On August 7, 2018 PRA Health Sciences, Inc. (the "Company") (NASDAQ: PRAH) reported the pricing of the previously announced secondary offering of shares of its common stock (Press release, PRA Health Sciences, AUG 7, 2018, View Source;p=RssLanding&cat=news&id=2362392 [SID1234528947]). An affiliate of, or a fund sponsored by, Kohlberg Kravis Roberts & Co. (the "Selling Stockholder"), has agreed to sell an aggregate of 6,500,000 shares of the Company’s common stock in an underwritten public offering at a price of $101.50 per share. The offering is expected to close on August 9, 2018, subject to customary closing conditions.

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!

Morgan Stanley and Goldman Sachs & Co. LLC acted as the underwriters for the offering.

The Company has filed a registration statement (including a prospectus) with the SEC for the offering to which this communication relates. Before you invest, you should read the prospectus in that registration statement, as well as the prospectus supplement related to this offering and other documents the Company has filed with the SEC for more complete information about the Company and this offering. You may obtain these documents for free by visiting EDGAR on the SEC Web site at: www.sec.gov. Alternatively, copies of the prospectus supplement and accompanying prospectus relating to the offering, when available, may be obtained from:

Morgan Stanley & Co. LLC
Attention: Prospectus Department
180 Varick Street, 2nd Floor
New York, NY 10014

Goldman Sachs & Co. LLC
Attention: Prospectus Department
200 West Street
New York, NY 10282
Telephone: 866-471-2526
Facsimile: 212-902-9316
[email protected]
This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Contact:

PRA Health Sciences, Inc.
Christine Rogers
919-786-8463
[email protected]

Mike Bonello
Chief Financial Officer
919-786-8270
[email protected]

Forward Looking Statements

This press release contains forward-looking statements that reflect, among other things, the Company’s current expectations and anticipated results of operations, all of which are subject to known and unknown risks, uncertainties and other factors that may cause the Company’s actual results, performance or achievements, market trends or industry results to differ materially from those expressed or implied by such forward-looking statements. For this purpose, any statements contained herein that are not statements of historical fact may constitute forward-looking statements. Without limiting the foregoing, words such as "anticipates," "believes," "estimates," "expects," "intends," "may," "plans," "projects," "should," "targets," "will" and the negative thereof and similar words and expressions are intended to identify forward-looking statements. Actual results may differ materially from the Company’s expectations due to a number of factors, including, that most of the Company’s contracts may be terminated on short notice, and that the Company may be unable to maintain large customer contracts or to enter into new contracts; the Company may underprice contracts, overrun its cost estimates or fail to receive approval or experience delays in documenting change orders; the historical indications of the relationship of backlog to revenues may not be indicative of their future relationship; if the Company is unable to achieve operating efficiencies or grow revenues faster than expenses, operating margins will be adversely affected; if the Company is unable to attract investigators and patients for its clinical trials, its clinical development business may suffer; the Company could be subject to employment liability with its embedded and functional outsourcing solutions as it places employees at the physical workplaces of its clients; the Company may be unable to recruit experienced personnel; changes in accounting standards may adversely affect the Company’s financial statements; the Company’s effective income tax rate may fluctuate which may adversely affect its operations, earnings, and earnings per share; the Company may be unable to maintain information systems or effectively update them; customer or therapeutic concentration could harm the Company’s business; the Company’s business is subject to risks associated with international operations, including economic, political and other risks, such as compliance with a myriad of laws and regulations, complications from conducting clinical trials in multiple countries simultaneously and changes in exchange rates; due to the global nature of its business, the Company may be exposed to liabilities under the Foreign Corrupt Practices Act and other similar non-U.S. laws; the Company may be unable to successfully develop and market new services or enter new markets; the Company’s failure to perform services in accordance with contractual requirements, regulatory standards and ethical considerations may subject it to significant costs or liability, damage its reputation and cause it to lose existing business or not receive new business; government regulators or customers may limit the scope of prescription or withdraw products from the market; government regulators may impose new regulations affecting the biopharmaceutical industry and the Company’s business; the Company’s services are related to treatment of human patients, and it could face liability if a patient is harmed; the Company’s insurance may not cover all of its indemnification obligations and other liabilities; the Company is subject to a number of additional risks associated with doing business outside of the United States, including foreign currency exchange fluctuations and restrictive regulations, as well as the risks and uncertainties associated with the United Kingdom’s expected withdrawal from the European Union; if the Company does not keep pace with rapid technological changes, its services may become less competitive or obsolete; the Company’s relationships with existing or potential clients who are in competition with each other may adversely impact the degree to which other clients or potential clients use its services; the Company may be unable to successfully identify, acquire and integrate businesses, services and technologies; the Company’s balance sheet includes a significant amount of goodwill and intangible assets and its results of operations may be adversely affected if the Company fails to realize the full value of its goodwill and intangible assets; the Company’s ability to utilize its net operating loss carryforwards and certain other tax attributes may be limited; if the Company is unable to manage its growth effectively, its business could be harmed; the Company’s reliance on third parties for data, products, services and intellectual property licenses could lead to an inability to access certain data or provide certain services; the biopharmaceutical services industry is fragmented and highly competitive; biopharmaceutical industry outsourcing trends could change and adversely affect the Company’s operations and growth rate; current and proposed laws and regulations regarding the protection of personal data could result in increased risks of liability or increased cost or could limit the Company’s service offerings; patent and other intellectual property litigation could be time consuming and costly; circumstances beyond the Company’s control could cause industry-wide reduction in demand for its services; the Company has substantial indebtedness and may incur additional indebtedness in the future, which could adversely affect the Company’s financial condition; and other factors that are set forth in the Company’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K filed with the SEC on February 22, 2018. The Company undertakes no obligation to update any forward-looking statement after the date of this release, whether as a result of new information, future developments or otherwise, except as may be required by applicable law.

