Month: March 2016

8-K – Current report

On March 11, 2016 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported financial and business results for the fourth quarter and full-year 2015 (Filing, Q4/Annual, Progenics Pharmaceuticals, 2015, MAR 11, 2016, View Source [SID:1234509494]).

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Key Business Highlights

RELISTOR, treatment for opioid-induced constipation (partnered with Valeant Pharmaceuticals, Inc., ("Valeant"))

· RELISTOR Net Sales for the Fourth Quarter 2015 Total $23.0 Million. Full year 2015 net sales totaled $43.8 million (as reported to us by our partner, Valeant).

· Oral RELISTOR Remains On-track for April 19, 2016 PDUFA. Progenics anticipates an FDA decision April 19, 2016 on the NDA submission for oral RELISTOR. If approved, Progenics would be entitled to a $50 million milestone payment and subsequent sales royalties and commercial milestones from Valeant.

· Subcutaneous RELISTOR Approved in Europe for All Opioid-Induced Constipation. In June 2015 the European Commission approved RELISTOR (methylnaltrexone bromide) Subcutaneous Injection for the treatment of opioid-induced constipation (OIC) when response to laxative therapy has not been sufficient in adult patients, aged 18 years and older.

Progenics Announces Fourth Quarter and Full-Year 2015 Financial Results

AZEDRA, Ultra-orphan radiotherapeutic candidate

· AZEDRA Ultra-Orphan Cancer Therapeutic Receives FDA Breakthrough Designation. In July 2015 the U.S. Food and Drug Administration (FDA) designated AZEDRA as a Breakthrough Therapy for the treatment of patients with iobenguane-avid metastatic or recurrent pheochromocytoma and paraganglioma.

· AZEDRA Completes Enrollment of 68 Patients in Pivotal Trial. In December 2015, Progenics achieved target enrollment in its pivotal Phase 2b trial of AZEDRA. A total of 68 patients have been enrolled.

· AZEDRA Topline Results Expected Between December 2016 and March 2017. In late 2016 or early 2017, Progenics expects to report top-line results from its ongoing pivotal Phase 2b study of AZEDRA. If positive, the Company expects to submit an NDA to the FDA in 1H 2017.

PSMA-Targeted Prostate Cancer Pipeline

· Exclusive Worldwide License Signed With Johns Hopkins University for PyL, PSMA-Targeted PET/CT Imaging Agent. In August 2015, the Company announced an exclusive worldwide licensing agreement with the Johns Hopkins University for imaging agent PyL.

· Pivotal Phase 3 Study Underway of 1404, PSMA-Targeted SPECT/CT Imaging Agent. Progenics has commenced a pivotal Phase 3 study of PSMA-targeted imaging agent 1404 for prostate cancer. The Phase 3 clinical trial is expected to enroll approximately 450 patients with newly diagnosed low-grade prostate cancer patients who are candidates for active surveillance, but nonetheless are planning to undergo radical prostatectomy. During the second half of 2016, Progenics expects to perform an interim analysis of the Phase 3 clinical trial of its PSMA-targeted imaging agent, 1404, to assess futility and evaluate the need for a sample size re-estimation.

· Acquired EXINI Diagnostics AB, a Swedish Developer of Artificial Intelligence-Based Image Analysis Tools. In November 2015, Progenics acquired EXINI Diagnostics AB, a Swedish developer of artificial intelligence-based analytical tools to improve the management of prostate cancer. The acquisition enhances the Company’s proprietary prostate cancer imaging programs, 1404 and PyL.

· Announced Data Highlighting EXINI’s Lead Artificial Intelligence-Based Analytical Tool, the Bone Scan Index (BSI), was Published in the January 2016 Issue of the Journal of Nuclear Medicine. In the paper, researchers from Memorial Sloan Kettering Cancer Center in New York and Lund University in Sweden reported that BSI overcomes a number of key limitations of manual image assessment by human readers and can provide an accurate, precise and reproducible platform for quantifying changes in bone scans of prostate cancer patients.

· Phase 1 Study of 1095, PSMA-Targeted Therapeutic for Metastatic Prostate Cancer, Planned at Memorial Sloan Kettering. Initiation of a Phase 1 study of 1095 planned for 2H 2016 at Memorial Sloan Kettering Cancer Center.

