AbbVie Inc (ABBV) Options

ABBV new 52 week high

According to ABBV’s 2Q24 CC, the 8% YoY growth in Botox sales was overstated by about 2x due to inventory restocking. Some of the YoY growth was also due to a price increase. Hence, the YoY change in Botox volume — excluding the restocking effect — was essentially nil.

ABBV 2Q24 CC transcript:

https://finance.yahoo.com/news/abbvie-abbv-q2-2024-earnings-193015976.html

ABBV lowered 2024 Botox guidance by $100M compared to the guidance given three months ago. (Source: today's 2Q24 CC.)

ABBV new 52 week high

ABBV reports 2Q24 results:

https://news.abbvie.com/2024-07-25-AbbVie-Reports-Second-Quarter-2024-Financial-Results

2Q24 sales were +6% YoY in constant currency. 2Q24 Humira sales were $2.81B, -30% YoY due to continued uptake of biosimilars in the US market. 2Q24 Skyrizi sales were $2.73B, +46% YoY. 2Q24 Rinvoq sales were $1.43B, +56% YoY. 2Q24 Botox sales (therapeutic + cosmetic) were $1.54B, +8% YoY.

New 2024 non-GAAP EPS guidance is $10.71-10.91, which includes a ($0.60) hit from IPR&D occurring in 1H24, of which the 2Q24 portion ($0.52) was not in the prior full-year 2024 guidance. The midpoint of the new guidance range ($10.81) is -3% from the actual $11.11 in 2023.

Cool! Thanks for the good news.

FDA approves ABBV’s Skyrizi for first-line ulcerative colitis:

https://finance.yahoo.com/news/u-fda-approves-skyrizi-risankizumab-221800724.html
• Approval supported by two Phase 3 clinical trials that evaluated SKYRIZI for the treatment of moderate to severe ulcerative colitis: a 12-week induction study, INSPIRE,1 and a 52-week maintenance study, COMMAND

• Data showed that clinical remission, the primary endpoint in both the induction and maintenance studies, was achieved along with endoscopic improvement, a key secondary endpoint

• SKYRIZI is the first IL-23 antagonist approved for both ulcerative colitis and Crohn's disease ABBV’s Rinvoq, which is oral, is also approved in UC and Crohn’s disease following first-line treatment with a TNF-a agent such as Humira (#msg-171942039). Thus, Skyrizi and Rinvoq together give ABBV a bruising one-two punch in IBD, which accounts for about 40% of the overall market addressed by these agents (and Humira).

ABBV says Skyrizi and Rinvoq will have combined worldwide sales of $27B by 2027, several billion more than the peak annual sales attained by Humira.

Mini-tender offers are cropping up more often in drug/biotech industry:

https://finance.yahoo.com/news/abbvie-recommends-shareholders-reject-tutanotas-200800730.html

For a stock like ABBV that has ample trading volume, it makes little sense for a shareholder to tender.

ABBV 1Q24 CC transcript:

https://finance.yahoo.com/news/q1-2024-abbvie-inc-earnings-052453398.html

ABBV reports 1Q24 results—raises 2024 guidance:

https://news.abbvie.com/2024-04-26-AbbVie-Reports-First-Quarter-2024-Financial-Results

New 2024 non-GAAP EPS guidance $11.13-11.33, up from the prior guidance of $11.05-11.25 three months ago. The new guidance includes an ($0.08) hit from IPR&D occurring in 1Q24, which was not in the prior full-year 2024 guidance.

The midpoint of the new range ($11.23) represents 1% YoY growth from the actual $11.11 in 2023. The lack of robust YoY growth is due, in large part, to the continued uptake of Humira biosimilars in the US market.

ABBV new 52 week hi

ABBV inks drug-discovery collaboration with (private) Tentarix:

https://finance.yahoo.com/news/abbvie-tentarix-announce-collaboration-develop-130500277.html AbbVie and Tentarix Biotherapeutics today announced a multi-year collaboration focused on the discovery and development of conditionally-active, multi-specific biologic candidates in oncology and immunology. The collaboration will integrate AbbVie's expertise in oncology and immunology with Tentarix's proprietary Tentacles™ platform.

Tentacles™ are multi-functional, conditionally-active antibody-based biologics that are designed specifically to activate immune cells that can modulate disease pathways, while potentially mitigating safety concerns associated with non-specific targeting of other immune cells. How are “tentacles” different from ADCs?

ABBV new 52 week high

Looking good, Abbvie!

Various Anslysts like us.

