On March 8, 2018 Cerus Corporation (Nasdaq: CERS) reported financial results for the fourth quarter and year ended December 31, 2017 (Press release, Cerus, MAR 8, 2018, View Source [SID1234524557]).

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Recent developments and highlights include:

Reported record fourth quarter product revenue of $16.2 million, an increase of 60% compared to the same period in the year prior.
Established 2018 annual product revenue guidance of $51 million to $53 million, which would represent a 17% to 22% increase over 2017 reported product revenue.
Successfully met primary safety and efficacy endpoints in SPARC, Cerus’ European Phase 3 clinical trial evaluating INTERCEPT red cell transfusions in thalassemia patients.
Completed an underwritten public offering of common stock raising gross proceeds of $57.5 million.
Advanced release assay for commercial manufacturing of the S303 compound used in the INTERCEPT red blood cell system to enable H2 2018 CE Mark submission.
"As we reported in our January 8, 2018 press release, we experienced a strong finish to 2017 with fourth quarter results exceeding our expectations. We saw robust sales activity in multiple geographies including France, the U.S., and the Middle East. In addition, we continue to make progress on the final CMC activities needed for the planned INTERCEPT red blood cell system CE Mark submission which will include data from the SPARC clinical study. In the U.S. we received IDE approval from the FDA to initiate our second Phase 3 RBC study," said William ‘Obi’ Greenman, Cerus’ president and chief executive officer. "With the $57.5 million of gross proceeds and the remaining borrowing availability under our growth capital facility, combined with BARDA funding, we believe we are now well capitalized to focus on commercial execution and on progressing our pipeline opportunities from late stage development to potential market launch."

Revenue

Product revenue for the fourth quarter of 2017 was $16.2 million, compared to $10.1 million during the same period in 2016. Product revenue for the year ended December 31, 2017 was $43.6 million, compared to $37.2 million for the year ended December 31, 2016. The increases in reported product revenue were driven by year-over-year increases in platelet kit demand, both in international and domestic markets, partially offset by declines in plasma kits and illuminator sales. Growth in sales from France and the U.S. were the primary drivers of the increased platelet kit sales in both periods. Demand for platelet kits was up more than 100% when comparing the fourth quarter of 2017 to the same period in 2016, and up almost 40% for the full year 2017 compared to 2016.

Government contract revenue from our Biomedical Advanced Research and Development Authority (BARDA) agreement was $2.4 million in the fourth quarter of 2017 compared to $1.8 million during the same period in 2016. Government contract revenue from our BARDA agreement for the year ended December 31, 2017 was $7.8 million, compared to $2.1 million for the year ended December 31, 2016.

Gross Margins

Gross margins on product revenue for the fourth quarter of 2017 were 44%, compared to 45% for the fourth quarter of 2016. Gross margins for the year ended December 31, 2017 were 48%, compared to 45% in the same period in 2016.

Despite the more than a 100% increase in demand for platelet kits, gross margins on product revenue for the fourth quarter of 2017 was relatively consistent compared to the same period in 2016 due to fewer illuminator sales in the fourth quarter of 2017 compared to the same period in 2016, as well as the impact of pricing from higher volume platelet contracts. Gross margin on product revenue for the full-year 2017 increased due to the increase in demand for higher margin platelet disposable kits and favorable foreign exchange rates. Going forward, the Company expects to continue to realize economies of scale and lower cost of goods sold from its primary kit manufacturing agreement due to tiered pricing, which declines as production volume tiers are achieved.

Operating Expenses

Total operating expenses were $20.3 million and $86.3 million for the quarter and year ended December 31, 2017, compared to $21.5 million and $80.4 million for the quarter and year ended December 31, 2016, respectively.

Selling, general, and administrative (SG&A) expenses for the fourth quarter of 2017 were $12.5 million compared to $12.4 million for the fourth quarter of 2016. SG&A expenses for the year ended December 31, 2017 were $52.4 million compared to $48.8 million in the same period in 2016. The increase in SG&A expenses was due largely to increased commercial activity in the U.S.

