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Biotech investors interested in seeing more details about these companies and a full list of their related stories can do so by typing the stock ticker symbol into the Stock Quotes box on the right side of the page.Acorda Therapeutics, Inc. (Nasdaq: ACOR) announced Ron Cohen, M.D., President & CEO, will present at the upcoming Lazard Capital Markets 6th Annual Healthcare Conference on Tuesday, November 17, 2009 at 3:10 p.m. ET at the St. Regis Hotel in New York, NY.Agilent Technologies Inc. (NYSE:A) announced it has purchased the MassCode Tag technology from Eurofins MWG Operon, a division of Eurofins.
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(Nasdaq: ENZN) announced data from its pipeline programs will be presented at the 2009 EORTC-NCI-AACR (European Organization for Research and Treatment of Cancer-National Cancer Institute-American Association for Cancer Research) annual meeting being held November 16-19, 2009 in Boston, Massachusetts.Exact Sciences Corp. (Nasdaq: EXAS) announced it will present at the Lazard Capital Markets Sixth Annual Healthcare Conference, which is being held Nov. 17-18, at the St. Regis Hotel in New York.Health Grades, Inc. (Nasdaq: HGRD), the leading healthcare ratings company, announced Kerry Hicks, President and Chief Executive Officer of Health Grade, will be presenting at the Sidoti & Company, LLC New York II Emerging Growth Institutional Investor Forum at The Grand Hyatt Hotel in New York on Friday, November 20, 2009, at 8:30 a.m. Eastern time.Inovio Biomedical Corporation (NYSE AMEX: INO) reported financial results for the three and nine months ended September 30, 2009.Mead Johnson Nutrition Company (NYSE: MJN) announced it intends to file a Registration Statement on Form S-4 with the Securities and Exchange Commission (SEC), which includes details of a proposed exchange offer whereby Bristol-Myers Squibb Company (BMS) shareholders can exchange some, none or all of their shares of BMS common stock for shares of Mead Johnson common stock.Metabolix, Inc. (NASDAQ: MBLX), a bioscience company focused on developing sustainable solutions for plastics, chemicals and energy, announced the complete on of its previously announced underwritten public offering of 3,450,000 shares of its common stock at a price of $9.00 per share for gross proceeds of approximately $31 million. NovaDel Pharma Inc. (NYSE:NVD), a specialty pharmaceutical company developing oral spray formulations for a broad range of marketed treatments, reported financial results for its third quarter and nine months ended September 30, 2009.Neogen Corporation (Nasdaq: NEOG) announced that its Board of Directors has approved a 3-for-2 stock split. OSI Pharmaceuticals, Inc. (NASDAQ: OSIP) announced the Oncologic Drugs Advisory Committee (ODAC) will review the use of Tarceva® (erlotinib) as a first-line maintenance therapy for patients with advanced non-small cell lung cancer (NSCLC) who have not progressed following first-line treatment with platinum-based chemotherapy at its December 16, 2009 meeting.PPD, Inc. (Nasdaq: PPDI) announced it has entered an agreement with Janssen Pharmaceutica N.V. to develop and commercialize two Phase II-ready therapeutic compounds, one to treat diarrhea-predominant irritable bowel syndrome (IBS-d) and the other to treat complicated skin and skin structure and respiratory infections.Roche`s (SWX:RO) (SWX:ROG) (Pink Sheets: RHHBY) RealTime ready Influenza A/H1N1 Detection Set for the 2009 H1N1 influenza virus has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA). Spectrum Pharmaceuticals, Inc. (NasdaqGM:SPPI), a commercial-stage biotechnology company with a primary focus in oncology, announced it has been selected for addition to the NASDAQ Biotechnology Index® (Nasdaq: NBI).Targacept, Inc. (NASDAQ: TRGT), a clinical-stage biopharmaceutical company developing a new class of drugs known as NNR Therapeutics™, announced it has been selected for addition to the NASDAQ Biotechnology Index (NASDAQ: NBI) effective with the U.S. market open on Monday, November 23, 2009.ZOLL Medical Corporation (Nasdaq GS: ZOLL), a manufacturer of medical devices and related software solutions, announced the R Series® defibrillators with new monitoring capability added as well as its new intravascular temperature management solutions are being exhibited in Booth #1417 at the American Heart Association Scientific Sessions 2009 November 15-17th at the Orange County Convention Center in Orlando.
