Successfully completed the transfer of the Zilretta™ manufacturing technology to Patheon - on track
for NDA submission in December
Met primary endpoint in clinical trial evaluating Zilretta in Type 2 diabetes patients with knee
osteoarthritis
Conference call scheduled for today at 4:30 p.m. ET
BURLINGTON, Mass., Nov. 07, 2016 (GLOBE NEWSWIRE) -- Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced financial results for the third quarter
ended September 30, 2016.
“Through recent executive hires and further expansion of our commercial and sales teams, we are laying the groundwork to realize
our commercialization goals for our investigational therapy, Zilretta™ (also referred to as FX006), in 2017,” said Michael Clayman,
M.D., President and Chief Executive Officer of Flexion. “We are looking forward to the upcoming podium presentation of Phase 3 data
evaluating Zilretta in patients with osteoarthritis of the knee at the American Association of Knee and Hip Surgeons (AAHKS)
meeting on November 11th and remain on track to submit a new drug application (NDA) for Zilretta to the U.S. Food and
Drug Administration in December.”
Third-Quarter Financial Results
The company reported a net loss of $17.8 million for the third quarter of 2016, compared to a net loss of $11.1
million for the third quarter of 2015.
Research and development expenses increased to $9.0 million in the third quarter of 2016, compared to $7.8 million for the same
period in 2015, due to an increase in personnel and other employee-related costs for additional headcount and stock based
compensation.
General and administrative expenses increased to $8.4 million in the third quarter of 2016, as compared to $3.2 million for the
same period in 2015, due primarily to additional costs associated with building a commercial infrastructure to effectively support
the potential commercialization of Zilretta.
As of September 30, 2016, the company had $161.5 million in cash, cash equivalents, and marketable securities compared to $118.6
million as of December 31, 2015.
Third Quarter Highlights and Recent News:
- Met primary endpoint in clinical trial evaluating Zilretta in Type 2 diabetes patients with knee osteoarthritis; results
demonstrated a markedly lower rise in blood glucose in patients receiving a Zilretta injection compared to patients receiving an
immediate-release triamcinolone acetonide (TCA) injection; difference was statistically significant (p<0.05, 2-sided) and
clinically relevant.
- Successfully completed the transfer of the Zilretta manufacturing technology to Patheon marking an important milestone that
enables NDA submission in December.
- Hired several senior level executives in preparation of an anticipated Zilretta commercial launch in 2017, including:
- Carolyn Beaty Scimemi, Esq. Chief Compliance Officer
- Mark Fraga, Vice President, Marketing
- John Magee, Vice President of Sales
- Adam Muzikant, Ph.D., Vice President, Business Development
- Dan Thornton, Vice President, Market Access
- Appointed Mark Stejbach to Flexion’s Board of Directors. Mr. Stejbach is Senior Vice President and Chief Commercial Officer
at Alkermes plc.
About Zilretta
Zilretta is being investigated as the first intra-articular extended-release, non-opioid treatment for patients with moderate to
severe knee OA pain. Zilretta employs proprietary microsphere technology combining TCA — a commonly administered, short-acting
corticosteroid — with a polymer (PLGA) intended to provide persistent concentrations of drug locally to both amplify the magnitude
and prolong the duration of pain relief.
To date, more than 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have
been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with
immediate-release TCA and placebo. Zilretta is an investigational agent and, as such, has not been approved by the FDA or any other
regulatory agencies.
About Flexion Therapeutics
Flexion 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. The company's lead product candidate, Zilretta, is being
investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive IA injections
for knee OA annually.
Conference Call
At 4:30 p.m. ET today, Flexion’s management will host a conference call and webcast to review third quarter financial results
and provide a general business update. 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# 4388754. The live webcast of the conference call can also be
accessed through the “Investors” tab on the Flexion Therapeutics website at www.flexiontherapeutics.com. A webcast replay will be available online after the call.
Forward-Looking Statements
Statements 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; our interpretation of the data and results from our
Zilretta clinical trials; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; our plans to
commercialize Zilretta, including the expected timing for commercial launch and Zilretta’s market potential; and the potential
therapeutic and other benefits of Zilretta, 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, which could delay or limit its future development or regulatory approval; our ability to meet anticipated
clinical trial commencement, enrollment and completion dates and regulatory filing dates for Zilretta; the fact that we will
require additional capital, including prior to commercializing Zilretta or any other product candidates, and may be unable to
obtain such additional capital in sufficient amounts or on terms acceptable to us; 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;
the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials
of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or 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 |
| |
|
|
|
|
September 30, |
| |
|
|
|
|
|
2016 |
|
|
|
2015 |
|
| Revenue |
|
|
|
|
$ |
- |
|
|
$ |
- |
|
| |
|
|
|
|
|
|
|
| Operating expenses: |
|
|
|
|
|
| Research and development |
|
|
|
9,047 |
|
|
|
7,829 |
|
| General and administrative |
|
|
|
8,388 |
|
|
|
3,197 |
|
| Total expenses |
|
|
|
17,435 |
|
|
|
11,026 |
|
| Loss from operations |
|
|
|
(17,435 |
) |
|
|
(11,026 |
) |
| Interest income (expense), net |
|
|
(140 |
) |
|
|
72 |
|
| Other income (expense) |
|
|
|
|
(207 |
) |
|
|
(182 |
) |
| Loss from operations before income tax |
|
|
(17,782 |
) |
|
|
(11,136 |
) |
| Net loss |
|
|
|
|
|
(17,782 |
) |
|
|
(11,136 |
) |
| |
|
|
|
|
| Basic and diluted net loss per share |
|
$ |
(0.65 |
) |
|
$ |
(0.52 |
) |
| Basic and diluted weighted average number of common shares
outstanding |
|
27,524 |
|
|
|
21,507 |
|
| |
|
|
|
|
|
|
| |
|
|
|
|
|
|
| |
|
|
| |
|
FLEXION THERAPEUTICS |
| |
|
SELECTED BALANCE SHEET DATA |
| |
|
(in thousands) |
| |
|
|
|
|
|
|
|
|
|
|
| |
|
|
|
|
September
30, |
|
|
|
December
31, |
|
| |
|
|
|
|
2016 |
|
|
|
2015 |
|
| |
|
|
|
|
|
|
| Cash and cash equivalents |
|
$ |
66,809 |
|
|
$ |
62,944 |
|
| Marketable securities |
|
|
94,696 |
|
|
|
55,660 |
|
| Total current assets |
|
|
|
161,086 |
|
|
|
112,103 |
|
| Working capital |
|
|
|
148,699 |
|
|
|
104,044 |
|
| Total assets |
|
|
|
174,421 |
|
|
|
127,139 |
|
| Total notes payable |
|
|
|
30,298 |
|
|
|
15,002 |
|
| Total stockholders' equity (deficit) |
|
138,031 |
|
|
|
103,987 |
|
Investor Contact David Carey Lazar Partners LTD T: 212-867-1768 dcarey@lazarpartners.com PR Contact Danielle Lewis Lazar Partners LTD T: 212-843-0211 dlewis@lazarpartners.com Corporate Contact Fred Driscoll Chief Financial Officer Flexion Therapeutics, Inc. T: 781-305-7763 fdriscoll@flexiontherapeutics.com
