UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO RULE 13a-16 OR 15d-16 UNDER THE
SECURITIES EXCHANGE ACT OF 1934
For the month of January, 2022
Commission File Number 001-35463
Taro Pharmaceutical Industries Ltd.
(Translation of registrant’s name into English)
14 Hakitor Street, Haifa Bay 2624761, Israel
(Address of principal executive office)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F Form 40-F
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): _____
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): _____
| Taro Pharmaceutical Industries Ltd. |
c/o Taro Pharmaceuticals U.S.A., Inc. | |
Three Skyline Drive | |
Hawthorne, New York 10532 | |
(NYSE: TARO) |
FOR IMMEDIATE RELEASE
CONTACTS:
William J. Coote VP, Chief Financial Officer (914) 345-9001 William.Coote@taro.com |
|
TARO PROVIDES RESULTS FOR DECEMBER 31, 2021
Hawthorne, NY, January 27, 2022 ─ Taro Pharmaceutical Industries Ltd. (NYSE: TARO) (“Taro” or the “Company”) today provided unaudited financial results for the quarter and nine months ended December 31, 2021.
Quarter ended December 31, 2021 Highlights ─ compared to December 31, 2020
Nine Months ended December 31, 2021 Highlights ─ compared to December 31, 2020
Cash Flow and Balance Sheet Highlights
Mr. Uday Baldota, Taro’s CEO, stated, “Despite the challenging market conditions, particularly in the U.S. generic market, we successfully defended our market share across each business. Our current quarter and nine month performance reflects this. With the intent of ever strengthening the future, we remain focused on high return R&D investments as well as the exploration of new business development opportunities.”
FDA Approvals and Filings
The Company recently received approvals from the U.S. Food and Drug Administration (“FDA”) for the Abbreviated New Drug Applications (“ANDAs”): Sildenafil Powder for Oral Suspension, 10 mg/mL and Adapalene Gel, USP 0.1%. The Company currently has a total of seventeen ANDAs awaiting FDA approval, including four tentative approvals.
Taro Pharmaceuticals U.S.A., Inc. (“Taro USA”) Signs Settlement Agreement with the Direct Purchaser Plaintiffs
Taro USA entered into a settlement agreement with the direct purchaser class on November 4, 2021, which, if approved by the court, will resolve all claims brought by the direct purchaser class against Taro USA and its parents, affiliates, officers and directors in the In re: Generic Pharmaceuticals Pricing Antitrust Litigation. Under the terms of the settlement agreement, Taro USA will pay a maximum of $67.6 million, subject to a reduction of up to $8.0 million depending on the decisions of certain class members to opt out of the settlement. The settlement is subject to approval by the court.
The Company cautions that the foregoing financial information is presented on an unaudited basis and is subject to change.
************************
About Taro
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company, dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products. For further information on Taro Pharmaceutical Industries Ltd., please visit the Company’s website at www.taro.com.
SAFE HARBOR STATEMENT
The unaudited consolidated financial statements have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments necessary to present fairly the financial condition and results of operations of the Company. The unaudited consolidated financial statements should be read in conjunction with the Company’s audited consolidated financial statements included in the Company’s Annual Report on Form 20-F, as filed with the SEC.
Certain statements in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements that do not describe historical facts or that refer or relate to events or circumstances the Company “estimates,” “believes,” or “expects” to happen or similar language, and statements with respect to the Company’s financial performance, availability of financial information, and estimates of financial results and information for fiscal year 2022. Although the Company believes the expectations reflected in such forward-looking statements to be based on reasonable assumptions, it can give no assurances that its expectations will be attained. Factors that could cause actual results to differ include general domestic and international economic conditions, industry and market conditions, changes in the Company's financial position, litigation brought by any party in any court in Israel, the United States, or any country in which Taro operates, regulatory and legislative actions in the countries in which Taro operates, and other risks detailed from time to time in the Company’s SEC reports, including its Annual Reports on Form 20-F. Forward-looking statements are applicable only as of the date on which they are made. The Company undertakes no obligations to update, change or revise any forward-looking statement, whether as a result of new information, additional or subsequent developments or otherwise.
**Financial Tables Follow**
TARO PHARMACEUTICAL INDUSTRIES LTD.
