PolyPid (NASDAQ:PYPD) Issues Quarterly Earnings Results, Misses Estimates By $1.15 EPS

PolyPid (NASDAQ:PYPD) released its quarterly earnings results on Wednesday. The company reported ($0.24) earnings per share for the quarter, missing the consensus estimate of $0.91 by ($1.15), FiscalAI reports. The company had revenue of $30.00 million for the quarter, compared to analyst estimates of $30.00 million.

Here are the key takeaways from PolyPid’s conference call:

• FDA review is nearing a key decision: D-PLEX100’s priority-review PDUFA date is November 28, with labeling discussions underway and scheduled FDA interactions described as on track. Approval and the planned early-2027 launch remain subject to FDA action; the company did not discuss inspection details.
• PolyPid and Azurity are preparing for a U.S. launch, with Azurity building its commercial teams and targeting hospitals. The company cautioned that formulary reviews happen account by account and adoption may take several months; a CMS decision on NTAP reimbursement is expected in August 2027.
• Label expansion is a potential growth driver: PolyPid plans to begin FDA discussions this quarter on expanding D-PLEX100 beyond colorectal surgery to broader abdominal procedures. The company has not yet received FDA feedback on what evidence or requirements would be needed.
• The EMA validated PolyPid’s D-PLEX100 application and began its review, with a decision expected in the second half of 2027. After ending its European agreement with ADVANZ PHARMA, PolyPid regained commercialization rights and said it is discussing potential partnerships.
• PolyPid reported $15.5 million in cash and short-term deposits at quarter-end and said it received a further $15 million Azurity payment in early October; management expects resources to fund operations into 2028. The company also plans PD01B’s pre-IND meeting and first-in-human study in the second half of 2027, while the program remains in development.

PolyPid Stock Performance

NASDAQ PYPD opened at $6.40 on Friday. PolyPid has a 52-week low of $3.50 and a 52-week high of $7.15. The company has a 50-day simple moving average of $5.35 and a 200 day simple moving average of $4.79. The company has a market capitalization of $122.11 million, a PE ratio of -4.74 and a beta of 1.43.

Analyst Upgrades and Downgrades

Several research firms have commented on PYPD. Wall Street Zen raised shares of PolyPid from a “hold” rating to a “buy” rating in a research report on Saturday, October 31st. Oppenheimer began coverage on PolyPid in a research note on Tuesday, October 27th. They issued an “outperform” rating and a $10.00 target price on the stock. Weiss Ratings reaffirmed a “sell (d-)” rating on shares of PolyPid in a report on Friday, September 18th. Craig Hallum set a $12.00 price target on PolyPid in a research report on Wednesday, July 22nd. Finally, HC Wainwright reiterated a “buy” rating and set a $13.00 price target on shares of PolyPid in a report on Thursday. Three analysts have rated the stock with a Buy rating and one has issued a Sell rating to the company’s stock. According to MarketBeat.com, the stock has an average rating of “Moderate Buy” and an average price target of $11.67.

PolyPid Company Profile

PolyPid Ltd. (NASDAQ: PYPD) is a clinical-stage biopharmaceutical company focused on developing locally administered therapies designed to provide controlled and sustained drug release at treatment sites. The company’s technology is intended to maintain therapeutic drug concentrations over extended periods while limiting systemic exposure. PolyPid’s lead product candidate is D-PLEX100, an investigational formulation based on doxycycline and the company’s proprietary PLEX polymeric matrix. It is being developed for the prevention of surgical-site infections, initially in patients undergoing colorectal surgery.