Sarepta Therapeutics Announces Third Quarter 2016 Financial Results and Recent Corporate Developments

On October 27, 2016 Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a commercial-stage developer of innovative RNA-targeted therapeutics, reported financial results for the three and nine months ended September 30, 2016 (Press release, Sarepta Therapeutics
, OCT 27, 2016, View Source;p=RssLanding&cat=news&id=2216471 [SID1234516045]).

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"We are thrilled that the first patient has been infused with EXONDYS 51. We are pleased with the early stages of the launch and that multiple insurance carriers are providing coverage for patients to have access to EXONDYS 51. We plan on providing a corporate update at the 35th Annual JP Morgan Healthcare Conference, after EXONDYS 51 has been available for a full quarter," said Edward Kaye, Sarepta’s chief executive officer.

"We believe our recent financing puts us in a strong financial position to execute on both our internal and external clinical development programs and global manufacturing development plans. We continue to evaluate the sale of the priority review voucher as a potential source of non-dilutive financing to help support these efforts and advance potential therapies for patients with DMD," said Sandy Mahatme, Sarepta’s chief financial officer.

Financial Results
For the third quarter of 2016, Sarepta reported a net loss of $56.7 million, or $1.18 per share, compared to a net loss of $51.9 million for the third quarter of 2015, or $1.25 per share. The incremental loss of $4.8 million was primarily the result of increased expenses related to the launch of EXONDYS 51.

Excluding $10.8 million of stock-based compensation expense and restructuring expenses, non-GAAP net loss for the third quarter of 2016 was $45.9 million, or $0.95 per share, compared to a non-GAAP net loss excluding $5.7 million of stock-based compensation expense of $46.3 million for the third quarter of 2015, or $1.11 per share.

No revenue was recognized for the three months ended September 30, 2016 and 2015.

Research and development expenses were $34.3 million for the third quarter of 2016, compared to $36.7 million for the third quarter of 2015, a decrease of $2.4 million. Non-GAAP research and development expenses (excluding $3.4 million of stock-based compensation and restructuring expenses) were $30.9 million for the third quarter of 2016, compared to $34.0 million (excluding $2.6 million of stock-based compensation expense) for the third quarter of 2015, a decrease of $3.1 million.

General and administrative expenses were $22.2 million for the third quarter of 2016, compared to $15.1 million for the third quarter of 2015, an increase of $7.1 million. Non-GAAP general and administrative expenses (excluding $7.4 million of stock-based compensation and restructuring expenses) were $14.8 million for the third quarter of 2016, compared to $12.0 million (excluding $3.1 million of stock-based compensation expense) for the third quarter of 2015, an increase of $2.8 million.

The Company had $406.6 million in cash, cash equivalents, short-term investments and restricted cash as of September 30, 2016 compared to $204.0 million as of December 31, 2015, an increase of $202.6 million. The increase was driven by the net proceeds received from the Company’s public offerings in June and September 2016, offset by the use of cash to fund the Company’s ongoing operations.

Use of Non-GAAP Measures
In addition to the GAAP financial measures set forth in this press release, the Company has included certain non-GAAP measurements: non-GAAP research and development expenses, non-GAAP general and administrative expenses, non-GAAP operating expense adjustments, non-GAAP net loss, and non-GAAP basic and diluted net loss per share, which present operating results on a basis adjusted for stock-based compensation and restructuring expenses.

Stock-based compensation expenses represent non-cash charges related to equity awards granted by Sarepta. Although these are recurring charges to operations, management believes the measurement of these amounts can vary substantially from period to period and depend significantly on factors that are not a direct consequence of operating performance that is within management’s control. Therefore, management believes that excluding these charges from non-GAAP research and development expenses, non-GAAP general and administrative expenses, non-GAAP net loss and non-GAAP net loss per share facilitates comparisons of the Company’s operational performance in different periods.

Restructuring related expenses have been excluded from non-GAAP research and development expenses, non-GAAP general and administrative expenses, non-GAAP net loss and non-GAAP net loss per share as the Company believes that the adjustments for these items represent more closely the sustainability of the Company’s operating performance and understanding of its financial results.

