Oncocyte Announces Pricing of $35 Million Public Offering of Common Stock

On February 5, 2021 Oncocyte Corporation (NYSE American: OCX), a molecular diagnostics company with a mission to provide actionable answers at critical decision points across the cancer care continuum, reported that it has priced the previously announced underwritten public offering of 7,780,000 shares of its common stock, at a public offering price of $4.50 per share (Press release, Oncocyte, FEB 5, 2021, View Source [SID1234574685]). The gross proceeds to the Company from this offering are expected to be approximately $35.0 million, before deducting the underwriting discounts and commissions and other estimated offering expenses payable by the Company. The offering is expected to close on or about February 9, 2021, subject to satisfaction of customary closing conditions. The Company has granted the underwriters a 30-day option to purchase up to an additional 1,167,000 shares of its common stock at the public offering price.

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!

Piper Sandler & Co. is acting as Sole Book-Runner for the offering. BTIG, LLC and Needham & Company are acting as Co-Lead Managers.

Oncocyte intends to use net proceeds from the offering to promote commercialization of its lead diagnostic test DetermaRx; to complete development of DetermaIO; and for development of future tests in its pipeline, including the CNI Monitor test that OncoCyte expects to acquire through a merger with Chronix Biomedical, Inc. Proceeds may also be used for pending acquisitions and post-acquisition obligations related to the Chronix merger, the purchase of the outstanding shares of Razor Genomics, Inc. common stock, and the earlier acquisition of Insight Genetics, Inc. Net proceeds not used for the foregoing purposes may be used for general corporate and working capital purposes and to invest in or acquire businesses or technologies that the Company believes are complementary to its business, although the Company has no other binding agreements to acquire any such business or technology.

The offering is being made pursuant to a "shelf" registration statement on Form S-3 (File No. 333-231980) that became effective with the Securities and Exchange Commission ("SEC") on June 18, 2019, the base prospectus contained therein and a prospectus supplement. A preliminary prospectus supplement and accompanying base prospectus relating to the offering and the shares of common stock being offered has been filed with the SEC. Before you invest, you should read the prospectus in the registration statement, the preliminary prospectus supplement, and other documents the Company has filed with the SEC for more complete information about the Company and this offering. Copies of the registration statement, the preliminary prospectus supplement and accompanying base prospectus may be obtained, when available, on the SEC’s website at View Source or, when available, by contacting: Piper Sandler & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by telephone at (800) 747-3924, or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any offer, solicitation, or sale of these securities in any state or other jurisdiction in which such an offer, solicitation or sale would be unlawful.

JUBILANT PHARMOVA – Q3 & 9M’FY21 RESULTS

On February 5, 2021 The Board of Jubilant Pharmova Limited reported to approve financial results for the quarter ended December 31st, 2020 (Press release, Jubilant Pharma, FEB 5, 2021, View Source [SID1234575193]).

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!

Commenting on the Company’s performance, Mr. Shyam S Bhartia, Chairman and Mr. Hari S Bhartia, CoChairman & Managing Director, Jubilant Pharmova said: "Q3’FY21 has witnessed a substantial improvement over the previous quarter despite continued adverse impact of the COVID-19 pandemic.

Pharma business delivered strong performance led by CDMO and Generics. We continue to see new business opportunities in CDMO, Generics and Specialty Pharma segments.

The company’s performance in the LSI business has been better due to good demand and improved pricing of select products.

Contract Research and Development Services business witnessed strong year-on-year growth in revenues led by healthy demand from customers.

We continue to expect strong performance in our businesses in Q4’FY21. During 9M’FY21, the Company reduced net debt on a constant currency basis by Rs 570 Crore. This is in addition to Rs 514 crore reduction in net debt during FY20.

We received the final NCLT order approving the demerger of our LSI business. The demerger is effective from February 1, 2021 and creates separate and focused entities: Jubilant Pharmova for pharmaceuticals, contract research and development services and proprietary novel drugs businesses and Jubilant Ingrevia for life science products and innovative solutions business; that will help in unlocking shareholder value."

