Reata Pharmaceuticals, Inc. to Report Third Quarter 2018 Financial Results and Provide an Update on Development Programs on Wednesday, November 7, 2018

On October 31, 2018 Reata Pharmaceuticals, Inc. (Nasdaq: RETA), a clinical-stage biopharmaceutical company, reported that the company will report third quarter 2018 financial results on Wednesday, November 7, 2018, before the U.S. financial markets open (Press release, Reata Pharmaceuticals, OCT 31, 2018, View Source [SID1234530549]). The company will host a conference call and live audio webcast at 8:00 a.m. ET on Wednesday, November 7, 2018, to discuss the financial results and provide an update on recent progress on its development programs.

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Third quarter financial results to be discussed during the call will be included in an earnings press release that will be available on the company’s website shortly before the call at View Source and will be available for 12 months after the call. The conference call can be accessed by dialing (844) 348-3946 (toll-free domestic) or (213) 358-0892 (international) and refer to conference ID 5199828. The audio webcast can be accessed through the Investors & News section of the company’s website at View Source The webcast will be archived and available for replay on the company’s website for at least 90 days after the event.

TRACON To Report Third Quarter 2018 Company Highlights And Financial Results On November 7, 2018

On October 31, 2018 TRACON Pharmaceuticals (NASDAQ:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted therapeutics for cancer and wet age-related macular degeneration, reported that it will report its third quarter 2018 financial and operating results after the close of U.S. financial markets on Wednesday, November 7, 2018 (Press release, Tracon Pharmaceuticals, OCT 31, 2018, View Source [SID1234530548]). In addition, management will host a conference call to provide an update on corporate activities and discuss the quarterly financial results.

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Conference call and webcast:
Date: November 7, 2018
Time: 4:30 pm Eastern Time (1:30 pm Pacific Time)
Dial-in: (855) 779-9066 (Domestic) or (631) 485-4859 (International)
Passcode: 6170289
Via web: www.traconpharma.com; "Events and Presentations" section within the "Investors" section
A replay of the webcast will be available for 60 days on the website.

PRA Health Sciences, Inc. Reports Third Quarter 2018 Results and Updates 2018 Guidance

On October 31, 2018 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended September 30, 2018 (Press release, PRA Health Sciences, OCT 31, 2018, View Source;p=RssLanding&cat=news&id=2374565 [SID1234530527]).

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For the three months ended September 30, 2018, revenue was $717.6 million, which represents growth of 23.3%, or $135.6 million, compared to the third quarter of 2017 at actual foreign exchange rates. On a constant currency basis, revenue grew $139.7 million, an increase of 24.0% compared to the third quarter of 2017. On January 1, 2018, the Company adopted Accounting Standards Codification Topic 606, "Revenue from Contracts with Customers," or ASC 606, using the modified retrospective method for all contracts that were not completed as of January 1, 2018. Prior periods have not been restated under this guidance and remain as previously reported. The primary impact of applying this new guidance on our statement of operations is that (i) we now recognize reimbursements from our customers for payments to investigators as revenue, whereas these payments and costs were previously recorded on a net basis, and (ii) we include all reimbursed costs in the total project costs when measuring our progress under our research contracts instead of recording these amounts on a separate basis.

Excluding the impact of the adoption of ASC 606 and reimbursement revenue, revenue increased $78.4 million, which represents growth of 15.8% at actual foreign exchange rates and 16.3% on a constant currency basis. Organic revenue growth, excluding the adoption of ASC 606, reimbursement revenue and revenue attributable to our Data Solutions segment, was 7.7% at actual foreign exchange rates and 8.2% on a constant currency basis.

Net new business for our Clinical Research segment for the quarter ended September 30, 2018 was $657.2 million, representing a net book-to-bill ratio of 1.28 for the period. Our calculation of the net book-to-bill ratio excludes the revenue impact of adopting ASC 606, excludes reimbursement revenue and excludes $60.6 million of revenue from our Data Solutions segment. Net new business during the quarter contributed to an ending backlog of $4.1 billion at September 30, 2018.

