Trius Therapeutics Reports Second Quarter 2013 Financial Results
06 Agosto 2013 - 10:00PM
Trius Therapeutics, Inc. (Nasdaq:TSRX), a biopharmaceutical company
focused on the discovery, development and commercialization of
innovative antibiotics for serious infections, announced today its
financial results for the second quarter ended June 30, 2013.
Recent Events
On July 30, 2013, Trius and Cubist Pharmaceuticals, Inc.
announced that they have entered into a merger agreement whereby
Cubist will acquire all outstanding shares of Trius for $13.50 per
share in cash upon the closing. In addition to the cash payment,
each Trius stockholder will receive one non-tradable Contingent
Value Right, or CVR, entitling the holder to receive an additional
cash payment of up to $2.00 per share if certain commercial sales
milestones are achieved. The total transaction is valued at up to
$818 million on a fully diluted basis. The transaction has been
approved by the Boards of Directors of both companies and it is
expected to close later this year, subject to required shareholder
and regulatory approvals as well as customary closing
conditions.
Second Quarter 2013 Financial Results
At June 30, 2013, Trius had cash, cash equivalents and
investments totaling $69.6 million. As of August 1, 2013, Trius had
48,268,557 shares outstanding.
For the second quarter of 2013, Trius reported a net loss of
$19.7 million versus a net loss of $14.4 million in the comparable
period in 2012. For the six months ended June 30, 2013, Trius
reported a net loss of $37.0 million compared to $22.0 million for
the same period in 2012. The increase in the net loss in the second
quarter of 2013 was primarily due to lower collaboration revenues
from our partnership with Bayer Pharma AG (Bayer) as well as from
our federal contracts. For the second quarter of 2013 and 2012,
Trius reported a net loss per share of $0.41 and $0.37,
respectively. For the six months ended June 30, 2013 and 2012,
Trius reported a net loss per share of $0.79 and $0.60,
respectively.
Revenues for the three months ended June 30, 2013 were $1.3
million compared to $6.2 million for the same period in 2012. In
the second quarter of 2012, the Company earned a $2.0 million
milestone payment from Bayer but received no similar payments in
the second quarter of 2013. For the six months ended June 30, 2013,
revenues were $3.0 million compared to $16.1 million for the same
period in 2012. The Company earned $7.0 million in milestone
payments from Bayer during the first half of 2012 but received no
similar payments in the current year. Federal contract revenues
also decreased from the prior year due to reduced government
funding for our research programs.
Research and development expenses for the three months ended
June 30, 2013 were $14.7 million compared to $16.4 million for the
same period in 2012. For the six months ended June 30, 2013 and
2012, research and development expenses were $27.2 million and
$33.2 million, respectively. The decrease in research and
development expenses was primarily the result of lower clinical and
development costs for tedizolid phosphate.
General and administrative expenses for the three months ended
June 30, 2013 increased to $5.5 million compared to $3.3 million
for the same period in 2012. For the six months ended June 30, 2013
and 2012, general and administrative expenses were $10.0 million
and $6.3 million, respectively. The increase in general and
administrative expenses was mostly due to an increase in commercial
launch planning activities for tedizolid phosphate.
Program Updates
Trius is preparing its New Drug Applications (NDA) for the oral
and intravenous dosage forms of tedizolid phosphate and plans to
submit them to the U.S. Food and Drug Administration (FDA) in the
second half of 2013.
Pending final agreement with regulatory authorities, Trius plans
to initiate a Phase 3 program for the treatment of pneumonia in the
second half of 2013 using the same 200 mg, once daily dose of
tedizolid phosphate tested to treat skin infections. In addition,
the Company is progressing with enabling studies for an
Investigational New Drug (IND) application for its Gyrase-B
development candidate with potent activity against Gram-negative
and Gram-positive bacterial pathogens. A Phase 1 clinical trial is
expected to start in 2014.
About Trius Therapeutics
Trius Therapeutics, Inc. is a biopharmaceutical company focused
on the discovery, development and commercialization of innovative
antibiotics for serious infections. The Company's lead
investigational drug, tedizolid phosphate, is a novel antibiotic
for the treatment of acute bacterial skin and skin structure
infections (ABSSSI) and serious Gram-positive infections, including
those caused by methicillin-resistant staphylococcus aureus (MRSA).
Trius has completed two Phase 3 ABSSSI trials for which it has
Special Protocol Assessments with the FDA and has partnered with
Bayer Pharma for the development and commercialization of tedizolid
phosphate outside of the U.S., Canada and the European Union. In
addition to the Company's tedizolid phosphate clinical program,
Trius has initiated IND-enabling studies for its Gyrase-B
development candidate with potent activity against Gram-negative
bacterial pathogens including multi-drug resistant strains of E.
coli, Klebsiella, Acinetobacter and Pseudomonas. For more
information, visit www.triusrx.com.
