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 (Date of earliest event reported): February 1, 2012
SAVIENT PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
Delaware | 0-15313 | 13-3033811 | ||
(State or Other Jurisdiction of Incorporation) |
(Commission File Number) |
(IRS Employer Identification No.) |
One Tower Center East Brunswick, NJ |
08816 | |||
(Address of Principal Executive Offices) | (Zip Code) |
Registrants telephone number, including area code: (732) 418-9300
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 February 1, 2012, Savient Pharmaceuticals, Inc. (the Company) issued a press release announcing, among other things, that the Company expects to report net sales of KRYSTEXXA® (pegloticase) for the three months ended December 31, 2011 of between $2.8 and $3.0 million, as compared to $1.9 million for the three months ended September 30, 2011. In addition, also on February 1, 2012, the Company held a publicly available live conference call to discuss this announcement. The transcript of the February 1, 2012 conference call and a copy of the press release dated February 1, 2012 are furnished in this filing as Exhibits 99.1 and 99.2, respectively.
The information in this Item 2.02 (including Exhibits 99.1 and 99.2) shall not be deemed filed for purposes of Section 18 of the Securities Exchange Act of 1934 (the Exchange Act) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 5.02. | Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers. |
(b), (c), (e) On February 1, 2012, John H. Johnson resigned from his role as Chief Executive Officer and President of the Company and resigned from the Board of Directors (the Board) of the Company, effective immediately.
The Board has appointed David Y. Norton as interim Chief Executive Officer, effective immediately. Mr. Norton, age 60, has served on the Board since September 2011 and will continue in that role.
Prior to joining the Company, from May 2009 to September 2011, Mr. Norton served as Company Group Chairman, Global Pharmaceuticals for Johnson & Johnson where he was responsible for leading and developing the strategic growth agenda, including the strategy for licensing, acquisitions and divestments, and ensuring alignment with global strategic functions, research and development and the commercial organization. From June 2006 to April 2009, Mr. Norton served as Johnson & Johnsons Company Group Chairman, Worldwide Commercial and Operations for the CNS, Internal Medicine Franchise and had held the position of Company Group Chairman for the pharmaceutical businesses in Europe, Middle East, and Africa, as well as for North America and Canada. During his thirty-two year career at Johnson & Johnson, Mr. Norton held a wide range of management positions of increasing responsibility in Europe, Australia, New Zealand and the United States.
There are no family relationships between Mr. Norton and any director or executive officer of the Company, and he has no direct or indirect material interest in any transaction required to be disclosed pursuant to Item 404(a) of Regulation S-K.
The Boards Compensation and Human Resources Committee has approved an annual base salary of $600,000 for Mr. Norton, to be prorated for the period that he is employed as Interim Chief Executive Officer of the Company.
Item 9.01. | Financial Statements and Exhibits |
(d) Exhibits
See Exhibit Index attached hereto.
- 1 -
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.
Date: February 3, 2012 | SAVIENT PHARMACEUTICALS, INC. | |||||
By: | /s/ Philip K. Yachmetz | |||||
Philip K. Yachmetz | ||||||
SVP & General Counsel |
EXHIBIT INDEX
Exhibit |
Description | |
99.1 | Transcript dated February 1, 2012 | |
99.2 | Press Release dated February 1, 2012 |
Exhibit 99.1
SAVIENT PHARMACEUTICALS
Executive Appointment Call
February 1, 2012
PARTICIPANTS
Corporate Participants
Philip K. Yachmetz Secretary, Senior Vice President & General Counsel
Stephen O. Jaeger Non-Executive Chairman
David Y. Norton Interim Chief Executive Officer
Louis Ferrari Senior Vice President-North American Commercial
Other Participants
Salveen J. Richter Analyst, Collins Stewart LLC
Joseph P. Schwartz Analyst, Leerink Swann LLC
Steve Byrne Analyst, Bank of America Merrill Lynch
Eric Schmidt Analyst, Cowen & Co.
Matthew J. Lowe Analyst, JPMorgan Securities LLC
MANAGEMENT DISCUSSION SECTION
Operator Introduction
Good morning, ladies and gentlemen, and thank you for standing by. Welcome to Savients Conference Call. At this time all participants are in listen-only mode. Later we will conduct a question-and-answer session. [Operator Instructions]
As a reminder, this conference will be recorded. I would now like to introduce your host for today, Mr. Philip Yachmetz, Senior Vice President and General Counsel for Savient Pharmaceuticals. Please go ahead.
