bluebird bio Announces First Quarter 2020 Earnings Conference Call and May Investor Event

On April 29, 2020 bluebird bio, Inc. (NASDAQ: BLUE) reported it will hold a conference call to discuss first quarter 2020 financial results and business updates on Monday, May 11 at 8:00 am ET (Press release, bluebird bio, APR 29, 2020, View Source [SID1234556739]).

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Investors may listen to the call on May 11, 2020 at 8:00 am ET by dialing (844) 825-4408 from locations in the United States or +1 (315) 625-3227 from outside the United States. Please refer to conference ID number 3355158.

In addition, members of the management team will participate in the BofA Securities Health Care Conference 2020, Thursday, May 14, at 10:20 a.m. ET.

To access the live webcasts of bluebird bio’s presentations, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source Replays of the webcasts will be available on the bluebird bio website for 90 days following the events.

Jounce Therapeutics to Announce First Quarter 2020 Financial Results and Host Conference Call on Wednesday, May 6, 2020

On April 29, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it will report first quarter 2020 financial results and provide a corporate update before market open on Wednesday, May 6, 2020 (Press release, Jounce Therapeutics, APR 29, 2020, View Source [SID1234556738]). Jounce Therapeutics’ management team will host a live conference call and webcast at 8:00 a.m. ET.

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Conference Call and Webcast
To access the conference call, please dial (866) 916-3380 (domestic) or (210) 874-7772 (international) and refer to conference ID 4044098. The live webcast can be accessed under "Events & Presentations" in the Investors and Media section of the company’s website at www.jouncetx.com. The webcast will be archived and made available for replay on the company’s website approximately two hours after the call and will be available for 30 days thereafter.

Kura Oncology to Report First Quarter 2020 Financial Results

On April 29, 2020 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company focused on the development of precision medicines for the treatment of cancer, reported that it will report first quarter 2020 financial results after the close of U.S. financial markets on Monday, May 4, 2020 (Press release, Kura Oncology, APR 29, 2020, View Source [SID1234556737]). Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT that day to discuss the financial results and provide a corporate update.

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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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The live call may be accessed by dialing 877-516-3514 for domestic callers and 281-973-6129 for international callers and entering the conference code: 2085246. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

LabCorp Announces 2020 First Quarter Results

On April 29, 2020 LabCorp(or the Company) (NYSE: LH) reported results for the first quarter ended March 31, 2020 (Press release, LabCorp, APR 29, 2020, View Source [SID1234556736]).

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"First and foremost, we are extremely proud of our dedicated and mission-driven colleagues around the world who are working tirelessly to develop and process COVID-19 diagnostic tests, to generate insights about the virus through innovative partnerships with leading companies like Adaptive Biotechnologies and Microsoft, Ciox Health, and Pacific Biosciences, and to accelerate the development of treatments and vaccines that will aid pandemic preparedness and prevention efforts," said Adam Schechter, president and CEO of LabCorp. "During the quarter we delivered solid performance across the company, especially considering the challenges associated with the COVID-19 pandemic. Looking forward, despite the unpredictability of this health crisis, we are well positioned financially and strategically to continue to serve our customers and drive long-term shareholder value. We stand ready to serve and support patients, and we will continue to do everything we can, as quickly as possible, to support the global response."

Consolidated Results

First Quarter Results

Revenue for the quarter was $2.82 billion, an increase of 1.2% over $2.79 billion in the first quarter of 2019. The increase in revenue was due to acquisitions of 3.4%, partially offset by the disposition of a business of 0.5% and lower organic revenue of 1.8%. The lower organic revenue includes the estimated negative impact from COVID-19 of 4.9% and lower Medicare and Medicaid pricing as a result of PAMA of 0.7%.

