Reaffirms Total Revenue Guidance of $100 Million for 2017
Conference Call Today at 8:30 AM ET
REHOVOT, Israel, Aug. 01, 2017 (GLOBE NEWSWIRE) -- Kamada Ltd. (Nasdaq:KMDA) (TASE:KMDA), a plasma-derived protein therapeutics company focused on orphan indications, today announced financial results for the three and six months ended June 30, 2017.
“Our second quarter financial performance was strong, and the momentum in our business is solid,” said Amir London, Kamada’s Chief Executive Officer. “Total quarterly revenues of $33 million represented a year-over-year increase of 71%. These revenues included approximately $11.5 million in sales that were delayed from the first quarter. Our revenues for the first six months of 2017 were $44 million, which was an increase of 31% over the first six months of 2016. In addition, gross margins for the second quarter 2017 increased to 36% from 30% in the second quarter last year. GLASSIA®, our intravenous Alpha-1 Antitrypsin (AAT) for the treatment of Alpha-1 Antitrypsin Deficiency (AATD), continues to be the major growth driver in our Proprietary Products segment and overall business. Based on our continued solid financial performance, we remain confident in our ability to reach $100 million in total revenue this year. We also expect to be cash flow positive this year and, with the additional funds raised in our recent follow-on offering, we will have sufficient capital resources to support our strategic plans.”
“We are also pleased to have an upcoming PDUFA date of August 29, 2017, for the completion of the review of the BLA for Kamada’s Anti-Rabies IgG, and we are looking forward to launching this product in the US in collaboration with Kedrion, our strategic partner, if approved by the FDA, before the end of this year,” continued Mr. London. “We have multiple additional expected upcoming clinical milestones, including a U.S. Phase 3 pivotal clinical trial for our proprietary inhaled AAT for the treatment of AATD, and a combined U.S. and European Phase 2/3 clinical trial for our G1-AAT IV for the treatment of acute Graft-Versus-Host Disease (GvHD), both of which we intend to initiate in 2018. We also expect top-line results from our Phase 2 trial for D1-AAT IV for the treatment of newly diagnosed Type-1 Diabetes in the second half of 2017.”
Financial Highlights for the Three Months Ended June 30, 2017:
- Total revenues were $32.5 million, a 71% increase from the $19.1 million reported in the second quarter of 2016.
- Revenues from the Proprietary Products segment were $26.9 million, a 122% increase from the $12.1 million reported in the second quarter of 2016. This included approximately $11.5 million in revenues that were delayed from the first quarter of 2017.
- Revenues from the Distributed Products segment were $5.7 million, an 18% decrease from the $7.0 million reported in the second quarter of 2016.
- Gross profit was $11.7 million, a 108% increase from the $5.6 million reported in the second quarter of 2016.
- Gross margin increased to 36% from 30% in the second quarter of 2016.
- Net income was $4.9 million, or $0.13 per share, compared to a net loss of $1.6 million, or a loss of $0.04 per share, in the second quarter of 2016.
- Adjusted net income was $5.1 million compared to adjusted net loss of $1.3 million in the second quarter of 2016.
Financial Highlights for the Six Months Ended June 30, 2017:
- Total revenues were $44.2 million, a 31% increase from $33.9 million in the first six months of 2016.
- Revenues from the Proprietary Products segment were $33.5 million, a 44% increase from $23.2 million in the first six months of 2016.
- Gross profit was $14.0 million, a 35% increase from the $10.4 million reported in the first six months of 2016.
- Gross margin increased to 32% from 31% in the first six months of 2016.
- Net income was $0.9 million, or $0.02 per share, compared to a net loss of $3.9 million, or a loss of $0.11 per share, in the same period of 2016.
- Adjusted net income was $1.3 million compared to an adjusted net loss of $3.2 million in the same period of 2016.
Recent Corporate Highlights:
- Submitted to the U.S. Food and Drug Administration (FDA) for review a proposed pivotal Phase 3 protocol for Kamada’s proprietary inhaled AAT therapy for the treatment of AATD. The Company expects a response from the FDA shortly in regards to the proposed protocol. If approved to move forward by the FDA, Kamada intends to proceed with a U.S. Phase 3 pivotal clinical trial as quickly as possible.
- Following discussions with the European Medicines Agency in regards to the study results of Kamada’s Phase 2/3 study in the EU with Inhaled AAT to treat AATD, the Company recently withdrew the Marketing Authorization Application in Europe. Kamada intends to resubmit the application, should the results of the Company’s planned Phase 3 U.S. pivotal study of inhaled AAT for AATD support this plan.
- Reached an agreement with Shire whereby the Investigational New Drug application approved by the FDA for the Phase 2/3 study evaluating Alpha-1 Antitrypsin (G1-AAT IV) for the treatment of acute Graft-Versus-Host Disease (GvHD) will be transferred from Shire to Kamada. Kamada will take full ownership and responsibility for the clinical development of the product in this indication. The Company expects to initiate a combined U.S. and European Phase 2/3 trial in 2018, following the completion of standardizing the study design across both territories.
- Received an undisclosed milestone payment from Shire under the supply and distribution agreement for GLASSIA®, Kamada’s intravenous (IV) Alpha-1 Antitrypsin (AAT). The milestone payment was triggered by Shire achieving a sales milestone for GLASSIA® in the U.S.
- Presented updated Phase 2 clinical trial data of the Company’s proprietary inhaled AAT therapy for the treatment of AATD at the 2017 American Thoracic Society International Conference.