How nice. Let’s rock on this week.

$$ ABBV $$

ABBV 4Q23 CC transcript:

https://finance.yahoo.com/news/abbvie-abbv-q4-2023-earnings-204515179.html

ABBV reports 4Q23 results—issues 2024 guidance:

https://news.abbvie.com/2024-02-02-AbbVie-Reports-Full-Year-and-Fourth-Quarter-2023-Financial-Results

2024 non-GAAP EPS guidance is $11.05-11.25, essentially flat relative to $11.11 in 2023. The lack of material YoY growth is due, in part, to the continued uptake of Humira biosimilars in the US market.

https://finance.yahoo.com/news/sight-sciences-announces-publication-successful-210500987.html

ABBV 3Q23 CC transcript:

https://finance.yahoo.com/news/abbvie-inc-nyse-abbv-q3-170643822.html

ABBV reports 3Q23 results—raises_2023 non-GAAP EPS guidance:

https://news.abbvie.com/news/press-releases/abbvie-reports-third-quarter-2023-financial-results.htm

The new 2023 non-GAAP EPS guidance is $11.19-11.23 (up from the prior range of $10.90-11.20). The sharp decline from 2022’s non-GAAP EPS of $13.77 is due to the launch of Humira biosimilars in the US market.

ABBV 2Q23 CC transcript:

https://finance.yahoo.com/news/q2-2023-abbvie-inc-earnings-050609256.html

ABBV reports 2Q23 results—raises_2023 non-GAAP EPS guidance:

https://news.abbvie.com/news/press-releases/abbvie-reports-second-quarter-2023-financial-results.htm

The new 2023 non-GAAP EPS guidance is $10.90-11.20 (up from the prior range of $10.57-19.97). The sharp decline from 2022’s non-GAAP EPS of $13.77 is due to the launch of Humira biosimilars in the US market. However, the uptake of Humira biosimilars in the US market has been somewhat slower than anticipated, which is the main reason for ABBV’s increasing its 2023 non-GAAP EPS guidance.

Reuters:
https://finance.yahoo.com/news/abbvie-raises-annual-profit-forecast-114058077.html

ABBV’s $21B buyout of PCYC is_looking_worse_lately:

https://www.fiercepharma.com/pharma/abbvie-sues-beigene-over-brand-new-imbruvica-patent-blood-cancer-battle-heats Because of Imbruvica’s toxicity [see #msg-170086344], the National Comprehensive Cancer Network (NCCN) recently downgraded its guidance on Imbruvica, removing the AbbVie/J&J drug from a “preferred” regimen status. The NCCN guidelines committee has instead placed [BGNE’s] Brukinsa above Imbruvica in several areas.

…Facing double pressure from Brukinsa and AstraZeneca’s Calquence, Imbruvica has been on fast decline. First-quarter sales of the first-generation BTK inhibitor dropped 25% year on year to $878 million for AbbVie. The above article is about a new patent-infringement suit by ABBV against BGNE.

Note: The 2015 buyout of PCYC gave ABBV only half the worldwide commercial rights to Imbruvica (#msg-111425234).

ABBV -3% on_announcement_of_low-priced Humira biosimilar from CHRS—including distribution by Mark’s Cuban’s CostPlus pharmacy:

https://www.globenewswire.com/news-release/2023/06/01/2680331/33333/en/Coherus-Announces-Industry-Wide-Lowest-List-Price-for-Adalimumab-Biosimilar-YUSIMRY-adalimumab-aqvh-Launching-in-July-2023.html

https://www.globenewswire.com/news-release/2023/06/01/2680351/33333/en/Mark-Cuban-Cost-Plus-Drug-Company-joins-forces-with-Coherus-to-make-YUSIMRY-a-HUMIRA-biosimilar-available-to-patients.html

ABBV/GMAB—FDA approves Epkinly—(epcoritamab)—for r/rDLBCL:

https://www.businesswire.com/news/home/20230518005495/en/EPKINLY%E2%84%A2-epcoritamab-bysp-Approved-by-U.S.-Food-and-Drug-Administration-as-the-First-and-Only-Bispecific-Antibody-to-Treat-Adults-with-Relapsed-or-Refractory-RR-Diffuse-Large-B-cell-Lymphoma-DLBCL/

Epkinly is a CD20-bispecific mAb. This is an accelerated approval based on a single-arm phase-2 trial.

FDA approves Rinvoq for Crohn’s disease:

https://finance.yahoo.com/news/u-fda-approves-rinvoq-upadacitinib-162500452.html

Rinvoq now has seven FDA–approved indications: RA; psoriatic arthritis; ankylosing spondylitis; axial spondyloarthritis; ulcerative colitis; and Crohn’s disease. In the five non-IBD indications (all except UC and Crohn’s), Rinvoq is indicated for second-line treatment following a TNF-a biologic.

ABBV now has three of the four IBD approvals it seeks: Rinvoq in UC and Crohn’s, and Skyrizi in Crohn’s. Based on phase-3 data (#msg-171517753), ABBV plans to submit a Skyrizi BLA for UC in 2023.

