On May 5, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company focused on helping conquer cancer globally through use of its proprietary tests, vast data sets and advanced analytics, reported financial results for the quarter ended March 31, 2022 (Press release, Guardant Health, MAY 5, 2022, View Source [SID1234613717]).

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!

Recent Highlights

Revenue of $96.1 million for the first quarter of 2022, an increase of 22% over the corresponding period of 2021
Reported 27,100 tests to clinical customers and 5,100 tests to biopharmaceutical customers in the first quarter of 2022, representing an increase of 47% and 45%, respectively, over the first quarter of 2021
Launched Shield as a Laboratory Developed Test (LDT) test, the Company’s first blood-based test for detection of early-stage colorectal cancer
Announced a partnership with Epic, a widely used comprehensive health record system in the United States, making the Company’s broad portfolio of cancer tests available to over 250 million patients with a record in Epic
Received regulatory approval for Guardant360 CDx in Japan for use in patients with advanced solid cancers as well as a companion diagnostic to identify patients with microsatellite instability-high, or MSI-High, solid tumors who may benefit from Keytruda and patients with MSI-High advanced colorectal cancer who may benefit from Opdivo
Received Medicare coverage for Guardant360 TissueNext test under the Molecular Diagnostics Services program (MolDX) LCD
"We delivered strong clinical volume growth this quarter and I am proud of our team’s work to establish Guardant as the leader in liquid biopsy through our high-performance testing portfolio and excellent customer service," said Helmy Eltoukhy, co-founder and co-CEO. "We now have more than 11,000 ordering oncologists and are seeing our core base of customers ordering more tests and using more Guardant products each quarter. Fueled by the launch of our most recent products, we are continuing to blaze a trail forward and help patients across all stages of cancer live longer and healthier lives with the data provided from our powerful blood tests."

"The recent launch of our Shield LDT screening test represents a major milestone in our commitment to transform cancer screening," said AmirAli Talasaz, co-founder and co-CEO. "If the ECLIPSE readout is close to our LDT validation performance, we are confident that Shield will become the leading non-invasive CRC screening methodology. Colorectal cancer screening is the start of this journey. We will soon expand into high-sensitivity multi-cancer screening, including lung and pancreas, where we believe cancer screening can save lives."

First Quarter 2022 Financial Results

Revenue was $96.1 million for the three months ended March 31, 2022, a 22% increase from $78.7 million for the three months ended March 31, 2021. Precision oncology revenue grew 32% driven predominantly by an increase in clinical testing volume and biopharma sample volume, which grew 47% and 45%, respectively, over the prior year period. Development services and other revenue decreased 20%, primarily due to the progression of collaboration projects with biopharmaceutical customers for companion diagnostic development and regulatory approval services, and discontinuation of our Guardant-19 COVID tests in August 2021, partially offset by royalty revenues earned during the three months ended March 31, 2022.

Gross profit, or total revenue less cost of precision oncology testing and cost of development services and other, was $64.1 million for the first quarter of 2022, an increase of $14.2 million from $49.9 million for the corresponding prior year period. Gross margin, or gross profit divided by total revenue, was 67%, as compared to 63% for the corresponding prior year period.

Operating expenses were $187.5 million for the first quarter of 2022, as compared to $157.8 million for the corresponding prior year period, an increase of 19%. Non-GAAP operating expenses were $158.7 million for the first quarter of 2022, as compared to $100.7 million for the corresponding prior year period.

Net loss attributable to Guardant Health, Inc. common stockholders was $123.2 million for the first quarter of 2022, as compared to $109.7 million for the corresponding prior year period. Net loss per share attributable to Guardant Health, Inc. common stockholders was $1.21 for the first quarter of 2022, as compared to $1.09 for the corresponding prior year period. Non-GAAP net loss was $93.2 million for the first quarter of 2022, as compared to $49.4 million for the corresponding prior year period. Non-GAAP net loss per share was $0.91 for the first quarter of 2022, as compared to $0.49 for the corresponding prior year period.

