Insmed INSM reported a third-quarter 2024 loss of $1.27 per share, wider than the Zacks Consensus Estimate of a loss of $1.19. In the year-ago quarter, the company posted a loss of $1.11 per share.

Insmed generated total revenues of $93.4 million during the quarter, up 18% year over year. Quarterly sales were in line with the Zacks Consensus Estimate.

Shares of INSM were down more than 4% on Thursday likely due to the earnings miss.

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Year to date, shares of Insmed have surged 117.1% against the industry’s 3.6% decline.

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More on INSM’s Quarterly Results

In the reported quarter, total revenues were generated entirely by its only marketed drug, Arikayce, which is approved for treating refractory mycobacterium avium complex (MAC) lung disease in adults with limited or no alternative treatment option.

The rise in Arikayce sales was driven by continued growth in demand across all marketed regions. Sales of the drug increased 13% to $66.9 million in the United States, while that in Japan rose 31% to $21.0 million. Sales in Europe and the rest of the world rallied 45% to $5.6 million.

In the reported quarter, research and development (R&D) expenses rose 38% year over year to $150.8 million. Selling, general and administrative (SG&A) expenses amounted to $118.9 million, up 31% from the year-ago figure. The uptick in both expenses is attributable to an increase in employee compensation and benefit-related expenses.

As of Sept. 30, 2024, Insmed had cash, cash equivalents and marketable securities of around $1.5 billion compared with $1.2 billion as of June 30, 2024. This surge in cash balance was due to the inflow of funds from the company’s at-the-market equity program, which added net proceeds of $371 million during the third quarter.

INSM Maintains 2024 Guidance

Management reiterated its sales guidance for the full year. It expects product sales for Arikayce to be between $340 million and $360 million, indicating 15% year-over-year growth at the midpoint of the range.

Updates on INSM’s Pipeline

Alongside the earnings release, Insmed announced that it is scheduled to meet the FDA before this year’s end to discuss the possibility of an accelerated approval to expand Arikayce’s label to treat all patients with MAC lung infection. In this regard, management is conducting the phase III ENCORE study, which is evaluating the drug as a potential treatment for newly infected patients with MAC lung disease.

If the FDA approves Arikayce’s label for newly infected patients with MAC lung disease, it will significantly expand the drug’s patient population. Management estimates the total addressable market (TAM) for refractory MAC to be around 30,000 patients in the United States, Europe and Japan. If the drug was also approved in the newly-infected patient population, the TAM would increase to around 275,000 patients in the combined markets. Based on these factors, we expect the drug to generate more than $1 billion in peak sales.

Insmed remains on track to submit a regulatory filing for brensocatib in bronchiectasis before the end of this year. If approved, brensocatib will be the first approved treatment for bronchiectasis patients. Management expects a commercial launch for the drug in the United States in mid-2025 (assuming priority review), followed by product launches in Europe and Japan in the first half of 2026.

Apart from bronchiectasis, Insmed is also evaluating brensocatib in the phase IIb BiRCh study in patients with chronic rhinosinusitis without nasal polyps (CRSsNP). A data readout is expected in the second half of 2025. Management also intends to initiate a mid-stage study on the drug in HS indication before 2024-end.

Management expects to report top-line data from a mid-stage study evaluating treprostinil palmitil inhalation powder (TPIP) in patients with pulmonary arterial hypertension (PAH) in the second half of 2025. It also plans to start a late-stage study next year evaluating TPIP in patients with pulmonary hypertension associated with interstitial lung disease (PH-ILD).

INSM’s Zacks Rank

Insmed currently has a Zacks Rank #3 (Hold).

Insmed, Inc. Price

Insmed, Inc. price | Insmed, Inc. Quote

Key Picks Among Biotech Stocks

Some better-ranked stocks from the sector are Amicus Therapeutics FOLD, Elevation Oncology ELEV and Castle Biosciences CSTL. While FOLD and ELEV sport a Zacks Rank #1 (Strong Buy) each at present, CSTL carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.

In the past 60 days, estimates for Amicus Therapeutics’ 2024 earnings per share (EPS) have moved up from 21 to 22 cents. EPS estimates for 2025 have increased from 50 to 53 cents during the same period. Year to date, shares of FOLD have lost 18.4%.

FOLD’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 23.96%.

In the past 60 days, estimates for Elevation Oncology’s 2024 loss per share have narrowed from 86 to 82 cents. Loss per share estimates for 2025 have narrowed from 90 to 86 cents during the same time. Year to date, shares of ELEV have rallied 11.7%.

ELEV’s earnings beat estimates in three of the trailing four quarters and missed the same in one, the average surprise being 12.05%.

In the past 90 days, estimates for Castle Biosciences’ 2024 loss per share have narrowed from $1.28 to 59 cents. Year to date, shares of Castle Biosciences have surged 60.1%.

CSTL’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 132.32%.

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