On October 28, 2020 PerkinElmer, Inc. (NYSE: PKI), a global leader committed to innovating for a healthier world, reported financial results for the third quarter ended October 4, 2020 (Press release, PerkinElmer, OCT 28, 2020, View Source [SID1234570413]).

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The Company reported GAAP earnings per share from continuing operations of $1.57, as compared to GAAP earnings per share from continuing operations of $0.53 in the third quarter of 2019. GAAP revenue for the quarter was $964.0 million, as compared to $706.9 million in the third quarter of 2019. GAAP operating income from continuing operations for the quarter was $248.0 million, as compared to $78.7 million for the same period a year ago. GAAP operating profit margin was 25.7% as a percentage of revenue, as compared to 11.1% in the third quarter of 2019.

Adjusted earnings per share from continuing operations for the quarter was $2.09, as compared to $1.06 in the third quarter of 2019. Adjusted revenue for the quarter was $964.2 million, as compared to $707.1 million in the third quarter of 2019. Adjusted operating income from continuing operations for the quarter was $304.3 million, as compared to $152.5 million for the same period a year ago. Adjusted operating profit margin was 31.6% as a percentage of adjusted revenue, as compared to 21.6% in the third quarter of 2019.

Adjustments for the Company’s non-GAAP financial measures have been noted in the attached reconciliations.

"I remain humbled by and immensely proud of how everyone within PerkinElmer has rallied together to tackle this year’s challenges," said Prahlad Singh, president and chief executive officer of PerkinElmer. "As we look to 2021 and beyond, the environment will undoubtedly be different from the future we imagined a year ago. However, I could not be more confident that we as an organization are headed in the right direction and better positioned to tackle the challenges of tomorrow."

Financial Overview by Reporting Segment for the Third Quarter

Discovery & Analytical Solutions

Third quarter 2020 revenue was $423.6 million, as compared to $426.9 million for the third quarter of 2019. Reported revenue decreased 1% and organic revenue decreased 3% as compared to the third quarter of 2019.
Third quarter 2020 operating income from continuing operations was $42.7 million, as compared to $52.3 million for the comparable prior period.
Third quarter 2020 adjusted operating income was $62.5 million, as compared to $86.2 million for the third quarter of 2019.

Diagnostics

Third quarter 2020 revenue was $540.4 million, as compared to $280.0 million for the third quarter of 2019. Reported revenue increased 93% and organic revenue increased 92% as compared to the third quarter of 2019.
Third quarter 2020 operating income from continuing operations was $223.8 million, as compared to $47.4 million for the comparable prior period.
Third quarter 2020 adjusted operating income was $260.3 million, as compared to $79.7 million for the third quarter of 2019.
Fourth Quarter 2020 Guidance

For the fourth quarter of 2020, the Company forecasts GAAP revenue in the range of $1.12 billion to $1.23 billion, GAAP earnings per share from continuing operations of $2.27 to $2.67 and, on a non-GAAP basis, which is expected to include the adjustments noted in the attached reconciliation, adjusted earnings per share of $2.60 to $3.00.

Conference Call Information

The Company will discuss its third quarter 2020 results and its outlook for business trends in a conference call on October 28, 2020 at 5:00 p.m. Eastern Time. To access the call, please dial (720) 405-2250 prior to the scheduled conference call time and provide the access code 6884834.

A live audio webcast of the call will be available on the Investors section of the Company’s Web site, www.perkinelmer.com. Please go to the site at least 15 minutes prior to the call in order to register, download, and install any necessary software. An archived version of the webcast will be posted on the Company’s Web site for a two-week period beginning approximately two hours after the call.

Use of Non-GAAP Financial Measures

In addition to financial measures prepared in accordance with generally accepted accounting principles (GAAP), this earnings announcement also contains non-GAAP financial measures. The reasons that we use these measures, a reconciliation of these measures to the most directly comparable GAAP measures, and other information relating to these measures are included below following our GAAP financial statements.

