Table of Contents


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
þ
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the Quarterly Period Ended September 30, 20172021
or
q
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
For the Transition Period from _____________ to _____________
Commission File Number:  000-30111
Lexicon Pharmaceuticals, Inc.
(Exact Name of Registrant as Specified in its Charter)
Delaware76-0474169
(State or Other Jurisdiction of

Incorporation or Organization)
(I.R.S. Employer

Identification Number)

88002445 Technology Forest PlaceBlvd.
11th Floor
The Woodlands, Texas 77381
(Address of Principal Executive Offices and Zip Code)
(281) 863-3000
(Registrant’s Telephone Number, Including Area Code)
Securities registered pursuant to Section 12(b) of the Act:
Title of each classTrading Symbol(s)Name of each exchange on which registered
Common Stock, par value $0.001LXRXThe Nasdaq Global Select Market
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.
YesþNo
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).
YesþNo
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company.  See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer     Accelerated filer þ ☑      Non-accelerated filer
Smaller reporting company    ☑      Emerging growth company  ☐        
If an emerging growth company, indicate by check mark if the registration has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. q
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).
YesNoþ


As of November 6, 2017, 105,587,7948, 2021, 148,895,707 shares of the registrant’s common stock, par value $0.001 per share, were outstanding.




Lexicon Pharmaceuticals, Inc.
 
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Item 2.
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Item 1.
Item 1A.
Item 6.
Item 6.


The Lexicon name and logo and XERMELO® are registered trademarks of Lexicon Pharmaceuticals, Inc.
 
——————


Factors Affecting Forward Looking Statements
This quarterly report on Form 10-Q contains forward-looking statements. These statements relate to future events or our future financial performance. We have attempted to identify forward-looking statements by terminology including “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “should” or “will” or the negative of these terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors, including the risks outlined under “Part II, Item 1A. - Risk Factors” and in our annual report on Form 10-K for the year ended December 31, 2016,2020, that may cause our or our industry’s actual results, levels of activity, performance or achievements to be materially different from any future results, levels or activity, performance or achievements expressed or implied by these forward-looking statements.
Although we believe that the expectations reflected in the forward-looking statements are reasonable, future results, levels of activity, performance or achievements may vary materially from our expectations. We are not undertaking any duty to update any of the forward-looking statements after the date of this quarterly report on Form 10-Q to conform these statements to actual results, unless required by law.





2


Part I – Financial Information
 
Item 1.  Financial Statements
 
Lexicon Pharmaceuticals, Inc.


Condensed Consolidated Balance Sheets
(In thousands, except par value)
 As of September 30,As of December 31,
 20212020
Assets(unaudited) 
Current assets:  
Cash and cash equivalents$92,118 $126,263 
Short-term investments28,800 26,012 
Accounts receivable23 395 
Prepaid expenses and other current assets3,064 5,049 
Total current assets124,005 157,719 
Property and equipment, net of accumulated depreciation and amortization of $4,849 and $5,815, respectively1,311 295 
Goodwill44,543 44,543 
Other assets2,471 1,231 
Total assets$172,330 $203,788 
Liabilities and Stockholders’ Equity  
Current liabilities:  
Accounts payable$8,345 $5,469 
Accrued liabilities14,208 29,691 
Current portion of long-term debt, net of deferred issuance costs11,693 11,646 
Total current liabilities34,246 46,806 
Other long-term liabilities1,481 611 
Total liabilities35,727 47,417 
Commitments and contingencies00
Stockholders’ Equity:  
Preferred stock, $0.01 par value; 5,000 shares authorized; no shares issued and outstanding— — 
Common stock, $0.001 par value; 225,000 shares authorized; 149,987 and 142,289 shares issued, respectively150 142 
Additional paid-in capital1,606,142 1,561,096 
Accumulated deficit(1,462,165)(1,400,018)
Accumulated other comprehensive loss(6)(6)
Treasury stock, at cost, 1,165 and 793 shares, respectively(7,518)(4,843)
Total stockholders’ equity136,603 156,371 
Total liabilities and stockholders’ equity$172,330 $203,788 

  As of September 30, As of December 31,
  2017 2016
Assets (unaudited)  
Current assets:    
Cash and cash equivalents $83,293
 $46,600
Short-term investments 113,524
 299,904
Accounts receivable, net of allowances of $4 10,597
 7,492
Inventory 2,149
 
Prepaid expenses and other current assets 4,458
 3,878
Total current assets 214,021
 357,874
Property and equipment, net of accumulated depreciation and amortization of $58,794 and $59,875, respectively 18,167
 19,390
Goodwill 44,543
 44,543
Other intangible assets, net of accumulated amortization of $1,030 and $0, respectively 52,327
 53,357
Other assets 429
 461
Total assets $329,487
 $475,625
Liabilities and Equity    
Current liabilities:    
Accounts payable $52,628
 $52,877
Accrued liabilities 12,729
 32,114
Current portion of deferred revenue 48,738
 63,372
Current portion of long-term debt, net of deferred issuance costs 14,633
 16,280
Total current liabilities 128,728
 164,643
Deferred revenue, net of current portion 26,545
 48,934
Long-term debt, net of deferred issuance costs 85,512
 85,167
Deferred tax liabilities 10,023
 18,675
Other long-term liabilities 303
 805
Total liabilities 251,111
 318,224
Commitments and contingencies 
 
Equity:    
Preferred stock, $.01 par value; 5,000 shares authorized; no shares issued and outstanding 
 
Common stock, $.001 par value; 225,000 shares authorized; 105,710 and 104,582 shares issued, respectively 106
 105
Additional paid-in capital 1,433,263
 1,411,222
Accumulated deficit (1,353,026) (1,250,363)
Accumulated other comprehensive loss (63) (195)
Treasury stock, at cost, 122 and 306 shares, respectively (1,904) (3,368)
Total equity 78,376
 157,401
Total liabilities and equity $329,487
 $475,625

The accompanying notes are an integral part of these condensed consolidated financial statements.



3


Lexicon Pharmaceuticals, Inc.


Condensed Consolidated Statements of Comprehensive LossIncome (Loss)
(In thousands, except per share amounts)
(Unaudited)
 Three Months Ended September 30,Nine Months Ended September 30,
 2021202020212020
Revenues:  
Net product revenue$— $6,542 $— $23,404 
Collaborative agreements— — — 33 
Royalties and other revenue23 92 284 359 
Total revenues23 6,634 284 23,796 
Operating expenses:  
Cost of sales (including finite-lived intangible asset amortization)— 633 — 1,929 
Research and development, including stock-based compensation of $1,138, $1,029, $3,608 and $5,154, respectively15,682 40,147 38,548 152,629 
Selling, general and administrative, including stock-based compensation of $1,574, $875, $4,741 and $5,440, respectively7,303 11,997 23,496 40,798 
Impairment loss on buildings— — — 1,600 
Total operating expenses22,985 52,777 62,044 196,956 
Other operating income:
Gain on sale of XERMELO— 132,818 — 132,818 
Income (loss) from operations(22,962)86,675 (61,760)(40,342)
Loss on debt extinguishments, net— (255)— (255)
Interest expense (171)(4,118)(507)(14,374)
Interest and other income, net11 301 120 1,892 
Net income (loss)$(23,122)$82,603 $(62,147)$(53,079)
Net income (loss) per common share, basic$(0.16)$0.77 $(0.43)$(0.50)
Net income (loss) per common share, diluted$(0.16)$0.71 $(0.43)$(0.50)
Shares used in computing net income (loss) per common share, basic145,820 107,309 144,558 106,974 
Shares used in computing net income (loss) per common share, diluted  145,820 117,552 144,558 106,974 
Other comprehensive income (loss):
Unrealized gain (loss) on investments— (277)(49)
Comprehensive income (loss)$(23,122)$82,326 $(62,146)$(53,128)
  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Revenues:        
Net product revenue $5,830
 $
 $10,443
 $
Collaborative agreements 21,112
 27,686
 46,781
 60,181
Subscription and license fees  
 31
 64
 119
Total revenues 26,942
 27,717
 57,288
 60,300
Operating expenses:        
Cost of sales (including finite-lived intangible asset amortization) 599
 
 1,361
 
Research and development, including stock-based compensation of $1,345, $1,051, $3,698 and $3,013, respectively 39,137
 52,533
 109,653
 137,751
Increase (decrease) in fair value of Symphony Icon, Inc. purchase liability 
 (2,146) 2,101
 (703)
Selling, general and administrative, including stock-based compensation of $1,235, $879, $3,516 and $2,709, respectively 16,724
 12,263
 50,069
 29,077
Total operating expenses 56,460
 62,650
 163,184
 166,125
Loss from operations  (29,518) (34,933) (105,896) (105,825)
Interest expense  (1,619) (1,646) (4,821) (4,933)
Interest and other income, net 415
 564
 1,393
 1,748
Net loss before taxes (30,722) (36,015) (109,324) (109,010)
Income tax benefit 
 
 8,652
 
Net loss $(30,722) $(36,015) $(100,672) $(109,010)
Net loss per common share, basic and diluted $(0.29) $(0.35) $(0.96) $(1.05)
Shares used in computing net loss per common share, basic and diluted   105,582
 103,885
 105,119
 103,799
         
Other comprehensive loss:        
Unrealized gain (loss) on investments 151
 (258) 132
 297
Comprehensive loss $(30,571) $(36,273) $(100,540) $(108,713)



The accompanying notes are an integral part of these condensed consolidated financial statements.



4


Lexicon Pharmaceuticals, Inc.


Condensed Consolidated Statements of Stockholders’ Equity / (Deficit)
(In thousands)
(Unaudited)
Common StockAdditional Paid-In CapitalAccumulated DeficitAccumulated Other Comprehensive Gain (Loss)Treasury Stock
SharesPar ValueTotal
Balance at December 31, 2019106,679 $106 $1,462,172 $(1,341,444)$84 $(3,817)$117,101 
Stock-based compensation— — 4,432 — — — 4,432 
Issuance of common stock under Equity Incentive Plans1,032 — — — — 
Repurchase of common stock— — — — — (923)(923)
Net loss— — — (66,611)— — (66,611)
Unrealized gain on investments— — — — 776 — 776 
Balance at March 31, 2020107,711 108 1,466,604 (1,408,055)860 (4,740)54,777 
Stock-based compensation— — 4,258 — — — 4,258 
Issuance of common stock under Equity Incentive Plans187 — — — — — — 
Repurchase of common stock— — — — — (103)(103)
Net loss— — — (69,071)— — (69,071)
Unrealized loss on investments— — — — (548)— (548)
Balance at June 30, 2020107,898 108 1,470,862 (1,477,126)312 (4,843)(10,687)
Stock-based compensation— — 1,904 — — — 1,904 
Issuance of common stock under Equity Incentive Plans9,333 14,087 — — — 14,096 
Net income— — — 82,603 — — 82,603 
Unrealized loss on investments— — — — (277)— (277)
Balance at September 30, 2020117,231 $117 $1,486,853 $(1,394,523)$35 $(4,843)$87,639 

The accompanying notes are an integral part of these condensed consolidated financial statements.











5


Lexicon Pharmaceuticals, Inc.

Condensed Consolidated Statements of Stockholders’ Equity
(In thousands)
(Unaudited)

Common StockAdditionalAccumulated Other
SharesPar ValuePaid-In CapitalAccumulated DeficitComprehensive Gain (Loss)Treasury StockTotal
Balance at December 31, 2020142,289 $142 $1,561,096 $(1,400,018)$(6)$(4,843)$156,371 
Stock-based compensation— — 2,851 — — — 2,851 
Issuance of common stock under Equity Incentive Plans1,263 547 — — — 548 
Issuance of common stock under an Open Market Sale Agreement, net of issuance fees2,000 16,397 — — — 16,399 
Repurchase of common stock— — — — — (2,675)(2,675)
Net loss— — — (20,958)— — (20,958)
Unrealized gain on investments— — — — 11 — 11 
Balance at March 31, 2021145,552 145 1,580,891 (1,420,976)(7,518)152,547 
Stock-based compensation— — 2,786 — — — 2,786 
Issuance of common stock under Equity Incentive Plans88 — — — 
Issuance fees related to Open Market Sale Agreement— — (31)— — — (31)
Net loss— — — (18,067)— — (18,067)
Unrealized loss on investments— — — — (10)— (10)
Balance at June 30, 2021145,640 146 1,583,653 (1,439,043)(5)(7,518)137,233 
Stock-based compensation— — 2,712 — — — 2,712 
Issuance of common stock under Equity Incentive Plans170 — 658 — — — 658 
Issuance of common stock under an Open Market Sale Agreement, net of issuance fees4,177 19,119 — — — 19,123 
Net loss— — — (23,122)— — (23,122)
Unrealized loss on investments— — — — (1)— (1)
Balance at September 30, 2021149,987 $150 $1,606,142 $(1,462,165)$(6)$(7,518)$136,603 

  Common Stock Additional   Accumulated Other    
  Shares Par Value Paid-In Capital Accumulated Deficit Comprehensive Gain (Loss) Treasury Stock Total
Balance at December 31, 2015 103,860
 $104
 $1,397,646
 $(1,108,934) $(219) $(2,747) $285,850
Stock-based compensation 
 
 5,722
 
 
 
 5,722
Issuance of common stock under Equity Incentive Plans 463
 
 2,943
 
 
 
 2,943
Repurchase of common stock 
 
 
 
 
 (621) (621)
Net loss 
 
 
 (109,010) 
 
 (109,010)
Unrealized gain on investments 
 
 
 
 297
 
 297
Balance at September 30, 2016 104,323
 $104
 $1,406,311
 $(1,217,944) $78
 $(3,368) $185,181
               
Balance at December 31, 2016 104,582
 $105
 $1,411,222
 $(1,250,363) $(195) $(3,368) $157,401
Cumulative effect of change in accounting principle 
 
 1,991
 (1,991) 
 
 
Issuance of common stock to designees of Symphony Icon Holdings LLC 660
 
 10,499
 
 
 
 10,499
Stock-based compensation 
 
 7,214
 
 
 
 7,214
Issuance of common stock under Equity Incentive Plans 468
 1
 5,480
 
 
 
 5,481
Issuance of treasury stock 
 
 (3,143) 
 
 3,143
 
Repurchase of common stock 
 
 
 
 
 (1,679) (1,679)
Net loss 
 
 
 (100,672) 
 
 (100,672)
Unrealized gain on investments 
 
 
 
 132
 
 132
Balance at September 30, 2017 105,710
 $106
 $1,433,263
 $(1,353,026) $(63) $(1,904) $78,376



The accompanying notes are an integral part of these condensed consolidated financial statements.

6



Lexicon Pharmaceuticals, Inc.
 
