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CRANBURY, NJ -- (MARKET WIRE) -- 02/22/07 -- Valera Pharmaceuticals (NASDAQ: VLRX), a
specialty pharmaceutical company focused on the development, acquisition
and commercialization of products for the urology and endocrinology
markets, today announced financial results for the three months and full
year ended December 31, 2006.
Valera also noted product milestones and other key events which occurred
since the Company's last earnings report, including:
-- Initiation of Phase I/II studies for its naltrexone implant for drug
addiction
-- The start of an expanded study for its biodegradable ureteral stent
-- Partnership with Indevus Pharmaceuticals for the co-promotion of
VANTAS®, Valera's twelve month LHRH implant for prostate cancer
-- Proposed acquisition of Valera by Indevus in a tax-free stock-for-
stock merger transaction, anticipated to close in April 2007
Fourth Quarter and Full Year 2006 Financial Results
Net product sales of VANTAS during the fourth quarter of 2006 were
approximately $3.2 million, primarily representing 2,324 units sold in the
United States at an average net selling price of $1,370. This compares to
fourth quarter 2005 net sales of approximately $5.2 million, based on 2,868
units sold at an average net selling price of $1,801. This decline in
product sales in the fourth quarter of 2006 compared to the fourth quarter
of 2005 reflects, in part, pricing pressure for the class of LHRH drugs,
exacerbated by changes in Medicare reimbursement rates, including certain
Medicare carriers adopting a policy that segregates twelve-month products
from other dosages, including one, three, four and six month injectable
products, and reimbursing the injectables at higher annual rates.
Valera noted that fourth-quarter 2006 net product sales of approximately
$3.2 million represented a sequential improvement of 10% from approximately
$2.9 million in the third quarter of 2006. Correspondingly, U.S. VANTAS
sales of 2,324 units in the fourth quarter of 2006 were up 18% from 1,968
units sold in the third quarter of 2006, offset by a 7% decline in average
unit selling price, respectively, to $1,370 from $1,478. As previously
reported, Valera believes that units shipped in the third quarter of 2006
had been adversely impacted by a loss in re-implantation procedures in that
quarter due to the interruption in VANTAS shipments in the third quarter of
2005.
Also, in keeping with Valera's previously noted commitment to pursue
options to mitigate the impact of the Medicare pricing environment, during
the fourth quarter of 2006 the Company continued to shift more of its sales
resources to attempt to capture non-Medicare market share. While still in
its early stages, Valera believes that this strategy will open greater
opportunities to leverage the advantages of its twelve month VANTAS
implant, including the convenience and efficiency for physicians in
administering to the needs of their patients. In order to broaden the
market penetration of VANTAS, on December 12, 2006 Valera entered into a
co-promotion agreement with Indevus Pharmaceuticals (NASDAQ: IDEV) under
which Indevus' sales force began co-promoting VANTAS in the United States
in
mid-January 2007. Indevus and Valera also agreed to the acquisition of
Valera by Indevus in a tax-free stock-for-stock merger, subject to approval
of each company's shareholders and other customary closing conditions.
Correspondingly, 2006 financial results reported by Valera include
approximately $0.8 million in merger related costs, primarily reflected in
fourth quarter G&A expenses.
Net product sales for the years ended December 31, 2006 and 2005 were
approximately $17.8 million and $26.8 million, respectively. The 33%
decrease in net product sales was primarily due to lower net average
selling prices due to decreased Medicare reimbursement rates of VANTAS as
well as increased competition around pricing in the class of LHRH drugs.
For the year ended December 31, 2006, Valera sold 11,663 units of VANTAS in
the United States at a net average selling price of $1,526 per unit as
compared to 11,514 units at a net average selling price of $2,327 for the
year ended December 31, 2005. Also, in 2006, as a result of pre-launch
shipments of VANTAS for Canada, Valera sold a total 169 units to Paladin
Labs, its marketing partner in Canada. Thus, worldwide unit sales of
VANTAS increased by 3%, or 318 units, for the year ended December 31, 2006,
as compared to the year ended December 31, 2005.
As of December 31, 2006, cash and cash equivalents were approximately $14.1
million, as compared to $2.3 million at December 31, 2005. The net
increase was primarily due to the proceeds Valera received from the initial
public offering of common stock in February 2006.
