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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark
One)
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☑ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934 |
For the Quarterly Period Ended June 30, 2020
or
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☐ |
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)
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Delaware |
76-0474169 |
(State or Other Jurisdiction of
Incorporation or Organization) |
(I.R.S. Employer
Identification Number) |
8800 Technology Forest Place
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:
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Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
Common Stock, par value $0.001 |
LXRX |
The 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.
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
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 such files).
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
☑
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.
☐
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange Act).
As of July 24, 2020, 107,105,853 shares of the registrant’s
common stock, par value $0.001 per share, were outstanding.
☐
Lexicon Pharmaceuticals, Inc.
Table of Contents
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Page |
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Item 1. |
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Condensed Consolidated Balance Sheets - June 30, 2020 (unaudited)
and December 31, 2019 |
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Condensed Consolidated Statements of Comprehensive Loss (unaudited)
- Three and Six Months Ended June 30, 2020 and 2019 |
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Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(unaudited) - Three and Six Months Ended June 30, 2020 and
2019 |
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Condensed Consolidated Statements of Cash Flows (unaudited) - Six
Months Ended June 30, 2020 and 2019 |
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Notes to Condensed Consolidated Financial Statements
(unaudited) |
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Item 2. |
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Item 3. |
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Item 4. |
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Item 1. |
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Item 1A. |
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Item 2 |
Unregistered Sales of Equity Securities and Use of
Proceeds
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Item 6. |
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The Lexicon name and logo and XERMELO®
are registered trademarks of Lexicon Pharmaceuticals, Inc.
Zynquista™ is a trademark 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,
2019, 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.
Part I – Financial Information
Item 1. Financial Statements
Lexicon Pharmaceuticals, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except par value)
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As of June 30, |
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As of December 31, |
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2020 |
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2019 |
Assets |
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(unaudited) |
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Current assets: |
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Cash and cash equivalents |
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$ |
86,943 |
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$ |
36,112 |
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Short-term investments |
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114,923 |
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235,547 |
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Accounts receivable, net |
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30,876 |
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56,532 |
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Inventory |
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3,989 |
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4,243 |
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Prepaid expenses and other current assets |
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9,461 |
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5,320 |
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Total current assets |
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246,192 |
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337,754 |
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Property and equipment, net of accumulated depreciation and
amortization of $63,360 and $61,741, respectively
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11,524 |
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14,047 |
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Goodwill |
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44,543 |
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44,543 |
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Intangible assets, net of accumulated amortization of $5,886 and
$5,003, respectively
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18,833 |
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19,716 |
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Other assets |
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1,448 |
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1,655 |
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Total assets |
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$ |
322,540 |
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$ |
417,715 |
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Liabilities and Equity |
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Current liabilities: |
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Accounts payable |
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$ |
29,763 |
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$ |
12,178 |
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Accrued liabilities |
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57,338 |
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42,151 |
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Current portion of long-term debt, net of deferred issuance
costs |
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10,457 |
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11,012 |
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Total current liabilities |
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97,558 |
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65,341 |
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Long-term debt, net of deferred issuance costs |
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234,807 |
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234,171 |
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Other long-term liabilities |
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862 |
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1,102 |
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Total liabilities |
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333,227 |
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300,614 |
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Commitments and contingencies |
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Stockholders’ Equity/(Deficit): |
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Preferred stock, $0.01 par value; 5,000 shares authorized; no
shares issued and outstanding
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— |
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— |
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Common stock, $0.001 par value; 225,000 shares authorized; 107,898
and 106,679 shares issued, respectively
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108 |
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106 |
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Additional paid-in capital |
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1,470,862 |
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1,462,172 |
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Accumulated deficit |
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(1,477,126) |
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(1,341,444) |
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Accumulated other comprehensive income |
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312 |
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84 |
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Treasury stock, at cost, 793 and 407 shares,
respectively
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(4,843) |
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(3,817) |
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Total stockholders’ equity/(deficit) |
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(10,687) |
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117,101 |
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Total liabilities and equity/(deficit) |
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$ |
322,540 |
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$ |
417,715 |
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The accompanying notes are an integral part of these condensed
consolidated financial statements.
Lexicon Pharmaceuticals, Inc.
Condensed Consolidated Statements of Comprehensive
Loss
(In thousands, except per share amounts)
(Unaudited)
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2020 |
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2019 |
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2020 |
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2019 |
Revenues: |
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Net product revenue |
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$ |
8,985 |
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$ |
8,672 |
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$ |
16,862 |
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$ |
15,412 |
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Collaborative agreements |
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25 |
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860 |
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33 |
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3,299 |
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Royalties and other revenue |
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153 |
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150 |
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267 |
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187 |
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Total revenues |
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9,163 |
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9,682 |
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17,162 |
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18,898 |
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Operating expenses: |
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Cost of sales (including finite-lived intangible asset
amortization)
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728 |
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1,327 |
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1,296 |
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1,880 |
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Research and development, including stock-based compensation of
$1,949, $1,903, $4,125 and $3,671, respectively
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57,301 |
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12,637 |
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112,482 |
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24,659 |
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Selling, general and administrative, including stock-based
compensation of $2,309, $1,863, $4,565 and $3,506,
respectively
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14,113 |
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14,263 |
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28,801 |
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28,373 |
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Impairment loss on buildings
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1,600 |
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— |
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1,600 |
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— |
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Total operating expenses |
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73,742 |
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28,227 |
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144,179 |
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54,912 |
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Loss from operations |
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(64,579) |
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(18,545) |
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(127,017) |
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(36,014) |
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Interest expense |
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(5,125) |
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(5,164) |
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(10,256) |
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(10,281) |
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Interest and other income, net |
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633 |
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691 |
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1,591 |
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1,480 |
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Net loss |
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$ |
(69,071) |
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$ |
(23,018) |
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$ |
(135,682) |
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$ |
(44,815) |
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Net loss per common share, basic and diluted |
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$ |
(0.65) |
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$ |
(0.22) |
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$ |
(1.27) |
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$ |
(0.42) |
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Shares used in computing net loss per common share, basic and
diluted
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107,073 |
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106,272 |
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106,804 |
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106,164 |
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Other comprehensive loss:
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Unrealized gain (loss) on investments
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(548) |
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53 |
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228 |
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98 |
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Comprehensive loss
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$ |
(69,619) |
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$ |
(22,965) |
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$ |
(135,454) |
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$ |
(44,717) |
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The accompanying notes are an integral part of these condensed
consolidated financial statements.
