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0000930413-09-005654.txt : 20091109
0000930413-09-005654.hdr.sgml : 20091109
20091109151107
ACCESSION NUMBER: 0000930413-09-005654
CONFORMED SUBMISSION TYPE: 8-K
PUBLIC DOCUMENT COUNT: 5
CONFORMED PERIOD OF REPORT: 20091104
ITEM INFORMATION: Results of Operations and Financial Condition
ITEM INFORMATION: Financial Statements and Exhibits
FILED AS OF DATE: 20091109
DATE AS OF CHANGE: 20091109
FILER:
COMPANY DATA:
COMPANY CONFORMED NAME: SAVIENT PHARMACEUTICALS INC
CENTRAL INDEX KEY: 0000722104
STANDARD INDUSTRIAL CLASSIFICATION: MEDICINAL CHEMICALS & BOTANICAL PRODUCTS [2833]
IRS NUMBER: 133033811
STATE OF INCORPORATION: DE
FISCAL YEAR END: 1231
FILING VALUES:
FORM TYPE: 8-K
SEC ACT: 1934 Act
SEC FILE NUMBER: 000-15313
FILM NUMBER: 091168034
BUSINESS ADDRESS:
STREET 1: ONE TOWER CENTER
CITY: EAST BRUNSWICK
STATE: NJ
ZIP: 08816
BUSINESS PHONE: 7324189300
MAIL ADDRESS:
STREET 1: ONE TOWER CENTER
CITY: EAST BRUNSWICK
STATE: NJ
ZIP: 08816
FORMER COMPANY:
FORMER CONFORMED NAME: BIO TECHNOLOGY GENERAL CORP
DATE OF NAME CHANGE: 19920703
8-K
1
c59308_8k.htm
c59308_8k.htm -- Converted by SEC Publisher, created by BCL Technologies Inc., for SEC Filing
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): November 4, 2009
Savient Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in Charter)
Delaware |
0-15313 |
13-3033811 |
(State or Other Juris- |
(Commission |
(IRS Employer |
diction of Incorporation) |
File Number) |
Identification No.) |
|
One Tower Center |
|
East
Brunswick, NJ |
08816 |
(Address of Principal Executive Offices) |
(Zip Code) |
Registrant’s telephone number, including area code: 732-418-9300
(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 (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o 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 November 4, 2009, Savient Pharmaceuticals, Inc. (the "Registrant") announced its financial results for the quarter ended September 30, 2009. The full text of the press release issued in connection with the announcement is
furnished as Exhibit 99.1 to this Current Report on Form 8-K.
In addition, on November 5, 2009, the Registrant held a publicly available live webcast discussion of its financial results for the quarter ended September 30, 2009. The transcript of the November 5, 2009 conference call is
furnished as Exhibit 99.2 to this Current Report on Form 8-K.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
Exhibit No.
|
|
Description
|
99.1
|
|
Press release dated November 4, 2009
|
99.2
|
|
Transcript dated November 5, 2009
|
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.
|
|
Savient Pharmaceuticals, Inc. |
|
Date: November 9, 2009 |
|
By: /s/ Philip K. Yachmetz |
|
|
Philip K. Yachmetz |
|
|
SVP, General Counsel & Secretary |
EXHIBIT INDEX
Exhibit No. |
|
Description |
99.1 |
|
Press release dated November 4, 2009 |
99.2 |
|
Transcript dated November 5, 2009 |
EX-99.1
2
c59308_ex99-1.htm
c59308_ex99-1.htm -- Converted by SEC Publisher, created by BCL Technologies Inc., for SEC Filing
EXHIBIT 99.1
Savient Pharmaceuticals Reports Third Quarter 2009 Financial Results
EAST BRUNSWICK, N.J., Nov 04, 2009 - Savient Pharmaceuticals, Inc. (Nasdaq: SVNT) today reported financial results for the three and nine months ended September 30, 2009,
ending the quarter with $67.5 million in cash and short-term investments, a reduction of $11.1 million from December 31, 2008. In October 2009, we raised $60.9 million in cash, net of $4.8 million of offering costs from an
underwritten public offering of 4,945,000 shares of our common stock. The effect of combining the offering with our existing cash brings Savient to approximately $128.4 million in cash and short-term investments as of September 30, 2009, on a
pro forma basis.
"Our strengthened cash position will support future important initiatives in addition to our focused efforts for the resubmission of our Biologics License Application for KRYSTEXXA(TM) to the U.S. Food and Drug
Administration for the treatment of chronic gout in patients refractory to conventional treatment, which we expect will be submitted in early 2010," stated Paul Hamelin, President of Savient.
Operational Key Events:
-
During July 2009, we completed the dosing phase of our open label extension (OLE) study for KRYSTEXXA. This study is currently in an observation only stage.
-
In July 2009, we received a complete response letter (CRL) from the U.S. Food and Drug Administration (FDA) stating that the FDA at that time could not approve our Biologics
License Application (BLA) for KRYSTEXXA. The complete response letter cited deficiencies with the chemistry, manufacturing and controls (CMC) section of the BLA and also
provided a draft of the proposed labeling and further guidance regarding a Risk Evaluation and Mitigation Strategy (REMS).
-
Our requested Type A meeting with the FDA occurred on September 14, 2009 to discuss the CRL and next steps. The meeting with the FDA provided clarification and alignment on a
resubmission plan for us to fully address all deficiencies and issues identified in the CRL. Since the resubmission will include REMS materials, this is subject to a Class 2
review cycle, meaning a Prescription Drug User Fee Act date for all components of our filing six months after the date of our resubmission.
-
In September 2009, we committed to a corporate restructuring plan where we reduced our workforce by 25 employees. We expect that this cost savings initiative will save $2.9
million through the year ending December 31, 2010, net of $1.2 million of severance-related expenses.
-
In October 2009, we raised $65.7 million from an underwritten public offering of 4,945,000 shares of our common stock that yielded $60.9 million in cash, net of $4.8
million of offering costs.
The net loss for the third quarter of 2009 was $13.9 million, or $0.23 per basic and diluted share, on total revenues of $0.3 million, compared with a net loss of $18.2 million, or $0.34 per basic
and diluted share, on total revenues of $0.5 million for the third quarter of 2008. Partially offsetting our net loss for the three months ended September 30, 2009 was non-cash gain of $11.8 million due to a valuation adjustment relating to
warrants that we issued in connection with our April 2009 registered direct offering. On a non-Generally Accepted Accounting Principles (GAAP) basis and excluding the $11.8 million non-cash gain due to a valuation adjustment on our warrants, our
net loss for the third quarter of 2009 was $25.7 million, or $0.42 per basic and diluted share, compared with a GAAP net loss for the third quarter of 2008 of $18.2 million, or $0.34 per basic and diluted share.
The net loss for the first nine months of 2009 was $90.6 million, or $1.56 per basic and diluted share, on total revenues of $2.1 million, compared with a net loss of $60.0 million, or $1.12 per
basic and diluted share, on total revenues of $2.1 million for the same period in 2008. The net loss for the nine months ended September 30, 2009 includes a non-cash charge of $24.1 million due to a valuation adjustment relating to warrants
that we issued in connection with our April 2009 registered direct offering. On a non-GAAP basis, excluding the $24.1 million non-cash charge, our net loss for the first nine months of 2009 was $66.5 million, or $1.15 per basic and
diluted share, compared with a GAAP net loss of $60.0 million for the nine months ended September 30, 2008, or $1.12 per basic and diluted share.
