AI
Tuesday, March 12, 2019 12:35:21 PM
3-11-19 Qtly CC-Transcript, PR(Q3FY19/qe1-31-19), Avid Revs History Table
*Revs Guidance (FY’19 fye 4-30-19): lower half of $51-55M. 1-31-19 Backlog=$43M
*Cash: 1-31-19: $27.8mm
*As of Mar 4, 2019: 56,074,509 shares o/s.
*10Q/1-31-19 iss. 3-11-19: https://tinyurl.com/yxqjs7an
*Avid Total Revs May03-Jan19: $332.1M
*Avid’s website: https://avidbio.com
This large post has 4 sections:
I. 3-11-19 Qtly. Earnings Conf. Call TRANSCRIPT (FY19/Q3 q/e 1-31-19)
II. 3-11-19 CDMO Press Release: Q3/FY19 Earnings & Developments
IV. Updated Table of Avid Revenues By Quarter (May’06-Current)
III. Updated O/S Shares History Table – 2006-curr.
…Recall: Avid’s FY runs May-Apr, so FY’19 = May’18-Apr’19.
((( Orig. transcript from SeekingAlpha.com [http://tinyurl.com/y4c38zx4 ] with numerous corrections made. )))
Link to webcast replay: http://ir.avidbio.com/events-and-presentations => https://edge.media-server.com/m6/p/v8r9ngvy
TRANSCRIPT 3-11-19 FY’19/Q3 Earnings Conf. Call (q/e 1-31-19) (Lias/Hart)
ROGER LIAS (CEO) – OPENING COMMENTS:
Thanks to all of you who’ve dialed in or joined the webcast today. I’m pleased to be able to discuss an extremely productive 3rd quarter, with notable advancements & achievements taking place across the business. From a financial perspective, Q3 was strong, as we beat the consensus estimates on both revenue & earnings/sh. while also increasing backlog. We achieved these results while continuing to manage our cash carefully and maintaining our positive bottom-line trajectory. Dan will provide more details regarding our financial performance in a moment. Operationally, we made numerous positive developments during the quarter as we continued to upgrade our process dev. capabilities, advanced our new business discussions, and completed a process validation campaign in anticipation of future commercial production. In addition, we have expanded scopes of work for multiple existing customer projects, contributing significantly to our revenue & backlog. To support this growth we’ve been successfully hiring the necessary additional talent. And most importantly, we continued to deliver high-quality pharmaceutical products to our clients and their patients. All of this positions us well for growth and achieving profitability, which we believe is now within reach in the coming FY [FY2020: fye 4-30-20]. These developments are a result of the considerable efforts that are being made to transition the business since we announced Avid Bioservices as a dedicated contract dev. & mfg. organization just 14mos. ago. With that summary I will turn the call over to Dan to provide a financial overview.
DANIEL HART (CFO) – OPENING COMMENTS:
Thanks, Roger. Before I begin, I’d like to recommend that everyone participating today refer to our 10-Q filing which we filed today for addl. details. [ https://tinyurl.com/yxqjs7an ] I’ll discuss our financial results from continuing operations for Q3 ended Jan. 31, 2019, starting with revenue. Q3 was a strong one, as we experienced an increase in the number of mfg. runs, both in process and completed in the current period compared to the prior period, primarily due to increased demand from a more diversified client base. As a result, we recognized revenue of $13.8M, an increase of 102% as compared to $6.8M in Q3 of the prior year. For the 9mos. ended 1-31-19, revenues were $36.5M, a 22% decrease as compared to revenues of $46.7M during the prior year period. This decrease was primarily attributed to the previously discussed temporary reduction in demand from our largest customer [Halozyme], which primarily impacted the first 6mos of FY2019 [fye 4-30-19].
Going forward, we expect client concentration to play less of a role in the business, as we diversify our customer base and continue to hire top talent, refine our business practices, systems, and other conditions necessary to operate as a preferred biologics CDMO. As we began our 2nd year as a fully dedicated CDMO, we’re proud to say that we have taken, and we will continue to take, the steps necessary to achieve profitability in the not-too-distant future. In addition, and importantly, during recent discussions with our customer Halozyme, we were informed that they are planned to increase production levels, which we believe will have a positive impact on our revenue and net income in the coming quarters. Roger will further elaborate during his remarks.
Our backlog had strong growth during Q3, growing to $43M, and it is continues to fuel our quarterly revenue goals. We expect to recognize a majority of this balance in FY2020. As a reminder, the company provided revenue guidance for the full FY2019 of $51-55M under the ASC 606 revenue recognition standard. As we approach the end of FY2019, we believe that we will be within the lower half of this range. Gross margins also increased for the 3 & 9mos ended 1-31-19. Gross margin for Q3 was a positive 15%, a significant increase compared to the negative GM of -61% in the prior year period. The increase in gross profit for Q3 was primarily attributed to product mix & volume, therefore resulting in increased cost absorption and decreased idle capacity costs. Idle capacity costs of $1.7M during Q3/FY2019 negatively impacted gross margin by approx. 13%. Gross margins for the 9mos ended 1-31-19 was 10%, a significant increase compared to a negative -2% in the prior year period. Similarly, this increase was primarily attributable to product mix & volume. This was the 3rd qtr in a row where we've seen positive improvement in our gross margins as compared to prior year. As we’ve stated previously, given fixed costs associated with highly regulated biologics mfg. under current Good Mfg. Practices, we expect margins will continue to improve as we increase capacity utilization. To this end, we continued an aggressive effort to both expand our customer base and extend current client projects to increase our backlog and improve overall capacity utilization.
I will now shift to operating expenses. Total SG&A for Q3/FY19 were $3.2M, a 33% decrease compared to the $4.8M in Q3/FY18. For the 9mos of FY19, SG&A expenses were $9.3M, a 24% decrease compared to the $12.3M in the first 9mos of FY18. The decreases for Q3 and the first 9mos of FY19 were primarily due to a reduction in personnel related costs, facility costs, and professional fees, including legal costs during FY2019 as compared to FY2018. For Q3, the company recorded consolidated net loss attributable to common stockholders of $2.6M, or $.05/sh., compared to $12.4M, or $.28/sh. for the same period of prior year. For the 1st 9mos of FY19, the company recorded consolidated net loss attributable to common stockholders of the $8.2M, or $.15/sh., compared to $28.4M, or $.63/sh., for the 1st 9mos of FY18. Cash & cash equivalents as of Jan. 31, 2019 were $27.8M, compared to $42.3M at FY18 ended April 30, 2018. This concludes my financial overview. I will now turn the call back over to Roger to provide a more detailed operational & commercial update.
ROGER LIAS (CEO) – Q3/FY19 OPERATIONAL & COMMERCIAL UPDATE:
Given the continued strength of our biologics CDMO market, and in particular the significant & persistent demand for products derived from mammalian cell culture, as expected our business dev. team remains exceptionally busy. During Q3, we actively participated in numerous industry events & conferences. We continue to see strong demand by the high-quality request for proposals that we are receiving and to work diligently to issue proposals for projects that are good fit for Avid’s technical capabilities and available capacity. It’s important to remember that the receipt of a request for proposal is just the first step in a long & highly complex sales cycle that includes significant technical interactions, quality audits and so on, in addition to commercial & legal negotiations. A period of 12mos from receipt of a request for proposals or execution of agreement is not uncommon, especially when dealing with major biotech and pharma companies that employ significant future planning. We continue to execute a 2-tiered strategy of pursuing both IND enabling early stage projects that contribute relatively quickly to revenue and build a pipeline of future mfg. opportunities as well as maintaining dialogue on later stage and marketed product opportunities. Accordingly, we remain engaged in discussions for multiple opportunities, many of which will require manufacturing in 2020 and beyond. We see positive trends fueling near-term revenue growth. Our Process Dev. Group is increasingly busy generating over 20% of revenue during Q3. As every project must pass through some phase process development, we believe this important business unit will ultimately account for up to 1/3 of our revenue.
In addition to prosecuting new business discussions, we continue to be highly successful in expanding scopes of work for existing customers as their projects progress through development. During Q3, we expanded multiple such projects, representing $23.8M in future revenue. To illustrate the significant contribution that existing customers make to our business growth, it’s worth noting that since the beginning of FY19 [5-1-18], project expansion orders from our current clients have increased by 68%. This increase is in net of the discontinuation of one of our smaller earlier stage projects due to this client’s clinical outcomes and not related to work undertaken at Avid. Such discontinuations are out of our control, but are an unavoidable occurrence in the development stage of CDMO business. Based on work undertaken recently, Avid’s overall client portfolio was significantly stronger and more stable than it was 12mos ago and we believe that our expanding customer base continues to de-risk our business.
I'm pleased to be able to report that contributing to this growth from current clients is an increasing demand from Halozyme Therapeutics, a manufacturer of recombinant human hyaluronidase supporting their Enhanced Technology platform. Halozyme has recently announced that Avid manufactures its products, not only for their current collaboration products, but also for collaboration product candidates currently in development. We believe the strength & forecast was driven by both key Halozyme partner for who Avid is the exclusive supplier, depleting inventory as previously anticipated, and perhaps more importantly, new launches and market growth for that partner’s commercial products and their expanding list of newer partners and partnered projects in development. We anticipate that this trend will continue into FY2020, as Halozyme’s partners advance their clinical dev. programs and begin preparing for commercialization. We certainly maintain an extremely good relationship with Halozyme and we look forward to continuing to support their growing needs. On the topic of commercialization, we’re pleased to report that we’ve recently completed a process validation campaign for a new scaled up mfg. process on behalf of Halozyme in anticipation of future commercial manufacturing. And we are also currently completing process validation campaigns for other clients. As a reminder, these process validation campaigns are required prior to the manufacture, launch, and marketing of commercial biopharmaceutical products and the details all and specifications resulting from the process validation are included as part of our customers’ biologics license applications to the FDA and in other global registry filings. Depending on the timing of such filings and associated regulatory reviews, it may be a significant period before production begins to generate addl. revenue for Avid, depending on the magnitude & duration of pivotal clinical trials and the time necessary for preparation, submission, review, and approval of regulatory applications. Once the process validation is completed, however, that customers is essentially locked into the process developed at Avid for commercial production within our facilities. Subject to completion of pivotal trials, the regulatory approval of these drugs each of these validation campaigns is highly likely therefore to result in future commercial production, significantly expanding Avid’s current business. Given advances with our process development infrastructure and capabilities, new business discussions, expansions of current customer projects and validation campaigns completed in ongoing, we're confident that we're building a robust pipeline that will generate sustainable business growth.
