Avid Bioservices Inc (CDMO) 2017 Q4 法說會逐字稿

Good day, ladies and gentlemen, and welcome to the Peregrine Pharmaceuticals Fourth Quarter and Year-end Fiscal 2017 Financial Results Conference Call. (Operator Instructions) As a reminder, this conference may be recorded.

I would now like to hand the conference over to Tim Brons of Peregrine's Investor Relations Group. Please go ahead.

Thank you. Good afternoon, and thank you for joining us. On today's call, we have: Steve King, President and Chief Executive Officer; Paul Lytle, Chief Financial Officer; and Joe Shan, Vice President of Clinical and Regulatory Affairs.

Today, our team will be providing an overview of the company's operations and progress, spanning Avid Bioservices contract manufacturing business, as well as our research and development programs and corporate activities.

After our prepared remarks, we will welcome your questions.

Before we begin, I'd like to caution that comments made during this conference call today, July 14, 2017, will contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 concerning the current belief of the company, which involves a number of assumptions, risks and uncertainties.

Actual results could differ from these statements, and the company undertakes no obligation to revise or update any statement made today. I encourage you to review all of the company's filings with the Securities and Exchange Commission concerning these and other matters.

With that, I will turn the call over to Steve King.

Thanks, Tim, and thanks to all of you who have dialed in and all of you who are participating via webcast today.

As most of you are aware, Peregrine is a diverse business with the common goal of improving the lives of patients with serious diseases. We do this by manufacturing high-quality pharmaceutical products through our contract manufacturing business, Avid Bioservices, and by advancing cancer therapies and diagnostics led by bavituximab, our novel immunotherapy product, through our research and development company, Peregrine.

We continue to believe there are significant opportunities for both of these businesses, but also recognize they are very distinct businesses with very different roads to success.

I will first discuss recent highlights for the 2 companies and then more about potential plans to ensure the success of both companies.

We are very pleased to announce that Avid Bioservices recorded its highest annual revenues to date during fiscal year 2017, topping $57 million, representing 30% revenue growth over the prior fiscal year. Revenues could have been even higher if not for the need to delay shipment of several already-released lots of material due to the needs of the customer.

While we are pleased at the continued year-over-year revenue growth, we are projecting relatively flat revenues this fiscal year due to recent changes in a large customer's forecast and a delayed regulatory filing for another significant customer. We expect both of these factors to be temporary and remain confident that Avid will continue to achieve growth in the future, as these customers are successful and as we add new customers to diversify our client base.

And on that front, we have recently signed 4 new customers that we expect to contribute significantly to top line revenues in the future. In addition, we successfully completed 3 process validation campaigns for existing third-party customers, which again, we believe can have a significant revenue impact as the customers make regulatory filings and begin to move toward inventory build for potential launch, followed of course, by the potential for commercial supply.

In addition to securing new customers and setting the stage for commercial production, we are continuing to make other important steps to ensure Avid's growth in the coming years. As part of this effort, we have recently installed 2 new 2,000 liter bioreactors in our Myford facility and we have already secured commitments for this capacity. Due to its state-of-the-art modular design, there is the potential to install additional bioreactors in our Myford facility, which will allow us to continue to meet the increasing demands and grow the future business with our current facilities.

Another part of our effort to attract new customers is to expand our service offerings. Our scientists have developed a state-of-the-art antibody discovery and characterization platform through which we can generate antibodies against virtually any target. These capabilities are meant to allow rapid screening for high-affinity antibodies that are developable. These capabilities are a natural extension of the services we already offer through Avid, and it represents an attractive way to bring in customers at a much earlier stage of development, with the potential to move them quickly into process development and cGMP manufacturing.

Switching gears to our R&D activities. While meeting our goal of reducing overall R&D spending by over 50% during fiscal year 2017, we were also able to generate some of the most compelling data to date supporting the combination of bavituximab and checkpoint inhibitors. We are working with some of the best institutions in the world that have been involved in the development of cancer immunotherapies.

Perhaps the most important recent preclinical findings came through original research from our collaborators at Memorial Sloan Kettering Cancer Center or MSKCC. The researchers at MSKCC presented promising preclinical data, combining PS-targeting antibodies with adoptive T-cell transfer therapy, which may support the combination of bavituximab with CAR-T cell immunotherapy in the future.

On the clinical front, we presented data from an analysis of the maturing SUNRISE Phase III clinical trial, showing that patients in the arm that received bavituximab and subsequent immune checkpoint inhibitors lived significantly longer than those on the cohort that received placebo and subsequently went on to immune checkpoint inhibitors.

