U.S. markets close in 17 minutes

Zogenix, Inc. (ZGNX)

NasdaqGS - NasdaqGS Real Time Price. Currency in USD
Add to watchlist
19.84-0.90 (-4.34%)
As of 3:42PM EST. Market open.
Full screen
Trade prices are not sourced from all markets
Gain actionable insight from technical analysis on financial instruments, to help optimize your trading strategies
Chart Events
Bullishpattern detected
Triple Moving Average Crossover

Triple Moving Average Crossover

Previous Close20.74
Open20.74
Bid19.81 x 900
Ask19.84 x 900
Day's Range19.56 - 20.99
52 Week Range16.65 - 32.42
Volume669,229
Avg. Volume941,303
Market Cap1.106B
Beta (5Y Monthly)1.38
PE Ratio (TTM)N/A
EPS (TTM)-3.90
Earnings DateMay 03, 2021 - May 07, 2021
Forward Dividend & YieldN/A (N/A)
Ex-Dividend DateN/A
1y Target Est48.70
Fair Value is the appropriate price for the shares of a company, based on its earnings and growth rate also interpreted as when P/E Ratio = Growth Rate. Estimated return represents the projected annual return you might expect after purchasing shares in the company and holding them over the default time horizon of 5 years, based on the EPS growth rate that we have projected.
Fair Value
XX.XX
Overvalued
Research that delivers an independent perspective, consistent methodology and actionable insight
Related Research
View more
  • Billionaire Jim Simons Snaps Up These 2 Biotech Stocks
    TipRanks

