Flamel Technologies (FLML) Misses Q2 EPS by 8c

August 8, 2016 7:14 AM EDT

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Flamel Technologies (NASDAQ: FLML) reported Q2 EPS of ($0.02), $0.08 worse than the analyst estimate of $0.06. Revenue for the quarter came in at $38.9 million versus the consensus estimate of $32.8 million.

Michael Anderson, Flamel’s Chief Executive Officer, commented, “We are particularly pleased with our second quarter results. Bloxiverz® averaged over 40% share of the neostigmine market during the quarter, and Vazculep® continued to build share to 32% of the 1mL market volume, while holding all of the 5mL and 10mL markets. We generated revenue of $38.9 million for the quarter and we look forward to launching our third sterile injectable product, Akovaz™, this month. We believe the market potential for Akovaz is the largest yet from our portfolio of previously unapproved marketed drugs, or UMDs.”

Mr. Anderson continued, “In addition to our strong UMD business, we continue to advance our pipeline of proprietary products forward. We received positive data from our Phase 1b trial with Medusa™ exenatide and, following guidance from FDA, we will be conducting an alcohol interaction study in the second half of 2016 with our Trigger Lock™ hydromorphone product to further test its abuse-deterrent capabilities.”

“In regards to our most important project, Micropump® sodium oxybate, we have been in dialogue with FDA and look forward to finalizing the Special Protocol Assessment for our Phase III trial in the very near term. We continue to make all the necessary preparations associated with running the trial, including registering clinical sites and preparing clinical supplies, in order to hit the ground running once we begin patient enrollment. Our once nightly version of sodium oxybate is a very exciting opportunity for us, and we are on track to complete our study in approximately one year, with the goal of filing a New Drug Application by the end of 2017 or early 2018,” concluded Mr. Anderson.

As a result of the stronger than expected market share for Bloxiverz, slightly better expected market conditions for Akovaz and the change in the Company’s ability to better estimate net selling price upon shipment of product from its warehouse, the Company is increasing its full year 2016 revenue guidance to the range of $125 to $140 million from its previous guidance range of $110 to $130 million. The Company expects to allocate a substantial amount of its R&D expenses on its sodium oxybate trial; however, timing of the spend will be slightly shifted to 2017 and, as a result, has lowered its 2016 R&D spending guidance to the range or $30 to $40 million from the range of $35 to $50 million.

For earnings history and earnings-related data on Flamel Technologies (FLML) click here.

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