Financial Results of Operations for the Three Months Ended September 30, 2009
Total revenues for the third quarter of 2009 were $0.3 million compared with $0.5 million for the third quarter of 2008, a decrease of $0.2 million mainly due to lower gross sales of Oxandrin(R) as a result
of decreased overall demand for the product from increased generic competition. Additionally, we adjusted our Oxandrin product return reserve in both the current and prior year quarters to reflect higher actual return experience. We expect that
sales of Oxandrin will continue to decline slightly or remain flat in future periods. The decrease in Oxandrin sales was partially offset by a $0.1 million increase in sales of our authorized generic oxandrolone, due to increased market share
being achieved by Watson Pharmaceuticals, Inc. (Watson), our authorized generic distributor.
Research and development expenses for the third quarter of 2009 were $17.7 million, compared with $10.9 million for the third quarter of 2008, an increase of $6.8 million, or 62%. The increase is primarily
due to $4.5 million in contingency charges recorded in the third quarter of 2009 relating to amending the fee schedule and total obligation under our services agreement with our proposed secondary source supplier of pegloticase active
pharmaceutical ingredient (API). We also incurred $1.0 million in higher expenses resulting from increased outside laboratory testing services supporting our OLE study for KRYSTEXXA.
Selling, general and administrative expenses for the third quarter of 2009 were $8.5 million, compared with $7.6 million for the third quarter of 2008, an increase of $0.9 million, or 13%, primarily due to
severance expense related to our plan of termination that reduced our workforce by 25 employees in the third quarter of 2009.
Investment income, net for the third quarter of 2009 was $0.5 million, compared with $0.3 million for the three months ended September 30, 2008, an increase of $0.2 million, or 48%, primarily due to
realized gains on the sale of short-term investments.
Other income, net for the third quarter of 2009 was $11.8 million, compared with Other expense, net of $0.1 million for the third quarter of 2008, an increase to income of $11.9 million as a result of the
non-cash gain on the mark-to-market valuation adjustment to our warrant liability during the three months ended September 30, 2009.
Financial Results of Operations for the Nine Months Ended September 30, 2009
Total revenues for the first nine months of 2009 were $2.1 million, consistent with the same period of 2008.
Research and development expenses for the first nine months of 2009 were $42.1 million, compared with $37.8 million for the same period of 2008, an increase of $4.3 million, or 11%. The increase was
primarily due to higher expenses of $3.5 million associated with the production of pegloticase API commercial batches at BTG, severance expense of $2.5 million recorded during the current year and contingency charges of $4.5 million
recorded in the third quarter of 2009 relating to amending the fee schedule and total obligation under a services agreement for the manufacture of conformance batches at our proposed secondary source supplier of pegloticase API. The above increases
in expense were partially offset by approximately $3.2 million of lower technology transfer costs from our proposed secondary source supplier of pegloticase API as the majority of the work was performed in the prior year and has now been
substantially completed. Additionally, we incurred lower expenses for reservation fees as the prior year period reflects a $2.2 million payment to BTG to reserve manufacturing space in their facility.
Selling, general and administrative expenses for the first nine months of 2009 were $25.4 million, compared with $27.3 million for the same period of 2008, a decrease of $1.9 million, or 7%. The decrease
was primarily due to lower legal fees of $3.2 million as the prior year results reflect expenses for Oxandrin-related patent infringement litigation and $2.1 million of lower compensation and benefits, including share-based compensation, due
primarily to decreased headcount and share-based awards. Partially offsetting the lower costs are $1.2 million in higher severance expenses, increased pre-launch market research and recruiting expenses of $1.1 million and $1.0 million,
respectively, both incurred in preparation for a potential commercial launch of KRYSTEXXA.
Investment income, net for the first nine months of 2009 was $0.3 million, compared with $1.7 million for the same period of 2008, a decrease of $1.4 million, or 84%. The lower investment income was
primarily due to decreased dividend and interest income from lower cash, cash equivalent and investment balances and as a result of lower yields earned on those investments.
Other expense, net for the first nine months of 2009 was $24.4 million, compared with $0.5 million for the same period of 2008, an increase of $23.9 million primarily as a result of the non-cash net loss on
the mark-to-market valuation adjustment to our warrant liability.
Use of Non-GAAP Measures
To supplement our consolidated financial statements presented in accordance with GAAP, we use the following measures defined as non-GAAP financial measures by the SEC: non-GAAP net loss and non-GAAP loss per basic and
diluted share. The presentation of this financial information is not
intended to be considered in isolation or as a substitute for the financial information prepared and presented in accordance with GAAP. In addition, the non-GAAP financial measures included in this press release may be
different from, and therefore not comparable to, similar measures used by other companies. Although certain non-GAAP financial measures used in this release exclude the accounting treatment of valuation adjustments associated with our outstanding
warrants to purchase shares of our common stock, these non-GAAP measures should not be relied upon independently.
Our management believes that these non-GAAP financial measures provide meaningful supplemental information regarding our performance by excluding certain expenses and expenditures that may not be indicative of our core
business operating results. We believe that both management and investors benefit from referring to these non-GAAP financial measures in assessing our performance and when planning, forecasting and analyzing future periods. These non-GAAP financial
measures also facilitate management's internal comparisons to our historical performance and our competitors' operating results. We believe that these non-GAAP measures are useful to investors in allowing for greater transparency with respect to
supplemental information used by management in its financial and operational decision making.
Conference Call Information
Savient's management team will host a live conference call and Webcast on Thursday, November 5 at 10:00 a.m. Eastern Time/7:00 a.m. Pacific Time to review the third quarter financial results. To participate by
telephone, please dial 888-397-5354 from the U.S. or 719-457-2615 for international callers. The conference identification number is 6621643. The live and archived Webcast can be accessed on the investor relations section of the Savient Web site at
www.savient.com. Please log on to Savient's Web site 15 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 1:00 p.m. Eastern Time on November 5, 2009 through 11:59 p.m. Eastern Time on November 19, 2009 by dialing (888) 203-1112 (domestic) or (719) 457-0820 (international) and
entering conference ID number 6621643.
About Savient Pharmaceuticals, Inc.
Savient Pharmaceuticals, Inc. is a specialty biopharmaceutical company focused on developing KRYSTEXXA(TM) (pegloticase) for the treatment of chronic gout in patients refractory to conventional therapy. Savient has
exclusively licensed worldwide rights to the technology related to KRYSTEXXA, formerly referred to as Puricase(R), from Duke University and Mountain View Pharmaceuticals, Inc. Savient also manufactures and supplies Oxandrin(R) (oxandrolone tablets,
USP) CIII in the U.S. Puricase is a registered trademark of Mountain View Pharmaceuticals, Inc.
Forward-Looking Language
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 potential FDA marketing approval for KRYSTEXXA(TM) (pegloticase),
whether any further clinical trials will be required, the actions that may be required of Savient by the FDA in connection with the BLA, the reversion to and revalidation of the Phase 3 manufacturing process, the timing of a resubmission to the FDA
in response to the complete response letter and the efficacy and safety of KRYSTEXXA 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, our Phase 3 clinical data, our current understanding of the complete response letter and on 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, the possibility that the FDA may raise
further issues regarding the BLA for KRYSTEXXA or require that we conduct additional clinical trials, our ability to commercialize and market acceptance of KRYSTEXXA; difficulties in obtaining financing; potential development of alternative or more
effective products by competitors; reliance on third parties to manufacture, market and distribute many of our products; 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 to shareholders. 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.
