HanAll Biopharma Reports First Quarter 2021 Financial Results

On May 6, 2021 HanAll Biopharma (KRX: 009420) (HanAll) reported that it achieved 27.8 billion won in sales, 5.4 billion won in operating profit and 4.5 billion won in net profit in the first quarter of this year (Press release, HanAll Biopharma, MAY 6, 2021, View Source [SID1234579411]).

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Sales and operating profit rose 26% and 80%, respectively, compared to the same period last year thanks to increased R&D revenue and increased product revenue. Operating margin increased to 19% from 14%, and net income for the period was estimated at 4.5 billion won, up 13 percent year-on-year.

The growth of R&D revenue including milestone payments from HL161 and HL036 licensed to Immunovant and Harbour BioMed was a main performance driver while domestic drug sales slightly increased year-on-year. HanAll remain committed to delivering innovative medicines for patients with its improved financial performance.

The company plans to start the second Phase 3 clinical trial in dry eye disease (DED) in the 2H of 2021, which is being co-developed with Daewoong Pharmaceutical.

Meanwhile, HanAll has recently appointed David Hernandez, former Head of Clinical Operations Japan at Merck Biopharma, as Vice President of Clinical Operations at HPI, a U.S. subsidiary of HanAll, to accelerate clinical trials of its current and future pipeline compounds.

ViewRay Reports First Quarter 2021 Results

On May 6, 2021 ViewRay, Inc. (Nasdaq: VRAY) (the "Company") reported financial results for the first quarter ended March 31, 2021 (Press release, ViewRay, MAY 6, 2021, View Source [SID1234579410]).

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First Quarter 2021 Highlights

Received seven new orders for MRIdian systems totaling $40.9 million, compared to four new orders totaling $22.6 million in the first quarter of 2020.
Total backlog increased to $264.3 million as of March 31, 2021, compared to $230.8 million as of March 31, 2020.
Total revenue of $15.5 million primarily from two revenue units, compared to $14.3 million primarily from three revenue units, including one system upgrade, in the first quarter of 2020.
Cash burn in the first quarter of 2021 was approximately $28 million, excluding the net proceeds from the January 2021 public offering, compared to approximately $36 million in the first quarter of 2020.
Cash and cash equivalents were $182.0 million as of March 31, 2021.
2021 Public Offering of Common Stock

As previously disclosed, in January 2021, the Company raised aggregate net proceeds of approximately $53.5 million after deducting the underwriting discounts, commissions, and estimated offering expenses via a public offering in which 11,856,500 shares of our common stock were issued and sold, including the full exercise of the underwriters’ option to purchase additional shares, at a price to the public of $4.85 per share.
"Our performance in the first quarter 2021 represents a solid step forward and progress on our mission to improve the paradigm of care for cancer patients globally," said Scott Drake, President and CEO. "Our clinical and innovation pipelines are driving commercial traction. We look forward to upcoming clinical trial data and advancements in our product pipeline which we expect will fuel future growth."

Financial Results

Total revenue for the three months ended March 31, 2021 was $15.5 million compared to $14.3 million for the same period last year.

Total gross profit for the three months ended March 31, 2021 was $0.3 million, compared to ($2.1) million for the same period last year.

Total operating expenses for the three months ended March 31, 2021 were $25.0 million, compared to $27.9 million for the same period last year.

Net loss for the three months ended March 31, 2021 was $26.7 million, or $0.17 per share, compared to $27.5 million, or $0.19 per share, for the same period last year.

ViewRay had total cash and cash equivalents of $182 million at March 31, 2021.

Financial Guidance

Due to the ongoing impact and uncertainty of the COVID-19 pandemic globally, the Company will not be providing financial guidance at this time.

Conference Call and Webcast

ViewRay will hold a conference call to discuss results on Thursday, May 6, 2021 at 4:30 p.m. ET / 1:30 p.m. PT. The dial-in numbers are (888) 771-4371 for domestic callers and (847) 585-4405 for international callers. The confirmation number is 50150605. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website, under "Financial Events and Webinars", for 14 days following the call. In addition, a telephonic replay of the call will be available until May 13, 2021. The replay dial-in numbers are (855) 859-2056 for domestic callers and (404) 537-3406 for international callers. Please use the conference ID number 8484107.

Gilead Sciences to Present at Upcoming Investor Conferences

On May 6, 2021 Gilead Sciences, Inc. (Nasdaq: GILD) reported that its executives will be speaking at the following investor conferences (Press release, Gilead Sciences, MAY 6, 2021, View Source [SID1234579409]):

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BofA Securities 2021 Virtual Health Care Conference on Thursday, May 13, 2021 at 2:00 p.m. ET
RBC Capital Markets 2021 Global Health Care Conference on Wednesday, May 19, 2021 at 10:20 a.m. ET
The live webcasts can be accessed at the company’s investors page at investors.gilead.com. The replays will be available for at least 30 days following the presentation.