The Company uses these non-GAAP measures as key performance measures for the purpose of evaluating operational performance and cash requirements internally. The Company also believes these non-GAAP measures increase comparability of period-to-period results and are useful to investors as they provide a similar basis for evaluating the Company’s performance as is applied by management. These non-GAAP measures are not intended to be considered in isolation or to replace the presentation of the Company’s financial results in accordance with GAAP. Use of the terms non-GAAP research and development expenses, non-GAAP general and administrative expenses, non-GAAP operating expense adjustments, non-GAAP net loss, and non-GAAP basic and diluted net loss per share may differ from similar measures reported by other companies, which may limit comparability, and are not based on any comprehensive set of accounting rules or principles. All relevant non-GAAP measures are reconciled from their respective GAAP measures in the attached table "Reconciliation of GAAP to Non-GAAP Net Loss."

Recent Corporate Developments

Duchenne Muscular Dystrophy Program
–Sarepta Therapeutics Announces FDA Accelerated Approval of EXONDYS 51 (eteplirsen) injection, an Exon Skipping Therapy to Treat Duchenne Muscular Dystrophy (DMD) Patients Amenable to Skipping Exon 51
–Sarepta Therapeutics and Summit Enter Into Exclusive License and Collaboration Agreement for European Rights to Summit’s Utrophin Modulator Pipeline for the Treatment of Duchenne Muscular Dystrophy
–Catabasis Pharmaceuticals and Sarepta Therapeutics Announce a Joint Research Collaboration in Duchenne Muscular Dystrophy
–Sarepta Therapeutics Announces First Patient Dosed in Phase III Clinical Trial of SRP-4045 and SRP-4053 for the Treatment of Duchenne Muscular Dystrophy Amenable to Exon 45 or 53 Skipping
–Sarepta Therapeutics Announces Favorable USPTO Decisions in Exon 51 and Exon 53 Composition of Matter Patent Interference Cases against BioMarin Pharmaceutical
Corporate Updates
–Sarepta Therapeutics Announces Pricing of $345 Million Public Offering of Common Stock

Conference Call
The Company will be hosting a conference call at 8:00 a.m. EDT, to discuss these financial results and other corporate updates. The conference call may be accessed by dialing (844) 534-7313 for domestic callers and (574) 990-1451 for international callers. The passcode for the call is 7029987. Please specify to the operator that you would like to join the "Sarepta Third Quarter 2016 Earnings Call." The conference call will be webcast live under the investor relations section of Sarepta’s website at www.sarepta.com and will be archived there following the call for 90 days. Please connect to Sarepta’s website several minutes prior to the start of the broadcast to ensure adequate time for any software download that may be necessary.

About EXONDYS 51
EXONDYS 51 uses Sarepta’s proprietary phosphorodiamidate morpholino oligomer (PMO) chemistry and exon-skipping technology to skip exon 51 of the dystrophin gene. EXONDYS 51 is designed to bind to exon 51 of dystrophin pre-mRNA, resulting in exclusion of this exon during mRNA processing in patients with genetic mutations that are amenable to exon 51 skipping. Exon skipping is intended to allow for production of an internally truncated dystrophin protein. Data from clinical studies of EXONDYS 51 in a small number of DMD patients have demonstrated a consistent safety and tolerability profile. The pivotal trials were not designed to evaluate long-term safety and a clinical benefit of EXONDYS 51 has not been established.

Important Safety Information
Adverse reactions observed in patients (N=8) treated with 30 or 50 mg/kg/wk of EXONDYS 51 with incidence ≥ 25% and higher than in the placebo group (N=4) (Study 1) were: balance disorder (38%), vomiting (38%) and contact dermatitis (25%). The most common adverse reactions were balance disorder and vomiting.

The following events were reported in ≥ 10% of patients treated with EXONDYS 51 for up to 208 weeks (N=88) and occurred more frequently than placebo in a controlled trial for 24 weeks (Study 1): vomiting, contusion, excoriation, arthralgia, rash, catheter site pain, and upper respiratory tract infection.

There have been reports of transient erythema, facial flushing, and elevated temperature occurring on the day of EXONDYS 51 infusion.

For the full prescribing information please refer to U.S. Full Prescribing Information at www.EXONDYS51.com.

Agenus Reports Third Quarter Financial Results and Recent Highlights

On October 27, 2016 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology (I-O) company developing antibodies, including checkpoint inhibitors and other checkpoint modulators and cancer vaccines, reported an update on its progress and reported financial results for the third quarter ended September 30, 2016 (Press release, Agenus, OCT 27, 2016, View Source [SID1234516081]).