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Nine Months Ended September 30,
20212020
Cash flows from operating activities:
Net loss$(62,147)$(53,079)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization180 2,590 
Stock-based compensation8,349 10,594 
Amortization of debt issuance costs46 995 
Gain on sale of XERMELO assets— (132,818)
Impairment loss on buildings— 1,600 
Loss on debt extinguishments, net— 255 
Changes in operating assets and liabilities:
Decrease in accounts receivable372 52,201 
Decrease in inventory— 345 
Decrease (increase) in prepaid expenses and other current assets1,985 (6,008)
Decrease in other assets459 314 
(Decrease) increase in accounts payable and other liabilities(13,433)14,281 
Net cash used in operating activities(64,189)(108,730)
Cash flows from investing activities:
Purchases of property and equipment(1,198)(33)
Proceeds from XERMELO sale— 160,385 
Purchases of investments(28,880)(53,197)
Maturities of investments26,092 229,500 
Net cash (used in) provided by investing activities(3,986)336,655 
Cash flows from financing activities:
Proceeds from issuance of common stock, net of fees36,705 — 
Repurchase of common stock(2,675)(1,026)
Repayment of debt borrowings— (210,760)
Net cash provided by (used in) financing activities34,030 (211,786)
Net (decrease) increase in cash and cash equivalents(34,145)16,139 
Cash and cash equivalents at beginning of period126,263 36,112 
Cash and cash equivalents at end of period$92,118 $52,251 
Supplemental disclosure of cash flow information:
Cash paid for interest$307 $16,892 
Supplemental disclosure of non-cash activities:
     Right-of-use asset$1,704 $— 
     Liabilities assumed by TerSera from the XERMELO sale$— $3,180 
     Common stock issued in satisfaction of convertible debt exchanges$— $14,096 
  Nine Months Ended September 30,
  2017 2016
Cash flows from operating activities:    
Net loss $(100,672) $(109,010)
Adjustments to reconcile consolidated net loss to net cash used in operating activities:    
Depreciation and amortization 2,475
 1,548
Increase (decrease) in fair value of Symphony Icon, Inc. purchase liability 2,101
 (703)
Stock-based compensation 7,214
 5,722
Amortization of debt issuance costs 412
 389
Deferred tax benefit (8,652) 
Loss on disposal of property and equipment 2
 12
Changes in operating assets and liabilities:    
(Increase) decrease in accounts receivable (3,105) 173
(Increase) in inventory (2,149) 
(Increase) decrease in prepaid expenses and other current assets (580) 7,694
(Increase) decrease in other assets 32
 (25)
Increase (decrease) in accounts payable and other liabilities (11,738) 18,705
Decrease in deferred revenue (37,023) (51,342)
Net cash used in operating activities (151,683) (126,837)
Cash flows from investing activities:    
Purchases of property and equipment (224) (83)
Purchases of investments (59,237) (336,649)
Maturities of investments 245,749
 298,525
Net cash provided by (used in) investing activities 186,288
 (38,207)
Cash flows from financing activities:    
Proceeds from issuance of common stock 5,481
 2,943
Repurchase of common stock (1,679) (621)
Repayment of debt borrowings (1,714) (1,495)
Net cash provided by financing activities 2,088
 827
Net increase (decrease) in cash and cash equivalents 36,693
 (164,217)
Cash and cash equivalents at beginning of period 46,600
 202,989
Cash and cash equivalents at end of period $83,293
 $38,772
     
Supplemental disclosure of cash flow information:    
Cash paid for interest $3,272
 $3,406
     
Supplemental disclosure of non-cash investing and financing activities:    
Common stock issued in satisfaction of Symphony Icon payment obligation $10,499
 $
Unrealized gain on investments $132
 $297


The accompanying notes are an integral part of these condensed consolidated financial statements.



7


Lexicon Pharmaceuticals, Inc.


Notes to Condensed Consolidated Financial Statements
(Unaudited)
 
1.Summary of Significant Accounting Policies
 
Basis of Presentation: The accompanying unaudited condensed consolidated financial statements of Lexicon Pharmaceuticals, Inc. (“Lexicon” or the “Company”) have been prepared in accordance with generally accepted accounting principles for interim financial information and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”). Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements.


In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included. Operating results for the nine-month period ended September 30, 20172021 are not necessarily indicative of the results that may be expected for the year ended December 31, 2017.2021.

The accompanying condensed consolidated financial statements include the accounts of Lexicon and its wholly-owned subsidiaries. Intercompany transactions and balances are eliminated in consolidation.
For further information, refer to the financial statements and footnotes thereto included in Lexicon’s annual report on Form 10-K for the year ended December 31, 2016,2020, as filed with the SEC. 
Use of Estimates: The preparation of financial statements in conformity with U. S.U.S. generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the period. Actual results could differ from those estimates.
 
Cash, Cash Equivalents and Short-Term Investments: Lexicon considers all highly-liquid investments with original maturities of three months or less to be cash equivalents.  As of September 30, 2017 and December 31, 2016,2021, short-term investments consistconsisted of U.S. treasury bills and corporate debt securities. As of December 31, 2020, short-term investments consisted of corporate debt securities. The Company’s short-term investments are classified as available-for-sale securities and are carried at fair value, based on quoted market prices of the securities.  The Company views its available-for-sale securities as available for use in current operations regardless of the stated maturity date of the security.  Unrealized gains and losses on such securities are reported as a separate component of stockholders’ equity.  Net realized gains and losses, interest and dividends are included in interest income.  The cost of securities sold is based on the specific identification method.
 
Accounts Receivable:  Lexicon records trade accounts receivable in the normal course of business related to the sale of products or services.   The allowance for doubtful accounts takes into consideration such factors as historical write-offs, the economic climate and other factors that could affect collectibility.  Write-offs are evaluated on a case by case basis.

Inventory: Inventories are determined at the lower of cost or market value with cost determined under the specific identification method and may consist of raw materials, work in process and finished goods. The Company began capitalizing inventory during the nine months ended September 30, 2017 once the U.S. Food and Drug Administration (“FDA”) approved XERMELO® (telotristat ethyl) as the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to approval of XERMELO were recorded as research and development expense in the consolidated statements of comprehensive loss. As a result, cost of sales for approximately the next two years will reflect a lower average per unit cost of materials. InventoryAccrued liabilities: Accrued liabilities consisted of the following asfollowing:
As of September 30,As of December 31,
20212020
(in thousands)
Accrued research and development services$7,544 $21,962 
Accrued compensation and benefits4,172 6,200 
Short term lease liability1,027 553 
Other1,465 976 
Total accrued liabilities$14,208 $29,691 

Leases: Lexicon determines if a contract is or contains a lease at inception or upon modification of September 30, 2017 (in thousands):
Raw materials $734
Work-in-process 41
Finished goods 1,374
Total inventory $2,149

Concentrationthe contract. A contract is or contains a lease if it conveys the right to control the use of Credit Risk: Lexicon’s cash equivalents, investments and accounts receivable represent potential concentrationsan identified asset for a period in exchange for consideration. Control over the use of credit risk. The Company attemptsthe identified asset means the lessee has both (a) the right to minimize potential concentrations of risk in cash equivalents and investments by placing investments in high-quality financial instruments. The Company’s accounts receivable are unsecured and are concentrated in pharmaceutical and biotechnology companies located in Europe and the United States.  The Company has not experienced any significant credit losses to date.  
Segment Information and Significant Customers: Lexicon operates in one business segment, which primarily focuses on the discovery, development and commercialization of pharmaceutical products for the treatment of human disease. Substantiallyobtain substantially all of the Company’s revenues have been derivedeconomic benefits from drug discovery alliances, target validation collaborations for the development and, in some cases, analysis of the physiological effects of genes altered in knockout mice, technology licenses, subscriptions to its databases, government grants and contracts, compound library sales and product sales.
Property and Equipment: Property and equipment that is held and used is carried at cost and depreciated using the straight-line method over the estimated useful life of the assets which ranges from three to 40 years.  Maintenance, repairs and minor replacements are charged to expense as incurred.  Leasehold improvements are amortized over the shorter of the estimated useful life or the remaining lease term.  Significant renewals and betterments are capitalized.

Other Intangible Assets: Other intangible assets, net consist of in-process research and development acquired in business combinations, which are reported at fair value, less accumulated amortization. Intangible assets with finite lives are amortized using the straight-line method over their estimated useful lives. During the nine months ended September 30, 2017, intangible assets relating to XERMELO of $24.7 million were reclassified from indefinite-lived to finite-lived assets once the FDA approved XERMELO. The Company recorded $0.4 million and $1.0 million in amortization expense related to this asset, which is recorded as cost of sales in the accompanying consolidated statements of comprehensive loss for the three and nine months ended September 30, 2017, respectively.

During the nine months ended September 30, 2017, the Company’s valuation allowance for its deferred tax assets decreased by $8.7 million due to the reclassification of intangible assets relating to XERMELO from indefinite-lived to finite-lived assets, which resulted in the related deferred tax liability now being considered a source of taxable income. The Company recorded a $8.7 million deferred tax benefit with a corresponding reduction in its deferred tax liability in the nine months ended September 30, 2017 as a result of this reclassification.

Impairment of Long-Lived Assets:  Long-lived assets and certain identifiable intangible assets to be held and used are reviewed for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Recoverability of assets to be held and used is measured by comparison of the carrying amount of an asset to future net cash flows expected to be generated by the asset. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount that the carrying amount of the assets exceeds the fair value of the assets. Assets to be disposed of are reported at the lower of the carrying amount or fair value less costs to sell. There was no impairment of long-lived assets in the nine months ended September 30, 2017 and 2016.

Indefinite lived intangible assets are also tested annually for impairment and whenever indicators of impairment are present. When performing the impairment assessment, the Company first assesses qualitative factors to determine whether it is necessary to recalculate the fair value of its intangible assets. If management believes, as a result of the qualitative assessment, that it is more likely than not that the fair value of the intangible assets is less than its carrying amount, the Company calculates the asset’s fair value. If the carrying valueuse of the asset exceeds its fairand (b) the right to direct the use of the asset. Lexicon does not apply this accounting to those leases with terms of twelve (12) months or less.


8


Operating lease right-of-use assets and associated lease liabilities are recorded in the balance sheet at the lease commencement date based on the present value thenof future lease payments to be made over the intangible asset is written down to its fair value.

Goodwill Impairment:  Goodwillexpected lease term. As the implicit rate is not amortized, but is tested at least annually for impairmentdeterminable in its leases, Lexicon uses its incremental borrowing rate of 9% at the reporting unit level.  The Company has determined thatcommencement date in determining the reporting unit is the single operating segment disclosed in its current financial statements. Impairment is the condition that exists when the carrying amount of goodwill exceeds its implied fair value.  The first step in the impairment process is to determine the fairpresent value of the reporting unit and then compare it to the carrying value, including goodwill.  If the fair value exceeds the carrying value, no further action is required and no impairment loss is recognized.  Additional impairment assessments may be performed on an interim basis if the Company encounters events or changes in circumstances that would indicate that, more likely than not, the carrying value of goodwill has been impaired.  There was no impairment of goodwill in the nine months ended September 30, 2017 and 2016.future payments.


Revenue Recognition: Revenues are recognized when persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the price is fixed or determinable and collectibility is reasonably assured.  


Product Revenues


ProductPrior to the Company’s sale of XERMELO and related assets to TerSera Therapeutics LLC (“TerSera”) in September 2020, product revenues consistconsisted of U.S.commercial sales of XERMELO in the United States and sales of bulk tablets of telotristat ethylXERMELO to Ipsen Pharma SAS (“Ipsen”). Product revenues arewere recognized oncewhen the Company meets all four revenue recognition criteria described above. In March 2017, Lexicon began shippingcustomer obtained control of XERMELO, which occurred upon delivery to its customers in the U.S.customer. The Company recognizesrecognized product revenue for product sales of XERMELO at the time the product is received by its specialty pharmacy customers net of applicable reserves for variable consideration, including allowances for customer credits, including estimated rebates, chargebacks, discounts, returns, distribution service fees, and government rebates, such as Medicare Part D coverage gap reimbursements in the U.S. These estimates were based on the most likely amount method for relevant factors such as current contractual and statutory requirements, industry data and forecasted customer buying and payment patterns. The Company’s net product revenues reflected the Company’s best estimates of the amounts of consideration to which it was entitled based on the terms of the respective underlying contracts. Product shipping and handling costs arewere considered a fulfillment activity when control transferred to the Company’s customers and such costs were included in cost of sales.

Customer Credits: The specialty pharmacies are offered various forms of consideration, including allowances, service fees and prompt payment discounts. Lexicon expects the specialty pharmacies will earn prompt payment discounts and, therefore, the Company deducts the full amount of these discounts from total product sales when revenues are recognized. Service fees are also deducted from product sales as they are earned.

Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program. Rebate amounts are based upon contractual agreements or legal requirements with public sector (e.g. Medicaid) benefit providers. Rebates are amounts owed after the final dispensing of the product to a benefit plan participant and are based upon contractual agreements or legal requirements with public sector benefit providers. The allowance for rebates is based on statutory discount rates and expected utilization. The Company’s estimates for expected utilization of rebates are based in part on third party market research data, and data received from the specialty pharmacies. Rebates are generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarter’s unpaid rebates. If actual future rebates vary from estimates, the Company may need to adjust prior period accruals, which would affect revenue in the period of adjustment.

Chargebacks: Chargebacks are discounts that occur when contracted customers purchase directly from a specialty pharmacy. Contracted customers, which currently consist primarily of Public Health Service institutions, non-profit clinics, and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The specialty pharmacy, in turn, charges back to Lexicon the difference between the price initially paid by the specialty pharmacy and the discounted price paid to the specialty pharmacy by the customer. The allowance for chargebacks is based on known sales to contracted customers.

Medicare Part D Coverage Gap: Medicare Part D prescription drug benefit mandates manufacturers to fund 50% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. The Company’s estimates for the expected Medicare Part D coverage gap are based on data received from the specialty pharmacies. Funding of the coverage gap is generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarters. If actual future funding varies from estimates, the Company may need to adjust prior period accruals, which would affect revenue in the period of adjustment.

Co-payment assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. The Company accrues a liability for co-payment assistance based on actual program participation and estimates of program redemption using data provided by third-party administrators.

Collaborative Agreements


Revenues under collaborative agreements include both license revenue and contract research revenue. ActivitiesThe Company performs the following five steps in determining the amount of revenue to recognize as it fulfills its performance obligations under collaborative agreementseach of its agreements: (i) identify the contract(s) with a customer; (ii) identify the performance obligation in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligation in the contract, and (v) recognize revenue when (or as) the Company satisfies the performance obligation. The Company applies this five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, the Company assesses the goods or services promised within each contract, determines those that are evaluatedperformance obligations and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. The Company develops assumptions that require judgment to determine if they representthe stand-alone selling price for each performance obligation identified in the contract.

At contract inception, the Company evaluates whether development milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a multiple elementsignificant revenue agreement. The Company identifiesreversal will not occur, the deliverablesassociated development milestone value is included in the transaction price. Development milestones that are not within the agreement and evaluates which deliverables represent separate unitscontrol of accounting.the Company or the licensee, including those requiring regulatory approval, are not considered probable of being achieved until those milestones are achieved. The Company accounts for those components as separate units of accounting if the following two criteria are met:

The delivered item or items have valuetransaction price is allocated to the customereach performance obligation on a relative stand-alone basis; and
If thereselling price basis, for which the Company recognizes revenue when (or as) the performance obligation is a general rightsatisfied. At the end of return relative toeach reporting period, the delivered items, delivery or performanceCompany re-evaluates the probability of achievement of the undelivered items is considered probabledevelopment milestones and within the Company’s control.


Factors considered in this determination include, among other things, whether any other vendors sell the items separatelyrelated constraint, and if the licensee could use the delivered item fornecessary, adjusts its intended purpose without the receiptestimates of the remaining deliverables. If multiple deliverables included in an arrangementoverall transaction price. Any such adjustments are separable into different units of accounting, the Company allocates the arrangement consideration to those units of accounting. The amount of allocable arrangement consideration is limited to amounts that are fixed or determinable. Arrangement consideration is allocated at the inception of the arrangement to the identified units of accounting basedrecorded on their relative estimated selling price. Revenue is recognized for each unit of accounting when the appropriate revenue recognition criteria are met.

Future milestone payments that are contingent upon the achievement of a substantive milestone are recognized in their entiretycumulative catch-up basis, which would affect collaboration revenues in the period of adjustment.

In agreements in which the milestone is achieved. A milestone is substantive if:

The consideration payable to the Company is commensurate with the Company’s performance necessary to achieve the milestone or the increase in value to the collaboration resulting from the Company’s performance;
Relates solelya license to the Company’s past performance;intellectual property is determined distinct from other performance obligations identified in the agreement, the Company recognizes revenue when the license is transferred to the licensee and the licensee is able to use and benefit from the license.
Is reasonable relative
For agreements that include sales-based royalties, including milestones based on a level of sales, the license is deemed to be the predominant item to which the royalties relate and the Company recognizes revenue at the later of (i) when the related sales occur or (ii) when the performance obligation to which some or all of the other deliverablesroyalty has been allocated has been satisfied (or partially satisfied).