Twist Bioscience Reports Second Quarter Fiscal 2021 Financial Results

On May 6, 2021 Twist Bioscience Corporation (NASDAQ: TWST), a company enabling customers to succeed through its offering of high-quality synthetic DNA using its silicon platform, reported financial results and business highlights for the second quarter of fiscal 2021 ended March 31, 2021 (Press release, Twist Bioscience, MAY 6, 2021, View Source [SID1234579408]).

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"The second quarter of our fiscal year delivered growth across all four areas of our business, with increasing revenue and very strong orders building momentum for the second half of the year," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We signed new biopharma partnerships with multiple associated programs, and we continue to drive increasing density for our data storage vertical.

"For the second half of fiscal 2021 we expect continued growth of our NGS and synbio customer base as we build out the Factory of the Future in Oregon. We intend to advance all programs with our biopharma partners while simultaneously generating data to support out-licensing for our proprietary antibodies. In addition, for data storage, we will continue to pursue innovative engineering and collaborate across the DNA Data Storage Alliance to prepare the market for this novel storage medium."

FISCAL 2021 SECOND QUARTER FINANCIAL RESULTS

Orders: Total orders received for the second quarter of fiscal 2021 were $41.7 million, compared to $24.6 million for the same period of fiscal 2020.
Revenue: Total revenues were $31.2 million for the second quarter of fiscal 2021 compared to $19.3 million for the same period of fiscal 2020.
Cost of Revenues: Cost of revenues for the second quarter of fiscal 2021 was $19.0 million compared to $13.6 million for the same period of fiscal 2020.
Research and Development Expenses: Research and development expenses for the second quarter of fiscal 2021 were $15.8 million compared to $10.6 million for the same period of fiscal 2020.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the second quarter of fiscal 2021 were $34.4 million compared to $27.2 million for the same period of fiscal 2020.
Net Loss: Net loss for the second quarter of fiscal 2021 was $37.9 million, or $0.78 per share, compared to $31.8 million, or $0.85 per share, for the second quarter of fiscal 2020.
Cash Position: As of March 31, 2021, the company had $555.7 million in cash, cash equivalents and short-term investments.
"We increased our margin to 39%, reflecting the impact of scaling our revenue, leveraging our fixed costs and the benefit of higher NGS product mix," commented Jim Thorburn, CFO of Twist. "Importantly, the solid results demonstrate excellent execution across all teams at Twist."

Fiscal Second Quarter 2021 and Recent Highlights

Shipped products to approximately 1,700 customers in the second quarter of fiscal 2021 versus approximately 1,400 in the same period of fiscal 2020.
Exercised our right of first refusal which gives a cost-effective option to double manufacturing capacity at the "Factory of the Future" just outside of Portland, Oregon
Launched the Twist NGS Methylation Detection System, a robust, end-to-end sample preparation and target enrichment solution for identifying methylated regions in the human genome. DNA methylation plays a key role in many biological processes including cancer.
Received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), together with Biotia, for the SARS-CoV-2 Next-Generation Sequencing (NGS) Assay.
Partnered with Watchmaker Genomics to enable innovative research across a wide range of high throughput sequencing applications including tumor profiling, inherited disease detection, liquid biopsy assays and minimal residual disease monitoring.
Added new synthetic RNA controls to develop, validate and verify tests for SARS-CoV-2. The new controls include the B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil) variants of SARS-CoV-2.
Announced three new NGS customers in APAC: Berry Genomics, Victoria Clinical Genetics Services (VCGS) and AcornMed Biotechnology.
Announced three new Twist Biopharma collaborations with Kyowa Kirin, Stanford’s Innovate Medicines Accelerator and Pure Biologics, bringing the total number of partners to 21. Twist Biopharma is now advancing 25 active programs through its partners, 17 of which have milestones and royalties. Additionally, nine programs are now completed.
Published positive preclinical data demonstrating that GLP-1R antibodies identified from Twist Biopharma’s proprietary G-protein coupled receptor (GPCR) libraries showed potent blood glucose control. Glucagon-like peptide-1 receptor (GLP-1R) is a class B GPCR that acts as the receptor for the incretin GLP-1, a peptide released to regulate insulin levels in response to food intake. The data were published online in mAbs.
Exercised our option to purchase all rights to a G-coupled protein receptor (GPCR) library and its proprietary Twist Antibody Optimization software, both developed in collaboration with Distributed Bio.
Named one of Fast Company’s World’s Most Innovative Companies for 2021.
Earned Great Place to Work certification.
Fiscal 2021 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2021. The following statements are forward-looking, and actual results could differ materially depending on market conditions and the factors set forth under "Forward-Looking Statements" below. Twist does not plan to update, nor does it undertake any obligation to update, this outlook in the future.

