On July 29, 2019 Verastem, Inc. (Nasdaq: VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported that Brian Stuglik, a member of the Board of Directors, has been named Chief Executive Officer (CEO) (Press release, Verastem, JUL 29, 2019, View Source [SID1234537857]).

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"Brian brings deep commercial and biopharmaceutical leadership experience that we believe will accelerate the growth of COPIKTRA and progress overall company goals," said Michael G. Kauffman, MD, PhD, Verastem Oncology’s Lead Director. "Throughout his career, Brian has demonstrated an ability to deliver results through a clear strategic vision, focused teams and excellent execution. We are confident that he will capitalize on the significant opportunities in front of the company on behalf of patients, customers and our shareholders."

Mr. Stuglik has more than three decades of experience in US and International pharmaceutical development, product strategy and commercialization, with a focus on Oncology. He spent the majority of his career at Eli Lilly and Company, culminating in his role as Global Vice President and Chief Marketing Officer, Oncology Global Marketing, advancing Lilly Oncology from a single approved product to a portfolio of marketed or late-stage compounds across more than 10 cancer types. In May of this year, he took on a strategic oversight and advisory role to Verastem Oncology’s commercial organization.

"I am honored to join the Verastem Oncology team as CEO and am energized to build on our commitment to patients as we realize the full potential of COPIKTRA and the pipeline," said Mr. Stuglik. "Being a member of the Board of Directors and, more recently, serving as a strategic partner to the team, I have great confidence in Verastem Oncology’s ability to rapidly progress our mission to improve the lives of cancer patients."

Mr. Stuglik will continue to serve as a member of the Board of Directors and will lead the company’s executive team. As recently announced, Dan Paterson, formerly the Chief Operating Officer has assumed the role of President and Chief Operating Officer and Rob Gagnon has expanded his role to Chief Business and Financial Officer.

As previously announced, the Company will host a conference call and webcast on Thursday, August 1, 2019 at 4:30 p.m. Eastern Time to discuss corporate updates and financial results for the second quarter ended June 30, 2019.

On July 29, 2019 Exact Sciences Corp. (Nasdaq: EXAS) reported that the company generated revenue of $199.9 million and screened approximately 415,000 people with Cologuard during the quarter ended June 30, 2019 (Press release, Exact Sciences, JUL 29, 2019, View Source [SID1234537842]). Second-quarter 2019 revenue and test volume grew 94 percent and 93 percent, respectively, from the same period of 2018.

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"The Exact Sciences team delivered another strong quarter, bringing us closer to our goal of capturing at least 40-percent share of the U.S. colorectal cancer screening market with Cologuard, from about 6 percent today," said Kevin Conroy, chairman and CEO of Exact Sciences. "The foundation we’ve built with our team, infrastructure, and commercial scale positions Exact Sciences well for continued growth."

Second-Quarter 2019 Financial Results

For the three-month period ended June 30, 2019, as compared to the same period of 2018 (where applicable):

Revenue was $199.9 million, an increase of 94 percent, and test volume was 415,000, an increase of 93 percent
Average Cologuard recognized revenue per test was unchanged at $479
Average Cologuard cost per test was $123, an improvement of $2 per test
Gross margin was 74 percent, an increase of 30 basis points
Operating expenses were $182.1 million, an increase of 68 percent
Net loss was $38.4 million, or $0.30 per share, compared to $36.4 million, or $0.30 per share
Non-cash interest expense related to convertible debt was $19.8 million, or $0.16 per share
Cash utilization was $43.3 million, compared to $45.3 million
Cash, cash equivalents and marketable securities were $1.2 billion at the end of the quarter
More than 13,000 healthcare providers ordered their first Cologuard test during the second quarter, and nearly 174,000 have ordered since the test was launched
2019 Outlook

The company anticipates revenue of $800-$810 million during 2019, an increase from prior guidance of $725-$740 million. The company’s updated guidance does not include the impact of the pending combination with Genomic Health.
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 "Forward-Looking Statements" section of this news release.

Second-Quarter and Genomic Health Combination Conference Call & Webcast

In light of the combination with Genomic Health announced separately today, Exact Sciences will not hold its previously announced earnings conference call that had been scheduled for July 30, 2019. The two companies will host a joint conference call today at 8:00 a.m. ET to discuss the transaction as well as each companies’ second-quarter 2019 financial 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 8288326. 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 (2018) 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, including those with a history of colorectal cancer and advanced adenoma, a family history of colorectal cancer, IBD or certain hereditary syndromes. 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 July 29, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), a clinical-stage biopharmaceutical company focused on creating innovative cancer immunotherapies, reported that members of the management team will participate in the following upcoming investor conferences (Press release, Arcus Biosciences, JUL 29, 2019, View Source [SID1234537858]):

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BTIG Biotechnology Conference on Monday, August 12, 2019, at 12:00 pm Eastern Time in New York. Juan Jaen, Ph.D., President, will participate in a panel discussion entitled, "Solid Tumors Beyond PD-1 Monotherapy."
2019 Wedbush PacGrow Healthcare Conference on Tuesday, August 13, 2019, at 8:35 am Eastern Time in New York. Juan Jaen, Ph.D., President, and Rekha Hemrajani, Chief Operating Officer and Chief Financial Officer, will participate in a fireside chat. To access the live audio webcast of the fireside chat, please visit the "Investors" section of the Arcus website at www.arcusbio.com. A replay of the webcast will be available for 30 days following the live event.