"We are delighted to have delivered another quarter with strong financial results on many fronts" said Colin Shannon, PRA’s Chief Executive Officer. "Our key financial metrics continue to improve, as highlighted by our new business wins, our strong revenue growth and our expanding margins. Our financial performance reflects our commitment to client delivery and the efforts of our employees."

Direct costs were $371.4 million during the three months ended September 30, 2018 compared to $326.9 million for the third quarter of 2017. The increase in direct costs was primarily due to an increase in labor-related costs of $11.1 million in our Clinical Research segment as we continue to hire billable staff to ensure appropriate staffing levels. In addition, our Data Solutions segment resulted in $29.4 million of incremental direct costs when compared to the third quarter of 2017. We also had a favorable impact of $6.1 million from fluctuation in foreign currency exchange rates during the three months ended September 30, 2018. Excluding the impact of the adoption of ASC 606 and reimbursement revenue, direct costs were 64.8% of revenue during the third quarter of 2018 compared to 66.1% of revenue during the third quarter of 2017.

Selling, general and administrative expenses were $92.6 million during the three months ended September 30, 2018 compared to $79.3 million for the third quarter of 2017. Excluding the impact of the adoption of ASC 606 and reimbursement revenue, selling, general and administrative costs were 16.2% of revenue during the third quarter of 2018 compared to 16.0% of revenue during the third quarter of 2017.

GAAP net income was $1.5 million for the three months ended September 30, 2018, or $0.02 per share on a diluted basis, compared to GAAP net income of $48.2 million for the three months ended September 30, 2017, or $0.73 per share on a diluted basis.

EBITDA was $64.4 million for the three months ended September 30, 2018, representing an increase of 6.7% compared to the third quarter of 2017. Adjusted EBITDA was $120.9 million for the three months ended September 30, 2018, representing growth of 29.6% compared to the third quarter of 2017.

Adjusted net income was $74.8 million for the three months ended September 30, 2018, representing growth of 29.3% compared to the third quarter of 2017. Adjusted net income per diluted share was $1.13 for the three months ended September 30, 2018, representing growth of 28.4% compared to the third quarter of 2017.

A reconciliation of our non-GAAP measures, including EBITDA, adjusted EBITDA, adjusted net income, adjusted net income per diluted share and our 2018 guidance, to the corresponding GAAP measures is included in this press release.

Nine Months Ended September 30, 2018 Financial Highlights

For the nine months ended September 30, 2018, revenue was $2,142.3 million, which represents growth of 33.6%, or $538.8 million, compared to the nine months ended September 30, 2017 at actual foreign exchange rates. On a constant currency basis, revenue grew $520.3 million, representing growth of 32.4% compared to the nine months ended September 30, 2017.

Excluding the impact of the adoption of ASC 606 and reimbursement revenue, revenue increased $328.3 million, which represents growth of 23.8% at actual foreign exchange rates and 22.8% on a constant currency basis. Organic revenue growth, excluding the adoption of ASC 606, reimbursement revenue and revenue attributable to our Data Solutions segment, was 12.6% at actual foreign exchange rates and 11.6% on a constant currency basis.

Reported GAAP income from operations was $184.6 million, reported GAAP net income was $82.5 million and reported GAAP net income per diluted share was $1.24 for the nine months ended September 30, 2018.

Adjusted Net Income was $197.2 million for the nine months ended September 30, 2018, an improvement of 31.4% compared to the same period in 2017. Adjusted Net Income per diluted share was $2.98 for the nine months ended September 30, 2018, up 30.7% compared to the same period in 2017.

Guidance

The Company is maintaining its 2018 revenue guidance of between $2.87 billion and $2.92 billion, representing as reported growth of 47% to 50%, constant currency growth of 18% to 20% excluding the impact of adopting ASC 606 and reimbursement revenue, and constant currency organic growth of 10% to 12% excluding the impact of adopting ASC 606 and reimbursement revenue. We are updating our GAAP net income per diluted share to between $2.21 and $2.26 and Adjusted Net Income per diluted share to between $4.22 and $4.27. We continue to estimate our annual effective income tax rate at approximately 24%, which includes the expected impact of the U.S. Tax Cuts and Jobs Act. 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 1.17 and a GBP rate of 1.33. All other foreign currency exchange rates are as of September 30, 2018.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on November 1, 2018, 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 9668676. The conference call will also be accessible, live via audio broadcast, on the Investor Relations section of the PRA website at investors.prahs.com. A replay of the conference call will be available online at investors.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 9668676.