Milestones and Key Events
Naltrexone Implant: During the fourth quarter of 2006, the Food and Drug
Administration (FDA) accepted Valera's Investigational New Drug Application
and Valera finalized all administrative arrangements with Johns Hopkins
necessary to begin clinical studies for VP004, a subcutaneous implant
utilizing Valera's Hydron technology to deliver naltrexone, over an
extended period of time, for the treatment of opioid addiction. This Phase
I/II clinical trial involves an open label study of the naltrexone implant
in approximately a dozen healthy volunteers with a history of opioid abuse.
The primary objective of the study is to investigate the extent of opiate
blockade following morphine challenges. The lead investigator is the
pioneering addiction researcher and renowned authority on naltrexone,
Donald Jasinski, M.D., Professor of Medicine, Chief Center for Chemical
Dependence, Johns Hopkins Bayview Medical Center.
Ureteral Stent: On November 8, 2006, Valera announced that it completed
proof-of-concept studies on a flexible, biodegradable polymer-based
ureteral stent. The Company has since advanced this development program in
a large porcine model study to establish safety and effectiveness necessary
to support the submission of a 510k device application with the FDA.
Valera believes that the successful development a pliable, biodegradable
ureteral stent, which could be voided naturally from the body with the
discharge of urine, potentially represents a significant advance over
existing plastic and metallic ureteral stents which are non-degradable and
require physician intervention to extract from the body. Valera further
noted that, pending the outcome of the study, the 510k submission could
occur by the end of 2007.
Indevus Pharmaceuticals: In December 2006, Indevus and Valera entered into
to a co-promotion agreement for VANTAS in the United States. Effective
January 15, 2007 the number of sales professionals essentially quadrupled
to approximately 105 representatives to promote and support future growth
opportunities for VANTAS. Additionally, the co-promotion agreement
provides Valera with the option to elect to enter into negotiations with
Indevus to grant Indevus a co-exclusive right to co-promote
SUPPRELIN®-LA. Separately, Valera announced in December 2006 that it
entered into a merger agreement with Indevus pursuant to which Indevus will
acquire Valera in a tax-free stock-for-stock merger transaction. In a
joint press release on December 12, 2006, David S. Tierney, M.D., President
and CEO of Valera, commented on the merger agreement, noting, "As we
entered into discussion for a co-promotional arrangement with Indevus, it
became apparent that our product offerings, the patient and physician
benefits, and the potential for shareholder returns would be enhanced by
leveraging the strengths of the combined companies." Additional
information on the proposed merger of Indevus and Valera is provided below.
About Valera Pharmaceuticals
Valera Pharmaceuticals is a specialty pharmaceutical company focused on
developing, acquiring, and commercializing products to treat urology and
endocrinology diseases and disorders. Utilizing its innovative Hydron
technology, Valera is developing soft, compact and flexible hydrogel-based
implants which can be designed to release therapeutic agents at a
controlled rate for up to twelve months. VANTAS®, a patent protected
once-per-year implant currently marketed by Valera for the palliative
treatment of advanced prostate cancer, employs this drug delivery
technology. A second product, SUPPRELIN®-LA is a twelve-month implant
currently under review by the FDA for the treatment of central precocious
puberty. Additional information about Valera Pharmaceuticals is available
at: http://www.valerapharma.com.
Proposed Indevus-Valera Merger
On December 12, 2006, Indevus Pharmaceuticals (NASDAQ: IDEV) and Valera
jointly announced that they have entered into a definitive agreement under
which Indevus will acquire Valera in a stock transaction valued at
approximately $120 million. The merger has been approved by the boards of
directors of both companies and is expected to be completed on or around
April 30, 2007. Closing of the merger is subject to approval of Valera's
stockholders, approval of Indevus' stockholders, and other customary
closing conditions.
