Business Update
- Global Phase 3 ARIKAYCE™ study advancing. 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 caused by Mycobacterium avium complex (MAC) (CONVERT™ or INS-212 study). The CONVERT study is taking place in 16 countries and more than 115 sites. The company continues to expect to achieve its enrollment objective in the second half of 2016.
- EMA regulatory review of ARIKAYCE progressing. The company submitted its responses to the European Medicine Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) 120-day questions in December 2015 and expects to receive the CHMP’s 180-day list of outstanding issues (LOI) in the first quarter of 2016. Insmed anticipates responding to the LOI and participating in an oral hearing with the CHMP in the second quarter of 2016 to address the LOI on the company’s marketing authorization application (MAA) for ARIKAYCE. The company continues to expect the CHMP to render an opinion on its MAA around the middle of 2016.
- Phase 1 clinical study of INS1009 underway. Insmed is conducting a phase 1 study of INS1009 in healthy subjects. INS1009 is the company’s nebulized treprostinil prodrug. The company believes INS1009 may offer a differentiated product profile with therapeutic potential in rare pulmonary disorders such as pulmonary arterial hypertension (PAH), idiopathic pulmonary fibrosis (IPF), sarcoidosis, and severe refractory asthma.
- INS1009 patent issued. The U.S. patent and trademark office issued U.S. patent no. 9,255,064 (the ‘064 patent) on February 9, 2016. The ‘064 patent, entitled “Prostacyclin compounds, compositions and methods of use thereof” is the first patent to issue with claims reciting INS1009. Other treprostinil prodrugs are also claimed and described in the patent. Methods of using treprostinil prodrugs, including INS1009, are described in the patent. The ‘064 patent provides exclusivity for INS1009 until October 24, 2034.
“Last year, Insmed made important progress advancing our clinical and regulatory activities and establishing the foundation of our commercial infrastructure for ARIKAYCE in Europe,” said Will Lewis, president and chief executive officer of Insmed. “We enhanced our global team and managed our resources, ending the year with $283 million in cash. In 2016, our priorities include completing patient enrollment in the phase 3 CONVERT study, advancing the European regulatory review of ARIKAYCE, and reporting new data from our internal research programs.”
Fourth Quarter Financial Results
For the fourth quarter of 2015, Insmed posted a net loss of $31.2 million, or $0.51 per share, compared with a net loss of $17.6 million, or $0.36 per share, for the fourth quarter of 2014.
Research and development expenses were $19.6 million for the fourth quarter of 2015, compared with $14.8 million for the fourth 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 fourth quarter of 2015 were $12.9 million, compared with $8.3 million for the fourth quarter of 2014. The increase was primarily related to pre-commercial activities in Europe and personnel-related expenses, including non-cash stock-based compensation expense.
Balance Sheet Highlights and Cash Guidance
As of December 31, 2015, Insmed had cash and cash equivalents of $283 million. 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. As a result, Insmed expects its cash-based operating expenses for the first half of 2016 will be in the range of $58 to $68 million. (Original Source)
Shares of Insmed closed yesterday at $12.39, down $0.13 or -1.04%. INSM has a 1-year high of $28.66 and a 1-year low of $11.84. The stock’s 50-day moving average is $13.65 and its 200-day moving average is $18.45.
On the ratings front, Insmed has been the subject of a number of recent research reports. In a report issued on January 7, Piper Jaffray analyst Joshua Schimmer maintained a Buy rating on INSM, with a price target of $29, which represents a potential upside of 134.1% from where the stock is currently trading. Separately, on November 9, UBS’s Matt Roden downgraded the stock to Hold and has a price target of $18.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joshua Schimmer and Matt Roden have a total average return of -24.1% and 14.4% respectively. Schimmer has a success rate of 17.1% and is ranked #3663 out of 3666 analysts, while Roden has a success rate of 54.8% and is ranked #207.
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.