To support anticipated growth we’re continuing to invest in upgrade of our facilities. In particular, we’ve invested in, and continue to invest in, process dev. facilities & equipment, which were in significant need of enhancement in order to best service the new projects that come into Avid. As a reminder, every project that comes into Avid Bioservices, whether it's early development work or transfer of a well-established manufacturing process, must first pass through our process dev. laboratories. Accordingly, these facilities are a critically important part of our business and a key factor in attracting new customers. As we reported last quarter, we’ve completed the upgrade to our first refurbished laboratory in the purification development area; work continues on other laboratories, including a major new upstream dev. laboratory suite to support development of cell culture processes, as well as other refurbishment work within our existing buildings. These new laboratories are being fitted with state-of-the-art equipment and capability enhancements that we expect will introduce considerable efficiencies. While we’re previously expected to take occupancy of the new upstream suite in Q1/Cal2019, our permitting delay will push this date back several months. This delay is solely a timing issue and there are no other factors contributing. Beyond the upgrades to our process development capabilities, we’re evaluating the need to expand mfg. capacity in order to support client needs & market demand. Our assessments are demand driven and based on a number of factors including increasing forecast related to current programs, visibility into the future needs of our current client base, ongoing business development discussions, and a robust pipeline of opportunities. As a more immediate precursor to expansion, we are implementing new operational procedures & systems to allow more efficient utilization of currently installed capacity. We are also planning capital improvement projects within our current facilities that will increase efficiency & throughput and prepare for future capacity build-out.
During Q3, we continued hiring for operational positions in manufacturing, quality, and process development, again in preparation for growth & expansion. Identifying, training, and retaining qualified personnel is critically important to our plans for growth. And we continue to take steps to ensure that prospective qualified employees are favorably aware of the opportunities at the company, both within our geographic location and across a broader biomanufacturing marketplace.
I strongly believe that another important factor in establishing Avid Bioservices as a preferred biologics CDMO is the adoption of new technologies that deliver value to clients by increasing the speed at which we can develop robust, scalable, and economically viable manufacturing processes and by greatly improving manufacturing throughput and facility utilization. Both objectives deliver a corresponding increase in revenue opportunity from installed capacity and differentiate Avid within our competitive marketplace. As a result, we are actively engaged in discussions with multiple vendors and leading industry stakeholders to evaluate possible technology collaborations and service extensions that will position Avid as a high value proposition thought leader and also, in some cases, deliver pipeline of opportunities as a new client capture. Avid was an early adopter of single-use manufacturing technologies, and in our dynamic and fast-moving market it’s imperative that we remain state-of-the-art organization offering cutting edge technology to support the evolving needs of our customers. As I hope is evident, we are rapidly putting into place the myriad components necessary to deliver sustainable growth & profitability. While we would of course like this to happen at a faster pace, it is necessary to understand the cadence of the business and the speed with which we are making transformative changes to the company. We’re progressing incredibly quickly, given the position that we were in just 12mos ago as an excess capacity player with little commercial infrastructure, and given the highly regulated technically challenging and customized work that we do and our long and incredibly complex sales cycles. Given these factors, I believe we made truly remarkable progress in our first year of operation as a dedicated CDMO.
To summarize, in the past 12mos, we have significantly diversified our client base, thus reducing risk and building a pipeline of future mfg. opportunities. We’ve built commercial & operational infrastructure to support growth. We have right-sized the organization, significantly cut costs, and increased capacity utilization resulting improved margins. As a result, we are firmly on track towards profitability and positive EBITDA. Driving these achievements is a truly exceptional team at Avid Bioservices, whose dedication and hard work have contributed to our successes to-date. Together, we continue to execute the plan as we build a sustainably profitable and admired company and firmly established Avid Bioservices as an acknowledged leader in the CDMO sector. This concludes my prepared remarks for today and we can now open the call up for questions.
Q&A: [beg. 18:40]
1. Joe Pantginis - H.C. Wainwright
JP: ”First, since you mentioned this a couple of times during your prepared comments, several quarters ago, you were obviously discussing being in such a hot area for mfg. capacity in the CDMO business. So how is hiring going and the ability to attract the right talent?”
Roger Lias: Yes, I am prepared now to say Joe it’s going well. If you’d have asked me 6mos ago, it was giving me some concern, we had some turnover as we expected in the transition of the business and we were keeping our heads above pretty well but not bringing in the talent at that time that I thought we needed to grow, but that's changed quite dramatically. It’s a tough field in general, not just for Avid. Across biomanufacturing right now, it’s critical and retention, but we’re at the point now where we’re quite comfortable; we’ve got the numbers under control and have a pretty nice plan for hiring to sustain the growth in the next 12mos. So I think right now I'm pretty comfortable.
JP: ”Re: backlog. First very nice to hear about the Halozyme increasing commitment. I was just curious how much of this commitment is in sort of your current backlog that you discussed? And also the particular client that sort of went away due to our negative clinical outcome. What was the impact size of data from a backlog perspective?”
Roger Lias: I don’t know if we’re in a position to give numbers because of client sensitivity. Certainly, the impact from the client that went away was negligible to us; it certainly wasn’t significant - it’s one of our smaller programs. So we’re comfortable with that. With respect to the actual magnitude of the Halozyme, we have both increased forecasts and we have better visibility to their longer-term needs as well. Certainly it’s significant contributor to the backlog, but again we've been working hard to diverse it. While we’re happy to have growth from Halozyme, we’re still looking to decrease the percentage contribution as a total from any individual customer, and we’re being successful in doing that. So it’s meaningful but it’s not half the backlog or anything like that.
2. Paul Knight - Janney
PK: ”Re: the increase in the backlog, part of that was Halozyme or no?”
Roger Lias: Yes part of it was Halozyme. Yes.
PK: ”When do you talk about the process dev. being 20% of revenue, what was that, a year ago?”
Roger Lias: Oh boy, off of, top of my -- probably it was approx. 10% last year.
PK: ”There doesn't seem to be a shortage of MAB mfg. Around. Is it the same in your region, do you believe there is a shortage?”
Roger Lias: Yes, the devil is in the details Paul, but I think overall capacity is certainly still tight. It’s much easier to talk on a macro level, but on a specific client-by-client, project-by-project basis, of course individual timelines scales of capacity, so on and so forth, even geographical location, IP, these will come into play. So I think there was a survey, which was published in April of this year by our Eric Langer [?] and BioPlan Associates where almost exactly 50% of respondents in a large survey listed concerns about capacity availability - that wasn't just monoclonals that was across biospace, but I think that’s about right, I think on a macro level where we as an industry are still relatively balanced compared to where we were a few years back. But on a project-by-project basis, I would suggest that capacity is still tight.
PK: ”And then you talked to about gross margin, I didn't quite catch about. Was there still some impact on GM due to idle capacity in Q3? What was that commentary I didn’t quite catch?”
Daniel Hart: Yes, Paul. We had about $1.7M of idle capacity costs that hit us in Q3. So as we continue to grow, though we're seeing pretty healthy margins on the service side, we have some dilutions in the amount of pass-through costs and material costs that we have are very low margin below 10% that gets added to our overall margin and then further diluted by idle capacity costs. But, as we continue forward and continue to grow the top-line and to fill out the capacity on the floor, those margins will start to increase.
PK: ”Was that $1.7M was a cost?”
Daniel Hart: Yes.
PK: ”You have talked about achieving profitability in FY2020 (fye 4-30-20). I guess when we think about quarterly rollout, are you basically as we get to the end of the year in those quarters you do hope you can get to profitability?”
Daniel Hart: Yes Paul. We're making improvements every day to our business. We'll give more thoughts on the timing of that when we come out with the FY2020 plan.
PK: ”Got it: on the rollout. When you talk about the new technology like single-use, is this a lineup that you believe you're able to offer that others aren't, or you're doing it faster? What's the dynamic around its technology like single-use?”
Roger Lias: I guess it's subset of single-use. We've been doing single-use for some time now, so I'm sure if we would call single-use as a concept new particularly anymore, although we were very early adopters, so we have a lot of experience. It’s individual assets within single-use processing. So, anytime we could, for instance, if there were Fast Flow resins which reduce the resident’s time in our facility so we could process in 5 hours instead of 10 or whatever it might be, that's also a benefit and to the benefit of our clients. So there is a whole host of -- it's not one sort of suite of technologies. There are some interesting concepts out there like continuous processing, which are alot closer to smaller molecules and they are for biologics right now, but that's certainly something we very much involved in discussions about. But it's taking a holistic look at the new technologies that are out there - high density cultures - there is a whole host of them out there, not specifically that are single-use. Are we better positioned than some of our competitors? In some ways we are. We have a lot more flexibility. Of course, the market has become through M&A, some of our competitors are not truly independent, they don’t actually have the ability probably to bring on some of the technologies that we do, because of parent company relationships and so on and so forth. But I don't overstate that, obviously the technology vendors out there are keen to get their technologies deployed in CDMOs as well as in product companies manufacturing their products actively. But I think we do have the ability to move more quickly. And of course we have space available and we're not quite as hampered by sort of some of the systems that are out there as well. It comes back to the same differentiator that we have in general in the marketplace. It’s combination of being agile and able to move quickly alongside the long regulatory track record is really exceptionally unusual. So we will make the most of that.
3. Steve Schwartz - First Analysis
SS: ”I will start off with SG&A expense and the hiring dynamics that are going on. You highlighted that not only you’ve brought people on but you lost a few people. So I think you know if you could net it all out what should we expect with respect to SG&A spending & salaries?”
Roger Lias: On SG&A we’re basically where we need to be; we’re flat. We don't expect any great change to SG&A as I said during the call. The hiring we’re doing is operational, these are revenue-generating people, whether it’s process dev. or quality lab folks releasing product or mfg. operators. So SG&A-wise, we don’t anticipate any great change in the coming 12mos. If it is, it will be based on things like project managers, for instance, as we bring in more projects, but it really should be minimal.
