Halozyme To Host Fourth Quarter And Full-Year 2018 Financial Results Webcast And Conference Call

On February 7, 2019 Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, reported that it will webcast its Quarterly Update Conference Call for the fourth quarter 2018 on Thursday, February 21 at 4:30 p.m. ET / 1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call (Press release, Halozyme, FEB 7, 2019, View Source [SID1234533144]). On the same date, Halozyme will release financial results for the fourth quarter and year ended December 31, 2018 following the close of trading.

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The call will be webcast live through the "Investors" section of Halozyme’s corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit the Investors page of www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The live call may be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 387156. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 68892505

Arvinas Announces Poster Presentation at ASCO 2019 Genitourinary Cancers Symposium

On February 7, 2019 Arvinas Inc. (Nasdaq: ARVN), a biotechnology company creating a new class of drugs based on protein degradation, reported that it will present a poster at the 2019 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), taking place February 14-16 in San Francisco (Press release, Arvinas, FEB 7, 2019, View Source [SID1234533163]). The presentation will highlight the company’s lead product candidate, ARV-110, an oral androgen receptor (AR)-targeted PROTAC (Proteolysis-Targeting Chimera) protein degrader for the treatment of men with metastatic castration-resistant prostate cancer. ARV-110 employs Arvinas’ proprietary PROTAC protein degradation technology.

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Presentation details are as follows:

Title: ARV-110: An oral androgen receptor PROTAC degrader for prostate cancer.
Abstract Number: 259
Poster: L16
Session Information: Poster Session A: Prostate Cancer
Session Date/Time: February 14; 11:30 a.m. – 1:00 p.m.; 5:30 – 6:30 p.m.
All abstracts for the Symposium will be released by ASCO (Free ASCO Whitepaper) on February 11, 2019 at 5:00 p.m. EST on meetinglibrary.asco.org.

About ARV-110
ARV-110 is an orally-bioavailable PROTAC protein degrader designed to selectively target and degrade androgen receptor (AR). ARV-110 is being developed as a potential treatment for men with metastatic castration-resistant prostate cancer (mCRPC). ARV-110 has demonstrated promising activity in preclinical models of AR mutation or overexpression, both common mechanisms of resistance to currently available AR-targeted therapies. Arvinas believes the differentiated pharmacology of ARV-110, including its iterative activity, has the potential to translate into improved clinical outcomes for patients.

BioLineRx Announces Closing of $15.4 Million Underwritten Public Offering of its American Depositary Shares and Warrants

On February 7, 2019 BioLineRx Ltd. (NASDAQ/TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that it has closed its previously reported underwritten public offering of 28,000,000 American Depositary Shares ("ADSs"), each representing one of its ordinary shares, and warrants to purchase 28,000,000 ADSs, at a public offering price of $0.55 per ADS and accompanying warrant (Press release, BioLineRx, FEB 7, 2019, View Source;p=irol-newsArticle&ID=2386604 [SID1234533128]). The warrants are exercisable immediately, expire five years from the date of issuance and have an exercise price of $0.75 per ADS. The gross proceeds of the offering were $15.4 million, before deducting underwriting discounts and commissions and offering expenses payable by BioLineRx, and excluding the exercise of any warrants. All of the securities in the offering were sold by BioLineRx. BioLineRx anticipates using the net proceeds from the offering for general corporate purposes, which may include, but are not limited to, working capital and funding clinical trials.

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Oppenheimer & Co. Inc. acted as sole book-running manager for the offering. Maxim Group LLC acted as co-manager for the offering.

The securities described above were issued pursuant to a shelf registration statement (File No. 333-222332) that was previously filed with, and declared effective by, the Securities and Exchange Commission ("SEC"). A final prospectus supplement related to the offering has been filed with the SEC and is available on the SEC’s website located at www.sec.gov. Copies of the final prospectus supplement may also be obtained from Oppenheimer & Co. Inc., 85 Broad St., 26th Floor, New York, New York 10004, Attention: Syndicate Prospectus Department, or by telephone: (212) 667-8055 or by email: [email protected].

