Search This Blog

Monday, January 7, 2019

AxoGen hit on preliminary Q4 results


AxoGen (AXGN -20.8%) is down on more than triple normal volume after its announcement of preliminary Q4 2018 and full-year results.
Q4 revenue was at least $23.4M, up 38% yoy but potentially shy of $24.2M consensus. Full-year revenue was at least $83.9M, also potentially short of $84.6M consensus.
2019 outlook: revenue growth of at least 35%. Gross margin to remain above 80%.
#JPM19

La Jolla hit after downbeat drug guidance


La Jolla Pharmaceutical Co. LJPC, -44.11% plummeted 44% in midday trade Monday to pace all Nasdaq losers, after the company provided downbeat guidance on its key drug that treats dangerously low blood pressure in adults with septic or other disruptive shock. The company said its fourth-quarter sales of Giapreza, which was launched in March 2018, rose 20% from a year ago to $4.2 million, with 2018 sales expected to reach $10.1 million. The Giapreza sales estimates of the two analysts that provided estimates to FactSet ranged from $5.2 million to $6.9 million for the fourth quarter and $11.1 million to $12.8 million for 2018. For 2019, La Jolla Pharmaceuticals said it expects Giapreza sales to rise to $24 million to $28 million, while analyst estimates ranged from $44.3 million to $55.0 million. The stock, on track for the lowest close since September 2013, has now plummeted 68% over the past three months

Biohaven announces acceptance of rimegepant IND filing in China


Biohaven Pharmaceutical and its wholly-owned Asia-Pacific subsidiary company, BioShin, announced the National Medical Products Administration, or NMPA, formerly, the China FDA, has accepted the investigational new drug, or IND, application for rimegepant, Biohaven’s lead oral calcitonin gene-related peptide, or CGRP, receptor antagonist product candidate, for the treatment of migraine. CGRP receptor antagonists represent a novel class of drug candidates for the treatment of migraine and are the first new class for the treatment of migraine in over 25 years. CGRP receptor antagonists potentially offer an alternative to current agents, particularly for patients who have contraindications to the use of triptans, such as those with underlying cardiovascular diseases, or those who have an inadequate response to standard therapies.

Sage SAGE-217 meets primary, secondary endpoints in Phase 3 trial


Sage Therapeutics reported top-line results from the Phase 3 ROBIN study. This study evaluated the effect of SAGE-217 30 mg on depressive symptoms in women with postpartum depression . After two weeks of outpatient treatment, patients treated with SAGE-217 had a statistically significant improvement of 17.8 points in the Hamilton Rating Scale for Depression score, compared to 13.6 for placebo, with statistically significant reductions in HAMD-17 compared to placebo maintained through the end of the four-week follow-up. Remission was achieved in 45% of patients treated with SAGE-217 for two weeks as measured by the HAMD-17 compared with 23% of patients receiving placebo. Results from secondary endpoints were statistically significant and consistent with the primary endpoint. SAGE-217 was generally well-tolerated with a safety profile consistent with that seen in earlier SAGE-217 trials. Overall reports of AEs were similar between SAGE-217 (58%) and placebo (51%). Two subjects experienced serious adverse events, one subject in each group.

Wright Medical announces three-year financial targets for 2019-2021


The company anticipates achieving its goal of 20% adjusted EBITDA margins for the full fourth quarter of 2019. The company also announced new three-year financial targets for 2019 through 2021: Deliver double-digit, constant currency net sales growth each year; Maintain adjusted gross margin in the high 70s% range each year; Expand adjusted EBITDA margin to the mid-20% range exiting 2021.

Nuvectra sees FY18 revenue $53.2M-$53.6M, consensus $52.94M


https://thefly.com/landingPageNews.php?id=2844225

Eli Lilly to acquire Loxo Oncology for $235.00 per share in cash, or about $8B


Eli Lilly and Company (LLY) and Loxo Oncology (LOXO) announced a definitive agreement for Lilly to acquire Loxo Oncology for $235.00 per share in cash, or approximately $8B. Loxo Oncology is a biopharmaceutical company focused on the development and commercialization of highly selective medicines for patients with genomically defined cancers. Under the terms of the agreement, Lilly will commence a tender offer to acquire all outstanding shares of Loxo Oncology for a purchase price of $235.00 per share in cash, or approximately $8B. The transaction is not subject to any financing condition and is expected to close by the end of the first quarter of 2019, subject to customary closing conditions, including receipt of required regulatory approvals and the tender of a majority of the outstanding shares of Loxo Oncology’s common stock. Following the successful closing of the tender offer, Lilly will acquire any shares of Loxo Oncology that are not tendered into the tender offer through a second-step merger at the tender offer price. The tender offer represents a premium of approximately 68% to Loxo Oncology’s closing stock price on January 4, 2019, the last trading day before the announcement of the transaction. Loxo Oncology’s board recommends that Loxo Oncology’s shareholders tender their shares in the tender offer. Additionally, a Loxo Oncology shareholder, beneficially owning approximately 6.6% of Loxo Oncology’s outstanding common stock, has agreed to tender its shares in the tender offer. This transaction will be reflected in Lilly’s financial results and financial guidance according to Generally Accepted Accounting Principles. Lilly will provide an update to its 2019 financial guidance, including the expected impact from the acquisition of Loxo Oncology, as part of its fourth-quarter and full-year 2018 financial results announcement on February 13, 2019.