Factors Affecting Future Performance

This press release contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements relating to estimates and projections of future earnings per share, cash flow and revenue growth and other financial results, developments relating to our customers and end-markets, and plans concerning business development opportunities, acquisitions and divestitures. Words such as "believes," "intends," "anticipates," "plans," "expects," "projects," "forecasts," "will" and similar expressions, and references to guidance, are intended to identify forward-looking statements. Such statements are based on management’s current assumptions and expectations and no assurances can be given that our assumptions or expectations will prove to be correct. A number of important risk factors could cause actual results to differ materially from the results described, implied or projected in any forward-looking statements. These factors include, without limitation: (1) markets into which we sell our products declining or not growing as anticipated; (2) the effect of the COVID-19 pandemic on our sales and operations; (3) fluctuations in the global economic and political environments; (4) our failure to introduce new products in a timely manner; (5) our ability to execute acquisitions and license technologies, or to successfully integrate acquired businesses and licensed technologies into our existing business or to make them profitable, or successfully divest businesses; (6) our failure to adequately protect our intellectual property; (7) the loss of any of our licenses or licensed rights; (8) our ability to compete effectively; (9) fluctuation in our quarterly operating results and our ability to adjust our operations to address unexpected changes; (10) significant disruption in third-party package delivery and import/export services or significant increases in prices for those services; (11) disruptions in the supply of raw materials and supplies; (12) the manufacture and sale of products exposing us to product liability claims; (13) our failure to maintain compliance with applicable government regulations; (14) regulatory changes; (15) our failure to comply with healthcare industry regulations; (16) economic, political and other risks associated with foreign operations; (17) our ability to retain key personnel; (18) significant disruption in our information technology systems, or cybercrime; (19) our ability to obtain future financing; (20) restrictions in our credit agreements; (21) discontinuation or replacement of LIBOR; (22) the United Kingdom’s withdrawal from the European Union; (23) our ability to realize the full value of our intangible assets; (24) significant fluctuations in our stock price; (25) reduction or elimination of dividends on our common stock; and (26) other factors which we describe under the caption "Risk Factors" in our most recent quarterly report on Form 10-Q and in our other filings with the Securities and Exchange Commission. We disclaim any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this press release.

On October 28, 2020 Allakos Inc. (the "Company") (Nasdaq: ALLK), a biotechnology company developing AK002 for the treatment of eosinophil and mast cell related diseases, reported the pricing of its previously announced underwritten public offering (Press release, Allakos, OCT 28, 2020, View Source [SID1234569696]). The size of the offering is $250 million of shares of its common stock. The Company is offering 3,048,781 shares at a public offering price of $82.00 per share. The offering is expected to close on November 2, 2020, subject to the satisfaction of customary closing conditions. In connection with the offering, the Company has granted the underwriters a 30-day option to purchase up to 457,317 additional shares of its common stock at the public offering price, less the underwriting discounts and commissions.

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Offering Summary

Jefferies, BofA Securities and SVB Leerink are acting as joint book-running managers for the offering.

LifeSci Capital LLC and William Blair are acting as the co-managers for the offering.

The Company currently expects to use the net proceeds from the offering for general corporate purposes.

An effective registration statement relating to the securities sold in this offering was filed with the Securities and Exchange Commission ("SEC") on August 5, 2019. Copies of the registration statement, the preliminary prospectus supplement and the accompanying prospectus relating to the offering have been filed with the SEC, and a final prospectus supplement and accompanying prospectus will be filed with the SEC and will be accessible through the SEC’s website at www.sec.gov. The offering was made only by means of a prospectus supplement and the accompanying prospectus. When available, copies of the final prospectus supplement and accompanying prospectus may be obtained from Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 1-877-547-6340, or by email at [email protected]; BofA Securities, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC 28255-0001, Attention: Prospectus Department, or by email at [email protected]; or SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at 1-800-808-7525, ext. 6132, or by email at [email protected].

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

On October 28, 2020 Natera, Inc. (NASDAQ: NTRA), a pioneer and global leader in cell-free DNA testing, reported that it will release results for its third quarter ended September 30, 2020, after the market close on November 5, 2020 (Press release, Natera, OCT 28, 2020, View Source [SID1234569439]). Natera will host a conference call and webcast at 1:30 p.m. PT (4:30 p.m. ET) to discuss its financial results, business activities, and financial outlook.

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On October 28, 2020 Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY) reported its consolidated financial results for the quarter and the half year ended September 30, 2020 (Press release, Dr Reddy’s, OCT 28, 2020, View Source [SID1234569287]). The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS).

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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

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*Q2 FY21 YoY sales growth of 20% adjusted for proprietary products out-licensing income in previous year

Commenting on the results, Co-chairman & MD, G V Prasad said, "We are pleased to report continued growth across all the markets and improved productivity which is reflected in the healthy EBITDA margin and RoCE. Our research teams are working on several potential remedies for COVID in addition to the already launched products."

All amounts in millions, except EPS. All US dollar amounts based on convenience translation rate of I USD = Rs. 73.54

* Includes income from Investments

All amounts in millions, except EPS. All US dollar amounts based on convenience translation rate of I USD = Rs. 73.54

Cyber Attack Update

On 22nd October 2020, we experienced an information security incident and consequently isolated the impacted IT services. This incident involved a ransom-ware attack. We promptly engaged leading outside cybersecurity experts, launched a comprehensive containment and remediation effort and investigation to address the incident.

As of date, our investigation has not ascertained if any data breaches in the incident pertain to personally identifiable information stored in the Company’s systems.

Recovery and restoration of all applications and data is underway. All critical operations are being enabled in a controlled manner.

