Close

Form 8-K SCICLONE PHARMACEUTICALS For: May 10

May 10, 2016 7:33 AM EDT

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

___________________________________________

FORM 8-K

__________________________________________

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934.

Date of Report:  May 10, 2016
(Date of earliest event reported)

___________________________________________

SciClone Pharmaceuticals, Inc.
(Exact name of registrant as specified in its charter)

___________________________________________





 

 



Delaware
(State or other jurisdiction
of incorporation) 

0-19825
(Commission File Number) 

94-3116852
(IRS Employer
Identification Number) 



950 Tower Lane, Suite 900, Foster City, CA
(Address of principal executive offices) 

 

94404
(Zip Code) 


(650) 358-3456
(Registrant's telephone number, including area code) 



Not Applicable
(Former Name or Former Address, if changed since last report)

___________________________________________



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) 


 

 

Item 2.02          Results of Operations and Financial Condition    



On May 10, 2016, SciClone Pharmaceuticals, Inc. issued a press release announcing final financial results for the first quarter ended March 31, 2016. The press release is attached hereto as Exhibit 99.1 and is incorporated by reference herein in its entirety. 



The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1 to this Current Report on Form 8-K, shall not be deemed to be “filed” for purposes of Section 18 of the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), or incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.





Item 9.01          Financial Statements and Exhibits

 

(d) The following exhibits are filed herewith:





 

Exhibit 99.1

Press release dated May 10, 2016





 

 


 

 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.





 

 

Dated: May 10, 2016

SCICLONE PHARMACEUTICALS, INC.



 

 



By:

/s/ Wilson W. Cheung



 

Wilson W. Cheung 



 

Chief Financial Officer and

Senior Vice President, Finance





 


 

 

Exhibit Index

 





Exhibit No.       Description

99.1                    Press release dated May 10, 2016.






Exhibit 99.1

Picture 2



Corporate Contacts





 

Wilson W. Cheung

Jane Green

Chief Financial Officer

Investors/Media

650.358.3434

650.358.1447

[email protected]

[email protected]



SCICLONE REPORTS FIRST QUARTER 2016 FINANCIAL RESULTS



ZADAXIN® Leads Continued Growth of Core Business in 2016





FOSTER CITY, CA – May 10, 2016 – SciClone Pharmaceuticals, Inc. (NASDAQ: SCLN) today reported financial results for the quarter ended March 31, 2016.



·

Revenues: In the first quarter 2016, SciClone reported revenues of $36.5 million, compared to $33.6 million for the same period in 2015.

·

GAAP Diluted EPS: In the first quarter 2016, SciClone reported GAAP diluted earnings per share of $0.15, compared to $0.17 for the same period in 2015.

·

Non-GAAP Diluted EPS: In the first quarter 2016, SciClone reported non-GAAP diluted earnings per share of $0.19, compared to $0.19 for the same period in 2015.



Revenues in the first quarter of 2016 were $36.5 million, a $2.9 million or 9% increase, compared to $33.6 million for the same period in 2015. ZADAXIN® revenues were $33.6 million in the first quarter of 2016, a $2.3 million or 7% increase, compared to $31.3 million for the same period in 2015. Promotion services revenues were $1.2 million for the first quarter of 2016, a $0.8 million or 195% increase, compared to $0.4 million in the same period in 2015.



On a GAAP basis, SciClone reported net income in the first quarter of 2016 of $7.9 million, or $0.16 and $0.15 per share on a basic and diluted basis, respectively, compared to net income of approximately $9.0 million, or $0.18 and $0.17 per share on a basic and diluted basis, respectively, for the same period in 2015.



SciClone’s non-GAAP net income in the first quarter of 2016 was $9.7 million, or $0.20 and $0.19 per share on a basic and diluted basis, respectively, compared with non-GAAP net income of $9.8 million, or $0.20 and $0.19 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: “Building on our 2015 momentum, we delivered another strong quarterly performance. Our core business, driven by ZADAXIN, continued to outpace the growth rate of the China pharma market. Today, ZADAXIN has achieved more than 40% of the value share in the thymalfasin market category in China, and our volume share has increased to 17%, an impressive achievement. We achieved substantial growth in

 


 

our oncology portfolio this quarter compared to prior quarters, including the products we promote for our pharmaceutical partners, Baxter and Pfizer. While still modest in size, our oncology portfolio is a key strategic asset for our Company. We anticipate continued growth in the coming years as we introduce additional anticancer products into the market.”