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The Company may receive payments from its licensees based on billing schedules established in each contract. Upfront payments and payments within the arrangement.

Commercial milestones will be accounted for as royalties andfees are recorded as deferred revenue upon achievementreceipt or when due, and may require deferral of the milestone, assuming all other revenue recognition criteriato a future period until the Company performs its obligations under the relevant agreement. Amounts are met. Subscription and license fees are recognizedrecorded as revenue uponaccounts receivable when the grant of the technology license when performanceCompany’s right to consideration is complete and there is no continuing involvement. Royalty revenues are recognized as earned in accordance with the contract terms at the time the royalty amount is fixed and determinable based on information received from the sublicensees and at the time collectibility is reasonably assured.unconditional.


Cost of Sales: Cost of sales consistsconsisted of third-party manufacturing costs, freight and indirect overhead costs associated with sales of XERMELO. The Company began capitalizing inventory during the nine months ended September 30, 2017 once the FDA approved XERMELO as the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to approval of XERMELO have been recorded as research and development expense in the consolidated statements of comprehensive loss. As a result, cost of sales for approximately the next two years will reflect a lower average per unit cost of materials. Product shipping and handling costs arewere included in cost of sales. Cost of sales also includesincluded the amortization of the in-process research and development intangible asset for XERMELO using the straight-line method over the estimated useful life of 14 years.


Research and Development Expenses: Research and development expenses consist of costs incurred for company-sponsored as well as collaborative research and development activities. These costs include direct and research-related overhead expenses and are expensed as incurred.  Technology license fees for technologies that are utilized in research and development and have no alternative future use are expensed when incurred. Substantial portions of the Company’s preclinical and clinical trials are performed by third-party laboratories, medical centers, contract research organizations and other vendors. For preclinical studies, the Company accrues expenses based upon estimated percentage of work completed and the contract milestones remaining. For clinical studies, expenses are accrued based upon the number of patients enrolled and the duration of the study. The Company’s estimates of the clinical study costs and costs to transition activities from Sanofi for the development of sotagliflozin for type 2 diabetes and heart failure, as well as the wind down of those activities, were based on estimates of the services to be received and efforts to be expended pursuant to contracts with multiple vendors and the CRO that conducted and managed the clinical studies on its behalf. The Company monitors patient enrollment, the progress of clinical studies and related activities to the extent possible through internal reviews of data reported to the Company by the vendors and clinical site visits. The Company’s estimates depend on the timeliness and accuracy of the data provided by the vendors regarding the status of each program and total program spending. The Company periodically evaluates the estimates to determine if adjustments are necessary or appropriate based on information it receives.
 
Stock-Based Compensation:  The Company recognizes compensation expense in its condensed consolidated statements of comprehensive loss for share-based payments, including stock options and restricted stock units issuedgranted to employees, based on their fair values on the date of the grant, with the compensation expense recognized over the period in which an employee is required to provide service in exchange for the stock award.  Stock-based compensation expense for awards without performance conditions is recognized on a straight-line basis. Stock-based compensation expense for awards with performance conditions is recognized over the period from the date the performance condition is determined to be probable of occurring through the time the applicable condition is met.  
 
The fair value of stock options is estimated at the date of grant using the Black-Scholes method.  The Black-Scholes option-pricing model requires the input of subjective assumptions.  Because the Company’s employee stock options have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in management’s opinion, the existing models do not necessarily provide a reliable single measure of the fair value of its employee stock options.  For purposes of determining the fair value of stock options, the Company segregates its options into two homogeneous groups, based on exercise and post-vesting employment termination behaviors, resulting in a change in the assumptions used for expected option lives and forfeitures.lives.  Historical data is used to estimate the expected option life for each group. Expected volatility is based

on the historical volatility in the Company’s stock price.  
















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The Company utilized the Black-Scholes valuation model for estimating the fair value of the stock option compensation granted, with the following weighted-average assumptions for stock options granted in the nine months ended September 30, 20172021 and 2016:2020:
 Expected VolatilityRisk-free Interest RateExpected TermDividend
Rate
September 30, 2021:    
Employees102 %0.6 %4— %
Officers and non-employee directors90 %1.1 %7— %
September 30, 2020:
Employees91 %1.3 %4— %
Officers and non-employee directors78 %1.4 %8— %

  Expected Volatility Risk-free Interest Rate Expected Term 
Dividend
Rate
September 30, 2017:        
Employees 61% 1.7% 4 %
Officers and non-employee directors 70% 2.2% 8 %
September 30, 2016:        
Employees 63% 1.1% 4 %
Officers and non-employee directors 83% 1.6% 8 %

The following is a summary of stock option activity under Lexicon’s stock-based compensation plans for the nine months ended September 30, 2017:2021:
 OptionsWeighted Average Exercise Price
 (in thousands) 
Outstanding at December 31, 20208,397 $7.12 
Granted1,448 6.88 
Exercised(281)4.31 
Expired(191)12.50 
Forfeited(733)8.92 
Outstanding at September 30, 20218,640 6.90 
Exercisable at September 30, 20215,092 $8.16 

  Options Weighted Average Exercise Price
  (in thousands)  
Outstanding at December 31, 2016 4,834
 $11.24
Granted 847
 14.51
Exercised (458) 11.98
Expired (149) 26.59
Forfeited (82) 13.55
Outstanding at September 30, 2017 4,992
 11.23
Exercisable at September 30, 2017 2,896
 $11.06


During the nine months ended September 30, 2017,2021, Lexicon also granted its employees and non-employee directors annual restricted stock units. TheseOutstanding employee restricted stock units vest in fourthree annual installments. Outstanding non-employee director restricted stock units vest fully on the first anniversary of the grant. The following is a summary of restricted stock units activity under Lexicon’s stock-based compensation plans for the nine months ended September 30, 2017:
  Shares 
Weighted Average Grant Date
Fair Value
  (in thousands)  
Outstanding at December 31, 2016 875
 $8.13
Granted 418
 14.44
Vested (286) 8.78
Forfeited (38) 10.98
Outstanding at September 30, 2017 969
 $10.55
2021:
 SharesWeighted Average Grant Date
Fair Value
 (in thousands) 
Outstanding at December 31, 20202,769 $4.35 
Granted663 8.22 
Vested(1,239)5.04 
Forfeited(217)4.96 
Outstanding at September 30, 20211,976 $5.15 
 
During the nine months ended September 30, 2017, Lexicon granted its non-employee directors 10,248 shares of restricted stock awards. The restricted stock awards had a weighted average grant date fair value of $15.61 per share and vested immediately.

Net Loss per Common Share: Net loss per common share is computed using the weighted average number of shares of common stock outstanding. Shares associated with convertible debt, stock options and restricted stock units are not included because they are antidilutive.






2.Recent Accounting Pronouncements






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2.           Recent Accounting Pronouncements
In May 2014,December 2019, the Financial Accounting Standards Board (“FASB”)FASB issued Accounting Standards Update (“ASU”) No. 2014-09, “Revenue from Contracts with Customers”, which2019-12, Income Taxes (Topic 740) Simplifying Accounting for Income Taxes, as part of its initiative to reduce complexity in the accounting standards. The guidance amended certain disclosure requirements that had become redundant, outdated or superseded. Additionally, this guidance amends FASB ASC Topic 606. ASU 2014-09 provides a single, comprehensive revenue recognition model for all contracts with customers. This standard contains principlesaccounting for the determinationinterim period effects of changes in tax laws or rates, and simplifies aspects of the measurement of revenue and the timing of when such revenueaccounting for franchise taxes. The guidance is recognized. Revenue recognition will reflect the transfer of goods or services to customers at an amount that is expected to be earned in exchange for those goods or services. In August 2015, the FASB issued ASU No. 2015-14, “Revenue from Contracts with Customers: Deferral of Effective Date”, which defers the effective date of ASU 2014-09 by one year. ASU 2014-09 is now effective for annual periods after December 15, 2017 including interim periods within that reporting period. Early application is permitted only for annual periods beginning after December 15, 2016,2020, including interim periods within that reporting period. Management plans to adopttherein. The adoption of ASU 2014-09 using2019-12 in the modified retrospective method.
The Company doesfirst quarter of 2021 did not expect that ASU 2014-09 will have a material impact on the recognition of revenue from product sales. Management is also currently evaluating the impact of the new standard on historical revenue recorded for its collaboration agreements. Specifically, the timing of recognition for certain contingent payments from the Company’s collaborators may be impacted by the adoption of the new revenue standard. ASU 2014-09 differs from the current accounting standard in many respects, such as in the accounting for variable consideration, including milestone payments or contingent payments, which are not dependent on the Company’s performance. Under the Company’s current accounting policy, Lexicon recognizes contingent or milestone payments as revenue in the period that the payment-triggering event occurs or is achieved. However, under the new revenue standard, it is possible to start to recognize contingent or milestone payments before the payment-triggering event is completely achieved, subject to management’s assessment of whether it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved.
In January 2016, the FASB issued ASU No. 2016-01, “Recognition and Measurement of Financial Assets and Financial Liabilities.” ASU 2016-01 requires that most equity investments be measured at fair value, with subsequent changes in fair value recognized in net income. The pronouncement also impacts financial liabilities under the fair value option and the presentation and disclosure requirements for financial instruments. This pronouncement is effective for fiscal years, and interim periods within those years, beginning after December 15, 2017, and early adoption is not permitted. Management does not expect the adoption of this pronouncement to have a material impact on Lexicon’scondensed consolidated financial statements.
In February 2016, the FASB issued ASU No. 2016-02, “Leases.” ASU 2016-02 requires companies that lease assets to recognize a right-of-use asset
3.           Cash and a lease liability, initially measured at the present value of the lease payments, in its balance sheet. The pronouncement will also require additional disclosures about the amount, timingCash Equivalents and uncertainty of cash flows arising from leases. This pronouncement is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018, and early adoption is permitted. Management is currently evaluating the impact of this pronouncement on Lexicon’s consolidated financial statements.Investments
In March 2016, the FASB issued ASU No. 2016-09, “Stock Compensation,” which is intended to simplify several aspects of the accounting for share-based payment award transactions. The Company adopted this pronouncement effective January 1, 2017. Upon adoption, the Company recognized approximately $6.1 million of accumulated excess tax benefits as deferred tax assets that under the previous guidance could not be recognized until the benefits were realized through a reduction in cash taxes paid. This part of the guidance is applied using a modified retrospective method with a cumulative-effect adjustment to the accumulated deficit for the excess tax benefits not previously recognized. However, given the full valuation allowance placed on the additional $6.1 million of deferred tax assets, the recognition of this provision of ASU 2016-09 had no impact to the Company’s accumulated deficit as of January 1, 2017. Additionally, the Company recorded an adjustment to accumulated deficit of $2.0 million as a result of making an entity-wide accounting policy election to account for forfeitures of share-based payment awards as they occur instead of estimating the number of awards that are expected to vest.


3.Cash and Cash Equivalents and Investments
 
The fair value of cash and cash equivalents and investments held at September 30, 20172021 and December 31, 20162020 are as follows:
 As of September 30, 2021
 Amortized CostGross Unrealized GainsGross Unrealized LossesEstimated Fair Value
 (in thousands)
Cash and cash equivalents$92,118 $— $— $92,118 
Securities maturing within one year:    
U.S. treasury securities15,123 — 15,124 
Corporate debt securities13,683 — (7)13,676 
Total short-term investments$28,806 $$(7)$28,800 
Total cash and cash equivalents and investments$120,924 $$(7)$120,918 
 As of December 31, 2020
 Amortized CostGross Unrealized GainsGross Unrealized LossesEstimated Fair Value
  (in thousands) 
Cash and cash equivalents$126,263 $— $— $126,263 
Securities maturing within one year:    
Corporate debt securities26,018 (11)26,012 
Total short-term investments$26,018 $$(11)$26,012 
Total cash and cash equivalents and investments$152,281 $$(11)$152,275 

  As of September 30, 2017
  Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value
  (in thousands)
Cash and cash equivalents $83,293
 $
 $
 $83,293
Securities maturing within one year:        
U.S. treasury securities 90,533
 
 (57) 90,476
Corporate debt securities 23,054
 
 (6) 23,048
Total short-term investments $113,587
 $
 $(63) $113,524
Total cash and cash equivalents and investments $196,880
 $
 $(63) $196,817
         
  As of December 31, 2016
  Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value
    (in thousands)  
Cash and cash equivalents $46,600
 $
 $
 $46,600
Securities maturing within one year:        
U.S. treasury securities 227,911
 1
 (107) 227,805
Corporate debt securities 72,188
 1
 (90) 72,099
Total short-term investments $300,099
 $2
 $(197) $299,904
Total cash and cash equivalents and investments $346,699
 $2
 $(197) $346,504

There were $7,000 inno realized losses forduring either of the nine months ended September 30, 2017,2021 and no realized gains or losses for the nine months ended September 30, 2016.2020, respectively. The cost of securities sold is based on the specific identification method.


4.Fair Value Measurements
4.            Fair Value Measurements
 
The Company uses various inputs in determining the fair value of its investments and measures these assets on a recurring basis. Assets and liabilities recorded at fair value in the condensed consolidated balance sheets are categorized by the level of objectivity associated with the inputs used to measure their fair value. The following levels are directly related to the amount of subjectivity associated with the inputs to fair valuation of these assets and liabilities:


Level 1 - quoted prices in active markets for identical investments, which include U.S. treasury securities
Level 2 - other significant observable inputs (including quoted prices for similar investments, market corroborated inputs, etc.), which includes corporate debt securities
Level 3 - significant unobservable inputs (including the Company’s own assumptions in determining the fair value of the Symphony Icon purchase consideration liability)

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The inputs or methodology used for valuing securities are not necessarily an indication of the credit risk associated with investing in those securities. The following table provides the fair value measurements of applicable Company assets and liabilities that are measured at fair value on a recurring basis according to the fair value levels describeddefined above as of September 30, 20172021 and December 31, 2016:2020.

 Assets and Liabilities at Fair Value as of September 30, 2021
 Level 1Level 2Level 3Total
(in thousands)
Assets
Cash and cash equivalents$92,118 $— $— $92,118 
Short-term investments15,124 13,676 — 28,800 
Total cash and cash equivalents and investments$107,242 $13,676 $— $120,918 
 Assets and Liabilities at Fair Value as of December 31, 2020
 Level 1Level 2Level 3Total
 (in thousands)
Assets
Cash and cash equivalents$126,263 $— $— $126,263 
Short-term investments— 26,012 — 26,012 
Total cash and cash equivalents and investments$126,263 $26,012 $— $152,275 
  Assets and Liabilities at Fair Value as of September 30, 2017
  Level 1 Level 2 Level 3 Total
  (in thousands)
Assets        
Cash and cash equivalents $83,293
 $
 $
 $83,293
Short-term investments 90,476
 23,048
 
 113,524
Total cash and cash equivalents and investments $173,769
 $23,048
 $
 $196,817

  Assets and Liabilities at Fair Value as of December 31, 2016
  Level 1 Level 2 Level 3 Total
  (in thousands)
Assets        
Cash and cash equivalents $45,093
 $1,507
 $
 $46,600
Short-term investments 227,805
 72,099
 
 299,904
Total cash and cash equivalents and investments $272,898
 $73,606
 $
 $346,504
Liabilities        
Accrued liabilities $
 $
 $18,912
 $18,912
Total liabilities $
 $
 $18,912
 $18,912
The Company’sCompany did not have any Level 3 assets or liabilities which consistedas of September 30, 2021 or December 31, 2020. Transfers between levels are recognized at the actual date of the Symphony Icon purchase consideration liability,circumstance that caused the transfer. There were no transfers between Level 1 and Level 2 during the periods presented.
Refer to Note 6, Debt Obligations, for fair value measurements of debt obligations.
5.          Property and Equipment

Property and equipment was estimated using a probability-based income approach utilizingcomprised of the following:

Estimated Useful LivesAs of
 In YearsSeptember 30, 2021December 31, 2020
 (in thousands)
Computers and software3-5$3,112 $3,826 
Furniture and fixtures5-71,762 1,867 
Leasehold improvements3-71,286 417 
Total property and equipment 6,160 6,110 
Less: Accumulated depreciation and amortization (4,849)(5,815)
Net property and equipment $1,311 $295 

During the nine months ended September 30, 2021, the Company retired $1.1 million of computers and software and furniture and fixtures, which had been fully depreciated. During the nine months ended September 30, 2021, the Company purchased $1.2 million of assets comprised of leasehold improvements, computers and software and furniture. The leasehold improvements are being amortized over the lease term.

