Reiterates Full-Year 2013 Net Cash Spend Guidance of $47 Million to $53 Million
Broad Strategic Update to be Provided by Year-End 2013
CRANBURY, N.J., Nov. 12, 2013 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for rare and orphan diseases, today announced financial results for the third quarter ended September 30, 2013. A broad strategic update on the Company's development programs and business development activities will be provided by year-end 2013.
John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics stated, "During the third quarter we continued to advance next-generation enzyme replacement therapies in Fabry, Pompe and MPS I utilizing our CHART™ platform. In addition, our ongoing Phase 3 studies of migalastat HCl monotherapy continued to advance toward further results in Fabry patients with amenable mutations. Our balance sheet also remains strong through our collaborations with GSK and Biogen, and with careful cost management. We look forward to providing what we believe will be important and positive updates on our portfolio and our future strategic direction in the coming weeks."
Financial Highlights for Third Quarter Ended September 30, 2013
- Cash, cash equivalents, and marketable securities totaled $60.5 million at September 30, 2013 compared to $99.1 million at December 31, 2012.
- Cash reimbursements received from GlaxoSmithKline (GSK) for shared development of migalastat HCl totaled $1.0 million compared to $3.7 million in the third quarter 2012.
- Total revenue of $39,000 consisted of research revenue received from Biogen Idec under the Parkinson's disease collaboration, which Amicus and Biogen entered on September 1, 2013. No revenue was recognized in the third quarter of 2012.
- Total operating expenses decreased to $15.2 million from $16.9 million in the third quarter 2012 primarily due to lower expenses in research and development.
- Net loss was $14.6 million, or $0.29 per share, compared to a net loss of $16.3 million, or $0.34 per share, for the third quarter 2012.
2013 Financial Guidance and Financial Outlook
Amicus continues to expect full-year 2013 net cash spend to total between $47 million and $53 million, including cash reimbursements received from GSK. Amicus and GSK are responsible for 40% and 60% of global development costs for migalastat HCl, respectively, in 2013 and beyond. The Company projects that the current cash position and anticipated Fabry program reimbursements from GSK are sufficient to fund operations into the fourth quarter of 2014.
Broad Strategic Update
Amicus expects to provide a broad strategic update on its development programs and business development activities in the next few weeks. At this time Amicus and GSK both remain blinded to the Stage 2 (12-month) data from the ongoing Phase 3 study (Study 011) of migalastat HCl monotherapy in patients with Fabry disease who have amenable mutations. In addition, all ongoing clinical studies are continuing per protocol.
About Amicus Therapeutics
Amicus Therapeutics (Nasdaq:FOLD) is a biopharmaceutical company at the forefront of therapies for rare and orphan diseases. The Company is developing novel, first-in-class treatments for a broad range of human genetic diseases, with a focus on delivering new benefits to individuals with lysosomal storage diseases. Amicus' lead programs include the small molecule pharmacological chaperones migalastat HCl as a monotherapy and in combination with enzyme replacement therapy (ERT) for Fabry disease; and AT2220 (duvoglustat HCl) in combination with ERT for Pompe disease.
Forward-Looking Statements
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to preclinical and clinical development of Amicus' candidate drug products, the timing and reporting of results from preclinical studies and clinical trials evaluating Amicus' candidate drug products, and the projected cash position for the Company. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "estimate," "intend," "potential," "plan," "targets," "likely," "may," "will," "would," "should" and "could," and similar expressions or words identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation by Amicus that any of its plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Amicus might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the goals, progress, timing and outcomes of discussions with regulatory authorities and the potential goals, progress, timing and results of preclinical studies and clinical trials, actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in the business of Amicus, including, without limitation: the potential that results of clinical or pre-clinical studies indicate that the product candidates are unsafe or ineffective; the potential that it may be difficult to enroll patients in our clinical trials; the potential that regulatory authorities may not grant or may delay approval for our product candidates; the potential that preclinical