surf1944
12 years ago
SciClone to Present at BIO CEO & Investor Conference on February 12th
Press Release: SciClone Pharmaceuticals, Inc. – Mon, Feb 4, 2013 4:00 PM EST
FOSTER CITY, CA--(Marketwire - Feb 4, 2013) - SciClone Pharmaceuticals, Inc. ( NASDAQ : SCLN ) today announced that Friedhelm Blobel, Ph.D., Chief Executive Officer, will present a corporate overview and business update at the 15th Annual BIO CEO & Investor Conference on Tuesday, February 12, 2013 at 2:00 pm ET at the Waldorf Astoria Hotel in New York City.
To access the live audio webcast of these presentations, please log on through a link located in the Investor Relations section of SciClone's website at www.sciclone.com, under the Calendar of Events tab. A replay of the webcast will be available one hour after the conclusion of the live events.
In addition, Dr. Blobel will participate in a panel discussion at the conference titled "Small Companies Thinking Big -- China Tactical Strategies" at 3:30 pm on February 11th.
About SciClone
SciClone Pharmaceuticals is a US-based, China-focused specialty pharmaceutical company with a product portfolio of therapies for oncology, infectious diseases and cardiovascular, urological, respiratory, and central nervous system disorders. SciClone's ZADAXIN® (thymalfasin) is approved in over 30 countries and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV) and certain cancers, and as a vaccine adjuvant, according to the local regulatory approvals. Besides ZADAXIN, SciClone markets about 14 mostly partnered products in China, including Depakine®, the most widely prescribed broad-spectrum anti-convulsant in China; Tritace®, an ACE inhibitor for the treatment of hypertension; Stilnox®, a fast-acting hypnotic for the short-term treatment of insomnia (marketed as Ambien® in the US); and Aggrastat®, a recently-launched interventional cardiology product. SciClone is also pursuing the registration of several other therapeutic products in China. SciClone is headquartered in Foster City, California. For additional information, please visit www.sciclone.com.
surf1944
13 years ago
SciClone Reports Financial Results for the Third Quarter 2012 and 2012 Outlook
MarketwirePress Release: SciClone Pharmaceuticals, Inc. – 3 hours
FOSTER CITY, CA--(Marketwire - Nov 9, 2012) - SciClone Pharmaceuticals, Inc. ( NASDAQ : SCLN ) today reported financial results for the third quarter and for the nine months ended September 30, 2012. In the third quarter, ZADAXIN® sales continued to perform well, with 12% revenue increase in the quarter and 22% increase year to date compared to the prior year, and, combined with revenue from other marketed products, driving our overall company revenue growth of 9% in the quarter and 30% year-to-date.
"While we are pleased with ZADAXIN's continued growth and believe there is significant opportunity for strong growth long term with this key product, there are several internal and external factors affecting our short term revenue in the China market, which we are addressing," commented Friedhelm Blobel, Ph.D., SciClone's President and Chief Executive Officer.
"Externally, while the China pharmaceuticals market is predicted to grow at a rate of 15% or more annually, and demand for high quality products remains high, the Chinese government is implementing measures to contain healthcare costs. Relative to the recently announced 18% national price reduction of ZADAXIN, we were able to negotiate a favorable outcome with our importer that resulted in less than a 5% revenue impact on our company. This was a very favorable outcome for us, but we believe the prolonged uncertainty of the pricing issue had a dampening effect on ZADAXIN sales to the hospital pharmacies. Internally, while there are important strategic benefits of the NovaMed acquisition, we are disappointed that the overall business has under-performed. We have taken expedient action to identify and address issues across our China organization, some of which may have affected ZADAXIN sales to the hospital pharmacies, and to put strategies in place designed to strengthen our business and improve our financial performance in subsequent quarters. We believe these actions will have a positive, long-term effect on our business and re-establish our company on a sustainable growth trajectory."
Comparable periods in 2011 referred to in this press release include the financial results of NovaMed Pharmaceuticals, Inc. (NovaMed) only for the period subsequent to our acquisition of NovaMed on April 18, 2011.
NovaMed Acquisition
We acquired NovaMed on April 18, 2011. The acquisition increased our portfolio of commercial and development-stage products through exclusive licensing and product service agreements with a number of leading pharmaceutical companies. However, although revenues from the NovaMed business have grown since the acquisition, and are expected to continue to grow in the fourth quarter, overall revenue growth and profitability have not met our expectations at the time of the acquisition. For the three and nine months ended September 30, 2012, we recognized a one-time non-cash impairment loss of approximately $42.7 million to fully write down the value of the Company's promotion and distribution contract rights intangible assets recorded as part of the acquisition of NovaMed as the undiscounted cash flows estimated to be generated by those assets were less than the carrying amounts of those assets. We also recorded a non-cash net tax benefit related to NovaMed of approximately $6.8 million, primarily due to the impairment of intangible assets, which resulted in reversal of related deferred tax liabilities, and the impact of recording a full valuation allowance on any remaining NovaMed deferred tax assets.
