On Thursday, Shares of Discovery Laboratories, Inc. (NASDAQ:DSCO), lost -40.43% to $0.280.
Discovery Laboratories, stated top line data from its recently accomplished AEROSURF® phase 2a clinical program in premature infants 29 to 34 week gestational age (GA) receiving nasal continuous positive airway pressure (nCPAP) for respiratory distress syndrome (RDS). The two-part program enrolled a total of 80 premature infants counting 40 infants in five AEROSURF dose groups and 40 control infants on nCPAP alone. The Company formerly declared top line data from the initial trial in May 2015. The Company is now reporting data on the overall phase 2a program in premature infants 29 to 34 week GA counting the recently accomplished phase 2a expansion study. The data are encouraging and suggest that aerosolized KL4 surfactant delivered to premature infants with RDS is generally safe and well tolerated and may decrease nCPAP failure and the need for intubation. The Company is now advancing AEROSURF to a phase 2b clinical trial starting with enrollment of premature infants 29 to 32 week GA.
Discovery Laboratories, Inc., a specialty biotechnology company, focuses on developing products for critical-care patients with respiratory disease and improving care in pulmonary medicine.
Shares of Derma Sciences Inc (NASDAQ:DSCI), declined -27.8% to $4.04, during its last trading session.
Derma Sciences, declares the termination of its Phase 3 clinical trials with aclerastide (DSC127) for diabetic foot ulcer healing. This action is based on futility determinations conducted by the Data Monitoring Committee (DMC) for the planned, pre-specified interim analyses regarding the primary efficacy endpoint of confirmed complete wound closure of the target ulcer within 12 weeks of the start of treatment. The decision to end the studies followed the recommendation by the DMC to stop enrollment in the studies. The DMC also stated that there were no safety concerns attributed to aclerastide.
“We are very disdesignated with the findings of the analyses of the DMC, but are grateful for the support and commitment from the participating patients and the study investigators,” said Edward J. Quilty, chairman and chief executive officer of Derma Sciences. “We have stopped further enrollment and initiated an orderly termination of the aclerastide trials and program, which we believe will be substantially complete by year end. We are also halting all development work with DSC127 in scar reduction and radiation dermatitis.”
The development program termination eliminates a projected cash burn of about $5 million per quarter in 2016. As of September 30, 2015 Derma Sciences had $49.4 million of cash and cash equivalents and $12.0 million of long-term investments. The Company’s primary focus is to continue to grow its advanced wound care net sales and improvement gross margins. The Derma Sciences Board of Directors and senior administration are committed to a path of profitable growth and positive operating cash flow in 2016, counting assessing all aspects of the Company’s operations and infrastructure that could enhance shareholder value.
Derma Sciences, Inc. operates as a tissue regeneration company in the wound care market. Its Advanced Wound Care segment offers MEDIHONEY dressings for managing non-chronic and hard-to-heal wounds, counting chronic ulcers, burns, and post-operative wounds; TCC-EZ system for patients with diabetic foot ulcers; AMNIOEXCEL for tissue repair, reconstruction, and replacement; and AMNIOMATRIX that is used as a wound covering in the treatment of localized tissue defects.
Finally, Shares of Fresh pet Inc (NASDAQ:FRPT), ended its last trade with -24.97% loss, and closed at $6.28.
Freshpet, stated financial results for its third quarter ended September 30, 2015.
Third Quarter 2015 Financial Highlights Contrast to Preceding Year Period
- Net sales were $30.6 million, up 35.8%
- Adjusted EBITDA raised $1.2 million to $2.3 million
- Freshpet Fridges raised 13.1% to 14,670 from 12,970
Year to Date Fiscal 2015 Financial Highlights Contrast to Preceding Year Period
- Net sales were $86.0 million, up 38.1%
- Adjusted EBITDA raised $5.5 million to $7.1 million
“In the third quarter, net sales raised 36%, driven by raised velocity per fridge, demonstrating continued consumer demand for Fresh pet’s simple, natural pet foods,” said Richard Thompson, Fresh pet’s Chief Executive Officer. “We made meaningful progress across several areas of our business, however, we practiced lower than predictable Fresh pet Fridge growth and our gross margin was negatively affected by manufacturing inefficiencies from new product innovation and the near term cost of adjusting processes on our primary products. As a result, we have updated our annual guidance to reflect these headwinds, and are intently focused on the execution of our operational and financial objectives. Going forward, we will further improve our manufacturing costs and processes, drive greater leverage across our business model and in turn, enhance long-term shareholder value.”
Third Quarter 2015
Net sales raised 35.8% to $30.6 million contrast to $22.5 million in the third quarter of 2014. Net sales for the third quarter of 2015 was driven by raised velocity across all channels and comprises $1.8 million associated with the Company’s Fresh pet Baked test product. The Company also practiced an improvement in Fresh pet Fridges, to 14,670 from 12,970 in the third quarter of 2014.
Gross profit was $14.0 million, or 45.9% of net sales, contrast to $10.9 million, or 48.3% of net sales for the same quarter last year. The decrease in gross profit margin was due to lower margin contribution from the Company’s Fresh pet Baked test product, which reduced third quarter 2015 gross margin by about 100 basis points. In addition, manufacturing throughput constraints associated new product innovation in addition to start-up costs from the implementation of new manufacturing processes further reduced gross margin by about 140 basis points.
Selling, general and administrative expenses (“SG&A”) were $15.6 million contrast to $12.2 million for the same quarter last year. As a percentage of net sales, SG&A reduced to 51.0% from 54.2% in the third quarter of 2014. After adjusting $1.3 million and $0.2 million for non-cash items related to stock-based compensation and the fair valuation of warrants in 2015 and 2014, respectively, SG&A reduced as a percentage of net sales to 46.8% from 53.2% of net sales in the third quarter of 2014.
Freshpet, Inc. manufactures and markets natural fresh foods, refrigerated meals, and treats for dogs and cats in the United States and Canada. The company offers its products under the Freshpet, Dognation, and Dog Joy names.