On August 1, 2018 Alkermes plc (Nasdaq: ALKS) reported that its corporate presentation will be webcast live at the 38th Annual Canaccord Genuity Growth Conference on Wednesday, Aug. 8, 2018 at 10:30 a.m. ET (3:30 p.m. BST) from Boston (Press release, Alkermes, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361402 [SID1234528866]). The presentation may be accessed under the Investors tab on www.alkermes.com and will be archived for 14 days.

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Alkermes plc is a fully integrated, global biopharmaceutical company developing innovative medicines for the treatment of central nervous system (CNS) diseases. The company has a diversified commercial product portfolio and a substantial clinical pipeline of product candidates for chronic diseases that include schizophrenia, depression, addiction and multiple sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an R&D center in Waltham, Massachusetts; a research and manufacturing facility in Athlone, Ireland; and a manufacturing facility in Wilmington, Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.

Contact:
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Investor Relations
+1 781 609 6377

On August 1, 2018 PRA Health Sciences, Inc. ("PRA," "we," "us" or the "Company") (NASDAQ: PRAH) reported financial results for the quarter ended June 30, 2018 (Press release, PRA Health Sciences, AUG 1, 2018, View Source [SID1234528665]).

For the three months ended June 30, 2018, revenue was $722.8 million, which represents growth of 35.4%, or $189.1 million, compared to the second quarter of 2017 at actual foreign exchange rates. On a constant currency basis, revenue grew $182.3 million, an increase of 34.2% compared to the second 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. The prior periods were not 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.

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Excluding the impact of the adoption of ASC 606 and reimbursement revenue, revenue increased $117.0 million, which represents growth of 25.6% at actual foreign exchange rates and 24.4% on a constant currency basis. Organic revenue growth, excluding the adoption of ASC 606, reimbursement revenue and $58.1 million of revenue attributable to our Data Solutions segment, was 12.9% at actual foreign exchange rates and 11.7% on a constant currency basis.

Net new business for our Clinical Research segment for the quarter ended June 30, 2018 was $670.0 million, representing a net book-to-bill ratio of 1.30 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 revenue from our Data Solutions segment. Net new business during the quarter contributed to an ending backlog of $3.9 billion at June 30, 2018.

"I am pleased with our second quarter performance, which included double-digit revenue, earnings and net new business growth when compared to the second quarter of 2017" said Colin Shannon, PRA’s Chief Executive Officer. "We continue to stay focused on our client deliverables and our strategic objectives. We are pleased to continue to add new clients and believe we are well-positioned to drive future growth."

Direct costs were $381.7 million during the three months ended June 30, 2018 compared to $300.6 million for the second quarter of 2017. The increase in direct costs was primarily due to an increase in labor-related costs of $36.4 million in our Clinical Research segment as we continue to hire billable staff to ensure appropriate staffing levels for our current studies and our future growth. In addition, our Data Solutions segment resulted in $41.6 million of incremental direct costs when compared to the second quarter of 2017. We also had an unfavorable impact of $5.3 million from fluctuation in foreign currency exchange rates during the three months ended June 30, 2018. Excluding the impact of the adoption of ASC 606 and reimbursement revenue, direct costs were 66.4% of revenue during the second quarter of 2018 compared to 65.6% of revenue during the second quarter of 2017.

Selling, general and administrative expenses were $91.2 million during the three months ended June 30, 2018 compared to $76.2 million for the second quarter of 2017. Excluding the impact of the adoption of ASC 606 and reimbursement revenue, selling, general and administrative costs were 15.9% of revenue during the second quarter of 2018 compared to 16.6% of revenue during the second quarter of 2017.

GAAP net income was $42.0 million for the three months ended June 30, 2018, or $0.64 per share on a diluted basis, compared to GAAP net income of $29.5 million for the three months ended June 30, 2017, or $0.45 per share on a diluted basis.

EBITDA was $102.6 million for the three months ended June 30, 2018, representing an increase of 55.9% compared to the second quarter of 2017. Adjusted EBITDA was $109.7 million for the three months ended June 30, 2018, representing growth of 28.5% compared to the second quarter of 2017.

Adjusted net income was $66.1 million for the three months ended June 30, 2018, representing 27.8% growth compared to the second quarter of 2017. Adjusted net income per diluted share was $1.00 for the three months ended June 30, 2018, representing 26.6% growth compared to the second 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.