This press release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Alkermes to Host Conference Call to Discuss Fourth Quarter and Year-End 2018 Financial Results

On February 7, 2019 Alkermes plc (Nasdaq: ALKS) reported that it will host a conference call and webcast presentation at 8:30 a.m. ET (1:30 p.m. BST) on Thursday, Feb. 14, 2019, to discuss the company’s fourth quarter and year-end 2018 financial results (Press release, Alkermes, FEB 7, 2019, https://www.prnewswire.com/news-releases/alkermes-to-host-conference-call-to-discuss-fourth-quarter-and-year-end-2018-financial-results-300791901.html [SID1234533145]). Management will also discuss financial expectations for 2019 and provide an update on the company.

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The webcast player and accompanying slides may be accessed on the Investors section of Alkermes’ website at www.alkermes.com. The conference call may be accessed by dialing +1 877 407 2988 for U.S. callers and +1 201 389 0923 for international callers.

A replay of the conference call will be available from 11:00 a.m. ET (4:00 p.m. BST) on Thursday, Feb. 14, 2019, through Thursday, Feb. 21, 2019, and may be accessed by visiting Alkermes’ website or by dialing +1 877 660 6853 for U.S. callers and +1 201 612 7415 for international callers. The replay conference ID is 13687392.

LabCorp Announces 2018 Fourth Quarter and Full Year Results and Provides 2019 Guidance

On February 7, 2019 LabCorp (or the Company) (NYSE: LH) reported results for the fourth quarter and year ended Dec. 31, 2018, and provided 2019 guidance (Press release, LabCorp, FEB 7, 2019, View Source;p=RssLanding&cat=news&id=2386499 [SID1234533164]).

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"LabCorp delivered another strong year in 2018, highlighted by 10% revenue growth and 20% adjusted EPS growth," said David P. King, chairman and chief executive officer. "Our fourth quarter results included an excellent performance by Covance, with a strong 1.34 book to bill, constant currency organic revenue growth of over 9%, and margin expansion of approximately 300 basis points. Non-operational items constrained our Diagnostics business, but excluding those items, the fundamental revenue, margin and cash flow generation characteristics of the business remained strong, and we delivered organic volume growth and favorable mix. Both businesses continued to benefit from differentiated, data-driven solutions and growth opportunities derived from our competitive advantages in data and analytics, patient engagement, scientific innovation, and therapeutic expertise. The power of our Diagnostic-Drug Development combination is translating into unique solutions for patients, customers, and partners, positioning us to deliver growth and shareholder value in the years ahead."

Effective Jan. 1, 2018, the Company adopted the FASB-issued converged standard on revenue recognition (ASC 606), using the full retrospective method. Unless otherwise indicated, all financial results in 2017 and comparisons to financial results in 2017 have been restated in this press release as if the Company had adopted ASC 606 on Jan. 1, 2017.

Consolidated Results

Fourth Quarter Results

Revenue for the quarter was $2.79 billion, an increase of 1.6% compared to $2.74 billion in the fourth quarter of 2017. The increase in revenue was primarily due to organic growth of 2.9% and acquisitions of 0.7%, partially offset by the negative impact from the disposition of businesses of 1.6%, and foreign currency translation of approximately 40 basis points.

Operating income for the quarter was $307.7 million, or 11.0% of revenue, compared to $330.6 million, or 12.0%, in the fourth quarter of 2017. The decrease in operating income and margin were primarily due to lower pricing as a result of the implementation of PAMA, the disposition of businesses, and higher personnel costs, partially offset by increased demand, the Company’s LaunchPad business process improvement initiative, acquisitions, and fewer restructuring charges and special items. The Company recorded restructuring charges, special items, and amortization, which together totaled $87.2 million in the quarter, compared to $102.0 million during the same period in 2017. Adjusted operating income (excluding amortization, restructuring charges, and special items) for the quarter was $394.9 million, or 14.2% of revenue, compared to $432.7 million, or 15.8%, in the fourth quarter of 2017.

