VERACYTE ANNOUNCES FIRST QUARTER 2018 FINANCIAL RESULTS

On May 1, 2018 Veracyte, Inc. (Nasdaq: VCYT) reported financial results for the first quarter ended March 31, 2018 and provided an update on recent business progress. For the first quarter of 2018, revenue was $20.0 million, an increase of 22%, compared to $16.4 million for the first quarter of 2017 (Press release, Veracyte, MAY 1, 2018, View Source [SID1234525901]).

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"We had a great quarter in which we beat revenue and genomic test volume growth expectations and generated strong momentum across our business," said Bonnie Anderson, chairman and chief executive officer of Veracyte. "Our team converted the majority of our thyroid business to the next-generation Afirma Genomic Sequencing Classifier, gained in-network status with Anthem and significantly accelerated our Percepta business. Additionally, we unveiled our new, RNA sequencing-based Afirma Xpression Atlas, which positions us to deliver even more value to physicians, while enabling new collaborations – beginning with Loxo Oncology – to help advance precision medicine efforts."

First Quarter 2018 Financial Results

For the first quarter of 2018, as compared to the first quarter of 2017:

Revenue was $20.0 million, an increase of 22%;
Genomic Volume was 6,864, an increase of 18%;
Gross Margin was 61%, a decline of 1%;
Operating Expenses, Excluding Cost of Revenue were $21.1 million, an increase of 20%;
Net Loss and Comprehensive Loss was ($9.2) million, an increase of 12%;
Basic and Diluted Net Loss Per Common Share was ($0.27), an increase of 13%;
Cash Burn1 was $7.6 million, an improvement of 8%; and
Cash and Cash Equivalents was $27.2 million at March 31, 2018.
1 A reconciliation of net cash used in operating activities to cash burn has been provided in the financial statement tables included in this press release. An explanation of cash burn is also included below under the heading "Non-GAAP Financial Measures."

First Quarter 2018 and Recent Business Highlights

Commercial Growth:

Reported 6,864 genomic tests in the first quarter of 2018, representing 18% growth as compared to the first quarter of 2017, and transitioned approximately 70% of the company’s thyroid business to the next-generation Afirma Genomic Sequencing Classifier (GSC), ahead of plan; and
Doubled the number of institutions that submitted samples for Percepta testing in the first quarter of 2018, compared to the fourth quarter of 2017.
Reimbursement Expansion:

Executed an in-network contract with Anthem, an independent Blues plan and one of the nation’s largest health benefits companies. This achievement nearly completes Veracyte’s contracting efforts to make the Afirma classifier available to patients nationally as an in-network service.
Evidence Development:

Presented the first real-world clinical utility data for the Afirma GSC at ENDO 2018 demonstrating that the genomic test enabled significantly more patients to avoid unnecessary thyroid surgery, compared to the original Afirma test;
Published the INTENSITY study in BMC Pulmonary Medicine, quantifying the challenges of obtaining an IPF diagnosis and the resulting negative impact on patients – and underscoring the clinical need for the Envisia classifier; and
Received acceptance of an abstract for a validation study demonstrating the performance of the Afirma Xpression Atlas to be presented at the American Association of Clinical Endocrinologists’ (AACE) 27th Annual Scientific & Clinical Congress in May 2018.
Scientific Innovation:

Unveiled the Afirma Xpression Atlas, an extension of the Afirma GSC, at ENDO 2018 in an oral presentation detailing the RNA sequencing-based platform’s ability to derive rich genomic content – 761 DNA variants and 130 RNA fusions in over 500 genes that are associated with thyroid cancer – from thyroid fine needle aspiration samples; and
Entered into a research collaboration with Loxo Oncology, which will leverage Veracyte’s Afirma Xpression Atlas platform to advance Loxo Oncology’s development of therapies for patients with genetically defined cancers, including thyroid cancer.
Updated 2018 Financial Outlook

Veracyte is increasing its 2018 annual revenue guidance to $83 million to $86 million, from its prior guidance of $81 million to $83 million. The company reiterates its annual cash burn guidance of $18 million to $22 million.

Ophthotech Corporation to Report First Quarter 2018 Financial Results and Host Conference Call on Wednesday, May 9, 2018

On May 1, 2018 Ophthotech Corporation (Nasdaq:OPHT) reported that it will report its first quarter 2018 financial and operating results on Wednesday, May 9, 2018 (Press release, Ophthotech, MAY 1, 2018, View Source [SID1234525919]). Following the announcement, Ophthotech’s management team will host a live conference call and webcast at 8:00 a.m. Eastern Time to discuss the Company’s financial results and provide a general business update.

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To participate in this conference call, dial 800-239-9838 (USA) or 323-794-2551 (International), passcode 2075643. A live, listen-only audio webcast of the conference call can be accessed on the Investor Relations section of the Ophthotech website at: www.ophthotech.com. A replay will be available approximately two hours following the live call for two weeks. The replay number is 888-203-1112 (USA Toll Free), passcode 2075643.

