Highlights of the second quarter of 2013 and recent weeks include:
- Achieved the Primary Endpoint in a Registrational Phase 3 Clinical Trial of ARIKACE® to treat Cystic Fibrosis (CF) Patients with Pseudomonas aeruginosa infections (Pa). The European and Canadian Phase 3 clinical trial of once-daily ARIKACE (liposomal amikacin for inhalation) achieved its primary endpoint of non-inferiority to twice-daily TOBI®(tobramycin inhalation solution) for relative change in forced expiratory volume in one second (FEV1) from baseline to end of study. Secondary endpoints showed comparability of once-daily ARIKACE compared with twice-daily TOBI consistent with the primary endpoint of the study.
- Granted Qualified Infectious Disease Product (QIDP) and Fast Track Designations for ARIKACE in Nontuberculous Mycobacteria (NTM) Lung Infections.
The U.S. Food and Drug Administration(FDA) granted ARIKACE QIDP and Fast Track designations for the treatment of NTM.
- Completed an Underwritten Public Offering.
Insmedcompleted an underwritten public offering of 6.9 million shares of common stock, which reflects the underwriters' exercise in full of their over-allotment option of 900,000 shares, which provided net proceeds to the Company of approximately $67.0 million.
- Received Notice of Allowance for Key European Composition-of-Matter Patent for ARIKACE. The European Patent Office notified
Insmedthat it intends to grant a key European composition of matter patent for ARIKACE. Once granted, the patent will provide protection for novel anti-infective formulations comprising an aminoglycoside and Insmed'sliposomal delivery technology, and methods for making the formulations. Amikacin is one of the aminoglycosides covered by the patent. The patent also includes claims relating to the use of the aminoglycoside/lipid formulations for treating pulmonary infections, including those caused by Pa and certain mycobacterial infections, among others.
Christine Pellizzarias General Counseland Secretary. In July, Ms. Pellizzari joined Insmedwith nearly 20 years of experience at development- and commercial-stage biopharmaceutical companies, including senior-level legal and strategic leadership roles at Aegerion Pharmaceuticals and Dendrite, Inc.
"Throughout the second quarter and in recent weeks we made significant progress in a number of areas critical to our goal of becoming a patient-centric biopharmaceutical company. We reported positive clinical data and regulatory developments, fortified our patent portfolio, enhanced our management team and strengthened our balance sheet. We are focused on preparing our regulatory filing for ARIKACE in
"With positive Phase 3 data for our CF indication and our QIDP and Fast Track designations for our NTM indication, we are actively moving forward with our strategy to bring once-daily ARIKACE to patients suffering from these orphan lung diseases in two indications in two geographies in two years," concluded
Second Quarter Financial Results
For the second quarter of 2013,
Research and development expenses in the second quarter of 2013 increased to
General and administrative expenses for the second quarter of 2013 increased to
Balance Sheet Highlights and Cash Guidance
The Company plans to fund further clinical development of ARIKACE, invest in third party manufacturing capacity and fund its efforts to obtain regulatory approvals. As a result, the Company estimates that its cash requirements to fund operations in second half of 2013 will be in the range of
A replay of the conference call will be accessible two hours after its completion through
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
-Tables to Follow-
|Consolidated Balance Sheets|
|(in thousands, except par value, share and per share data)|
|Cash and cash equivalents||$||74,588||$||90,782|
|Certificate of deposit||2,195||2,153|
|Prepaid expenses and other current assets||1,783||643|
|Total current assets||78,566||93,578|
|In-process research and development||58,200||58,200|
|Fixed assets, net||1,855||1,666|
|Liabilities and shareholders' equity|
|Accrued lease expense, current||301||295|
|Capital lease obligations, current||69||96|
|Current portion of long term debt||4,650||3,007|
|Total current liabilities||18,101||15,747|
|Accrued lease expense, long-term||514||647|
|Capital lease obligations, long-term||32||64|
|Additional paid-in capital||462,944||455,325|
|Warrant to purchase common stock||-||790|
|Total shareholders' equity||105,184||120,882|
|Total liabilities and shareholders' equity||$||138,725||$||153,561|
|Consolidated Statements of Comprehensive Loss|
|(in thousands, except per share data)|
|Three Months Ended
||Six Months Ended
|Research and development||12,225||7,745||22,559||12,484|
|General and administrative||7,544||2,238||11,520||4,763|
|Total operating expenses||19,769||9,983||34,079||17,247|
|Gain on sale of assets, net||-||-||2||5|
|Loss before income taxes||(8,854||)||(9,694||)||(23,753||)||(16,537||)|
|Provision (benefit) for income taxes||-||2||(1,221||)||4|
|Basic and diluted net loss per share||$||(0.28||)||$||(0.39||)||$||(0.71||)||$||(0.67||)|
|Weighted average basic and diluted common shares outstanding||31,754||24,875||31,654||24,867|
|Unrealized (loss) gain on short-term investments, net of taxes||-||(30||)||-||186|