Adjusted EBITDA loss was $86.6 million for the first quarter of 2022, as compared to a $45.4 million loss for the corresponding prior year period.

Cash, cash equivalents and marketable securities were $1.6 billion as of March 31, 2022.

2022 Guidance

Guardant Health continues to expect full year 2022 revenue to be in the range of $460 million to $470 million, representing 23% to 26% growth over full year 2021.

Webcast Information

Guardant Health will host a conference call to discuss the first quarter 2022 financial results after market close on Wednesday, May 5, 2022 at 1:30 pm Pacific Time / 4:30 pm Eastern Time. A webcast of the conference call can be accessed at View Source The webcast will be archived and available for replay for at least 90 days after the event.

Non-GAAP Measures

Guardant Health has presented in this release certain financial information in accordance with U.S. Generally Accepted Accounting Principles (GAAP) and also on a non-GAAP basis, including non-GAAP cost of precision oncology testing, non-GAAP research and development expense, non-GAAP sales and marketing expense, non-GAAP general and administrative expense, non-GAAP loss from operations, non-GAAP net loss, non-GAAP net loss attributable to Guardant Health, Inc., common stockholders, non-GAAP net loss per share attributable to Guardant Health, Inc. common stockholders, basic and diluted, and Adjusted EBITDA.

We define our non-GAAP measures as the applicable GAAP measure adjusted for the impacts of stock-based compensation and related employer payroll tax payments, changes in estimated fair value of redeemable noncontrolling interest, contingent consideration, acquisition related expenses, amortization of intangible assets, and other non-recurring items.

Adjusted EBITDA is defined as net loss attributable to Guardant Health, Inc. common stockholders adjusted for interest income, interest expense, other income (expense), net, provision for (benefit from) income taxes, depreciation and amortization expense, stock-based compensation expense and related employer payroll tax payments, adjustments relating to redeemable noncontrolling interest and contingent consideration and, if applicable in a reporting period, acquisition-related expenses and other non-recurring items.

We believe that the exclusion of certain income and expenses in calculating these non-GAAP financial measures can provide a useful measure for investors when comparing our period-to-period core operating results, and when comparing those same results to that published by our peers. We exclude certain other items because we believe that these income (expenses) do not reflect expected future operating expenses. Additionally, certain items are inconsistent in amounts and frequency, making it difficult to perform a meaningful evaluation of our current or past operating performance. We use these non-GAAP financial measures to evaluate ongoing operations, for internal planning and forecasting purposes, and to manage our business.

These non-GAAP financial measures are not intended to be considered in isolation from, as substitute for, or as superior to, the corresponding financial measures prepared in accordance with GAAP. There are limitations inherent in non-GAAP financial measures because they exclude charges and credits that are required to be included in a GAAP presentation, and do not present the full measure of our recorded costs against its revenue. In addition, our definition of the non-GAAP financial measures may differ from non-GAAP measures used by other companies.

On May 5, 2022 NantHealth, Inc. (NASDAQ-GS: NH), a leading provider of enterprise solutions that help businesses transform complex data into actionable insights, reported financial results for its first quarter ended March 31, 2022 (Press release, NantHealth, MAY 5, 2022, View Source [SID1234613716]).

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 pleased to start the year with positive momentum, with our 2022 first quarter revenue increasing over the previous quarter," said Ron Louks, Chief Operating Officer, NantHealth.

"To help drive further growth, we continue to invest in the development of our products and services, including the expansion of our cloud and data analytics capabilities. These investments are delivering results in multiple ways, including the launch of several new applications on our new cloud platform. Eviti Connect expansion continued with Autoimmune Diseases and our NantHealth Partner Portal which added on-demand customer access to interactive reporting. We are also seeing continued interest in our data enrichment services, as well as pilot programs for The OpenNMS Group Inc.’s cloud services."

