|
 |
Below is a list of our clients attending the Cowen and Company 34th Annual Health Care Conference, March 4-6 in Boston. Please contact your Sales Representative at Cowen if you wish to schedule a meeting(s) with any of our public companies. If you wish to schedule a meeting(s) with one of our private clients, please email us at cknoll@bplifescience.com or call (415) 375-3340 Ext. 105 and we’ll do our best to accommodate your availability.
Cowen & Company 34th Annual Health Care Conference Blueprint Client Profiles
 | Cerus Corporation (NASDAQ: CERS) - Biomedical products company focused in the field of blood safety and a global leader in blood pathogen inactivation via commercialized INTERCEPT system for platelets and plasma. CERS continues to post significant sales growth, demonstrating 52% revenue growth in 2012 and 28% growth in 3Q13 over the comparable 2012 period. |
Profile:INTERCEPT blood system is commercialized in the EU, the Commonwealth of Independent States, the Middle East, and select countries in other areas of the world. In the U.S., the Company is advancing toward regulatory approval in both indications. In December, 2013, CERS announced it had submitted the fourth and final module toward an INTERCEPT plasma PMA in the U.S. The Company also filed the first of three modules for its INTERCEPT Platelets PMA in September, 2013. INTERCEPT platelet and plasma are currently utilized by over 100 centers across 20 EMEA countries.
Market Cap: $533M (as of February 18, 2014)
Cash:$53.3M (at September 30, 2013)
|
Key Catalysts & Upcoming Milestones
- Projected full year 2013 revenue guidance of $41-$43M (as reiterated on 3Q13 call)
- PMA application for INTERCEPT plasma completed last December in U.S.; FDA approval expected 2H14
- PMA application for INTERCEPT platelets expected to be complete by March, 2014 in U.S.; FDA approval expected 1Q15
- Cerus plans to file regulatory submission for INTERCEPT with Health Canada in 1H 2014
|
 | Sunshine Heart (NASDAQ: SSH) - Medical device company developing C-Pulse heart assist therapy, a minimally-invasive treatment for Class III and ambulatory Class IV heart failure. C-Pulse has received CE Mark certification and is now in a U.S. pivotal trial, initiated in November, 2012. |
Profile:C-Pulse therapy is unique in that it is non-blood contacting and offers patients the ability to disconnect from the device. C-Pulse received CE Mark certification in 2012 and is in an ongoing post-market study in the EU (OPTIONS HF), which has completed eight patient implants (as of January, 2014). In addition, the Company initiated a U.S. pivotal trial in November of 2012 for C-Pulse (COUNTER HF). Eight sites are currently activated with three patients enrolled in the trial to-date. The Company has developed an official weaning protocol for patients previously implanted with a C-Pulse device as part of the Company’s initial feasibility study. Four patients have been fully weaned from the device, demonstrating significant reduction in heart failure and heart failure related symptoms.
Market Cap:$152M (as of February 18, 2014)
Cash:$59.8M (at September 30, 2013)
|
Key Catalysts & Upcoming Milestones
- U.S. pivotal trial COUNTER HF finished 2013 with three enrollments, eight activated centers, and 22 additional centers committed to participate. Full enrollment in COUNTER HF is expected by year-end 2015
- Established weaning protocol will enable feasibility study patients with superior improvement in symptoms to disconnected from therapy going forward
- Developing a next-gen fully-implantable C-Pulse system offering increased safety profile and opening up new market for angina patients
- Successful acute and chronic animal studies now completed
- Executed over-subscribed $46M follow-on offering in September of 2013
|
 | Singulex (Private) - Next generation in vitro diagnostics company leveraging novel technology in Single Molecule Counting (SMC) to create new market for ultra-sensitive immunoassays. Commercial stage business anchored by robust CLIA lab revenues, which fund IVD R&D program |
Profile:In addition to developing ultra-sensitive immunoassays, Singulex’s SMC technology offers the potential to displace many molecular diagnostic testing platforms as well as expand protein discovery. Flagship Erenna system utilizes SMC to offer best-in-class sensitivity providing disease risk assessment earlier than standard of care solutions. Company is managing a growing open research platform contracted by 60 pharma and academia institutions worldwide along with a wholly-owned CLIA lab ($54M in 2013 revenues). |
Key Catalysts & Upcoming Milestones
- Exploring a U.S. IPO targeted for next 12 months
- 2013 revenue $65MM; 40% Y/Y growth
- Developing first in-house IVD panel featuring cardiac troponin I (inflammation panel for cardiovascular disease)
- Ramping up sales force in selected territories, driving Erenna installed base
- IVD clinical trial initiation anticipated in 2015; U.S. launch of first panel in 2016/2017
- New York State launch of cTnl testing thru CLIA lab services expected 2H2014
|
 | Alchemia (ASX: ACL) - Drug discovery and development company with an FDA approved drug (fondaparinux) and late stage oncology pipeline (Phase II and III). |
Profile: Alchemia is marketing FDA approved fondaparinux, an injectible antithrombotic in the US, as well as other major markets via partner Dr. Reddy’s Laboratories. The Company is also developing a late stage oncology product pipeline with multiple ongoing trials through its proprietary HyACT drug delivery platform, which targets anti-cancer drugs to solid tumours. Lead asset HA-Irinotecan is in a pivotal Phase III clinical trial for the treatment of metastatic colorectal cancer. HA-Irinotecan is also in two Phase II investigator-sponsored trials, one of which is in collaboration with Merck Serono combining HA-Irinotecan with Erbitux® (cetuximab). Alchemia is also exploring additional small molecule drug discovery targets via an internal discovery platform VAST, based on the Company’s deep chemistry expertise. The VAST technology is being developed in collaboration with leading academic institutions and is partnered with AstraZeneca AB. Erbitux® is a trademark of Merck KGaA.
