Actionable news
0
All posts from Actionable news
Actionable news in REGN: Regeneron Pharmaceuticals, Inc.,

Regeneron Reports Third Quarter 2015 Financial And Operating Results

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

Third quarter 2015 EYLEA

(aflibercept) Injection global net sales increased

to $1.105 billion (consisting of

$734 million

in the U.S. and

$371 million

in rest of world

versus third quarter 2014

Third quarter 2015 non-GAAP net income

$403 million

per diluted share, versus third quarter 2014

Raised estimated full year 2015 EYLEA U.S. net sales growth guidance to 50% - 55% over 2014, from the previous guidance of 45% - 50%

-- Regeneron Pharmaceuticals, Inc. (NASDAQ:

today an nounced financial results for the third quarter of 2015 and provided an update on development programs.

Financial Highlights

($ in millions, except per share data)

Three Months Ended

September 30,

% Change

EYLEA U.S. net product sales

Total revenues

Non-GAAP net income

Non-GAAP net income per share - diluted

* See note (4) below for an explanation of revisions made to certain amounts previously reported for the three months ended September 30, 2014.

"Our commercial business continues to advance with increased demand for EYLEA, our marketed medicine for serious retinal diseases, and continued launch progress with Praluent, our new therapy for hypercholesterolemia," said Leonard S. Schleifer, M.D., Ph.D., President and Chief Executive Officer of Regeneron. "Regeneron also continues to progress the next wave of candidates from our strong pipeline, including sarilumab for rheumatoid arthritis, the BLA for which was recently submitted to the U.S. FDA, and dupilumab, which is in Phase 3 trials for atopic dermatitis and asthma."

Business Highlights

(aflibercept) Injection for Intravitreal Injection

In the third quarter of 2015, net sales of EYLEA in the United States increased

$445 million

in the third quarter of 2014. Overall distributor inventory levels remained within the Company's one- to two-week targeted range.

Bayer HealthCare commercializes EYLEA outside the United States. In the third quarter of 2015, net sales of EYLEA outside of the United States

were

, compared to

$277 million

in the third quarter of 2014. In the third quarter of 2015, Regeneron recognized

$131 million

from its share of net profit from EYLEA sales outside the United States, compared to

$85 million

In October 2015, the European Commission granted marketing authorization of EYLEA for the treatment of visual impairment due to myopic choroidal neovascularization.

(alirocumab) Injection for the Treatment of High Low-Density Lipoprotein (LDL) Cholesterol

In July 2015, following the U.S. Food and Drug Administration (FDA) approval of Praluent for the treatment of adults with heterozygous familial hypercholesterolemia (HeFH) or clinical atherosclerotic cardiovascular disease (ASCVD), who require additional lowering of LDL cholesterol, the Company and Sanofi commenced their launch of Praluent. The effect of Praluent on cardiovascular morbidity and mortality has not been determined.

In the third quarter of 2015, net sales of Praluent in the United States were

$4 million

. Product sales for Praluent are recorded by Sanofi, and the Company shares in any profits or losses from the commercialization of Praluent.

In October 2015, Praluent was included in the Express Scripts National Preferred Formulary, the nation’s largest formulary covering approximately 25 million Americans.

In September 2015, the European Commission granted marketing authorization of Praluent for the treatment of adult patients with primary hypercholesterolemia (HeFH and non-familial) or mixed dyslipidemia as an adjunct to diet (a) in combination with a statin, or statin with other lipid-lowering therapies in patients unable to reach their LDL-cholesterol goals with the maximally-tolerated statin, or (b) alone or in combination with other lipid-lowering therapies for patients who are statin intolerant, or for whom a statin is contraindicated.

In July 2015, the Company and Sanofi reported that the Phase 3 ODYSSEY JAPAN trial met its primary endpoint.

The Phase 3 ODYSSEY program remains ongoing.

Pipeline Progress

Regeneron has thirteen fully human monoclonal antibodies generated using the Company's

VelocImmune

technology in clinical development, including five in collaboration with Sanofi

. In addition to Praluent, highlights from the antibody pipeline include:

Sarilumab

, the Company's antibody targeting IL-6R for rheumatoid arthritis, is currently being studied in the global Phase 3 SARIL-RA program. A Biologics License Application (BLA) in the United States was recently submitted to the FDA.

Dupilumab

, the Company's antibody that blocks signaling of IL-4 and IL-13, is currently being studied in atopic dermatitis, asthma, nasal polyps, and eosinophilic esophagitis.

Multiple Phase 3 studies of dupilumab in atopic dermatitis are currently underway. Phase 3 pivotal trials in atopic dermatitis are fully enrolled.

The Phase 2 study in atopic dermatitis in adolescents and children completed enrollment.

The second pivotal study of dupilumab in patients with uncontrolled persistent asthma continues to enroll patients.

Fasinumab

, an antibody targeting Nerve Growth Factor (NGF), entered Phase 2b/3 clinical development (sixteen-week study) for pain due to osteoarthritis in the second quarter of 2015. In September 2015, the Company and Mitsubishi Tanabe Pharma Corporation (MTPC) entered into a strategic collaboration providing MTPC with exclusive development and commercial rights to fasinumab in Japan and certain other countries in Asia.

REGN2222

, an antibody targeting the respiratory syncytial virus (RSV), entered Phase 3 clinical development in the third quarter of 2015.

Third Quarter 2015 Financial Results

Product Revenues:

Net product sales were

$738 million

in the third quarter of 2015, compared to

$449 million

in the third quarter of 2014. EYLEA net product sales in the United States were

Total Revenues:

Total revenues, which include product revenues described above, increased by

$1,137 million

$726 million

in the third quarter of 2014. Total revenues also include collaboration revenues of

$382 million

$269 million

in the third quarter of 2014. Collaboration revenues in the third quarter of 2015 increased primarily due to higher reimbursement of the Company's research and development expenses under its antibody collaboration with Sanofi and an increase in the Company's net profit from commercialization of EYLEA outside the United States. Refer to Table 4 for a summary of collaboration revenue.

Research and Development (R&D) Expenses:

GAAP R&D expenses were

$426 million

$338 million

in the third quarter of 2014. The higher R&D expenses in the third quarter of 2015 were principally due to higher development costs related to dupilumab and higher headcount to support the Company's increased R&D activities. In addition, in the third quarter of 2015, R&D-related non-cash share-based compensation expense was

$64 million

$46 million

Selling, General, and Administrative (SG&A) Expenses:

GAAP SG&A expenses were

$210 million

$144 million

in the third quarter of 2014. The increase in SG&A expenses was primarily due to higher headcount and headcount-related costs and higher commercialization expenses related to Praluent. These increases were partly offset by a third quarter 2014 incremental charge related to the Branded Prescription Drug Fee, based on final regulations issued by the Internal Revenue Service (IRS) in July 2014. In addition, in the third quarter of 2015, SG&A-related non-cash...


More