In 2020, the Company recorded an appropriate discount rate. Subsequent changes inimpairment loss of $1.6 million to reduce the faircarrying value of the Symphony Icon purchase consideration liabilityassets comprising its campus in The Woodlands, Texas, which were recorded as an increase or decreasesold in Symphony Icon purchase liability expense in the accompanying consolidated statements of comprehensive loss. The following table summarizes the change in consolidated balance sheet carrying value associated with Level 3 liabilities for the nine months ended September 30, 2017 and 2016 (in thousands):
Balance at December 31, 2016 $18,912
Change in valuation of purchase consideration payable to former Symphony Icon stockholders 2,101
Payment of contingent payment obligation with common stock and cash (21,013)
Balance at September 30, 2017 $
   
Balance at December 31, 2015 $22,815
Change in valuation of purchase consideration payable to former Symphony Icon stockholders (703)
Payment of contingent payment obligation with cash (3,200)
Balance at September 30, 2016 $18,912
The Company also has assets that under certain conditions are subjectDecember 2020, to measurement atits estimated fair value, on a non-recurring basis. These assets include goodwill associatedless estimated selling costs. Concurrent with the acquisitions of Coelacanth Corporation in 2001 and Symphony Icon in 2010 and intangible assets associatedsale, the Company entered into a leaseback agreement with the acquisitionpurchaser with respect to a portion of Symphony Iconthe facilities for a period of up to six months and in 2010. See Note 6, Arrangements with Symphony Icon, Inc., for additional information. For these assets, measurement at fair value in periods subsequentJune 2021, the Company relocated its corporate offices to their initial recognition is applicable if one or more is determined to be impaired.another facility.



5.Debt Obligations
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6.          Debt Obligations
Convertible Debt. In November 2014, Lexicon completed an offering of $87.5 million in aggregate principal amount of its 5.25% Convertible Senior Notes due 2021 (the “Notes”“Convertible Notes”). The conversion feature did not meet the criteria for bifurcation as required by generally accepted accounting principles and the entire principal amount was recorded as long-term debt on the Company’s condensed consolidated balance sheets.

In September 2020, the Company entered into separate, privately negotiated exchange agreements to exchange $75.8 million aggregate principal amount of the Convertible Notes for consideration valued at 85% of the principal amount of the Convertible Notes. In September 2020, the Company issued 9,332,471 shares of the Company’s common stock and paid $44.0 million in cash, which included $1.1 million of accrued interest, to exchange $67.1 million aggregate principal amount of such Convertible Notes. The Company recorded the exchanges under the accounting requirements for debt extinguishment of convertible instruments. As a result, a debt extinguishment gain of $8.4 million was recorded and is included in the accompanying condensed consolidated statement of comprehensive income (loss) for the three and nine months ended September 30, 2020. As of September 30, 2021, the carrying value of the remaining Convertible Notes was $11.7 million and is included in the current portion of long-term debt, net of deferred issuance costs in the accompanying condensed consolidated balance sheet.
The remaining Convertible Notes are governed by an indenture (the “Indenture”), dated as of November 26, 2014, between the Company and Wells Fargo Bank, N.A., as trustee. The Convertible Notes bear interest at a rate of 5.25% per year, payable semiannually in arrears on June 1 and December 1 of each year, beginning on June 1, 2015. The Convertible Notes mature on December 1, 2021. The Company may not redeem the Convertible Notes prior to the maturity date, and no sinking fund is provided for the Convertible Notes.
Holders of the Convertible Notes may convert their Convertible Notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date. Upon conversion, the Company will deliver for each $1,000 principal amount of converted Convertible Notes a number of shares of its common stock equal to the conversion rate, as described in the Indenture. The conversion rate is initially 118.4553 shares of common stock per $1,000 principal amount of Convertible Notes (equivalent to an initial conversion price of $8.442 per share of common stock). The conversion rate is subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that occur prior to the maturity date, the Company will increase the conversion rate for a holder who elects to convert its Convertible Notes in connection with such a corporate event in certain circumstances.
If the Company undergoes a fundamental change, holders may require the Company to repurchase for cash all or any portion of their Convertible Notes at a fundamental change repurchase price equal to 100% of the principal amount of the Convertible Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date.
In connection with the issuance of the Notes, the Company incurred $3.4 million of debt issuance costs, which offsets long-term debt on the consolidated balance sheets. The debt issuance costs are amortized as interest expense over the expected life of the Notes using the effective interest method. The Company determined the expected life of the debt was equal to the seven-year term of the Notes. As of September 30, 2017, the balance of unamortized debt issuance costs was $2.0 million.
The fair value of the remaining Convertible Notes was $141.6$11.9 million as of September 30, 20172021 and was determined using Level 2 inputs based on the indicative pricing published by certain investment banks or trading levels of the Convertible Notes, which are not listed on any securities exchange or quoted on an inter-dealer automated quotation system.
MortgageBioPharma Term Loan. In April 2004, Lexicon obtained a $34.0 million mortgage on its facilities in The Woodlands, Texas.  The mortgage loan originally had a ten-year term with a 20-year amortization and a fixed interest rate of 8.23%. The mortgage was amended in September 2013 to extend the maturity date from April 2014 to AprilDecember 2017, with the mortgage loan’s monthly payment amount and fixed interest rate each remaining unchanged. In April 2017, the mortgage was amended to extend the maturity date to April 2018, with the mortgage loan’s monthly payment amount and fixed interest rate each remaining unchanged.  The mortgage had a principal balance outstanding of $14.7 million as of September 30, 2017. This entire balance is recorded as current portion of long-term debt in the accompanying consolidated balance sheet as of September 30, 2017 as there is a balloon payment due in April 2018. The buildings and land that serve as collateral for the mortgage loan are included in property and equipment at $59.2 million and $2.7 million, respectively, before accumulated depreciation, as of September 30, 2017. The fair value of Lexicon’s mortgage loan approximates its carrying value.  The fair value of Lexicon’s mortgage loan was determined using Level 2 inputs using discounted cash flow analysis, based on the Company’s estimated current incremental borrowing rate.


6.Arrangements with Symphony Icon, Inc.
On June 15, 2007, Lexicon entered into a seriesloan agreement with BioPharma under which $150.0 million was funded in December 2017 (the “BioPharma Term Loan”). The BioPharma Term Loan was scheduled to mature in December 2022, bore interest at 9% per year, subject to additional interest if an event of related agreements providing fordefault occurred and was continuing, and was payable quarterly.
The BioPharma Term Loan was subject to mandatory prepayment provisions that required prepayment upon a change of control or receipt of proceeds from certain non-ordinary course transfers of assets. The Company repaid the financingBioPharma Term Loan in whole, together with required prepayment and make-whole premiums, upon closing of the clinical development of certain of its drug candidates, including XERMELO along with any other pharmaceutical compositions modulatingsale in September 2020. The Company recorded the same targets as those drug candidates (the “Programs”). The agreements included a Novatedrepayment under the accounting requirements for debt extinguishment and Restated Technology License Agreement pursuant to which the Company licensed to Symphony Icon, a then wholly-owned subsidiary of Symphony Icon Holdings LLC (“Holdings”), the Company's intellectual property rights related to the Programs. Holdings contributed $45 million to Symphony Icon in order to fund the clinical development of the Programs.

Under a Share Purchase Agreement, dated June 15, 2007, between the Company and Holdings, the Company issued and sold to Holdings 1,092,946 shares of its common stock on June 15, 2007 in exchange for $15 million and an exclusive purchase option (the “Purchase Option”) that gave the Company the right to acquire all of the equity of Symphony Icon, thereby allowing the Company to reacquire all of the Programs. On July 30, 2010, Lexicon entered into an Amended and Restated Purchase Option Agreement (the “Purchase Option Agreement”) with Symphony Icon and Holdings and simultaneously exercised the Purchase Option, thereby reacquiring the Programs. Pursuant to the amended terms of the Purchase Option, Lexicon paid Holdings $10 million on July 30, 2010 and issued 1,891,074 shares of common stock to designees of Holdings on July 30, 2012 in satisfaction of an additional $35 million base payment obligation.
Lexicon also agreed to make up to $45 million in additional contingent payments, which would consist of 50% of any consideration Lexicon receives pursuant to any licensing transaction (a “Licensing Transaction”) under which Lexicon grants a third party rights to commercialize XERMELO or other pharmaceutical compositions modulating the same target as XERMELO (the “LG103 Programs”), subject to certain exceptions. The contingent payments would be due if and when Lexicon receives such consideration from a Licensing Transaction. In the event Lexicon received regulatory approval in the United States for the marketing and sale of any product resulting from the LG103 Programs prior to entering into a Licensing Transaction for the commercialization of such product in the United States, in lieu of any contingent payment from such a Licensing Transaction, Lexicon would pay Holdings the sum of $15 million and the amount of certain expenses Lexicon incurred after its exercise of the Purchase Option which were attributable to the development of such product, reduced by up to 50% of such sum on account of any contingent payments paid prior to such United States regulatory approval attributable to any such Licensing Transaction outside of the United States with respect to such product. In the event Lexicon made any such payment upon United States regulatory approval, Lexicon would have no obligation to make subsequent contingent payments attributable to any such Licensing Transactions for the commercialization of such product outside the United States until the proceeds of such Licensing Transactions exceed 50% of the payment made as a result, a loss of such United States regulatory approval. The contingent payments were payable in cash or a combination of cash$8.6 million was recognized and common stock, in Lexicon’s discretion, provided that no more than 50% of any contingent payment would be paid in common stock. In December 2014, Lexicon paid $5.8 million in cash and issued 666,111 shares of common stock to designees of Holdings in satisfaction of a $11.5 million contingent payment obligation as a result of receiving an upfront payment pursuant to Lexicon’s license and collaboration agreement with Ipsen. In April 2015, Lexicon paid $0.75 million in cash to Holdings in satisfaction of its contingent payment obligation as a result of receiving an additional upfront payment from Ipsen in March 2015. In September 2016, Lexicon paid $3.2 million in cash to Holdings in satisfaction of its contingent payment obligation as a result of receiving a milestone payment from Ipsen in August 2016 (see Note 8, Collaboration and License Agreements).
In September 2016, Lexicon entered into an amendment (the “Amendment”) to the Purchase Option Agreement with Holdings and Symphony Icon pursuant to which Lexicon agreed to pay Holdings $21.0 million upon Lexicon’s receipt of regulatory approval in the United States for the marketing and sale of XERMELO, such buyout amount to be in lieu of any remaining payments which may be or become payable to Holdings under the Purchase Option Agreement. The buyout amount may be paid in cash or a combination of cash and common stock, in Lexicon’s discretion, provided that no more than 50% of any contingent payment will be paid in common stock. In March 2017, Lexicon paid $10.5 million in cash and issued 659,905 shares of common stock to designees of Holdings in satisfaction of its remaining contingent payment obligation as a result of receiving regulatory approval in the United States for the marketing and sale of XERMELO.
Lexicon accounted for the exercise of the Purchase Option and acquisition of Symphony Icon as a business combination. In connection with its acquisition of Symphony Icon, Lexicon paid $10.0 million in cash, and also agreed to pay Holdings additional base and contingent payments as discussed above. The fair value of the base and contingent consideration payments was $45.6 million and was estimated by applying a probability-based income approach utilizing an appropriate discount rate. This estimation was based on significant inputs that are not observable in the market, referred to as Level 3 inputs. Key assumptions include: (1) a discount rate of 14% for the base payments; (2) a discount rate of 18% for the contingent payments; and (3) a probability adjusted contingency. No discount rate was used in the valuation of the contingent consideration liability as of December 31, 2016 as the expected buyout was short-term in nature. As programs progress, the probability adjusted contingency was adjusted as necessary. Subsequent changes in the fair value of the Symphony Icon purchase consideration liability were recorded as increase or decrease in fair value of Symphony Icon purchase liability expenseis included in the accompanying condensed consolidated statementsstatement of comprehensive loss. The fair value ofincome (loss) for the Symphony Icon purchase consideration liability increased by $2.1 million during thethree and nine months ended September 30, 2017 and decreased by $0.7 million during the nine months ended September 30, 2016.2020.




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7.            Commitments and Contingencies
 
Operating Lease Obligations:  A Lexicon subsidiaryLexicon’s operating leases include office space in The Woodlands, Texas and Basking Ridge, New Jersey under anand will expire in August 2025 and December 2022, respectively. Under its lease agreements, Lexicon is obligated to pay property taxes, insurance, and maintenance costs.

As of September 30, 2021, the right-of-use assets for the office space leases had a balance of $2.5 million, which is included in other assets in the condensed consolidated balance sheet. Current and non-current liabilities relating to the leases were $1.0 million and $1.5 million, respectively, which are included in accrued liabilities and other long-term liabilities in the condensed consolidated balance sheet, respectively.

The following table reconciles the undiscounted cash flows of the operating lease agreement,liability to the termrecorded lease liability at September 30, 2021:

 (in thousands)
2021$286 
20221,163 
2023531 
2024544 
2025370 
Thereafter— 
Total undiscounted operating lease liability2,894 
Less: amount of lease payments representing interest(386)
Present value of future lease payments2,508 
Less: short-term operating lease liability(1,027)
Long-term operating lease liability$1,481 


Legal Proceedings.  On January 28, 2019, a purported securities class action complaint captioned Daniel Manopla v. Lexicon Pharmaceuticals, Inc., Lonnel Coats, Jeffrey L. Wade and Pablo Lapuerta, M.D. was filed against the Company and certain of which beganits officers in June 2015the U.S. District Court for the Southern District of Texas, Houston Division. The Company’s motion to dismiss was granted and terminatesthe action was dismissed with prejudice by the District Court on August 14, 2020. The judgment of the District Court was affirmed by the U.S. Court of Appeals for the Fifth Circuit on September 10, 2021. The lawsuit purported to be a class action brought on behalf of purchasers of the Company’s securities during the period from March 11, 2016 through July 29, 2019. The complaint alleged that the defendants violated federal securities laws by making materially false and misleading statements and/or omissions concerning data from the Company’s Phase 3 clinical trials of sotagliflozin in December 2022. Rent expense is recognizedtype 1 diabetes patients and the prospects of FDA approval of sotagliflozin for the treatment of type 1 diabetes. The complaint purported to assert claims for violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. The complaint sought, on a straight-line basis overbehalf of the lease term.  The maximum potentialpurported class, an unspecified amount of future paymentsmonetary damages, interest, fees and expenses of attorneys and experts, and other relief.

Sanofi Arbitration. On October 16, 2020, the Company couldinitiated arbitration proceedings against Sanofi-Aventis Deutschland GmbH (“Sanofi”) seeking to recover damages for breach of contract relating to the Termination and Settlement Agreement and Mutual Releases with Sanofi, dated September 9, 2019 (the “Termination Agreement”). In September 2020, Sanofi withheld approximately $23.2 million from the final $26 million payment due to the Company under the Termination Agreement, offsetting certain third party costs and internal costs incurred by Sanofi and asserted by Sanofi to be requiredpayable by the Company under the terms of the Termination Agreement. The Company disputed that at least a significant portion of such costs were properly reimbursable by the Company under the terms of the Termination Agreement and asserted that, in any event, Sanofi was not permitted to makewithhold any of such costs under the terms of the Termination Agreement. The Company was seeking payment of $15.6 million in such disputed costs, together with late interest and attorneys’ fees and costs. Sanofi was seeking declaratory judgment that the Company is liable for all disputed costs previously withheld and damages for any additional costs properly reimburseable under the terms of the Termination Agreement in excess of those previously withheld, together with late interest and attorneys’ fees. On November 5, 2021, the arbitration panel issued a judgment in Sanofi’s favor. The amount of Sanofi’s attorneys’ fees and costs subject to reimbursement cannot be reasonably estimated at this agreement is $3.3 million as of September 30, 2017. Additionally, Lexicon leases certain equipment under operating leases.time.

