On April 30, 2020 Seattle Genetics, Inc. (Nasdaq:SGEN) reported financial results for the first quarter ended March 31, 2020 (Press release, Seattle Genetics, APR 30, 2020, View Source [SID1234556838]). The Company also highlighted ADCETRIS (brentuximab vedotin) and PADCEV (enfortumab vedotin-ejfv) commercial and development accomplishments, TUKYSA (tucatinib) U.S. Food and Drug Administration (FDA) approval and launch as well as progress with its lead programs to treat cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"We have had a remarkable start to 2020, delivering record product sales in the first quarter that are now coming from both ADCETRIS and PADCEV. Notably, strong PADCEV sales in the first full quarter of launch reflect the unmet need among patients with metastatic bladder cancer," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "With the recent approval of TUKYSA for patients with metastatic HER2-positive breast cancer, we have now launched our third product just four months after our second. In addition, we are investing in potential label expansions in all three products to maximize their use to patients in need. We are also preparing for European commercial operations and have hired general managers in major European markets ahead of potential ex-U.S. approvals of TUKYSA. With two new products, growing revenues, and an advancing pipeline of novel cancer programs, we have exciting prospects for future growth."

Lead Program Highlights
ADCETRIS

Ex-U.S. Regulatory Progress: In March 2020, Takeda received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use to extend the marketing authorization for ADCETRIS to include ADCETRIS in combination with CHP (cyclophosphamide, doxorubicin, prednisone) as a treatment for adult patients with previously untreated systemic anaplastic large cell lymphoma. The positive opinion is based on results of the phase 3 ECHELON-2 trial.

Expanded Collaboration with Bristol-Myers Squibb for Trial in Early Stage Hodgkin Lymphoma: In April 2020, Seattle Genetics and Bristol-Myers Squibb agreed to co-fund an additional cohort in an ongoing trial that will evaluate the combination of ADCETRIS, OPDIVO (nivolumab) and chemotherapy for frontline stage I and II Hodgkin lymphoma.

PADCEV

Presented Updated Results from Phase 1b/2 Trial in First-Line Urothelial Cancer at 2020 ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium: In February 2020, updated results from the EV-103 trial in patients with previously untreated locally advanced or metastatic urothelial cancer who were ineligible for treatment with cisplatin-based chemotherapy were presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium. The results in 45 patients demonstrated a confirmed objective response rate of 73.3 percent with a median follow-up of 11.5 months. Median duration of response had not been reached. The study results continued to meet outcome measures for safety.

Received Breakthrough Therapy Designation in First-line Advanced Urothelial Cancer: In February 2020, the FDA granted Breakthrough Therapy designation for PADCEV in combination with KEYTRUDA (pembrolizumab) for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting.

Potential Accelerated Approval Pathway for PADCEV in First-line Advanced Urothelial Cancer: In April 2020, the Company announced that based on discussions with the FDA, data from the randomized cohort K in the phase 1b/2 EV-103 trial, along with other data from the EV-103 trial evaluating PADCEV combined with Merck’s KEYTRUDA as first-line therapy for cisplatin-ineligible patients with locally advanced or metastatic urothelial cancer, could potentially support registration under accelerated approval regulations in the U.S. The primary outcome measures are objective response rate and duration of response. Seattle Genetics and its PADCEV partner, Astellas, are evaluating the combination of PADCEV and KEYTRUDA under clinical collaboration agreements with Merck.

First Patient Dosed in Phase 3 Clinical Trial in First-line Advanced Urothelial Cancer: In April 2020, the first patient was dosed in the EV-302 trial evaluating the combination of PADCEV and KEYTRUDA with or without chemotherapy versus chemotherapy alone in patients with previously untreated locally advanced or metastatic urothelial cancer. EV-302 includes metastatic urothelial cancer patients who are either eligible or ineligible for cisplatin-based chemotherapy. The trial has dual primary endpoints of progression-free survival and overall survival and is intended to support global registrations and potentially serve as a confirmatory trial if accelerated approval is granted based on EV-103.