First Half 2018 Financial Highlights

For the six months ended June 30, 2018, revenue was $1,424.7 million, which represents growth of 39.5%, or $403.2 million, compared to the six months ended June 30, 2017 at actual foreign exchange rates. On a constant currency basis, revenue grew $380.6 million, representing growth of 37.3% compared to the six months ended June 30, 2017.

Excluding the impact of the adoption of ASC 606 and reimbursement revenue, revenue increased $249.9 million, which represents growth of 28.2% at actual foreign exchange rates and 26.4% on a constant currency basis. Organic revenue growth, excluding the adoption of ASC 606, reimbursement revenue and $114.9 million of revenue attributable to our Data Solutions segment, was 15.3% at actual foreign exchange rates and 13.4% on a constant currency basis.

Reported GAAP income from operations was $145.7 million, reported GAAP net income was $81.0 million and reported GAAP net income per diluted share was $1.22 for the six months ended June 30, 2018.

Adjusted Net Income was $122.3 million for the six months ended June 30, 2018, an improvement of 32.8% compared to the same period in 2017. Adjusted Net Income per diluted share was $1.85 for the six months ended June 30, 2018, up 32.1% compared to the same period in 2017.

The Company is updating its full year 2018 revenue guidance to 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 606 and reimbursement revenue, and constant currency organic growth of 10% to 12% excluding the impact of adopting 606 and reimbursement revenue. We expect GAAP net income per diluted share to between $2.92 and $3.02 and Adjusted Net Income per diluted share to between $4.13 and $4.23. We continue to anticipate an annual effective income tax rate estimate of 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 interpretations, analysis, and additional guidance that may be issued by regulatory agencies as it relates to the U.S. Tax Cuts and Jobs Act.

Our guidance assumes a EURO rate of 1.20 and a GBP rate of 1.37. All other foreign currency exchange rates are as of June 30, 2018.

Conference Call Details

PRA will host a conference call at 9:00 a.m. ET on August 2, 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 9692658. 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 9692658.

Additional Information

A financial supplement with second quarter 2018 results, which should be read in conjunction with this press release, may be found in Investor Relations section of our website at investors.prahs.com in a document titled "Q2 2018 Earnings Presentation."

On August 1, 2018 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $102.9 million and completed approximately 215,000 Cologuard tests during the quarter ended June 30, 2018 (Press release, Exact Sciences, AUG 1, 2018, View Source [SID1234528655]). Second-quarter 2018 revenue and Cologuard test volume grew by 78 percent and 59 percent, respectively, from the same period of 2017.

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"We are excited about the continued growth of our physician ordering base, as well as their increasing Cologuard utilization, which led to a record quarter for revenue, volume and gross profit," said Kevin Conroy, chairman and CEO of Exact Sciences. "We are optimistic about the company’s future, including the opportunity to expand Cologuard’s label to reach even more people in the 45 to 49 age group, given the American Cancer Society’s recent guideline update."

Second-Quarter 2018 Financial Results

For the three-month period ended June 30, 2018, as compared to the same period of 2017 (where applicable):

· Revenue was $102.9 million, an increase of 78 percent, and test volume was 215,000, an increase of 59 percent

· Average recognized revenue per test was $479, an improvement of 12 percent

· Average cost per test was $125, an improvement of 6 percent

· Gross margin was 74 percent, an increase of 510 basis points

· Operating expenses were $108.7 million, an increase of 53 percent

· Net loss was $36.4 million or $0.30 per share, compared to $30.8 million or $0.27 per share

· Non-cash interest expense related to convertible debt was $6.7 million, or $0.05 per share

· Cash utilization was $45.3 million, compared to $43.9 million

· Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter

· More than 10,000 healthcare providers ordered their first Cologuard test during the second quarter, and nearly 121,000 have ordered since the test was launched

2018 Outlook

· The company continues to anticipate revenue of $420-$430 million for 2018

The company’s guidance for revenue is a forward-looking statement. It is subject to various risks and uncertainties that could cause the company’s actual results to differ materially from the anticipated targets. There can be no assurance the company will meet these financial projections. See the cautionary information about forward-looking statements in the "Safe Harbor Statement" section of this press release.