Operating loss for the quarter was ($192.6) million, compared to operating income of $318.2 million in the first quarter of 2019. The decrease in operating income was primarily due to the estimated negative impact from COVID-19 (including the impairments to goodwill and other assets), higher personnel costs (primarily driven by merit increases and one additional payroll day), and PAMA, partially offset by other organic growth, acquisitions, and LaunchPad savings. The Company recorded restructuring charges, special items, impairments, and amortization, which together totaled $558.5 million in the quarter, compared to $93.2 million during the same period in 2019. This increase includes COVID-19 related impairments on goodwill and other assets of $437.4 million, or approximately 3.7% of the Company’s total goodwill and intangible assets. In addition, the Company recorded $21.9 million of other COVID-19 related costs. Adjusted operating income (excluding amortization, restructuring charges, special items, and impairments) for the quarter was $365.9 million, resulting in a 12.9% operating margin, compared to $411.4 million, or 14.7%, in the first quarter of 2019. The $45.5 million decline in adjusted operating income and 190 basis point decline in adjusted operating margin were due to the estimated negative impact from COVID-19 of $72 million and PAMA of $19.8 million.

Net losses for the quarter were ($317.2) million, compared to net earnings of $185.6 million in the first quarter of 2019. Diluted EPS were ($3.27) in the quarter compared to $1.86 in the same period in 2019. Adjusted EPS (excluding amortization, restructuring charges, special items, and impairments) were $2.37 in the quarter, a decrease of 9.5% compared to $2.62 in the first quarter of 2019.

Operating cash flow for the quarter was $203.8 million, compared to $165.8 million in the first quarter of 2019. The increase in operating cash flow was due to favorable working capital, partially offset by lower cash earnings as the result of COVID-19. Capital expenditures totaled $106.6 million, compared to $94.2 million a year ago. As a result, free cash flow (operating cash flow less capital expenditures) was $97.2 million, up 35.8% compared to $71.6 million in the first quarter of 2019.

At the end of the quarter, the Company’s cash balance and total debt were $323.6 million and $6.2 billion, respectively. During the quarter, the Company repurchased $100.0 million of stock, representing approximately 0.6 million shares.

First Quarter Segment Results

The following segment results exclude amortization, restructuring charges, special items, impairments, and unallocated corporate expenses.

LabCorp Diagnostics

Revenue for the quarter, adjusting out the increase in accounts receivable reserves as a result of the COVID-19 pandemic, was $1.70 billion, a decrease of 1.2% from $1.72 billion in the first quarter of 2019. The decrease in revenue was due to a 2.9% decline in organic revenue, partially offset by acquisitions of 1.7%. The organic revenue decline includes the estimated negative impact from COVID-19 of 5.4% and PAMA of 1.1%.

Total volume (measured by requisitions) decreased by 4.4% as organic volume declined by 6.1%, partially offset by acquisition volume of 1.6%. The decline in organic volume includes the estimated negative impact from COVID-19 of 7.3% due to reduced demand for testing, which declined 50% to 55% versus the Company’s normal daily levels at the end of the quarter. This reduction in demand impacted testing volumes broadly and was marginally offset by an increase in demand for COVID-19 tests. In addition, organic volume was negatively impacted by lower consumer genetics demand, mostly offset by an additional one-half revenue day and favorable weather. Revenue per requisition increased by 3.4% due to mix and acquisitions, partially offset by the negative impact from PAMA and the September 2019 nonrenewal of the BeaconLBS – UnitedHealthcare contract pertaining to the Florida market. The increase related to mix was primarily driven by the COVID-19 pandemic, which reduced the demand for routine testing at a rate greater than esoteric testing.

Adjusted operating income for the quarter was $254.2 million, or 14.9% of revenue, compared to $310.4 million, or 18.0%, in the first quarter of 2019. The $56.2 million decline in adjusted operating income and 310 basis point decline in adjusted operating margin were primarily due to the estimated negative impact from COVID-19 of $62 million and PAMA of $19.8 million, partially offset by price mix. In addition, the benefit of LaunchPad savings essentially offset the higher personnel costs (including one additional payroll day). The Company remains on track to deliver approximately $200 million of net savings from its three-year Diagnostics LaunchPad initiative by the end of 2021.

Covance Drug Development

Revenue for the quarter was $1.14 billion, an increase of 6.4% over $1.07 billion in the first quarter of 2019. The increase in revenue was due to acquisitions of 6.2% and organic growth of 1.6% (which includes the estimated negative impact from COVID-19 of 2.5%), partially offset by the disposition of a business of 1.2% and negative foreign currency translation of 0.1%.

