AbbVie Inc (ABBV) Quote

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.
For the year ended December 31, 2023, other operating expenses increased to $258.3 million from $212.9 million for the same period in 2022, an increase of $45.4 million, or 21.3%, primarily as a result of the following factors:
•Research and development expenses increased from $22.3 million to $34.3 million, an increase of 53.6%, primarily due to expenses related to a 505(b)(2) filing for one product of approximately $1.6 million, expenses related to ANDA filings, and a higher level of activity associated with ongoing and new projects in the year ended December 31, 2023.

No mention of expenses for the second NDA from 2023 Q3.

I also checked their Q1 2024 10-Q filing. Here they apparently filed a third NDA:

For the three months ended March 31, 2024, other operating expenses, net increased to $68.0 million from $59.2 million for the same period in 2023, an increase of $8.8 million, or 14.8%, primarily as a result of the following factors:
•Research and development expenses increased from $5.9 million to $10.5 million, an increase of $4.6 million or 77.4%, primarily due to expenses related to a FDA filing fee for a 505(b)(2) for one product of approximately $2.0 million, and a higher level of activity associated with ongoing and new projects in the three months ended March 31, 2024.

Still no accounting for the expense to file the NDA in Q3 of 2023. Q2 10-Q filing made no mention of NDA research expenses.

As stated it looks like another company is financing the regulatory process for this one NDA. And ANIP has not provided info or indications for any of the three NDAs and no PDUFA dates. Though Tezruly (an oral solution terazosin) was approved July 29th. It is the first FDA approved oral solution for an alpha-1 blocker and has patent protection to 2041. This was likely one of the two NDAs filed in Q3 2023.

The lack of info surrounding the three NDA filings, the likelihood that they have a yet to be disclosed a partner for one of the NDA's and the Certification (related to NDA filings) to delay submitting clinical trial results point to the possibility of the FDA reviewing an NDA for the first female testosterone. If so, then AbbVie may be their partner, assuming Dr. Snabes is still involved.

JMHO

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.

Company’s strong R&D organization delivered five new product launches and filed three new ANDAs and two new 505(b)(2) applications in the quarter; retained number two ranking in Competitive Generic Therapy (CGT) approvals

ANIP's press release

From ANIP's 10-Q filing
Research and development expenses increased from $7.7 million to $11.1 million, an increase of $3.5 million or 45.2%, primarily due to expenses related to a 505(b)(2) filing for one product of approximately $1.6 million, and a higher level of activity associated with ongoing and new projects in the three months ended September 30, 2023.

ANIP's 10-Q filing -see Other Operating Expenses on page 43

The $3.2 million NDA submission fee assumes that it relates to the Libigel clinical trials having to be reviewed. Which is consistent with the certification request to delay submitting trial results.

FDA user fee table

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.

ABBV new 52 week high

ABBV new 52 week high

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