    Billionaire Jim Simons Snaps Up These 2 Biotech Stocks

    Quant trading guru Jim Simons is calling it a day, sort of. The mathematician and cryptologist is famous in the investing community for bringing his analytical eye to the world of the stock exchange, creating both the quant trading revolution and a personal fortune now estimated at more than $22 billion. His has been a career of multifaceted success, and his innovations on Wall Street have influenced the strategies of two successive generations of traders. Simons has stepped down as Chairman of Renaissance Technologies ahead of his 83th birthday next month. However, Simons remains involved as a board member. On his way out, Simons staked new positions in two biotech stocks. Following Simons’ stock moves is a viable strategy for investors of all strips. To get an idea of just how good a strategy, we’ve opened up the TipRanks database and pulled the details on these two names; It appears the rest of the Street projects plenty of upside. Let’s find out what makes them compelling buys. Zogenix, Inc. (ZGNX) We’ll start with Zogenix, a small-cap biotech firm working on new therapies for the treatment of rare diseases. The company has two lead products: Fintepla, which has been approved by the FDA for use in treating epilepsy caused by Dravet Syndrome, and MT1621, which is in mid-stage trial as a treatment for Thymidine Kinase 2 deficiency (TK2d), a rare and frequently fatal metabolic disease in children. The company has seen total net US product sales of $9.6 million since the drug’s July 2020 launch; of that total, $8.1 million was realized in 4Q20. As of December 31, 2020, there were 550 Dravet syndrome patients enrolled in Fintepla programs. Also in December, the European Commission approved Fintepla for use, and the drug launched in Germany. Fintepla is currently undergoing testing as a treatment for Lennox-Gastaut syndrome, and other rare epileptic diseases, to expand the patient base. Zogenix’ second drug candidate, MT1621, was acquired in 2019 from Modis Therapeutics. MT1621 is a potential treatment for TK2d, a rare and deadly disease of early childhood. The drug acts through Deoxynucleoside substrate enhancement therapy, a novel approach that has demonstrated efficacy in early phase studies. At this point, Zogenix needs to complete a Phase 1 human renal PK study, a nonclinical tox study in dogs, and genotoxicology/reproductive tox studies, and management indicated that it plans to make a New Drug Application (NDA) to the FDA in 1H22. The company’s solid position is bound to attract investor attention – and Jim Simons bought in to the tune of more than 245,000 shares in Q4. His stake in the company is now worth over $5 million. Covering Zogenix for Needham, analyst Serge Belanger noted that the Fintepla launch in the US was ‘off to a promising start.’ “It appears that late-2020 trends of enrollment in the REMS program and Fintepla onboarding have continued into early-2021. All patients receiving Fintepla as part of U.S.-based OLE trials are expected to be on commercial product by 1Q21-end,” Belanger wrote. To this end, Belanger rates ZGNX a Buy, and his $48 price target implies a robust 131% upside potential for the next 12 months. (To watch Belanger’s track record, click here) Overall, Wall Street appears to agree with the Needham view that Zogenix is a stock worth buying. The recent analyst reviews break down 6 to 2 in favor of Buy versus Hold, making the consensus rating a Strong Buy. Shares are priced at $20.74, and the $47 average target suggests a 128% upside on the one-year horizon. (See ZGNX stock analysis on TipRanks) Wave Life Sciences (WVE) The next stock we’re looking at is Wave Life Sciences, which focuses on precision medicine, designing oligonucleotides to safely deliver more effective, precisely targeted, therapeutic agents. The company has a pipeline of 10 drug candidates, in various stages of development in the treatment of serious diseases with, in the company’s words, ‘few or no treatment options.’ Wave Life Sciences uses an integrated approach to develop new nucleic acid therapeutics. The approach uses rational design to counter flaws in genetic replication, giving more consistent therapeutic effects from medications that are specifically targeted to particular diseases. The company's development program targeting Huntington’s disease is the most advanced. This is a severe inherited neurodegenerative disorder, with symptoms usually setting in between ages 30 and 50, and worsening over time. The company’s two most advanced drug candidates, WVE-120101 and WVE-120102, are in Phase 1b/2a trials, with reports on results expected by the end of this month. In addition, open-label extension (OLE) trials are ongoing for patients outside the US. In addition to these two drug candidates, Wave has several programs ongoing for the treatment of other rare diseases. The pipeline includes potential therapies for ALS, Duchenne muscular dystrophy, and various retinal diseases. These pipeline projects are all at preclinical stages. During the fourth quarter, Jim Simons’ Renaissance bought 235,620 shares of WVE, a substantial buy that shows confidence in the company’s pipeline. At current valuation, the stake – a new position for Simons – is worth $2.224 million. 5-star analyst Andrew Fein, of H.C. Wainwright, noted that Wave’s stock performance this year will depend largely on the results of the PRECISION HD-1 and HD-2 studies, and he believes there's reason for optimism. “[Our] positive view of the PRECISION studies stems from: (1) the selective targeting of either SNP1 or SNP2 knocks down expression of mutant Huntington protein (mHTT) while leaving wild-type HTT largely intact, which may improve the safety profile compared to competitor therapies that also target wild-type proteins…; (2) novel ASO modification chemistry makes a compelling case as seen by data, showing significantly higher transcript knockdown relative to traditional approaches; (3) Wave’s intrathecal dosing strategy should overcome systemic inflammatory responses seen in other programs; and (4) higher dosing cohorts should alleviate investor concerns of efficacy relative to competitor programs,” Fein opined. On the strength of these studies, Fein maintains his Buy rating and his $20 price target. At current levels, that target suggests an upside of 112% for the year ahead. (To watch Fein’s track record, click here) All in all, there are 5 reviews on record for WVE shares, with 3 saying Buy and 2 to Hold, making the analyst consensus a Moderate Buy. The average price target here is $17.80, implying a one-year upside of 84% from the share price of $9.76. (See WVE stock analysis on TipRanks) To find good ideas for biotech stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

  • Zogenix to Participate in the Raymond James Institutional Investors Conference
    GlobeNewswire

    Zogenix to Participate in the Raymond James Institutional Investors Conference

    EMERYVILLE, Calif., March 02, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today announced that Michael Smith, Executive Vice President, Chief Financial Officer, and Treasurer, will present a corporate overview and participate in a fireside chat on Wednesday, March 3, 2021, at the Raymond James Institutional Investors Conference. Zogenix Presentation DetailsDate:Wednesday, March 3, 2021Time: 3:50 PM Eastern Time The presentation will be webcast live and archived for 90 days on Zogenix's Investor Relations website at https://zogenixinc.gcs-web.com. About ZogenixZogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company’s first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare epilepsy, and one for MT1621, an investigational therapy for the treatment of a rare genetic disorder called TK2 deficiency. Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies. CONTACTS: ZogenixMelinda BakerSenior Director, Corporate Communications+1 (510) 788-8732 | corpcomms@zogenix.com InvestorsBrian Ritchie Managing Director, LifeSci Advisors LLC+1 (212) 915-2578 | britchie@lifesciadvisors.com MediaStefanie Tuck, Vice President, Porter Novelli+1 (978) 390-1394 | stefanie.tuck@porternovelli.com