Software and Services Q1 Highlights:

Clinical Decision Support (Eviti):
Signed a multi-year renewal with a leading nonprofit, multi-state health plan serving government sponsored programs. The agreement significantly expands the scope of Eviti Connect for Oncology services provided to the plan, including the addition of full delegation services and evidence-based radiation oncology care
Expanded full delegation capabilities to include radiation oncology services in addition to medical oncology, enabling customers to assign prior authorization decisions to NantHealth
New functionality that allows health plan customers to approve and assign a prior authorization Eviti code to portions of a treatment plan, eliminating the need for complete plan resubmission and speeding up treatment to patients
Payer Engagement (NaviNet):
Received HITRUST certification, a highly stringent benchmark that ensures NantHealth continues to meet key regulations and industry-defined security requirements. This places NantHealth and NaviNet Open in an elite group of organizations worldwide that have earned this status for information security
In May 2022, won the MedTech Breakthrough "Healthcare Insurance Innovation Award," recognized for the platform’s innovative ability to break through digital health and technology markets
Enhanced NaviNet Open Authorizations with new processes for automating the collection of additional procedure code modifiers and reducing the need for manual follow-up by the health plan
Network Monitoring and Management (The OpenNMS Group, Inc.):
Released OpenNMS Meridian 2022, the optimized and hardened version of the OpenNMS platform available to annual maintenance subscribers for use in production environments. Meridian 2022 features enhanced security, improved analytics for NetFlow processing, simplified Minion communication and enhanced geolocation with IP addresses
Signed several new professional services agreements with customers using the Horizon and Meridian versions of the OpenNMS platform. This work in collaboration with customers helps to improve the extensibility, reliability, and scalability of the platform for the entire user community
Completed global delivery of 1U hardware appliances, expanding the existing hardware appliance beta program with a large consumer electronics retailer
First Quarter Financial Results: 2022 vs 2021

For the 2022 first quarter:

Total net revenue was $16.4 million compared with $16.2 million.
Gross profit was $9.2 million, or 56% of total net revenue, compared with $9.1 million, or 56% of total net revenue.
Selling, general and administrative (SG&A) expenses increased to $15.0 million from $12.5 million.
Research and development (R&D) expenses increased to $5.7 million from $5.0 million.
Net loss from continuing operations, net of tax, was $16.0 million, or $0.14 per share, compared with $15.4 million, or $0.14 per share.
On a non-GAAP basis, net loss from continuing operations was $12.2 million, or $0.11 per share, compared with $9.6 million, or $0.09 per share.
At March 31, 2022, cash and cash equivalents totaled $16.1 million.
Conference Call Information and Forward-Looking Statements

Later today, the company will host a conference call at 1:30 p.m. PT (4:30 p.m. ET) to review its results of operations for the first quarter ended March 31, 2022. The conference call will be available to interested parties by dialing 800-920-5526 from the U.S. or Canada, or 212-231-2907 from international locations. The call will be broadcast via the Internet at www.nanthealth.com. Listeners are encouraged to visit the website at least 10 minutes prior to the start of the scheduled presentation to register, download and install any necessary audio software. A playback of the call will be archived and accessible on the same website for at least three months.

Discussion during the conference call may include forward-looking statements regarding topics such as the company’s financial status and performance, regulatory and operational developments, and other comments the company may make about its future plans or prospects in response to questions from participants on the conference call.

Use of Non-GAAP Financial Measures

This news release contains references to Non-GAAP financial measures, including adjusted net loss and adjusted net loss per share, which are financial measures that are not prepared in conformity with United States generally accepted accounting principles (U.S. GAAP). The Company’s management believes that the presentation of Non-GAAP financial measures provides useful supplementary information regarding operational performance, because it enhances an investor’s overall understanding of the financial results for the Company’s core business. Additionally, it provides a basis for the comparison of the financial results for the Company’s core business between current, past and future periods. Other companies may define these measures in different ways. Non-GAAP financial measures should be considered only as a supplement to, and not as a substitute for or as a superior measure to, financial measures prepared in accordance with U.S. GAAP. Non-GAAP per share numbers are calculated based on one class of common stock and do not incorporate the effects, if any, of using the two-class method.

