Insmed (NASDAQ: INSM) reported Q4 EPS of ($1.16), $0.10 worse than the analyst estimate of ($1.06). Revenue for the quarter came in at $9.8 million versus the consensus estimate of $6.89 million.

"2018 was a pivotal year for Insmed, with the U.S. approval and launch of ARIKAYCE® (amikacin liposome inhalation suspension), the first and only FDA-approved treatment for patients with refractory Mycobacterium avium complex (MAC) lung disease. We are very pleased with the strong momentum we've seen since launch, including a wide breadth of prescribers, steady additions of new patients, and positive reimbursement trends," commented Will Lewis, Chairman and Chief Executive Officer of Insmed. "In 2019, we are focused on continuing our efforts to execute a successful U.S. launch while pursuing our strategic priorities, including completing the design and protocol of the confirmatory study required for the full U.S. approval of ARIKAYCE, which is intended to support use of ARIKAYCE in a front-line setting; accelerating our global expansion to support potential regulatory filings for ARIKAYCE in Europe and Japan; and advancing our pipeline to bring other potential therapies to market for patients with serious and rare diseases."

Fourth Quarter and Full-Year 2018 Financial Results

• Total revenue for the fourth quarter and full year ended December 31, 2018 was $9.8 million, comprising U.S. net sales of $9.2 million and ex-U.S. net sales of $0.6 million. The ex-U.S. net sales reflect utilization from the Temporary Authorization for Use (Autorisation Temporaire d\'Utilisation or ATU) program in France.
• Cost of product revenues (excluding amortization of intangible assets) was $2.4 million for the fourth quarter of 2018. Prior to the approval of ARIKAYCE, the company expensed manufacturing and material costs as research and development expenses.
• Research and development expenses were $39.9 million for the fourth quarter of 2018, compared with $33.9 million for the fourth quarter of 2017. For the full year of 2018, research and development expenses were $145.3 million compared with $109.7 million for the full year of 2017. The increase was primarily due to an increase in external manufacturing expenses and higher compensation and related expenses due to an increase in headcount.
• Selling, general and administrative expenses for the fourth quarter of 2018 were $54.0 million, compared with $31.4 million for the fourth quarter of 2017. For the full year of 2018, selling, general and administrative expenses were $168.2 million compared with $79.2 million for the full year of 2017. The increase was primarily due to higher compensation and related expenses due to an increase in headcount and an increase in expenses relating to pre-commercial planning activities in preparation for the launch of ARIKAYCE.
• For the fourth quarter of 2018, Insmed reported a net loss of $91.6 million, or $1.19 per share, compared with a net loss of $65.4 million, or $0.85 per share, for the fourth quarter of 2017. For the full year of 2018, Insmed reported a net loss of $324.3 million, or $4.22 per share, compared with a net loss of $192.6 million, or $2.89 per share, for the full year of 2017.

GUIDANCE:

Insmed sees FY2019 revenue of $80-90 million, versus the consensus of $59.57 million.

• As of December 31, 2018, Insmed had cash and cash equivalents of $495.1 million.
• The Company's total costs and expenses for the fourth quarter of 2018 were $97.6 million and for the full year of 2018 were $317.2 million.
• The cash-based operating expenses for the fourth quarter of 2018 were $86.9 million and for the full year of 2018 were $283.7 million.
• The Company expects full-year 2019 revenues for ARIKAYCE to be in the range of $80 million to $90 million.

For earnings history and earnings-related data on Insmed (INSM) click here.