SVNT-I
(Tables to Follow)
###
SAVIENT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
(Unaudited)
(In thousands, except share data)
|
|
September 30, |
|
|
December 31, |
|
|
|
2009 |
|
|
2008 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current Assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
67,474 |
|
|
$ |
76,315 |
|
Short-term investments |
|
|
3 |
|
|
|
2,282 |
|
Accounts receivable, net |
|
|
592 |
|
|
|
822 |
|
Inventories, net |
|
|
940 |
|
|
|
1,892 |
|
Recoverable income taxes |
|
|
|
|
|
|
5,526 |
|
Prepaid expenses and other current assets |
|
|
1,516 |
|
|
|
2,782 |
|
Total current assets |
|
|
70,525 |
|
|
|
89,619 |
|
Deferred income taxes, net |
|
|
5,200 |
|
|
|
4,200 |
|
Property and equipment, net |
|
|
1,111 |
|
|
|
1,393 |
|
Other assets (including restricted cash) |
|
|
1,297 |
|
|
|
3,010 |
|
Total assets |
|
$ |
78,133 |
|
|
$ |
98,222 |
|
|
LIABILITIES AND STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Current Liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
5,651 |
|
|
$ |
5,888 |
|
Deferred revenues |
|
|
327 |
|
|
|
451 |
|
Warrant liability |
|
|
36,617 |
|
|
|
|
|
Other current liabilities |
|
|
23,707 |
|
|
|
18,650 |
|
Total current liabilities |
|
|
66,302 |
|
|
|
24,989 |
|
Other liabilities |
|
|
11,059 |
|
|
|
9,809 |
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
Stockholders Equity: |
|
|
|
|
|
|
|
|
Preferred stock$.01 par value 4,000,000 shares authorized; no
shares issued |
|
|
|
|
|
|
|
|
Common stock$.01 par value 150,000,000 shares |
|
|
|
|
|
|
|
|
authorized; 61,658,000 issued and outstanding at |
|
|
|
|
|
|
|
|
September 30, 2009 and 54,654,000 shares issued and |
|
|
|
|
|
|
|
|
outstanding at December 31, 2008 |
|
|
617 |
|
|
|
547 |
|
Additional paid-in-capital |
|
|
242,400 |
|
|
|
214,467 |
|
Accumulated deficit |
|
|
(242,248 |
) |
|
|
(151,614 |
) |
Accumulated other comprehensive income |
|
|
3 |
|
|
|
24 |
|
Total stockholders equity |
|
|
772 |
|
|
|
63,424 |
|
Total liabilities and stockholders equity |
|
$ |
78,133 |
|
|
$ |
98,222 |
|
SAVIENT PHARMACEUTICALS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(In thousands, except per share data)
|
|
Three Months |
|
|
Nine Months |
|
|
|
Ended |
|
|
Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product sales, net |
|
$ |
328 |
|
|
$ |
499 |
|
|
$ |
2,092 |
|
|
$ |
1,958 |
|
Other revenues |
|
|
- |
|
|
|
43 |
|
|
|
4 |
|
|
|
125 |
|
|
|
|
328 |
|
|
|
542 |
|
|
|
2,096 |
|
|
|
2,083 |
|
Cost and expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods sold |
|
|
374 |
|
|
|
303 |
|
|
|
1,237 |
|
|
|
855 |
|
Research and development |
|
|
17,670 |
|
|
|
10,875 |
|
|
|
42,071 |
|
|
|
37,762 |
|
Selling, general and administrative |
|
|
8,538 |
|
|
|
7,563 |
|
|
|
25,403 |
|
|
|
27,277 |
|
|
|
|
26,582 |
|
|
|
18,741 |
|
|
|
68,711 |
|
|
|
65,894 |
|
|
Operating loss from continuing operations |
|
|
(26,254 |
) |
|
|
(18,199 |
) |
|
|
(66,615 |
) |
|
|
(63,811 |
) |
Investment income, net |
|
|
502 |
|
|
|
340 |
|
|
|
273 |
|
|
|
1,704 |
|
Other income (expense), net |
|
|
11,812 |
|
|
|
(148 |
) |
|
|
(24,356 |
) |
|
|
(460 |
) |
|
Loss from continuing operations before income taxes |
|
|
(13,940 |
) |
|
|
(18,007 |
) |
|
|
(90,698 |
) |
|
|
(62,567 |
) |
Income tax benefit |
|
|
(64 |
) |
|
|
(863 |
) |
|
|
(64 |
) |
|
|
(3,673 |
) |
|
Loss from continuing operations |
|
|
(13,876 |
) |
|
|
(17,144 |
) |
|
|
(90,634 |
) |
|
|
(58,894 |
) |
Loss from discontinued operations, net of taxes |
|
|
|
|
|
|
(1,070 |
) |
|
|
|
|
|
|
(1,070 |
) |
|
Net loss |
|
$ |
(13,876 |
) |
|
$ |
(18,214 |
) |
|
$ |
(90,634 |
) |
|
$ |
(59,964 |
) |
|
Loss per common share, from continuing operations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.23 |
) |
|
$ |
(0.32 |
) |
|
$ |
(1.56 |
) |
|
$ |
(1.10 |
) |
Diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.32 |
) |
|
$ |
(1.56 |
) |
|
$ |
(1.10 |
) |
|
Loss per common share, from discontinued operations: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
|
|
|
$ |
(0.02 |
) |
|
$ |
|
|
|
$ |
(0.02 |
) |
Diluted |
|
$ |
|
|
|
$ |
(0.02 |
) |
|
$ |
|
|
|
$ |
(0.02 |
) |
|
Loss per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.23 |
) |
|
$ |
(0.34 |
) |
|
$ |
(1.56 |
) |
|
$ |
(1.12 |
) |
Diluted |
|
$ |
(0.23 |
) |
|
$ |
(0.34 |
) |
|
$ |
(1.56 |
) |
|
$ |
(1.12 |
) |
|
Weighted-average number of common and common |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
equivalent shares: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
60,922 |
|
|
|
53,617 |
|
|
|
58,192 |
|
|
|
53,479 |
|
Diluted |
|
|
60,922 |
|
|
|
53,617 |
|
|
|
58,192 |
|
|
|
53,479 |
|
SAVIENT PHARMACEUTICALS, INC. AND SUBSIDIARIES
RECONCILIATION OF NON-GAAP NET LOSS TO GAAP NET LOSS
(Unaudited)
(In millions, except per share data)
Below is a reconciliation of the non-GAAP net loss and loss per basic and diluted share amounts presented in this press release to the GAAP net loss and loss per basic and diluted share amounts presented in this press
release (amounts in millions except per share data):
|
|
Quarter Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
GAAP net loss |
|
$ |
(13.9 |
) |
|
$ |
(18.2 |
) |
|
$ |
(90.6 |
) |
|
$ |
(60.0 |
) |
Impact of change in warrant valuation |
|
|
11.8 |
|
|
|
|
|
|
|
(24.1 |
) |
|
|
|
|
Non-GAAP net loss |
|
$ |
(25.7 |
) |
|
$ |
(18.2 |
) |
|
$ |
(66.5 |
) |
|
$ |
(60.0 |
) |
|
|
|
|
Quarter Ended |
|
|
Nine Months Ended |
|
|
|
September 30, |
|
|
September 30, |
|
|
|
|
2009 |
|
|
2008 |
|
|
2009 |
|
|
2008 |
|
GAAP loss per basic and diluted share |
|
$ |
(0.23 |
) |
|
$ |
(0.34 |
) |
|
$ |
(1.56 |
) |
|
$ |
(1.12 |
) |
Impact of change in warrant valuation |
|
|
0.19 |
|
|
|
|
|
|
|
(0.41 |
) |
|
|
|
|
Non-GAAP
loss per basic and diluted share |
|
$ |
(0.42 |
) |
|
$ |
(0.34 |
) |
|
$ |
(1.15 |
) |
|
$ |
(1.12 |
) |
EX-99.2
3
c59308_ex99-2.htm
c59308_ex99-2.htm -- Converted by SEC Publisher, created by BCL Technologies Inc., for SEC Filing
EXHIBIT 99.2
![](c59308_ex99-2x1x1.jpg) |
Savient Pharmaceuticals, Inc. Company p |
|
SVNT Ticker p |
|
Q3 2009 Earnings Call Event Type p |
|
Nov. 5, 2009 Date p |
|
MANAGEMENT DISCUSSION SECTION
Operator: Welcome to Savients
Third Quarter 2009 Earnings Call. Following managements prepared
remarks, we will hold a question and answer session. [Operator Instructions].
