8-K

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 8-K

 

 

Current Report

Pursuant to Section 13 or 15(d) of

the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 11, 2015

 

 

RETROPHIN, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware 001-36257 27-4842691

(State or other jurisdiction of

incorporation)

(Commission

File Number)

(I.R.S. Employer

Identification No.)

 

12255 El Camino Real, San Diego, CA 92130
(Address of principal executive offices) (Zip Code)

Registrant’s telephone number, including area code: (646) 837-5863

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))


 

 

 

Item 2.02 Results of Operations and Financial Condition.

On May 11, 2015, Retrophin, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended March 31, 2015. A copy of the press release and accompanying information is attached as Exhibit 99.1 to this current report.

The information in this Item 2.02, and Exhibit 99.1 attached hereto, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. The information in this Item 2.02, and Exhibit 99.1 attached hereto, shall not be incorporated by reference into any registration statement or other document filed with the Securities and Exchange Commission, whether filed before or after the date hereof regardless of any general incorporation language in any such filing, unless the registrant expressly sets forth in such filing that such information is to be considered “filed” or incorporated by reference therein.

 

Item 8.01 Other Events.

On May 11, 2015, the Company disclosed that it is required to pay (i) tiered high single-digit to low double-digit royalties on worldwide net sales of Cholbam™ (currently high single-digit royalties, based on current worldwide net sales of Cholbam™) and (ii) low single-digit royalties on net sales of Chenodal® in the United States.

Forward-Looking Statements

Statements contained in this Current Report on Form 8-K 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. Risks are described more fully in the Company’s filings with the Securities and Exchange Commission, including without limitation the Company’s most recent Quarterly Report on Form 10-Q and other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this Current Report on Form 8-K speak only as of the date on which they were made. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Item 9.01    Financial Statements and Exhibits.

(d) Exhibits

99.1       Press release of Retrophin, Inc. dated May 11, 2015


 

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

RETROPHIN, INC.
Dated: May 12, 2015 By:

  /s/ Stephen Aselage

Name:  Stephen Aselage
Title: Chief Executive Officer
EX-99.1

Exhibit 99.1

 

 

 

 

LOGO

Contact:

Retrophin, Inc.

Chris Cline, CFA

Manager, Investor Relations

646-564-3680

IR@retrophin.com

Retrophin Reports First Quarter 2015 Financial Results

First quarter revenues increased 23% sequentially to $17.4 million

Cholbam received FDA approval; launch underway

SAN DIEGO (May 11, 2015) – Retrophin, Inc. (NASDAQ: RTRX) today reported its first quarter 2015 financial results.

 

   

Net product sales for the first quarter 2015 were $17.4 million

   

Non-GAAP operating income for the first quarter 2015 was $1.4 million, compared to a non-GAAP operating loss of $17.5 million for the same period in 2014

   

Cash, cash equivalents and marketable securities as of March 31, 2015 totaled $126.3 million

“The first quarter proved to be a very productive start to 2015, as we continued to execute against our strategy,” said Stephen Aselage, Chief Executive Officer of Retrophin. “We established ourselves as a leader in the treatment of bile acid disorders with the addition of Cholbam to our commercial portfolio, and acquired a Pediatric PRV in the process. Thiola continued to achieve meaningful commercial growth, and we significantly strengthened our balance sheet with a successful follow-on offering. Combining these accomplishments with better cost controls implemented at the end of last year, Retrophin is in a great position to remain aggressive in business development activities and continue driving our pipeline forward.”

Quarter Ended March 31, 2015

Net product sales for the first quarter of 2015 were $17.4 million, compared to $27,900 for the first quarter of 2014.

Selling, general and administrative expenses for the first quarter of 2015 were $14.9 million on a GAAP basis, compared to $15.1 million for the same period in 2014. On a non-GAAP adjusted basis, selling, general and administrative expenses were $8.0 million for the first quarter of 2015, compared to $12.3 million for the same period in 2014. The decrease is largely attributable to the reduction of extraordinary consulting fees.

