Lexicon Pharmaceuticals Reports Fourth Quarter and Full-Year 2021 Financial Results and Provides Clinical Update
February 28 2022 - 6:01AM
Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today reported
financial results for the three months and full-year ended December
31, 2021 and provided an update on key milestones.
“We remain focused on advancing sotagliflozin
for the millions of people suffering from heart failure and living
with type 2 diabetes on a daily basis. We announced today that we
voluntarily withdrew the sotagliflozin NDA to correct a technical
issue that we recently identified, and we plan to promptly resubmit
early in the second quarter of 2022,” said Lonnel Coats, Lexicon’s
chief executive officer. “In addition, we are looking forward to
completing and announcing top-line results in the coming months
from our two proof-of-concept Phase 2 studies of LX9211 in diabetic
peripheral neuropathic pain and post-herpetic neuralgia.”
Fourth Quarter Highlights
Sotagliflozin
- Lexicon submitted a New Drug
Application (NDA) to the FDA at the end of the fourth quarter of
2021 seeking approval for the marketing and sale of sotagliflozin,
to reduce the risk of cardiovascular death, hospitalization for
heart failure, and urgent visits for heart failure in adult
patients with type 2 diabetes with either worsening heart failure
or additional risk factors for heart failure irrespective of left
ventricular ejection fraction. Today, Lexicon announced its
voluntary withdrawal and planned near-term resubmission of the NDA
to correct a technical issue with the submission recently
identified by the company.
- A new analysis evaluating the
clinical benefit of sotagliflozin in heart failure and blood
glucose control across the full range of kidney function was
presented at the American Heart Association Scientific Sessions
2021. Sotagliflozin significantly reduced total cardiovascular
deaths, hospitalizations for heart failure, and urgent visits for
heart failure, as well as decreased hemoglobin A1c, across the full
range of kidney function studied, including individuals with
moderate-to-severe chronic kidney disease.
LX9211
- Patient enrollment continued in two
ongoing Phase 2 clinical studies of LX9211: RELIEF-DPN-1 for the
treatment of diabetic peripheral neuropathic pain and RELIEF-PHN-1
for the treatment of post-herpetic neuralgia. Lexicon anticipates
completing recruitment this week for RELIEF-DPN-1 and expects
top-line results for the study by the end of the second quarter of
2022. Top-line results for RELIEF-PHN-1 are expected in the third
quarter of 2022.
Fourth Quarter and Full-Year 2021
Financial Highlights
Unless otherwise stated, all comparisons are for
the fourth quarter and full year of 2021 compared to the fourth
quarter and full year of 2020.
Revenues: Revenues were
negligible for the fourth quarters of 2021 and 2020. Full-year
revenues were negligible in 2021 as compared to $24.0 million for
2020, primarily due to the absence of product revenues in 2021 as a
result of Lexicon’s sale of its XERMELO product and related assets
to TerSera Therapeutics LLC during the third quarter of 2020.
Research and Development (R&D)
Expenses: R&D expenses for the fourth quarter of 2021
increased to $16.5 million from $1.0 million for the corresponding
period in 2020. The R&D expense in the fourth quarter of 2020
reflected a reduction in external clinical development cost
estimates primarily related to sotagliflozin R&D expenses.
Full-year R&D expenses decreased to $55.0 million in 2021 from
$153.6 million in 2020, primarily due to lower sotagliflozin
clinical external research expenses, partially offset by higher
LX9211 clinical external research expenses.
Selling, General and Administrative
(SG&A) Expenses: SG&A expenses for the fourth
quarter of 2021 increased to $8.8 million from $6.4 million for the
corresponding period in 2020, primarily due to higher legal fees
during the quarter. Full-year SG&A expenses for 2021 decreased
to $32.3 million from $47.2 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 in September 2020.
Net Income (Loss): Net loss for
the fourth quarter of 2021 was $25.6 million, or $0.17 per share,
as compared to a net loss of $5.5 million, or $0.04 per share, in
the corresponding period in 2020. For the fourth quarter of 2021
and 2020, net loss included non-cash, stock-based compensation
expense of $2.2 million and $2.7 million, respectively. Net loss
for the full-year was $87.8 million, or $0.60 per share, in 2021 as
compared to a net loss of $58.6 million, or $0.53 per share, in
2020. For the full years of 2021 and 2020, net loss included
non-cash, stock-based compensation expense of $10.6 million and
$13.3 million, respectively.
