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Lexicon Pharmaceuticals Provides Clinical Pipeline Update And Reports 2014 Fourth Quarter And Full Year Financial Results

Key Takeaway: Lexicon Pharmaceuticals Provides Clinical Pipeline Update And Reports 2014 Fourth Quarter And Full Year 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%
average across 13 past catalysts
Cash runway
~61 mo
Minimal dilution risk
Lead asset
Sotagliflozin
Phase 3 · Type 1 Diabetes Mellitus

Full Press Release Details

THE WOODLANDS, Texas,March 4, 2015/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 endedDecember 31, 2014.
"We enter 2015 in a strong financial position to develop our two lead drug candidates, telotristat etiprate and sotagliflozin," said Lonnel Coats, Lexicon's president and chief executive officer. "This year will be key for Lexicon as we complete a pivotal Phase 3 trial of telotristat etiprate in patients with carcinoid syndrome and initiate Phase 3 trials for sotagliflozin in patients with type 1 diabetes."
InOctober 2014, Lexicon completed a collaboration agreement with Ipsen Pharma SAS for the commercialization of telotristat etiprate, with a focus on carcinoid syndrome, in markets outsidethe United States,Canadaand Japan.  Under the agreement, Lexicon is eligible to receive up to approximately$145 millionin aggregate upfront and milestone payments, including an upfront payment of$23 million.  In addition, Lexicon is entitled to receive royalties on net sales of telotristat etiprate by Ipsen.
Also in the fourth quarter of 2014, Lexicon completed concurrent debt and equity financings that resulted in gross proceeds of$293.4 million.  After fees and offering expenses, the financings resulted in net proceeds of$286.0 millionand are reflected in the company's financial results as ofDecember 31, 2014.  In the aggregate, the financings consisted of the issuance of approximately 204.9 million shares of common stock, with gross proceeds of$205.9 million, and$87.5 millionin aggregate principal amount of 5.25% convertible senior notes due 2021.

Progress in Clinical Pipeline

• Telotristat etiprate (LX1032):  Lexicon is nearing completion of enrollment in TELESTAR, its pivotal Phase 3 clinical trial of telotristat etiprate in carcinoid syndrome, with the last patient expected to be randomized inMarch 2015.  Telotristat etiprate is an inhibitor of tryptophan hydroxylase (TPH) that reduces peripheral serotonin production without affecting brain serotonin levels.
• Sotagliflozin (LX4211):  Lexicon continues to progress with the initiation of Phase 3 clinical trials of sotagliflozin in type 1 diabetes, with the anticipation that enrollment will commence in the first half of 2015.  Sotagliflozin is a dual inhibitor of sodium-glucose transporters 1 and 2 (SGLT1 and SGLT2).  In parallel with Phase 3, Lexicon is also progressing with a Phase 2 clinical trial of sotagliflozin in collaboration with JDRF, focused in individuals with type 1 diabetes younger than age 30 with high A1C, representative of a population of particularly high unmet need.

Financial Results

Revenues:Lexicon's revenues for the three months endedDecember 31, 2014increased to$21.5 millionfrom$1.4 millionfor the corresponding period in 2013, primarily due to revenues recognized from the license and collaboration agreement with Ipsen Pharma SAS.  For the year endedDecember 31, 2014, revenues increased to$22.9 millionfrom$2.2 millionfor the corresponding period in 2013.
Research and Development Expenses:Research and development expenses for the three months endedDecember 31, 2014decreased one percent to$20.0 millionfrom$20.3 millionfor the corresponding period in 2013.  For the year endedDecember 31, 2014, research and development expenses decreased to$89.3 millionfrom$89.7 millionfor the corresponding period in 2013.
Change 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 endedDecember 31, 2014, the fair value of the Symphony Icon purchase liability increased by$0.9 millionas compared to a decrease of$5.3 millionin the corresponding period in 2013.  For the year endedDecember 31, 2014, the fair value of the Symphony Icon purchase liability increased by$1.4 millionas compared to a decrease of$2.2 millionin the corresponding period in 2013.
General and Administrative Expenses:General and administrative expenses for the three months endedDecember 31, 2014increased 17 percent to$4.0 millionfrom$3.4 millionfor the corresponding period in 2013.  For the year endedDecember 31, 2014, general and administrative expenses increased 13 percent to$19.4 millionfrom$17.1 millionfor the corresponding period in 2013.
Impairment Loss on Buildings:InSeptember 2014, Lexicon determined its buildings and land should be classified as assets held for sale.  Lexicon recognized a non-cash impairment loss on its buildings of$13.1 millionfor the year endedDecember 31, 2014, as a result of writing down the buildings to the estimated net selling price.
Consolidated Net Loss:Net loss for the three months endedDecember 31, 2014was$2.9 million, or$0.00per share, compared to a net loss of$17.4 million, or$0.03per share, in the corresponding period in 2013.  Net loss for the year endedDecember 31, 2014was$100.3 million, or$0.19per share, compared to a net loss of$104.1 million, or$0.20per share, for the corresponding period in 2013.  For the three months and year endedDecember 31, 2014, net loss included non-cash, stock-based compensation expense of$1.5 millionand$7.1 million, respectively.  For the three months and year endedDecember 31, 2013, net loss included non-cash, stock-based compensation expense of$1.7 millionand$7.4 million, respectively.
Cash and Investments:As ofDecember 31, 2014, Lexicon had$339.3 millionin cash and investments, as compared to$57.9 millionas ofSeptember 30, 2014and$129.1 millionas ofDecember 31, 2013.