"Over the past year, we have achieved significant progress across all three areas of our business – our partnered OIC therapy, RELISTOR, our ultra-orphan radiotherapeutic candidate, AZEDRA, and our prostate cancer pipeline," said Mark Baker, CEO of Progenics. "I expect 2016 to be a transformational year for our Company with a number of important milestones. We begin the year in a strong financial position, and Oral RELISTOR, if approved, will trigger a milestone payment and sales royalties that we can use to further advance AZEDRA toward commercialization while also developing our pipeline of therapeutic and imaging agents that we believe have the potential to change how prostate cancer is diagnosed and treated."
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Progenics Announces Fourth Quarter and Full-Year 2015 Financial Results
Fourth Quarter and Full-Year 2015 Financial Results
Net loss attributable to Progenics for the quarter was $7.1 million, or $0.10 per basic and diluted share, compared to a net loss of $12.2 million, or $0.18 per basic and diluted share in the 2014 period. Net loss attributable to Progenics for the full-year 2015 was $39.1 million, or $0.56 per basic and diluted share, compared to net income of $4.4 million, or $0.06 per basic and diluted share for the full-year 2014.

Progenics ended the year with cash and cash equivalents of $74.1 million, reflecting decreases of $16.3 million in the quarter and $45.2 million from 2014 year-end, primarily resulting from $40.1 million used in operating activities and $6.5 million used to acquire a majority interest in EXINI Diagnostics AB.

Total revenue for the fourth quarter increased $5.7 million over the fourth quarter of 2014, due primarily to $4.1 million higher RELISTOR royalty income and recognition of $1.5 million milestone payment from CytoDyn for dosing of the first patient in Phase 3 clinical trial for PRO 140. Current full-year revenues were $8.7 million, down from $44.4 million in the prior year, reflecting a decrease in collaboration revenue of $39.2 million. This resulted primarily from the recognition of a $40.0 million development milestone in the third quarter of 2014, for the U.S. marketing approval for subcutaneous RELISTOR in non-cancer pain patients, partially offset by an increase in RELISTOR royalty revenue to $6.6 million in 2015 from $3.1 million in 2014.

Fourth quarter research and development expenses increased by $1.7 million compared to the corresponding period in 2014, primarily due to higher AZEDRA and 1404 clinical trial expenses, partially offset by lower PSMA ADC-related expenses. Full-year research and development expenses decreased by $0.4 million compared to the corresponding period in 2014, primarily due to lower clinical trial expenses for PSMA ADC and lower share-based compensation expense, partially offset by higher AZEDRA-related expenses.

The fourth quarter 2015 general and administrative expenses decreased by $0.2 million compared to the corresponding period in 2014, primarily due to lower legal expenses. Full-year 2015 general and administrative expenses increased by $2.7 million compared to the prior year, primarily due to a legal reserve and expenses related to an action brought by a former employee and higher compensation expenses. Non-cash items for the quarter and year resulted from increased estimates for fair value of contingent consideration liability related to the 2013 acquisition of Molecular Insight.

SRI International to Support Anti-Cancer Vaccine Studies for NIH Center

On March 11, 2016 SRI International reported it will carry out pre-clinical studies on compounds and vaccines to determine if they can act as preventive agents against cancer under a $19.8 million contract with a National Institutes of Health center (Press release, SRI International, MAR 11, 2016, View Source [SID:1234509502]).

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The company said Thursday its biosciences division will work to examine the effectiveness of experimental vaccines and test biomarkers in an effort to parallel how the body responds to treatment.

NIH’s National Cancer Institute has awarded SRI two task orders to develop a mesothelin-based vaccine against ovarian cancer and novel models to test how preventative agents act against the disease.

"Discovery and development of cancer preventative agents is an area that is underserved, primarily because the length of required clinical trials can be resource-prohibitive for many companies," said Lidia Sambucetti, SRI Biosciences senior director for cancer biology, center for discovery technologies and principal investigator for the contract.

Sambucetti added the project aims to address this issue through the company’s biomarker discovery efforts in an effort to shorten the time of clinical trials.

SRI researchers are also working on a model to test experimental drugs to prevent ovarian cancer.

XALKORI® (crizotinib) Approved by U.S. FDA for the Treatment of Patients with ROS1-Positive Metastatic Non-Small Cell Lung Cancer

On March 11, 2016 Pfizer Inc. (NYSE:PFE) reported that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for XALKORI (crizotinib) to treat patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive (Press release, Pfizer, MAR 11, 2016, View Source [SID:1234509499]).

