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FLXN

Flexion

$10.96

0.22 (2.05%)

16:42
04/24/19
04/24
16:42
04/24/19
16:42

Flexion announces post-hoc analysis of Zilretta data published

Flexion announced that the results from a post-hoc analysis of data from the pivotal Phase 3 trial of Zilretta were published in Advances in Therapy. The findings indicated that patients with unilateral osteoarthritis, or OA, knee pain experienced pain relief with a single intra-articular injection of Zilretta compared to immediate-release triamcinolone acetonide in crystalline suspension, or TAcs, as measured by Average Daily Pain, or ADP, intensity scores. The analysis also indicated that Zilretta patients in this subgroup experienced improvements on OA-specific measures of pain, stiffness, function and quality of life scores that lasted up to six months. The objective of the analysis was to characterize the primary endpoint of the trial, change in ADP, within a subgroup of randomized patients with unilateral OA knee pain. The analysis showed that patients in this subgroup who were treated with Zilretta experienced a magnitude of analgesic effect, with ADP scores that were reduced by greater than 60% at Week 3-17. These results suggest that bilateral knee pain may have been a confounding factor in the pivotal trial, which assessed the impact of Zilretta treatment in only one knee. A single intra-articular injection of Zilretta provided significant improvement in pain at Week 12 compared with placebo and TAcs to patients with unilateral knee OA, as measured by ADP-intensity scores. Zilretta provided participants with unilateral knee OA improvements in WOMAC-A, WOMAC-B, WOMAC-C and quality of life scores at Weeks 4, 8, and 12 compared with TAcs and up to six months compared with placebo. Patients treated with Zilretta used less rescue medication for pain compared with both the placebo and TAcs groups and adverse events were similar in frequency across treatment groups, with most reported as mild or moderate and unrelated to the study agent.

FLXN Flexion
$10.96

0.22 (2.05%)

04/10/19
WELS
04/10/19
NO CHANGE
WELS
Outperform
Flexion a 'compelling value' amid selloff on executive exit, says Wells Fargo
Shares of Flexion Therapeutics are trading lower after the company announced at an investor conference that it made a decision to hire a Chief Commercial Officer and that its current head of commercial, Dan Deardorf, will be leaving the company shortly, Wells Fargo analyst David Maris tells investors in a research note. Flexion also reaffirmed its 2019 revenue guidance of $65M-$80M, Maris points out. After speaking with management, the analyst believes Flexion "was not thrilled" with 2018 Zilretta growth and is looking for ways to accelerate growth and uptake of Zilretta. This is creating additional uncertainty with investors, especially since earlier this year the 2019 sales guidance fell below consensus, says Maris. Further, "it seems reasonable to think that when things are going exceptionally well in a launch, the head of commercial typically does not leave," he contends. Nonetheless, Maris believes that at less than two-times 2020 sales for a "growing product," Flexion shares represent a "compelling value." Zilretta will be a growth product for the next several years, he writes. Maris keeps an Outperform rating on Flexion, which is down 17%, or $2.06, to $10.36 in afternoon trading.
04/10/19
RAJA
04/10/19
NO CHANGE
RAJA
Strong Buy
Flexion replacing Zilretta commercial head 'unanticipated,' says Raymond James
Noting that Flexion's CEO announced at an investor conference that the company has parted ways with its Senior VP of Commercial Operations Dan Deardorf and is looking to replace him with a Chief Commercial Officer, Raymond James analyst Elliot Wilbur commented that the news was "completely unanticipated" and there "will no doubt be a new round of jitters around the launch trajectory of Zilretta" following the announcement. Seeking to ease those concerns, the company reiterated its annual revenue guidance of $65M-$80M, said Wilbur, who added that "the management shuffle certainly isn't going to bolster confidence in the product's near-term velocity." The analyst, who said it "is still early in the Zilretta launch phase and not too late to course correct," keeps a Strong Buy rating on Flexion shares.
01/04/19
BMOC
01/04/19
NO CHANGE
Target $34
BMOC
Outperform
Flexion price target lowered to $34 from $36 at BMO Capital
BMO Capital analyst Gary Nachman lowered his price target on Flexion to $34 after the company's FY19 outlook for Zilretta sales disclosed yesterday. The analyst states that the management has deliberately set an "appropriately conservative" target, adding that Zilretta momentum should accelerate "with the J-code in place effective January 1st". Nachman also believes that the set-up on the stock has "improved meaningfully".
01/04/19
NEED
01/04/19
NO CHANGE
Target $36
NEED
Buy
Flexion price target lowered to $36 from $42 at Needham
Needham analyst Serge Belanger lowered his price target on Flexion to $36 after its yesterday's guidance for FY19 Zilretta sales of $65M-$80M came in below the Street consensus of $97.8M. The analyst states that although the outlook may appear disappointing at first, investors may welcome the "expectation reset" that should yield a "more accurate guidepost" for Zilretta growth. The analyst also lowered his FY19 EPS view to ($3.89) from ($2.63) to reflect the slower launch ramp but kept his Buy rating on the shares based on the company's potential for its product to serve as the front-line treatment for Osteoarthritis knee pain.

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