On May 3, 2023 Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, reported financial results for the first quarter ended March 31, 2023 and provided recent business highlights (Press release, Personalis, MAY 3, 2023, View Source [SID1234630938]).

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Recent Business Updates

•
Announced a collaboration with Cancer Research UK, University College London, and the Francis Crick Institute to utilize our ultra-sensitive NeXT Personal tumor-informed liquid biopsy assay for the TRACERx study, a groundbreaking lung cancer initiative, to identify and track minimal residual disease (MRD) potentially before recurrence is detected through standard of care technologies

•
Presented new data to highlight NeXT Personal’s unparalleled sensitivity in four posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, including initial findings from research with University Medical Center Hamburg-Eppendorf (UKE), which showed that NeXT Personal may improve the ability to predict responses or resistance to immunotherapy earlier than imaging

•
Extended partnership with AstraZeneca to use NeXT Personal to explore ultra-sensitive MRD measurement, including clinically relevant and personalized variant tracking, for clinical research and drug development

•
Partnered with Criterium and the Academic Breast Cancer Consortium (ABRCC) to conduct a prospective clinical trial to validate the clinical performance of the NeXT Personal assay to evaluate MRD and subsequent recurrence in patients with early-stage, resectable triple negative breast cancer (TNBC)

•
Appointed Chris Hall as Chief Executive Officer (CEO) and a member of the Board, in addition to his role as President; promoted Aaron Tachibana to Chief Operating Officer (COO), in addition to his role as Chief Financial Officer (CFO); and promoted Richard Chen to Executive Vice President, Chief Medical Officer (CMO) and R&D

"We grew revenue 24% in the first quarter relative to the first quarter of last year, demonstrating consistent execution against our sharpened strategic focus in both our clinical and biopharma businesses," said Chris Hall, President and CEO of Personalis. "We are continuing to pursue revenue growth in three areas: winning in the MRD space, enabling customers to develop personalized cancer vaccines, and supporting biopharmaceutical customers with their clinical trials. This focus paves the way for us to enter into the clinical diagnostics market this year and become a critical partner in cancer recurrence monitoring and detection."

First Quarter Financial Highlights

•
Reported total company revenue of $18.9 million for the first quarter of 2023, representing a 24% increase compared with $15.2 million for the first quarter of 2022

o
Revenue from pharma tests, enterprise, and other customers of $15.9 million in the first quarter of 2023, representing a 35% increase compared with $11.7 million in the first quarter of 2022; revenue from enterprise customers includes revenue from Natera of $9.5 million in the first quarter of 2023

o
Revenue from population sequencing for the U.S. Department of Veterans Affairs Million Veterans Program (VA MVP) of $3.0 million in the first quarter of 2023, compared with $3.5 million in the first quarter of 2022

•
Cash, cash equivalents, and short-term investments of $148.9 million as of March 31, 2023

•
Net loss of $28.7 million, and net loss per share of $0.61 based on a weighted-average basic and diluted share count of 46.7 million in the first quarter of 2023

Second Quarter and Full Year 2023 Outlook

Personalis expects the following for the second quarter of 2023:

•
Total company revenue of $16 million to $17 million
•
Revenue from pharma tests, enterprise sales, and other customers of $13 million to $14 million
•
Revenue from population sequencing of approximately $3 million

Personalis expects the following for the full year of 2023:

•
Total company revenue in the range of $68 million to $72 million
•
Revenue from pharma tests, enterprise sales, and all other customers in the range of $59 million to $63 million
•
Revenue from population sequencing of approximately $9 million
•
Net loss of approximately $103 million, reduced from $113 million in 2022 due to realization of headcount reduction savings, partially offset by investments in clinical evidence generation and non-cash depreciation expense for the new facility
•
Cash usage of approximately $75 million, reduced from $119 million in 2022

Webcast and Conference Call Information

Personalis will host a conference call to discuss the first quarter financial results after market close on Wednesday, May 3, 2023 at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call can be accessed live by dialing 877-451-6152 for domestic callers or 201-389-0879 for international callers.The live webinar can be accessed at View Source A replay of the webinar will be available shortly after the conclusion of the call and will be archived on the company’s website.

