Register for free to join our community of investors and share your ideas. You will also get access to streaming quotes, interactive charts, trades, portfolio, live options flow and more tools.
ZCOR: Merged with a wholly-owned subsidiary of Assertio Holdings, Inc., pursuant to which the shareholders of ZCOR will receive 2.5 shares of common stock of Assertio Holdings, Inc. for each share of ZCOR common stock; Please see SEC filing disclosures for additional details.
FINRA deleted symbol:
https://otce.finra.org/otce/dailyList?viewType=Deletions
Zyla Life Sciences (OTCQX: ZCOR) is being acquired by Assertio Therapeutics, Inc. (NASDAQ GS: ASRT). Shareholders of Zyla will receive 2.5 shares of Assertio common stock for each share they own. The deal will require the shareholder approval of both companies. We are investigating whether more fulsome disclosures on valuation should be required here. To learn more, message me here or at jgrabar@grabarlaw.com.
Zyla Life Sciences Reports Third Quarter 2019 Financial Results
-- Positive net cash flow of $6.5 million for the quarter ended September 30, 2019 --
-- Net product sales grew to $22.4 million, an increase of 175% over the 2018 third quarter, due to the expanded product portfolio --
Nov 14, 2019
WAYNE, Pa., Nov. 14, 2019 /PRNewswire/ -- Zyla Life Sciences (OTCQX: ZCOR) ("Zyla" or the "Company"), a commercial-stage life sciences company, today reported financial results for the third quarter ended September 30, 2019, including net sales from commercial products: SPRIX® (ketorolac tromethamine) Nasal Spray, the SoluMatrix® products, VIVLODEX® (meloxicam), TIVORBEX® (indomethacin) and ZORVOLEX® (diclofenac)), INDOCIN® (indomethacin) suppositories, INDOCIN® oral suspension and OXAYDO® (oxycodone HCI, USP) tablets for oral use only –CII.
Zyla Life Sciences Logo. (PRNewsFoto/Zyla Life Sciences) (PRNewsfoto/ZYLA LIFE SCIENCES )
"With our expanded product portfolio, we had third quarter net product sales of $22.4 million, almost three times net product sales for the same period in 2018," said Todd Smith, president and chief executive officer of Zyla. "In the third quarter, we generated $6.5 million in net cash due to our product portfolio expansion, while maintaining similar operating expenses and commercial infrastructure. We continue to identify areas to increase efficiencies and improve our commercial impact."
Recent Event
The Company appointed Todd N. Smith as president, chief executive officer and a director, effective October 23, 2019.
2019 Third Quarter Financial Results
Cash Position: As of September 30, 2019, Zyla had cash and restricted cash totaling $19.0 million. Cash generated from operating activities for the three months ended September 30, 2019 was $6.8 million.
Net Product Sales: Net product sales were $22.4 million for the three months ended September 30, 2019 compared to $8.2 million for the three months ended September 30, 2018. The increase was largely due to the addition of the five acquired products at the end of January 2019.
Cost of Sales (excluding product rights amortization): Cost of sales was $10.4 million for the three months ended September 30, 2019 compared to $1.8 million for the three months ended September 30, 2018. The increase was driven by higher product sales as a result of the five new products acquired at the end of January 2019 and the revaluation of inventory in connection with the reorganization.
G&A Expenses: General and administrative expenses were $6.0 million for the three months ended September 30, 2019 compared to $5.6 million for the three months ended September 30, 2018. The increase was attributable to $0.4 million of higher administrative expense and $0.4 million of higher Food and Drug Administration fees related to products acquired during 2019, partially offset by a $0.4 million decrease in post-marketing study fees related to ARYMO® ER (morphine sulfate) extended-release tablets for oral use —CII which the Company discontinued in September 2018 and OXAYDO.
S&M Expenses: Sales and marketing expenses were $9.3 million for the three months ended September 30, 2019 compared to $7.9 million for the three months ended September 30, 2018. The $1.4 million increase was primarily attributable to $1.0 million of marketing programs for the acquired products and $0.4 million of other sales and marketing costs.
R&D Expenses: Research and development expenses were essentially zero for the three months ended September 30, 2019 compared to $1.0 million for the three months ended September 30, 2018. This decrease was driven by a discontinuation of R&D programs that did not directly support the growth of Zyla's commercial business.
Restructuring and Other Charges: There were no restructuring and other charges during the three months ended September 30, 2019. Restructuring and other charges of $13.9 million for the three months ended September 30, 2018 reflect costs related to the discontinuation of ARYMO ER of $8.2 million, a termination payment to Halo Pharmaceuticals of $3.1 million and legal fees related to the filing of the Company's Chapter 11 bankruptcy case of $2.6 million.
Interest Expense: Interest expense was $3.7 million for the three months ended September 30, 2019 compared to $32.9 million for the three months ended September 30, 2018. Interest expense for the three months ended September 30, 2019 includes non-cash interest and amortization of debt discount totaling $1.8 million. The interest expense for the three months ended September 30, 2018 includes non-cash interest and amortization of debt discount totaling $29.8 million and included the acceleration of the debt discounts due to the revaluation of these instruments due to the events of default.
Other Gain: Other gain was $1.1 million for the three months ended September 30, 2019 compared to $0.1 million for the three months ended September 30, 2018.
Net Loss: Net loss for the three months ended September 30, 2019 was $10.3 million compared to a net loss of $51.2 million for the three months ended September 30, 2018.
