Welcome!

Microsoft Cloud Authors: Pat Romanski, Lori MacVittie, Andreas Grabner, Jim Kaskade, John Basso

News Feed Item

BioSpecifics Technologies Corp. Reports Third Quarter 2012 Financial Results

LYNBROOK, N.Y., Nov. 8, 2012 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in Europe and Eurasia, today announced its financial results for the third quarter ended September 30, 2012 and provided a corporate update.

"We are very happy with the ongoing clinical development progress for our XIAFLEX pipeline, including the recent submission of a sBLA filing by our partner Auxilium for the potential treatment of Peyronie's disease," said Thomas L. Wegman, President of BioSpecifics. "Additionally, Auxilium recently completed enrollment in its cellulite Phase Ib and frozen shoulder Phase IIa studies and began enrollment for its 600 patient label expansion study for Dupuytren's contracture patients with multiple palpable cords. We look forward to reporting top-line data from each of these studies in the fourth quarter of 2012, the first quarter of 2013 and the first half of 2014, respectively. We also anticipate that we will complete enrollment in our internally-managed human and canine lipoma Phase II trials during the first half of 2013. In addition, we are very encouraged by the ongoing commercial initiatives Auxilium has implemented to continue to expand XIAFLEX sales for Dupuytren's contracture in the U.S."

Third Quarter 2012 Financial Results
BioSpecifics reported net income of $0.5 million for the third quarter ended September 30, 2012, or $0.07 per basic and diluted common share, compared to a net income of $0.3 million, or $0.04 per basic and diluted common share, for the same period in 2011.

Total revenue for the third quarter of 2012 was $2.4 million, compared to $1.9 million for the same period in 2011.

Royalty, mark-up on cost of goods sold, and earn-out revenues for the third quarter of 2012 were $2.3 million, compared to $1.8 million for the same period in 2011. Royalty and mark-up on cost of goods sold revenues recognized under BioSpecifics' agreement with Auxilium Pharmaceuticals, Inc. (Auxilium) for the third quarter of 2012 were $1.5 million, compared to $1.1 million for the same period in 2011. Royalty revenues recognized from DFB Biotech, Inc. for the third quarter of 2012 and 2011 were $0.8 million in each period.

Total licensing revenue consisting of licensing, sublicensing fees and milestones for the third quarter of 2012 and 2011 were $0.1 million in each period. These licensing fees related to cash payments received in prior years and amortized over the expected development period. Milestone payments recognized in the third quarter of 2012 were $28,500, compared to zero in the same period in 2011. In the third quarter of 2012, milestones recognized related to the Notice of Compliance (approval) by Health Canada for XIAFLEX for the treatment of Dupuytren's contracture in adults with a palpable cord in Canada granted to Actelion Pharmaceuticals Ltd. (Actelion).

Research and development expenses for the third quarter 2012 were $0.3 million, compared to $0.2 million for the same period in 2011. The increase in research and development expenses was primarily due to expenses related to BioSpecifics' clinical development programs for XIAFLEX in human and canine lipomas.

General and administrative expenses for the third quarter of 2012 were $1.4 million, compared to $1.2 million for the same period in 2011. The increase in general and administrative expenses was due to legal fees, consulting services and third party royalty fees partially offset by lower stock based compensation.

As of September 30, 2012, BioSpecifics had cash and cash equivalents and investments of $9.0 million, compared to $8.8 million on June 30, 2012.

XIAFLEX for Dupuytren's Contracture
Worldwide net revenues for XIAFLEX, as reported by Auxilium on November 7, 2012, were $15.7 million for the third quarter of 2012, $13.2 million of which were in the U.S., representing a 29% increased over the same period in 2011.

Auxilium is currently conducting an open-label clinical trial evaluating XIAFLEX for the concurrent treatment of multiple palpable cords in approximately 600 adult patients with Dupuytren's contracture in the U.S. This study began enrollment in the third quarter of 2012 and top-line data are expected in the first half of 2014. If successful, this study may allow Auxilium to seek a XIAFLEX label expansion from the U.S. Food and Drug Administration (FDA) for the concurrent treatment of multiple palpable cords in adult Dupuytren's contracture patients.

In the third quarter of 2012, Auxilium also completed enrollment in its Phase IV Dupuytren's contracture retreatment clinical trial. Top-line data from this study are expected in the fourth quarter of 2013.

In September 2012, Auxilium announced a safety update following 30 months of post-approval use of XIAFLEX in the U.S. for the treatment of adult Dupuytren's contracture patients with a palpable cord, which demonstrated that there was no clinically meaningful change in the nature of events that were expected relative to the clinical trial safety profile.