Second-Quarter Conference Call & Webcast

Company management will host a conference call and webcast on Wednesday, Aug. 1, 2018, at 5 p.m. ET to discuss second-quarter 2018 results. The webcast will be available at www.exactsciences.com. Domestic callers should dial 877-201-0168 and international callers should dial +1-647-788-4901.

An archive of the webcast will be available at www.exactsciences.com. A replay of the conference call will be available by calling 800-585-8367 domestically or 416-621-4642 internationally. The access code for the replay of the call is 4260268. The webcast, conference call and replay are open to all interested parties.

About Cologuard

Cologuard was approved by the FDA in August 2014 and results from Exact Sciences’ prospective 90-site, point-in-time, 10,000-patient pivotal trial were published in the New England Journal of Medicine in March 2014. Cologuard is included in the American Cancer Society’s (2014) colorectal cancer screening guidelines and the recommendations of the U.S. Preventive Services Task Force (2016) and National Comprehensive Cancer Network (2016). Cologuard is indicated to screen adults of either sex, 50 years or older, who are at average risk for colorectal cancer. Cologuard is not for everyone and is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high-risk individuals. False positives and false negatives do occur. Any positive test result should be followed by a diagnostic colonoscopy.

Following a negative result, patients should continue participating in a screening program at an interval and with a method appropriate for the individual patient. Cologuard performance when used for repeat testing has not been evaluated or established. Medicare and most major insurers cover Cologuard. For more information about Cologuard, visit www.cologuardtest.com. Rx Only.

On August 1, 2018 Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases reported financial results for the second quarter of 2018 and recent operational highlights (Press release, Atara Biotherapeutics, AUG 1, 2018, View Source [SID1234528632]).

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"The future of T-cell immunotherapy is both off-the-shelf and across multiple therapeutic areas," said Isaac Ciechanover, M.D., Chief Executive Officer and President of Atara Biotherapeutics. "During the second quarter, we continued to advance our robust T-cell immunotherapy pipeline, highlighted by our ongoing Phase 3 studies of tab-cel in patients with EBV+ PTLD and Phase 1 study of ATA188 in patients with progressive multiple sclerosis. In parallel, we continue to build Atara’s global commercial and operational capabilities in anticipation of the first tab-cel Phase 3 results and submission of an EU conditional marketing authorization application in the first half of 2019. We are also preparing to expand our pipeline with the development of the next generation of chimeric antigen receptor T cell (CAR T) technologies. This is an exciting time for Atara as we enter the next phase of the Company’s growth as a leader in off-the-shelf, allogeneic T-cell immunotherapy."

Recent Highlights and Anticipated Upcoming Milestones

Tab-cel (tabelecleucel)

Two Phase 3 clinical studies are ongoing (MATCH and ALLELE) to evaluate tab-cel (tabelecleucel) in patients with Epstein-Barr virus associated post-transplant lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab following hematopoietic cell transplant (HCT) or solid organ transplant (SOT).
11 clinical sites for the MATCH and 13 for the ALLELE studies are now open for enrollment in the U.S. with additional sites expected to open in the U.S. and other geographies.

Presented positive long-term outcomes including durable remissions and encouraging safety findings from two Phase 2 studies of tab-cel in EBV+ PTLD at the 23rd Congress of the European Hematology Association (EHA) (Free EHA Whitepaper).
One- and three-year overall survival (OS) for tab-cel treated patients with EBV+ PTLD following HCT who failed rituximab (n=35) was 68% and 55%, respectively. Median OS was not reached after a median of 23.3 months of follow-up in this patient group.
In patients with EBV+ PTLD following SOT who failed rituximab, the one- and three-year OS after treatment with tab-cel (n=14) was 64% and 43%, respectively. Median survival in this patient group was 21.3 months.
None of the EBV+ PTLD patients who had complete or partial responses (CR or PR) after treatment with tab-cel died of EBV+ PTLD. Two-year OS for these responding patients was 83% and 86% following HCT (n=24) and SOT (n=7), respectively.
Tab-cel was associated with durable objective response rate (CR plus PR) of 69% and 50% in patients with EBV+ PTLD following HCT and SOT, respectively, who have failed rituximab.

U.S. Food and Drug Administration (FDA) accepted IND to initiate a Phase 1/2 clinical study of tab-cel in combination with Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA (pembrolizumab), in patients with platinum-resistant or recurrent EBV-associated nasopharyngeal carcinoma (NPC) that Atara plans to initiate in the second half of 2018.