The terms of our acquisition of NovaMed provided for the contingent consideration of up to an additional $43.0 million in earn-out payments upon the successful achievement of revenue and earnings targets. We re-measure the fair value of the contingent consideration each quarter, which resulted in a non-cash gain of $12.8 million for the third quarter of 2012, compared to a gain of $2.2 million for the same period in the prior year. The significant reduction in the valuation of the contingent consideration expense during the third quarter of 2012 was primarily related to the decrease in the estimated probability of achieving targets relating to NovaMed's product distribution agreements, including in particular the renewal of the Depakine services agreement with Sanofi for a five-year term. We are currently negotiating an extension of that agreement, but believe that any initial extension will be for less than a five-year term. For the nine months ended September 30, 2012, contingent consideration gain was $14.9 million, compared with $1.4 million for the same period last year.
SciClone reported that revenues increased by 9% for the quarter ended September 30, 2012, to $40.7 million, compared to revenues for the same period in the prior year of $37.4 million. Revenues increased by 30% for the nine months ended September 30, 2012, to $120.1 million, compared to revenues for the same period in the prior year of $92.2 million.
The importers and distributors who are our customers tend to purchase infrequent large orders of ZADAXIN inventory to facilitate their distribution and sale to Chinese hospital pharmacies. The timing of infrequent large orders may significantly affect the ZADAXIN channel inventory levels and may cause fluctuations to our reported sales and profitability for each quarterly period.
Financial Results
During the third quarter and particularly in September 2012, we believe that there was a significant increase in ZADAXIN channel inventory levels. We believe the overall market for thymalfasin has continued to grow, but that our strategy of increasing demand for ZADAXIN through various measures, including the expansion of our ZADAXIN sales force, has not led to increased demand during 2012 for ZADAXIN in the hospital pharmacies. We continue to believe that we can increase penetration in the market and grow demand for ZADAXIN. During the nine months ended September 30, 2012, we believe that our sales to our customers have exceeded the pace at which our customers have been able to sell ZADAXIN through to other parties, primarily hospital pharmacies. For the six months ended June 30, 2012, we believe that the levels of ZADAXIN channel inventory grew moderately. For the three months ended September 30, 2012, we believe that the levels of ZADAXIN channel inventory grew significantly. We believe that approximately $14 million of our revenue recognized in the three months ended September 30, 2012 related to the increase of ZADAXIN channel inventory levels at our customers in China.
The increase in revenues in the third quarter and year to date was also affected by the inclusion of the NovaMed primary care and oncology business revenues since the date of the acquisition. For the third quarter ending September 30, 2012, ZADAXIN revenues increased 12% to $31.2 million compared to revenues for the same period in the prior year of $27.9 million, and revenues attributable to the primary care and oncology product lines were $9.5 million for both quarters ended September 30, 2012 and 2011. For the nine months ended September 30, 2012, ZADAXIN revenues increased 22% to $91.4 million compared to revenues for the same period in the prior year of $75.0 million, and revenues attributable to the primary care and oncology product lines increased 67% to $28.7 million, compared to revenues for the same period in the prior year of $17.2 million.
On a pro forma basis, assuming NovaMed had been acquired on January 1, 2011, the revenues for the quarter and nine months ended September 30, 2012 of $40.7 million and $120.1 million would have been compared to $37.4 million and $100.2 million, an increase of $3.3 million or 9% and $19.9 million or 20%, respectively.
On a GAAP basis, SciClone's net loss for the third quarter of 2012 was $13.5 million, compared with net income of $10.2 million for the same period in the prior year, or a net loss of $0.24 per share on both a basic and diluted basis for the three months ended September 30, 2012, compared with a net gain of $0.18 and $0.17 per share on a basic and diluted basis, respectively, for the same period in the prior year. The loss was due to a one-time, non-cash impairment charge of approximately $42.7 million, offset in part by certain non-cash gains, which related to our NovaMed acquisition. For the nine months ended September 30, 2012, SciClone reported net income of $5.8 million, compared with $16.1 million for the same period in the prior year, or $0.10 per share on both a basic and diluted basis, compared with $0.30 and $0.28 per share on a basic and diluted basis, respectively, for the same period in the prior year.
SciClone's non-GAAP net income for the third quarter of 2012 was $11.7 million, compared with non-GAAP income of $9.8 million for the same period of last year, or $0.21 and $0.20 per share on a basic and diluted basis, respectively, for the three months ended September 30, 2012, and $0.17 and $0.16 per share on a basic and diluted basis, respectively, for the three months ended September 30, 2011. For the nine months ended September 30, 2012, SciClone's non-GAAP net income was $32.7 million, compared with non-GAAP income of $22.2 million for the same period of last year, or $0.57 and $0.55 per share on a basic and diluted basis for the nine months ended September 30, 2012, respectively, compared to $0.41 and $0.39 per share on a basic and diluted basis, respectively, for the same period of last year.
SciClone 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 to comparable GAAP measures were derived principally as a result of the NovaMed acquisition and are provided in the accompanying table titled "Reconciliation of GAAP to Non-GAAP Net Income."
Sales and marketing expenses for the third quarter of 2012 were $17.0 million, compared with $15.2 million for the same period in the prior year. The increase of $1.8 million was primarily a result of the additional expansion in China by approximately 130 sales, marketing, and sales support representatives since last year, which significantly expanded SciClone's sales and marketing capabilities. The Company now has a combined sales organization comprised of approximately 850 sales and marketing focused professionals in China. For the nine months ended September 30, 2012, sales and marketing expenses were $52.4 million, compared with $33.3 million, for the same period last year.