News Zyla Life Sciences Announces Management Changes
Zyla Life Sciences Logo. (PRNewsFoto/Zyla Life Sciences) (PRNewsfoto/ZYLA LIFE SCIENCES )
NEWS PROVIDED BY
Zyla Life Sciences
Oct 23, 2019, 09:00 ET
WAYNE, Pa., Oct. 23, 2019 /PRNewswire/ -- Zyla Life Sciences (OTCQX: ZCOR) ("Zyla"), a commercial-stage life sciences company, today announced that Robert Radie, has resigned as president, chief executive officer and director of the Company to pursue other opportunities. Mr. Radie will continue to serve as principal financial officer until December 31, 2019 in order to ensure a smooth transition. Additionally, the Company announced the appointment of Todd N. Smith as president, chief executive officer and director, effective immediately.
"On behalf of the board, I want to thank Bob for his contributions and service to Zyla and its leadership team during the last seven years," said Timothy P. Walbert, chairman of the board, Zyla. "I would also like to welcome Todd Smith to the Company. He is an accomplished executive with significant experience driving deal making and commercial success in different therapeutic areas and I am confident that he will continue that track record at Zyla."
Mr. Smith has more than 25 years of experience in the biopharmaceutical industry. Before joining the Company, from 2017 through February 2019, Mr. Smith, served as chief executive officer and a director of Iroko Pharmaceuticals Inc., a privately-owned pharmaceutical company, from which the Company purchased five products in early 2019. During the period October 2014 through June 2015, Mr. Smith served as the chief commercial officer of Ophthotech Corporation, a biopharmaceutical company focused on developing novel therapeutics to treat ophthalmic diseases. Since 2014, Mr. Smith has also held multiple senior roles at privately owned pharmaceutical and medical device companies. Additionally, he has held a variety of senior commercial and marketing roles at organizations including Horizon Therapeutics plc, a public biopharmaceutical company focused on rare and rheumatic diseases, and Abbott, a public healthcare products company.
Forward Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. In some cases, you can identify forward-looking statements by the word "will," or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this press release, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain, including, but not limited to, risks related to: anticipated benefits of our acquisition of products from Iroko Pharmaceuticals, Inc. and its affiliates and the impact of the acquisition on our earnings, capital structure, strategic plan and results of operations; our ability to continue as a going concern, including our ability to access cash when necessary; our ability to comply with our debt covenants; the impact of our bankruptcy on our business going forward, including with regard to relationships with vendors and customers, employee attrition and the costs and expenses resulting from our bankruptcy; the trading price of our common stock and the liquidity of the trading market with respect thereto; our ability to satisfy the initial listing requirements of the Nasdaq Stock Market; our ability to maintain our key license arrangements, including our license agreement with iCeutica Inc., which has alleged a material breach thereof; our ability to recruit or retain key scientific or management personnel or to retain our executive officers; our ability to obtain and maintain regulatory approval of our products and the labeling claims that we believe are necessary or desirable for successful commercialization of our products; the impact of strengthening any of the labels for our products; our ability to maintain the intellectual property position of our products; our ability to operate our business without infringing the intellectual property rights of others; our ability to identify and reliance upon qualified third parties to manufacture our products, particularly single source suppliers; our ability to execute on our sales and marketing strategy, including developing relationships with customers, physicians, payors and other constituencies and differentiating our products in a crowded therapeutic area; our ability to commercialize our products, and to do so successfully; the rate and degree of receptivity in the marketplace and among physicians to our products; the costs of commercialization activities, including marketing, sales and distribution; the size and growth potential of the markets for our products, and our ability to service those markets; our ability to obtain reimbursement and third-party payor contracts for our products; the impact of commercial access wins on patient access to our products; the entry of any generic products for SPRIX Nasal Spray or our other products or the loss of exclusivity with regard to any of our licenses; any delay in or inability to reformulate SPRIX Nasal Spray; our ability to find and hire qualified sales professionals; the success of products that compete with our products that are or become available; the regulatory environment and recently enacted and future legislation and regulations regarding the healthcare system, including relating to social concerns about limiting the use of opioids; the outcome of any litigation or disputes in which we are or may be involved; our ability to integrate and grow any businesses or products that it may acquire; and general market conditions.
You should refer to the "Risk Factors" section of our most recent Annual Report on Form 10-K and our other filings with the United States Securities and Exchange Commission for a discussion of additional important factors that may cause our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these risks and uncertainties, readers are cautioned not to place undue reliance on any forward-looking statements included herein or that may be made elsewhere from time to time by, or on behalf of, us. Furthermore, such forward-looking statements speak only as of the date of this report. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
About Zyla Life Sciences
Zyla is a commercial life sciences business committed to bringing important medicines to patients and healthcare providers. The company is currently focused on marketing its portfolio of medicines for pain and inflammation. Zyla's portfolio includes seven medicines: SPRIX® (ketorolac tromethamine) nasal spray, ZORVOLEX® (diclofenac), VIVLODEX® (meloxicam), TIVORBEX® indomethacin), INDOCIN® (indomethacin) suppositories, INDOCIN® oral suspension and OXAYDO® (oxycodone HCI, USP) tablets for oral use only — CII. To augment its portfolio, Zyla is seeking to acquire additional development candidates or approved medicines to develop and commercialize.
