Celgene Reports Second Quarter 2016 Operating and Financial Results

7/28/16

SUMMIT, N.J.--(BUSINESS WIRE)--Celgene Corporation (NASDAQ:CELG) reported net product sales of $2,745 million for the second quarter of 2016, a 22 percent increase from the same period in 2015. Net product sales growth includes a 1 percent negative impact from currency exchange effects. Second quarter total revenue increased 21 percent to $2,754 million compared to $2,278 million in the second quarter of 2015.

Net income for the second quarter of 2016 based on U.S. GAAP (Generally Accepted Accounting Principles), was $598 million or $0.75 per diluted share compared to $356 million or $0.43 per diluted share in the second quarter of 2015. Adjusted net income for the second quarter of 2016 was $1,152 million or $1.44 per diluted share compared to $1,019 million or $1.23 per diluted share for the second quarter of 2015.

“Our first-half 2016 operating results were outstanding and we are pleased with the progress made advancing many key corporate objectives,” said Mark J. Alles, Chief Executive Officer of Celgene Corporation. “This strong momentum increases our confidence in our near- and longer-term outlook as we continue to invest in innovative research and the development of transformational therapies for patients worldwide.”

Second Quarter 2016 Financial Highlights

Unless otherwise stated, all comparisons are for the second quarter of 2016 compared to the second quarter of 2015. The adjusted operating expense categories presented below exclude share-based employee compensation expense, upfront collaboration expense and a litigation-related loss contingency accrual expense. Please see the attached Reconciliation of GAAP to Adjusted Net Income for further information.

Net Product Sales Performance

  • REVLIMID® sales for the second quarter increased 18 percent year-over-year to $1,701 million and were driven by new patient market share gains and increased duration. U.S. sales of $1,080 million and international sales of $621 million increased 24 percent and 9 percent year-over-year, respectively.
  • POMALYST®/IMNOVID® sales for the second quarter were $318 million, an increase of 35 percent year-over-year. U.S. sales were $185 million and international sales were $133 million, an increase of 29 percent and 46 percent year-over-year, respectively. POMALYST®/IMNOVID® sales grew due to increased volume from duration gains.
  • ABRAXANE® sales for the second quarter were $249 million, a 2 percent increase year-over-year. U.S. sales of $175 million increased 3 percent year-over-year. International sales were $74 million.
  • OTEZLA® sales for the second quarter were $242 million, a 170 percent increase year-over-year. U.S. sales were $217 million and international sales were $25 million. Sales were driven by market share gains and increased prescriber adoption.
  • In the second quarter, all other product sales, which include THALOMID®, ISTODAX®, VIDAZA® and an authorized generic version of VIDAZA® drug product in the U.S., were $235 million compared to $242 million in the second quarter of 2015.

Research and Development (R&D)

On a GAAP basis, R&D expenses were $949 million for the second quarter of 2016 compared to $1,110 million for the same period in 2015. The change was primarily driven by a decrease in upfront collaboration expenses compared to the previous year, partially offset by early research and clinical trial activity related to the acquisitions of Receptos, Inc. and Quanticel Pharmaceuticals, Inc. that closed in the second half of 2015. Adjusted R&D expenses were $601 million for the second quarter of 2016 compared to $477 million for the second quarter of 2015. Adjusted R&D does not include upfront collaboration expenses but does reflect the increase in early research and clinical trial activity.

Selling, General, and Administrative (SG&A)

On a GAAP basis, SG&A expenses were $732 million for the second quarter of 2016 compared to $617 million for the same period in 2015. The increase was primarily due to a loss contingency accrual expense of $100 million related to a contractual dispute. Adjusted SG&A expenses were $547 million for the second quarter of 2016 compared to $541 million for the second quarter of 2015.

Cash, Cash Equivalents, and Marketable Securities

Operating cash flow was $936 million in the second quarter of 2016. Celgene ended the quarter with approximately $6.4 billion in cash, cash equivalents and marketable securities.

In the second quarter of 2016, Celgene purchased approximately 3.4 million of its shares at a total cost of approximately $343 million. In June 2016, the share repurchase authorization was increased by an additional authorization of $3 billion. As of June 30, 2016, the Company had approximately $5.1 billion remaining under the stock repurchase program.

About Celgene

Celgene Corporation, headquartered in Summit, New Jersey, is an integrated global biopharmaceutical company engaged primarily in the discovery, development and commercialization of innovative therapies for the treatment of cancer and inflammatory diseases through next-generation solutions in protein homeostasis, immuno-oncology, epigenetics, immunology and neuro-inflammation. For more information, please visit www.celgene.com. Follow Celgene on Social Media: @Celgene, Pinterest, LinkedIn, FaceBook and YouTube.

About REVLIMID®

In the U.S., REVLIMID® (lenalidomide) in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma. REVLIMID® is indicated for patients with transfusion-dependent anemia due to Low- or Intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. REVLIMID® is approved in the U.S. for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. Limitations of Use: REVLIMID® is not indicated and is not recommended for the treatment of chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

About ABRAXANE®

In the U.S., ABRAXANE® for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) is indicated for the treatment of metastatic breast cancer after failure of combination chemotherapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated. ABRAXANE® is indicated for the first-line treatment of locally advanced or metastatic non-small cell lung cancer, in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy. ABRAXANE® is also indicated for the first-line treatment of metastatic adenocarcinoma of the pancreas in combination with gemcitabine.

About POMALYST®

In the U.S., POMALYST® (pomalidomide) is indicated for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy.

About OTEZLA®

In the U.S., OTEZLA® (apremilast) is indicated for the treatment of adult patients with active psoriatic arthritis. OTEZLA® is indicated in the U.S. for the treatment of patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy.

Recent Deals

Interested in advertising your deals? Contact Edwin Warfield.