The corporate presentation for wound care specialist Derma Sciences (OTC:DSCI) is available in PDF format at the BioMedReports.com stock research section.
The presentation highlights the following about Derma Sciences: (1) new Advanced Wound Care Products are selling at a current run rate approaching $10 million in revenue, including total annualized MEDIHONEY revenues in excess of $3.5 million with a gross margin of 70%; (2) total revenues are expected to exceed $50 million in 2009 including sales from the introduction of four new advanced wound care products since 4Q08; and (3) an enterprise value for the Company that is about 0.5X trailing 12-month sales despite its recently launched wound dressing product, a strong novel pharmaceutical candidate for wound healing in Phase 2 development (at an estimated expense of $1.7M), and $3.5 million dollars in core business EBITDA to help support future growth/R&D initiatives.
As of its corporate presentation dated 8/21/09, Derma Sciences reported that it continues to move forward with a Phase 2 clinical trial of DSC127, which has the potential to be only the second approved drug on the market for accelerated wound healing. The Company stated that 33% of patients are currently enrolled in a Phase 2 diabetic foot ulcer study. DSC127 (which is an analog of a naturally occurring peptide called Angiotensin that has been shown to increase keratinocyte proliferation, increase extracellular matrix production, and increase vascularization) was licensed from the University of Southern California during 4Q07 and patient enrollment for a Phase 2 study began during 4Q08.
This study of 75 patients will look at the percentage of diabetic ulcers completely healed over a 12-week period in addition to other outcomes. Histological examination reveals that DSC127 accelerates collagen deposition six-fold and the patented amino acid peptide optimizes the wound healing capabilities of Angiotensin while removing all blood pressure effects of the compound. The Phase II results for the DSC127 Diabetic Ulcer trial are scheduled for release during early 3Q10, with an estimated date for this entry of 7/31/10.
Systagenix, which is a division of Johnson & Johnson (NYSE:JNJ), currently markets Regranex as the only FDA-approved treatment for wound healing with annual sales of about $100M. However, this product carries a black box warning that states, "An increased risk of mortality secondary to malignancy was observed in patients treated with three or more tubes of Regranex Gel in a post-marketing retrospective cohort study. . . should be used with caution in patients with known malignancy." In addition, DSC127 has been shown in pre-clinical animal studies to be more effective than Regranex and Shire (NASDAQ:SHPGY) licensed the rights to a scar prevention drug (Juvista or Human TGFbeta3) from UK-based Renovo (LON:RNVO) (ROVOF.PK) in June 2007 which was in late Phase 2 development at the time (now in Phase 3 trials) in a deal that included $75M in up-front cash, milestone-related payments that could total approximately 10X the up-front payment, and future sales royalties if approved for marketing.
Derma Sciences reported that gross U.S. MEDIHONEY sales increased by 125% and 94% to $664,766 and $1.14 million (M) during 2Q09 and 1H09, respectively, compared to the year-ago periods. The Company also announced record first-month sales of $58,458 for BIOGUARD, which was launched in late June and represents a new anti-microbial advanced wound care product. Gross sales of key new advanced wound care products in the U.S. increased by 93% during 1H09 to a level of $2.14M versus $1.1M in the year-ago period.
On 7/27/09, the Company announced that a paper published in the European Journal of Clinical Microbiological Infectious Diseases details how a certain kind of honey can be an effective agent in topical wound care, particularly where antibiotic resistance is an issue. The report describes the palliative effects of Leptospermum honey, which contains unique plant-derived components that make it an ideal wound dressing with favorable properties that include low pH levels, the ability to help remove non-vital tissue from the wound area, stimulate new tissue growth, and reported reduction in scarring and pain levels. This study adds to a growing base of scientific literature for medicinal honey and wound care, including 15 peer-review published journal articles and 25 clinical posters or abstracts presented at major wound care conferences since the Company launched MEDIHONEY.