For full prescribing information, boxed warnings and medication guides, please visit the following sites for each product: sprix.com, vivlodex.com, zorvolex.com, tivorbex.com and oxaydo.com. Prescribing information, the boxed warning and medication guide for INDOCIN suppositories and oral suspension can be found at dailymed.nlm.nih.gov.
Media and Investor Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: ir@zyla.com
Tel: 484-259-7370
SOURCE Zyla Life Sciences
Related Links
http://www.egalet.com
Look at the volume!
Purdue Pharma files for bankruptcy as the firm blamed for triggering America's opioid crisis cuts a $12bn deal - but prosecutors vow to recover billions from owners the Sackler family
https://www.dailymail.co.uk/news/article-7467651/Purdue-Pharma-files-bankruptcy-Sunday-night.html
$MNK it gives me great pleasure
Mallinckrodt -23% as it reportedly taps restructuring firms
Sep. 4, 2019 5:07 PM ET|About: Mallinckrodt plc (MNK)|By: Jason Aycock, SA News Editor
Mallinckrodt (NYSE:MNK) has sunk 23.3% after hours after Bloomberg reports the company's hired firms to explore restructuring.
The company has hired Latham & Watkins as a law firm and AlixPartners as consultants to advise on the potential costs from thousands of opioid lawsuits.
It may consider bankruptcy if the liabilities aren't manageable, according to the report.
Egalet Corp. changed to Zyla Life Sciences:
https://otce.finra.org/otce/dailyList?viewType=Symbol%2FName%20Changes
Egalet mentioned here. Heavy volume yesterday.
http://industrynewsblog.com/77981/global-demerol-meperidine-market-insights-deep-analysis-2019-2024-purdue-pharma-egalet-boehringer-ingelheim-janssen-sanofi/
Egalet Corp. NEW shares, ticker ZCOR:
https://otce.finra.org/otce/dailyList?viewType=Additions
EGLTQ: Bankruptcy PLAN effective. All shares cancelled:
https://otce.finra.org/otce/dailyList?viewType=Deletions
The common stock is now cancelled, as the bankruptcy effective date was yesterday.
http://www.sec.gov/Archives/edgar/data/1586105/000110465919005192/0001104659-19-005192-index.htm
The ticker will likely show up on FINRA's Daily List for elimination early next week, at which point the old common stock will cease to trade forever.
Thanks for the breakdown
Shareholders get nothing. The common stock is being cancelled.
"the cancellation on the Effective Date of all of Egalet Corp.’s common stock and all other equity interests in Egalet Corp."
http://www.sec.gov/Archives/edgar/data/1586105/000110465919002111/a19-2907_28k.htm
The Effective date is scheduled for January 31. The stock will trade until then but will disappear forever once the bankruptcy plan is confirmed and FINRA cancels the ticker. That is likely to happen without any additional notice.
So shareholders get nothing? I’m kinda confused on the news can anyone break it down for idiots like me
Question for the board: If one were to buy this stock as a “Q”, and the company comes out of Chapt 11 status, will the Q stock then convert back to regular shares, or will one need to re-buy shares of the company?
EGLT management has screwed up everything else, maybe they'll botch the BK.
$EGLTQ: $50Million in Cash & Holdings
Press Release: Egalet Reports Third Quarter 2018 Financial ResultsFont size: A | A | A
6:05 AM ET 11/19/18 | Dow Jones
RELATED QUOTES
9:49 AM ET 11/19/18
Symbol Last % Chg
EGLTQ
0.02 5.00%
Real time quote.
Press Release: Egalet Reports Third Quarter 2018 Financial Results
Egalet Reports Third Quarter 2018 Financial Results
-- Highest quarterly revenue for SPRIX Nasal Spray and OXAYDO --
PR Newswire
WAYNE, Pa., Nov. 19, 2018
WAYNE, Pa., Nov. 19, 2018 /PRNewswire/ -- Egalet Corporation (Nasdaq: EGLT) ("Egalet"), a fully integrated specialty pharmaceutical company focused on developing, manufacturing and marketing innovative treatments for pain, today reported financial results for the third quarter ended September 30, 2018 including results from commercial products: SPRIX(R) (ketorolac tromethamine) Nasal Spray and OXAYDO(R) (oxycodone HCI, USP) tablets for oral use only --CII.
"In the third quarter, we grew our commercial products and had the highest revenue for any quarter since we acquired SPRIX and licensed OXAYDO in January 2015," said Bob Radie, president and chief executive officer of Egalet. "For the remainder of the year, we are focused on continuing to grow SPRIX and OXAYDO revenues and working toward the anticipated first quarter 2019 closing of our previously-announced acquisition and financial restructuring."
2018 Third Quarter Financial Results
-- Cash Position: As of September 30, 2018, Egalet had cash, marketable
securities and restricted cash totaling $50.6 million.
-- Net Product Sales: There were net product sales of $8.2 million for the
three months ended September 30, 2018 compared to $6.7 million for the
same period in 2017. Net product sales for the three months ended
September 30, 2018 consisted of $6.1 million for SPRIX Nasal Spray, $1.9
million for OXAYDO and $174,000 for ARYMO ER. Net product sales for the
three months ended September 30, 2017 consisted of $5.0 million for SPRIX
Nasal Spray, $1.4 million for OXAYDO and $208,000 for ARYMO ER. Due to
the adoption of ASC 606 on January 1, 2018, net product sales for the
three months ended September 30, 2017 reflected prescriptions dispensed
to patients and net product sales for the three months ended September
30, 2018 reflected shipments to customers.
