[DewDiligence]

Milvexian—>FDA Fast Track designation for_all_indications:

https://finance.yahoo.com/news/milvexian-granted-u-fda-fast-105900364.html

The three indications BMY is pursuing in phase-3 are: secondary stroke prevention; ACS; and primary stroke prevention in patients with AF.

[DewDiligence]

BMY’s BMS-986278 for IPF will advance to phase-3:

https://www.businesswire.com/news/home/20230519005266/en

[DewDiligence]

IMMP +65% on interim (single-arm) phase-2 data for LAG-3 drug with Keytruda in NSCLC:

https://finance.yahoo.com/news/immutep-efti-combination-pembrolizumab-achieves-120000596.html

IMMP’s eftilagimod alpha is a LAG-3 protein that targets the same biologic pathway as BMY’s relatlimab, one of the component drugs (along with Opdivo) in Opdulag.

BMY’s Opdulag, which was FDA approved in Mar 2022 for first-line melanoma, is already selling at an annualized rate of $500M in the US alone (#msg-171784010).

Please see #msg-168259768 for related info.

[DewDiligence]

BMY’s ASCO/EHA/ICML lineup:

https://www.businesswire.com/news/home/20230510006079/en

[DewDiligence]

$3.4M insider sale yesterday by BMY’s CSO, Rupert Vessey:

https://www.sec.gov/Archives/edgar/data/14272/000001427223000114/xslF345X04/wf-form4_168323704827586.xml

Unless Vessey is buying a house, a sale of this size at this price level is somewhat concerning.

[DewDiligence]

BMY 1Q23 CC transcript:

https://finance.yahoo.com/news/q1-2023-bristol-myers-squibb-042637576.html

[DewDiligence]

BMY 1Q23 results…

PR:
https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibb-Reports-First-Quarter-Financial-Results-for-2023/default.aspx

CC slides:
https://s21.q4cdn.com/104148044/files/doc_presentations/2023/BMY-2023-Q1-Results-Presentation-Appendix.pdf

2023 non-GAAP EPS guidance remains $7.95-8.25, +4% YoY at the midpoint of the range.

[DewDiligence]

BMY’s CCO, Christopher Boerner—>CEO effective 11/1/23:

https://www.sec.gov/ix?doc=/Archives/edgar/data/0000014272/000114036123020605/brhc20052030_8k.htm

CEO, Giovanni Caforio will become Executive Chairman on 11/1/23. Between now and 11/1/23, Boerner will have the title of COO.

[DewDiligence]

CHMP approves Camzyos:

https://finance.yahoo.com/news/bristol-myers-squibb-receives-positive-184200509.html

[DewDiligence]

CHMP approves Breyanzi in second-line LBCL:

https://www.businesswire.com/news/home/20230330005697/en

FDA approval in this indication came in Jun 2022 (#msg-169240243).

[DewDiligence]

BMY, EVO extend/expand neurodegeneration collaboration:

https://www.accesswire.com/viewarticle.aspx?id=746175&lang=en

The collaboration now runs for another eight years, and EVO receives an additional $50M in up-front cash.

Note that BMY and EVO are also collaborating in protein degradation (#msg-168811996).

[DewDiligence]

EC approves Sotyktu for psoriasis:

https://finance.yahoo.com/news/bristol-myers-squibb-receives-european-105900011.html

Essentially same label as FDA’s.

[DewDiligence]

TAK-279 vs Sotyktu (from biopharmadive.com): #msg-171480207.

[DewDiligence]

BMY will not launch Opdualag in Germany due to pricing constraints on FDC (combination) drugs:

https://endpts.com/bristol-myers-axes-german-launch-of-new-cancer-drug-citing-pricing-hurdles/

[DewDiligence]

BMY/JNJ unveil_phase-3_program_for Milvexian—50,000 patients_across_three_ trials_in secondary stoke prevention, ACS, and AF/primary stroke prevention:

https://www.businesswire.com/news/home/20230228006466/en

Enrollment has begun for the Librexia STROKE trial, which is evaluating milvexian in addition to standard of care antiplatelet therapy for stroke prevention in patients after an acute ischemic stroke or high-risk transient ischemic attack. The Librexia ACS trial, which will evaluate event reduction in acute coronary syndromes in addition to standard of care antiplatelet therapy, and the Librexia AF trial, which will investigate milvexian compared to apixaban [Eliquis] in the prevention of stroke in patients with atrial fibrillation, will also initiate during the first half of 2023.

Milvexian is an oral FXIa inhibitor. The phase-3 trial in secondary stroke prevention is at: https://www.clinicaltrials.gov/ct2/show/NCT05702034 .

The commercial impetus for the Milvexian program is to supersede Eliquis (BMY) and Xarelto (JNJ) when those drugs go off-patent or become subject to Medicare price-setting. The competition for Milvexian is Bayer’s Asundexian, another oral FXIa inhibitor that started a somewhat less aggressive phase-3 program (#msg-169841711) that does not have a trial for ACS.