Net earnings in the quarter were $157.9 million, compared to $687.8 million in the fourth quarter of 2017. Diluted EPS were $1.56 in the quarter compared to $6.63 in the same period in 2017. During the quarter, the Company recorded a $24.5 million loss on the disposition of its U.S. forensics laboratory testing business, a non-cash $7.5 million settlement charge recorded on one of its legacy pension plans, and a write-off of an investment in its venture fund of $5.2 million (all charges recorded in other income (expense)). In addition, the Company recorded $7.7 million in deferred income tax expense resulting from a revaluation of its deferred tax liabilities after merging Chiltern International, Inc. into Covance, Inc. These charges reduced net earnings and diluted EPS by $29.5 million and $0.29, respectively. In the fourth quarter of 2017, the Company recorded a net benefit of $519.0 million in net earnings, or $5.00 per diluted share, due to the implementation of the Tax Cuts and Jobs Act of 2017 (TCJA), which resulted in a favorable re-valuation of deferred taxes, partially offset by the deemed repatriation tax.

Adjusted EPS (excluding amortization, restructuring charges, and special items) were $2.52 in the quarter, an increase of 11.0% compared to $2.27 in the fourth quarter of 2017. The Company’s adjusted earnings in the quarter were negatively impacted by approximately $0.04 per diluted share due to lower volume caused by the impact from adverse weather.

Operating cash flow and free cash flow (operating cash flow less capital expenditures) for the quarter were $486.4 million and $364.2 million, respectively, each of which was reduced by the net tax payment of approximately $105 million related to the disposition of businesses. Excluding these non-recurring items, operating cash flow would have been $591.4 million, compared to $565.0 million in the fourth quarter of 2017, as the benefit from higher cash earnings was partially offset by increased working capital. Capital expenditures totaled $122.2 million, compared to $96.1 million a year ago. As a result, free cash flow in the quarter would have been $469.2 million excluding the tax payment on the disposition of businesses, compared to $468.9 million in the fourth quarter of 2017.

At the end of the quarter, the Company’s cash balance and total debt were $426.8 million and $6.1 billion, respectively. During the quarter, the Company repurchased $400.0 million of stock representing approximately 2.5 million shares, paid down $400.0 million of debt, and invested $38.7 million in acquisitions. On Feb. 6, 2019, the board replaced the Company’s existing share repurchase plan with a new plan authorizing repurchase of up to $1.25 billion in the Company’s shares.

Full Year Results

Revenue was $11.33 billion, an increase of 9.9% over last year’s $10.31 billion. The increase in revenue was due to acquisitions of 7.6%, organic growth of 2.7%, and the benefit from foreign currency translation of approximately 30 basis points, partially offset by the impact from the disposition of businesses of 0.7%.

Operating income was $1,325.7 million, or 11.7% of revenue, compared to $1,305.2 million, or 12.7%, in 2017. The increase in operating income was primarily due to acquisitions, organic revenue growth, and the Company’s LaunchPad initiatives, partially offset by the implementation of PAMA, personnel costs, and higher restructuring charges and special items. The decline in operating margin was primarily due to the implementation of PAMA, higher personnel costs, as well as the mix impact from the acquisition of Chiltern. The Company recorded restructuring charges, special items, and amortization which together totaled $397.6 million, compared to $367.2 million during the same period in 2017. This increase was due to higher amortization expense, and the payment of a one-time bonus to non-bonus-eligible employees following the implementation of the TCJA. Adjusted operating income (excluding amortization, restructuring charges, and special items) was $1.72 billion, or 15.2% of revenue, compared to $1.67 billion, or 16.2%, last year.