On May 5, 2022 Repare Therapeutics Inc. ("Repare" or the "Company") (Nasdaq: RPTX), a leading clinical-stage precision oncology company, reported financial results for the first quarter ended March 31, 2022 (Press release, Repare Therapeutics, MAY 5, 2022, View Source [SID1234613715]).

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!

"The first quarter was marked by significant progress in our RP-3500 program, including the comprehensive new dataset from the TRESR trial which was part of the featured oral presentation at the AACR (Free AACR Whitepaper) conference this year, and that the United States Adopted Names (USAN) council has adopted ‘camonsertib’ as the nonproprietary (generic) name in the United States, and the International Nonproprietary Names (INN) council has accepted ‘camonsertib’ as proposed INN for RP-3500," said Lloyd M. Segal, President and Chief Executive Officer of Repare. "The findings continue to demonstrate camonsertib’s promising clinical benefit given as monotherapy in patients with solid tumors with multiple genotypes and potential best-in-class safety and tolerability profile for ATR inhibitors. Beyond ATM, encouraging data in other genotypes suggest further validation of our STEP2 platform to identify other synthetic lethalities as we expand TRESR and develop our pipeline of synthetic lethal candidates. We look forward to providing updates on the potential of camonsertib as monotherapy and initial data of camonsertib in combination with PARP inhibitors or gemcitabine expected in the second half of this year."

First Quarter 2022 Review and Operational Updates:

Announced updated clinical data from the ongoing Phase 1/2 TRESR (Treatment Enabled by SNIPRx) clinical trial of camonsertib, a potent and selective oral small molecule inhibitor of ATR (Ataxia-Telangiectasia and Rad3-related protein kinase) for the treatment of solid tumors with specific synthetic-lethal genomic alterations including those in the ATM gene (Ataxia-Telangiectasia mutated kinase) at the 2022 AACR (Free AACR Whitepaper) Annual Meeting.
Updated data showed camonsertib monotherapy continues to appear safe and well tolerated. Expectedly, Grade 1-2 anemia was the most common treatment-related adverse event and was well controlled in patients. Only 24.2% of all patients in the 3 days on 4 days off schedule experienced Grade 3 anemia, and none experienced Grade 4 anemia.

Camonsertib monotherapy resulted in durable clinical benefit across tumor types and genomic alterations. Overall clinical benefit rate (CBR) for all patients was 43%, and 47% in patients after PARP inhibitor (PARPi) failure.

Promising results were observed particularly in patients with advanced ovarian cancer (n = 20). 90% of evaluated patients had prior PARPi failure, and 85% of evaluated patients were platinum resistant. In these patients, overall response (OR) was 25%, including one complete response (CR), three partial responses (PR) as determined by RECIST 1.1 criteria, and one durable and ongoing CA125 response. CBR was 75% and median progression-free survival (mPFS) was 35 weeks.

Clinical benefit was also observed in patients with tumors harboring BRCA1 and BRCA2 genomic alterations, as predicted by SNIPRx. In patients with BRCA1/2 mutated tumors (n = 37), ORR was 14% and included two patients with ovarian cancer, and one each with breast cancer, head and neck squamous cell carcinoma, and melanoma. CBR was 43% with a mPFS of 15 weeks in the BRCA1/2 population; in patients specifically with BRCA1 mutations, the CBR was 48%.

In patients with ATM loss-of-function (LOF) tumors (n = 34), ORR was 9% including one RECIST 1.1 confirmed/unconfirmed response, and two prostate specific antigen (cPSA) responses. CBR in patients with ATM LOF was 44%, with mPFS of 17 weeks.

New sequencing data demonstrated biallelic gene LOF, an emerging biomarker for synthetic lethal therapies, can potentially be leveraged to further enrich for patients most likely to benefit from camonsertib. CBR in patients with biallelic LOF was significantly higher (47%) compared to the CBR in patients with non-biallelic tumors (15%).