Continued Dr. Blobel: “We are continuing to implement academic marketing strategies to build the market for DC Bead® as a novel treatment for liver cancer and alternative to conventional TACE procedures using gels. We are seeing increased utilization in the market, which we believe will translate into growing sales this year. Our development portfolio continues to progress on track, and we anticipate achieving important regulatory milestones in the next few years.”



For the first quarter of 2016, sales and marketing (S&M) expenses were $12.4 million, compared with $11.4 million for the same period in 2015. The increase in S&M for first quarter of 2016, compared to the same period in 2015, related to increases in sales and marketing efforts for ZADAXIN.



For the first quarter of 2016, research and development (R&D) expenses were $1.5 million, compared with $1.1 million of R&D expenses for the same period of 2015. R&D was higher for the first quarter of 2016, compared to the first quarter of 2015, related to in-licensing agreements with certain business partners and R&D activities in China.



For the first quarter of 2016, general and administrative (G&A) expenses were $7.4 million, compared with $7.0 million for the same period in 2015. G&A was higher for the first quarter of 2016, compared to the first quarter of 2015, related to higher legal costs primarily in connection with the Company’s strategic review to maximize shareholder value and related to higher stock-based compensation expenses.



For the first quarter of 2016, tax provision was $1.9 million, compared with $0.6 million for the same period in 2015. The $1.9 million tax provision for the first quarter of 2016 included a $1.2 million uncertain tax provision for our China operations from 2013 to 2015.



As of March 31, 2016, cash, cash equivalents and short-term investments totaled $114.7 million, compared to $101.4 million as of December 31, 2015, 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.



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.”





2

 


 

Conference Call Today



SciClone is hosting a conference call today at 8:30 am ET (5:30 am PT) to provide a financial update. The call will be hosted by Friedhelm Blobel, Ph.D., President and Chief Executive Officer, and Wilson W. Cheung, Senior Vice President and Chief Financial Officer.



 

LIVE CALL: 

877.674.6420 (US/Canada)



920.663.6281



Passcode: 89832477



 

The conference call will contain forward-looking statements. Interested parties who wish to listen to the webcast should visit the Investor Relations section of SciClone's website at www.sciclone.com. The information provided on the teleconference is accurate only at the time of the conference call, and SciClone will take no responsibility for providing updated information except as required by law.



About SciClone



SciClone Pharmaceuticals is a revenue-generating, specialty pharmaceutical company with a substantial commercial business in China and a product portfolio spanning major therapeutic markets including oncology, infectious diseases and cardiovascular disorders. SciClone’s proprietary lead product, 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 an immune system enhancer, according to the local regulatory approvals. The Company has successfully in-licensed and commercialized products with the potential to become future market leaders and to drive the Company's long-term growth, including DC Bead®, a novel treatment for liver cancer. Through its promotion business with pharmaceutical partners, SciClone also markets multiple branded products in China which are therapeutically differentiated. SciClone is a publicly-held corporation based in Foster City, California, and trades on the NASDAQ Global Select Market under the symbol SCLN. For additional information, please visit www.sciclone.com.

Forward-Looking Statements

This press release contains forward-looking statements regarding expected future events and SciClone’s financial results and expectations, including, without limitation, statements regarding SciClone’s business strategy and growth, product and development portfolios, market opportunities, and statements regarding the exploration of strategic alternatives.  Readers are urged to consider statements that include the words "may," "will," "would," "could," "should," "might," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," “approximately” or the negative of those words or other comparable words to be uncertain and forward-looking. These statements are subject to risks and uncertainties that are difficult to predict and actual outcomes may differ materially. These include risks and uncertainties relating to: the course, cost and outcome of regulatory matters, including future pricing decisions by authorities in China; the dependence of SciClone’s sales of ZADAXIN in China; SciClone’s ability to execute on its goals in China and on its objectives for revenue in fiscal 2016; SciClone’s ability to implement and maintain controls over its financial reporting;  the dependence of its current and future revenue and prospects on third-party license, promotion or distribution agreements, including the need to renew such agreements, enter into similar agreements, or end arrangements that SciClone does not believe are beneficial; operating an international business,

3

 


 

including currency exchange fluctuations; uncertainty in the prospects for unapproved products, including uncertainties as to pricing and competition and risks relating to the clinical trial process and related regulatory approval process and the process of initiating trials at, and enrolling patients at, clinical sites. Please also refer to other risks and uncertainties described in SciClone's filings with the SEC. All forward-looking statements are based on information currently available to SciClone and SciClone assumes no obligation to update any such forward-looking statements. 



