Image source: The Motley Fool.
Kamada Ltd (KMDA -2.15%)
Q2Â 2020 Earnings Call
Aug 12, 2020, 8:30 a.m. ET
Contents:
- Prepared Remarks
- Questions and Answers
- Call Participants
Prepared Remarks:
Operator
Thank you for standing by, this is the conference operator. Welcome to the Kamada Ltd. Second Quarter 2020 Earnings Conference Call.
[Operator Instructions]
I would now like to turn the conference over to Troy Williams of LifeSci Advisors. Please go ahead.
Troy Williams -- Investor Relations, LifeSci Advisors
Thank you, and good morning, everyone. This is Troy Williams of LifeSci Advisors. Thank you all for participating in today's call.
Joining me from Kamada are Amir London, Chief Executive Officer, and Chaime Orlev, Chief Financial Officer. Earlier this morning, Kamada announced financial results for the three and six months ended June 30, 2020. If you have note received this news release, please go to the Investors page of the company's website at www.kamada.com.
Before we begin, I would like to caution that comments made during this conference call by management will contain forward-looking statements that involve risks and uncertainties regarding the operations and future results of Kamada. I encourage you to review the company's filings with the Securities and Exchange Commission, including, without limitation, the company's Forms 20-F and 6-K, which identify specific factors that may cause actual results or events to differ materially from those described in the forward-looking statements.
Furthermore, the content of this conference call contains time-sensitive information that is accurate only as of the date of the live broadcast, August 12, 2020. Kamada undertakes no obligation to revise or update any statements to reflect events or circumstances after the date of this conference call.
With that said, it is my pleasure to turn the call over to Amir London, CEO. Amir?
Amir London -- Chief Executive Officer
Thank you, Troy. My thanks also to our investors and analysts for your interest in Kamada and for participating in today's call. I hope you all are keeping safe and healthy in these challenging times.
Let me begin by discussing the significant progress we have achieved in the development of our plasma-derived immunoglobulin product as a potential therapy for COVID-19 disease. Following our announcement in June of being the first company globally with an availability of a COVID-19 IgG product for compassionate-use treatment in Israel, earlier this week, we announced initiation of a Phase 1/2 clinical study in Israel. This is an open-label, single-arm, multi-center study to assess the safety, pharmacokinetics and pharmacodynamics of our IgG product in 12 hospitalized, non-ventilated COVID-19 patients with pneumonia. Our product has also been evaluated for SARS-CoV-2 neutralization activity, and the preliminary results are highly encouraging and suggests potential high neutralization titer. Lastly, we intend to further explore the potential of our IgG product to prevent COVID-19 disease in healthy subjects at risk in a separate study.
We are very excited for this meaningful progress, and we believe our product has the potential to be an effective treatment for hospitalized non-ventilated COVID-19 patients with pneumonia, and we look forward to the results of this trial later this year. As a reminder, this milestone is part of our global collaboration agreement established in April 2020 with Kedrion Biopharma for the development, manufacturing and distribution of our IgG product as a potential treatment for COVID-19 patients. Pursuant to the collaboration between the two companies, Kedrion is responsible for the collection of COVID-19 convalescent plasma from US-recovered patients. Kedrion is already collecting the plasma through its plasma business unit, KEDPLASMA, at 23 FDA-approved centers across the United States.
We intend to expand our COVID-19 clinical development program to the US and plan to conduct a pre-IND meeting with the US FDA during the current quarter in order to obtain FDA acceptance for our proposed clinical development program. If FDA clearance of the IND is received, Kamada and Kedrion intend to initiate the clinical program in the US in early 2021.
Moving on, I'd like to report that we are accelerating our commercial and business development efforts and we are working to mitigate the effect of the planned transition of GLASSIA manufacturing to Takeda during 2021. I am optimistic that our organic commercial growth as well as additional business development opportunities, funded by our strong cash position, will result in resumed revenue and profitability growth beginning in 2023. As a reminder, we anticipate revenues of approximately $65 million from sales of GLASSIA to Takeda this year, and in the range of $25 million to $50 million in 2021 based on Takeda's supply needs. In addition, based on the agreement between the companies, upon the initiation of sales of GLASSIA manufactured by Takeda, we will receive royalty payments from Takeda at a rate of 12% on net sales through August 2025 and at a rate of 6% thereafter until 2040, with a minimum of $5 million annually for each of the years from 2022 to 2040.
