Welcome!

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)


2013


2012


2013


2012



(unaudited)


(unaudited)



Revenues:









        Collaborative research


$     1,376


$        218


$     2,109


$        783

        Subscription and license fees


34


-


113


306

               Total revenues


1,410


218


2,222


1,089

Operating expenses:









Research and development, including stock-based compensation

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


20,263


20,990


89,682


82,574

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

purchase liability


(5,289)


(200)


(2,210)


9,887

General and administrative, including stock-based compensation

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


3,412


3,920


17,121


17,043

               Total operating expenses


18,386


24,710


104,593


109,504

Loss from operations


(16,976)


(24,492)


(102,371)


(108,415)

Interest income


21


55


157


213

Interest expense


(477)


(520)


(1,971)


(2,114)

Other income, net


18


84


59


105

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   


513,523


507,619


513,117


489,707

 

Consolidated Balance Sheet Data

As of December 31,


As of December 31,

(In thousands)

2013


2012


(unaudited)



Cash and investments

$     129,128


$     223,208

Property and equipment, net

41,362


42,634

Goodwill    

44,543


44,543

Other intangible assets

53,557


53,557

Total assets

274,160


371,778

Deferred revenue

13,600


14,038

Current and long-term debt

21,877


23,451

Other long-term liabilities

32,386


32,283

Accumulated deficit

(1,003,959)


(899,832)

Total stockholders' equity

170,163


266,678

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
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...
Major trends and emerging technologies – from virtual reality and IoT, to Big Data and algorithms – are helping organizations innovate in the digital era. However, to create real business value, IT must think beyond the ‘what’ of digital transformation to the ‘how’ to harness emerging trends, innovation and disruption. Architecture is the key that underpins and ties all these efforts together. In the digital age, it’s important to invest in architecture, extend the enterprise footprint to the cl...
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor – all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
"Dice has been around for the last 20 years. We have been helping tech professionals find new jobs and career opportunities," explained Manish Dixit, VP of Product and Engineering at Dice, 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.
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smar...
Rapid innovation, changing business landscapes, and new IT demands force businesses to make changes quickly. In the eyes of many, containers are at the brink of becoming a pervasive technology in enterprise IT to accelerate application delivery. In this presentation, attendees learned about the: The transformation of IT to a DevOps, microservices, and container-based architecture What are containers and how DevOps practices can operate in a container-based environment A demonstration of how ...
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...
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, drew together recent research and lessons learned from emerging and established compa...
Without a clear strategy for cost control and an architecture designed with cloud services in mind, costs and operational performance can quickly get out of control. To avoid multiple architectural redesigns requires extensive thought and planning. Boundary (now part of BMC) launched a new public-facing multi-tenant high resolution monitoring service on Amazon AWS two years ago, facing challenges and learning best practices in the early days of the new service. In his session at 19th Cloud Exp...
"Venafi has a platform that allows you to manage, centralize and automate the complete life cycle of keys and certificates within the organization," explained Gina Osmond, Sr. Field Marketing Manager at Venafi, in this SYS-CON.tv interview at DevOps at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Effectively SMBs and government programs must address compounded regulatory compliance requirements. The most recent are Controlled Unclassified Information and the EU's GDPR have Board Level implications. Managing sensitive data protection will likely result in acquisition criteria, demonstration requests and new requirements. Developers, as part of the pre-planning process and the associated supply chain, could benefit from updating their code libraries and design by incorporating changes. In...
"Coalfire is a cyber-risk, security and compliance assessment and advisory services firm. We do a lot of work with the cloud service provider community," explained Ryan McGowan, Vice President, Sales (West) at Coalfire Systems, Inc., 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.
Regulatory requirements exist to promote the controlled sharing of information, while protecting the privacy and/or security of the information. Regulations for each type of information have their own set of rules, policies, and guidelines. Cloud Service Providers (CSP) are faced with increasing demand for services at decreasing prices. Demonstrating and maintaining compliance with regulations is a nontrivial task and doing so against numerous sets of regulatory requirements can be daunting task...
CloudJumper, a Workspace as a Service (WaaS) platform innovator for agile business IT, has been recognized with the Customer Value Leadership Award for its nWorkSpace platform by Frost & Sullivan. The company was also featured in a new report(1) by the industry research firm titled, “Desktop-as-a-Service Buyer’s Guide, 2016,” which provides a comprehensive comparison of DaaS providers, including CloudJumper, Amazon, VMware, and Microsoft.
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...