The data was impressive, has been very well-received by KOLs, and we believe strongly supports advancing bavituximab in combination with immune checkpoint inhibitors such as PD-1 and PDL-1 inhibitors. Joe will talk more about this data shortly.

The data presented AACR by the researchers at MSKCC and Peregrine collectively provide growing validation for the potential bavituximab in combination with immune-stimulating therapies such as those we are exploring in our collaboration with the National Comprehensive Cancer Network, or NCCN, which will evaluate novel bavituximab combinations in glioblastoma, head and neck cancer and hepatocellular carcinoma, including a PD-1 combination. This collaboration is advancing well. And again, Joe will provide more details on the 3 trials during his prepared remarks.

The antibody discovery platform discussed earlier could also be instrumental on the R&D side of the business, allowing us to rapidly identify antibodies against already validated targets, as well as the potential to identify novel targets.

As we think about diversifying our development pipeline to include lower risk, already validated targets, this new capability could help us to identify developable antibodies that could have short-term value as the need for such antibodies is on the rise, and this approach fits very well into our core capabilities and experience in the development of monoclonal antibodies. You can expect to hear more about this new capability over the coming months on both sides of our business.

Lastly, on the R&D side, we are pleased to report that the company continues to make progress with its PS-targeting exosome diagnostic technology that is designed to detect and monitor cancer. Our scientists have successfully optimized the assay, and we are currently preparing to generate additional data, testing the diagnostic with the expanded -- with an expanded set of human samples. Such data will be important to partnering discussions, and we'll keep you posted on progress.

Both Peregrine and Avid have achieved important milestones in recent quarters. We are proud of both businesses and believe each has strong potential. However, we also recognize that they have very different business models and pathways to growth.

As a result, we understand that some of our shareholders have divergent goals for the company's future, depending on if they're more focused on Avid or our R&D business.

So as part of our continuous evaluation of very strategic options that we believe may enhance value for all of our stockholders, we are seriously considering the possibility of separating our 2 distinct businesses. We are still at the early stages of evaluating the strategic opportunity, but are diligently moving forward with the analysis.

I'll now turn the call over to the other members of our team who will give a detailed overview of our clinical, corporate and CDMO activities. We will begin with Joe Shan, Vice President of Clinical and Regulatory Affairs. Joe?

Thanks, Steve. As Steve mentioned just a few moments ago, despite a significant reduction in research and development spending over the past fiscal year, we were able to continue patient treatment and follow-up in the Phase III SUNRISE trial, thus allowing the clinical data to further mature.

At the AACR Annual Meeting in April, we presented the most important and compelling data to date supporting bavituximab's potential to improve the outcome of anti-PD-1 or PDL-1 immune checkpoint inhibitors.

Among a subgroup of 91 patients who were treated with checkpoint inhibitors, subsequent to the assigned SUNRISE treatment, median overall survival was not yet reached for the 45 patients who received bavituximab plus bavituximab -- docetaxel as opposed to bavituximab compared to a median survival of 13 months for the 46 patients who received docetaxel plus placebo, with a hazard ratio of 0.43 and p-value of 0.005. This statistically significant difference in survival provides a strong clinical rationale for combining bavituximab with checkpoint inhibitors.

We are encouraged by the positive response received from investigators and thought leaders regarding this sub-group analysis and exploring ways to advance the program, as resources permit.

In the meantime, as we focus the biomarker analyses on this subgroup of patients, we are seeing some intriguing results and plan to present of our findings at key conferences later in the year.

At ASCO in June, we presented additional supportive data demonstrating that patients in the bavituximab containing arm who had low PDL-1 baseline expression on tumor cells who typically experience poor response to PD-1 or PDL-1 checkpoint inhibitors lived significantly longer than patients with high baseline PDL-1 expression. These data further support the hypothesis that bavituximab may modulate the tumor microenvironment to complement and enhance the antitumor activity of checkpoint inhibitors.

Though the SUNRISE trial database was locked at the end of March of this year, patients who were still receiving bavituximab at that time were transitioned to compassionate use programs and some continue to remain on treatment. We believe bavituximab is active as some patients have been on treatment for as long as up to 2.5 years and has a good safety profile, making it a useful candidate for combining with other therapies, and we remain deeply committed to advancing the drug.

Now let me provide a brief update on our collaboration, starting with the NCCN trials.

At present, 2 of the 3 clinical trials are now open for enrollment. The third trial at the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins is a Phase II study of pembrolizumab and bavituximab for recurrent or metastatic head and neck cancer that has progressed on anti-PD-1 therapy, and this trial is expected to be initiated by the end of the year.