Philip K. Yachmetz, Secretary, Senior Vice President & General Counsel
Thank you, operator. Good morning, everyone and thank you for joining us this morning to discuss the announcement we made earlier. A copy of the press release we issued this morning can be found on our website www.savient.com.
Before we begin todays call, I would like to read our Safe Harbor statement. Comments made during this conference call will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Savient Pharmaceuticals. In particular, we need to stress that when we discuss information regarding the safety and efficacy
of KRYSTEXXA®, status of our KRYSTEXXA marketing efforts and additional plans related thereto, market demand and reimbursement for KRYSTEXXA, our view of the refractory chronic gout or RCG market, and our market expansion plans including the marketing authorization application pending before the European Medicines Agency are forward-looking statements. No inference of the overall success of these matters can be implied, as they are subject to a number of risks and uncertainties. We encourage you to review our press release dated February 1, 2012, and our companys filings with the Securities and Exchange Commission, including without limitation our Form 10-Q, which was filed on November 8, 2011. Each of these contain important factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of this live broadcast February 1, 2012. We undertake no obligation to revise or update our statements to reflect events or circumstances that occur after the date of this conference call.
Joining me on the call today is Stephen Jaeger, our Chairman and our new Interim Chief Executive Officer, David Norton. Ken Zuerblis, our Chief Financial Officer and Lou Ferrari, our Executive Vice President & President of North American Commercial Operations are also in the room with us and will be available during the Q&A portion of this mornings call.
With that, I will now turn the call over to Stephen Jaeger, our Chairman.
Stephen Jaeger, Non-Executive Chairman
Thank you Phil. Good morning and thank you for joining us. As we announced this morning, David Norton has been appointed to the role of Interim Chief Executive Officer of Savient, replacing John Johnson, who has resigned from his position to become President, Chief Executive Officer and Chairman-Elect of Dendreon Corporation.
For those of you who are not familiar with David, he is a well-respected executive with 38 years of experience in the pharmaceutical and biotechnology industry. He is a valued member of our Board and a critical contributor to the growth Savient has realized. I have been impressed by the depth and breadth of his expertise as well as his leadership abilities.
Prior to joining Savient, David spent 32 years at Johnson & Johnson and held a wide range of management positions in Europe, Australia, New Zealand and the United States.
We look forward to leveraging Davids global commercial expertise, specifically in developing and leading strategic growth agendas, to increase awareness and understanding of KRYSTEXXA and achieve our goal of bringing relief to patients suffering from refractory chronic gout around the world.
Given Davids extensive experience and familiarity with Savient and its growth strategy, we anticipate that this will be a seamless transition.
Over the past year, we have assembled a deep bench of talented, experienced and dedicated pharmaceutical executives who are committed to the continued success of KRYSTEXXA. In order to fully leverage the expertise of our management team, today we also announced that Lou Ferrari has been promoted to the role of Executive Vice President, President North American Commercial Operations. In his new role, Lou will work hand in hand with David to maximize our commercial operations and help drive Savient forward. With Lous commercial expertise, Davids leadership and the significant experience and dedication of our strong management team, I am confident that Savient is in good hands.
Before I turn the call over to David for some remarks, I would like to briefly discuss the success we are having with KRYSTEXXA.
As you know, our core asset, KRYSTEXXA, is the first and only FDA approved therapy for the treatment of RCG, a condition with tremendous unmet medical need. We have made great strides over the past year in the commercialization of KRYSTEXXA and believe we have laid the foundation for KRYSTEXXAs long-term success. We achieved many milestones in 2011 including: building our commercial infrastructure, receiving a permanent J-Code, publishing our Phase III data in JAMA, establishing our peer network, reaching over 90% of our tier 1 rheumatologists, filing our MAA application for approval in the EU and many more. Now, for the first time, we have the key building blocks in place, and as we continue to focus on education and awareness, I am confident that we are well positioned to capitalize on the significant long-term potential of KRYSTEXXA.
As weve previously noted, we estimated that the United States RCG market to be approximately 120,000 patients, or 4.2% of the overall annual treated gout population. We expect the United States RCG market to grow at a rate similar to the overall gout market, which is approximately 3.5% annually. Further, the prevalence of gout is even larger outside the United States.
With that, I would like to hand it over to David.
David Y. Norton, Interim Chief Executive Officer
Good morning everyone and thank you, Stephen.
