Flexion Therapeutics Reports Second Quarter 2017 Financial Results and Recent Business Highlights
August 08 2017 - 4:05PM
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported financial
results for the quarter ended June 30, 2017. The company reported a
net loss of $28.9 million for the second quarter of 2017, compared
to a net loss of $14.2 million for the same period of 2016.
Research and development costs increased to $11.8 million in the
second quarter of 2017, as compared to $8.9 million in the second
quarter of 2016, due primarily to an increase of $3.0 million in
personnel and other employee-related costs for additional headcount
and stock compensation expense. General and administrative expenses
increased to $15.1 million in the first quarter of 2017, as
compared to $5.2 million for the same period in 2016, due primarily
to costs associated with increased headcount and expenses related
to the potential launch and commercialization of Zilretta (FX006),
Flexion’s lead investigational program for pain associated with
osteoarthritis (OA) of the knee.
As of June 30, 2017, the company had approximately $359.9
million in cash, cash equivalents and marketable securities
compared with $210.3 million as of December 31, 2016.
Recent News and
Highlights:
- On May 2, 2017, Flexion completed an offering of convertible
senior notes due in 2024, providing a capital infusion of
approximately $201 million (gross proceeds) and extending the
company’s cash runway well into 2019.
- The company has fully staffed its sales leadership team and is
actively recruiting approximately 100 field sales representatives
who will be hired on a contingent basis conditional upon Zilretta’s
approval by the U.S. Food and Drug Administration (FDA). Pending
regulatory approval, the company expects to launch Zilretta in the
fourth quarter of 2017.
- A Phase 3 clinical trial to evaluate the safety of repeat
administration of Zilretta has been fully enrolled. Study
participants will be followed for 52 weeks, and the final data
readout is expected in the second half of 2018.
- The full data set from a Phase 2 clinical trial of Zilretta in
patients with Type 2 diabetes and OA of the knee was presented at
the American Diabetes Association's 77th Scientific Sessions.
The data demonstrated that Zilretta was not associated with the
significant rise in blood glucose seen with an immediate-release
steroid in patients with Type 2 diabetes and OA of the knee.
- A health economics analysis of Zilretta was presented at the
International Society for Pharmacoeconomics and Outcomes Research
22nd International Meeting. The study, which utilized established
health economic metrics, demonstrated that Zilretta has the
potential to be a cost-effective therapy in OA of the knee.
- Company executives provided updates on commercialization plans
and two clinicians shared their medical perspectives on Zilretta
during an Investor and Analyst Day held on July 10, 2017.
Management announced plans to initiate clinical trials of Zilretta
in OA of the hip and shoulder by year-end.
- During the Investor and Analyst Day presentation, the company
unveiled a new pre-clinical pipeline candidate, FX101 (fluticasone
extended-release), for the potential treatment of OA pain in large
joints. The program is expected to follow the 505(b)(2) pathway.
Based on robust pre-clinical pharmacokinetic data, the company
believes FX101 has the potential to provide pain relief for up to
six months.
- Flexion’s executive team was strengthened by the recent
appointment of Mark Levine as General Counsel and Corporate
Secretary. Additionally, the company has named Anna Diaz Triola as
Vice President, Marketing. Ms. Triola brings nearly 20 years of
marketing experience in biotechnology companies and deep commercial
expertise in new product launches, new product planning, and
patient advocacy and engagement across a variety of disease
areas.
“Flexion’s strong momentum continued to build throughout the
second quarter,” said Michael Clayman, M.D., President and Chief
Executive Officer. “Our commercial organization made
impressive strides preparing for the potential launch of Zilretta,
and we are eagerly anticipating our Prescription Drug User Fee Act
(PDUFA) action date of October 6, 2017.”
Dr. Clayman added, “The full enrollment of the repeat
administration study of Zilretta represents a major milestone, and
we look forward to our planned initiation of new clinical trials in
OA of the hip and shoulder by year-end. We are also very pleased to
introduce FX101, an important addition to our pipeline, which we
believe has the potential to make a meaningful difference for
patients confronting OA pain.”
Conference Call Flexion’s management will host
a conference call today at 4:30 p.m. ET. The dial-in number for the
conference call is 855-770-0022 for domestic participants and
908-982-4677 for international participants, with Conference ID #
56227594. A live webcast of the conference call can also be
accessed through the “Investors” tab on the Flexion Therapeutics
website, and a replay will be available online after the call.
About Osteoarthritis (OA) of the Knee OA is
the most common joint disease, affecting more than 30 million
Americans and accounting for more than $185 billion in annual
expenditures. In 2015, more than 14 million Americans were
diagnosed with OA of the knee and the average age of
physician-diagnosed knee OA has fallen by 16 years, from 72 in
the 1990s to 56 in the 2010s. OA prevalence is expected to continue
to increase as a result of aging, obesity and sports injuries. Each
year, more than five million OA patients in the U.S. receive either
an immediate-release corticosteroid or hyaluronic acid
intra-articular injection for knee pain.
