News Feed Item

Lexicon Pharmaceuticals Provides Clinical Pipeline Update And Reports 2013 Fourth Quarter And Full Year Financial Results

Conference Call and Webcast at 11:00 a.m. Eastern Time

THE WOODLANDS, Texas, Feb. 28, 2014 /PRNewswire/ -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), a biopharmaceutical company focused on developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three months and year ended December 31, 2013.

"We made important progress in our late-stage drug development programs in 2013, completing multiple studies of LX4211 for diabetes and increasing enrollment in our pivotal Phase 3 trial for telotristat etiprate for carcinoid syndrome," said Dr. Arthur T. Sands, president and chief executive officer of Lexicon. "In 2014, we expect to focus our resources on advancing those programs through clinical development and preparing for the transition to commercialization."

Key Developments in 2013

  • LX4211:  Lexicon announced positive top-line results from a proof-of-concept study of LX4211, a dual inhibitor of sodium-glucose transporters 1 and 2, in patients with type 2 diabetes and moderate to severe renal impairment.  LX4211 achieved the primary endpoint of reducing post-prandial glucose and was well tolerated, with treatment emergent adverse events being characterized as mild or moderate in severity and evenly distributed between LX4211 and placebo.  Lexicon also completed the pioneer portion of a Phase 2 clinical trial of LX4211 in patients with type 1 diabetes, in which LX4211 was given in combination with insulin.  Lexicon completed enrollment of patients in the placebo-controlled, expansion portion of the trial and expects to report top-line results near the end of the first quarter of 2014. 
  • Telotristat etiprate (LX1032):  Lexicon made significant progress in the enrollment of carcinoid syndrome patients in a pivotal Phase 3 clinical trial of telotristat etiprate, an inhibitor of tryptophan hydroxylase (TPH) that reduces peripheral serotonin production without affecting brain serotonin levels.  Lexicon also initiated a companion study of telotristat etiprate in the same indication.
  • LX1033:  Lexicon completed a Phase 2 clinical trial of LX1033, an inhibitor of TPH that acts locally in the gastrointestinal tract to reduce serotonin production without impacting brain serotonin levels.  Top-line data from the study, which evaluated the safety and tolerability of LX1033 and its effect on symptoms associated with irritable bowel syndrome, showed that all treatment groups, including placebo, showed significant improvements in stool consistency over time.  However, such improvements in patients treated with LX1033 were not statistically significant relative to those treated with placebo.  

In January 2014, Lexicon announced plans to focus its resources on its late-stage drug development programs, principally LX4211 and telotristat etiprate, in preparation for the transition to commercialization.  The change in focus involves personnel reductions, primarily in research, discovery and support positions, during the first and second quarter of 2014.  With the change in focus, Dr. Sands indicated his intention to develop a succession plan with the board of directors to identify a new chief executive officer for the next phase of Lexicon's growth.  The board of directors has initiated a search for a new chief executive officer and has designated a subcommittee of the board of directors to assist in those efforts.  It is planned that Dr. Sands will continue as chief executive officer until that process is complete.

Financial Results

Revenues:  Lexicon's revenues for the three months ended December 31, 2013 increased 547 percent to $1.4 million from $0.2 million for the corresponding period in 2012, primarily due to revenues recognized from a collaboration with a non-profit institute supporting the Phase 2 development of LX4211 in type 1 diabetes. For the year ended December 31, 2013, revenues increased 104 percent to $2.2 million from $1.1 million for the corresponding period in 2012.

Research and Development Expenses:  Research and development expenses for the three months ended December 31, 2013 decreased three percent to $20.3 million from $21.0 million for the corresponding period in 2012.  For the year ended December 31, 2013, research and development expenses increased nine percent to $89.7 million from $82.6 million for the corresponding period in 2012.

Increase (Decrease) in Fair Value of Symphony Icon Purchase Liability:  In connection with the acquisition of Symphony Icon, Lexicon made an initial estimate of the fair value of the liability for the associated base and contingent payments.  Changes in this liability, based on the development of the programs and the time until such payments are expected to be made, are recorded in Lexicon's consolidated statements of operations. For the three months ended December 31, 2013, the fair value of the Symphony Icon purchase liability decreased by $5.3 million as compared to a decrease of $0.2 million in the corresponding period in 2012.  The decrease was primarily attributable to a reduction in the liability associated with Lexicon's LX1033 development program in diarrhea-predominant irritable bowel syndrome.  For the year ended December 31, 2013, the fair value of the Symphony Icon purchase liability decreased by $2.2 million as compared to an increase of $9.9 million in the corresponding period in 2012.

