Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today reported
financial results and provided a business update for the three
months ended June 30, 2019.
“We are pleased that recent preliminary results
of three Phase 3 clinical trials support the potential benefits
Zynquista may bring to people with type 2 diabetes and particularly
those with chronic kidney disease,” said Lonnel Coats, Lexicon’s
president and chief executive officer. “We are disappointed in
Sanofi’s announcement of its purported termination of our alliance
but are encouraged by the results that we have received thus far.
We expect the balance of the core Phase 3 studies will be completed
this year. As for our XERMELO business, we saw 24% growth in
XERMELO net sales in the U.S. in the second quarter of 2019 versus
the same period in 2018 and continue to make good progress on that
front while effectively managing our resources and spend.”
Second Quarter Product and Pipeline
Highlights
XERMELO® (telotristat
ethyl)
- XERMELO U.S. net sales were $7.4 million in the second quarter
of 2019.
- The Telotristat Ethyl for
Advanced Biliary Tract
Cancer, or TELE-ABC, study, a Phase 2a clinical
study of telotristat ethyl in patients with biliary tract cancer,
continues to enroll patients.
Zynquista™ (sotagliflozin)
- In April, the European Commission granted marketing
authorization for Zynquista in both a 200-mg and 400-mg dose for
use as an adjunct to insulin therapy to improve blood sugar
(glycemic) control in adults with type 1 diabetes (T1D) mellitus
with a body mass index (BMI) ≥ 27 kg/m2, who have failed to achieve
adequate glycemic control despite optimal insulin therapy.
Second Quarter 2019 Financial
Highlights
Revenues: Revenues for the
three months ended June 30, 2019 decreased to $9.7 million from
$13.8 million for the corresponding period in 2018, primarily due
to lower revenues recognized from our collaboration and license
agreement with Sanofi, partially offset by an increase in net
product revenues. Net product revenues for the three months ended
June 30, 2019 included $7.4 million from net sales of XERMELO in
the U.S. and $1.3 million from the sales of bulk XERMELO tablets to
Ipsen, cumulatively up 19% from the prior year quarter.
Cost of Sales: Cost of sales
related to sales of XERMELO for the three months ended June 30,
2019 and 2018 was $1.3 million and $0.8 million, respectively.
Research and Development (R&D)
Expenses: Research and development expenses for the three
months ended June 30, 2019 decreased to $12.6 million from $26.5
million for the corresponding period in 2018, primarily due to
lower external clinical development costs relating to
Zynquista.
Selling, General and Administrative
(SG&A) Expenses: Selling, general and administrative
expenses for the three months ended June 30, 2019 decreased to
$14.3 million from $16.8 million for the corresponding period in
2018, primarily due to decreased marketing costs.
Net Loss: Net loss for the
three months ended June 30, 2019 was $23.0 million, or $0.22 per
share, compared to a net loss of $34.5 million, or $0.33 per share,
in the corresponding period in 2018. For the three months ended
June 30, 2019 and 2018, net loss included non-cash, stock-based
compensation expense of $3.8 million and $2.9 million,
respectively.
Cash and Investments: As of
June 30, 2019, Lexicon had $106.0 million in cash and investments,
as compared to $160.1 million as of December 31, 2018.
Anticipated Near-Term
Milestones
- September 2019 – Presentation of new analyses from pivotal
studies of Zynquista in type 1 diabetes at the 55th Annual Meeting
of the European Association for the Study of Diabetes (EASD)
- 2H 2019 – Topline Phase 1b data for LX9211
- 2H 2019 – Topline results from core Phase 3 studies for
Zynquista in type 2 diabetes
- 2H 2019 – Completion of patient enrollment of the initial
safety cohort in the Phase 2 study of telotristat ethyl in biliary
tract cancer
Conference Call and Webcast
Information
Lexicon management will hold a live conference
call and webcast today at 8:00 am EDT / 7:00 am CDT 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 5789855. 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 XERMELO (telotristat
ethyl)
Discovered using Lexicon’s unique approach to
gene science, XERMELO (telotristat ethyl) is the first and only
approved oral therapy for carcinoid syndrome diarrhea in
combination with somatostatin analog (SSA) therapy in adults
inadequately controlled by SSAs. XERMELO targets tryptophan
hydroxylase, an enzyme that mediates the excess serotonin
production within metastatic neuroendocrine tumor (mNET) cells.