Auxilium's strategic partner Actelion expects to make XIAFLEX commercially available to adult Dupuytren's contracture patients in Canada in the first half of 2013. In addition, Actelion expects to file for approval of XIAFLEX for the treatment of Dupuytren's contracture in Australia, Brazil and Mexico by the end of the 2012.

XIAFLEX for Peyronie's Disease
On November 7, 2012, BioSpecifics announced Auxilium's submission of a supplemental Biologics License Application (sBLA) to the FDA for XIAFLEX for the potential treatment of Peyronie's disease, an excess of inelastic collagen causing penile curvature deformity. If approved by the FDA, which Auxilium anticipates by the end of 2013, XIAFLEX is expected to be the first and only biologic therapy indicated for the treatment of Peyronie's disease.

The sBLA submission is based on data from the Auxilium's IMPRESS (The Investigation for Maximal Peyronie's Reduction Efficacy and Safety Studies) Phase III clinical program and other controlled and uncontrolled clinical studies. In August 2012, BioSpecifics announced that additional data were presented at the Sexual Medicines Society of North America (SMSNA)/International Society for Sexual Medicine (ISSM) Joint Annual Meeting on August 27 and 29, 2012 in Chicago, IL. These data demonstrated that 58% of patients with curvature deformity of 30 to 60, and 73% of patients with curvature deformity of 60 to 90 degrees, reported that they were "very bothered" or "extremely bothered" about their condition. In addition, photographs and data were presented from a subset of IMPRESS patients involved in the first study ever to use 3-D photographic technology for 360 degree assessment of penile curvature deformity in Peyronie's disease patients.

Additional Anticipated Milestones for XIAFLEX Pipeline
BioSpecifics is currently managing the clinical development of XIAFLEX for the treatment of human lipoma and canine lipoma in two Phase II clinical trials. BioSpecifics anticipates that it will complete enrollment for its 14 patient dose escalation Phase II trial for the treatment of human lipoma in the first half of 2013. BioSpecifics anticipates that it will also complete enrollment for Chien-804, its Phase II clinical trial evaluating 32 canines with benign subcutaneous lipomas randomized 1:1 XIAFLEX to placebo, during the same time period.

Auxilium is currently managing the clinical development of XIAFLEX for the treatment of cellulite and frozen shoulder syndrome (adhesive capsulitis). In the third quarter of 2012, Auxilium completed enrollment in its cellulite Phase Ib and frozen shoulder Phase IIa studies. Top-line data from the Phase Ib single site, open-label dose escalation study of XIAFLEX for cellulite are expected in the fourth quarter of 2012. Top-line data from the Phase IIa study of XIAFLEX for frozen shoulder are expected in the first quarter of 2013.

Auxilium and Pfizer Inc. Collaboration Termination
As reported by Auxilium on November 7, 2012, Auxilium and Pfizer Inc. have terminated their collaboration agreement for the development, commercialization and supply of XIAPEX for the treatment of Dupuytren's contracture and the potential treatment of Peyronie's disease in the European Union and certain other European and Eurasian countries to be effective as of April 24, 2013. After the termination date, rights to commercialize XIAPEX and responsibility for regulatory activities for XIAPEX in these countries will revert to Auxilium.

Webcast and Conference Call
BioSpecifics will host a conference call today at 4:30 p.m. EST to discuss these third quarter 2012 results.

In order to participate in the conference call, please dial 1-800-860-2442 (domestic) or 1-412-858-4600 (international). The live webcast can be accessed under "Calendar of Events" in the Investor Relations section of the Company's website at www.biospecifics.com or you may use the link: http://www.videonewswire.com/event.asp?id=90670.

A replay of the call will be available one hour after the end of the conference on November 8, 2012 until 9:00 a.m. EST on November 23, 2012. To access the replay, please dial 1-877-344-7529 (domestic) or 1-412-317-0088 (international) and reference the access code 10020975. The archived webcast will be available for 90 days in the Investor Relations section of BioSpecifics' website at www.biospecifics.com.

About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for twelve clinical indications. Injectable collagenase is currently marketed as XIAFLEX® in the U.S. for the treatment of adult Dupuytren's contracture patients with a palpable cord by Auxilium Pharmaceuticals, Inc. (Auxilium) and is approved for Dupuytren's contracture in the European Union and Canada. XIAFLEX is also in clinical development for the treatment of several additional promising indications: Auxilium recently submitted a supplemental Biologics License Application (sBLA) to the FDA for XIAFLEX for the potential treatment of Peyronie's disease based on positive results reported from its two Phase III clinical studies. Auxilium is also testing XIAFLEX for frozen shoulder syndrome (adhesive capsulitis) and cellulite in Phase IIa and Phase Ib clinical trials, respectively. BioSpecifics is currently managing the clinical development of XIAFLEX for the treatment of human lipoma and canine lipoma, which are both in Phase II clinical trials.  Auxilium is currently partnered with Asahi Kasei Pharma Corporation for the development and commercialization of injectable collagenase for Dupuytren's contracture and Peyronie's disease in Japan and with Actelion Pharmaceuticals Ltd. for these same indications in Canada, Australia, Brazil and Mexico. Pfizer Inc. has marketing rights to XIAPEX® (the EU trade name for XIAFLEX) for Dupuytren's contracture in 46 countries in Eurasia through April 24, 2013. For more information, please visit www.biospecifics.com.