As a reminder, this call is being recorded today, November 5, 2009.
I would now like to turn the conference
over to Philip Yachmetz, Senior Vice President and General Counsel
for Savient Pharmaceuticals. Please go ahead.
Philip K. Yachmetz, Senior
Vice President and General Counsel
Good morning and welcome to Savient
Pharmaceuticals third quarter 2009 financial results conference
call. Yesterday, we issued a press release providing financial results
and highlights for the third quarter of 2009. This press release is
available on our website at www.savient.com.
Before todays conference
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 the information regarding the KRYSTEXXA or pegloticase
BLA, the pathway and progress forward in our plans to address the issues
relating to manufacturing and CMC cited by the FDA in a complete response
letter that we received in August 2009, the status of BTG remediation
of its 483 deficiencies, any data concerning the efficacy and safety
of KRYSTEXXA, our preparations for regulatory submissions for KRYSTEXXA
outside the United States, our work with secondary supply sources for
KRYSTEXXA and related matters, no inference of the overall success
with respect to these matters can be implied as they are subject to
a number of risks and uncertainty.
We encourage you to review the
companys filings with the Securities and Exchange Commission,
including without limitation, our quarterly report on Form 10-Q, our
Annual Report on Form 10-K, and a press release issued by the company
on November 4, 2009, which identify 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 contain time-sensitive information that is accurate
only as of the date of this live broadcast, November 5, 2009. We undertake
no obligation to revise or update any statements to reflect events
or circumstances that occur after the date of this conference call. |
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www.CallStreet.com 212-849-4070 Copyright © 2001-2009 CallStreet |
1 |
![](c59308_ex99-2x2x1.jpg) |
Savient
Pharmaceuticals, Inc.
Company p |
|
SVNT
Ticker p |
|
Q3 2009
Earnings Call
Event Type p |
|
Nov. 5,
2009
Date p |
|
Joining
me on the call this morning is David Gionco, our Group Vice President
and Chief Financial Officer and Paul Hamelin, our President.
At this time, Id like
to turn the call over to David.
David Gionco, Group Vice
President and Chief Financial Officer
Thank you, Philip. Lets
review the financial results for the third quarter and nine months
ended September 30, 2009 that we reported in last nights press
release. This press release highlights our financial results and
I refer you to our quarterly report on Form 10-Q for more specifics
and details. We plan to file our Form 10-Q on Monday, November 9th.
The net loss for the third quarter of 2009 was $13.9 million
or $0.23 per share compared with a net loss of $18.2 million
or $0.34 per share for the third quarter a year ago. Significantly
offsetting our net loss for the three months ended September 30,
2009 was a non-cash gain of $11.8 million or $0.19 per share
due to a valuation adjustment on our warrants that we issued in connection
with our April 2009 registered direct offering. On a non-Generally
Accepted Accounting Principles basis, where Generally Accepted Accounting
Principles is referred to as GAAP and excluding the $11.8 million
valuation adjustment on our warrant liability, our net loss for the
third quarter of 2009 was $25.7 million or $0.42 per share
compared with a GAAP net loss for the third quarter of 2008 of $18.2
million or $0.34 per share.
The net loss for the first nine
months of 2009 was $90.6 million or $1.56 per share compared
with a net loss of $60.0 million or $1.12 per share for the
first nine months of 2008. We ended the third quarter with $67.5
million in cash and short-term investments. In October 2009, we raised $60.9
million in cash from an underwritten public offering of 4.9 million
shares of our common stock.
On a pro forma basis and after
giving effect to the offering, we would have had approximately $128.4
million in cash and short-term investments as of September 30, 2009.
Looking more closely at the detail, total revenues for the third
quarter of 2009 were $300,000, a reduction of $200,000 from
the same period in 2008. Revenue in total for the first nine months
of 2009 was $2.1 million, consistent with the prior year. Our
revenues consist of product sales of Oxandrin, our branded drug that
promotes weight gain following involuntary weight loss and oxandrolone,
our authorized generic equivalent of Oxandrin. We expect that revenues
for Oxandrin and oxandrolone will continue to decline slightly or
remain flat in future periods due to increased generic competition
and lower overall demand for the product.
Research and development expenses
were $17.7 million in the third quarter of 2009, up from $10.9
million in the third quarter of 2008, an increase of $6.8 million.
The higher expenses were primarily due to
$4.5 million in contingency charges recorded in the third quarter of 2009,
relating to obligations under our services |
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|
www.CallStreet.com 212-849-4070 Copyright © 2001-2009 CallStreet |
2 |
![](c59308_ex99-2x2x1.jpg) |
Savient
Pharmaceuticals, Inc.
Company p |
|
SVNT
Ticker p |
|
Q3 2009
Earnings Call
Event Type p |
|
Nov. 5,
2009
Date p |
|
agreement
with our proposed secondary source supplier of pegloticase, which is
the active pharmaceutical ingredient in KRYSTEXXA.
Additionally, research and development
expenses were higher than the prior year quarter by $1 million
resulting from increased outside laboratory testing services supporting
our open label extension study for KRYSTEXXA, as the program was extended
to cover a longer time period. Year-to-date, R&D expenses were $42.1
million, $4.3 million higher than 2008. The reasons for this increase
are consistent with the reasons just discussed for the three-month
period.
Moving over to selling and general
and administrative expenses, these costs were $8.5 million in the
third quarter of 2009, an increase of approximately $900,000 from
the third quarter of 2008. The increase was primarily due to severance
expenses related to our plan of termination that reduced our workforce
by 25 employees during the third quarter of 2009. Year-to-date selling,
general and administrative expenses were $25.4 million, $1.9
million lower than 2008. The decrease is primarily due to lower outside
legal fees in the prior year reflecting expenses for Oxandrin-related
patent infringement litigation.
To summarize, we believe we are
financially well positioned to support the ongoing projects and initiatives
required to resubmit our BLA for KRYSTEXXA to the FDA to obtain marketing
approval. This concludes the financial portion of the conference call
and Id like to now turn the call over to Paul.