On May 3, 2023 OPKO Health, Inc. (NASDAQ: OPK) reported business highlights and financial results for the three months ended March 31, 2023 (Press release, Opko Health, MAY 3, 2023, View Source [SID1234630936]).

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First quarter business highlights include the following:

OPKO Health’s ModeX Therapeutics, Inc. (ModeX) entered into an exclusive worldwide license and collaboration agreement with Merck to develop MDX-2201 for Epstein-Barr virus. Under the terms of the agreement, OPKO received a $50.0 million upfront payment and is eligible to receive up to an additional $872.5 million upon the achievement of prespecified development and commercial milestones. In addition, upon commercial launch of MDX-2201, OPKO is eligible to receive royalties on global net sales. Merck will be responsible for clinical and regulatory costs and activities, as well as product commercialization.

Sales are underway by Pfizer for NGENLA (somatrogon) in 17 countries including Japan, Germany and the United Kingdom; NGENLA has been approved in 41 countries and Pfizer continues to work with the FDA to obtain approval in the U.S. NGENLA treats pediatric patients with decreased growth due to insufficient growth hormone and reduces the injection frequency from once daily to once weekly. NGENLA is the first once-weekly product approved for the treatment of pediatric growth hormone deficiency in Japan, Canada, Australia, the United Kingdom, Taiwan, United Arab Emirates and Brazil, and was recently approved in Korea and Turkey. Its European Union marketing authorization is valid in all EU Member States, as well as in Iceland, Norway and Liechtenstein. Pfizer expects to launch in all priority international markets by year-end.

BioReference Health is one of the first commercial laboratories to offer a dual-stain triage test to enhance cervical cancer screenings. The CINtec PLUS Cytology test from Roche Diagnostics is the only approved dual-stain triage test for patients who have a high-risk human papillomavirus result. The dual-stain biomarker test allows healthcare providers to assess a patient’s risk for cervical pre-cancer more accurately and quickly. BioReference is driving innovation to its portfolio with new tests to provide valuable information for healthcare providers and their patients.
First Quarter Financial Results

Pharmaceuticals: Revenue from products in the first quarter of 2023 increased to $40.4 million from $36.6 million in the first quarter of 2022, driven by sales in our international operating companies and an increase in sales of Rayaldee to $6.6 million from $5.1 million in the prior-year period. Revenue from the transfer of intellectual property was $64.8 million in the first quarter of 2023 compared with $6.0 million in the 2022 period. The increase in revenue from the transfer of intellectual property reflects a $50.0 million upfront payment from Merck, a $7.0 million milestone payment from Vifor Fresenius Medical Care Renal Pharma triggered by the German price approval related to Rayaldee and a $2.5 million milestone payment from Nicoya Therapeutics related to the submission of its investigational new drug application to China’s Center for Drug Evaluation for Rayaldee. Total costs and expenses were $86.3 million in the first quarter of 2023, up from $60.7 million in the prior-year period. The increase was mainly due to a $12.5 million payment to Sanofi that accrued under a Sanofi In-License Agreement between ModeX and Sanofi, and research expenses at ModeX, which was acquired in May 2022. Operating income was $19.0 million in the first quarter of 2023, compared with an operating loss of $18.1 million in the first quarter of 2022.

Diagnostics: Revenue from services in the first quarter of 2023 was $132.4 million compared with $286.6 million in the prior-year period. Revenue decreased due to lower COVID-19 testing volume. BioReference processed approximately 68,000 COVID-19 PCR tests in the first quarter of 2023, representing 4.8% of total volume, versus 2.0 million tests in the first quarter of 2022, representing 46.9% of total volume. Furthermore, revenue decreased by $36.1 million due to the sale of GeneDx in April 2022. Total costs and expenses were $172.4 million in the first quarter of 2023 compared with $330.1 million in the first quarter of 2022, resulting in an operating loss of $40.0 million compared with an operating loss of $43.5 million in the 2022 period, which included approximately $16.0 million from GeneDx. BioReference is implementing significant cost-reduction initiatives as it strives to return to profitability.