SS: ”Re: the pipeline, how would you parse out the $43M between mfg. and process dev.?”
Roger Lias: An interesting question. I’m not sure we have it right at hand. I mean it’s probably somewhere between currently we're 20% PD and we are aiming toward 33%. So, I'm guessing it will still be 20% or a little bit higher PD as PD grows. But the process dev. contribution for this coming year will probably be greater than 20% and less than 30%, if I were to guess.
SS: ”That's good. That's helpful to walk through.”
Roger Lias: And percentage wise, Steve, it doesn't take much of a change in mfg. to put the percentages out the window anyway.
SS: ”Re: Halozyme, in FY '18, they were about 55% of your revenue stream and certainly the news today that they've come to you for additional dev. work and what have you in manufacturing. That's fantastic news. Where do you think they finish up FY '19 and even in FY '20, where do you think they stand relative to that 55% of FY '18?”
Roger Lias: Yes. I think, probably, they’ll be reduced. Before the nice increase in forecast that we got, I would have given you a lower number, but for the coming FY2020, maybe they'll achieve as much as 40% because of some growth, significant growth, in forecast. But again, over time, we should see, it's not a bad problem to have, but we should see continued reduction in their percentage contribution. But we were happy to take a significant kick up recently.
SS: ”That’s fantastic news on both sides. You mentioned capital spending on some laboratory projects and the one got pushed out, it sounds like into what, Q1/FY20, because of the permitting situation. Can you just guide us for what your CapEx could be over the next couple of quarters given these projects?”
Daniel Hart: Sure, Steve. The CapEx related to the build-out of the PD labs is a little more than 50%. So, I'm going to say it’s substantially spent going into this last quarter here. The delays aren't adding significant costs, it's just a matter of timing. So, I would anticipate that our Q4, I'd call it, about $1 million in CapEx, if not less.
ROGER LIAS (CEO) – CLOSING COMMENTS:
I'd just like to thank everybody for dialing in and joining by webcast. We're certainly looking forward to continuing on our current trajectory and I feel that we've put in a strong quarter. So, we appreciate everybody's support and we look forward to the next earnings call. Thank you.
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3-11-19: Avid Bioservices Reports Financial Results for First Quarter FY2019 Ended Jan. 31, 2019 and Recent Developments
GlobalNewsWire: https://tinyurl.com/y2btdhqf
-- Achieved Revenue of $13.8 Million, an Increase of 102% Compared to Prior Year Quarter
-- Signed Project Expansion Orders with Existing Customers Representing $23.8 Million
-- Completed Process Validation Campaign for Future Commercial Production with Other Validations Ongoing
TUSTIN, March 11, 2019: Avid Bioservices, Inc. (NASDAQ:CDMO/CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced financial results for the third quarter of fiscal year (FY) 2019 ended January 31, 2019, and provided an update on its contract manufacturing operations, and other corporate highlights.
HIGHLIGHTS SINCE OCTOBER 31, 2018
* “The third quarter was busy and productive as reflected by our strong financial results,” said Roger Lias, Ph.D., President and CEO.
* “Our process development group is increasingly busy, now contributing over 20% of revenues. With respect to new projects, we continue to see growth in the number of RFPs received. We are increasingly recognized as an attractive service-provider within the biologics outsourcing market and continue to work diligently to close new business opportunities.
* “Importantly, we continue to successfully expand our scopes of work with existing customers, and during the third quarter, we expanded multiple ongoing projects. Since the beginning of fiscal 2019, project expansion orders from our current clients have increased by 68%, demonstrating the significant contribution that existing customers make to our business.
* “Looking to future growth, we are pleased to report that we have recently completed a process validation campaign for one of our clients and have others ongoing. These validation campaigns precede commercial production. Pending completion of pivotal clinical trials and regulatory approval, each of these validations is highly likely to result in future production in support of product launch.
* “During the past 12 months we have significantly diversified our client base, thus reducing risk and building a pipeline of future manufacturing opportunities. We have built commercial and operational infrastructure to support growth, right-sized the organization, significantly cut costs, and increased capacity utilization resulting in improved margins. As a result, we are firmly on-track towards profitability and positive EBITDA.
* “Driving these achievements is the truly exceptional team at Avid Bioservices whose dedication and hard work have contributed to our successes to-date. Together we continue to execute to-plan as we build a sustainably profitable and admired company and firmly establish Avid Bioservices as an acknowledged leader in the CDMO sector.”
FINANCIAL HIGHLIGHTS AND GUIDANCE
* Contract manufacturing revenue was $13.8 million for the third quarter of FY 2019, an increase of 102% compared to $6.8 million for the third quarter of FY 2018. This increase is primarily due to increased demand from a more diversified client base.
* Revenue backlog grew significantly during the third quarter from existing customers. As of January 31, 2019 revenue backlog was $43 million, the majority of which is expected to be recognized in FY 2020.
* Gross margin for the third quarter was a positive 15%, a significant improvement compared to a gross margin of negative 61% during the prior year period. The increase in gross margin for the quarter was primarily attributed to our product mix and volume.
* Selling, general & administrative expenses for the third quarter of FY 2019 were $3.2 million, a 33% decrease compared to $4.8 million for the third quarter of FY 2018.
* For the third quarter of FY 2019, the company recorded consolidated net loss attributable to common stockholders of $2.6 million, or $.05 per share, compared to a consolidated net loss attributable to common stockholders of $12.4 million, or $.28 per share, for the third quarter of FY 2018.
* Avid reported $27.8 million in cash and cash equivalents as of January 31, 2019, compared to $42.3 million on April 30, 2018.
* The company expects to end the fiscal year within the lower half of its revenue guidance of $51-55 million.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the SEC today. [ https://tinyurl.com/yxqjs7an ]
RECENT DEVELOPMENTS
* Signed project expansion orders during the third quarter with current clients representing future revenue in the amount of $23.8 million.
* Completed a process validation campaign for future commercial production during the third quarter and have other process validations ongoing.
* Process development operations contributed over 20% of revenue during the third quarter.
CONFERENCE CALL
Avid will host a conference call and webcast this afternoon, March 11, 2019, at 4:30PM EDT (1:30PM PDT). To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: http://ir.avidbio.com/events.cfm .
ABOUT AVID BIOSERVICES, INC.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include CGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. http://www.avidbio.com
Forward-Looking *snip*
AVID BIOSERVICES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(in thousands, except share and per share information)
Three Months Ended Nine Months Ended
January 31, January 31,
2019 2018 2019 2018
Contract manufacturing revenue $ 13,781 $ 6,819 $ 36,548 $ 46,678
Cost of contract manufacturing 11,731 10,951 32,972 47,641
Gross profit (loss) 2,050 (4,132 ) 3,576 (963 )
Operating expenses:
Selling, general and administrative 3,242 4,824 9,273 12,273
Restructuring charges — — — 1,258
Total operating expenses 3,242 4,824 9,273 13,531
Operating loss (1,192 ) (8,956 ) (5,697 ) (14,494 )
Interest and other income, net 9 28 190 65
Loss from continuing operations before income taxes $ (1,183 ) $ (8,928 ) $ (5,507 ) $ (14,429 )
Income tax benefit 44 — 217 —
Loss from continuing operations $ (1,139 ) $ (8,928 ) $ (5,290 ) $ (14,429 )
Income (loss) from discontinued operations, net of tax — (2,076 ) 739 (10,404 )
Net loss $ (1,139 ) $ (11,004 ) $ (4,551 ) $ (24,833 )
Comprehensive loss $ (1,139 ) $ (11,004 ) $ (4,551 ) $ (24,833 )
Series E preferred stock accumulated dividends (1,442 ) (1,442 ) (3,604 ) (3,604 )
Net loss attributable to common stockholders $ (2,581) $ (12,446 ) $ (8,155 ) $ (28,437 )
Basic and diluted weighted average
common shares outstanding 56,068,844 45,225,804 55,949,164 45,032,335
Basic and diluted net (loss) income per common share
attributable to common stockholders:
Continuing operations $ (0.05 ) $ (0.23 ) $ (0.16 ) $ (0.40 )
Discontinued operations $ — $ (0.05 ) $ 0.01 $ (0.23 )
Net loss per share attributable to
common stockholders $ (0.05) $ (0.28 ) $ (0.15 ) $ (0.63 )
AVID BIOSERVICES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share information)
January 31, April 30,
2019 2018 Unaudited
ASSETS
Current assets:
Cash and cash equivalents $ 27,758 $ 42,265
Trade and other receivables 7,885 3,754
Contract assets 3,912 —
Inventories 8,660 16,129
Prepaid expenses 567 679
Assets of discontinued operations — 5,000
Total current assets 48,782 67,827
Property and equipment, net 25,876 26,479
Restricted cash 1,150 1,150
Other assets 302 304
Total assets $ 76,110 $ 95,760
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 2,916 $ 1,909
Accrued payroll and related costs 2,549 2,564
Contract liabilities 14,620 27,935
Other current liabilities 638 905
Liabilities of discontinued operations 125 4,550
Total current liabilities 20,848 37,863
Deferred rent, less current portion 2,105 2,159
Capital lease, less current portion 93 —
Commitments and contingencies
Stockholders’ equity:
Preferred stock—$0.001 par value; 5,000,000 shares authorized; 1,647,760
shares issued and outstanding at January 31, 2019 and April 30, 2018,
respectively 2 2
Common stock—$0.001 par value; 150,000,000 shares authorized;
56,072,291 and 55,689,222 shares issued and outstanding at January 31,
2019 and April 30, 2018, respectively 56 55
Additional paid-in capital 613,947 614,810
Accumulated deficit (560,941 ) (559,129 )
Total stockholders’ equity 53,064 55,738
Total liabilities and stockholders’ equity $ 76,110 $ 95,760
CONTACTS:
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
- - - - - - - -
From 10-Q header: “As of Mar 4, 2019, there were 56,074,509 shares outstanding.”
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-18 iss. 7-16-18 https://tinyurl.com/ydc8vew5 PR: https://tinyurl.com/y93fux9h (Cash 4-30-18=$42.3mm)
Latest 10Q 1-31-19 iss. 3-11-19 https://tinyurl.com/yxqjs7an PR: https://tinyurl.com/y2btdhqf (Cash 1-31-19=$27.8mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY19'Q3(qe 1-31-19), per the 10-Q (https://tinyurl.com/y2btdhqf ) issued 3-11-19.