-- Cost of Sales (excluding product rights amortization): Cost of sales was
$1.8 million for the three months ended September 30, 2018 and $1.2
million for the same period in 2017. Cost of sales for SPRIX Nasal Spray,
OXAYDO and ARYMO ER for the three months ended September 30, 2018
reflects the average cost of inventory shipped to wholesalers and
specialty pharmaceutical companies during the period. Cost of sales for
SPRIX Nasal Spray and OXAYDO for the three months ended September 30,
2017 reflects the average cost of inventory produced and dispensed to
patients in the period. Cost of sales for ARYMO ER for the three months
ended September 30, 2017 includes the portion of inventory produced after
the FDA approval of ARYMO ER in January 2017. The portion of inventory
produced before the FDA approval of ARYMO ER was recorded in research and
development expense in prior periods.
-- G&A Expenses: General and administrative expenses were $5.6 million for
the three months ended September 30, 2018 compared to $6.8 million for
the same period in 2017. The decrease in the period was due to a decrease
in post-marketing study fees and salary expense as well as decreases in
administrative and consultant fees incurred in the three months ended
September 30, 2018.
-- S&M Expenses: Sales and marketing expenses were $7.9 million for the
three months ended September 30, 2018 compared to $8.8 million for the
same period in 2017.
-- R&D Expenses: Research and development expenses were $1.0 million for the
three months ended September 30, 2018 compared to $2.1 million for the
same period in 2017. The decrease was driven by a reduction in clinical
studies expense of $1.1 million in the three months ended September 30,
2018.
-- Restructuring and Other Charges: Restructuring and other charges of $13.9
million for the three months ended September 30, 2018 reflect costs
related to the discontinuation of ARYMO ER of $8.2 million, a charge
related to the termination payment to Halo Pharmaceuticals of $3.1
million and legal fees incurred in the three months ended September 30,
2018 related to the filing of the Chapter 11 Cases of $2.6 million.
Restructuring and other charges of $3.0 million for the three months
ended September 30, 2017 reflect costs related to Egalet's expense
reduction plan announced in August 2017 to decrease the operating
expenses that did not directly support the growth of Egalet's commercial
business.
-- Change in Fair Value of Warrant Liability and Derivative Liability:
During the three months ended September 30, 2018, Egalet recognized a
change in the fair value of its derivative liabilities of $4.0 million.
The change in fair value of the derivative liability is due primarily to
the changes in the value of Egalet's common stock during the three months
ended September 30, 2018.
-- Interest Expense: Interest expense for the three months ended September
30, 2018 was $32.9 million compared to interest expense of $4.7 million
for the same period in 2017. The increase was driven primarily by the
acceleration of the amortization of the debt discounts related to our
5.50% Notes, 6.50% Notes and 13% Notes.
-- Net Loss: Net loss for the three months ended September 30, 2018 was
($51.2 million), or ($0.93) per share, compared to a net loss of ($18.9
million), or ($0.46) per share for the same period in 2017.
Recent Announcement
On October 31, 2018, Egalet announced it had entered into an asset purchase agreement to acquire four marketed products from Iroko Pharmaceuticals, Inc. ("Iroko"). If consummated, the proposed transaction will enable Egalet to focus on marketing predominantly non-narcotic pain products. To facilitate this transaction and reorganize Egalet's capital structure, Egalet has initiated proceedings under Chapter 11 of the United States Bankruptcy Code in the District of Delaware. As part of its restructuring, Egalet has filed a plan of reorganization that is supported by a majority in dollar amount of all classes of Egalet's debt holders. Additional information on the transaction and filing is contained in a report on Form 8-K filed with the Securities and Exchange Commission.
About Egalet
Egalet, a fully integrated specialty pharmaceutical company, is focused on developing, manufacturing and commercializing innovative treatments for pain. Given the need for acute and chronic pain products and the issue of prescription opioid abuse, Egalet is focused on bringing non-narcotic products and abuse-discouraging formulations of opioids to patients and healthcare providers. Egalet currently promotes two approved products: SPRIX(R) (ketorolac tromethamine) Nasal Spray and OXAYDO(R) (oxycodone HCI, USP) tablets for oral use only --CII. Egalet also has a pipeline of products developed using Guardian(R) Technology which it may look to partner. The Company plans to continue to grow revenues of its commercial products, explore business development opportunities and leverage its proprietary Guardian Technology.
For full prescribing information on SPRIX, including the boxed warning and medication guide, please visit sprix.com. For full prescribing information on OXAYDO, including the boxed warning and medication guide, please visit oxaydo.com.