Id like to start off by saying how honored I am that the Board has chosen me to lead Savient during such an exciting time for the Company.
As Stephen mentioned, I have extensive experience in the pharmaceutical and biotechnology industry, most notably from my many years at Johnson & Johnson. Prior to joining the Savient Board, I was Company Group Chairman, Global Pharmaceuticals for Johnson & Johnson, where I was responsible for leading and developing the strategic growth agenda, including strategy for licensing, acquisitions and divestments, and ensuring alignment with global strategic functions, research and development and the commercial organizations.
As a member of the Savient Board, Ive been intimately involved in determining the strategic direction of the Company and strongly believe in the long-term prospects of KRYSTEXXA. Im looking forward to leveraging my experience and the strength of the existing management team to further the Companys success.
Im impressed by all Savient has accomplished over the past year. Now that we have all the necessary pieces in place, we are well positioned to leverage the heightened awareness of refractory chronic gout and KRYSTEXXA to further enhance the reach of the drug.
I know that there is still much to do and I am eager to continue building on the momentum the team has generated. Looking forward, we plan to improve the traction of the U.S. launch, including building on the depth and breadth of KRYSTEXXA sales, continuing our education and awareness programs as well as beginning phase two of our launch.
We are also committed to attaining regulatory approval in Europe and beginning commercialization. There is currently no available EMA approved treatment for RCG in Europe, so we are really excited about the prospects for KRYSTEXXA. Dave Veitch, a seasoned veteran, will head up our European operations as President of Savient in Europe, and we have engaged regional medical scientists and have reimbursement plans and KOL engagement
underway. The foundation for making KRYSTEXXA available on a named patient basis is in place, and we expect KRYSTEXXA to be available shortly. We are working hard to ensure that we are able to hit the ground running when we receive EMA approval. At the same time, we will also continue to assess opportunities and the potential partnerships for the rest of the world.
Finally, I am sure that you also saw that we announced that we expect KRYSTEXXA sales for the fourth quarter 2011 to be in the range of $2.8 to $3.0 million. Sales of KRYSTEXXA continued to move in the right direction and are indicative of the progress we are making.
And as previously mentioned, we ended the third quarter with approximately $202 million in cash, cash equivalents and short-term investments. At that time we said we had enough cash, cash equivalents and short-term investments to fund our operations for at least 18 months. Well have more to say and further detail to offer on our fourth quarter and year-end call scheduled for February 27, but in light of todays news, we wanted to give you a snapshot of where we are.
Im excited about this opportunity and look forward to working with the Board, the management team and our talented employees to build on our recent accomplishments and further the commercialization of KRYSTEXXA.
With that Ill turn it back over to Stephen.
Stephen Jaeger, Non-Executive Chairman
Thanks very much, David.
That concludes our prepared remarks, let me turn the call back over to the operator and we will open up the call up for questions and answers.
QUESTION AND ANSWER SECTION
Operator: We are now opening the line for questions. [Operator Instructions] Thank you. Your fist question is coming from Salveen Richter with Collins Stewart.
<Q Salveen Richter Collins Stewart LLC>: Hi, thanks for taking my question. David, just wanted to get some color on, given Johns departure, how will that affect the KRYSTEXXA launch and the strategic outlook for the company, and just maybe basically if your outlook here or strategic view differs from the prior view?
<A David Norton Savient Pharmaceuticals, Inc.>: Look, we are looking for a pretty seamless transition here. The senior management is in place, and I give credit to John for building an established team of strong professionals. I look to lean on them and continue it. Obviously, I may add my own flavor, but I we are looking as an organization and as a Board as a seamless transition to continue gaining traction for the drug. Well obviously have more detail about that in the earnings call in February. But you still look today that the sales we put out prematurely were in line with estimates, maybe a little higher than some estimates, so were pretty confident in the direction right now.
<Q Salveen Richter Collins Stewart LLC>: Okay. Can you give us any color on January trends just given receipt of the J-Code and now that you have the MSLs on Board as well?
<A David Norton Savient Pharmaceuticals, Inc.>: Look, I may say this a couple of times this morning, but Id probably like to refrain from doing that till February 27; this is day one. For me, its a change of the organization, so its probably appropriate to do it at that time.
<Q Salveen Richter Collins Stewart LLC>: Okay. Thank you.
Operator: Your next question comes from the line of Joseph Schwartz with Leerink.