• Total Avid Revs since May’03: $332.1M
• 3-11-19: FY'19 (May'18-Apr'19) Avid revs guidance lower half of $51-55M (committed B/L=$43 at 1-31-19).
• Inventories at 1-31-19 total $8.7M, DOWN from $9.7M at 10-31-18.
Avid’s website: http://www.avidbio.com
- - - - - - - - CDMO’s Fiscal Qtr’s (FY runs May – April):
FY’16-Q1 = q/e 7-31-15 – rep. 9-9-15 Wed (after mkt)
FY’16-Q2 = q/e 10-31-15 – rep. 12-10-15 Thu (after mkt)
FY’16-Q3 = q/e 1-31-16 – rep. 3-9-16 Wed (B4 mkt)
FY’16-Q4 = q/e 4-30-16 – rep. 7-14-16 Thu (after mkt)
FY’17-Q1 = q/e 7-31-16 – rep. 9-8-16 Thu (after mkt)
FY’17-Q2 = q/e 10-31-16 – rep. 12-12-16 Mon (after mkt)
FY’17-Q3 = q/e 1-31-17 – rep. 3-13-17 Mon (after mkt)
FY’17-Q4 = q/e 4-30-17 – rep. 7-14-17 Fri (after mkt)
FY’18-Q1 = q/e 7-31-17 – rep. 9-11-17 Mon (after mkt)
FY’18-Q2 = q/e 10-31-17 – rep. 12-11-17 Mon (after mkt)
FY’18-Q3 = q/e 1-31-18 – rep. 3-12-18 Mon (after mkt)
FY’18-Q4 = q/e 4-30-18 – rep. 7-16-18 Mon (after mkt)
FY’19-Q1 = q/e 7-31-18 – rep. 9-10-18 Mon (after mkt)
FY’19-Q2 = q/e 10-31-18 – rep. 12-10-18 Mon (after mkt)
FY’19-Q3 = q/e 1-31-19 – rep. 3-11-19 Mon (after mkt)
= = = = = = = = = = = =
“Going Concern” stmt. ELIMINATED from 10-K pub. 7-11-13; RE-INSTATED in 10-K pub. 7-14-17…
2012: 4-30-12 10-K iss. 7-16-12 Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations & recurring neg. cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.” http://tinyurl.com/79o57b2
2013 & 2014 & 2015 & 2016 10-K's: http://tinyurl.com/p58jcbw etc...=> (((NO GOING CONCERN STATEMENT INCLUDED.)))
2017 7-14-17: “Going Concern” re-instated in the 4-30-17 10-K (pg.13) http://tinyurl.com/ycxu4l5n
CASH a/o 1-31-14: $63.2mm
CASH a/o 2-15-14: $79.7mm
CASH a/o 4-30-14: $77.5mm
CASH a/o 6-30-14: $78.3mm
CASH a/o 7-31-14: $73.3mm
CASH a/o 10-31-14: $64.4mm
CASH a/o 1-31-15: $55.2mm
CASH a/o 4-30-15: $68.0mm
CASH a/o 7-31-15: $59.0mm
CASH a/o 10-31-15: $72.0mm
CASH a/o 1-31-16: $67.5mm
CASH a/o 4-30-16: $61.4mm
CASH a/o 7-31-16: $44.2mm
CASH a/o 10-31-16: $49.5mm
CASH a/o 1-31-17: $41.5mm
CASH a/o 4-30-17: $46.8mm
CASH a/o 7-31-17: $37.3mm
CASH a/o 10-31-17: $27.7mm
CASH a/o 1-31-18: $17.9mm
CASH a/o 2-28-18: $41.7mm
CASH a/o 4-30-18: $42.3mm
CASH a/o 7-31-18: $37.5mm
CASH a/o 10-31-18: $32.7mm
CASH a/o 1-31-19: $27.8mm
CDMO - O/S Shares History (’06–curr.)
Click here for 4/30/06–12/8/16 Peregrine Pharm. share history: https://tinyurl.com/y76cbyt5
**PPHM shares were 1:5 R/S eff. 10-19-09 (~237mm/$.64=>~47.4mm/$3.20) http://tinyurl.com/ykuw588
**PPHM shares were 1:7 R/S eff. 7-10-17 (315mm/$.606=>45mm/$4.24) http://tinyurl.com/ycohqn6j
1-31-17: 271,068,464 +13,926,930 (1-31-17 10Q iss. 3-13-17)
3-10-17: 297,709,478 +26,641,014 (“ “ “)
4-30-17: 44,014,040(x7)=308,098,280 +10,388,802 (4-30-17 10K iss. 7-14-17)
7-10-17: 45,069,188 +1,055,148 (“ “ “)
7-31-16: 45,094,154 +24,966 (7-31-17 10Q iss. 9-11-17)
8-25-17: 45,096,081 +1,927 (8-25-17 Amended 10K http://tinyurl.com/yb5jq7vc )
9-6-17: 45,096,081 nochg (7-31-17 10Q iss. 9-11-17)
10-31-16: 45,172,632 +76,551 (10-31-17 10Q iss. 12-11-17)
11-27-17: 45,210,608 +37,976 (14A/Proxy iss. 12-7-17 https://tinyurl.com/y7qprpg9 )
12-6-17: 45,212,760 +2,152 (10-31-17 10Q iss. 12-11-17)
1-8-18: 45,253,038 +40,278 (2-8-18 13D https://tinyurl.com/ya43sc3r )
1-31-18: 45,257,180 +4,142 (1-31-18 10Q iss. 3-12-18)
...2-20-18: Avid Raises ~$21.8M net, selling 10,294,445sh.@$2.25 (underwriter: Wells Fargo)
…... 8-K: https://tinyurl.com/ya3nenth 424B5: https://tinyurl.com/ycpshgxl
3-7-18: 55,552,233 +10,295,053 (1-31-18 10Q)
4-30-18: 55,689,222 +133,989 (4-30-18 10K)
7-10-18: 55,793,107 +103,885 (4-30-18 10K)
9-5-18: 56,001,456 +208,349 (7-31-18 10Q)
10-31-18: 56,063,488 +62,032 (10-31-18 10Q)
12-3-18: 56,067,867 +4,379 (10-31-18 10Q)
1-31-19: 56,072,291 +4,424 (1-31-19 10Q)
3-4-19: 56,074,509 +2,218 (1-31-19 10Q)
*Revs Guidance (FY’19 fye 4-30-19): lower half of $51-55M. 1-31-19 Backlog=$43M
*Cash: 1-31-19: $27.8mm
*As of Mar 4, 2019: 56,074,509 shares o/s.
*10Q/1-31-19 iss. 3-11-19: https://tinyurl.com/yxqjs7an
*Avid Total Revs May03-Jan19: $332.1M
*Avid’s website: https://avidbio.com
This large post has 4 sections:
I. 3-11-19 Qtly. Earnings Conf. Call TRANSCRIPT (FY19/Q3 q/e 1-31-19)
II. 3-11-19 CDMO Press Release: Q3/FY19 Earnings & Developments
IV. Updated Table of Avid Revenues By Quarter (May’06-Current)
III. Updated O/S Shares History Table – 2006-curr.
…Recall: Avid’s FY runs May-Apr, so FY’19 = May’18-Apr’19.
((( Orig. transcript from SeekingAlpha.com [http://tinyurl.com/y4c38zx4 ] with numerous corrections made. )))
Link to webcast replay: http://ir.avidbio.com/events-and-presentations => https://edge.media-server.com/m6/p/v8r9ngvy
TRANSCRIPT 3-11-19 FY’19/Q3 Earnings Conf. Call (q/e 1-31-19) (Lias/Hart)
ROGER LIAS (CEO) – OPENING COMMENTS:
Thanks to all of you who’ve dialed in or joined the webcast today. I’m pleased to be able to discuss an extremely productive 3rd quarter, with notable advancements & achievements taking place across the business. From a financial perspective, Q3 was strong, as we beat the consensus estimates on both revenue & earnings/sh. while also increasing backlog. We achieved these results while continuing to manage our cash carefully and maintaining our positive bottom-line trajectory. Dan will provide more details regarding our financial performance in a moment. Operationally, we made numerous positive developments during the quarter as we continued to upgrade our process dev. capabilities, advanced our new business discussions, and completed a process validation campaign in anticipation of future commercial production. In addition, we have expanded scopes of work for multiple existing customer projects, contributing significantly to our revenue & backlog. To support this growth we’ve been successfully hiring the necessary additional talent. And most importantly, we continued to deliver high-quality pharmaceutical products to our clients and their patients. All of this positions us well for growth and achieving profitability, which we believe is now within reach in the coming FY [FY2020: fye 4-30-20]. These developments are a result of the considerable efforts that are being made to transition the business since we announced Avid Bioservices as a dedicated contract dev. & mfg. organization just 14mos. ago. With that summary I will turn the call over to Dan to provide a financial overview.
DANIEL HART (CFO) – OPENING COMMENTS:
Thanks, Roger. Before I begin, I’d like to recommend that everyone participating today refer to our 10-Q filing which we filed today for addl. details. [ https://tinyurl.com/yxqjs7an ] I’ll discuss our financial results from continuing operations for Q3 ended Jan. 31, 2019, starting with revenue. Q3 was a strong one, as we experienced an increase in the number of mfg. runs, both in process and completed in the current period compared to the prior period, primarily due to increased demand from a more diversified client base. As a result, we recognized revenue of $13.8M, an increase of 102% as compared to $6.8M in Q3 of the prior year. For the 9mos. ended 1-31-19, revenues were $36.5M, a 22% decrease as compared to revenues of $46.7M during the prior year period. This decrease was primarily attributed to the previously discussed temporary reduction in demand from our largest customer [Halozyme], which primarily impacted the first 6mos of FY2019 [fye 4-30-19].
Going forward, we expect client concentration to play less of a role in the business, as we diversify our customer base and continue to hire top talent, refine our business practices, systems, and other conditions necessary to operate as a preferred biologics CDMO. As we began our 2nd year as a fully dedicated CDMO, we’re proud to say that we have taken, and we will continue to take, the steps necessary to achieve profitability in the not-too-distant future. In addition, and importantly, during recent discussions with our customer Halozyme, we were informed that they are planned to increase production levels, which we believe will have a positive impact on our revenue and net income in the coming quarters. Roger will further elaborate during his remarks.
