Quest Diagnostics Reports Second Quarter 2019 Financial Results

On July 23, 2019 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the second quarter ended June 30, 2019 (Press release, Quest Diagnostics, JUL 23, 2019, View Source [SID1234537660]).

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"Our volume growth accelerated in the second quarter due to our expanded network access, and we continued to build momentum through the first half of 2019," said Steve Rusckowski, Chairman, CEO and President. "This strong volume growth combined with our strategy to drive operational excellence helped offset the significant reimbursement pressures we are experiencing this year. We are excited by our new Preferred Lab Network status within UnitedHealthcare, which represents a multi-year opportunity that will build over time."

For further details impacting the year-over-year comparisons related to operating income, operating income as a percentage of net revenues, income from continuing operations attributable to Quest Diagnostics, and diluted EPS from continuing operations, see note 2 of the financial tables attached below.

Beginning in 2019, the company has changed how it presents adjusted income measures to additionally exclude amortization expense for all periods presented. We believe this presentation provides investors with additional insight to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business.

The outlook for reported diluted EPS from continuing operations was updated to greater than $5.29 from the previous outlook of greater than $5.16 due to the impact of special items in the second quarter. For a reconciliation of adjusted diluted EPS to reported diluted EPS from continuing operations, see note 5 to the financial tables attached below.

Note on Non-GAAP Financial Measures

As used in this press release the term "reported" refers to measures under the accounting principles generally accepted in the United States ("GAAP"). The term "adjusted" refers to non-GAAP operating performance measures that exclude special items such as restructuring and integration charges, amortization expense, excess tax benefit ("ETB") associated with stock-based compensation and other items.

Non-GAAP adjusted measures are presented because management believes those measures are useful adjuncts to GAAP results. Non-GAAP adjusted measures should not be considered as an alternative to the corresponding measures determined under GAAP. Management may use these non-GAAP measures to evaluate our performance period over period and relative to competitors, to analyze the underlying trends in our business, to establish operational budgets and forecasts and for incentive compensation purposes. We believe that these non-GAAP measures are useful to investors and analysts to evaluate our performance period over period and relative to competitors, as well as to analyze the underlying trends in our business and to assess our performance. The additional tables attached below include reconciliations of non-GAAP adjusted measures to GAAP measures.

Conference Call Information

Quest Diagnostics will hold its quarterly conference call to discuss financial results beginning at 8:30 a.m. Eastern Time today. The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, passcode: Investor; or via live webcast on the company’s website at www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 800-871-1320 for domestic callers or 402-280-1688 for international callers. No passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on July 23, 2019 until midnight Eastern Time on August 6, 2019. Anyone listening to the call is encouraged to read the company’s periodic reports, on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.

Dr. Reddy’s Q1 FY11 Financial Results: Revenue at Rs. 16.8 billion ($363 million); EBITDA at Rs. 3.4 billion ($74 million); Profit after Tax at Rs. 2.1 billion ($45 million)

On July 22, 2019 Dr. Reddy’s Laboratories Ltd. (NYSE: RDY) reported its unaudited financial results for the quarter ended June 30, 2010 under International Financial Reporting Standards (IFRS) (Press release, Dr Reddy’s, JUL 22, 2019, View Source [SID1234540967]).

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Key Highlights

Consolidated revenues are at Rs. 16.8 billion ($363 million) in Q1 FY11 versus Rs. 18.2 billion ($392 million) in Q1 FY10. Excluding the revenues from sumatriptan in the previous year, the year-on-year growth is 4%.
Revenues from Global Generics for Q1 FY11 are at Rs. 11.9 billion ($257 million). Excluding the revenues from sumatriptan, the year-on-year growth is 9%.
Revenues from PSAI are at Rs. 4.5 billion ($97 million) in Q1 FY11.
Profit before Tax for Q1 FY11 is at Rs. 2.5 billion ($53 million).
EBITDA of Rs. 3.4 billion ($74 million) in Q1 FY11, represents 20% to revenues.
Profit after Tax for Q1 FY11 is at Rs. 2.1 billion ($45 million).
During the quarter, the company launched 32 new generic products, filed 26 new product registrations and filed 3 DMFs globally.
During the quarter, Dr. Reddy’s transferred dossiers and trademarks for nine currently marketed products in Brazil to GSK, for a consideration of $4 million. The agreement also provides for additional consideration towards other products in the pipeline based on specified milestones. The milestone payments under this deal will be recognized as revenue over the term of the product supply agreement.