Adjusted operating income for the quarter was $150.8 million, or 13.2% of revenue, compared to $138.0 million, or 12.8%, in the first quarter of 2019. The $12.8 million increase in adjusted operating income and 30 basis point increase in adjusted operating margin were primarily due to organic demand, acquisitions net of the disposition, and LaunchPad savings, partially offset by higher personnel costs and the estimated negative impact from COVID-19 of $12 million. The Company remains on track to deliver approximately $150 million of net savings from its three-year Drug Development LaunchPad initiative by the end of 2020.

Net orders and net book-to-bill during the trailing twelve months were $5.83 billion and 1.26, respectively. Backlog at the end of the quarter was $11.30 billion, unchanged from last quarter, and the Company expects approximately $3.9 billion of its backlog to convert into revenue in the next twelve months.

Outlook for 2020

Given the ongoing and rapidly changing nature of the COVID-19 pandemic, there is significant uncertainty regarding the duration and severity of the pandemic as well as any future government restrictions. As a result, the Company is withdrawing its 2020 financial guidance provided on February 13, 2020.

The Company has provided below some details on how COVID-19 is impacting LabCorp’s performance and some of the actions LabCorp is taking to help mitigate this impact as well as details regarding LabCorp’s liquidity.

COVID-19 Impact on Performance and Mitigating Actions LabCorp is Taking

LabCorp began the year with strong performance, in line with expectations; however, the Company has since been impacted by COVID-19, including overall customer caution as well as government restrictions and social distancing guidelines.

In LabCorp Diagnostics, demand for testing declined 50% to 55% versus the Company’s normal daily levels at the end of the first quarter. This reduction in demand impacted testing volumes broadly but was heavily weighted towards routine tests. This volume reduction in the base business appears to have stabilized. LabCorp expects to offset some of the volume shortfall by increasing capacity for its Serological Antibody tests to over 200 thousand tests per day by mid-May as well as increasing capacity for its Molecular COVID-19 tests (which include its at-home test kit offering).

In Covance Drug Development, performance has been challenged by COVID-19 due to actions clients are taking that are slowing clinical trial progress and the associated testing as well as reductions in trial site access in certain countries and interruptions in the supply chain that can temporarily delay study activity.

The Company is taking numerous actions to help mitigate the financial impact from the COVID-19 pandemic. Some of these actions include reducing our cash outflows through delaying certain capital expenditures, temporarily suspending its share repurchase program, and applying a heightened threshold to acquisition activity. The Company is also taking actions regarding its workforce including implementing furloughs; delaying hiring; reducing temporary and contract workers, intern positions, and overtime; suspending discretionary merit adjustment for all employees; and suspending 401(k) contributions for all U.S. employees. LabCorp is also taking actions to utilize available stimulus / CARES Act benefits including deferral of payroll taxes, CMS stimulus to providers, and suspension of Medicare sequestration.

Liquidity

The Company expects to deliver solid adjusted EPS and free cash flow in 2020. As of March 31, 2020, the Company had $324 million of cash and $924 million available under its revolving credit facility, which matures in 2022. During the fourth quarter of 2020, $412 million of the Company’s senior notes become payable. The Company maintains investment grade debt ratings and believes that it will be able to repay these notes with available cash on hand, cash generated from operations, borrowings under its revolving credit facility, or through refinancing in the public debt market. LabCorp’s term loan and revolving credit facility require LabCorp to maintain a leverage ratio of 4.0x debt to last twelve months EBITDA. Violation of that covenant could preclude LabCorp from borrowing on the revolving credit facility and trigger required repayment of the Company’s $375 million term loan. While LabCorp expects to maintain compliance with this covenant, the Company is having discussions with its banks to add future flexibility to this covenant, given the uncertainty related to the COVID-19 pandemic.

Use of Estimated COVID-19 Impact

The Company has provided in this press release the Company’s estimates for the net impact from COVID-19 on the Company’s revenue, operating income, operating margin, and Diagnostics’ volume. These estimates were determined using methodologies and assumptions that vary depending on the specific segment and situation. For LabCorp Diagnostics, estimates are based on comparisons to daily historical volume run rates prior to COVID-19. For Covance Drug Development, estimates are based on multiple factors including, but not limited to, discussions with clients/partners of measures that may delay clinical trial progress and the associated testing, volume reductions and location-specific actions to ensure worker safety in our facilities, the impact of remote versus in-person activities and services, and supply chain delays. The Company believes these estimates are useful to investors as an additional data point to consider in evaluating the Company’s operational performance in the quarter. It is the Company’s expectation that it will not be able to break-out the impact from COVID-19 in future quarters.