Additional Merger Information and Where to Find It
In connection with the merger between Valera and Indevus, Indevus filed a
registration statement on Form S-4 with the SEC on January 29, 2007,
containing a preliminary joint proxy statement/prospectus and other
relevant materials. The information in such preliminary joint proxy
statement/prospectus is not complete and may be changed. Such preliminary
joint proxy statement/prospectus is not an offer to sell and is not
soliciting an offer to buy these securities in any jurisdiction where the
offer or sale is not permitted. The final joint proxy statement/prospectus
will be mailed to the stockholders of Valera and Indevus. INVESTORS AND
SECURITY HOLDERS OF VALERA AND INDEVUS ARE URGED TO READ THE FINAL JOINT
PROXY STATEMENT/PROSPECTUS AND THE OTHER RELEVANT MATERIALS WHEN THEY
BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT
VALERA, INDEVUS AND THE MERGER. The registration statement and joint proxy
statement/prospectus and other relevant materials (when they become
available), and any other documents filed by Valera or Indevus with the
SEC, may be obtained free of charge at the SEC's web site at www.sec.gov.
In addition, investors and security holders may obtain free copies of the
documents (when they are available) filed with the SEC by Valera by
contacting Valera Pharmaceuticals, Inc., 7 Clarke Drive, Cranbury, NJ 08512
Attn: Investor Relations. Investors and security holders may obtain free
copies of the documents filed with the SEC by Indevus by directing a
request to: Indevus Pharmaceuticals, Inc., 33 Hayden Avenue, Lexington, MA
02421-7966, Attn: Investor Relations.
Participants in the Merger Solicitation
Valera, Indevus and their respective executive officers and directors may
be deemed to be participants in the solicitation of proxies from the
stockholders of Valera and Indevus in favor of the merger. Information
regarding Valera's directors and executive officers and their ownership of
Valera common stock is set forth in Valera's Annual Report on Form 10-K for
the year ended December 31, 2006, which is being filed with the SEC on or
about February 22, 2007. Information about the executive officers and
directors of Indevus and their ownership of Indevus common stock is set
forth in Indevus' Annual Report on Form 10-K for the year ended
September 30, 2006, which was filed with the SEC on December 7, 2006, as
amended by the Annual Report on Form 10-K/A filed with the SEC on January
26, 2007, and the preliminary proxy statement for Indevus' 2007 Annual
Meeting of Stockholders, which was filed with the SEC on January 29, 2007.
Investors and security holders may obtain more detailed information
regarding the direct and indirect interests of Valera, Indevus and their
respective executive officers and directors in the merger by reading the
joint proxy statement/prospectus regarding the merger when it becomes
available.
This press release contains forward-looking statements that are not
historical facts but rather are based on current expectations, estimates
and projections about Valera's industry, beliefs and assumptions. Words
such as "anticipates," "expects," "intends," "plans," "believes," "seeks"
and "estimates," and variations of these words and similar expressions, are
intended to identify forward-looking statements. These statements are not
guarantees of future performance and are subject to risks, uncertainties
and other factors, some of which are beyond Valera's control, are difficult
to predict and could cause actual results to differ materially from those
expressed, implied or forecasted in the forward-looking statements. In
addition, the forward-looking events discussed in this press release might
not occur. These risks and uncertainties include, among others, those
described in "Risk Factors'' contained in Valera's Form 10-K which is being
filed with the SEC on or about February 22, 2007, and as may be further
updated from time to time, as well as Form S-4 filed by Indevus with
respect to the proposed merger discussed above. You are cautioned not to
place undue reliance on these forward-looking statements. You should read
Valera's filings with the SEC, including Forms 10-K and 10-Q, the documents
that Valera refers to therein and have filed as exhibits, and the Form S-4
filed by Indevus with respect to the proposed merger with the understanding
that actual future results and events may be materially different from what
Valera currently expects. The forward-looking statements included in this
press release reflect Valera's views and assumptions only as of the date of
this press release. Except as required by law, Valera undertakes no
obligation to update any forward-looking statement, whether as a result of
new information, future events, or otherwise.