In addition to GLASSIA contribution, we expect KEDRAB's revenue and US market share to continue to grow. As a reminder, KEDRAB US market share increased from approximately 10% in 2018 to approximately 20% in 2019, and it continues to grow. In addition, we anticipate continued strong contribution from our distributed product in Israel, both existing product as well as new product, which we will be launching in Israel during the next few years. Going forward, we also expect meaningful growth from our existing proprietary IgG product portfolio as well as GLASSIA in the international markets outside of the US. Moreover, the contract manufacturing agreement we signed in late 2019 for an FDA-approved commercial-stage specialty hyper-immune globulin product, which is currently in its technology-transfer phase, is expected to have significant contribution to our plant utilization and growth starting in the beginning of 2023. In addition to all of that, we believe that our leading development programs, the IgG product for COVID-19 and the Inhaled AAT, if approved, have substantial market opportunities.
Beyond the significant existing internal potential growth catalyst, we intend to utilize our strong balance sheet to identify additional business development opportunities that leverage our expertise and manufacturing capabilities. We are optimistic about the future of our business, and we are confident that our actions will generate significant shareholder value.
Let's now turn to the current status of our InnovAATe Phase 3 clinical program for our proprietary Inhaled AAT for the treatment of Alpha-1 Antitrypsin deficiency. As you will recall, we've been recruiting patients into the Phase 3 trial in Europe through February 2020. However, as we said on our last call in March, due to the effect of the COVID-19 pandemic on healthcare systems, recruitment into the study was temporarily halted. I am pleased to report today that recruitment into the study restarted in June. As a reminder, InnovAATe is a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial designed to assess efficacy and safety of Inhaled AAT in patients with Alpha-1 deficiency and moderate lung disease.
Up to 250 patients will be randomized 1:1 to receive either Inhaled AAT at a dose of 80 milligram once-daily or placebo over two years of treatment. The primary endpoint of the InnovAATe trial is lung function measured by FEV1. Secondary endpoints include changes in lung density, as measured by CT scan, as well as other parameters of disease severity, such as additional pulmonary functions, exacerbations rate and six-minute walk test.
Before I turn the call over to Chaime for his review of the second quarter and the first half of 2020 financial review, I'd like to take this opportunity and mention the recent changes in our Board of Directors, which were also announced this morning. First, I would like to thank Mr. Leon Recanati for his contribution to Kamada as an investor, Director and Chairman, an office he held for the last seven years. His continued support and contribution to Kamada, and to myself personally, was invaluable. I believe that Ms. Lilach Asher-Topilsky's nomination as Kamada's Chairperson is indicative of FIMI's confidence in the company's long-term growth prospects, market position, corporate strategy and our solid management team. Over the past several months since Lilach's appointment to Kamada Board, she's made significant contribution, and I congratulate her on her appointment, and I look forward to our continued successful corporation. As a background, the FIMI Opportunity Fund is the leading private equity investor in Israel and is Kamada's lead shareholder.
Lastly, I'm happy to welcome Professor Ari Shamiss to Kamada's Board of Directors. Ari's extensive experience as a senior executive at leading hospitals in Israel will be important in strengthening our business, including our commercial product as well as our clinical pipeline. Professor Shamiss is a highly respected healthcare authority in Israel, and we look forward to his significant contribution to Kamada.
With that, I'll now ask Chaime to review our financial results. Chaime?
Chaime Orlev -- Chief Financial Officer
Thank you, Amir, and good day, everyone.