  • Zogenix Provides Corporate Update and Reports Fourth Quarter and Full-Year 2020 Financial Results
    GlobeNewswire

    Zogenix Provides Corporate Update and Reports Fourth Quarter and Full-Year 2020 Financial Results

    Positive momentum continues for U.S. launch of FINTEPLA® (fenfluramine) oral solution in Dravet syndrome, with total net product sales of $8.1 million in the fourth quarter; total net sales of $9.6 million since launch in July 2020 As of December 31, 2020, over 550 Dravet syndrome patients referred to the FINTEPLA REMS program, with 416 patients receiving reimbursed therapy, approximately 60% of whom were new to FINTEPLAFINTEPLA for Dravet syndrome approved by European Commission in December 2020 and launched in Germany this monthOn track to submit applications for FINTEPLA in Lennox-Gastaut syndrome in the U.S. in Q3 2021 and in Europe in Q4 2021Planned New Drug Application (NDA) submission in first half of 2022 for MT1621 in TK2 deficiencyEnded 2020 with $505.1 million in cash, cash equivalents and marketable securities EMERYVILLE, Calif., Feb. 25, 2021 (GLOBE NEWSWIRE) -- Zogenix (NASDAQ: ZGNX), a global biopharmaceutical company developing and commercializing rare disease therapies, today provided a corporate update and announced financial results for the fourth quarter and full-year ended December 31, 2020. The Company will host a conference call today, Thursday, February 25, at 4:30 PM Eastern Time/1:30 PM Pacific Time. “We are very pleased to have concluded 2020 with strong momentum across all of our programs, especially the robust U.S. launch of FINTEPLA® in Dravet syndrome, where we saw strong adoption by existing and new prescribing physicians and patients, and partnerships with U.S. payors to provide optimal access for all appropriate patients,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “We expect several additional key catalysts for FINTEPLA in Dravet syndrome in the year ahead in the U.S. and in Europe, where we recently launched FINTEPLA in Germany and are actively preparing for additional European country launches and, with our partner Nippon Shinyaku, are preparing to submit a J-NDA in the second half of the year.” “Our goal is also to continue expanding the eligible patient population for FINTEPLA in other indications, based on strong safety and efficacy data from our clinical trials,” continued Dr. Farr. “In the U.S. and Europe, we are advancing FINTEPLA for multiple other treatment-resistant epilepsies, including Lennox-Gastaut syndrome (LGS), for which we anticipate submitting global regulatory filings. We are also planning to initiate a Phase 3 trial for CDKL5 in the second half of 2021, and assess additional severe, treatment-resistant epilepsies through the initiation of other investigator-initiated clinical studies.” Corporate Update FINTEPLA for the treatment of seizures associated with Dravet syndrome:° As of December 31, 2020, 492 prescribers had successfully completed the Risk Evaluation and Mitigation Strategy (REMS) certification process° As of December 31, 2020, over 550 Dravet syndrome patients had been referred to the FINTEPLA REMS program to become eligible to receive therapy, and 416 patients were receiving reimbursed therapy, of which approximately 60% were new to FINTEPLA° Received European Commission approval on December 21, 2020; FINTEPLA commercially available in Germany as of February 1, 2021° Received temporary authorisation to use in France from the French National Agency for Medicines and Health Products Safety in January 2021; expect patients to begin treatment with FINTEPLA in France during current quarter° Anticipate submission of a Japan-NDA to Japan’s Pharmaceutical and Medical Devices Agency in the second half of 2021° Presented new long-term (3 year) safety and efficacy data for FINTEPLA in Dravet syndrome at American Epilepsy Society (AES) Annual Meeting in December 2020, which demonstrated durable effectiveness in significantly reducing seizuresFINTEPLA for the treatment of seizures associated with LGS:° Completed all required studies for submission. Compilation of data package is ongoing with anticipated filing of sNDA in the third quarter of 2021° Anticipate submitting Marketing Authorization Application with European Medicines Agency in fourth quarter of 2021° Presented full results from Phase 3 study of FINTEPLA in LGS and its efficacy in reducing convulsive seizure frequency at AES Annual MeetingFINTEPLA for the treatment of seizures associated with CDKL5 Deficiency Disorder:° New data presented from investigator-initiated