Research and development (R&D) expenses for the fourth quarter of 2017 were $7.8 million compared to $8.8 million for the fourth quarter of 2016. R&D expenses in the quarter declined primarily due to the timing of activities related to the BARDA agreement. R&D expenses for the year ended December 31, 2017 were $33.7 million compared to $31.3 million in the same period in 2016. The increase in R&D expenses was primarily tied to increased headcount costs and costs tied to the clinical development of our INTERCEPT red blood cell program, the pursuit of supplemental approvals for the platelet and plasma systems, and activities related to our BARDA agreement.

Operating and Net Loss

Operating losses during the fourth quarter of 2017 were $10.9 million, compared to $15.1 million during the fourth quarter of 2016, and $57.5 million compared to $61.4 million for years ended December 31, 2017 and 2016, respectively.

Net loss for the fourth quarter of 2017 was $11.5 million, or $0.10 per diluted share, compared to a net loss of $13.5 million, or $0.13 per diluted share, for the fourth quarter of 2016. Net loss for the year ended December 31, 2017, was $60.6 million, or $0.56 per diluted share, compared to a net loss of $62.9 million, or $0.62 per diluted share, for the same period of 2016.

Cash, Cash Equivalents and Investments

At December 31, 2017, the Company had cash, cash equivalents and short-term investments of $60.7 million compared to $71.6 million at December 31, 2016.

At December 31, 2017, the Company had approximately $29.8 million in outstanding debt under its loan agreement with Oxford Finance. The loan agreement provides for an additional $10 million term loan and an extension of the interest only period upon the Company achieving pre-determined revenue levels.

In January 2018, the Company completed an underwritten public offering of its common stock for gross proceeds of $57.5 million, before deducting offering expenses payable by the Company.

QUARTERLY CONFERENCE CALL

The Company will host a conference call and webcast at 4:15 p.m. Eastern time today to discuss its financial results and provide a general business overview and outlook. To access the live webcast, please visit the Investor Relations page of the Cerus website at View Source Alternatively, you may access the live conference call by dialing (866) 235-9006 (U.S.) or (631) 291-4549 (international).

A replay will be available on the Company’s website, or by dialing (855) 859-2056 (U.S.) or (404) 537-3406 (international) and entering conference ID number 3395359. The replay will be available approximately three hours after the call through March 22, 2018

On March 8, 2018 Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX) reported financial results and provided a business update for the fourth quarter and full-year 2017 (Press release, Progenics Pharmaceuticals, MAR 8, 2018, View Source [SID1234524570]).

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"2017 was a year of strong progress for our targeted oncology pipeline programs, capped by the FDA’s acceptance for review of the New Drug Application (NDA) for AZEDRA," said Mark Baker, Chief Executive Officer of Progenics. "AZEDRA has the potential to be a transformative treatment option for patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, rare and life-threatening neuroendocrine tumors for which there are no approved therapies in the U.S. As we approach the FDA’s action date, we are readying our commercial organization for launch upon potential approval."

Mr. Baker continued, "We also continue to build momentum in advancing our development-stage PSMA-targeted radiopharmaceutical programs, which are designed to find, fight and follow prostate cancer. We have completed enrollment in our Phase 3 study for 1404, with results anticipated in the third quarter, and we expect to complete our current Phase 2/3 study for PyL in the second half of this year."

