Sientra Inc (NASDAQ: SIEN) is headed for the top early on in the market today, and for good reason. Late yesterday, the company announced that it has received FDA approval surrounding one of its supplements, allowing for a push to commercialization. As you could imagine, with the approval in mind, investors are pushing the stock for the top. Today, we’ll talk about:
- The FDA approval;
- what we’re seeing from SIEN as a result;
- and what we’ll be watching for ahead.
SIEN Announces FDA Approval
As mentioned above, Sientra is having an overwhelmingly strong start to the trading session this morning after announcing FDA approval. In a press release issued late yesterday, the company announced that the United States Food and Drug Administration has approved its PMA supplement. This approval means that the company now has the ability to commercialize its OPUS-branded breast implant products that are manufactured by Vesta.
In the release, SIEN also announced that the approval will unlock the door to funding. In fact, as a result of the approval, the company now has access to an additional $10 million tranche of term debt. This tranche is made available under the company’s credit facility with MidCap Financial Services and Silicon Valley Bank. In a statement, Jeffrey M. Nugent, Chairman and CEO at SIEN, had the following to offer:
This FDA approval allows us to commercialize our OPUS-branded breast implants with an improved manufacturing process and represents a critical milestone for Sientra. The approval culminates over two years of successful collaboration between the Sientra and Vesta teams. We now once again have access to a supply of implants to support our plan to regain and grow share in the U.S. breast implant market for both augmentation and reconstruction. Our decision to manufacture finished goods product prior to approval has positively positioned us to begin meeting customer demand immediately. We will continue our precision-controlled selling strategy through the first half of 2018 as the new Vesta facility scales its manufacturing to full supply capabilities, which we anticipate will occur during the second half of this year.
As Sientra continues to expand into categories beyond breast surgery, we decided to rebrand our breast products with a name that symbolizes what they represent. We chose the name Sientra OPUS, the only brand of silicone gel breast implants and tissue expanders marketed exclusively to board-certified plastic surgeons. OPUS signifies an artist’s best body of work and for our brand, the name evokes excellence, quality, performance and artistry. We believe our OPUS products provide the true artists with the best tools available to achieve optimal results.
Since October 2015, the entire Sientra team has been determined to overcome each successive challenge stemming from our former Brazilian manufacturer. With today’s FDA approval, we have closed the final chapter of our transition and positioned the Company with a diversified portfolio of differentiated products to capitalize on significant market opportunities for each of our two core businesses. Overall, we are now poised to continue executing an integrated commercial aesthetics strategy. In the immediate term, we will be leveraging the American Society for Aesthetic Plastic Surgery (ASAPS) annual meetings held later this month to showcase each of our brands. Looking further ahead, we expect 2018 to be another pivotal year in which we deliver meaningful incremental value to our customers, patients, and shareholders.
What We’re Seeing From The Stock
With the news that the FDA has approved a product, allowing for the company to move forward with commercialization, investors are clearly excited. This excitement can be seen in the gains on the stock. As our regular readers would likely have guessed, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:26), SIEN is trading at $12.45 per share after a gain of $1.40 per share or 12.67% thus far today.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on SIEN. In particular, we’re interested in following the story surrounding the newly approved supplement, and the company’s efforts to bring it to market. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!