Our backlog had strong growth during Q3, growing to $43M, and it is continues to fuel our quarterly revenue goals. We expect to recognize a majority of this balance in FY2020. As a reminder, the company provided revenue guidance for the full FY2019 of $51-55M under the ASC 606 revenue recognition standard. As we approach the end of FY2019, we believe that we will be within the lower half of this range. Gross margins also increased for the 3 & 9mos ended 1-31-19. Gross margin for Q3 was a positive 15%, a significant increase compared to the negative GM of -61% in the prior year period. The increase in gross profit for Q3 was primarily attributed to product mix & volume, therefore resulting in increased cost absorption and decreased idle capacity costs. Idle capacity costs of $1.7M during Q3/FY2019 negatively impacted gross margin by approx. 13%. Gross margins for the 9mos ended 1-31-19 was 10%, a significant increase compared to a negative -2% in the prior year period. Similarly, this increase was primarily attributable to product mix & volume. This was the 3rd qtr in a row where we've seen positive improvement in our gross margins as compared to prior year. As we’ve stated previously, given fixed costs associated with highly regulated biologics mfg. under current Good Mfg. Practices, we expect margins will continue to improve as we increase capacity utilization. To this end, we continued an aggressive effort to both expand our customer base and extend current client projects to increase our backlog and improve overall capacity utilization.
I will now shift to operating expenses. Total SG&A for Q3/FY19 were $3.2M, a 33% decrease compared to the $4.8M in Q3/FY18. For the 9mos of FY19, SG&A expenses were $9.3M, a 24% decrease compared to the $12.3M in the first 9mos of FY18. The decreases for Q3 and the first 9mos of FY19 were primarily due to a reduction in personnel related costs, facility costs, and professional fees, including legal costs during FY2019 as compared to FY2018. For Q3, the company recorded consolidated net loss attributable to common stockholders of $2.6M, or $.05/sh., compared to $12.4M, or $.28/sh. for the same period of prior year. For the 1st 9mos of FY19, the company recorded consolidated net loss attributable to common stockholders of the $8.2M, or $.15/sh., compared to $28.4M, or $.63/sh., for the 1st 9mos of FY18. Cash & cash equivalents as of Jan. 31, 2019 were $27.8M, compared to $42.3M at FY18 ended April 30, 2018. This concludes my financial overview. I will now turn the call back over to Roger to provide a more detailed operational & commercial update.
ROGER LIAS (CEO) – Q3/FY19 OPERATIONAL & COMMERCIAL UPDATE:
Given the continued strength of our biologics CDMO market, and in particular the significant & persistent demand for products derived from mammalian cell culture, as expected our business dev. team remains exceptionally busy. During Q3, we actively participated in numerous industry events & conferences. We continue to see strong demand by the high-quality request for proposals that we are receiving and to work diligently to issue proposals for projects that are good fit for Avid’s technical capabilities and available capacity. It’s important to remember that the receipt of a request for proposal is just the first step in a long & highly complex sales cycle that includes significant technical interactions, quality audits and so on, in addition to commercial & legal negotiations. A period of 12mos from receipt of a request for proposals or execution of agreement is not uncommon, especially when dealing with major biotech and pharma companies that employ significant future planning. We continue to execute a 2-tiered strategy of pursuing both IND enabling early stage projects that contribute relatively quickly to revenue and build a pipeline of future mfg. opportunities as well as maintaining dialogue on later stage and marketed product opportunities. Accordingly, we remain engaged in discussions for multiple opportunities, many of which will require manufacturing in 2020 and beyond. We see positive trends fueling near-term revenue growth. Our Process Dev. Group is increasingly busy generating over 20% of revenue during Q3. As every project must pass through some phase process development, we believe this important business unit will ultimately account for up to 1/3 of our revenue.
In addition to prosecuting new business discussions, we continue to be highly successful in expanding scopes of work for existing customers as their projects progress through development. During Q3, we expanded multiple such projects, representing $23.8M in future revenue. To illustrate the significant contribution that existing customers make to our business growth, it’s worth noting that since the beginning of FY19 [5-1-18], project expansion orders from our current clients have increased by 68%. This increase is in net of the discontinuation of one of our smaller earlier stage projects due to this client’s clinical outcomes and not related to work undertaken at Avid. Such discontinuations are out of our control, but are an unavoidable occurrence in the development stage of CDMO business. Based on work undertaken recently, Avid’s overall client portfolio was significantly stronger and more stable than it was 12mos ago and we believe that our expanding customer base continues to de-risk our business.
I'm pleased to be able to report that contributing to this growth from current clients is an increasing demand from Halozyme Therapeutics, a manufacturer of recombinant human hyaluronidase supporting their Enhanced Technology platform. Halozyme has recently announced that Avid manufactures its products, not only for their current collaboration products, but also for collaboration product candidates currently in development. We believe the strength & forecast was driven by both key Halozyme partner for who Avid is the exclusive supplier, depleting inventory as previously anticipated, and perhaps more importantly, new launches and market growth for that partner’s commercial products and their expanding list of newer partners and partnered projects in development. We anticipate that this trend will continue into FY2020, as Halozyme’s partners advance their clinical dev. programs and begin preparing for commercialization. We certainly maintain an extremely good relationship with Halozyme and we look forward to continuing to support their growing needs. On the topic of commercialization, we’re pleased to report that we’ve recently completed a process validation campaign for a new scaled up mfg. process on behalf of Halozyme in anticipation of future commercial manufacturing. And we are also currently completing process validation campaigns for other clients. As a reminder, these process validation campaigns are required prior to the manufacture, launch, and marketing of commercial biopharmaceutical products and the details all and specifications resulting from the process validation are included as part of our customers’ biologics license applications to the FDA and in other global registry filings. Depending on the timing of such filings and associated regulatory reviews, it may be a significant period before production begins to generate addl. revenue for Avid, depending on the magnitude & duration of pivotal clinical trials and the time necessary for preparation, submission, review, and approval of regulatory applications. Once the process validation is completed, however, that customers is essentially locked into the process developed at Avid for commercial production within our facilities. Subject to completion of pivotal trials, the regulatory approval of these drugs each of these validation campaigns is highly likely therefore to result in future commercial production, significantly expanding Avid’s current business. Given advances with our process development infrastructure and capabilities, new business discussions, expansions of current customer projects and validation campaigns completed in ongoing, we're confident that we're building a robust pipeline that will generate sustainable business growth.
To support anticipated growth we’re continuing to invest in upgrade of our facilities. In particular, we’ve invested in, and continue to invest in, process dev. facilities & equipment, which were in significant need of enhancement in order to best service the new projects that come into Avid. As a reminder, every project that comes into Avid Bioservices, whether it's early development work or transfer of a well-established manufacturing process, must first pass through our process dev. laboratories. Accordingly, these facilities are a critically important part of our business and a key factor in attracting new customers. As we reported last quarter, we’ve completed the upgrade to our first refurbished laboratory in the purification development area; work continues on other laboratories, including a major new upstream dev. laboratory suite to support development of cell culture processes, as well as other refurbishment work within our existing buildings. These new laboratories are being fitted with state-of-the-art equipment and capability enhancements that we expect will introduce considerable efficiencies. While we’re previously expected to take occupancy of the new upstream suite in Q1/Cal2019, our permitting delay will push this date back several months. This delay is solely a timing issue and there are no other factors contributing. Beyond the upgrades to our process development capabilities, we’re evaluating the need to expand mfg. capacity in order to support client needs & market demand. Our assessments are demand driven and based on a number of factors including increasing forecast related to current programs, visibility into the future needs of our current client base, ongoing business development discussions, and a robust pipeline of opportunities. As a more immediate precursor to expansion, we are implementing new operational procedures & systems to allow more efficient utilization of currently installed capacity. We are also planning capital improvement projects within our current facilities that will increase efficiency & throughput and prepare for future capacity build-out.
During Q3, we continued hiring for operational positions in manufacturing, quality, and process development, again in preparation for growth & expansion. Identifying, training, and retaining qualified personnel is critically important to our plans for growth. And we continue to take steps to ensure that prospective qualified employees are favorably aware of the opportunities at the company, both within our geographic location and across a broader biomanufacturing marketplace.
I strongly believe that another important factor in establishing Avid Bioservices as a preferred biologics CDMO is the adoption of new technologies that deliver value to clients by increasing the speed at which we can develop robust, scalable, and economically viable manufacturing processes and by greatly improving manufacturing throughput and facility utilization. Both objectives deliver a corresponding increase in revenue opportunity from installed capacity and differentiate Avid within our competitive marketplace. As a result, we are actively engaged in discussions with multiple vendors and leading industry stakeholders to evaluate possible technology collaborations and service extensions that will position Avid as a high value proposition thought leader and also, in some cases, deliver pipeline of opportunities as a new client capture. Avid was an early adopter of single-use manufacturing technologies, and in our dynamic and fast-moving market it’s imperative that we remain state-of-the-art organization offering cutting edge technology to support the evolving needs of our customers. As I hope is evident, we are rapidly putting into place the myriad components necessary to deliver sustainable growth & profitability. While we would of course like this to happen at a faster pace, it is necessary to understand the cadence of the business and the speed with which we are making transformative changes to the company. We’re progressing incredibly quickly, given the position that we were in just 12mos ago as an excess capacity player with little commercial infrastructure, and given the highly regulated technically challenging and customized work that we do and our long and incredibly complex sales cycles. Given these factors, I believe we made truly remarkable progress in our first year of operation as a dedicated CDMO.
To summarize, in the past 12mos, we have significantly diversified our client base, thus reducing risk and building a pipeline of future mfg. opportunities. We’ve built commercial & operational infrastructure to support growth. We have right-sized the organization, significantly cut costs, and increased capacity utilization resulting improved margins. As a result, we are firmly on track towards profitability and positive EBITDA. Driving these achievements is a truly exceptional team at Avid Bioservices, whose dedication and hard work have contributed to our successes to-date. Together, we continue to execute the plan as we build a sustainably profitable and admired company and firmly established Avid Bioservices as an acknowledged leader in the CDMO sector. This concludes my prepared remarks for today and we can now open the call up for questions.
