Kamada (KMDA)

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Kamada Reports Fiscal Year and Fourth Quarter 2021 Financial Results; Provides Revenue and Profitability Guidance with Significant Growth Expected in 2022

https://finance.yahoo.com/news/kamada-reports-fiscal-fourth-quarter-110000920.html

Total Revenues for Fiscal Year 2021 were $103.6 Million and Fourth Quarter 2021 Revenues were $31.5 Million.

Fiscal Year 2022 Revenues are Expected to Range Between $125 Million to $135 Million, Representing a 20% to 30% Increase over 2021; 2022 EBITDA Margins Anticipated Between 12%-15%, Representing More Than 2.5X over 2021 EBITDA.

Integration of Newly Acquired Portfolio of Four FDA-Approved Commercial Products is Progressing as Planned with Expanded Sales in International Markets.

Advancing the Plan for the Opening of New U.S. Plasma Collection Centers.

Company Expands U.S. Leadership Team with Multiple Key Hires to Drive Sales of Proprietary Products and Expansion of Plasma Collection Operations.

Added Two New Biosimilar Product Candidates in Israel; Increasing the Expected Potential Collective Annual Peak Sales of the Entire Biosimilar Portfolio of 11 Product Candidates to over $40 Million.

Pivotal Phase 3 InnovAATe Trial for Inhaled AAT for the Treatment of Alpha-1 Antitrypsin Deficiency Progressing with the Opening of New Sites to Expand Recruitment.

GLASSIA® Royalty Payments from Takeda to Commence During Q2 2022.

REHOVOT, Israel, March 15, 2022 (GLOBE NEWSWIRE) -- Kamada Ltd. (NASDAQ: KMDA; TASE: KMDA.TA), a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, today announced financial results for the 12 and three months ended December 31, 2021.

"2021 was a transformational year for Kamada in our path toward becoming a global leader in the plasma-derived specialty hyperimmune market. With the recent acquisition of the portfolio of four FDA-approved commercial products, that generated annual global revenue in 2021 of approximately $41.9 million with over 50% gross margins of which approximately $5.4 million of revenue was recognized by the Company, and the establishment of Kamada Plasma, our U.S. based plasma collection company, we are embarking on a new and exciting chapter in the company’s evolution. We are building on the strong foundation established over the years and entering 2022 as a "New Kamada" – a fully integrated specialty plasma company, with six FDA-approved products and strong commercial capabilities in the U.S. market, as well as a global commercial footprint in over 30 countries," said Amir London, Kamada’s Chief Executive Officer.

"Our business performed as expected during 2021, and we look ahead to 2022 for which our revenue guidance is between $125 million to $135 million, representing a 20% to 30% growth compared to 2021, with expected EBITDA margins of 12% to 15%, which would represent more than 2.5x of the 2021 EBITDA. This strong guidance reflects the benefits stemmed from our new undertaken strategic direction and our expectation of rapid return to revenue and profitability growth in 2022. We further expect continued growth at a double-digit rate in the foreseeable years ahead."

“I am happy to report that over the past few months we have made significant progress with all our key growth catalysts, and we are implementing the needed steps to realize our significant growth potential. The integration of the newly acquired immunoglobulins portfolio is well underway in the U.S., as well as in the international markets. We are progressing with our plans for the opening of new plasma collection centers in the U.S. We have expanded our portfolio of Biosimilar product candidates to be distributed in the Israeli market, increasing our expected peak potential annual biosimilar sales, within several years of launch, to over $40 million. In addition, we are expanding our inhaled AAT pivotal Phase 3 trial with up to six additional clinical sites to be opened by mid-2022. Further, commencing in the second quarter of 2022, we are expecting to begin receiving GLASSIA royalty payments from Takeda, improving our profitability and cash position," concluded Mr. London.