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In 2015, the FDA granted Breakthrough Therapy and Priority Review designations for this indication. XALKORI also is indicated for patients with metastatic NSCLC whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.1

"Today’s approval of XALKORI for ROS1-positive metastatic NSCLC represents an important milestone for patients who previously had limited treatment options," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. "As the only FDA-approved biomarker-driven therapy that includes two distinct molecular targets in metastatic NSCLC, ROS1 and ALK, XALKORI exemplifies our commitment to precision drug development and to identifying the right treatment for the right patient."

ROS1 rearrangements occur when the ROS1 gene attaches to another gene and changes the way each gene normally functions, which can contribute to cancer-cell growth. Epidemiology data suggest that ROS1 rearrangements occur in approximately one percent of NSCLC cases.2 Of the estimated 1.5 million new cases of NSCLC worldwide each year, roughly 15,000 may be driven by oncogenic ROS1 fusions.2,3,4

"The approval of crizotinib for metastatic ROS1-positive non-small cell lung cancer represents another significant step forward in biomarker-driven cancer care," said Dr. Alice Shaw, Associate Professor of Medicine at Massachusetts General Hospital and Harvard Medical School, and principal study investigator. "As with ALK-positive lung cancer, ROS1-positive lung cancer defines a distinct subset of patients for whom crizotinib is efficacious."

The approval is based on a multicenter, single-arm Phase 1 study (Study 1001) that included 50 patients with ROS1-positive metastatic NSCLC treated with 250 mg of XALKORI orally twice daily. The efficacy outcome measures in this study were objective response rate and duration of response.1

The results of this study showed that XALKORI exhibited marked anti-tumor activity in patients with ROS1-positive metastatic NSCLC, with an objective response rate of 66 percent (95% CI: 51%, 79%) by an independent radiology review. There was one complete response and 32 partial responses. The median duration of response was 18.3 months (95% CI: 12.7 months, not reached). Additionally, the safety profile of XALKORI in ROS1-positive metastatic NSCLC was generally consistent with that observed in patients with ALK-positive metastatic NSCLC.1

An FDA-approved test for the detection of ROS1 rearrangements in NSCLC is not currently available; however, laboratory developed tests are available. A companion diagnostic test is currently under development to identify patients with ROS1-positive metastatic NSCLC who may benefit from treatment with XALKORI.

Additionally, the European Medicines Agency (EMA) is reviewing an application to extend the marketing authorization of XALKORI to include the treatment of adult patients with ROS1-positive advanced NSCLC. In Europe, XALKORI is indicated for the first-line treatment of adults with ALK-positive advanced NSCLC and for the treatment of adults with previously treated ALK-positive advanced NSCLC.

About XALKORI (crizotinib)

XALKORI is a kinase inhibitor indicated in the U.S. for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test, and for the treatment of patients with metastatic NSCLC whose tumors are ROS1-positive. XALKORI was the first ALK inhibitor approved in the U.S. and has been used to treat more than 8,000 patients to date.5

XALKORI Important Safety Information

Hepatotoxicity: Drug-induced hepatotoxicity with fatal outcome occurred in 0.1% of patients treated with XALKORI across clinical trials (n=1719). Transaminase elevations generally occurred within the first 2 months. Monitor with liver function tests including ALT, AST, and total bilirubin every 2 weeks during the first 2 months of treatment, then once a month and as clinically indicated, with more frequent repeat testing for increased liver transaminases, alkaline phosphatase, or total bilirubin in patients who develop transaminase elevations. Permanently discontinue for ALT/AST elevation >3 times ULN with concurrent total bilirubin elevation >1.5 times ULN (in the absence of cholestasis or hemolysis); otherwise, temporarily suspend and dose-reduce XALKORI as indicated.

Interstitial Lung Disease (Pneumonitis): Severe, life-threatening, or fatal interstitial lung disease (ILD)/pneumonitis can occur. Across clinical trials (n=1719), 2.9% of XALKORI-treated patients had any grade ILD, 1.0% had Grade 3/4, and 0.5% had fatal ILD. ILD generally occurred within 3 months after initiation of treatment. Monitor for pulmonary symptoms indicative of ILD/pneumonitis. Exclude other potential causes and permanently discontinue XALKORI in patients with drug-related ILD/pneumonitis.