and clinical studies could be delayed because we identify serious side effects or other safety issues; the potential that we will need additional funding to complete all of our studies and, our dependence on third parties in the conduct of our clinical studies. Further, the results of earlier preclinical studies and/or clinical trials may not be predictive of future results. With respect to statements regarding projections of the Company's cash position, actual results may differ based on market factors and the Company's ability to execute its operational and budget plans. In addition, all forward looking statements are subject to other risks detailed in our Annual Report on Form 10-K for the year ended December 31, 2012, as well as any subsequent quarterly reports on Form 10-Q. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Amicus undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
| Table 1 | |||||
| Amicus Therapeutics, Inc. | |||||
| (a development stage company) | |||||
| Consolidated Statements of Operations | |||||
| (Unaudited) | |||||
| (In thousands, except share and per share amounts) | |||||
| Period from | |||||
| February 4, | |||||
| 2002 | |||||
| (inception) | |||||
| Three Months | Nine Months | To | |||
| Ended September 30, | Ended September 30, | Sept. 30, | |||
| 2012 | 2013 | 2012 | 2013 | 2013 | |
| Revenue: | |||||
| Research revenue | $ -- | $ 39 | $ 11,591 | $ 39 | $ 57,532 |
| Collaboration and milestone revenue | -- | -- | 6,820 | -- | 64,382 |
| Total revenue | $ -- | $ 39 | $ 18,411 | $ 39 | $ 121,914 |
| Operating Expenses: | |||||
| Research and development | $ 11,499 | $ 10,110 | $ 39,226 | $ 32,824 | $ 348,717 |
| General and administrative | 4,995 | 4,635 | 14,909 | 14,288 | 146,901 |
| Restructuring charges | -- | -- | -- | -- | 1,522 |
| Impairment of leasehold improvements | -- | -- | -- | -- | 1,030 |
| Depreciation and amortization | 422 | 429 | 1,284 | 1,318 | 13,086 |
| In-process research and development | -- | -- | -- | -- | 418 |
| Total operating expenses | 16,916 | 15,174 | 55,419 | 48,430 | 511,674 |
| Loss from operations | (16,916) | (15,135) | (37,008) | (48,391) | (389,760) |
| Other income (expenses): | |||||
| Interest income | 92 | 36 | 235 | 147 | 14,536 |
| Interest expense | (19) | (7) | (77) | (26) | (2,448) |
| Change in fair value of warrant liability | 553 | 517 | (1,941) | 874 | 2,427 |
| Other income | -- | -- | 21 | -- | 252 |
| Loss before tax benefit | (16,290) | (14,589) | (38,770) | (47,396) | (374,993) |
| Income tax benefit | -- | -- | -- | -- | 8,708 |
| Net loss | (16,290) | (14,589) | (38,770) | (47,396) | (366,285) |
| Deemed dividend | -- | -- | -- | -- | (19,424) |
| Preferred stock accretion | -- | -- | -- | -- | (802) |
| Net loss attributable to common stockholders | $ (16,290) | $ (14,589) | $ (38,770) | $ (47,396) | $ (386,511) |
| Net loss attributable to common stockholders per common share – basic and diluted | $ (0.34) | $ (0.29) | $ (0.88) | $ (0.96) | |
| Weighted-average common shares outstanding – basic and diluted | 48,513,647 | 49,621,188 | 44,255,885 | 49,621,188 | |
| Table 2 | ||
| Amicus Therapeutics, Inc. | ||
| (a development stage company) | ||
| Consolidated Balance Sheets | ||
| (Unaudited) | ||
| (in thousands, except share and per share amounts) | ||
| December 31, | September 30, | |
| 2012 | 2013 | |
| Assets: | ||
| Current assets: | ||
| Cash and cash equivalents | $ 33,971 | $ 30,047 |
| Investments in marketable securities | 65,151 | 30,448 |
| Receivable due from GSK | 3,225 | 2,121 |
| Prepaid expenses and other current assets | 2,270 | 1,692 |
| Total current assets | 104,617 | 64,308 |
| Property and equipment, less accumulated depreciation and amortization of $8,501 and $9,751 at December 31, 2012 and September 30, 2013, respectively | 5,029 | 4,356 |
| Other non-current assets | 442 | 442 |
| Total Assets | $ 110,088 | $ 69,106 |
| Liabilities and Stockholders' Equity | ||
| Current liabilities: | ||
| Accounts payable and accrued expenses | $ 8,845 | $ 8,166 |
| Current portion of secured loan | 398 | 398 |
| Warrant liability | -- | 34 |
| Total current liabilities | 9,243 | 8,598 |
| Deferred reimbursements | 30,418 | 34,019 |
| Warrant liability, non-current | 908 | -- |
| Secured loan, less current portion | 299 | -- |
| Commitments and contingencies | ||
| Stockholders' equity: | ||
| Common stock, $.01 par value, 125,000,000 shares authorized, 49,631,672 shares issued and outstanding at December 31, 2012, 49,631,672 shares issued and outstanding at September 30, 2013 | 556 | 556 |
| Additional paid-in capital | 387,539 | 392,213 |
| Accumulated other comprehensive income | 14 | 5 |
| Deficit accumulated during the development stage | (318,889) | (366,285) |
| Total stockholders' equity | 69,220 | 26,489 |
| Total Liabilities and Stockholders' Equity | $ 110,088 | $ 69,106 |
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