Biotech Roundup: Celldex Therapeutics, Inc. (CLDX), Keryx Biopharmaceuticals (KERX), BioDelivery Sciences International, Inc. (BDSI)

Biotech stocks are notoriously volatile as a pipeline update or FDA announcement can instantly send share prices through the roof. Below, analysts weigh in on several small-cap biotech stocks as they release earnings and provide pipeline updates. Here’s the latest on Celldex Therapeutics, Inc. (NASDAQ:CLDX), Keryx Biopharmaceuticals (NASDAQ:KERX), and BioDelivery Sciences International, Inc. (NASDAQ:BDSI).

Celldex Therapeutics, Inc.

Mara Goldstein of Cantor weighed in on Celldex as the company’s pipeline progresses. With advancements in varlilumab and Rintega, the analyst is optimistic on the near-term opportunities for the company. The company announced earnings on February 25, posting a fourth quarter loss per share of ($0.33); a narrower loss than the analyst’s forecast of ($0.37) thanks to “slightly higher revenue and lower R&D.”

Varlilumab, a pipeline therapy for several forms of cancer, is moving into Phase 2 testing in combination with Opdivo; a therapy from Bristol-Myers Squibb. The analyst believes this decision is “the validation in advancing the program, which was based on an undisclosed set of clinical parameters.” The analyst also points to Rintega, a pipeline cancer therapy, which is “getting closer to a final readout.”

Overall, the analyst is bullish on Celldex’s “data rich year” ahead. Due to the company’s strong pipeline and cash runway of about $290 million, Goldstein maintained a Buy rating on the stock on February 26 but lowered her price target from $31 to $25 given “contraction in the broader biotechnology market.” However, she maintains that Celldex’s “growing pipeline and cash runway through 2017 provide a strong rationale to like the shares in spite of the broader weakness in the biotech market.”

Mara Goldstein has a 28% success rate recommending stocks with a 16.6% average loss per rating. According to TipRanks, 2 other analysts who have weighed in on Celldex in the last 3 months are bullish on the stock. The average 12-month price target is $33.50, marking over a 300% potential upside from current levels.

Keryx Biopharmaceuticals

Although the company released solid earnings last week, posting in-line total revenue of $5.8 million, analysts are becoming increasingly concerned about Auryxia’s slow take off. Auryxia is an FDA approved treatment for patients with chronic kidney disease on dialysis. Analyst Whitney Ijem of J.P. Morgan points out that the slow take off of this drug is slightly worrisome.

For the fourth quarter, the company posted Auryxia revenue of $4.8 million compared to $3.1 million in the quarter prior. Ijem is not impressed by this growth rate. The analyst explains, “On the one hand, doc feedback continues to indicate that Auryxia’s profile is of interest. On the other hand, scripts continue to falter and we’re not sure that potential growth drivers in 2016 are going to meaningfully move the needle.”

Going forward, all eyes will be on Auryxia prescription data and updates. Ijem has lowered her 2016 Auryxia sales estimate from $48 million to $32 million, and lowered her peak Auryxia sales estimate to $500 million from $700 million.

Due to uncertainties surrounding the Auryxia launch, Ijem downgraded Keryx from Overweight to Neutral on February 26 and removed the price target. The analyst concludes, “Bottom line, we still think Auryxia is a promising drug, but commercial concerns (lack of conviction in a near-term launch inflection and lower outer-year share assumptions) lead us to step aside as we await clarity on potential upside to our current assumptions.”

Ijem has a 20% success rate recommending stocks with a 16.2% average loss per rating. According to TipRanks, 3 analysts are bullish on Keryx while one remains neutral. The average 12-month price target between these 4 analysts is $7, marking a 92% potential upside from current levels.

BioDelivery Sciences International, Inc.

Following BioDelivery’s analyst and investor day last week, analyst Edward White of FBR & Co. weighed in on the company in light of pipeline updates. The analyst is bullish on the company thanks to Bunavail and the company’s Buprenorphine Injection Depot programs.

Bunavail is a FDA approved drug to treat opioid dependence in the form of a buccal film that sticks to the inside of the cheek. The drug was approved in October and the analyst comments that although “the launch has not gone as we had anticipated,” he believes “sales will ramp up in 2016 as Bunavail gains greater market penetration.” White is bullish on the future of the drug as he believes it is superior to its competitors, Suboxone and Zubsolv, and has already built a “good physician base.” Furthermore, there is room for sales to drastically increase. White explains that under the current Drug Addiction Treatment of 2000 Act, doctors with special certifications can treat up to 100 patients for opioid addiction with Bunavail. However, the analyst believes this cap may be lifted as soon as this summer and increased to as many as 500 patients.

The analyst is also bullish on BioDelivery’s Buprenorphine Depot Injection; a pre-clinical injection therapy to use in opioid dependence and pain. Management indicated that the treatment could file for an Investigational New Drug application by the third quarter.

Due to the company’s pipeline updates, Ed White reiterated an Outperform rating on BioDelivery on February 26. The analyst has a $13 price target on the stock, marking over a 200% potential upside from current levels.

White has a 14% success rate recommending stocks with a 22.5% average loss per rating. According to TipRanks, all 3 analysts who have rated the stock in the last 3 months are bullish with an average 12-month price target of $9.33, marking a 145% potential upside from where shares last closed.

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