Forward-Looking Statements
Statements contained in this press release regarding matters
that are not historical facts are "forward-looking statements"
within the meaning of the Private Securities Litigation Reform Act
of 1995. Because such statements are subject to risks and
uncertainties, actual results may differ materially from those
expressed or implied by such forward-looking statements. Such
statements include, but are not limited to, statements regarding
Trius' proposed transaction with Cubist, the expected timeline for
completing the transaction, Trius' ability to successfully complete
its ongoing clinical trials and development programs, the timing of
Trius' NDA filings for tedizolid phosphate for the treatment of
ABSSSI, the timing of the initiation of a Phase 3 program for
tedizolid for the treatment of pneumonia and the timing of the
initiation of a Phase 1 clinical trial for Trius' Gyrase-B
development candidate. Risks that contribute to the uncertain
nature of the forward-looking statements include: the possibility
that certain conditions to the completion of the transaction,
including required regulatory approvals, between Trius and Cubist
are not satisfied, or that the transaction may otherwise not be
completed on a timely manner, or at all; the ability of Cubist to
successfully integrate Trius' operations and employees, and for
Trius and Cubist to otherwise realize the anticipated benefits of
the transaction; the accuracy of Trius' estimates regarding
expenses, future revenues and capital requirements; the success and
timing of Trius' preclinical studies and clinical trials;
regulatory developments in the United States and foreign countries;
changes in Trius' plans to develop and commercialize its product
candidates; Trius' ability to obtain additional financing; Trius'
ability to obtain and maintain intellectual property protection for
its product candidates; and the loss of key scientific or
management personnel. These and other risks and uncertainties are
described more fully in Trius' most recently filed SEC documents,
including its Form 10-K, Forms 10-Q and other documents filed with
the United States Securities and Exchange Commission, including
those factors discussed under the caption "Risk Factors" in such
filings. All forward-looking statements contained in this press
release speak only as of the date on which they were made. Trius
undertakes no obligation to update such statements to reflect
events that occur or circumstances that exist after the date on
which they were made.
|
Trius Therapeutics,
Inc. |
Statements of
Operations |
(In thousands except
per share data) |
|
|
Three Months Ended June
30, |
Six Months Ended June
30, |
|
2013 |
2012 |
2013 |
2012 |
|
(Unaudited) |
(Unaudited) |
Revenues: |
|
|
|
|
Contract research |
$ 261 |
$ 2,220 |
$ 790 |
$ 5,231 |
Collaboration and license fees |
1,030 |
4,004 |
2,228 |
10,825 |
|
|
|
|
|
Total revenues |
1,291 |
6,224 |
3,018 |
16,056 |
|
|
|
|
|
Operating expenses: |
|
|
|
|
Research and development |
14,683 |
16,379 |
27,228 |
33,225 |
General and administrative |
5,543 |
3,311 |
10,047 |
6,315 |
|
|
|
|
|
Total operating expenses |
20,226 |
19,690 |
37,275 |
39,540 |
|
|
|
|
|
Loss from operations |
(18,935) |
(13,466) |
(34,257) |
(23,484) |
|
|
|
|
|
Other income (expense): |
|
|
|
|
Interest income |
8 |
7 |
19 |
7 |
Fair value adjustment of common stock
warrant liability |
(757) |
(955) |
(2,726) |
1,462 |
Other income (expense) |
2 |
— |
2 |
(3) |
|
|
|
|
|
Total other income (expense) |
(747) |
(948) |
(2,705) |
1,466 |
|
|
|
|
|
Net loss |
$ (19,682) |
$ (14,414) |
$ (36,962) |
$ (22,018) |
|
|
|
|
|
Net loss per share, basic and diluted |
$ (0.41) |
$ (0.37) |
$ (0.79) |
$ (0.60) |
Weighted-average shares outstanding, basic
and diluted |
47,948 |
38,715 |
46,990 |
36,955 |
|
|
Trius Therapeutics,
Inc. |
Balance
Sheets |
(In thousands except
share data) |
|
|
June 30, 2013
|
December 31,
2012 |
|
(Unaudited) |
|
Assets |
|
|
Current assets: |
|
|
Cash and cash equivalents |
$ 15,316 |
$ 16,370 |
Short-term investments,
available-for-sale |
54,256 |
49,659 |
Accounts receivable |
1,918 |
5,698 |
Prepaid expenses and other current
assets |
1,429 |
2,254 |
Total current assets |
72,919 |
73,981 |
Property and equipment, net |
836 |
990 |
Restricted cash |
151 |
151 |
Other assets |
149 |
152 |
Total assets |
$ 74,055 |
$ 75,274 |
|
|
|
Liabilities and stockholders'
equity |
|
|
Current liabilities: |
|
|
Accounts payable |
$ 5,420 |
$ 6,761 |
Accrued liabilities |
7,358 |
7,762 |
Common stock warrant liability |
6,574 |
3,848 |
Current portion of deferred revenue |
23 |
116 |
Total liabilities |
19,375 |
18,487 |
|
|
|
Stockholders' equity: |
|
|
Preferred stock, $0.0001 par value;
10,000,000 shares authorized at June 30, 2013 and December 31,
2012; no shares issued and outstanding at June 30, 2013 and
December 31, 2012 |
— |
— |
Common stock, $0.0001 par value;
200,000,000 shares authorized at June 30, 2013 and December 31,
2012; 48,047,472 and 40,661,360 shares issued and outstanding at
June 30, 2013 and December 31, 2012, respectively |
6 |
5 |
Additional paid-in capital |
240,950 |
206,093 |
Accumulated other comprehensive
income |
6 |
9 |
Accumulated deficit |
(186,282) |
(149,320) |
Total stockholders' equity |
54,680 |
56,787 |
Total liabilities and stockholders'
equity |
$ 74,055 |
$ 75,274 |
CONTACT: Public Relations Contact:
Laura Kempke at MSLGROUP
trius@mslgroup.com
781-684-0770
Investor Relations Contact:
Stefan Loren at Westwicke Partners, LLC
sloren@westwicke.com
443-213-0507
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