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Lexicon Pharmaceuticals Provides Clinical Pipeline Update And Reports 2013 Third Quarter Financial Results

Key Takeaway: Lexicon Pharmaceuticals Provides Clinical Pipeline Update And Reports 2013 Third Quarter Financial Results

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+111%
120-day peak, hindsight
Typical move
11%
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Cash runway
~61 mo
Minimal dilution risk
Lead asset
Sotagliflozin
Phase 3 · Type 1 Diabetes Mellitus

Full Press Release Details

THE WOODLANDS, Texas,Nov. 12, 2013/PRNewswire/ --Lexicon Pharmaceuticals, Inc.(Nasdaq:LXRX), a biopharmaceutical company focused on discovering and developing breakthrough treatments for human disease, today updated its drug development progress and reported financial results for the three and nine months endedSeptember 30, 2013.
"We have continued to make significant progress in the advancement of our clinical pipeline, highlighted by our announcement of positive top-line results from a phase 2 study of LX4211 in patients with type 2 diabetes and moderate to severe renal impairment," said Dr. Arthur T. Sands, president and chief executive officer of Lexicon.

Progress in Clinical Pipeline

• LX4211:  LX4211 is a dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT1 and SGLT2).  SGLT1 is primarily responsible for glucose absorption in the gastrointestinal tract and SGLT2 is responsible for most of the glucose reabsorption performed by the kidney.  Lexicon announced positive top-line results from a phase 2 study of LX4211 in patients with type 2 diabetes and moderate to severe renal impairment, and is proceeding with preparations for the initiation of Phase 3 clinical trials of LX4211 in type 2 diabetes.  Lexicon also continues to enroll patients in a phase 2 trial of LX4211 in type 1 diabetes.
• Telotristat etiprate (LX1032):  Telotristat etiprate is an inhibitor of tryptophan hydroxylase that reduces peripheral serotonin production without affecting brain serotonin levels.  Lexicon announced top-line results from a pilot study of telotristat etiprate in patients with mild to moderate ulcerative colitis, and plans to maintain focus on its ongoing Phase 3 program for telotristat etiprate in carcinoid syndrome. Lexicon continues to enroll patients in a pivotal Phase 3 clinical trial of telotristat etiprate in carcinoid syndrome.
• LX1033: LX1033 is an inhibitor of tryptophan hydroxylase that acts locally in the gastrointestinal tract to reduce serotonin production without impacting brain serotonin levels. Lexicon completed enrollment of patients in a Phase 2 clinical trial of LX1033 in diarrhea-predominant IBS, with top-line results expected to be released inNovember 2013.

Financial Results

Revenues:Lexicon's revenues for the three months endedSeptember 30, 2013decreased 36 percent to$0.2 millionfrom$0.4 millionfor the corresponding period in 2012, primarily due to decreases in technology license fees.  For the nine months endedSeptember 30, 2013, revenues decreased seven percent to$0.8 millionfrom$0.9 millionfor the corresponding period in 2012.
Research and Development Expenses:Research and development expenses for the three months endedSeptember 30, 2013increased 32 percent to$25.4 millionfrom$19.2 millionfor the corresponding period in 2012.  The increase was primarily attributable to increases in external clinical and preclinical research and development costs resulting from the advancement of our clinical pipeline, partially offset by decreases in facility costs.  For the nine months endedSeptember 30, 2013, research and development expenses increased 13 percent to$69.4 millionfrom$61.6 millionfor the corresponding period in 2012.
Increase 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.  The increase in fair value of the Symphony Icon purchase liability was$1.3 millionand$5.8 millionfor the three months endedSeptember 30, 2013and 2012, respectively, and was$3.1 millionand$10.1 millionfor the nine months endedSeptember 30, 2013and 2012, respectively.
General and Administrative Expenses:General and administrative expenses for the three months endedSeptember 30, 2013increased seven percent to$4.7 millionfrom$4.4 millionfor the corresponding period in 2012.  The increase was primarily attributable to increases in market research, consulting and personnel costs.  For the nine months endedSeptember 30, 2013, general and administrative expenses increased four percent to$13.7 millionfrom$13.1 millionfor the corresponding period in 2012.
Consolidated Net Loss:Net loss for the three months endedSeptember 30, 2013was$31.7 million, or$0.06per share, compared to a net loss of$29.5 million, or$0.06per share, in the corresponding period in 2012.  Net loss for the nine months endedSeptember 30, 2013was$86.7 million, or$0.17per share, compared to a net loss of$85.3 million, or$0.18per share, for the corresponding period in 2012.  For the three and nine months endedSeptember 30, 2013, net loss included non-cash, stock-based compensation expense of$1.8 millionand$5.7 million, respectively. For the three and nine months endedSeptember 30, 2012, net loss included non-cash, stock-based compensation expense of$1.6 millionand$4.9 million, respectively.
Cash and Investments:As ofSeptember 30, 2013, Lexicon had$151.2 millionin cash and investments, as compared to$175.4 millionas ofJune 30, 2013and$223.2 millionas ofDecember 31, 2012.