General and Administrative Expenses:  General and administrative expenses for the three months ended December 31, 2013 decreased 13 percent to $3.4 million from $3.9 million for the corresponding period in 2012.  For the year ended December 31, 2013, general and administrative expenses increased slightly to $17.1 million from $17.0 million for the corresponding period in 2012.

Consolidated Net Loss:  Net loss for the three months ended December 31, 2013 was $17.4 million, or $0.03 per share, compared to a net loss of $24.9 million, or $0.05 per share, in the corresponding period in 2012. Net loss for the year ended December 31, 2013 was $104.1 million, or $0.20 per share, compared to a net loss of $110.2 million, or $0.23 per share, for the corresponding period in 2012. For the three months and year ended December 31, 2013, net loss included non-cash, stock-based compensation expense of $1.7 million and $7.4 million, respectively. For the three months and year ended December 31, 2012, net loss included non-cash, stock-based compensation expense of $1.6 million and $6.5 million, respectively.

Cash and Investments:  As of December 31, 2013, Lexicon had $129.1 million in cash and investments, as compared to cash and investments of $151.2 million as of September 30, 2013 and $223.2 million as of December 31, 2012.

Lexicon Conference Call
Lexicon management will hold a conference call to discuss its clinical development progress and financial results for 2013 and financial guidance for 2014 at 11:00 a.m. Eastern Time on February 28, 2014.

The dial-in number for the conference call is 888-645-5785 (within the US/Canada) or 970-300-1531 (international).  The conference ID for all callers is 30511451.  Investors can access a live webcast of the call at www.lexpharma.com.  An archived version of the webcast will be available on the website through March 28, 2014.

About Lexicon
Lexicon is a biopharmaceutical company focused on developing breakthrough treatments for human disease.  Lexicon has clinical-stage drug programs for diabetes, carcinoid syndrome, and other indications, all of which were discovered by Lexicon's research team.  Lexicon has used its proprietary gene knockout technology to identify more than 100 promising drug targets.  For additional information about Lexicon and its programs, please visit www.lexpharma.com.

Safe Harbor Statement
This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of LX4211, telotristat etiprate (LX1032) and LX1033, including characterizations of the results of and projected timing of clinical trials of such compounds, and the potential therapeutic and commercial potential of LX4211, telotristat etiprate (LX1032) and LX1033.  In addition, this press release also contains forward-looking statements relating to Lexicon's growth and future operating results, discovery and development of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information.  All forward-looking statements are based on management's current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including those relating to Lexicon's ability to successfully conduct clinical development of LX4211, telotristat etiprate (LX1032) and LX1033 and preclinical and clinical development of its other potential drug candidates, obtain necessary regulatory approvals, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its drug candidates, that may cause Lexicon's actual results to be materially different from any future results expressed or implied by such forward-looking statements.  Information identifying such important factors is contained under "Risk Factors" in Lexicon's annual report on Form 10-K for the year ended December 31, 2012, as filed with the Securities and Exchange Commission.  Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.


Lexicon Pharmaceuticals, Inc.

Selected Financial Data

Consolidated Statements of Operations Data

Three Months Ended

December 31,

Year Ended

December 31,

(In thousands, except per share data)








        Collaborative research

$     1,376

$        218

$     2,109

$        783

        Subscription and license fees





               Total revenues





Operating expenses:

Research and development, including stock-based compensation

of $997, $798, $4,376 and $3,673, respectively





Increase (decrease) in fair value of Symphony Icon, Inc

purchase liability





General and administrative, including stock-based compensation

of $696, $792, $3,045 and $2,822, respectively





               Total operating expenses





Loss from operations





Interest income





Interest expense





Other income, net





Consolidated net loss

$  (17,414)

$  (24,873)

$ (104,126)

$ (110,211)

Consolidated net loss per common share, basic and diluted

$     (0.03)

$     (0.05)

$     (0.20)

$     (0.23)

Shares used in computing consolidated net loss per common share, basic and diluted   






Consolidated Balance Sheet Data

As of December 31,

As of December 31,

(In thousands)




Cash and investments

$     129,128

$     223,208

Property and equipment, net






Other intangible assets



Total assets



Deferred revenue



Current and long-term debt



Other long-term liabilities



Accumulated deficit



Total stockholders' equity



SOURCE Lexicon Pharmaceuticals, Inc.

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.

