On October 28, 2022 ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company applying a precision medicine approach to developing genetically targeted therapies for cardiovascular diseases, reported third quarter 2022 financial results and provided a corporate update (Press release, Arca biopharma, OCT 28, 2022, View Source [SID1234622571]).

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In May 2022, the Company retained Ladenburg Thalmann & Co. Inc. to act as its financial advisor to explore and evaluate strategic options for maximizing stockholder value. Potential strategic alternatives that may be explored or evaluated as part of this process include the potential for an acquisition, merger, business combination or other strategic transaction involving the Company. The Board has not set a timetable for the conclusion of this review, nor has it made any decisions related to any further actions or potential strategic options at this time. There can be no assurance, however, that this process will result in any such transaction.

Third Quarter 2022 Summary Financial Results

Cash and cash equivalents were $43.9 million as of September 30, 2022, compared to $53.4 million as of December 31, 2021. ARCA believes that its current cash and cash equivalents, will be sufficient to fund its operations at the current levels through at least the end of 2023. The Company’s review of its strategic options may impact this projection.

Research and development (R&D) expenses were $1.0 million for the quarter ended September 30, 2022, compared to $3.4 million for the corresponding period in 2021. In the third quarter of 2022, ARCA implemented a strategic reduction of the workforce and recorded total restructuring charges of approximately $0.8 million, of which $0.5 million and $0.3 million were recognized in research and development and general and administrative expenses, respectively, in connection with the restructuring, all in the form of one-time termination benefits. The $2.4 million decrease in R&D expenses in the third quarter was primarily related to the completion of enrollment in the rNAPc2 Phase 2b clinical trial in the fourth quarter of 2021, partially offset by the restructuring charges discussed above. R&D expenses in 2022 are expected to be lower than 2021.

General and administrative (G&A) expenses were $1.5 million for the quarter ended September 30, 2022, compared to $1.3 million for the corresponding period in 2021. The $0.2 million increase in G&A expenses was primarily a result of the restructuring charges discussed above. G&A expenses in 2022 are expected to be slightly higher than 2021 as we maintain administrative activities to support our ongoing operations along with the one-time termination benefits recorded in the third quarter 2022.

Total operating expenses for the quarter ended September 30, 2022 were $2.6 million compared to $4.7 million for the third quarter of 2021.

Net loss for the quarter ended September 30, 2022 was $2.3 million, or $0.16 per basic and diluted share, compared to $4.7 million, or $0.33 per basic and diluted share in the third quarter of 2021.

On October 28, 2022 Akari Therapeutics, Plc (Nasdaq: AKTX), a late-stage biotechnology company developing advanced therapies for autoimmune and inflammatory diseases, reported that Akari received a letter from Nasdaq Listing Qualifications indicating that Akari is not in compliance with the minimum bid price requirement for continued listing set forth in Listing Rule 5550(a)(2), which requires listed securities to maintain a minimum bid price of $1.00 per share (Press release, Akari Therapeutics, OCT 28, 2022, View Source [SID1234622570]).

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The rules also provide Akari a compliance period of 180 calendar days to regain compliance. According to the letter, Akari has from October 24, 2022 until April 24, 2023 to regain compliance with the minimum bid price requirement. Akari can regain compliance, if at any time during this 180-day period, the closing bid price of its ADSs is at least $1.00 for a minimum of ten consecutive business days, in which case Akari will be provided with a written confirmation of compliance and this matter will be closed. In the event Akari does not regain compliance after the initial 180-day period, Akari may then be eligible for an additional time if it meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period.

If Akari cannot demonstrate compliance by the end of the second 180-day period, Nasdaq staff will notify Akari that its ADSs are subject to delisting.

The letter has no immediate effect on Akari’s Nasdaq listing or the trading of its ADSs, and during the grace period, as may be extended, Akari’s ADSs will continue to trade on the Nasdaq Capital Market under the symbol "AKTX".

On October 28, 2022 Leidos Holdings, Inc. (NYSE:LDOS) reported that its Board of Directors has declared a quarterly cash dividend of $0.36 per outstanding share of common stock of Leidos Holdings, Inc (Press release, Leidos, OCT 28, 2022, View Source [SID1234622569]). The cash dividend is payable on December 30, 2022, to stockholders of record as of the close of business on December 15, 2022.

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On October 28, 2022 Amgen (NASDAQ:AMGN) reported that its Board of Directors declared a $1.94 per share dividend for the fourth quarter of 2022 (Press release, Amgen, OCT 28, 2022, View Source [SID1234622568]). The dividend will be paid on December 8, 2022, to all stockholders of record as of the close of business on November 17, 2022.

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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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October 28, 2022: Dr. Reddy’s Laboratories Ltd. (BSE: 500124 | NSE: DRREDDY | NYSE: RDY | NSEIFSC: DRREDDY) reported its consolidated financial results for the quarter and the half year ended September 30, 2022 (Press release, Dr Reddy’s, OCT 28, 2022, View Source [SID1234622567]). The information mentioned in this release is on the basis of consolidated financial statements under International Financial Reporting Standards (IFRS).

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Revenue Analysis

Global Generics (GG)

Revenues from GG segment at Rs. 55.9 billion:

Ø Year-on-year growth of 18% and sequential quarter growth of 26% driven by launch of the Lenalidomide capsules in the US market (as part of the volume limited settlement with innovator) and sequential quarter improvement in Russia sales. However, the growth was partly offset by price erosion in our generic markets and higher base due to covid product sales in previous year.