ABBV expects combined sales of Skyrizi and Rinvoq to teach $17.5B in 2025 and $21B in 2027 (#msg-170905881).

Muddy Waters doesn't like the way Abbvie and Chinook have been presenting data on atrasentan:

https://d.muddywatersresearch.com/content/uploads/2023/05/MW_KDNY_20230516.pdf

ABBV reports 1Q23 results—raises non-GAAP EPS guidance:

https://news.abbvie.com/news/press-releases/abbvie-reports-first-quarter-2023-financial-results.htm

2023 non-GAAP EPS has been raised $0.10 at both the lower and upper bounds of the range, which is now $10.72-$11.12. This a sharp decline from 2022’s $13.77 due to the launch of Humira biosimilars in the US market.

ABBV—FDA expands Qulipta label_to prevention of chronic migraine:

https://finance.yahoo.com/news/u-fda-approves-qulipta-atogepant-234100408.html

Previously, Qulipta was approved for prevention of episodic migraine, but not chronic migraine. The distinction between the two indications is arbitrary but industry-standard. Chronic migraine is defined as a condition that causes >=15 headache days per month of which >=8 days are migraine.

ABBV’s migraine portfolio also includes Ubrelvy for treatment of acute migraine and Botox for prevention of chronic migraine.

Qulipta’s main competition is PFE’s Nurtec.

Skyrizi phase-3 in UC hits all endpoints:

https://www.prnewswire.com/news-releases/risankizumab-skyrizi-achieves-primary-and-all-secondary-endpoints-in-phase-3-induction-study-in-patients-with-ulcerative-colitis-301779462.html

Skyrizi is currently approved in Crohn’s disease, but not in UC.

ABBV advances Rinvoq to phase-3 in lupus:

https://www.prnewswire.com/news-releases/abbvie-advances-upadacitinib-rinvoq-to-phase-3-clinical-trials-in-systemic-lupus-erythematosus-301779254.html

ABBV receives CRL for ABBV-951 due to FDA questions about the pump delivery device:

https://www.prnewswire.com/news-releases/abbvie-provides-regulatory-update-on-abbv-951-foscarbidopafoslevodopa-new-drug-application-301777945.html

ABBV 4Q22 CC transcript:

https://www.fool.com/earnings/call-transcripts/2023/02/09/abbvie-abbv-q4-2022-earnings-call-transcript/

ABBV pipeline update:

https://investors.abbvie.com/static-files/9200a822-5d4b-4a1d-a4f3-720cb7b76723

ABBV reports 4Q22 results—issues 2023 guidance:

https://news.abbvie.com/news/press-releases/abbvie-reports-full-year-and-fourth-quarter-2022-financial-results.htm

ABBV’s 2023 non-GAAP EPS guidance is $10.70-11.10, a sharp decline from 2022’s $13.77 due to the launch of Humira biosimilars in the US market.

ABBV introduces Juvederm Volux—a_dermal_filler_for jawline augmentation:

https://finance.yahoo.com/news/juv-derm-volux-xc-improvement-130000644.html

This offering expands the Juvederm XC product line, which includes, in ascending order of heaviness: Volbella (for lips); Vollure (for nasolabial folds); Voluma (for mid-face augmentation), and Volux (for jawline).

ABBV JPM slide set:

https://investors.abbvie.com/static-files/4d7aae8a-65ca-45f9-bc0f-a169b5a7dc9d

ABBV now_expects Skyrizi/Rinvoq combined_2025_ sales_>=$17.5B—(up_from_prior_guidance_of_>=$15B):

https://finance.yahoo.com/news/abbvie-raises-sales-outlook-two-141249692.html

ABBV also expects peak combined annual sales of these two drugs will exceed $21B in 2027.

All this despite the JAK limitation of Rinvoq to the second-line setting in most indications.

ABBV in Investor's Daily

https://www.investors.com/news/technology/abbvie-stock-briefly-breaks-out-on-a-new-cancer-deal/

ABBV’s neurotoxin, AGN-151607 misses primary endpoint in prevention of PAOF (PostOperative Atrial Fibrillation) in cardiac-surgery patients:

https://finance.yahoo.com/news/abbvie-announces-breaking-results-phase-173100778.html

AGN-151607 is a Type-A botulinum toxin that, unlike Botox, is intended for cardiology indications.

ABBV 3Q22 CC transcript:

https://www.fool.com/earnings/call-transcripts/2022/10/28/abbvie-abbv-q3-2022-earnings-call-transcript/

ABBV 3Q22 results:

https://news.abbvie.com/news/press-releases/abbvie-reports-third-quarter-2022-financial-results.htm

Why does ABBV show up as delisted?