Latest Stories
Redis is not only the fastest database, but it has become the most popular among the new wave of applications running in containers. Redis speeds up just about every data interaction between your users or operational systems. In his session at 18th Cloud Expo, Dave Nielsen, Developer Relations at Redis Labs, will shares the functions and data structures used to solve everyday use cases that are driving Redis' popularity.
There is an ever-growing explosion of new devices that are connected to the Internet using “cloud” solutions. This rapid growth is creating a massive new demand for efficient access to data. And it’s not just about connecting to that data anymore. This new demand is bringing new issues and challenges and it is important for companies to scale for the coming growth. And with that scaling comes the need for greater security, gathering and data analysis, storage, connectivity and, of course, the...
Much of the value of DevOps comes from a (renewed) focus on measurement, sharing, and continuous feedback loops. In increasingly complex DevOps workflows and environments, and especially in larger, regulated, or more crystallized organizations, these core concepts become even more critical. In his session at @DevOpsSummit at 18th Cloud Expo, Andi Mann, Chief Technology Advocate at Splunk, will show how, by focusing on 'metrics that matter,' you can provide objective, transparent, and meaningfu...
Many private cloud projects were built to deliver self-service access to development and test resources. While those clouds delivered faster access to resources, they lacked visibility, control and security needed for production deployments. In their session at 18th Cloud Expo, Steve Anderson, Product Manager at BMC Software, and Rick Lefort, Principal Technical Marketing Consultant at BMC Software, will discuss how a cloud designed for production operations not only helps accelerate developer...
Manufacturers are embracing the Industrial Internet the same way consumers are leveraging Fitbits – to improve overall health and wellness. Both can provide consistent measurement, visibility, and suggest performance improvements customized to help reach goals. Fitbit users can view real-time data and make adjustments to increase their activity. In his session at @ThingsExpo, Mark Bernardo Professional Services Leader, Americas, at GE Digital, will discuss how leveraging the Industrial Interne...
Artificial Intelligence has the potential to massively disrupt IoT. In his session at 18th Cloud Expo, AJ Abdallat, CEO of Beyond AI, will discuss what the five main drivers are in Artificial Intelligence that could shape the future of the Internet of Things. AJ Abdallat is CEO of Beyond AI. He has over 20 years of management experience in the fields of artificial intelligence, sensors, instruments, devices and software for telecommunications, life sciences, environmental monitoring, process...
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
The IETF draft standard for M2M certificates is a security solution specifically designed for the demanding needs of IoT/M2M applications. In his session at @ThingsExpo, Brian Romansky, VP of Strategic Technology at TrustPoint Innovation, will explain how M2M certificates can efficiently enable confidentiality, integrity, and authenticity on highly constrained devices.
Increasing IoT connectivity is forcing enterprises to find elegant solutions to organize and visualize all incoming data from these connected devices with re-configurable dashboard widgets to effectively allow rapid decision-making for everything from immediate actions in tactical situations to strategic analysis and reporting. In his session at 18th Cloud Expo, Shikhir Singh, Senior Developer Relations Manager at Sencha, will discuss how to create HTML5 dashboards that interact with IoT devic...
We're entering the post-smartphone era, where wearable gadgets from watches and fitness bands to glasses and health aids will power the next technological revolution. With mass adoption of wearable devices comes a new data ecosystem that must be protected. Wearables open new pathways that facilitate the tracking, sharing and storing of consumers’ personal health, location and daily activity data. Consumers have some idea of the data these devices capture, but most don’t realize how revealing and...
SYS-CON Events announced today that Ericsson has been named “Gold Sponsor” of SYS-CON's @ThingsExpo, which will take place on June 7-9, 2016, at the Javits Center in New York, New York. Ericsson is a world leader in the rapidly changing environment of communications technology – providing equipment, software and services to enable transformation through mobility. Some 40 percent of global mobile traffic runs through networks we have supplied. More than 1 billion subscribers around the world re...
In the world of DevOps there are ‘known good practices’ – aka ‘patterns’ – and ‘known bad practices’ – aka ‘anti-patterns.' Many of these patterns and anti-patterns have been developed from real world experience, especially by the early adopters of DevOps theory; but many are more feasible in theory than in practice, especially for more recent entrants to the DevOps scene. In this power panel at @DevOpsSummit at 18th Cloud Expo, moderated by DevOps Conference Chair Andi Mann, panelists will dis...
Struggling to keep up with increasing application demand? Learn how Platform as a Service (PaaS) can streamline application development processes and make resource management easy.
We’ve worked with dozens of early adopters across numerous industries and will debunk common misperceptions, which starts with understanding that many of the connected products we’ll use over the next 5 years are already products, they’re just not yet connected. With an IoT product, time-in-market provides much more essential feedback than ever before. Innovation comes from what you do with the data that the connected product provides in order to enhance the customer experience and optimize busi...
The increasing popularity of the Internet of Things necessitates that our physical and cognitive relationship with wearable technology will change rapidly in the near future. This advent means logging has become a thing of the past. Before, it was on us to track our own data, but now that data is automatically available. What does this mean for mHealth and the "connected" body? In her session at @ThingsExpo, Lisa Calkins, CEO and co-founder of Amadeus Consulting, will discuss the impact of wea...