In our August 2009 article titled “Treating Parkinson’s Disease: Investment Opportunities and Challenges,” we reviewed some of the historical challenges associated with developing treatments for Parkinson’s disease [PD] and cited reasons for optimism going forward in addition to highlighting several promising companies making progress. Since that time, many of the companies we featured have reported clinical progress, presented promising new data, and produced significant returns for investors – with several stocks reaching 52-week highs. In view of renewed investor enthusiasm for companies working in the area of PD, the purpose of this article is to provide an update on previously mentioned companies and introduce some new players that are making headlines in the PD space.

Improvements on Existing Therapies

(SRDX) SurModics Misses Earnings Estimates

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.

Array BioPharma Inc. (Nasdaq:ARRY) will report financial results for the first quarter of fiscal 2010 on Monday, November 2, 2009, and will hold a conference call on Tuesday, November 3, 2009 at 9:00 a.m. eastern time to discuss these results.

Alexion Pharmaceuticals, Inc. (Nasdaq:ALXN) announced Dr. Leonard Bell, Chief Executive Officer of Alexion Pharmaceuticals, will present at the 20th Annual Healthcare Conference in New York City at 3:55 p.m. ET on Wednesday, November 4, 2009.

Clinical Data, Inc. (NASDAQ:CLDA) announced it has raised gross proceeds of approximately $47.4 million through the public offering of 2,750,000 newly issued shares of its common stock at a price of $17.25 per share.

Somaxon Pharmaceuticals, Inc. (NASDAQ:SOMX) announced it will release its 2009 third quarter financial results after the market closes on Thursday, November 5, 2009.

SciClone Pharmaceuticals, Inc. (NASDAQ:SCLN) announced a corporate restructuring will reduce its U.S.-based workforce by approximately 17%, primarily in research and development.

Safeguard Scientifics, Inc. (NYSE:SFE), a holding company builds value in growth-stage life sciences and technology companies, announced it led a $17.4 million Series B financing round for Quinnova Pharmaceuticals, Inc., with participation from existing investors Thomas, McNerney & Partners and H.I.G. BioVentures.

A.P. Pharma (Nasdaq:APPA), a specialty pharmaceutical company, announced on October 26, 2009, the Company received notice the Nasdaq Listing Qualifications Panel (Panel) has granted the Company’s request to transfer the listing of the Company’s common stock from The Nasdaq Global Market to The Nasdaq Capital Market, which will take effect with the opening of the market on Wednesday, October 28, 2009.

CardioNet, Inc. (NASDAQ:BEAT) announced the U.S. Patent and Trademark office has granted patent number 7,587,237 (“Biological Signal Management”) to CardioNet.

Neoprobe Corporation (OTC:NEOP), a diversified developer of innovative oncology surgical and diagnostic products, announced it would report its financial results for the third quarter of 2009 on Monday, November 2, 2009 after the close of the financial markets.

Alcon, Inc. (NYSE:ACL) reported global sales rose 5.9 percent to $1,614 million for the third quarter of 2009, or a 9.0 percent increase excluding the impact of foreign exchange fluctuations.

Antares Pharma, Inc. (NYSE:AIS) announced Dr. Paul K Wotton, Ph.D., President and Chief Executive Officer, will present at the 20th Annual Oppenheimer Healthcare Conference on Tuesday, November 3, 2009 at 4:30 pm ET (Eastern Time).

Nektar Therapeutics (Nasdaq:NKTR) announced it has completed enrollment ahead of schedule in its Phase 2 clinical study of NKTR-102 in platinum-resistant ovarian cancer.NKTR-102 is Nektar's investigational proprietary compound currently being evaluated in Phase 2 clinical development in ovarian, breast and colorectal cancers.

Arrayit Corporation (OTC:ARYC) announced the sale of a system to the Center of Excellence for Nucleic Acid-Based Technologies (CENAT) in Poznan, Poland.

Enzon Pharmaceuticals, Inc. (NASDAQ:ENZN) announced it will report its financial results for the quarter ended September 30, 2009, on Tuesday, November 3, 2009 at approximately 8:00 am Eastern Time (ET).

Advaxis, Inc., (OTC:ADXS), the live, attenuated Listeria monocytogenes (Lm) biotechnology company, completed a second Company-run debt financing, as of October 26, 2009.

BioSphere Medical, Inc. (NASDAQ:BSMD) – the pioneer in the use of bioengineered microspheres to treat uterine fibroids, hypervascularized tumors and vascular malformations by a minimally invasive, image-guided medical procedure called embolotherapy –reported financial results for the three and nine months ended September 30, 2009.

Phase Forward Incorporated (NASDAQ:PFWD), a leading provider of data management solutions for clinical trials and drug safety, announced it will be hosting an analyst session on Wednesday, November 4, 2009, in conjunction with the Phase Forward 8th Annual International Users Conference in Boston, MA.