COVID-19 Update

We continue our fight against the current pandemic by ensuring health and safety of our employees and business partners by adopting adequate precautionary measures. We continued our operations across plants enabling us to serve our patients across markets.

During the quarter we saw gradual recovery in the market demand across India, Russia and other markets after a low demand in Q1 FY 21, although the demand is yet to fully recover to pre-covid levels.

We launched COVID-19 treatment drugs Avigan (Favipiravir) and Remdesivir. We further strengthened our development pipeline for COVID-19 treatment drugs including the vaccine candidate Sputnik V.

Revenue Analysis

Global Generics (GG)

Revenues from GG segment at Rs. 39.8 billion:

Year-on-year growth of 21% and sequential quarter growth of 14%, were driven primarily on account of new product launches, volume traction in the base business and integration of the acquired business from Wockhardt in India.
North America

Revenues from North America at Rs. 18.3 billion:

Year-on-year growth of 28%, driven by contribution from new products launched, increase in volumes of our base products and aided by a favorable forex rate, which was partially offset by price erosion.
Sequential growth of 6%, on account of volume traction in the base business and new product launches, offset by adverse forex movement and price erosion.
We launched nine new products including Ciprofloxacin & Dexamethasone Otic Suspension, Fulvestrant Injection, OTC Diclofenac and OTC Olapatadine.
We filed two new ANDAs during the quarter. As of 30th September 2020, cumulatively 94 generic filings are pending for approval with the USFDA (92 ANDAs and 2 NDAs under 505(b)(2) route). Of the 92 ANDAs, 50 are Para IVs and we believe 26 have ‘First to File’ status.
Europe

Revenues from Europe at Rs. 3.8 billion:

Year-on-year growth of 36% and sequential growth of 6%, primarily on account of new product launches and favorable forex movement.
We also forayed into a new country Austria, beyond our EU5 markets.
India

Revenues from India at Rs. 9.1 billion:

Year-on-year growth of 21% and sequential growth of 46% is primarily on account of revenues from the acquired business of Wockhardt and contribution from new products including the Avigan (Favipiravir) and Remdesivir launched for treatment of Covid-19.
Emerging Markets

Revenues from Emerging Markets at Rs. 8.6 billion. Year-on-year growth of 4%. Sequential growth of 8%:

Revenues from Russia at Rs. 4.0billion. Year-on-year decline of 3% is primarily on account of weakening Ruble. Sequential growth of 22% contributed by increased volumes with a gradual recovery in market demand after Q1 was impacted due to COVID-19.
Revenues from other CIS countries and Romania market at Rs. 2.0 billion. Year-on-year growth of 19% and sequential growth of 43% driven by both base business and new product launches.
Revenues from Rest of World (RoW) territories at Rs. 2.7billion. Year-on-year growth of 7% driven by new products. Sequential decline of 20% is on account of lower volumes sold for existing products.
Pharmaceutical Services and Active Ingredients (PSAI)

Revenues from PSAI at Rs. 8.5 billion:

Year-on-year growth of 20% driven by new products, growth in the services business and favorable forex rate.
Sequential decline of 1% on account of lower volumes of certain products, partially offset by new products and growth in the services business.
During the quarter we filed DMF for one product in the US.
Proprietary Products (PP) & Others

Revenues from PP & Others at Rs. 622 million:

Year-on-year decline of 92%. Q2 FY 20 was higher due to income from sale of the US and select territory rights for two of Neurology franchise products pertaining to PP.
Sequential growth of 14%.
Income Statement Highlights:

Gross profit margin at 53.9%:
Decline of 360 bps over previous year, which was impacted due to inclusion of revenue from sale of Neurology franchise products in the previous year, partially offset by improvement in productivity and favorable forex rates. Sequentially the margin reduced by 210 bps, primarily on account of lower export incentives, adverse forex and product mix.
Gross profit margin for GG and PSAI business segments are at 59.4% and 26.8% respectively.
SG&A expenses at Rs. 13.1 billion, reduced by 1% year-on-year due to certain one-off expenses last year, which was partly offset by incremental costs post the integration of the acquired divisions from Wockhardt in this year. Sequentially it increased by 3% primarily due to the integration of the acquired divisions from Wockhardt and pickup in sales & marketing activities post un-lock.
R&D expenses at Rs. 4.4 billion. As % to revenues these are: Q2 FY21: 8.9% | Q1 FY 21: 9.0% | Q2 FY20: 7.6%. Our focus continues on building a healthy pipeline of new products across our markets including development of products pertaining to COVID-19 treatment.
Other operating income at Rs. 149 million compared to Rs. 135 million in Q2 FY20.
Net Finance income at Rs. 237 million compared to Rs. 231 million in Q2 FY20.
Profit before Tax at Rs. 8.6 billion, increased by 12% year-on-year and reduced by 2% sequentially.
Profit after Tax at Rs. 7.6 billion. The effective tax rate is ~ 11.6% for the quarter, which is lower primarily due to recognition of deferred tax assets for one of our subsidiaries.
Diluted earnings per share is at Rs. 45.83.
Other Highlights:

EBITDA at Rs. 12.7 billion and the EBITDA margin is 25.9%.
Capital expenditure is at Rs. 2.5 billion.
Free cash-flow generated during the quarter stood at Rs. 6.0 billion.
Net debt of the company is at Rs. 1.4 billion as on September 30, 2020. Consequently, net debt to equity ratio is 0.01.
Earnings Call Details (05:30 pm IST, 08:00 am EDT, Oct 28, 2020)

The management of the Company will host an earnings call to discuss the Company’s financial performance and answer any questions from the participants.

No password/pin number is necessary to dial in to any of the above numbers. The operator will provide instructions on asking questions before and during the call.

Play Back: The play back will be available after the earnings call, till November 4th, 2020. For play back dial in phone No: +91 22 7194 5757 | +91 22 6663 5757, and Playback Code is 97779.

Transcript: Transcript of the Earnings call will be available on the Company’s website: www.drreddys.com

On October 28, 2020 NRG Oncology reported that Researchers involved in the phase II RTOG 0526 trial studying low dose rate (LDR) prostate brachytherapy (BT) following local recurrence (LR) after external beam radiotherapy (EBRT) for patients with low-to-intermediate risk prostate cancer reported late Grade 3 gastrointestinal and genitourinary adverse events (AEs) occurring in 14% of trial participants (Press release, NRG Oncology, OCT 28, 2020, View Source [SID1234569286]). Results from a follow up of a minimum of 5-years of patients that participated on the trial suggest that 5-year freedom from biochemical failure (BF) stands at 68% and remains steady with the 10-year rate being 54%. This report was presented at the virtual edition of the American Society for Radiation Oncology’s (ASTRO) Annual Meeting in October 2020.

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"Low and intermediate risk prostate cancer typically recurs locally in 10-30% of men following EBRT. Prior to this study, most data available on salvage brachytherapy in prostate cancer was retrospective and stemmed from single-center studies with multiple variables regarding doses and technique. With such a high recurrence rate afflicting this patient population, it was crucial to expand data on this modality in a multicenter study with defined methods," stated Juanita M. Crook, MD, FRCPC, of the Cancer Centre for the Southern Interior at the University of British Columbia and lead author of the NRG-RTOG 0526 abstract.

In order to be eligible for NRG-RTOG 0526, prostate cancer patients needed to have low or intermediate risk prostate cancer prior to EBRT in addition to having a proven LR thirty or more months following their EBRT. 92 patients were analyzed for the study and followed for a minimum of 5 years after their salvage brachytherapy. Participants on NRG-RTOG 0526 received a minimum dose of 140 Gy with I-125 or 120 G with Pd-103. Researchers followed clinical outcomes at 5 year or greater including objectives such as disease-specific survival, overall survival, time to biochemical failure, and patterns of recurrence.

As initially reported, 14% of participants experienced late Grade 3 gastrointestinal and genitourinary AEs at a median follow up of 6.9 years. The median prior EBRT dose was 74 Gy and the median interval since EBRT was received was 85 months. Androgen deprivation therapy was combined with salvage BT in only 16% of cases. The 5-year freedom from biochemical failure rate was 68%, which is comparable to other salvage modalities. At 10 years, the biochemical failure rate was 54% (95% CI: 43-66). Disease-free survival at 5 years was 61% but fell to 33% at 10 years. Nineteen patients died. Four patients had local recurrence (5% at 10 years), and 14 had distant failure with a 10-year rate of 19% (95% CI:10-29). None of the clinical or treatment factors was significantly associated with participants’ overall survival, disease-free survival, or local, distant, or biochemical failure.

This project was supported by grants UG1CA189867 (NRG Oncology NCORP), U10CA180868 (NRG Oncology Operations), U10CA180822 (NRG Oncology SDMC) from the National Cancer Institute (NCI), part of the National Institutes of Health.

Citation

Crook JM, Rodgers JP, Pisansky TM, Trabulsi EJ, Amin MB, Bice, Jr. WS, Morton GC, Pervez N, Vigneault E, Catton CN, Michalski JM, Roach, III M, Beyer DC, Rossi PJ, Horwitz EM, Donavanik V, Sandler HM. (2020, October). Salvage Low Dose Rate Prostate Brachytherapy: Clinical Outcomes of a Phase II Trial for Local Recurrence after External Beam Radiotherapy (NRG/RTOG -0526). Paper presented at the annual meeting of the American Society for Radiation Oncology. Virtual meeting platform.