A poster presentation, titled "Circulating tumor DNA (ctDNA) determinants of improved outcomes in patients (pts) with advanced solid tumors receiving the ataxia telangiectasia and Rad3-related inhibitor (ATRi), RP-3500, in the phase 1/2a TRESR trial (NCT04497116)" (abstract #367586) will be presented at the 2022 ASCO (Free ASCO Whitepaper) Annual meeting in June.

Announced camonsertib dose selection Phase 1 monotherapy safety data from the Phase 1/2 TRESR Trial at the 2022 ESMO (Free ESMO Whitepaper) Targeted Anticancer Therapies Congress
This comprehensive safety analysis from three monotherapy dosing schedules of camonsertib at therapeutic doses confirmed the acceptable tolerability of the recommended phase 2 dose (160mg 3 days on/4 days off).

Anemia was the most common reported toxicity with less than 25% of patients experiencing grade 3 toxicities.

A dose modification plan that includes 2 alternative dosing schedules was established to mitigate the on-target toxicity of anemia and maintain patients on a camonsertib dosing schedule that targets antitumor activity.

A nomogram, based on cycle 1 assessment of toxicities, is being prospectively evaluated to identify patients at increased risk of anemia and inform early intervention.

Announced publication of preclinical data in Nature demonstrating the potential of PKMYT1 inhibitor RP-6306 in tumors with CCNE1 amplification
In April 2022, the Company announced that preclinical data demonstrating inhibition of CCNE1-amplified tumor growth in vivo by selective inhibition of PKMYT1 using RP-6306, a first-in-class small molecule candidate targeting PKMYT1, were published in Nature.

SNIPRx, the Company’s proprietary, genome-wide, CRISPR-based screening approach, was used to uncover CCNE1 amplification as synthetic lethal to PKMYT1 inhibition. Data show PKMYT1 inhibition is a promising therapeutic target in CCNE1-amplified cancers.

Phase 1 clinical trials are currently evaluating RP-6306 as a monotherapy (MYTHIC) as well as in combination with gemcitabine (MAGNETIC) for the treatment of molecularly selected advanced solid tumors. The Company recently initiated an additional Phase 1 (MINOTAUR) clinical trial of RP-6306 in combination with FOLFIRI also for the treatment of molecularly selected advanced solid tumors.

Initiated patient enrollment in a new arm of its Phase 1 MYTHIC clinical trial designed to evaluate the safety and tolerability of RP-6306 in combination with camonsertib in patients with advanced solid tumors.
Appointed Philip Herman to Executive Leadership Team as EVP, Commercial & New Product Development
In January 2022, the Company appointed Philip Herman as EVP, Commercial & New Product Development. Mr. Herman was most recently Chief Commercial Officer of Y-mAbs Therapeutics and led the successful launch of DANYELZA (naxitamab).
First Quarter 2022 Financial Results:

Cash and cash equivalents and marketable securities: Cash and cash equivalents and marketable securities as of March 31, 2022 were $311.7 million.
Research and development expenses, net of tax credits (Net R&D): Net R&D expenses were $26.5 million and $16.5 million for the three months ended March 31, 2022 and 2021, respectively. The year-over-year increase in Net R&D expenses was primarily due to direct external costs related to the Company’s camonsertib and RP-6306 programs, and personnel related expenses, including share-based compensation.
General and administrative (G&A) expenses: G&A expenses were $8.8 million and $5.2 million for three months ended March 31, 2022 and 2021, respectively. The year-over-year increase in G&A expenses was primarily due to personnel related costs, including share-based compensation, as we scale the organization, and professional fees related to the Company’s transition from emerging growth company and smaller reporting company status at the end of 2021.
Net loss: Net loss was $34.8 million, or $0.83 per share in the three months ended March 31, 2022, and $21.4 million, or $0.58 per share in the three months ended March 31, 2021.
About Repare Therapeutics’ SNIPRx Platform

Repare’s SNIPRx platform is a genome-wide CRISPR-based screening approach that utilizes proprietary isogenic cell lines to identify novel and known synthetic lethal gene pairs and the corresponding patients who are most likely to benefit from the Company’s therapies based on the genetic profile of their tumors. Repare’s platform enables the development of precision therapeutics in patients whose tumors contain one or more genomic alterations identified by SNIPRx screening, in order to selectively target those tumors in patients most likely to achieve clinical benefit from resulting product candidates.