Research and development (R&D) expenses for the third quarter of 2012 totaled $0.9 million, compared with $3.0 million for the same period in the prior year. Following the Company's announcement on March 2, 2012 regarding the futility of our SCV-07 clinical development program in oral mucositis, the Company has reduced its future US-based clinical development expenses this year and expects further substantial decreases in R&D expenses in 2013. For the nine months ended September 30, 2012, research and development expenses were $5.8 million, compared with $9.2 million, for the same period last year.
General and administrative expenses for the third quarter of 2012 were $5.7 million, compared with $5.2 million for the same period in the prior year. The increase in 2012 was primarily due to higher professional expenses related to legal, accounting and tax matters. For the nine months ended September 30, 2012, general and administrative expenses were $14.1 million, compared with $19.4 million, for the same period last year.
At September 30, 2012, cash and cash equivalents, restricted cash, and investments totaled $89.2 million, compared with $67.0 million at December 31, 2011. The increase in SciClone's cash balance was primarily due to the cash generated by the Company's commercial operations, partially offset by $18.5 million used in the nine months ended September 30, 2012 for the repurchase of SciClone stock.
We concluded that certain deficiencies in the design and operation of internal controls primarily related to a NovaMed product represented, in aggregate, a material weakness. We have taken steps to correct that material weakness in the fourth quarter and additional information on the material weakness is contained in the company's Form 10-Q which will be filed on November 9, 2012.
Revised Financial Outlook for 2012
Since the acquisition of NovaMed, we have put strategies in place designed to expand and strengthen our sales and marketing infrastructure in China, with the goal of meeting the growing demand for pharmaceuticals in the China market. The expansion of our sales force, with the addition of more than 130 sales, marketing, and sales support representatives since last year, and organization of the sales force into business units focusing on ZADAXIN, primary care and oncology, were consistent with this goal. We believe that these strategies had a positive effect on our business in the year following the acquisition. However, we believe that several developments in the third quarter of 2012 had, or may yet have, material impacts on the growth rate of our business in China and the Company's financial results in the second half of 2012. These developments pertain to: a reduction in the retail price for ZADAXIN and other products which we believe had been anticipated by the market but occurred later in the year than expected; the channel inventory and sales growth of ZADAXIN; NovaMed acquisition matters, including our licensing and product services agreements with third parties and contingent consideration remeasurement; internal control issues primarily within the NovaMed organization; and management turnover. These issues are discussed in detail in the Management Discussion and Analysis section of the company's Form 10-Q filed on November 9, 2012.
We believe that these and other factors contributed to the increase in channel inventory, and due to that increase SciClone is revising down its anticipated 2012 revenues to be between $152 and $157 million, from previously anticipated revenues of between $165 and 170 million. The Company is also revising its previously anticipated non-GAAP earnings per share for the full year 2012 to be between $0.62 and $0.68 from the previously anticipated range of between $0.72 and $0.78. The Company is revising up the anticipated year-end cash, restricted cash and investments balances to greater than $90 million from previously anticipated cash balances of greater than $85 million, excluding the cash impact of any future repurchase of common stock from its share repurchase program.
Increase in Share Repurchase Plan Reserve
Our Board of Directors approved an increase in our reserve for our share repurchase program of $10.0 million. We have been repurchasing our stock over the last several quarters as the Board believes such purchases are in the interest of all of our stockholders. The balance available for repurchases as of today is $16.2 million.
Conference Call Today
SciClone is hosting a conference call today at 8:30 am ET to provide a financial update. The call will be hosted by Friedhelm Blobel, Ph.D., President and CEO, Gary Titus, Senior Vice President and CFO.
LIVE CALL:
877 261 8992 (U.S./Canada)
847 619 6548 (International)
Passcode: 33695874
surf1944
13 years ago
2 Biotech Stocks That Could Jump On Hepatitis C Breakthroughs
April 27, 2012 |
I believe the best investments in the biotech market are in companies focused on the treatment of chronic diseases. There are many people suffering from diseases for which there are no cures, but medical science has developed ways to manage these illnesses and make it possible to live a full life, even when a person is sick. One of the diseases that fit into this category is hepatitis C. There are several companies focused on the treatment and management of hepatitis C and its side effects.
Hepatitis C (HCV) is an infection that causes the inflammation of the liver. The only common link it has with other hepatitis infections is the fact that it is contagious. Hepatitis C is transmitted through contact with blood infected with the disease. The most common medical treatments for HCV are interferons and ribavirin, usually used in combination with one another.
Interferons are virus-fighting proteins and include medications such as Pagsys by Genentech, Roferon made by Roche (RHHBY.PK), and Intron A, originally made by the Schering-Plough Corporation, but now sold by Merck (MRK) following a 2009 merger of the two companies. Ribavirin drugs include Rebetol and Copegus, made by Schering-Plough and Roche Pharmaceuticals, respectively. When combined with interferons, ribavirins work much like antibiotics.
There are also several investigational drugs being studied in the treatment of HCV. Thymosin alpa-1 by SciClone Pharmaceuticals (SCLN) works by enhancing the body's immune system, ISIS 14803 by Isis Pharmaceuticals (ISIS) disrupts HCS during cell division, and VX-497 by Vertex Pharmaceuticals (VRTX) which is an interferon.