VALERA PHARMACEUTICALS, INC
STATEMENTS OF OPERATIONS
(in thousands, except per share amounts)
Three months ended Year ended
December 31, December 31,
-------------------- --------------------
2006 2005 2006 2005
--------- --------- --------- ---------
Net product sales $ 3,196 $ 5,166 $ 17,845 $ 26,798
Licensing revenue 5 7 121 34
--------- --------- --------- ---------
Total net revenue 3,201 5,173 17,966 26,832
Operating costs and expenses:
Cost of product sales 1,110 1,183 5,107 5,966
Research and development 1,860 1,519 7,574 5,930
Selling and marketing 2,434 2,523 12,139 10,754
General and administrative 2,556 1,371 8,154 5,500
Amortization of intangible
assets 27 - 79 -
--------- --------- --------- ---------
Total operating costs and
expenses 7,987 6,596 33,053 28,150
--------- --------- --------- ---------
Loss from operations (4,786) (1,423) (15,087) 1,318
--------- --------- --------- ---------
Interest income 193 21 967 70
Interest expense 1 (18) (26) (21)
--------- --------- --------- ---------
Loss before income taxes (4,592) (1,420) (14,146) (1,269)
(Benefit from) provision for
income taxes (191) 75 (207) 75
--------- --------- --------- ---------
Net loss $ (4,401) $ (1,495) $ (13,939) $ (1,344)
========= ========= ========= =========
Basic and diluted net loss per
share $ (0.29) $ (0.90) $ (1.03) $ (0.81)
Basic and diluted weighted
average number of shares
outstanding 14,935 1,667 13,580 1,667
Proforma basic and diluted net
loss per share $ (0.29) $ (0.14) $ (0.96) $ (0.13)
Proforma basic and diluted
weighted average number of
shares outstanding 14,935 10,855 14,547 10,590
Note: Proforma weighted average shares assumes conversion of preferred
shares into common shares as of the beginning of each period.
VALERA PHARMACEUTICALS, INC
BALANCE SHEETS
(in thousands, except par value)
December 31, December 31,
2006 2005
------------ ------------
ASSETS
Current assets:
Cash and cash equivalents $ 14,069 $ 2,340
Accounts receivable, net of allowances of
$257 and $385 at December 31, 2006 and 2005,
respectively 2,661 4,488
Inventories, net 5,911 3,191
Prepaid and other current assets 877 726
------------ ------------
Total current assets 23,518 10,745
Property, plant and equipment, net 7,849 4,194
Deferred offering costs 1,378
Intangible assets, net of accumulated
amortization of $79 at December 31, 2006 446 -
Other non current assets 152 215
------------ ------------
Total assets $ 31,965 $ 16,532
============ ============
LIABILITIES AND SHAREHOLDERS EQUITY (DEFICIT)
Current liabilities:
Accounts payable $ 2,594 $ 1,421
Accrued liabilities 3,318 4,607
Note payable - 1,525
Deferred revenue - current - 329
Capital lease obligations - current 9 18
------------ ------------
Total current liabilities 5,921 7,900
Capital lease obligations - long term 13 -
Deferred revenue - long term 300 300
Commitments and contingent liabilities
Series A 6% Cumulative Convertible Preferred
Stock, $0.001 par value; 0 and 7,000 shares
issued and outstanding; liquidation preference
- $0 and $7,598 at December 31, 2006 and
December 31, 2005, respectively - 13,604
Series B 10% Cumulative Convertible Preferred
Stock, $0.001 par value; 0 and 22,069 shares
issued and outstanding; liquidation
preference - $0 and $20,221 at December 31, 2006
and 2005, respectively - 15,082
Series C 6% Cumulative Convertible Preferred
Stock, $0.001 par value; 0 and 11,600 shares
issued and outstanding; liquidation preference
- $0 and $12,590 at December 31, 2006 and
2005, respectively - 11,239
Shareholders equity (deficit):
Common stock, $0.001 par value; 30,000
authorized, 14,937 and 1,667 shares issued
and outstanding at December 31, 2006 and
2005, respectively 15 2
Additional paid-in-capital 79,316 8,696
Deferred stock-based compensation - (630)
Accumulated deficit (53,600) (39,661)
------------ ------------
Total shareholders equity (deficit) 25,731 (31,593)
------------ ------------
Total liabilities and shareholders equity
(deficit) $ 31,965 $ 16,532
============ ============
Contact at Valera Pharmaceuticals
Stuart Z. Levine, Ph.D.
Director, Investor Relations
609-409-9010 Ext. 3202 Email Contact