Legal Proceedings.
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In addition, Lexicon is from time to time party to claims and legal proceedings that arise in the normal course of its business and that it believes will not have, individually or in the aggregate, a material adverse effect on its results of operations, financial condition or liquidity.

8.Collaboration and License Agreements
8.           Collaboration and License Agreements
 
Lexicon has derived substantially all of its revenues from drug discovery and development collaborations,alliances, target validation collaborations for the development and, in some cases, analysis of the physiological effects of genes altered in knockout mice, product sales, government grants and contracts, technology licenses, subscriptions to its databases and compound library sales.
Ipsen. In October 2014, Lexicon entered into a License and Collaboration Agreement, which was subsequently amended in March 2015 (collectively, the “Ipsen Agreement”), with Ipsen for the development and commercialization of XERMELO outside of the United States and Japan (the “Licensed Territory”). The Ipsen Agreement was assigned to TerSera in September 2020 in connection with the XERMELO sale.
Prior to the XERMELO sale, Lexicon had earned certain milestone payments and royalties from Ipsen. Revenue, including royalty revenue, recognized under the Ipsen Agreement was $0.3 million for the nine months ended September 30, 2020.
Sanofi. In November 2015, Lexicon entered into a Collaboration and License Agreement, which was subsequently amended in July 2017 (collectively, the “Sanofi Agreement”), with Sanofi for the worldwide development of Lexicon’s diabetes drug candidate sotagliflozin. In December 2016, Sanofi terminated its rights under the Sanofi Agreement with respect to Japan.
Effective as of September 9, 2019 (the “Settlement Date”), Lexicon entered into the Termination Agreement with Sanofi, pursuant to which the Sanofi Agreement was terminated and certain associated disputes between Lexicon and Sanofi were settled.
Under the terms of the Termination Agreement, Lexicon regained all rights to sotagliflozin and assumed full responsibility for the worldwide development and commercialization of sotagliflozin in all indications. Sanofi paid Lexicon $208 million in September 2019 and $26 million in each of March and September 2020 (less amounts withheld by Sanofi offsetting certain third party costs and internal costs incurred by Sanofi and asserted by Sanofi to be payable by Lexicon under the terms of the Termination Agreement), and neither party owes any additional payments pursuant to the Sanofi Agreement. The parties have cooperated in the transition of responsibility for ongoing clinical studies and other activities, and each party is responsible for its own expenses associated with such transition, subject to certain exceptions. See Note 7, Commitments and Contingencies, for additional information. Beginning in March 2020, Lexicon closed out early the clinical studies related to the Phase 3 development program for sotagliflozin in type 2 diabetes, heart failure and chronic kidney disease. Subsequent to the Termination Agreement, Lexicon has granted Sanofino remaining performance obligations to Sanofi.

9.Other Capital Agreements
Common Stock: In 2020, Lexicon entered into an exclusive, worldwide (excluding Japan), royalty-bearing right and license under its patent rights and know-how to develop, manufacture and commercialize sotagliflozin. Subject to specified exceptions, neither party may (a) perform clinical development activitiesOpen Market Sale AgreementSM (the “Sales Agreement”) with Jefferies LLC (“Jefferies”) relating to any other compound which inhibits sodium-glucose cotransporters type 1 or type 2 or (b) commercialize any such compoundsthe shares of its common stock. Lexicon may offer and sell common stock having an aggregate sales price of up to $50.0 million from time to time through Jefferies acting as its sales agent. In 2020, Lexicon sold 3,709,233 shares of its common stock at a price of $1.992 per share pursuant to the Sales Agreement, resulting in net proceeds of $7.0 million. In January 2021, Lexicon sold 2,000,000 shares of its common stock at a price of $8.463 per share pursuant to the Sales Agreement, resulting in net proceeds of $16.4 million. In August and September 2021, Lexicon sold an aggregate of 4,176,953 shares of its common stock at a price of $4.732 per share pursuant to the Sales Agreement, resulting in net proceeds of $19.1 million. The net proceeds are reflected as issuances of common stock in the United States, countriesaccompanying condensed consolidated financial statements.


10.     Asset Sale
In September 2020, the Company completed the sale of the European UnionXERMELO® and certain other specified countries, in each case during the royalty terms applicable in such countries. Among the specified exceptions isrelated assets to TerSera. The upfront consideration paid by TerSera, subject to a right Lexicon retained to pursue the development of its LX2761 drug candidate, with respect to which Lexicon granted Sanofi certain rights of first negotiation specifiedworking capital adjustment as set forth in the Sanofi Agreement.Asset Purchase and Sale Agreement, was $160.4 million and the net gain recognized in connection with the XERMELO sale was $132.8 million. The gain is reflected on the condensed consolidated statement of comprehensive income (loss) for the three and nine months ended September 30, 2020.
Under the Sanofi Agreement, Sanofi paid Lexicon an upfront payment of $300 million. In addition, Lexicon is
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The Company remains eligible to receive from Sanofi (a)development, regulatory and sales milestone payments of up to an aggregate of $110$65 million upon the achievement of four development milestones relating to the results of certain Phase 3 clinical trials of sotagliflozin in type 2 diabetes patients, (b) up to an aggregate of $220 million upon the achievement of four regulatory milestones relating to the first commercial sale following regulatory approval of sotagliflozin for type 1 and type 2 diabetes, respectively, in each of the United States and Europe, of which two milestones representing the substantial majority of such aggregate amount relate to type 2 diabetes and the remaining two milestones relate to type 1 diabetes, (c) $100 million upon the achievement of a milestone based on the results of either of two outcomes studies in type 2 diabetes patients, the completion of which would likely occur after initial regulatory approval of sotagliflozin in type 2 diabetes, and (d) up to an aggregate of $990 million upon the achievement of six commercial milestones that will be achieved upon reaching specified levels of sales. The Company believes that each of the development and regulatory milestones under the Sanofi Agreement is substantive. Due to the uncertainty surrounding the achievement of the future development and regulatory milestones, these payments will not be recognized as revenue unless and until they are earned, as the Company is not able to reasonably predict if and when the milestones will be achieved. Commercial milestones, which are not encompassed within the definition of milestones under generally accepted accounting principles, will be accounted for as royalties and recorded as revenue upon achievement of the milestone, assuming all other revenue recognition criteria were met. Lexicon is also entitled to tiered, escalating royalties ranging from low double digit percentages to forty percent of net sales of sotagliflozin, based on indication and territory, with royalties for the higher band of such range attributable to net sales for type 1 diabetes in the United States, and subject in each case to customary royalty reduction provisions.
Lexicon will continue to be responsible for all clinical development activities relating to type 1 diabetes and has exercised an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of sotagliflozin for the treatment of type 1 diabetes in the United States. Under the terms of its exercised co-promotion option, Lexicon will fund forty percent of the commercialization costs relating to such co-promotion activities. Sanofi will be responsible for all clinical development and commercialization of sotagliflozin for the treatment of type 2 diabetes worldwide and will be solely responsible for the commercialization of sotagliflozin for the treatment of type 1 diabetes outside the United States. Lexicon will share in the funding of a portion of the planned type 2 diabetes development costs over the next three years, up to an aggregate of $100 million. Sanofi will book sales worldwide in all indications.

The parties are responsible for using commercially reasonable efforts to perform their development and commercialization obligations pursuant to mutually approved development and commercialization plans.
The parties’ activities under the Sanofi Agreement are governed by a joint steering committee and certain other governance committees which reflect equal or other appropriate representation from both parties. If the applicable governance committee is not able to make a decision by consensus and the parties are not able to resolve the issue through escalation to specified senior executive officers of the parties, then Sanofi will have final decision-making authority, subject to limitations specified in the Sanofi Agreement.
The Sanofi Agreement will expire upon the expiration of all applicable royalty terms for all licensed products in all countries. The royalty term for each licensed product in each country is the period commencing on the effective date of the Sanofi Agreement and ending on the latest of expiration of specified patent coverage, expiration of specified regulatory exclusivity and 10 years following the first commercial sale in the applicable country. Either party may terminate the Sanofi Agreement in the event of an uncured material breach by the other party. Prior to completion of the core development activities for type 2 diabetes specified in the development plan, Sanofi may terminate the Sanofi Agreement on a country-by-country and licensed product-by-licensed product basis, in the event of (a) notification of a material safety issue relating to the licensed product or the class of sodium-glucose cotransporters type 1 or type 2 inhibitors resulting in a recommendation or requirement that Lexicon or Sanofi cease development, (b) failure to achieve positive results with respect to certain clinical trial results, (c) the occurrence of specified fundamental adverse events or (d) the exploitation of the licensed product infringing third party intellectual property rights in specified major markets and Sanofi is unable to obtain a license to such third party intellectual property rights.
The Company considered the following deliverables with respect to the revenue recognition of the $300 million upfront payment:
• The exclusive worldwide license granted to Sanofi to develop and commercialize sotagliflozin;
• The development services Lexicon is performing for sotagliflozin relating to type 1 diabetes; and
• The funding Lexicon will provide for development relating to type 2 diabetes.
The Company determined that the license had stand-alone value because it is an exclusive license that gives Sanofi the right to develop and commercialize sotagliflozin or to sublicense its rights. In addition, sotagliflozin is currently in development and it is possible that Sanofi or another third party could conduct clinical trials without assistance from Lexicon. As a result, the Company considers the license and the development services under the Sanofi Agreement to be separate units of accounting. The Company recognized the portion of the consideration allocated to the license immediately because Lexicon delivered the license and earned the revenue at the inception of the arrangement. The Company is recognizing as revenue the amount allocated to the development services for type 1 diabetes and the obligation to provide funding for development services for type 2 diabetes over the period of time Lexicon performs services or provides funding, currently expected to be through 2020.
The Company determined that the initial allocable arrangement consideration was the $300 million upfront payment because it was the only payment that was fixed and determinable at the inception of the arrangement. There was considerable uncertainty at the date of the agreement as to whether Lexicon would earn milestone payments or royalty payments. As such, the Company did not include those payments in the allocable consideration. The Company allocated the allocable consideration based on the relative best estimate of selling price of each unit of accounting. The Company estimated the selling price of the license deliverable by applying a probability-based income approach utilizing an appropriate discount rate. The significant inputs the Company used to determine the projected income of the license included: exercising the option to co-promote, estimated future product sales, estimated cost of goods sold, estimated operating expenses, income taxes, and an appropriate discount rate. The Company estimated the selling price of the development services for type 1 diabetes by using internal estimates of the cost to hire third parties to perform the services over the expected period to perform the development. The Company estimated the obligation to provide funding for type 2 diabetes by using internal estimates of the expected cash flows and timing for $100 million in funding.
As a result of the allocation, the Company recognized $126.8 million of the $300 million upfront payment for the license in 2015. The Company is recognizing the $113.8 million allocated to the development services deliverable and the $59.4 million allocated to the funding deliverable over the estimated period of performance as the development and funding occurs. Revenue recognized under the Sanofi Agreement was $39.5 million and $52.7 million for the nine months ended September 30, 2017 and 2016, respectively.

Ipsen Pharma SAS. In October 2014, Lexicon entered into a License and Collaboration Agreement, which was subsequently amended in March 2015 (collectively, the “Ipsen Agreement”), with Ipsen for the development and commercialization of telotristat ethyl outside of the United Statesin patients with biliary tract cancer and Japan (the “Licensed Territory”).
Under the Ipsen Agreement, Lexicon granted Ipsen an exclusive, royalty-bearing right and license under its patent rights and know-how to commercialize telotristat ethyl in the Licensed Territory. Ipsen is responsible for using diligent efforts to commercialize telotristat ethyl in the Licensed Territory pursuant to a mutually approved commercialization plan. Subject to certain exceptions, Lexicon will be responsible for conducting clinical trials required to obtain regulatory approval for telotristat ethyl for carcinoid syndrome in the European Union, including those contemplated by a mutually approved initial development plan, and will have the first right to conduct most other clinical trials of telotristat ethyl. Lexicon is responsible for the costs of all clinical trials contemplated by the initial development plan. The costs of additional clinical trials will be allocated between the parties basedmid-teens royalty payments on the nature of such clinical trials. Under the Ipsen Agreement, Ipsen has paid Lexicon an aggregate of $30.9 million through September 30, 2017, consisting of $24.5 million in upfront payments and a $6.4 million milestone payment in August 2016 upon the acceptance of the filing submitted by Ipsen to the European Medicines Agency for telotristat ethyl as an adjunct to somatostatin analog therapy for the long-term treatment of carcinoid syndrome. In September 2017, Ipsen received approval from the European Commission for the marketing of telotristat ethyl in all member states of the European Union, Norway and Iceland, thereby Lexicon earning a milestone payment, which was received in October 2017. In addition, Lexicon is eligible to receive from Ipsen (a) up to an aggregate of approximately $21 million upon the achievement of specified regulatory and commercial launch milestones and (b) up to an aggregate of €72 million upon the achievement of specified sales milestones. Due to the uncertainty surrounding the achievement of the future regulatory and sales milestones, these payments will not be recognized as revenue unless and until they are earned as the Company is not able to reasonably predict if and when the milestones will be achieved. Lexicon is also entitled to tiered, escalating royalties ranging from low twenties to mid-thirties percentages of net sales of telotristat ethylXERMELO in the Licensed Territory, subject to a credit for amounts previously paid to Lexicon by Ipsen for the manufacture and supply of such units of telotristat ethyl. Lexicon and Ipsen have entered into a commercial supply agreement pursuant to which Lexicon will supply Ipsen’s commercial requirements of telotristat ethyl, and Ipsen will pay an agreed upon transfer price for such commercial supply.
biliary tract cancer. The Company considered the following deliverables with respect to the revenue recognition of the $24.5 million upfront payments:
The exclusive license granted to Ipsen to develop and commercialize telotristat ethyl in the Licensed Territory;
The development services Lexicon is performing for telotristat ethyl;
The obligation to participate in committees which govern the development of telotristat ethyl until commercialization; and
The obligation to supply commercial supply of telotristat ethyl, under a commercial supply agreement.

The Company determined that the license had stand-alone value because it is an exclusive license that gives Ipsen the right to develop and commercialize telotristat ethyl or to sublicense its rights. In addition, telotristat ethyl is currently in development and it is possible that Ipsen or another third party could conduct clinical trials without assistance from Lexicon. As a result, the Company considers the license and the development services under the Ipsen Agreement to be separate units of accounting. The Company recognized the portion of the consideration allocated to the license immediately because Lexicon delivered the license and earned the revenue at the inception of the arrangement. The Company is recognizing as revenue the amount allocated to the development services and the obligation to participate in committees over the period of time Lexicon performs services, currently expected to be complete by mid-2018.
Due to the inherent uncertainty in obtaining regulatory approval, the applicability of the commercial supply agreement is outside the control of Lexicon and Ipsen. Accordingly, the Company has determined that these amounts are constrained until the commercial supply agreementachievement, if any, of specific events. If or when the constraint is a contingent deliverable at the onset of the Ipsen Agreement. As a result,determined to be resolved, the Company has determinedwill re-evaluate the commercial supply agreement doesoverall gain in connection with the XERMELO sale and recognize an adjustment on a cumulative catch-up basis in the period that the determination is made.

