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Bristol-Myers Squibb Reports Third Quarter Financial Results

The following excerpt is from the company's SEC filing.

Increases Revenues 4% to $4.1 Billion

Posts Third Quarter GAAP EPS of $0.42 and Non-GAAP EPS of $0.39

Achieves Significant U.S. Regulatory and Clinical Milestones in Immuno-Oncology

Opdivo

Approved for Previously-Treated Metastatic Non-Squamous Non-Small Cell Lung Cancer Regardless of PD-L1 Expression

Opdivo-Yervoy

Regimen Approved for Metastatic Melanoma

Granted Breakthrough Therapy Designation for Metastatic Renal Cell Carcinoma

Refines 2015 GAAP EPS Guidance Range to $1.02 - $1.07 and Increases Non-GAAP EPS Guidance Range to $1.85 - $1.90

Bristol-Myers Squibb Company (NYSE:BMY) today reported results for the third quarter of 2015, which were highlighted by strong global sales, key regulatory and clinical milestones in Immuno-Oncology and the completion of several business development transactions strengthening the company’s diversified pipeline.

“In the third quarter we advanced our leadership position in Immuno-Oncology with two accelerated approvals in the U.S. and the presentation of important new clinical data that demonstrates the breadth and depth of our development program,” said Giovanni Caforio, M.D., chief executive officer, Bristol-Myers Squibb. “We delivered strong operational performance driven by top-line growth, the successful launch of

and continuing positive trends for

Eliquis

. I remain confident in our strategy and that we are entering our exciting next chapter in a position of strength.”

$ amounts in millions, except per share amounts

Change

Total Revenues

GAAP Diluted EPS

Non-GAAP Diluted EPS

THIRD QUARTER FINANCIAL RESULTS

Bristol-Myers Squibb posted third quarter 2015 revenues of $4.1 billion, an increase of 4% compared to the same period a year ago. Global revenues increased 11% adjusted for foreign exchange impact.

U.S. revenues increased 4% to $2.0 billion in the quarter compared to the same period a year ago. International revenues increased 4%, or 19% adjusted for foreign exchange impact.

Gross margin as a percentage of revenues was 73.0% in the quarter compared to 74.3% in the same period a year ago.

Marketing, selling and administrative expenses decreased 4% to $983 million in the quarter.

Advertising and product promotion spending increased 13% to $193 million in the quarter.

Research and development expenses increased 15% to $1.1 billion in the quarter.

The effective tax rate was 26.0% in the quarter, compared to 27.4% in the third quarter last year.

The company reported net earnings attributable to Bristol-Myers Squibb of $706 million, or $0.42 per share, in the quarter compared to net earnings of $721 million, or $0.43 per share, a year ago.

The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $648 million, or $0.39 per share, in the third quarter, compared to $750 million, or $0.45 per share, for the same period in 2014. An overview of specified items is discussed under the “Use of Non-GAAP Financial Information” section.

Cash, cash equivalents and marketable securities were $10.0 billion, with a net cash position of $2.8 billion, as of September 30, 2015.

THIRD QUARTER PRODUCT AND PIPELINE UPDATE

Bristol-Myers Squibb’s global sales in the third quarter included

Daklinza

Sunvepra,

which grew by $353 million,

Opdivo

which grew by $304 million,

Eliquis,

which grew by $250 million,

Orencia

, which grew 9%, and

Sprycel

, which grew 7%.

In October, the U.S. Food and Drug Administration (FDA) approved

for the treatment of previously treated patients with non-squamous (NSQ) non-small cell lung cancer (NSCLC) regardless of PD-L1 expression, which expands upon the current indication for

in patients with previously treated squamous (SQ) NSCLC.

is the only PD-1 inhibitor approved for previously treated metastatic SQ and now NSQ NSCLC patients regardless of PD-L1 expression

and the only PD-1 inhibitor approved by the FDA to deliver superior overall survival compared to docetaxel in previously treated metastatic NSCLC. The accelerated approval was based on data from CheckMate -057, a Phase 3 study that evaluated the survival of patients with NSQ NSCLC who had progressed during or after one prior platinum doublet-based chemotherapy regimen.