Market Cap:A$189M (as of February 18, 2014)
Cash:$16.4M (at December 31, 2013)
|
Key Catalysts & Upcoming Milestones
- Data read-out for lead pivotal Phase 3 trial of HA-Irinotecan expected in 1H 2014
- Potential partnership deal to commence commercialization process for HA-Irinotecan planned for 2014
- Licensing activities for HA-Irinotecan de-risk and provide flexibility with fondaparinux revenue stream
- Fondaparinux growth and stabilization in 2014 forecasted from improved manufacturing costs, profit share arising from ROW sales and continued competitiveness of US sales force
- Dr Reddy’s plans to launch fondaparinux in Canadian market in Q1 2014 and to file for generic approval in several additional markets in coming months
|
 | Mast Therapeutics (NYSE MKT: MSTX) - Developing therapies for significant unmet needs within hematological diseases. Lead asset (MST-188 ) in pivotal Phase 3 trial for sickle cell disease (SCD) |
Profile: MST-188 is being developed for SCD and acute limb ischemia (ALI). A QT-QTc study of MST-188 has demonstrated that the drug is well tolerated with no adverse effects on cardiac repolarization. SCD is a largely untapped market opportunity representing an unmet medical need, given no currently approved treatment agents and an incidence of 90,000 to 100,000 cases in the U.S. MST-188 is also in clinical studies for secondary indication ALI with a clinical proof-of-concept study expected to initiate in 1Q14.
Market Cap:$84M (as of February 18, 2014)
Cash: $49.4M (at September 30, 2013)
|
Key Catalysts & Upcoming Milestones
- MST-188 received orphan drug designation from the FDA for acute limb ischemia November, 2013
- Enrollment is progressing on track to open nearly 40 clinical sites in the U.S. by year-end. Full enrollment is expected by year-end 2015
- February, 2014 acquisition of Aires Pharmaceuticals diversifies pipeline with additional phase two asset in pulmonary hypertension
- Company is evaluating partnerships to fund additional MST-188 development
- Planned expansion of MST-188 into larger markets (e.g., acute decompensated heart failure, stroke)
- Ongoing proof-of-concept non-clinical study in heart failure with data expected 1Q14
|
 | Nexvet (Private) - Biopharma company focused on the global animal pharmaceutical market. Exploring mezzanine round and potential US IPO. |
Profile: Nexvet is developing a robust pipeline of animal pharmaceutical products under platform technology PETisation, which provides rapid conversion of disease modifying proteins. PETisation provides many advantages to current development techniques, enabling species-specific drug targets (canine, feline, etc), which prevent potential immune reactions seen in today’s marketed products. Humanization of proteins is also possible through PETisation, an additional competitive advantage where previous platforms have failed. Lead clinical asset NV-01 is currently in development for canine pain, along with add-on applications NV-02 and NV-03 for feline and equine pain. Multiple early stage pipeline products are also in development across oncology and autoimmune disease. Nexvet is a beneficiary of a significant nation-wide R&D tax-credit provided by the AU government for product development done in Australia.
|
Key Catalysts & Upcoming Milestones
- Nexvet is exploring a potential near-term mezzanine financing round and is seeking to undergo an IPO in either the US or AU market in 2014
- Clinical trial initiations and pipeline advancement over next 12 months for NV-01 in canine pain and add-on applications
- Animal pharma market $25B today and growing rapidly, offering attractive market economics, given historic resistance to recent recessions and shallow generic pricing declines
- 50%+ reduction in regulatory timelines (USDA) versus human biologics (FDA) from proof-of-concept to commercialization
|
|
 |
|
|