockbuster/
ABBV

[lilLu]

https://www.fiercebiotech.com/biotech/abbvie-bets-370m-pivotal-eye-disease-gene-therapy-puts-up-1-4b-biobucks
ABBV

[lilLu]

https://www.thestreet.com/investing/abbvie-could-be-good-defensive-play
ABBV

[DewDiligence]

ABBV -8% on_new_FDA-label_warnings_for JAK inhibitors_including Rinvoq:

https://www.fda.gov/drugs/drug-safety-and-availability/fda-requires-warnings-about-increased-risk-serious-heart-related-events-cancer-blood-clots-and-death

This update affects other JAK inhibitors approved, or seeking approval, for inflammatory diseases: PFE’s Xeljanz and Abrocitinib; and LLY/INCY’s Olumiant. The update does not affect JAK inhibitors approved for other indications, and it does not affect TYK2 inhibitors such as BMY’s Deucravacitinib.

The FDA’s safety review of the JAK class in inflammatory diseases was triggered by the results of a Xeljanz long-term safety study reported in Jan 2021 (#msg-161253317).

ABBV is affected so strongly by today’s FDA action because Rinvoq was expected to become a mega-blockbuster, cushioning the blow from Humira’s looming patent expiration.

[lilLu]

https://www.fool.com/investing/2021/08/15/better-dividend-stock-abbvie-or-pfizer/
ABBV

[lilLu]

https://www.fool.com/investing/2021/08/10/3-key-takeaways-from-abbvies-second-quarter-earnin/

[lilLu]

Strong quarter!!!

[lilLu]

https://finance.yahoo.com/news/abbvie-reports-second-quarter-2021-114400726.html

[DewDiligence]

ABBV’s 2Q21 results:

https://news.abbvie.com/news/press-releases/abbvie-reports-second-quarter-2021-financial-results.htm

[lilLu]

https://finance.yahoo.com/news/beat-likely-abbvie-abbv-earnings-160604017.html
ABBV

[conix]

Chart of ABBV

[lilLu]

https://www.fiercebiotech.com/biotech/abbvie-posts-pivotal-data-age-related-long-sightedness-drug

[lilLu]

https://finance.yahoo.com/news/abbvie-abbv-earnings-expected-grow-190007614.html

[lilLu]

https://seekingalpha.com/news/3718676-fda-approves-abbvies-skin-treatment-dalvance-for-pediatric-indication

[lilLu]

https://seekingalpha.com/article/4438183-abbvie-primed-to-climb-wall-of-worry
ABBV

[lilLu]

https://seekingalpha.com/article/4437771-abbvie-the-path-to-30-percent-annual-returns
ABBV