Full Press Release Details
Senior Director, Investor Relations
First Quarter 2016 Financial Results
First quarter revenues increased 67 percent year-over-year
Enrollment of the Phase 2 DUET study of sparsentan completed; top-line results expected third quarter 2016
SAN DIEGO (May 3, 2016) Retrophin, Inc. (NASDAQ: RTRX) today reported its first quarter 2016 financial results.
In the first quarter, we made tangible progress on the strategic initiatives enabling 2016 to be a transformational year for Retrophin, said
Stephen Aselage, chief executive officer of Retrophin. Completing enrollment of the DUET study of sparsentan was a great accomplishment, and we expect top-line results in the third quarter. We also plan to initiate a trial evaluating the
efficacy of RE-024 in PKAN patients during the second half of 2016. Additionally, our recently launched commercial efforts are gaining traction across all products and should yield increased growth through the remainder of the year.
Quarter Ended March 31, 2016
for the first quarter of 2016 were $29.0 million, compared to $17.4 million for the same period in 2015. The increase was primarily due to new patients initiating treatment with Thiola and Chenodal , and contributions from Cholbam , which was acquired in March 2015. The
Company expects sales growth to accelerate through the balance of 2016 due to increasing net patient additions to all three products, and reiterates its full-year guidance of $130.0 to $140.0 million.
Selling, general and administrative expenses for the first quarter of 2016 were $19.1 million, compared to $14.9 million for the same period in 2015. The
increase is attributable to additional headcount supporting expanded commercial efforts and amortization related to the addition of Cholbam. SG&A experienced a one-time benefit of $3.0 million in the first quarter of 2016 due to the reversal of
disputed legal fees as a result of a settlement with the Company s former external legal counsel. On a non-GAAP adjusted basis, selling, general and administrative expenses were $11.0 million for the first quarter of 2016, compared to $9.9
million for the same period in 2015.
Research and development expenses for the first quarter of 2016 were $14.7 million, compared to $10.3 million for
the same period in 2015. The increase is largely due to clinical trial expense supporting the Phase 2 DUET study of sparsentan in patients with focal segmental glomerulosclerosis (FSGS), and the preparation of an efficacy trial of RE-024 in patients
with pantothenate kinase-associated neurodegeneration (PKAN). On a non-GAAP adjusted basis, research and development expenses were $12.1 million for the first quarter of 2016, compared to $7.9 million for the same period in 2015.
Total other income for the first quarter of 2016 was $14.4 million, compared to $7.7 million for the same period in 2015. The difference is largely
attributable to a gain resulting from a decrease in the Company s derivative liability due to share price fluctuation and a reduction in interest expense after the prepayment of the Company s credit facility in July 2015. This was
partially offset by a bargain purchase gain in the first quarter of 2015 related to the acquisition of Cholbam.
Tax benefit of $5.1 million for the first
quarter of 2016 was primarily due to a favorable effective tax rate as a result of orphan drug and research and development tax credits.
the first quarter of 2016 was $11.2 million, or $0.31 per basic share, compared to $39.7 million, or $1.46 per basic share for the same period in 2015. Non-GAAP adjusted net income for the first quarter of 2016 was $5.2 million, or $0.14 per basic
share, compared to a net loss of $4.8 million, or $0.18 per basic share for the same period in 2015.
As of March 31, 2016, the Company had cash, cash
equivalents, marketable securities and notes receivable of $315.4 million.
Commercial Product Updates
Cholbam (cholic acid)
Chenodal (chenodeoxycholic acid)
Share Repurchase Program
of Directors has approved the repurchase of up to an aggregate $40.0 million of its common stock. Repurchases may be made from time-to-time via purchases on the open market, privately negotiated transactions, accelerated stock repurchases,
pre-planned trading programs or other means subject to market conditions as management may deem appropriate. The timing of any repurchases and the actual number of shares repurchased will depend on a variety of factors, including stock price,
corporate and regulatory requirements and other market and economic conditions. The Company may suspend or discontinue this repurchase program at any time and makes no representations, warranties or guarantees that such a buy-back will ultimately
Conference Call Information
host a conference call and webcast today, Tuesday, May 3, 2016 at 4:30 p.m. ET to discuss first quarter 2016 financial results. To participate in the conference call, dial +1-855-219-9219 (U.S.) or +1-315-625-6891 (International), confirmation code
92067921 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 3, 2016 to 7:30 p.m. ET, May 10, 2016. The replay number
is +1-855-859-2056 (U.S.) or +1-404-537-3406 (International), confirmation code 92067921.