Lexicon Pharmaceuticals, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(Deficit)
(In thousands)
(Unaudited)
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Common Stock |
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Additional |
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Accumulated Other |
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Shares |
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Par Value |
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Paid-In Capital |
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Accumulated Deficit |
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Comprehensive Gain (Loss) |
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Treasury Stock |
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Total |
Balance at December 31, 2018 |
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106,162 |
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$ |
106 |
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$ |
1,447,954 |
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$ |
(1,471,577) |
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$ |
(12) |
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$ |
(2,876) |
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$ |
(26,405) |
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Stock-based compensation |
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— |
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— |
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3,411 |
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— |
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— |
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— |
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3,411 |
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Issuance of common stock under Equity Incentive Plans |
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517 |
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— |
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— |
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— |
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— |
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— |
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— |
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Repurchase of common stock |
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— |
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— |
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— |
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— |
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— |
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(941) |
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|
(941) |
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Net loss |
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— |
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— |
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— |
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(21,797) |
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— |
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— |
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(21,797) |
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Unrealized gain on investments |
|
— |
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— |
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— |
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— |
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|
45 |
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— |
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45 |
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Balance at March 31, 2019 |
|
106,679 |
|
|
106 |
|
|
1,451,365 |
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(1,493,374) |
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33 |
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(3,817) |
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|
(45,687) |
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Stock-based compensation |
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— |
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— |
|
|
3,766 |
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— |
|
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— |
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— |
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3,766 |
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Net loss |
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— |
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— |
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— |
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(23,018) |
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— |
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|
— |
|
|
(23,018) |
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Unrealized gain on investments |
|
— |
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— |
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— |
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— |
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53 |
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— |
|
|
53 |
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Balance at June 30, 2019 |
|
106,679 |
|
|
$ |
106 |
|
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$ |
1,455,131 |
|
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$ |
(1,516,392) |
|
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$ |
86 |
|
|
$ |
(3,817) |
|
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$ |
(64,886) |
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at December 31, 2019 |
|
106,679 |
|
|
$ |
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 Plans |
|
1,032 |
|
|
2 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
2 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Repurchase of common stock |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(923) |
|
|
(923) |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
(66,611) |
|
|
— |
|
|
— |
|
|
(66,611) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unrealized gain on investments |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
776 |
|
|
— |
|
|
776 |
|
Balance at March 31, 2020 |
|
107,711 |
|
|
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 Plans |
|
187 |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
Repurchase of common stock |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(103) |
|
|
(103) |
|
Net loss |
|
— |
|
|
— |
|
|
— |
|
|
(69,071) |
|
|
— |
|
|
— |
|
|
(69,071) |
|
Unrealized loss on investments |
|
— |
|
|
— |
|
|
— |
|
|
— |
|
|
(548) |
|
|
— |
|
|
(548) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance at June 30, 2020 |
|
107,898 |
|
|
108 |
|
|
1,470,862 |
|
|
(1,477,126) |
|
|
312 |
|
|
(4,843) |
|
|
(10,687) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
Lexicon Pharmaceuticals, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Six Months Ended June 30, |
|
|
|
|
2020 |
|
2019 |
Cash flows from operating activities: |
|
|
|
|
Net loss |
|
$ |
(135,682) |
|
|
$ |
(44,815) |
|
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
Depreciation and amortization |
|
1,806 |
|
|
1,811 |
|
|
|
|
|
|
Stock-based compensation |
|
8,690 |
|
|
7,177 |
|
Amortization of debt issuance costs |
|
726 |
|
|
708 |
|
|
|
|
|
|
Impairment loss on building |
|
1,600 |
|
|
— |
|
Changes in operating assets and liabilities: |
|
|
|
|
Decrease in accounts receivable |
|
25,656 |
|
|
344 |
|
Decrease in inventory |
|
254 |
|
|
403 |
|
Increase in prepaid expenses and other current assets |
|
(4,141) |
|
|
(3,957) |
|
Decrease in other assets |
|
207 |
|
|
186 |
|
Increase (decrease) in accounts payable and other
liabilities |
|
32,532 |
|
|
(13,842) |
|
Decrease in deferred revenue |
|
— |
|
|
(535) |
|
Net cash used in operating activities |
|
(68,352) |
|
|
(52,520) |
|
Cash flows from investing activities: |
|
|
|
|
Purchases of property and equipment |
|
— |
|
|
(70) |
|
|
|
|
|
|
Purchases of investments |
|
(37,148) |
|
|
(106,706) |
|
Maturities of investments |
|
158,000 |
|
|
91,600 |
|
Net cash provided by (used in) investing activities |
|
120,852 |
|
|
(15,176) |
|
Cash flows from financing activities: |
|
|
|
|
|
|
|
|
|
Repurchase of common stock |
|
(1,026) |
|
|
(941) |
|
|
|
|
|
|
Repayment of debt borrowings |
|
(643) |
|
|
(643) |
|
|
|
|
|
|
Net cash used in financing activities |
|
(1,669) |
|
|
(1,584) |
|
Net increase (decrease) in cash and cash equivalents |
|
50,831 |
|
|
(69,280) |
|
Cash and cash equivalents at beginning of period |
|
36,112 |
|
|
80,386 |
|
Cash and cash equivalents at end of period |
|
$ |
86,943 |
|
|
$ |
11,106 |
|
|
|
|
|
|
Supplemental disclosure of cash flow information: |
|
|
|
|
Cash paid for interest |
|
$ |
9,569 |
|
|
$ |
9,610 |
|
|
|
|
|
|
The accompanying notes are an integral part of these condensed
consolidated financial statements.
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 six-month period
ended June 30, 2020 are not necessarily indicative of the
results that may be expected for the year ended December 31,
2020.
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, 2019, as filed with the
SEC.
Use of Estimates:
The preparation of financial statements in conformity with 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 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 June 30, 2020, short-term
investments consisted of U.S. treasury bills and corporate debt
securities. As of December 31, 2019, short-term investments
consisted of U.S. treasury bills. 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, net of an allowance
for expected credit losses.
Inventory:
Inventory is comprised of the Company’s approved product it is
commercializing in the United States, XERMELO®
(telotristat ethyl). 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. Inventory consisted of the
following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, |
|
As of December 31, |
|
|
2020 |
|
2019 |
|
|
(in thousands) |
|
|
Raw materials |
|
$ |
1,154 |
|
|
$ |
3,182 |
|
Work-in-process |
|
$ |
2,185 |
|
|
$ |
153 |
|
Finished goods |
|
650 |
|
|
908 |
|
Total inventory |
|
$ |
3,989 |
|
|
$ |
4,243 |
|
Accrued liabilities:
Accrued liabilities consisted of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, |
|
As of December 31, |
|
|
2020 |
|
2019 |
|
|
(in thousands) |
|
|
Accrued research and development services |
|
$ |
47,721 |
|
|
$ |
29,033 |
|
Accrued compensation and benefits |
|
6,697 |
|
|
9,644 |
|
Short term lease liability |
|
553 |
|
|
553 |
|
Other |
|
2,367 |
|
|
2,921 |
|
Accrued liabilities |
|
$ |
57,338 |
|
|
$ |
42,151 |
|
Revenue Recognition:
Product Revenues
Product revenues consist of commercial sales of XERMELO in the
United States and sales of bulk tablets of XERMELO to Ipsen Pharma
SAS (“Ipsen”). Product revenues are recognized when the customer
obtains control of the Company’s product, which occurs upon
delivery to the customer. The Company recognizes product revenue
net of applicable reserves for variable consideration, including
allowances for customer credits, 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 are 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 reflect the
Company’s best estimates of the amounts of consideration to which
it is entitled based on the terms of the respective underlying
contracts. Product shipping and handling costs are considered a
fulfillment activity when control transfers to the Company’s
customers and such costs are included in cost of
sales.