Q&A: [beg. 18:40]
1. Joe Pantginis - H.C. Wainwright
JP: ”First, since you mentioned this a couple of times during your prepared comments, several quarters ago, you were obviously discussing being in such a hot area for mfg. capacity in the CDMO business. So how is hiring going and the ability to attract the right talent?”
Roger Lias: Yes, I am prepared now to say Joe it’s going well. If you’d have asked me 6mos ago, it was giving me some concern, we had some turnover as we expected in the transition of the business and we were keeping our heads above pretty well but not bringing in the talent at that time that I thought we needed to grow, but that's changed quite dramatically. It’s a tough field in general, not just for Avid. Across biomanufacturing right now, it’s critical and retention, but we’re at the point now where we’re quite comfortable; we’ve got the numbers under control and have a pretty nice plan for hiring to sustain the growth in the next 12mos. So I think right now I'm pretty comfortable.
JP: ”Re: backlog. First very nice to hear about the Halozyme increasing commitment. I was just curious how much of this commitment is in sort of your current backlog that you discussed? And also the particular client that sort of went away due to our negative clinical outcome. What was the impact size of data from a backlog perspective?”
Roger Lias: I don’t know if we’re in a position to give numbers because of client sensitivity. Certainly, the impact from the client that went away was negligible to us; it certainly wasn’t significant - it’s one of our smaller programs. So we’re comfortable with that. With respect to the actual magnitude of the Halozyme, we have both increased forecasts and we have better visibility to their longer-term needs as well. Certainly it’s significant contributor to the backlog, but again we've been working hard to diverse it. While we’re happy to have growth from Halozyme, we’re still looking to decrease the percentage contribution as a total from any individual customer, and we’re being successful in doing that. So it’s meaningful but it’s not half the backlog or anything like that.
2. Paul Knight - Janney
PK: ”Re: the increase in the backlog, part of that was Halozyme or no?”
Roger Lias: Yes part of it was Halozyme. Yes.
PK: ”When do you talk about the process dev. being 20% of revenue, what was that, a year ago?”
Roger Lias: Oh boy, off of, top of my -- probably it was approx. 10% last year.
PK: ”There doesn't seem to be a shortage of MAB mfg. Around. Is it the same in your region, do you believe there is a shortage?”
Roger Lias: Yes, the devil is in the details Paul, but I think overall capacity is certainly still tight. It’s much easier to talk on a macro level, but on a specific client-by-client, project-by-project basis, of course individual timelines scales of capacity, so on and so forth, even geographical location, IP, these will come into play. So I think there was a survey, which was published in April of this year by our Eric Langer [?] and BioPlan Associates where almost exactly 50% of respondents in a large survey listed concerns about capacity availability - that wasn't just monoclonals that was across biospace, but I think that’s about right, I think on a macro level where we as an industry are still relatively balanced compared to where we were a few years back. But on a project-by-project basis, I would suggest that capacity is still tight.
PK: ”And then you talked to about gross margin, I didn't quite catch about. Was there still some impact on GM due to idle capacity in Q3? What was that commentary I didn’t quite catch?”
Daniel Hart: Yes, Paul. We had about $1.7M of idle capacity costs that hit us in Q3. So as we continue to grow, though we're seeing pretty healthy margins on the service side, we have some dilutions in the amount of pass-through costs and material costs that we have are very low margin below 10% that gets added to our overall margin and then further diluted by idle capacity costs. But, as we continue forward and continue to grow the top-line and to fill out the capacity on the floor, those margins will start to increase.
PK: ”Was that $1.7M was a cost?”
Daniel Hart: Yes.
PK: ”You have talked about achieving profitability in FY2020 (fye 4-30-20). I guess when we think about quarterly rollout, are you basically as we get to the end of the year in those quarters you do hope you can get to profitability?”
Daniel Hart: Yes Paul. We're making improvements every day to our business. We'll give more thoughts on the timing of that when we come out with the FY2020 plan.
PK: ”Got it: on the rollout. When you talk about the new technology like single-use, is this a lineup that you believe you're able to offer that others aren't, or you're doing it faster? What's the dynamic around its technology like single-use?”
Roger Lias: I guess it's subset of single-use. We've been doing single-use for some time now, so I'm sure if we would call single-use as a concept new particularly anymore, although we were very early adopters, so we have a lot of experience. It’s individual assets within single-use processing. So, anytime we could, for instance, if there were Fast Flow resins which reduce the resident’s time in our facility so we could process in 5 hours instead of 10 or whatever it might be, that's also a benefit and to the benefit of our clients. So there is a whole host of -- it's not one sort of suite of technologies. There are some interesting concepts out there like continuous processing, which are alot closer to smaller molecules and they are for biologics right now, but that's certainly something we very much involved in discussions about. But it's taking a holistic look at the new technologies that are out there - high density cultures - there is a whole host of them out there, not specifically that are single-use. Are we better positioned than some of our competitors? In some ways we are. We have a lot more flexibility. Of course, the market has become through M&A, some of our competitors are not truly independent, they don’t actually have the ability probably to bring on some of the technologies that we do, because of parent company relationships and so on and so forth. But I don't overstate that, obviously the technology vendors out there are keen to get their technologies deployed in CDMOs as well as in product companies manufacturing their products actively. But I think we do have the ability to move more quickly. And of course we have space available and we're not quite as hampered by sort of some of the systems that are out there as well. It comes back to the same differentiator that we have in general in the marketplace. It’s combination of being agile and able to move quickly alongside the long regulatory track record is really exceptionally unusual. So we will make the most of that.
3. Steve Schwartz - First Analysis
SS: ”I will start off with SG&A expense and the hiring dynamics that are going on. You highlighted that not only you’ve brought people on but you lost a few people. So I think you know if you could net it all out what should we expect with respect to SG&A spending & salaries?”
Roger Lias: On SG&A we’re basically where we need to be; we’re flat. We don't expect any great change to SG&A as I said during the call. The hiring we’re doing is operational, these are revenue-generating people, whether it’s process dev. or quality lab folks releasing product or mfg. operators. So SG&A-wise, we don’t anticipate any great change in the coming 12mos. If it is, it will be based on things like project managers, for instance, as we bring in more projects, but it really should be minimal.
SS: ”Re: the pipeline, how would you parse out the $43M between mfg. and process dev.?”
Roger Lias: An interesting question. I’m not sure we have it right at hand. I mean it’s probably somewhere between currently we're 20% PD and we are aiming toward 33%. So, I'm guessing it will still be 20% or a little bit higher PD as PD grows. But the process dev. contribution for this coming year will probably be greater than 20% and less than 30%, if I were to guess.
SS: ”That's good. That's helpful to walk through.”
Roger Lias: And percentage wise, Steve, it doesn't take much of a change in mfg. to put the percentages out the window anyway.
SS: ”Re: Halozyme, in FY '18, they were about 55% of your revenue stream and certainly the news today that they've come to you for additional dev. work and what have you in manufacturing. That's fantastic news. Where do you think they finish up FY '19 and even in FY '20, where do you think they stand relative to that 55% of FY '18?”
Roger Lias: Yes. I think, probably, they’ll be reduced. Before the nice increase in forecast that we got, I would have given you a lower number, but for the coming FY2020, maybe they'll achieve as much as 40% because of some growth, significant growth, in forecast. But again, over time, we should see, it's not a bad problem to have, but we should see continued reduction in their percentage contribution. But we were happy to take a significant kick up recently.
SS: ”That’s fantastic news on both sides. You mentioned capital spending on some laboratory projects and the one got pushed out, it sounds like into what, Q1/FY20, because of the permitting situation. Can you just guide us for what your CapEx could be over the next couple of quarters given these projects?”
Daniel Hart: Sure, Steve. The CapEx related to the build-out of the PD labs is a little more than 50%. So, I'm going to say it’s substantially spent going into this last quarter here. The delays aren't adding significant costs, it's just a matter of timing. So, I would anticipate that our Q4, I'd call it, about $1 million in CapEx, if not less.
ROGER LIAS (CEO) – CLOSING COMMENTS:
I'd just like to thank everybody for dialing in and joining by webcast. We're certainly looking forward to continuing on our current trajectory and I feel that we've put in a strong quarter. So, we appreciate everybody's support and we look forward to the next earnings call. Thank you.
= = = = = = = = = = = = = = = = = = = = = = = = = = = = = == = = =
3-11-19: Avid Bioservices Reports Financial Results for First Quarter FY2019 Ended Jan. 31, 2019 and Recent Developments
GlobalNewsWire: https://tinyurl.com/y2btdhqf
-- Achieved Revenue of $13.8 Million, an Increase of 102% Compared to Prior Year Quarter
-- Signed Project Expansion Orders with Existing Customers Representing $23.8 Million
-- Completed Process Validation Campaign for Future Commercial Production with Other Validations Ongoing
TUSTIN, March 11, 2019: Avid Bioservices, Inc. (NASDAQ:CDMO/CDMOP), a dedicated biologics contract development and manufacturing organization (CDMO) working to improve patient lives by providing high quality development and manufacturing services to biotechnology and pharmaceutical companies, today announced financial results for the third quarter of fiscal year (FY) 2019 ended January 31, 2019, and provided an update on its contract manufacturing operations, and other corporate highlights.
HIGHLIGHTS SINCE OCTOBER 31, 2018
* “The third quarter was busy and productive as reflected by our strong financial results,” said Roger Lias, Ph.D., President and CEO.
* “Our process development group is increasingly busy, now contributing over 20% of revenues. With respect to new projects, we continue to see growth in the number of RFPs received. We are increasingly recognized as an attractive service-provider within the biologics outsourcing market and continue to work diligently to close new business opportunities.
* “Importantly, we continue to successfully expand our scopes of work with existing customers, and during the third quarter, we expanded multiple ongoing projects. Since the beginning of fiscal 2019, project expansion orders from our current clients have increased by 68%, demonstrating the significant contribution that existing customers make to our business.
* “Looking to future growth, we are pleased to report that we have recently completed a process validation campaign for one of our clients and have others ongoing. These validation campaigns precede commercial production. Pending completion of pivotal clinical trials and regulatory approval, each of these validations is highly likely to result in future production in support of product launch.