Q3’FY21 Highlights
A. Consolidated
 Revenue at Rs 2,664 Crore, as compared with Rs 2,315 Crore in Q3’FY20; up 15% YoY
 Reported EBITDA at Rs 653 Crore as compared with Rs 513 Crore in Q3’FY20; up 27% YoY. EBITDA margin at 24.5% vs. 22.2% in Q3’FY20
 Finance costs at Rs 59 Crore vs. Rs 72 Crore in Q3’FY20
Net Profit at Rs 310 Crore versus Rs 203 Crore in Q3’FY20. EPS of Rs 19.5 vs. Rs 12.8 in Q3’FY20; up 52% YoY
 Capital expenditure for the quarter was Rs 104 Crore Jubilant Pharmova Limited 1A, Sector 16A, Noida – 201301, India Tel.: +91 120 4361000 www.jubilantpharmova.com Segment Wise Analysis B. Pharmaceuticals Segment
Pharmaceuticals revenue was at Rs 1,692 Crore vs. Rs 1,450 Crore in Q3’FY20
 Pharmaceuticals EBITDA recorded at Rs 499 Crore as compared with Rs 411 Crore in Q3’FY20 with a margin of 29.5% as compared to 28.4% in Q3’FY20
 R&D spent during the quarter of Rs 45 Crore – 2.6% to segment sales. R&D debited to P&L is Rs 47 Crore – 2.8% to segment sales
 CMO business’ revenue grew based on strong demand from customers as well as new deals
 Five separate clinical and commercial supply agreements for COVID-19 treatment and vaccine candidates signed in 9M’FY21. Remdesivir of Gilead approved by the US FDA has been contributing to CMO revenue growth
 Started contract manufacturing of Eli Lily’s Bamlanivimab, a drug that has been granted Emergency Use Authorization by the US FDA for treatment of COVID-19 and COVID-19 vaccine candidate NVX-CoV2373 of Novavax, biotechnology company developing next-generation vaccines for serious infectious diseases
 Revenue growth during the quarter was also led by strong performance in key products in Generics segment, especially in the US market and also by launch of Remdesivir in various countries including India C. Life Science Ingredients Segment
 LSI revenue was at Rs 893 Crore against Rs 797 Crore in Q3’FY20
 Strong growth witnessed in Nutrition and Health Solutions and Life Science Chemicals business driven by improved pricing in both the segments
 EBITDA at Rs 155 Crore increased by 55% YoY with margin of 17.4% as compared to 12.6% in Q3’FY20
 Strong improvement in profitability is driven by improvement in prices across several products as well as recovery in volumes in Nutrition and Life Sciences Chemicals D. Contract Research and Development Services Segment
 Revenue at Rs 79 Crore increased by 17% YoY
 Reported EBITDA at Rs 29 Crore vs. Rs 22 Crore in Q3’FY20 with a margin of 36.4% vs. 32.9% in Q3’FY20
 Higher demand from biotech companies for integrated services, functional chemistry and DMPK
 Company continues to witness strong demand conditions in this business 9M’FY21 Highlights E. Consolidated
 Consolidated Revenue at Rs 6,932 Crore vs. Rs 6,763 Crore in 9M’FY20
 EBITDA at Rs 1,457 Crore vs. Rs 1,438 Crore in 9M’FY20. EBITDA margin at 21.0% vs. 21.3% in 9M’FY20
 Finance costs at Rs 199 Crore down 8% YoY
 Net Profit at Rs 622 Crore vs. Rs 638 Crore in 9M’FY20. EPS of Rs 39.1 vs. Rs 40.0 in 9M’FY20  Capex of Rs 285 Crore in 9M’FY21
Net debt reduced by Rs 570 Crore during 9M’FY21 Segment Wise Analysis F. Pharmaceuticals Segment
Pharmaceuticals revenue at Rs 4,304 Crore vs. Rs 4,231 Crore in 9M’FY20
 EBITDA at Rs 1,020 Crore vs. Rs 1,127 Crore in 9M’FY20. Margin of 23.7% as compared to 26.6% in 9M’FY20 G. Life Science Ingredients Segment
 LSI revenue at Rs 2,413 Crore vs Rs 2,356 Crore in 9M’FY20
EBITDA at Rs 418 Crore up 34% YoY with margin of 17.3% as compared to 13.3% in 9M’FY20 H. Contract Research and Development Services Segment
 Revenues at Rs 211 Crore up 20% YoY
 EBITDA was at Rs 67 Crore up from Rs 52 Crore in 9M’FY20

I. Business Outlook
 We continue to see improvement in demand in most of our business segments be it CMO, Generics, API or Life Science Ingredients
 Given the strong demand recovery and new business sign-ups, we believe COVID-19 is not likely to have a material impact on our overall performance during FY21, provided the pandemic situation does not materially deteriorate going forward
 Overall, we continue to see strong performance in our businesses in Q4’FY21
 For Pharmaceutical business, we continue to see strong performance in Q4
 For LSI business, we expect to achieve close to double-digit revenue growth and significant growth in EBITDA with higher margin and a very healthy cash generation in FY21