We continue to be pleased with the momentum in our business, especially in light of the ongoing operating challenges posed by the COVID-19 pandemic. We demonstrated solid year-over-year top-line growth during the first six months of 2020. In the second quarter, total revenues were $33.1 million compared to $35.3 million for the second quarter of 2019. While this represents a decrease of 6%, for the first six months of 2020, our total revenues of $66.4 million represented an increase of 7% as compared to the $62.1 million of total revenues generated in the six months of 2019. It should be noted that in response to challenges in market conditions due to the COVID-19 pandemic, we expedited certain sales at the end of the first quarter of this year, thus shifting them away from the second quarter.
Our revenue increase in the first half of 2020 was also driven by 28% year-over-year increase in sales of our distributed products. We expect our distributed products in Israel to continue to be an important driver of our growth prospects. Moreover, longer-term, we anticipate that this segment will improve our overall gross margins.
The company's business activity and commercial operation were affected by certain COVID-19 pandemic-related factors, and the company had taken several actions to ensure its manufacturing plan remains operational, with limited disruption to its business continuity, even with the emergency regulation recently reinforced in Israel due to the pandemic. Moreover, to date, we have not seen any meaningful supply shortages in the US market for GLASSIA or KEDRAB, and we do not anticipate shortages in the foreseeable future. We also have not seen nor do we expect any significant supply shortages for our distributed products in Israel in the foreseeable future.
While the COVID-19-related disruptions had various effects on the company's business activities, commercial operations, revenue and operational expenses, as a result of the actions taken by the company to date, its overall results of operation for the first six months of 2020 and financial position as of June 30, 2020, were not materially affected. Company expects that continued actions will allow meeting its annual revenue guidance. However, a number of COVID-19-related factors may still have an effect on the company's future financial position and results of operations. With that said, we are reiterating our previously provided full-year 2020 revenue guidance of between $132 million and $137 million.
Turning to profitability. For the second quarter of 2020, total gross profit was $11.1 million compared to $13.6 million reported in the second quarter of 2019. Proprietary gross margins in the second quarter of 2020 were 43%, down 3 percentage points as compared to the second quarter of 2019. This decrease is in line with our previous guidance of an annual 3 to 5 percentage point decrease, which is attributable to a change in sale product mix and reduced plant utilization. The different mix is a result of inventory management by our distributors and timing of our product shipments. Similar influence also impacted the Distribution segment profitability this quarter. For the first half of this year, our total gross profit was $22.6 million and gross margins were 34%. This compares to $24.8 million of total gross profit and 40% margins in the first half of 2019.
Operating expenses, including research and development, sales and marketing, G&A, as well as other expenses, totaled $7.1 million in the second quarter of 2020, as compared to $7.2 million in the second quarter of 2019. For the first half of the year, these costs totaled $13.7 million compared to the $13.2 million in the first half of 2019. The COVID-19- related delay in enrollment in the company's pivotal Phase 3 InnovAATe clinical trial resulted in lower-than-expected increase in research and development expenses. As Amir noted, enrollment in this trial has now resumed, and we would expect our operating expenses to increase accordingly over the second half of 2020. Our original guidance for annual research and development expense was for an expected 20% to 25% increase. Given the delays mentioned earlier, we currently expect 15% to 17% increase for full-year 2020 as compared to 2019.
Moving on. Net income was $3.5 million or $0.08 per share in the second quarter of 2020 as compared to net income of $6.1 million or $0.15 per share in the second quarter of 2019. For the six months of 2020, net income was $8.7 million or $0.20 per share as compared to net income of $11.1 million or $0.27 per share in the six months of 2019. During the second quarter and first half of 2020, we continued to generate cash from operating activities, and we maintained a strong balance sheet with a total of $104.7 million of cash, cash equivalents and short-term investments as of June 30, 2020, as compared to $73.9 million at December 31, 2019. Part of the increase is related to the $25 million private placement with the FIMI Opportunity Fund closed earlier this year.
That concludes our prepared remarks. We will now open the call for questions. Operator?
Questions and Answers:
Operator
[Operator Instructions]
The first question is from Raj Denhoy of Jefferies. Please go ahead.
Raj Denhoy -- Jefferies -- Analyst
Hi, good morning. I wonder if maybe I could start with some of the reports during the quarter of the compassionate use of a plasma product from you guys in Israel to treat COVID patients. Anything you can offer anecdotally about the use so far and what you're seeing with the product?