Net earnings in 2018 were $883.7 million, or $8.61 per diluted share, compared to $1,227.1 million, or $11.81 per diluted share, last year. Net earnings and diluted EPS in 2018 benefitted from the net gain on disposition of businesses of $112.9 million and $1.10 per diluted share, respectively. In addition, the Company recorded a non-cash $7.5 million settlement charge on one of its legacy pension plans, and a write-off of an investment in its venture fund of $5.2 million. The Company also recorded $7.7 million in income tax expense resulting from a revaluation of its deferred tax liabilities after merging Chiltern International, Inc. into Covance, Inc. Due to the implementation of the TCJA, the Company recorded a charge of $45.0 million, or $0.44 per diluted share in 2018, and a net benefit of $519.0 million in net earnings, or $5.00 per diluted share in 2017. The net impact from these items increased net earnings and diluted EPS in 2018 by $50.8 million and $0.50 per diluted share, respectively.

Adjusted EPS (excluding amortization, restructuring charges, and special items) were $11.02, an increase of 19.8% compared to $9.20 in 2017.

Operating cash flow and free cash flow (operating cash flow less capital expenditures) were $1,305.4 million and $925.6 million, respectively, each of which was reduced by the net tax payment of approximately $105 million related to the disposition of businesses (the Company realized gross proceeds from the disposition of businesses of $658.2 million in cash reflected in Cash Flows from Investing Activities). Excluding these non-recurring items, operating cash flow would have been $1,410.4 million, compared to $1,498.1 million in 2017, as the benefit of higher cash earnings was more than offset by an increase in working capital. Capital expenditures totaled $379.8 million, compared to $312.9 million in 2017. As a result, free cash flow would have been $1,030.6 million excluding the tax payment on the disposition of businesses, compared to $1,185.2 million in 2017.

During the year, the Company repurchased $700.0 million of stock representing approximately 4.3 million shares, paid down $695.0 million of debt, and invested $117.8 million in acquisitions.

***

The following segment results reflect the Company’s retrospective adoption of ASC 606 on Jan. 1, 2017, and exclude amortization, restructuring charges, special items and unallocated corporate expenses.

Fourth Quarter Segment Results

LabCorp Diagnostics

Revenue for the quarter was $1.69 billion, a decrease of 2.8% from $1.74 billion in the fourth quarter of 2017. Revenue benefitted from acquisitions of 0.4% and favorable mix of 0.7%, which were more than offset by the negative impact from the disposition of businesses of 2.6%, the implementation of PAMA of 1.0%, and foreign currency translation of approximately 0.2%. Excluding the impact from PAMA, foreign currency translation, adverse weather of approximately 0.4%, as well as the year on year impact from the calendar of approximately 0.8%, organic revenue for the quarter would have increased by approximately 1.8%.

Excluding the disposition of businesses, revenue per requisition decreased by 0.4%, driven by the negative impact from PAMA of 1.0%. Total volume (measured by requisitions) excluding the disposition of businesses increased by 0.3%, as acquisition volume contributed 0.4% and organic volume declined by 0.1%. Excluding the impact from adverse weather and the year on year impact from the calendar, organic volume would have increased approximately 1.1%.

Adjusted operating income (excluding amortization, restructuring charges and special items) for the quarter was $279.3 million, or 16.5% of revenue, compared to $357.0 million, or 20.5%, in the fourth quarter of 2017. Operating income and margin declined primarily due to the impact from PAMA of approximately $18 million or 80 basis points, the year on year impact from the calendar of approximately $20 million or 100 basis points, adverse weather, the disposition of businesses, and personnel costs, partially offset by cost reductions and acquisitions. Excluding the disposition of businesses, impact from PAMA, adverse weather, as well as the year on year impact from the calendar, adjusted operating income and margin would have been approximately $328.6 million and 18.5%, respectively.

In addition, the Company has started phase II of LabCorp Diagnostics’ LaunchPad initiative. The Company is focused on eliminating manual processes, digitizing the business, using technology to improve quality, operations and service, and enhancing the consumer experience, which are designed to unlock new avenues for growth and contribute to improvement in long-term margins. This initiative is expected to generate pre-tax net savings of approximately $200 million over the three-year period ending in 2021, with pre-tax, one-time charges expected to be approximately $40 million.

