Medical device company Shockwave Medical Inc. (SWAV:NASDAQ), which is focused on developing a system of tools that utilize Intravascular Lithotripsy (IVL) to treat severely calcified cardiovascular disease, today announced "a preliminary forecast revenue range for the first quarter 2021, ahead of its participation in the Wells Fargo MedTech R&D Spotlight Call Series held earlier today."
Shockwave Medical's President and CEO Doug Godshall stated, "We are pleased by the encouraging performance in the first quarter and, in particular, with the excellent reception of our newly-launched C2 Coronary IVL product in the United States...I commend our team on their extraordinary preparation and execution of the launch of C2 and am so grateful for the collaborative partnership we have with our customers. The entire Shockwave Medical organization remains focused on our mission to deliver life changing products to patients suffering from calcified arterial disease."
The company highlighted the activities surrounding the launch of its C2 System which was approved by the U.S. Food and Drug Administration (FDA) in February for use in calcified de-novo coronary arteries prior to implanting a stent.
The firm indicated that since gaining FDA approval, its territory managers have secured an average of a little more than 1.5 accounts in the U.S. per month, which is in line with its strategy of rolling out the product in an organized and sustainable manner. Shockwave noted that in parallel to the rollout, peripheral revenue in the U.S. has continued to grow sequentially month-over-month in Q1/21.
The company noted that thus far the performance of the C2 System has been on par with the results experienced in international markets.
Shockwave advised that to date more than 120 customers in the U.S. have purchased the C2 Launch Kit and that the orders typically average around 6 C2 units each. The company noted that already about half of the U.S. clients that have initiated launch of the C2 System have completed the launch activities and are now able to use IVL independently.
The firm noted in addition that "five live cases utilizing C2 in U.S. centers have been performed in conjunction with the recent Cardiovascular Research Technologies (CRT) and Scottsdale Interventional Forum (SIF) Conferences."
The company provided some limited preliminary financial data and reported that it expects revenue of $31-32 million in Q1/21, which would represent an increase of 104-111% over Q1/20. The firm noted that the estimates are preliminary and unaudited and thus are subject to adjustment.
Shockwave Medical is a medical device company based in Santa Clara, Calif., that is focused on the development and commercialization of transformative products, tools and approaches in treating calcified cardiovascular disease. The company stated that its goal is to create a new standard of minimally invasive care for the interventional treatment of atherosclerotic cardiovascular disease. The firm noted that its technology employs its "differentiated and proprietary local delivery of sonic pressure waves for the treatment of calcified plaque, which the company refers to as Intravascular Lithotripsy (IVL)."
Shockwave Medical started the day with a market capitalization of around $3.6 billion with approximately 34.8 million shares outstanding and a short interest of about 6.6%. SWAV shares opened nearly 12% higher today at $115.00 (+$12.02, +11.67%) over yesterday's $102.98 closing price. The stock has traded today between $113.53 to $122.31 per share and is closed at $122.89 (+$19.91, +19.33%).
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