On August 7, 2018 OPKO Health, Inc.(NASDAQ:OPK) reported its financial results and business highlights for the three months ended June 30, 2018 (Press release, Opko Health, AUG 7, 2018, View Source [SID1234528499]).

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!

Financial Highlights

Net loss for the quarter decreased by 63% to $6.2 million or $0.01 a share on revenues of $263.7 million during the three months ended June 30, 2018, compared to net loss of $16.9 million or $0.03 per share on revenues of $292.6 million for the comparable period of 2017.

Revenues from products during the three months ended June 30, 2018 include $4.8 million from RAYALDEE and revenues from services were $216.1 million for the 2018 period compared with $233.9 million for the corresponding 2017 period.

Revenue and net loss for the three months ended June 30, 2017 benefited from a non-recurring $10 million milestone payment for VARUBI while net loss for the three months ended June 30, 2018 benefited from the reduction of contingent consideration expense of $15.4 million attributable to changes in assumptions regarding the timing of milestone payments.

During the three months ended June 30, 2018, costs of revenue and selling, general and administrative expenses decreased by approximately 9%, or $26.0 million, compared to the 2017 period. Research and Development expenses were $29.2 million compared to $33.1 million for the corresponding 2017 period.
Business Highlights

RAYALDEE total prescriptions reported by IMS for Q2 2018 increased 467% compared with Q2 2017 and 36% compared with Q1 2018: As of August 1, 2018, more than 83% of patients have access to RAYALDEE under their insurance plans. Fresenius Medical Care Renal Pharma (Vifor Fresenius) received approval from Health Canada to market RAYALDEE in Canada for the treatment of secondary hyperparathyroidism (SHPT) in adults with stage 3 or 4 chronic kidney disease (CKD) and vitamin D insufficiency.

4Kscore utilization in Q2 2018 increased 10% compared with Q2 2017. Utilization of the 4Kscore continues to improve with nearly 20,500 4Kscore tests performed during the three months ended June 30, 2018 compared to 18,600 tests performed during the second quarter of 2017.

Geoff Monk Appointed as General Manager, BioReference Laboratories: Mr. Monk has more than 20 years of management experience in the diagnostic laboratory business and was previously Managing Director of the New York and New Jersey unit of Quest Diagnostics.

Advanced the Phase 2b trial for our SARM (selective androgen receptor modulator) to treat benign prostatic hyperplasia (BPH): Enrollment is ongoing in this dose ranging study for our orally administered SARM. This medicine is expected to improve symptoms of BPH by reducing prostate size and, on the basis of data from a previous trial in 350 men, increase muscle mass and bone strength and decrease body fat. BPH affects approximately 50 million men in the U.S.