[DewDiligence]

Opdivo PDUFA date for adjuvant melanoma—>10/13/23:

https://finance.yahoo.com/news/u-food-drug-administration-accepts-115900042.html

The corresponding MAA has been validated by the EMA, starting the review clock.

The sBLA and MAA are based on the CHECKMATE-076 study, which showed HR=0.42 for the primary RFS endpoint (#msg-170239823).

[DewDiligence]

BMY’s ACC lineup:

https://www.businesswire.com/news/home/20230224005299/en

[DewDiligence]

BMY/TVST report Abecma data from phase-3 KarMMa-3 study:

https://www.businesswire.com/news/home/20230209005647/en

At a median follow up of 18.6 months, treatment with Abecma (n=254) demonstrated a clinically meaningful and statistically significant improvement in the primary endpoint of progression-free survival (PFS) compared with standard regimens (n=132), with a median PFS of 13.3 months (95% CI: 11.8-16.1) vs. 4.4 months (95% CI: 3.4-5.9), respectively (HR:0.49; p<0.0001).

Abecnma is currently FDA-approved for fifth-line MM; the results above should enable a label expansion into the third-line setting.

[DewDiligence]

BMY -2.5% today—possible reason is that the CEO just sold $18M worth of stock—approximately half his holding—(the Form-4 filing hit the wires last night after the close):

https://www.sec.gov/Archives/edgar/data/14272/000001427223000044/xslF345X03/wf-form4_167590496019590.xml

It's hard to interpret a transaction of this size as non-bearish. I wonder if Giovanni Caforio is planning to retire in the next 12-18 months.

[DewDiligence]

Bayer enrolls first phase-3 patients for FXIa inhibitor, Asundexian:

https://www.businesswire.com/news/home/20230208005322/en

• The OCEANIC program will investigate the efficacy and safety of asundexian (BAY2433334) in the prevention of stroke in patients with atrial fibrillation and also patients with a non-cardioembolic ischemic stroke or high-risk transient ischemic attack (TIA)
2
• OCEANIC-AF and OCEANIC-STROKE are expected to enroll more than 27,000 patients in over 40 countries

Bayer’s competition in this arena is BMY/JNJ’s Milvexian (#msg-169818942, #msg-169841711), which is awaiting the start of phase-3.

[DewDiligence]

BMY 4Q22 CC transcript:

https://www.fool.com/earnings/call-transcripts/2023/02/02/bristol-myers-squibb-bmy-q4-2022-earnings-call-tra/

[DewDiligence]

BMY’s Sotyktu patients are coming approximately 1/3 from treatment-naïve, 1/3 for Otezla switches, and 1/3 from biologic switches. (Source: 4Q22 CC.)

[DewDiligence]

BMY 4Q22 CC slides:

https://s21.q4cdn.com/104148044/files/doc_presentations/2022/BMY-Q4-2022-Results-Presentation-with-Appendix.pdf

[DewDiligence]

BMY 4Q22 results—2023 guidance:

https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibb-Reports-Fourth-Quarter-and-Full-Year-Financial-Results-for-2022/default.aspx

2023 non-GAAP EPS guidance is $7.95-8.25; at the midpoint of the range, this is a 4% increase relative to 2022’s non-GAAP EPS of $7.70.

[DewDiligence]

CHMP approves BMY’s Sotyktu for psoriasis:

https://www.businesswire.com/news/home/20230125005858/en

[DewDiligence]

Addendum—Breyanzi is the first CAR-T to show efficacy in CLL, as far as I know. rrCLL is a large market; if Breyanzi’s complete-response rate after, say, 5 years is as high as 15-20%, this indication could be a meaningful commercial contributor.

Breyanzi, which is currently approved for various forms of relapsed NHL, has annualized sales of under $200M.

[DewDiligence]

BMY’s Breyanzi meets primary endpoint in rrCLL/SLL single-arm trial:

https://finance.yahoo.com/news/bristol-myers-squibb-announces-transcend-115900140.html

Bristol Myers Squibb today announced topline results from TRANSCEND CLL 004, a Phase 1/2, open-label, single-arm, multicenter study evaluating Breyanzi (lisocabtagene maraleucel) in adults with relapsed or refractory (R/R) chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Results from TRANSCEND CLL 004 showed the study met the primary endpoint of complete response rate compared to historical control in the prespecified subset of patients with R/R CLL that was refractory to a BTK inhibitor and pretreated with a BCL-2 inhibitor.

The trial listing is at:
https://www.clinicaltrials.gov/ct2/show/NCT03331198

[DewDiligence]

BMY’s JPM webcast slides:

https://www.sec.gov/Archives/edgar/data/14272/000114036123000970/brhc10046308_99-1.htm

[DewDiligence]

BMY’s Breyanzi continues to show robust results in second-line LBCL after longer follow-up:

https://www.fiercepharma.com/pharma/bristol-myers-bolsters-breyanzis-earlier-lymphoma-case-elevated-car-t-fight-against-gilead-0

Data from the same trial presented one year ago (at ASH 2021) are in #msg-164317285.