Safe Harbor
Statements included in this press release (including but not limited to upcoming milestones) that are not historical in nature and contain the words "anticipate," "believe," "estimate," "expect," "intend," "may," "plan," "predict," "project," "suggest," "target," "potential," "will," "would," "could," "should," "continue," "look forward to" and other similar expressions are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on management's current expectations and are subject to known and unknown uncertainties and risks. Actual results could differ materially from those discussed due to a number of factors, including, but not limited to: the costs of Egalet's restructuring and the ability to emerge expeditiously, including there being no substantial objection to or litigation with respect to the restructuring; Egalet's ability to satisfy the requirements of its restructuring support agreement, including consummation of its proposed plan of reorganization; Egalet's expected motions to be filed in its Chapter 11 proceeding and the dispositions of such motions; Egalet's continued operations and customer and supplier relationships while in a Chapter 11 proceeding; the resources needed to support Egalet's operations while in a Chapter 11 proceeding; Egalet's ability to lower debt and interest payments, operate its business and satisfy its obligations while in a Chapter 11 proceeding; the public disclosure of sensitive business information, including projections, as part of the Chapter 11 proceedings; the anticipated benefits of the proposed Iroko acquisition and the impact of the Iroko acquisition on Egalet's earnings, capital structure, strategic plan and results of operations; the occurrence of any event, change or other circumstance that could give rise to the termination of the asset purchase agreement related to Egalet's acquisition of products from Iroko (the "Iroko Acquisition"), the failure of the closing conditions to the Iroko Acquisition to be satisfied (or any material delay in satisfying such conditions); the failure to consummate the Iroko Acquisition; the costs, fees, expenses and charges (if any) related to the Iroko Acquisition and Egalet's restructuring; Egalet's ability to continue as a going concern; the trading price of Egalet's common stock and the liquidity of the trading market with respect thereto, including the fact that
(MORE TO FOLLOW) Dow Jones Newswires
November 19, 2018 06:02 ET (11:02 GMT)
Press Release: Egalet Reports Third Quarter 2018 -2-
Egalet's bankruptcy plan contemplated by the restructuring support agreement provides for all existing equity interests of its common stockholders to be cancelled and for its common stockholders to lose the full amount of their investment; Egalet's ability to satisfy Nasdaq initial listing requirements; Egalet's ability to recruit or retain key scientific or management personnel or to retain our executive officers; Egalet's ability to obtain and maintain regulatory approval of Egalet's or Iroko's products and the labeling claims that Egalet believes are necessary or desirable for successful commercialization of its products and product candidates; the impact of strengthening any of the labels for Egalet's products; Egalet's ability to maintain the intellectual property position of Egalet's or Iroko's products; Egalet's ability to identify and reliance upon qualified third parties to manufacture its products; Egalet's ability to commercialize its and Iroko's products, and to do so successfully; the costs of commercialization activities, including marketing, sales and distribution; the size and growth potential of the markets for Egalet's products and product candidates, and Egalet's ability to service those markets; Egalet's ability to obtain reimbursement and third-party payor contracts for its and Iroko's products; the impact of commercial access wins on patient access to SPRIX; the entry of any generic products for SPRIX or other products; any delay in or inability to reformulate SPRIX; Egalet's ability to find and hire qualified sales and other professionals and to retain those professionals during the pendency of Egalet's bankruptcy; the rate and degree of receptivity in the marketplace and among physicians to Egalet's and Iroko's products; the success of products that compete with Egalet's that are or become available; the regulatory environment and social concerns about limiting the use of opioids; Egalet's ability to integrate and grow any businesses or products that it may acquire; general market conditions; and other risk factors set forth in Egalet's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the United States Securities and Exchange Commission (SEC) and in other filings Egalet makes with the SEC from time to time. While Egalet may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to update or revise any forward-looking-statements contained in this press release whether as a result of new information or future events, except as may be required by law.
Media and Investor Contact:
E. Blair Clark-Schoeb
Senior Vice President, Communications
Email: ir@egalet.com
Tel: 484-259-7370
Egalet Corporation and Subsidiaries
Consolidated Balance Sheets
(in thousands, except share and per share data)
December 31, 2017 September 30, 2018
(unaudited)
Assets
Current assets:
Cash and cash equivalents $ 31,090 $ 34,248
Marketable securities,
available for sale 59,953 15,966
Accounts receivable 4,120 10,841
Inventory 3,225 3,039
Prepaid expenses and other
current assets 2,672 848
Other receivables 893 991
Total current assets 101,953 65,933
Intangible assets, net 6,583 4,816
Restricted cash 400 400
Property and equipment, net 9,911 1,158
Deposits and other assets 1,011 308
Total assets $ 119,858 $ 72,615
Liabilities and stockholders'
deficit
Current liabilities:
Accounts payable $ 10,160 $ 6,708
Accrued expenses 16,104 27,001
Deferred revenue 7,456 --
Debt - current, net 1,081 129,372
Warrant liability 8,166 --
Total current liabilities 42,967 163,081
Debt - non-current portion, net 98,890 1,221
Deferred income tax liability 26 25
Derivative liability 16,623 --
Other liabilities 727 583
Total liabilities 159,233 164,910
