On October 30, 2019 PDL BioPharma, Inc. ("PDL" or "the Company") (NASDAQ: PDLI) reported that it will release its third quarter 2019 financial results for the period ended September 30, 2019, on Wednesday, November 6, 2019, after market close (Press release, PDL BioPharma, OCT 30, 2019, View Source [SID1234550075]). PDL’s management will host a conference call and webcast that day at 4:30 p.m. Eastern time to discuss the operating and financial results and recent developments. A slide presentation relating to the call will be available via the webcast link on the PDL website at View Source

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!

Conference Call Details
To access the live conference call via phone, please dial (844) 535-4071 from the United States and Canada or (706) 679-2458 internationally. The conference ID is 3195828. Please dial in approximately 10 minutes prior to the start of the call. A telephone replay will be available for one week following the call and may be accessed by dialing (855) 859-2056 from the United States and Canada or (404) 537-3406 internationally. The replay passcode is 3195828.

To access the live and subsequently archived webcast of the conference call, go to the Company’s website and go to "Events & Presentations." Please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.

On October 30, 2019 AIVITA Biomedical, Inc., a biotechnology company specializing in innovative stem cell applications, reported the publication of an article titled "Genomic, Proteomic, and Immunologic Associations with a Durable Complete Remission of Measurable Metastatic Melanoma Induced by a Patient-Specific Dendritic Cell Vaccine" in the journal Human Vaccines and Immunotherapeutics (Press release, AIVITA Biomedical, OCT 30, 2019, View Source [SID1234550028]). Robert O. Dillman, M.D., Chief Medical Officer at AIVITA, Gabriel Nistor, M.D., Chief Science Officer, and Aleksandra J. Poole, Ph.D., Vice President, Research & Development, authored the article.

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 article focuses on a melanoma patient treated in a prior Phase 2 study with AIVITA’s immunotherapy, autologous dendritic cells loaded with autologous tumor antigens derived from tumor-initiating cells. The analyses concern the immune mechanism of action that led to a complete response in the patient with progressive, refractory, metastatic melanoma. The analyses included elucidation of the genes in the patient’s tumor cells and normal cells, more than 100 blood markers before and after vaccination, and the patient’s immune cells.

The article is available at Taylor & Francis Online here: View Source

CLINICAL TRIAL DETAIL

OVARIAN CANCER

AIVITA’s ovarian Phase 2 double-blind study is active and enrolling approximately 99 patients who are being randomized in a 2:1 ratio to receive either the autologous cancer stem cell-targeting immunotherapy or autologous monocytes as a comparator.

Patients eligible for randomization and treatment will be those (1) who have undergone debulking surgery, (2) for whom a cell line has been established, (3) who have undergone leukapheresis from which sufficient monocytes were obtained, (4) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), and (5) who have completed primary therapy. The trial is not open to patients with recurrent ovarian cancer.

For additional information about AIVITA’s AVOVA-1 trial patients can visit: www.clinicaltrials.gov/ct2/show/NCT02033616

GLIOBLASTOMA

AIVITA’s glioblastoma Phase 2 single-arm study is active and is enrolling approximately 55 patients to receive the cancer stem cell-targeting immunotherapy.

Patients eligible for treatment will be those (1) who have recovered from surgery such that they are about to begin concurrent chemotherapy and radiation therapy (CT/RT), (2) for whom an autologous tumor cell line has been established, (3) have a Karnofsky Performance Status of > 70 and (4) have undergone successful leukapheresis from which peripheral blood mononuclear cells (PBMC) were obtained that can be used to generate dendritic cells (DC). The trial is not open to patients with recurrent glioblastoma.

For additional information about AIVITA’s AV-GBM-1 trial please visit: www.clinicaltrials.gov/ct2/show/NCT03400917

MELANOMA

AIVITA’s melanoma Phase 1B open-label, single-arm study will establish the safety of administering anti-PD1 monoclonal antibodies in combination with AIVITA’s cancer stem cell-targeting immunotherapy in patients with measurable metastatic melanoma. The study will also track efficacy of the treatment for the estimated 14 to 20 patients. This trial is not yet open for enrollment.