Idenix (IDIX) is easily my favorite option for investors interested in companies that are focused on hepatitis C. Its current price is just under $9 and it is best known for its development of telbivudine, a drug marketed under the names Sebivo and Tyzeka. Idenix has five drugs in its pipeline focused on hepatitis C. Two are in Phase II trials and three are in the preclinical stage. Though preclinical drugs can be an iffy gamble, I am always excited by companies that understand the importance of a strong backup plan. Idenix also has an HIV drug in late phase two trials in its pipeline.
Another thing I like about Idenix is the agreement it shares with Novartis Pharmaceuticals (NVS) regarding telbivudine. Idenix collects royalty payments from the sale of the drug that was developed through a joint relationship. This passive income from an already marketed drug is an earnings bonus, especially considering it bears little responsibility for marketing and selling the drug. Should a future drug in the pipeline fail, passive income can help keep your company strong.
More recently, Idenix received good news from the FDA in February concerning IDX 184. According to Idenix President and Chief Executive Officer Ron Renaud, "… clinical programs have made significant progress in the past few months. For IDX184, we are looking forward to initiating a combination study with a protease inhibitor and ribavirin in the near-term to establish the safety and potency of an all-oral IDX184-containing regimen, and, if successful, potentially support a phase III clinical program."
Like all biotech companies, Idenix does have some risk, but it is priced relatively low. This means investors stand to make a great deal from an investment, should any of the long-term treatments for hepatitis C gain a strong following. It could see ups and downs over the years in a volatile market, but I believe it will continue to earn steady if investors are patient.
A mid-April report boosted Idenix stock a bit based on successful Phase I clinical trials for IDX719. The treatment achieved the potent viral load reductions researchers had hoped for. Prices rose 7% to nearly $8.50 in response to the study.
Investors looking for a higher value stock than Idenix, but still interested in hepatitis C developments, should consider Vertex Pharmaceuticals. The Vertex drug Incevik is a prescription medicine currently on the market. It is used with the medicines peginterferon alfa and ribavirin to treat chronic hepatitis C infections in adults with stable liver problems. Vertex also has three drugs in its pipeline intended to treat hepatitis C. One is in Phase II trials and two are in Phase I trials.
There is some concern from investors that the new crop of hepatitis C drugs could potentially cure the disease. This would eliminate the lucrative market of chronic treatment, but would make a large temporary splash. Experts agree it will likely be at least a decade before there is an impact from these "cures," but it is information investors should keep on their back-burners. If the market continues to head in this direction, Idenix could go from a smart long-term investment to a big short-term money maker. Regardless, I think Idenix and Vertex are both good investments now.
Idenix should be considered one of the future heavy hitters in the HCV market. In February the company began a 30-patient, ongoing 12-week phase IIb study of IDX184, an HCV nucleotide inhibitor. The study uses pegylated interferon and ribavirin with IDX184. The drug continues to be safe and well tolerated, with no serious adverse effects reported. The study is currently blind, but further data is expected in the second half of 2012. Positive study results could produce a small bump, but I do not believe it will be a big enough ripple to affect buying or selling decisions.
If forced to pick between Idenix and Vertex, I would base my decision solely on how much I want to spend. Vertex is pricier, but both companies offer a lot of potential. Owners of Idenix should be very excited by the company's outlook for the future. Competition is often fierce in the biotech market, but Idenix is a strong contender and will be a steady earner in any portfolio. If you are looking to invest in a company focused on hepatitis C, Idenix is a great option.
Disclosure: I have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
http://seekingalpha.com/article/535631-2-biotech-stocks-that-could-jump-on-hepatitis-c-breakthroughs?source=yahoo
dav1234
13 years ago
SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced that results from a pre-planned interim analysis of the phase 2b trial of SCV-07 in patients with oral mucositis (OM) indicate that the trial would not meet the pre-specified efficacy endpoints. After conferring with the study's independent Data Monitoring Committee (DMC), the Company has decided to discontinue development of SCV-07 in this indication. SciClone is notifying the FDA and study investigators of the trial's discontinuation. No additional patients will be enrolled in the trial. Dosing of subjects currently enrolled in the trial will be discontinued, but subjects will be followed per protocol for a full year.
"Oral mucositis remains a debilitating condition for cancer patients who are in need of effective therapeutic options. We express our sincere appreciation to the investigators and patients who have participated in the phase 2b trial," said Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone. "While we certainly would have preferred to see a positive outcome from the SCV-07 phase 2b trial interim analysis, as a practical matter, we now have the opportunity to complete our transition to a China-focused specialty pharmaceutical company. This will enable us to further curtail our US development expenses and focus resources on continuing to grow our commercial business in China, expand sales of our broad portfolio of marketed products and build our track record of impressive growth in revenue, profitability and earnings per share."
Following the originally planned completion of the phase 2b trial in mid-2012, SciClone had anticipated a significant decrease in development expenses beginning later this year. SciClone now anticipates that decreases in clinical activities and expenses related to the trial will begin earlier this year, and will have a positive impact on the company's full-year 2012 profitability and earnings.