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Agenus Logo
"In the third quarter we advanced our pre-clinical and clinical programs and focused our efforts on our product development plans with an intent to commercialize Agenus’ first generation of I-O products in the next five years," commented Garo H. Armen, Ph.D., Chairman and CEO of Agenus. "We have delineated our clinical development path as it relates to our monoclonal antibodies, targeting the foundational immune checkpoints CTLA-4 and PD-1. In addition, we are steering our antibody vaccine combinations towards the clinic. Our world class team, along with our diverse portfolio and capabilities, are key differentiators for Agenus to compete in the field and to deliver on the promise of immunotherapy."

Recent Highlights

Our first CTLA-4 antibody AGEN1884 advanced in the clinic.
Our novel checkpoint antibodies and vaccine programs progressed in various stages of development.
GlaxoSmithKline’s Shingrix vaccine candidate containing Agenus’ QS-21 Stimulon for prevention of shingles in adults aged 50 years or older, was filed for US regulatory approval.
Jean-Marie Cuillerot, M.D. appointed Vice President and Global Head of Clinical Development.
James Gorman, M.D., Ph.D. appointed Vice President of Strategic Planning and Portfolio Management.
Projected Near-Term Milestones

Phase 1 trial initiation for OX40 agonist INCAGN1949 in collaboration with Incyte.
Phase 1 trial initiation for PD-1 antagonist AGEN2034.
Clinical study initiation combining CTLA-4 and PD-1 antagonists.
Third party-sponsored randomized trial initiation for Prophage together with a checkpoint antagonist in newly diagnosed glioblastoma.
Phase 1 trial initiation for AutoSynVax.
Consummation of additional strategic partnerships.
Third Quarter 2016 Financial Results

For the third quarter ended September 30, 2016, Agenus reported a net loss attributable to common stockholders of $40.8 million which includes $18.7 million of non-cash expenses. This compares to a net loss attributable to common stockholders for the third quarter of 2015 of $13.2 million which included $4.1 million of non-cash income. Net loss was $0.47 per share, and $0.16 per share, basic and diluted, for the three months ended September 30, 2016 and 2015, respectively. The increase in net loss attributable to common stockholders for the three months ended September 30, 2016, compared to the net loss attributable to common stockholders for the same period in 2015, was largely due to the $22.7 million increase in non-cash expenses primarily from fair value adjustments of the contingent obligations in addition to $4.9 million applicable to the advancement of the checkpoint and cancer vaccine programs.

For the nine months ended September 30, 2016, the company reported a net loss attributable to common stockholders of $101.0 million, which includes $35.9 million in non-cash expenses, compared with a net loss attributable to common stockholders of $72.4 million, which included $22.5 million in non-cash expenses, for the nine months ended September 30, 2015. Net loss was $1.16 per share and $0.95 per share, basic and diluted for the nine months ended September 30, 2016 and 2015, respectively.

Cash, cash equivalents and short-term investments were $95.4 million as of September 30, 2016.

10-Q – Quarterly report [Sections 13 or 15(d)]

Alder Biopharmaceuticals has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 10-Q, Alder Biopharmaceuticals, 2017, OCT 27, 2016, View Source [SID1234521702]).

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Sobi™ publishes its report for the third quarter 2016, raises guidance

On October 27, 2016 Swedish Orphan Biovitrum AB (publ) (Sobi) reported its results for the third quarter 2016 (Press release, Swedish Orphan Biovitrum, OCT 27, 2016, View Source;Media/News/RSS/?RSS=View Source [SID1234516046]). Revenue for the quarter totalled SEK 1,171 M (786), an increase of 49 per cent compared to previous year. Based on strong performance across the portfolio and an earlier launch for Alprolix, the company has raised guidance for the full year.

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Business highlights Q3 2016

Elocta reimbursed in the UK, Italy, France and Spain
Alprolix reimbursed in the UK
Long term Elocta and Alprolix data presented at WHF 2016 World Congress
Orfadin capsule filing validated by Health Canada
Milan Zdravkovic appointed as SVP, Head of R&D
Financial highlights Q3 2016 (Q3 2015)

Total revenue of SEK 1,171 M (786), an increase of 49 per cent
Product revenue of SEK 1,009 M (645), an increase of 56 per cent (57 per cent at CER)
Gross margin of 67 per cent (62)
EBITA of SEK 282 M (97)
Ended the quarter with a cash position of SEK 824 M
Earnings per share 0.53 SEK (0.02)
"Results in the third quarter had a positive contribution from the ongoing launch of Elocta, from an earlier than anticipated launch for Alprolix and from Kineret. We continue to lay the foundation for a sustainable haemophilia business in Europe with both Elocta and Alprolix gaining several important reimbursement approvals in major markets", said Geoffrey McDonough, CEO and President at Sobi.