Collaborative Agreements
Revenues under collaborative agreements include both license
revenue and contract research revenue. The Company performs the
following five steps in determining the amount of revenue to
recognize as it fulfills its performance obligations under each 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 and determines those that are performance 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 the
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 significant revenue
reversal will not occur, the associated development milestone value
is included in the transaction price. Development milestones that
are not within the control of the Company or the licensee,
including those requiring regulatory approval, are not considered
probable of being achieved until those approvals are received. The
transaction price is allocated to each performance obligation on a
relative stand-alone selling price basis, for which the Company
recognizes revenue when (or as) the performance obligation is
satisfied. At the end of each reporting period, the Company
re-evaluates the probability of achievement of the development
milestones and any related constraint, and if necessary, adjusts
its estimates of the overall transaction price. Any such
adjustments are recorded on a cumulative catch-up basis, which
would affect collaboration revenues in the period of
adjustment.
In agreements in which a license to the Company’s 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.
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, 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 royalty has been allocated has been satisfied (or partially
satisfied).
The Company may receive payments from its licensees based on
billing schedules established in each contract. Up-front payments
and fees are recorded as deferred revenue upon receipt or when due,
and may require deferral of revenue recognition to a future period
until the Company performs its obligations under these agreements.
Amounts are recorded as accounts receivable when the Company’s
right to consideration is unconditional.
Cost of Sales:
Cost of sales consists of third-party manufacturing costs, freight
and indirect overhead costs associated with sales of XERMELO.
Product shipping and handling costs are included in cost of sales.
Cost of sales also includes 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 development of sotagliflozin for type 2 diabetes, heart
failure and chronic kidney disease, including the costs to close
out those studies, were based on actual costs incurred for
activities completed subsequent to the transition date and
estimates of the services to be received and efforts to be expended
pursuant to contracts with multiple vendors and the CRO that has
conducted and managed and is now closing out 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 issued
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. 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. 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 options granted in the six months ended
June 30, 2020 and 2019:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Expected Volatility |
|
Risk-free Interest Rate |
|
Expected Term |
|
Dividend
Rate |
June 30, 2020: |
|
|
|
|
|
|
|
|
Employees |
|
90 |
% |
|
1.3 |
% |
|
4 |
|
— |
% |
Officers and non-employee directors |
|
78 |
% |
|
1.4 |
% |
|
8 |
|
— |
% |
June 30, 2019: |
|
|
|
|
|
|
|
|
Employees |
|
63 |
% |
|
2.4 |
% |
|
4 |
|
— |
% |
Officers and non-employee directors |
|
63 |
% |
|
2.6 |
% |
|
8 |
|
— |
% |
The following is a summary of stock option activity under Lexicon’s
stock-based compensation plans for the six months ended
June 30, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Options |
|
Weighted Average Exercise Price |
|
|
(in thousands) |
|
|
Outstanding at December 31, 2019 |
|
7,695 |
|
|
$ |
8.95 |
|
Granted |
|
3,445 |
|
|
3.25 |
|
|
|
|
|
|
Expired |
|
(236) |
|
|
12.92 |
|
Forfeited |
|
(298) |
|
|
7.45 |
|
Outstanding at June 30, 2020 |
|
10,606 |
|
|
7.05 |
|
Exercisable at June 30, 2020 |
|
4,972 |
|
|
$ |
9.72 |
|
During the six months ended June 30, 2020, Lexicon granted its
employees annual restricted stock units. Outstanding employee
restricted stock units vest in three to four annual installments.
The following is a summary of restricted stock units activity under
Lexicon’s stock-based compensation plans for the six months ended
June 30, 2020:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares |
|
Weighted Average Grant Date
Fair Value |
|
|
(in thousands) |
|
|
Outstanding at December 31, 2019 |
|
2,830 |
|
|
$ |
6.35 |
|
Granted |
|
3,144 |
|
|
3.27 |
|
Vested |
|
(1,219) |
|
|
6.56 |
|
Forfeited |
|
(339) |
|
|
4.16 |
|
Outstanding at June 30, 2020 |
|
4,416 |
|
|
$ |
4.27 |
|
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
In November 2018, the Financial Accounting Standards Board ("FASB")
issued Accounting Standards Update ("ASU") No. 2018-18,
Collaborative Arrangements (Topic 808): Clarifying the Interaction
between Topic 808 and Topic 606. This targeted amendment to Topic
808 clarifies that certain transactions resulting from a
collaborative agreement should be accounted for as revenue under
Topic 606 when the collaborative arrangement participant is a
customer for a good or service that is a distinct unit-of-account.
This amendment is effective for fiscal years, and interim periods
within years presented, beginning after December 15, 2019, and
should be applied retrospectively to the date of initial
application of Topic 606. The Company has applied the provisions of
Topic 606 to account for its transactions for collaboration
arrangements, including recognition, measurement, presentation and
disclosure requirement, and adoption of this ASU did not have a
material impact on the condensed consolidated financial
statements.
In January 2017, the FASB issued ASU No. 2017-04,
Intangibles-Goodwill and Other, which is intended to simplify the
subsequent measurement of goodwill. The pronouncement allows an
entity, during its annual or interim goodwill
impairment evaluation, to compare the fair value of a reporting
unit with its carrying amount. An impairment charge is immediately
recognized by which the carrying amount exceeds the fair value.
This ASU is effective for fiscal years, and interim periods within
those years, beginning after December 15, 2019. The adoption of
this ASU did not have a material impact on the condensed
consolidated financial statements.
3. Cash
and Cash Equivalents and Investments
The fair value of cash and cash equivalents and investments held at
June 30, 2020 and December 31, 2019 are as
follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of June 30, 2020 |
|
|
|
|
|
|
|
|
Amortized Cost |
|
Gross Unrealized Gains |
|
Gross Unrealized Losses |
|
Estimated Fair Value |
|
|
(in thousands) |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
86,943 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
86,943 |
|
Securities maturing within one year: |
|
|
|
|
|
|
|
|
U.S. treasury securities |
|
110,503 |
|
|
312 |
|
|
— |
|
|
110,815 |
|
Corporate debt securities |
|
4,108 |
|
|
— |
|
|
— |
|
|
4,108 |
|
Total short-term investments |
|
$ |
114,611 |
|
|
$ |
312 |
|
|
$ |
— |
|
|
$ |
114,923 |
|
Total cash and cash equivalents and investments |
|
$ |
201,554 |
|
|
$ |
312 |
|
|
$ |
— |
|
|
$ |
201,866 |
|
|
|
|
|
|
|
|
|
|
|
|
As of December 31, 2019 |
|
|
|
|
|
|
|
|
Amortized Cost |
|
Gross Unrealized Gains |
|
Gross Unrealized Losses |
|
Estimated Fair Value |
|
|
|
|
(in thousands) |
|
|
|
|
Cash and cash equivalents |
|
$ |
36,112 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
36,112 |
|
Securities maturing within one year: |
|
|
|
|
|
|
|
|
U.S. treasury securities |
|
235,463 |
|
|
94 |
|
|
(10) |
|
|
235,547 |
|
|
|
|
|
|
|
|
|
|
Total short-term investments |
|
$ |
235,463 |
|
|
$ |
94 |
|
|
$ |
(10) |
|
|
$ |
235,547 |
|
Total cash and cash equivalents and investments
|
|
$ |
271,575 |
|
|
$ |
94 |
|
|
$ |
(10) |
|
|
$ |
271,659 |
|
There were no realized losses during either of the six months ended
June 30, 2020 and 2019, respectively. The cost of securities
sold is based on the specific identification method.