Completed Enrollment in Second Cohort of EV-201 Trial: In April 2020, Seattle Genetics and Astellas completed enrollment in the second cohort of the EV-201 trial for patients who previously received a PD-1 or PD-L1 inhibitor but were not candidates for treatment with cisplatin chemotherapy. Data from the second cohort could potentially serve as the basis for a second PADCDEV indication.

Entered into Agreement with Merck to Evaluate PADCEV in Muscle Invasive Bladder Cancer (MIBC): In April 2020, Seattle Genetics and Astellas entered into an agreement with Merck under which Merck will amend its ongoing phase 3 trial in cisplatin-ineligible MIBC patients to include an arm evaluating PADCEV in combination with KEYTRUDA.

First Patient Dosed in Phase 2 Clinical Trial in Solid Tumors: In March 2020, the first patient was dosed in the phase 2 EV-202 clinical trial evaluating single-agent PADCEV in a range of solid tumors.
TUKYSA

Received FDA Approval: In April 2020, TUKYSA was approved by the FDA in combination with trastuzumab and capecitabine for the treatment of adult patients with advanced unresectable or metastatic HER2-positive breast cancer, including patients with brain metastases, who have received one or more prior anti-HER2-based regimens in the metastatic setting. Approval was granted four months ahead of the PDUFA target action date under the FDA’s Real-Time Oncology Review pilot program. TUKYSA is also part of Project Orbis, an initiative of the FDA Oncology Center of Excellence that provides a framework for concurrent submission and review of oncology drugs across participating global health authorities.

HER2CLIMB Data Selected for Oral Presentation at ASCO (Free ASCO Whitepaper): Additional analyses of the treatment effect of the TUKYSA regimen in metastatic HER2-positive breast cancer patients with brain metastases in the HER2CLIMB trial were selected for an oral presentation at the ASCO (Free ASCO Whitepaper) Virtual Scientific Program taking place May 29-31, 2020.

Marketing Authorization Application Validated by the EMA: In January 2020, the Marketing Authorization Application (MAA) for TUKYSA was validated by the European Medicines Agency (EMA). The EMA validation of the MAA confirms that the submission is sufficiently complete to begin the formal review process.
Tisotumab Vedotin

Tisotumab Vedotin innovaTV 204 Pivotal Trial Topline Results: Seattle Genetics and Genmab expect to report topline data late in the second or into the third quarter of 2020 for the innovaTV 204 pivotal trial of tisotumab vedotin in patients with recurrent and/or metastatic cervical cancer who have relapsed or progressed after standard of care treatment.
For additional information on Seattle Genetics’ pipeline, visit www.seattlegenetics.com/pipeline.
Legal Dispute with Daiichi Sankyo Co. Ltd.

In November 2019, Seattle Genetics submitted an arbitration demand to the American Arbitration Association regarding the ownership of certain technology used by Daiichi Sankyo in the breast cancer drug ENHERTU (DS-8201, [Fam-] trastuzumab deruxtecan), among other product candidates. The demand alleges that the linker and other antibody-drug conjugate (ADC) technology used in these agents are improvements to Seattle Genetics’ pioneering ADC technology, the ownership of which was assigned to Seattle Genetics under the terms of a 2008 collaboration agreement between the companies. On November 4, 2019, Daiichi Sankyo attempted to have the case heard in federal court. On April 27, 2020, it was ruled that the dispute should be resolved in arbitration and that the arbitration process should move forward.

FIRST QUARTER 2020 FINANCIAL RESULTS
Revenues: Total revenues in the first quarter ended March 31, 2020 increased to $234.5 million, compared to $195.2 million for the same period in 2019. Revenues are comprised of the following three components:

Royalty Revenues: Royalty revenues in the first quarter were $20.4 million, compared to $15.6 million in the first quarter of 2019. Royalty revenues are primarily driven by sales of ADCETRIS outside the U.S. and Canada by Takeda and, to a lesser extent, sales of Polivy (polatuzumab vedotin-piiq) by Roche.