Cardinal Health Reports Second-Quarter Results for Fiscal Year 2021

On February 5, 2021 Cardinal Health (NYSE: CAH) reported second-quarter fiscal year 2021 revenue of $41.5 billion, an increase of 5% from the second quarter of last year (Press release, Cardinal Health, FEB 5, 2021, View Source [SID1234574686]). Second-quarter GAAP operating earnings increased 38% to $461 million, primarily due to the beneficial comparison to the prior-year charge related to voluntary surgical gown recalls. GAAP diluted earnings per share (EPS) increased to $2.13, primarily due to the tax effect of a self-insurance loss.

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!

Non-GAAP operating earnings decreased 3% to $628 million in the quarter, and this decrease included a modest net negative impact from COVID-19. The Pharmaceutical segment was adversely affected by COVID-19, while the Medical segment experienced a net positive impact. Non-GAAP diluted EPS increased 14% to $1.74 in the quarter, benefiting from a lower non-GAAP effective tax rate.

"As we collectively navigate the pandemic, we remain committed to supporting customers, patients, and communities around the world," said Mike Kaufmann, CEO of Cardinal Health. "Our second-quarter results demonstrate our resilient business model, strong fundamentals, and the adaptability of our dedicated employees. We remain focused on optimizing our core businesses, investing in key areas, and efficiently deploying capital to drive long-term, sustainable growth."

Second-quarter revenue for the Medical segment increased 7% to $4.3 billion, driven by a net positive impact from COVID-19. This increase was primarily due to the impact of personal protective equipment (PPE) sales and higher volumes in our lab business, partially offset by the adverse effects of cancelled or deferred elective procedures.

Medical segment profit increased 21% to $236 million in the second quarter, due to the net positive impact from COVID-19 and cost savings, which included global manufacturing efficiencies. The net positive impact from COVID-19 was primarily due to higher volumes in our Lab business and an increased contribution from PPE, partially offset by the adverse effects of cancelled or deferred elective procedures.

Tax rate
During the second quarter of fiscal 2021, our wholly-owned insurance subsidiary recorded a self-insurance pre-tax loss in its fiscal 2020 statutory financial statements related to charges previously accrued in the company’s consolidated financial statements. This self-insurance pre-tax loss, which did not impact the company’s pre-tax consolidated results, is currently deductible on our fiscal 2020 consolidated federal income tax return, and contributed to a significant net operating loss for tax purposes. In addition, pursuant to the Coronavirus Aid, Relief and Economic Security Act enacted by the United States Congress in March 2020, this net operating loss will be carried back to fiscal years 2015-2018 to recover previously-paid Federal taxes at rates that were in effect at that time.

Accordingly, the second-quarter fiscal 2021 GAAP effective tax rate of (47.6)% reflects a benefit of $420 million associated with the net operating loss carryback. Additionally, we intend to file for a federal income tax refund of $974 million, primarily as a result of the net operating loss carryback, which we expect to receive within 12 months. The company has recorded a corresponding current asset on its second quarter fiscal 2021 consolidated balance sheet.

The second-quarter fiscal 2021 non-GAAP effective tax rate of 13.2% reflects the impact of certain discrete items.

Fiscal year 2021 outlook1
Cardinal Health raised its fiscal year 2021 guidance range for non-GAAP diluted earnings per share attributable to Cardinal Health, Inc. to $5.85 to $6.10, from the prior range of $5.65 to $5.95.

The company does not provide forward-looking guidance on a GAAP basis as certain financial information, the probable significance of which cannot be determined, is not available and cannot be reasonably estimated. See "Use of Non-GAAP Measures" following the attached schedules for additional explanation.

Recent highlights

Cardinal Health Board of Directors approved a quarterly dividend of $0.4859 per share. The dividend will be payable on April 15, 2021 to shareholders of record at the close of business on April 1, 2021.
The company reached an agreement with the Centers for Disease Control and Prevention (CDC) to act as a network administrator in Phase 2 of the Federal Pharmacy Partnership Strategy for COVID-19. Additionally, the Cardinal Health OptiFreight Logistics business was selected by the Ohio Department of Health to support efforts to distribute COVID-19 vaccines.
For the 13th consecutive year, Cardinal Health was honored as one of the "Best Places to Work for LGBTQ Equality" by the Human Rights Campaign (HRC) Foundation, achieving 100% on the HRC’s 2021 Corporate Equality Index (CEI).
Upcoming webcasted investor events

Barclays Global Healthcare Conference at 8:35 a.m. Eastern, March 9
Webcast
Cardinal Health will host a webcast today at 8:30 a.m. Eastern to discuss second quarter results. To access the webcast and corresponding slide presentation, go to the Investor Relations page at ir.cardinalhealth.com. No access code is required.

