Quest Diagnostics Reports Third Quarter 2018 Financial Results

On October 23, 2018 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported financial results for the third quarter ended September 30, 2018 and updated its outlook for full-year 2018 (Press release, Quest Diagnostics, OCT 23, 2018, View Source [SID1234530338]).

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"We grew revenues and continued to deliver strong earnings growth in the third quarter," said Steve Rusckowski, Chairman, President and CEO. "We had a productive quarter, announcing three acquisitions and a Professional Lab Services agreement. We are updating our full-year revenue guidance to reflect lower than expected revenue performance this year, which has been affected in large part by industry headwinds we called out in the previous quarter. Looking ahead, our acquisition pipeline, along with our expanding health plan access, including UnitedHealthcare beginning January 1, position us well for growth in 2019."
ng, general and administrative expenses for the three and nine months ended September 30, 2017 have been restated to reflect the impact of new revenue recognition rules that became effective January 1, 2018 and were adopted on a retrospective basis. Under the new rules, the Company reports uncollectible balances associated with patient responsibility as a reduction in net revenues; historically these amounts were classified as bad debt expense within selling, general and administrative expenses.

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

The updated outlook for revenue growth in 2018 represents management’s estimates for 2018 versus 2017 reported revenues adjusted to reflect the impact of new revenue recognition rules that became effective January 1, 2018. Full-year 2017 revenues adjusted to reflect the new rules were $7,402 million. See note 5 of 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 measures as follows: (i) for the purpose of income measures the term "adjusted" refers to operating performance measures that exclude special items such as restructuring and integration charges, excess tax benefit ("ETB") associated with stock based compensation and other items; and (ii) the term "adjusted diluted EPS excluding amortization" represents the company’s diluted EPS before the impact of special items (described above) and amortization expense.

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 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 in listen-only mode by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467, passcode: Investor; or via live webcast on the Company’s website at www.QuestDiagnostics.com/investor.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-483-9044 for domestic callers or 203-369-1586 for international callers. No passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on October 23, 2018 until midnight Eastern Time on November 6, 2018. 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.

KN035, a Global Leading Subcutaneously-administered PD-L1 Antibody, Starts Late-stage Clinical Development

On October 23, 2018 Alphamab Oncology and 3D Medicines Inc. (3D Med) reported PD-L1 antibody KN035 has entered late stage clinical development, including phase III for bile tract carcinoma (cholangiocarcinoma) and phase II for MSI-H solid tumors have been initiated in China (Press release, Alphamab, OCT 23, 2018, View Source [SID1234530317]). It is also announced that the poster entitled "Phase I Study of KN035, A Novel Fusion anti-PD-L1 Antibody Administered Subcutaneously in Patients with Advanced Solid Tumors in the USA" (poster No. 1456) was presented at the 2018 Annual Congress of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper).

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KN035 is the first-in-class PD-L1 single-domain antibody with distinct features over all other PD- (L) 1 antibodies. KN035 has the advantages of subcutaneous injection and good stability at room temperature. These would be of great value to improve patients’ compliance and quality of life and to help realize the goal of long-term management of cancer as a chronic disease. So far, more than 300 patients have participated in KN035 clinical trials in the United States, Japan and China.

The phase I trial in the United States was designed as a 3+3 open dose-escalation study in patients with advanced and inoperable tumors. The main endpoints were tolerance to KN-035 and safety, with the secondary endpoints were to evaluate the pharmacokinetic of KN-035, the maximum tolerance dose and the antitumor effect as a single drug. The drug was given subcutaneously at a dosage of 0.01, 0.03, 0.1, 0.3, 1.0, 2.5, 5.0 and 10.0 mg/kg weekly.

In the US phase I trial, a total of 18 subjects were enrolled as of July 5, 2018. In the 17 subjects who finished efficacy evaluation, 2 partial response (PR) and 5 stable disease (SD) were confirmed, according to the RECIST1.1 criterion. No dose-limiting toxicity (DLT) was observed in this trial. The exposure to KN035 increased proportionally with dose. Average half-life of KN035 was about 200 hours.

Dr. Ting Xu, Chairman and CEO of Alphamab Oncology, said, "KN035 is currently the sole PD-L1 antibody through subcutaneous injection with excellent bioavailability and distribution. We expect that the clinical progress of KN035 will further demonstrate its advantages. In addition to the indications being tested, we plan to leverage KN035’s unique profile to explore its potential utility in maintenance, adjuvant therapy and neo-adjuvant therapy. We hope to provide patients with an alternative and convenient option."

Dr. John Gong, CEO of 3D Med, added, "We are excited with the data from the phase I clinical study conducted in the US. It demonstrated the safety and good pharmacokinetics of KN035 in patients with advanced cancer, as well as encouraging initial treatment efficacy. We look forward to further advancing the KN035 clinical trials in the US with the leading oncologists there"

Amgen Announces 2018 Fourth Quarter Dividend

On October 23, 2018 Amgen (NASDAQ:AMGN) reported that its Board of Directors declared a $1.32 per share dividend for the fourth quarter of 2018 (Press release, Amgen, OCT 23, 2018, View Source;p=RssLanding&cat=news&id=2373021 [SID1234530307]). The dividend will be paid on Dec. 7, 2018, to all stockholders of record as of the close of business on Nov. 16, 2018.

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Portola Pharmaceuticals to Announce Third Quarter 2018 Financial Results and Host Conference Call on Wednesday, November 7, 2018

On October 23, 2018 Portola Pharmaceuticals, Inc. (Nasdaq: PTLA) reported that it will host a webcast and conference call to discuss the Company’s financial results for the quarter ended September 30, 2018, and provide a general business overview on Wednesday, November 7, 2018, at 4:30 p.m. ET (1:30 p.m. PT) (Press release, Portola Pharmaceuticals, OCT 23, 2018, View Source;p=RssLanding&cat=news&id=2372929 [SID1234530302]).

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Conference Call Details
The live conference call on Wednesday, November 7, 2018, at 4:30 p.m. ET, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765) 507-2588 internationally and using the passcode 3387315. The webcast can be accessed live on the Investor Relations section of the Company’s website at View Source It will be archived for 30 days following the call.

Epigenomics AG successfully completes capital increase; gross proceeds of EUR 22.3 million

On October 23, 2018 Epigenomics AG (FSE: ECX; OTCQX: EPGNY) ("Company") reported that it has fully placed the new shares from the capital increase resolved on October 7, 2018 of up to EUR 12,007,180 (corresponds to 50% of the existing share capital) (Press release, Epigenomics, OCT 23, 2018, View Source [SID1234530229]). Accordingly, the Company’s share capital will be increased from currently EUR 24,014,360 to EUR 36,021,540 by 12,007,180 new registered shares of the Company against contribution in cash and partly in kind.

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The private placement with selected qualified investors was significantly oversubscribed. All shares of the private placement were allocated to multiple new institutional investors in the U.S.A, including healthcare funds.

Gross proceeds of the capital increase amount to EUR 22.33 million, thereof EUR 21.25 million in cash. Furthermore, the financial liabilities from the redemption of a convertible bond subscribed by Cathay Fortune International Company Limited are reduced by EUR 1.08 million from EUR 7.1 million to EUR 6.02 million.

The capital increase needs to be registered in the commercial register, which the Executive Board will apply for shortly. The inclusion of the new shares under the Company’s existing listing (ISIN DE000A11QW50) is currently expected at or around October 29, 2018.