study in CDKL5 Deficiency Disorder, an infantile-onset genetic seizure disorder, at AES Annual Meeting° Anticipate initiating a Phase 3 study of FINTEPLA for the treatment of CDKL5 Deficiency Disorder during the second half of 2021MT1621 for the treatment of TK2d:° Studies are proceeding as planned and Company anticipates the submission of an NDA in the first half of 2022Tevard Research Collaboration:° Zogenix and Tevard collaborating to identify and develop novel tRNA-based gene therapies for Dravet syndrome and other genetic epilepsies Fourth Quarter 2020 Financial Results The Company recorded $8.5 million in revenue for the fourth quarter ended December 31, 2020. This included total net product sales of FINTEPLA of $8.1 million, in addition to $0.4 million in revenue as a result of the March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded $1.9 million in revenue for the corresponding period of 2019.Research and development expenses for the fourth quarter ended December 31, 2020, totaled $36.0 million, compared to $35.8 million in the fourth quarter ended December 31, 2019. Selling, general and administrative expenses for the fourth quarter ended December 31, 2020, totaled $29.2 million, up from $18.7 million in the fourth quarter ended December 31, 2019. The increase was driven by commercial launch in the U.S. and launch preparations Europe.Net loss for the fourth quarter ended December 31, 2020, was $70.2 million, or a net loss of $1.26 per share, compared with a net loss of $56.1 million, or a net loss of $1.26 per share, in the fourth quarter ended December 31, 2019. Year Ended December 31, 2020 Financial Results Compared to Year Ended December 31, 2019 The Company recorded $13.6 million in revenue for the year ended December 31, 2020. This included total net product sales of FINTEPLA of $9.6 million, in addition to $4.0 million in revenue as a result of the March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded in $3.6 million revenue for the corresponding period of 2019.Research and development expenses for the year ended December 31, 2020, totaled $138.0 million, up from $115.6 million in the year ended December 31, 2019, as the Company expanded clinical activities in LGS and MT1621, partially offset by decreased spending in Dravet syndrome.Selling, general and administrative expenses for the year ended December 31, 2020, totaled $99.6 million, up from $60.8 million in the year ended December 31, 2019, as the Company continued investment related to the launch of FINTEPLA for the treatment of Dravet syndrome in the U.S. and prepared for prospective launch in Europe.Net loss for the year ended December 31, 2020, was $209.4 million, or a net loss of $3.90 per share, compared with a net loss of $419.5 million, or a net loss of $9.74 per share, in the year ended December 31, 2019. The decrease in net loss was primarily attributable to the 2019 acquisition of Modis.As of December 31, 2020, the Company had $505.1 million in cash, cash equivalents, and marketable securities, compared to $251.2 million at December 31, 2019. Conference Call DetailsThursday, February 25, at 4:30 PM Eastern Time / 1:30 PM Pacific TimeToll Free: 877-407-9716International: 201-493-6779Conference ID: 13715661Webcast: http://public.viavid.com/index.php?id=143250 About ZogenixZogenix is a global biopharmaceutical company committed to developing and commercializing therapies with the potential to transform the lives of patients and their families living with rare diseases. The company’s first rare disease therapy, FINTEPLA® (fenfluramine) oral solution has been approved by the U.S. FDA and the European Medicines Agency and is in development in Japan for the treatment of seizures associated with Dravet syndrome, a rare, severe lifelong epilepsy. The company has two additional late-stage development programs underway: one for FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome, another rare epilepsy, and one for MT1621, an investigational therapy for the treatment of a rare genetic disorder called TK2 deficiency. Zogenix is also collaborating with Tevard Biosciences to identify and develop potential next-generation gene therapies for Dravet syndrome and other genetic epilepsies. Forward Looking Statements Zogenix cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “intends,” “potential,” “suggests,” “assuming,” “designed,” and similar expressions are intended to identify forward-looking statements. These statements include timing of commercial launch of FINTEPLA for the treatment of Dravet syndrome in additional