Stockholders' deficit:
Common stock--$0.001 par value;
75,000,000 and 275,000,000
shares authorized at December
31, 2017 and September 30,
2018, respectively; 45,939,663
and 56,772,101 shares issued
and outstanding at December
31, 2017 and September 30,
2018, respectively 46 53
Additional paid-in capital 254,871 275,680
Accumulated other comprehensive
income 1,008 912
Accumulated deficit (295,300) (368,940)
Total stockholders' deficit (39,375) (92,295)
Total liabilities and
stockholders' deficit $ 119,858 $ 72,615
Egalet Corporation and Subsidiaries
Consolidated Statements of Operations (Unaudited)
(in thousands, except share and per share data)
Three Months Ended Nine Months Ended
September 30, September 30,
2017 2018 2017 2018
Revenue
Net product sales $6,651 $8,153 $18,333 $21,857
Total revenue 6,651 8,153 18,333 21,857
Costs and Expenses
Cost of sales (excluding
amortization of product
rights) 1,249 1,773 3,646 5,553
Amortization of product
rights 528 526 1,554 1,594
General and
administrative 6,849 5,556 27,811 19,322
Sales and marketing 8,803 7,932 27,402 26,006
Research and development 2,073 956 13,187 3,258
Restructuring and other
charges 2,983 13,864 2,983 13,864
Total costs and expenses 22,485 30,607 76,583 69,597
Loss from operations (15,834) (22,454) (58,250) (47,740)
Other (income) expense:
Change in fair value of
warrant and derivative
liability (1,500) (3,986) (1,513) (12,292)
Interest expense, net 4,675 32,891 13,958 40,251
Other (gain) loss (60) (132) 106 (158)
Gain on foreign currency
exchange (1) -- (1) (1)
3,114 28,773 12,550 27,800
Loss before provision
(benefit) for income
taxes (18,948) (51,227) (70,800) (75,540)
Provision (benefit) for
income taxes -- -- -- --
Net loss $(18,948) $(51,227) $(70,800) $(75,540)
Per share information:
Net loss per share of
common stock, basic and
diluted $(0.46) $(0.93) $(2.32) $(1.45)
Weighted-average shares
outstanding, basic and
diluted 41,149,838 55,192,542 30,525,158 51,944,358
View original content to download multimedia:www.prnewswire.com/news-releases/egalet-reports-third-quarter-2018-financial-results-300752338.html
SOURCE Egalet Corporation
/Web site: http://www.egalet.com
> Dow Jones Newswires
November 19, 2018 06:02 ET (11:02 GMT)
Egalet 3Q Rev $6.65M >EGLT
(MORE TO FOLLOW) Dow Jones Newswires (212-416-2800)
November 19, 2018 06:04 ET (11:04 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
Egalet 3Q Loss/Shr 46c >EGLT
(MORE TO FOLLOW) Dow Jones Newswires (212-416-2800)
November 19, 2018 06:04 ET (11:04 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
Correct: Egalet 3Q Rev $8.15M >EGLT
(MORE TO FOLLOW) Dow Jones Newswires (212-416-2800)
November 19, 2018 06:04 ET (11:04 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
*DJ Correct: Egalet 3Q Loss/Shr 93c >EGLT
(MORE TO FOLLOW) Dow Jones Newswires (212-416-2800)
November 19, 2018 06:05 ET (11:05 GMT)
Copyright (c) 2018 Dow Jones & Company, Inc.
Scumbag CEO statement about earnings...
"In the third quarter, we grew our commercial products and had the highest revenue for any quarter since we acquired SPRIX and licensed OXAYDO in January 2015," said Bob Radie, president and chief executive officer of Egalet. "For the remainder of the year, we are focused on continuing to grow SPRIX and OXAYDO revenues and working toward the anticipated first quarter 2019 closing of our previously-announced acquisition and financial restructuring."
Had to dump this crap. Hopefully the BK judge will at least comment on what incompetent scumbags these guys have proven to be.
Saw a house I would like to buy. Think I'll go bankrupt then put in an offer.
lowly retailers will be offered no new shares of new company
in exchange for their lost shares, believe snup
been there done that , learned the hard way but experience
matters today.
eltp
will indeed give your monies back
Hope some trust snup
snupDAWGoled
Mrlucky,
legal not legal, us retail shareholders are never EVER thought about
it is the game,
eglt shareholders are done, the company aint, it will reposition
and next batch of shareholders will buy into its dream
I am sorry, take my advise , I learned the hard way also.
snup
May be legal but smells unethical to me if they try to screw shareholders.
Like Yogi said, "It ain't over until it's over".
Mr.Lucky,
believe me I experienced it too.
do your dd man and ride the train about
to take off
snup
sorry about egalet, board, I have had this happen in my lifetime
believe me, it will go lower, best to sell at current price
what is left of it. yes it may briefly in near future trade up
but you got to pounce on that tiny crack to sell
eltp is an 8 cent stock with great catalysts coming, do your dd
I know that feeling, been there done that , wish I had someone
back then to guide what I had left.
thank me in six months,
snupDAWGoled Lehman bros. remember them any one? ouch
hope I helped someone,
yes, IT WILL CRASH FROM THIS LEVEL, TRUST ME.
Weird! I really thought it was a typo with the acquisition.
EGLT: effective Nov. 1,2018 EGLT will change to EGLTQ, bankruptcy:
http://otce.finra.org/DLSymbolNameChanges
Bankruptcy and acquisition on same day. I'm sure I could declare bankruptcy and buy a new house the same day.
Egalet filled Chapter 11 today.
https://www.inforuptcy.com/filings/debke_174955-1-18-bk-12439-egalet-corporation
Getting rid of Stan Musial. Maybe they can get somebody named Ernie Banks to replace him.
http://archive.fast-edgar.com//20181018/AQAOB62C8Z22SZZ222TQ2ZZZONMNZ2Z2N2A2/
Aren't they due to get the designation anti abusive for snorting soon?
What are you referring too on that page?
On September 28, 2018, Egalet Corporation (the “Company”) notified the U.S. Food and Drug Administration that, for business reasons, the Company is discontinuing the manufacture and promotion of Arymo® ER (morphine sulfate) extended-release tablets (“ARYMO ER”) effective September 28, 2018 (the “Discontinuation”). As part of its notice, the Company requested that the Orange Book staff move ARYMO ER to the “Discontinued Drug Products List” of the Approved Drug Products and Therapeutic Equivalence Evaluations (Orange Book) publication, and that the User Fee staff note the discontinued status of the product.