About Zilretta Zilretta is being investigated
as the first intra-articular, extended-release treatment for
patients with OA related knee pain. Zilretta employs proprietary
microsphere technology combining triamcinolone acetonide — a
commonly administered, short-acting corticosteroid — with a poly
lactic-co-glycolic acid matrix. In February 2017, the FDA accepted
the company's New Drug Application for Zilretta in OA of the knee.
Under the Prescription Drug User Fee Act, the agency has
established a user fee goal date of October 6, 2017.
About Flexion Therapeutics Flexion Therapeutics
(Nasdaq:FLXN) is a specialty pharmaceutical company focused on the
development and commercialization of novel, local therapies for the
treatment of patients with musculoskeletal conditions, beginning
with OA, a type of degenerative arthritis. The company’s core
values are focus, ingenuity, tenacity, transparency and fun.
Flexion was named one of the Boston Business
Journal's 2017 Best Places to Work.
Forward-Looking StatementsStatements in this
press release regarding matters that are not historical facts,
including, but not limited to, statements relating to the future of
Flexion; our ongoing development of Zilretta and the planned
development of FX101; the expected timing of the clinical trial
studying repeat administration of Zilretta and planned clinical
trials of Zilretta in hip and shoulder joints; potential regulatory
approval of Zilretta; our plans to commercialize Zilretta and its
market potential; expected increases in the rate of individuals
with OA of the knee; the potential therapeutic and other benefits
of Zilretta and any other product candidates; and our expected cash
runway, are forward-looking statements. These forward-looking
statements are based on management's expectations and assumptions
as of the date of this press release and are subject to numerous
risks and uncertainties, which could cause actual results to differ
materially from those expressed or implied by such statements.
These risks and uncertainties include, without limitation, risks
associated with the process of discovering, developing,
manufacturing and obtaining regulatory approval for drugs that are
safe and effective for use as human therapeutics; the fact that
results of past clinical trials may not be predictive of subsequent
trials; our reliance on third parties to manufacture and conduct
clinical trials of Zilretta and our other product candidates, which
could delay or limit their future development or regulatory
approval; the fact that we may spend our available cash resources
or require additional financing faster than we currently expect,
whether due to pursuing additional business opportunities,
unexpected expenditures or otherwise; our ability to meet
anticipated clinical trial enrollment and completion dates; the
risk that we may not be able to maintain and enforce our
intellectual property, including intellectual property related to
Zilretta; competition from alternative therapies; regulatory
developments and safety issues, including difficulties or delays in
obtaining regulatory approvals to market Zilretta; Zilretta may
not be successfully commercialized, including as a result of
the FDA’s or other regulatory authorities’ decisions regarding
labeling and other matters that could affect its availability or
commercial potential; risks related to key employees, markets,
economic conditions, health care reform, prices and reimbursement
rates; and other risks and uncertainties described in our filings
with the Securities and Exchange Commission (SEC), including under
the heading "Risk Factors" in our most recent Annual Report on Form
10-K and subsequent filings with the SEC. The forward-looking
statements in this press release speak only as of the date of this
press release, and we undertake no obligation to update or revise
any of the statements. We caution investors not to place
considerable reliance on the forward-looking statements contained
in this press release.
|
|
FLEXION THERAPEUTICS |
|
|
CONDENSED CONSOLIDATED STATEMENT OF
OPERATIONS |
|
|
(in thousands, except for per share
information) |
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended |
|
|
|
|
|
June 30, |
|
|
|
|
|
2017 |
|
2016 |
Revenue |
|
|
|
$ |
- |
$ |
- |
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Research and development |
|
|
11,769 |
|
8,905 |
General and administrative |
|
|
15,133 |
|
5,215 |
Total expenses |
|
|
26,902 |
|
14,120 |
Loss from
operations |
|
|
(26,902) |
|
(14,120) |
Interest
income (expense), net |
|
(2,090) |
|
93 |
Other
income (expense) |
|
|
|
112 |
|
(158) |
Loss from
operations before income tax |
|
(28,880) |
|
(14,185) |
Net loss |
|
|
|
|
(28,880) |
|
(14,185) |
|
|
|
|
Basic and
diluted net loss per share |
$ |
(0.91) |
$ |
(0.63) |
Basic and
diluted weighted |
|
|
|
|
average
number of common shares outstanding |
31,826 |
|
22,666 |
|
|
|
|
|
|
|
|
|
|
|
FLEXION THERAPEUTICS SELECTED BALANCE SHEET
DATA(in thousands) |
|
|
|
|
June 30, |
|
December 31, |
|
|
|
|
2017 |
|
2016 |
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ 197,179 |
|
$ 30,915 |
Marketable
securities |
|
162,680 |
|
179,413 |
Total
current assets |
|
|
362,193 |
|
209,393 |
Working
capital |
|
|
342,388 |
|
191,853 |
Total
assets |
|
|
374,656 |
|
226,262 |
Total notes
payable |
|
|
27,551 |
|
30,533 |
Total
convertible notes |
133,484 |
|
- |
Total
stockholders' equity (deficit) |
203,379 |
|
187,032 |
Contact:
Scott Young
Sr. Director, Corporate Communications & Investor Relations
Flexion Therapeutics, Inc.
T: 781-305-7194
syoung@flexiontherapeutics.com
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