* “During the past 12 months we have significantly diversified our client base, thus reducing risk and building a pipeline of future manufacturing opportunities. We have built commercial and operational infrastructure to support growth, right-sized the organization, significantly cut costs, and increased capacity utilization resulting in improved margins. As a result, we are firmly on-track towards profitability and positive EBITDA.
* “Driving these achievements is the truly exceptional team at Avid Bioservices whose dedication and hard work have contributed to our successes to-date. Together we continue to execute to-plan as we build a sustainably profitable and admired company and firmly establish Avid Bioservices as an acknowledged leader in the CDMO sector.”
FINANCIAL HIGHLIGHTS AND GUIDANCE
* Contract manufacturing revenue was $13.8 million for the third quarter of FY 2019, an increase of 102% compared to $6.8 million for the third quarter of FY 2018. This increase is primarily due to increased demand from a more diversified client base.
* Revenue backlog grew significantly during the third quarter from existing customers. As of January 31, 2019 revenue backlog was $43 million, the majority of which is expected to be recognized in FY 2020.
* Gross margin for the third quarter was a positive 15%, a significant improvement compared to a gross margin of negative 61% during the prior year period. The increase in gross margin for the quarter was primarily attributed to our product mix and volume.
* Selling, general & administrative expenses for the third quarter of FY 2019 were $3.2 million, a 33% decrease compared to $4.8 million for the third quarter of FY 2018.
* For the third quarter of FY 2019, the company recorded consolidated net loss attributable to common stockholders of $2.6 million, or $.05 per share, compared to a consolidated net loss attributable to common stockholders of $12.4 million, or $.28 per share, for the third quarter of FY 2018.
* Avid reported $27.8 million in cash and cash equivalents as of January 31, 2019, compared to $42.3 million on April 30, 2018.
* The company expects to end the fiscal year within the lower half of its revenue guidance of $51-55 million.
More detailed financial information and analysis may be found in Avid Bioservices’ Quarterly Report on Form 10-Q, which will be filed with the SEC today. [ https://tinyurl.com/yxqjs7an ]
RECENT DEVELOPMENTS
* Signed project expansion orders during the third quarter with current clients representing future revenue in the amount of $23.8 million.
* Completed a process validation campaign for future commercial production during the third quarter and have other process validations ongoing.
* Process development operations contributed over 20% of revenue during the third quarter.
CONFERENCE CALL
Avid will host a conference call and webcast this afternoon, March 11, 2019, at 4:30PM EDT (1:30PM PDT). To listen to the conference call, please dial (877) 312-5443 or (253) 237-1126 and request the Avid Bioservices conference call. To listen to the live webcast, or access the archived webcast, please visit: http://ir.avidbio.com/events.cfm .
ABOUT AVID BIOSERVICES, INC.
Avid Bioservices is a dedicated contract development and manufacturing organization (CDMO) focused on development and CGMP manufacturing of biopharmaceutical products derived from mammalian cell culture. The company provides a comprehensive range of process development, high quality CGMP clinical and commercial manufacturing services for the biotechnology and biopharmaceutical industries. With 25 years of experience producing monoclonal antibodies and recombinant proteins in batch, fed-batch and perfusion modes, Avid's services include CGMP clinical and commercial product manufacturing, purification, bulk packaging, stability testing and regulatory strategy, submission and support. The company also provides a variety of process development activities, including cell line development and optimization, cell culture and feed optimization, analytical methods development and product characterization. http://www.avidbio.com
Forward-Looking *snip*
AVID BIOSERVICES, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (UNAUDITED)
(in thousands, except share and per share information)
Three Months Ended Nine Months Ended
January 31, January 31,
2019 2018 2019 2018
Contract manufacturing revenue $ 13,781 $ 6,819 $ 36,548 $ 46,678
Cost of contract manufacturing 11,731 10,951 32,972 47,641
Gross profit (loss) 2,050 (4,132 ) 3,576 (963 )
Operating expenses:
Selling, general and administrative 3,242 4,824 9,273 12,273
Restructuring charges — — — 1,258
Total operating expenses 3,242 4,824 9,273 13,531
Operating loss (1,192 ) (8,956 ) (5,697 ) (14,494 )
Interest and other income, net 9 28 190 65
Loss from continuing operations before income taxes $ (1,183 ) $ (8,928 ) $ (5,507 ) $ (14,429 )
Income tax benefit 44 — 217 —
Loss from continuing operations $ (1,139 ) $ (8,928 ) $ (5,290 ) $ (14,429 )
Income (loss) from discontinued operations, net of tax — (2,076 ) 739 (10,404 )
Net loss $ (1,139 ) $ (11,004 ) $ (4,551 ) $ (24,833 )
Comprehensive loss $ (1,139 ) $ (11,004 ) $ (4,551 ) $ (24,833 )
Series E preferred stock accumulated dividends (1,442 ) (1,442 ) (3,604 ) (3,604 )
Net loss attributable to common stockholders $ (2,581) $ (12,446 ) $ (8,155 ) $ (28,437 )
Basic and diluted weighted average
common shares outstanding 56,068,844 45,225,804 55,949,164 45,032,335
Basic and diluted net (loss) income per common share
attributable to common stockholders:
Continuing operations $ (0.05 ) $ (0.23 ) $ (0.16 ) $ (0.40 )
Discontinued operations $ — $ (0.05 ) $ 0.01 $ (0.23 )
Net loss per share attributable to
common stockholders $ (0.05) $ (0.28 ) $ (0.15 ) $ (0.63 )
AVID BIOSERVICES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share information)
January 31, April 30,
2019 2018 Unaudited
ASSETS
Current assets:
Cash and cash equivalents $ 27,758 $ 42,265
Trade and other receivables 7,885 3,754
Contract assets 3,912 —
Inventories 8,660 16,129
Prepaid expenses 567 679
Assets of discontinued operations — 5,000
Total current assets 48,782 67,827
Property and equipment, net 25,876 26,479
Restricted cash 1,150 1,150
Other assets 302 304
Total assets $ 76,110 $ 95,760
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable $ 2,916 $ 1,909
Accrued payroll and related costs 2,549 2,564
Contract liabilities 14,620 27,935
Other current liabilities 638 905
Liabilities of discontinued operations 125 4,550
Total current liabilities 20,848 37,863
Deferred rent, less current portion 2,105 2,159
Capital lease, less current portion 93 —
Commitments and contingencies
Stockholders’ equity:
Preferred stock—$0.001 par value; 5,000,000 shares authorized; 1,647,760
shares issued and outstanding at January 31, 2019 and April 30, 2018,
respectively 2 2
Common stock—$0.001 par value; 150,000,000 shares authorized;
56,072,291 and 55,689,222 shares issued and outstanding at January 31,
2019 and April 30, 2018, respectively 56 55
Additional paid-in capital 613,947 614,810
Accumulated deficit (560,941 ) (559,129 )
Total stockholders’ equity 53,064 55,738
Total liabilities and stockholders’ equity $ 76,110 $ 95,760
CONTACTS:
• Stephanie Diaz (Investors) Vida Strategic Partners 415-675-7401 sdiaz@vidasp.com
• Tim Brons (Media) Vida Strategic Partners 415-675-7402 tbrons@vidasp.com
- - - - - - - -
From 10-Q header: “As of Mar 4, 2019, there were 56,074,509 shares outstanding.”
- - - - - - - - - - - - - - - - -
Latest 10K 4-30-18 iss. 7-16-18 https://tinyurl.com/ydc8vew5 PR: https://tinyurl.com/y93fux9h (Cash 4-30-18=$42.3mm)
Latest 10Q 1-31-19 iss. 3-11-19 https://tinyurl.com/yxqjs7an PR: https://tinyurl.com/y2btdhqf (Cash 1-31-19=$27.8mm)
ALL SEC filings for PPHM: http://tinyurl.com/6d4jw8
= = = = = = = = = = = = = = = = = = = = = = = = = = = =
Updated PPHM REVS-BY-QTR TABLE, now thru FY19'Q3(qe 1-31-19), per the 10-Q (https://tinyurl.com/y2btdhqf ) issued 3-11-19.
• Total Avid Revs since May’03: $332.1M
• 3-11-19: FY'19 (May'18-Apr'19) Avid revs guidance lower half of $51-55M (committed B/L=$43 at 1-31-19).
• Inventories at 1-31-19 total $8.7M, DOWN from $9.7M at 10-31-18.
Avid’s website: http://www.avidbio.com
AVID GROSS PROFITABILITY BY QTR: DEFER CUST
QTR (1000’s) Rev$ COGS$ Prof$ GP% REV$ INVEN$ DEP.
FY13Q1 7-31-12 4,135 2,024 2,111 51% 6,056 5,744 10,224
FY13Q2 10-31-12 6,061 3,703 2,358 39% 6,221 5,426 8,500
FY13Q3 1-31-13 6,961 3,651 3,310 47% 5,061 4,635 6,729
FY13Q4 4-30-13 4,176 3,217 959 23% 4,171 4,339 8,059
FY14Q1 7-31-13 4,581 2,670 1,911 42% 4,164 5,679 8,528
FY14Q2 10-31-13 7,354 4,195 3,159 43% 3,468 4,033 7,658
FY14Q3 1-31-14 3,885 2,416 1,469 38% 4,329 5,224 8,646
FY14Q4 4-30-14 6,474 3,829 2,645 41% 5,241 5,530 5,760
FY15Q1 7-31-14 5,496 3,583 1,913 35% 4,670 5,998 6,226
FY15Q2 10-31-14 6,263 4,139 2,124 34% 3,612 5,379 7,549
FY15Q3 1-31-15 5,677 3,113 2,564 45% 5,752 6,148 8,311
FY15Q4 4-30-15 9,308 4,758 4,550 49% 6,630 7,354 11,363
FY16Q1 7-31-15 9,379 4,608 4,771 51% 8,291 10,457 9,599
FY16Q2 10-31-15 9,523 4,741 4,782 50% 9,688 12,554 14,935
FY16Q3 1-31-16 6,672 3,896 2,776 42% 15,418 15,189 22,433
FY16Q4 4-30-16 18,783 9,721 9,062 48% 15,418 15,189 24,212
FY17Q1 7-31-16 5,609 3,062 2,547 45% 21,531 25,274 21,731
FY17Q2 10-31-16 23,370 15,441 7,929 34% 17,980 25,924 26,928
FY17Q3 1-31-17 10,747 7,974 2,773 26% 26,367 33,829 26,210
FY17Q4 4-30-17 17,904 11,782 6,122 34% 28,500 33,099 17,017
FY18Q1 7-31-17 27,077 20,448 6,629 24% 13,433 24,235 14,322
FY18Q2 10-31-17 12,782 16,242 -3,460 -27% 7,473 16,518 13,138
FY18Q3 1-31-18 6,819 10,951 -4,132 -61% 6,633 14,218 17,602
FY18Q4 4-30-18 6,943 8,904 -1,961 -28% 10,922 16,129 17,013
FY19Q1 7-31-18 12,589 11,397 1,192 9% --,--- 9,168 --,---*
FY19Q2 10-31-18 10,178 9,844 334 3% --,--- 9,736 --,---*
FY19Q3 1-31-19 13,781 11,731 2050 15% --,--- 8,660 --,---*
*7-31-18 10Q: “prior-yr amts related to deferred revenue
& cust deposits have been reclass’d to contract liabilities.”