Fiscal Year 2022 Guidance
Kamada currently expects to generate fiscal year 2022 total revenues in a range of $125 million to $135 million which would represent a 20% to 30% growth compared to fiscal year 2021. The Company also anticipates generating EBITDA, during 2022, at a rate of 12% to 15% of total revenues, representing more than 2.5x of the EBITDA for the year ended December 31, 2021.

Financial Highlights for the Year Ended December 31, 2021

Total revenues were $103.6 million in the year ended December 31, 2021, as compared to $133.2 million recorded in the year ended December 31, 2020. This decrease was primarily due to the transition of GLASSIA manufacturing to Takeda resulting in an overall $38.7 million year over year decrease, and a year over year decrease of $6.4 million in KEDRAB sales to Kedrion as a result of a high level of product inventory at Kedrion as of December 31, 2020, due to the COVID-19 pandemic effect on KEDRAB sales by Kedrion during 2020. These decreases were partially offset by $5.4 million of revenues generated from the newly acquired portfolio between November 22, 2021, through December 31, 2021, as well as an increase in revenues of our other Proprietary products.

Gross profit was $30.3 million in the year ended December 31, 2021, compared to $47.6 million reported in the year ended December 31, 2020. The decrease compared to 2020 is primarily attributed to the overall change in product sales mix, specifically the decrease in sales of GLASSIA to Takeda and KEDRAB to Kedrion (as detailed above).

Net loss was $2.2 million, or $(0.05) per share, in the year ended December 31, 2021, as compared to net income of $17.1 million, or $0.38 per share, in the year ended December 31, 2020.

EBITDA, as detailed in the tables below, was $5.4 million in the year ended December 31, 2021, as compared to $25.1 million in the year ended December 31, 2020. Adjusted EBITDA, excluding certain costs, as detailed in the tables below, was $7.2 million for the year ended December 31, 2021.

Non-IFRS adjusted EBITDA for the year ended December 31, 2021, as detailed in the reconciliation table below, is presented excluding the following: (i) approximately $1.2 million in legal and other related fees associated with completing the acquisition transactions; and (ii) an expense of approximately $0.6 million related to excess severance remuneration for the employees who were laid-off as part of downsizing, following the transition of GLASSIA manufacturing to Takeda.

Cash used in operating activities was $8.8 million in the year ended December 31, of 2021, as compared to cash provided by operating activities of $19.1 million in the year ended December 31, 2020.

Financial Highlights for the Three Months Ended December 31, 2021

Total revenues were $31.5 million in the fourth quarter of 2021, equivalent to the revenues recorded in the fourth quarter of 2020.

Gross profit was $6.6 million in the fourth quarter of 2021, compared to $10.2 million reported in the fourth quarter of 2020.

Net loss was $5.0 million, or $(0.11) per share, in the fourth quarter of 2021, as compared to net income of $1.6 million, or $0.04 per share, in the fourth quarter of 2020.

EBITDA, as detailed in the tables below, was $(1.3) million in the fourth quarter of 2021, as compared to $4.0 million in the fourth quarter of 2020. Adjusted EBITDA, excluding certain costs, as detailed in the table below, was $(0.5) million in the fourth quarter of 2021.

Non-IFRS adjusted EBITDA for the fourth quarter of 2021, as detailed in the reconciliation table below, is presented excluding approximately $0.7 million in legal and other related fees associated with completing the acquisitions transaction.

Cash used in operating activities was $5.0 million in the fourth quarter of 2021, as compared to cash provided by operating activities of $12.7 million in the fourth quarter of 2020.

Balance Sheet Highlights
As of December 31, 2021, the Company had cash, cash equivalents, and short-term investments of $18.6 million, as compared to $109.3 million on December 31, 2020. The primary use of cash during 2021 was the acquisition of four FDA-approved plasma-derived hyperimmune commercial products. Kamada’s working capital as of December 31, 2021, comprising of current assets (excluding cash and cash equivalents, and short-term investments) net of current liabilities, totaled $57.4 million, representing an increase of $13.7 million compared to December 31, 2020.

