Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
Whether it involves ANIP or not, AbbVie must be working on some type of deal. This past week was the first time, since spinning off from Abbott Laboratories, that AbbVie did not present at the Morgan Stanley Global Healthcare Conference. Obviously something more important appears to be in the works, which justified the new CEO missing an opportunity to lay out his vision and address questions.
Good point Dew Diligence. I checked the SEC website and went through and checked ANIP's filings. They had three NDAs under review two were filed in Q3 2023, only one showed up as an expense in the 10-Q filing for that quarter. ANIP filed another NDA in Q1 2024 and the related 10-Q filing shows it paid the submission fee that quarter. To date the second NDA filed in Q3 2023 does not show up in any of ANIP's SEC filings. The PDUFA date is likely sometime this month.
I checked the SEC website this time and found neither their 10-k filing or any 10-Q filing showed expenses for an NDA submission related to the second NDA filed in Q3 2023.
The following is from 10-k.
Could be a timing issue—i.e. the filing fee for the other 505b2 submission might be charged in 3Q24 rather than 2Q24.
p.s. The document you linked to contains edited changes in red. It cannot be the ANIP's actual 10-Q filing.
ANIP never confirmed the submission fee for one of the NDAs filed in Q3, They announced they filed two NDAs and in the 10 Q filing they said R&D was increased by paying for one NDA. Process of elimination points to another party funding the regulatory process for one of the NDAs
The following is from their earnings release.
What is your source for the $3.2M payment by a third party?
Dew Diligence, I believe in the past that AbbVie had no interest in Female Testoterone (ANIP's Libigel).
I am wondering if that may have changed. In Q3 2023 ANIP filed an NDA for an undisclosed drug where the application fee (approx. $3.2 million) was paid for by an undisclosed. It appears that a Certification request to delay submitting results for Libigel was filed October 27, 2021. For your followers info a Certification is requested to delay posting results when an NDA has been or will be filed.
Seeing that the study director for all Libigel trials was Dr. Michael C. Snabes, who is a Sr. Director with AbbVie Global Research and Development. According to Snabes 4,000 years of data showed that restoring testosterone in post menopausal women at risk of CV events reduced the risk of a CV event by at least 70%. It also showed that it reduced the risk of breast cancer events by an undisclosed amount. They could be sitting on 10 year of safety and efficacy data regarding HSDD and maybe more indications.
https://clinicaltrials.gov/study/NCT00612742?term=biosante&rank=2&tab=results
If AbbVie is ANIP's partner for the first FDA approved female testosterone the application may have been assisted by the Intrinsa portfolio which AbbVie received in their merger with Allergan.
ANIP has never been announced the PDUFA or the fact that another party paid for the NDA filing.
Just trying to figure out who their partner might be. I am leaning toward AbbVie. However, they also have ties to Merck.
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 lowered 2024 Botox guidance by $100M compared to the guidance given three months ago. (Source: today's 2Q24 CC.)
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
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 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 inks drug-discovery collaboration with (private) Tentarix:
https://finance.yahoo.com/news/abbvie-tentarix-announce-collaboration-develop-130500277.html
Looking good, Abbvie!
Various Anslysts like us.
How nice. Let’s rock on this week.
$$ ABBV $$
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.
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 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
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 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 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.
Followers
|
80
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
768
|
Created
|
12/08/12
|
Type
|
Free
|
Moderators DewDiligence |
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |