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
ChatOps is an emerging topic that has led to the wide availability of integrations between group chat and various other tools/platforms. Currently, HipChat is an extremely powerful collaboration platform due to the various ChatOps integrations that are available. However, DevOps automation can involve orchestration and complex workflows. In his session at @DevOpsSummit at 20th Cloud Expo, Himanshu Chhetri, CTO at Addteq, will cover practical examples and use cases such as self-provisioning infra...
Blockchain. A day doesn’t seem to go by without seeing articles and discussions about the technology. According to PwC executive Seamus Cushley, approximately $1.4B has been invested in blockchain just last year. In Gartner’s recent hype cycle for emerging technologies, blockchain is approaching the peak. It is considered by Gartner as one of the ‘Key platform-enabling technologies to track.’ While there is a lot of ‘hype vs reality’ discussions going on, there is no arguing that blockchain is b...
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 settle...
The cloud era has reached the stage where it is no longer a question of whether a company should migrate, but when. Enterprises have embraced the outsourcing of where their various applications are stored and who manages them, saving significant investment along the way. Plus, the cloud has become a defining competitive edge. Companies that fail to successfully adapt risk failure. The media, of course, continues to extol the virtues of the cloud, including how easy it is to get there. Migrating...
No hype cycles or predictions of a gazillion things here. IoT is here. You get it. You know your business and have great ideas for a business transformation strategy. What comes next? Time to make it happen. In his session at @ThingsExpo, Jay Mason, an Associate Partner of Analytics, IoT & Cybersecurity at M&S Consulting, presented a step-by-step plan to develop your technology implementation strategy. He also discussed the evaluation of communication standards and IoT messaging protocols, data...
You know you need the cloud, but you’re hesitant to simply dump everything at Amazon since you know that not all workloads are suitable for cloud. You know that you want the kind of ease of use and scalability that you get with public cloud, but your applications are architected in a way that makes the public cloud a non-starter. You’re looking at private cloud solutions based on hyperconverged infrastructure, but you’re concerned with the limits inherent in those technologies.
Coca-Cola’s Google powered digital signage system lays the groundwork for a more valuable connection between Coke and its customers. Digital signs pair software with high-resolution displays so that a message can be changed instantly based on what the operator wants to communicate or sell. In their Day 3 Keynote at 21st Cloud Expo, Greg Chambers, Global Group Director, Digital Innovation, Coca-Cola, and Vidya Nagarajan, a Senior Product Manager at Google, discussed how from store operations and ...
In his session at 21st Cloud Expo, Raju Shreewastava, founder of Big Data Trunk, provided a fun and simple way to introduce Machine Leaning to anyone and everyone. He solved a machine learning problem and demonstrated an easy way to be able to do machine learning without even coding. Raju Shreewastava is the founder of Big Data Trunk (www.BigDataTrunk.com), a Big Data Training and consulting firm with offices in the United States. He previously led the data warehouse/business intelligence and B...
"IBM is really all in on blockchain. We take a look at sort of the history of blockchain ledger technologies. It started out with bitcoin, Ethereum, and IBM evaluated these particular blockchain technologies and found they were anonymous and permissionless and that many companies were looking for permissioned blockchain," stated René Bostic, Technical VP of the IBM Cloud Unit in North America, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Conventi...
A strange thing is happening along the way to the Internet of Things, namely far too many devices to work with and manage. It has become clear that we'll need much higher efficiency user experiences that can allow us to more easily and scalably work with the thousands of devices that will soon be in each of our lives. Enter the conversational interface revolution, combining bots we can literally talk with, gesture to, and even direct with our thoughts, with embedded artificial intelligence, whic...
The need for greater agility and scalability necessitated the digital transformation in the form of following equation: monolithic to microservices to serverless architecture (FaaS). To keep up with the cut-throat competition, the organisations need to update their technology stack to make software development their differentiating factor. Thus microservices architecture emerged as a potential method to provide development teams with greater flexibility and other advantages, such as the abili...
Product connectivity goes hand and hand these days with increased use of personal data. New IoT devices are becoming more personalized than ever before. In his session at 22nd Cloud Expo | DXWorld Expo, Nicolas Fierro, CEO of MIMIR Blockchain Solutions, will discuss how in order to protect your data and privacy, IoT applications need to embrace Blockchain technology for a new level of product security never before seen - or needed.
Leading companies, from the Global Fortune 500 to the smallest companies, are adopting hybrid cloud as the path to business advantage. Hybrid cloud depends on cloud services and on-premises infrastructure working in unison. Successful implementations require new levels of data mobility, enabled by an automated and seamless flow across on-premises and cloud resources. In his general session at 21st Cloud Expo, Greg Tevis, an IBM Storage Software Technical Strategist and Customer Solution Architec...
The use of containers by developers -- and now increasingly IT operators -- has grown from infatuation to deep and abiding love. But as with any long-term affair, the honeymoon soon leads to needing to live well together ... and maybe even getting some relationship help along the way. And so it goes with container orchestration and automation solutions, which are rapidly emerging as the means to maintain the bliss between rapid container adoption and broad container use among multiple cloud host...
Blockchain is a shared, secure record of exchange that establishes trust, accountability and transparency across business networks. Supported by the Linux Foundation's open source, open-standards based Hyperledger Project, Blockchain has the potential to improve regulatory compliance, reduce cost as well as advance trade. Are you curious about how Blockchain is built for business? In her session at 21st Cloud Expo, René Bostic, Technical VP of the IBM Cloud Unit in North America, discussed the b...