Retrophin, Inc.
Aug 4, 2015

Retrophin Reports Second Quarter 2015 Financial Results

Second quarter revenue of $24.1 million

Full year 2015 revenue projected to be $95 to $100 million

SAN DIEGO--(BUSINESS WIRE)-- Retrophin, Inc. (NASDAQ: RTRX) today reported its second quarter 2015 financial results.

"We are very pleased with the ongoing progress made in the second quarter," said Stephen Aselage, Chief Executive Officer of Retrophin. "The 39 percent top-line increase over the first quarter illustrates continued robust growth of Thiola® and a strong start to the Cholbam® launch. With the advancement of RE-024 into the clinic and the recent sale of our Priority Review Voucher for $245 million, we continued to take meaningful steps to deliver long-term shareholder value."

Quarter Ended June 30, 2015

Net product sales for the second quarter of 2015 were $24.1 million, compared to $5.7 million for the second quarter of 2014. The increase is due to the acquisition and subsequent commercial launch of two additional orphan disease products, Thiola and Cholbam.

Selling, general and administrative expenses for the second quarter of 2015 were $19.7 million on a GAAP basis, compared to $9.6 million for the same period in 2014. On a non-GAAP adjusted basis, selling, general and administrative expenses were $11.6 million for the second quarter of 2015, compared to $5.1 million for the same period in 2014. The increase is primarily driven by operational and commercialization efforts to support Thiola and Cholbam.

Research and development expenses for the second quarter of 2015 were $10.6 million on a GAAP basis, compared to $13.3 million for the same period in 2014. On a non-GAAP adjusted basis, research and development expenses were $8.6 million for the second quarter of 2015, compared to $12.1 million for the same period in 2014. The decrease is largely due to the elimination of spend on non-core research and development efforts and timing of preclinical studies.

Total other expense for the second quarter of 2015 was $18.7 million, compared to other income of $26.5 million for the same period in 2014. The change is primarily due to a $62.4 million increase in expense related to the Company's derivative instruments and a $2.3 million expense related to the prepayment of the Company's $45 million credit facility due 2018. The increase in expense was offset by a $15.5 million gain resulting from the legal settlement with Questcor Pharmaceuticals, Inc. and a decrease in finance expense of $4.7 million related to the issuance of the Company's senior convertible notes in the second quarter of 2014.

Income tax expense for the second quarter of 2015 was $0.02 million compared to a benefit of $2.5 million for the same period in 2014.

Net loss for the second quarter of 2015 was $25.5 million, or $0.73 per basic share on a GAAP basis, compared to net income of $11.8 million, or $0.46 per basic share for the same period in 2014. Non-GAAP adjusted net income for the second quarter of 2015 was $13.9 million, or $0.40 per basic share, compared to a net loss of $13.3 million, or $0.52 per basic share for the same period in 2014.

Commercial Product Updates

Thiola® (tiopronin)

Cholbam® (cholic acid)

Chenodal® (chenodeoxycholic acid)

Pipeline Updates

Sparsentan

RE-024

RE-034

Second-Half 2015 Outlook

The Company expects full year 2015 net product sales to be in the range of $95 to $100 million. Going forward, management will provide annual top-line financial guidance when year-end financial results are announced.

Conference Call Information

Retrophin will host a conference call and webcast today, Tuesday, August 4, at 4:30 p.m. ET to discuss second quarter 2015 financial results. To participate in the conference call, dial +1 855-219-9219 (U.S.) or +1-315-625-6891 (International), confirmation code 91222829 shortly before 4:30 p.m. ET. The webcast can be accessed at www.retrophin.com, in the Events and Presentations section. A replay of the call will be available 7:30 p.m. ET, August 4, 2015 to 11:59 p.m., August 11, 2015. The replay number is 855-859-2056 (U.S.) or 404-537-3406 (International), confirmation code 91222829.