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, revaluation of acquisition related contingent consideration, stock-based compensation and depreciation and amortization expense, change in fair value of derivative instruments; income tax provision; bargain purchase
gain (ii) the historical non-GAAP SG&A expense measures exclude from GAAP SG&A expenses, as applicable, stock-based compensation expense, and depreciation and amortization expense; (iii) the historical non-GAAP R&D expense measures
exclude from GAAP R&D expenses, as applicable, stock-based compensation expense, and depreciation and amortization expense.
Retrophin is a fully integrated biopharmaceutical company dedicated to delivering life-changing therapies to people living with rare diseases who have
few, if any, treatment options. The Company s approach centers on its pipeline featuring clinical-stage assets targeting rare diseases with significant unmet medical needs, including sparsentan for focal segmental glomerulosclerosis (FSGS), a
disorder characterized by progressive scarring of the kidney often leading to end-stage renal disease, and RE-024 for pantothenate kinase-associated neurodegeneration (PKAN), a life-threatening neurological disorder that typically begins in early
childhood. Research exploring the potential of early-stage assets, including RE-034, in several rare diseases is also underway. Retrophin s R&D efforts are supported by revenues from the Company s marketed products Chenodal , Cholbam and Thiola .
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, success of its commercial products as well as risks and uncertainties associated with the Company s preclinical and clinical stage pipeline. Specifically, the Company faces risks associated with market acceptance of its
marketed products including efficacy, safety, price, reimbursement and benefit over competing therapies. The risks and uncertainties the Company faces with respect to its preclinical and clinical stage pipeline include risk that the Company s
research programs will not identify preclinical 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 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 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, 2016 | December 31, 2015 | |||||||
| (unaudited) | ||||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash | $ | 23,262 | $ | 37,805 | ||||
| Marketable securities | 199,083 | 191,799 | ||||||
| Accounts receivable, net | 13,400 | 12,458 | ||||||
| Inventory, net | 3,230 | 2,536 | ||||||
| Prepaid expenses and other current assets | 3,093 | 2,378 | ||||||
| Prepaid taxes | 8,498 | 8,107 | ||||||
| Note receivable, current | 47,173 | 46,849 | ||||||
| Total current assets | 297,739 | 301,932 | ||||||
| Property and equipment, net | 417 | 428 | ||||||
| Other asset | 1,859 | 1,859 | ||||||
| Intangible assets, net | 160,260 | 161,536 | ||||||
| Goodwill | 936 | 936 | ||||||
| Note receivable, long term | 45,889 | 45,573 | ||||||
| Total assets | $ | 507,100 | $ | 512,264 | ||||
| Liabilities and Stockholders Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 4,647 | $ | 7,639 | ||||
| Accrued expenses | 20,392 | 23,820 | ||||||
| Other current liabilities | 1,235 | 958 | ||||||
| Guaranteed minimum royalty, short term | 2,000 | 2,000 | ||||||
| Business combination-related contingent consideration | 13,873 | 13,754 | ||||||
| Derivative financial instruments, warrants | 24,470 | 38,810 | ||||||
| Total current liabilities | 66,617 | 86,981 | ||||||
| Convertible debt | 43,929 | 43,766 | ||||||
| Other non-current liabilities | 2,889 | 3,066 | ||||||
| Guaranteed minimum royalty, long term | 8,689 | 8,885 | ||||||
| Business combination-related contingent consideration, less current portion | 46,426 | 45,267 | ||||||