Research and development expenses for the first quarter of 2015 were $10.3 million on a GAAP basis, compared to $6.9 million for the same period in 2014. On a non-GAAP adjusted basis, research and development expenses were $7.8 million for the first quarter of 2015, compared to


$5.3 million for the same period in 2014. The increase reflects expenses related to the addition of headcount to support the ongoing enrollment efforts for the Phase 2 DUET trial for sparsentan and development of RE-024 and RE-034.

Total other income for the first quarter of 2015 was $7.7 million, compared to an expense of $53.6 million for the same period in 2014. The change is primarily due to a bargain purchase gain of $48.6 million net of tax as a result of the acquisition of Cholbam™ and the associated Rare Pediatric Disease Priority Review Voucher (“Pediatric PRV”), and a $16.8 million decrease in expense related to the Company’s derivative instruments. The gain was offset by a $3.8 million increase in interest expense related to the Company’s senior convertible notes and term loan facility. Included in the $3.8 million interest expense increase was a $1.1 million charge related to new warrants issued to secure a line of credit for the Cholbam™ transaction. The Company ultimately chose not to draw down the line of credit and alternatively used proceeds from its follow-on equity offering in March to finance the transaction. The gain in other income was also offset by a $0.6 million increase in finance expense.

Income tax benefit of approximately $40 million for the first quarter of 2015 resulted from the Company’s Cholbam™ acquisition, which generated a bargain purchase gain of $48.6 million net of tax, and together with the potential sale of the Pediatric PRV is projected to create taxable income. The Company recorded a deferred tax liability, which resulted in the release of a valuation allowance and the recording of a corresponding income tax benefit.

Net income for the first quarter of 2015 was $39.7 million, or $1.46 per basic share on a GAAP basis, compared to a net loss of $75.7 million, or $3.25 per share for the same period in 2014. Non-GAAP adjusted net loss for the first quarter of 2015 was $1.1 million, or $0.04 per share, compared to $17.5 million, or $0.75 per share for the same period in 2014.

Commercial Product Updates

Thiola® (tiopronin)

 

   

As of May 11, 2015, more than 725 patients were receiving Thiola® therapy.

 

   

Retrophin is expanding its salesforce from 16 to 24 members, which will allow coverage of an additional 500 to 600 potential prescribers. These efforts are expected to continue the strong momentum created thus far in the re-launch.

Cholbam™ (cholic acid)

 

   

Cholbam™ shipped to the first commercial patient in April and the Company has more than a dozen patients already on therapy.

 

   

In addition to initiating the transition of approximately 30 patients from the clinical trial extension to commercial therapy, several new patients have also been identified and begun Cholbamtreatment.


Chenodal® (chenodeoxycholic acid)

 

   

Retrophin continues to have a constructive dialogue with the U.S. Food and Drug Administration (FDA) to determine an acceptable pathway for the addition of cerebrotendinous xanthomatosis (CTX) to the Chenodal® label.

 

   

In April, Retrophin initiated start-up activities for its screening study of the prevalence of CTX in pediatric and adolescent patients with idiopathic bilateral cataracts. The study will include approximately 50 centers for testing, with the goal of screening 500 total patients.

Pipeline Updates

Sparsentan

 

   

The Phase 2 DUET study of sparsentan for the treatment of focal segmental glomerulosclerosis (FSGS) continues to enroll toward the target of 100 patients by year-end 2015.

 

   

The Data Monitoring Committee recently met and unanimously approved continuation of DUET enrollment into the highest dose cohort.

RE-024

 

   

The Company filed an Investigational New Drug Application (IND) in the first quarter of 2015 to support a Phase 1 study of RE-024 in healthy volunteers. The FDA notified Retrophin on April 28, 2015 that the Phase 1 study may proceed.

 

   

Retrophin has initiated the screening of healthy volunteers for its Phase 1 trial of safety and tolerability of single doses of RE-024. Subjects are expected to begin dosing in the second quarter of 2015.

 

   

On May 5, 2015, the FDA Office of Orphan Products Development (OOPD) granted orphan drug designation to RE-024 for the treatment of pantothenate kinase-associated neurodegeneration (PKAN).

