Insmed (INSM) Misses Q3 EPS by 1c, Revenues Beat

Insmed (NASDAQ: INSM) reported Q3 EPS of ($0.68), $0.01 worse than the analyst estimate of ($0.67). Revenue for the quarter came in at $38.9 million versus the consensus estimate of $35.89 million.

Third Quarter 2019 Financial Results

• Total revenue for the third quarter ended September 30, 2019 was $38.9 million, comprising U.S. net sales of $37.8 million and ex-U.S. net sales of $1.1 million. The ex-U.S. net product sales include $0.9 million from the Temporary Authorization for Use (Autorisation Temporaire d\'Utilisation or ATU) program in France and $0.2 million from the named patient program in Germany, both compassionate use programs.
• Cost of product revenues (excluding amortization of intangible assets) was $6.4 million for the third quarter of 2019.
• Research and development expenses were $34.3 million for the third quarter of 2019, compared with $39.5 million for the third quarter of 2018.
• Selling, general and administrative expenses for the third quarter of 2019 were $53.3 million, compared with $44.4 million for the third quarter of 2018. The increase was primarily due to milestone payments and other external expenses related to ARIKAYCE.
• For the third quarter of 2019, Insmed reported a GAAP net loss of $60.7 million, or $0.68 per share, compared with a GAAP net loss of $87.7 million, or $1.14 per share, for the third quarter of 2018.

"We remain very pleased with the continued strong performance of the US launch of ARIKAYCE® (amikacin liposome inhalation suspension). Insmed remains guided by our desire to have a positive impact on patients' lives and is powered by our shared sense of purpose to deliver therapies to small patient populations experiencing big health problems," commented Will Lewis, Chairman and Chief Executive Officer of Insmed. "We are also progressing well with our global expansion efforts including filing for regulatory approval of ARIKAYCE in the EU last quarter and advancing our planned regulatory filings in Japan in first half of 2020. We are also looking forward to the topline results from the WILLOW study which we expect in the first quarter of 2020."

Financial Guidance and Balance Sheet

As of September 30, 2019, Insmed had cash and cash equivalents of $535.6 million. The Company's total costs and expenses for the third quarter of 2019 were $95.4 million, compared with total costs and expenses for the third quarter of 2018 of $84.0 million. Cash-based operating expenses, as defined below, for the third quarter of 2019 were $72.6 million, compared with cash-based operating expenses for the third quarter of 2018 of $75.1 million.

The Company now expects full-year 2019 total revenue for ARIKAYCE to be in the range of $133 million to $138 million.

The Company plans to continue to invest in the following key activities in 2019:

1. support of the U.S. launch and commercialization of ARIKAYCE;
2. clinical trials including (a) the development and verification of a PRO for NTM lung disease as a pivotal step toward initiating a confirmatory clinical study of ARIKAYCE, (b) the six-month Phase 2 WILLOW study of INS1007 in patients with non-CF bronchiectasis, and (c) the advancement of other pipeline programs including INS1009 and our earlier-stage research pipeline;
3. global expansion in Europe and Japan to support pre-commercial activities in those regions and potential regulatory filings in Japan; and
4. buildout of an additional third-party manufacturing facility to increase long-term production capacity for ARIKAYCE and its new corporate headquarters facility.

Insmed continues to expect cash-based operating expenses to be in the range of $140 million to $155 million for the second half of 2019. In addition, the Company continues to expect capital expenditures, including those related to its new corporate headquarters facility as well as payments classified within other assets for the future right-of-use asset related to the buildout of an additional third-party manufacturing facility, to be in the range of $20 million to $30 million for the second half of 2019.

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

You May Also Be Interested In

• Alphabet (GOOGL) soars 16% on Q1 results beat, first-ever dividend
• Atlassian (TEAM) comes ahead of Street estimates in Q1 but shares tumble
• Gilead Sciences (GILD) Misses Q1 EPS by 288c