The XERMELO sale did not meet the definition ofcriteria for reporting discontinued operations as there was not a deliverablestrategic shift that needs to be accounted for at the inception of the arrangement. The Company has also determined that there is no significant and incremental discount related to the commercial supply agreement that should be accounted for at the inception of the arrangement.
The Company determined that the initial allocable arrangement consideration was the $24.5 million upfront payments because they were the only payments that were fixed and determinable at the inception of the arrangement. There was considerable uncertainty at the date of the agreement as to whether Lexicon would earn milestone payments, royalty payments or payments for finished drug product. As such, the Company did not include those payments in the allocable consideration. The Company allocated the allocable consideration based(or will have) a major effect on the relative best estimate of selling price of each unit of accounting. The Company estimated the selling price of the license deliverable by applying a probability-based income approach utilizing an appropriate discount rate. The significant inputs the Company used to determine the projected income of

the license included: estimated future product sales, estimated cost of goods sold, estimated operating expenses, income taxes, and an appropriate discount rate. The Company estimated the selling price of the development services by using internal estimates of the cost to hire third parties to perform the services over the expected period to perform the development. The Company estimated the selling price of the obligation to participate in committees by using internal estimates of the number of internal hours and salary and benefits costs to perform these services.
As a result of the allocation, the Company recognized $21.2 million of the $24.5 million upfront payments for the license in 2014, and an additional $1.4 million in 2015 upon entering into the amendment. The Company is recognizing the $1.7 million allocated to the development services deliverable over the estimated period of performance as development occurs, and is recognizing the $0.1 million allocated to the committee participation deliverable ratably over the estimated period of performance. Milestone payments that are contingent upon the achievement of a substantive milestone are recognized in their entirety in the period in which the milestone is achieved. The Company recognized the $5.1 million milestone payment earned in 2017 inCompany’s operations. For the three and nine months ended September 30, 2017,2020, the pretax net loss on the condensed consolidated statement of comprehensive income (loss) for the Company’s XERMELO operations is $2.1 million and $12.1 million, respectively.
As a result of the XERMELO sale, the Company implemented a reduction in force which reduced its workforce by approximately fifty percent. The Company incurred and recognized severance charges of approximately $5.5 million through September 30, 2020. Of this charge, $2.5 million was recorded in research and development expense and $3.0 million was recorded in selling, general and administrative expense in the $6.4 million milestone payment earned in 2016 inaccompanying condensed consolidated statement of comprehensive income (loss) for the three and nine months ended September 30, 2016. Revenue recognized under2020.


11.    Earnings (Loss) Per Share

The following is a summary of Lexicon’s earnings (loss) per share calculations and reconciliations of the Ipsen Agreementnumerators and the denominators of the basic and diluted per share calculations.
(in thousands, except per share data)Three Months Ended September 30,Nine Months Ended September 30,
2021202020212020
Numerator:
Net income (loss)$(23,122)$82,603 $(62,147)$(53,079)
  Add interest on Convertible Notes— 1,258 — — 
Adjusted net income (loss)$(23,122)$83,861 $(62,147)$(53,079)
Denominator:
Shares used in computing net income (loss) per common share, basic145,820 107,309 144,558 106,974 
Add effect of potential dilutive securities:
  Share based compensation awards— 51 — — 
  Convertible Notes— 10,192 — — 
Shares used in computing net income (loss) per common share, diluted145,820 117,552 144,558 106,974 
Net income (loss) per share - basic$(0.16)$0.77 $(0.43)$(0.50)
Net income (loss) per share - diluted$(0.16)$0.71 $(0.43)$(0.50)

For periods presented with a net loss, the weighted average number of shares outstanding are the same for both basic and diluted net loss per common share. The average number of shares associated with stock options and restricted stock units that were excluded from diluted earnings per share that would potentially dilute earnings per share in the future was $7.9 million10,615 and $6.8 million11,773, respectively, for the three months ended September 30, 2021 and 2020, and 10,615 and 11,859, respectively, for the nine months ended September 30, 20172021 and 2016, respectively. Revenue for2020. For periods presented with a net loss, the nine months ended September 30, 2017 includes $0.8 million from salesshares associated with the Convertible Notes are not included in the computation of bulk tablets of telotristat ethyl to Ipsen.diluted earnings per share because they are antidilutive.

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Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations
Item 2.  Management’s Discussion and Analysis of Financial Condition and Results of Operations
 
Overview
 
We are a biopharmaceutical company focused on the development and commercializationwith a mission of breakthrough treatments for human disease.pioneering medicines that transform patients’ lives. We are presently devoting most of our resources to the commercialization orresearch and development of our four most advanced drug programs:candidates:


We have obtained approval from the FDA to sell our first commercial product, XERMELO® (telotristat ethyl), an orally-delivered small molecule drug for the treatment of carcinoid syndrome diarrhea in combination with somatostatin analog, or SSA, therapy in adults inadequately controlled by SSA therapy. We have commenced sales and marketing of XERMELO, and it is now commercially available to patients in the United States. We have granted Ipsen Pharma SAS an exclusive, royalty-bearing right to commercialize XERMELO outside of the United States and Japan, and Ipsen has obtained approval from the European Commission to market XERMELO in the member states of the European Union, Norway and Iceland.
We are developing sotagliflozin, an orally-delivered small molecule drug candidate, as a treatment for type 1heart failure and type 21 diabetes. We have reported positive top-line dataresults from two pivotal Phase 3 clinical trials evaluating the effect of sotagliflozin on long-term outcomes related to cardiovascular death and a thirdheart failure in approximately 10,500 and 1,200 patients, respectively. We are now preparing an application for regulatory approval to market sotagliflozin for heart failure in the United States and, if approved, for the commercial launch of sotagliflozin in the United States.
We have reported positive results from three Phase 3 clinical trialtrials evaluating the effect of sotagliflozin inon type 1 diabetes patients. We havein approximately 800,800 and 1,400 patients, respectively. The FDA issued a complete response letter regarding our application for regulatory approval to market sotagliflozin for type 1 diabetes in the United States and, at our request, has issued a public Notice of Opportunity for Hearing on whether there are grounds for denying approval of our application. The Office of the FDA Commissioner has granted Sanofiour joint request with the FDA’s Center for Drug Evaluation and Research to extend the previously granted abeyance of such proceedings until November 26, 2021 to allow for the continuation of good faith discussions between the parties. Sotagliflozin has been approved in the European Union for use as an exclusive, worldwide (excluding Japan), royalty-bearing rightadjunct to develop, manufacture and commercialize sotagliflozin, and Sanofi is presently conducting Phase 3 developmentinsulin therapy in the treatment of sotagliflozin in type 2 diabetes.1 diabetes, but has not yet been commercially launched.
We are developing LX2761, an orally-delivered small molecule drug candidate, as a treatment for diabetes. We are presently conducting Phase 1 clinical development of LX2761. We have granted Sanofi certain rights of first negotiation with respect to the future development and commercialization of LX2761.
We are developing LX9211, an orally-delivered small molecule drug candidate, as a treatment for neuropathic pain. We are presently conductinghave reported results from two Phase 1 clinical trials of LX9211 and are now conducting a Phase 2 clinical trial of LX9211 in diabetic peripheral neuropathic pain and a second Phase 2 clinical trial of LX9211 in post-herpetic neuralgia. LX9211 has received Fast Track designation from the FDA for development in diabetic peripheral neuropathic pain.
We are conducting preclinical research and development and preparing to conduct clinical development of LX9211.
Compounds from our most advanced drug programs, as well as compounds from a number of additional drug programs originating from our internal drug discovery efforts.
LX9211 originated from our collaborative neuroscience drug discovery efforts with Bristol-Myers Squibb, and developmentsotagliflozin and compounds from a number of additional drug programs that we have advanced into various stages of clinical and preclinical development, originated from our own internal drug discovery efforts. TheseThose efforts were driven by a systematic, target biology-driven approach in which we used gene knockout technologies and an integrated platform of advanced medical technologies to systematically study the physiological and behavioral functions of almost 5,000 genes in mice and assessed the utility of the proteins encoded by the corresponding human genes as potential drug targets. We have identified and validated in living animals, or in vivo,, more than 100 targets with promising profiles for drug discovery.


We are working both independently and through strategic collaborations and strategic alliances with third parties to capitalize on our drug target discoveries and drug discovery and development programs. We seek to retain exclusive or co-exclusive rights to the benefits of certain drug discovery and development programs by developing and commercializing drug candidates from those programs internally, particularly in the United States for indications treated by specialist physicians. We seek to collaborate with other pharmaceutical and biotechnology companies such as Ipsen and Sanofi, with respect to drug discovery or the development and commercialization of certain of our drug candidates, particularly with respect to commercialization in territories outside the United States or commercialization in the United States for indications treated by primary care physicians, or when the collaboration may otherwise provide us with access to expertise and resources that we do not possess internally or are complementary to our own. Our collaborations and strategic alliances include arrangements with TerSera Therapeutics LLC, under which we are eligible to receive milestone and royalty payments relating to XERMELO in biliary tract cancer, and with Genentech, Inc., under which we are eligible to receive milestone and royalty payments relating to its UTTR1147a (IL-22 Fc) biotherapeutic drug candidate.


We commercially launched XERMELO following regulatory approval in February 2017 for the treatment of carcinoid syndrome diarrhea in combination with SSA therapy in adults inadequately controlled by SSA therapy in the United States. Prior to the launch of XERMELO, wehave derived substantially all of our revenues from strategic collaborations and other research and development collaborations and technology licenses.licenses, as well as from commercial sales of XERMELO following our commercial launch of the product in February 2017 until our sale of XERMELO and related assets to TerSera in September 2020. To date, we have generated a substantial portion of our revenues from a limited number of sources.


Our operating results and, in particular, our ability to generate additional revenues are dependent on many factors, including our ability to successfully commercialize XERMELO in the United States; the amount and timing of payments, if any, under our existing collaboration agreements with Sanofi, Ipsen and other entities; the success of our ongoing preclinicalnonclinical and clinical development efforts and ability to obtain necessary regulatory approvals;approvals of the drug candidates which are the subject of such efforts; the ability of our collaborators and licensees to successfully develop and commercialize products and our receipt of milestone payments and royalties from such efforts; our
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success in establishing new collaborations and licenses;licenses, particularly for the timing and willingnesscommercialization of such new collaborators to commercialize products that would result

in milestone payments and royalties and their success in such efforts;sotagliflozin for heart failure; and general and industry-specific economic conditions which may affect research and development expenditures.


Future revenues from our commercialization of XERMELOcollaborations and strategic licenses are uncertain because they depend on a number of factors, including market acceptance of XERMELO, the success of our sales, marketing, medical affairs, distribution and other commercialization activities and the cost and availability of reimbursement for XERMELO.

Future revenues from our existing collaborations are uncertain because they depend, to a large degree, on the achievement of milestones and payment of royalties we earn from any future products developed under the collaborations.development and commercialization efforts of our collaborators and licensees. Our ability to secure future revenue-generating agreements will depend upon our ability to address the needs of our potential future collaborators and licensees, and to negotiate agreements that we believe are in our long-term best interests.  We may determine, as we have with certain of our drug candidates, including XERMELO in the United States and Japan, that our interests are better served by retaining rights to our discoveries and advancing our therapeutic programs to a later stage, which could limit our near-term revenues and increase expenses.  Because of these and other factors, our operating results have fluctuated in the past and are likely to do so in the future, and we do not believe that period-to-period comparisons of our operating results are a good indication of our future performance.


Since our inception, we have incurred significant losses and, as of September 30, 2017,2021, we had an accumulated deficit of $1.4$1.5 billion. Our losses have resulted principally from costs incurred in research and development, selling, general and administrative costs associated with our operations, and non-cash stock-based compensation expenses associated with stock options and restricted stock units granted to employees and consultants. Research and development expenses consist primarily of salaries and related personnel costs, external research costs related to our nonclinical and clinical efforts, material costs, facility costs, depreciation on property and equipment, and other expenses related to our drug discovery and development programs. Selling, general and administrative expenses consist primarily of salaries and related expenses for executive, sales and marketing, and administrative personnel, professional fees and other corporate expenses, including information technology, facilities costs and general legal activities. We expect to continue to incur significant research and development costs in connection with the continuing development of our drug candidates. As a result, we will need to generate significantly higher revenues to achieve profitability.
Critical Accounting Policies
The preparation of financial statements in conformity with generally accepted accounting principles requires us to make judgments, estimates and assumptions in the preparation of our condensed consolidated financial statements and accompanying notes.  Actual results could differ from those estimates.  We believe there have been no significant changes in our critical accounting policies as discussed in our Annual Report on Form 10-K for the year ended December 31, 2016.2020.
Recent Accounting Pronouncements
See Note 2, Recent Accounting Pronouncements, of the NotesThere are no recent accounting pronouncements that could have a material impact to Consolidated Financial Statements (unaudited), for a discussion of the impact of the new accounting standards on our condensed consolidated financial statements (unaudited).statements.

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Results of Operations
 
Revenues
 
Total revenues and dollar and percentage changes as compared to the corresponding periods in the prior year are as follows (dollar amounts are presented in millions):
 Three Months Ended September 30,Nine Months Ended September 30,
 2021202020212020
Total revenues$— $6.6 $0.3 $23.8 
Dollar decrease$(6.6)$(23.5) 
Percentage decrease(100)%(99)% 
  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Total revenues $26.9
 $27.7
 $57.3
 $60.3
Dollar decrease $(0.8)   $(3.0)  
Percentage decrease (3)%   (5)%  
 

Net product revenue – Net product revenue for the three months ended September 30, 2020 was $6.5 million, and for the nine months ended September 30, 20172020 was $5.8 million$23.4 million. We sold XERMELO and $10.4 million, respectively, duerelated assets to revenues recognized from the sale of XERMELO in the United States and sales of bulk tablets of telotristat ethyl to Ipsen.TerSera on September 8, 2020. Product revenues arewere recorded net of estimated product returns, pricing discounts including rebates offered pursuant to mandatory federal and state government programs and chargebacks,

prompt pay discounts and distribution fees and co-pay assistance. Revenue recognition policies require estimates of the aforementioned sales allowances each period.
Collaborative agreementsRoyalties and other revenueRevenue from collaborative agreements for the three months ended September 30, 2017 decreased 24% to $21.1 million,Royalties and other revenues for the nine months ended September 30, 20172021 decreased 22%21% to $46.8$0.3 million primarily dueas compared to revenues recognized as a result of the timing of clinical trial activities under the collaboration and license agreement with Sanofi.
corresponding period in 2020.


Cost of Sales


Cost of sales for the three and nine months ended September 30, 2017 was $0.6 million and $1.4 million, respectively. We began capitalizing inventory during the nine months ended September 30, 2017 once the FDA approved XERMELO as the related costs were expected to be recoverable through the commercialization of the product. Costs incurred prior to FDA approval were recorded as research and development expenses in the consolidated statements of comprehensive loss. Cost of sales consists of third-party manufacturing costs, freight and indirect overhead costs associated with sales of XERMELO. The pre-commercialization inventory is expected to be sold over approximately the next two years. As a result, costCost of sales for the next two years will reflect a lower average per unit cost of materials. Cost of saleswas $0.6 million and $1.9 million for the three and nine monthsmonthly periods ended September 30, 2017 includes $0.42020, respectively, and included $0.3 million and $1.0$1.2 million, respectively, of amortization of intangible assets relating to XERMELO.


Research and Development Expenses
 
Research and development expenses and dollar and percentage changes as compared to the corresponding periods in the prior year are as follows (dollar amounts are presented in millions):
 Three Months Ended September 30,Nine Months Ended September 30,
 2021202020212020
Total research and development expense$15.7 $40.1 $38.5 $152.6 
Dollar decrease$(24.4)$(114.1) 
Percentage decrease(61)%(75)% 
  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Total research and development expense $39.1
 $52.5
 $109.7
 $137.8
Dollar decrease $(13.4)   $(28.1)  
Percentage decrease (26)%   (20)%  
Research and development expenses consist primarily of third-party and other services principally related to nonclinical and clinical development activities, salaries and other personnel-related expenses, stock-based compensation expense, and facility and equipment costs.