Consolidated: Consolidated total revenues for the first quarter of 2023 were $237.6 million compared with $329.2 million for the comparable period of 2022. Operating loss for the first quarter of 2023 decreased $41.8 million to $30.6 million from $72.4 million for the 2022 quarter. Net loss for the first quarter of 2023 was $18.3 million, or $0.02 per share, compared with a net loss of $55.4 million, or $0.08 per share, for the 2022 quarter. Net loss for the first quarter of 2023 included non-cash income of $8.3 million due to an increase in the fair value of OPKO’s GeneDx Holdings (formerly Sema4 Holdings Corp) investment and non-cash income of $8.5 million as a result of GeneDx Holdings achieving specific revenue targets for the 2022 fiscal year.

Cash and cash equivalents: Cash and cash equivalents were $110.8 million as of March 31, 2023, which does not include the $50 million upfront payment from Merck that was received in April 2023.
Conference Call and Webcast Information

OPKO’s senior management will provide a business update, discuss first quarter financial results, provide financial guidance and answer questions during a conference call and live audio webcast today beginning at 4:30 p.m. Eastern time. Participants are encouraged to pre-register for the conference call here. Callers who pre-register will receive a unique PIN to gain immediate access to the call and bypass the live operator. Participants may register at any time, including up to and after the call start time. Those unable to pre-register may participate by dialing 833-630-0584 (U.S.) or 412-317-1815 (International). A webcast of the call can also be accessed at OPKO’s Investor Relations page and here.

A telephone replay will be available until May 10, 2023 by dialing 877-344-7529 (U.S.) or 412-317-0088 (International) and providing the passcode 4576780. A webcast replay will be available beginning approximately one hour after the completion of the live conference call here.

On May 3, 2023 Neurocrine Biosciences, Inc. (Nasdaq: NBIX) reported its financial results for the first quarter ended March 31, 2023 and provided an update on its 2023 financial guidance (Press release, Neurocrine Biosciences, MAY 3, 2023, View Source [SID1234630935]).

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"INGREZZA’s first quarter results highlight the steady progress we are making to help improve the lives of patients living with tardive dyskinesia, yet we still have a tremendous opportunity to help even more patients for many years to come," said Kevin Gorman, Ph.D., Chief Executive Officer of Neurocrine Biosciences. "We are executing well across our clinical portfolio and anticipate several important milestones in the months ahead including the August 20th PDUFA date for valbenazine for the treatment of chorea associated with Huntington disease. In addition, we remain on-track for top-line data in the second half of this year for several investigational programs, including crinecerfont for the treatment of pediatric and adult congenital adrenal hyperplasia."

Three Months Ended

March 31,

(unaudited, in millions, except per share data)

2023

2022

Revenues:

Product sales, net

$ 415.3

$ 305.0

Collaboration revenue

5.1

5.6

Total revenues

$ 420.4

$ 310.6

GAAP Research and Development (R&D)

$ 139.5

$ 102.2

Non-GAAP R&D

$ 125.7

$ 89.7

GAAP Selling, General and Administrative (SG&A)

$ 242.7

$ 200.7

Non-GAAP SG&A

$ 216.6

$ 176.2

GAAP net (loss) income

$ (76.6)

$ 13.9

GAAP (loss) earnings per share – diluted

$ (0.79)

$ 0.14

Non-GAAP net (loss) income

$ (49.5)

$ 29.7

Non-GAAP (loss) earnings per share – diluted

$ (0.51)

$ 0.30

(unaudited, in millions)

March 31,

2023

December 31,

2022

Total cash, cash equivalents and marketable securities

$ 1,139.2

$ 1,288.7

First Quarter INGREZZA Net Product Sales Highlights:

INGREZZA first quarter 2023 net product sales were $410 million and grew 36% compared vs. the first quarter 2022
Record number of new patients received therapy during the first quarter of 2023
First Quarter Financial Highlights:

First quarter 2023 GAAP net loss and loss per share of $77 million and $0.79, respectively, compared with first quarter 2022 GAAP net income and earnings per share of $14 million and $0.14, respectively
First quarter 2023 non-GAAP net loss and loss per share of $50 million and $0.51, respectively, compared with first quarter 2022 non-GAAP net income and earnings per share of $30 million and $0.30, respectively
Differences in first quarter 2023 GAAP and non-GAAP operating expenses compared with first quarter 2022 driven by:
Acquired In-Process R&D (IPR&D) expense of $144 million in first quarter 2023 associated with expansion of strategic partnership with Voyager Therapeutics, Inc. (Voyager)
Increased R&D expense in support of an expanded and advancing clinical portfolio
Increased SG&A expense primarily due to ongoing commercial initiatives, including the deployment of the expanded salesforce in April 2022
At March 31, 2023, the Company had cash, cash equivalents and marketable securities of approximately $1.1 billion
A reconciliation of GAAP to non-GAAP financial results can be found in Table 3 and Table 4 at the end of this earnings release.

Recent Events:

On January 8, 2023, we entered into a new strategic collaboration with Voyager, which became effective on February 21, 2023, to acquire the worldwide rights to Voyager’s GBA1 gene therapy program for Parkinson’s disease and other GBA1-mediated diseases and three gene therapy programs directed to rare central nervous system targets for up-front consideration of $175 million.
In the first quarter of 2023, we provided BIAL with written notice of termination of the license agreement to commercialize and market ONGENTYS (opicapone), an approved adjunctive therapy for patients with Parkinson’s disease, in the United States and Canada. We determined that continued commercialization of ONGENTYS is unsustainable. The termination is anticipated to be effective in December 2023. ONGENTYS is an important, safe and effective adjunctive treatment option for Parkinson’s disease patients. We intend to work with BIAL to ensure an orderly transition of the commercialization of ONGENTYS and to ensure patients have continued access to ONGENTYS.
Reiterated 2023 INGREZZA Sales and Updated Operating Expense Guidance:

Range

(in millions)

Low

High

INGREZZA Net Product Sales 1

$ 1,670

$ 1,770

GAAP R&D expense 2

$ 550

$ 580

Non-GAAP R&D expense 5

$ 495

$ 525

GAAP and Non-GAAP IPR&D3

$ 144

$ 144

GAAP SG&A expense 4

$ 850

$ 870

Non-GAAP SG&A expense 5

$ 730

$ 750

1.

INGREZZA sales guidance for fiscal 2023 reflects expected sales of INGREZZA in tardive dyskinesia only.

2.

GAAP R&D guidance reflects the progression of the Company’s pipeline including multiple compounds in mid- to late-phase clinical development, meaningful investments in the muscarinic portfolio and expanded pre-clinical research efforts. GAAP R&D guidance includes amounts for milestones that are probable of achievement or have been achieved.

3.

IPR&D guidance reflects acquired in-process research and development once significant collaboration and licensing arrangements have been completed. IPR&D guidance includes $143.9 million associated with the new strategic collaboration with Voyager.

4.

GAAP SG&A guidance reflects the continued investment in the expanded commercial organization to support INGREZZA and to support the anticipated approval for valbenazine to treat patients with chorea associated with Huntington disease.

5.

Non-GAAP guidance adjusted to exclude estimated non-cash stock-based compensation expense of $55 million in R&D and $120 million in SG&A.