| Deferred income tax liability, net | 19,318 | 24,328 | ||||||
| Total liabilities | 187,868 | 212,293 | ||||||
| Stockholders Equity: | ||||||||
| 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; 36,592,435 and 36,465,853 issued and 36,592,435 and 36,465,853 outstanding, respectively | 4 | 4 | ||||||
| Additional paid-in capital | 373,327 | 365,802 | ||||||
| Accumulated deficit | (53,937 | ) | (65,153 | ) | ||||
| Accumulated other comprehensive loss | (162 | ) | (682 | ) | ||||
| Total stockholders equity | 319,232 | 299,971 | ||||||
| Total liabilities and stockholders equity | $ | 507,100 | $ | 512,264 |
RETROPHIN, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(in thousands, except share and per share data)
| Three months ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| Net product sales | $ | 29,008 | $ | 17,372 | ||||
| Operating expenses: | ||||||||
| Cost of goods sold | 757 | 274 | ||||||
| Research and development | 14,672 | 10,347 | ||||||
| Selling, general and administrative | 19,125 | 14,855 | ||||||
| Change in valuation of contingent consideration | 2,695 | |||||||
| Total operating expenses | 37,249 | 25,476 | ||||||
| Operating loss | (8,241 | ) | (8,104 | ) | ||||
| Other income (expenses): | ||||||||
| Other income, net | 210 | 311 | ||||||
| Interest expense, net | (163 | ) | (3,798 | ) | ||||
| Finance expense | (600 | ) | ||||||
| Change in fair value of derivative instruments | 14,340 | (36,753 | ) | |||||
| Bargain purchase gain | 48,578 | |||||||
| Total other income, net | 14,387 | 7,738 | ||||||
| Income (loss) before provision for income taxes | 6,146 | (366 | ) | |||||
| Income tax benefit | 5,070 | 40,021 | ||||||
| Net income | $ | 11,216 | $ | 39,655 | ||||
| Per share data: | ||||||||
| Net earnings per common share, basic | $ | 0.31 | $ | 1.46 | ||||
| Net earnings (loss) per common share, diluted | $ | (0.08 | ) | $ | 1.32 | |||
| Weighted average common shares outstanding, basic | 36,520,186 | 27,157,883 | ||||||
| Weighted average common shares outstanding, diluted | 37,947,479 | 30,380,694 |
RETROPHIN, INC. AND SUBSIDIARIES
RECONCILIATION OF GAAP REPORTED TO NON-GAAP ADJUSTED INFORMATION
thousands, except share and per share data)
| Three months ended March 31, | ||||||||
| 2016 | 2015 | |||||||
| GAAP Operating Loss | $ | (8,241 | ) | $ | (8,104 | ) | ||
| R&D Operating Expense | (14,672 | ) | (10,347 | ) | ||||
| Stock Compensation | 2,486 | 2,220 | ||||||
| Amortization & Depreciation | 82 | 221 | ||||||
| Subtotal non-GAAP items | 2,568 | 2,441 | ||||||
| Non-GAAP R&D Expense | (12,104 | ) | (7,906 | ) | ||||
| SG&A Operating Expense | (19,125 | ) | (14,855 | ) | ||||
| Stock Compensation | 4,307 | 3,354 | ||||||
| Amortization & Depreciation | 3,810 | 1,558 | ||||||
| Subtotal non-GAAP items | 8,117 | 4,912 | ||||||
| Non-GAAP SG&A Expense | (11,008 | ) | (9,943 | ) | ||||
| Change in valuation of contingent consideration | 2,695 | |||||||
| Subtotal non-GAAP items | 13,380 | 7,353 | ||||||
| Non-GAAP Operating Income (Loss) | 5,139 | (751 | ) | |||||
| GAAP Net Income | 11,216 | 39,655 | ||||||
| Non-GAAP Operating Expense Adjustments | 13,380 | 7,353 | ||||||
| Change in fair value of derivative instruments | (14,340 | ) | 36,753 | |||||
| Bargain purchase gain | (48,578 | ) | ||||||
| Income Tax benefit | (5,070 | ) | (40,021 | ) | ||||
| Non-GAAP Net Income (Loss) | $ | 5,186 | $ | (4,838 | ) | |||
| Per Share Data: | ||||||||
| Net earnings (loss) per common share, basic | $ | 0.14 | $ | (0.18 | ) | |||
| Weighted average common shares outstanding, basic | 36,520,186 | 27,157,883 |
Note: Certain adjustments / reclassifications have been made to prior periods to conform to current year presentation.