Last but certainly is not least, our collaborators at MSKCC presented a preclinical study at the AACR Annual Meeting, which evaluated and compared the antitumor activity and side effects of adoptive T-cell transfer therapy in combination with either PS-targeting or anti-OX40 antibodies in mice with advanced melanoma.

While PS targeting and anti-OX40 demonstrated comparable tumor regression when administered in combination with adoptive T-cells, only the PS-targeting combination achieved these results without any off-target toxicities. In contrast, the anti-OX40 treatment combination elicited off-target inflammatory side effects.

Toxicities have limited the clinical potential of adoptive T-cell transfer in CAR-T approaches to date. The absence of toxicity with PS-targeting and adoptive T-cell transfer in this initial mouse melanoma experiment may have important future implications for combination strategies in solid tumors.

I'll wrap up by saying how excited we are about these recent clinical and preclinical findings, which really set the stage for combining bavituximab with other immunotherapies, and we look forward to providing updates on our progress over the coming months.

This concludes my comments today, and I'll turn the call over to Paul Lytle, Chief Financial Officer. Paul?

Thanks, Joe. Let me switch gears now to discuss our financial results for the quarter and full fiscal year 2017.

Our overall guidance this past fiscal year focused on increasing revenue from our contract manufacturing business, Avid, while also reducing our spending on research and development as we seek to position the company closer to overall profitability.

During fiscal year 2017, we achieved both a substantial increase in revenue and a significant reduction in R&D expenses.

Let me first talk about top line revenues. Contract manufacturing revenue for the fourth quarter of fiscal year 2017 was $17.9 million and $57.6 million for the full fiscal year, representing 30% year-over-year growth.

And while we missed the low end of our revenue guidance of $60 million, we were ready to shift approximately $10 million in manufacturing revenue at the end of the fiscal year that was unfortunately delayed due to events outside Avid's control. This revenue will now be shifted from fiscal year 2017 into fiscal year 2018.

Regarding our revenue guidance, as Steve mentioned earlier, we currently expect revenue in fiscal year 2018 to remain consistent with fiscal year 2017. As temporary production roles are a common part of the CDMO industry, it emphasizes the need to continually expand and diversify our customer base.

During fiscal year '16 and prior to the Myford facility being built, we had minimal available production slots in our Franklin facility to offer to new customers. And therefore, we had historically limited abilities to diversify our customer base.

As we built and commissioned the state-of-the-art Myford facility in March of 2016, diversifying our customer base was a key focus. We immediately secured 1 new customer that has completed process validation at Myford and we have recently signed project work for 4 new customers, including 1 project that is in late-stage development.

Based on our current book of business, we are providing fiscal year 2018 revenue guidance of between $50 million and $55 million, which is consistent with the revenue projections we made at this time last year. This projection is based on current information and is supported by a current revenue backlog of approximately $58 million under signed contracts, most of which we expect to recognize during fiscal year 2018.

I'll now address our efforts to reduce overall spending on research and development. As we announced last June, our internal drug development strategy has shifted away from large, late-stage clinical trials to small, cost-effective early-stage clinical trials designed to attract potential partners to further advance our products. Our goal in adopting this strategy was to further reduce R&D spending by 50% in fiscal year '17 versus fiscal year '16.

We are pleased to report that our R&D expenses declined 52% over the same prior year period, exceeding our targeted reduction. Although we have generated some of the most promising bavituximab data to date, as Steve and Joe just covered, we are still expecting to further reduce R&D spending by 40% or more in fiscal year '18 unless we can secure additional funding to further advance this program in connection with the -- in connection with exploring the various strategic options, including a possible separation of our 2 distinct businesses.

In summary, the increase in manufacturing revenue, combined with the decrease in R&D spending has translated into a reduction in our net loss by 56% for the quarter and 49% for the full fiscal year 2017 versus the same prior year periods.

Switching gears now. I'd like to provide a quick update on the recently affected reverse stock split.

As I outlined during the Q3 earnings call, Peregrine was committed to taking the necessary steps to preserve its NASDAQ listing. While we executed this reverse stock split last -- as a last resort, we firmly believe that doing so was in the long-term interest of our stockholders. To maintain our continued listing on NASDAQ Capital Market, our minimal closing bid price has to close at or above $1 for 10 consecutive trading days. As of the close today, we are now 5 days into that process, with a minimum closing bid of $1 or higher.

This concludes my financial overview, and I will now open the call up for questions. Belinda?

(Operator Instructions) And our first question comes from the line of Kumar Raja from NOBLE Capital.

So given that revenues are going to be flat comparatively year-over-year, how should we think about expenses, obviously [weighed] if I'm looking at reducing the R&D expenses? And also the cost, obviously, they were a little bit higher. So when do you expect them to be -- go to like a margin, which are comparatively better than what we have been seeing?

