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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.
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.
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).
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).
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.
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.
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).
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.
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
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)
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
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.
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.
Study procedures
There are 9 clinical visits and 14 telephone contacts during the course of the study (Figure 1). Office visits will occur at screening and randomization and at 3, 6, and 12 months postrandomization and yearly thereafter. Telephone contacts will be completed at week 6, month 9, and at 3-month intervals unless a clinical visit is required. Subjects are instructed to contact sites if they believe that they have experienced a CV event or breast cancer. At each scheduled contact, participants are asked about adverse events and health care and hospitalizations; questioned about specific androgenic side effects, potential CV events, and breast cancer; and undergo other assessments of safety and tolerability as well as laboratory measures.
Efficacy will be evaluated at office visits and telephone contacts using the Subject Global Assessment and Perception of Benefit Questions.Participants who discontinue study drug will be encouraged to complete all study visits, examinations, and questionnaires and to report potential CV events and breast cancer.
Breast and endometrial safety examinations
Breast examination and mammography will be performed at baseline and annually. Endometrial biopsy will be performed at baseline and at study years 1, 2, and 5. Participants with vaginal bleeding will undergo uterine evaluation that includes an endometrial biopsy. Study medication will be discontinued in participants with evidence of uterine cancer, complex or adenomatous hyperplasia, or atypia.
The 3,656 participant trial was an adaptive trial under an FDA Special Protocol Assessment set up in two parts, the first part being pre-commercialization. For which Biosante appears to have met.
ANIP has deflected or stopped responding to shareholder questions related to Libigel development since 2016. The full 5 year, 3,656 participant study would have been completed in August 2016. The Certification/Extension request to delay submission of results on October 27, 2021, is puzzling, unless an NDA has been filed or was about to be filed by a company other than ANIP. Logic dictates that if an NDA is being filed, AbbVie with Dr Snabes, would have been in the best position to take the first FDA approved female testosterone product across the finish line. Especially since AbbVie now owns the Intrinsa data.
The position statement issued in September 2019, provides guidelines in administering testosterone considered to be a benchmark. It provides clinical guidance regarding the use of testosterone therapy in women, examining the effect on sexual function; well-being, mood, and cognition; musculoskeletal effects; cardiovascular and breast health; as well side effects and adverse events. This is first time expert global agreement has been provided on how testosterone should be measured in women and how it should be therapeutically prescribed.
The Position Statement is largely based on the findings of the Safety and efficacy of testosterone for women: a systematic review and meta-analysis of randomized controlled trial data. The study reviewed 36 clinical trials (excluding all phase 3 LibiGel clinical trials), involving 8,480 participants in total. The Position Statement found that though no established indications for testosterone therapy for women existed, clinicians have been treating women with testosterone for decades, uncertain of the benefits and the risks. In most countries, including the United States, testosterone therapy is prescribed off-label male testosterone or compounded therapies. They also found that further investigation is warranted with respect to an individual's well-being, musculoskeletal and cognitive health and long-term safety. (LibiGel should address the long-term safety issue when the trial data is finally published.)
The Position Statement has been endorsed by the following organizations:
The International Menopause Society, The Endocrine Society, The European Menopause and Andropause Society, The International Society for Sexual Medicine, The International Society for the Study of Women's Sexual Health, The North American Menopause Society, The Federacion Latinoamericana de Sociedades de Climaterio y Menopausia, The Royal College of Obstetricians and Gynaecologists, The International Society of Endocrinology, The Endocrine Society of Australia, and The Royal Australian and New Zealand College of Obstetricians and Gynaecologists.
According to the Position Statement, testosterone should only be used to treat HSDD after other options have not proved beneficial and testing shows that a women is testosterone deficient. It only recommends transdermal or cream applications. Where an appropriate approved female testosterone preparation is not available, off label, prescribing of an approved male formulation is considered reasonable. It does not recommend injectables, pellets or formulations that result in supraphysiological blood concentrations of testosterone, or compounded testosterone.
In the end AbbVie may not be interested in female testosterone. But they appear miles ahead of any competition should they want to enter a market with potentially no competition until December of 2033.
Question for the board, is AbbVie interested in being the leader in male and female testosterone restoration and advancing the benefits beyond hypogonadism?
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.
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