Use of Non-GAAP Financial Measures

To supplement Retrophin's financial results and guidance presented in accordance with U.S. generally accepted accounting principles (GAAP), the Company uses certain non-GAAP adjusted financial measures in this press release and the accompanying tables. The Company believes that these non-GAAP financial measures are helpful in understanding its past financial performance and potential future results. They are not meant to be considered in isolation or as a substitute for comparable GAAP measures, and should be read in conjunction with the consolidated financial statements prepared in accordance with GAAP. Retrophin's management regularly uses these supplemental non-GAAP financial measures internally to understand, manage and evaluate its business and make operating decisions. In addition, Retrophin believes that the use of these non-GAAP measures enhances the ability of investors to compare its results from period to period and allows for greater transparency with respect to key financial metrics the Company uses in making operating decisions.

Investors should note that these non-GAAP financial measures are not prepared under any comprehensive set of accounting rules or principles and do not reflect all of the amounts associated with the Company's results of operations as determined in accordance with GAAP. Investors should also note that these non-GAAP financial measures have no standardized meaning prescribed by GAAP and, therefore, have limits in their usefulness to investors. In addition, from time to time in the future the Company may exclude other items, or cease to exclude items that it has historically excluded, for purposes of its non-GAAP financial measures; Because of the non-standardized definitions, the non-GAAP financial measures as used by the Company in this press release and the accompanying tables may be calculated differently from, and therefore may not be directly comparable to, similarly titled measures used by the Company's competitors and other companies.

As used in this press release, (i) the historical non-GAAP net income (loss) measures exclude from GAAP net income (loss), as applicable, intangible asset amortization, stock-based compensation expense, executive severance charges, transaction and license fees, change in fair value of derivative liabilities, depreciation expense, non-cash interest and finance expenses; adjust the income tax provision to the estimated amount of taxes that are payable in cash; (ii) the historical non-GAAP SG&A expense measures exclude from GAAP SG&A expenses, as applicable, intangible asset amortization, stock-based compensation expense, executive severance charges, transaction and license fees, legal fee and settlements, and depreciation expense; (iii) the historical non-GAAP R&D expense measures exclude from GAAP R&D expenses, as applicable, intangible asset amortization, stock-based compensation expense, transaction and license fees and depreciation expense.

About Retrophin

Retrophin is a pharmaceutical company focused on the development, acquisition and commercialization of drugs for the treatment of serious, catastrophic or rare diseases for which there are currently no viable options for patients. The Company's approved products include Chenodal®, Cholbam®, and Thiola®, and its pipeline includes compounds for several catastrophic diseases, including focal segmental glomerulosclerosis (FSGS), pantothenate kinase-associated neurodegeneration (PKAN), infantile spasms, nephrotic syndrome and others. For additional information, please visit www.retrophin.com.

Forward-Looking Statements

This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, regarding the research, development and commercialization of pharmaceutical products. Without limiting the foregoing, these statements are often identified by the words "may", "might", "believes", "thinks", "anticipates", "plans", "expects", "intends" or similar expressions. In addition, expressions of our strategies, intentions or plans are also forward-looking statements. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among the factors that could cause actual results to differ materially from those indicated in the forward-looking statements are risks and uncertainties associated with the Company's business and finances in general, as well as risks and uncertainties associated with the Company's pre-clinical and clinical stage pipeline as well as its sales and marketing strategies. Specifically, the risks and uncertainties the Company faces with respect to its pre-clinical and clinical stage pipeline include risk that the Company's research programs will not identify pre-clinical candidates for further development and risk that the Company's clinical candidates will not be found to be safe or effective. Specifically, the Company faces risk that the sparsentan Phase 2 clinical trials will fail to demonstrate that sparsentan is safe or effective; risk that the sparsentan Phase 2 program will be delayed for regulatory or other reasons; risk that the Company will be unable to complete Phase 1 clinical trials of RE-024, risk that RE-024 will not progress to Phase 2 or later clinical trials for safety, regulatory or other reasons; risk that the Company will be unable to file an IND for RE-034 or initiate Phase 1 clinical trials for regulatory or other reasons, and for each of the programs risk associated with enrollment of clinical trials for rare diseases. The Company faces risks associated with market acceptance and competition for its marketed products. The Company faces risk that it will be unable to raise additional funding required to complete development of any or all of its product candidates; risk relating to the Company's dependence on contractors for clinical drug supply and commercial manufacturing; uncertainties relating to patent protection and intellectual property rights of third parties; risks and uncertainties relating to competitive products and technological changes that may limit demand for the Company's products. You are cautioned not to place undue reliance on these forward-looking statements as there are important factors that could cause actual results to differ materially from those in forward-looking statements, many of which are beyond our control. The Company undertakes no obligation to publicly update forward-looking statement, whether as a result of new information, future events, or otherwise. Investors are referred to the full discussion of risks and uncertainties as included in the Company's filings with the Securities and Exchange Commission.

