On August 1, 2018 Blueprint Medicines Corporation (NASDAQ: BPMC), a leader in discovering and developing targeted kinase medicines for patients with genomically defined diseases, reported its participation in the following upcoming investor conferences (Press release, Blueprint Medicines, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361416 [SID1234528389]):

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!

38th Annual Canaccord Genuity Growth Conference in Boston, MA on Wednesday, August 8, 2018 at 3:00 p.m. E.T.

2018 Wedbush PacGrow Healthcare Conference in New York, NY on Wednesday, August 15, 2018 at 9:10 am. E.T.

A live webcast of each presentation will be available by visiting the Investors section of Blueprint Medicines’ website at View Source A replay of the webcast will be archived on Blueprint Medicines’ website for 30 days following each presentation.

On August 1, 2018 Cell Medica (or ‘the Company’), a leader in the development, manufacture and marketing of personalised cellular immunotherapeutics for the treatment of cancer, reported that it has appointed Chris Nowers as Chief Executive Officer and Executive Director (Press release, Cell Medica, AUG 1, 2018, https://cellmedica.com/press-releases/cell-medica-appoints-new-ceo-drive-car-tcr-clinical-development-commercialisation/ [SID1234528417]). His appointment follows founder Gregg Sando’s decision to step down as Chief Executive Officer and Director of the Company and is effective 1 August 2018.

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!

Mr Nowers joins Cell Medica from the cancer immunotherapy company Kite Pharma (Kite), where he was Head of Europe and responsible for the full commercialisation of the CAR-T therapy axicabtagene ciloleucel. At Kite he built the European organisation from the ground up and, post the $12 Bn acquisition by Gilead Sciences in 2017, was subsequently responsible for the continued expansion of the Kite organisation within the Europe, Middle East and Africa structure. Previous to his role at Kite, he has had a career spanning more than 25 years in the biopharma industry. He has held a number of senior leadership roles that included CEO of Avantogen Oncology, General Management roles at Amgen, and senior global and regional commercial leadership roles at Bristol-Myers Squibb (BMS). Whilst at BMS, he built and led teams that delivered the successful launches of the checkpoint inhibitors ipilimumab and nivolumab.

Mr Sando, a pioneer in the field of cellular immunotherapy, established Cell Medica in 2006 and led the company’s transition into the CAR-T technology space. The upcoming initiation of clinical trials investigating CAR-modified cell therapy products will mark an important new chapter in the Company’s development. He will assist over the coming months in transitioning to new senior leadership.

Annalisa Jenkins, Chair of Cell Medica, commented:

"We would like to thank Gregg for his vision and commitment over the last 12 years, which has led to Cell Medica becoming a leader in cellular immunotherapy for cancer. He has built an experienced international team with the capability to build on existing research partnerships and develop the internal pipeline to maximise shareholder value.

"We are pleased to welcome Chris as Cell Medica’s new CEO. His experience in the commercialisation of oncology programmes is an excellent fit for the Company’s ambitions as we progress towards realising our goals of delivering compelling new cellular immunotherapies for the treatment of cancer patients."

Gregg Sando commented:

"It has been a great experience founding Cell Medica and leading a team of dedicated colleagues and research collaborators who have been working together to transform the treatment of cancer through cell-based immunotherapy. The Company is well positioned for an exciting future and it is now time to transition to new leadership who will take our products and technology through clinical development and commercialisation. My thanks and appreciation to the extended Cell Medica team and partners, past and present."

Chris Nowers commented:

"Cell Medica has an exciting array of technologies that will help unlock the potential of personalised cellular immunotherapies for both blood cancers and solid tumours. I look forward to working with the Company’s talented executive and scientific teams to take these promising treatments to patients through clinical development."

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.

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!

"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 Pieris Pharmaceuticals, Inc. (NASDAQ: PIRS), a biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for cancer, respiratory and other diseases, reported that it will host a second quarter 2018 investor call on Thursday, August 9, 2018 at 8:00 AM (EDT) to discuss financial results and provide a corporate update (Press release, Pieris Pharmaceuticals, AUG 1, 2018, View Source [SID1234528288]).

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!

To access the call, participants may dial 877-407-8920 (US & Canada) or 412-902-1010 (International) at least 10 minutes prior to the start of the call.

An archived replay of the call will be available for 30 days by dialing 877-660-6853 (Toll Free US & Canada) or 201-612-7415 (International) and providing the Conference ID #13661472.

On August 1, 2018 Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) reported financial and operational results for the second quarter ended June 30, 2018 (Press release, Vanda Pharmaceuticals, AUG 1, 2018, View Source;p=RssLanding&cat=news&id=2361415 [SID1234528307]).

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!

"We are excited with the year to date HETLIOZ sales performance, which demonstrates continued strength, and our HETLIOZ life cycle management program, which positions the product well for additional future growth," said Mihael H. Polymeropoulos, M.D., Vanda’s President and CEO. "We are focused on our upcoming clinical milestones from the tradipitant gastroparesis study and the HETLIOZ Smith-Magenis Syndrome study."