QT Interval Prolongation: QTc prolongation can occur. Across clinical trials (n=1616), 2.1% of patients had QTcF (corrected QT by the Fridericia method) ≥500 ms and 5.0% had an increase from baseline QTcF ≥60 ms by automated machine-read evaluation of ECGs. Avoid use in patients with congenital long QT syndrome. Monitor with ECGs and electrolytes in patients with congestive heart failure, bradyarrhythmias, electrolyte abnormalities, or who are taking medications that prolong the QT interval. Permanently discontinue XALKORI in patients who develop QTc >500 ms or ≥60 ms change from baseline with Torsade de pointes, polymorphic ventricular tachycardia, or signs/symptoms of serious arrhythmia. Withhold XALKORI in patients who develop QTc >500 ms on at least 2 separate ECGs until recovery to a QTc ≤480 ms, then resume at a reduced dose.

Bradycardia: Symptomatic bradycardia can occur. Across clinical trials, bradycardia occurred in 12.7% of patients treated with XALKORI (n=1719. Avoid use in combination with other agents known to cause bradycardia. Monitor heart rate and blood pressure regularly. In cases of symptomatic bradycardia that is not life-threatening, hold XALKORI until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm, re-evaluate the use of concomitant medications, and adjust the dose of XALKORI. Permanently discontinue for life-threatening bradycardia due to XALKORI; however, if associated with concomitant medications known to cause bradycardia or hypotension, hold XALKORI until recovery to asymptomatic bradycardia or to a heart rate of ≥60 bpm. If concomitant medications can be adjusted or discontinued, restart XALKORI at 250 mg once daily with frequent monitoring.

Severe Visual Loss: Across clinical trials, the incidence of Grade 4 visual field defect with vision loss was 0.2% (n=1719). Discontinue XALKORI in patients with new onset of severe visual loss (best corrected vision less than 20/200 in one or both eyes). Perform an ophthalmological evaluation. There is insufficient information to characterize the risks of resumption of XALKORI in patients with a severe visual loss; a decision to resume should consider the potential benefits to the patient.

Vision Disorders: Most commonly visual impairment, photopsia, blurred vision or vitreous floaters, occurred in 63.1% of 1719 patients. The majority (95%) of these patients had Grade 1 visual adverse reactions. 0.8% of patients had Grade 3 and 0.2% had Grade 4 visual impairment. The majority of patients on the XALKORI arms in Studies 1 and 2 (>50%) reported visual disturbances which occurred at a frequency of 4-7 days each week, lasted up to 1 minute, and had mild or no impact on daily activities.

Embryo-Fetal Toxicity: XALKORI can cause fetal harm when administered to a pregnant woman. Advise of the potential risk to the fetus. Advise females of reproductive potential and males with female partners of reproductive potential to use effective contraception during treatment and for at least 45 days (females) or 90 days (males) respectively, following the final dose of XALKORI.

ROS1-positive Metastatic NSCLC: Safety was evaluated in 50 patients with ROS1-positive metastatic NSCLC from a single-arm study, and was generally consistent with the safety profile of XALKORI evaluated in patients with ALK-positive metastatic NSCLC. Vision disorders occurred in 92% of patients in the ROS1 study; 90% of patients had Grade 1 vision disorders and 2% had Grade 2.

Adverse Reactions: Safety was evaluated in a phase 3 study in previously untreated patients with ALK-positive metastatic NSCLC randomized to XALKORI (n=171) or chemotherapy (n=169). Serious adverse events were reported in 34% of patients treated with XALKORI, the most frequent were dyspnea (4.1%) and pulmonary embolism (2.9%). Fatal adverse events in XALKORI-treated patients occurred in 2.3% of patients, consisting of septic shock, acute respiratory failure, and diabetic ketoacidosis. Common adverse reactions (all grades) occurring in ≥25% and more commonly (≥5%) in patients treated with XALKORI vs chemotherapy were vision disorder (71% vs 10%), diarrhea (61% vs 13%), edema (49% vs 12%), vomiting (46% vs 36%), constipation (43% vs 30%), upper respiratory infection (32% vs 12%), dysgeusia (26% vs 5%), and abdominal pain (26% vs 12%). Grade 3/4 reactions occurring at a ≥2% higher incidence with XALKORI vs chemotherapy were QT prolongation (2% vs 0%), and constipation (2% vs 0%). In patients treated with XALKORI vs chemotherapy, the following occurred: elevation of ALT (any grade [79% vs 33%] or Grade 3/4 [15% vs 2%]); elevation of AST (any grade [66% vs 28%] or Grade 3/4 [8% vs 1%]); neutropenia (any grade [52% vs 59%] or Grade 3/4 [11% vs 16%]); lymphopenia (any grade [48% vs 53%] or Grade 3/4 [7% vs 13%]); hypophosphatemia (any grade [32% vs 21%] or Grade 3/4 [10% vs 6%]). In patients treated with XALKORI vs chemotherapy, renal cysts occurred (5% vs 1%). Nausea (56%), decreased appetite (30%), fatigue (29%), and neuropathy (21%) also occurred in patients taking XALKORI.