       
RETROPHIN, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
June 30, 2015
(in thousands)
 
June 30, 2015

December 31,

(unaudited)

2014

Assets
 
Current assets:
Cash $ 127,746 $ 18,204
Marketable securities 5,862 9,556
Accounts receivable, net 11,467 7,960
Inventory, net 2,005 801
Pediatric priority review voucher, held for sale 96,250 -
Prepaid expenses and other current assets   1,407     813  
Total current assets 244,737 37,334
 
Property and equipment, net 509 671
Other asset 2,016 2,265
Intangible assets, net 168,251 94,265
Goodwill 936 936
Deferred tax asset   8,691     -  
Total assets $ 425,140   $ 135,471  
 
Liabilities and Stockholders' Equity (Deficit)
 
Current liabilities:
Deferred technology purchase liability $ 1,000 $ 1,000
Accounts payable 4,778 7,124
Accrued expenses 20,328 27,883
Other liability 897 938
Acquisition-related contingent consideration 4,363 2,118
Derivative financial instruments, warrants 91,200 27,990
Deferred income tax liability 8,691 -
Note payable   41,125     40,486  
Total current liabilities 172,382 107,539
 
Convertible debt 43,593 43,288
Other liability 12,149 12,234
Acquisition-related contingent consideration, less current portion 46,235 9,520
Deferred income tax liability, net   -     141  
 
Total liabilities   274,359     172,722  
 
Commitments and contingencies
 
Stockholders' Deficit:

Preferred stock Series A $0.001 par value; 20,000,000
shares authorized; 0 issued and outstanding

- -

Common stock $0.0001 par value; 100,000,000 shares
authorized; 35,072,757 and 26,428,071 issued and
35,072,757 and 26,048,480 outstanding, respectively

3 3
Additional paid-in capital 318,280 140,851
Treasury stock, at cost, none and 379,591, respectively - (3,215 )
Accumulated deficit (168,262 ) (179,175 )
Accumulated other comprehensive income   760     4,285  
Total stockholders' equity (deficit)   150,781     (37,251 )
Total liabilities and stockholders' equity (deficit) $ 425,140   $ 135,471  
 
       
RETROPHIN, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

June 30, 2015

(in thousands)
 
Three months ended June 30, Six months ended June 30,
2015 2014 2015 2014
(unaudited) (restated) (unaudited) (restated)
 
Net product sales $ 24,068 $ 5,742 $ 41,440 $ 5,770
 
Operating expenses:
Cost of goods sold 637 35 912 36
Research and development 10,563 13,310 20,910 20,253
Selling, general and administrative   19,692     9,579     34,547     24,725  
Total operating expenses   30,892     22,924     56,369     45,014  
       
OPERATING LOSS   (6,824 )   (17,182 )   (14,929 )   (39,244 )
 
OTHER INCOME (EXPENSE):
Litigation settlement gain 15,500 - 15,500 -
Early prepayment penalty (2,250 ) - (2,250 ) -
Other income (expense), net 402 370 229 375
Interest income (expense), net (2,922 ) (2,179 ) (6,720 ) (2,179 )
Finance expense - (4,708 ) (600 ) (4,708 )
Change in fair value of derivative instruments-loss (29,418 ) 32,979 (66,171 ) (20,635 )
Bargain purchase gain   -     -     49,063     -  
Total other income (expense), net   (18,688 )   26,462     (10,949 )   (27,147 )
 