XERMELO is approved in the United States, the European Union and
certain additional countries for the treatment of carcinoid
syndrome diarrhea in combination with SSA therapy in adults
inadequately controlled by SSA therapy. Carcinoid syndrome is a
rare condition that occurs in patients living with metastatic NETs
(mNETs) and is characterized by frequent and debilitating diarrhea.
XERMELO targets the overproduction of serotonin inside mNET cells,
providing an additional treatment option for patients suffering
from carcinoid syndrome diarrhea.
Lexicon has granted Ipsen an exclusive
royalty-bearing right and license to commercialize XERMELO outside
of the United States and Japan. We are commercializing XERMELO in
the United States and Ipsen is commercializing XERMELO in multiple
countries, including the United Kingdom and Germany.
XERMELO
(telotristat ethyl) Important Safety
Information
- Warnings and Precautions: XERMELO may cause
constipation, which can be serious. Monitor for signs and symptoms
of constipation and/or severe, persistent, or worsening abdominal
pain in patients taking XERMELO. Discontinue XERMELO if severe
constipation or severe, persistent, or worsening abdominal pain
develops.
- Adverse Reactions: The most common adverse
reactions (≥5%) include nausea, headache, increased
gamma-glutamyl-transferase, depression, flatulence, decreased
appetite, peripheral edema, and pyrexia.
- Drug Interactions: If necessary, consider
increasing the dose of concomitant CYP3A4 substrates, as XERMELO
may decrease their systemic exposure. If combination treatment with
XERMELO and short-acting octreotide is needed, administer
short-acting octreotide at least 30 minutes after administering
XERMELO.
For more information about XERMELO, see Full Prescribing
Information at www.xermelo.com.
About Zynquista
(sotagliflozin)
Discovered using Lexicon’s unique approach to
gene science, Zynquista is an oral dual inhibitor of two proteins
responsible for glucose regulation known as sodium-glucose
co-transporter types 1 and 2 (SGLT1 and SGLT2). SGLT1 is
responsible for glucose absorption in the gastrointestinal tract,
and SGLT2 is responsible for glucose reabsorption by the kidney.
Zynquista is approved in the European Union (EU) for use as an
adjunct to insulin therapy to improve blood sugar (glycemic)
control in adults with type 1 diabetes with a body mass index ≥ 27
kg/m2, who could not achieve adequate glycemic control despite
optimal insulin therapy. Outside of such approval, Zynquista is
investigational and has not been approved by any other regulatory
authority for type 1 or type 2 diabetes.
Lexicon has granted Sanofi an exclusive
worldwide (excluding Japan) license to develop, manufacture and
commercialize Zynquista. Lexicon remains responsible for all
clinical development activities relating to type 1 diabetes and
Sanofi is responsible for all clinical development activities of
Zynquista for the treatment of type 2 diabetes. Sanofi has
delivered to Lexicon a notice purporting to terminate the alliance.
Lexicon has notified Sanofi that it considers the notice invalid
and Sanofi to be in breach of contract.
About Lexicon
Pharmaceuticals
Lexicon is a fully integrated 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. In addition to its first commercial product,
XERMELO, Lexicon has a pipeline of promising drug candidates in
clinical and preclinical development in diabetes and metabolism,
oncology and neuropathic pain. For additional information, please
visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking
statements,” including statements relating to Lexicon’s long-term
outlook on its business, including the status of its alliance with
Sanofi, the commercialization of XERMELO (telotristat ethyl) and
Zynquista (sotagliflozin), and the clinical development of, the
regulatory filings for, and the potential therapeutic and
commercial potential of telotristat ethyl, sotagliflozin, LX2761
and LX9211. In addition, this press release also contains forward
looking statements relating to Lexicon’s growth and future
operating results, discovery, development and commercialization 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 commercialize
XERMELO, successfully conduct preclinical and clinical development
and obtain necessary regulatory approvals of telotristat ethyl,