About SCV-07 and the Phase 2b Trial
The interim analysis included data on 85 subjects. The DMC had no safety concerns, but recommended discontinuing enrolling subjects into the trial as all three dosage arms indicated no efficacy of the drug relative to the primary or secondary OM endpoints.
SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule that appears to stimulate the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells. SCV-07 has been shown to be efficacious in animal models of immune-sensitive diseases, including prevention of oral mucositis, treatment of cancer and viral infections, and enhancement of response to vaccines.
Initiated in January 2011, the Phase 2b trial of SCV-07 is a multicenter, randomized, double blind placebo-controlled study examining three doses of SCV-07, including two higher doses than those used in the Phase 2a study, to assess the drug's impact on modifying the course of oral mucositis in patients with head and neck cancer. The primary endpoint is the reduction in the proportion of patients with clinically assessed ulcerative OM, defined as WHO grade greater than or equal to 2 at the time they have received a cumulative radiation dose of 45 Gy.
About SciClone
SciClone Pharmaceuticals is a revenue-generating, profitable, specialty pharmaceutical company with a substantial commercial business in China and a product portfolio of therapies for oncology, infectious diseases and cardiovascular, urological, respiratory, and central nervous system disorders. SciClone's ZADAXIN® (thymalfasin) is approved in over 30 countries and may be used for the treatment of hepatitis B (HBV), hepatitis C (HCV), as a vaccine adjuvant, and certain cancers according to the local regulatory approvals. Besides ZADAXIN, SciClone markets nearly 20 mostly partnered products in China, including Depakine®, the most widely prescribed broad-spectrum anti-convulsant in China; Tritace®, an ACE inhibitor for the treatment of hypertension; Stilnox®, a fast-acting hypnotic for the short-term treatment of insomnia (marketed as Ambien® in the US); and Aggrastat®, a recently-launched interventional cardiology product. SciClone is also developing SCV-07 in a phase 2b trial for the delay to onset of oral mucositis in patients with head and neck cancer. SciClone is also pursuing the registration of several other therapeutic products in China. SciClone is headquartered in Foster City, California. For additional information, please visit www.sciclone.com.
surf1944
14 years ago
SciClone Reports Financial Results for the Second Quarter of 2011
Year End Cash and Investments Guidance Updated
Press Release Source: SciClone Pharmaceuticals, Inc. On Tuesday August 9, 2011, 4:05 pm EDT
FOSTER CITY, CA--(Marketwire -08/09/11)- SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN - News) today reported financial results for the second quarter of 2011. Revenues for the quarter were $33.1 million compared to $20.7 million for the same period last year. For the six months ended June 30, 2011, revenues were $54.8 million, compared with $38.7 million last year. The increase in revenues in the second quarter and year to date is a result of SciClone's growing ZADAXIN® business and the addition of NovaMed Pharmaceuticals, Inc. revenues from the date of acquisition on April 18, 2011.
SciClone reported non-GAAP net income of $7.5 million, for the second quarter of 2011, compared with non-GAAP net income of $6.2 million, for the same period last year. For the six months ended June 30, 2011, non-GAAP net income was $12.4 million, compared with non-GAAP net income of $10.7 million, for the same period last year.
For the six months and for the quarter ending June 30, 2011, the number of shares of common stock used in computing basic and diluted earnings per share increased compared to the same period in 2010 as a result of the 8,298,110 shares issued in the acquisition of NovaMed in the second quarter and by approximately 1,897,000 shares due to stock option exercises year to date. Non-GAAP earnings per share were $0.13 on both a basic and diluted basis for the second quarter of 2011, and $0.13 on a basic and $0.12 on a diluted basis, for the same period last year. For the six months ended June 30, 2011, non-GAAP earnings per share were $0.24 per share on a basic and $0.23 on a diluted basis, compared with $0.23 on a basic and $0.22 on a diluted basis for the same period last year.
SciClone believes this non-GAAP information is useful for investors by offering them the ability to better understand how management evaluates the business. The non-GAAP calculations and reconciliation to comparable GAAP measures were derived principally as a result of the NovaMed acquisition and is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Net Income."
"It has been a very exciting first half of 2011, as we've successfully built upon our strategy of creating a market-leading specialty pharmaceutical company in China, which continues to be the foundation of our success. We are also optimistic that with our increased visibility and resources in China, we are a more attractive licensee for that market," commented Friedhelm Blobel, Ph.D., SciClone's President and Chief Executive Officer. "With the addition of NovaMed's product portfolio as well our expanded operational and sales and marketing capabilities, we are well positioned to grow sales in China for ZADAXIN and our marketed products, including Depakine®, Stilnox®, and Aggrastat®. We look forward to further growing revenues and earnings this year."
On a GAAP basis, SciClone reported net income of $2.0 million, or $0.04 per share on a basic and $0.03 per share on a diluted basis for the three months ended June 30, 2011, compared with net income of $5.5 million, or $0.12 per share on a basic and $0.11 per share on a diluted basis, for the same period last year. For the six months ended June 30, 2011, SciClone reported net income of $5.8 million, or $0.11 on both a basic and diluted basis, compared with net income of $9.7 million, or $0.20 per share on a basic and diluted basis, for the same period last year.