"A significant milestone after the quarter was the orphan designation approval by the European Commission for our development candidate SOBI003 – a chemically modified human recombinant sulfamidase for the treatment of mucopolysaccharidosis type IIIA (Sanfilippo A syndrome). MPS IIIA is a severe and debilitating disease with devastating consequences for patients, and there is presently no treatment available."

Financial Summary
Q3 Q3 Jan-Sep Jan-Sep Full year
Amounts in SEK M 2016 2015 Change 2016 2015 Change 2015
Total revenues1 1 171 786 49% 3 913 2 414 62% 3 228
Gross profit 782 486 61% 2 791 1 486 88% 2 007
Gross margin 67% 62% 71% 62% 62%
EBITA 282 97 >100% 1 334 343 >100% 433
EBIT (Operating profit/loss) 171 25 >100% 1 034 129 >100% 146
Profit/loss for the period 143 5 >100% 710 77 >100% 68
1Jan-Sep 2016 revenues include a one-time credit in Q1 of SEK 322 M relating to the first commercial sales of Elocta, and a one-time credit in Q2 of SEK 386 M relating to first commercial sales of Alprolix.
Outlook 2016 – guidance raised

For the full-year 2016, Sobi now expects revenues of SEK 5,125—5,200 M (4,800-5,000). Revenues include one-time credits for Elocta of SEK 322 M and for Alprolix of SEK 386 M which do not impact cash. Gross margin is now expected to be 70 per cent (68-70) and EBITA for the full-year in the range of SEK 1,475–1,525 M (1,200-1,300).

The original outlook was published 29 February 2016.

Sobi’s report for the third quarter 2016 can be found on View Source;Media/Financial-Reports/

Celgene Reports Third Quarter 2016 Operating and Financial Results

On October 27, 2016 Celgene Corporation (NASDAQ:CELG) reported net product sales of $2,969 million for the third quarter of 2016, a 28 percent increase from the same period in 2015. Net product sales growth includes a 1 percent negative impact from currency exchange effects (Press release, Celgene, OCT 27, 2016, View Source [SID1234516035]).

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Third quarter total revenue increased 28 percent to $2,983 million compared to $2,334 million in the third quarter of 2015.

Net income for the third quarter of 2016 based on U.S. GAAP (Generally Accepted Accounting Principles), was $171 million or $0.21 per diluted share compared to a net loss of $34 million or $0.04 per diluted share in the third quarter of 2015. The results for the third quarter of 2016 include increased research and development expenses as a result of the EngMab AG acquisition. The net loss in the third quarter of 2015 reflected costs related to strategic transactions including the collaboration with Juno Therapeutics and the acquisition of Receptos.

Adjusted net income for the third quarter of 2016 was $1,263 million or $1.58 per diluted share compared to $1,011 million or $1.23 per diluted share for the third quarter of 2015.

"Continued outstanding execution by our teams around the world led to another strong quarter of revenue growth and progress advancing many of our most important strategic programs," said Mark J. Alles, Chief Executive Officer of Celgene Corporation. "Our increasing enterprise-wide momentum has us on-track to exceed key 2016 objectives and positions us well for sustained long-term growth."

Third Quarter 2016 Financial Highlights

Unless otherwise stated, all comparisons are for the third quarter of 2016 compared to the third quarter of 2015. The adjusted operating expense categories presented below exclude share-based employee compensation expense, collaboration-related upfront expense, research and development asset acquisition expense and a litigation-related loss contingency accrual expense. Please see the attached Use of Non-GAAP Financial Measures and Reconciliation of GAAP to Adjusted Net Income for further information relevant to the interpretation of adjusted financial measures and reconciliations of these adjusted financial measures to the most comparable GAAP measures, respectively.