Fourth Quarter and Recent Key Business Highlights

AZEDRA, Ultra-orphan radiotherapeutic candidate

Action Date for AZEDRA New Drug Application (NDA) Set for April 30th
In December 2017, Progenics announced that the FDA accepted for review the NDA for AZEDRA in patients with malignant, recurrent, and/or unresectable pheochromocytoma and paraganglioma, rare neuroendocrine tumors for which there are currently no approved treatment options in the U.S. The FDA granted Progenics’ request for Priority Review and has set an action date of April 30, 2018 under the Prescription Drug User Fee Act (PDUFA). AZEDRA holds Breakthrough Therapy designation and Orphan Drug status, as well as Fast Track designation.
Clinical Data from Pivotal Phase 2b AZEDRA Study Presented at Major Medical Meetings
In October 2017, Progenics presented the positive results from its pivotal Phase 2b study evaluating AZEDRA at the North American Neuroendocrine Tumor Society (NANETS) 2017 Annual Symposium and the 30th Annual Congress of the European Association of Nuclear Medicine (EANM). Progenics also plans to present biochemical tumor marker data from this study at the upcoming Endocrine Society (ENDO) Annual Meeting in March 2018.
PSMA-Targeted Prostate Cancer Pipeline

Enrollment Complete in Phase 3 Study of 1404
In January 2018, Progenics announced the completion of enrollment in its Phase 3 study of 1404, a PSMA-targeted small molecule SPECT/CT imaging agent designed to visualize prostate cancer. The study enrolled approximately 450 patients in the U.S. and Canada with newly-diagnosed or low-grade prostate cancer, whose biopsy indicates a histopathologic Gleason grade of ≤ 3+4 severity and/or are candidates for active surveillance. Top-line data is expected in the third quarter of 2018.
Phase 2/3 Study of PyL Ongoing
Progenics continues to enroll patients in the Phase 2/3 study of PyL, a PSMA-targeted PET/CT imaging agent, evaluating diagnostic accuracy in patients with recurrent and/or metastatic prostate cancer. The Company expects to complete enrollment of this study in the second half of 2018 and initiate a second Phase 3 study in patients with biochemical recurrence of prostate cancer.
Enrollment Ongoing in Phase 1 Study for 1095
Progenics continues to enroll patients in the Phase 1 open-label dose escalation study of 1095, a small molecule radiotherapeutic that selectively binds to PSMA, in patients with metastatic castration-resistant prostate cancer (mCRPC) who have demonstrated tumor avidity to 1095.
Initiation of Phase 1 Study for PSMA-TTC Expected in 2018
Progenics expects its partner Bayer to initiate a Phase 1 study of PSMA-Targeted Thorium Conjugate (PSMA-TTC) in patients with mCRPC by year end 2018. Bayer was previously granted exclusive worldwide rights to develop and commercialize products using Progenics’s PSMA antibody technology in combination with Bayer’s alpha-emitting radionuclides.
RELISTOR, treatment for OIC (partnered with Valeant Pharmaceuticals International, Inc.)

RELISTOR Quarterly Net Sales Reached Record Level of $24.6 Million in Q4’17
Full-year 2017 net worldwide sales totaled $73.1 million as reported by our partner, Valeant. The fourth quarter 2017 net sales translated to $3.7 million in royalty revenue for Progenics, while the full year net sales resulted in $11.0 million in royalty revenue. Net sales of RELISTOR grew 44% over the prior quarter.
Fourth Quarter and Full-Year 2017 Financial Results

Fourth quarter 2017 revenue totaled $3.9 million, down from $4.7 million in the fourth quarter of 2016. Revenue for the 2017 period reflects RELISTOR royalty income of $3.7 million compared to $2.4 million in the corresponding period of 2016. The prior year period included milestone revenue of $2.0 million from Bayer for the collaboration of the Company’s PSMA antibody technology in combination with Bayer’s alpha-emitting radionuclides. The full-year 2017 revenue totaled $11.7 million, down from $69.4 million for the full-year of 2016, resulting primarily from the prior year milestone revenue of $50 million for the July 19, 2016 FDA approval of RELISTOR Tablets, and the recognition of $7 million in upfront and development milestone payments from Bayer.