Paul Hamelin, President
Thank you, David. Good morning
everyone and thank you for joining us. We would like to review the
past quarters highlights and boy, what a busy productive quarter
it has been, and well also provide an update on the progress
that weve made towards our resubmission towards obtaining our
regulatory approval of KRYSTEXXA or pegloticase for the treatment of
chronic gout in patients who are refractory to conventional therapy.
Wed like to begin by reviewing
the significant progress milestones weve achieved during the
third quarter of this year. After concluding a successful Advisory
Panel meeting in mid June for the 14 to 1 vote for approval by the
Advisory Committee, we began the third quarter with detailed interactions
with the FDA on KRYSTEXXA product labeling and post-approval commitments.
On July 30, we received a complete
response letter from the FDA, which unfortunately did not clear us
for approval, but outlined the open or deficient items related primarily
to the CMC issues, which we need to complete in a resubmission, which
will lead us to hopefully a potential approval in the third quarter
of 2010. The complete response letter, or CRL as we will sometimes
refer to it, allowed us to request a Type A meeting with the FDA to
discuss the in-depth |
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|
www.CallStreet.com 212-849-4070 Copyright © 2001-2009 CallStreet |
3 |
![](c59308_ex99-2x2x1.jpg) |
Savient
Pharmaceuticals, Inc.
Company p |
|
SVNT
Ticker p |
|
Q3 2009
Earnings Call
Event Type p |
|
Nov. 5,
2009
Date p |
|
the
deficient items noted by the FDA in the complete response letter. This
important meeting occurred in mid September. As we previously discussed
in the webcast shortly following the meeting, we obtained alignment
and clarity with the FDA and what we believe to be all the issues necessary
for a successful resubmission.
Approximately three weeks after
this Type A meeting in early October, we received the final written
meeting minutes from the FDA confirming and documenting the consensus
reached at the meeting in regards to these items necessary for resubmission.
The most recent exciting third quarter event was the announcement in
early October that we had successfully secured through our public offering
of common stock an additional $60.9 million. While we have and
we continue to be financially prudent with our operational expenses,
obtaining the additional cash resources enables us to further sustain
operations and address additional strategic projects. However, please
be assured that our companys primary focus continues and remains
to be to seek FDA approval of KRYSTEXXA as rapidly as possible. But
now with a stronger balance sheet, were able to now re-engage
in driving at least two other important strategic activities that we
believe will enhance the near-term value of KRYSTEXXA.
During 2009 with reduced resources
we had slowed down or stopped our efforts into these strategic projects
as we focus exclusively on the FDA approval. We now plan to accelerate
the process of engaging a second global source supplier of bulk product
and a second fill and finish manufacturer for pegloticase and also
return to our plan of action to seek regulatory approvals of KRYSTEXXA
in other countries outside the U.S., specifically the EU. Continuing
with our busy third quarter highlights, weve just returned from
participation in the 2009 ACR annual meeting or the American College
of Rheumatology Annual Scientific Meeting. We had multiple abstracts
and poster papers relating to pegloticase clinical program in the treatment
of chronic gout patients for refractory to conventional therapy.
These posters and abstracts, Im
just going to read the titles that will give you an idea of the comprehensive
nature of the scientific content that we presented. First was a poster
and abstract on the chronic use of pegloticases overall safety
and efficacy. A second important poster was first application of Computer-Assisted
Analysis of Digital Photographs for Assessing Tophus Response Phase
3 studies in pegloticase. A third important poster was improvement
in health related quality of life in patients with treatment failure
gout treated with pegloticase as measured by SF-6D derived utility.
A fourth important poster was
routine serum uric acid monitoring, which predicts antibody-mediated
loss of response and infusion reaction risk during pegloticase therapy.
And last the cost of treatment failure gout, a claims based analysis.
Those five posters were very important and we feel that there was excellent
interest and attendance of these poster presentations by practicing
clinicians and thought leaders, which signifies the growing attention
and awareness of KRYSTEXXA and |
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|
www.CallStreet.com 212-849-4070 Copyright © 2001-2009 CallStreet |
4 |
![](c59308_ex99-2x2x1.jpg) |
Savient
Pharmaceuticals, Inc.
Company p |
|
SVNT
Ticker p |
|
Q3 2009
Earnings Call
Event Type p |
|
Nov. 5,
2009
Date p |
|
the
need for new treatment options for chronic gout patients for refractory
to conventional therapy.
Another milestone in the quarter
was the completion of a very in-depth important comprehensive quantitative
market research study to quantify the size of the chronic gout patient
population for refractory to conventional therapy. These patients of
course have failed to normalize their serum uric acid, their signs
and symptoms are inadequately controlled with xanthine oxidase inhibitors.
Based upon our extensive market research, which included specialists
like the rheumatologists and nephrologists, but also included primary
care physicians and patients, we believe that the crippling severe
chronic gout patient population size is somewhere between 100,000 to
170,000 patients, which is higher than our original estimates from
2006, where we had stated we felt the market was between 25,000 and
100,000 patients.. These patients, as defined by our research criteria,
average six or more flares a year, and tophi were present in over 70%
of these patients.
Lets focus for few minutes
on our forward path towards resubmission. We continue to believe that
were well positioned to file the resubmissions with the FDA in
the first quarter of 2010, which is the timeframe that we previously
stated. The resubmission of KRYSTEXXA BLA will contain the following
components. It will contain comparability analytics from three new
consecutive validation batches of API and drug substance, which will
then be used also as commercial launch material. This resubmission
will also contain REMS materials as requested by the FDA. It will also
include another markup of the FDAs recommended label. And lastly, a
standard clinical safety update.
The product stability data submission,
per the recommendation from the FDA, will be provided to the FDA during
the review period so as not to hold up or delay our resubmission and
it will include six months real-time stability, plus prior stability
data from previous production runs demonstrating product stability
out for 30 months. The FDA agreed that the total data sets would be
considered in determining the shelf life for launch. The FDA requested
that we submit the new stability data on these three new batches no
later than one month prior to the future PDUFA date.
Over the past several weeks, key
members of our manufacturing and quality team have spent a lot of time
in Israel working directly with the BTG Israel team as part of our
concerted resubmission campaign efforts to address the CMC and manufacturer
requirements as identified by the FDA in the complete response letter.
Activities at BTG are advancing well and the workplan that was submitted
by BTG after the June 2009 inspection. Progress is continuing to address
and correct deficiencies cited during this pre-approval inspection
of BTG and to-date, we believe the documentation of the correction
of these deficiencies will be submitted by BTG to the FDA in advance
of our planned resubmission. |
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|
|
www.CallStreet.com 212-849-4070 Copyright © 2001-2009 CallStreet |
5 |
![](c59308_ex99-2x2x1.jpg) |
Savient
Pharmaceuticals, Inc.
Company p |
|
SVNT
Ticker p |
|
Q3 2009
Earnings Call
Event Type p |
|
Nov. 5,
2009
Date p |
|
After
the BTG report is submitted to the FDA, and after we file our resubmission
in the first quarter 2010, the FDA will then determine if an additional
inspection of the facility is necessary. From an operational approach,
both BTG and Savient are planning for a reinspection. So we can be
as prepared as possible should the FDA decide to reinspect. In our
opinion, if a reinspection is needed, we believe theres adequate
time for such an inspection to occur within the review cycle of our
resubmission and it should not hold up the resubmission PDUFA approval
deadline.
