Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results for the three months and full-year ended December
31, 2020 and provided an update on key milestones.
“During 2020, we substantially strengthened our balance sheet by
eliminating 95% of our debt and returned to our roots by focusing
on the advancement of our research and development pipeline,” said
Lonnel Coats, Lexicon’s president and chief executive
officer. “We took key steps to advance our pipeline by
initiating two proof-of-concept Phase 2 studies of LX9211 in
diabetic peripheral neuropathic pain and post-herpetic
neuralgia. We efficiently closed out the sotagliflozin Phase
3 clinical program and, based on positive data from two of those
Phase 3 studies, SCORED and SOLOIST, we believe that sotagliflozin
has the potential to become an important new treatment option for
heart failure patients with type 2 diabetes. We will be working
expeditiously to file an NDA for sotagliflozin in heart failure in
the second half of this year. With minimal debt and cash
sufficient to fund our planned operations for two years, we entered
2021 in a solid financial position to execute on these
objectives.”
Fourth Quarter Highlights
LX9211
- Patient enrollment continued in
RELIEF-DPN-1, a Phase 2 clinical study of LX9211 for the treatment
of diabetic peripheral neuropathic pain. Enrollment is expected to
total approximately 300 patients at approximately 30 clinical
sites.
- Patient enrollment commenced in
RELIEF-PHN 1, a Phase 2 clinical study of LX9211 for the treatment
of post-herpetic neuralgia. Enrollment is expected to total
approximately 74 patients at approximately 30 clinical sites.
- Lexicon received Fast Track
designation from the FDA for the development of LX9211 in diabetic
peripheral neuropathic pain.
Sotagliflozin
- SOLOIST and SCORED Phase 3 studies
achieved their primary endpoints by demonstrating statistically
significant reductions in total cardiovascular deaths,
hospitalizations for heart failure and urgent heart failure visits
in patients treated with sotagliflozin as compared with
placebo.
- Data from both studies were
presented at the Late-Breaking Science Session of the American
Heart Association Scientific Sessions 2020 and simultaneously
published in two separate articles in The New England Journal of
Medicine.
Corporate Activities
- Lexicon raised $70 million in net
proceeds from common stock sales.
2021 Anticipated Milestones and
Events
- NDA filing for sotagliflozin in
heart failure.
- Active efforts to secure strategic
alliance for sotagliflozin in heart failure.
- Phase 2 study results from
RELIEF-DPN-1 for LX9211 in diabetic peripheral neuropathic
pain.
- Phase 2 study results from
RELIEF-PHN-1 for LX9211 in post-herpetic neuralgia.
- Additional publications for
sotagliflozin and LX9211.
Fourth Quarter and Full-Year 2020
Financial Highlights
Unless otherwise stated, all comparisons are for
the fourth quarter and full year of 2020 compared to the fourth
quarter and full year of 2019.
Revenues: Revenues for the
fourth quarter of 2020 decreased to $0.2 million from $8.7 million
for the corresponding period in 2019, primarily due to the
elimination of product revenues as a result of the sale of XERMELO
during the third quarter of 2020. Full-year 2020 revenues decreased
to $24.0 million from $322.1 million in 2019. Full-year 2019
revenues included collaborative revenues of $289.2 million,
primarily from the termination of the alliance with Sanofi and
recognition of the remaining amounts for performance obligations
from the initial agreement with Sanofi.
Research and Development (R&D)
Expenses: Due to a reduction in external clinical
development cost estimates primarily related to sotagliflozin,
research and development expenses for the fourth quarter of 2020
decreased to $1.0 million from $40.6 million for the corresponding
period in 2019. Full-year R&D expenses for 2020 increased to
$153.6 million from $91.9 million in 2019, primarily due to
increases in external clinical development costs related to
sotagliflozin subsequent to the termination of the alliance with
Sanofi in September 2019.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the fourth quarter of 2020 decreased to $6.4 million
from $14.6 million for the corresponding period in 2019, primarily
due to lower salaries and benefits as a result of reductions in
personnel and elimination of marketing expenses following the sale
of XERMELO in the third quarter of 2020. Full-year SG&A
expenses for 2020 decreased to $47.2 million from $56.8 million,
primarily due to lower salaries and benefits and marketing
costs.
Gain on Sale of XERMELO: A gain
of $132.6 million was recognized during 2020 from the sale of
XERMELO and related assets to TerSera Therapeutics LLC in September
2020.