Agreed. Not only is there a gap to fill, does no one notice the outside of lower BB's on the weekly? Divergence in the RSI?
I am positioned.
Full disclosure. I am a trader, and I only hold my positions temporarily. I am not an investor. Do your own DD.
Very interesting indeed. I can see this easily going back to the NASDAQ.
Before anyone rebuttals, and laughs at this statement. Please know that I'm dead serious. DD is serious.
But maybe not, you never know! Haha!
Funny no mention of this from the 18th. HMMMMMMMM........................
https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=report.page
First of all the company is not in as bad a position as all say.
The company's evaluation is several times more than its current stock price. I have not studied its product portfolio. But the company fundamentals deserve a far better price than what we see.
There is absolutely no reason for the company to even look in the direction of bankruptcy.
IMHO.
I have not bought any position in this company yet. I am looking for an entry point after I complete my due diligence (I am still working on it)
wow up +50% at noon. Maybe they are not dead yet.
NASD to pink ouch...That's like selling your Porsche and getting a volkswagon beetle..
Thank you!
I have not bought any position in this stock yet. Also, I do not have a paid subscription. I have just begun my research. Let me see where it gets me to. Then I will decide to buy or not.
I’m not sure I was here sharing the ADF article from Seeking alpha.
Maybe ask AMA on other board.
If you have paid subscription search Eaglet and EGLT on other board.
Either way good luck hope it turns around for you.
EGLT
Hi NASDAQ
You know me from the ELTP board.
I just got onto this stock yesterday when some one mentioned about its enormous potential elsewhere.
Unable to understand its drastic fall during the last couple of days. Do you have any DD to spare for me? I would appreciate if you can PM me.
Thanks in advance!
I guess bankruptcy is next
This Amendment No. 2 to the Schedule TO is being filed to terminate and withdraw the Offer. As further described in the Form 8-K, the Company is terminating and withdrawing the Offer and is pursuing other options with respect to restructuring the 5.50% Notes and the Company’s other indebtedness, securities and obligations. The Company will not accept for payment any of the 5.50% Notes tenders by the Holders and will promptly return all 5.50% Notes tendered by the Holders pursuant to the Offer.
EGLT: Delisted from the Nasdaq to the OTC:
http://otce.finra.org/DLAdditions
more bad news from the FDA today.
It increases cost.
The generics are still in control of the corrupt FDA.
https://www.prnewswire.com/news-releases/fda-takes-important-steps-to-encourage-appropriate-and-rational-prescribing-of-opioids-through-final-approval-of-new-safety-measures-governing-the-use-of-immediate-release-opioid-analgesic-medications-300714855.html
SILVER SPRING, Md., Sept. 18, 2018 /PRNewswire/ -- Today, the U.S. Food and Drug Administration took new steps as part of its broader efforts to address the opioid crisis by approving the final Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS). This new plan includes several measures to help better communicate the serious risks about the use of opioid pain medications to patients and health care professionals. This expanded REMS now, for the first time, applies to immediate-release (IR) opioid analgesics intended for use in an outpatient setting. The new REMS also applies to the extended-release and long-acting (ER/LA) opioid analgesics, which have been subject to a REMS since 2012.
The REMS program requires, for the first time, that training be made available to health care providers who are involved in the management of patients with pain, and not only to prescribers. For example, the training provided through the REMS must be made available to nurses and pharmacists. The new REMS also requires that the education cover broader information about appropriate pain management, including alternatives to opioids for the treatment of pain. The agency is also approving new product labeling containing information about the health care provider education available through the new REMS.
"Opioid addiction is an immense public health crisis. Addressing it is one of the FDA's highest priorities. As part of our comprehensive work in this area, we're taking new steps to rationalize prescribing and reduce overall exposure to these drugs as a way to cut the rate of new addiction. Many people who become addicted to opioids will have their first exposure in the medical setting. Providers have a critical role to play in making sure these products are appropriately prescribed to patients. Our new effort is aimed at arming providers with the most current and comprehensive information on the appropriate management of pain. This includes ensuring that prescriptions are written for only appropriate purposes and durations of use. Today's action, importantly, subjects immediate-release opioids – which are the most commonly prescribed opioid products – to a more stringent set of requirements. The action also adds new labeling for all opioids to raise awareness about available educational materials on prescribing these powerful medications," said FDA Commissioner Scott Gottlieb, M.D. "Appropriate prescribing practices and education are important steps that we're prioritizing to help address the human and financial toll of this crisis. Our aim is to make sure the medical community can take advantage of the available education on pain management and safe use of opioid analgesic products. At the same time, we're also taking new steps to advance the development of evidence-based, indication-specific guidelines to help further guide appropriate prescribing of opioids. The goal is that these guidelines will provide evidence-based information on the proper number of opioid doses that should be dispensed for different medical conditions for which these drugs may be indicated. The aim is to reduce overall dispensing as a way to further reduce exposure to these drugs. Our goal is to help prevent patients from becoming addicted by decreasing unnecessary or inappropriate exposure to opioids and fostering rational prescribing to enable appropriate access to those patients who have legitimate medical need for these medicines."
