Avid Bioservices Inc (CDMO)

[golfho]

My hopes for this coming quarterly C. C.

From the previous C. C.

Revenue for the quarter was $15.3M

Our backlog at the end of Q1 of 2020 was approx. $61M

We are reporting cash & cash equivalents as of July 31, 2019 of $28.9M as compared to $32.4M as of the prior FY ended April 30, 2019.

FROM TRACY KINJERSKI (VP, BUSINESS OPERATIONS)

As we announced in early July, Avid signed 2 new contract mfg. service agreements to support the development of novel drug candidates during Q1. The agreements include the addition of one of the world's leading pharmaceutical companies to Avid's growing list of customers, as well as the expansion of the relationship with one of the company's existing biotechnology customers. The onboarding processes for both of these projects were initiated during Q1 and they are proceeding well. As a reminder, I'd like to restate the importance of winning new business with existing customers. While some of this business results from the expansion of a current project, much of this new business is from completely new projects, requiring development and/or manufacturing of new molecule.

During Q1, Avid also successfully completed a process validation campaign for a scaled-up mfg. process on behalf of an existing customer in anticipation of future commercial manufacturing. This represents our 1st process validation of FY20, followed by the completion of 2 in FY19.

FROM RICK HANCOCK (CEO)

I'd now like to provide a brief update regarding operations at Avid. With respect to our expansion work, we continue to make progress with the process development lab at our Franklin facility. This purpose built state-of-the-art facility will house Avid's expanded upstream & downstream process development capabilities. We remain on track to begin operations in this facility in the fall of calendar 2019. More broadly, we continue the ongoing evaluation of our facilities, equipment, and processes. It is the goal of the organization to optimize where possible, update where necessary, and ensure that we are employing the most effective technologies and processes to ensure our standing as a leading CDMO. As we conduct this review, we are finding areas for improvement. It is always our intent to identify any potential problems before they occur, and to this end, Avid conducts a comprehensive annual maintenance overhaul, during which time, our facilities may be partially or completely shut down. We are currently in the middle of this annual process. Because of the significant amount of work that was done during last year's shutdown, this year will require less downtime. Last year, both facilities were shut down for more than 3 weeks. This year, Franklin was down for less than 2 weeks, and at Myford, we will only have a partial shutdown affecting only the exterior of the building. As a result of our annual maintenance overhaul, we expect anomalies in both revenue and margins during Q2/FY20, but we do not expect this to impact our ability to achieve our stated revenue guidance for the year.

OK…

So what to expect…

Revenue for the quarter subtracted from the backlog of orders should be:
$61M - $15.3M = $45.7M

If we manage to sign new orders worth ~$15M we will have maintained pace with projections.

If we sign new orders in excess of ~$15M, we will be well on our way to sustained profitability.

They implied that production for the second quarter would be impacted by scheduled maintenance for that quarter. There should NOT be any additional unexpected negative impacts to revenue.

With regard to “The agreements include the addition of one of the world's leading pharmaceutical companies” Hopefully this is related to a contract for a biologic that is being produced by the original developer; and the pharmaceutical company is trying to develop a second source. i.e. HALO’s Enhanze being produce by AVID and then COOK (Or who ever they are called now). Implied is that once the regulatory approval is given we will receive prompt orders for delivery. This, to me will be an immediate and continuing impact event.

The “development and/or manufacturing of new molecules”, in my view is a long term effort, taking up to a decade before real productions occurs. Important future revenue sources but very lumpy. i.e. You develop a biologic and test in in the lab and then perhaps some animal testing. If successful a few years later a small PI trial. No need to go on, we’ve all been through this drill.

WRT the three process validations completed. They should start to produce revenue by end of calendar year 2019

In conclusion:

More like my hope is…

1- There will be a significant increase in backlog.

2- There will be an increase in cash & cash equivalents because of deposits made as part of new signed contracts.

3- There will be an increase in projected revenue (Guidance) for FY 2020 from ~$60M - ~$65M to $70M - $75M…

We can only hope…

I wish a BELATED Happy Thanksgiving to all and a happy and healthy holiday season.

Regards
golfho