Abbvie Inc (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

[lilLu]

https://seekingalpha.com/article/4437199-abbvie-firing-on-all-cylinders

[lilLu]

After 1 year of treatment over half had successful results, remission endpoint. Only 14% on placebo that's huge news! It works. Looking forward to moving forward.

[lilLu]

https://www.fiercepharma.com/pharma/abbvie-s-rinvoq-continues-march-toward-ulcerative-colitis-nod-even-as-fda-jak-delays-loom

[DewDiligence]

Rinvoq meets_all_primary_and_secondary_endpts_in UC-maintenance phase-3:

https://finance.yahoo.com/news/upadacitinib-rinvoq-met-primary-secondary-120000332.html

[DewDiligence]

Rinvoq FDA review in PA delayed (again) due to JAK-class safety issues:

https://finance.yahoo.com/news/abbvie-provides-regarding-rinvoq-upadacitinib-123000377.html

[lilLu]

Another successful phase1 and completed acquisition.
https://www.biospace.com/article/abbvie-exercising-right-to-buy-teneoone-and-its-lead-multiple-myeloma-asset/

[lilLu]

Man I love divi's!
https://www.fool.com/investing/2021/06/22/2-dividend-stocks-that-could-be-paying-you-10-with/
ABBV

[oxnous]

ABBV has been a good core holding to just accumulate dividends and get capital appreciation

[lilLu]

A few years ago it was a buy. Now it's a strong buy!
https://www.fool.com/investing/2021/03/02/warren-buffett-and-cathie-wood-just-bought-this-ju/

[lilLu]

https://seekingalpha.com/article/4435421-abbvie-beyond-humira-framing-a-bright-future

[DewDiligence]

ABBV 1Q21 results:

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

[$Pistol Pete$]

$ABBV $112.49

[DewDiligence]

ABBV—Rinvoq sBLA for atopic dermatitis extended three months for FDA to review additional data submitted during the review—new PDUFA is “late 3Q21”:

https://finance.yahoo.com/news/abbvie-announces-extension-review-supplemental-211800386.html

This is the second Rinvoq sBLA whose review was recently extended by the FDA—the other was the sBLA in psoriatic arthritis (#msg-162613514). In both cases, the FDA seems unsure about the risk/benefit tradeoff.

Bottom line: ABBV’s peak sales projection for Rinvoq may be too optimistic. ABBV has been saying that Rinvoq and Skyrizi combined will do $15B of annual sales by 2025.

[conix]

I added too on that drop. Overreaction by the market, imo.

There are few high dividend pharmaceutical stocks out there. Great diversification add.

[JohnLocke101]

Nice. SVB upps target from 140 to 144

[DewDiligence]

Atogepant for prevention of episodic migraine has PDUFA date in late 3Q21:

https://www.prnewswire.com/news-releases/us-fda-accepts-abbvies-new-drug-application-for-atogepant-for-the-preventive-treatment-of-migraine-301257758.html

This drug came from Allergan.

[JohnLocke101]

Nice add on the drop. I’m going to add to a core position here next week. It’s nice to have stocks like these in a balanced portfolio especially in a bit of an uncertain environment.

[oxnous]

Picked up some more ABBV. Dividend is too sweet to ignore.

[DewDiligence]

Rinvoq PDUFA date for psoriatic arthritis extended 3 months to “late 2Q21”:

https://finance.yahoo.com/news/abbvie-announces-extension-review-supplemental-124500090.html

AbbVie recently received an information request from the FDA for an updated assessment of the benefit-risk profile for upadacitinib in psoriatic arthritis. AbbVie responded to the request and the FDA will require additional time for a full review of the submission.

Separately, AbbVie received a similar request from the FDA related to the sNDA for upadacitinib in atopic dermatitis, which is being prepared and will be submitted to the FDA shortly.

[adtime]

HUGE SET UP HERE 108.5 reference

[Taurus69]

$abbv $106.6 v -1.25 (-1.16%)
Volume: 7,218,576 @03/03/21 7:58:24 PM EST

[Taurus69]

$abbv $107.75 ^ 0.42 (0.39%)
Volume: 9,249,971 @02/26/21 7:58:44 PM EST

[Taurus69]

$abbv $104.47 ^ 0.72 (0.69%)
Volume: 3,725,009 @02/12/21 6:41:58 PM EST

[DewDiligence]

ABBV pipeline update:

https://investors.abbvie.com/static-files/9c3dba8e-5447-4e55-a78f-d167a91b1e99

[DewDiligence]

ABBV 4Q20 results:

https://news.abbvie.com/news/press-releases/abbvie-reports-full-year-and-fourth-quarter-2020-financial-results.htm

[conix]

ABBV Chart

[Taurus69]

$abbv $111.0 v -1.62 (-1.44%)
Volume: 5,417,311 @01/21/21 7:41:26 PM EST

[DewDiligence]

ABBV/AGN presentation_lineup_at “Toxins 2021” conference:

https://finance.yahoo.com/news/allergan-aesthetics-allergan-abbvie-company-140000028.html

Abstracts will be available online on 1/16/21.