- Appointed Michal Stein, M.D., as Vice President and Medical Director for Immunology. Dr. Stein will lead Kamada’s medical affairs in all of the Company’s Immunology and specific IgG products and indications, such as Type-1 Diabetes, GvHD, transplantations, and Anti-Rabies IgG.
Upcoming Milestones:
- PDUFA date of August 29, 2017 for the completion of the review of the BLA for Anti-Rabies IgG therapy.
- Expect to receive FDA approval to conduct a pivotal Phase 3 trial for inhaled AAT.
- Last patient enrolled in February 2017 in the Company’s Type-1 Diabetes Phase 2 trial; top-line results anticipated in the second half of 2017.
- Completed patient recruitment in the Company’s lung transplantation Phase 2 trial; expect to have an interim report from this trial in the second half of 2017.
- Anticipate submitting Clinical Trial Application for IV AAT in GvHD in Europe in the second half of 2017, and initiating the combined U.S. and European trial in 2018.
Second Quarter 2017 Financial Results Compared to Second Quarter 2016 Financial Results
Total revenues were $32.5 million, a 71% increase from the $19.1 million reported in the second quarter of 2016. Revenues from the Proprietary Products segment included approximately $11.5 million in revenues that were delayed from the first quarter, and were $26.9 million, a 122% increase from the $12.1 million reported in the second quarter of 2016. Revenues from the Distributed Products segment were $5.7 million, an 18% decrease from the $7.0 million reported in the second quarter of 2016.
Gross profit was $11.7 million, a 108% increase from the $5.6 million reported in the second quarter of 2016. Gross margin increased to 36% from 30% in the second quarter of 2016, primarily as a result of an increase in revenues from the Proprietary Products segment.
R&D expenses in the second quarter of 2017 were $3.5 million, essentially flat as compared to the second quarter of 2016. Selling, general and administrative expenses were $3.2 million, up 18% from the $2.7 million reported in the same period in 2016. Operating income in the second quarter of 2017 was $5.0 million, compared to the $0.6 million operating loss recorded in the same period of 2016. Net income for the second quarter of 2017 was $4.9 million, or $0.13 per diluted share, compared to a net loss of $1.6 million, or loss of $0.04 per diluted share, in the same period of 2016.
Adjusted EBITDA for the second quarter of 2017 was $6.1 million, compared with Adjusted EBITDA for the second quarter of 2016 of $0.6 million. Adjusted net income for the second quarter of 2017 was $5.1 million, compared with an adjusted net loss of $1.3 million in the second quarter of 2016.
Six Months Ended June 30, 2017 vs. June 30, 2016
Total revenues were $44.2 million, a 31% increase from the $33.9 million reported in the first six months of 2016. Revenues from the Proprietary Products segment were $33.5 million, a 44% increase from the $23.2 million reported in the six month period of 2016. Revenues from the Distributed Products segment were $10.7 million, essentially flat with the $10.6 million reported in the six month period of 2016.
Gross profit was $14.0 million, a 35% increase from the $10.4 million reported in the six month period of 2016. Gross margin increased to 32% from 31% in the six month period of 2016.
R&D expenses were $6.6 million, a decrease of 13% as compared to $7.6 million in the same period of 2016. Selling, general and administrative expenses were $6.1 million, an increase of 13% compared to $5.4 million in the same period of 2016. The Company reported operating income of $1.3 million, compared with an operating loss of $2.6 million in the same period of 2016. Net income was $0.9 million, or $0.02 per diluted share, compared with a net loss of $3.9 million, or $0.11 per diluted share, in the same period of 2016.
Adjusted EBITDA was $3.5 million, compared with negative Adjusted EBITDA of $0.2 million for the same period of 2016. Adjusted net income was $1.3 million compared to an adjusted net loss of $3.2 million in the six month period of 2016.
Balance Sheet Highlights
As of June 30, 2017, the Company had cash, cash equivalents and short term investments of $26.9 million, compared with $28.6 million as of December 31, 2016. Kamada generated $0.4 million of cash from operations and used $1.9 million for capital expenditures in the second quarter of 2017.
2017 Revenue Guidance
For the year ending December 31, 2017, Kamada continues to expect total revenues to be $100 million, with Proprietary Products revenues between $76 and $78 million and Distributed Products revenues between $22 and $24 million.
Conference Call
Kamada management will host an investment community conference call at 8:30am Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by dialing 888-221-9591 (from within the U.S.), 1 80 924 6042 (from Israel), or 719-325-4893 (International) and entering the conference identification number: 2753969. The call will also be webcast live on the Internet on the Company’s website at www.kamada.com.
A replay of the call will be accessible two hours after its completion through August 15 by dialing 844-512-2921 (from within the U.S.) or 412-317-6671 (from outside the U.S.) and entering the conference identification number: 2753969. The call will also be archived for 90 days on the Company’s website at www.kamada.com.
About Kamada
Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and has a commercial product portfolio and a robust late-stage product pipeline. The Company uses its proprietary platform technology and know-how for the extraction and purification of proteins from human plasma to produce Alpha-1 Antitrypsin (AAT) in a highly-purified, liquid form, as well as other plasma-derived Immune globulins. AAT is a protein derived from human plasma with known and newly-discovered therapeutic roles given its immunomodulatory, anti-inflammatory, tissue-protective and antimicrobial properties.
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