LOSS BEFORE INCOME TAXES (25,512 ) 9,280 (25,878 ) (66,391 )
 
Income tax benefit (provision)   (15 )   2,525     40,006     2,460  
 
NET INCOME (LOSS) $ (25,527 ) $ 11,805   $ 14,128   $ (63,931 )
 
PER SHARE DATA:
Net income (loss) per common share, basic $ (0.73 ) $ 0.46   $ 0.45   $ (2.61 )
Net income (loss) per common share, diluted $ (0.73 ) $ (0.77 ) $ 0.44   $ (2.61 )
Weighted average common shares outstanding, basic   34,957,134     25,635,277     31,079,053     24,491,477  
Weighted average common shares outstanding, diluted   34,957,134     27,326,442     34,825,722     24,491,477  
 
Comprehensive Income (Loss):
Net income (loss) $ (25,527 ) $ 11,805 $ 14,128 $ (63,931 )
Unrealized gain (loss) (30 ) (103 ) (7 ) 519
Foreign currency translation   (298 )   -     (3,519 )   -  
Comprehensive Income (loss) $ (25,855 ) $ 11,702   $ 10,602   $ (63,412 )
 
       
RETROPHIN, INC. AND SUBSIDIARIES
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
June 30, 2015
(unaudited)
 
Three Months Ended June 30, Six Months Ended June 30,
2015 2014 2015 2014
 
GAAP OPERATING LOSS $ (6,824 ) $ (17,182 ) $ (14,929 ) $ (39,244 )
 
R&D Operating Expense (10,563 ) (13,310 ) (20,910 ) (20,253 )
Stock Compensation 1,748 410 3,968 958
Transaction & license fees - 696 150 1,565
Amortization & Depreciation   193     63     414     305  
Subtotal non-GAAP items   1,941     1,169     4,532     2,828  
NON-GAAP R&D EXPENSE   (8,622 )   (12,141 )   (16,378 )   (17,425 )
 
SG&A Operating Expense (19,692 ) (9,579 ) (34,547 ) (24,725 )
Legal Expense (A) 1,388 2,095 3,351 2,095
Stock Compensation 3,244 2,218 6,598 5,075
Amortization & Depreciation   3,463     166     5,021     179  
Subtotal non-GAAP items   8,095     4,479     14,970     7,349  
NON-GAAP SG&A EXPENSE   (11,597 )   (5,100 )   (19,577 )   (17,376 )
       
Subtotal non-GAAP items   10,037     5,648     19,502     10,177  
NON-GAAP OPERATING INCOME (LOSS)   3,213     (11,534 )   4,573     (29,067 )
 
 
GAAP NET INCOME /(LOSS) (25,527 ) 11,805 14,128 (63,931 )
 
Non-GAAP Operating Loss Adjustments 10,037 5,648 19,502 10,177
Finance Expense - 4,708 1,650 4,708
Change in fair value of derivative instruments-loss 29,418 (32,979 ) 66,171 20,635
Bargain purchase (gain), net (A) - - (49,063 ) -
Income Tax (benefit)/provision (A)   15     (2,525 )   (40,006 )   (2,460 )
NON-GAAP NET INCOME (LOSS) $ 13,943   $ (13,343 ) $ 12,382   $ (30,871 )
 
 
PER SHARE DATA:
Net gain (loss) per common share, basic $ 0.40   $ (0.52 ) $ 0.40   $ (1.26 )
Weighted average common shares outstanding, basic   34,957,134     25,635,277     31,079,053     24,491,477  
 
(A) Non-recurring items
 

Retrophin, Inc.
Chris Cline, CFA
Director, Investor Relations
646-564-3680
IR@retrophin.com

Source: Retrophin, Inc.

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