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BMY 2Q22 results:
https://news.bms.com/news/corporate-financial/2022/Bristol-Myers-Squibb-Reports-Second-Quarter-Financial-Results-for-2022/default.aspx
2022 non-GAAP EPS guidance remains $7.44-7.74.
CHMP approves Opdulag for first-line melanoma:
https://finance.yahoo.com/news/bristol-myers-squibb-receives-positive-105900006.html
Opdulag, an FDC of Opdivo and Relatlimb (anti-LAG-3), received FDA approval in this indication in Mar 2022 (#msg-168259775).
BMY sets all-time intraday and closing highs.
The CELG-CVR lawsuit didn’t make a dent, evidently.
FDA approves BMY’s Breyanzi for second-line LBCL:
https://www.businesswire.com/news/home/20220427005982/en
The approval is based on phase-3 data reported one year ago, in which Breyanzi showed statsig-superior EFS compared to SoC (#msg-164317285).
Breyanzi will compete in this newly approved indication with GILD’s Yescarta (#msg-167110232).
Breyanzi was initially FDA-approved for third-line LBCL in Feb 2021 (#msg-161552697). This is the drug at the heart of the lawsuit by former CELG shareholders (#msg-169238809).
BMY acquires TPTX for $76.00 cash—a 122% premium to yesterday’s close:
https://www.businesswire.com/news/home/20220603005198/en
As a result of the acquisition, BMY is reducing 2022 non-GAAP EPS guidance by $0.08 plus a charge for in-process R&D to be determined later. (BMY’s prior 2022 non-GAAP EPS guidance was $7.44-7.74.)
IMTX, BMY expand oncology collaborations (plural):
https://finance.yahoo.com/news/immatics-bristol-myers-squibb-expand-105900729.html
BMY will_advance Deucravacitinib to_phase-3_in lupus, based on phase-2 data presented at EULAR:
https://www.businesswire.com/news/home/20220531005751/en
Deucravacitinib is under FDA and EMA review in psoriasis; the PDUFA date is 9/10/22 (#msg-166931026).
FDA approves Opdivo/chemo and Opdivo/Yervoy in_first-line esophageal cancer_regardless_of_PD-L1_status:
https://finance.yahoo.com/news/u-food-drug-administration-approves-221100701.html
These approvals are based on the CHECKMATE-648 study. See #msg-164194868 for details.
Synopsis of MRK's (anti-LAG-3) favezelimab data from ASCO abstract:
https://www.biopharmadive.com/news/asco-merck-favezelimab-lag3-hodgkin-trial/624457/
Favezelimab might eventually compete with BMY’s Opdualag (#msg-168259768), but it has a long way to go.
Please see #msg-168259803 and https://twitter.com/DewDiligence/status/1395141087413538822 for related info.
BMY’s lineup at ASCO and EHA:
https://finance.yahoo.com/news/bristol-myers-squibb-data-asco-105900815.html
Opdivo/Yervoy failed to show statsig-superior OS compared to chemotherapy in first-line bladder cancer in patients with PD-LI>=1%:
https://finance.yahoo.com/news/bristol-myers-squibb-provides-checkmate-105900892.html
MRK’s Keytruda and Roche’s Tecentriq have also whiffed in this setting.
BMY extends/expands drug-discovery collaboration with EVO:
#msg-168811996
BMY 1Q22 results:
PR:
https://news.bms.com/news/corporate-financial/2022/Bristol-Myers-Squibb-Reports-First-Quarter-Financial-Results-for-2022/default.aspx
CC slides:
https://s21.q4cdn.com/104148044/files/doc_presentations/2022/BMY-2022-Q1-Results-Investor-Presentation.pdf
2022 non-GAAP EPS was lowered by $0.21 due to an FASB accounting change regarding in-process R&D (i.e. accounting for acquisitions). The updated range for 2022 non-GAP EPS (unchanged other than the item described above) is $7.44-7.74.
FDA approves BMY’s Camzyos (mavacamten) for obstructive hypertrophic cardiomyopathy:
https://news.bms.com/news/corporate-financial/2022/U.S.-Food-and-Drug-Administration-Approves-Camzyos-mavacamten-for-the-Treatment-of-Adults-With-Symptomatic-New-York-Heart-Association-Class-II-III-ObstructiveHypertrophic-Cardiomyopathy-HCM-to-Improve-Functional-Capacity-and-Symptoms/default.aspx
BMY thinks Camzyos will have peak annual sales of at least $4B. This is the drug BMY got in the $13.1B acquisition of MYOK in Oct 2020 (#msg-158698900).