Today, wed also like to
update everyone on the current status of our next important milestone,
which is the manufacture of three validation batches of drug product.
Recall our manufacturing validation campaign was to return to the pegloticase
API manufacturing process using the same concentration of PEG which
we had used in manufacturing the Phase 3 product. This manufacturing
campaign is advancing in line with our plans and expectations and probably
the number one question that we get asked these days is, what is the
status of these three batches?
We can confirm today that weve
completed the physical manufacture of three consecutive Pegloticase
API batches using the Phase 3 PEGylation concentration process and
were pleased with the early, but not yet complete results. We
will like to remind everyone that the analytic testing of these three
batches is not complete and therefore we cannot make any definitive
conclusions as for the quality and comparability of API at this time.
Furthermore, these three batches
are currently continuing through our supply chain process and will
undergo filling, finishing and final release testing at Enzon in the
U.S. and then will be placed immediately up on real-time stability.
Wed like to remind everyone that it is the totality of all the
analytic testing, in-process and release data and analytics on both
the API and the finished product at Enzon that is required to be included
in our resubmission. We continue to believe were on track for
filing a resubmission in the first quarter of 2010. Beyond what weve
just shared, it would be premature for us to comment or speculate any
further on the status of these three important batches.
In summary, our focus will remain
on achieving key milestones in order to meet our objectives of obtaining
approvals for KRYSTEXXA. We believe were in a strong cash position,
enabled to sustain ourselves through the regulatory approval process
and beyond and we continue to believe that a worldwide partnership
for the commercialization of KRYSTEXXA or a broader strategic transaction
is needed to unlock future shareholder value.
With that, operator, I would like
to turn the call back over to you and open it up for Q&A. |
|
|
|
|
www.CallStreet.com 212-849-4070 Copyright © 2001-2009 CallStreet |
6 |
![](c59308_ex99-2x2x1.jpg) |
Savient
Pharmaceuticals, Inc.
Company p |
|
SVNT
Ticker p |
|
Q3 2009
Earnings Call
Event Type p |
|
Nov. 5,
2009
Date p |
|
QUESTION
AND ANSWER SECTION
Operator: Thank you. [Operator
Instructions]. Well take our first question from Kim Lee with
Wedbush Securities.
<Q Kimberly Lee>: Good
morning, two questions for you. First is, when will you get the final
results from the API batches? And two, can you give us some clarity
on how your ongoing discussions have been so far with the FDA through
this partner? Thanks.
<A Paul Hamelin>: Okay,
thanks Kim. As weve said, weve manufactured through API,
these three batches and all the analytics that are necessary for the
resubmission will be in our hand in this fourth quarter of 2009. So
once we have all the analytics in our hand this fourth quarter, we
will then put together the resubmission which we intend to resubmit
in the first quarter of next year. So, keep in mind again what were
reporting on today is that we have the three batches, consecutive batches
API-manufactured at this point in time.
To your second question about
our interactions with the FDA, this third quarter we had tremendous
quality time with the FDA to address many, many issues and specifically
all the issues that were raised in the complete response letter. At
this juncture, the interactions with the FDA are a bit quieter because
the responsibility is now on Savient to accrue this data and information
and put these documents together to lead us to the resubmission in
the first quarter of next quarter, which at that point in time one
would expect that our interactions with the agency will increase again.
<Q Kimberly Lee>: Great.
Thanks a lot.
<A Paul Hamelin>: Thanks
Kim.
Operator: Our next question comes
from Craig Gordon with Cowen and Company.
<Q Craig Gordon>: Good
morning. Thank you for that update. Just a couple of questions, now
that you have produced the three batches, do you have an estimate as
to how many further additional batches you can produce prior to the
Q3 2010 potential PDUFA date?
<A Paul Hamelin>: Yeah
Craig. We will continue to produce additional batches leading up to
a potential third quarter launch and well continue to manufacture
later this year and certainly into 2010. We have the adequate time
during the resubmission process and review process to produce any additional
batches that we feel necessary to prepare us for launch. So, we should
be in very good shape.
<Q Craig Gordon>: Great.
And then just in terms of time as you guys have mentioned that youre
exploring a second API locally and filler and also an EU |
|
|
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|
www.CallStreet.com 212-849-4070 Copyright © 2001-2009 CallStreet |
7 |
![](c59308_ex99-2x2x1.jpg) |
Savient
Pharmaceuticals, Inc.
Company p |
|
SVNT
Ticker p |
|
Q3 2009
Earnings Call
Event Type p |
|
Nov. 5,
2009
Date p |
|
filing.
Can you give us some more specifics as to when these milestones can
be expected to be achieved especially the EMEA filing? Is that a 2010
event do you think? And thank you.
<A Paul Hamelin>: Yeah.
Craig, let me break that down on second source supply of both product
or API. Weve already done tech transfer from the BTG organization
to an organization here in the United States, Diosynth. That tech transfer
has occurred. In 2010 Diosynth will run three validation batches in
their facility and with the analytics and those three batches, we will
use that as an opportunity to do a resubmission to the BLA for the
United States and obviously it will also put us in a situation where
we could source product potentially not only out of BTG, but out of
Diosynth in other markets. As it relates to European filing, were
still evaluating the timelines for us to complete the conversion of
our existing BLA and additional documents for EMEA and we havent
given specific guidance as to when we think a resubmission or submission
to Europe will occur at this point in time. Well, I think were
optimistic that we can probably get that done in 2010 and will refine
that timing here in the future as we coalesce a plan.
<Q Craig Gordon>: Thanks,
great and congratulations on your progress.
Operator: Our next question comes
from Collins Stewart, Salveen Kochnover.
<Q Salveen Kochnover>: Good
morning and thanks for taking my questions. In terms of manufacturing
the three KRYSTEXXA batches, how long does it take to complete the
final validation in fill and finish processes?
<A Paul Hamelin>: Yeah
at this point Salveen, since we have three consecutive API batches
complete, we need to move to fill finish that is a relatively short
process and timeline. The longer timeline is actually accruing all
the analytics to both the API, all the testing and analytics to the
API, and to the fill-finish product. So, thats what well
be generating and accruing here in the remaining 60 days of 2009, which
will then use and package up for our first quarter of 10 resubmission.
Thats where we are working, those are the relative timeframes
as we go forward.
<Q Salveen Kochnover>: Okay,
and then how long does it typically take to translate a U.S. clinical
data fed into an EU regulatory filings?
<A Paul Hamelin>: Its
more complicated than just converting i.e. language conversion, because
you have to put it in different format for Europe. You also have to
convert it into metrics. You also have to provide expert reports generated
by specialists or thought leaders in Europe. So, it is a more intricate
filing that we need to put together, so its not just a simple
conversion for Europe, whereas in some other markets, around the world
it is just a language conversion which potentially makes it easier
to file than in other markets. |
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www.CallStreet.com 212-849-4070 Copyright © 2001-2009 CallStreet |
8 |
![](c59308_ex99-2x2x1.jpg) |
Savient
Pharmaceuticals, Inc.
Company p |
|
SVNT
Ticker p |
|
Q3 2009
Earnings Call
Event Type p |
|
Nov. 5,
2009
Date p |
|
<Q Salveen
Kochnover>: And then just,
do you expect R&D and SG&A expense to come in over the next
few quarters?