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
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 that are
measured at fair value on a recurring basis according to the fair
value levels defined above as of June 30, 2020 and
December 31, 2019.
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets and Liabilities at Fair Value as of June 30,
2020 |
|
|
|
|
|
|
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
|
|
(in thousands) |
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
86,943 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
86,943 |
|
Short-term investments |
|
110,815 |
|
|
4,108 |
|
|
— |
|
|
114,923 |
|
Total cash and cash equivalents and investments |
|
$ |
197,758 |
|
|
$ |
4,108 |
|
|
$ |
— |
|
|
$ |
201,866 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Assets and Liabilities at Fair Value as of December 31,
2019 |
|
|
|
|
|
|
|
|
Level 1 |
|
Level 2 |
|
Level 3 |
|
Total |
|
|
(in thousands) |
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
36,112 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
36,112 |
|
Short-term investments |
|
235,547 |
|
|
— |
|
|
— |
|
|
235,547 |
|
Total cash and cash equivalents and investments |
|
$ |
271,659 |
|
|
$ |
— |
|
|
$ |
— |
|
|
$ |
271,659 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
The Company did not have any Level 3 assets or liabilities as of
June 30, 2020 or December 31, 2019. Transfers between
levels are recognized at the actual date of circumstance that
caused the transfer. There were no transfers between Level 1 and
Level 2 during the periods presented.
The Company also has assets that under certain conditions are
subject to measurement at fair value on a non-recurring basis.
These assets include goodwill associated with the acquisitions of
Coelacanth Corporation in 2001 and Symphony Icon in 2010, and
intangible assets associated with the acquisition of Symphony Icon
in 2010. For these assets, measurement at fair value in periods
subsequent to their initial recognition is applicable if one or
more is determined to be impaired.
Refer to Note 5, Debt Obligations, for fair value measurements of
debt obligations.
Refer to Note 8, Impairment Loss on Buildings, for fair value
measurement of fixed assets.
5. 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 “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.
The 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 Convertible Notes, the
Company incurred $3.4 million of debt issuance costs. The debt
issuance costs are amortized as interest expense over the expected
life of the Convertible Notes using the effective interest method.
The Company determined the expected life of the debt was equal to
the seven-year term of the Convertible Notes. As of June 30,
2020, the balance of unamortized debt issuance costs was
$0.7 million, which offsets long-term debt on the condensed
consolidated balance sheets. As of June 30, 2020, the carrying
value of the Convertible Notes was $86.8 million.
The fair value of the Convertible Notes was $44.7 million as
of June 30, 2020 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.
Mortgage Loan. In
August 2018, a wholly owned subsidiary of Lexicon entered into a
term loan and security agreement, refinancing the previously
existing mortgage on its facilities in The Woodlands, Texas (the
“Property”). The loan agreement provides for a $12.9 million
mortgage on the Property and has a two-year term with a 10-year
amortization. The mortgage loan bears interest at a rate per annum
equal to the greater of (a) the 30-day LIBOR rate plus 5.5% and (b)
7.5% and provides for a balloon payment of $10.3 million due in
August 2020. Lexicon incurred $0.4 million of debt issuance costs
in connection with the mortgage loan, which offsets the current
portion of long-term debt on the condensed consolidated balance
sheets and are amortized as interest expense over the two-year term
of the loan agreement. As of June 30, 2020, the balance of
unamortized debt issuance costs was $0.03 million. The condensed
consolidated balance sheet includes mortgage debt, the carrying
value of the debt, of $10.5 million as of June 30, 2020 and is
included in current portion of long-term debt. The buildings and
land that serve as collateral for the mortgage loan are included in
property and equipment at $57.6 million and $2.7 million,
respectively, before accumulated depreciation, as of June 30,
2020. The fair value of the loan agreement approximates its
carrying value. The fair value of the loan agreement was
determined using Level 2 inputs using discounted cash flow
analysis, based on the Company’s estimated current incremental
borrowing rate.
BioPharma Term Loan. In
December 2017, Lexicon entered into a loan agreement with BioPharma
Credit PLC and BioPharma Credit Investments IV Sub LP under which
$150.0 million was funded in December 2017 (the “BioPharma Term
Loan”). The BioPharma Term Loan matures in December 2022, bears
interest at 9% per year, subject to additional interest if an event
of default occurs and is continuing, and is payable
quarterly.
The BioPharma Term Loan is subject to mandatory prepayment
provisions that require prepayment upon a change of control or
receipt of proceeds from certain non-ordinary course transfers of
assets. The Company may prepay the BioPharma Term Loan in whole at
its option at any time. Any prepayment of the BioPharma Term Loan
is subject to customary make-whole premiums and prepayment
premiums.
The Company’s obligations under the BioPharma Term Loan are secured
by a first lien security interest in substantially all of the
assets of the Company and certain of its subsidiaries, other than
its facilities in The Woodlands, Texas. The loan agreement contains
certain customary representations and warranties, affirmative and
negative covenants and events of default applicable to the Company
and certain of its subsidiaries, including among other things,
covenants restricting dispositions, fundamental changes in the
business, mergers or acquisitions, indebtedness, encumbrances,
distributions, investments, transactions with affiliates and
subordinated debt. If an event of default occurs and is continuing,
all amounts outstanding under the BioPharma Term Loan may be
declared immediately due and payable.
In connection with the BioPharma Term Loan, the Company incurred
$4.1 million of debt issuance costs. The debt issuance costs are
amortized as interest expense over the expected life of the
BioPharma Term Loan using the effective interest method. The
Company determined the expected life of the debt was equal to the
five-year term of the BioPharma Term Loan. As of June 30,
2020, the balance of unamortized debt issuance costs was $2.0
million, which offsets long-term debt on the condensed consolidated
balance sheets. As of June 30, 2020, the carrying value of the
BioPharma Term Loan was $148.0 million.
The fair value of the BioPharma Term Loan approximates its carrying
value. The fair value of the BioPharma Term Loan was determined
using Level 2 inputs using discounted cash flow analysis,
based on the Company’s estimated current incremental borrowing
rate.
6. Commitments
and Contingencies
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 its officers in the U.S. District Court
for the Southern District of Texas, Houston Division. A first
amended complaint was filed on July 30, 2019 and Lexicon filed a
motion to dismiss such first amended complaint on September 30,
2019. The plaintiff filed an opposition to Lexicon's motion to
dismiss on November 14, 2019 and Lexicon filed a reply in support
of its motion to dismiss on December 13, 2019. The lawsuit purports
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 alleges that the defendants
violated federal securities laws by making materially false and
misleading statements and/or omissions concerning data from its
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 purports 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 seeks, on behalf of the purported class, an unspecified
amount of monetary damages, interest, fees and expenses of
attorneys and experts, and other relief.