Covance Drug Development

Revenue for the quarter was $1.10 billion, an increase of 9.6% over $1.00 billion in the fourth quarter of 2017. The increase in revenue was due to organic growth of 9.3% and acquisitions of 1.2%, partially offset by the negative impact from foreign currency translation of approximately 90 basis points.

Adjusted operating income (excluding amortization, restructuring charges and special items) for the quarter was $153.5 million, or 14.0% of revenue, compared to $110.9 million, or 11.1%, in the fourth quarter of 2017. The increase in operating income and margin were primarily due to organic demand, LaunchPad savings and acquisitions, partially offset by personnel costs. The Company is on track to deliver $150 million of net savings from its three-year Covance LaunchPad initiative by the end of 2020, and $30 million of cost synergies from the integration of Chiltern by the end of 2019.

Net orders and net book-to-bill during the trailing twelve months were $5.44 billion and 1.26, respectively. Backlog at the end of the quarter was $9.76 billion compared to $9.40 billion last quarter, and the Company expects approximately $3.9 billion of its backlog to convert into revenue in the next twelve months.

***

Outlook for 2019

The following guidance assumes foreign exchange rates effective as of Dec. 31, 2018, for the full year, and includes the estimated impact from currently anticipated capital allocation, including acquisitions and share repurchases.

Revenue growth of 0.5% to 2.5% over 2018 revenue of $11.33 billion, which includes the negative impact from the disposition of businesses of approximately 1% and foreign currency translation of approximately 0.4%.
The change in revenue in LabCorp Diagnostics is expected to be -4.0% to -2.0% as compared to 2018 revenue of $7.03 billion, which includes the negative impact from the disposition of businesses of approximately 2%. Excluding the disposition of businesses, the change in revenue in LabCorp Diagnostics is expected to be approximately -2.0% to 0.0%, primarily due to organic volume growth, favorable test mix, and acquisitions, offset by the impact of PAMA of -1.6%, changes in certain managed care contracts and laboratory provider networks, as well as foreign currency translation of approximately 0.3%.
Revenue growth in Covance Drug Development of 5.0% to 9.0% over 2018 revenue of $4.31 billion, which includes the negative impact from foreign currency translation of approximately 0.6%.
Adjusted EPS of $11.00 to $11.40, a change of 0% to 3% as compared to $11.02 in 2018.
Free cash flow (operating cash flow less capital expenditures) of $950 million to $1.05 billion, compared to $925.6 million in 2018.
Use of Adjusted Measures

The Company has provided in this press release and accompanying tables "adjusted" financial information that has not been prepared in accordance with GAAP, including adjusted EPS, adjusted operating income, free cash flow, and certain segment information. The Company believes these adjusted measures are useful to investors as a supplement to, but not as a substitute for, GAAP measures, in evaluating the Company’s operational performance. The Company further believes that the use of these non-GAAP financial measures provides an additional tool for investors in evaluating operating results and trends, and growth and shareholder returns, as well as in comparing the Company’s financial results with the financial results of other companies. However, the Company notes that these adjusted measures may be different from and not directly comparable to the measures presented by other companies. Reconciliations of these non-GAAP measures to the most comparable GAAP measures are included in the tables accompanying this press release.

The Company today is furnishing a Current Report on Form 8-K that will include additional information on its business and operations. This information will also be available in the investor relations section of the Company’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source Analysts and investors are directed to the Current Report on Form 8-K and the website to review this supplemental information.

A conference call discussing LabCorp’s quarterly results will be held today at 9:00 a.m. EDT and is available by dialing 844-634-1444 (615-247-0253 for international callers). The access code is 1669755. A telephone replay of the call will be available through Feb. 21, 2019, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The access code for the replay is 1669755. A live online broadcast of LabCorp’s quarterly conference call on Feb. 7, 2019, will be available at View Source or at View Source beginning at 9:00 a.m. EDT. This webcast will be archived and accessible through Jan. 31, 2020.