<A David Gionco>: Salveen,
this is David. We dont normally give specific guidance on where
our expenses will be going forward, but with our plan here to move
forward with the secondary source supplier and secondary fill finisher
we would expect that R&D should be consistent in the next few quarters
compared to the last few quarters.
<Q Salveen Kochnover>: Thank
you.
<A Paul Hamelin>: Thanks,
Salveen.
Operator: Our next question comes
from Joseph Schwartz with Leerink Swann. Mr. Schwartz, please go ahead.
<A Paul Hamelin>: Good
morning, Joe.
Operator: [Operator Instructions].
With no response, well move on to Andrew Vaino with Roth Capital
Partners.
<Q Andrew Vaino>: Yeah,
thanks for taking the call. I was wondering if you could just provide
us a niche more color on the marketing survey that you did to establish
the market size of 100 to 170k, for example how many physicians does
this represent, what were their specialties?
<A Paul Hamelin>: Yeah,
we use a couple of different outside market research organizations
that are very well known that many pharmaceutical and biotech companies
use. They sized it to give us the statistical accuracy which is why
were pretty confident in the data that were reporting.
The specialists that we survey were a large number of rheumatologists,
a large number of nephrologists and those are the two principal specialists
who will infuse the product once approved. And then we also took this
opportunity to (inaudible) significantly to primary care physicians,
interns and family practitioners and we did that because we know that
there are a lot of patients who are chronic outpatients, who are refractory
to conventional therapy, that are in those existing practices as well.
And then the third major group, we took this opportunity to actually,
to conduct more extensive market research with the patients and thats
important obviously to in order to be able to quantify and triangulate
the specialist, the primary care and the patient groups. So its
on that research that we feel that the market size here for the types
of patients that will be eligible candidates hopefully for KRYSTEXXA
at launch will be in the range of 100,000 to 170,000 patients. And
that is a larger market opportunity than what we expressed a few years
ago and a few years ago we just didnt have as extensive market
research as what we do today. |
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Savient
Pharmaceuticals, Inc.
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<Q Andrew
Vaino>: Can you comment more
specifically though on the actual numbers of physicians and the geographic
distributions?
<A Paul Hamelin>: Well
the numbers of physicians, you mean the exact number of physicians
that we interviewed?
<Q Andrew Vaino>: Well,
plus or minus 25.
<A Paul Hamelin>: Its
a good question Andrew, I apologize. I dont know the numbers
of those patients or physicians off the top of my head. I am certain,
it is over a couple of hundred. I just dont remember the individual
cell set.
<Q Andrew Vaino>: Okay.
Great, thanks.
Operator: And John Newman with
Oppenheimer has our next question.
<Q John Newman>: Hi
guys. Thanks for taking the question. I wonder if you could provide
some details on whether the analytical methods for both the API and
the finished product have been finalized and what types of analytical
methods you would be using? Thanks.
<A Paul Hamelin>: Yeah.
So John, the analytic methods, there are many, probably as many as
two dozen to three dozen different metrics that we analyze through
the course of the API production and then the fill/finish. So its
numerous and its extensive. All of those analytics we have discussed
at length with the FDA and was the subject of a lot of our time and
energy at our complete response letter and our Type A meeting with
the FDA.
So, we are in the process of evaluating
all of the output of those analytics, but we dont have all of
the data points from those two to three dozen tests. We do not have
all those data points in our possession at this time. We only have
a few early analytics in our possession and the remaining analytics
will come to us over the next 60 days here. But, rest assured in the
next 60 days, well have all the analytics for the API and all
the analytics from the drug product, final drug product release and
that will form our resubmission backbone.
<Q John Newman>: Okay.
And any update on discussions or thoughts with the agency over the
potential REMS program for KRYSTEXXA?
<A Paul Hamelin>: Yeah
the agency was in our complete response letter, which was then confirmed
in our face-to-face Type A meeting, was very specific with us on what
they want us to do in our REMS program. So, to our thought process
today, its not ambiguous at all. Its very specific. The
agency wants us to ensure that we can provide a medication guide to
all patients who receive KRYSTEXXA therapy and they also are requiring
us to provide a very specific communication plan to physicians, meaning
uricase physicians being rheumatologists, |
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Pharmaceuticals, Inc.
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nephrologists
and the infusion center staff. So very specific communication plans
to both patients and the prescribing physicians.
So again I think at this point
in time, weve got a real good handle on what is required. Weve
actually prepared those materials and submitted those materials, per
the FDAs request as part of our briefing book for our Type A
meeting, and while the agency at the time didnt give us detailed
responses of the REMS materials that weve provided, they did
say that we had correctly interpreted what they were intending as --
for our REMS program. So again, I think were in very good shape
there.
<Q John Newman>: Okay,
great, and just one quick last question. I know that you said previously
you dont really expect a black box in the final label, but given
the type of patients that youll be treating and the efficacy
that the product has demonstrated, do you think it would really have
any commercial impact if you did receive a black box?
<A Paul Hamelin>: Well
John, you know at this juncture, certainly we dont have final
agreed label with the FDA. But I can say with some confidence, based
on the conversations and the interactions with labels that we have
had thus far, there has been no indication that a black box will be
in our final label. But again, that could change. From our perspective
though, as a company, even if we have a black box to your point, because
there is no other therapeutic products or competitives here, we dont
think its going to be a barrier at all to the commercialization
if we do end up with the black box. So we dont think one way
or the other it has a whole lot of impact, as we go forward. Okay.
<Q John Newman>: Great,
thank you.
<A Paul Hamelin>: Thanks
John.
Operator: Next we have Carol Werther
with Summer Street Research.
<Q Carol Werther>: Thanks
for taking the question. I was wondering if you could discuss any of
the post marketing studies that the FDA might require you to do?
<A Paul Hamelin>: Yeah,
we talked briefly, webcast or two, and again Im going to caveat
my response Carol, to you at this time, is not finalized, just typically
we dont have a final agreed post approval plan until approval.
But certainly, in our conversations that weve had with the agency
thus far, theres not been a requirement for a, if you will, a
registry. We have had discussions and as we reported earlier, that
the agency wants us to conduct a post approval observational trial
and collect safety data in that patient population, along with some
efficacy data. But certainly that looks to be the direction that the
agency has given us at this point in time for a post approval commitment.
And I am certain we will probably |
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Pharmaceuticals, Inc.
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have
a few other potential post approval commitments, but I think at this
point in time its a little bit early and -- to address anything
else of those nature. Okay, thanks, Carol.
<Q Carol Werther>: Thanks.
Operator: Next we go to Joseph
Schwartz with Leerink Swann.
<Q Joseph Schwartz>: I
was wondering, if you could give us an update on your work to establish
a second manufacturing supplier at Diosynth? And is that something
that a strategic transaction would most likely wait until after that,
that has seen to be successful or what are your thoughts on that process?
<A Paul Hamelin>: Well,
Joe we have felt for quite a while now, which is that we needed a second
API source supplier for a lot of different reasons. One is, as you
know, currently our BTG manufacturing facility is in Israel. And we
wanted to ensure that we had a second source supply of API in a different
region of the world. We also, from a business standpoint, wanted to
take the opportunity to ensure that we can continue to get as low a
cost of goods as possible in the future. And we believe having a second
source supplier like Diosynth, will be able to provide us with lower
cost of goods, which is clearly important in the global commercialization
of the product.