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 net income, adjusted EPS (or adjusted net income per share), adjusted operating income, adjusted operating margin, 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 providing an investor relations presentation with additional information on its business and operations, which is available in the investor relations section of the Company’s website at View Source Analysts and investors are directed to 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 3137489. A telephone replay of the call will be available through May 13, 2020, and can be heard by dialing 855-859-2056 (404-537-3406 for international callers). The access code for the replay is 3137489. A real-time webcast of LabCorp’s quarterly conference call on April 29, 2020, will be available at LabCorp Investor Relations website

beginning at 9:00 a.m. EDT. This webcast will be archived and accessible through April 16, 2021.

Boston Scientific Announces Results For First Quarter 2020

On April 29, 2020 Boston Scientific Corporation (NYSE: BSX) reported that sales of $2.543 billion during the first quarter of 2020 (Press release, Boston Scientific, APR 29, 2020, View Source [SID1234556735]). This represents growth of 2.0 percent on a reported basis, 3.2 percent on an operational1 basis and a decline of 2.9 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP earnings of $11 million or $0.01 per share (EPS), compared to GAAP earnings of $424 million or $0.30 per share a year ago, and achieved adjusted earnings per share of $0.28 for the period, compared to $0.35 a year ago.

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"During this global pandemic, we are grounded in the urgency of providing important medical products and therapies to those who need them–in particular, many patients with acute needs," said Mike Mahoney, chairman and chief executive officer, Boston Scientific. "We continue to balance short-term adjustments to our plans while strengthening our long-term strategy to serve our customers and deliver high performance. I’m confident in our ability to bring meaningful, innovative products to market, and grateful for our team’s winning spirit as we navigate the impact of these challenges."

First quarter financial results and recent developments:

Reported GAAP earnings of $0.01 per share. Achieved adjusted earnings per share of $0.28. On March 30, 2020, the company withdrew its Q1 2020 sales and EPS guidance, originally provided on February 5, 2020.
Generated first quarter sales growth/(decline) in our reportable segments4, compared to the prior year period:
MedSurg: 1.1 percent reported, 2.1 percent operational and organic
Rhythm and Neuro: (7.2) percent reported, (6.2) percent operational and (8.6) percent organic
Cardiovascular: 5.5 percent reported, 7.0 percent operational and (2.5) percent organic
Generated first quarter regional5 sales growth/(decline), compared to the prior year period:
U.S.: 3.5 percent reported and operational
EMEA (Europe, Middle East and Africa): (1.6) percent reported and 1.3 percent operational
APAC (Asia-Pacific): (6.4) percent reported and (4.8) percent operational
Emerging Markets3: (10.1) percent reported and (5.4) percent operational
Received CE Mark for the ACURATE neo2 Aortic Valve System, a next-generation transcatheter aortic valve implantation (TAVI) technology to treat patients with severe aortic stenosis that builds on the clinical performance of the original ACURATE neo platform.
Received FDA approval for the DIRECTSENSE RF Technology, the only tool available to monitor the effect of radiofrequency (RF) energy delivery via changes in local impedance around the tip of a catheter during cardiac ablation procedures.
Received CE Mark for the SpyGlass Discover Digital Catheter, a novel single-use surgical endoscope, for use in diagnostic and therapeutic applications during pancreaticobiliary surgery and percutaneous procedures. SpyGlass Discover enables physician access to the pancreaticobiliary system, allowing them to take a single-stage approach to treating patients with bile duct stones.
Received an expanded indication from the FDA for the VENOUS WALLSTENT Self-Expanding Stent, which can now be used to treat patients suffering from blockages in the iliofemoral veins. Iliofemoral deep vein thrombosis (DVT) represents approximately one-quarter of all lower extremity DVT cases.6
Announced positive three-year data for the WATCHMAN Left Atrial Appendage Closure Device — the largest real-world analysis of the device to-date with 38,000 patients from the National Cardiovascular Data Registry (NCDR)-LAAO Registry — at the virtual meeting of the American College of Cardiology/World Congress of Cardiology and continue to demonstrate the device is safe and effective for a broad population of patients with non-valvular atrial fibrillation.
Published positive five-year clinical data in The Journal of Urology confirming that Rezûm Water Vapor Therapy is an effective, long-term treatment for men with benign prostatic hyperplasia (BPH) and offers sustained improvement of lower urinary tract symptoms and quality of life for patients while preserving sexual function. Only 4.4 percent of patients required surgical retreatment through the five years of the clinical trial, demonstrating the therapy’s durability.
Increased available liquidity to approximately $2.6 billion by entering into a new $1.25 billion term loan agreement to refinance borrowings under the company’s revolving credit agreement, and enhanced financial flexibility by amending financial covenants in outstanding credit arrangements.
Signed a virtual energy power purchase agreement (VPPA) that represents another key step the company has taken to achieve its goal of global carbon neutral manufacturing and distribution by 2030. The agreement will address the electricity load for the company’s U.S. operations, which represents 45 percent of its total carbon footprint.
Launched efforts to help address the global impact of COVID-19, including collaborations with the University of Minnesota and others to develop the Coventor, an emergency resuscitator granted Emergency Use Authorization by the FDA, and a reusable personal respirator, as well as the production of face shields for frontline healthcare workers.
Reached a definitive agreement to divest the company’s commercial Intrauterine Health franchise — comprised of the Symphion Tissue Removal System, the Resectr Tissue Resection Device and the Genesys HTA System — to Minerva Surgical. The transaction is expected to close in the coming days, subject to customary closing conditions.

