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Trius Therapeutics Reports 2012 Fourth Quarter and Full Year 2012 Financial Results



Trius Therapeutics Reports 2012 Fourth Quarter and Full Year 2012 Financial
Results

SAN DIEGO, March 12, 2013 (GLOBE NEWSWIRE) -- 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 fourth quarter and
year ended December 31, 2012.

"As we approach the announcement of our Phase 3 top line data from the
ESTABLISH 2 study near the end of this quarter, and subsequent NDA filing
later this year, we are pleased to report our financial performance for 2012,"
said Jeffrey Stein, Ph.D., President and Chief Executive Officer at Trius.

At December 31, 2012, Trius had cash, cash equivalents and investments
totaling $66.0 million. In January 2013, Trius raised an additional $31.6
million in net proceeds in a follow-on public offering.

For the fourth quarter of 2012, Trius reported a net loss of $14.2 million
versus a net loss of $12.5 million in the comparable period in 2011. For the
year ended December 31, 2012, Trius reported a net loss of $53.9 million
compared to $18.3 million for the same period in 2011. The net loss during the
three months and year ended December 31, 2012 was largely due to clinical and
nonclinical development activities for tedizolid phosphate, our lead
investigational drug in Phase 3 clinical development. For the fourth quarter
of 2012, Trius reported a net loss per share of $0.36 versus $0.44 in the
fourth quarter of 2011. For the year ended December 31, 2012 and 2011, Trius
reported a net loss per share of $1.42 and $0.69, respectively. The increase
in the net loss was primarily due to the fact that the Company received an
upfront payment of $25.0 million in the prior year upon entering into a
collaboration and license agreement with Bayer Pharma AG (Bayer), but received
no similar payments in the current year. Aside from this one-time payment, the
increase in the net loss for both the three months and year ended December 31,
2012 was largely due to higher clinical and nonclinical development expenses
for tedizolid phosphate.

Revenues for the three months ended December 31, 2012 were $5.2 million
compared to $5.0 million for the same period in 2011. For the year ended
December 31, 2012, revenues were $27.2 million compared to $41.0 million for
the same period in 2011. The decrease in revenues during the year ended
December 31, 2012 was due to the $25.0 million upfront payment received from
Bayer in 2011. Excluding this one-time payment, revenues for the year ended
December 31, 2012 increased $11.2 million primarily due to sponsored
development activities and milestone payments from our collaboration with
Bayer.

Research and development expenses for the three months ended December 31, 2012
were $16.5 million compared to $13.8 million for the same period in 2011. For
the year ended December 31, 2012 and 2011, research and development expenses
were $69.0 million and $49.5 million, respectively. The increase in research
and development expenses was primarily related to higher clinical trial and
development costs for tedizolid phosphate.

General and administrative expenses for the three months ended December 31,
2012 increased to $4.7 million compared to $2.8 million for the same period in
2011. For the years ended December 31, 2012 and 2011, general and
administrative expenses were $15.4 million and $11.3 million, respectively.
The increase in general and administrative expenses was primarily due to an
increase in commercial planning activities in 2012.

As of March 1, 2013, Trius had 47,854,151 shares outstanding.

Program Updates & Upcoming Events

In December 2012, Trius completed enrollment of its ESTABLISH 2 study, the
second Phase 3 trial in acute bacterial skin and skin structure infections, or
ABSSSI. The study remains on track to report top line data near the end of the
first quarter in 2013. In 2012 and early 2013, Trius also completed additional
clinical trials needed to support its planned New Drug Application (NDA)
filing. If the ESTABLISH 2 study endpoints are met, Trius plans to file its
NDA during the second half of 2013.

Pending 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 that is currently being
tested to treat skin infections. In addition, the Company is progressing with
enabling studies for its Investigational New Drug (IND) 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 new, novel antibiotic in Phase 3 clinical development for the
treatment of ABSSSI and serious Gram-positive infections, including those
caused by methicillin-resistant staphylococcus aureus (MRSA). Trius has two
Special Protocol Assessments with the FDA for its two Phase 3 ABSSSI trials
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' ability to
successfully complete its ongoing clinical trials and development programs,
the timing of reporting top line data for the ESTABLISH 2 study, the timing of
Trius' NDA filing, the timing of the initiation of a Phase 3 program 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 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     Year Ended
                                December 31,           December 31,  
                                2012       2011        2012        2011  
                                (Unaudited)            (Unaudited)
Revenues:                                                           
Collaboration and license fees  $ 4,131    $ 1,484     $ 18,659    $ 28,925 
Contract research                1,025      3,517       8,526       12,086 
                                                                    
Total revenues                   5,156      5,001       27,185      41,011 
                                                                    
Operating expenses:                                                 
Research and development         16,466     13,782      69,023      49,503 
General and administrative       4,653      2,788       15,395      11,339 
                                                                    
Total operating expenses         21,119     16,570      84,418      60,842 
                                                                    
Loss from operations            (15,963)    (11,569 )   (57,233 )   (19,831 )
                                                                    
Other income (expense):                                             
Interest income                  13         3           33          21 
Fair value adjustment of stock   1,723      (946 )      3,276       1,558 
warrant liability
Other income (expense)           (1)         1          (4)         2 
                                                                    
Total other income (expense)     1,735      (942 )      3,305       1,581
                                                                    
Net loss                        $ (14,228) $ (12,511 ) $ (53,928 ) $ (18,250 )
Net loss per share, basic and   $ (0.36)   $ (0.44 )   $ (1.42 )   $ (0.69 )
diluted
Weighted-average shares          39,618     28,597      38,083      26,517 
outstanding, basic and diluted

 
 
 
Trius Therapeutics, Inc.
 
Balance Sheets
(In thousands except share and per share data)
                                                                   
                                                     December 31, December 31,
                                                     2012         2011  
                                                     (unaudited)   
Assets                                                             
Current assets:                                                    
Cash and cash equivalents                            $ 16,370     $ 11,381
Short-term investments, available-for-sale            49,659       47,762
Accounts receivable                                   5,698        4,272
Prepaid expenses and other current assets             2,254        3,272
Total current assets                                  73,981       66,687
Property and equipment, net                           990          1,037
Restricted cash                                      151           150
Other assets                                          152          251
Total assets                                         $ 75,274     $ 68,125
                                                                   
Liabilities and stockholders' equity                               
Current liabilities:                                               
Accounts payable                                     $ 6,761      $ 3,774
Accrued liabilities                                   7,762        6,959
Common stock warrant liability                       3,848         7,124
Current portion of deferred revenue                   116          377
Total liabilities                                     18,487       18,234
                                                                   
Stockholders' equity:                                              
Preferred stock, $0.0001 par value; 10,000,000
shares authorized at December 31, 2012 and December   —            —
31, 2011; no shares issued and outstanding at
December 31, 2012 and December 31, 2011
Common stock, $0.0001 par value; 200,000,000 shares
authorized at December 31, 2012 and December 31,
2011; 40,661,360 and 28,663,548 shares issued and     5            4
outstanding at December 31, 2012 and December 31,
2011, respectively
Additional paid-in capital                            206,093      145,272
Accumulated other comprehensive income                9            7
Accumulated deficit                                  (149,320)     (95,392)
Total stockholders' equity                            56,787       49,891
Total liabilities and stockholders' equity           $ 75,274     $ 68,125

CONTACT: Public Relations Contact:
         Laura Kempke/Andrew Law 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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