Completed the enrollment of a Global Phase 3 study of somatrogon (hGH-CTP) in Growth Hormone Deficient Children: The somatrogon Phase 3 trial is a randomized, open-label, active-controlled study taking place in over 30 countries. This study enrolled approximately 225 treatment naïve children with growth hormone deficiency (GHD) who were randomized 1:1 into two arms: once-weekly somatrogon vs once-daily Genotropin. The primary endpoint of the trial is height velocity at 52 weeks. Secondary endpoints are safety and pharmacodynamic endpoints.

Japanese Phase 3 registration trial of somatrogon in growth hormone deficient children continues to enroll patients: The global and Japanese pediatric studies utilize the multiple dose pen device that will be launched commercially upon approval.

Completed the enrollment of a Phase 2b clinical trial for our once-weekly oxyntomodulin dual GLP1-Glucagon agonist to treat type 2 diabetes and obesity: In a previous Phase 2 trial in 420 overweight patients with type 2 diabetes, the drug was shown to be safe and effective. The current trial is to study a new dosing schedule to achieve even greater weight loss.
Premarket Approval (PMA) application for Claros point-of-care PSA test under review by FDA: OPKO has submitted a PMA for a PSA test utilizing the Claros 1 immunoassay analyzer, a novel diagnostic instrument that can provide rapid, quantitative blood test results in 10 minutes in the physician’s office with only a finger stick drop of whole blood. A second product utilizing the Claros platform to measure testosterone is advancing toward a 510(k) submission to the FDA.
Initiation of two additional Phase 2 clinical trials anticipated in 2018:

RAYALDEE in dialysis patients with SHPT: Together with our partners, Vifor Fresenius and Japan Tobacco, OPKO is developing RAYALDEE for Stage 5 CKD patients with SHPT undergoing dialysis and anticipates initiating a global Phase 2 trial during Q3 of this year.

OPKO’s NK-1 antagonist to treat pruritus (itching) in Stage 5 CKD patients undergoing dialysis: An Investigational New Drug application was submitted to the FDA and a single-dose Phase 2a trial is commencing. Pruritus is often a problem for renal dialysis patients.
Conference Call & Webcast Information

OPKO’s senior management will provide a business update and discuss results in greater detail in a conference call and live audio webcast at 4:30 p.m. Eastern time today. The conference call dial-in and webcast information is as follows:

WHEN:
DOMESTIC DIAL-IN:
INTERNATIONAL DIAL-IN:
PASSCODE:
WEBCAST:
Tuesday, August 7, 2018 at 4:30 p.m. Eastern time.
(866) 634-2258
(330) 863-3454
9243717
investor.opko.com/events
For those unable to participate in the live conference call or webcast, a replay will be available beginning August 7, 2018 two hours after the close of the conference call. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 9243717. The replay can be accessed for a period of time on OPKO’s website at View Source

On August 7, 2018 Cancer Genetics, Inc. (Nasdaq: CGIX), a leader in enabling precision medicine for oncology through molecular markers and diagnostics, reported that it will release its financial results for the second quarter ended June 30, 2018 on Tuesday, August 14, 2018 during pre-market hours (Press release, Cancer Genetics, AUG 7, 2018, View Source [SID1234528566]). The Company will hold a conference call at 8:30 a.m. Eastern on Tuesday, August 14, 2018 to discuss the financial results and provide an update on its strategic direction and key organizational improvements being made by the Company.

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 & WEBCAST
Tuesday, August 14, 2018, 8:30 a.m. Eastern Time
Domestic: 800-289-0438
International: 323-794-2423
Conference ID: 1766530
Webcast: View Source
Replay – Available through August 28, 2018
Domestic: 844-512-2921
International: 412-317-6671
Conference ID: 1766530

On August 7, 2018 Syros Pharmaceuticals (NASDAQ: SYRS), a biopharmaceutical company pioneering the discovery and development of medicines to control the expression of genes reported financial results for the quarter ended June 30, 2018 and provided an update on recent accomplishments and upcoming events (Press release, Syros Pharmaceuticals, AUG 7, 2018, View Source [SID1234528484]).