sotagliflozin, LX2761, LX9211 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, 2018, 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 |
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Lexicon Pharmaceuticals, Inc. |
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Selected Financial Data |
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Consolidated
Statements of Operations Data |
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
(In thousands, except per
share data) |
|
2019 |
|
2018 |
|
2019 |
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2018 |
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(Unaudited) |
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(Unaudited) |
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|
Revenues: |
|
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|
|
|
|
|
|
|
|
Net product revenue |
|
$ |
8,672 |
|
|
$ |
7,316 |
|
|
$ |
15,412 |
|
|
$ |
12,776 |
|
|
|
Collaborative agreements |
|
|
860 |
|
|
|
6,404 |
|
|
|
3,299 |
|
|
|
26,236 |
|
|
|
Royalties and other revenue |
|
|
150 |
|
|
|
78 |
|
|
|
187 |
|
|
|
160 |
|
|
|
Total revenues |
|
|
9,682 |
|
|
|
13,798 |
|
|
|
18,898 |
|
|
|
39,172 |
|
|
|
Operating expenses: |
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|
|
|
|
|
|
|
|
|
Cost of sales (including finite-lived intangible |
|
|
|
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|
|
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asset amortization) |
|
|
1,327 |
|
|
|
838 |
|
|
|
1,880 |
|
|
|
1,371 |
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|
|
Research and development, including stock-based |
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compensation of $1,903, $1,395, $3,671 and $3,050,
respectively |
|
|
12,637 |
|
|
|
26,477 |
|
|
|
24,659 |
|
|
|
74,173 |
|
|
|
Selling, general and administrative, including
stock-based |
|
|
|
|
|
|
|
|
|
|
compensation of $1,863, $1,503, $3,506 and $2,922,
respectively |
|
|
14,263 |
|
|
|
16,755 |
|
|
|
28,373 |
|
|
|
31,612 |
|
|
|
Total operating expenses |
|
|
28,227 |
|
|
|
44,070 |
|
|
|
54,912 |
|
|
|
107,156 |
|
|
|
Loss from operations |
|
|
(18,545 |
) |
|
|
(30,272 |
) |
|
|
(36,014 |
) |
|
|
(67,984 |
) |
|
|
Interest expense |
|
|
(5,164 |
) |
|
|
(5,187 |
) |
|
|
(10,281 |
) |
|
|
(10,300 |
) |
|
|
Interest and other income,
net |
|
|
691 |
|
|
|
910 |
|
|
|
1,480 |
|
|
|
1,915 |
|
|
|
Net loss |
|
$ |
(23,018 |
) |
|
$ |
(34,549 |
) |
|
$ |
(44,815 |
) |
|
$ |
(76,369 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
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Net loss per common share, basic and diluated |
|
$ |
(0.22 |
) |
|
$ |
(0.33 |
) |
|
$ |
(0.42 |
) |
|
$ |
(0.72 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in computing net
loss per common share, basic |
|
|
|
|
|
|
|
|
|
|
and diluted |
|
|
106,272 |
|
|
|
105,848 |
|
|
|
106,164 |
|
|
|
105,758 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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As
of |
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As of |
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Consolidated Balance
Sheet Data |
|
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|
|
June 30, 2019 |
|
December 31,
2018 |
|
|
(In thousands) |
|
|
|
|
|
(Unaudited) |
|
|
|
|
Cash and
investments |
|
|
|
|
|
$ |
105,977 |
|
|
$ |
160,052 |
|
|
|
Property and equipment,
net |
|
|
|
|
|
|
15,007 |
|
|
|
15,865 |
|
|
|
Goodwill |
|
|
|
|
|
|
44,543 |
|
|
|
44,543 |
|
|
|
Other intangible
assets |
|
|
|
|
|
|
49,236 |
|
|
|
50,119 |
|
|
|
Total assets |
|
|
|
|
|
|
233,143 |
|
|
|
284,136 |
|
|
|
Deferred revenue |
|
|
|
|
|
|
26,511 |
|
|
|
27,046 |
|
|
|
Current and long-term
debt |
|
|
|
|
|
|
245,068 |
|
|
|
245,002 |
|
|
|
Accumulated
deficit |
|
|
|
|
|
|
(1,516,392 |
) |
|
|
(1,471,577 |
) |
|
|
Total stockholders'
equity (deficit) |
|
|
|
|
|
|
(64,886 |
) |
|
|
(26,405 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
For Investor Inquiries:
Kimberly Lee, D.O.Head of Investor Relations and
Corporate StrategyLexicon Pharmaceuticals(281)
863-3383klee@lexpharma.com
For Media Inquiries:
Chas SchultzExecutive Director, Corporate
Communications and Patient AdvocacyLexicon Pharmaceuticals(281)
863-3421cschultz@lexpharma.com
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