2023 Expected Pipeline Milestones and Key Activities

Program

Indication

2023 Milestones / Key Activities

Valbenazine*

(Selective VMAT2 Inhibitor)

Chorea in Huntington Disease

PDUFA Aug. 20, 2023

Crinecerfont

(CRF1 Receptor Antagonist)

Congenital Adrenal Hyperplasia (Adult)

Top-Line Registrational Data in Early Q4 2023

Congenital Adrenal Hyperplasia (Pediatric)

Top-Line Registrational Data in Early Q4 2023

NBI-921352**

(Selective NaV1.6 Channel Blocker)

Focal Onset Seizure in Adults

Top-Line Phase 2 Data in Q4 2023

NBI-1065846†

(GPR-139 Agonist)

Anhedonia in Major Depressive Disorder

Top-Line Phase 2 Data in Q4 2023

NBI-1117570‡

(Dual M1/ M4 Agonist)

Treatment of Schizophrenia

Initiate Phase 1 Study

New Chemical Entity
or Entities

Indication(s) TBD

Initiate at Least One Phase 1 Study

Key: VMAT2 = Vesicular Monoamine Transporter 2; CFR1 = Corticotropin-Releasing Factor Type 1; NaV1.6 = Sodium Channel, Voltage-Gated; M1 / M4 = M1 / M4 Muscarinic Receptor; GPR = Orphan G Protein Coupled Receptor

Neurocrine Biosciences Partners: * Mitsubishi Tanabe Pharma Corporation has commercialization rights in East Asia; ** In-Licensed from Xenon Pharmaceuticals; † Partnered with Takeda Pharmaceutical Company Limited; ‡ In-Licensed from Sosei Group Corporation

Conference Call and Webcast Today at 8:00 AM Eastern Time
Neurocrine Biosciences will hold a live conference call and webcast today at 8:00 a.m. Eastern Time (5:00 a.m. Pacific Time). Participants can access the live conference call by dialing 800-895-3361 (US) or 785-424-1062 (International) using the conference ID: NBIX. The webcast can also be accessed on Neurocrine Biosciences’ website under Investors at www.neurocrine.com. A replay of the webcast will be available on the website approximately one hour after the conclusion of the event and will be archived for approximately one month.

On May 3, 2023 NanoString Technologies, Inc. (NASDAQ:NSTG), a leading provider of life science tools for discovery and translational research, reported its financial results for the first quarter ended March 31, 2023 (Press release, NanoString Technologies, MAY 3, 2023, View Source [SID1234630934]).

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"2023 is off to a strong start, with spatial biology revenue up more than 75% over the prior year," said Brad Gray, President and CEO of NanoString. "Demand for our CosMx Spatial Molecular Imager is robust, with new orders driving an increase in CosMx backlog even as we accelerated shipments in the first quarter. We also generated sequential and year-over-year growth in consumable revenue across all our platforms."
First Quarter Financial Highlights
•Total revenue of $35.8 million
•Spatial biology revenue of $17.1 million
•nCounter revenue, inclusive of all service and other revenue, of $18.7 million
•Cash, cash equivalents and short-term investments balance of $154.6 million as of March 31, 2023
Spatial Biology
•Accelerated CosMx shipments during Q1, resulting in Q1 spatial biology instrument revenue growth of 110% year-over-year
•Increased CosMx revenue backlog in Q1, with revenue to be recognized in future periods from cumulative orders received exceeding $40 million
•Grew total spatial biology system installed base to approximately 385 systems, an increase of approximately 31% year-over-year
•Recorded spatial biology consumables revenue growth of 44% year-over-year, with steady GeoMx consumables pull-through over a larger installed base supplemented by growing shipments of CosMx consumables
•Approximately 120 abstracts highlighted at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. Nearly 60 spatial abstracts using GeoMx or CosMx, an increase of more than 40% over the prior year
•Total peer-reviewed publications featuring our spatial biology platforms were approximately 232 as of March 31, 2023, representing an increase of approximately 122 publications in the last 12 months
nCounter
•Total installed base of our nCounter platforms of approximately 1,130, an increase of approximately 6% year-over-year
•Total peer-reviewed publications featuring nCounter were approximately 6,820 as of March 31, 2023, representing an increase of approximately 1,570 publications in the last 12 months