Right. So I think that -- a couple of things. Yes, obviously, as revenues fluctuate, we have to watch the costs associated with the both the biomanufacturing business as well as our R&D expenditures. I think, if you look at this year's R&D budget, it is even significantly down from last year. So that, that's obviously going to be further cost savings on the R&D side. Of course, that's kind of counterintuitive, given the fact we have some really exciting data coming out, so I think it's one of the reasons for looking at these strategic alternatives is, really feel like we should be putting more money into R&D, not taking more money out of it, but we also have to deal with financial realities of today. And so we'll make those adjustments as we go along. But our goal is to find a strategic alternative that will allow us to move the R&D, sort of forward, independently of the Avid business. Then on the Avid side, as far as the cost of goods go, I think part of that was bringing onboard the Myford facility. So last year, even though we did obviously some nice business in the facility and it's been busy since day 1, it's still not running at full capacity. When you do the process validations, they're a little bit more cumbersome, a little more complex. So there's more costs associated with those runs. So I think as we get into more full utilization of the facility in kind of campaign mode, where you're running multiple runs of the same product simultaneously, we'll see those costs of goods come down because they simply get spread out over more runs. So I think we'll see. We're constantly looking at the business, adjusting the expenses in order to continue to have a profitable biomanufacturing business and also, to watch our overall corporate finances.

And in terms of making a strategic decision in terms of separating the manufacturing versus the clinical trials business, what are you all thinking in terms of the time line for making such a decision? And what kind of challenges and opportunities do you see there? And I have one more question on the clinical data, which was presented at ASCO. So obviously, you guys have seen that patients who had low PD-1 expression, they are surviving longer. So these patients -- what treatments are they on after like, after moving from bavituximab? Are they on any other treatments? Or are they just continuing on bavituximab?

So I'll let Joe answer that.

So the ASCO [post data you] referred to was an analysis done on a subset of patients selected by, whether or not we had tumor tissue to evaluate the PDL-1, and that ended up being a relatively small percentage of the total number of patients enrolled in the SUNRISE trial. We have not dissected that small number of patients further by what treatment they went on after the SUNRISE trial, so...

Yes. But most of the patients I believe, did receive the subsequent immunotherapy. That was all primarily PD-1 inhibitors, probably all primarily Opdivo, given the timing, as far as that subset. But the rest of the data, as Joe said is -- [can start to get] small numbers.

On the opportunities for the businesses, as far as the kind of the process, I think it is a process. Obviously, there's a lot of considerations that you can imagine, that need to be taken into account as we're looking at different structures that might work and thinking about all those avenues. There's things such as taxes, where we have to think about. There's the overall net operating losses of the company that we want to make sure we get full utilization of. So there's just a lot of complexities. So we don't currently have a particular time line we're marching to. I would say we will diligently move forward the thinking process. And at the appropriate time, we'll update as we get closer and closer to being in a position to have a clear direction.

And Kumar, we're looking at a number of potential opportunities. So it depends on which type of opportunity that we move forward with, will depend -- will basically dictate the time line, so.

And our next question comes from the line of Andrew D'Silva from B. Riley.

Just a couple of quick questions here. I'll start off on the CDMO side of the business. You've talked about committed contracts thus far to date. Do you have a sense at this point as when some of these really higher revenue periods should hit -- should smooth out, maybe relative to last year or be lumpy, like it was last year, in your opinion? Then, what needs to take place for you to get closer to that 40% to 50% gross margin range that was discussed previously?

Yes. Overall, the CDMO business is generally, has lumpy revenue streams because you have a mix of customers, sometimes they're at an earlier stage and they do a few manufacturing runs and then they go away for a while and they come back for their, for the next set of runs. And then you have commercial supply, where it can go up and down depending on the product and the launch and the time lines of your commercial customers. And then, with respect to our particular lumpiness, we've had issues with, even our third-party vendors where we had delays in testing over the last fiscal year that caused some lumpiness in our revenue streams. So our goal is to expand and diversify our customer base. I think the more customers we have in the mix, the less lumpy the revenue streams would be. We also want to make sure we secure good commercial customers that we -- like the ones we have today, that do provide kind of a consistent supply or consistent need for manufacturing. And I think the more diversified you can get and the more commercial you can get, I think the less lumpiness you'll see in future revenues, and that's our, kind of our goal moving forward. And I think you're going to see some lumpiness in terms of fiscal year '18, that -- as our customers submit their BLAs and go through the commercial launch and inventory build, as Steve mentioned earlier, I think you'll see less lumpiness going forward in the fiscal '19 time period.