Net Product Sales Performance

REVLIMID sales for the third quarter increased 30 percent year-over-year to $1,891 million and were driven by new patient market share gains and increased duration. U.S. sales of $1,153 million and international sales of $738 million increased 29 percent and 32 percent year-over-year, respectively.
POMALYST/IMNOVID sales for the third quarter were $341 million, an increase of 33 percent year-over-year. U.S. sales were $203 million and international sales were $138 million, an increase of 35 percent and 30 percent year-over-year, respectively. POMALYST/IMNOVID sales grew due to increased volume from duration gains.
OTEZLA sales for the third quarter were $275 million, a 98 percent increase year-over-year. U.S. sales were $245 million and international sales were $30 million. Sales were driven by market share gains and increased prescriber adoption.
ABRAXANE sales for the third quarter were $233 million, a 1 percent increase year-over-year. U.S. sales of $144 million decreased 1 percent year-over-year. International sales were $89 million.
In the third quarter, all other product sales, which include THALOMID, ISTODAX, VIDAZA and an authorized generic version of VIDAZA drug product in the U.S., were $229 million compared to $234 million in the third quarter of 2015.
Research and Development (R&D)

On a GAAP basis, R&D expenses were $1,653 million for the third quarter of 2016 compared to $1,305 million for the same period in 2015. The increase was primarily driven by a $623.3 million asset acquisition expense associated with the purchase of EngMab AG and an increase in early research and clinical trial activity, partially offset by decreases in expenses related to collaboration-related upfront expenses. Adjusted R&D expenses were $644 million for the third quarter of 2016 compared to $488 million for the third quarter of 2015.

Selling, General, and Administrative (SG&A)

On a GAAP basis, SG&A expenses were $698 million for the third quarter of 2016 compared to $550 million for the same period in 2015. The increase was primarily due to a 2016 litigation-related loss contingency accrual expense as well as an increase in donations to independent patient assistance organizations. Adjusted SG&A expenses were $591 million for the third quarter of 2016 compared to $474 million for the third quarter of 2015.

Cash, Cash Equivalents, and Marketable Securities

Operating cash flow was $723 million in the third quarter of 2016. Celgene ended the quarter with approximately $6.9 billion in cash, cash equivalents and marketable securities.

In the third quarter of 2016, Celgene purchased approximately 2.5 million of its shares at a total cost of approximately $273 million. As of September 30, 2016, the Company had approximately $4.9 billion remaining under the stock repurchase program.

2016 Guidance Updated

Previous 2016 Guidance Updated 2016 Guidance
Net Product Sales
Total Approximately $11.0B Approximately $11.2B
REVLIMID Approximately $6.8B Approximately $7.0B
GAAP diluted EPS $3.82 to $4.05 $3.12 to $3.29
Adjusted diluted EPS $5.70 to $5.75 $5.88 to $5.92
GAAP operating margin Approximately 37% Approximately 31%
Adjusted operating margin Approximately 54.0% Unchanged
Weighted average diluted shares 806M 804M
Net product sales guidance for POMALYST/IMNOVID, ABRAXANE and OTEZLA remain unchanged.

2017 Targets Updated

Total net product sales are expected to be at the high end of the range of $12.7 billion to $13.0 billion
REVLIMID net sales are expected to be more than $8.0 billion versus the previous target of approximately $8.0 billion
Adjusted diluted EPS is expected to be at the high end of the range of $6.75 to $7.00
The net product sales target for ABRAXANE and adjusted diluted share count remain unchanged.

Product and Pipeline Updates

Hematology/Oncology

A supplemental New Drug Application (sNDA) was filed with the U.S. Food and Drug Administration (FDA) for the expanded indication of REVLIMID as maintenance treatment in newly diagnosed multiple myeloma (NDMM) patients after receiving an autologous stem-cell transplant (ASCT). The sNDA was granted Priority Review and the Prescription Drug User Fee Act (PDUFA) date for the submission is February 24, 2017. In June, an application was submitted to the European Medicines Agency (EMA) for the review of REVLIMID as maintenance treatment in NDMM patients after receiving an ASCT. A decision on the European Union (EU) application is expected in the first half of 2017.
In August, the European Commission approved the inclusion of data from a pooled analysis of patients with relapsed and/or refractory multiple myeloma and impaired renal function in the IMNOVID label.
Celgene expects to submit a new drug application (NDA) to the FDA for enasidenib (AG-221) in relapsed and/or refractory acute myeloid leukemia (AML) with isocitrate dehydrogenase-2 (IDH2) mutation by year-end. The NDA will be based on data from an ongoing phase I/II trial in patients with relapsed and/or refractory AML and other advanced hematologic malignancies with an IDH2 mutation.
Data at hematology and oncology medical congresses presented in the third quarter and expected in the fourth quarter include:

Data from multiple sponsored and independent studies evaluating the use of ABRAXANE as a single agent or in combination with novel agents and novel regimens in patients with metastatic pancreatic cancer, metastatic breast cancer and non-small cell lung cancer (NSCLC) were presented during the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) 2016 Annual Meeting in October.
Celgene’s collaboration partner Triphase Accelerator Corporation is expected to present results from a phase I trial evaluating marizomib in combination with bevacizumab in recurrent glioblastoma at the Society for Neuro-Oncology (SNO) meeting in November.
Data from the abound program of ABRAXANE in NSCLC are expected to be presented at the IASLC World Conference on Lung Cancer in December.
Data from the phase II tnAcity trial evaluating ABRAXANE in combination with gemcitabine or carboplatin in patients with triple negative breast cancer are expected at The San Antonio Breast Cancer Symposium (SABCS) in December.
At the 2016 American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December, data presentations expected include:
Phase III Myeloma XI trial evaluating REVLIMID as induction and maintenance therapy in patients with NDMM following ASCT.
Final overall survival data from the phase III MM-020 trial evaluating REVLIMID in combination with low-dose dexamethasone in patients with NDMM who were not candidates for stem-cell transplant.
Phase III REMARC trial comparing REVLIMID maintenance to placebo in elderly patients with diffuse large B-cell lymphoma (DLBCL) previously treated with rituximab plus chemotherapy (R-CHOP).
Phase III CONTINUUM trial comparing REVLIMID maintenance to placebo in chronic lymphocytic leukemia following second-line therapy.
Interim data from the phase III MAGNIFYTM trial with REVLIMID in combination with R-CHOP in patients with relapsed and/or refractory indolent lymphoma.
Phase Ib trial evaluating CC-122 in combination with obinutuzumab in patients with relapsed and/or refractory DLBCL or indolent non-Hodgkin’s lymphoma.
Inflammation & Immunology (I&I)

Data at I&I medical congresses presented in the third quarter and expected in the fourth quarter include:

Long-term data from the phase II RADIANCE trial evaluating ozanimod in relapsing multiple sclerosis were presented at the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in September.
Phase Ib trial evaluating the effects of oral GED-0301 (mongersen) on both endoscopic and clinical outcomes in patients with active Crohn’s disease were presented at the United European Gastroenterology Week (UEGW) in October. The phase III program continues to enroll with data expected in 2018.
Phase II trial of RPC4046 in patients with eosinophilic esophagitis were presented at UEGW and the American College of Gastroenterology (ACG) meetings in October.
Phase II TOUCHSTONE trial evaluating ozanimod as induction and maintenance in patients with ulcerative colitis presented at UEGW and ACG.
Pooled 3-year data analyses from ESTEEM 1 and 2 and PALACE 1-3 trials were presented at the European Academy of Dermatology and Venereology (EADV) meeting in October.
Phase IIb trial of OTEZLA in Japanese patients with moderate-to-severe psoriasis were presented at EADV. This trial will be used to support the regulatory approval in Japan.
At the 2016 American College of Rheumatology annual meeting in November, data presentations expected include:
Three-year safety and efficacy data from the PALACE program with OTEZLA in psoriatic arthritis.
Four-year safety and efficacy data from PALACE 3 trial with OTEZLA in DMARD- and/or biologic-experienced psoriatic arthritis patients.
Pooled three-year data from the PALACE program for the enthesitis and dactylitis and HAQ-DI endpoints.
52-week data from the PSA-006 trial of OTEZLA in biologic-naïve patients with active psoriatic arthritis.
Phase II safety and dose-ranging trial of CC-220 in systemic lupus erythematosus. The second part of the phase II trial evaluating improvement in skin manifestations and improvement in the Cutaneous Lupus Area and Severity Index (CLASI) score is enrolling.
An encore presentation of the phase Ib trial evaluating the effects of oral GED-0301 on both endoscopic and clinical outcomes in patients with active Crohn’s disease are expected at the Advances in Inflammatory Bowel Diseases (AIBD) meeting in December.
Business Update

In September, Celgene completed a transaction to acquire Switzerland-based, privately-held biotechnology company EngMab AG for $625.3 million plus contingent development, regulatory and commercial milestones. EngMab’s lead molecule is EM901, a T-cell bi-specific antibody targeting B-cell maturation antigen (BCMA). The acquisition includes an additional undisclosed program. The Company plans to file an Investigational New Drug (IND) application for EM901 in late 2017. The transaction was accounted as an asset acquisition, resulting in $623.3 million of research and development expense and $2.0 million of net working capital acquired.