<Q Joseph Schwartz Leerink Swann LLC>: Hi, thanks. I think John had last said that he expected an acceleration mid-year, if Im not mistaken. I know those expectations have changed a couple times, but can you bring us up to speed, if thats the case, is when you expect to gain more traction?
<A David Norton Savient Pharmaceuticals, Inc.>: Yeah, I think if I recall correctly, John said that traction would start to pick up in the second quarter. And obviously you folks will be able to look at that after we present the fourth quarter results, youll be able to see that. But I will stay with Johns suggestion and his comments that the second quarter is where we expect to see it picking up.
<Q Joseph Schwartz Leerink Swann LLC>: Okay. And as far as the EMA approval process goes, can you give us any color on how youve been navigating the questioning phases since it is broken up in that way?
<A David Norton Savient Pharmaceuticals, Inc.>: Thats correct. Were answering the questions now. We expect, and I think this was what was referenced before that this would be launched in the second half of the year. But we are on track to do that and we have not had any reason to believe that that would change.
<Q Joseph Schwartz Leerink Swann LLC>: Great, thank you.
Operator: Your next question comes from the line of Steve Byrne with Bank of America.
<Q Steve Byrne Bank of America Merrill Lynch>: Hi, David. With this product being on the market now for a year, from your vantage point looking back, would you say that it was priced appropriately? And perhaps more importantly, what would be your outlook for potential pricing action going forward?
<A David Norton Savient Pharmaceuticals, Inc.>: Look, again, it might be a little premature. I think we have to look at that. I think its a fair question. Give me a little time to look at it and see where we go. But again, I think this call was really about the management change. I will look in and dig in with the team and looking at the product, but I think its a fair question and you can ask me that next time. How about that?
<Q Steve Byrne Bank of America Merrill Lynch>: All right, very well. Thank you.
Operator: Your next question comes from the line of Eric Schmidt with Cowen & Company.
<Q Eric Schmidt Cowen & Co.>: Hey, good morning. David, you mentioned, I think, that John during his tenure built a group of highly qualified individuals. How do you retain such individuals in his absence? And is there a plan already in place to offer maybe compensation incentives?
<A David Norton Savient Pharmaceuticals, Inc.>: Well, look, I do give credit to John for building this team. Some of them I know, because I worked with them at Johnson & Johnson. So, John has a relationship, but so do I. It is important for us to maintain this management team. They are excellent. You would have seen that Lou Ferrari got a promotion, and thats a reflection of the organizations confidence in him. Ken Bahrt is critical to the organization from a development point of view. Ive spent time with Ken already. And of course, you know you asked about retention programs, you would expect us to be looking at those and I dont think well be any different to any other company.
<Q Eric Schmidt Cowen & Co.>: Thank you.
Operator: Your next question comes from the line of Cory Kasimov with JPMorgan.
<Q Matthew Lowe JPMorgan Securities LLC>: Hi, there. Its actually Matt Lowe in for Cory today. I was just wondering going forward in the future, is there a particular area that you may be more focused on than in the past, maybe perception of infusion reactions, awareness of the drug in general, reimbursement, anything that you kind of will be more focused on in the future. And then I guess a follow-up question would be, if there was any adverse effect of physicians waiting for the J-code in January and adverse effect on the 4Q sales trend? Thanks.
<A David Norton Savient Pharmaceuticals, Inc.>: Look, let me address the strategy question first. I think we are on track to maintain the same approach that weve had before addressing the issues. In relation to the J-code, maybe I think its best if Lou can answer that. Hes been pretty closely involved. So he can give you the real specifics around that.
<A Louis Ferrari Savient Pharmaceuticals, Inc.>: All right, thank you. I think that you know, as John has said in the past of the J-code, I think the approval I guess, the approval with the J-code has been received very well, but it does take time for the J-code to get loaded. And it does take time for that to take place in the system in the computerized systems and so on. I also would say that, it does make ease of reimbursement a lot better, especially in the rheumatology community. But our strategy at all has not changed and the way we look at that has not changed at all.
<A David Norton Savient Pharmaceuticals, Inc.>: Are there any further questions?
Operator: Thank you. That was your final question. Ladies and gentlemen, this does conclude your call for today. You may now disconnect.