On July 29, 2019 Illumina, Inc. (NASDAQ: ILMN) reported its financial results for the second quarter of fiscal year 2019 (Press release, Illumina, JUL 29, 2019, View Source [SID1234537843]).

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Second quarter 2019 results:

•Revenue of $838 million, a 1% increase compared to $830 million in the second quarter of 2018
•GAAP net income attributable to Illumina stockholders for the quarter of $296 million, or $1.99 per diluted share, compared to $209 million, or $1.41 per diluted share, for the second quarter of 2018
•Non-GAAP net income attributable to Illumina stockholders for the quarter of $200 million, or $1.35 per diluted share, compared to $212 million, or $1.43 per diluted share, for the second quarter of 2018. Non-GAAP net income excludes a $92 million unrealized gain from a strategic investment that completed an initial public offering (see the table entitled "Reconciliation Between GAAP and Non-GAAP Net Income Attributable to Illumina Stockholders" for a reconciliation of these GAAP and non-GAAP financial measures)
•Cash flow from operations of $143 million compared to $295 million in the second quarter of 2018. Cash flow from operations for the second quarter of 2019 included an $84 million payment of the accreted debt discount related to the conversion of our 2019 Notes
•Free cash flow (cash flow from operations less capital expenditures) of $96 million for the quarter compared to $218 million in the second quarter of 2018. Free cash flow for the second quarter of 2019 included the convertible notes payment, referenced above

Gross margin in the second quarter of 2019 was 68.4% compared to 69.3% in the prior year period. Excluding amortization of acquired intangible assets, non-GAAP gross margin was 69.5% for the second quarter of 2019 compared to 70.3% in the prior year period.

Research and development (R&D) expenses for the second quarter of 2019 were $166 million compared to $151 million in the prior year period. R&D expenses as a percentage of revenue were 19.8% compared to 18.2% in the prior year period.

Selling, general and administrative (SG&A) expenses for the second quarter of 2019 were $202 million compared to $197 million in the prior year period. Excluding acquisition-related expenses, non-GAAP SG&A expenses as a percentage of revenue were 23.1% compared to 23.7% in the prior year period.

Depreciation and amortization expenses were $49 million and capital expenditures for free cash flow purposes were $47 million during the second quarter of 2019. At the close of the quarter, the company held $3.2 billion in cash, cash equivalents and short-term investments, compared to $3.5 billion as of December 30, 2018.

"While our second quarter results clearly fell short of our expectations, we remain committed to leading innovation in genomics, and to enabling our global community of 6,300 customers who unlock more of the human genome each day in an effort to improve human health and, in many cases, save lives," said Francis deSouza, President and CEO. "In addition to continued sequencing consumables growth, we are encouraged by the sequential and year-over-year growth in shipments across our high, mid, and low-throughput sequencing system portfolio, including a record number of NextSeq Dx systems, reflecting the growing clinical opportunity."

Updates since our last earnings release:

•Launched Veriseq NIPT v2, enabling a genome-wide screen which almost doubles the detection of chromosomal abnormalities
•Partnered with AnchorDx, a molecular diagnostics company, to develop clinical oncology products for the Chinese market
•Expanded Illumina Accelerator to Cambridge, UK, further catalyzing the rapidly growing genomics industry in Europe and surrounding markets
•Repaid $632 million of 2019 Convertible Notes that matured on June 15, 2019, leaving $1.3 billion of convertible debt outstanding due in 2021 and 2023

Financial outlook and guidance

The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance. Please see our Reconciliation of Non-GAAP Financial Guidance included in this release for a reconciliation of the GAAP and non-GAAP financial measures.

For fiscal 2019, the company expects year over year revenue growth of approximately 6%, and now expects GAAP earnings per diluted share attributable to Illumina stockholders of $6.41 to $6.51 and non-GAAP earnings per diluted share attributable to Illumina stockholders of $6.00 to $6.10.

Except for acquisition-related expenses incurred during the first half of 2019 which are reflected in our GAAP guidance, this guidance excludes any impact from the pending acquisition of Pacific Biosciences, which we now expect to close in Q4 2019.