1. Operational revenue growth excludes the impact of foreign currency fluctuations.

2. Organic revenue growth excludes the impact of foreign currency fluctuations and sales from the recent acquisitions of Vertiflex, Inc. and BTG plc (BTG), each with no prior year comparable sales. Organic revenue growth also excludes the impact of the divestiture of our global embolic microspheres portfolio, a transaction entered into in connection with obtaining the antitrust clearances required to complete the BTG transaction.

3. We define Emerging Markets as the 20 countries that we believe have strong growth potential based on their economic conditions, healthcare sectors and our global capabilities.

4. We have three historical reportable segments comprised of Medical Surgical (MedSurg), Rhythm and Neuro, and Cardiovascular, which represent an aggregation of our operating segments that generate revenues from the sale of medical devices (Medical Devices). As part of our acquisition of BTG on August 19, 2019, we acquired an Interventional Medicine business, which is now included in our Peripheral Interventions operating segment’s revenues from the date of acquisition.

5. As part of our acquisition of BTG on August 19, 2019, we acquired a specialty pharmaceuticals business (Specialty Pharmaceuticals). Subsequent to acquisition, Specialty Pharmaceuticals is now a stand-alone operating segment presented alongside our Medical Device reportable segments. Specialty Pharmaceuticals net sales are substantially U.S. based. Our chief operating decision maker (CODM) reviews financial information of our globally managed Specialty Pharmaceuticals operating segment at the worldwide level without further disaggregation into regional results. As such, Specialty Pharmaceuticals net sales are presented globally, and our Medical Devices reportable segments regional net sales results do not include Specialty Pharmaceuticals.

6. Foley, T. R., Waldo, S. W., & Armstrong, E. J. (2015, November 24). Iliofemoral Deep Vein Thrombosis. Retrieved from View Source

Guidance for Remainder of 2020

On March 30, 2020, the company withdrew its sales and EPS guidance for the full year 2020, originally provided on February 5, 2020. Due to the uncertain scope and duration of the COVID-19 pandemic, timing of global recovery and economic normalization, the company is unable to estimate the overall impacts on its operations and financial results for the remainder of 2020.

Conference Call Information

Boston Scientific management will be discussing these results with analysts on a conference call today at 8:00 a.m. EDT. The company will webcast the call to interested parties through its website: www.bostonscientific.com. Please see the website for details on how to access the webcast. The webcast will be available for approximately one year on the Boston Scientific website.