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.
7. Collaboration
and License Agreements
Lexicon has derived substantially all of its revenues from drug
discovery and development 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”).
Under the Ipsen Agreement, Lexicon granted Ipsen an exclusive,
royalty-bearing right and license under its patent rights and
know-how to commercialize XERMELO in the Licensed Territory. Ipsen
is responsible for using diligent efforts to commercialize XERMELO
in the Licensed Territory pursuant to a mutually approved
commercialization plan. Subject to certain exceptions, Lexicon was
responsible for conducting clinical trials required to obtain
regulatory approval for XERMELO for carcinoid syndrome in the
European Union, including those contemplated by a mutually approved
initial development plan, and has the first right to conduct most
other clinical trials of XERMELO. Lexicon was 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 based on the nature of such clinical
trials. Under the Ipsen Agreement, Ipsen has paid Lexicon an
aggregate of $47.2 million through June 30, 2020, consisting
of $24.5 million in upfront payments and a $6.4 million milestone
payment upon the acceptance of the filing submitted by Ipsen to the
European Medicines Agency for XERMELO as an adjunct to somatostatin
analog therapy for the long-term treatment of carcinoid syndrome, a
$5.1 million milestone upon Ipsen’s receipt of approval from the
European Commission for the marketing of XERMELO in all member
states of the European Union, Norway and Iceland, a $3.8 million
milestone upon Ipsen’s first commercial sale in Germany, a $3.8
million milestone upon Ipsen’s first commercial sale in the United
Kingdom, a $1.3 million milestone upon Ipsen’s receipt of approval
from Health Canada and a $2.3 million milestone upon Ipsen’s first
commercial sale in Canada. In addition, Lexicon is eligible to
receive from Ipsen (a) up to an aggregate of approximately
$9.6 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. Milestone payments that are contingent upon the
achievement of a substantive milestone are deemed constrained.
Lexicon is also entitled to tiered, escalating royalties ranging
from low twenties to mid-thirties percentages of net sales of
XERMELO 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 XERMELO. Lexicon and Ipsen have entered into a
commercial supply agreement pursuant to which Lexicon will supply
Ipsen’s commercial requirements of XERMELO, and Ipsen pays an
agreed upon transfer price for such commercial supply.
The Company considered the following as its performance obligations
with respect to the revenue recognition of the $24.5 million
upfront payments:
•The
exclusive license granted to Ipsen to develop and commercialize
XERMELO in the Licensed Territory;
•The
development services Lexicon is performing for
XERMELO;
•The
obligation to participate in committees which govern the
development of XERMELO until commercialization; and
•The
obligation to supply commercial supply of XERMELO, 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 XERMELO or to sublicense its rights. In
addition, at the time of the agreement, it would have been possible
for Ipsen or another third party to 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 performance obligations. The Company recognized the
portion of the transaction price allocated to the license
immediately because Lexicon delivered the license and earned the
revenue at the inception of the arrangement. The Company recognized
as revenue the amount allocated to the development services and the
obligation to participate in committees over the period of time
Lexicon performed the services, which was completed in
2018.
The Company determined that the commercial supply agreement is a
contingent deliverable at the onset of the Agreement. There was
inherent uncertainty in obtaining regulatory approval at the time
of the agreement, thus, making the applicability of the commercial
supply agreement outside the control of Lexicon and Ipsen. As a
result, the Company has determined the commercial supply agreement
does not meet the definition of a performance obligation 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 transaction price 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 transaction
price. The Company allocated the transaction price based on the
relative best estimate of selling price of each performance
obligation. 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 recognized the
$1.7 million allocated to the development services performance
obligation over the period of performance as development occurred,
and recognized the $0.1 million allocated to the committee
participation performance obligation ratably over the period of
performance. Milestone payments that are contingent upon the
achievement of a substantive milestone are deemed constrained. If
or when the constraint is determined to be resolved, the Company
will re-evaluate the overall transaction price and recognize an
adjustment on a cumulative catch-up basis in the period that the
adjustment was evaluated. Revenue recognized under the Agreement
was $0.2 million and $3.1 million for the six months ended
June 30, 2020 and 2019, respectively. Royalty revenue of $0.2
million and $0.1 million was recognized for the six months ended
June 30, 2020 and 2019, respectively.
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 a Termination and Settlement Agreement and Mutual
Releases (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,
$26 million in March 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 is obligated to pay $26
million within twelve months of the Settlement Date, and neither
party will owe 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. In March 2020,
Lexicon announced its plan to close out the clinical studies
related to the Phase 3
development program for sotagliflozin in type 2 diabetes, heart
failure and chronic kidney disease. Revenue relating to the
Termination Agreement was recognized in the third quarter of 2019.
Revenue recognized under collaboration agreements with Sanofi was
$0.3 million for the six months ended June 30,
2019.
8. Impairment
Loss on Buildings
In July 2020, Lexicon's wholly owned subsidiary entered into a real
estate purchase and sale agreement under which Lexicon agreed to
sell its facilities in The Woodlands, Texas for a purchase price of
$11.5 million. The sale agreement is subject to normal and
customary closing conditions, including a study period, which
extends until August 24, 2020, during which the purchaser may
conduct inspections, analyses and other studies of the property and
may terminate the agreement in its discretion. Such sale is also
subject to the negotiation and execution by the parties of a
leaseback agreement for a period of up to nine months with respect
to a portion of the property concurrently with
closing.
As of June 30, 2020, the assets are classified as held and
used. The Company determined the net carrying value of the
buildings and related assets exceeds the estimated purchase price,
which is deemed the current fair value, by $1.6 million. As a
result, the Company recorded an impairment loss on the buildings in
the accompanying condensed consolidated statement of comprehensive
loss for the six months ended June 30, 2020.
Item 2. Management’s Discussion and Analysis of
Financial Condition and Results of Operations
Overview
We are a biopharmaceutical company with a mission of pioneering
medicines that transform patients’ lives. We are devoting most of
our resources to the commercialization or development of our three
most advanced drugs and drug candidates:
•We
are commercializing XERMELO®
(telotristat ethyl), an orally-delivered small molecule drug, in
the United States for the treatment of carcinoid syndrome diarrhea
in combination with somatostatin analog, or SSA, therapy in adults
inadequately controlled by SSA therapy. We have granted Ipsen
Pharma SAS, or Ipsen, an exclusive, royalty-bearing right to
commercialize XERMELO outside of the United States and Japan. Ipsen
is commercializing XERMELO in the United Kingdom, Germany and
multiple additional countries. We are also developing telotristat
ethyl as a treatment for biliary tract cancer and are conducting a
Phase 2a clinical trial of telotristat ethyl in biliary tract
cancer patients.
•We
are developing Zynquista™ (sotagliflozin), an orally-delivered
small molecule drug candidate, as a treatment for type 1
diabetes. The FDA has issued a complete response letter regarding
our application for regulatory approval to market sotagliflozin for
type 1 diabetes in the United States and has confirmed that
position in denying two appeals of the complete response letter.