The paper concluded that honey is an effective topical antimicrobial agent that could help reduce some of the current pressures that are promoting antibiotic resistance. Derma Sciences has strong IP (intellectual property, patents) around dressing configurations that include honey, exclusive rights for MEDIHONEY in the Americas (with the expectation of obtaining worldwide rights by the end of 2009), and a partnership with New Zealand-based Comvita, which controls 75% of the Leptospermum honey harvested. MEDIHONEY dressings, a unique line of products containing active Leptospermum honey, provide a moist, occlusive environment conducive to optimal wound healing, enabling them to work effectively in the presence of wound fluid, blood, and tissue, promoting an optimal healing environment.
BIOGUARD Barrier Dressings provide a barrier to bacterial contamination while also providing greater than 5-log (99.999%) average reductions of common pathogens within the dressings with a distinguishing feature that includes the ability to function even in the presence of wound fluid and blood. The active component of the dressings is a non-toxic polymer (p-DADMAC) that is patented for use in wound dressings and licensed on an exclusive basis since 2007 from Quick-Med Technologies (QMDT.OB). Also, the active component is non-leaching, which is an important feature since leaching antimicrobials can interfere with wound healing and lead to the development of resistant strains of microbial pathogens.
Overall net sales came in at $11.6M and $22M during 2Q09 and 1H09, respectively, compared to $13.1M and $24.8M in the year-ago periods. The revenue decline was principally driven by lower sales from the First Aid Division, which the Company attributed to a weakening of the economy and a decrease in Canadian net sales attributable to unfavorable foreign currency exchange and inventory rationalization on the part of its exclusive Canadian distributor. During 1H09, the majority of the Company's sales occurred in the U.S. market (73%) with 22% of sales occurring in Canada. However, the Company noted that despite the sales decline for the First Aid division, gross margins for this segment have improved during 2009.
The Company's gross profit margin increased to 29.6% and 30.8% during 2Q09 and 1H09, respectively, as compared to 27% and 26.9% in the year-ago periods. Derma attributed the increase in gross profit margin to cost-effective manufacturing for its First Aid division combined with growth in its higher margin advanced wound care business. Selling, general, and administrative expenses decreased by 17.4% and 14% during 2Q09 and 1H09, respectively, compared to the year-ago periods.
Derma Sciences posted a net loss of $560,502 or ($0.01/share) and $1.3M or ($0.03/share) during 2Q09 and 1H09, respectively, as compared to the year-ago periods. The Company's posted an impressive improvement in its overall cash flow during 1H09 as it generated positive cash flow from operating activities of $198,492 as compared to the use of $5.26M in cash from operating activities in the year-ago period. The Company ended 2Q09 with about 40.3M shares of common stock outstanding, $167,040 in unrestricted cash + equivalents, $11.5M of inventories, restricted cash of $2M (reflecting the amended credit and security agreement with use subject to approval by the lender), accounts receivable of $3.2M, total current liabilities of $9.2M (including $3.8M in amended line of credit borrowings and $2.6M in accounts payable), and long-term debt of $2.9M.
As of 6/30/09, the Company had warrants outstanding to purchase 8.8M shares of its common stock at a weighted average price of about $0.98 over a period of five expiration dates ranging from April 2011 to March 2014. In addition, Derma Sciences has 9.4M options outstanding and 6.6M which are exercisable at the end of 2Q09 with average exercise prices of $0.63 and $0.68, respectively. The Company had a total of 25.1M shares of common stock shares reserved as of 6/30/09, which include the warrants and options outlined above in addition to convertible preferred shares and restricted common stock.
The Company consists of the following three operating segments: wound care, wound closure and specialty securement devices and skin care. Products in the wound care segment account for about 94% of total net sales and 91.4% of gross profits through 1H09 and this division consists of basic + advanced dressings, adhesive strips, ointments, and sprays. Wound closure and specialty securement device products include wound closure strips, nasal tube fasteners, and a variety of catheter fasteners while the skin care segment consists of antibacterial skin cleansers, hair and body soaps, lotions, and moisturizers.
Derma Sciences has an impressive track record with regard to insider ownership and open market buying and as of the Company's 8/21/09 corporate presentation there is 17% insider + 63% institutional ownership of the outstanding shares of common stock. Excluding the recent option grants at a zero cost basis on 6/1/09 for a total of 150,000 shares; insiders have purchased 228,100 shares of common stock since 12/3/07 at a weighted average cost basis of $0.56/share, which represents a 36.5% premium to the closing stock price on 8/27/09 of $0.41/share.