Research and development expenses increased by $0.3 million and $5.0 million in the fourth quarter and full-year 2017, respectively, compared to the corresponding periods in 2016. The full-year increase resulted primarily from higher clinical costs for PyL and higher consulting expenses in preparation for the AZEDRA NDA filing, partially offset by lower clinical costs for AZEDRA. Fourth quarter and full-year general and administrative expenses increased by $2.2 million and $1.6 million, respectively, compared to the corresponding prior periods in 2016, primarily attributable to higher costs associated with building commercial capabilities in preparation for a potential AZEDRA approval and launch. Progenics also recorded non-cash adjustments of ($0.7 million) and $2.6 million in the fourth quarter and full-year 2017, respectively, related to changes in the fair value estimate of the contingent consideration liability. For the three months and year ended December 31, 2017, Progenics recognized interest expense of $1.2 million and $4.8 million, respectively, related to the RELISTOR royalty-backed loan.

In December 2017, the Tax Cuts and Jobs Act (the "Tax Act"), was signed into law. Among other provisions, the Tax Act reduces the U.S. federal statutory corporate income tax rate from 35% to 21% effective for 2018 and provides for an indefinite carryforward period for net operating losses. As a result, the Company recorded an income tax benefit of approximately $11.7 million in 2017, primarily related to the reduction in the federal tax rate and the use of the Company’s deferred tax liability related to indefinite-lived intangible assets (naked tax credit) as a source of income to release a portion of its valuation allowance recorded against deferred tax assets.

Net loss attributable to Progenics for the fourth quarter was $2.7 million or $0.04 per diluted share, compared to a net loss of $7.2 million or $0.10 per diluted share in the corresponding 2016 period. Net loss for the full-year 2017 was $51.0 million or $0.73 per diluted share, compared to net income of $10.8 million or $0.15 per diluted share for the full-year 2016.

Progenics ended the year with cash and cash equivalents of $90.6 million, reflecting a decrease of $7.7 million in the quarter and $48.3 million from 2016 year-end. In order to maintain a strong financial position, in the fourth quarter of 2017 and in January 2018, the Company raised $14.5 million in net proceeds from sales of its common stock under its "at-the-market" (ATM) facility, with $5.0 million received through December 31, 2017 and the remainder received in January.

OncoMed has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, OncoMed, 2018, MAR 8, 2018, View Source [SID1234524627]).

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On March 7, 2018 Foundation Medicine (NASDAQ:FMI) reported financial and operational results for the fourth quarter and year ended December 31, 2017 (Press release, Foundation Medicine, MAR 7, 2018, View Source [SID1234524506]). Highlights for the quarter and year included:

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Fourth quarter revenue of $48.9 million, 70% year-over-year growth;
Full year 2017 revenue of $152.9 million, 31% year-over-year growth;
20,044 clinical tests reported in the fourth quarter, 57% year-over-year growth;
67,375 clinical tests reported in 2017, 54% year-over-year growth;
Received approval from the U.S. Food & Drug Administration (FDA) under the parallel review process for FoundationOne CDx, the first broad comprehensive genomic profiling test for all solid tumors incorporating multiple companion diagnostics. Simultaneously, the Centers for Medicare and Medicaid Services (CMS) issued a preliminary National Coverage Determination (NCD) for FoundationOne CDx;
Entered into new and expanded biopharma collaborations for molecular information solutions including companion diagnostics, molecular profiling, data insights, and biomarker discovery, validation and development such as tumor mutational burden (TMB) and tumor mutational burden in blood (bTMB); and
Published 95 peer-reviewed manuscripts in top medical and scientific journals and presented 141 podium talks and posters at scientific and medical meetings.
"Foundation Medicine’s 2017 results and achievements, including record revenue and clinical volume and the landmark FDA approval of FoundationOne CDx, position our company for continued value creation and competitive differentiation," stated Troy Cox, chief executive officer of Foundation Medicine. "Our strategic priorities in 2018 include the successful commercial launch of FoundationOne CDx, driving global clinical adoption of our solutions, expanding reimbursement progress, and entering new biopharma partnerships, all of which we believe will accelerate our business and keep us on the leading edge of innovation."

