Highlights of the third quarter of 2014 include:
- Reported its U.S. regulatory strategy to initiate one global phase 3 confirmatory study of ARIKAYCE™, or liposomal amikacin for inhalation, for patients with nontuberculous mycobacterial (NTM) lung infections who failed prior standard of care treatment;
- Announced plans to file a Market Authorization Application (MAA) by year-end 2014 with the
European Medicines Agency (EMA) for ARIKAYCE for the treatment of two orphan lung diseases: NTM lung infections and Pseudomonas aeruginosa lung infections in patients with cystic fibrosis (CF); - Strengthened the Company's balance sheet with an underwritten public offering, which provided net proceeds of approximately
$108.0 million ; and - Introduced INS-1009 (inhaled treprostinil), the Company's novel inhalation formulation of a proven prostacyclin for the treatment of pulmonary arterial hypertension (PAH), with the presentation of several pre-clinical studies at the
European Respiratory Society meeting.
"We are pleased with the recent regulatory clarity for our NTM program in both
Third Quarter Financial Results
For the third quarter of 2014,
Research and development expense for the third quarter of 2014 increased to
General and administrative expense for the third quarter of 2014 was
Balance Sheet Highlights and Cash Guidance
As of
The Company plans to continue to fund further clinical development of ARIKAYCE, increase its investment in third-party manufacturing capacity, support efforts to obtain regulatory approvals and prepare for ARIKAYCE commercialization. As a result,
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Forward-looking statements
This release contains forward-looking statements. Words, and variations of words, such as "intend," "expect," "will," "anticipate," "believe," "continue," "propose" and similar expressions are intended to identify forward-looking statements. Investors are cautioned that such statements in this release, including statements relating to the status, results and timing of clinical trials and clinical data, the anticipated benefits of Insmed's products, the anticipated timing of regulatory submissions, and the ability to obtain required regulatory approvals, bring products to market and successfully commercialize products constitute forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, without limitation, failure or delay of European, Canadian,
| Consolidated Balance Sheets | |||||||||||
| (in thousands, except par value, share and per share data) | |||||||||||
| As of |
As of |
||||||||||
| (Unaudited) | |||||||||||
| Assets | |||||||||||
| Current assets: | |||||||||||
| Cash and cash equivalents | $ | 167,311 | $ | 113,894 | |||||||
| Prepaid expenses and other current assets | 3,532 | 2,269 | |||||||||
| Total current assets | 170,843 | 116,163 | |||||||||
| In-process research and development | 58,200 | 58,200 | |||||||||
| Fixed assets, net | 5,982 | 1,812 | |||||||||
| Other assets | 418 | 323 | |||||||||
| Total assets | $ | 235,443 | $ | 176,498 | |||||||
| Liabilities and shareholders' equity | |||||||||||
| Current liabilities: | |||||||||||
| Accounts payable | $ | 8,867 | $ | 5,929 | |||||||
| Accrued expenses | 3,547 | 3,905 | |||||||||
| Accrued compensation | 3,032 | 2,839 | |||||||||
| Accrued lease expense, current | 317 | 307 | |||||||||
| Deferred rent | 321 | 129 | |||||||||
| Capital lease obligations, current | 16 | 64 | |||||||||
| Current portion of long term debt | 5,178 | 3,283 | |||||||||
| Total current liabilities | 21,278 | 16,456 | |||||||||
| Accrued lease expense, long-term | 185 | 380 | |||||||||
| Debt, long-term | 14,713 | 16,338 | |||||||||
| Total liabilities | 36,176 | 33,174 | |||||||||
| Shareholders' equity: | |||||||||||
|
Common stock, |
496 | 391 | |||||||||
| Additional paid-in capital | 651,904 | 534,554 | |||||||||
| Accumulated deficit | (453,133 | ) | (391,621 | ) | |||||||
| Total shareholders' equity | 199,267 | 143,324 | |||||||||
| Total liabilities and shareholders' equity | $ | 235,443 | $ | 176,498 | |||||||
| Consolidated Statements of Comprehensive Loss (Unaudited) | |||||||||||||||||||||
| (in thousands, except per share data) | |||||||||||||||||||||
|
Three Months ended |
Nine Months ended |
||||||||||||||||||||
| 2014 | 2013 | 2014 | 2013 | ||||||||||||||||||
| Other revenue | $ | - | $ | - | $ | - | $ | 11,500 | |||||||||||||
| Operating expenses: | |||||||||||||||||||||
| Research and development | 15,200 | 12,095 | 41,493 | 34,654 | |||||||||||||||||
| General and administrative | 8,204 | 4,747 | 22,806 | 16,267 | |||||||||||||||||
| Total operating expenses | 23,404 | 16,842 | 64,299 | 50,921 | |||||||||||||||||
| Operating loss | (23,404 | ) | (16,842 | ) | (64,299 | ) | (39,421 | ) | |||||||||||||
| Investment income | 12 | 40 | 41 | 141 | |||||||||||||||||
| Interest expense | (594 | ) | (525 | ) | (1,795 | ) | (1,802 | ) | |||||||||||||
| Other (expense) / income, net | (4 | ) | - | 152 | 2 | ||||||||||||||||
| Loss before income taxes | (23,990 | ) | (17,327 | ) | (65,901 | ) | (41,080 | ) | |||||||||||||
| Benefit from income taxes | - | - | (4,389 | ) | (1,221 | ) | |||||||||||||||
| Net loss and comprehensive loss | $ | (23,990 | ) | $ | (17,327 | ) | $ | (61,512 | ) | $ | (39,859 | ) | |||||||||
| Basic and diluted net loss per share | $ | (0.54 | ) | $ | (0.46 | ) | $ | (1.50 | ) | $ | (1.19 | ) | |||||||||
|
Weighted average basic and diluted |
44,082 | 37,389 | 40,882 | 33,577 | |||||||||||||||||
Investor Relations:
LHA
Senior Vice President
afields@lhai.com
or
Managing Director
bvoss@lhai.com