Exhibit 99.2
Contact: | ||
Mary Coleman | Kelly Sullivan / Jennifer Friedman | |
Savient Pharmaceuticals, Inc. | Joele Frank, Wilkinson Brimmer Katcher | |
information@savient.com | ksullivan@joelefrank.com / jfriedman@joelefrank.com | |
(732) 418-9300 | (212) 355-4449 |
SAVIENT PHARMACEUTICALS APPOINTS DAVID Y. NORTON
INTERIM CHIEF EXECUTIVE OFFICER
Pre-Announces Range of KRYSTEXXA® Net Sales for Fourth Quarter 2011
Conference Call for Investors Scheduled Today at 8:30 A.M. Eastern Time
EAST BRUNSWICK, N.J. February 1, 2012 Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today announced that the Companys Board of Directors has appointed David Y. Norton, a member of the Savient Board and former Company Group Chairman, Global Pharmaceuticals for Johnson & Johnson, to the role of Interim Chief Executive Officer, effective immediately. Mr. Norton succeeds John H. Johnson who has resigned as Chief Executive Officer, President and a director of Savient to become President, Chief Executive Officer and Chairman-Elect of Dendreon Corporation. The Board will conduct a search process for a permanent Chief Executive Officer.
The Company also announced today that Louis Ferrari has been promoted to the position of Executive Vice President, President North American Commercial Operations. In his new role, Mr. Ferrari will continue to be a critical contributor to the Companys continued rollout of KRYSTEXXA. He will work directly with Mr. Norton and continue to be responsible for managing the efficiency and productivity of Savients commercial operations.
David is a distinguished executive with 38 years of experience in the pharmaceutical and biotechnology industry, said Stephen O. Jaeger, Chairman of the Savient Board of Directors. Davids extensive global commercial experience, including expertise in leading and developing strategic growth agendas, will be invaluable as we continue the commercialization of KRYSTEXXA, the first and only FDA approved therapy for the treatment of refractory chronic gout. As a member of the Savient Board, David has been intimately involved in determining the strategic direction of the Company and strongly believes in the long-term prospects for KRYSTEXXA. One of Savients most significant accomplishments over the past year has been building a deep bench of talented and experienced pharmaceutical executives who are dedicated to the continued success of KRYSTEXXA. We are confident that the transition will be seamless. We look forward to leveraging Davids expertise in his new role to increase awareness and understanding of KRYSTEXXA and achieve our goal of bringing relief to patients suffering from refractory chronic gout around the world.
I am honored that the Board has selected me to lead Savient during this exciting time for the Company, said Mr. Norton. Savient achieved many milestones over the past year including confirming the U.S. refractory chronic gout market size, publishing Phase III data in JAMA and receiving a permanent J-Code. Now, for the first time, we have all of the necessary pieces in place to capitalize on the heightened awareness of refractory chronic gout and KRYSTEXXA in 2012. I look forward to working with our Board of Directors, management team and employees to build on our recent accomplishments and further enhance the reach of this one-of-a-kind treatment.
On behalf of the Board of Directors, I would like to thank John for his contributions to Savient and to the commercialization of KRYSTEXXA, Mr. Jaeger concluded. We wish him well in his future endeavors.
KRYSTEXXA Net Sales for Fourth Quarter 2011
Savient also today announced that it expects to report that net sales of KRYSTEXXA grew in the fourth quarter to a range of between $2.8 and $3.0 million for the three months ended December 31, 2011, as compared to $1.9 million for the three months ended September 30, 2011.
The Company will provide its full financial results for the three months and year ended December 31, 2011 on its fourth quarter and year-end 2011 earnings call, scheduled for February 27, 2012.
About David Norton
David Norton joined the Savient Board in September 2011. Mr. Norton previously served as Company Group Chairman, Global Pharmaceuticals for Johnson & Johnson where he was responsible for leading and developing the strategic growth agenda, including the strategy for licensing, acquisitions and divestments, and ensuring alignment with global strategic functions, research and development and the commercial organizations. Prior to that, Mr. Norton served as Johnson & Johnsons Company Group Chairman, Worldwide Commercial and Operations for the CNS, Internal Medicine and Virology franchise and had held the position of Company Group Chairman for Johnson & Johnsons pharmaceutical businesses in Europe, the Middle East, and Africa, as well as for North America and Canada. During his thirty-two year career at Johnson & Johnson, Mr. Norton held a wide range of management positions of increasing responsibility in Europe, Australia, New Zealand and the United States. He began his career there as a product manager for Janssen Pharmaceutica in Australia and advanced to international product manager at Janssens Belgium headquarters where he later served as managing director of Janssen Australia and New Zealand. Mr. Norton is currently Chairman of the Board of Directors of the American Foundation for Suicide Prevention. He previously served as a member of the Board of Directors of the Pharmaceutical Research and Manufacturers of America (PhRMA) and was a Board member of the Alliance for Aging Research.
