THE WOODLANDS, Texas,
May 2, 2017 /PRNewswire/
-- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX), today
reported financial results for the three months ended March 31, 2017 and provided an overview of key
milestones for the company's newly-launched commercial product,
XERMELO™, and its pipeline drug candidates.
"The first quarter was a transformative one for Lexicon marked
by the approval and launch of XERMELO in the U.S. I am extremely
proud of the extraordinary men and women at Lexicon who ensured
that XERMELO was available to patients within days following
approval," said Lonnel Coats,
Lexicon's president and chief executive officer. "Eight weeks into
the launch, we continue to make significant strides in providing
access to XERMELO and communicating its benefits to patients. We
are very pleased with the speed and depth of XERMELO adoption,
which we believe is a reflection of the early positive feedback we
have received from both patients and physicians. In addition, we
continue to advance our robust pipeline of drug candidates and look
forward to reporting on multiple milestones, including new data
from our three Phase 3 sotagliflozin trials, starting this
month."
First Quarter 2017 Product and Pipeline Progress
XERMELO (telotristat ethyl) 250 mg
- On February 28th, the
U.S. Food and Drug Administration (FDA) approved XERMELO as the
first and only oral therapy for the treatment of carcinoid syndrome
diarrhea in combination with somatostatin analog (SSA) therapy in
adults inadequately controlled by SSA therapy.
- Prescriptions for XERMELO were available to patients that same
day, and the drug was available for shipment within 72 hours of
launch.
- The Company initiated its LexCares™ program within hours of
launch to ensure access and appropriately remove adherence hurdles
for patients in need of this innovative therapy.
Sotagliflozin
- In May, the Company expects to report additional efficacy data
from the U.S. Phase 3 inTandem1 study. Data will include secondary
endpoints such as body weight and blood pressure in hypertensive
type 1 diabetes mellitus (T1DM) patients.
- In Q3 2017, Lexicon anticipates additional data release from
the E.U. and Israel Phase 3 inTandem2 study in patients with T1DM.
Data will include secondary endpoints such as body weight and blood
pressure in hypertensive T1DM patients, as well as pooled
continuous glucose monitoring (CGM) results from inTandem1 and
inTandem2.
- Lexicon previously announced that primary endpoints were met in
both the inTandem1 and inTandem2 studies, demonstrating a
statistically significant reduction in A1C at 24 weeks on a
background of optimized insulin.
- The Company anticipates top-line data release in mid-2017 from
the global Phase 3 inTandem3 study evaluating approximately 1,400
T1DM patients treated with sotagliflozin 400mg once daily or
placebo on a background of any insulin therapy, but without insulin
optimization prior to randomization. The primary endpoint of the
study is the proportion of patients with A1C less than 7.0% and no
severe hypoglycemia and no diabetic ketoacidosis (DKA) events.
- Lexicon's partner, Sanofi, continues to enroll type 2 diabetes
mellitus (T2DM) patients in several Phase 3 clinical trials.
LX2761
- Phase 1 clinical trials for LX2761 remain ongoing, and the
Company anticipates the release of data this year from these
studies in healthy subjects and patients with T2DM.
LX9211
- The Company expects to file an IND for LX9211 in neuropathic
pain in mid-2017, followed by initiation of a Phase 1 clinical
trial this year.
First Quarter 2017 Financial Highlights
Revenues: Lexicon's revenues for the three months ended
March 31, 2017 increased to
$18.3 million from $12.5 million for the corresponding period in
2016, primarily due to revenues recognized from the collaboration
and license agreement with Sanofi. Revenues for the three months
ended March 31, 2017 included
$0.7 million of net revenues
recognized in March 2017 from the
sale of XERMELO in the U.S.
Cost of Sales: Lexicon had cost of sales related to sales
of XERMELO of $0.2 million for the
three months ended March 31, 2017,
including finite-lived intangible asset amortization. Lexicon began
capitalizing inventory during the three months ended March 31, 2017 following FDA approval of XERMELO,
as the related costs were expected to be recoverable through the
commercialization of the product. Manufacturing costs for XERMELO
incurred prior to FDA approval were recorded as research and
development expenses. The pre-commercialization inventory of
XERMELO is expected to be sold over approximately the next two
years. As a result, cost of sales for XERMELO for the next two
years will reflect a lower average per unit cost of materials than
would otherwise be expected. During the three months ended
March 31, 2017, intangible assets
relating to XERMELO of $24.7 million
were reclassified from indefinite-lived to finite-lived assets once
the FDA approved XERMELO, and the Company began amortizing this
asset using the straight-line method over its estimated useful
life. Cost of sales for the three months ended March 31, 2017 includes $0.1 million of amortization of this intangible
asset.
Research and Development Expenses: Research and
development expenses for the three months ended March 31, 2017 increased 18 percent to
$43.6 million from $37.0 million for the corresponding period in
2016, primarily due to increases in external clinical development
costs relating to sotagliflozin.
Increase in Fair Value of Symphony Icon Purchase
Liability: In connection with the acquisition of Symphony Icon,
Lexicon made an initial estimate of the fair value of the liability
for the associated base and contingent payments. Changes in this
liability, based on the development of the programs and the time
until such payments are expected to be made, are recorded in
Lexicon's consolidated statements of operations. For the three
months ended March 31, 2017 and 2016,
the fair value of the Symphony Icon purchase liability increased by
$2.1 million and $1.0 million, respectively. During the three
months ended March 31, 2017, Lexicon
made the final payment in cash and common stock related to the
Symphony Icon purchase liability.