Patients eligible for treatment will be those (1) for whom a cell line has been established, (2) who have undergone leukapheresis from which sufficient monocytes were obtained, (3) have an ECOG performance grade of 0 or 1 (Karnofsky score of 70-100%), (4) who have either never received treatment for metastatic melanoma or were previously treated with enzymatic inhibitors of the BRAF/MEK pathway because of BRAF600E/K mutations and (5) are about to initiate anti-PD1 monotherapy.

On October 30, 2019 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended September 30, 2019 (Press release, PRA Health Sciences, OCT 30, 2019, View Source [SID1234550044]).

"Our third quarter financial results produced solid revenue growth and double digit earnings growth," said Colin Shannon, PRA’s Chief Executive Officer. "During the quarter we finalized a $500.0 million stock repurchase plan and repurchased and retired $300.0 million of common stock in connection with KKR’s clean-up trade. We are excited for our next chapter and I would like to thank KKR for their partnership. Our focus will remain on delivering shareholder returns and also delivering broad and flexible services to our clients. We look forward to continuing to position PRA for success in the future."

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!

Net new business for our Clinical Research segment for the three months ended September 30, 2019 was $669.4 million, representing a net book-to-bill ratio of 1.22 for the period. This net new business contributed to an ending backlog of $4.6 billion at September 30, 2019.

For the three months ended September 30, 2019, revenue was $780.7 million, which represents growth of 8.8%, or $63.1 million, compared to the three months ended September 30, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $69.3 million, an increase of 9.7% compared to the third quarter of 2018. By segment, the Clinical Research segment generated revenues of $719.0 million, while the Data Solutions segment generated revenues of $61.7 million.

Direct costs, exclusive of depreciation and amortization, were $389.3 million during the three months ended September 30, 2019 compared to $371.4 million for the three months ended September 30, 2018 at actual foreign exchange rates. On a constant currency basis, direct costs increased $24.6 million compared to the third quarter of 2018. 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 49.9% of revenue during the third quarter of 2019 compared to 51.8% of revenue during the third quarter of 2018.

Selling, general and administrative expenses were $95.5 million during the three months ended September 30, 2019 compared to $92.6 million for the three months ended September 30, 2018. Selling,

general and administrative costs were 12.2% of revenue during the third quarter of 2019 compared to 12.9% of revenue during the third quarter of 2018.

GAAP net income was $83.0 million for the three months ended September 30, 2019, or $1.25 per share on a diluted basis, compared to GAAP net income of $1.5 million for the three months ended September 30, 2018, or $0.02 per share on a diluted basis.

Adjusted net income was $87.2 million for the three months ended September 30, 2019, representing growth of 16.6% compared to the three months ended September 30, 2018. Adjusted net income per diluted share was $1.32 for the three months ended September 30, 2019, representing growth of 16.8% compared to the three months ended September 30, 2018.

EBITDA was $128.6 million for the three months ended September 30, 2019, representing an increase of 99.6% compared to the three months ended September 30, 2018. Adjusted EBITDA was $137.8 million for the three months ended September 30, 2019, representing growth of 14.0% compared to the three months ended September 30, 2018.

A reconciliation of our non-GAAP measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our 2019 guidance, to the corresponding GAAP measures is included in this press release.

Nine Months Ended September 30, 2019 Financial Highlights

For the nine months ended September 30, 2019, revenue was $2,266.0 million, which represents growth of 5.8%, or $123.7 million, compared to the nine months ended September 30, 2018 at actual foreign exchange rates. On a constant currency basis, revenue grew $150.7 million, representing growth of 7.0% compared to the nine months ended September 30, 2018.

Reported GAAP income from operations was $262.5 million, reported GAAP net income was $168.2 million and reported GAAP net income per diluted share was $2.53 for the nine months ended September 30, 2019.

Adjusted Net Income was $242.3 million for the nine months ended September 30, 2019, an improvement of 22.9% compared to the same period in 2018. Adjusted Net Income per diluted share was $3.64 for the nine months ended September 30, 2019, up 22.1% compared to the same period in 2018.

Guidance

The Company is maintaining its 2019 revenue guidance between $3.02 billion and $3.10 billion, representing as reported growth of 5% to 8% and constant currency growth of 6% to 8%. We are updating our GAAP net income per diluted share to between $3.58 and $3.64 and Adjusted Net Income per diluted share to between $5.07 and $5.12, representing growth of 18% to 20%.