Conference Call and Webcast
The Company will host a live conference call and webcast beginning at 8:30 a.m. Eastern Time on February 1, 2012 to discuss this announcement and to answer questions. To participate by telephone, please dial:
Domestic: | (877) 278-8171 | |||||
International: | (574) 941-7303 | |||||
Conference ID: | 48497482 |
The live and archived webcast can be accessed on the investor relations section of the Savient website at www.savient.com. Please log on to Savients website fifteen minutes prior to the start of the call to ensure adequate time for any downloads that may be necessary.
A telephone replay will be available from 11:15 a.m. Eastern Time on February 1, 2012 through 12:00 a.m. Eastern Time on March 1, 2012 by dialing:
Domestic: | (800) 585-8367 | |||||
International: | (404) 537-3406 | |||||
Conference ID: | 48497482 |
ABOUT SAVIENT PHARMACEUTICALS, INC.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing and commercializing KRYSTEXXA® (pegloticase) for the treatment of chronic gout in adult patients refractory to conventional therapy. Savient has exclusively licensed worldwide rights to the technology related to KRYSTEXXA and its uses from Duke University (Duke) and Mountain View Pharmaceuticals, Inc. (MVP). Duke developed the recombinant uricase enzyme and MVP developed the PEGylation technology used in the manufacture of KRYSTEXXA. MVP and Duke have been granted U.S. and foreign patents disclosing and claiming the licensed technology and, in addition, Savient owns or co-owns U.S. and foreign patents and patent applications, which collectively form a broad portfolio of patents covering the composition, manufacture and methods of use and administration of KRYSTEXXA. Savient also manufactures and supplies Oxandrin® (oxandrolone tablets, USP) CIII in the U.S. For more information, please visit the Companys website at www.savient.com.
FORWARD-LOOKING STATEMENTS
All statements other than statements of historical facts included in this press release are forward-looking statements that are subject to certain risks, trends and uncertainties that could cause actual results and achievements to differ materially from those expressed in such statements. These risks, trends and uncertainties are in some instances beyond our control. Words such as anticipate, believe, estimate, expect, intend, plan, will and other similar expressions identify forward-looking statements, although not all forward-looking statements contain these identifying words. In particular, any statements regarding the safety and efficacy of KRYSTEXXA®, status of our KRYSTEXXA marketing efforts and additional plans related thereto, market demand and reimbursement for KRYSTEXXA, our view of the refractory chronic gout (RCG) market size, and our market expansion plans including our MAA filing before the EMA are forward-looking statements. These forward-looking statements involve substantial risks and uncertainties and are based on our assessment and interpretation of the currently available data and information, current expectations, assumptions, estimates and projections about our business and the biopharmaceutical and specialty pharmaceutical industries in which we operate. Important factors that may affect our ability to achieve the matters addressed in these forward-looking statements include, but are not limited to, our ability to commercialize KRYSTEXXA; the risk that the market for KRYSTEXXA is smaller than we have anticipated; our ability to retain the personnel; our reliance on third parties to manufacture KRYSTEXXA; competition from existing therapies and therapies that are currently under development, including therapies that are significantly less expensive than KRYSTEXXA; our ability to gain market acceptance for KRYSTEXXA among physicians,
patients, health care payers and others in the medical community; whether we are able to obtain financing, if needed; economic, political and other risks associated with foreign operations; risks of maintaining protection for our intellectual property; risks of an adverse determination in intellectual property litigation; and risks associated with stringent government regulation of the biopharmaceutical industry and other important factors set forth more fully in our reports filed with the Securities and Exchange Commission, to which investors are referred for further information. We may not actually achieve the plans, intentions or expectations disclosed in our forward-looking statements, and you should not place undue reliance on our forward-looking statements, which speak only as of the date of publication of this press release. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that we make. Our forward-looking statements do not reflect the potential impact of any future acquisitions, mergers, dispositions, joint ventures or investments that we may make. We do not have a policy of updating or revising forward-looking statements and, except as required by law, assume no obligation to update any forward-looking statements.
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