Includes amortization charge of Rs. 288 million ($6 million) in Q1 FY11 and Rs. 507 million ($11 million) in Q1 FY10.

Includes forex loss of Rs. 225 million ($5 million) in Q1 FY11 and Rs. 84 million ($2 million) in Q1 FY10.

Global Generics

Revenues from Global Generics segment are at Rs. 11.9 billion ($257 million) in Q1 FY11. Excluding the revenues from sumatriptan in the US, the growth is 9%.

Revenues from North America at Rs. 3.9 billion ($84 million) in Q1 FY11 versus Rs. 6.0 billion ($130 million) in Q1 FY10. Excluding the revenues from sumatriptan, the growth is 5% in dollar currency.
As at June 30, 2010, total cumulative ANDA filings are 163. Total ANDAs pending approval at the USFDA are 71 of which 36 are Para IVs and 12 are FTFs.
Revenues from Europe at Rs. 1.9 billion ($42 million) in Q1 FY11 versus Rs. 2.1 billion ($45 million) in Q1 FY10.
Revenues from Germany decrease by 18% to Rs. 1.3 billion ($28 million) in Q1 FY11. For the same period the decline in Euro currency is 6%.
Revenues from Rest of Europe grew by 29% to Rs. 516 million ($11 million) in Q1 FY11 largely led by the 21% growth in UK.
Revenues from Russia & Other CIS markets at Rs. 2.6 billion ($55 million) in Q1 FY11 versus Rs. 1.9 billion ($40 million) in Q1 FY10, or a growth of 36%.
Revenues in Russia at Rs. 2.1 billion ($44 million) in Q1 FY11 versus Rs. 1.5 billion ($33 million) in Q1 FY10 or a year-on-year growth of 35%.
Dr. Reddy’s year-on-year secondary prescription sales growth stands at 33% versus industry’s growth of 21%. (Source: Pharmexpert April-May 2010)
Revenues in Other CIS markets increase by 43% to Rs. 489 million ($11 million) in Q1 FY11 versus Rs. 342 million ($7 million) in Q1 FY10.
Revenues in India at Rs. 2.8 billion ($60 million) in Q1 FY11 versus Rs. 2.4 billion ($52 million) in Q1 FY10, a growth of 16% which is largely led by volume growth of existing products.
Dr. Reddy’s year-on-year secondary prescription sales growth is 22% versus industry’s growth of 20%.
(Source: ORG IMS MAT Jun 2010)
11 new products launched during the quarter.
Pharmaceutical Services and Active Ingredients (PSAI)

Revenues from PSAI are at Rs. 4.5 billion ($97 million) in Q1 FY11.
During the quarter, 3 DMFs were filed globally. The cumulative DMF filings as of Jun 10 are 378.
Income Statement Highlights:

Gross profit at Rs. 8.9 billion ($192 million) in Q1 FY11 at a margin of 53% to revenues versus 56% in Q1 FY10. This change in gross margin is largely on account of a favorable mix of high margin revenues from sumatriptan in the previous year.
Selling, General & Administration (SG&A) expenses excluding amortization for the quarter is at Rs. 5.2 billion ($112 million) or a decline of 4% over the previous year. Excluding the one-time charges recorded on account of betapharm workforce restructure costs of Rs. 496 million ($11 million) and the closure of Atlanta facility of Rs. 71 million ($2 million) in the previous year, SG&A grew by 7%.
Amortization expenses for the quarter is at Rs. 288 million ($6 million) versus Rs. 507 million ($11 million) in Q1 FY10. This decline is on account of the impairment of intangibles recorded in Q3 FY10.
Other Operating Income of Rs. 186 million ($4 million) in Q1 FY11 versus Rs. 35 million ($1 million) in Q1 FY10.
R&D expenses at Rs. 993 million ($21 million) in Q1 FY11.
Finance costs (net) are at Rs. 177 million ($4 million) in Q1 FY11 versus Rs. 135 million ($3 million) in Q1 FY10. The change is mainly on account of higher forex loss during the quarter
Net forex loss of Rs. 225 million ($5 million) in Q1 FY11 versus Rs. 84 million ($2 million) in Q1 FY10.
EBITDA at Rs. 3.4 billion ($74 million) in Q1 FY11 represents 20% to sales.
Net Profit after Tax for Q1 FY11 is at Rs. 2.1 billion ($45 million).
Diluted EPS is at Rs. 12.3 ($0.3) for the quarter.
Capital expenditure for the quarter is at Rs. 1.9 billion ($40 million).

Entry into a Material Definitive Agreement

On July 22nd, 2019, Mateon Therapeutics, Inc., a Delaware corporation (the "Company") reported that it entered into a note purchase agreement (the "Note Purchase Agreement") with PointR Data, Inc. Pursuant to the Note Purchase Agreement, the Company issued a convertible promissory note (the "Convertible Note") to PointR Data, Inc. in the principal amount of $200,000 (Press release, Mateon Therapeutics, JUL 22, 2019, View Source [SID1234537694]). PointR Data is developing Artificial Intelligence/Deep Learning Platform for multiple business verticals including life sciences.

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The Convertible Note bears interest at a rate of 8% per annum. Interest payments are due monthly on the 15th day of each calendar month (or the next business day thereafter), and are payable, at the option of the Holder, either in cash or in shares of the Company’s common stock, par value $0.01 per share (the "Common Stock"), valued at the closing price of the Common Stock on the principal market on which the Common Stock is either traded or quoted at such time.

The Convertible Note is due and payable on demand by the holder (a) at any time after January 1, 2020 or (b) upon the occurrence of an Event of Default (as defined in the Convertible Note and the Note Purchase Agreement). The Company can prepay the Convertible Note upon notice to the holder without penalty.

All amounts outstanding under the Convertible Note will be automatically be converted into the Company’s securities issued in next equity financing raising gross proceeds of $10 million or more (a "Qualified Financing") at the price per share paid by investors in the Qualified Financing.

The Convertible Note and the Note Purchase Agreement contain customary Events of Default, including nonpayment, breach of warranty or covenant, and bankruptcy. In addition, the Convertible Note is being issued in connection with the preliminary evaluation of the Company’s acquisition of PointR Data, Inc. Discussion are in the early states and there are no definitive agreements or arrangements in place for any such acquisition at this time. It is an Event of Default under the Note Purchase Agreement, and PointR Data, Inc. shall have the right to demand repayment of the Convertible Promissory Note, if the Company ceases to negotiate in good faith for a potential acquisition of PointR Data, Inc.

The Company’s payment obligations under the Convertible Note are secured by certain MRI imaging data and related information (the "Subject Data"). Effective upon an Event of Default, in addition to any other remedies available to PointR Data, Inc. the Company will automatically grant PointR Data, Inc. a perpetual, irrevocable, world-wide, non-exclusive, royalty-free, fully paid-up, sublicensable, and transferable license to use the Subject Data. The license granted to Holder pursuant to this Section 7 shall survive the termination or repayment of this Note (but shall only be effective from and after the occurrence of an Event of Default).

On July 22, 2019, under the terms of the Note Purchase Agreement, the Company issued a $200,000 principal amount Convertible Note to PointR Data, Inc.

Additional information on the terms of the Convertible Note, including the interest rate, payment terms, conversion rights and events of default, is contained in Item 1.01 of this Current Report on Form 8-K, and is incorporated by reference herein.

Item 3.02 Unregistered Sales of Equity Securities.