Collaboration and License Agreement Revenues: Amounts earned under the Company’s ADCETRIS and ADC collaborations were $15.6 million in the first quarter, compared to $44.6 million for the same period in 2019. Collaboration revenues for the first quarter of 2019 included a $30.0 million milestone from Takeda triggered by European Commission approval of ADCETRIS in combination with chemotherapy for frontline Hodgkin lymphoma.
Research and Development (R&D) Expenses: R&D expenses in the first quarter were $195.2 million, compared to $158.3 million in the first quarter of 2019. The increase in 2020 primarily reflects increased investment in the Company’s pipeline.
Selling, General and Administrative (SG&A) Expenses: SG&A expenses in the first quarter were $122.2 million, compared to $80.3 million in the first quarter of 2019. The increase was primarily attributed to increased field sales personnel for Seattle Genetics’ recently commercialized products, PADCEV and TUKYSA, as well as higher infrastructure costs to support the Company’s continued growth.

Cost of Sales: Cost of sales in the first quarter were $29.4 million, compared to $10.3 million in the first quarter of 2019. The increase in 2020 is primarily due to the gross profit share with Astellas based on PADCEV sales, which was $16.4 million in the first quarter of 2020, as well as higher ADCETRIS sales volumes.

Non-cash, share-based compensation cost for the first three months of 2020 was $33.6 million, compared to $25.7 million for the same period in 2019.

Net Loss: Net loss for the first quarter of 2020 was $168.4 million, or $0.98 per diluted share, compared to net loss of $13.3 million, or $0.08 per diluted share, for the first quarter of 2019. Net loss in the first quarter of 2020 included a net investment loss of $59.1 million primarily associated with Seattle Genetics’ common stock holdings in Immunomedics, which are marked-to-market, compared to a net investment gain of $38.1 million in the first quarter of 2019.

Cash and Investments: As of March 31, 2020, Seattle Genetics had $799.6 million in cash and investments and holdings of Immunomedics common stock valued at $104.1 million.

2020 FINANCIAL OUTLOOK
The Company continues to monitor the impact of the COVID-19 global pandemic on its business and is taking appropriate steps to protect the safety of employees, healthcare professionals and patients. Seattle Genetics’ 2020 financial guidance remains unchanged from that provided on February 6, 2020 and is detailed below.

Conference Call Details
Seattle Genetics’ management will host a conference call and webcast with supporting slides to discuss its first quarter 2020 financial results and provide an update on business activities. The event will be held today at 1:30 p.m. Pacific Time (PT); 4:30 p.m. Eastern Time (ET). The live event and supporting slides will be simultaneously webcast and available for replay from the Seattle Genetics website at www.seattlegenetics.com, under the Investors section. Investors may also participate in the conference call by calling 888-220-8474 (domestic) or 720-452-9217 (international). The conference ID is 7835915. A replay of the audio only will be available by calling 888-203-1112 (domestic) or 719-457-0820 (international), using conference ID 7835915. The telephone replay will be available until 5:00 p.m. PT on May 3, 2020.

On April 30, 2020 Amgen (NASDAQ:AMGN) reported financial results for the first quarter of 2020 and discussed the company’s response to the COVID-19 pandemic (Press release, Amgen, APR 30, 2020, View Source [SID1234556837]).
First Quarter Performance
Key results include:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Total revenues increased 11% to $6.2 billion in comparison to the first quarter of 2019, driven by higher unit demand, offset partially by lower net selling prices.

Product sales increased 12% globally, driven by volume growth across a number of our newer products, including Otezla (apremilast), Repatha (evolocumab), MVASI (bevacizumab-awwb), KANJINTI (trastuzumab-anns) and Evenity (romosozumab-aqqg), offset partially by declines in select products from the impact of biosimilar and generic competition.