Amir London -- Chief Executive Officer
Hi Raj. Thank you for the question. Thank you for joining the call. There were a few treatments of compassionate use. The procedure in Israel is that this approval for compassionate-use treatment goes between the medical center and the treating physician and the Ministry of Health. So Kamada is not part of this process. We basically made the product available for the medical centers, and they need to apply and get kind of a named patient approval for the treatment. So this is not data that is available to Kamada.
The clinical study, which was started just recently, is sponsored by Kamada. And the data from that study, of course, will be available and will be shared in due time with the public. As we announced earlier this week, we are encouraged by the neutralization data that we have seen in the different assays that we are performing. And we just need to wait now, not too long before we have the data from the clinical study. Important to mention, the clinical study is for the less severe patients, meaning not the ones that got a compassionate use. The compassionate use is given to patients that were severely ill, while the clinical study, as we've just described, is for hospitalized but not ventilated patients.
We believe that that's the right population for this type of treatment. We believe that you need to catch those patients, if I can use the term, while they're highly viral, but before their situation worsens significantly in order for IgG to be effective.
Raj Denhoy -- Jefferies -- Analyst
That's helpful. You also mentioned that you're looking at the product as a preventative -- potential preventative to COVID. Is there anything you can offer in terms of what that looks like? Is that a separate trial entirely? Or how do we think about the timing of that?
Amir London -- Chief Executive Officer
Yeah. So this will be a separate trial. We are now in discussions with the regulators and the KOLs in regards to that study. It's going to be the same product while the dosing might be different. We will be testing different doses in order to rate -- to get to the optimal dose for preventive or prophylactic treatment compared to sick patients. Now there are different approaches to that. You may think about the medical stuff. You may think about patients or people that were -- that are at high-risk and have been exposed to a sick COVID patient like a post-exposure prophylactic. You may think about the elderly population. So there are different opportunities, different populations, which potentially meet this criteria, and we are in advanced discussions with different relevant parties on how to design that study and to what population.
Raj Denhoy -- Jefferies -- Analyst
That's helpful. And then maybe just a couple more. So Kedrion is your partner, you mentioned, obviously, in the United States, collecting plasma for you here. What has been the status of their collection efforts? How successful have they been in actually collecting convalescent plasma? There's been some reports of it being somewhat more difficult perhaps to get supply. So how is Kedrion faring?
Amir London -- Chief Executive Officer
So there's a good progress in the collection. Kedrion has a large network of plasma collection centers in the US. They've put most of those centers -- they are included in the collection effort. This plasma, US plasma, will be supplied to Kamada in order for us to initiate also our US clinical program. So the plasma we are currently using for the Israeli study is plasma that was collected from convalescent patients in Israel. We moved very fast already in March in terms of working here in Israel with the local authorities on defining the path forward, collecting -- working with the Israeli National Blood Bank on the collection. And this allowed us, if you may remember in June, to be the first company globally to announce availability of a plasma-derived COVID IgG and also to be the first globally to initiate a clinical study. So we are very happy with the progress we've been making, and we believe that it's very high potential for a successful treatment for COVID-19 patients.
Raj Denhoy -- Jefferies -- Analyst
That's helpful. Maybe just one last one on the quarter. So the last couple of quarters now, we've seen distributed product sales has been quite strong, crested $10 million this quarter. I think, Chaime, you mentioned it's going to be continued contributor at a higher rate here. So maybe just some background in terms of what's driving that higher revenue from distributed products over the short term? I realize there's other things coming longer term, but I'm more curious about what's been pushing it recently.
Amir London -- Chief Executive Officer
Yes. So over the last few years, we have been expanding our portfolio of distributed products for Israel, and we've been signing quite a lot of new agreements for the Israeli market with different international partners. So some of it is new products that have been registered over the last two years and have been launched into the early market. Some of it is an increase in the plasma-derived product, our legacy products, like IVIG that we've been selling in Israel for many years. There was additional stocking of IVIG product in Israel by the hospitals because of the pandemic. So this also had some contribution to our second quarter sales.