Looks like it's starting to rollover.
NKTR -24%/AH on_termination_of Bempeg program following phase-3 failures in RCC and bladder cancer:
https://finance.yahoo.com/news/nektar-bristol-myers-squibb-announce-203000621.html
BMY presents full dataset from CHECKMATE-816 trial in neoadjuvant NSCLC:
https://finance.yahoo.com/news/neoadjuvant-opdivo-nivolumab-chemotherapy-significantly-151500888.html
Opdivo/chemo received FDA approval in this indication one month ago, based on the above data (#msg-168093570).
EU approves three new Opdivo indications…
1. Opdivo + chemo in first-line esophageal cancer with PD-L1>=1% (based on CHECKMATE-648):
https://finance.yahoo.com/news/bristol-myers-squibb-receives-european-105500913.html
2. Opdivo + Yervoy in same indication as above (also based on CHECKMATE-648):
https://finance.yahoo.com/news/bristol-myers-squibb-receives-european-105000567.html
3. Opdivo monotherapy in adjuvant MIUC with PD-L1>=1% (based on CHECKMATE-274):
https://finance.yahoo.com/news/bristol-myers-squibb-receives-european-104500445.html
Updated Cumulative Results Of Treatment With Mavacamten
https://www.acc.org/Latest-in-Cardiology/Articles/2022/04/02/13/22/Sun-945am-Treatment-Mavacamten-acc-2022
Certainly BMY never would've parted with China franchise.
LianBio might be better play for mavacamten
https://www.investorvillage.com/smbd.asp?mb=2294&mn=8977&pt=msg&mid=23095516
BMY’s reports detailed Mavacamten data from phase-3 VALOR trial:
https://www.businesswire.com/news/home/20220401005495/en
I just grabbed a few puts for September. Looking at 10 year chart, every time it hit new highs there was a pull back. Just a little gamble. Definitely a good company to own shares in.
Reblozyl sBLA in beta thalassemia PDUFA extended three months to 6/27/22 due b/c additional data was submitted during the review:
https://finance.yahoo.com/news/bristol-myers-squibb-announces-prescription-105900565.html
BMY inks oncology-drug-discovery collaboration with (private) Volastra Therapeutics:
https://www.biospace.com/article/releases/volastra-therapeutics-announces-drug-discovery-collaboration-with-bristol-myers-squibb/
$30M up-front cash; $1.1B biobucks.
Addendum—BMY has projected $4B+ peak sales of Opdualag by 2029.
FDA label:
https://t.co/R7v5xodScz
FDA approves Opdualag—a_co-formulated_FDC_of Opdivo and anti-LAG-3 relatlimab—in first-line melanoma:
https://www.businesswire.com/news/home/20220304005561/en
The approval is based on the RELATIVITY-047 trial, which tested Opdivo + relatlimab against Opdivo monotherapy and had a PFS HR=0.75 (#msg-163914232).
In first-line melanoma, Opdulag offers comparable efficacy to Opdivo + Yervoy with less toxicity.
My abbreviated take:
https://twitter.com/DewDiligence/status/1395141087413538822
BMY sues AZN claiming Imfinzi infringes Opdivo patent:
https://finance.yahoo.com/news/bristol-myers-sues-astrazeneca-over-172412187.html
https://tmsnrt.rs/3ieYLvz
Keytruda monotherapy-vs-placebo DFS HR=0.76 in adjuvant* NSCLC, irrespective of PD-L1 status, in phase-3 KEYNOTE-091 trial:
https://www.businesswire.com/news/home/20220317005084/en
Although the DFS endpoint was statig, the effect size was so-so (HR=0.76). The statsig outcome was reported on 1/10/22 (https://www.merck.com/news/mercks-keytruda-pembrolizumab-showed-statistically-significant-improvement-in-disease-free-survival-versus-placebo-as-adjuvant-treatment-for-patients-with-stage-ib-iiia-non-small-cell/ ), but the details were not disclosed until today.
Curiously, in the pre-specified subgroup with PD-L1>=50%, Keytruda’s DFS compared to placebo had a non-statsig HR=0.82—a worse result than in the overall trial.
The HR for OS, a secondary endpoint that is not yet mature, was 0.87.