countries in Europe, including France; Zogenix’s expectations on the submission of a J-NDA by Nippon Shinyaku in Japan; the timing and ability of Zogenix to complete regulatory submissions in the United States and the European Union for FINTEPLA in LGS; Zogenix’s plans to expand FINTEPLA in other indications including the timing or success of a Phase 3 clinical trial in CDKL5 deficiency disorder and investigator-initiated clinical trials in other indications; Zogenix’s belief that the recent Type B meeting with the FDA supports an NDA submission for MT1621 in TK2 deficiency and the timing of such submission. These statements are based on Zogenix’s current beliefs and expectations. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: Zogenix may not be successful in executing its sales and marketing strategy for the commercialization of FINTEPLA in the U.S. and Europe, including due to the costs and procedures related to the REMS certification process or controlled access program; the COVID-19 pandemic may disrupt Zogenix’s business operations, impairing the ability to commercialize FINTEPLA and may delay Zogenix’s development plans for FINTEPLA and MT1621; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA or MT1621 that could limit development or commercialization, or that could result in recalls or product liability claims; additional data from Zogenix’s ongoing studies may contradict or undermine the data previously reported; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995. CONTACTS: ZogenixMelinda BakerSenior Director, Corporate Communications+1 (510) 788-8732 | corpcomms@zogenix.comInvestorsBrian Ritchie Managing Director, LifeSci Advisors LLC+1 (212) 915-2578 | britchie@lifesciadvisors.comMediaStefanie Tuck, Vice President, Porter Novelli+1 (978) 390-1394 | stefanie.tuck@porternovelli.com Zogenix, Inc.Condensed Consolidated Balance Sheets (Unaudited)(in thousands) December 31, 2020 2019Assets Current assets: Cash and cash equivalents$166,916 $62,070 Marketable securities 338,193 189,085 Accounts receivable, net 3,824 - Inventory 1,026 - Prepaid expenses 7,279 8,593 Acquisition holdback placed in escrow - 25,000 Other current assets 4,936 2,491 Total current assets 522,174 287,239 Property and equipment, net 8,724 9,424 Operating lease right-of-use assets 7,748 7,774 Intangible asset, net 98,558 102,500 Goodwill 6,234 6,234 Other non-current assets 7,692 1,079 Total assets$651,130 $414,250 Liabilities and stockholders’ equity Current liabilities: Accounts payable$11,945 $7,979 Accrued and other current liabilities 54,964 30,117 Acquisition holdback liability - 24,444 Deferred revenue, current 5,318 5,927 Current portion of operating lease liabilities 1,688 1,322 Current portion of contingent consideration 8,800 25,600 Total current liabilities 82,715 95,389 Deferred revenue, non-current 5,479 7,425 Operating lease liabilities, net of current portion 10,314 10,752 Contingent consideration, net of current portion 33,600 38,200 Deferred tax liability - 17,425 Convertible Senior Notes 149,353 - Total liabilities 281,461 169,191 Stockholders’ equity: Common stock 56 45 Additional paid-in capital 1,694,524 1,360,092 Accumulated other comprehensive (loss) income (71) 379 Accumulated deficit (1,324,840) (1,115,457)Total stockholders’ equity 369,669 245,059 Total liabilities and stockholders’ equity$651,130 $414,250 Zogenix, Inc.Condensed Consolidated Statements of Operations (Unaudited)(in thousands, except per share amounts) Three Months Ended December 31, Twelve Months Ended December 31, 20202019 20202019Revenues: Net product sales$8,067 $- $9,587 $- Collaboration revenue 435 1,949 4,056 3,648 Total revenues 8,502 1,949 13,643 3,648 Operating costs and expenses: Cost of product sales (excluding intangible asset amortization) 402 - 542 - Research and development 35,964 35,820 138,002 115,639 Selling, general and administrative 29,242 18,653 99,574 60,792 Intangible asset amortization 1,971 - 3,942 - Acquired IPR&D and related costs 6,200 2,000 10,700 251,438 Change in fair value of contingent consideration 2,500 2,900 8,600 5,600 Total operating expenses 76,279 59,373 261,360 433,469 Loss from operations (67,777) (57,424) (247,717) (429,821)Other income (expense): Interest income 387 1,283 2,891 9,802 Interest expense (3,759) - (3,759) - Other income, net 979 81 21,777 516 Loss from operations before income taxes (70,170) (56,060) (226,808) (419,503)Income tax benefit - - (17,425) - Net loss$(70,170)$(56,060) $(209,383)$(419,503) Net loss per share, basic and diluted$(1.26)$(1.26) $(3.90)$(9.74)