Quarterly conference call information

The conference call will begin at 2:00 pm Pacific Time (5:00 pm Eastern Time) on Monday, July 29, 2019. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website under the "Company" tab at www.illumina.com. Alternatively, individuals can access the call by dialing 1 (844) 647-5490, or 1 (615) 247-0295 outside North America, both with conference ID 3469888.
A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

On July 29, 2019 Medpace Holdings, Inc. (Nasdaq: MEDP) ("Medpace") reported financial results for the second quarter ended June 30, 2019 (Press release, Medpace, JUL 29, 2019, View Source [SID1234537859]).

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"In the second quarter, the business environment remained strong, and our competitive win rate remained healthy," said August J. Troendle, President & Chief Executive Officer. "Cancellations in the quarter returned to an anticipated historical range from elevated levels the past two quarters."

Second Quarter 2019 Financial Results

Revenue for the three months ended June 30, 2019 increased 25.8% to $214.1 million, compared to $170.1 million for the comparable prior-year period. On a constant currency organic basis, revenue for the second quarter of 2019 increased 26.0% compared to the second quarter of 2018.

Backlog as of June 30, 2019 grew 19.6% to $1.2 billion from $979.7 million as of June 30, 2018. Net new business awards were $279.2 million, representing a net book-to-bill ratio of 1.30x for the second quarter of 2019, as compared to $239.9 million for the comparable prior-year period. The Company calculates the net book-to-bill ratio by dividing net new business awards by revenue.

For the second quarter of 2019, total direct costs were $150.3 million, compared to total direct costs of $116.7 million in the second quarter of 2018. Selling, general and administrative (SG&A) expenses were $23.6 million, compared to SG&A expenses of $20.5 million in the second quarter of 2018.

GAAP net income for the second quarter of 2019 was $27.5 million, or $0.73 per diluted share, versus GAAP net income of $16.6 million, or $0.45 per diluted share, for the second quarter of 2018. This resulted in a net income margin of 12.8% and 9.7% for the second quarter of 2019 and 2018, respectively.

EBITDA for the second quarter of 2019 increased 20.3% to $40.2 million, or 18.8% of revenue, compared to $33.4 million, or 19.7% of revenue, for the comparable prior-year period. On a constant currency basis, EBITDA for the second quarter of 2019 increased 18.2% from the second quarter of 2018.

Adjusted Net Income for the second quarter of 2019 increased 35.7% to $30.4 million compared to $22.4 million for the comparable prior-year period. Adjusted Net Income per diluted share for the second quarter of 2019 was $0.81, representing an increase of 32.8%, compared to Adjusted Net Income per diluted share of $0.61 for the comparable prior-year period.

A reconciliation of the Company’s non-GAAP financial measures, including EBITDA, EBITDA margin, Adjusted Net Income, and Adjusted Net Income per diluted share to the corresponding GAAP measures is provided below.

Balance Sheet and Liquidity

The Company’s Cash and cash equivalents were $20.1 million at June 30, 2019, and the Company generated $46.6 million in cash flow from operating activities during the second quarter of 2019. Additionally, the Company paid off its remaining outstanding obligations against its term loan during the second quarter of 2019.

Financial Guidance

The Company forecasts 2019 revenue in the range of $840.0 million to $860.0 million, representing growth of 19.2% to 22.1% over 2018 revenue of $704.6 million. GAAP net income for full year 2019 is forecasted in the range of $93.4 million to $97.4 million. Additionally, full year 2019 EBITDA is expected in the range of $144.0 million to $150.0 million.

Based on forecasted 2019 revenue of $840.0 million to $860.0 million and GAAP net income of $93.4 million to $97.4 million, diluted earnings per share (GAAP) is forecasted in the range of $2.49 to $2.60. Adjusted Net Income for 2019 is forecasted in the range of $105.7 million to $109.7 million, compared to Adjusted Net Income of $95.5 million for 2018. Furthermore, Adjusted Net Income per diluted share for 2019 is expected in the range of $2.82 to $2.93 per share.

Conference Call Details

Medpace will host a conference call at 9:00 a.m. ET, Tuesday, July 30, 2019, to discuss its second quarter 2019 results.

To participate in the conference call, dial 800-219-7113 (domestic) or 574-990-1030 (international) using the passcode 6197355.

To access the conference call via webcast, visit the "Investors" section of Medpace’s website at medpace.com. The webcast replay of the call will be available at the same site approximately one hour after the end of the call.

A supplemental slide presentation will also be available at the "Investors" section of Medpace’s website prior to the start of the call.

A recording of the call will be available at 12:00 p.m. ET on Tuesday, July 30, 2019 until 12:00 p.m. ET on Tuesday, August 13, 2019. To hear this recording, dial 855-859-2056 (domestic) or 404-537-3406 (international) using the passcode 6197355.