2023 Outlook
The company updated its previous financial outlook for 2023, with results now expected as follows:
•Total revenue of $175 to $185 million, as compared to the previous range of $170 to $180 million.
◦Spatial biology revenue of $100 to $105 million, as compared to the previous spatial biology revenue range of $95 to $100 million
◦nCounter revenue, inclusive of all service and other revenue, of $75 to $80 million, unchanged from the previous guidance range
•Adjusted EBITDA loss of $65 to $75 million, unchanged from the previous range
Financial Results
We have elected to present selected non-GAAP, or adjusted, financial measures, including Adjusted EBITDA. These adjusted financial measures are calculated excluding certain items that may make it more challenging to compare our GAAP operating results across periods. Such items may include stock-based compensation, depreciation and amortization, or one-time charges such as transaction related fees and expenses or restructuring charges and severance costs. A reconciliation of adjusted financial measures to the nearest comparable GAAP financial measure can be found in the tables at the end of this press release.
(dollars in thousands) Three Months Ended March 31,
GAAP Non-GAAP
2023 2022 2023 2022
Total revenue $ 35,805 $ 31,080 $ 35,805 $ 31,080
Cost of revenue 22,871 14,778 20,552 13,789
Gross margin 36 % 52 % 43 % 56 %
Research and development 16,118 17,417 12,655 14,956
Selling, general and administrative 37,366 36,355 29,762 29,397
Adjusted EBITDA N / A N / A (27,164) (27,062)
Non-operating expense, net (688) (2,030) (688) (2,030)
Net loss $ (41,238) $ (39,500) $ (27,852) $ (29,092)

Supplemental Information

As a supplement to the table above, we have posted to the investor relations section of our website, at View Source, supplemental financial data that include our adjusted financial measures as compared to the nearest comparable GAAP financial measures, for the first quarter of 2023 and for each quarter of and the full year of 2022.

Conference Call

Management will host a conference call today beginning at 1:30 pm PT / 4:30 pm ET to discuss these results and answer questions. Investors and other interested parties can register for the call in advance by visiting View Source After registering, an email confirmation will be sent including dial-in details and unique conference call codes for entry. Registration is open throughout the call, but to ensure connection for the full call, registration in advance is recommended. The link to the webcast and audio replay will be made available at the Investor Relations website: www.nanostring.com. A replay of the call will be available beginning May 3, 2023 at 7:30pm ET through midnight ET on May 17, 2023. To access the replay, dial (866) 813-9403 or (929) 458-6194 and reference Conference ID: 573494. The webcast will also be available on our website for one year following the completion of the call.

Non-GAAP, or Adjusted, Financial Information

We believe that the presentation of non-GAAP, or adjusted, financial information provides important supplemental information to management and investors regarding financial and business trends relating to our financial condition and results of operations. Reconciliation of adjusted financial measures to the most directly comparable financial result as determined in accordance with GAAP are included at the end of this press release following the accompanying financial data. A reconciliation of adjusted guidance measures, including Adjusted EBITDA, to corresponding GAAP measures is not available without unreasonable effort due to the uncertainty regarding certain expenses that may be incurred in the future, and we are also unable to predict the probable significance of such adjusted guidance measures. Accordingly, in reliance on the exception provided by Item 10(e)(1)(i)(B) of Regulation S-K, we have not provided a reconciliation for adjusted guidance measures provided in this press release. For further information regarding why we believe that these adjusted measures provide useful information to investors, the specific manner in which management uses these measures and some of the limitations associated with the use of these measures, please refer to "Notes Regarding Non-GAAP Financial Information" at the end of this press release.

On May 3, 2023 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that members of management will present at the Bank of America Securities 2023 Healthcare Conference on Wednesday, May 10, 2023 at 12:20 p.m. Eastern Time (Press release, Mersana Therapeutics, MAY 3, 2023, View Source [SID1234630932]).

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A live webcast of this event will be available on the Investors & Media section of Mersana’s website at www.mersana.com. An archived replay will be available for approximately 90 days following the event.