Zynquista has been 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.
We were previously conducting a comprehensive Phase 3 development
program for sotagliflozin in type 2 diabetes, heart failure and
chronic kidney disease and are currently closing out the clinical
trials included in such development program.
•We
are developing LX9211, an orally-delivered small molecule drug
candidate, as a treatment for neuropathic pain. We have reported
top-line results from two Phase 1 clinical trials of LX9211 and are
preparing to initiate a Phase 2 clinical trial of
LX9211.
Compounds from our most advanced drug programs, as well as
compounds from a number of additional drug discovery and
development programs that we have advanced into various stages of
clinical and preclinical development, originated from our own
internal drug discovery efforts. These 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 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 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.
We commercially launched XERMELO following regulatory approval in
the United States in February 2017 for the treatment of carcinoid
syndrome diarrhea in combination with SSA therapy in adults
inadequately controlled by SSA therapy. Prior to the launch of
XERMELO, we derived substantially all of our revenues from
strategic collaborations and other research and development
collaborations and technology licenses. 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
and the amount of revenues generated from such commercialization
efforts; Ipsen's ability to successfully commercialize XERMELO
outside of the United States and Japan and our receipt of any
milestone payments and royalties; the success of our ongoing
nonclinical and clinical development efforts and ability to obtain
necessary regulatory approvals of the drug candidates which are the
subject of such efforts; our ability to effectively close out the
Phase 3 development program for sotagliflozin in type 2 diabetes,
heart failure and chronic
kidney disease in a timely manner; our success in establishing new
collaborations and licenses; and general and industry-specific
economic conditions which may affect research and development
expenditures.
Future revenues from our commercialization of XERMELO are uncertain
because they depend on a number of factors, including market
acceptance of XERMELO, the success of our sales, marketing,
distribution and other commercialization activities and the cost
and availability of reimbursement for XERMELO.
Future revenues from our collaboration with Ipsen are uncertain
because they depend, to a large degree, on the achievement of
milestones and payment of royalties we earn from Ipsen’s
commercialization of XERMELO. 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
June 30, 2020, we had an accumulated deficit of
$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 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, 2019.
Recent Accounting Pronouncements
There are no recent accounting pronouncements that have a material
impact to our condensed consolidated financial
statements.
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):
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|
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Three Months Ended June 30, |
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|
Six Months Ended June 30, |
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|
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Total revenues |
|
$ |
9.2 |
|
|
$ |
9.7 |
|
|
$ |
17.2 |
|
|
$ |
18.9 |
|
Dollar decrease |
|
$ |
(0.5) |
|
|
|
|
$ |
(1.7) |
|
|
|
Percentage decrease |
|
(5) |
% |
|
|
|
(9) |
% |
|
|
•Net
product revenue
– Net product revenue for the three months ended June 30, 2020
increased 21% to $9.0 million, and for the six months ended
June 30, 2020 increased 19% to $16.9 million as compared to
the corresponding periods in 2019 from revenues recognized from the
sale of XERMELO in the United States. Revenue from sales of bulk
tablets of XERMELO to Ipsen were $1.3 million for the three and six
months ended June 30, 2019. Product revenues are 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
agreements
– Revenue from collaborative agreements for the three and six
months ended June 30, 2019 was $0.9 million and $3.3 million,
primarily due to revenues recognized from clinical trial activities
and a milestone for the first commercial sale in Canada under the
collaboration and license agreement with Ipsen.
Cost of Sales
Total cost of sales and dollar and percentage changes as compared
to the corresponding periods in the prior year are as follows
(dollar amounts are presented in millions):
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Three Months Ended June 30, |
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|
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Six Months Ended June 30, |
|
|
|
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2020 |
|
2019 |
|
2020 |
|
2019 |
Total cost of sales |
|
$ |
0.7 |
|
|
$ |
1.3 |
|
|
$ |
1.3 |
|
|
$ |
1.9 |
|
Dollar decrease |
|
$ |
(0.6) |
|
|
|
|
$ |
(0.6) |
|
|
|
Percentage decrease |
|
(45) |
% |
|
|
|
(31) |
% |
|
|
Cost of sales consists of third-party manufacturing costs, freight
and indirect overhead costs associated with sales of XERMELO. Cost
of sales for the three and six months ended June 30, 2019
included costs related to the bulk tablet sales to Ipsen. The
pre-commercialization inventory is expected to be sold over
approximately the next nine months. As a result, cost of sales for
the next nine months will reflect a lower average per unit cost of
materials. Cost of sales for each of the three and six months ended
June 30, 2020 and 2019 includes $0.4 million and $0.9 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):
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Three Months Ended June 30, |
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|
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Six Months Ended June 30, |
|
|
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Total research and development expense |
|
$ |
57.3 |
|
|
$ |
12.6 |
|
|
$ |
112.5 |
|
|
$ |
24.7 |
|
Dollar increase |
|
$ |
44.7 |
|
|
|
|
$ |
87.8 |
|
|
|
Percentage increase |
|
353 |
% |
|
|
|
356 |
% |
|
|
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
June 30, 2020 increased to $48.9 million from $3.2 million,
and for the six months ended June 30, 2020 increased to $94.2
million from $5.6 million as compared to the corresponding periods
in 2019 primarily due to increases in external clinical development
costs relating to sotagliflozin subsequent to the termination of
our collaboration with Sanofi. 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 June 30, 2020
decreased 16% to $4.5 million, and for the six months ended
June 30, 2020 decreased 11% to $10.0 million as compared to
the corresponding periods in 2019, primarily due to lower
headcount. Salaries, bonuses, employee benefits, payroll taxes,
recruiting and relocation costs are included in personnel
costs.
•Stock-based
compensation
– Stock-based compensation expense for each of the three months
ended June 30, 2020 and 2019 was $1.9 million, and for the six
months ended June 30, 2020 increased 12% to $4.1 million as
compared to the corresponding period in 2019, primarily due to
shorter vesting periods of the annual restricted stock unit awards
granted in recent years.
•Facilities
and equipment –
Facilities and equipment costs for each of the three months ended
June 30, 2020 and 2019 was $0.6 million, and for each of the
six months ended June 30, 2020 and 2019 was $1.3
million.
•Other
–
Other costs for the three months ended June 30, 2020 decreased
12% to $1.3 million as compared to the corresponding period in
2019, primarily due to decreases in travel and continuing medical
education grants, and for each of the six months ended
June 30, 2020 and 2019 was $2.8 million.
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):
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Three Months Ended June 30, |
|
|
|
Six Months Ended June 30, |
|
|
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
Total selling, general and administrative expense |
|
$ |
14.1 |
|
|
$ |
14.3 |
|
|
$ |
28.8 |
|
|
$ |
28.4 |
|
Dollar increase (decrease) |
|
$ |
(0.2) |
|
|
|
|
$ |
0.4 |
|
|
|
Percentage increase (decrease) |
|
(1) |
% |
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|
2 |
% |
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|
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 and six months ended June 30,
2020 decreased 4% to $6.8 million and $14.3 million, respectively,
as compared to the corresponding periods in 2019, primarily due to
lower headcount. 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
June 30, 2020 increased 11% to $3.2 million, and for the six
months ended June 30, 2020 increased 10% to $6.1 million as
compared to the corresponding periods in 2019, primarily due to
higher legal fees.