Foundation Medicine reported total revenue of $48.9 million in the fourth quarter of 2017, compared to $28.8 million in the fourth quarter of 2016. Total revenue for the year ended December 31, 2017 was $152.9 million, compared to $116.9 million in 2016.

Revenue from biopharmaceutical companies was $33.4 million in the fourth quarter of 2017 and $99.7 million for the full year ended December 31, 2017, compared to $19.0 million and $78.8 million in the fourth quarter and full year ended December 31, 2016, respectively. The company reported 6,206 tests to biopharmaceutical customers in the fourth quarter of 2017 and 15,587 tests for the full year ended December 31, 2017.

Revenue from clinical testing was $15.5 million in the fourth quarter of 2017 and $53.2 million for the full year ended December 31, 2017, compared to $9.8 million and $38.1 million in the fourth quarter and full year ended December 31, 2016, respectively. The company reported 20,044 clinical tests to ordering physicians in the fourth quarter of 2017, compared to a total of 12,788 tests reported during the fourth quarter of 2016, an increase of 57%. A total of 67,375 clinical tests were reported to ordering physicians for the full year ended December 31, 2017, compared to 43,686 clinical tests reported in 2016, an increase of 54%.

Based on the new revenue reporting the company initiated during 2017, Molecular Information Services revenue was $37.4 million in the fourth quarter of 2017 and $117.2 million for the full year ended December 31, 2017, compared to $20.4 million and $81.7 million in the fourth quarter and full year ended December 31, 2016, respectively. Pharma Research and Development Services revenue was $11.5 million in the fourth quarter of 2017 and $35.7 million for the full year ended December 31, 2017, compared to $8.4 million and $35.1 million in the fourth quarter and full year ended December 31, 2016, respectively.

Total operating expenses for the fourth quarter of 2017 were approximately $59.9 million compared with $47.1 million for the fourth quarter of 2016. For the full year, operating expenses were $228.6 million, compared to $173.9 million in 2016. Net loss was $38.1 million in the fourth quarter of 2017, or $1.05 loss per share, and net loss for the full year was $161.5 million, or a $4.50 loss per share.

Cash and cash equivalents at December 31, 2017 was approximately $71.4 million, including $30 million in new borrowings received during the fourth quarter under the company’s Credit Facility Agreement with Roche Finance.

2018 Outlook

The company expects 2018 revenue will be in the range of $200 million to $220 million.
The company expects to deliver between 90,000 and 100,000 clinical tests in 2018.
The company expects operating expenses will be in the range of $250 million to $260 million in 2018.
Conference Call and Webcast Details
The company will conduct a conference call today, Wednesday, March 7th at 4:30 p.m. Eastern Time to discuss its financial performance for the 2017 fourth quarter and other business activities, including matters related to future performance. To access the conference call via phone, dial 1-877-270-2148 from the United States or dial 1-412-902-6510 internationally. Dial in approximately ten minutes prior to the start of the call. The live, listen-only webcast of the conference call may be accessed by visiting the investors section of the company’s website at investors.foundationmedicine.com. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the company’s website for two weeks following the call.

On March 7, 2018 Daiichi Sankyo Company, Limited (hereafter, Daiichi Sankyo) reported that the first patient has been dosed in a global phase 2 study evaluating the safety and efficacy of DS-8201, an investigational HER2-targeting antibody drug conjugate (ADC), in patients with HER2-expressing advanced colorectal cancer who have received at least two prior lines of standard treatment (Press release, Daiichi Sankyo, MAR 7, 2018, View Source [SID1234524505]).

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An increase in the number of approved targeted therapies for advanced colorectal cancer over the past decade has helped improve outcomes for some patients, however efficacy and tolerability of second and third-line treatments remain limited.[1], [2], [3], [4], [5]Approximately 3 percent of colorectal cancers overexpress the HER2 protein, which is a well-established therapeutic target in breast and gastric cancer.1 In addition, research indicates that HER2 amplification may be associated with resistance to anti-epidermal growth factor receptor (EGFR)-targeted therapy and shorter survival.[6],[7] Currently, no approved HER2-targeting therapies exist for patients with colorectal cancer.