GAAP earnings per share (EPS) decreased 3% to $3.07 driven by the amortization of costs associated with our Nov. 21, 2019 acquisition of Otezla, offset partially by increased revenues.

GAAP operating income decreased 5% to $2.4 billion and GAAP operating margin decreased 6.8 percentage points to 40.0% driven by the amortization of intangible assets from our Otezla acquisition.

Non-GAAP EPS increased 17% to $4.17 driven by increased revenues and fewer weighted-average shares outstanding.

Non-GAAP operating income increased 15% to $3.2 billion and non-GAAP operating margin increased 1.5 percentage points to 53.9%.

The Company generated $2.0 billion of free cash flow in the first quarter versus $1.7 billion in the first quarter of 2019.

2020 total revenues guidance reaffirmed at $25.0-$25.6 billion; EPS guidance revised to $10.65-$11.45 on a GAAP basis and reaffirmed at $14.85-$15.60 on a non-GAAP basis.

"I am inspired by the many ways my colleagues at Amgen and others across the industry are stepping up to meet the greatest public health challenge of our lifetime," said Robert A. Bradway, chairman and chief executive officer. "We are committed to an uninterrupted supply of our medicines to patients; advancing potential new medicines to treat serious diseases, including COVID-19; making a difference in the communities where we live and work; and creating long-term value for shareholders."

AMGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS

References in this release to "non-GAAP" measures, measures presented "on a non-GAAP basis" and to "free cash flow" (computed by subtracting capital expenditures from operating cash flow) refer to non-GAAP financial measures. Adjustments to the most directly comparable GAAP financial measures and other items are presented on the attached reconciliations.
Product Sales Performance

Total product sales increased 12% for the first quarter of 2020 versus the first quarter of 2019 driven by 15% volume growth.

Prolia (denosumab) sales increased 10% driven by higher unit demand.

EVENITY launched in the U.S. and Japan in the first half of 2019, generating $100 million of sales in the first quarter of 2020.

Repatha sales increased 62% driven by 98% volume growth, offset partially by lower net selling price. Repatha’s net selling price was impacted by the removal of our original list price option to improve patient affordability, especially for Medicare patients.

Aimovig (erenumab-aooe) sales increased 20% driven by 46% volume growth, offset partially by lower net selling price as we expanded patient access.

Parsabiv (etelcalcetide) sales increased 39% driven by higher unit demand, offset partially by lower net selling price.

Otezla was acquired on Nov. 21, 2019 and generated $479 million of sales in the first quarter of 2020.

Enbrel (etanercept) sales were flat as favorable changes to estimated sales deductions and inventory were offset by lower unit demand and lower net selling price.

AMGEVITA (adalimumab) generated $86 million of sales in the first quarter of 2020 and is the most prescribed adalimumab biosimilar in Europe.

KYPROLIS (carfilzomib) sales increased 14% driven by higher unit demand and to a lesser extent, higher net selling price.

XGEVA (denosumab) sales increased 2% driven by higher unit demand.

Vectibix (panitumumab) sales increased 19% driven by higher unit demand.

Nplate (romiplostim) sales increased 15% driven by higher unit demand.

AMGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS

BLINCYTO (blinatumomab) sales increased 36% driven by higher unit demand.

KANJINTI generated $119 million of sales in the first quarter of 2020.

MVASI generated $115 million of sales in the first quarter of 2020.

Neulasta (pegfilgrastim) sales decreased 40% driven by the impact of competition on unit demand and net selling price.

NEUPOGEN (filgrastim) sales decreased 11% driven by the impact of competition on unit demand.

EPOGEN (epoetin alfa) sales decreased 29% driven by lower net selling price and unfavorable changes to estimated sales deductions.

Aranesp (darbepoetin alfa) sales increased 2% driven by higher unit demand and favorable changes in inventory, offset by lower net selling price.

Sensipar/Mimpara (cinacalcet) sales decreased 42% driven by the impact of competition on unit demand, offset partially by favorable changes to estimated sales deductions and inventory.

AMGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS

** Other includes GENSENTA, IMLYGIC, Corlanor and Bergamo.
Operating Expense, Operating Margin and Tax Rate Analysis
On a GAAP basis:

Total Operating Expenses increased 23% driven by Otezla-related expenses, including the amortization of intangible assets. Cost of Sales margin increased 5.7 percentage points driven by amortization of intangible assets acquired in the Otezla acquisition and an increase in milestone payments, offset partially by lower manufacturing costs. Research & Development (R&D) expenses increased 8% driven by higher late-stage development program support of our oncology portfolio, primarily AMG 510 (sotorasib), along with the recently acquired Otezla, offset partially by recoveries from our collaboration with BeiGene. Selling, General & Administrative (SG&A) expenses increased 14% due to our first full quarter of Otezla commercial-related expenses.

Operating Margin decreased 6.8 percentage points to 40.0% driven by the amortization of intangible assets from our Otezla acquisition.

Tax Rate decreased 4.2 percentage points due primarily to amortization related to the Otezla acquisition, changes in jurisdictional mix of earnings and an increase in net discrete tax benefits.

AMGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS
Page 5

On a non-GAAP basis:

Total Operating Expenses increased 7% driven by Otezla-related expenses. Cost of Sales margin decreased 1.6 percentage points driven by lower manufacturing costs, offset partially by an increase in milestone payments. R&D expenses increased 8% driven by higher late-stage development program support of our oncology portfolio, primarily AMG 510 (sotorasib), along with the recently acquired Otezla, offset partially by recoveries from our collaboration with BeiGene. SG&A expenses increased 12% due to our first full quarter of Otezla commercial-related expenses.

Operating Margin increased 1.5 percentage points to 53.9%.

Tax Rate decreased 1.8 percentage points due primarily to changes in jurisdictional mix of earnings and an increase in net discrete tax benefits.
$Millions, except percentages

Cash Flow and Balance Sheet

The Company generated $2.0 billion of free cash flow in the first quarter of 2020 versus $1.7 billion in the first quarter of 2019.

The Company’s first quarter 2020 dividend of $1.60 per share was declared on Dec. 11, 2019, and was paid on March 6, 2020, to all stockholders of record as of Feb. 14, 2020, representing a 10% increase from the first quarter of 2019.

During the first quarter, the Company repurchased 4.3 million shares of common stock at a total cost of $933 million. At the end of the first quarter, the Company had $5.5 billion remaining under its stock repurchase authorization.

2020 Guidance
For the full year 2020, the Company reaffirmed total revenues and non-GAAP EPS guidance:

Total revenues in the range of $25.0 billion to $25.6 billion, unchanged from previous guidance.

On a GAAP basis, EPS in the range of $10.65 to $11.45 and a tax rate in the range of 10.5% to 11.5%.

On a non-GAAP basis, EPS in the range of $14.85 to $15.60 and a tax rate in the range of 13.5% to 14.5%, unchanged from previous guidance.

Capital expenditures to be approximately $600 million.

First Quarter Product and Pipeline Update
The Company provided the following updates on selected product and pipeline programs:
AMG 510 (sotorasib)

The Company will present the following clinical data as part of the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, May 29-31:

Updated results from the Phase 1 dose escalation study in patients with advanced colorectal cancer.

Updated results from the Phase 1 dose escalation study in patients with advanced solid tumors other than non-small-cell lung cancer (NSCLC) and colorectal cancer.

The Company reiterated its expectation of initial data in 2020 from a potentially pivotal Phase 2 monotherapy study in patients with advanced NSCLC, including at least six months of response data.

BiTE Programs

The Company expects initial data from Phase 1 dose escalation studies of the following half-life extended BiTE molecules in H2 2020:

AMG 160 targeting PSMA (prostate specific membrane antigen)

AMG 701 targeting BCMA (B-cell maturation antigen)

AMG 757 targeting DLL3 (Delta-like ligand 3)

Updated results from the Phase 1 dose escalation study of AMG 330, a bispecific T-cell engager molecule targeting CD33, in patients with relapsed/refractory acute myeloid leukemia will be presented as part of the ASCO (Free ASCO Whitepaper)20 Virtual Scientific Program, May 29-31.

AMGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS
Page 7

KYPROLIS

The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of Nov. 15, 2020 for the supplemental New Drug Application (sNDA) to expand the Prescribing Information to include KYPROLIS in combination with dexamethasone and DARZALEX (daratumumab) for patients with relapsed or refractory multiple myeloma based on data from the Phase 3 CANDOR study.

In February, a variation to the marketing authorization application was submitted to the European Medicines Agency to expand the indication for Kyprolis in relapsed multiple myeloma based on data from the Phase 3 CANDOR study.
XGEVA

In April, a marketing authorization for the treatment of skeletal related events was accepted for review by the Center for Drug Evaluation in China. XGEVA is included in our strategic collaboration with BeiGene.
ABP 798 (biosimilar rituximab)

The FDA has set a Biosimilar User Fee Act target action date of Dec. 19, 2020 for the Biologics License Application for ABP 798, a biosimilar candidate to Rituxan (rituximab).
Otezla

Data from the Phase 3 study in patients with mild-to-moderate psoriasis are expected in Q2 2020.

In April, the U.S. Food and Drug Administration (FDA) approved the sNDA to add scalp psoriasis data to the U.S. Prescribing Information.

In April, the European Commission (EC) approved an additional indication for the treatment of adult patients with oral ulcers associated with Behçet’s Disease who are candidates for systemic therapy.

Tezepelumab

The Company reiterated its expectation of data from the Phase 3 NAVIGATOR study in patients with severe uncontrolled asthma by the end of 2020.
Omecamtiv mecarbil

In February, the Data Monitoring Committee for the Phase 3 GALACTIC-HF study completed the second and final planned interim analysis for futility and superiority and recommended that the study continue without changes to its conduct.

The Company reiterated its expectation of data from GALACTIC-HF in Q4 2020.
Repatha

In March, the Company announced that Repatha significantly reduced low-density lipoprotein cholesterol (LDL-C) in patients who are human immunodeficiency virus-positive and have high LDL-C despite stable background lipid-lowering therapy.
AMG 890

A Phase 2 study is expected to begin in the second half of 2020 for AMG 890, a small interfering RNA molecule that lowers lipoprotein(a).

AMGEN REPORTS FIRST QUARTER 2020 FINANCIAL RESULTS
Page 8

COVID-19

The Company announced that Otezla, an oral treatment approved in more than 50 countries for inflammatory diseases such as psoriasis and psoriatic arthritis, will be investigated as a potential immunomodulatory treatment in adult patients with COVID-19 in upcoming platform trials.

In April, the Company announced a collaboration with Adaptive Biotechnologies to discover and develop fully human neutralizing antibodies targeting SARS-CoV-2 to potentially prevent or treat COVID-19.

The Company provided the following updates on aspects of its R&D activities

Study start-up activities are continuing where possible to allow rapid site activation and enrollment when that becomes feasible.

Study procedures are being implemented consistent with recent guidance from regulators to maintain patient safety and study data integrity.

Enrollment is paused in clinical trials where there is uncertainty around the ability of sites to ensure subject safety or data integrity.

Research activities are increasing in various geographies as the situation safely permits.

Medical conferences and journals are being engaged to ensure continued dissemination of important data in a timely manner.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc.
DARZALEX is a registered trademark of Janssen Biotech, Inc.
Rituxan is a registered trademark of Biogen Inc.
Tezepelumab is being developed in collaboration with AstraZeneca
Omecamtiv mecarbil is being developed under a collaboration between Amgen and Cytokinetics, with funding and strategic support from Servier

On April 30, 2020 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the three months ended March 31, 2020 (Press release, PRA Health Sciences, APR 30, 2020, View Source [SID1234556836]).