•Stock-based
compensation
– Stock-based compensation expense for the three months ended
June 30, 2020 increased 24% to $2.3 million, and for the six
months ended June 30, 2020 increased 30% to $4.6 million as
compared to the corresponding periods in 2019, primarily due to
shorter vesting periods of the annual restricted stock unit awards
granted in recent years.
•Facilities
and equipment
– Facilities and equipment costs for each of the three months ended
June 30, 2020 and 2019 were $0.5 million and for each of the
six months ended June 30, 2020 and 2019 were $0.9
million.
•Other
–
Other costs for the three months ended June 30, 2020 decreased
32% to $1.3 million, and for the six months ended June 30,
2020 decreased 17% to $3.0 million as compared to the corresponding
periods in 2019, primarily due to decreases in travel expenses due
to the COVID-19 pandemic.
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.
Interest Expense and Interest and Other Income, Net
Interest Expense. Interest
expense for each of the three months ended June 30, 2020 and
2019 was $5.1 million, and for each of the six months ended
June 30, 2020 and 2019 was $10.3 million.
Interest and Other Income, Net.
Interest and other income, net for the three months ended
June 30, 2020 and 2019 was $0.6 million and $0.7 million,
respectively, and for the six months ended June 30, 2020 and
2019 was $1.6 million and $1.5 million, respectively.
Net loss and Net loss per Common Share
Net loss and Net loss per Common Share.
Net loss increased to $69.1 million in the three months ended
June 30, 2020 from $23.0 million in the corresponding period
in 2019. Net loss per common share increased to $0.65 in the three
months ended June 30, 2020 from $0.22 in the corresponding
period in 2019. Net loss increased to $135.7 million in the six
months ended June 30, 2020 from $44.8 million in the
corresponding period in 2019. Net loss per common share increased
to $1.27 in the six months ended June 30, 2020 from $0.42 in
the corresponding period in 2019.
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 we received under our strategic and other collaborations,
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 financing
arrangements with Symphony Icon Holdings LLC.
As of June 30, 2020, we had $201.9 million in cash, cash
equivalents and short-term investments. As of December 31,
2019, we had $271.7 million in cash, cash equivalents and
short-term investments. We used cash of $68.4 million from
operations in the six months ended June 30, 2020. The net loss
for the period of $135.7 million was partially offset by a net
decrease in operating assets net of liabilities of $54.5 million,
non-cash charges of $8.7 million related to stock-based
compensation expense, $2.5 million related to depreciation and
amortization expense, including amortization of debt issuance
costs, and $1.6 million related to the impairment loss. Investing
activities provided cash of $120.9 million in the
six months ended June 30, 2020, primarily due to net
maturities of investments of $120.9 million. Financing
activities used cash of $1.7 million, primarily to repurchase $1.0
million of common stock and to repay $0.6 million of debt
borrowings.
Other commitments.
In April 2019, Zynquista 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 certain European
regulatory pricing approvals, we will be required to make certain
royalty payments, totaling $4.5 million, in three equal annual
installments of $1.5 million.
Facilities.
In August 2018, our subsidiary, Lex-Gen Woodlands, L.P., entered
into a term loan and security agreement, refinancing the previously
existing mortgage on our facilities in The Woodlands, Texas. The
loan agreement provides for a $12.9 million mortgage on the
property and has a two-year term with a 10-year amortization. The
mortgage loan bears interest at a rate per annum equal to the
greater of (a) the 30-day LIBOR rate plus 5.5% and (b) 7.5% and
provides for a balloon payment of $10.3 million due in August
2020.
In July 2020, Lex-Gen Woodlands, L.P. entered into a real estate
purchase and sale agreement under which we agreed to sell our
facilities in The Woodlands, Texas for a purchase price of $11.5
million. Such sale is subject to normal and customary closing
conditions, including a study period, which extends until August
24, 2020, during which the purchaser may conduct inspections,
analyses and other studies of the property and may terminate the
agreement in its discretion. Such sale is also subject to the
negotiation and execution by the parties of a leaseback agreement
for a period of nine months with respect to a portion of the
property concurrently with closing.
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 our ability to successfully
commercialize XERMELO in the United States and the amount of
revenues generated from such commercialization efforts; Ipsen’s
ability to successfully commercialize XERMELO outside of the United
States and Japan and our receipt of any milestone payments and
royalties; our ability to effectively close out the Phase 3
development program for sotagliflozin in type 2 diabetes, heart
failure and chronic kidney disease in a timely manner; the success
of our ongoing nonclinical and clinical development efforts and
ability to obtain necessary regulatory approvals of the drug
candidates which are the subject of such efforts; our success in
establishing new collaborations and licenses; 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 continue commercializing
XERMELO in the United States; to successfully complete our
nonclinical and clinical development efforts with respect to
telotristat ethyl, 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 XERMELO product sales 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 convertible notes, or make a cash
payment to holders of our convertible notes to induce conversion
pursuant to the terms of the 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 $201.9 million in cash and cash
equivalents and short-term investments as of June 30, 2020. We
believe that the working capital available to us will be sufficient
to meet our cash requirements for at least the next 12 months.
We are not subject to interest rate sensitivity on our outstanding
Convertible Notes and our BioPharma Term Loan as each generally
have a fixed rate of 5.25% and 9% per annum, respectively. 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. The BioPharma Term Loan
bears interest payable quarterly in arrears, and provides for
interest-only payments followed by payment of principal at maturity
in December 2022.
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
See “Disclosure about Market Risk” under “Item 2. Management’s
Discussion and Analysis of
Financial Condition and Results of Operations” for quantitative and
qualitative disclosures about market risk.
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. There were no changes in our
internal control over financial reporting during the three months
ended June 30, 2020 that have materially affected, or are
reasonably likely to materially affect, our internal control over
financial reporting.
Part II -- Other Information
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. A first amended
complaint was filed on July 30, 2019 and we filed a motion to
dismiss such first amended complaint on September 30, 2019. The
plaintiff filed an opposition to our motion to dismiss on November
14, 2019 and we filed a reply in support of our motion to dismiss
on December 13, 2019. The lawsuit purports 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 alleges
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
purports 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 seeks, on behalf of the
purported class, an unspecified amount of monetary damages,
interest, fees and expenses of attorneys and experts, and other
relief.
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. 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 Business and Industry
•We
face business disruption and related risks resulting from the
outbreak of the novel coronavirus 2019 (COVID-19), including
significant restrictions in the ability of our field commercial and
medical teams to interact with third parties, delays in the
enrollment of ongoing clinical trials and the initiation of planned
clinical trials and other operational impacts, each of which could
have a material adverse effect on our business.
•We
depend heavily on the commercial success of XERMELO. If we do not
achieve commercial success with XERMELO, our business will suffer
and our stock price will likely decline.
•We
depend heavily on our ability to obtain regulatory approval in the
United States for sotagliflozin in type 1 diabetes. If we fail to
obtain such regulatory approval or fail to successfully
commercialize sotagliflozin for type 1 diabetes in the United
States upon regulatory approval, our business will suffer and our
stock price will likely decline.
