Hyperion Therapeutics Announces First Quarter 2013 Operating Results

Hyperion Therapeutics Announces First Quarter 2013 Operating Results

      First Net Sales of RAVICTI Post-approval Reported at $0.8 Million
                    Strong Cash Position of $102.7 million

SOUTH SAN FRANCISCO, Calif., May 9, 2013 (GLOBE NEWSWIRE) -- Hyperion
Therapeutics, Inc. (Nasdaq:HPTX) today reported the first commercial net sales
of RAVICTI™ (glycerol phenylbutyrate) Oral Liquid as part of its financial
operating results for the first quarter ended March 31, 2013.

Recent highlights:

  *RAVICTI received approval from the U.S. Food and Drug Administration (FDA)
    for treatment of Urea Cycle Disorders
  *Completed a follow-on public offering with net proceeds of $63.7 million
  *Received a key patent from the U.S. Patent Trademark Office for fasting
    ammonia that extends through 2032
  *Exercised the option to purchase both BUPHENYL® and AMMONUL®
  *Received Orphan Drug Exclusivity for RAVICTI from the FDA

"The February approval of our first product, RAVICTI, was a significant
milestone for Hyperion Therapeutics and we are proud to bring this important
new drug to the UCD community," said Donald J. Santel, president and chief
executive officer of Hyperion Therapeutics, Inc. "We believe our launch one
month earlier than anticipated reflects our commercial preparedness and our
commitment to provide RAVICTI to patients. We were also able to effectively
establish our specialty distribution model which provides important services
not previously offered to the UCD community, including our patient assistance
program. We've made good progress in providing Ravicti to patients thanks to
effective communication with payers, and we are clearly off to an encouraging
start. In April we exercised our option to acquire BUPHENYL and AMMONUL which
provides us with added opportunities to diversify our portfolio and further
serve the UCD community. Additionally, receiving patent approval and orphan
exclusivity further enhances the value of Hyperion's UCD franchise."

First Quarter 2013 Financial Results

Hyperion reported a net loss of $9.0 million for the first quarter of 2013, or
a net loss per share of $0.52, compared with a net loss of $11.9 million, or a
net loss per share of $25.33 for the same period of 2012.

Revenue

RAVICTI net sales were $0.8 million for the first quarter of 2013,
representing orders received by patients post-approval. The FDA granted
approval of RAVICTI on February 1, 2013.

Operating Expenses

Cost of goods sold was $68,000 for the first quarter of 2013. Cost of goods
sold related to the sales of RAVICTI is not representative of Hyperion's
future expectations of this expense as manufacturing related expenses
associated with RAVICTI sales during the first quarter of 2013 were recorded
to research and development expenses in periods prior to approval.

Research and development expenses for the first quarter of 2013 were $1.8
million compared with $8.9 million for the same period in 2012. The decrease
was primarily due to $5.7 million in expenses incurred in connection with the
purchase of RAVICTI in 2012 as well as a decrease in clinical development
costs primarily due to the completion of our HE Phase II trial in 2012. Total
research and development stock-based compensation expense for the first
quarter of 2013 was $0.1 million compared with $37,000 for the same period in
2012.

Selling, general and administrative expenses for the first quarter 2013 were
$7.9 million compared to $2.3 million for the same period of 2012. The
increase in the first quarter compared to the same period last year was
primarily due to an increase in employee-related costs as a result of new
hires in the commercial organization, increases in consulting expenses and
other commercial and administrative related infrastructure expenses pertaining
to the commercialization of RAVICTI. Total selling, general and administrative
stock-based compensation expense for the first quarter of 2013 was $0.4
million compared with $41,000 for the same period in 2012.

As of March 31, 2013, Hyperion had cash and cash equivalents of $102.7
million, an increase of $52.8 million from December 31, 2012. The increase is
primarily due to net proceeds of $63.7 million received from the Company's
follow-on public offering, partially offset by cash used in operations of
$10.8 million.

Conference Call and Webcast

Hyperion's management will discuss the Company's financial results for the
quarter ended March 31, 2013, as well as provide a general business update,
during a conference call beginning at 4:30 p.m. EDT/1:30 p.m. PDT today,
Thursday, March 9, 2013.

To access the live teleconference, please dial (877) 847-7188 (U.S.) or (408)
427-3787 (International) and reference the conference ID# 46599927. To access
the webcast, please go to the Events & Presentation page on the Investors
section of the Company's web site at www.hyperiontx.com.