Impetus for ABBV selloff today:

https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-26-29-september-2022 Imbruvica (ibrutinib): new risk minimisation measures, including dose modifications, due to the increased risk for serious cardiac events

This DHPC aims to inform healthcare professionals about an increased risk of fatal and serious cardiac arrhythmias and cardiac failure with the use of ibrutinib.

...Patients with advanced age, Eastern Cooperative Oncology Group (ECOG) performance status >-2, or cardiac co-morbidities may be at greater risk of cardiac events including sudden fatal cardiac events.

The PRAC advises that a clinical evaluation of cardiac history and function should be performed before starting a treatment with ibrutinib. In patients with risk factors for cardiac events, benefits and risks should be assessed before initiating treatment with the medicine and alternative treatment may be considered. Patients should be carefully monitored during treatment for signs of deterioration of cardiac function and be clinically managed.

Ibrutinib should be withheld for any new onset or worsening of grade 2 cardiac failure or grade 3 cardiac arrhythmias. Treatment may be resumed as per new dose modification recommendations.

The DHPC for Imbruvica will be forwarded to EMA’s human medicines committee (CHMP). Following the CHMP decision, the DHPC will be disseminated to healthcare professionals by the marketing authorisation holder, according to an agreed communication plan, and published on the ‘Direct healthcare professional communications’ page and in national registers in EU Member States.Emphasis added.

Imbruvica (ibrutinib) Pharmacyclics (AbbVie)
2021 Sales $9,777,000,000.00

Data was excellent. Doubled CR of (ABBV) ibrutinib alone in MCL

Data in P53 mutant CCL is game changing

ABBV Let this sink in on how valuable this combo is $$$ for ABBV

Two ROR1 acquisitions Merck acquired early clinical data VelsoBio.. for $2.8 Billion & Boehringer buys NBE Therapeutics $1.5Billion ROR1 deal last year.

$ONCT

Great informant video of ABBV & ONCT combos in the clinic (cancer stem cells)


$ONCT

ABBV 2 trials one with ibrutinib & the other zilovertamab with Oncternal Therapeutics ROR1 molecule the data speaks for itself. This is going to be huge for ABBV bottom line.

ABBV with Oncternal Therapeutics Presents Updated Interim Data for Zilovertamab in Combination with Ibrutinib at ASCO 2022 Phase 3 starts in a few weeks in ths usa.
May 26, 2022 at 5:15 PM EDT

Updated MCL and CLL data from the CIRLL study are encouraging and continue to improve
ORR of 85% (23 of 27 evaluable patients) and CR rate of 41% (11 of 27 evaluable patients) for patients with MCL treated with zilovertamab plus ibrutinib compare favorably to historical ORR of 66% and CR of 20% for ibrutinib monotherapy
Data from p53-mutated MCL and CLL patients show encouraging response rates in sub-group analyses. Landmark PFS was over 80% at 15 months for MCL and 100% at 36 months for CLL in p53-mutated patients treated with zilovertamab plus ibrutinib
The combination of zilovertamab and ibrutinib continued to be well tolerated, with an adverse event profile consistent or improved compared with historical data for ibrutinib monotherapy.
ONCT is going to help ABBV with ibrutinib sales & with investigator-initiated studies, including a Phase 2 clinical trial of zilovertamab in combination with venetoclax, a Bcl-2 inhibitor, in patients with relapsed/refractory CLL, and in a Phase 1b study of zilovertamab in combination with docetaxel in patients with metastatic castration-resistant prostate cancer (mCRPC).
I think ABBV buys ONCT sooner than later 10 drugs in their pipeline.

ZILO-301: Phase III study of zilovertamab + ibrutinib vs ibrutinib in R/R MCL
(VIDEO 2 min)


$ONCT
$ABBV

ABBV 2Q22 results:

https://investors.abbvie.com/news-releases/news-release-details/abbvie-reports-second-quarter-2022-financial-results

2022 non-GAAP EPS guidance is unchanged at $13.78-13.98, including a $0.23 charge for in-process R&D during 1H22, but no IPR&D charge relating to 2H22 insofar as M&A activity during 1H22 is not yet known

ABBV set aside $2B to settle opioid litigation (https://finance.yahoo.com/news/1-abbvie-sets-aside-2-121111751.html ), but this charge is excluded from the non-GAAP results are guidance.

ABBV submits NDA/MAA for Rinvoq in Crohn’s disease:

https://finance.yahoo.com/news/abbvie-submits-regulatory-applications-fda-124500484.html

ABBV submits Qulipta sNDA for prevention of chronic migraine:

https://finance.yahoo.com/news/abbvie-submits-supplemental-drug-application-120000934.html

The FDA approved Qulipta for prevention of episodic migraine in Oct 2021 (#msg-166135709).