In October, the FDA approved

in combination with

for the treatment of patients with BRAF

V600 wild-type unresectable or metastatic melanoma.

The approval marks the first and only FDA approval of a regimen of two Immuno-Oncology agents in cancer. The indication was approved under accelerated approval based on tumor response rate and durability of response data from CheckMate -069. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

In September, the FDA granted Breakthrough Therapy Designation to

Opdivo

for the potential indication of advanced or metastatic renal cell carcinoma (RCC). This designation is based on results of CheckMate -025, a Phase 3 study that evaluated the survival of patients with previously treated advanced or metastatic clear-cell RCC versus everolimus. The trial was stopped early in July 2015 because an assessment conducted by the independent Data Monitoring Committee concluded that the study met its primary endpoint of overall survival.

In September, the FDA accepted for filing and review a Supplemental Biologics License Application (sBLA) for the

regimen to include clinical data from CheckMate -067, a landmark Phase 3 trial in patients with previously untreated advanced melanoma. If approved, this application would expand upon the initial

Opdivo+Yervoy

regimen, which was approved based on tumor response rate and safety data from the Phase 2 randomized trial, CheckMate -069. The FDA granted Priority Review for this application with a target action date of January 23, 2016.

In September, the company announced results from two Phase 3 clinical trials at the 2015 European Cancer Congress:

CheckMate -025 - In this study comparing

to everolimus in patients with advanced RCC after prior anti-angiogenic treatment,

demonstrated significant overall survival (OS) benefit compared to the standard of care with a median OS benefit of 25 months compared to 19.6 months for everolimus and clinical benefit regardless of level of PD-L1 expression. The safety profile shown

was consistent with previously reported

trials. The results were published in

The New England Journal of Medicine

CheckMate -057 - In this study evaluating

vs. docetaxel in previously treated patients with advanced NSQ NSCLC,

continued to demonstrate superior OS with an estimated 39% of patients alive at 18 months versus 23% for docetaxel, based on a minimum follow-up of 17.1 months.

also continued to demonstrate a reduction in the risk of death by 28%. Grade 3-4 treatment-related adverse events were reported in 10% of patients treated with

versus 54% in the docetaxel arm. The results were published in

In September, the company announced results from multiple clinical trials at the World Conference on Lung Cancer in Denver:

CheckMate -017 and CheckMate -063 - In these two studies evaluating patients with previously treated SQ NSCLC,

demonstrated sustained survival benefit with an estimated 18 month OS rate of 27% (CheckMate -063) to 28% (CheckMate -017); survival benefit was independent of PD-L1 expression. The safety profile of

was consistent with previously-reported trials, and in CheckMate -017, was also favorable compared to docetaxel.

CheckMate -012 - In this multi-arm Phase 1b study evaluating

in patients with chemotherapy-naïve advanced NSCLC, new dosing schedules of the

arms confirmed objective response rates (ORR) ranging from 13% to 39% depending on the administered regimen, and encouraging efficacy with highest ORR for the

3 mg and

1 mg (31% to 39%) regimen. Median duration of response was not reached in any of these arms with a median follow-up of 6.2 months to 16.6 months, and median progression-free survival ranged from 4.9 months to 10.6 months. Treatment-related serious adverse events reported in these cohorts for CheckMate -012 were consistent with other previously reported

cohorts of this trial, and the new dosing schedules resulted in less toxicity than previously-reported dosing schedules, and an acceptable tolerability profile with 10% or fewer subjects discontinuing for grade 3-4 adverse events.

In August, the company announced that the FDA extended the action date for the sBLA for

for the treatment of patients with previously untreated advanced melanoma. The company submitted...


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