Lexicon Conference Call

Lexicon management will hold a conference call to discuss its clinical development progress and financial results for the third quarter of 2013 at11:00 a.m. Eastern TimeonNovember 12, 2013. 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 97923296. Investors can access a live webcast of the call atwww.lexpharma.com. An archived version of the webcast will be available on the website throughDecember 12, 2013.

About Lexicon

Lexicon is a biopharmaceutical company focused on discovering breakthrough treatments for human disease.  Lexicon currently has multiple drug programs in clinical development for diabetes, irritable bowel syndrome, 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.  Lexicon has focused drug discovery efforts on these biologically-validated targets to create its extensive pipeline of clinical and preclinical programs.  For additional information about Lexicon and its programs, please visitwww.lexpharma.com.

Safe Harbor Statement

This press release contains "forward-looking statements",includingstatements 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, advance additional candidates into preclinical and clinical development, 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 endedDecember 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, IncSelected Financial Data
Consolidated Statements of Operations Data Three Months EndedSeptember 30, Nine Months EndedSeptember 30,
(In thousands, except per share data) 2013 2012 2013 2012
(unaudited) (unaudited)
Revenues:
Collaborative research $     238 $        214 $     733 $     565
Subscription and license fees - 158 79 306
Total revenues 238 372 812 871
Operating expenses:
Research and development, including stock-based compensationof $1,027, $923, $3,379 and $2,875, respectively 25,400 19,192 69,419 61,584
Increase in fair value of Symphony Icon, Inc. purchase liability 1,338 5,844 3,079 10,087
General and administrative, including stock-based compensationof $723, $669, $2,349 and $2,030, respectively 4,716 4,396 13,709 13,123
Total operating expenses 31,454 29,432 86,207 84,794
Loss from operations (31,216) (29,060) (85,395) (83,923)
Interest income 39 44 136 158
Interest expense (492) (527) (1,494) (1,594)
Other income, net 11 4 41 21
Consolidated net loss $    (31,658) $  (29,539) $    (86,712) $    (85,338)
Consolidated net loss per common share, basic and diluted $  (0.06) $  (0.06) $  (0.17) $  (0.18)
Shares used in computing net loss attributable to Lexicon Pharmaceuticals, Inc.  per common share, basic and diluted 513,419 490,049 512,980 483,693

Lexicon Pharmaceuticals, Inc

Selected Financial Data

Consolidated Statements of Operations Data

Three Months Ended

September 30,

Nine Months Ended

September 30,

(In thousands, except per share data)

(unaudited)

(unaudited)

Revenues:
Collaborative research
$     238
$        214
$     733
$     565
Subscription and license fees
-
158
79
306
Total revenues
238
372
812
871
Operating expenses:
Research and development, including stock-based compensation
of $1,027, $923, $3,379 and $2,875, respectively
25,400
19,192
69,419
61,584
Increase in fair value of Symphony Icon, Inc. purchase liability
1,338
5,844
3,079
10,087
General and administrative, including stock-based compensation
of $723, $669, $2,349 and $2,030, respectively
4,716
4,396
13,709
13,123
Total operating expenses
31,454
29,432
86,207
84,794
Loss from operations
(31,216)
(29,060)
(85,395)
(83,923)
Interest income
39
44
136
158
Interest expense
(492)
(527)
(1,494)
(1,594)
Other income, net
11
4
41
21
Consolidated net loss
$    (31,658)
$  (29,539)
$    (86,712)
$    (85,338)
Consolidated net loss per common share, basic and diluted
$  (0.06)
$  (0.06)
$  (0.17)
$  (0.18)
Shares used in computing net loss attributable to Lexicon Pharmaceuticals, Inc.  per common share, basic and diluted
513,419
490,049
512,980
483,693
Consolidated Balance Sheet Data As of September 30, As of December 31,
(In thousands) 2013 2012
(unaudited)
Cash and investments $        151,210 $     223,208
Property and equipment, net 41,838 42,634
Goodwill 44,543 44,543
Other intangible assets 53,557 53,557
Total assets 299,458 371,778
Deferred revenue 14,090 14,038
Current and long-term debt 22,284 23,451
Other long-term liabilities 37,391 32,283
Accumulated deficit (986,544) (899,832)
Total stockholders' equity 185,710 266,678

Consolidated Balance Sheet Data

As of September 30,

As of December 31,

(In thousands)

(unaudited)

Cash and investments
$        151,210
$     223,208
Property and equipment, net
41,838
42,634
Goodwill
44,543
44,543
Other intangible assets
53,557
53,557
Total assets
299,458
371,778
Deferred revenue
14,090
14,038
Current and long-term debt
22,284
23,451
Other long-term liabilities
37,391
32,283
Accumulated deficit
(986,544)
(899,832)
Total stockholders' equity
185,710
266,678
Last updated: Nov 12, 2013