Research and development expenses for the second quarter of 2011 totaled $3.1 million, compared with $2.4 million for the same period last year. The increase was primarily related to clinical trial-related expenses including the initiation of the Company's phase 2b clinical trial for the delay to onset of oral mucositis in the first quarter of 2011. For the six months ended June 30, 2011, research and development expenses were $6.2 million, compared with $5.1 million for the same period last year. SciClone expects its research and development expenses to be at around this level for the next few quarters until the Company completes the current phase 2b clinical trial with the expectation that a partner would fund any non-China focused future trials with SCV-07, and to decline significantly in 2012 and beyond.
Sales and marketing expenses for the second quarter of 2011 were $12.9 million, compared with $5.6 million for the same period last year. The increase was primarily due to increased sales activities, including the size of SciClone's significantly increased sales force as a result of its acquisition of NovaMed and employee-related costs associated with the expanding sales efforts for SciClone's lead product ZADAXIN. For the six months ended June 30, 2011, sales and marketing expenses were $18.1 million, compared with $10.6 million for the same period last year. SciClone expects sales and marketing expenses in 2011 to be higher compared to 2010 as a result of its acquisition of NovaMed and also due to increased sales efforts for ZADAXIN, primarily in China.
General and administrative expenses for the second quarter of 2011 were $8.3 million compared with $3.4 million for the same period last year. The increase in general and administrative expenses in the second quarter of 2011 was primarily a result of one time transaction costs of approximately $3.3 million related to its acquisition of NovaMed, NovaMed's ongoing general and administrative expenses of approximately $0.7 million, and expenses associated with the Company's compliance activities of approximately $0.7 million. For the six months ended June 30, 2011, general and administrative expenses were $14.2 million, compared with $6.6 million for the same period last year. SciClone expects its general and administrative expenses to decrease in the second half of 2011.
Cash and investments totaled $49.1 million at June 30, 2011, compared with $56.5 million at December 31, 2010. The decrease in SciClone's cash balance is primarily due to the $24.6 million consideration paid in the second quarter as part of the acquisition of NovaMed on April 18, 2011 offset by cash generated by SciClone's operations.
Financial Outlook Update
SciClone is confirming its previous guidance and anticipates that its 2011 GAAP revenue will be between $133 and $138 million which excludes NovaMed's revenue prior to the closing of the acquisition on April 18, 2011. As a result of the various charges relating to the acquisition, and in order to provide what the Company believes is appropriate information on its operational results, SciClone is providing guidance on earnings per share on a non GAAP basis for 2011, and reporting GAAP as well as non GAAP EPS on a quarterly basis. SciClone's non GAAP EPS will exclude charges and write offs related to the acquisition, which may vary from quarter to quarter and which cannot be predicted at this time. SciClone's earnings per share for 2011, excluding charges and write offs related to the acquisition of NovaMed and employee stock-based compensation, are in line with its previous guidance and expected to be between $0.52 and $0.57 per share. SciClone is updating its guidance on cash, cash equivalents, and short and long term investments from greater than $45 million to greater than $55 million at the end of 2011, with $24.6 million having been paid to NovaMed shareholders as part of the initial consideration in the second quarter of this year.
Second Quarter 2011 Pipeline and Business Updates
With the acquisition of NovaMed in April of 2011, SciClone moved forward with its strategic goal of expanding its presence in China with additional key pharmaceutical assets, new therapeutic areas of focus, and an expanded management team, including a current sales force of over 680 professionals. Together with the products acquired from NovaMed, the SciClone portfolio now has 18 marketed products and spans major therapeutic areas including oncology, infectious diseases, and cardiovascular, urological, respiratory and central nervous system disorders. Over time, SciClone expects to optimize this product mix by shifting it to higher margin proprietary and in-licensed products, for which it recognizes the top line revenues. SciClone also has a strong pipeline of product candidates, which are in clinical trials or in other stages of the regulatory approval process in China, including DC Bead which has entered the last part of its regulatory process with a filing of its initial clinical study data with the SFDA. Through the NovaMed acquisition, SciClone now also has exclusive licensing and promotion agreements, for which it receives promotion fees, with a number of leading pharmaceutical companies. Although SciClone expects that ZADAXIN will continue to lead its product sales, the Company anticipates the addition of NovaMed products will increase its future revenues and strengthen its rapidly growing pharmaceutical business in China over the coming years. SciClone continues to look for in-licensing opportunities, with a focus on late-stage or approved branded, well-differentiated products that if not yet approved have a clear regulatory pathway in China based on existing approvals outside of China.
In June, SciClone announced new data from preclinical studies of SCV-07, the Company's lead development product candidate, which showed that the compound successfully inhibited the growth of a variety of tumor cell lines in mice.