"Given the existing unmet medical need for advanced colorectal cancer, we are exploring the smart delivery of chemotherapy with DS-8201 as a potential new type of targeted treatment for patients with HER2-expressing disease who have progressed on or become resistant to standard therapies," said Antoine Yver, MD, MSc, Executive Vice President and Global Head, Oncology Research and Development, Daiichi Sankyo. "Similar to our breast and gastric cancer programs, we are pursuing a development path focused first on patients with HER2-overexpressing tumors followed by potential expansion to include patients with advanced colorectal cancer with lower levels of HER2 expression."

About the DS-8201 Colorectal Cancer Phase 2 Study

The global, multi-center, phase 2, open-label, three-cohort study will investigate the safety and efficacy of DS-8201 in patients with HER2-expressing advanced colorectal cancer. The first part of the study will enroll patients with HER2-positive (defined as IHC3+ or IHC2+/ISH+) advanced colorectal cancer. The primary endpoint of the study is overall response rate. Secondary endpoints include progression-free survival, overall survival, duration of response, disease control rate, pharmacokinetics and safety. Exploratory endpoints include time to response and biomarker analysis. This part of the study is expected to enroll approximately 50 patients in North America, Europe and Japan.

Following the outcome of the first part of the study, two additional exploratory cohorts may proceed to enroll patients whose tumors have lower levels of HER2-expression. For more information about the study, visit ClinicalTrials.gov.

About Colorectal Cancer

Colorectal cancer is the third most common cancer worldwide. In 2012, there were approximately 1.36 million new cases diagnosed and 690,000 deaths worldwide.[8] Approximately 25 percent of patients have metastatic disease at diagnosis, meaning the disease has spread to distant organs, and about 50 percent of patients with colorectal cancer will eventually develop metastases.[9] Prognosis for these patients remains poor.[10]

About DS-8201

DS-8201 is the lead product in the investigational ADC Franchise of the Daiichi Sankyo Cancer Enterprise. ADCs are targeted cancer medicines that deliver cytotoxic chemotherapy ("payload") to cancer cells via a linker attached to a monoclonal antibody that binds to a specific target expressed on cancer cells. Designed using Daiichi Sankyo’s proprietary ADC technology, DS-8201 is a smart chemotherapy comprised of a humanized HER2 antibody attached to a novel topoisomerase I inhibitor payload by a tetrapeptide-based linker. It is designed to target and deliver chemotherapy inside cancer cells and reduce systemic exposure to the cytotoxic payload (or chemotherapy) compared to the way chemotherapy is commonly delivered.

In addition to the phase 2 study in HER2-expressing advanced colorectal cancer, DS-8201 is currently in pivotal phase 2 clinical development for HER2-positive unresectable and/or metastatic breast cancer resistant or refractory to T-DM1 (DESTINY-Breast01) in North America, Europe and Asia, and pivotal phase 2 development for HER2-positive advanced gastric cancer resistant or refractory to trastuzumab (DESTINY-Gastric01) in Japan and South Korea. DS-8201 is also in phase 1 development for other HER2-expressing advanced/unresectable or metastatic solid tumors.

DS-8201 has been granted Breakthrough Therapy designation for the treatment of patients with HER2-positive, locally advanced or metastatic breast cancer who have been treated with trastuzumab and pertuzumab and have disease progression after ado-trastuzumab emtansine (T-DM1), and Fast Track designation for the treatment of HER2-positive unresectable and/or metastatic breast cancer in patients who have progressed after prior treatment with HER2-targeted therapies including T-DM1 by the U.S. Food and Drug Administration (FDA). DS-8201 is an investigational agent that has not been approved for any indication in any country. Safety and efficacy have not been established.