SUMMARY CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
(U.S. dollars in thousands, except share data)
| Quarter Ended |
|
| Nine Months Ended |
| ||||||||||
| December 31, |
|
| December 31, |
| ||||||||||
| 2021 |
|
| 2020 |
|
| 2021 |
|
| 2020 |
| ||||
Sales, net | $ | 138,984 |
|
| $ | 140,145 |
|
| $ | 418,083 |
|
| $ | 400,622 |
|
Cost of sales |
| 62,937 |
|
|
| 66,957 |
|
|
| 202,293 |
|
|
| 180,900 |
|
Impairment |
| 13 |
|
|
| — |
|
|
| 13 |
|
|
| — |
|
Gross profit |
| 76,034 |
|
|
| 73,188 |
|
|
| 215,777 |
|
|
| 219,722 |
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
| ||||
Research and development |
| 14,201 |
|
|
| 14,081 |
|
|
| 39,648 |
|
|
| 43,565 |
|
Selling, marketing, general and administrative |
| 24,841 |
|
|
| 22,798 |
|
|
| 72,501 |
|
|
| 69,121 |
|
Settlements and loss contingencies |
| 26 |
|
|
| — |
|
|
| 61,446 |
|
|
| 478,924 |
|
Operating income (loss) * |
| 36,966 |
|
|
| 36,309 |
|
|
| 42,182 |
|
|
| (371,888 | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Financial income, net: |
|
|
|
|
|
|
|
|
|
|
| ||||
Interest and other financial income |
| (2,090 | ) |
|
| (4,001 | ) |
|
| (7,501 | ) |
|
| (16,989 | ) |
Foreign exchange expense |
| 544 |
|
|
| 2,036 |
|
|
| 555 |
|
|
| 1,207 |
|
Other gain, net |
| 990 |
|
|
| 863 |
|
|
| 3,714 |
|
|
| 2,792 |
|
Income (loss) before income taxes |
| 39,501 |
|
|
| 39,137 |
|
|
| 52,842 |
|
|
| (353,313 | ) |
Tax expense |
| 13,188 |
|
|
| 6,101 |
|
|
| 21,980 |
|
|
| 18,545 |
|
Net income (loss) |
| 26,313 |
|
|
| 33,036 |
|
|
| 30,862 |
|
|
| (371,858 | ) |
Net income (loss) attributable to non-controlling interest |
| — |
|
|
| 117 |
|
|
| — |
|
|
| (14,991 | ) |
Net income (loss) attributable to Taro * | $ | 26,313 |
|
| $ | 32,919 |
|
| $ | 30,862 |
|
| $ | (356,867 | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Net income (loss) per ordinary share attributable to Taro: |
|
|
|
|
|
|
|
|
|
|
| ||||
Basic and Diluted * | $ | 0.70 |
|
| $ | 0.86 |
|
| $ | 0.82 |
|
| $ | (9.33 | ) |
|
|
|
|
|
|
|
|
|
|
|
| ||||
Weighted-average number of shares used to compute net income (loss) per share: |
|
|
|
|
|
|
|
|
|
|
| ||||
Basic and Diluted |
| 37,584,891 |
|
|
| 38,254,231 |
|
|
| 37,659,478 |
|
|
| 38,256,963 |
|
|
|
|
|
|
|
|
|
|
|
|
| ||||
May not foot due to rounding. |
|
|
|
|
|
|
|
|
|
|
|
* Excluding the settlement and loss contingencies charges of $61.4 million and $478.9 million for the nine months ended December 31, 2021 and 2020, Operating income was $103.6 million and $107.0 million, Net income attributable to Taro was $99.2 million and $107.1 million, and basic and diluted earnings per share was $2.64 and $2.80, respectively.
TARO PHARMACEUTICAL INDUSTRIES LTD.
SUMMARY CONSOLIDATED BALANCE SHEETS
(U.S. dollars in thousands)
| December 31, |
|
| December 31, |
| ||
| 2021 |
|
| 2020 |
| ||
ASSETS | (unaudited) |
|
| (audited) |
| ||
CURRENT ASSETS: |
|
|
|
|
| ||
Cash and cash equivalents | $ | 318,103 |
|
| $ | 605,177 |
|
Short-term and current maturities of long-term bank deposits |
| 35,573 |
|
|
| — |
|
Marketable securities |
| 433,403 |
|
|
| 418,480 |
|
Accounts receivable and other: |
|
|
|
|
| ||
Trade, net |
| 224,666 |
|
|
| 213,539 |
|
Other receivables and prepaid expenses |
| 43,047 |
|
|
| 53,347 |
|
Inventories |
| 182,446 |
|
|
| 180,292 |
|
TOTAL CURRENT ASSETS |
| 1,237,238 |
|
|
| 1,470,835 |
|
Marketable securities |
| 536,348 |
|
|
| 557,209 |
|
Property, plant and equipment, net |
| 193,995 |
|
|
| 205,508 |
|
Deferred income taxes |
| 125,659 |
|
|
| 142,007 |
|
Other assets |
| 29,779 |
|
|
| 31,314 |
|
TOTAL ASSETS | $ | 2,123,019 |
|
| $ | 2,406,873 |
|
|
|
|
|
|
| ||
LIABILITIES AND SHAREHOLDERS' EQUITY |
|
|
|
|
| ||
CURRENT LIABILITIES: |
|
|
|
|
| ||
Trade payables | $ | 43,685 |
|
| $ | 61,166 |
|
Other current liabilities |
| 351,108 |
|
|
| 615,135 |
|
TOTAL CURRENT LIABILITIES |
| 394,793 |
|
|
| 676,301 |
|
Deferred taxes and other long-term liabilities |
| 31,672 |
|
|
| 35,115 |
|
TOTAL LIABILITIES |
| 426,465 |
|
|
| 711,416 |
|
|
|
|
|
|
| ||
Taro shareholders' equity |
| 1,696,554 |
|
|
| 1,703,649 |
|
Non-controlling interest |
| — |
|
|
| (8,192 | ) |
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY | $ | 2,123,019 |
|
| $ | 2,406,873 |
|
TARO PHARMACEUTICAL INDUSTRIES LTD.