Since 2012, manufacturers of ER/LA opioid analgesics have been subject to a REMS that requires as its primary component, that training be made available to prescribers of those products. To meet this requirement, drug companies with approved ER/LA opioid analgesics have been providing unrestricted grants to accredited continuing education providers for the development of education courses for prescribers based on content outlined by the FDA. As part of the final action being taken today, these REMS requirements now also apply to IR opioid analgesic products intended for outpatient use. The IR drugs account for about 90 percent of all opioid pain medications prescribed for outpatient use. Additionally, the entire class of transmucosal immediate-release fentanyl (TIRF) prescription medicines have been subject to a REMS since December 2011.
In addition to expanding the REMS to include IR opioid analgesic products intended for outpatient use, the agency has approved the new FDA Opioid Analgesic REMS Education Blueprint for Health Care Providers Involved in the Treatment and Monitoring of Patients with Pain (Blueprint). This includes updated educational content. The agency believes that all health care providers involved in the management of patients with pain should be educated about the safe use of opioids so that when they write or dispense a prescription for an opioid analgesic, or monitor patients receiving these medications, they can help ensure the proper product is selected for the patient and used with appropriate clinical oversight. It is expected that continuing education training under the modified REMS will be available to health care providers by March 2019.
Today's action greatly expands the number of products covered by the REMS. Prior to today, the ER/LA Opioid Analgesic REMS included 62 products. But the modified Opioid Analgesic REMS now requires that 347 opioid analgesics intended for outpatient use be subject to these REMS requirements. The REMS program continues to include Medication Guides for patients and caregivers to read, new Patient Counseling Guides to assist health care providers with important discussions with patients, and plans for assessing the program's effectiveness.
The FDA is also approving new safety labeling changes for all opioid analgesic products intended for use in an outpatient setting. For the first time, the FDA is requiring the labeling for those products to include information about the availability of education through the REMS for prescribers and other health care providers who are involved in the treatment and monitoring of patients with pain. The new labeling includes information about REMS-compliant education in the Boxed Warning and Warnings and Precautions sections of labeling and strongly encourages providers to complete a REMS-compliant education program; counsel patients and caregivers on the safe use, risks, and appropriate storage and disposal of these products; emphasize to patients and their caregivers the importance of reading the Medication Guide every time it is provided by their pharmacist; and to consider other tools to improve patient, household and community safety.
There is no mandatory federal requirement that prescribers or other health care providers take the training provided through the REMS and completion of the training is not a precondition to prescribing opioid analgesics to patients. However, the FDA's Opioid Policy Steering Committee continues to consider whether there are circumstances when the FDA should require some form of mandatory education for health care providers and how the agency would pursue such a goal. The FDA also recently awarded a contract to the National Academies of Sciences, Engineering, and Medicine to help develop a framework to assist medical professional societies in creating evidence-based guidelines on appropriate opioid analgesic prescribing to treat acute pain resulting from specific medical conditions and common surgical procedures for which these drugs are prescribed. The agency's aim is to reduce unnecessary and/or inappropriate exposure to opioids by making certain that prescribers are properly informed about appropriate prescribing recommendations, that providers understand how to identify abuse by individual patients, and know how to get patients with opioid use disorder into treatment. The crisis of opioid addiction is a public health tragedy of enormous proportions. The FDA's goal is to reduce serious adverse outcomes resulting from inappropriate prescribing, misuse and abuse of opioid analgesics, while maintaining patient access to pain medications.
As part of the U.S. Department of Health and Human Services' Five-Point Strategy to Combat the Opioid Crisis, the FDA remains committed to addressing the national crisis of opioid addiction on all fronts, with a significant focus on decreasing unnecessary and/or inappropriate exposure to opioids and preventing new addiction; supporting the treatment of those with opioid use disorder; fostering the development of novel pain treatment therapies and opioids more resistant to abuse and misuse; and taking action against those who contribute to the illegal importation and sale of opioid products. The FDA will also continue to evaluate how drugs currently on the market are used, in both medical and illicit settings, and take regulatory action where needed.
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.
Media Inquiries: Lyndsay Meyer, 240-402-5345, lyndsay.meyer@fda.hhs.gov; Michael Felberbaum, 240-402-9548, michael.felberbaum@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
SOURCE U.S. Food and Drug Administration
Amazing how this one gets zero recognition in a critical industry right now
Followers
|
32
|
Posters
|
|
Posts (Today)
|
0
|
Posts (Total)
|
672
|
Created
|
10/27/14
|
Type
|
Free
|
Moderators |
Enterprise Value (EV), using $99M total debt, $91M cash and 75M OS (fully diluted):
- $61M EV at 70c and
- $108M EV @ $1.33
EV-2 using $160M total liabilities, $91M cash and 75M OS (fully diluted):
- $122M EV at 70c and
- $169M EV @ $1.33
EV-3 using $99M total debt, $91M cash and 47M OS (current):
- $41M EV at 70c and
- $71M EV @ $1.33
Recent Status / Catalysts
- Arymo ER Sales Increase
- Completion of Debt Swap @ around $1.33/sh, fixing $50M mcap listing deficiency, removes going concern note
- Removal of the Debt Covenant triggered the going concern note (PR 3/23)
- $6B opioid crisis budget omnibus bill signed 3/23 instead of $2.8B
- $1 SP Listing Extension if required, RS as last resort (PR 3/23)
- 002 and Guardian Partnership / Sales - Extended Arymo ER Label in Oct '18
- Lawsuit Settlement (Arymo ER Extended Label Dispute)
Volume | |
Day Range: | |
Bid Price | |
Ask Price | |
Last Trade Time: |