On May 5, 2022 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that financial results for the first quarter ended March 31, 2022 (Press release, Puma Biotechnology, MAY 5, 2022, View Source [SID1234613714]). Unless otherwise stated, all comparisons are for the first quarter of 2022 compared to the first quarter of 2021.

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!

Product revenue, net consists entirely of revenue from sales of NERLYNX, Puma’s first commercial product. Product revenue, net in the first quarter of 2022 was $40.7 million, compared to product revenue, net of $45.8 million in the first quarter of 2021.

Based on accounting principles generally accepted in the United States (GAAP), Puma reported net loss of $3.4 million, or $0.08 per basic and diluted share, for the first quarter of 2022, compared to net income of $16.5 million, or $0.41 per basic share and $0.40 per diluted share, for the first quarter of 2021.

Non-GAAP adjusted net loss was $0.3 million, or $0.01 per basic and diluted share, for the first quarter of 2022, compared to non-GAAP adjusted net income of $22.4 million, or $0.56 per basic share and $0.55 per diluted share, for the first quarter of 2021. Non-GAAP adjusted net income excludes stock-based compensation expense. For a reconciliation of GAAP net income (loss) to non-GAAP adjusted net income (loss) and GAAP net income (loss) per share to non-GAAP adjusted net income (loss) per share, please see the financial tables at the end of this news release.

Net cash used in operating activities for the first quarter of 2022 was $26.9 million, compared to $15.7 million provided by operating activities in the first quarter of 2021. At March 31, 2022, Puma had cash, cash equivalents and marketable securities of $73.9 million, compared to cash, cash equivalents and marketable securities of $82.1 million at December 31, 2021.

"2021 was an important year for Puma as we made operational changes to maximize the efficiency of the Puma team and the environment with which we operate," said Alan H. Auerbach, Chairman, Chief Executive Officer and President of Puma. "We remain committed to increasing awareness of and access to NERLYNX as an option to reduce the risk of recurrence for patients battling HER2-positive breast cancer; the inclusion of NERLYNX in the updated NCCN guidelines is an important step to expanding the awareness and utilization of neratinib for high-risk patients."

Mr. Auerbach added, "We anticipate the following key milestones over the next 12 months: (i) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in HER2-mutated HR-positive breast cancer (H1 2022); (ii) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in HER2-mutated biliary tract cancer (H1 2022); (iii) reporting Phase II data from the cohort of patients in the SUMMIT basket trial of neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations (H2 2022); (iv) conducting a pre-NDA meeting with the FDA to discuss the potential for an accelerated approval pathway of neratinib in HER2-mutated HR-positive breast cancer (H2 2022); (v) conducting a meeting with the FDA to discuss the potential for an accelerated approval pathway for neratinib in non-small cell lung cancer patients with EGFR exon 18 mutations who have previously been treated with an EGFR tyrosine kinase inhibitor (2022); (vi) reporting Phase II TBCRC-022 trial data from Cohort 4B and 4C of the combination of Kadcyla plus neratinib in patients with HER2-positive breast cancer with brain metastases who have previously been treated with Kadcyla (H2 2022); and (vii) reporting Phase II data from the SUMMIT trial of neratinib in cervical cancer patients with HER2 mutations (H2 2022)."

Revenue

Total revenue consists of product revenue, net from sales of NERLYNX, Puma’s first commercial product, license revenue from Puma’s sub-licensees and royalty revenue. For the first quarter ended March 31, 2022, total revenue was $45.7 million, of which $40.7 million was net product revenue and $5.0 million was royalty revenue. This compares to total revenue of $98.2 million in the first quarter of 2021, of which $45.8 million was net product revenue, $50.0 million was license revenue and $2.4 million was royalty revenue.

Operating Costs and Expenses

Total operating costs and expenses were $46.4 million for the first quarter of 2022, compared to $78.0 million for the first quarter of 2021.