We as a result of those
kind of strategic reasons, we started year and a half ago with a tech
transfer process into Diosynth, that is complete. We were prepared
this fall to run validation batches at Diosynth, but because we were
in discussions with the FDA and our type A meeting around the analytics
and the things necessary for approval, we suspended our activities
with Diosynth, meaning we didnt produce the validation batches,
but we will do that next year in 2010. And then we will be able to
take that information and the comparability packet that way and use
it to submit, hopefully post-approval an application to source product
in the United States out of Diosynth as well as BTG.
<Q Joseph Schwartz>: Okay.
And can you also update us on what work youre doing to advance
the EMEA filing? Whatre you prepared to do and what would you
leave for a potential partner or someone else to take over the reigns
on that aspect of the opportunity?
<A Paul Hamelin>: Well,
we have a small team internally here that is working with a larger
team of outside consultants and experts who have converted and successfully
filed applications in Europe. So that team is working and plotting
a timeline and identifying all the components that are necessary for
this submission. And were going to continue that work. And as
I noted earlier, we havent given specific guidance as to when
well file that next year with the EMEA Health Authority, but
we think thats eminently achievable. And so, well continue
on that course. |
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Savient
Pharmaceuticals, Inc.
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Q3 2009
Earnings Call
Event Type p |
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2009
Date p |
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<Q Joseph
Schwartz>: Great. Thanks a
lot.
Operator: Our next question will
go to Liisa Bayko with JMP Securities.
<Q Liisa Bayko>: Hi.
Thanks for taking the question. I know one of the components of the
resubmission is a safety update. Is there anything so far in the safety
that youve been collecting that is different from what weve
seen before?
<A Paul Hamelin>: Liisa,
if youll recall in the BLA and in the supplement of BLA that
we filed this last year and what was discussed at Advisory Committee,
was not only our Phase 3, but a significant portion of the open label
extension. And that formed the 120 day safety updates. So, as part
of any new resubmission, its very standard for the agency to
ask for any additional safety and clinical or safety and efficacy data
thats been generated since those filings. And thats basically
what were doing. Keep in mind, also, that as of the end of June
of this year, we dont have patients being exposed to drug anymore.
We still have the open label extension trial ongoing, but all those
patients are not on drug, theyre on an observation period. Then
well continue to collect the data and the information on those
individuals as we go forward.
<Q Liisa Bayko>: Okay,
great. And then just finally could comment on your cash and how you
feel about your cash position going into 2010?
<A Paul Hamelin>: Well,
I certainly feel better about our cash position having raised the 60
million that we just did this quarter. And then Ill let David
put some perspective around that.
<A David Gionco>: Yeah,
sure on a pro forma basis, we have as of September 30, 2009, we have
approximately $128 million of cash and short-term investments at
that time. We believe, based on our current operating plan, we believe
that that cash will last and fund our operations for at least the next
two years. So, we feel pretty comfortable in that realm right now with
the recent financing that took place.
<Q Liisa Bayko>: Is
that assuming a commercial build, or what does that assume?
<A David Gionco>: No,
that assumes our current operating plan, whereby were focused
on obtaining a strategic partnership, a global partnership and/or other
strategic transactions.
<Q Liisa Bayko>: Okay,
thats helpful. Thank you very much.
<A Paul Hamelin>: Thanks
Liisa.
Operator: Next well go to
Eun Yang with Jefferies. |
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Savient
Pharmaceuticals, Inc.
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Earnings Call
Event Type p |
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Date p |
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<Q Eun
Yang>: Thank you for taking
my questions. If I missed to this earlier, I apologize. In terms
of the six month stability test, have you started?
<A Paul Hamelin>: Each
batch Eun, as we produce the API, we shift to Enzon, Enzon then does
final fill/finish, as soon as final fill/finish is complete, it immediately
goes up on stability. So we will have the stability data, six months
real-time stability, from these three batches, well in advance of our
potential PDUFA date. Thats again based on us doing our re-submission
in the first quarter of next year, and a potential PDUFA date of third
quarter of next year. So were in good shape on that stability.
And again, I think theres another very important subtext to that
question which is ultimately folks are asking, whats the shelf
life that will come if you get approved and thats where the importance
of the earlier discussions, its not just the six months real-time
stability of the new three batches, but the agency has agreed that
the existing stability data that weve already generated on multiple
batches, where we demonstrate stability out to 30 months. That will
also be part of their thought process in ultimately granting us whatever
will be our launch timeframe. So its a combination of six months
and 30 months from several other batches that will be used to establish
our launch shelf life timeframe. So I think were confident that
well have a very adequate shelf life at launch.
<Q Eun Yang>: Thanks.
So will you submit the six months of stability data sometime first
half or at least one month prior to the potential PDUFA date? Or do
that be considered as a amendment, so that this could potentially push
that PDUFA?
<A Paul Hamelin>: Yeah
Eun, again the FDA suggested this to us. And they suggested that we
submit this one month prior to the PDUFA. And clearly, we explored
would that somehow cause us to miss the PDUFA and the agency said no.
So it was their recommendation for us to do this and what that allows
both the company and the FDA, it allows us to do the resubmission early
in 2010, and allows them to review the resubmission at the same time
were generating that stability data and the stability data then,
again this is what the FDA wanted, will allow them within a month of
PDUFA date to establish a shelf life.
<Q Eun Yang>: Thank
you. And my last question is on the potential comparable product Novartis
recently announced a positive data in how to check out patients with
marker IL-1 antibody product. Just want to, get your thoughts on how
this product you think would think kind of impact or like impact the
usage of KRYSTEXXA once approved or how is it going to be relatively
positioned to KRYSTEXXA in terms of treating hard to treat gout patients?
<A Paul Hamelin>: Yeah.
Eun, typically, I try to refrain from discussing or talking about other
clinical programs and products as Ive just not as acquainted
with the information as what those companies are. But I can say in
general, as we look at other gout approaches or gout therapies whether
they are on markets today or |
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Savient
Pharmaceuticals, Inc.
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Earnings Call
Event Type p |
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2009
Date p |
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they
are in clinical development, the vast majority of them look to be complementary.
And if I am correct in recalling that the program that you are speaking
about is geared to reducing or dealing with the pain of flares, and
so again we would think that would be probably complementary to KRYSTEXXA,
because if you recall in our clinical development, when a patient goes
on KRYSTEXXA therapy just as if they were going on allopurinol or Uloric,
you see an increase in flares in the first few months. And so again
we think, potentially another therapeutic approach might be excellent
here to reduce the flares in those early months.
<A Paul Hamelin>: Thank
you, Eun.
Operator: Well now take
a follow-up question from Carol Werther.
<Q Carol Werther>: Thank
you. I was just wondering, could you share with us how many patients
you think you will be able treat if and when you are approved in the
third quarter next year?
<A Paul Hamelin>: Carol,
we think the size of the market opportunity that reflects the patient
population that we studied is in the range of 100,000 to 170,000 patients.
Weve never specifically though identified or said, we think we
can treat x amount of those in x amount of time. So, really want to
refrain from trying to give any kind of market guidance or projections,
but just suffice to say that I think we are confident that the size
of the eligible population is just 100 to 170,000 patients and we believe
those would be ideal candidates over time for this drug.
<Q Carol Werther>: Okay,
thank you.
<A Paul Hamelin>: Thanks
Carol.
Operator: And there are no further
questions at this time. This concludes todays conference. We
do appreciate your participation.
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-----END PRIVACY-ENHANCED MESSAGE-----