Derma Sciences presents a unique opportunity in the micro-cap biomed space since it has a core business focused on wound care which generates revenue and operating cash flow to fund the Phase 2 clinical development for a treatment (DC127) that targets a prescription drug market that is about 5X the Company's current market cap (based on Regranex sales of $100M). In addition, pre-clinical data suggests DC127 may offer both safety and efficacy advantages over Regranex and the licensing deal by Shire for a scar prevention treatment that included a $75M up-front payment suggests Derma Sciences has the potential to secure a licensing deal that could include an up-front cash payment in excess of its current market cap of around $20M.
Derma Sciences (OTC:DSCI) (DSCI.OB) is a truly unique and highly undervalued company within the micro-cap biomed space which currently targets a prescription drug market that is about 5x its present market cap.
The company is developing a patented topical drug for accelerated healing and scar prevention and newly launched Advanced Wound Care products approaching $10M, including the highly received MEDIHONEY, and BIOGUARD, both of which have garnered tremendeous success and continue to increase sales annually. The real gem however lies within their DSC127 phase II pipeline drug. Derma Sciences reported that it continues to move forward with clinical trials of DSC127, which has the potential to be only the second approved drug on the market for accelerated wound healing, a market with over $100M in sales anually.
Derma Sciences, Inc. is a fully integrated manufacturer, marketer and supplier of a complete line of products for wound and skin care. The products can be broken down into five categories: Advanced Wound Care, Traditional Wound Care, Burn Care, Skin Care and Bathing, and Specialty Securement and Closure Devices. With two wholly owned and operated manufacturing facilities in Toronto and China, they also offer exceptional contract manufacturing services for OEM or private label products.Derma Sciences recently gave an Investor Relations presentation which shed light on key financial statistics, cash flows and revenues. The presentation highlights the following about Derma Sciences: (1) new Advanced Wound Care Products are selling at a current run rate approaching $10 million in revenue, including total annualized MEDIHONEY revenues in excess of $3.5 million with a gross margin of 70%; (2) total revenues are expected to exceed $50 million in 2009 including sales from the introduction of four new advanced wound care products since 4Q08; and (3) an enterprise value for the Company that is about 0.5X trailing 12-month sales despite its recently launched wound dressing product, a strong novel pharmaceutical candidate for wound healing in Phase 2 development (at an estimated expense of $1.7M), and $3.5 million dollars in core business EBITDA to help support future growth/R&D initiatives.Like silver, honey has been used for centuries for its antimicrobial properties. Most regular honeys possess the ability to provide antimicrobial properties for limited times within a wound.
MEDIHONEY dressings provide a moist, occlusive environment conducive to optimal wound healing. As wound exudate is absorbed, the
alginate forms a gel, making the dressings easy to remove without disrupting the wound bed. The dressings are indicated for the management of moderate to heavily exuding wounds such as:
diabetic foot ulcers
Venous stasis leg ulcers
Arterial leg ulcers
Leg ulcers of mixed etiology
Pressure ulcers (I-IV)
1st and 2nd degree burns
Donor sites
Traumatic and surgical wounds
Derma Sciences reported that gross U.S. MEDIHONEY sales increased by 125% and 94% to $664,766 and $1.14 million (M) during 2Q09 and 1H09, respectively, compared to the year-ago periods.
MEDIHONEY was also the focus of a major press conference at North Shore Long Island Jewish Hospital in Manhasset, NY. At the press conference, clinicians detailed the case of a patient who appeared to be heading towards a lower extremity amputation (LEA) due to a non-healing wound associated with an extremely rare fungal infection.
According to Mary Brennan, RN, CWOCN, Clinical Nurse Specialist for Wounds at North Shore, “MEDIHONEY helped to turn this wound around for him and allowed us back on track for healing. We had used other therapies, but this was the product that made the difference in a very short time.”