The Company secured a $40 million credit facility from Bank Hapoalim, Israel’s leading commercial bank. The credit facility is comprised of a $20 million 5-year term loan and a $20 million short-term revolving credit facility. As of December 31, 2021, the Company drew-down the entire long-term loan and did not utilize the short-term revolving credit facility.

Conference Call
Kamada management will host an investment community conference call on Tuesday, March 15, 2022, at 8:30am Eastern Time to present the Company’s results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 877-407-0792 (from within the U.S.), 1-809-406-247 (from Israel), or 201-689-8263 (International) and entering the conference identification number: 13727620. The call will also be webcast live on the Internet at:
https://viavid.webcasts.com/starthere.jsp?ei=1533883&tp_key=876a5d54ec

Non-IFRS financial measures
We present EBITDA and adjusted EBITDA because we use this non-IFRS financial measure to assess our operational performance, for financial and operational decision-making, and as a means to evaluate period-to-period comparisons on a consistent basis. Management believes this non-IFRS financial measure are useful to investors because: (1) they allow for greater transparency with respect to key metrics used by management in its financial and operational decision-making and provide investors with a meaningful perspective on the current underlying performance of the Company’s core ongoing operations; and (2) they exclude the impact of certain items that are not directly attributable to our core operating performance and that may obscure trends in the core operating performance of the business. Non-IFRS financial measures have limitations as an analytical tool and should not be considered in isolation from, or as a substitute for, our IFRS results. We expect to continue reporting non-IFRS financial measures, adjusting for the items described below, and we expect to continue to incur expenses similar to certain of the non-cash, non-IFRS adjustments described below. Accordingly, unless otherwise stated, the exclusion of these and other similar items in the presentation of non-IFRS financial measures should not be construed as an inference that these items are unusual, infrequent or non-recurring. EBITDA and adjusted EBITDA are not recognized terms under IFRS and do not purport to be an alternative to IFRS terms as an indicator of operating performance or any other IFRS measure. Moreover, because not all companies use identical measures and calculations, the presentation of EBITDA and adjusted EBITDA may not be comparable to other similarly titled measures of other companies. EBITDA and adjusted EBITDA are defined as net income (loss), plus income tax expense, plus or minus financial income or expenses, net, plus or minus income or expense in respect of securities measured at fair value, net, plus or minus income or expenses in respect of currency exchange differences and derivatives instruments, net, plus depreciation and amortization expense, plus non-cash share-based compensation expenses and certain other costs.

About Kamada
Kamada Ltd. (the “Company”) is a vertically integrated global biopharmaceutical company, focused on specialty plasma-derived therapeutics, with a diverse portfolio of marketed products, a robust development pipeline and industry-leading manufacturing capabilities. The Company’s strategy is focused on driving profitable growth from our current commercial activities as well as our manufacturing and development expertise in the plasma-derived biopharmaceutical market. The Company’s commercial products portfolio includes its developed and FDA approved products GLASSIA® and KEDRAB® as well as its recently acquired FDA approved plasma-derived hyperimmune products CYTOGAM®, HEPAGAM B®, VARIZIG® and WINRHO®SDF. The Company has additional four plasma-derived products which are registered in markets outside the U.S. The Company distributes its commercial products portfolio directly, and through strategic partners or third-party distributors in more than 30 countries, including the U.S., Canada, Israel, Russia, Brazil, Argentina, India and other countries in Latin America and Asia. The Company has a diverse portfolio of development pipeline products including an inhaled AAT for the treatment of AAT deficiency for which the Company is currently conducting the InnovAATe clinical trial, a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. The Company leverages its expertise and presence in the Israeli pharmaceutical market to distribute in Israel more than 20 products that are manufactured by third parties and have recently added eleven biosimilar products to its Israeli distribution portfolio, which, subject to EMA and the Israeli MOH approvals, are expected to be launched in Israel between the years 2022 and 2028. FIMI Opportunity Fund, the leading private equity investor in Israel, is the Company’s lead shareholder, beneficially owning approximately 21% of the outstanding ordinary shares.