Forward Looking Statements
This release includes "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are "forward-looking statements." The forward-looking statements include statements concerning, among other things, the timing of results from Auxilium's clinical trials for Dupuytren's contracture (phase IIIb for concurrent treatment of multiple palpable cords and phase IV retreatment), cellulite, and frozen shoulder; the timing of the potential FDA approval, if any, of XIAFLEX for Peyronie's disease; the timing for completing enrollment for trials for the use of XIAFLEX as a treatment of human lipoma and canine lipoma; being encouraged by Auxilium's ongoing commercial initiatives to continue to expand XIAFLEX sales for Dupuytren's contracture in the U.S.; the potential for Auxilium to receive approval to expand the label for Dupuytren's contracture; the timing of making XIAFLEX available in Canada as a treatment of Dupuytren's contracture; the timing of filing for approval of XIAFLEX for the treatment of Dupuytren's contracture in Australia, Brazil, and Mexico; the potential for XIAFLEX to be the first and only biologic therapy indicated for the treatment of Peyronie's disease; and the potential for XIAFLEX as a treatment in additional indications. In some cases, these statements can be identified by forward-looking words such as "believe," "expect," "anticipate," "plan," "estimate," "likely," "may," "will," "could," "continue," "project," "predict," "goal," the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on BioSpecifics' current expectations and its projections about future events. There are a number of important factors that could cause BioSpecifics' actual results to differ materially from those indicated by such forward-looking statements, including the ability of BioSpecifics' partner, Auxilium, and its partners, Asahi Kasei Pharma Corporation and Actelion Pharmaceuticals Canada Inc., to achieve their objectives for XIAFLEX in their applicable territories; the potential market for XIAFLEX in a given indication, the potential of XIAFLEX to be used in additional indications, and the initiation, timing and outcome of clinical trials of XIAFLEX for additional indications; the timing of regulatory filings and action; the receipt of any applicable milestone payments from Auxilium; and other risk factors identified in BioSpecifics' Annual Report on Form 10-K for the year ended December 31, 2011, its Quarterly Reports on Form 10-Q for the first and second quarters of 2012, and its Current Reports on Form 8-K filed with the Securities and Exchange Commission. All forward-looking statements included in this release are made as of the date hereof, and BioSpecifics assumes no obligation to update these forward-looking statements.

BioSpecifics Technologies Corp.

Consolidated Statements of Operations

(Unaudited)










Three months ended


Nine months ended


September 30,


September 30,


2012


2011


2012


2011

Revenues:








   Net sales

$        3,378


$      1,683


$     12,128


$     13,457

   Royalties

2,307,073


1,810,436


6,698,355


4,461,683

   Licensing revenues

137,774


109,276


926,324


4,265,327

   Consulting fees

-


-


-


46,667

        Total Revenues

2,448,225


1,921,395


7,636,807


8,787,134









Costs and expenses:








   Research and development

293,221


224,150


947,119


707,015

   General and administrative

1,375,477


1,245,145


3,614,125


4,172,687

        Total costs and expenses

1,668,698


1,469,295


4,561,244


4,879,702









Operating income

779,527


452,100


3,075,563


3,907,432









Other income:








   Interest and other income

8,292


7,813


27,556


55,540









Income before income tax

787,819


459,913


3,103,119


3,962,972

   Income tax benefit (expense)

(316,772)


(190,077)


(1,223,000)


2,567,328









Net income

$   471,047


$  269,836


$1,880,119


$6,530,300









Basic net income per share

$         0.07


$        0.04


$        0.30


$        1.03









Diluted net income per share

$         0.07


$        0.04


$        0.27


$        0.92









Shares used in computation of basic net income per share

6,343,210


6,362,951


6,341,031


6,337,237









Shares used in computation of diluted net income per share

6,961,652


7,085,945


6,985,290


7,133,341









BioSpecifics Technologies Corp.