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 second half of 2018 promises to be an important time for Syros," said Nancy Simonian, M.D., Chief Executive Officer of Syros. "Over the next several months, we plan to report initial clinical data from our Phase 2 trial evaluating the safety and efficacy of SY-1425 in combination with standard-of-care and targeted agents in genomically defined subsets of patients with acute myeloid leukemia and myelodysplastic syndrome. We plan to open expansion cohorts in the ongoing Phase 1 trial of SY-1365 in multiple patient populations with ovarian and breast cancers, as well as report data from the dose-escalation portion of the trial. Notably, we expect this to be the first-ever reported human clinical data on a selective inhibitor of CDK7, which is gaining increased recognition as an important new drug target in oncology. Together, we believe these clinical results will provide important insights into these programs and hopefully bring us closer to our vision of translating our leadership in gene control into medicines that provide profound benefit for patients."

Upcoming Milestones

Syros plans to report initial clinical data in the fourth quarter of 2018 from cohorts in its Phase 2 trial evaluating the safety and efficacy of SY-1425 in combination with azacitidine in RARA and IRF8 biomarker-positive patients with newly diagnosed acute myeloid leukemia (AML) who are not suitable candidates for standard chemotherapy, and in combination with daratumumab in biomarker-positive patients with relapsed or refractory AML and higher-risk myelodysplastic syndrome (MDS).
Syros plans to open expansion cohorts in the fall of 2018 in its Phase 1 trial of SY-1365. These expansion cohorts will evaluate SY-1365 as a single agent and in combination with standard-of-care therapies in multiple patient populations with ovarian and breast cancers.
Syros plans to report clinical data in the fourth quarter of 2018 from the dose escalation portion of its Phase 1 trial of SY-1365 in patients with advanced solid tumors.
Syros plans to select a new development candidate from its preclinical pipeline by the end of 2018.
Recent Pipeline Highlights

In July 2018, the European Medicines Agency (EMA) granted SY-1425 orphan drug designation for the treatment of AML. The EMA orphan drug designation is granted to medicines being developed for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition with a prevalence of not more than five in 10,000 people in the European Community. EMA orphan drug designation benefits include protocol assistance, access to the EU centralized authorization procedure, reduced EU regulatory filing fees and 10 years of market exclusivity.
In June 2018, Syros presented on the design of its Phase 1 clinical trial of SY-1365 at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. Based on preclinical data, which showed robust anti-tumor activity in ovarian and breast cancers, Syros designed the expansion phase of its trial to initially focus on these tumors. Expansion cohorts will evaluate the safety, tolerability and preliminary clinical activity of SY-1365 in:
Three ovarian cancer patient populations in earlier- and later-stages of disease, as either a single agent or in combination with carboplatin;
Hormone receptor-positive, CDK4/6 inhibitor-resistant breast cancer patients, in combination with fulvestrant;
Patients with solid tumors of any histology to evaluate pharmacodynamic endpoints and measures of biological activity in paired tumor biopsies.
Recent Corporate Highlights

In June 2018, Syros announced the appointment of Michael W. Bonney, Chief Executive Officer of Kaleido Biosciences, to its Board of Directors.
Second Quarter 2018 Financial Results

Cash, cash equivalents and marketable securities as of June 30, 2018 were $124.4 million, compared with $72 million on December 31, 2017. During the second quarter, Syros sold $16.6 million in common stock under its at-the-market sales facility.

For the second quarter 2018, Syros reported a net loss of $14 million, or $0.43 per share, compared to a net loss of $13.4 million, or $0.52 per share, for the same period in 2017.

Revenues were $0.4 million for the second quarter of 2018, which relate entirely to Syros’ collaboration with Incyte. Syros did not record revenues in the second quarter of 2017.
Research and development (R&D) expenses were $11.1 million for the second quarter of 2018, as compared to $10 million for the same period in 2017. This increase was primarily attributable to an increase in costs associated with Syros’ Phase 1 clinical trial of SY-1365 and increased headcount.
General and administrative (G&A) expenses were $3.8 million for the second quarter of 2018, as compared to $3.5 million for the same period in 2017. This increase was primarily attributable to an increase in employee-related costs.
Financial Guidance

Based on its current plans, Syros believes that its existing cash, cash equivalents and marketable securities will be sufficient to fund its planned operating expenses and capital expenditure requirements into 2020.