SurModics, Inc. (Nasdaq: SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, announced it will host a live webcast of its fourth quarter and fiscal year 2009 conference call on Wednesday, November 4, at 4:00 p.m. CT.

Genta Incorporated (OTC:GETA) announced the Company will host a conference call and live audio webcast to review top-line results of its Phase 3 trial of Genasense® in patients with advanced melanoma.

UnitedHealth Group (NYSE:UNH) announced the company has appointed both Christopher J. Walsh and Mitchell Zamoff to the position of executive vice president and general counsel, effective immediately.

CNS Response, Inc. (OTC:CNSO) announced that the company will present top-line results from its multi-site clinical trial next week at the U.S. Psychiatric and Mental Health Congress.

Bio Solutions Corp. (OTC:BISU) announced the introduction of their new website:  http://www.bio-solutionscorp.com".

Lannett Company, Inc. (NYSE:LCI), a manufacturer of generic pharmaceuticals, announced the company will release its fiscal 2010 first-quarter financial results on Monday, November 9, 2009.

Catalyst Health Solutions, Inc. (NASDAQ:CHSI), a pharmacy benefit management company, announced its financial results for the third quarter ended September 30, 2009.

SuperGen, Inc. (Nasdaq:SUPG), a pharmaceutical company dedicated to the discovery and development of novel cancer therapies, announced Mohammad Azab, M.D., Chief Medical Officer, will present at the Merriman Curhan Ford 6th Annual Investor Summit on Tuesday November 10, 2009 in New York.

Unigene Laboratories, Inc. (OTC:UGNE) will release financial results for the quarter ended September 30, 2009, after the market closes on Monday, November 9, 2009.

Emisphere Technologies, Inc. (OTC:EMIS) announced management will host a conference call to discuss the Company’s financial and operational results for the third quarter ended September 30, 2009 on Monday, November 9, 2009 at 10:00 AM EST.

BioClinica™, Inc. (NASDAQ:BIOC), a global provider of clinical trial services, announced its financial results for the quarter and nine months ended September 30, 2009.

Universal Detection Technology (OTC:UNDT), a developer of early-warning monitoring technologies to protect people from bioterrorism and other infectious health threats, announced it is expanding its product catalogue to include a consumer-ready kit for the detection of black mold.

Emdeon® (NYSE:EM), a leading provider of healthcare revenue and payment cycle management solutions, announced its eRx Network® will provide real-time electronic billing solutions to retail pharmacies for the nation's top 25 medical payers in light of the dramatic increase in H1N1 vaccinations being administered by pharmacies.

Phase Forward (NASDAQ:PFWD), a leading provider of data management solutions for clinical trials and drug safety, today announced its senior vice president and chief financial officer, Chris Menard, and senior vice president of integration and product strategy, Martin Young, will present at the 18th Annual Credit Suisse Healthcare Conference at the Arizona Biltmore Hotel in Phoenix, Arizona.

Medidata Solutions (NASDAQ:MDSO), a leading global provider of hosted clinical development solutions, announced a multi-year contract extension with Shire plc (NASDAQ:SHPGY) for use of Medidata Grants Manager™ and CRO Contractor™ benchmarking and analysis tools for investigator site and contract research organization (CRO) trial budget planning and forecasting.

Opexa Therapeutics, Inc. (NASDAQ:OPXA), a company developing a novel T-cell therapy for multiple sclerosis (MS), reported financial results for the quarter ended September 30, 2009, and provided details on further developments.

AcuMedSpa Holdings, Inc. (OTC:AMSZ) is pleased to announce that it has reached an agreement with Santa Barbara Medical Innovations (SBMI) to become a preferred provider of the popular Zerona protocol which is a proven, non-invasive cold laser solution for unwanted body fat as well as for body slimming and contouring. Zerona has been featured in dozens of magazines and on TV shows such as "Rachael Ray," "Extra" and "The Doctors."

Advanced Life Sciences Holdings, Inc. (OTC:ADLS), announced it will host a conference call and webcast discussing the Company's 2009 third quarter results on Tuesday, November 10, 2009 at 10:00 a.m. (EST).

InterMune, Inc. (Nasdaq:ITMN) announced it has submitted an electronic New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA) seeking approval to market pirfenidone for the treatment of patients with idiopathic pulmonary fibrosis (IPF).

Javelin Pharmaceuticals, Inc. (NYSE:JAV) announced its CEO, Martin J. Driscoll, and Stephen J. Tulipano, CFO, will host a conference call to discuss the Company's quarterly results for the period ending September 30, 2009.

Lannett Company, Inc. (NYSE:LCI), a manufacturer of generic pharmaceuticals, announced the company will release its fiscal 2010 first-quarter financial results on Monday, November 9, 2009.