Conference Call Information
SciClone is hosting a conference call today at 4:30 pm ET to provide a financial update. The call will be hosted by Friedhelm Blobel, Ph.D., President and CEO, Gary Titus, Senior Vice President and CFO.
surf1944
14 years ago
SciClone Presents New Preclinical Data Highlighting Potential Role of SCV-07 in Cancer Treatment at 2011 ASCO Annual Meeting
SCV-07 Demonstrates Antitumor Activity in Various Cancer Xenograft Studies in Mice; Potential Mechanism of Action for Inhibition of Mucositis and Tumor Progression Identified
Press Release Source: SciClone Pharmaceuticals, Inc. On Saturday June 4, 2011, 3:00 pm EDT
FOSTER CITY, CA--(Marketwire - 06/04/11) - SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN - News) ("Company") today announced new data from preclinical studies of SCV-07, the Company's lead development product candidate, which showed that the compound successfully inhibited the growth of a variety of tumor cell lines in mice. These results suggest that the use of SCV-07 as a treatment for oral mucositis (OM) in patients with a variety of cancers should not interfere with the antitumor effects of primary cancer therapy, but may in fact enhance the tumor response of conventional therapy. Additionally, SciClone researchers have identified potential molecular and cellular mechanisms by which SCV-07 may be able to inhibit both mucositis and tumor progression. These data are being presented today in two poster presentations at the 2011 American Society of Clinical Oncology ("ASCO") Annual Meeting in Chicago.
In one study, researchers inoculated nude mice with various tumor cell lines and once tumors were established, randomized the mice to receive various doses of SCV-07 or the study's control vehicle. Tumors were then measured every two days and tumor volume and tumor growth were calculated using standard measurement tools. Study results showed that tumors in SCV-07-treated animals grew more slowly than those in the control group, with the reduction being generally dose dependent and statistically significant at higher doses. The tumor cell lines examined in this study included human head and neck cancer, human acute promyelocytic leukemia, human acute lymphoblastic leukemia, human melanoma, and murine T cell lymphoma. Results from these studies were presented today at the ASCO meeting in a poster titled "Anti-tumor activity of the immunomodulatory peptide gamma-D-glutamyl-L-tryptophan in leukemia, lymphoma, and head and neck cancer xenograft models."
"As we are currently developing SCV-07 as prevention for OM in patients with head and neck cancer, it is important that we establish that the compound will not interfere with the effectiveness of patients' primary cancer treatment. These study results suggest that SCV-07 may not negatively impact patient response to primary cancer treatment, and also suggest that SCV-07 may in fact enhance antitumor activity," said Cynthia Tuthill, PhD, Vice President and Chief Scientific Officer of SciClone. "These findings provide further support for SCV-07 as a potential treatment for OM and we look forward to continuing to make progress with our ongoing Phase 2b study of SCV-07 in this indication."
In a second study, researchers explored the molecular and cellular activities associated with SCV-07 treatment in various tumor cell lines, in order to understand more about the mechanism by which the compound triggers inhibition of OM and tumor progression. Findings showed that treatment with SCV-07 set in motion a series of molecular processes including activation of the protein tyrosine phosphatase SHP-2, inhibition of phosphorylation of STAT3, and changes in cytokine production. These molecular processes led to important shifts in key immune system components such as macrophages and T cells which ultimately produced the immune responses that may be responsible for inhibiting both OM and tumor progression. These findings offer important insight into the potential mechanisms of action for SCV-07 and support further investigation in this area. Results from this study were presented today at the ASCO meeting in a poster titled "Identification of signaling pathways involved in the mechanism of action of the immunomodulatory peptide gamma-D-glutamyl-L-tryptophan."
About Oral Mucositis
OM is a common, painful, debilitating complication of cancer treatment, and SciClone estimates that total medical costs reached around $4.2 billion in the U.S. and $10 billion worldwide in 2010. OM is a condition in which the sensitive cells lining the mouth and throat are damaged by cancer treatments such as chemotherapy (with or without radiation) and become painful mouth sores. Severe OM has been reported to occur in about 50% of patients who receive chemoradiation for the prevention of cancers of head and neck (Sonis, Core Evidence, 2009). Importantly, radiation to the head and neck, especially when it includes the tissues of the mouth, pharynx and hypopharynx, results in significant ulcerative OM in greater than 90% of patients (Manas et al, Clinical Translational Oncology, 2009) and can compromise the patient's ability or willingness to accept a complete course of therapy. Symptoms can include painful ulcers in the mouth and throat, redness and swelling of the gums, dryness and overall soreness in the mouth, and difficulty eating, swallowing, talking and drinking. In addition to the symptoms of OM and its impact on quality of life and continued therapy, mucositis can cause adverse effects on a variety of other health and economic outcomes, such as a risk of serious infection, the need for parenteral nutrition and narcotic analgesia, and increased hospitalization and feeding-tube placement. The National Cancer Institute estimates that 450,000 patients per year in the U.S. suffer from OM during cancer therapy.
About SCV-07
SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule that appears to stimulate the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells. SCV-07 has been shown to be efficacious in animal models of immune-sensitive diseases, including prevention of oral mucositis, treatment of cancer and viral infections, and enhancement of response to vaccines.
SCV-07 is protected by composition of matter patents as well as multiple method of treatment patents. SciClone has exclusive worldwide rights to SCV-07 outside of Russia, where the molecule has been approved for stimulation of depressed immune systems.