And looking into the future, like you said, we have signed some highly promising, encouraging additional agreements like the one that was signed late last year with Alvotech, and this will be a significant driver to our growth in terms of the biosimilar portfolio. So we are very happy with the progress we are making with distributed products in Israel, and we are very encouraged by the rate it's going, also looking into the future, 2021 and beyond.
Raj Denhoy -- Jefferies -- Analyst
So for the second half of the year, we shouldn't assume it stays above $10 million. There was a little bit of perhaps higher selling -- higher sales this quarter. So maybe it falls back a little bit in the second half, do you think?
Amir London -- Chief Executive Officer
Correct. I think you need to stick to what we [Phonetic] just said, that we are reiterating our full-year projection, and we are on track to meet it. We've been telling investors and analysts in over the years, don't judge us by quarter-by-quarter, but look at our annual projection and annual performance. We've been very good in the last few years giving an annual projection and meeting it and the same applies for this year 2020.
Raj Denhoy -- Jefferies -- Analyst
Great. That's helpful. Thank you.
Operator
The next question is from Keay Nakae of Chardan. Please go ahead.
Keay Nakae -- Chardan -- Analyst
Yes. Thanks for the IgG hyperimmune. What are you measuring for efficacy endpoints in the Phase 1/2 in Israel?
Amir London -- Chief Executive Officer
So currently -- hi Keay, how are you? So currently, it's a Phase 1/2 study, so of course, we are measuring safety, and we are looking also at PK and PD, pharmacokinetics and pharmacodynamics data, but also being an open-label study. Basically, we will have data on each and every patient, and we'll be also looking at a number of hospital days and when the patient has been hopefully recovered and released from the hospital. But the official endpoints, of course, are safety and pharma -- PK and PD.
Keay Nakae -- Chardan -- Analyst
So just trying to extend that to the prophylactic use. Do you have a sense from the regulatory authorities what you'd need to demonstrate in order for it to be used prophylactically?
Amir London -- Chief Executive Officer
Not yet. Like I answered the previous question, prophylactic or post-exposure prophylactic is definitely an area or direction that we're interested in. This is part of the discussion that we are having internally and with the KOLs and with the treating physicians, and we initiated also with authorities in order to have a clear path forward, what will be required in terms of the path forward, the clinical, the medical, the regulatory path forward for potentially approval -- future approval of prophylactic treatment. This PK data, things like that, all of it is in discussions.
Keay Nakae -- Chardan -- Analyst
Are you getting a sense that if you have no safety issues and you can demonstrate some level of antibodies within some, I guess, relatively short period of time, this protection isn't that long-lasting. Would that be sufficient, in your view, at least today, to have something approved for prophylactic use?
Amir London -- Chief Executive Officer
We believe -- and this is very preliminary, what I'm just saying, this is not -- I'm putting a disclaimer now. This has not been fully discussed and definitely approved or agreed with the regulators. But potentially having the ability to compare the PK data, the antibodies level of a prophylactic IgG to an active vaccine that will be approved, this could be a potential one way to look at the product. So definitely, when you're looking at healthy individuals, it has to do some -- it has to do -- it has to be, sorry, some type of PK data, because you're not treating sick patients. So this is one of the ways to look at it. Alternatively, so that could be a very large study that you are treating patients and then you see who gets sick and who doesn't get sick compared to some type of control group. This is another option. But again, it will depend on how the regulators would like to see such a path and a potential future approval.
Keay Nakae -- Chardan -- Analyst
Okay. That's helpful. Maybe switching to the operations side and the gross margin. How much lower should we expect that the gross margins will trend down to?
Amir London -- Chief Executive Officer
So we gave -- Chaime, do you want to help me here? We gave a projection of...?
Chaime Orlev -- Chief Financial Officer
Yeah, we gave a projection that 3 to 5 percentage points drop in gross margins in the proprietary sector as compared to last year. And we still stand behind that guidance.
Amir London -- Chief Executive Officer
And last year, it was 46%.