Unilife Medical Solutions Limited (OTC:UNIFF) (Unilife Australia) entered into a Merger Implementation Agreement with Unilife Corporation (Unilife USA) to facilitate the proposed redomiciliation of the Unilife group in the United States of America (Proposed Transaction).

Aeolus Pharmaceuticals, Inc. (OTC:AOLS) reported researchers from National Jewish Health and McGill University have completed a series of preliminary studies demonstrating that AEOL 10150 protects lungs from chlorine gas exposure in mice.

Pro-Pharmaceuticals, Inc. (OTC:PRWP) announced it has closed a $310,000 tranche of a private placement of up to $6.0 million with 10X Fund, L.P., which is purchasing unregistered Series B convertible preferred stock and warrants.

Affymax, Inc. (Nasdaq:AFFY) and Takeda Pharmaceutical Global Research & Development Center, Inc., announced data from a Phase 2 clinical trial of Hematide™ showing that Hematide increased hemoglobin and reduced or eliminated the need for blood transfusion in most patients with erythropoietin-induced pure red cell aplasia (PRCA).

Alkermes, Inc. (NASDAQ:ALKS) announced its corporate presentation will be webcast live by Credit Suisse on Wednesday, November 11, 2009, at 5:00 p.m MT (7:00 p.m. ET) from the Arizona Biltmore Hotel in Phoenix, Arizona.

Flamel Technologies (Nasdaq:FLML) expects to release its financial results for the third quarter of 2009 the morning of November 16th, before the market opening.

Neurogen Corporation (NASDAQ:NRGN), a drug development company, announced it will release its third quarter 2009 financial results on Friday, November 6, 2009 before the opening of the U.S. financial markets.

Santarus, Inc. (NASDAQ:SNTS), a specialty biopharmaceutical company, reported financial and operating results for the quarter ended September 30, 2009.

Genta Incorporated (OTC:GETA) announced the Company will release its third quarter 2009 financial results on Monday, November 16, 2009.

Gilead Sciences, Inc. (Nasdaq:GILD) announced its corporate presentation will be webcast from the 18th Annual Credit Suisse Healthcare Conference in Phoenix.

SurModics, Inc. (Nasdaq:SRDX), a leading provider of drug delivery and surface modification technologies to the healthcare industry, reported financial results for the fourth quarter and fiscal year ended September 30, 2009.

SurModics’ (SRDX) fourth-quarter earnings per share came in at 18 cents, below the Zacks Consensus Estimate of 20 cents. The company reported revenues of $19.2 million, down 17% compared to the year ago period. In addition to quarterly results, SurModics came out with fiscal year 2009 results. The company recorded revenues of $121.5 million in 2009, up 25%, compared to $97 million in the previous year and earnings per share of $1.07 for 2009.

On a business unit basis, apart from Diagnostic, revenues from the other three segments – Cardiovascular, Ophthalmology and Other Markets, recorded a decline in revenues for the fourth quarter. While Diagnostic revenues increased 2% year over year to $4.6 million, revenues for the other three segments declined 12% to $9.8 million, 29% to $1.9 million and 41% to $2.9 million, respectively.

Cardiovascular segment results were impacted by the continuing decline in Cypher sales. SurModics derives a substantial majority of its drug delivery revenue from the Cypher stent, which is marketed by Johnson & Johnson’s (JNJ) Cordis division. However, Cypher faces stiff competition from Boston Scientific Corp.’s (BSX) Taxus drug-eluting stent, and stents from Medtronic (MDT) and Abbott Vascular, a division of Abbott (ABT). Johnson & Johnson reported a 27% year over year decline in Cypher sales which came in at $211 million.

Although the Ophthalmology segment did not perform well this quarter, we expect it to improve based on the company’s recent agreement with Genentech.

Revenues in each of the four business units are derived from three primary sources: royalties and license fees from licensing patented surface modification and drug delivery technologies and in vitro diagnostic formats to customers; the sale of reagent chemicals to licensees of its technologies, stabilization products to the diagnostics industry and coated glass slides to the genomics market; research and development fees generated on customer projects.

For the reported quarter, royalties and license fees accounted for 49% of total revenues with product sales and research and development, accounting for 29% and 22%, respectively. Despite a 15% decline in operating expenses, operating margin declined to 20.7% compared to 22.9% in the fourth quarter of 2008.
 
At the end of the fourth quarter, SurModics had $20.6 million of cash and short term investments, down from $24.6 million at the end of September 2008. During the fiscal year, the company repurchased about $15 million of stock and is left with another $7 million for further repurchases.

SurModics, Inc. (SRDX)

Q4 2009 Earnings Call

November 4, 2009 5:00 PM

SurModics, Inc. (SRDX)

Q4 2009 Earnings Call

November 4, 2009 5:00 PM

(SRDX) Surmodics Inks Licensing Deal With Roche