Presentation slides and a webcast replay will be available until February 4, 2022.

Applied DNA Schedules Fiscal 2021 First Quarter Financial Results Conference Call and Webcast for Thursday, February 11, 2021

On February 5, 2021 Applied DNA Sciences, Inc. (NASDAQ: APDN) reported that it will report fiscal 2021 first quarter financial results after market close on Thursday, February 11, 2021 (Press release, Applied DNA Sciences, FEB 5, 2021, View Source [SID1234574687]). The Company’s management will discuss the results during a conference call and simultaneous webcast at 4:30 p.m. ET that same day. Presentation slides will also be posted to the ‘IR Calendar’ section of the Company’s corporate website and embedded into the live webcast.

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!

Conference Call and Webcast Information – Live

Date: Thursday, February 11, 2021, at 4:30 p.m. Eastern Daylight Time

Dial in: 844-887-9402 or 412-317-6798 (international)

Conference ID: 10151013

Hosts: Dr. James A. Hayward, chairman, president, and CEO; Beth Jantzen, chief financial officer; Judith Murrah, chief operating officer

Webcast: View Source

Conference Call and Webcast Information – Replay

A telephonic replay of the conference call will be available for one week beginning one hour after the end of the live conference call.

Dial in: 877-344-7529 or 412-317-0088 (international)

Conference ID: 10151013

Webcast: View Source

Availability: Telephonic replay: until Thursday, February 18, 2021; webcast replay: 1 year

The webcast and accompanying PowerPoint presentation will also be archived on the ‘IR Calendar’ page listed under the Investor Relations drop-down menu on the Company’s website.

Ipsen to showcase commitment to going beyond traditional outcome measures for patients living with renal cell carcinoma at ASCO GU 2021

On February 5, 2021 Ipsen (Euronext: IPN; ADR: IPSEY) reported that new data from its growing oncology portfolio will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium (ASCO GU), taking place virtually from 11-13 February 2021 (Press release, Ipsen, FEB 5, 2021, View Source [SID1234574671]).11 A total of 10 abstracts spanning several genitourinary cancers including advanced RCC, and metastatic, castration-resistant prostate cancer (mCRPC), highlight the utility of Ipsen’s medicines and its commitment to advancing patient care.1-10

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 presentations showcased at ASCO (Free ASCO Whitepaper) GU exemplify Ipsen’s commitment to prioritize outcome measures which directly impact patients’ lives," said Amauri Soares, Vice President, Medical Affairs Oncology, Ipsen. "New data from the Phase III CheckMate -9ER trial highlight how first-line treatment with the combination of cabozantinib and nivolumab has the potential to extend the lives of patients living with advanced RCC without having to compromise on quality of life compared with sunitinib. We’re looking forward to sharing these data with the medical community at ASCO (Free ASCO Whitepaper) GU and bringing this important treatment option to patients at the earliest opportunity."

Highlights from key data on Ipsen medicines to be presented during the ASCO (Free ASCO Whitepaper) GU 2021 Symposium include:

Extended follow-up outcomes data from the CheckMate -9ER study including patients living with advanced RCC and sarcomatoid features (sRCC) – an aggressive histologic subtype associated with poor prognoses1
Patient reported outcomes of patients living with advanced RCC – additional analysis from the CheckMate -9ER study of the combination of Cabometyx (cabozantinib) with Opdivo (nivolumab) versus sunitinib2
A comparative, retrospective real-world evidence study suggesting Cabometyx (cabozantinib) was associated with a significantly higher response rate versus other TKIs (axitinib, lenvatinib, pazopanib, sorafenib, sunitinib) in patients living with metastatic renal cell carcinoma (mRCC) following checkpoint inhibitor (CPI) treatment3
Findings from a study using machine learning to explore the potential synergistic effects of Cabometyx (cabozantinib) and a programmed cell death protein 1 (PD1) inhibitor in mRCC4
Trial design of the Phase III randomized, open-label CONTACT-02 study of Cabometyx (cabozantinib) plus Tecentriq (atezolizumab) versus second novel hormone therapy (NHT) in patients living with mCRPC5