About SciClone's Phase 2b OM Study
SciClone initiated in January 2011 its phase 2b clinical trial of SCV-07 for the prevention of oral mucositis. The study is examining three doses of SCV-07, including two higher doses than those used in the company's phase 2a study, to assess the drug's impact on modifying the course of OM in patients with head and neck cancer. In addition, the trial is further evaluating SCV-07's safety and tolerability in this patient population, as well as the role played by specific genetic profiles on patient response to the treatment.
mlkrborn
15 years ago
SciClone Announces Topline Results From Phase 2b Clinical Trial of SCV-07 for Treatment of Chronic Hepatitis C
Date : 12/15/2010 @ 4:10PM
Source : MarketWire
Stock : SciClone Pharmaceuticals, Inc. (SCLN)
Quote : 3.66 -0.33 (-8.27%) @ 7:22AM
SciClone Announces Topline Results From Phase 2b Clinical Trial of SCV-07 for Treatment of Chronic Hepatitis C
Sciclone (NASDAQ:SCLN)
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SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today announced topline results from the Company's phase 2b clinical trial of SCV-07 for the treatment of hepatitis C (HCV). The study evaluated the safety and immunomodulatory effects of SCV-07 as a monotherapy and in combination with ribavirin in relapsed HCV patients. Study data demonstrated SCV-07 to be safe and well-tolerated at both administered doses. Topline results showed a clear biological signal from SCV-07 but did not meet the study's primary efficacy endpoint of a 2 log reduction in viral load from baseline level. A secondary measure of efficacy, defined as a reduction in viral load of greater than 0.5 log from baseline level, was seen in 38.5% of the low-dose patients (5/13) and in 44.4% of the high-dose patients (8/18). Additionally, while no patients in the low-dose group achieved greater than a 1 log reduction, 3 of the high-dose patients achieved greater than a 1 log reduction in viral load. This proof of concept study was designed to provide an estimate of SCV-07's treatment effect in relapsed HCV patients and guide further studies of SCV-07 in addressing this chronic infection.
"Although the data showed an interesting biological signal, due to the rapidly changing landscape of effective treatments which increase the complexity and risks of developing drugs in chronic HCV, we have decided not to continue development in this indication. On another front, we continue to be excited about the potential for SCV-07 in the prevention of oral mucositis in patients with head and neck cancer and the initiation of our phase 2b study, which should begin by early 2011," stated Friedhelm Blobel, Ph.D., President and Chief Executive Officer of SciClone. "Our primary focus remains on rapidly growing our commercially successful specialty pharmaceutical business in China and other key emerging markets to increase profitability and generate cash for our shareholders."
Study Design
The phase 2b multicenter, multi-dose, open-label study was designed to evaluate the safety and immunomodulatory effects of SCV-07 as a monotherapy or in combination with ribavirin in non-cirrhotic patients with genotype 1 chronic HCV who have relapsed after at least 44 weeks of treatment with pegylated interferon and ribavirin. The study, which also monitored biomarkers of immune activation and HCV viral load dynamics, included two treatment cohorts of 20 patients each who received SCV-07 at a dose of either 0.1 mg/kg or 1.0 mg/kg. The eight week treatment period included four weeks of SCV-07 monotherapy followed by four weeks of SCV-07 in combination with ribavirin. The trial also included three follow-up visits within seven weeks after the completion of treatment.
About SCV-07
SCV-07 (gamma-D-glutamyl-L-tryptophan) is a small molecule which appears to stimulate the immune system through inhibition of STAT3 signaling and the resulting effects on T-helper 1 cells. SCV-07 has been shown to be efficacious in animal models of immune-sensitive diseases, including prevention of oral mucositis, treatment of cancer, viral infections, and enhancement of response to vaccines.
Additionally, SciClone is currently planning to initiate a phase 2b study of SCV-07 for the prevention of oral mucositis by early 2011. As compared to the company's recently completed phase 2a trial, the phase 2b study design is expected to include higher doses of SCV-07 and be adequately powered to demonstrate statistical significance. Additionally, researchers expect to continue to investigate the role of specific genetic profiles on patient response to SCV-07, as well as the potential link between cytokine activity and SCV-07's sub-cellular mechanism of action.
SCV-07 is protected by composition of matter patents as well as multiple method of treatment patents. SciClone has exclusive worldwide rights to SCV-07 outside of Russia, where the molecule has recently been approved for stimulation of depressed immune systems.
About SciClone
SciClone Pharmaceuticals (NASDAQ: SCLN) is a revenue-generating, China-centric, specialty pharmaceutical company with a substantial international business and a product portfolio of novel therapies for cancer and infectious diseases. The Company is focused on continuing sales growth and executing a clinical development strategy with prudently managed costs. ZADAXIN® (thymalfasin) is approved in over 30 countries for the treatment of hepatitis B (HBV) and hepatitis C (HCV), certain cancers, and as a vaccine adjuvant. In addition to further studying thymalfasin's use as a vaccine enhancer, SciClone is planning to evaluate SCV-07 in a phase 2b trial to modify the course of oral mucositis in patients with head and neck cancer; and recently completed a phase 2b trial of SCV-07 for the treatment of HCV. The Company also has exclusive commercialization and distribution rights in China to a novel treatment for advanced liver cancer, DC Bead®, currently under review by regulatory agencies in that country. Additionally, SciClone owns exclusive commercialization and distribution rights to the anti-nausea drug ondansetron RapidFilm® in China, including Hong Kong and Macau, and Vietnam. The Company intends to seek regulatory approval for the product, commonly used to treat and prevent nausea and vomiting caused by chemotherapy, radiotherapy, and surgery, in these markets. For additional information, please visit www.sciclone.com.
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