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Biotech Receives Device Approval in Five More Countries; Revenue Up 122% YOY

Source: Streetwise Reports


October 25, 2017 ( Newswire) Maxim Group reported on this firm's Q3/17 earnings, as well as its progress in obtaining international regulatory clearances for its medical system.

According to an Oct. 18 research note by Maxim analyst Anthony Vendetti, Viveve Medical Inc.'s (VIVE:NASDAQ) preliminary Q3/17 revenue of about $4.1 million was "up roughly 122% year over year, relatively in line with our estimate of $4.2M and above consensus of $3.7M."

Based on the quarter's results, Vendetti concluded, "We would continue to be buyers of Viveve after announcing preliminary Q3/17 revenue above the consensus estimate."

The analyst noted this women's health and wellness company "continues to build its installed base and make progress with additional international regulatory clearances."

For instance, in Q3/17, the company shipped 60 Geneveve systems, taking the number of installed machines to 365, and sold approximately 2,700 related consumables.

Additionally, Viveve "announced new regulatory clearances for the product in five additional countries," Vendetti said. Those are Bahrain, Kuwait, Qatar and Mexico for the treatment of vaginal laxity, and Taiwan for electrocoagulation to achieve hemostasis during surgery.

The biotech also continues to advance its clinical program, Vendetti indicated. It is preparing to submit an investigational device exemption request to the FDA so it may start its Viveve II clinical study. "Barring any regulatory hurdles, we expect the company to commence its Phase 3 trial by 2017E, with a readout of data projected for mid-2019," Vendetti wrote.

In the United States, the Geneveve device is "currently cleared for electrocoagulation and hemostasis," the analyst explained. "In our opinion, the possibility of gaining an expanded FDA approval for the improvement of female sexual function represents the major growth opportunity for the company."

Following Viveve's announcement of its Q3/17 revenue, Maxim Group changed its projected earnings estimate for the company from $15.1 million to $15.2 million but left all other estimates "relatively unchanged," Vendetti said.

Maxim has a Buy rating and $11 per share 12-month target price on Viveve, whose stock is now trading at around $5.53 per share.

The company's Q3/17 earnings call is scheduled for Wednesday, Nov. 8, 2017, at 5 p.m. ET.

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