North America

Revenues from North America at Rs. 28.0 billion:

Ø Year-on-year growth of 48% and sequential quarter growth of 57%, driven by launch and scale up of new products and favorable movement of forex rates, which was partly offset by price erosion in some of our key molecules.

Ø During this quarter, we launched 7 new products. These were Lenalidomide capsules (as part of the volume limited settlement with innovator), Fesoterodine Fumarate tablets, Bortezomib Inj 3.5 mg, Neostigmine PFS, Potassium Chloride UD, Fexofenadine HCl + Pseudoephedrine HCl ER tablets, and Oxaliplatin Inj in Canada.

Ø We filed one ANDA during the quarter. As of 30th September 2022, cumulatively 81 generic filings are pending for approval with the USFDA (78 ANDAs and 3 NDAs under 505(b)(2) route). Out of these 81 pending filings, 42 are Para IVs and we believe 22 have ‘First to File’ status.

Europe

Revenues from Europe at Rs. 4.2 billion, with year-on-year growth of 2% and sequential quarter growth of 1%. This was driven by volume traction in base business and new product launches across our markets, however, it was partially offset by price erosion in some molecules and the impact of adverse forex rates during the quarter. We launched ten new products across countries during this quarter.

India

Revenues from India at Rs. 11.5 billion:

Ø Year-on-year growth of 1% impacted due to higher base of Q1 FY22, which included contribution from covid product sales. Adjusted for this, we have grown in double digit.
Ø Sequential quarter declined by 14% primarily on account of high base impact, as we had recognized divestment income of a few non-core brands in Q1 FY23.
Ø We launched two new products during the quarter. These were Curaprox and Stig.

Emerging Markets

Revenues from Emerging Markets at Rs. 12.2 billion. Year-on-year decline of 6% and sequential quarter growth of 36%:

Ø Revenues for Russia at Rs. 5.9 billion. Year-on-year growth of 4% was on account of new product launches, increase in sales prices and favorable movement of forex rates, partly offset by reduction in base volumes. Sequential quarter growth of 85% was primarily due to lower sales base of Q1 FY23, which was impacted due to channel inventory normalization.

Ø Revenues from other CIS countries and Romania at Rs. 2.2 billion. Year-on-year decline of 1% due to reduction in base volumes and adverse movement of forex rates, partly offset by increase in sales prices and new product launches. Sequential quarter growth of 13% was driven by increase in base volumes and new product launches, partly offset by adverse movement of forex rates.

Ø Revenues from Rest of World (RoW) markets at Rs. 4.1 billion. Year-on-year decline of 18% was on account of reduction in the covid product sales in current quarter vs. last year, decrease in sales prices, which was partly offset by new product launches. Sequential growth of 6% was driven by new product launches, partly offset by a reduction in base volumes and sales price of some of our products.

Pharmaceutical Services and Active Ingredients (PSAI)

Revenues from PSAI at Rs. 6.4 billion with a year-on-year decline of 23% and sequential decline of 9%.

Ø Year-on-year decline was primarily on account lower volumes due to higher base in Q2 FY22 which had covid product sales, partly offset by new product sales and favorable forex rates.
Ø sequential decline was majorly due to lower traction in the volumes for some of our products, partly offset by new product sales.
Ø During the quarter we filed three DMFs in the US.

Income Statement Highlights:

Ø Gross profit margin for the quarter at 59.1%:

– Increased by ~565 bps over previous year and ~920 bps sequentially, majorly driven due to product mix (including new products), accruals related to production linked incentive scheme, which was partly offset by price erosion and provision made on inventory for covid products.
– Gross profit margin for GG and PSAI business segments are at 65.4% and 3.6% respectively. Gross profit margin of PSAI have been impacted due to covid inventory provision and adverse impact of manufacturing overheads which are at similar levels over lower sales base.

Ø Selling, general & administrative (SG&A) expenses at Rs. 16.6 billion, increased by 4% on a year-on-year basis and by 7% sequentially, in line with the business growth.

Ø Research & development (R&D) expenses at Rs. 4.9 billion. As % to revenues – Q2 FY23: 7.7% | Q1 FY23: 8.3% | Q2 FY22: 7.7%. We continue to invest in R&D to build a healthy pipeline of products across our markets.

Ø Other operating income at Rs. 0.3 billion compared to Rs. 1.7 billion in Q2 FY22. Q2 FY22 was higher on account of recognition of income towards sale of rights relating to anti-cancer agent E7777 (denileukin diftitox).

Ø Net Finance expense at Rs. 156 million compared to net finance income of Rs. 319 million in Q2 FY22.

Ø Profit before Tax at Rs. 16.1 billion, increased by 27% year-on-year and by 10% sequentially.

Ø Profit after Tax at Rs. 11.1 billion. The effective tax rate is 30.9% for the quarter.

Ø Diluted earnings per share is at Rs. 66.89.

Other Highlights:

Ø EBITDA is at Rs. 19.3 billion and the EBITDA margin is 30.6%.

Ø Capital expenditure is at Rs. 2.5 billion.

Ø Free cash flow is at Rs. 5.8 billion.

ØNet cash surplus for the company is at Rs. 13.7 billion as on September 30, 2022. Consequently, net debt to equity ratio is (0.07).

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