Net Income (Loss): Net loss for
the fourth quarter of 2020 was $5.5 million, or $0.04 per share, as
compared to a net loss of $51.1 million, or $0.48 per share, in the
corresponding period in 2019. For the three months ended December
31, 2020 and 2019, net loss included non-cash, stock-based
compensation expense of $2.7 million and $3.5 million,
respectively. Net loss for the year ended December 31, 2020 was
$58.6 million, or $0.53 per share, as compared to a net income of
$130.1 million, or $1.16 per diluted share, in 2019. For the years
ended December 31, 2020 and 2019, net loss included non-cash,
stock-based compensation expense of $13.3 million and $14.2
million, respectively.
Cash and Investments: As of
December 31, 2020, Lexicon had $152.3 million in cash and
investments, as compared to $271.7 million as of December 31,
2019.
Conference Call and Webcast
Information
Lexicon management will hold a live conference
call and webcast today at 5:00 pm ET / 4:00 pm CT to review its
financial and operating results and to provide a general business
update. The dial-in number for the conference call is 888-645-5785
(U.S./Canada) or 970-300-1531 (international). The conference ID
for all callers is 3793713. The live webcast and replay may be
accessed by visiting Lexicon’s website at
www.lexpharma.com/investors. An archived version of the webcast
will be available on the website for 14 days.
About Lexicon
Pharmaceuticals
Lexicon is a biopharmaceutical company with a
mission of pioneering medicines that transform patients’ lives.
Through its Genome5000™ program, Lexicon scientists studied the
role and function of nearly 5,000 genes and identified more than
100 protein targets with significant therapeutic potential in a
range of diseases. Through the precise targeting of these proteins,
Lexicon is pioneering the discovery and development of innovative
medicines to safely and effectively treat disease. Lexicon advanced
one of these medicines to market and has a pipeline of promising
drug candidates in discovery and clinical and preclinical
development in neuropathic pain, heart failure, diabetes and
metabolism and other indications. For additional information,
please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to Lexicon’s financial
position and long-term outlook on its business, including the
clinical development of, regulatory filings for, and potential
therapeutic and commercial potential of LX9211, sotagliflozin and
its other potential drug candidates. In addition, this press
release also contains forward looking statements relating to
Lexicon’s growth and future operating results, discovery and
development of products, strategic alliances and intellectual
property, as well as other matters that are not historical facts or
information. All forward-looking statements are based on
management’s current assumptions and expectations and involve
risks, uncertainties and other important factors, specifically
including Lexicon’s ability to meet its capital requirements,
successfully conduct preclinical and clinical development and
obtain necessary regulatory approvals of LX9211, sotagliflozin and
its other potential drug candidates on its anticipated timelines,
achieve its operational objectives, obtain patent protection for
its discoveries and establish strategic alliances, as well as
additional factors relating to manufacturing, intellectual property
rights, and the therapeutic or commercial value of its drug
candidates. Any of these risks, uncertainties and other factors may
cause Lexicon’s actual results to be materially different from any
future results expressed or implied by such forward-looking
statements. Information identifying such important factors is
contained under “Risk Factors” in Lexicon’s annual report on Form
10-K for the year ended December 31, 2019, as filed with the
Securities and Exchange Commission. Lexicon undertakes no
obligation to update or revise any such forward-looking statements,
whether as a result of new information, future events or
otherwise.