Additional Information

A financial supplement with third quarter 2018 results, which should be read in conjunction with this press release, may be found in the Investor Relations section of our website at investors.prahs.com in a document titled "Q3 2018 Earnings Presentation."

Aeterna Zentaris to Announce Third Quarter 2018 Financial and Operating Results on November 6, 2018

On October 31, 2018 Aeterna Zentaris Inc. (NASDAQ:AEZS) (TSX: AEZS) reported that it will announce its third quarter 2018 financial and operating results after market close on Tuesday, November 6, 2018 (Press release, AEterna Zentaris, OCT 31, 2018, View Source [SID1234530472]). The Company will host a conference call to discuss these results on Wednesday, November 7, 2018 at 8:30 a.m. Eastern Time.

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Participants may access the conference call by telephone using the following numbers:

Toll-Free: 877-407-8029, Confirmation #13684540
Toll: 201-689-8029, Confirmation # 13684540
A replay will also be available on the Company’s website for a period of 30 days.

OncBioMune CEO Dr. Jonathan Head Speaking at 2018 Global Summit on Genitourinary Malignancies

On October 31, 2018 OncBioMune Pharmaceuticals, Inc. (OTCQB:OBMP) ("OncBioMune" or the "Company"), a clinical-stage biopharmaceutical company engaged in the development of a proprietary therapeutic cancer vaccine immunotherapy and targeted cancer therapies, is pleased to inform shareholders that the Company’s CEO, Dr. Jonathan Head, has been asked to present alongside other well renowned faculty speakers at Oncology Meeting Innovations’ 2018 Global Summit on Genitourinary Malignancies (Press release, Oncbiomune, OCT 31, 2018, View Source [SID1234530470]). This year’s conference is being held November 1-4, 2018 at Fairmont Banff Springs hotel in Banff, Alberta, Canada.

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Dr. Head is scheduled to speak at 11:30 AM CT on Friday, November 2, 2018 during the session titled, "Immunotherapy in GU Malignancies." Dr. Head will be discussing the qualities and therapeutic benefits of ProscaVax, the Company’s novel immunotherapeutic vaccine for prostate cancer, documented through a successfully completed Phase 1a clinical trial in late-stage prostate cancer patients. Dr. Head’s presentation will further include information on the upcoming Phase 2 clinical trials, one to be hosted at a teaching hospital of Harvard University enrolling early-stage prostate cancer patients and a second at Urology Clinics of North Texas planned to enroll recurrent prostate cancer patients.

"It’s an honor to be selected to speak at OMI’s Global Summit. I look forward to discussing ProscaVax with the scientific and academic community as a new treatment candidate for prostate cancer, a disease greatly in need of new options for men," commented Dr. Head. "Now that we are closing in on commencing both Phase 2 trials, we intend to dedicate more time towards spreading the word about ProscaVax and the potential we believe it holds to fill a large gap in oncology."

Oncology Meeting Innovations’ Global Summit on Genitourinary Malignancies is a four-day meeting fostering discussion and debate on the evolution of treatment in prostate cancer, renal cell carcinoma, and bladder cancer. Topics will include current standards of care, and the evolving clinical landscape in the treatment of GU cancers. The summit features a focused approach towards individual patient populations through case-based discussions. Panel discussions will highlight clinical application of approved and emerging agents as well as the challenges within the field of GU Oncology. The Summit will assemble translational scientists, clinical researchers, and key community oncologists to further progress this rapidly evolving area of oncology.

About Prostate Cancer

According to the American Cancer Society (ACS), prostate cancer is the most common type of cancer in men other than skin cancer, with about 1 in 9 men diagnosed during their lifetime. ACS estimates that about 164,690 new cases of prostate cancer will be diagnosed during 2018 and approximately 29,430 men will die from the disease this year. Prostate cancer is the second leading cause of cancer death in men, trailing only lung cancer. Approximately 2.9 million men are living with prostate cancer today. The average age of diagnosis is 66, with the disease considered rare in men under the age of 40