Third-party and other services – Third-party and other services for the three months ended September 30, 20172021 decreased 31%66% to $30.5$10.7 million, and for the nine months ended September 30, 20172021 decreased 28%81% to $81.9$23.4 million, as compared to the corresponding periods in 2016,2020 primarily due to decreases in external clinical development costs relating to sotagliflozin.sotagliflozin subsequent to the wind down of the activities beginning in March 2020. Third-party and other services relate principally to our clinical trial and related development activities, such as nonclinical and clinical studies and contract manufacturing.


Personnel – Personnel costs for the three months ended September 30, 2017 increased 10%2021 decreased 55% to $5.1$2.5 million, and for the nine months ended September 30, 2017 increased 24%2021 decreased 51% to $17.2$7.6 million, as compared to the corresponding periods in 2016,2020, primarily due to increaseslower employee salaries and benefit costs as a result of the reduction in personnel.force of our
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personnel in September 2020. Salaries, bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included in personnel costs.


Stock-based compensation – Stock-based compensation expenseexpenses for the three months ended September 30, 20172021 increased 28%11% to $1.3$1.1 million, and for the nine months ended September 30, 2017 increased 23%2021 decreased 30% to $3.7$3.6 million, as compared to the corresponding periods in 2016.
2020, primarily due to cancellation of unvested share-based awards as a result of the reduction in force of our personnel in September 2020.


Facilities and equipment – Facilities and equipment costs for the three months ended September 30, 20172021 decreased 11%33% to $0.8$0.4 million, and for the nine months ended September 30, 20172021 decreased 8%41% to $2.3$1.2 million, as compared to the corresponding periods in 2016.
2020, primarily due to lower depreciation expense subsequent to the sale of our facilities in December 2020.


Other – Other costs for the three months ended September 30, 20172021 decreased 4%25% to $1.4$0.9 million, and for the nine months ended September 30, 2017 increased 20%2021 decreased 30% to $4.5$2.8 million, as compared to the corresponding periods in 2016.
2020, primarily due to lower insurance and software license expenses.

Increase (Decrease) in Fair Value of Symphony Icon Liability

The fair value of the Symphony Icon purchase liability increased by $2.1 million in the nine months ended September 30, 2017 and decreased by $2.1 million and $0.7 million in the three and nine months ended September 30, 2016, respectively (see Note 6, Arrangements with Symphony Icon, Inc., of the Notes to Consolidated Financial Statements (unaudited), for more information).


Selling, General and Administrative Expenses
 
Selling, general and administrative expenses and dollar and percentage changes as compared to the corresponding periods in the prior year are as follows (dollar amounts are presented in millions):
  Three Months Ended September 30, Nine Months Ended September 30,
  2017 2016 2017 2016
Total selling, general and administrative expense $16.7
 $12.3
 $50.1
 $29.1
Dollar increase $4.5
   $21.0
  
Percentage increase 36%   72%  
Three Months Ended September 30,Nine Months Ended September 30,
 2021202020212020
Total selling, general and administrative expense$7.3 $12.0 $23.5 $40.8 
Dollar decrease$(4.7)$(17.3) 
Percentage decrease(39)%(42)%
Selling, general and administrative expenses consist primarily of personnel costs to sell XERMELO and to support our research and development activities, professional and consulting fees, stock-based compensation expense, and facility and equipment costs.

Personnel – Personnel costs for the three months ended September 30, 2017 increased 90%2021 decreased 69% to $7.1$2.4 million, and for the nine months ended September 30, 2017 increased 134%2021 decreased 64% to $22.9$7.9 million, as compared to the corresponding periods in 2016,2020, primarily due to increaseslower employee salaries and benefit costs as a result of the reduction in personnel, including increases in sales and marketingforce of our personnel in connection with commercialization of XERMELO.September 2020. Salaries, bonuses, employee benefits, payroll taxes, recruiting and relocation costs are included in personnel costs.


Professional and consulting fees – Professional and consulting fees for the three months ended September 30, 20172021 increased 11% to $2.2 million, primarily as a result of higher legal fees, partially offset by lower marketing expenses. Professional and consulting fees for the nine months ended September 30, 2021 decreased 9%8% to $5.8$7.4 million, as compared to the corresponding periods in 2020, primarily due to lower marketing expenses and professional and consulting fees, partially offset by higher legal fees.

Stock-based compensation – Stock-based compensation expenses for the three months ended September 30, 2021 increased 80% to $1.6 million, and for the nine months ended September 30, 2017 increased 17%2021 decreased 13% to $15.7$4.7 million, as compared to the corresponding periods in 2016,2020, primarily due to changescancellation of unvested share-based awards as a result of the reduction in marketing and consulting costsforce of our personnel in connection with commercialization of XERMELO.
September 2020.


Stock-based compensation – Stock-based compensation expense for the three months ended September 30, 2017 increased 41% to $1.2 million, and for the nine months ended September 30, 2017 increased 30% to $3.5 million, as compared to the corresponding periods in 2016, primarily due to awards granted to sales and marketing personnel.

Facilities and equipment – Facilities and equipment costs for the three months ended September 30, 2017 increased 26%2021 decreased 18% to $0.5$0.4 million, and for the nine months ended September 30, 2017 increased 37%2021 decreased 23% to $1.6$1.1 million, as compared to the corresponding periods in 2016.
2020, primarily due to lower property taxes and depreciation expense subsequent to the sale of our facilities in December 2020.

Other – Other costs for the three months ended September 30, 2017 increased 136%2021 decreased 26% to $2.1$0.7 million, and for the nine months ended September 30, 2017 increased 210%2021 decreased 41% to $6.4$2.3 million, as compared to the corresponding periods in 2016,2020, primarily due to increasesdecreases in travel due to the COVID-19 pandemic and contributions to a foundation supporting carcinoid syndrome patients.software license expense.

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Impairment Loss on Buildings

In July 2020, our subsidiary, Lex-Gen Woodlands, L.P., entered into a real estate purchase and sale agreement to sell our facilities in the Woodlands, Texas. We recognized an impairment loss of $1.6 million as a result of writing down the buildings to the estimated net selling price.

Gain on the sale of XERMELO

In September 2020, a gain of $132.8 million was recognized in connection with the sale of XERMELO and related assets to TerSera.

Loss on Debt Extinguishments, Net

Immediately following the closing of the sale of XERMELO and related assets to TerSera in September 2020, we repaid term borrowings of $150.0 million to BioPharma Credit PLC and BioPharma Credit Investments IV Sub LP. A debt extinguishment loss of $8.6 million was recognized.

In September 2020, we entered into separate, privately negotiated exchange agreements to exchange $67.1 million aggregate principal amount of its 5.25% Convertible Senior Notes due 2021, or the Convertible Notes. As a result, a debt extinguishment gain of $8.4 million was recognized.

Interest Expense and Interest and Other Income, Net
Interest Expense.  Interest expense for each of the three months ended September 30, 2017 and 2016 was $1.6 million and for the nine months ended September 30, 2017 and 2016 was $4.82021 decreased 96% to $0.2 million, and $4.9$0.5 million, respectively.respectively, as compared to the corresponding periods in 2020, primarily due to our repayment of our $150 million BioPharma term loan in September 2020 and our exchange of $75.8 million in aggregate principal amount of Convertible Notes in September and October 2020.


Interest and Other Income, Net. Interest and other income, net for the three and nine months ended September 30, 2017 and 20162021 was $0.4$0.01 million and $0.6$0.1 million, respectively, and for the nine months ended September 30, 2017three and2016 was $1.4 million and $1.7 million, respectively.


Income Tax Benefit

The income tax benefit for the nine months ended September 30, 20172020 was $8.7 million. During$0.3 million and $1.9 million, respectively.

Net Income (Loss) and Net Income (Loss) per Common Share

Net income (loss) and Net income (loss) per Common Share. Net loss was $23.1 million, or $0.16 per share, in the ninethree months ended September 30, 2017, the Company’s valuation allowance for its deferred tax assets decreased by $8.72021 as compared to net income of $82.6 million, due to the reclassification of intangible assets relating to XERMELO from indefinite-lived to finite-lived assets, which resultedor $0.71 per diluted share, in the related deferred tax liability now being considered a source of taxable income. The Company recorded a $8.7corresponding period in 2020. Net loss was $62.1 million, deferred tax benefit with a corresponding reduction in its deferred tax liabilityor $0.43 per share, in the nine months ended September 30, 20172021 as a result of this reclassification.
Consolidated Net Loss and Consolidated Net Losscompared to $53.1 million, or $0.50 per Common Share
Consolidated Net Loss and Consolidated Net Loss per Common Share. Consolidated net loss decreased to $30.7 million in the three months ended September 30, 2017 from $36.0 millionshare, in the corresponding period in 2016. Consolidated net loss per common share decreased to $0.29 in the three months ended September 30, 2017 from $0.35 in the corresponding period in 2016. Consolidated net loss decreased to $100.7 million in the nine months ended September 30, 2017 from $109.0 million in the corresponding period in 2016. Consolidated net loss per common share decreased to $0.96 in the nine months ended September 30, 2017 from $1.05 in the corresponding period in 2016.2020.
Our quarterly operating results have fluctuated in the past and are likely to do so in the future, and we believe that quarter-to-quarter comparisons of our operating results are not a good indication of our future performance.

Liquidity and Capital Resources
We have financed our operations from inception primarily through sales of common and preferred stock, contract and milestone payments to uswe received under our collaborations and strategic and other collaborations,licenses, target validation, database subscription and technology license agreements, product sales, government grants and contracts, and financing under debt and lease arrangements. We have also financed certain of our research and development activities under our agreementsfinancing arrangements with Symphony Icon, Inc.From our inception through September 30, 2017, we had received net proceeds of $1.4 billion from issuances of common and preferred stock and convertible debt. In addition, from our inception through September 30, 2017, we received $809.0 million in cash payments from strategic and other collaborations, target validation, database subscription and technology license agreements, sales of compound libraries and reagents, product sales, and government grants and contracts, of which $738.2 million had been recognized as revenues through September 30, 2017.
As of September 30, 2017,2021, we had $196.8$120.9 million in cash, cash equivalents and short-term investments. As of December 31, 2016,2020, we had $346.5$152.3 million in cash, cash equivalents and short-term investments. We used cash of $151.7$64.2 million infrom operations in the nine months ended September 30, 2017.2021. This consisted primarily of the consolidated net loss for the period of $100.7$62.1 million and a net decrease in other operating liabilities net of assets of $54.6 million and the deferred tax benefit of $8.7$10.6 million, partially offset by non-cash charges of $7.2$8.3 million related to stock-based compensation expense, $2.5 million related to depreciation and amortization expense and $2.1 million related to the increase in fair value of the Symphony Icon purchase liability.expense. Investing activities providedused cash of $186.3$4.0 million in the nine months ended September 30, 2017,2021, primarily due to net maturitiespurchases of investments of $186.5 million.$2.8 million and $1.2 million of asset purchases. Financing activities provided cash of $2.1$34.0 million, primarily as a result of $36.7 million net proceeds from issuancethe sales of common stock during January, August and September of $5.5 million,2021 under our Open Market Sale AgreementSM with Jefferies LLC which was partially offset by cash$2.7 million used to repurchase common stockstock.
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Other commitments. In April 2019, sotagliflozin was approved in the European Union for use as an adjunct to insulin therapy to improve glycemic control in adults with type 1 diabetes and a body mass index ≥ 27 kg/m2, who could not achieve adequate glycemic control despite optimal insulin therapy. Upon the achievement of $1.7 million and repay debt borrowings of $1.7 million.
Texas Institute for Genomic Medicine. In July 2005,certain European regulatory pricing approvals, we received an award from the Texas Enterprise Fund for the creation of a knockout mouse embryonic stem cell library containing 350,000 cell lines for the Texas Institute for Genomic Medicine, or TIGM, using our proprietary gene trapping technology, which we completed in 2007. We also equipped TIGM with the bioinformatics software required for the management and analysis of data relating to the library. The Texas Enterprise Fund made an additional award to the Texas A&M University System for the creation of facilities and infrastructure to house the library.
Under the terms of our award, we were responsible for the creation of a specified number of jobs beginning in 2012, reaching an aggregate of 1,616 new jobs in Texas by December 31, 2016. We maywill be required to repay the state a portionmake certain royalty payments, totaling $4.5 million, in three equal annual installments of the award if we fail to meet those job obligations.We will receive credits against those job obligations based on funding received by TIGM and certain related parties from sources other than the State of Texas. We will also receive credits against those jobs obligations for any surplus jobs we created. Subject to these credits, the State may require us to repay $2,415 for each job we fell short of the number of jobs to be created beginning in 2013. Our maximum aggregate exposure for such payments is approximately $14.2 million, including $10.3 million through 2017, without giving effect to any jobs created or credits to which we may be entitled.$1.5 million.

Facilities. In April 2004, we obtained a $34.0 million mortgage onDecember 2020, our subsidiary, Lex-Gen Woodlands, L.P., sold our facilities in The Woodlands, Texas.Texas for $11.9 million. Concurrent with such sale, we entered into a leaseback agreement with respect to 38,000 square feet of such facilities for a period of up to six months, with monthly gross rent payments of $101,000, which ended on June 15, 2021. In February 2021, we leased a 25,000 square-foot office space in The mortgage loan originally had a ten-yearWoodlands, Texas and in June 2021, we relocated our corporate offices. The term with a 20-year amortizationof the sublease extends from March 1, 2021 through August 31, 2025, and a fixed interest rate of 8.23%. The mortgage was amended in September 2013provides for escalating yearly base rent payments starting at $506,000 and increasing to extend the maturity date from April 2014 to April 2017, with the mortgage loan’s monthly payment amount and fixed interest rate each remaining unchanged.  In April 2017, the mortgage was amended to extend the maturity date to April 2018, with the mortgage loan’s monthly payment amount and fixed interest rate each remaining unchanged. The mortgage had a principal balance outstanding of $14.7 million as of September 30, 2017. The entire principal balance is recorded as current portion of long-term debt$557,000 in the accompanying consolidated balance sheet asfinal year of September 30, 2017 as there is a balloon payment due in April 2018.the lease.
In March 2015, our subsidiary Lexicon Pharmaceuticals (New Jersey), Inc. leased a 25,000 square-foot office space in Basking Ridge, New Jersey. The term of the lease extends from June 1, 2015 through December 31, 2022, and provides for escalating yearly base rent payments starting at $482,000 and increasing to $646,000 in the final year of the lease.
Our future capital requirements will be substantial and will depend on many factors, including the market acceptance and commercial success of XERMELO in the United Statesour ongoing nonclinical and clinical development efforts and the revenues we generate from that approved product; Sanofi’s success in obtainingability to obtain necessary regulatory approvals of sotagliflozin in type 1 diabetes; the progress and scopedrug candidates which are the subject of Sanofi’s development activities with respect to sotagliflozin in type 2 diabetes patients;such efforts; the timing, progress and results of clinical trialsability of our other drug candidates;collaborators and licensees to successfully develop and commercialize products and our receipt of milestone payments and royalties from such efforts; our success in establishing new collaborations and licenses, particularly for the amount and timingcommercialization of payments, if any, under our existing collaboration agreements with Sanofi, Ipsen and other entities;sotagliflozin for heart failure; the amount and timing of our research, development and commercialization expenditures; the resources we devote to developing and supporting our products and other factors.  Our capital requirements will also be affected by any expenditures we make in connection with license agreements and acquisitions of and investments in complementary technologies and businesses.  We expect to continue to devote substantial capital resources to commercialize XERMELO; to support Sanofi’s efforts to seek regulatory approval in the United States for sotagliflozin in type 1 diabetes; tosuccessfully complete our nonclinical and clinical development efforts with respect to sotagliflozin, LX9211 and our other drug candidates; and for other general corporate activities.  We believe that our current unrestricted cash and investment balances and cash and revenues we expect to derive from sales of XERMELO, strategic and other collaborations and other sources will be sufficient to fund our operations for at least the next 12 months.  During or after this period, if cash generated by operations is insufficient to satisfy our liquidity requirements, we will need to sell additional equity or debt securities or obtain additional credit arrangements.  Additional financing may not be available on terms acceptable to us or at all. The sale of additional equity or convertible debt securities may result in additional dilution to our stockholders.