Selected Consolidated Balance Sheet Data

 (Unaudited)








September 30,


December 31,



2012


2011

Cash and cash equivalents


$  3,823,860


$3,196,831

Short term investments


5,190,000


5,000,000

Accounts and income tax receivable, net


3,276,526


3,481,637

Deferred tax assets (short and long-term)


2,428,545


3,047,955

Deferred royalty buydown


2,750,000


1,250,000

Working capital


12,169,287


11,970,264

Total assets


17,840,782


16,265,073

Long-term liabilities


224,673


276,520

Total stockholders' equity


16,696,443


14,872,314






SOURCE BioSpecifics Technologies Corp.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

@ThingsExpo Stories
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
Financial Technology has become a topic of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 20th Cloud Expo at the Javits Center in New York, June 6-8, 2017, will find fresh new content in a new track called FinTech.
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
"At ROHA we develop an app called Catcha. It was developed after we spent a year meeting with, talking to, interacting with senior citizens watching them use their smartphones and talking to them about how they use their smartphones so we could get to know their smartphone behavior," explained Dave Woods, Chief Innovation Officer at ROHA, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Fusion, a leading provider of cloud services, will exhibit at SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY. Fusion, a leading provider of integrated cloud solutions to small, medium and large businesses, is the industry’s single source for the cloud. Fusion’s advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including cloud...
Video experiences should be unique and exciting! But that doesn’t mean you need to patch all the pieces yourself. Users demand rich and engaging experiences and new ways to connect with you. But creating robust video applications at scale can be complicated, time-consuming and expensive. In his session at @ThingsExpo, Zohar Babin, Vice President of Platform, Ecosystem and Community at Kaltura, discussed how VPaaS enables you to move fast, creating scalable video experiences that reach your aud...
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place June 6-8, 2017, at the Javits Center in New York City, New York, is co-located with 20th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry p...
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, provided an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life sett...
DevOps is being widely accepted (if not fully adopted) as essential in enterprise IT. But as Enterprise DevOps gains maturity, expands scope, and increases velocity, the need for data-driven decisions across teams becomes more acute. DevOps teams in any modern business must wrangle the ‘digital exhaust’ from the delivery toolchain, "pervasive" and "cognitive" computing, APIs and services, mobile devices and applications, the Internet of Things, and now even blockchain. In this power panel at @...
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportunity. Submit your speaking proposal ...
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
The many IoT deployments around the world are busy integrating smart devices and sensors into their enterprise IT infrastructures. Yet all of this technology – and there are an amazing number of choices – is of no use without the software to gather, communicate, and analyze the new data flows. Without software, there is no IT. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, Dave McCarthy, Director of Products at Bsquare Corporation; Alan Williamson, Principal...
Extracting business value from Internet of Things (IoT) data doesn’t happen overnight. There are several requirements that must be satisfied, including IoT device enablement, data analysis, real-time detection of complex events and automated orchestration of actions. Unfortunately, too many companies fall short in achieving their business goals by implementing incomplete solutions or not focusing on tangible use cases. In his general session at @ThingsExpo, Dave McCarthy, Director of Products...
Internet of @ThingsExpo has announced today that Chris Matthieu has been named tech chair of Internet of @ThingsExpo 2017 New York The 7th Internet of @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, New York. Chris Matthieu is the co-founder and CTO of Octoblu, a revolutionary real-time IoT platform recently acquired by Citrix. Octoblu connects things, systems, people and clouds to a global mesh network allowing users to automate and control design flo...
Unsecured IoT devices were used to launch crippling DDOS attacks in October 2016, targeting services such as Twitter, Spotify, and GitHub. Subsequent testimony to Congress about potential attacks on office buildings, schools, and hospitals raised the possibility for the IoT to harm and even kill people. What should be done? Does the government need to intervene? This panel at @ThingExpo New York brings together leading IoT and security experts to discuss this very serious topic.
Businesses and business units of all sizes can benefit from cloud computing, but many don't want the cost, performance and security concerns of public cloud nor the complexity of building their own private clouds. Today, some cloud vendors are using artificial intelligence (AI) to simplify cloud deployment and management. In his session at 20th Cloud Expo, Ajay Gulati, Co-founder and CEO of ZeroStack, will discuss how AI can simplify cloud operations. He will cover the following topics: why clou...
In this strange new world where more and more power is drawn from business technology, companies are effectively straddling two paths on the road to innovation and transformation into digital enterprises. The first path is the heritage trail – with “legacy” technology forming the background. Here, extant technologies are transformed by core IT teams to provide more API-driven approaches. Legacy systems can restrict companies that are transitioning into digital enterprises. To truly become a lead...
Internet-of-Things discussions can end up either going down the consumer gadget rabbit hole or focused on the sort of data logging that industrial manufacturers have been doing forever. However, in fact, companies today are already using IoT data both to optimize their operational technology and to improve the experience of customer interactions in novel ways. In his session at @ThingsExpo, Gordon Haff, Red Hat Technology Evangelist, will share examples from a wide range of industries – includin...