RE-034

 

   

Retrophin continues development of RE-034, which may include initiation of IND-enabling studies in 2015.

Conference Call Information

Retrophin will host a conference call and webcast today, Monday, May 11, at 4:30 p.m. ET to discuss first 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 36758378 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, May 11, 2015 to 11:59 p.m., May 18, 2015. The replay number is 855-859-2056 (U.S.) or 404-537-3406 (International), confirmation code 36758378.


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 initiate and/or 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

March 31, 2015

 

    March 31, 2015  
(unaudited)
      December 31,    
2014
 

Assets

Current assets:

Cash

   $ 120,174,877        $ 18,204,282    

Marketable securities

  6,159,962       9,556,098    

Accounts receivable, net

  8,162,535       7,959,411    

Inventory, net

  1,718,365       800,507    

Pediatric priority review voucher, held for sale

  96,250,000         

Prepaid expenses and other current assets

  1,077,355       813,364    
  

 

 

   

 

 

 

Total current assets

  233,543,094       37,333,662    

Property and equipment, net

  618,620       670,796    

Security deposits

  337,014       337,014    

Restricted cash

  40,000       40,000    

Other asset

  1,987,364       1,888,035    

Intangible assets, net

  169,835,098       94,265,530    

Goodwill

  935,935       935,935    

Deferred tax asset

  8,691,307         
  

 

 

   

 

 

 

Total assets

   $ 415,988,432        $ 135,470,972    
  

 

 

   

 

 

 

Liabilities and Stockholders’ Equity (Deficit)

Current liabilities:

Deferred technology purchase liability

   $ 1,000,000        $ 1,000,000    

Accounts payable

  5,913,027       7,124,330    

Accrued expenses

  19,346,699       27,882,995    

Other liability

  943,615       938,209    

Acquisition-related contingent consideration

  2,880,577       2,117,565    

Derivative financial instruments, warrants

  63,390,000       27,990,000    

Deferred income tax liability

  8,691,307         

Note payable

       40,485,452    
  

 

 

   

 

 

 

Total current liabilities

  102,165,225       107,538,551    

Convertible debt

  43,439,333       43,287,814    

Note payable

  40,803,627         

Other liability

  12,294,520       12,234,513    

Acquisition-related contingent consideration, less current portion

  48,718,710       9,519,662    

Deferred income tax liability, net

       141,151    
  

 

 

   

 

 

 

Total liabilities

  247,421,415       172,721,691    
  

 

 

   

 

 

 

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; 34,845,450 and 26,428,071 issued and 34,845,450 and 26,048,480 outstanding, respectively

  3,485       2,643    

Additional paid-in capital

  310,210,811       140,850,551    

Treasury stock, at cost, none and 379,591, respectively

       (3,214,608)    

Accumulated deficit

  (142,734,440)       (179,174,858)    

Accumulated other comprehensive income

  1,087,161       4,285,553    
  

 

 

   

 

 

 

Total stockholders’ equity (deficit)

  168,567,017       (37,250,719)    
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity (deficit)

   $ 415,988,432        $ 135,470,972    
  

 

 

   

 

 

 


RETROPHIN, INC. AND SUBSIDIARIES

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)

March 31, 2015

 

 

 

Three months ended March 31,

 

 
  2015
(unaudited)
  2014
(restated)
 

Net product sales

  $ 17,371,800        $ 27,900     

Operating expenses:

Cost of goods sold

  274,447        900     

Research and development

  10,346,456        6,942,323     

Selling, general and administrative

  14,855,340        15,146,346     
  

 

 

   

 

 

 

Total operating expenses

  25,476,243        22,089,569     
  

 

 

   

 

 

 
                                   
  

 

 

   

 

 

 

OPERATING LOSS

  (8,104,443)       (22,061,669)    
  

 

 

   

 

 

 

OTHER INCOME (EXPENSE):

Gain on sale of asset

  204,198        -         

Interest income (expense), net

  (3,798,533)       536     

Finance expense

  (600,000)       -         

Realized gain on sale of marketable securities, net

  107,368        4,664     

Change in fair value of derivative instruments-loss

  (36,752,960)       (53,613,802)    