From time to time, our board of directors may authorize us to repurchase shares of our common stock, repurchase, in cash or common stock, our outstanding Notes,convertible notes, or make a cash payment to holders of our Notesconvertible notes to induce a conversion of the notes pursuant to the terms of the Notes,convertible notes, in each case, in privately negotiated transactions, publicly announced programs or otherwise. If and when our board of directors should determine to authorize any such action, it would be on terms and under market conditions that our board of directors determines are in the best interest of us and our stockholders. Any such actions could deplete significant amounts of our cash resources and/or result in additional dilution to our stockholders.


Disclosure about Market Risk
 
We are exposed to limited market and credit risk on our cash equivalents which have maturities of three months or less at the time of purchase. We maintain a short-term investment portfolio which consists of U.S. Treasury bills and corporate debt securities that mature three to 12 months from the time of purchase, which we believe are subject to limited market and credit risk. We currently do not hedge interest rate exposure or hold any derivative financial instruments in our investment portfolio.
We had approximately $196.8$120.9 million in cash and cash equivalents and short-term investments as of September 30, 2017.2021. We believe that the working capital available to us will be sufficient to fundmeet our operationscash requirements for at least the next 12 months. We are not subject to interest rate sensitivity on our outstanding Convertible Notes as they generally have a fixed rate of 5.25% per annum. The Convertible Notes interest is payable in cash semi-annually in arrears and matures in December 2021, unless earlier converted or repurchased in accordance with their terms.
We have operated primarily in the United States and substantially all sales to date have been made in U.S. dollars. Accordingly, we have not had any material exposure to foreign currency rate fluctuations.

Item 3.Quantitative and Qualitative Disclosures About Market Risk
Item 3.  Quantitative and Qualitative Disclosures About Market Risk
See “Disclosure about Market Risk” under “Item 2. Management’s Discussion and Analysisof Financial Condition and Results of Operations” for quantitative and qualitative disclosures about market risk.

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Item 4.Controls and Procedures
Item 4.  Controls and Procedures
Our principal executive officer and principal financial officer have concluded that our disclosure controls and procedures (as defined in rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934) are effective to ensure that the information required to be disclosed by us in the reports we file under the Securities Exchange Act is gathered, analyzed and disclosed with adequate timeliness, accuracy and completeness, based on an evaluation of such controls and procedures as of the end of the period covered by this report.

During the nine months ended September 30, 2017, we implemented processes and internal controls to record net product revenue, cost of sales, and inventory as a result of the FDA approval and commercial launch of XERMELO. The implementation of these processes resulted in changes to internal control over financial reporting, which we believe were material. There were no other changes in our internal control over financial reporting during the ninethree months ended September 30, 2017 identified in connection with the evaluation required by Rule 13a-15(d) and 15d-15(d) of the Exchange Act2021 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.


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Part II -- Other Information 


Item 1.Legal Proceedings
Item 1.  Legal Proceedings
 
Securities Class Action Litigation. On January 28, 2019, a purported securities class action complaint captioned Daniel Manopla v. Lexicon Pharmaceuticals, Inc., Lonnel Coats, Jeffrey L. Wade and Pablo Lapuerta, M.D. was filed against us and certain of our officers in the U.S. District Court for the Southern District of Texas, Houston Division. Our motion to dismiss was granted and the action was dismissed with prejudice by the District Court on August 14, 2020. The judgment of the District Court was affirmed by the U.S. Court of Appeals for the Fifth Circuit on September 10, 2021. The lawsuit purported to be a class action brought on behalf of purchasers of our securities during the period from March 11, 2016 through July 29, 2019. The complaint alleged that the defendants violated federal securities laws by making materially false and misleading statements and/or omissions concerning data from our Phase 3 clinical trials of sotagliflozin in type 1 diabetes patients and the prospects of FDA approval of sotagliflozin for the treatment of type 1 diabetes. The complaint purported to assert claims for violations of Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder. The complaint sought, on behalf of the purported class, an unspecified amount of monetary damages, interest, fees and expenses of attorneys and experts, and other relief.

Sanofi Arbitration. On October 16, 2020, we initiated arbitration proceedings against Sanofi seeking to recover damages for breach of contract relating to the Termination and Settlement Agreement and Mutual Releases with Sanofi, dated September 9, 2019. In September 2020, Sanofi withheld approximately $23.2 million from the final $26 million payment due to us under the termination and settlement agreement, offsetting certain third party costs and internal costs incurred by Sanofi and asserted by Sanofi to be payable by us under the terms of the termination and settlement agreement. We disputed that at least a significant portion of such costs were properly reimbursable by us under the terms of the termination and settlement agreement and asserted that, in any event, Sanofi was not permitted to withhold any of such costs under the terms of the termination and settlement agreement. We were seeking payment of $15.6 million in such disputed costs, together with late interest and attorneys’ fees and costs. Sanofi was seeking a declaratory judgment that we are liable for all disputed costs previously withheld and damages for any additional costs properly reimbursable under the terms of the termination and settlement agreement in excess of those previously withheld, together with late interest and attorneys’ fees. On November 5, 2021, the arbitration panel issued a judgment in Sanofi’s favor. The amount of Sanofi’s attorneys’ fees and costs subject to reimbursement cannot be reasonably estimated at this time.

Normal Course Legal Proceedings. In addition, we are from time to time party to claims and legal proceedings that arise in the normal course of our business and that we believe will not have, individually or in the aggregate, a material adverse effect on our results of operations, financial condition or liquidity.



Item 1A.
Item 1A.  Risk Factors

The following risks and uncertainties are important factors that could cause actual results or events to differ materially from those indicated by forward-looking statements. The factors described below are not the only ones we face and additional risks and uncertainties not presently known to us or that we currently deem immaterial also may impair our business operations.
Risks Related to Our Need for Additional FinancingBusiness and Our Financial ResultsIndustry
We will need additional capital in the future and, if it is unavailable, we will be forced to delay, reduce or eliminate our commercialization efforts or product development programs. If additional capital is not available on reasonable terms, we will be forced to obtain funds, if at all, by entering into financing agreements on unattractive terms.

We have a history of net losses, and we expect to continue to incur net losses and may not achieve or maintain profitability.

Our operating results have been and likely will continue to fluctuate, and we believe that period-to-period comparisons of our operating results are not a good indication of our future performance.

We have substantial indebtedness that may limit cash flow available to invest in the ongoing needs of our business.

We may not have the ability to raise the funds necessary to repurchase the notes evidencing our existing indebtedness upon a fundamental change, and our future debt may contain limitations on our ability to repurchase the notes.

Risks Related to the Commercialization or Development of XERMELO and Our Drug Candidates
We will depend heavily on the commercial success of XERMELO in the United States. If we do not achieve commercial success with XERMELO, our business will suffer and our stock price will likely decline.

Clinical testing of our drug candidates in humans is an inherently risky and time-consuming process that may fail to demonstrate safety and efficacy, which could result in the delay, limitation or prevention of regulatory approval.


•    Our drug candidates are subject to a lengthy and uncertain regulatory process that may not result in the necessary regulatory approvals, which could adversely affect our and our collaborators’ ability to commercialize products.


•    We depend on our ability to gain alignment with certain regulatory authorities on our regulatory strategy for sotagliflozin in heart failure and obtain regulatory approval to market sotagliflozin for heart failure in the United States. If we fail to effectively gain such alignment or obtain such regulatory approval, our business will suffer and our stock price will likely decline.

•    The commercial success of XERMELO and any other products that we or our collaborators may develop will depend upon the degree of market acceptance among physicians, patients, health care payers private health insurers and the medical community.


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•    If we are unable to implement and maintainreestablish an effective and specialized sales force, marketing infrastructure and distribution capabilities, we will not be able to successfully commercialize XERMELOany products that we or our drug candidates successfully.collaborators may develop.


•    If we are unable to obtainmaintain adequate coverage and reimbursement from third-party payorspayers for XERMELO and any other products that we or our collaborators may develop, our revenues and prospects for profitability will suffer.


•    We may not be able to manufacture products that we or our collaborators may develop in commercial quantities, which would impair our ability to commercialize such products.

•    We and our collaborators are subject to extensive and rigorous ongoing regulation relating to XERMELO and any other approved products.products that we or our collaborators may develop.


•    We are subject to certain healthcare laws, regulation and enforcement; our failure to comply with those laws could have a material adverse effect on our results of operations and financial condition.


•    Current healthcare laws and regulations and future legislative or regulatory reforms to the healthcare system may negatively affect our revenues and prospects for profitability.


•    Our competitors may develop products that make XERMELOimpair the value of any products that we or our collaborators’collaborators may develop.

•    We face business disruption and related risks resulting from the outbreak of the novel coronavirus, or COVID-19, including delays in the enrollment of ongoing clinical trials and other products obsolete.operational impacts, each of which could have a material adverse effect on our business.


Risks Related to Our Capital Requirements and Financial Results

•    We will need additional capital in the future and, if it is unavailable, we will be forced to delay, reduce or eliminate our research and development programs and our planned commercial launch, if approved, of sotagliflozin for heart failure in the United States. If additional capital is not available on reasonable terms, we will be forced to obtain funds, if at all, by entering into financing agreements on unattractive terms.

•    We have a history of net losses, and we expect to continue to incur net losses and may not be ableachieve or maintain profitability.

•    Our operating results have fluctuated and likely will continue to manufacturefluctuate, and we believe that period-to-period comparisons of our drug candidatesoperating results are not a good indication of our future performance.

•    We have indebtedness that may limit cash flow available to invest in commercial quantities, which would prevent us from commercializingthe ongoing needs of our drug candidates.business.


Risks Related to Our Relationships with Third Parties


•    We depend on third-party manufacturers, including sole source suppliers,our ability to manufacture commercial quantities of XERMELO. We may not be able to maintain these relationships and could experience supply disruptions outside of our control.

We rely on a single third-party logistics provider and two independent specialty pharmacies for distribution of XERMELO in the United States, and their failure to distribute XERMELO effectively would adversely affect sales of XERMELO.

We are significantly dependent upon ourestablish collaborations with Ipsen, Sanofi and other pharmaceutical and biotechnology companies.companies for the development and commercialization of our other drug candidates. If we are unable to establish such collaborations, or if pharmaceutical products are not successfully and timely developed and commercialized under oursuch collaborations, our opportunities to generate revenues from milestones and royaltiesour other drug candidates will be greatly reduced.


•    Conflicts with our collaborators could jeopardize the success of our collaborative agreements and harm our product development efforts.


•    We rely on third parties to carry out drugour nonclinical studies and clinical trials, which may harm or delay our research and development activities.efforts.


•    We lack the capability to manufacture materials for nonclinical studies, clinical trials or commercial sales and rely on third parties to manufacture our drug candidates, which may harm or delay our productresearch and development and commercialization efforts.


Risks Related to Our Intellectual Property

•    If we are unable to adequately protect our intellectual property, third parties may be able to use our products and technologies, which could adversely affect our ability to compete in the market.

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•    We may be involved in patent litigation and other disputes regarding intellectual property rights and may require licenses from third parties for our planned nonclinical and clinical development and commercialization activities. We may not prevail in any such litigation or other dispute or be able to obtain required licenses.


We have not sought patent protection outside of the United States for some of•    Data breaches and cyber-attacks could compromise our inventions,intellectual property or other sensitive information and some of our licensed patents only provide coverage in the United States. As a result, our international competitors could be granted foreign patent protection with respectcause significant damage to our discoveries.business, reputational harm and financial loss.


•    We may be subject to damages resulting from claims that we, our employees or independent contractors have wrongfully used or disclosed alleged trade secrets of their former employers.


Risks Related to Our Employees Advisors and Facilities Operations

•    If we are unable to manage our growth, our business, financial condition, results of operations and prospects may be adversely affected.

•    The loss of key personnel or the inability to attract and retain additional personnel could impair our ability to operate and expand our operations.


Our collaborations with outside scientists may be subject to restriction and change.

Data breaches and cyber-attacks could compromise our intellectual property or other sensitive information and cause significant damage to our business and reputation.

Facility security breaches may disrupt our operations and harm our operating results.

•    Our facilities are located near coastal zones, and the occurrence of a hurricane or other disaster could damage our facilities and equipment, which could harm our operations.


Risks Related to Environmental and Product Liability
•    We have used hazardous chemicals and radioactive and biological materialssubstances in our business. Any claims relating to improper handling, storage or disposal of these materialssubstances could be time consuming and costly.


•    Our business has a substantial risk of product liability and we face potential product liability exposure far in excess of our limited insurance coverage.

Risks Related to Our Common Stock
•    Invus, L.P., Invus C.V. and theirits affiliates own a controlling interest in our outstanding common stock and may have interests which conflict with those of our other stockholders.


Conversion of the notes evidencing our current indebtedness may dilute the ownership interest of our existing stockholders, including holders who had previously converted their notes, or may otherwise depress the price of our common stock.

•    Invus has additional rights under ourits stockholders’ agreement with Invus, L.P.relating to the membership of our board of directors, which provides Invus with substantial influence over certain significant corporate matters.


•    Our stock price may be extremely volatile.


•    We may engage in future acquisitions,are subject to securities litigation, which may beis expensive and time consuming and from which we may not realize anticipated benefits.could divert management attention.


•    Future issuances or sales of our common stock, or the perception that such issuances or sales may occur, may depress our stock price.


•    If we are unable to meet Nasdaq continued listing requirements, Nasdaq may take action to delistsecurities or industry analysts do not publish research or publish inaccurate or unfavorable research about our common stock.business, our stock price and trading volume could decline.


For additional discussion of the risks and uncertainties that affect our business, see “Item 1A. Risk Factors” included in our annual report on Form 10-K for the year ended December 31, 20162020 as filed with the Securities and Exchange Commission.
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Item 6.  Exhibits

Item 6.Exhibits

Exhibit No.Description
*†10.1
*31.1
*31.2
*32.1
101.INSXBRL Instance Document
101.SCHXBRL Taxonomy Extension Schema Document
101.CALXBRL Taxonomy Extension Calculation Linkbase Document
101.DEFXBRL Taxonomy Extension Definition Linkbase Document
101.LABXBRL Taxonomy Extension Label Linkbase Document
101.PREXBRL Taxonomy Extension Presentation Linkbase Document
104
Cover Page Interactive Data File (embedded within the Inline XBRL document)
_____________________
*Filed herewith.
*Filed herewith.
Confidential treatment has been requested for a portion of this exhibit.  The confidential portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.





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Signatures
 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

Lexicon Pharmaceuticals, Inc.
Date:November 8, 20179, 2021By:/s/ Lonnel Coats
Lonnel Coats
President and Chief Executive Officer

Date:November 8, 20179, 2021By:/s/ Jeffrey L. Wade
Jeffrey L. Wade
Executive Vice President Corporate and Administrative Affairs and Chief Financial Officer




Index to Exhibits

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Exhibit No.Description
*†10.1Amendment No. 1 to Collaboration and License Agreement, dated July 1, 2017, with Sanofi-Aventis Deutschland GmbH
*31.1Certification of Principal Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
*31.2Certification of Principal Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
*32.1Certification of Principal Executive and Principal Financial Officers Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
101.INSXBRL Instance Document
101.SCHXBRL Taxonomy Extension Schema Document
101.CALXBRL Taxonomy Extension Calculation Linkbase Document
101.DEFXBRL Taxonomy Extension Definition Linkbase Document
101.LABXBRL Taxonomy Extension Label Linkbase Document
101.PREXBRL Taxonomy Extension Presentation Linkbase Document
_____________________
*Filed herewith.
Confidential treatment has been requested for a portion of this exhibit.  The confidential portions of this exhibit have been omitted and filed separately with the Securities and Exchange Commission.



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