•We
depend heavily on our ability to effectively close out the clinical
trials included in the Phase 3 clinical development program for
sotagliflozin in type 2 diabetes, heart failure and chronic kidney
disease in a timely manner. If we fail to effectively close out
such program on the anticipated timelines, our cash position 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.
•The
commercial success of any products that we or our collaborators may
develop will depend upon the degree of market acceptance among
physicians, patients, health care payers and the medical
community.
•If
we are unable to maintain an effective and specialized sales force,
marketing infrastructure and distribution capabilities, we will not
be able to successfully commercialize any products that we or our
collaborators may develop.
•If
we are unable to obtain adequate coverage and reimbursement from
third-party payers for any 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 any 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.
•Pricing
for pharmaceutical products has come under increasing scrutiny by
governments, legislative bodies and enforcement agencies. These
activities may result in actions that have the effect of reducing
our revenue or harming our business or reputation.
•Our
competitors may develop products that impair the value of any
products that we or our collaborators may develop.
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
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.
•If
we do not effectively manage our affirmative and restrictive
covenants under the BioPharma Term Loan, our financial condition
and results of operations could be adversely affected.
Risks Related to Our Relationships with Third Parties
•We
are significantly dependent upon our collaborations with Ipsen and
other pharmaceutical and biotechnology companies. If pharmaceutical
products are not successfully and timely developed and
commercialized under our collaborations, our opportunities to
generate revenues from milestones and royalties will be greatly
reduced.
•Conflicts
with our collaborators could jeopardize the success of our
collaborative agreements and harm our product development
efforts.
•We
depend on third-party manufacturers, including sole source
suppliers, 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 a limited
distribution network of specialty pharmacies and specialty
distributors for distribution of XERMELO in fulfillment of
prescriptions in the United States, and their failure to distribute
XERMELO effectively would adversely affect sales of
XERMELO.
•We
rely on third parties to carry out drug development
activities.
•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 product 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.
•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.
•Data
breaches and cyber-attacks could compromise our intellectual
property or other sensitive information and cause significant
damage to our business and reputation.
•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 Employees 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.
•Facility
security breaches may disrupt our operations, subject us to
liability 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
materials in our business. Any claims relating to improper
handling, storage or disposal of these materials 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 their affiliates own a controlling interest in
our outstanding common stock and may have interests which conflict
with those of our other stockholders.
•Invus
has additional rights under our stockholders’ agreement with Invus,
L.P. relating to the membership of our board of directors, which
provides Invus with substantial influence over significant
corporate matters.
•Our
stock price may be extremely volatile.
•We
are subject to securities litigation, which is expensive and could
divert management attention.
•Future
sales of our common stock, or the perception that such sales may
occur, may depress our stock price.
•Conversion
of our 5.25% Convertible Senior Notes due 2021 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.
•If
securities or industry analysts do not publish research or publish
inaccurate or unfavorable research about our business, our stock
price and trading volume could decline.
•We
may engage in future acquisitions, which may be expensive and time
consuming and from which we may not realize anticipated
benefits.
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,
2019 as filed with the Securities and Exchange
Commission.
Item 2. Unregistered Sales of Equity Securities and Use of
Proceeds
The following table provides information about our purchases of
shares of our common stock during the three months ended June 30,
2020:
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Period |
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Total Number of Shares Purchased |
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Average Price Paid Per Share |
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Total Number of Shares Purchased as Part of Publicly Announced
Plans or Programs |
|
Maximum Number of Shares that May Yet be Purchased Under the Plans
or Programs
(3)
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April 1-30, 2020 |
|
52,318 |
(1)
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$ |
1.96 |
|
(2)
|
— |
|
— |
May 1-31, 2020 |
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— |
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$ |
— |
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|
— |
|
— |
June 1-30, 2020 |
|
— |
|
$ |
— |
|
|
— |
|
— |
(1) Represents shares retained by us in satisfaction of the
tax withholding obligations of recipients of restricted stock units
granted in December 2019 under our 2017 Equity Incentive Plan with
respect to the vesting of such restricted stock units.
(2) Represents the market price of our common stock on the
date of vesting of such restricted stock units, calculated in
accordance with the process for determination of fair market value
under our 2017 Equity Incentive Plan.
(3) In the future, we may grant additional equity securities
under our 2017 Equity Incentive Plan for which the recipient's tax
withholding obligations with respect to the grant or vesting of
such securities may be satisfied by our retention of a portion of
such securities. Further, for any such equity securities which are
subject to vesting conditions, the number of equity securities
which we may retain in satisfaction of the recipient's tax
withholding obligations may be dependent on the continued
employment of such recipient or other performance-based conditions.
Accordingly, we cannot predict with any certainty either the total
amount of equity securities or the approximate dollar value of such
securities that we may purchase in future years.
Item 6. Exhibits
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Exhibit No. |
|
Description |
10.1 |
— |
Real Estate Purchase and Sale Agreement,
dated July 10, 2020, between Lex-Gen Woodlands, L.P. and C Cubed
Holdings, LLC (filed as Exhibit 10.1 to the Company’s Current
Report on Form 8-K dated July 10, 2020 and incorporated by
reference herein).
|
*31.1
|
— |
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*31.2
|
— |
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*32.1
|
— |
|
101.INS
|
— |
XBRL Instance Document |
101.SCH
|
— |
XBRL Taxonomy Extension Schema Document |
101.CAL
|
— |
XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF
|
— |
XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB
|
— |
XBRL Taxonomy Extension Label Linkbase Document |
101.PRE
|
— |
XBRL Taxonomy Extension Presentation Linkbase Document |
_____________________
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.
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Lexicon Pharmaceuticals, Inc. |
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Date: |
July 29, 2020 |
By: |
/s/ Lonnel Coats |
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Lonnel Coats |
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President and Chief Executive Officer |
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Date: |
July 29, 2020 |
By: |
/s/ Jeffrey L. Wade |
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Jeffrey L. Wade |
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Executive Vice President, Corporate and Administrative Affairs and
Chief Financial Officer |
Index to Exhibits
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Exhibit No. |
|
Description |
10.1 |
— |
Real Estate Purchase and Sale Agreement,
dated July 10, 2020, between Lex-Gen Woodlands, L.P. and C Cubed
Holdings, LLC (filed as Exhibit 10.1 to the Company’s Current
Report on Form 8-K dated July 10, 2020 and incorporated by
reference herein).
|
*31.1
|
— |
|
*31.2
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— |
|
*32.1
|
— |
|
101.INS
|
— |
XBRL Instance Document |
101.SCH
|
— |
XBRL Taxonomy Extension Schema Document |
101.CAL
|
— |
XBRL Taxonomy Extension Calculation Linkbase Document |
101.DEF
|
— |
XBRL Taxonomy Extension Definition Linkbase Document |
101.LAB
|
— |
XBRL Taxonomy Extension Label Linkbase Document |
101.PRE
|
— |
XBRL Taxonomy Extension Presentation Linkbase Document |
_____________________
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