Coherus BioSciences Management to Present at the Bank of America Merrill Lynch Health Care Conference in Las Vegas, Nevada

On May 1, 2018 Coherus BioSciences, Inc. (Nasdaq:CHRS) reported that senior management will be presenting at the Bank of America Merrill Lynch Health Care Conference on Wednesday, May 16, 2018 at 11:40 am ET being held in Las Vegas, Nevada (Press release, Coherus Biosciences, MAY 1, 2018, View Source;p=RssLanding&cat=news&id=2345957 [SID1234525880]).

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The audio portion of the presentation will be available on the investors page of the Coherus BioSciences website at View Source

Zymeworks Reports 2018 First Quarter Financial Results

On May 1, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, today reported financial results for the quarter ended March 31, 2018 (Press release, Zymeworks, MAY 1, 2018, View Source [SID1234525902]).

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"Over the last few months we have added to our clinical and business momentum," said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. "In addition to the milestones highlighted below, we continue to be encouraged by the clinical progress of our lead candidate, ZW25, and are honored that the updated data was selected for an oral presentation at the upcoming American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting next month.

First Quarter 2018 Business Highlights and Recent Developments

Added New Clinical Sites for ZW25 in Canada and the United States; Data Selected for Oral Presentation at ASCO (Free ASCO Whitepaper)
To give more clinicians access to its novel bispecific antibody, Zymeworks announced the opening of new sites in Canada and the United States for its ongoing adaptive Phase 1 study of ZW25. Updated data, from the dose escalation and expansion cohort parts of the study, will be highlighted at an oral presentation at the upcoming ASCO (Free ASCO Whitepaper) annual meeting in Chicago.
Identified ZW49, a Novel Antibody-Drug Conjugate (ADC), as a Clinical Candidate
ZW49 is a proprietary bispecific ADC targeting two distinct locations of the HER2 receptor resulting in enhanced delivery of Zymework’s proprietary ZymeLink cytotoxic payload to cancer cells. Preclinical data, presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April demonstrated ZW49 to be active and well tolerated in models of high and low HER2-expressing cancers. Zymeworks expects to file an Investigational New Drug (IND) application this year in order to begin a clinical trial with ZW49.
Expanded Corporate Collaboration with Celgene
Zymeworks has expanded its relationship with Celgene. Under the terms of the agreement, the research program term has been extended by two years and additional licenses for two products have been added for a total of 10 potential products under the collaboration. Zymeworks is entitled to receive an expansion fee and is eligible to receive up to US$328 million in additional development and commercial milestones resulting in total future potential milestones of US$1.64 billion, plus royalties on worldwide sales.
Financial Results for the Quarter Ended March 31, 2018

Revenue for the three months ended March 31, 2018 was $0.04 million as compared to $0.23 million in the same period in 2017, primarily due to a $0.2 million decrease in research support payments from Daiichi Sankyo as research and development activities under the agreement with Daiichi Sankyo shifted to our partner.

For the three months ended March 31, 2018, research and development expenditures were $13.1 million as compared to $9.1 million for the same period in the prior year. This was primarily due to an increase in clinical costs for ZW25 and development costs for ZW49 in 2018, which was partially offset by a decrease in early stage research and development activities in platform technologies compared to the same period in 2017. General and administrative expenses were $7.1 million for the three months ended March 31, 2018 and $6.3 million for the same period in 2017. The change between the periods was primarily due to an increase in compensation costs and professional fees. The compensation costs increase was the result of new hires as well as an increase in stock-based compensation expense.

The net loss for the three months ended March 31, 2018 increased to $21.2 million as compared to $15.9 million for the same period in 2017, primarily due to increased research & development and general administrative expenses, as well as increase in the fair value of warrant liabilities which was partially offset by impairment charges recorded in 2017. Zymeworks expects research and development expenditures to increase over time due to the ongoing development of product candidates and other clinical, preclinical, and regulatory activities.

As of March 31, 2018, Zymeworks had $70.0 million in cash and cash equivalents and short-term investments. Zymeworks expects to continue receiving revenue from its existing and future corporate collaborations, including technology access fees, research and development fees for services rendered, and milestone-based payments. However, Zymeworks’ ability to receive these payments is dependent upon either Zymeworks or its collaborators successfully completing specified research and development activities.

Pacira Pharmaceuticals to Present at Two Healthcare Conferences in May

On May 1, 2018 Pacira Pharmaceuticals, Inc. (NASDAQ:PCRX) reported that members of its management team are scheduled to present at the following two healthcare conferences (Press release, Pacira Pharmaceuticals, MAY 1, 2018, View Source;p=RssLanding&cat=news&id=2345862 [SID1234525920]):

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Deutsche Bank 43rd Annual Health Care Conference in Boston, on Wednesday, May 9 at 2:10 PM ET
Bank of America Merrill Lynch 2018 Healthcare Conference in Las Vegas, on Tuesday, May 15, at 1:40 PM PT (4:40PM ET)
A live audio webcast of the Pacira presentations can be accessed by visiting the "Investors & Media" section of the company’s website at investor.pacira.com. A replay of the webcasts will be archived on the Pacira website for two weeks following the presentation dates.