ABBV reports 3Q23 results—raises_2023 non-GAAP EPS guidance:
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 reports 2Q23 results—raises_2023 non-GAAP EPS guidance:
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.
ABBV’s $21B buyout of PCYC is_looking_worse_lately:
ABBV -3% on_announcement_of_low-priced Humira biosimilar from CHRS—including distribution by Mark’s Cuban’s CostPlus pharmacy:
ABBV/GMAB—FDA approves Epkinly—(epcoritamab)—for r/rDLBCL:
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:
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).
ABBV reports 1Q23 results—raises non-GAAP EPS guidance:
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:
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:
Skyrizi is currently approved in Crohn’s disease, but not in UC.
ABBV receives CRL for ABBV-951 due to FDA questions about the pump delivery device:
ABBV reports 4Q22 results—issues 2023 guidance:
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:
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 now_expects Skyrizi/Rinvoq combined_2025_ sales_>=$17.5B—(up_from_prior_guidance_of_>=$15B):
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’s neurotoxin, AGN-151607 misses primary endpoint in prevention of PAOF (PostOperative Atrial Fibrillation) in cardiac-surgery patients:
AGN-151607 is a Type-A botulinum toxin that, unlike Botox, is intended for cardiology indications.
Why does ABBV show up as delisted?
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.
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)
ABBV 2Q22 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 Qulipta sNDA for prevention of chronic migraine:
The FDA approved Qulipta for prevention of episodic migraine in Oct 2021 (#msg-166135709).
Didn't expect that. Bailed and wiped out most of last months ABBV flip gains. That's how it goes sometimes. :)
ABBV 1Q22 results:
Non-GAAP EPS has been lowered by $0.08 due to a FASB accounting change re in-process R&D (i.e. accounting for acquisitions). The new range is $13.92-14.12.
Or perhaps we are done correcting? :) Earning coming soon.
Thanks DewDilligence, you are most likely right about Androgel, but I found it odd that they had a 48 month estimated completion for their trial though having 60 month time frame. At the very least the estimated completion date should have been June 2023. Though the time to Major Adverse Cardiac Event is the primary outcome and they are looking a cardiovascular a nd prostate cancer safety. The trial is also looking at other indications including: sexual activity, depression, bone fractures and anemia diabetes.
As for Libigel, there appears to be more to the story. As you stated it did fail to show efficacy for HSDD due to a large placebo effect. But the larger safety trial was also measuring efficacy and had a surgically menopausal population similar in size to the total of the two pivotal efficacy trials. They efficacy her was being measured in similar method used in the Intrinsa trials. The results form this trial have yet to be released. Secondary outcomes for this trial were never disclosed, as well.
It is true that ABBT/ABBV have never publicly owned or expressed an interest in female testosterone. However, I and a few others can attest to the fact that Dr. Michael Snabes' Linkedin profile, at one time, stated that he worked for AbbVie as early as January 2013 while working for Biosante at the same time. His linked in work history now reads as if there was no overlap, with him starting at AbbVie in April 2013.
Additionally up until, ATRS was issued a patent for using Testosterone to treat HSDD, ABBT was seeking a similar patent.
Dr. Snabes discovered that Libigel reduced Cardiovascular events over placebo ( never publicly disclosed). It appears that Libigel safety/efficacy trial or at least the observation of the 3,656 participants went beyond the December 2012 completion date. This became evident on December 19, 2015, when during the patent prosecution for reducing cardiovascular events (Dr. Snabes as inventor) they added the claim that restoring testosterone also reduced breast cancer events. In September 2012, the reduction in breast cancer events by restoring testosterone was not present. Interestingly, the support for the claim that it reduced cardiovascular events is well documented in the specifications of their patent application, but there is no such support for the breast cancer reduction claim. If ANIP had continued the work to make such a claim they would likely provided the supportive information to their claim in the specifications document accessible through the Public Pair. It also would have shown up in their R&D expenses as ANIP is a smaller company and it would be hard to hide the expenses related the follow-up of the participants.
According to the American Heart Journal article titled "A cardiovascular safety study of LibiGel (testosterone gel) in postmenopausal women with elevated cardiovascular risk and hypoactive sexual desire disorder" which also credits Dr Snabes.
Question for the board, is AbbVie interested in being the leader in male and female testosterone restoration and advancing the benefits beyond hypogonadism?
I see that AbbVie was the primary sponsor for the clinal trial titled A Study to Evaluate the Effect of Testosterone Replacement Therapy (TRT) on the Incidence of Major Adverse Cardiovascular Events (MACE) and Efficacy Measures in Hypogonadal Men (TRAVERSE) which was estimated to have 6,000 participants and a study time frame to completion of approx. 60 months. However, when first posted they had an estimated completion of 48 month completion Start date May 2018 and completion June 2022. Additionally the stopped recruiting at with 5,246 participants.
It appears they were more concerned to meeting their original completion date of June 2022, than getting 6,000 participants.
Then I see that after 9 years of dormancy, the clinical trial titled Safety and Efficacy of LibiGel® for Treatment of Hypoactive Sexual Desire Disorder in Postmenopausal Women (BLOOM), involving 3,656 postmenopausal women at an elevated risk of cardiovascular events, was updated on October 27, 2021 by submitted a Certification/Extension request to delay submission of results. As it currently stands there us no obligation to submit results as the primary completion date was well before January 18, 2017 when the Final Rule for submitting results applied. It is more likely an NDA has been file or in the works, where a Certification request would be required. Arguably AbbVie would be best positioned to submit the NDA, as the Study Director, Dr Michael Snabes is now a Senior Medical Director , AbbVie Global Clinical Research and Development. In this trial he discover that restoring Testosterone reduced the risk of cardiovascular events by at least 70% over expected outcomes and by an undisclosed percentage over placebo. Additionally, by December 2015, it was discovered that it reduced breast cancer events over expected events and over placebo. None of this information has been made public other than in patent application and subsequent.
If AbbVie were intent on advancing the benefits of testosterone restoration, there is a 700,000 participant trial titled Evaluation of Association Between Testosterone Levels, Dementia, and Adverse Mental Health Outcomes due to be completed in November 2022, which could drive interest in the potential benefit of testosterone restoration.
Wondering if it is another tool in countering LOE for Humira.
Good luck to all.