All told, this is not a great dataset, IMO, but it may be enough for FDA approval. These data may put Keytruda at a competitive disadvantage to Tecentriq and Opdivo in early-stage NSCLC.
*Stage 1b-IIIa.
NKTR’s Bempeg fails as addend to Opdivo in first-line melanoma:
https://finance.yahoo.com/news/bristol-myers-squibb-nektar-announce-105900961.html
TEVA launches first US generic Revlimid—but the generic volume is constrained by a prior patent settlement between CELG and Allergan (#msg-119362355):
FDA approves Opdivo/chemo in neoadjuvant* NSCLC, irrespective of PD-L1 status:
https://www.businesswire.com/news/home/20220301006264/en
This is a large potential market and Opdivo is the only FDA-approved immunotherapy in the NSCLC neoadjuvant setting (i.e. before surgical resection).
The approval is based on the CHECKMATE-816 study, where Opdivo/chemo bested chemo alone with the HR for EFS=0.63. Additionally, 24% of patients in the Opdivo/chemo arm had a pathological complete response (no detectable cancer) vs 2% in the chemo-only arm.
OS, which was not a primary endpoint in this trial, had an impressive HR=0.57; however, so little alpha was allocated to OS in the statistical analysis plan that the HR=0.57 result was not deemed statsig.
*Stage Ib, II, or IIIa.
Opdivo sBLA in resectable NSCLC has 7/13/22 PDUFA date (with FDA priority review):
https://www.businesswire.com/news/home/20220225005538/en
BHVN licenses SMA drug candidate—taldefgrobep alfa (a/k/a BMS-986089) from BMY for undisclosed milestone payments and royalties:
https://finance.yahoo.com/news/biohaven-licenses-taldefgrobep-alfa-phase-115000615.html
CHMP approves three new Opdivo indications with PD-L1 expression >=1%...
Opdivo monotherapy in adjuvant MIUC:
https://www.businesswire.com/news/home/20220223006231/en
Opdivo/Yervoy in first-line esophageal:
https://www.businesswire.com/news/home/20220224006058/en
Opdivo/chemo in first-line esophageal:
https://www.businesswire.com/news/home/20220224006066/en
Mavacamten phase-3 succeeds in patients with obstructive HCM eligible for septal reduction therapy:
https://www.businesswire.com/news/home/20220215005925/en
Note: The above is a narrower indication than the one BMY is seeking in the existing NDA that has a 4/28/22 PDUFA date.
BMY sells $6B of 10-40yr notes:
https://finance.yahoo.com/news/bristol-myers-squibb-prices-6-213900129.html
• $1.75B of 10yr notes @2.95%
• $1.25B of 20yr notes @3.55%
• $2.00B of 30yr notes @3.70%
• $1.00B of 40yr notes @3.90%
I wouldn’t buy a long-term bond from any company at such paltry interest rates.
BMY executes $5B ASR* agreements, following through on announcement made 1/10/22 (in conjunction with JPM conference):
https://finance.yahoo.com/news/bristol-myers-squibb-enters-5-115900629.html
*Accelerated Share Repurchase.
BMY 4Q21 results…
PR:
https://s21.q4cdn.com/104148044/files/doc_financials/quarterly_reports/2021/BMY-Q42021-Earnings-Press-Release.pdf
CC slides:
https://s21.q4cdn.com/104148044/files/doc_presentations/2021/BMY-2021-Q4-Results-Investor-Presentation.pdf
BMY reiterates 2022 non-GAAP EPS guidance of $7.65-7.95 and the $15B buyback program with $5B of the $15B to be purchased during 1Q22.
CHMP approves Breyanzi for second-line lymphomas:
https://finance.yahoo.com/news/bristol-myers-squibb-receives-positive-115900026.html
BMY, IPSC ink drug-discovery collaboration:
https://finance.yahoo.com/news/century-therapeutics-bristol-myers-squibb-115900071.html
BMY issues 2022 non-GAAP EPS guidance of $7.65-7.95—starts $15M share-repurchase program with $5M ASR in 1Q22:
https://finance.yahoo.com/news/bristol-myers-squibb-highlight-long-114500205.html
Retiring 11% of the outstanding shares of such a large pharmaceutical company is quite the vote of confidence by management!
FDA approves BMY’s Orencia for prevention of graft-versus-host disease; Orencia is the first drug approved for this indication:
https://www.fda.gov/news-events/press-announcements/fda-approves-first-drug-prevent-graft-versus-host-disease
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