[DewDiligence]

BMY’s ASH presentations:

https://finance.yahoo.com/news/bristol-myers-squibb-announces-first-115900939.html

[DewDiligence]

BMY boosts annualized dividend to $2.28—(from $2.16):

https://finance.yahoo.com/news/bristol-myers-squibb-announces-dividend-211600245.html

At the current share price ($79.88), the new annualized payout is a yield of 2.9%.

[DewDiligence]

BMY’s ASH lineup:

https://finance.yahoo.com/news/bristol-myers-squibb-data-ash-115900163.html

[DewDiligence]

BMY’s AHA presentation lineup:

https://finance.yahoo.com/news/data-reinforcing-impact-bristol-myers-105900941.html

[DewDiligence]

BMY scores phase-3 win for Reblozyl in a new MDS indication:

https://www.businesswire.com/news/home/20221029005019/en

[DewDiligence]

BMY 3Q22 CC transcript:

https://www.fool.com/earnings/call-transcripts/2022/10/26/bristol-myers-squibb-bmy-q3-2022-earnings-call-tra/

[DewDiligence]

BMY 3Q22 CC slides:

https://s21.q4cdn.com/104148044/files/doc_presentations/2022/BMY-2022-Q3-Results-Investor-Presentation.pdf

[DewDiligence]

BMY 3Q22 results—2022 non-GAAP guidance unchanged:

https://www.businesswire.com/news/home/20221026005143/en

Non-GAAP EPS guidance remains $7.44-7.74.

This PR wasn’t supposed to come out until Wednesday morning. (Somebody must have goofed.)

[DewDiligence]

Camzyos sNDA for prevention of SRT* in patients with symptomatic obstructive HCM has 6/16/23 PDUFA date:

https://finance.yahoo.com/news/u-food-drug-administration-fda-105900322.html

*Septal Reduction Therapy, a surgical intervention to correct a structural heart defect.

[DewDiligence]

BMY—Opdivo monotherapy—>RFS HR=0.42 in adjuvant melanoma:

https://finance.yahoo.com/news/bristol-myers-squibb-presents-data-203000448.html

Bristol Myers Squibb today announced results from the Phase 3 CheckMate-76K trial, in which Opdivo (nivolumab) as an adjuvant therapy demonstrated a statistically significant and clinically meaningful benefit in recurrence-free survival (RFS) versus placebo in patients with completely resected stage IIB or IIC melanoma. At a pre-specified interim analysis, the trial met its primary endpoint of recurrence-free survival (RFS); Opdivo reduced the risk of recurrence or death by 58% versus placebo (hazard ratio [HR] 0.42; 95% CI 0.30-0.59; p < 0.0001).

This trial was open to all comers regardless of PD-L1 status. The RFS HR of 0.42 is quite impressive and should lead to another approved indication for Opdivo in the adjuvant setting.

BMY announced the success of this trial on 9/15/22 (#msg-169956859), but the details were disclosed for the first time today.

[DewDiligence]

Opdivo monotherapy shows statsig RFS in adjuvant melanoma (fully resected Stage IIB/C):

https://finance.yahoo.com/news/bristol-myers-squibb-announces-adjuvant-105900730.html

These results are from the phase-3 CHECKMATE-76K trial. Details to be presented at a medical conference.

[joe_techi]

https://biopharma.media/deucravacitinib-miracle-drug-for-autoimmune-diseases-1094/

Hangs a bit but loads

[DewDiligence]

What is the link for that? TIA

[joe_techi]

Sotyktu: Miracle Pill for Autoimmune Diseases

"Given both deucravacitinib’s new mechanism of action and its very acceptable safety profile, it has the ability to make billions of dollars for Bristol-Myers Squibb. Well, it will give immeasurably suffering patients an extra chance for healing.

For U.S. patients, the price of Sotyktu is set at $6,146 (excluding discounts and rebates) for a one-month course of treatment. A year’s worth of therapy would cost $74,000. This is one-third more than the cost of treating psoriasis with Otezla (apremilast).

According to industry forecasts, deucravacitinib sales will reach $2.4 billion annually by 2026. Peak demand for deucravacitinib will easily reach $4 billion annually."

https://biopharma.media/deucravacitinib-miracle-drug-for-autoimmune-diseases-1094/

[DewDiligence]

Perfect timing—BMY reports 2yr Sotyktu data in psoriasis at EADV conference:

https://finance.yahoo.com/news/bristol-myers-squibb-announces-sotyktu-063000160.html

[DewDiligence]

FDA approves Sotyktu (deucravacitinib) for psoriasis:

https://investors.bms.com/iframes/press-releases/press-release-details/2022/U.S.-Food-and-Drug-Administration-Approves-Sotyktu-deucravacitinib-Oral-Treatment-for-Adults-with-Moderate-to-Severe-Plaque-Psoriasis/default.aspx

The label does not include JAK-like black-box warnings or usage restrictions, validating BMY’s contention that Sotyktu's TYK2 target is well differentiated from JAK1/2/3.

BMY expects eventual Sotyktu approval in other autoimmune indications and foresees peak annual sales of at least $4B.