On July 22, 2019, the Company issued a $200,000 principal amount Convertible Note to PointR Data, Inc.

The Convertible Note was issued in reliance upon the exemption from registration requirements pursuant to Section 4(a)(2) under the Securities Act of 1933, as amended, the rules promulgated thereunder and pursuant to applicable state securities laws and regulations.

References to Agreements

The descriptions of the Note Purchase Agreement and the Convertible Note in this report do not purport to be complete and are qualified in their entirety by reference to the forms of Note Purchase Agreement and Convertible Note, which are attached as Exhibits to this Current Report on Form 8-K, and each of which is incorporated herein by reference.

The agreements have been included to provide investors and stockholders with information regarding their respective terms. Those agreements are not intended to provide any other factual information about the Company. The representations, warranties and covenants contained in those agreements were made only for purposes of those agreements and as of specific dates, were solely for the benefit of the parties to those agreements, may be subject to limitations agreed upon by the contracting parties, and may be subject to standards of materiality applicable to the contracting parties that differ from those applicable to investors. Investors are not third-party beneficiaries under any of the agreements and should not rely on the representations, warranties or covenants or any descriptions thereof as characterizations of the actual state of facts or condition of the Company. Moreover, information concerning the subject matter of the representations and warranties may change after the date of the agreements, which subsequent information may or may not be fully reflected in the Company’s public disclosures.

Delcath Systems Closes $20 Million Private Placement

On July 17, 2019 Delcath Systems, Inc. ("Delcath," the "Company", "we", "our" or "us" (OTCPK: DCTH) reported that it has closed on its previously announced private placement with gross proceeds of $20 million at a combined price of $1,000 per Unit (Press release, Delcath Systems, JUL 17, 2019, View Source [SID1234537659]). Each Unit consists of one preferred share initially convertible into 16,667 shares of common stock at an initial conversion price of $0.06 per share and a common stock purchase warrant. Each whole warrant entitles the holder to purchase one share of common stock at an initial exercise price of $0.06 for a period of five years from the date of the Company’s anticipated reverse stock split.

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Commenting on the announcement, Jennifer K. Simpson, Ph.D., MSN, CRNP President and CEO of Delcath, said, "This capital investment is our most significant financing in two years. With this transaction we have positioned the Company to complete enrollment for the Registration trial in ocular melanoma liver metastases, which we believe may be able to release top line data in 2020. We have worked very closely with fundamental investors who believe in our therapy and the potential it represents in ocular melanoma."

Roth Capital Partners acted as the sole placement agent for the offering. After the placement agent fees and estimated offering expenses payable by the Company, the Company has received net proceeds of approximately $18.35 million. The offering closed on July 15, 2019.

The securities offered in the private placement have not been registered under the Securities Act of 1933, as amended or applicable under state securities laws. Accordingly, the securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws. As part of the transaction, the Company has agreed to file a resale registration statement on Form S-1 with the Securities and Exchange Commission by August 21, 2019 for purposes of registering the resale of the shares of common stock issuable upon conversion of the preferred shares and upon exercise of the warrants issued in the private placement.

This notice does not constitute an offer to sell or the solicitation of an offer to buy the securities, nor shall there be any sale of the securities in any state in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state. Any offering of the securities under the resale registration statement will only be by means of a prospectus.

Compugen Second Quarter 2019 Conference Call Scheduled for Monday, August 5, 2019 at 8:30 AM ET

On July 22, 2019 Compugen Ltd. (NASDAQ: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported that the Company will release its second quarter 2019 financial results on Monday, August 5, 2019 before the U.S. financial markets open (Press release, Compugen, JUL 22, 2019, View Source [SID1234537657]). Management will host a corresponding conference call and webcast to review the results and provide a corporate update at 8:30 AM ET.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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To access the live conference call by telephone, please dial 1-888-407-2553 from the U.S., or +972-3-918-0644 internationally. The call will also be available via live webcast through Compugen’s website, located at the following link. Following the live audio webcast, a replay will be available on the Company’s website.