SciClone, SciClone Pharmaceuticals, the SciClone Pharmaceuticals design, the SciClone logo and ZADAXIN are registered trademarks of SciClone Pharmaceuticals, Inc. in the United States and numerous other countries.



SCICLONE PHARMACEUTICALS, INC.

UNAUDITED CONSOLIDATED STATEMENTS OF INCOME

(in thousands, except per share amounts)



 

 

 

 

 

 



 

Three Months Ended



 

March 31,



 

 

 

 

 

 



 

2016

 

2015

Revenues:

 

 

 

 

 

 

Product sales, net

 

$

35,320 

 

$

33,168 

Promotion services

 

 

1,179 

 

 

400 

Total net revenues

 

 

36,499 

 

 

33,568 

Operating expenses:

 

 

 

 

 

 

Cost of product sales

 

 

5,813 

 

 

4,597 

Sales and marketing

 

 

12,352 

 

 

11,356 

Research and development

 

 

1,467 

 

 

1,088 

General and administrative

 

 

7,443 

 

 

7,044 

Total operating expenses

 

 

27,075 

 

 

24,085 

Income from operations

 

 

9,424 

 

 

9,483 

Non-operating income (expense):

 

 

 

 

 

 

Interest and investment income

 

 

259 

 

 

112 

Other income (expense), net

 

 

128 

 

 

(63)

Income before provision for income tax

 

 

9,811 

 

 

9,532 

Provision for income tax

 

 

1,947 

 

 

570 

Net income

 

$

7,864 

 

$

8,962 



 

 

 

 

 

 

Basic net income per share

 

$

0.16 

 

$

0.18 

Diluted net income per share

 

$

0.15 

 

$

0.17 



 

 

 

 

 

 

Basic shares outstanding

 

 

49,589 

 

 

49,964 

Diluted shares outstanding

 

 

51,955 

 

 

52,278 



4

 


 

SCICLONE PHARMACEUTICALS, INC.

RECONCILIATION OF GAAP TO NON-GAAP NET INCOME

(in thousands, except per share amounts)

(unaudited)





 

 

 

 

 

 



 

Three Months Ended



 

March 31,



 

 

 

 

 

 



 

2016

 

2015

GAAP net income

 

$

7,864 

 

$

8,962 

Non-GAAP adjustments:

 

 

 

 

 

 

Employee stock-based compensation

 

 

1,293 

 

 

806 

Strategic review expense

 

 

547 

 

 

 —

Non-GAAP net income

 

$

9,704 

 

$

9,768 



 

 

 

 

 

 

Non-GAAP basic net income per share

 

$

0.20 

 

$

0.20 

Non-GAAP diluted net income per share

 

$

0.19 

 

$

0.19 



 

 

 

 

 

 

Weighted average shares used in computing

 

 

 

 

 

 

Non-GAAP basic net income per share

 

 

49,589 

 

 

49,964 

Non-GAAP diluted net income per share

 

 

51,955 

 

 

52,278 



SciClone management uses these non-GAAP financial measures to monitor and evaluate the Company’s operating results and trends on an on-going basis and internally for operations, budgeting and financial planning purposes. SciClone believes the non-GAAP information is useful for investors by offering them the ability to better understand how management evaluates the business. These non-GAAP measures have limitations, however, because they do not include all items of income and expenses that affect SciClone. These non-GAAP financial measures that management uses are not prepared in accordance with, and should not be considered in isolation of, or as an alternative to, measurements required by GAAP.

SciClone’s non-GAAP financial measures exclude the following items from GAAP net income and net income per share:

·

Employee stock-based compensation. The effects of non-cash employee stock-based compensation.

·

Strategic review expense. The effects of costs incurred related to the Company’s strategic review for the purpose of maximizing shareholder value.

5

 


 

SCICLONE PHARMACEUTICALS, INC.

UNAUDITED SELECTED BALANCE SHEET DATA

(in thousands)

75



 

 

 

 

 

 



 

March 31,

 

December 31,



 

2016

 

2015

Cash, cash equivalents, and short-term investment

 

$

114,689 

 

$

101,403 

Accounts receivable, net

 

 

32,434 

 

 

39,363 

Inventories

 

 

12,158 

 

 

10,976 

Short-term restricted cash

 

 

 —

 

 

12,826 

Goodwill

 

 

33,215 

 

 

32,979 

Total assets

 

 

210,350 

 

 

216,619 

Total current liabilities

 

 

20,766 

 

 

36,820 

Total shareholders' equity

 

 

189,501 

 

 

179,712 



6

 




Serious News for Serious Traders! Try StreetInsider.com Premium Free!

You May Also Be Interested In





Related Categories

SEC Filings