Insmed Incorporated (NASDAQ:INSM), a global biopharmaceutical company focused on the unmet needs of patients with rare diseases, today reported financial results for the third quarter and nine months ended September 30, 2015.
- Global Phase 3 ARIKAYCE™ study update. Patient enrollment continues in the company’s global phase 3 study of ARIKAYCE (liposomal amikacin for inhalation or LAI) in nontuberculous mycobacteria (NTM) lung disease (CONVERT™ or INS-212 study). The company has secured health authority clearance in 12 countries with CONVERT study sites and 83 sites are open. Securing regulatory clearance for a few countries in Asia and Europe has taken longer than expected. In addition, while patient screening is going well at many sites, the ramp of enrollment at certain centers is slower than expected largely due to administrative delays. As a result, the company expects to achieve its enrollment objective six to 12 months later than its initial expectation of enrolling the study by the end of 2015. Insmed has taken a number of steps to accelerate enrollment, including enhancing its clinical operations team with new talent.
- EMA regulatory review of ARIKAYCE is progressing. The company remains on track to submit its responses to the European Medicine Agency’s (EMA) 120-day questions before the end of 2015. The 120-day questions are part of EMA’s review of the company’s marketing authorization application (MAA) for ARIKAYCE.
- INS1009 advancing toward clinical development. Insmed recently submitted an Investigational New Drug (IND) application and remains on track to begin a phase 1 clinical study of INS1009 before the end of 2015. INS1009 is the company’s nebulized treprostinil prodrug that is being developed as a treatment for pulmonary arterial hypertension (PAH).
- Management team enhancements. The company recently made key enhancements to its senior leadership team, including the recent hire of Reinilde Heyrman, MD, senior vice president, clinical operations and development, and the promotion of Drayton Wise to vice president of sales and marketing. Dr. Heyrman will have direct oversight over the development and registration-readiness of Insmed’s pipeline. Dr. Heyrman has 24 years of global clinical development experience at companies such as Bellerophon Therapeutics, Ikaria, Inc. (Mallinckrodt Pharmaceuticals), Daiichi-Sankyo, and Pharmacia and Upjohn (Pfizer). Mr. Wise joined Insmed in 2014 and previously worked at Novartis, where he led the U.S. sales launch of the TOBI Podhaler®, Novartis’ leading inhaled antibiotic for cystic fibrosis patients.
- Patient-focused drug development meeting hosted by U.S. Food and Drug Administration (FDA) for NTM lung disease highlights unmet medical need. As part of its patient-focused drug development program, the FDA recently conducted a public meeting for NTM lung disease in order to obtain patients’ perspectives on the impact of NTM lung disease on daily life and treatment approaches. During the afternoon’s scientific workshop, Insmed participated on a panel with academic experts and discussed the unique aspects of developing drugs to treat NTM lung disease.
“We are making important progress advancing our efforts to support the approval and commercial launch of ARIKAYCE,” said Will Lewis, president and chief executive officer. “Across the globe we are supporting the cause of patients with NTM lung disease by progressing our landmark CONVERT study, raising disease awareness, and ensuring launch-readiness. We remain pleased with patient and physician receptivity to the CONVERT study and are working hard to augment the enrollment process of this trial. We continue to be encouraged by the commercial opportunity that will flow from treating eligible patients and believe our trial design will increase the probability of a successful outcome. We are also excited about our preclinical programs for PAH, including INS1009, which will soon enter the clinic, and the overall progress from our research team.”
For the third quarter of 2015, Insmed posted a net loss of $31.0 million, or $0.50 per share, compared with a net loss of $24.0 million, or $0.54 per share, for the third quarter of 2014.
Research and development expenses were $19.2 million for the third quarter of 2015, compared with $15.2 million for the third quarter of 2014. The increase was primarily due to the company’s global phase 3 CONVERT study of ARIKAYCE in NTM lung disease.
General and administrative expenses for the third quarter of 2015 were $11.0 million, compared with $8.2 million for the third quarter of 2014. The increase was primarily related to pre-commercial activities in Europe and non-cash stock-based compensation expense.
Balance Sheet Highlights and Cash Guidance
As of September 30, 2015, Insmed had cash and cash equivalents of $311.0 million. Insmed ended the third quarter of 2015 with $25.3 million in short-term debt and working capital of $272.6 million.
Insmed continues to expect its cash operating expenses for the second half of 2015 will be in the range of $50 million to $60 million. As previously reported, the company will continue to invest in the following activities for the remainder of 2015: (i) clinical development of ARIKAYCE, (ii) regulatory and pre-commercial initiatives for ARIKAYCE, and (iii) initiating a phase 1 clinical study of INS1009. (Original Source)
Shares of Insmed closed yesterday at $19.86. INSM has a 1-year high of $28.66 and a 1-year low of $12.65. The stock’s 50-day moving average is $19.56 and its 200-day moving average is $23.03.
On the ratings front, Insmed has been the subject of a number of recent research reports. In a report issued on October 6, H.C. Wainwright analyst Andrew Fein reiterated a Buy rating on INSM, with a price target of $35, which represents a potential upside of 76.2% from where the stock is currently trading. Separately, on September 23, Piper Jaffray’s Joshua Schimmer reiterated a Buy rating on the stock and has a price target of $51.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Fein and Joshua Schimmer have a total average return of 9.7% and -3.5% respectively. Fein has a success rate of 47.6% and is ranked #556 out of 3827 analysts, while Schimmer has a success rate of 38.8% and is ranked #3582.
Insmed Inc is a biopharmaceutical company engaged in developing and commercializing inhaled therapies for patients battling serious lung diseases that are often life threatening. Its products candidates includes ARIKAYCE.