Biotech Values

[mr_o]

Celgene announces 2014 financial outlook and 2013 results

Celgene Corporation Announces 2014 Financial Outlook and Preliminary 2013 Results
2013 Total Revenue Expected to be $6.5 Billion; Total Net Product Sales Expected to be $6.4 Billion
2013 Adjusted Diluted EPS Expected to be Approximately $5.96 which Includes a $0.13 Per Share Negative Impact from Collaboration-Related Payments to Partners (GAAP Range of $3.37 to $3.39)
2014 Guidance: Total Net Product Sales of $7.3 Billion to $7.4 Billion; REVLIMID® Net Sales of $4.9 Billion to $5.0 Billion; Adjusted Diluted EPS of $7.00 to $7.20 (GAAP Range of $5.54 to $5.92)
Long-Term Targets Raised: 2015 Total Net Product Sales and Adjusted Diluted EPS of $8.5 Billion to $9.5 Billion and $9.00 to $9.50, Respectively; 2017 Total Net Product Sales and Adjusted Diluted EPS of $13.0 Billion to $14.0 Billion and Approximately $15.00, Respectively
SUMMIT, N.J.--(BUSINESS WIRE)--Jan. 13, 2014-- Celgene Corporation (NASDAQ:CELG) provided its preliminary 2013 results and financial outlook for 2014 and beyond at the 32nd Annual J.P. Morgan Healthcare Conference. In 2013, total revenue is expected to be approximately $6.5 billion and total net product sales are expected to be $6.4 billion. Adjusted diluted earnings per share (EPS) is expected to be approximately $5.96. Based on U.S. Generally Accepted Accounting Principles (GAAP), diluted EPS is expected to be in the range of $3.37 to $3.39. In 2014, total net product sales are expected to be $7.3 billion to $7.4 billion, a 16 percent year-over-year increase. Adjusted diluted EPS is expected to be $7.00 to $7.20, a 19 percent year-over-year increase based on the mid-point of the range. On a GAAP basis, diluted EPS is expected to be in the range of $5.54 to $5.92.

“Our 2013 accomplishments and confidence in our core business position us for another year of outstanding execution across all financial metrics in 2014 as we launch our I&I franchise and anticipate achieving many other significant milestones,” said Bob Hugin, Celgene’s Chairman and Chief Executive Officer. “2013 momentum and confidence in our business model leads us to raise our 2015 and 2017 targets.”

Preliminary 2013 Financial Results Year-Over-Year (Unaudited)

Total net product sales are expected to be $6.4 billion, up 18 percent year-over-year
REVLIMID®: $4,280 million, 14 percent year-over-year increase
ABRAXANE®: $649 million, 52 percent year-over-year increase
POMALYST®/IMNOVID®: $305 million
Adjusted operating margin is expected to be approximately 48.4 percent for the full year, up 30 basis points (bps) year-over-year and includes the impact of $65 million in collaboration-related payments to partners. GAAP operating margin is expected to be approximately 27.9 percent, a decrease of 385 bps year-over-year, primarily due to increased upfront payments to collaboration partners in 2013
Adjusted 2013 diluted EPS is expected to be approximately $5.96, a 21 percent year-over-year increase. This includes a $0.13 per share negative impact from collaboration-related payments to partners. On a GAAP basis, diluted EPS is expected to be in the range of $3.37 to $3.39
For the fourth quarter of 2013 adjusted diluted EPS is expected to be approximately $1.51 which includes a $0.10 per share negative impact from collaboration-related payments to partners. On a GAAP basis, diluted EPS is expected to be in the range of $0.50 to $0.52
Certain activities involved in determining the audited results for the fiscal year ended December 31, 2013 are in process and could result in the final reported audited results being different from the unaudited results noted in this press release. Please see the attached Reconciliation of Estimated/Projected GAAP to Adjusted Measures for further information.

