MannKind (MNKD) shares are up 11 cents, almost 2%, at $7.11 after the company this morning reported a Q1 loss of 40 cents per share, 4 cents better than expected, and said it was preparing to meet with the Food & Drug Administration after the Government raised questions last month about the company’s inhaled insulin product in development, Afrezza.
Operating expenses fell markedly from Q4 to $40.6 million from $55.8 million, helped by a 25% drop in R&D as the company incurred lower expenses for Afrezza’s development.
In a conference call with management, COO Hakan Edstrom said the company had completed a successful inspection of its manufacturing facility in france, part of the response to the FDA.
Scientific director Peter Richardson said a report prepared for a meeting with the FDA coming up in June will show test results for the company’s inhaler device, known as “Dreamboat,” that will resolve FDA questions about labeling of the product.
“Specifically, the cartridges and packaging will meet the FDA’s requirements for product identification and dosing, as well as being able to label the product in insulin-equivalent doses as requested by the Agency, and preferred by ourselves and prescribers,” said Richardson.
On the downside, chair and CEO Alfred Mann said the company’s mobilization to address the FDA would “slow progress” on the company’s other products.
The company announced last week it had obtained new test data showing the safety and efficacy of Afrezza, rebutting some claims by critics on both fronts.
The company burned through $41 million of cash in the quarter, leaving it with $31.5 million. With $176.5 million to draw upon in credit, the company said it can make it through Q1 of next year, and is exploring ways to fund itself beyond that point. MannKind also filed a $200 million shelf registration but said it had no plans to issue any securities at this time.
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