Tercica (MM) (NASDAQ:TRCA)
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Tercica, Inc. (Nasdaq: TRCA) today announced financial results for the
quarter ended June 30, 2008. Net product sales totaled $6.2 million,
compared to $2.0 million in the second quarter of 2007. Net product
sales for Increlex®
and Somatuline® Depot
in the second quarter of 2008 were $4.6 million and $1.6 million,
respectively.
Net loss for the second quarter of 2008 was $11.4 million, or $0.22 per
share, compared to a net loss of $12.8 million, or $0.26 per share, for
the second quarter of 2007.
Cash, cash equivalents and short-term investments as of June 30, 2008
were $71.4 million, compared to $94.9 million as of March 31, 2008.
Company Updates
Agreement and Plan of Merger with Ipsen.
On June 4, 2008, Tercica announced that Tercica and an affiliate of
Ipsen, S.A. entered into an agreement and plan of merger by which an
affiliate of Ipsen would acquire all of the shares of Tercica common
stock that Ipsen does not currently own at a price of $9.00 per share
in cash.
On July 24, 2008, Tercica announced the expiration of the waiting
period under the Hart-Scott-Rodino Antitrust Improvements Act and
clearance by the German antitrust regulatory authority in connection
with the agreement and plan of merger. Assuming satisfaction of the
closing conditions in the agreement and plan of merger, including
stockholder approval, Tercica estimates that the completion of the
merger transaction should take effect late in the third quarter or
early in the fourth quarter of 2008.
On July 24, 2008, Tercica also announced that Ipsen exercised in full
the warrant issued by Tercica in October 2006, converted in full three
convertible notes issued by Tercica in October 2006 and September
2007, and purchased 410,831 additional shares of the common stock of
Tercica upon exercise of its pro rata rights to purchase shares in
connection with other equity issuances by Tercica. Total cash proceeds
from the warrant exercise and purchase of additional shares by Ipsen
were $40.3 million.
Somatuline®
Depot
In a meeting on July 15, 2008 with the Food and Drug Administration
(FDA), Tercica discussed the development program for Somatuline®
Depot in the treatment of carcinoid syndrome, caused by certain
neuroendocrine tumors (NET). Based on the outcome of this meeting,
Tercica plans to initiate a Phase III clinical trial in this
indication in the U.S. by the end of 2008. Based on Tercica’s
most recent assessment, Tercica believes that the market for
somatostatin analogues in this indication is significantly larger than
that for acromegaly.
Increlex®
In a meeting on July 30, 2008 with the FDA, preliminary data from MS
301, a Phase IIIb study evaluating the use of Increlex®
in patients with Primary IGFD, a less severe and more prevalent form
of IGFD, was discussed. These preliminary data suggest that the study
will meet its primary endpoint of statistically significant increase
in first-year height velocity compared to the observation-only group.
Furthermore, no new safety issues were identified in this study.
For approval in this expanded indication, the FDA has requested
additional long-term clinical data. Based on the FDA’s
request, Tercica plans to review the regulatory strategy for Primary
IGFD.
These FDA discussions and Tercica’s plan to
review the regulatory strategy for Primary IGFD do not have any impact
on the proposed merger transaction with Ipsen.
About Tercica
Tercica is a biopharmaceutical company committed to improving endocrine
health by partnering with the endocrine community to develop and
commercialize new therapeutics for short stature and other metabolic
disorders. For further information on Tercica, please visit www.tercica.com.
Safe Harbor Statement
Except for the historical statements contained herein, this press
release contains forward-looking statements concerning Tercica's
prospects and results, including that: (A) Tercica estimates that
completion of the transaction contemplated by the agreement and plan of
merger with an affiliate of Ipsen should take effect late in the third
quarter or early in the fourth quarter of 2008; (B) the MS 301 study
will meet its primary endpoint of statistically significant increase in
first-year height velocity compared to the observation-only group; (C)
Tercica expects to initiate a Phase III clinical trial of Somatuline®
Depot for the treatment of carcinoid syndrome caused by certain
neuroendocrine tumors by the end of 2008; and (D) Tercica believes that
the market for somatostatin analogues in the treatment of carcinoid
syndrome caused by certain neuroendocrine tumors is significantly larger
than that for acromegaly. Because Tercica's forward-looking statements
are subject to risks and uncertainties, there are important factors that
could cause actual results to differ materially from those in the
forward-looking statements. These factors include, without limitation,
risks and uncertainties related to the following: (i) regarding (A)
above, the transactions contemplated by the agreement and plan of merger
with an affiliate of Ipsen may not be consummated as the transaction is
subject to certain closing conditions, the closing of the transaction
may be delayed and the expected benefits of the transaction may not be
realized; (ii) regarding (B) above, the risks and uncertainty of any
clinical trial, including unexpected final results that may not be
consistent with the preliminary results of the trial; (iii) regarding
(C) above, Tercica may have protocol or other technical and
non-technical issues preventing or delaying the commencement of the
trial; (iv) regarding (D) above, Tercica’s
assessment of the market for somatostatin analogues in the treatment of
carcinoid syndrome caused by certain neuroendocrine tumors may be
incorrect and may be significantly less than Tercica expects; and (v)
the risks and uncertainties disclosed from time to time in reports filed
by Tercica with the Securities and Exchange Commission (SEC), including
most recently Tercica's Form 10-Q for the quarter ending March 31, 2008
filed with the SEC on May 12, 2008. Tercica disclaims any obligation or
undertaking to update or revise any forward-looking statements contained
in this press release.