Cost of Sales

Cost of sales was $10.8 million for the first quarter of 2022, compared to $29.6 million for the first quarter of 2021. Cost of sales in the first quarter of 2021 included $20.0 million for a termination fee paid to a former sub-licensee for the return of commercial rights to NERLYNX in Greater China, partially offset by higher royalties due on increased non-U.S partner sales.

Selling, General and Administrative Expenses

Selling, general and administrative expenses were $20.4 million for the first quarter of 2022, compared to $28.2 million for the first quarter of 2021. The $7.8 million decrease resulted primarily from decreases of approximately $3.1 million in professional fees and expenses, primarily related to a decrease in consulting costs for marketing and commercialization support; $2.9 million in payroll and related costs due to reduced headcount; and $1.4 million in stock-based compensation also due to reduced headcount.

Research and Development Expenses

Research and development expenses were $15.2 million for the first quarter of 2022, compared to $20.2 million for the first quarter of 2021. The $5.0 million decrease resulted primarily from decreases of $2.5 million in internal R&D costs related primarily to reduced payroll costs; $1.3 million in stock-based compensation due to the impact of headcount reductions in 2021; $0.7 million in consultants and contractors due to the close of the CONTROL study and the winding down of the SUMMIT study; and $0.5 million in clinical trial expenses due to reduced study costs as noted above.

Total Other Income (Expenses)

Total other expenses were $2.7 million for the first quarter of 2022, compared to total other expenses of $3.7 million for the first quarter of 2021. The $1.0 million decrease in other expenses resulted primarily from lower interest expense on the milestone installment payments to Pfizer as well as lower costs related to our outstanding debt.

Conference Call

Puma Biotechnology will host a conference call to report its first quarter 2022 financial results and provide an update on the Company’s business and outlook at 1:30 p.m. PDT/4:30 p.m. EDT on Thursday, May 5, 2022. The call may be accessed by dialing (866) 682-6100 (domestic) or (862) 298-0702 (international). Please dial in at least 10 minutes in advance and inform the operator that you would like to join the "Puma Biotechnology Conference Call." A live webcast of the conference call and presentation slides may be accessed on the Investors section of the Puma Biotechnology website at View Source A replay of the call will be available approximately one hour after completion of the call and will be archived on Puma’s website for 90 days.

On May 5, 2022 -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 2022 ended March 31, 2022 (Press release, Twist Bioscience, MAY 5, 2022, View Source [SID1234613713]).

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’re building momentum through the first half of fiscal 2022, with another consecutive quarter of record revenue and orders," said Emily M. Leproust, Ph.D., CEO and co-founder of Twist Bioscience. "We continued to deliver a wide range of products to our customers through the Omicron surge, while bolstering our balance sheet to reduce downside risk in this unpredictable market."

"Twist Biopharma added 5 new partnerships and 15 programs, with Twist Boston (Abveris) actively working on 81 programs today. For data storage, we are building important relationships with key industry associations and are debugging our integrated CMOS chip for production capacity now, both critical for the introduction of our storage solutions," continued Dr. Leproust.

"We remain committed to managing our cash burn in our drive toward adjusted EBITDA break even for the core business, which we expect to occur when we reach $300 million in revenue for SynBio and NGS," added Jim Thorburn, CFO of Twist.

FISCAL 2022 SECOND QUARTER FINANCIAL RESULTS

Orders: Total orders received for the second quarter of fiscal 2022 were $55.0 million compared to $41.7 million for the same period of fiscal 2021.
Revenue: Total revenues for the second quarter of fiscal 2022 were $48.1 million compared to $31.2 million for the same period of fiscal 2021.
Cost of Revenues: Cost of revenues for the second quarter of fiscal 2022 was $29.7 million compared to $19.0 million for the same period of fiscal 2021.
Research and Development Expenses: Research and development expenses for the second quarter of fiscal 2022 were $31.2 million compared to $15.8 million for the same period of fiscal 2021.
Selling, General and Administrative Expenses: Selling, general and administrative expenses for the second quarter of fiscal 2022 were $54.0 million compared to $34.4 million for the same period of fiscal 2021.
Net Loss: Net loss attributable to common stockholders for the second quarter of fiscal 2022 was $60.7 million, or $1.13 per share, compared to $37.9 million, or $0.78 per share, for the same period of fiscal 2021.
Cash Position: As of March 31, 2022, the company had $604.4 million in cash, cash equivalents and investments.
Recent Highlights:

SynBio and NGS

Shipped products to approximately 2,000 customers in the second quarter of fiscal 2022, versus approximately 1,700 in the second quarter of fiscal 2021.
Shipped approximately 124,000 genes during the second quarter of fiscal 2022, compared with approximately 90,000 in the second quarter of fiscal 2021.
Entered into four-year supply agreement with Ginkgo Bioworks, which includes a $58 million minimum in all product purchases over the lifetime of the contract with Ginkgo having the option to access significantly more products from Twist.
Launched Twist High Throughput Antibody Production, a gene-to-antibody production platform that enables customers to turn digital DNA sequences into purified IgG antibodies for therapeutic discovery and screening applications.
Launched encapsulated synthetic RNA positive controls for SARS-CoV-2 that can be shipped and stored at room temperature to enable Twist to serve customers in regions that do not have an effective cold chain system or easy access to ultra-cold storage and may also allow the use of the controls in point of care settings.
Partnered with C2i Genomics to develop whole-genome cancer reference materials to be used to provide diagnostic labs with the ability to better validate and monitor the quality of whole-genome cancer screening and minimal residual disease (MRD) products.
Created a replicon tool with Eleven Therapeutics to be used to study viral genome replication and antiviral drug screening for SARS-CoV-2 as well as vaccine and therapeutic development.
BioPharma and DNA Data Storage

Signed an agreement with Kriya to discover and optimize novel antibodies to be used with Kriya’s gene therapy technology platform in oncology applications.
Signed a collaboration with MediSix Therapeutics to discover novel antibodies to be developed as T-cell therapies.
Announced that the DNA Data Storage Alliance, of which Twist is a founding member, has grown to more than 50 members.
Joined the Storage Networking Industry Association (SNIA) as a voting member.
Became a part of the Digital Preservation Coalition’s (DPC) Supporter Program.
Corporate

Raised $269.8 million in net proceeds in an upsized underwritten public offering of common stock.
Updated Fiscal 2022 Financial Guidance

The following statements are based on Twist’s current expectations for fiscal 2022. 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.

For the full fiscal year 2022, Twist provided the following updated financial guidance:

Revenue is now expected to be in the range of $191 million – $199 million
SynBio revenue including Ginkgo Bioworks is expected to be in the range of $71 million to $73 million
NGS revenue is estimated to be in the range of $94 million to $96 million
Biopharma revenue is estimated to be approximately $26 million to $30 million
Gross margin is expected to be 37% for fiscal 2022 which reflects the impact of expected costs associated with ramping our Wilsonville, Oregon "Factory of the Future" facility to bring it online; excluding these expected costs, gross margin would be 42% to 44%
Operating expenses including R&D and SG&A are expected to be approximately $335 million for the year
Net loss is expected to be approximately $260 to $265 million, reflecting the impact of the Abveris acquisition in stock-based compensation and includes:
R&D is expected to be approximately $130 million
Approximately $40 million for DNA data storage
Stock-based compensation is expected to be approximately $85 million
Depreciation is expected to be $13 million
Capital expenditures are expected to be $90-$100 million, including building out the "Factory of the Future"
Conference Call Information

The company plans to hold a conference call and live audio webcast for analysts and investors at 4:30 p.m. Eastern Time today 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 7377195. A telephonic replay of the conference call will be available beginning approximately four hours after the call through May 12, 2022 and may be accessed by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international). The replay conference ID is 7377195. The webcast replay will be available for two weeks. If a participant will be listen-only, they are encouraged to listen via the webcast on Twist’s investor page.