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Reaffirms Total Revenue Guidance of $100 Million for 2017
Conference Call Today at 8:30 AM ET
REHOVOT, Israel – August 1, 2017 — Kamada Ltd. (Nasdaq: KMDA) (KMDA.TA), a plasmaderived 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:
8226; Total revenues were $32.5 million, a 71% increase from the $19.1 million reported in the
second quarter of 2016.
8226; 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.
8226; 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.
8226; Gross profit was $11.7 million, a 108% increase from the $5.6 million reported in the second
quarter of 2016.
8226; Gross margin increased to 36% from 30% in the second quarter of 2016.
8226; 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.
8226; 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:
8226; Total revenues were $44.2 million, a 31% increase from $33.9 million in the first six
months of 2016.
8226; Revenues from the Proprietary Products segment were $33.5 million, a 44% increase
from $23.2 million in the first six months of 2016.
8226; Gross profit was $14.0 million, a 35% increase from the $10.4 million reported in the
first six months of 2016.
8226; Gross margin increased to 32% from 31% in the first six months of 2016.
8226; 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.
8226; 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:
8226; 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.
8226; 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.
8226; 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.
8226; 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.
8226; 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.
8226; 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:
8226; PDUFA date of August 29, 2017 for the completion of the review of the BLA for anti-rabies
IgG therapy.
8226; Expect to receive FDA approval to conduct a pivotal Phase 3 trial for Inhaled AAT.
8226; 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.
8226; 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.
8226; 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 to $78 million and Distributed Products
revenues between $22 to $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, tissueprotective and antimicrobial properties. The Company's flagship product is GLASSIA®, the first and only liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. Food and Drug Administration. Kamada markets GLASSIA® in the U.S. through a strategic partnership with Baxalta (now part of Shire plc) and in other counties through local distributors. In addition to GLASSIA®, Kamada has a product line of seven other pharmaceutical products administered by injection or infusion, that are marketed through distributors in more than 15 countries, including Israel, Russia, Brazil, India and other countries in Latin America and Asia. Kamada has five latestage plasma-derived protein products in development, including an inhaled formulation of AAT for the treatment of AAT deficiency for which a MAA was submitted to the EMA after completing a pivotal Phase 2/3 clinical trials in Europe. Kamada has also completed its Phase 2 clinical trials in the U.S for the treatment of AAT deficiency with inhaled AAT. In addition, Kamada's intravenous AAT is in development for other indications such as type-1 diabetes, GvHD and prevention of lung transplant rejection. Kamada also leverages its expertise and presence in the plasma-derived protein therapeutics market by distributing more than 10 complementary products in Israel that are manufactured by third parties.
Cautionary Note Regarding Forward-Looking Statements
This release includes forward-looking statements within the meaning of Section 27A of the U.S.
Securities Act of 1933, as amended, Section 21E of the U.S. Securities Exchange Act of 1934, as
amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of
1995. Forward-looking statements are statements that are not historical facts, such as statements
regarding assumptions and results related to financial results forecast, commercial results, timing
and results of clinical trials and EMA and U.S. FDA submissions and authorizations.
Forwardlooking
statements are based on Kamada's current knowledge and its present beliefs and
expectations regarding possible future events and are subject to risks, uncertainties and
assumptions. Actual results and the timing of events could differ materially from those anticipated
in these forward-looking statements as a result of several factors including, but not limited to,
unexpected results of clinical trials, delays or denial in the U.S. FDA or the EMA approval process,
additional competition in the AATD market or further regulatory delays. The forward-looking
statements made herein speak only as of the date of this announcement and Kamada undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or
circumstances, except as otherwise required by law.
CONTACTS:
Gil Efron
Deputy CEO & Chief Financial Officer
IR@kamada.com
Bob Yedid
LifeSci Advisors, LLC
646-597-6989
Bob@LifeSciAdvisors.com