Cash and Investments: As of
December 31, 2021, Lexicon had $86.7 million in cash and
investments, as compared to $152.3 million as of December 31,
2020.
Conference Call and Webcast
Information
Lexicon management will hold a live conference
call and webcast today at 8:00 am ET / 7:00 am 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 8051406. 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 heart failure, neuropathic pain, 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 sotagliflozin, LX9211 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 sotagliflozin, LX9211 and
its other potential drug candidates on its anticipated timelines,
successfully commercialize any products for which it obtains
regulatory approval, 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, 2020, 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, |
|
Years Ended December 31, |
|
(In thousands, except per share data) |
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
(Unaudited) |
|
(Unaudited) |
|
Revenues: |
|
|
|
|
|
|
|
|
|
Net product revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
- |
|
|
$ |
23,404 |
|
|
Collaborative agreements |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
33 |
|
|
Royalties and other revenue |
|
|
14 |
|
|
|
199 |
|
|
|
298 |
|
|
|
558 |
|
|
Total revenues |
|
|
14 |
|
|
|
199 |
|
|
|
298 |
|
|
|
23,995 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Cost of sales (including finite-lived intangible |
|
|
|
|
|
|
|
|
|
asset amortization) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,929 |
|
|
Research and development, including stock-based |
|
|
|
|
|
|
|
|
|
compensation of $676, $1,223, $4,284
and $6,376, respectively |
|
|
16,498 |
|
|
|
992 |
|
|
|
55,046 |
|
|
|
153,621 |
|
|
Selling, general and administrative, including stock-based |
|
|
|
|
|
|
|
|
|
compensation of $1,552, $1,457,
$6,293 and $6,898, respectively |
|
|
8,846 |
|
|
|
6,432 |
|
|
|
32,342 |
|
|
|
47,230 |
|
|
Impairment loss on buildings |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
1,600 |
|
|
Total operating expenses |
|
|
25,344 |
|
|
|
7,424 |
|
|
|
87,388 |
|
|
|
204,380 |
|
|
Other operating income: |
|
|
|
|
|
|
|
|
|
Gain (loss) on sale of XERMELO |
|
|
- |
|
|
|
(233 |
) |
|
|
- |
|
|
|
132,585 |
|
|
Loss from operations |
|
|
(25,330 |
) |
|
|
(7,458 |
) |
|
|
(87,090 |
) |
|
|
(47,800 |
) |
|
Gain on debt extinguishments, net |
|
|
- |
|
|
|
1,258 |
|
|
|
- |
|
|
|
1,003 |
|
|
Interest expense |
|
|
(295 |
) |
|
|
(170 |
) |
|
|
(802 |
) |
|
|
(14,544 |
) |
|
Interest and other income, net |
|
|
14 |
|
|
|
875 |
|
|
|
134 |
|
|
|
2,767 |
|
|
Net loss |
|
$ |
(25,611 |
) |
|
$ |
(5,495 |
) |
|
$ |
(87,758 |
) |
|
$ |
(58,574 |
) |
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per common share, basic and diluted |
|
$ |
(0.17 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.60 |
) |
|
$ |
(0.53 |
) |
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net loss per |
|
|
|
|
|
|
|
|
|
common share, basic and diluted |
|
|
148,897 |
|
|
|
122,359 |
|
|
|
145,652 |
|
|
|
110,841 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of |
|
As of |
|
Consolidated Balance Sheet Data |
|
|
|
|
|
Dec. 31, 2021 |
|
Dec. 31, 2020 |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
Cash and investments |
|
|
|
|
|
$ |
86,743 |
|
|
$ |
152,275 |
|
|
Property and equipment, net |
|
|
|
|
|
|
1,176 |
|
|
|
295 |
|
|
Goodwill |
|
|
|
|
|
|
44,543 |
|
|
|
44,543 |
|
|
Total assets |
|
|
|
|
|
|
136,909 |
|
|
|
203,788 |
|
|
Current debt |
|
|
|
|
|
|
- |
|
|
|
11,646 |
|
|
Accumulated deficit |
|
|
|
|
|
|
(1,487,776 |
) |
|
|
(1,400,018 |
) |
|
Total stockholders' equity |
|
|
|
|
|
|
113,595 |
|
|
|
156,371 |
|
|
|
|
|
|
|
|
|
|
|
|
For Inquiries:
Chas SchultzExecutive Director, Corporate
Communications and Investor RelationsLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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