Expect to present updated tab-cel results in patients with EBV+ cancers in the second half of 2018.
ATA188 & ATA190 for Multiple Sclerosis (MS)

Announced publication of new research findings advancing the understanding of Epstein-Barr Virus (EBV) infection in the MS-affected brain.
The findings were reported in an article online and published in the July 2018 print issue of Neurology: Neuroimmunology & Neuroinflammation, an official journal of the American Academy of Neurology.

A Phase 1 clinical study to evaluate off-the-shelf, allogeneic ATA188 in patients with progressive MS is also underway across clinical sites in the U.S. and Australia.
The primary objective of the Phase 1 study is to assess the safety of ATA188 in patients followed for at least one year after the first dose. Key secondary endpoints in the study include measures of clinical improvement such as expanded disability status scale (EDSS) and annualized relapse rate (ARR), as well as MRI imaging.
The first results from the ongoing ATA188 Phase 1 study in patients with progressive MS are expected in the first half of 2019.
Plan to initiate a randomized autologous ATA190 study in progressive MS patients in 2019.
Development Pipeline

Plan to rapidly advance novel gene-edited CAR T development programs from recently expanded T-cell immunotherapy collaboration with Memorial Sloan Kettering Cancer Center (MSK), leveraging our existing off-the-shelf T-cell immunotherapy technology platform, manufacturing expertise and research and development capabilities.
Expect to start Phase 1 study for ATA621 targeting both JC and BK viruses in 2019.
Corporate

Commenced operations at Atara T Cell Operations & Manufacturing (ATOM) facility in the second quarter of 2018, with completion to support clinical production expected in 2019.
Appointed Utpal Koppikar as Chief Financial Officer. Utpal has an accomplished track record in global biotechnology financial operations.
In June 2018 we exercised our option under a license agreement with QIMR Berghofer to an exclusive, worldwide license to develop and commercialize additional T-cell immunotherapy programs including ATA190, as well as the option to license additional technology.
Second Quarter 2018 Financial Results

Cash, cash equivalents and short-term investments as of June 30, 2018 totaled $417.0 million, which we believe will enable us to expand our near-term pipeline and accelerate pre-commercial activities as well as fund our previously planned operations to mid-2020. In the second quarter of 2018, we sold approximately 1.0 million shares of common stock pursuant to our "at-the-market" (ATM) facility for net proceeds of $47.6 million, after deducting commissions and other offering expenses.
We reported net losses of $50.9 million, or $1.15 per share, for the second quarter of 2018, as compared to $27.4 million, or $0.94 per share, for the same period in 2017.
Research and development expenses were $33.4 million for the second quarter of 2018, as compared to $18.3 million for the same period in 2017. The increase in the second quarter of 2018 was due to costs associated with our continuing expansion of research and development activities, including:
clinical trial, manufacturing and outside service costs related to the two Phase 3 clinical trials of tab-cel in patients with EBV+ PTLD and the Phase 1 clinical trial of allogeneic ATA188 in patients with MS;
higher payroll and related costs from increased headcount, and
an increase in allocated facilities and information technology expenses.
Research and development expenses include $3.4 million and $2.0 million of non-cash stock-based compensation expenses in the second quarters of 2018 and 2017, respectively.
General and administrative expenses were $19.2 million for the second quarter of 2018, as compared to $9.6 million for the same period in 2017. The increase in the second quarter of 2018 was primarily due to increases in professional services costs and payroll and related costs driven by increased headcount to support the Company’s expanding operations. General and administrative expenses include $4.6 million and $3.7 million of non-cash stock-based compensation expenses in the second quarters of 2018 and 2017, respectively.

On August 1, 2018 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH), a clinical-stage biopharmaceutical company focused on addressing key mechanisms of tumor drug resistance, reported that Michael Taylor, Ph.D., President and Chief Executive Officer, will present at the 38th Annual Canaccord Genuity Growth Conference on Wednesday, August 8, 2018 at 3:30 PM ET at the InterContinental Boston Hotel (Press release, Deciphera Pharmaceuticals, AUG 1, 2018, View Source [SID1234528442]).

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A live webcast of the event will be available on the "Events and Presentations" page in the "Investors" section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the presentation.