Drug Interactions: Exercise caution with concomitant use of moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice which may increase plasma concentrations of crizotinib. Avoid concomitant use of strong CYP3A inducers and inhibitors. Avoid concomitant use of CYP3A substrates with narrow therapeutic range in patients taking XALKORI. If concomitant use of CYP3A substrates with narrow therapeutic range is required in patients taking XALKORI, dose reductions of the CYP3A substrates may be required due to adverse reactions.

Lactation: Because of the potential for adverse reactions in breastfed infants, advise females not to breast feed during treatment with XALKORI and for 45 days after the final dose.

Hepatic Impairment: XALKORI has not been studied in patients with hepatic impairment. As crizotinib is extensively metabolized in the liver, hepatic impairment is likely to increase plasma crizotinib concentrations. Use caution in patients with hepatic impairment.

Renal Impairment: Administer XALKORI at a starting dose of 250 mg taken orally once daily in patients with severe renal impairment (CLcr <30 mL/min) not requiring dialysis. No starting dose adjustment is needed for patients with mild and moderate renal impairment.

For more information and full Prescribing Information, visit www.XALKORI.com (link is external).

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

(Filing, Annual, BioLineRx, 2015, MAR 10, 2016, View Source [SID:1234509467])

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8-K – Current report

On March 10, 2016 SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) reported financial results for the quarter and year ended December 31, 2015 (Filing, Q4/Annual, SciClone Pharmaceuticals, 2015, MAR 10, 2016, View Source [SID:1234509495]).

· Revenues: Revenues for the full year 2015 were $157.3 million, compared to $134.8 million for the full year of 2014. In the fourth quarter of 2015, revenues were $42.9 million, compared to $41.4 million for the same period in 2014.

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· GAAP Diluted EPS: GAAP diluted earnings per share for the full year 2015 were $0.56, compared to $0.48 for the full year of 2014. In the fourth quarter of 2015, GAAP diluted earnings per share were $0.24, compared to $0.07 for the same period in 2014.

· Non-GAAP Diluted EPS: Non-GAAP diluted earnings per share for the full year 2015 were $1.00, compared to $0.75 for the full year of 2014. In the fourth quarter of 2015, non-GAAP diluted earnings per share were $0.30, compared to $0.29 for the same period in 2014.

For the year ended December 31, 2015, SciClone reported revenues of $157.3 million, a 17% increase compared to $134.8 million for the same period last year. ZADAXIN revenues were $146.1 million for the year ended December 2015, a $20.0 million or 16% increase, compared to $126.1 million last year. Promotion services revenues were $2.9 million for the year ended December 31, 2015, a $0.1 million or 4% increase, compared to $2.8 million last year. Revenues in the fourth quarter of 2015 were $42.9 million, a $1.4 million or 3% increase, compared to $41.4 million for the same period in 2014. ZADAXIN revenues were $40.2 million in the fourth quarter of 2015, a $1.2 million or 3% increase, compared to $39.0 million for the same period in 2014. Promotion services revenues were $0.9 million for the fourth quarter of 2015, a $0.2 million or 29% increase, compared to $0.7 million in the same period in 2014.

On a GAAP basis, SciClone reported net income for the year ended December 31, 2015 of $29.5 million, or $0.59 and $0.56 per share on a basic and diluted basis, respectively, after deducting $10.8 million in settlement expense for the US Securities and Exchange Commission (SEC) investigation recorded in the second quarter of 2015, compared with net income of $25.2 million, or $0.49 and $0.48 on a basic and diluted basis, respectively, for the same period in 2014. SciClone’s net income in the fourth quarter of 2015 was $12.5 million, or $0.25 and $0.24 per share on a basic and diluted

basis, respectively, compared to net income of approximately $3.5 million, or $0.07 per share on a basic and diluted basis for the same period in 2014.

As previously disclosed, in February 2016, SciClone entered into a settlement agreement with the SEC that fully resolved the SEC’s investigation. Under the terms of the settlement agreement, SciClone paid a total of $12.8 million, including disgorgement, prejudgment interest, and a penalty. The payment is in line with the charges SciClone previously recorded and disclosed in its Form 10-Q filed with the SEC on August 10, 2015. As part of the agreement, the Company neither admits nor denies it engaged in any wrongdoing. The Department of Justice (DOJ) has also completed its related investigation and has declined to pursue any action.