Selling, General and Administrative Expenses: Selling,
general and administrative expenses for the three months ended
March 31, 2017 increased 77 percent
to $14.9 million from $8.4 million for the corresponding period in
2016, primarily due to increased costs incurred in connection with
the commercial launch of XERMELO.
Income Tax Benefit: Income tax benefit for the
three months ended March 31, 2017 was
$8.7 million. During the three
months ended March 31, 2017,
Lexicon's valuation allowance for its deferred tax assets decreased
by $8.7 million due to the
reclassification of intangible assets relating to XERMELO from
indefinite-lived to finite-lived assets. This resulted in the
related deferred tax liability now being considered a source of
taxable income. Lexicon recorded an $8.7
million deferred tax benefit with a corresponding reduction
in its deferred tax liability in the three months ended
March 31, 2017 as a result of this
reclassification.
Consolidated Net Loss: Net loss for the three months
ended March 31, 2017 was $34.9 million, or $0.33 per share, compared to a net loss of
$34.9 million, or $0.34 per share, in the corresponding period in
2016. For the three months ended March 31,
2017 and 2016, net loss included non-cash, stock-based
compensation expense of $2.2 million and $1.8
million, respectively.
Cash and Investments: As of March
31, 2017, Lexicon had $259.7
million in cash and investments, as compared to $346.5 million as of December 31, 2016. Cash used during the three
months ended March 31, 2017 included
a final $10.5 million cash payment to
Symphony Icon and significant funding in support of Lexicon's Phase
3 clinical trials of sotagliflozin in T1DM, which the Company
expects will decrease as 2017 progresses. Lexicon's use of
cash remains consistent with prior guidance, and the Company
continues to expect that its current liquidity and capital
resources, together with expected revenues, will be sufficient to
fund its operations at least through 2018.
Conference Call and Webcast Information
Lexicon management will hold a live conference call and webcast
today at 6:00 pm EDT / 5:00 pm 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 8318299. 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
Lexicon is a fully integrated biopharmaceutical company that is
applying a unique approach to gene science based on Nobel
Prize-winning technology to discover and develop precise medicines
for patients with serious, chronic conditions. Through its
Genome5000™ program, Lexicon scientists have studied the role and
function of nearly 5,000 genes over the last 20 years and have
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 XERMELO, Lexicon has a pipeline of
promising drug candidates in clinical and pre-clinical development
in diabetes and metabolism 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 commercialization of
XERMELO (telotristat ethyl) 250 mg and clinical development of
sotagliflozin, LX2761 and LX9211. 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 the degree of
market acceptance of XERMELO, the availability of coverage and
reimbursement for XERMELO, Lexicon's dependence on third parties
for manufacturing and distribution of XERMELO, Lexicon's compliance
with applicable legal and regulatory requirements and other factors
relating to the commercialization of XERMELO. Other risks include
Lexicon's ability to meet its capital requirements, successfully
conduct preclinical and clinical development and obtain necessary
regulatory approvals of sotagliflozin, LX2761, LX9211 and its other
potential drug candidates, 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, 2016, 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
March
31,
|
(In thousands,
except per share data)
|
|
2017
|
|
2016
|
|
|
(unaudited)
|
|
|
|
|
|
Revenues:
|
|
|
|
|
Net product
revenue
|
|
$
721
|
|
$
-
|
Collaborative
agreements
|
|
17,565
|
|
12,494
|
Subscription and
license fees
|
|
7
|
|
-
|
Total
revenues
|
|
18,293
|
|
12,494
|
Operating
expenses:
|
|
|
|
|
Cost of sales
(including finite-lived intangible asset amortization)
|
|
225
|
|
-
|
Research and
development, including stock-based compensation of $1,184 and $989, respectively
|
|
43,581
|
|
37,002
|
Increase in fair value
of Symphony Icon, Inc. purchase liability
|
|
2,101
|
|
965
|
Selling, general and
administrative, including stock-based compensation
of $1,047 and $846,
respectively
|
|
14,871
|
|
8,398
|
Total operating expenses
|
|
60,778
|
|
46,365
|
Loss from
operations
|
|
(42,485)
|
|
(33,871)
|
Interest
expense
|
|
(1,588)
|
|
(1,649)
|
Interest and other
income, net
|
|
530
|
|
637
|
Consolidated net loss
before taxes
|
|
(43,543)
|
|
(34,883)
|
Income tax
benefit
|
|
8,652
|
|
-
|
Consolidated net
loss
|
|
$
(34,891)
|
|
$(34,883)
|
|
|
|
|
|
Consolidated net loss
per common share, basic and diluted
|
|
$
(0.33)
|
|
$
(0.34)
|
|
|
|
|
|
Shares used in
computing consolidated net loss per common share, basic
and diluted
|
|
104,461
|
|
103,682
|
|
|
Consolidated
Balance Sheet Data
|
|
As of March
31,
|
|
As of December
31,
|
(In
thousands)
|
|
2017
|
|
2016
|
|
|
(unaudited)
|
|
|
Cash and
investments
|
|
$
259,743
|
|
$
346,504
|
Property and
equipment, net
|
|
18,995
|
|
19,390
|
Goodwill
|
|
44,543
|
|
44,543
|
Other intangible
assets
|
|
53,210
|
|
53,357
|
Total
assets
|
|
396,264
|
|
475,625
|
Deferred
revenue
|
|
97,922
|
|
112,306
|
Current and long-term
debt
|
|
101,021
|
|
101,447
|
Accumulated
deficit
|
|
(1,287,245)
|
|
(1,250,363)
|
Total stockholders'
equity
|
|
134,603
|
|
157,401
|
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SOURCE Lexicon Pharmaceuticals, Inc.