Bargain purchase gain

  48,578,208        -         
  

 

 

   

 

 

 

Total other income (expense), net

  7,738,281        (53,608,602)    
  

 

 

   

 

 

 

LOSS BEFORE INCOME TAXES

  (366,162)       (75,670,271)    

Income tax benefit (provision)

  40,021,151        (65,376)    
  

 

 

   

 

 

 

NET INCOME (LOSS)

  $       39,654,989        $     (75,735,647)    
  

 

 

   

 

 

 

PER SHARE DATA:

Net income (loss) per common share, basic

  $ 1.46        $ (3.25)    
  

 

 

   

 

 

 

Net income (loss) per common share, diluted

  $ 1.32        $ (3.25)    
  

 

 

   

 

 

 

Weighted average common shares outstanding, basic

  27,157,883        23,334,967     
  

 

 

   

 

 

 

Weighted average common shares outstanding, diluted

  30,380,694        23,334,967     
  

 

 

   

 

 

 

Comprehensive Income (Loss):

Net income (loss)

  $ 39,654,989        $ (75,735,647)    

Unrealized gain (loss)

  (3,198,391)       622,076     
  

 

 

   

 

 

 

Comprehensive Income (loss)

  $ 36,456,598        $     (75,113,571)    
  

 

 

   

 

 

 


RETROPHIN, INC. AND SUBSIDIARIES

RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION

March 31, 2015

(unaudited)

 

 

Three Months Ended March 31,

 

 
  2015   2014  

GAAP OPERATING LOSS

  $ (8,104,443)       $ (22,061,669)    

R&D Operating Expense

  (10,346,456)       (6,942,323)    

Stock Compensation

  2,219,698        547,733     

Transaction & license fees

  150,000        868,198     

Amortization & Depreciation

  220,916        242,720     
  

 

 

      

 

 

 

  Subtotal non-GAAP items

  2,590,614        1,658,651     
  

 

 

      

 

 

 

NON-GAAP R&D EXPENSE

  (7,755,842)       (5,283,672)    
  

 

 

      

 

 

 

SG&A Operating Expense

  (14,855,340)       (15,146,346)    

Legal Expense (A)

  1,963,228        -         

Stock Compensation

  3,353,580        2,857,143     

Amortization & Depreciation

  1,557,788        13,218     
  

 

 

      

 

 

 

  Subtotal non-GAAP items

  6,874,596        2,870,361     
  

 

 

      

 

 

 

NON-GAAP SG&A EXPENSE

  (7,980,744)       (12,275,985)    
  

 

 

      

 

 

 
                                           
  

 

 

      

 

 

 

  Subtotal non-GAAP items

  9,465,210        4,529,012     
  

 

 

      

 

 

 

NON-GAAP OPERATING INCOME (LOSS)

  1,360,767        (17,532,657)    
  

 

 

      

 

 

 

GAAP NET INCOME /(LOSS)

  39,654,989        (75,735,647)    

Non-GAAP Operating Loss Adjustments

  9,465,210        4,529,012     

Finance Expense

  1,650,000        -         

Change in fair value of derivative instruments-loss

  36,752,960        53,613,802     

Bargain purchase (gain), net (A)

  (48,578,208)       -         

Income Tax (benefit)/provision (A)

  (40,021,151)       65,376     
  

 

 

      

 

 

 

NON-GAAP NET LOSS

  $     (1,076,200)       $  (17,527,457)    
  

 

 

      

 

 

 

PER SHARE DATA:

Net income (loss) per common share, basic

  $ (0.04)       $ (0.75)    
  

 

 

      

 

 

 

Net income (loss) per common share, diluted

  $ (0.04)       $ (0.75)    
  

 

 

      

 

 

 

Weighted average common shares outstanding, basic

  27,157,883        23,334,967     
  

 

 

      

 

 

 

Weighted average common shares outstanding, diluted

  30,380,694        23,334,967     
  

 

 

      

 

 

 

(A) Non-recurring items