Lexicon Conference Call

Lexicon management will hold a conference call to discuss its clinical development progress and financial results for 2014 and financial guidance for 2015 at10:00 a.m. Eastern TimeonMarch 4, 2015.  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 98067025.  Investors can access a live webcast of the call atwww.lexpharma.com.  An archived version of the webcast will be available on the website throughApril 4, 2015.

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 visitwww.lexpharma.com.

Safe Harbor Statement

This press release contains "forward-looking statements," including statements relating to Lexicon's clinical development of sotagliflozin (LX4211) and telotristat etiprate (LX1032), including characterizations of the results of and projected timing of clinical trials and the potential therapeutic and commercial potential of sotagliflozin and telotristat etiprate.  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 meet its capital requirements, successfully conduct clinical development of sotagliflozin and telotristat etiprate 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 endedDecember 31, 2013, 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 EndedDecember 31, Year EndedDecember 31,
(In thousands, except per share data) 2014 2013 2014 2013
(unaudited) (unaudited)
Revenues:
Collaborative agreements $   21,482 $     1,376 $   22,593 $     2,109
Subscription and license fees - 34 261 113
Total revenues 21,482 1,410 22,854 2,222
Operating expenses:
Research and development, including stock-based compensationof $825, $997, $4,020 and $4,376, respectively 20,031 20,263 89,279 89,682
Increase (decrease) in fair value of Symphony Icon, Inc. purchaseliability 910 (5,289) 1,428 (2,210)
General and administrative, including stock-based compensationof $672, $696, $3,061 and $3,045, respectively 3,988 3,412 19,411 17,121
Impairment loss on buildings - - 13,102 -
Total operating expenses 24,929 18,386 123,220 104,593
Loss from operations (3,447) (16,976) (100,366) (102,371)
Interest expense (892) (477) (2,253) (1,971)
Interest and other income, net 1,336 39 2,255 216
Consolidated net loss before taxes (3,003) (17,414) (100,364) (104,126)
Income tax benefit 70 - 70 -
Consolidated net loss $    (2,933) $  (17,414) $ (100,294) $ (104,126)
Consolidated net loss per common share, basic and diluted $  0.00 $  (0.03) $  (0.19) $      (0.20)
Shares used in computing net loss attributable to Lexicon Pharmaceuticals, Inc.  per common share, basic and diluted 593,694 513,523 534,432 513,117

Lexicon Pharmaceuticals, Inc.

Selected Financial Data

Consolidated Statements of Operations Data

Three Months Ended

December 31,

Year EndedDecember 31,

(In thousands, except per share data)

(unaudited)

(unaudited)

Revenues:
Collaborative agreements
$   21,482
$     1,376
$   22,593
$     2,109
Subscription and license fees
-
34
261
113
Total revenues
21,482
1,410
22,854
2,222
Operating expenses:
Research and development, including stock-based compensationof $825, $997, $4,020 and $4,376, respectively
20,031
20,263
89,279
89,682
Increase (decrease) in fair value of Symphony Icon, Inc. purchaseliability
910
(5,289)
1,428
(2,210)
General and administrative, including stock-based compensationof $672, $696, $3,061 and $3,045, respectively
3,988
3,412
19,411
17,121
Impairment loss on buildings
-
-
13,102
-
Total operating expenses
24,929
18,386
123,220
104,593
Loss from operations
(3,447)
(16,976)
(100,366)
(102,371)
Interest expense
(892)
(477)
(2,253)
(1,971)
Interest and other income, net
1,336
39
2,255
216
Consolidated net loss before taxes
(3,003)
(17,414)
(100,364)
(104,126)
Income tax benefit
70
-
70
-
Consolidated net loss
$    (2,933)
$  (17,414)
$ (100,294)
$ (104,126)
Consolidated net loss per common share, basic and diluted
$  0.00
$  (0.03)
$  (0.19)
$      (0.20)
Shares used in computing net loss attributable to Lexicon Pharmaceuticals, Inc.  per common share, basic and diluted
593,694
513,523
534,432
513,117
Consolidated Balance Sheet Data As of December 31, As of December 31,
(In thousands) 2014 2013
(unaudited)
Cash and investments $     339,339 $     129,128
Assets held for sale 23,849 -
Property and equipment, net 1,080 41,362
Goodwill 44,543 44,543
Other intangible assets 53,357 53,557
Total assets 471,376 274,160
Deferred revenue 14,297 13,600
Current and long-term debt 107,667 21,877
Other long-term liabilities 23,535 32,386
Accumulated deficit (1,104,252) (1,003,958)
Total stockholders' equity 284,018 170,163

Consolidated Balance Sheet Data

As of December 31,

As of December 31,

(In thousands)

(unaudited)

Cash and investments
$     339,339
$     129,128
Assets held for sale
23,849
-
Property and equipment, net
1,080
41,362
Goodwill
44,543
44,543
Other intangible assets
53,357
53,557
Total assets
471,376
274,160
Deferred revenue
14,297
13,600
Current and long-term debt
107,667
21,877
Other long-term liabilities
23,535
32,386
Accumulated deficit
(1,104,252)
(1,003,958)
Total stockholders' equity
284,018
170,163
Last updated: Mar 4, 2015