Insmed Reports Third Quarter 2016 Financial Results and Provides Business Update
Enrollment objective achieved in phase 3 CONVERT study
Conference call today at
- Achieved enrollment objective in global phase 3 study of ARIKAYCE™. Today the company announced that it has achieved its patient enrollment objective in the phase 3 study of ARIKAYCE (liposomal amikacin for inhalation). The study, which is known as CONVERT or INS-212, is evaluating ARIKAYCE in treatment refractory nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC). The primary efficacy endpoint is the proportion of subjects who achieve culture conversion at Month 6 in the ARIKAYCE plus multi-drug regimen arm compared to the multi-drug regimen without ARIKAYCE arm.
- Published phase 2 study of ARIKAYCE. In
October 2016, the American Journal of Respiratory and Critical Care Medicinepublished the company's phase 2 study of ARIKAYCE in NTM lung disease. The manuscript, which is entitled "Randomized Trial of Liposomal Amikacin for Inhalation in Nontuberculous Mycobacterial Lung Disease" by Olivier et al. is accessible online at http://www.atsjournals.org/.
- Presented new analyses of phase 2 study of ARIKAYCE at CHEST. A poster describing the stability and consistency of effect with ARIKAYCE treatment in the phase 2 study was recently presented at the CHEST annual meeting.
- Presented new NTM disease burden data at
ISPOR European Congress. Three posters describing the burden of NTM lung disease were recently presented at the International Society for Pharmacoeconomicand Outcomes Research (ISPOR) Annual European Congress.
- Secured global exclusive rights to novel oral inhibitor of dipeptidyl peptidase I.
In October, the company acquired the global exclusive rights to INS1007 (formerly known as AZD7986) from AstraZeneca. INS1007 is a small molecule, reversible inhibitor of dipeptidyl peptidase I (DPP1), an enzyme responsible for activating neutrophil serine proteases (NSPs) in neutrophils when they are formed in the bone marrow. In chronic inflammatory lung diseases, neutrophils accumulate in the airways and result in excessive active NSPs that cause lung destruction and inflammation. The company expects to begin a phase 2 dose-ranging study of INS1007 in non-cystic fibrosis (non-CF) bronchiectasis in 2017. Non-CF bronchiectasis is a rare, progressive, neutrophil-driven pulmonary disorder with no approved therapies.
- Presented phase 1 study of INS1009 at ERS 2016. In September, results from a phase 1 study of INS1009 were presented at the
European Respiratory Society International Congress. The study was a randomized, double-blind, placebo-controlled single ascending dose study of INS1009 to determine its safety, tolerability, and pharmacokinetics in healthy volunteers. The pharmacokinetic characteristics supported once- or twice-daily whereas existing inhaled therapies are dosed four to nine times per day. The adverse event profile was consistent with other inhaled prostanoids. INS1009 is the company's inhaled treprostinil prodrug, which may offer therapeutic potential in rare pulmonary disorders.
- Appointed chief commercial officer. The company enhanced its senior leadership team with the appointment of
Roger Adsettas chief commercial officer. Prior to joining Insmed, Mr. Adsettwas senior vice president, head of the gastrointestinal and internal medicine business unit at Shire plc. In that capacity he oversaw Shire's global commercial P&L across six specialty and two rare disease brands. Before joining Shire, Mr. Adsettworked at AstraZeneca for 11 years. Mr. Adsettwill be charged with overseeing the development and execution of Insmed'sglobal commercial strategy.
"Recent months have been marked by strong progress across all aspects of our business," said
Third Quarter Financial Results
For the third quarter of 2016,
Research and development expenses were
General and administrative expenses for the third quarter of 2016 were
Balance Sheet Highlights and Cash Guidance
The company is investing in the following activities in 2016:
(i) clinical development of ARIKAYCE, (ii) regulatory and pre-commercial initiatives for ARIKAYCE, and (iii) preclinical and clinical activities for its earlier-stage pipeline.
A replay of the conference call will be accessible approximately two hours after its completion through
"Insmed" and "ARIKAYCE" are the company's trademarks. All other trademarks, trade names or service marks appearing in this press release are the property of their respective owners.
This press release contains forward looking statements. "Forward-looking statements," as that term is defined in the Private Securities Litigation Reform Act of 1995, are statements that are not historical facts and involve a number of risks and uncertainties. Words herein such as "may," "will," "should," "could," "would," "expects," "plans," "anticipates," "believes," "estimates," "projects," "predicts," "intends," "potential," "continues," and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) identify forward-looking statements.
Forward-looking statements are based upon the company's current expectations and beliefs, and involve known and unknown risks, uncertainties and other factors, which may cause actual results, performance and achievements and the timing of certain events to differ materially from the results, performance, achievements or timing discussed, projected, anticipated or indicated in any forward-looking statements. Such factors include, among others, the factors discussed in Item 1A "Risk Factors" in the company's Annual Report on Form 10-K for the year ended
The company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date they are made.
Financial Statements to Follow
|Consolidated Statements of Net Loss|
|(in thousands, except per share data)|
| Three Months Ended || Nine Months Ended |
|Research and development||23,433||19,221||67,851||54,631|
|General and administrative||13,716||11,024||38,498||30,272|
|Total operating expenses||37,149||30,245||106,349||84,903|
|Other income (expense), net||45||(67||)||92||(36||)|
|Loss before income taxes||(37,735||)||(30,962||)||(107,800||)||(86,938||)|
|Provision for income taxes||25||-||71||-|
|Basic and diluted net loss per share||$||(0.61||)||$||(0.50||)||$||(1.74||)||$||(1.51||)|
|Weighted average basic and diluted |
common shares outstanding
|Consolidated Balance Sheets|
|(in thousands, except par value and share data)|
|As of||As of|
|Cash and cash equivalents||$||200,518||$||282,876|
|Prepaid expenses and other current assets||5,778||5,242|
|Total current assets||206,296||288,118|
|In-process research and development||58,200||58,200|
|Fixed assets, net||10,274||8,092|
|Liabilities and shareholders' equity|
|Other current liabilities||647||683|
|Current portion of long-term debt||-||3,113|
|Total current liabilities||23,458||22,259|
|Other long-term liabilities||676||572|
|Common stock, |
|authorized shares, 61,877,905 and 61,813,995 issued and outstanding shares at ||619||618|
|Additional paid-in capital||914,049||900,043|
|Accumulated other comprehensive loss||(5||)||-|
|Total shareholders' equity||217,829||311,698|
|Total liabilities and shareholders' equity||$||276,644||$||356,556|
Insmed Incorporated: Susan MescoHead of Investor Relations 908-947-4326
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