SciClone reported non-GAAP net income for the year ended December 31, 2015 of $52.2 million, or $1.05 and $1.00 per share on a basic and diluted basis, respectively, compared with non-GAAP net income of $39.7 million, or $0.77 and $0.75 on a basic and diluted basis, respectively, for the prior year. SciClone’s non-GAAP net income in the fourth quarter of 2015 was $15.5 million, or $0.31 and $0.30 per share on a basic and diluted basis, respectively, compared with non-GAAP net income of $15.4 million, or $0.30 and $0.29 per share on a basic and diluted basis, respectively, for the same period of the prior year.

Friedhelm Blobel, PhD, SciClone’s Chief Executive Officer commented: "We are very pleased with our overall 2015 financial results, including the continuing success and growth of ZADAXIN, as well as the full resolution of the SEC and DOJ investigations. These important accomplishments position us well to continue our growth trajectory in 2016. We are especially pleased with the continued strong demand for ZADAXIN, which grew 16% over the prior year and thus clearly faster than its generic competitors, and remains a major growth driver for our company. DC Bead continues to gain traction in the marketplace, supported by successful implementation of academic marketing strategies, as does our overall oncology portfolio and our promoted products."

"Despite macro-economic variables, the China pharmaceutical market grew about 8% to 9% in 2015, still significantly outpacing Western market growth rates, and continuing to represent meaningful opportunities for SciClone to continue to expand our business. The extensive regulatory reforms underway in China are showing signs of increasing the speed and efficiency of drug reviews and approvals. We anticipate that this trend will continue, and have a beneficial impact on our ability to advance our development portfolio."

"We are looking forward to conducting a full review of strategic alternatives with the goal of maximizing shareholder value. We continue to believe that SciClone represents a unique opportunity in the China pharma market, and that our commercial experience, reputation for high quality products, industry-leading compliance and partner-of-choice status should translate into opportunities to benefit our stakeholders."

For the year ended December 31, 2015, SciClone reported sales and marketing (S&M) expenses of $54.0 million, compared with $48.5 million for last year. For the fourth quarter of 2015, S&M expenses were $14.9 million, compared with $13.5 million for the same period in 2014. The increase in S&M for the fourth quarter of 2015, compared to the same period in 2014, related to increases in our sales and marketing efforts for ZADAXIN and DC Bead.

For the year ended December 31, 2015, SciClone reported research and development (R&D) expenses of $12.3 million, which included $7.5 million in upfront and milestone payments related to new in-license arrangements, primarily with Theravance Biopharma, Inc., compared with $14.6 million for last year, which included $11.0 million in upfront payments under our in-license arrangement primarily related to The Medicines Company for two cardiovascular products, Angiomax (bivalirudin) and Cleviprex (clevidipine). R&D expenses for the three months ended December 31, 2015 were $3.6 million which included $2.0 million in milestone payments under our in-license arrangements, compared with $11.6 million for the same period last year, which included $11.0 million in upfront payments as noted above which were recorded in the fourth quarter of 2014.

For the year ended December 31, 2015, SciClone reported general and administrative (G&A) expenses of $27.9 million, compared with $22.7 million for last year. For the fourth quarter of 2015, G&A expenses were $6.5 million, compared with $5.3 million for the same period in 2014, an increase of $1.2 million primarily related to our China entity restructuring, higher professional consulting fees for business development strategy, higher stock-based compensation expense, and lower credits to bad debt expense for recovery of previously written-off accounts receivable.

As of December 31, 2015, cash, cash equivalents and short-term investments totaled $101.4 million excluding the $12.8 million of restricted cash held in escrow as of December 31, 2015 for the SEC settlement which was released and paid in February 2016, compared to $86.3 million as of December 31, 2014.

SciClone has had a share repurchase program under which its Board of Directors had authorized $80.5 million, of which approximately $78.1 million had been utilized through December 31, 2015. The share repurchase program expired on December 31, 2015 and is currently under strategic review by the Board.

SciClone has presented non-GAAP information above as the Company believes this non-GAAP information is useful for investors, taken in conjunction with SciClone’s GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of SciClone’s operating results as reported under GAAP. The non-GAAP calculations and reconciliation are provided in the accompanying table titled "Reconciliation of GAAP to Non-GAAP Net Income."

In light of the strategic review underway at SciClone, the Company does not plan to provide revenue and earnings per share guidance for 2016.