SUMMARY CONSOLIDATED STATEMENT OF CASH FLOWS
(Unaudited)
(U.S. dollars in thousands)
| Nine Months Ended December 31, |
| |||||
| 2021 |
|
| 2020 |
| ||
Cash flows from operating activities: |
|
|
|
|
| ||
Net income (loss) | $ | 30,862 |
|
| $ | (371,858 | ) |
Adjustments required to reconcile net income (loss) to net cash used in operating activities: |
|
|
|
|
| ||
Depreciation and amortization |
| 19,248 |
|
|
| 17,337 |
|
Impairment of long-lived assets |
| 13 |
|
|
| — |
|
Realized loss on sale of long-lived assets |
| 551 |
|
|
| — |
|
Change in derivative instruments, net |
| (536 | ) |
|
| (390 | ) |
Effect of change in exchange rate on marketable securities and bank deposits |
| (39 | ) |
|
| (4,288 | ) |
Deferred income taxes, net |
| 15,003 |
|
|
| (31,877 | ) |
(Increase) decrease in trade receivables, net |
| (11,129 | ) |
|
| 6,395 |
|
Increase in inventories, net |
| (2,154 | ) |
|
| (16,454 | ) |
Decrease (increase) in other receivables, income tax receivables, prepaid expenses and other |
| 10,973 |
|
|
| (11,962 | ) |
(Decrease) increase in trade, income tax, accrued expenses and other payables |
| (270,482 | ) |
|
| 405,233 |
|
Expense from amortization of marketable securities bonds, net |
| 7,734 |
|
|
| 2,579 |
|
Net cash used in operating activities |
| (199,956 | ) |
|
| (5,285 | ) |
|
|
|
|
|
| ||
Cash flows from investing activities: |
|
|
|
|
| ||
Purchase of plant, property & equipment, net |
| (9,121 | ) |
|
| (14,210 | ) |
Investment in other intangible assets |
| (120 | ) |
|
| (117 | ) |
Investment in short-term bank deposits, net |
| (35,573 | ) |
|
| — |
|
(Investment in) proceeds from marketable securities, net |
| (17,161 | ) |
|
| 60,122 |
|
Net cash (used in) provided by investing activities |
| (61,975 | ) |
|
| 45,795 |
|
|
|
|
|
|
| ||
Cash flows from financing activities: |
|
|
|
|
| ||
Purchase of treasury stock |
| (24,934 | ) |
|
| (3,243 | ) |
Net cash used in financing activities |
| (24,934 | ) |
|
| (3,243 | ) |
|
|
|
|
|
| ||
Effect of exchange rate changes on cash and cash equivalents |
| (209 | ) |
|
| 2,297 |
|
(Decrease) increase in cash and cash equivalents |
| (287,074 | ) |
|
| 39,564 |
|
Cash and cash equivalents at beginning of period |
| 605,177 |
|
|
| 513,354 |
|
Cash and cash equivalents at end of period | $ | 318,103 |
|
| $ | 552,918 |
|
|
|
|
|
|
| ||
Cash Paid during the year for: |
|
|
|
|
| ||
Income taxes | $ | 5,667 |
|
| $ | 24,169 |
|
Cash Received during the year for: |
|
|
|
|
| ||
Income taxes | $ | 2,351 |
|
| $ | 4,093 |
|
Non-cash investing transactions: |
|
|
|
|
| ||
Purchase of property, plant and equipment included in accounts payable | $ | 763 |
|
| $ | 453 |
|
Non-cash financing transactions: |
|
|
|
|
| ||
Purchase of treasury stock | $ | — |
|
| $ | 559 |
|
Purchase of marketable securities, net | $ | — |
|
| $ | 580 |
|
#####
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: January 27, 2022
TARO PHARMACEUTICAL INDUSTRIES LTD.
By: /s/ Uday Baldota
Name: Uday Baldota
Title: Chief Executive Officer and Director