We continue to estimate our annual effective income tax rate at approximately 24%. Our effective tax rate may differ from this estimate, due to, among other things, changes to estimates of the geographic allocation of our pre-tax income as well as changes in guidance from regulatory agencies related to interpretation, analysis and guidance of the U.S. Tax Cuts and Jobs Act.

Our guidance assumes a EURO rate of 1.15 and a GBP rate of 1.30. All other foreign currency exchange rates are as of September 30, 2019.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on October 31, 2019, 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 6427745. 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 6427745.

Additional Information

A financial supplement with third quarter 2019 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 "Q3 2019 Earnings Presentation."

On October 30, 2019 The Mary Kay FoundationSM, a decades-long leader in the mission to eliminate cancers affecting women, reported that donated $100,000 to Baylor Scott & White Dallas Foundation to help fund research conducted by Dr. Joyce O’Shaughnessy, breast oncologist with TEXAS Oncology and the Celebrating Women Chair in breast cancer research at Baylor University Medical Center (Press release, The Mary Kay Foundation, OCT 30, 2019, View Source [SID1234550060]). Dr. O’Shaughnessy’s deep portfolio of research includes the study of triggers that may cause heightened sensitivity of triple negative breast cancer (TNBC) cells and the effectiveness of therapies based on this sensitivity.

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!

TNBC is a high-risk breast cancer with few effective options for patients. It usually affects younger women, African American women, and women with a BRCA1 genetic mutation. Compared with other breast cancer subtypes, TNBC is associated with a worse prognosis, including shorter time to recurrence in early-stage diseases (within 3 years) and a shorter time between recurrence and death in the metastatic setting (between 9-12 months).

"At The Mary Kay Foundation, our mission is to eradicate cancers that affect women around the world, and each year we invest millions in groundbreaking research and support for organizations like Baylor Scott & White," said Dr. Lucy Gildea, Chief Scientific Officer of Mary Kay Inc. "We’re honored to help fund Dr. O’Shaughnessy’s potentially lifesaving research, and we look forward to following along and learning how these results might impact the prognosis of metastatic TNBC patients in the future."

Dr. O’Shaughnessy has focused her research on the metastatic TNBC population due to the very high, unmet medical need. Dr. O’Shaughnessy has worked with Baylor Scott & White Research Institute, which oversees research efforts and provides staffing and other clinical support for the healthcare system, to also design and develop Investigator Initiated Studies examining TNBC.

"The goal of this work is to understand more about the pathways that might allow patients to achieve highly durable complete responses to their treatment and to determine the molecular characteristics of TNBCs that predict the benefit from different treatment strategies," said Dr. O’Shaughnessy. "This type of work could expand the options available to patients with metastatic diseases and bring greater hope to those in need."

"As the largest not-for-profit healthcare system in Texas, Baylor Scott & White relies upon generous donations from organizations like The Mary Kay FoundationSM to continue our innovative research on behalf of patients," said Rowland K. Robinson, president of Baylor Scott & White Dallas Foundation. "We’ve seen promising results from Dr. O’Shaughnessy’s trials so far. And, with The Mary Kay Foundation’s support, we’re hopeful her important work will continue to help us gain additional insight to better serve those with metastatic triple negative breast cancer."

Over the course of more than two decades, The Mary Kay FoundationSM has awarded more than $80 million to women’s shelters and domestic violence service providers, as well as cancer research programs and related causes throughout the United States.

On October 30, 2019 ANI Pharmaceuticals, Inc. (NASDAQ: ANIP) reported that the Company plans to release its third quarter and year-to-date 2019 financial results on Wednesday, November 6, 2019, before the opening of the U.S. financial markets (Press release, ANI Pharmaceuticals, OCT 30, 2019, View Source [SID1234550076]). The earnings press release will be accessible through the Investor Relations section of the Company’s website, www.anipharmaceuticals.com.

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!

Arthur S. Przybyl, President and Chief Executive Officer, and Stephen P. Carey, Vice President, Finance, and Chief Financial Officer, also plan to host a conference call to review those results starting at 10:30am Eastern Time on Wednesday, November 6, 2019. The call will be open to the public and can be accessed through a conference line by dialing (866) 776-8875. The conference ID is 2599456.

A recording of the conference call will be available within two hours of the completion of the call and will remain accessible for a period of seven days following the call. To access the replay, dial (800) 585-8367. The access code for the replay is 2599456.