"During these unprecedented times, we have focused on the health and safety of employees putting into practice what we have always said about our people being our most important asset. Due to the ongoing impact of COVID-19, we have prioritized employees’ well-being and have worked diligently with our customers to ensure that we mitigate the impact that this pandemic is having on their studies," said Colin Shannon, PRA’s President and Chief Executive Officer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"Our first quarter financial results were impacted by the pandemic, particularly during the latter part of the quarter, when decisions on new business were delayed and stay-at-home orders created challenges in conducting our business. However, we still produced revenue and earnings that were in line with the guidance we provided back in February. As the world started moving into lockdown we worked creatively with clients to help them find solutions for their on-going studies. Through the use of our mobile health platform and our remote monitoring technology, we were able to mitigate some of the impact the lockdown had on our financial results.

"With all the uncertainty of how this pandemic will unfold, it is extremely difficult to estimate the impact to our financial results, but we will continue to manage our business in a very fiscally responsible manner and continue to be innovative in finding solutions for our clients. We have significantly reduced our debt levels over the past few years, and we are well-positioned to weather the challenging economic conditions that we may continue to face. I would also like to add that we are extremely thankful to all those who are helping the world get through this global pandemic."

Net new business for our Clinical Research segment for the three months ended March 31, 2020 excluding reimbursement revenue was $604.7 million, representing a net book-to-bill ratio of 1.10 for the period. Net new business for our Clinical Research segment for the three months ended March 31, 2020 including reimbursement revenue was $955.9 million, representing a net book-to-bill of 1.32 for the period. During the quarter, our net new business awards were impacted by the COVID-19 pandemic as business development activities began to slow at the end of the quarter with bid-defense meetings and study award decisions being postponed due to restrictions put in place as a result of the pandemic. This net new business, excluding reimbursement revenue, contributed to an ending backlog of $4.7 billion at March 31, 2020.

For the three months ended March 31, 2020, revenue was $783.7 million, which represents growth of 8.5%, or $61.7 million, compared to the three months ended March 31, 2019 at actual foreign exchange rates. On a constant currency basis, revenue grew $67.0 million, an increase of 9.3% compared to the first quarter of 2019. By segment, the Clinical Research segment generated revenues of $726.1 million, while the Data Solutions segment generated revenues of $57.6 million.

Direct costs, exclusive of depreciation and amortization, were $403.9 million during the three months ended March 31, 2020 compared to $377.9 million for the three months ended March 31, 2019 at actual foreign exchange rates. On a constant currency basis, direct costs increased $32.5 million compared to the first quarter of 2019. The increase in direct costs continues to be driven by increased labor costs in our Clinical Research segment and increased data costs in our Data Solutions segment. Direct costs were 51.5% of revenue during the first quarter of 2020 compared to 52.3% of revenue during the first quarter of 2019.

Selling, general and administrative expenses were $107.0 million during the three months ended March 31, 2020 compared to $97.1 million for the three months ended March 31, 2019. Selling, general and administrative costs were 13.6% of revenue during the first quarter of 2020 compared to 13.4% of revenue during the first quarter of 2019.

GAAP net income was $40.7 million for the three months ended March 31, 2020, or $0.63 per share on a diluted basis, compared to GAAP net income of $44.1 million for the three months ended March 31, 2019, or $0.66 per share on a diluted basis.

EBITDA was $103.3 million for the three months ended March 31, 2020, representing a decrease of 7.9% compared to the three months ended March 31, 2019. Adjusted EBITDA was $112.1 million for the three months ended March 31, 2020, representing a decrease of 4.3% compared to the three months ended March 31, 2019.

Adjusted net income was $67.3 million for the three months ended March 31, 2020, representing a decrease of 8.1% compared to the three months ended March 31, 2019. Adjusted net income per diluted share was $1.05 for the three months ended March 31, 2020, representing a decrease of 4.5% compared to the three months ended March 31, 2019.