Okay. But still, a little bit too early for you guys to get a sense of what the quarterly impact might be this year from a seasonality standpoint?

Yes. It's quite complex, in terms of timing and lot release. And as we mentioned in the script, we had $10 million in revenue that was expected to ship by the end of April. And due to unforeseen events that were outside our control, that now has shifted into fiscal '18. So that's a large, lumpy number.

Right, right. Okay, that makes a lot of sense. And then, when we start thinking about R&D, you mentioned that should continue to decline year-over-year. I'm just kind of curious, how does that work, now that you're expected to start a Phase II trial in the back half of this fiscal year?

Yes. So this one, we haven't committed to starting new studies. The only new studies that we've committed to are the NCCN studies, which are, they were all funded under $2 million grants. So at this point, that's the only thing we're really committed to. And I think again, in order to start new studies beyond that, I think it's one of the reasons, again, that we're looking at the strategic alternatives for the company, because I think in order to do that, we need to raise dedicated funding for that. At the same time, we recognize that for the Avid business to continue to grow, we should raise dedicated funding for that business, and in order to add on to our capabilities, to upgrade some of our capabilities and then to add on more capacity at the right time. So I think right now, it's sort of status quo as we move forward on the R&D front. And again, as we're able to, I think really have a clearly defined pathway forward for the R&D business with the appropriate funding, then I know our group already has some plans of what could be the next study designs.

It might be -- the Phase II that you alluded to, that does fall under our NCCN grant, and that was a $2 million grant, some of which was paid last fiscal year and then there's some being paid this fiscal year. But that covers 3 trials being run by this group, by this consortium.

Okay, so there shouldn't be too much of an impact then, as we go through the year unless you guys decide to be more aggressive or are able to get the adequate funds?

Correct.

Okay. And your previous comments kind of give me a good segue into my final question. You talked about potential strategic relationships and you also have -- and I think it's a preclinical collaboration with Sloan Kettering, can you maybe elaborate how that collaboration maybe gets extended into clinical work? And then, how it works when you tie in that strategic partner? Does that all have to be like rehashed out, or are there some covenants in there that make that a simple process?

Yes. So I think that the, one of the goals of the group at Sloan Kettering is to directly translate what they're doing on the preclinical front into clinical studies at the institution. And so they typically only want to work on things that they have that opportunity for. So I think if we think about the possibility of bavi in combination with CAR-T therapy, then we would expect that once they've generated the right amount of data, then we would have a discussion with obviously one of the CAR-T companies about collaborating on moving that forward under the umbrella of the group there at Sloan Kettering. And again, we're working with, probably the top immunology lab when it comes to the development of immune checkpoint inhibitors there, and they have very, very tight clinical connections. Jedd Wolchok obviously, is the head of the lab there, and he's very well connected. So yes, we would expect actually that some doors can open through the collaboration and through the introductions, because we know the clinicians at Sloan Kettering already work with all the major pharma. And so there's already good connections there that can help really, hopefully expedite those into clinical development.

That's interesting. Does it have to be CAR-T or are other immuno-oncology optionalities open as well? Or are you kind of just focused strictly on that vertical right now?

No, they're doing -- that's one of their favorite projects. So they've really been excited about the data, because if you look at the results that were presented, it's really the ability of bavituximab to enhance the activity of the adoptive T-cell therapy versus the lack of any additional toxicity and when they compared it with an agent like OX-40 that actually also increased activity, but also had more safety events, then they really like that approach. But now this could extend to PD-1, PDL-1, probably quite a number of other molecules that there's an interest in. So there's a lot of interest across the board, because I think as the field is maturing and more results are coming out, you're running into 2 things. One is, drugs just don't work well together, either from a safety standpoint or there's no enhanced efficacy, and we're seeing more and more of that reported. And I think there's a real window of opportunity here. In addition, of course, you have patients that are on treatment that develop a resistance to the therapies, and that opens up another door for again, based on our mechanism of action for bavi to potentially reinvigorate the ability of the PD-1/PDL-1 inhibitor. So the Sloan Kettering group, there's quite a number of actual researchers there working on it, each of which are looking at a different aspect. So CAR-T and adoptive T-cell is just simply one of those.

Thank you. And I'm showing no further questions at this time. I'd like to hand the call back over to Mr. Steve King for any closing remarks.

Yes. I'd like to thank you all again for participating in today's phone call. As always, I want to thank you, our stockholders, for your continued support. And I would like to especially thank our patients, their families and the investigators that are participating in our bavituximab clinical trials. With that, we will conclude the call.