A telephone replay will be available approximately two hours after the call
for one week by dialing (855) 859-2056 (U.S.) or (404) 537-3406
(International) and entering conference ID# 46599927. A replay of the webcast
will be available on the Events & Presentation page on the Company's web site
for 30 days.

About Hyperion Therapeutics

Hyperion Therapeutics, Inc. is a commercial stage biopharmaceutical company
committed to developing and delivering life-changing treatments for orphan
diseases and hepatology. For more information, please visit www.hyperiontx.com

Ravicti Safety Information

RAVICTI is indicated for use as a nitrogen-binding agent for chronic
management of adult and pediatric patients ≥2 years of age with UCDs who
cannot be managed by dietary protein restriction and/or amino acid
supplementation alone. RAVICTI must be used with dietary protein restriction
and, in some cases, dietary supplements (eg, essential amino acids, arginine,
citrulline, protein-free calorie supplements). RAVICTI is not indicated for
the treatment of acute hyperammonemia in patients with UCDs because more
rapidly acting interventions are essential to reduce plasma ammonia levels.
The safety and efficacy of RAVICTI for the treatment of N-acetylglutamate
synthase (NAGS) deficiency has not been established. The use of RAVICTI in
patients <2 months of age is contraindicated.

For additional Important Safety Information, including Warnings and
Precautions, Adverse Events, Drug Interactions, and Special Populations,
please see full Prescribing Information
(http://www.ravicti.com/files/RAVICTI_Prescribing_Information.pdf) and
Medication Guide (http://www.ravicti.com/files/RAVICTI_Medication_Guide.pdf)
for RAVICTI.



Hyperion Therapeutics, Inc.
Consolidated Statements of Operations
(In thousands, except share and per share amounts)


                                                         Three Months Ended
                                                        March31,
                                                         (Unaudited)
                                                        2013       2012
Product Revenue, net                                     $783      —
                                                                  
Costs and Expenses:                                                
Cost of sales                                            68      —
Research and development                                 1,849   8,902
Selling, general and administrative                      7,934    2,323
                                                                  
Total costs and expenses                                 9,851     11,225
                                                                  
Loss from operations                                     (9,068)   (11,225)
Interest income                                          1        4
Interest expense                                         (408)     (1,040)
Other income (expense), net                              500       375
                                                                  
Net loss attributable to common stockholders             $(8,975)  $ (11,886)
                                                                  
Net loss per share attributable to common stockholders:            
Basic and diluted                                        $(0.52)   $(25.33)
                                                                  
Weighted average number of shares used to compute net              
loss per share of common stock:
Basic and diluted                                        17,366,848 469,319
                                                                  



Hyperion Therapeutics, Inc.
Consolidated Balance Sheets
(In thousands) 


                                      March31, 2013     December31,
                                       (unaudited)        2012 ^(1)
Assets                                                   
Current assets                                           
Cash and cash equivalents              $102,666          $49,853
Accounts Receivable                    819               —
Inventories                            473               —
Prepaid expenses and other current     1,080             1,155
assets
                                                        
Total current assets                   105,038           51,008
                                                        
Property and equipment, net            345               49
Other non-current assets               140               147
                                      
Total assets                           $105,523          $51,204
                                                        
Liabilities and Stockholders' Equity                     
Current liabilities                                      
Accounts payable                       $1,343           $2,177
Accrued liabilities                    2,897            2,540
Notes payable, current portion         5,039            4,348
                                                        
Total current liabilities              9,279             9,065
Notes payable, net of current portion  6,513             7,750
                                                        
Total liabilities                      15,792            16,815
                                                        
Stockholders' equity                                     
Preferred stock                        —                 —
Common stock                           2                2
Additional paid-in capital             237,701           173,384
Deficit accumulated during the         (147,972)         (138,997)
development stage
                                                        
Total stockholders' equity             89,731            34,389
                                                        
Total liabilitiesand stockholders'    $105,523          $51,204
equity
                                                        
(1) Derived from the audited financial statements, included in the
Company's Annual Report on Form 10-K/A for the year ended December 31,      
2012.
                                                        

CONTACT: Jeffrey Farrow, CFO
         (650) 745-7816
         Jeff.farrow@hyperiontx.com
        
         Kristie Kuhl, Media Relations
         (203) 556-7417
         kkuhl@makovsky.com