...q/e 4-30-18: contract-liabilities=27,935 <=reclassified
...a/o 7-31-18: contract-liabilities=17,994
...a/o 10-31-18: contract-liabilities=17,307
...a/o 1-31-19: contract-liabilities=14,620
FY13 TOTAL: 21,333 12,595 8,738 41%*
FY14 TOTAL: 22,294 13,110 9,184 41%*
FY15 TOTAL: 26,744 15,393 11,151 42%*
FY16 TOTAL: 44,357 22,966 21,391 48%*
FY17 TOTAL: 57,630 38,259 19,371 34%*
FY18 TOTAL: 53,621 56,545 -2,924 -5%*
*Avid Net-Profit(Selling/G&A) not split out from PPHM-Corp. in the fin’s.
AVID TOTAL REV’s BY YEAR):
FY04 4-30-04 3,039 (Avid-Revs didn’t incl. Avid’s Gov’t work)
FY05 4-30-05 4,684
FY06 4-30-06 3,005
FY07 4-30-07 3,492
FY08 4-30-08 5,897
FY09 4-30-09 12,963
FY10 4-30-10 13,204
FY11 4-30-11 8,502
FY12 4-30-12 14,783
FY13 4-30-13 21,333
FY14 4-30-14 22,294
FY15 4-30-15 26,744
FY16 4-30-16 44,357
FY17 4-30-17 57,630
FY18 4-30-18 53,621
FY19 1-31-19 36,548 <=YTD/9mos.
**TOTAL: 332,096 (5/1/2003–1/31/19)
.
QTLY. NET PROFIT/LOSS BY QTR:
(“attributable to common stockholders”; ie, incl. PREF Div’s**)
**2-11-14: PPHM Raises $16.2M, 700k Pref. Shares w/10.5% DIV.
FY16Q1 7-31-15 -15,101,000
FY16Q2 10-31-15 -14,578,000
FY16Q3 1-31-16 -18,227,000
FY16Q4 4-30-16 -13,264,000
FY17Q1 7-31-16 -12,437,000
FY17Q2 10-31-16 -4,498,000
FY17Q3 1-31-17 -9,216,000
FY17Q4 4-30-17 -6,714,000
FY18Q1 7-31-17 -2,647,000
FY18Q2 10-31-17 -14,066,000
FY18Q3 1-31-18 -12,446,000
FY18Q4 4-30-18 +1,578,000 <=includes $9,154,000 income from disc. operations.
FY19Q1 7-31-18 -3,403,000
FY19Q2 10-31-18 -2,893,000
FY19Q3 1-31-19 -2,581,000
Period Halozyme Coherus-BioSci. Other-Custs
FYE 4-30-14 91% 8%
FYE 4-30-15 79% 9%
FYE 4-30-16 69% 26% 5%
FYE 4-30-17 58% 26% 16%
FYE 4-30-18 55% 22% 23%
...(cust. Splits not given in 7-31-18+ 10Q’s)
- - - - - - - - CDMO’s Fiscal Qtr’s (FY runs May – April):
FY’16-Q1 = q/e 7-31-15 – rep. 9-9-15 Wed (after mkt)
FY’16-Q2 = q/e 10-31-15 – rep. 12-10-15 Thu (after mkt)
FY’16-Q3 = q/e 1-31-16 – rep. 3-9-16 Wed (B4 mkt)
FY’16-Q4 = q/e 4-30-16 – rep. 7-14-16 Thu (after mkt)
FY’17-Q1 = q/e 7-31-16 – rep. 9-8-16 Thu (after mkt)
FY’17-Q2 = q/e 10-31-16 – rep. 12-12-16 Mon (after mkt)
FY’17-Q3 = q/e 1-31-17 – rep. 3-13-17 Mon (after mkt)
FY’17-Q4 = q/e 4-30-17 – rep. 7-14-17 Fri (after mkt)
FY’18-Q1 = q/e 7-31-17 – rep. 9-11-17 Mon (after mkt)
FY’18-Q2 = q/e 10-31-17 – rep. 12-11-17 Mon (after mkt)
FY’18-Q3 = q/e 1-31-18 – rep. 3-12-18 Mon (after mkt)
FY’18-Q4 = q/e 4-30-18 – rep. 7-16-18 Mon (after mkt)
FY’19-Q1 = q/e 7-31-18 – rep. 9-10-18 Mon (after mkt)
FY’19-Q2 = q/e 10-31-18 – rep. 12-10-18 Mon (after mkt)
FY’19-Q3 = q/e 1-31-19 – rep. 3-11-19 Mon (after mkt)
= = = = = = = = = = = =
“Going Concern” stmt. ELIMINATED from 10-K pub. 7-11-13; RE-INSTATED in 10-K pub. 7-14-17…
2012: 4-30-12 10-K iss. 7-16-12 Pg.68: “As more fully described in Note 2, the Company’s recurring losses from operations & recurring neg. cash flows from operating activities raise substantial doubt about its ability to continue as a going concern.” http://tinyurl.com/79o57b2
2013 & 2014 & 2015 & 2016 10-K's: http://tinyurl.com/p58jcbw etc...=> (((NO GOING CONCERN STATEMENT INCLUDED.)))
2017 7-14-17: “Going Concern” re-instated in the 4-30-17 10-K (pg.13) http://tinyurl.com/ycxu4l5n
CASH a/o 1-31-14: $63.2mm
CASH a/o 2-15-14: $79.7mm
CASH a/o 4-30-14: $77.5mm
CASH a/o 6-30-14: $78.3mm
CASH a/o 7-31-14: $73.3mm
CASH a/o 10-31-14: $64.4mm
CASH a/o 1-31-15: $55.2mm
CASH a/o 4-30-15: $68.0mm
CASH a/o 7-31-15: $59.0mm
CASH a/o 10-31-15: $72.0mm
CASH a/o 1-31-16: $67.5mm
CASH a/o 4-30-16: $61.4mm
CASH a/o 7-31-16: $44.2mm
CASH a/o 10-31-16: $49.5mm
CASH a/o 1-31-17: $41.5mm
CASH a/o 4-30-17: $46.8mm
CASH a/o 7-31-17: $37.3mm
CASH a/o 10-31-17: $27.7mm
CASH a/o 1-31-18: $17.9mm
CASH a/o 2-28-18: $41.7mm
CASH a/o 4-30-18: $42.3mm
CASH a/o 7-31-18: $37.5mm
CASH a/o 10-31-18: $32.7mm
CASH a/o 1-31-19: $27.8mm
CDMO - O/S Shares History (’06–curr.)
Click here for 4/30/06–12/8/16 Peregrine Pharm. share history: https://tinyurl.com/y76cbyt5
**PPHM shares were 1:5 R/S eff. 10-19-09 (~237mm/$.64=>~47.4mm/$3.20) http://tinyurl.com/ykuw588
**PPHM shares were 1:7 R/S eff. 7-10-17 (315mm/$.606=>45mm/$4.24) http://tinyurl.com/ycohqn6j
1-31-17: 271,068,464 +13,926,930 (1-31-17 10Q iss. 3-13-17)
3-10-17: 297,709,478 +26,641,014 (“ “ “)
4-30-17: 44,014,040(x7)=308,098,280 +10,388,802 (4-30-17 10K iss. 7-14-17)
7-10-17: 45,069,188 +1,055,148 (“ “ “)
7-31-16: 45,094,154 +24,966 (7-31-17 10Q iss. 9-11-17)
8-25-17: 45,096,081 +1,927 (8-25-17 Amended 10K http://tinyurl.com/yb5jq7vc )
9-6-17: 45,096,081 nochg (7-31-17 10Q iss. 9-11-17)
10-31-16: 45,172,632 +76,551 (10-31-17 10Q iss. 12-11-17)
11-27-17: 45,210,608 +37,976 (14A/Proxy iss. 12-7-17 https://tinyurl.com/y7qprpg9 )
12-6-17: 45,212,760 +2,152 (10-31-17 10Q iss. 12-11-17)
1-8-18: 45,253,038 +40,278 (2-8-18 13D https://tinyurl.com/ya43sc3r )
1-31-18: 45,257,180 +4,142 (1-31-18 10Q iss. 3-12-18)
...2-20-18: Avid Raises ~$21.8M net, selling 10,294,445sh.@$2.25 (underwriter: Wells Fargo)
…... 8-K: https://tinyurl.com/ya3nenth 424B5: https://tinyurl.com/ycpshgxl
3-7-18: 55,552,233 +10,295,053 (1-31-18 10Q)
4-30-18: 55,689,222 +133,989 (4-30-18 10K)
7-10-18: 55,793,107 +103,885 (4-30-18 10K)
9-5-18: 56,001,456 +208,349 (7-31-18 10Q)
10-31-18: 56,063,488 +62,032 (10-31-18 10Q)
12-3-18: 56,067,867 +4,379 (10-31-18 10Q)
1-31-19: 56,072,291 +4,424 (1-31-19 10Q)
3-4-19: 56,074,509 +2,218 (1-31-19 10Q)