Keay Nakae -- Chardan -- Analyst
Right. So I guess what I'm asking, is that for this year, what happens as we kind of roll into the first half of next year?
Amir London -- Chief Executive Officer
So we think it's little bit too early now -- [Speech Overlap] yeah, it's a little bit too early now to give an answer to that. We are expecting feedback from Takeda later this year in preparation for 2021 for what's going to be their demand. We mentioned it's going to be between $25 million to $50 million in sales, and it depends on when the transfer of GLASSIA to Takeda will be completed and when they expect to have the FDA approval. This, of course, will have an impact on our 2021 projection, also a potential impact of the COVID-19 IgG. So there are few items, a few things that need to be cleared between now and end of this year before we can give an educated projection for next year.
Keay Nakae -- Chardan -- Analyst
Okay. And then just finally for the rabies product. And just in terms of the overall market for the rabies product, are we seeing any growth there constrained by outdoor activity related to COVID?
Amir London -- Chief Executive Officer
So our sales this year -- our sales are to Kedrion and they sell it in the US market. So in terms of the in-market sales, we believe that during the COVID outbreak, there have been maybe two or three months of potential slowdown of sales due to the, like you said, less outdoor activities, but things are ramping up again now when life in most of the US is returning to normal.
Keay Nakae -- Chardan -- Analyst
Okay. All right. That's all I have. Thank you.
Operator
Next question is from Gaddi Hassan [Phonetic], a private investor. Please go ahead.
Gaddi Hassan -- Private Investor -- Analyst
Hi Amir. I have a question about the trial that you just started. And I believe you have, as you say, you will have data as you are rolling up people, and you will know in a few weeks, what is the result. If the result would be satisfying, do you expect that we can see that you can start the compassionate treatment to get -- to do it with payments, like to -- try to sell this treatment? Also, you don't have any yet an agreement to sell it as the FDA approval or something like that. If you can sell it as a compassionate treatment by payment, before you have -- even begin the phase -- whatever it was intent to do next year to start with the FDA, I don't know it will be -- again, you have to repeat the Phase 1/2 or you have -- maybe you will take this result and continue to Phase 2/3 in the United States?
Amir London -- Chief Executive Officer
Thank you, Gaddi. I'll first answer the latter part of your question, in regard to the US path forward. So as we said, we are going to hold a pre-IND meeting with the FDA this quarter. So all those issues will be raised and will be discussed as part of that process, and then we'll have better clarity and we will announce the plan forward in terms of the needed studies. In terms of your question regarding paid compassionate treatment, so it's a little bit too early right now to give you an answer for that. It's an option, but we will need to wait for the data and to have the discussions with the relevant authorities before we can provide any feedback about it.
Gaddi Hassan -- Private Investor -- Analyst
Okay. Thank you very much.
Operator
This concludes the question-and-answer session. I would like to turn the call back over to Amir London for any closing remarks.
Amir London -- Chief Executive Officer
Thank you very much.
In summary, we are pleased with how our business performed in the first half of 2020, especially as the global COVID-19 pandemic persisted. We have an extremely strong balance sheet and the fundamentals of our business are solid. Our IgG product development program for the treatment of COVID-19 continues to advance very fast. In addition, we continue to drive strategic growth from our core business, including GLASSIA, KEDRAB and our distributed products in Israel. We anticipate that our business development activities will have a meaningful role in our future growth. And I'm also very excited about the potential of our InnovAATe pivotal Phase 3 trial for our unique Inhaled AAT program and are encouraged that enrollment has now been resumed. We remain highly confident in Kamada's long-term outlook for success.
Thank you for joining us on today's call, and we look forward to providing you with further updates on our progress in the coming months. We hope all of you stay healthy and safe. Thank you very much.
Operator
[Operator Closing Remarks]
Duration: 0 minutes
Call participants:
Troy Williams -- Investor Relations, LifeSci Advisors
Amir London -- Chief Executive Officer
Chaime Orlev -- Chief Financial Officer
Raj Denhoy -- Jefferies -- Analyst
Keay Nakae -- Chardan -- Analyst
Gaddi Hassan -- Private Investor -- Analyst