There are over 50,000 LEAs each year in the United States alone. The 3-year mortality rate post-LEA is estimated to be around 50%.BIOGUARD provides a barrier to bacterial contamination while also providing greater than 5-log (99.999%) average reductions of common pathogens within the dressings with a distinguishing feature that includes the ability to function even in the presence of wound fluid and blood. The active component of the dressings is a non-toxic polymer (p-DADMAC) that is patented for use in wound dressings and licensed on an exclusive basis since 2007 from Quick-Med Technologies (QMDT.OB). Also, the active component is non-leaching, which is an important feature since leaching antimicrobials can interfere with wound healing and lead to the development of resistant strains of microbial pathogens.
The Company announced record first-month sales of $58,458 for BIOGUARD, which was launched in late June and represents a new anti-microbial advanced wound care product. Gross sales of key new advanced wound care products in the U.S. increased by 93% during 1H09 to a level of $2.14M versus $1.1M in the year-ago period.
DSC127 – Accelerated Wound Healing
DSC127 is an analog of a naturally occuring peptide, Angiotensin, and was developed at the University of Southern California. It has been shown to increase keratinocyte proliferation, increase extracellular matrix production, and increase vascularization. Additionally, histological examination has shown that DSC127 accelerated collagen deposition six-fold. All these help to accelerate dermal tissue repair. The patented amino acid peptide optimizes the wound healing capabilities of Angiotensin while removing all blood pressure effects of the compound.
Extensive pre-clinical studies have demonstrated the efficacy of the compound in accelerating healing and reducing scar formation. Pre-clinical studies thus far have shown:
Improved in-growth of host tissue into artificial skins
Accelerated healing in full thickness skin excision wounds in rats and diabetic mice
Accelerated healing in partial thickness thermal injuries in guinea pigs
Accelerated healing in a random flap skin model in rats Improved scar reduction in rats
A Phase I safety study in humans was completed in Q4 2007, and patients are currently enrolling into the Phase II efficacy study. This study of 75 patients will look at percentage of diabetic ulcers completely healed over a 12-week period, among other outcomes.More importantly, DSC127 has shown to have a significant competitive and medical advantage over its rival Systagenix, which is a division of Johnson & Johnson (NYSE:JNJ). J&J currently markets Regranex as the only FDA-approved treatment for wound healing with annual sales of about $100M. However, this product carries a black box warning that states, “An increased risk of mortality secondary to malignancy was observed in patients treated with three or more tubes of Regranex Gel in a post-marketing retrospective cohort study. . . should be used with caution in patients with known malignancy.” In addition, DSC127 has been shown in pre-clinical animal studies to be more effective than Regranex and Shire (NASDAQ:SHPGY) licensed the rights to a scar prevention drug (Juvista or Human TGFbeta3) from UK-based Renovo (LON:RNVO) (ROVOF.PK) in June 2007 which was in late Phase 2 development at the time (now in Phase 3 trials) in a deal that included $75M in up-front cash, milestone-related payments that could total approximately 10X the up-front payment, and future sales royalties if approved for marketing.As with any company, insider and institutional holders represent a sense of stability and reassurance for potential investors. Derma Sciences does not disappoint in this aspect, maintaining an impressive track record with regard to insider ownership and open market buying. As of the Company’s 8/21/09 corporate presentation there is 17% insider + 63% institutional ownership of the outstanding shares of common stock.Derma Sciences presents a unique opportunity in the micro-cap biomed space since it has a core business focused on wound care which generates revenue and operating cash flow to fund the Phase 2 clinical development for a treatment (DC127) that targets a prescription drug market that is about 5X the Company’s current market cap (based on Regranex sales of $100M). In addition, pre-clinical data suggests DC127 may offer both safety and efficacy advantages over Regranex and the licensing deal by Shire for a scar prevention treatment that included a $75M up-front payment suggests Derma Sciences has the potential to secure a licensing deal that could include an up-front cash payment in excess of its current market cap of around $20M.
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Disclosure: Position in DSCI
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Derma Sciences is a truly unique and highly undervalued company within the micro-cap biomed space which currently targets a prescription drug market that is about 5x its present market cap. The company is developing a patented topical drug for accelerated healing and scar prevention and newly launched Advanced Wound Care products approaching $10M, including the highly received MEDIHONEY, and BIOGUARD, both of which have garnered tremendeous success and continue to increase sales annually.[More...]
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