Additional Information about the Proposed Merger Transaction and
Where You Can Find It
Tercica has filed a preliminary proxy statement with the SEC relating to
a solicitation of proxies from its stockholders in connection with a
special meeting of stockholders of Tercica to be held for the purpose of
voting on the adoption of the agreement and plan of merger with an
affiliate of Ipsen relating to the proposed merger transaction. Tercica
and Beaufour Ipsen Pharma also filed a transaction statement on Schedule
13E-3 with the SEC relating to the transactions contemplated by the
agreement and plan of merger. BEFORE MAKING ANY VOTING DECISION WITH
RESPECT TO THE PROPOSED TRANSACTION, SECURITY HOLDERS ARE URGED TO READ
THE DEFINITIVE PROXY STATEMENT, TRANSACTION STATEMENT ON SCHEDULE 13E-3
AND OTHER RELEVANT MATERIALS WHEN THEY BECOME AVAILABLE BECAUSE THEY
WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION. The
preliminary and definitive proxy statement, transaction statement on
Schedule 13E-3 and other relevant materials, and any other documents
filed by Tercica with the SEC, may be obtained free of charge at the
SEC's website at www.sec.gov. In
addition, stockholders of Tercica may obtain free copies of the
documents filed with the SEC by contacting Tercica's Investor Relations
department at (650) 624-4992 or Investor Relations, Tercica, Inc., 2000
Sierra Point Parkway, Suite 400, Brisbane, California 94005. You may
also read and copy any reports, statements and other information filed
by Tercica with the SEC at the SEC public reference room at 100 F
Street, NE, Room 1580, Washington, D.C. 20549. Please call the SEC at
1-800-SEC-0330 or visit the SEC's website for further information on its
public reference room.
Tercica and its executive officers and directors may be deemed to be
participants in the solicitation of proxies from the stockholders of
Tercica in favor of the transactions contemplated by the agreement and
plan of merger. A list of the names of Tercica's executive officers and
directors, a description of their respective interests in Tercica, and
any additional benefits they will receive in connection with the
proposed merger transaction are set forth in the preliminary proxy
statement filed in connection with the special meeting of stockholders
of Tercica to be held for the purpose of voting on the adoption of the
agreement and plan of merger, and in any documents subsequently filed by
its directors and executive officers under the Securities and Exchange
Act of 1934, as amended.
If and to the extent that executive officers or directors of Tercica
will receive any additional benefits in connection with the transactions
contemplated by the agreement and plan of merger that are unknown as of
the date of this filing, the details of such benefits will be described
in the definitive proxy statement, and security holders may obtain
additional information regarding the interests of Tercica's executive
officers and directors in the proposed merger transaction by reading the
preliminary proxy statement.
TERCICA, INC.
(In thousands, except per share data)
(Unaudited)
Statements of Operations
Three Months EndedJune 30,
Six Months Ended June 30,
2008
2007
2008
2007
Net revenues
Net product sales
$
6,214
$
2,048
$
10,562
$
3,139
License revenue
194
194
388
388
Royalty revenue
104
—
169
—
Total net revenues
6,512
2,242
11,119
3,527
Costs and expenses:
Cost of sales(a)
3,565
1,131
6,706
1,632
Manufacturing start-up costs(a)
1,749
742
3,293
840
Research and development(a)
5,403
4,101
11,512
9,013
Selling, general and administrative(a)
15,514
10,282
27,889
19,833
Amortization of intangibles
703
—
1,405
—
Total costs and expenses
26,934
16,256
50,805
31,318
Operating loss
(20,422
)
(14,014
)
(39,686
)
(27,791
)
Interest expense
1,331
190
2,596
378
Other income (expense)
9,743
—
11,700
—
Interest and other income, net
609
1,397
1,716
2,968
Provision for income taxes
5
—
10
—
Net loss
$
(11,406
)
$
(12,807
)
$
(28,876
)
$
(25,201
)
Basic and diluted net loss per share
$
(0.22
)
$
(0.26
)
$
(0.56
)
$
(0.50
)
Shares used to compute basic and diluted net loss per share
51,624
50,178
51,597
50,161
(a) Includes non-cash stock-based compensation expense as follows:
Cost of sales
$
32
$
—
$
66
$
—
Manufacturing start-up costs
38
—
66
—
Research and development
388
525
745
1,049
Selling, general and administrative
1,119
1,110
2,168
2,087
Total
$
1,577
$
1,635
$
3,045
$
3,136
June 30,
December 31,
2008
2007
Balance Sheet Data
Cash, cash equivalents and short-term investments
$
71,416
$
113,485
Restricted short-term investments
540
440
Total assets
146,872
176,683
Total liabilities
108,781
113,524
Total stockholders’ equity
38,091
63,159