Lexicon
Pharmaceuticals, Inc. |
|
Selected
Financial Data |
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statements of Operations Data |
|
Three Months Ended December 31, |
|
Year Ended December 31, |
|
|
(In
thousands, except per share data) |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
(Unaudited) |
|
|
|
(Unaudited) |
|
|
|
|
Revenues: |
|
|
|
|
|
|
|
|
|
|
Net product revenue |
|
$ |
- |
|
|
$ |
8,568 |
|
|
$ |
23,404 |
|
|
$ |
32,331 |
|
|
|
Collaborative agreements |
|
|
- |
|
|
|
22 |
|
|
|
33 |
|
|
|
289,231 |
|
|
|
Royalties and other revenue |
|
|
199 |
|
|
|
137 |
|
|
|
558 |
|
|
|
511 |
|
|
|
Total revenues |
|
|
199 |
|
|
|
8,727 |
|
|
|
23,995 |
|
|
|
322,073 |
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
Cost of sales (including finite-lived intangible |
|
|
|
|
|
|
|
|
|
|
asset amortization) |
|
|
- |
|
|
|
774 |
|
|
|
1,929 |
|
|
|
3,231 |
|
|
|
Research and development, including stock-based |
|
|
|
|
|
|
|
|
|
|
compensation of $1,223, $1,727,
$6,376 and $7,096, respectively |
|
|
992 |
|
|
|
40,606 |
|
|
|
153,621 |
|
|
|
91,924 |
|
|
|
Selling, general and administrative, including stock-based |
|
|
|
|
|
|
|
|
|
|
compensation of $1,457, $1,752,
$6,898 and $7,122, respectively |
|
|
6,432 |
|
|
|
14,564 |
|
|
|
47,230 |
|
|
|
56,835 |
|
|
|
Impairment loss on buildings |
|
|
- |
|
|
|
- |
|
|
|
1,600 |
|
|
|
- |
|
|
|
Impairment loss on intangible asset |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
28,638 |
|
|
|
Total operating expenses |
|
|
7,424 |
|
|
|
55,944 |
|
|
|
204,380 |
|
|
|
180,628 |
|
|
|
Other
operating income: |
|
|
|
|
|
|
|
|
|
|
Gain (loss) on sale of XERMELO |
|
|
(233 |
) |
|
|
- |
|
|
|
132,585 |
|
|
|
- |
|
|
|
Income
(loss) from operations |
|
|
(7,458 |
) |
|
|
(47,217 |
) |
|
|
(47,800 |
) |
|
|
141,445 |
|
|
|
Gain on debt
extinguishments, net |
|
|
1,258 |
|
|
|
- |
|
|
|
1,003 |
|
|
|
- |
|
|
|
Interest
expense |
|
|
(170 |
) |
|
|
(5,191 |
) |
|
|
(14,544 |
) |
|
|
(20,676 |
) |
|
|
Interest and
other income, net |
|
|
875 |
|
|
|
1,270 |
|
|
|
2,767 |
|
|
|
3,350 |
|
|
|
Net income
(loss) before income taxes |
|
|
(5,495 |
) |
|
|
(51,138 |
) |
|
|
(58,574 |
) |
|
|
124,119 |
|
|
|
Income tax
benefit |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
6,014 |
|
|
|
Net income
(loss) |
|
$ |
(5,495 |
) |
|
$ |
(51,138 |
) |
|
$ |
(58,574 |
) |
|
$ |
130,133 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net income
(loss) per common share, basic |
|
$ |
(0.04 |
) |
|
$ |
(0.48 |
) |
|
$ |
(0.53 |
) |
|
$ |
1.23 |
|
|
|
Net income
(loss) per common share, diluted |
|
$ |
(0.04 |
) |
|
$ |
(0.48 |
) |
|
$ |
(0.53 |
) |
|
$ |
1.16 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used
in computing net income (loss) per common share, basic |
|
|
122,359 |
|
|
|
106,272 |
|
|
|
110,841 |
|
|
|
106,218 |
|
|
|
Shares used
in computing net income (loss) per common share, diluted |
|
|
122,359 |
|
|
|
106,272 |
|
|
|
110,841 |
|
|
|
116,747 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
|
|
Consolidated Balance Sheet Data |
|
|
|
|
|
December 31, 2020 |
|
December 31, 2019 |
|
(In
thousands) |
|
|
|
|
|
(Unaudited) |
|
|
|
|
Cash and investments |
|
|
|
$ |
152,275 |
|
|
$ |
271,659 |
|
|
|
Property and equipment, net |
|
|
|
|
295 |
|
|
|
14,047 |
|
|
|
Goodwill |
|
|
|
|
44,543 |
|
|
|
44,543 |
|
|
|
Other intangible assets |
|
|
|
|
- |
|
|
|
19,716 |
|
|
|
Total assets |
|
|
|
|
203,788 |
|
|
|
417,715 |
|
|
|
Current and long-term debt |
|
|
|
|
11,646 |
|
|
|
245,183 |
|
|
|
Accumulated deficit |
|
|
|
|
(1,400,018 |
) |
|
|
(1,341,444 |
) |
|
|
Total stockholders' equity |
|
|
|
|
156,371 |
|
|
|
117,101 |
|
|
|
For Inquiries:
Chas SchultzExecutive Director, Corporate
Communications and Investor RelationsLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From Jun 2024 to Jul 2024
Lexicon Pharmaceuticals (NASDAQ:LXRX)
Historical Stock Chart
From Jul 2023 to Jul 2024