For the full fiscal year 2021, Twist provided the following updated financial guidance:

Increasing revenue guidance in the range of $121 million to $129 million
Revenue from Ginkgo Bioworks expected to be in the range of $11 to $12 million
Synbio revenue excluding Ginkgo Bioworks is expected to be in the range of $43 to $46 million
NGS revenue is estimated to be in the range of $62 to $66 million
Biopharma revenue is estimated to be approximately $5 million
Gross margin is expected to be 36% to 38% for fiscal 2021
Operating expenses including R&D and SG&A are expected to be $192 million for the year
Net loss expected in the range of $144 million to $150 million to reflect our increased investments in our commercial organization and research and development activities
R&D is expected to be approximately $66 million
Stock-based compensation is expected to be approximately $33 million
Depreciation is expected to be $10 million
Capital expenditures are expected to be $40 million, including expansion into "Factory of the Future"
Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors today at 4:30 p.m. Eastern Time to discuss its financial results and provide an update on the company’s business. The call can be accessed by dialing (866) 688-0947 (domestic) or (409) 217-8781 (international) and refer to the conference ID 4647559. A telephonic replay of the conference call will be available beginning approximately four hours after the call through May 20, 2021 and may be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international). The replay conference ID is 4647559. The webcast replay will be available for two weeks.

Given the circumstances globally, it is recommended to dial-in at most 15 to 20 minutes prior to the call start to reduce waiting times. If a participant will be listen-only, they are encouraged to listen via the webcast on Twist’s investor page.

Castle Biosciences Recognized for Skin Cancer Diagnostics Innovation in 2021 MedTech Breakthrough Awards Program

On May 6, 2021 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported that it has been selected as the winner of the "Best New Technology Solution for Oncology" award in the fifth annual MedTech Breakthrough Awards program (Press release, Castle Biosciences, MAY 6, 2021, View Source [SID1234579407]). The award recognizes Castle’s DecisionDx-SCC and DecisionDx DiffDx-Melanoma genomic tests, both newly launched in the second half of 2020.

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Castle Biosciences develops and commercializes diagnostic and prognostic tests for dermatologic cancers. The Company’s tests are designed to provide clinically actionable, tumor-specific genomic information to enable more accurate skin cancer treatment plan decisions. Castle believes that the traditional approach to developing a treatment plan for dermatologic cancers using clinical and pathology factors alone can be improved by incorporating personalized genomic information.

In 2020, Castle launched two new genomic tests designed to improve the management of skin cancer, DecisionDx-SCC and DecisionDx DiffDx-Melanoma. DecisionDx-SCC is the Company’s proprietary gene expression profile (GEP) test that is designed to predict the risk of metastasis for patients with cutaneous squamous cell carcinoma who have one or more risk factors. DecisionDx DiffDx-Melanoma is designed to provide a highly accurate, objective result to aid dermatopathologists and dermatologists in characterizing suspicious pigmented lesions. Castle believes these two recently launched tests complement Castle’s GEP test for invasive cutaneous melanoma, DecisionDx-Melanoma, which is a proprietary GEP test that uses an individual patient’s tumor biology to predict risk of cutaneous melanoma metastasis or recurrence, as well as sentinel lymph node positivity independent of traditional staging factors.

The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the innovation, hard work and success in a range of health and medical technology categories, including Robotics, Clinical Administration, Telehealth, Patient Engagement, Electronic Health Records (EHR), mHealth, Medical Devices, Medical Data and many more. This year’s program attracted more than 3,850 nominations from over 17 different countries throughout the world.

"Skin cancers continue to be the most commonly diagnosed cancers, with around 5.5 million new cases diagnosed annually in the U.S., and Castle is addressing this challenge head-on," said James Johnson, managing director, MedTech Breakthrough. "When individualized genomic information is incorporated with traditional clinical and pathology factors used to assess risk, physicians and patients can make more informed treatment decisions, in line with each patient’s risk. Castle is driving innovation in this space, and we are thrilled to recognize Castle in our 2021 MedTech Breakthrough Awards program."

"The approach that physicians traditionally use to determine risk–reviewing clinical and pathological factors like patient history and pathology lab results— is necessary and lifesaving. But adding personalized, precise genomic information to predict the likelihood of any individual’s skin cancer’s future spread or return, or for aiding clinicians with difficult-to-diagnose potential melanoma cases, has the potential to improve patient care," said Derek Maetzold, president and chief executive officer at Castle Biosciences. "We developed DecisionDx-SCC and DecisionDx DiffDx-Melanoma to answer this significant unmet medical need in skin cancer management, and we are thrilled to receive this 2021 MedTech Breakthrough Award in recognition of our innovation in this breakthrough approach and technology to support it."