Conference Call and Webcast:

Syros will host a conference call today at 8:30 a.m. ET to discuss these second quarter 2018 financial results and provide a corporate update.

The live call may be accessed by dialing (866) 595-4538 for domestic callers or (636) 812-6496 for international callers and referencing conference ID number: 8675009. A live webcast of the conference call will be available online on the Investors & Media section of the Syros website at www.syros.com. An archived replay of the webcast will be available for approximately 90 days.

On August 7, 2018 Alder BioPharmaceuticals, Inc. (NASDAQ:ALDR), a biopharmaceutical company focused on developing novel therapeutic antibodies for the treatment of migraine, reported its financial results for the second quarter ended June 30, 2018 (Press release, Alder Biopharmaceuticals, AUG 7, 2018, View Source [SID1234528500]).

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!

"During the second quarter, the new data we presented from our Phase 3 clinical trials in episodic and chronic migraine further highlighted eptinezumab’s encouraging clinical profile for migraine prevention, including increased efficacy following additional quarterly infusions," said Robert W. Azelby, president and chief executive officer of Alder. "Alder is focused on changing the treatment paradigm for the millions of patients living with the disabling effects of migraine and we remain on track to submit a high-quality BLA to the U.S. Food and Drug Administration in the first quarter of 2019."

Recent Company Highlights

Presented new PROMISE 1 and PROMISE 2 Phase 3 clinical trial data for eptinezumab, Alder’s lead investigational product candidate for migraine prevention targeting calcitonin gene-related peptide (CGRP), at the American Academy of Neurology (AAN) and the American Headache Society Meeting (AHS) during the second quarter. Highlights include:
One-year data from the PROMISE 1 Phase 3 trial demonstrated long-term and increasing efficacy in episodic migraine following the third and fourth quarterly infusions.1
Six-month data for eptinezumab from the PROMISE 2 Phase 3 trial demonstrated improved efficacy for chronic migraine following the second quarterly infusion.1
These data from PROMISE 1 and PROMISE 2 continue to reinforce eptinezumab’s potential competitive clinical profile.

Alder’s one-year safety study of eptinezumab was completed with a safety profile consistent with previous eptinezumab studies.

All milestones remain on track for Alder’s planned BLA submission in Q1 2019.
Second Quarter 2018 Financial Results

As of June 30, 2018, Alder had $536.1 million in cash, cash equivalents, investments and restricted cash compared to $587.0 million as of March 31, 2018.
Research and development expenses for the second quarter ended June 30, 2018 totaled $52.8 million, compared to $65.3 million for the same period in 2017. The decrease in expenses was primarily due to lower eptinezumab clinical trial expense as the company nears completion of patient treatments for several clinical trials, offset by an increase in compensation as a result of an increase in internal headcount, and consulting fees to support manufacturing activities and the planned BLA submission.
General and administrative expenses for the second quarter ended June 30, 2018 totaled $12.2 million, compared to $9.5 million for the same period in 2017. The increase in spending was primarily due to an increase in stock-based compensation and expenses to support commercial readiness activities.
Net loss applicable to common stockholders for the second quarter ended June 30, 2018 totaled $70.7 million, or $1.04 per share, compared to net loss of $74.6 million, or $1.48 per share on a fully-diluted basis, for the same period in 2017.
Financial Outlook

Alder believes its available cash, cash equivalents, short-term investments and restricted cash will be sufficient to meet the company’s projected operating requirements into 2020.
1. For additional details regarding the trial results, please refer to Alder’s previous data press releases, which can be found at View Source

Conference Call and Webcast
Alder will host a conference call today at 5:00 p.m. ET to discuss these financial results and recent corporate highlights. The live call may be accessed by dialing (877) 430-4657 for domestic callers or (484) 756-4339 for international callers, and providing conference ID number 9588479. The webcast will be broadcast live and can be accessed from the Events & Presentations page in the Investors section of Alder’s website at www.alderbio.com. The accompanying slides are available now at the Events & Presentations page in the Investors section of Alder’s website at www.alderbio.com. The webcast will be available for replay following the call for at least 30 days.