Celgene Forecasts Strong Product Sales and Earnings Growth in 2014

Total revenue expected to be approximately $7.5 billion, an increase of 15 percent year-over-year
Total net product sales are expected to be $7.3 billion to $7.4 billion, an increase of 16 percent year-over-year based on the mid-point of the range
REVLIMID® net sales are expected to be in the range of $4.9 billion to $5.0 billion, an increase of 16 percent year-over-year based on the mid-point of the range
Adjusted operating margin expected to be approximately 50 percent after investments across the entire organization, including the Inflammation and Immunology (I&I) franchise; GAAP operating margins are expected to be approximately 39 percent
Adjusted diluted EPS expected to be in the range of $7.00 to $7.20, an increase of approximately 19 percent year-over-year based on the mid-point of the range. On a GAAP basis, diluted EPS is expected to be in the range of $5.54 to $5.92
Raising 2015 and 2017 Long-term Financial Targets

Raising 2015 net product sales target to $8.5 billion to $9.5 billion from $8.0 billion to $9.0 billion
Raising 2015 adjusted diluted EPS target to $9.00 to $9.50 from $8.00 to $9.00
Raising 2017 net product sales target to $13.0 billion to $14.0 billion from $12.0 billion plus
2017 net product sales targets expected to be:
REVLIMID®: $7.0 billion (previously $6.0 billion)
POMALYST®/IMNOVID®: $1.5 billion (previously $1.0 billion)
ABRAXANE®: $1.5 billion to $2.0 billion (unchanged)
OTEZLA® (apremilast): $1.5 billion to $2.0 billion (unchanged)
2017 operating margin expected to be approximately 57 percent (previously 55 percent)
2017 fully diluted share count is expected to be 425 million (previously 430 million)
Raising 2017 adjusted diluted EPS target to approximately $15.00 from $13.00 to $14.00
2014 Expected Milestones

Hematology

Submit REVLIMID® newly diagnosed multiple myeloma with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA)
Data from the VIDAZA® phase III AZA-AML-001 in elderly newly diagnosed acute myeloid leukemia (AML)
Submit VIDAZA® for approval in AML in Europe
Data from phase III MDS-005 trial of REVLIMID® in non-del5q myelodysplastic syndrome (MDS)
Data from pivotal phase II MCL-002 trial of REVLIMID® in relapsed and refractory mantle cell lymphoma
Complete enrollment in the phase III REMARC trial with REVLIMID® as maintenance in patients with diffuse large B-cell lymphoma responding to R-CHOP induction
Complete enrollment in the phase III RELEVANCE® trial of REVLIMID® in combination with rituximab in newly diagnosed follicular lymphoma
Complete enrollment in the phase III CONTINUUM trial with REVLIMID® maintenance after second-line treatment in chronic lymphocytic leukemia (CLL)
Submit POMALYST®/IMNOVID® for relapsed and refractory multiple myeloma (RRMM) for approval in Japan
Phase I data on MOR202 in RRMM
Initial phase I/II data of CC-292 in combination with REVLIMID® in CLL
Initial data on novel combinations with CC-122, CC-292 and CC-223 in lymphoma
Phase II data on sotatercept (ACE-011) and ACE-536 in MDS and ß-thalassemia
Initiate phase III trial of sotatercept/ACE-536 in ß-thalassemia
Oncology

Launch of ABRAXANE® in pancreatic cancer in Europe and other international markets
Initiate the phase III trial of ABRAXANE® in adjuvant pancreatic cancer
Initiate phase III trial of ABRAXANE® maintenance in first line stage IIIB/IV squamous cell non-small cell lung cancer
Phase I data of AZA-ST-001, a priming study of CC-486 in combination with carboplatin or ABRAXANE® in solid tumors
Phase Ib data of demcizumab combinations in pancreatic cancer and non-small cell lung cancer
I&I

FDA approval of OTEZLA® in psoriatic arthritis and psoriasis
Opinion from the European Committee for Medicinal Products for Human Use (CHMP) for OTEZLA® in psoriatic arthritis and psoriasis
Data from phase III POSTURE trial in ankylosing spondylitis
Presentation of additional data from the phase III ESTEEM program in psoriasis at the American Academy of Dermatology meeting in March
Initiation of phase II trials of OTEZLA® in Crohn’s disease, ulcerative colitis and atopic dermatitis
Advance CC-220 into phase II (systemic lupus erythematosus, scleroderma, sarcoidosis)
Phase II data on CC-292 in rheumatoid arthritis
Data from phase II trial of sotatercept in renal anemia
Initiate phase III trial with OTEZLA® in Behçet's disease


Link
http://ir.celgene.com/phoenix.zhtml?c=111960&p=irol-newsArticle&ID=1890273&highlight=