Guidance

The Company is withdrawing its full year 2020 guidance. Due to the uncertain scope and duration of the COVID-19 pandemic and uncertain timing of global recovery and economic normalization, the Company is unable to estimate with confidence the full-year overall impact on its global operations.

For Q2 2020, the Company expects to achieve total revenues between $705.0 million and $740.0 million, GAAP net income per diluted share of between $0.32 and $0.46, adjusted net income per diluted share of between $0.75 and $0.90, and an effective income tax rate of 23%.

Our Q2 2020 guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30. All other foreign currency exchange rates are as of March 31, 2020.

A reconciliation of our non-GAAP measures, EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our Q2 2020 guidance to the corresponding GAAP measures is included in this press release.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on May 1, 2020, to discuss the contents of this release and other relevant topics. To participate, please dial (877) 930-8062 within the United States or (253) 336-7647 outside the United States approximately 10 minutes before the scheduled start of the call. The conference ID for the call is 7450977. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investor.prahs.com. A replay of the conference call will be available online at investor.prahs.com. In addition, an audio replay of the call will be available for one week following the call and can be accessed by dialing (855) 859-2056 within the United States or (404) 537-3406 outside the United States. The replay ID is 7450977.

Additional Information

A financial supplement with first quarter 2020 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investor.prahs.com in a document titled "Q1 2020 Earnings Presentation."

On April 30, 2020 Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE), a biopharmaceutical company focused on the development of novel products for serious rare and ultra-rare genetic diseases, reported that it will host a conference call on Wednesday, May 6, 2020 at 5pm ET to discuss first quarter 2020 financial results and provide a corporate update (Press release, Ultragenyx Pharmaceutical, APR 30, 2020, http://ir.ultragenyx.com/news-releases/news-release-details/ultragenyx-host-conference-call-first-quarter-2020-financial [SID1234556835]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The live and replayed webcast of the call will be available through the company’s website at View Source To participate in the live call by phone, dial (855) 797-6910 (USA) or (262) 912-6260 (International) and enter the passcode 9455159. The replay of the call will be available for one year.

On April 30, 2020 NeuBase Therapeutics, Inc. (Nasdaq: NBSE), a preclinical-stage biotechnology company focused on developing next generation therapies to treat rare genetic diseases caused by mutant genes, reported the closing of its previously announced underwritten public offering of 6,037,500 shares of its common stock (inclusive of 787,500 shares that were sold pursuant to the underwriters’ full exercise of their option to purchase additional shares of NeuBase’s common stock), at a price to the public of $6.00 per share (Press release, NeuBase Therapeutics, APR 30, 2020, View Source [SID1234556834]). The net proceeds to NeuBase from the offering are expected to be approximately $33.3 million, after deducting the underwriting discounts and commissions and other estimated offering expenses payable by NeuBase. NeuBase intends to use the net proceeds from this offering for working capital and general corporate purposes and to advance the development of its product candidates and expand its pipeline.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

Oppenheimer & Co. Inc. and BTIG acted as the joint book-running managers for the offering, and Chardan and National Securities Corporation, a wholly-owned subsidiary of National Holdings, Inc. (Nasdaq: NHLD), acted as the co-managers.

The securities described above were offered by NeuBase pursuant to a shelf registration statement on Form S-3 (File No. 333-220487) previously filed with the Securities and Exchange Commission (the "SEC") on September 15, 2017 and declared effective by the SEC on September 27, 2017. A final prospectus supplement and the accompanying prospectus relating to and describing the offering was filed with the SEC. Electronic copies of the preliminary prospectus supplement and, when available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained by visiting the SEC’s website at www.sec.gov or by contacting Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by e-mail at [email protected], or BTIG, LLC, Attention: Equity Capital Markets, 65 East 55th Street, New York, NY 10022, by telephone at (212) 593-7555 or by e-mail at [email protected].

This press release does not constitute an offer to sell or the 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 the registration or qualification under the securities laws of any such state or jurisdiction.