Key Highlights:

Total net product sales from HETLIOZ and Fanapt were $47.4 million during the second quarter of 2018, a 9% increase compared to $43.6 million in the first quarter of 2018 and a 13% increase compared to $42.1 million in the second quarter of 2017.
HETLIOZ (tasimelteon)

HETLIOZ net product sales were $28.0 million in the second quarter of 2018, a 10% increase compared to $25.4 million in the first quarter of 2018 and a 25% increase compared to $22.5 million in the second quarter of 2017.
Fanapt (iloperidone)

Fanapt net product sales were $19.3 million in the second quarter of 2018, a 6% increase compared to $18.2 million in the first quarter of 2018 and a 1% decrease compared to $19.5 million in the second quarter of 2017.
Research and Development

HETLIOZ

Results from the JET study, a 3-night transatlantic Phase II study of the effects of tasimelteon on jet lag disorder showed effectiveness in treating travelers who flew from the US to the UK. Vanda expects to submit a supplemental New Drug Application to the U.S. Food and Drug Administration for HETLIOZ for the treatment of jet lag disorder by the end of 2018.
Enrollment in the Smith-Magenis Syndrome clinical study is ongoing. Results are expected by the end of 2018.
Tradipitant

In June 2018, Vanda initiated EPIONE, a Phase III study of tradipitant for chronic pruritus in atopic dermatitis.
A tradipitant clinical study for the treatment of gastroparesis is ongoing. Results are expected by the end of 2018.
VTR-297 (histone deacetylase (HDAC) inhibitor)

A VTR-297 Phase I study (1101) in patients with hematologic malignancies is expected to begin by the end of 2018.
Cash, cash equivalents and marketable securities (Cash) were $231.2 million as of June 30, 2018. During the second quarter of 2018, Cash decreased by $17.6 million and included a $25.0 million milestone payment based on cumulative HETLIOZ net product sales.

Non-GAAP Financial Results

For the second quarter of 2018, Non-GAAP net income was $7.7 million, or $0.15 per share, compared to Non-GAAP net income of $1.6 million, or $0.03 per share, for the second quarter of 2017.

Vanda provides Non-GAAP financial information, which it believes can enhance an overall understanding of its financial performance when considered together with GAAP figures. Refer to the sections of this press release entitled "Non-GAAP Financial Information" and "Reconciliation of GAAP to Non-GAAP Financial Information."

2018 Financial Guidance

Vanda reiterates its prior 2018 net product sales guidance and provides an update to Non-GAAP Operating Expenses and Year-End 2018 Cash guidance and expects to achieve the following financial objectives in 2018

Vanda has scheduled a conference call for today, Wednesday, August 1, 2018, at 4:30 PM ET. During the call, Vanda’s management will discuss the second quarter 2018 financial results and other corporate activities. Investors can call 1-800-708-4539 (domestic) or 1-847-619-6396 (international) and use passcode 47289344. A replay of the call will be available on Wednesday, August 1, 2018, beginning at 7:00 PM ET and will be accessible until Wednesday, August 8, 2018, at 11:59 PM ET. The replay call-in number is 1-888-843-7419 for domestic callers and 1-630-652-3042 for international callers. The passcode number is 47289344.

The conference call will be broadcast simultaneously on Vanda’s website,
www.vandapharma.com
. Investors should click on the Investor Relations tab and are advised to go to the website at least 15 minutes early to register, download, and install any necessary software or presentations. The call will also be archived on Vanda’s website for a period of 30 days.

Non-GAAP Financial Information

Vanda believes that the Non-GAAP financial information provided in this press release can assist investors in understanding and assessing the ongoing economics of Vanda’s business and reflect how it manages the business internally and sets operational goals. Vanda’s "Non-GAAP Selling, general and administrative expenses" and "Non-GAAP Research and development expenses" exclude stock-based compensation. Vanda’s "Non-GAAP Net income (loss)," "Non-GAAP Net income (loss) per share" and "Non-GAAP Operating expenses excluding Cost of goods sold" exclude stock-based compensation and intangible asset amortization.

Vanda believes that excluding the impact of these items better reflects the recurring economic characteristics of its business, as well as Vanda’s use of financial resources and its long-term performance.

This press release includes a projection of 2018 Non-GAAP Operating expenses, excluding Cost of goods sold, a forward-looking Non-GAAP financial measure under the heading "2018 Financial Guidance." This Non-GAAP financial measure is determined by excluding cost of goods sold, stock-based compensation and intangible asset amortization. Vanda is unable to reconcile this Non-GAAP guidance to GAAP because it is difficult to predict the future impact of these adjustments.

These Non-GAAP financial measures, as presented, may not be comparable to similarly titled measures reported by other companies since not all companies may calculate these measures in an identical manner and, therefore, they are not necessarily an accurate measure of comparison between companies.

The presentation of these Non-GAAP financial measures is not intended to be considered in isolation or as a substitute for guidance prepared in accordance with GAAP. The principal limitation of these Non-GAAP financial measures is that they exclude significant elements that are required by GAAP to be recorded in Vanda’s financial statements. In addition, they are subject to inherent limitations as they reflect the exercise of judgments by management in determining these Non-GAAP financial measures. In order to compensate for these limitations, Vanda presents its Non-GAAP financial guidance in connection with its GAAP guidance. Investors are encouraged to review the reconciliation of our Non-GAAP financial measures to their most directly comparable GAAP financial measure.